chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: heart palpitations; clouded ears; ringing in the ears; swollen feet; brain fog; weight gain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 1, single (Lot number: 33036BD) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Feb2022, outcome "not recovered", described as "brain fog"; INNER EAR DISORDER (non-serious) with onset 17Feb2022, outcome "not recovered", described as "clouded ears"; PALPITATIONS (non-serious) with onset 17Feb2022, outcome "not recovered", described as "heart palpitations"; TINNITUS (non-serious) with onset 17Feb2022, outcome "not recovered", described as "ringing in the ears"; PERIPHERAL SWELLING (non-serious) with onset 17Feb2022, outcome "not recovered", described as "swollen feet"; WEIGHT INCREASED (non-serious) with onset 17Feb2022, outcome "not recovered", described as "weight gain". The events "heart palpitations", "clouded ears", "ringing in the ears", "swollen feet", "brain fog" and "weight gain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, inner ear disorder, tinnitus, peripheral swelling, feeling abnormal, weight increased.  Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient received the first dose on 16Feb2022 and second dose on 16Mar2022 but after both doses she experienced clouded ears, ringing in the ears, heart palpitations, swollen feet, brain fog and weight gain. Still till this day in Sep2022 experiencing clouded ears where its hard for her to hear at times and periodically heart palpitations, brain fog, and increase weight gain. The events required Doctor or other healthcare professional office/clinic visit. The patient had covid prior vaccination. The patient was not covid tested post vaccination. The patient had no/none known allergies and no other medical history.   No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo/ 2 dose was not quite as bad but still not good 14 days later; This is a spontaneous report received from a contactable reporter The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Lot number: EW0173), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE; MULTIVIT [VITAMINS NOS]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER8731; Anatomical Location: Left arm), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Vertigo". The following information was reported: VERTIGO (non-serious) with onset 21May2021, outcome "recovered", described as "Vertigo/ 2 dose was not quite as bad but still not good 14 days later". The event "vertigo/ 2 dose was not quite as bad but still not good 14 days later" required physician office visit. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient experienced vertigo with all the three doses and afraid to get second booster. The patient had no covid-19 prior to vaccination. Patient had no known allergies.
Age: 21.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: patient felt faint 5 min after injections, blackedout for approx 10 sec then came to as if nothing happened
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Administration issue Used Baksnap syringe 23g 1.5 ml, safety not depressed in pt arm, small portion (est 0.02 to 0.04 ml) remained in syringe.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Diarrhoea, Influenza like illness, Nausea, Pain
Clinical narrative: Patient received Flucelvax vaccine yesterday at 12pm. Patient called this morning at 930am describing feeling achy and having flu like symptoms that began earlier this morning. At 1230pm today her husband called and indicated that they went to the walk in clinic because she began experiencing abdominal pain, N/V, and diarrhea. The walk in clinic recommended that she go to the ER. Awaiting further details
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Patient received Flucelvax vaccine yesterday at 12pm. Patient called this morning at 930am describing feeling achy and having flu like symptoms that began earlier this morning. At 1230pm today her husband called and indicated that they went to the walk in clinic because she began experiencing abdominal pain, N/V, and diarrhea. The walk in clinic recommended that she go to the ER. Awaiting further details
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphthous ulcer
Clinical narrative: canker sore which lasted for only 2 hours
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given Pfizer covid 19 vaccine Age 5-11 by a LPN who is supervised by me.  The nurse is allowed to give the vaccine without my presence.  The patient was given the vaccine on 09/09/2022. The vaccine was expired on 08/31/2022.  The parent was notified of the event on 09/16/2022.
Sex: M
Vaccine: COVID19-2
Symptoms: Contusion
Clinical narrative: patient reported bruising on left auxilia. Patient states no discomfort but states he did not have this bruising before getting the vaccine. Patient will monitor for any sign of pain or swelling and will contact pharmacy and doctor on Monday if any further symptom occur.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash, Skin warm
Clinical narrative: pain after injection. rash, warm to touch
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Approximately 24 hours after the vaccine was injected, the patient had a red rash around the injection site. This red rash was warm to the touch, and felt hard as well. The rash continued to grow until it was approximately 2.25 inches from the injection site, approximately 48 hours after the procedure.  Doctor visit has so far resulted in treating it as an allergic reaction to the flu vaccine.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous
Clinical narrative: Approximately 24 hours after the vaccine was injected, the patient had a red rash around the injection site. This red rash was warm to the touch, and felt hard as well. The rash continued to grow until it was approximately 2.25 inches from the injection site, approximately 48 hours after the procedure.  Doctor visit has so far resulted in treating it as an allergic reaction to the flu vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Pain in extremity, Pustule, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Got vaccinations Thursday night. No side effects, save a sore arm the following day. Woke up Saturday morning with a terrible rash. Very prominent on my face, secondarily on my neck and inner arms, plus a few isolated spots on my forearms, torso, and legs. Rash is made up of itchy, raised, red bumps with a few spots developing into blister-like pustules filled with clear fluid.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Rash vesicular
Clinical narrative: Got vaccinations Thursday night. No side effects, save a sore arm the following day. Woke up Saturday morning with a terrible rash. Very prominent on my face, secondarily on my neck and inner arms, plus a few isolated spots on my forearms, torso, and legs. Rash is made up of itchy, raised, red bumps with a few spots developing into blister-like pustules filled with clear fluid.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Blister, Erythema, Eyelid rash, Off label use, Oral mucosal eruption
Clinical narrative: Got vaccinations Thursday night. No side effects, save a sore arm the following day. Woke up Saturday morning with a terrible rash. Very prominent on my face, secondarily on my neck and inner arms, plus a few isolated spots on my forearms, torso, and legs. Rash is made up of itchy, raised, red bumps with a few spots developing into blister-like pustules filled with clear fluid.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLUC4, COVID19-2, FLUC4
Symptoms: Pain in extremity, Product use issue, Pruritus, Rash
Clinical narrative: Got vaccinations Thursday night. No side effects, save a sore arm the following day. Woke up Saturday morning with a terrible rash. Very prominent on my face, secondarily on my neck and inner arms, plus a few isolated spots on my forearms, torso, and legs. Rash is made up of itchy, raised, red bumps with a few spots developing into blister-like pustules filled with clear fluid.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site nodule, Joint swelling, Muscle spasms, Pain
Clinical narrative: Severe joint pain and swelling in the arm/shoulder - continuing even 3 months now. Knot still present at the injection site. Muscle spasms in the deltoid area where the injection was provided and radiate pain and spasms up to the neck and down through the hands. Color in the hand is  darker than other hand. Circulation is decreased in the hand on the side that the shot was given.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor peripheral circulation, Skin discolouration
Clinical narrative: Severe joint pain and swelling in the arm/shoulder - continuing even 3 months now. Knot still present at the injection site. Muscle spasms in the deltoid area where the injection was provided and radiate pain and spasms up to the neck and down through the hands. Color in the hand is  darker than other hand. Circulation is decreased in the hand on the side that the shot was given.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient experienced syncope a few minutes after flu shot administered. Was sitting in chair, head slumped forward, called her name, and tapped her shoulder and she regained consciousness.  Had patient lay flat, cool damp cloth applied. She felt better and was observed with no further issues.
Age: 1.0
Sex: F
Vaccine: COVID19, FLUA4, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Right thigh cellulitis noted on 9/17/22
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came back to pharmacy next day after shot complaining of sore arm, arm swelling, and redness around injection site. Patient has been using ibuprofen and cold compresses to help.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Started to experience dermatographia about two weeks after the vaccine. Started to take Zyrtec daily to avoid near constant itching. Still experiencing today 9/17/22 but can stretch Zyrtec doses to every 2-3 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal disorder
Clinical narrative: Constant Desire to dig up nose
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna bivalent, patient is under 18 years of age.
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema
Clinical narrative: THE DAY AFTER RECEIVING THE FLU AND COVID VACCINES THE PATIENT REPORTED REDNESS AND BRUISING BELOW AREA WHERE FLU VACCINE WAS ADMINISTERED. PATIENT CONTACTED PRIMARYY CARE PHYSICIAN WHO INSTRUCTED PATIENT TO GO TO ER. PATIENT WAS DIAGNOSED WITH CELLULITIS AND RECEIVED ANTIBIOTICS FOR TREATMENT.
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: The vaccinator used a 5/8" needle to vaccinate the patient in their left anterolateral thigh.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: The vaccinator vaccinated the patient in the left anterolateral thigh using a 5/8" needle.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: The vaccinator administered the COVID-19 vaccine in the left vastus lateralis using a 5/8" needle.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo/Booster was about 20 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 as dose 3 (booster), single (Lot number: Fl3209), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: ER8731, Anatomical location: Arm Left), administration date: 14Apr2021, for Covid-19 immunisation, reaction(s): "vertigo"; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0173, Anatomical location: Arm Left), administration date: 07May2021, for Covid-19 immunisation, reaction(s): "Vertigo". The following information was reported: VERTIGO (non-serious) with onset 2022, outcome "recovered", described as "Vertigo/Booster was about 20 days later". The event "vertigo/booster was about 20 days later" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient experienced vertigo with all the three doses and afraid to get second booster. The patient did not have any other vaccines in four weeks. The patient had no covid-19 prior to vaccination. The patient was tested negative for Covid-19 post vaccination. The patient had no known allergies and other medical history. Other medications in two weeks included Multi vitamins.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201157238 Same patient/Vaccine/event, different dose;US-PFIZER INC-202201157337 Same patient/Vaccine/event, different dose;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 12Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history, no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Sep2022) Positive; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid to treat COVID 19, treatment start date: 01Sep2022, treatment stop date: 06Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Weight, Weight increased
Clinical narrative: heart palpitations/periodically heart palpitations; clouded ears; ringing in the ears; swollen feet; brain fog; weight gain; its hard for me to hear at times; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2022 as dose 2, 0.3 ml single (Lot number: FK9894) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 33036BD, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2022, when the patient was 39-year-old, for Covid-19 Immunization, reaction(s): "heart palpitations"; BNT162b2 (Dose Number: 1, Batch/Lot No: 33036BD, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2022, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "clouded ears", "ringing in the ears", "swollen feet", "brain fog", "weight gain".  The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "heart palpitations/periodically heart palpitations"; INNER EAR DISORDER (non-serious), outcome "not recovered", described as "clouded ears"; TINNITUS (non-serious), outcome "not recovered", described as "ringing in the ears"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "swollen feet"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "brain fog"; WEIGHT INCREASED (non-serious), outcome "not recovered", described as "weight gain"; HYPOACUSIS (non-serious), outcome "not recovered", described as "its hard for me to hear at times". The events "heart palpitations/periodically heart palpitations", "clouded ears", "ringing in the ears", "swollen feet", "brain fog", "weight gain" and "its hard for me to hear at times" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, inner ear disorder, tinnitus, peripheral swelling, feeling abnormal, weight increased, hypoacusis.  Clinical information: Patient reported that, I received the first dose on 16Feb2022 and second dose on 16Mar2022 but after both doses I experienced clouded ears, ringing in the ears, heart palpitations, swollen feet, brain fog and weight gain. Still til this day in Sep2022 experiencing clouded ears where its hard for me to hear at times and periodically heart palpitations, brain fog, and increase weight gain. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient did not have covid prior to vaccination. Patient did not have covid tested post vaccination. There were no known Allergies. Other medical history was none. No other vaccine was taken in four weeks. No other medications were taken in two weeks.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Extreme fatigue; Loss of appetite; Severe headache; Bodily aches and pains Some symptoms lasting longer then 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraine headaches" (unspecified if ongoing), notes: other medical history: migraine headaches; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: Tetracycline, latex. Concomitant medication(s) included: FAMOTIDINE; VIT D [VITAMIN D NOS]; B 12; CRANBERRY [ASCORBIC ACID;VACCINIUM SPP.]. Past drug history included: Known allergies: tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline, latex. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Location of injection: Arm Left, Vaccine administration date: 19Jan2021, Vaccine Administration Time: 03:00 PM), administration date: 19Jan2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Location of injection: Arm Left, Vaccine administration date: 01Apr2022), administration date: 01Apr2022, when the patient was 79-year-old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Bodily aches and pains Some symptoms lasting longer then 2 days"; FATIGUE (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Extreme fatigue"; DECREASED APPETITE (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Loss of appetite"; HEADACHE (non-serious) with onset 10Sep2022 at 18:00, outcome "not recovered", described as "Severe headache". Therapeutic measures were not taken as a result of fatigue, decreased appetite, headache, pain.  Additional information: Facility type vaccine was pharmacy or Drug Store No other vaccine in four weeks. Other medications in two weeks was Famotidine, Vit D, B12,Cranberry Capsules. No Covid prior vaccination and no Covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history : Diabetes; "Hypertension" (unspecified if ongoing), notes: other medical history : Hypertension. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid for COVID 19 Treatment was received from 30Aug2022 to 03Sep2022.No known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure and Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 at 13:00 as dose 2, single (Lot number: EL3302) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulosis" (unspecified if ongoing), notes: other medical history: Diverticulosis; "osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Feb2021, when the patient was 77-year-old, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 24Feb2021, outcome "recovered", described as "The morning following the day of the second shot and again the morning following the day of the third shot, I passed out". Therapeutic measures were not taken as a result of loss of consciousness. Clinical course: The morning following the day of the second shot, I passed out. This happened 12 plus hours after the shot, so was not a reaction from fear of the shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Patient did not receive any other vaccine on the same day of COVID vaccination. Patient was vaccinated with third dose of Pfizer COVID 19  vaccine (Lot number: FF8839) on 21Sep2021 at 09:00 AM, in Left arm for covid-19 immunization. Sender's Comments: Linked Report(s) : US-PFIZER INC-202201156976 same reporter/patient, different drug dose/AE;
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunization. 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) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received Other medication in 2 weeks. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "known allergies: cipro"; Rocephin, reaction(s): "known allergies: rocephin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment, brand: PAXLOVID, treatment start date: 31Aug2022, treatment stop date: 05/Sep/2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left leg and on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Other medical history included hypertension with known allergies to Macrobid. Concomitant medication(s) included: AMLODIPINE, start date: 01Dec2021. Other medication in 2 weeks included Amlodipine taken from 01Dec2021. Past drug history included: Known allergy: macrobid, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Report was about COVID-19 treatment. Patient received the vaccine. Patient received Paxlovid from 29Aug2022 to 02Sep2022 for treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This case was split from master case 202201157463 to capture a patient received BNT162B2 and experienced pulmonary embolism.  This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown".  Clinical Course: Information was received from a physician concerning a patient, who received Suspect product apixaban for Pulmonary embolism (5 milligram(s) 2 every 1 Day), lot number: Unknown. On an unknown date, the patient experienced arthralgia (knee pain) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. The status of apixaban medication is unknown. Concomitant medications were not reported. The reporter did not provide a causal assessment for event arthralgia to product apixaban. Tracking of Changes: 08-Sep-2022: Initial information was received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: daily I have a headache every day on the right side more intense; tired I can't exercise like I used to; Dose Number: 1 25Mar2021 Dose Number: 2 04Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Aug2021 as dose 2, single (Lot number: EW0198) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single; Batch/Lot No: EN6207; Location of injection: Arm Right), administration date: 25Mar2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Aug2021, outcome "unknown", described as "Dose Number: 1 25Mar2021 Dose Number: 2 04Aug2021"; HEADACHE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "daily I have a headache every day on the right side more intense"; FATIGUE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "tired I can't exercise like I used to". Therapeutic measures were not taken as a result of headache, fatigue.  Additional information: Patient did not received any other vaccine in four weeks, other medications in two weeks: No.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Left arm pruritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: Fm0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex" (unspecified if ongoing), notes: known allergies Latex. Concomitant medication(s) included: TYLENOL; CLARITIN [CLARITHROMYCIN]; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (Other vaccine same date product Pfizer,, Other vaccine same date lot number Ek5730,, Other vaccine same date dose number 1,, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine"; Bnt162b2 (Other vaccine same date product Pfizer,, Other vaccine same date lot number El183,, Other vaccine same date dose number 2,, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine"; Bnt162b2 (Other vaccine same date product Pfizer,, Other vaccine same date lot number Fc3183,, Other vaccine same date dose number 3,, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovering" and all described as "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". Therapeutic measures were taken as a result of vaccination site rash, vaccination site pruritus, vaccination site pain.  Additional information: Facility of vaccine was pharmacy or drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient developed left arm pruritic rash with pain 4x6 cm. Reported as this was only rash after 4 previous vaccines, and this was the bivalent vaccine. Patient treated with tylenol and steroid ointment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: Fc3183), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL; CLARITIN [LORATADINE]; FLONASE [MOMETASONE FUROATE]. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: Ek5730, Anatomical location: left arm), for Covid-19 immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine", "Left arm puritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine"; Bnt162b2 (Dose 2, single, Lot number: El183, Anatomical location: left arm), for Covid-19 immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine", "Left arm puritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine".  The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE RASH (non-serious), outcome "recovering" and all described as "Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine". Therapeutic measures were taken as a result of vaccination site pain, vaccination site rash.  Additional information included: Patient did not receive any other vaccine in four weeks. If Covid prior vaccination: No. If Covid tested post vaccination: No. Ae treatment: Tylenol, steroid ointment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: El183), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (other vaccine same date product=Pfizer,, other vaccine same date lot number=Ek5730,, other vaccine same date dose number=1,, other vaccine same date vaccine location=Left arm,), for COVID-19 immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine".  The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE RASH (non-serious), outcome "recovering" and all described as "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site pain, vaccination site rash.  Additional information: Facility of vaccine was pharmacy or drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient developed left arm pruritic rash with pain 4x6 cm. Reported as this was only rash after 4 previous vaccines, and this was the bivalent vaccine. Patient treated with tylenol and steroid ointment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: Ek5730), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". Therapeutic measures were taken as a result of vaccination site rash, vaccination site pain.   Additional information: It was reported that, On 10Sep2022 06:30 AM, Left arm puritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine, with outcome Recovering. The patient received treatment as Tylenol, steroid ointment. The patient did not receive other vaccine in four weeks. Other medication in two weeks included Tylenol, claritin, Flonase. There was no covid prior vaccination. There was no covid tested post vaccination. Other medical history: None
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EN6207), in right arm and on 04Aug2021 as dose 2, single (Lot number: EW0198) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: She was vaccinated and boosted and she contracted Covid; She was vaccinated and boosted and she contracted Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 53-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bacterial vaginosis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flagyl, reaction(s): "She is allergic to generics of Flagyl.", notes: She is allergic to generics of Flagyl. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She was vaccinated and boosted and she contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: Patient was vaccinated and boosted and she contracted Covid. Patient had J&J and then she got one booster and she will probably get another today.  3 months since she had Covid and now she can have a booster and the doctor said wait 3 months and she will get the Bivalent booster. Patient does not have her vaccine card handy. She is allergic all forms of generic and if she can't take the generic what is she supposed to do and she requires the brand. Name, NDC, Lot and expiration are unknown for all generics that she is allergic too.  She took all of the brand she had. She was done with the brand and discarded it and she only has rest of one gel and she only took one tube of it and the next day she noticed she was sick again and she didn't think something not taken by mouth would make her sick and she was surprised.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Ulcerative colitis" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis. Concomitant medication(s) in 2 weeks included: PREDNISONE; LIALDA. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (07Sep2022) Negative, notes: Tested negative for Covid on 07Sep; (12Sep2022) Positive, notes: Tested positive again on 12Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took anti-viral product Paxlovid for Treatment of COVID-19 started from 02Sep2022 to 06Sep2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported events and suspect BNT162B2 cannot be excluded .The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate