chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: Vaccine induced Thrombocytopenia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EW0151) as dose 1, single for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient was not Pregnant at Time of Vaccination. Relevant medical history included: "thrombocytopenia", start date: 2011 (unspecified if ongoing), notes: One brief acute case of thrombocytopenia in 2011 that resolved completely. Platelets have been normal for 10 years with no treatment. Known allergies included Penicillin and CT IV contrast. Concomitant medications in two weeks included: PEPCID AC occasionally. The patient experienced Vaccine induced Thrombocytopenia in 2021. Platelet count was 226 two and a half weeks prior to dose (on 18Mar) 1 week post vaccine, platelets were 69. 1 week + 3 days platelets were 42. 40mg Prednisone was started at 42 to prevent further decline. The outcome was recovered in 2021. AE resulted in Doctor or other healthcare professional office/clinic visit. AE treatment included 40 mg of Prednisone tapered over 5 weeks. No covid prior vaccination. No covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE (OMICRON VARIANT); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive (omicron variant). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive (omicron variant) was not reported. This report was non-serious. This report was associated with product quality complaint number: 90000209840.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, COVID-19, Heart rate, Heart rate abnormal
Clinical narrative: Covid test result Positive / Date 24Dec2021; Covid test result Positive / Date 24Dec2021; Heart rate suddenly going to 83; Bp shot up very bad both lower and upper; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 18:00 (Lot number: ewo179) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "catch a cold very easy type of allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0171, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome unknown; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome recovered (2021); BLOOD PRESSURE ABNORMAL (non-serious) with onset 2021, outcome recovered (2021). The events heart rate suddenly going to 83 and bp shot up very bad both lower and upper were evaluated at the physician office visit. It was reported that patient did not receive other vaccine in four weeks. Heart rate suddenly going to 83 Bp shot up very bad both lower and upper (83bps Heart rate felt to be pounding worst than 150 while running on a treadmill). No covid prior vaccination. The patient underwent the following laboratory tests and procedures: blood pressure measurement (unspecified date) shot up very bad both lower and upper; heart rate (unspecified date) 83bps Heart rate felt to be pounding worst than 150 while running on a treadmill; sars-cov-2 test (24Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of heart rate abnormal, blood pressure abnormal.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result Positive / Date 24Dec2021; Covid test result Positive / Date 24Dec2021; Heart rate suddenly going to 83; Bp shot up very bad both lower and upper; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 18:00 (Lot number: ewo179) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "catch a cold very easy type of allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0171, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome unknown; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome recovered (2021); BLOOD PRESSURE ABNORMAL (non-serious) with onset 2021, outcome recovered (2021). The events heart rate suddenly going to 83 and bp shot up very bad both lower and upper were evaluated at the physician office visit. It was reported that patient did not receive other vaccine in four weeks. Heart rate suddenly going to 83 Bp shot up very bad both lower and upper (83bps Heart rate felt to be pounding worst than 150 while running on a treadmill). No covid prior vaccination. The patient underwent the following laboratory tests and procedures: blood pressure measurement (unspecified date) shot up very bad both lower and upper; heart rate (unspecified date) 83bps Heart rate felt to be pounding worst than 150 while running on a treadmill; sars-cov-2 test (24Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of heart rate abnormal, blood pressure abnormal.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Covid test result Positive / Date 24Dec2021; Covid test result Positive / Date 24Dec2021; Heart rate suddenly going to 83; Bp shot up very bad both lower and upper; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 18:00 (Lot number: ewo179) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "catch a cold very easy type of allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0171, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome unknown; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome recovered (2021); BLOOD PRESSURE ABNORMAL (non-serious) with onset 2021, outcome recovered (2021). The events heart rate suddenly going to 83 and bp shot up very bad both lower and upper were evaluated at the physician office visit. It was reported that patient did not receive other vaccine in four weeks. Heart rate suddenly going to 83 Bp shot up very bad both lower and upper (83bps Heart rate felt to be pounding worst than 150 while running on a treadmill). No covid prior vaccination. The patient underwent the following laboratory tests and procedures: blood pressure measurement (unspecified date) shot up very bad both lower and upper; heart rate (unspecified date) 83bps Heart rate felt to be pounding worst than 150 while running on a treadmill; sars-cov-2 test (24Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of heart rate abnormal, blood pressure abnormal.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip dry, Lip swelling, Paraesthesia, Swollen tongue
Clinical narrative: extreme thirst; lips started peeling; swelling of her lips, tongue and gums and everything is tender; swelling of her lips, tongue and gums and everything is tender; it is hard to breath; tingling feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 10Jul2021 12:30 (Lot number: EW0198) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "phenylketonuria" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flonase for seasonal allergies. Vaccination history included: Flu vaccine, for immunization. The following information was reported: THIRST (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "extreme thirst"; LIP DRY (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "lips started peeling"; LIP SWELLING (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), SWOLLEN TONGUE (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021) and all described as "swelling of her lips, tongue and gums and everything is tender"; DYSPNOEA (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "it is hard to breath"; PARAESTHESIA (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "tingling feeling". Therapeutic measures were taken as a result of thirst, lip dry, lip swelling, swollen tongue, paraesthesia. Additional information: The patient noted when the issue with the swelling of her lips, tongue and gums happened she had to take her rescue inhaler and took a while to bring her symptoms under control. She normally takes Advair once in the morning and carries her rescue inhaler with her. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: extreme thirst; lips started peeling; swelling of her lips, tongue and gums and everything is tender; swelling of her lips, tongue and gums and everything is tender; it is hard to breath; tingling feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 10Jul2021 12:30 (Lot number: EW0198) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "phenylketonuria" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flonase for seasonal allergies. Vaccination history included: Flu vaccine, for immunization. The following information was reported: THIRST (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "extreme thirst"; LIP DRY (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "lips started peeling"; LIP SWELLING (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), SWOLLEN TONGUE (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021) and all described as "swelling of her lips, tongue and gums and everything is tender"; DYSPNOEA (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "it is hard to breath"; PARAESTHESIA (non-serious) with onset 12Jul2021, outcome "recovered" (12Jul2021 23:00), described as "tingling feeling". Therapeutic measures were taken as a result of thirst, lip dry, lip swelling, swollen tongue, paraesthesia. Additional information: The patient noted when the issue with the swelling of her lips, tongue and gums happened she had to take her rescue inhaler and took a while to bring her symptoms under control. She normally takes Advair once in the morning and carries her rescue inhaler with her. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Respiratory disorder, SARS-CoV-2 test, Sinus headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) reported in response to letter sent to cross-linked case for a patient. A 19-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Feb2021 09:30 (Lot number: EK4176, Expiration Date: 30Apr2021) 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, Single, Time: 08: 30 AM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot number: EJ1686, Expiration date: 31Mar2021), administration date: 18Jan2021, for COVID-19 immunisation, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: SINUS HEADACHE (non-serious) with onset 30Jun2021 16:00, outcome "recovering", described as "Headache sinus"; COUGH (non-serious), RESPIRATORY DISORDER (non-serious) all with onset 30Jun2021 16:00, outcome "recovering" and all described as "Respiratory coughing congestion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinus headache, cough, respiratory disorder.Additional information: Vaccination facility type was hospital. Vaccine was not administered at military facility. Seriousness criteria was not serious. Adverse event required to visit withheld urgent care. Treatment received.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Feeling abnormal, Gait disturbance
Clinical narrative: Started walking with shoulders forwards and wider gait. Then significant imbalance and several falls.; Started walking with shoulders forwards and wider gait. Then significant imbalance and several falls.; Significant brain fog; Started walking with shoulders forwards and wider gait. Then significant imbalance and several falls.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 10:00 (Lot number: EL9269) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00 PM), administration date: 01Feb2021, when the patient was 73 years old, for covid 19 immunization. The following information was reported: FALL (disability), BALANCE DISORDER (disability), GAIT DISTURBANCE (disability) all with onset 06Mar2021, outcome "unknown" and all described as "Started walking with shoulders forwards and wider gait. Then significant imbalance and several falls."; FEELING ABNORMAL (disability) with onset 06Mar2021, outcome "unknown", described as "Significant brain fog". The events "started walking with shoulders forwards and wider gait. then significant imbalance and several falls.", "started walking with shoulders forwards and wider gait. then significant imbalance and several falls.", "significant brain fog" and "started walking with shoulders forwards and wider gait. then significant imbalance and several falls." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fall, balance disorder, feeling abnormal, gait disturbance. No other vaccine in four weeks. Began about 3 weeks after second vaccine. Started walking with shoulders forwards and wider gait. Then significant imbalance and several falls. Significant brain fog. Ae resulted in visit to Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No covid prior vaccination. Not covid tested post vaccination. No Known allergies.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypersomnia, Limb discomfort
Clinical narrative: swelling on Face; Rash on Face; Sweating; Inability to fully lift arm. Noticeable decrease in strength.; Extreme tiredness; Headaches; Slept for 20 out of 24 hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jun2021 12:00 (Lot number: EW0181) as dose 1, single and administered in arm left, administration date 09Aug2021 12:00 (Lot number: FC3181) as dose 2, single for covid-19 immunization. Relevant medical history included: "Allergic to penicillin" (unspecified if ongoing), notes: Penicillin; "left ventricular hydropathy" (unspecified if ongoing). Concomitant medication(s) included: FUROSEMIDE. The following information was reported: SWELLING FACE (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "swelling on Face"; RASH (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Rash on Face"; HYPERHIDROSIS (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Sweating"; LIMB DISCOMFORT (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Inability to fully lift arm. Noticeable decrease in strength."; FATIGUE (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Extreme tiredness"; HEADACHE (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Headaches"; HYPERSOMNIA (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Slept for 20 out of 24 hours". Therapeutic measures were not taken as a result of swelling face, rash, hyperhidrosis, limb discomfort, fatigue, headache, hypersomnia.  Additional information: Rash and swelling on Face Inability to fully lift arm. Noticeable decrease in strength. Extreme tiredness. Slept for 20 out of 24 hours on 10Aug2021 Headaches, Sweating. No treatment received for the reported events.The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Device Date was 10Aug2021. The patient received Furosemide within 2 weeks of vaccination.    No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: swelling on Face; Rash on Face; Sweating; Inability to fully lift arm. Noticeable decrease in strength.; Extreme tiredness; Headaches; Slept for 20 out of 24 hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jun2021 12:00 (Lot number: EW0181) as dose 1, single and administered in arm left, administration date 09Aug2021 12:00 (Lot number: FC3181) as dose 2, single for covid-19 immunization. Relevant medical history included: "Allergic to penicillin" (unspecified if ongoing), notes: Penicillin; "left ventricular hydropathy" (unspecified if ongoing). Concomitant medication(s) included: FUROSEMIDE. The following information was reported: SWELLING FACE (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "swelling on Face"; RASH (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Rash on Face"; HYPERHIDROSIS (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Sweating"; LIMB DISCOMFORT (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Inability to fully lift arm. Noticeable decrease in strength."; FATIGUE (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Extreme tiredness"; HEADACHE (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Headaches"; HYPERSOMNIA (non-serious) with onset 10Aug2021 04:00, outcome "not recovered", described as "Slept for 20 out of 24 hours". Therapeutic measures were not taken as a result of swelling face, rash, hyperhidrosis, limb discomfort, fatigue, headache, hypersomnia.  Additional information: Rash and swelling on Face Inability to fully lift arm. Noticeable decrease in strength. Extreme tiredness. Slept for 20 out of 24 hours on 10Aug2021 Headaches, Sweating. No treatment received for the reported events.The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Device Date was 10Aug2021. The patient received Furosemide within 2 weeks of vaccination.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block right, Disease recurrence, Echocardiogram, Electrocardiogram, Overdose
Clinical narrative: nurse gave her 1.8 mL instead of the 0.3 ml dose; Right Bundle branch block; Right Bundle branch block; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the parent.  A 16 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in deltoid right, administration date 15Sep2021 (Lot number: EW0191, Expiration Date: 19Sep2021) as dose 2, 1.8 ml single for COVID-19 immunisation. Relevant medical history included: "Right Bundle branch block" in May2021 (unspecified if ongoing). The patient had no prior vaccinations (within 4 weeks). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, intramuscular, Lot: F63180), administration date: 25Aug2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: OVERDOSE (hospitalization) with onset 15Sep2021, outcome "unknown", described as "nurse gave her 1.8 mL instead of the 0.3 ml dose"; BUNDLE BRANCH BLOCK RIGHT (hospitalization), DISEASE RECURRENCE (hospitalization) all with onset 2021, outcome "unknown" and all described as "Right Bundle branch block". The patient was hospitalized for the events on 15Sep2021. The events were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (May2021) unknown results; electrocardiogram: (unspecified date) right bundle branch block. Additional information: Specific relevant test for thromboembolic events with thrombocytopenia was none. The patient's parent was asking if there is any information speaking to the adverse effects or toxicity that would be experienced if a person was administered "double the dose" or a larger dose than recommended of the Pfizer covid vaccine. The patient was at school and was getting her second injection of the Pfizer covid vaccine, but the nurse gave her 1.8 ml instead of the 0.3 ml dose. On 15Sep2021, the patient was brought to the emergency room for evaluation and observation. She was stable and discharged. Initially asking what the normal dose of the vaccine should be, the patient's parent reported that he was just in the ER and they did an EKG, his daughter has a right Bundle branch block and "they don't think anyone has been given a larger dose than what is recommended or have been dosed this high" and asking if there is any information on label or off label speaking to this.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Implantation complication, Pregnancy, Vaginal haemorrhage
Clinical narrative: I got the second COVID-19 vaccine on 5/21/2021, four days after confirmed ovulation on 5/17/2021. I found out a week later on 5/28/2021 I was pregnant. I then started spotting on 5/30/2021, early miscarriage on 5/31/2021. This ended up being the first of three early miscarriages I had in the following six months.  I have never had trouble with early miscarriages and implantation failure prior to the vaccine, and had two children prior to the vaccine (2018 & 2020).
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchy hives; Itchy hives; Body began to break out in red, itchy hives; This spontaneous case was retrieved on 06-Dec-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1795131-1), reported by other non-healthcare professional (consumer) and concerned a 63-year-old, female patient.   The patient's concurrent conditions included high blood pressure, type two diabetes and allergy to erythromycin. The patient's concomitant medication included ibuprofen, Armour thyroid (thyroid), Metformin (metformin hydrochloride) and Losartan (losartan potassium), all used for unreported indication.  On14-Sep-2021, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication: not reported, dose reported as one, route of administration reported: intramuscular and anatomical location: left arm). The batch number was not reported.  On 16-Sep-2021, two days after receiving influence virus vaccine polyvalent, the patient's body began to break out in red, itchy hives all over her body. They appeared in patches, some hives were small, some were very large. They would itch for approx. Four to six hours before beginning to fade. When they faded the skin in the middle of each hive would turn normal colour, but there would be a bright red line outlining the hive. While patches were fading, new patches of hives in different body areas would begin to appear.  On an unspecified day in Sep-2021, about a week and a half after receiving influenza virus vaccine polyvalent, the patient went to physician assistants (PA) who was associated with her medical doctor's office and she prescribed the patient with unspecified shot. Also, the patient was treated with six 20 mg pills of prednisone, the pills to be taken once per day. The PA also prescribed Hydroxyzine (hydroxyzine hydrochloride) to be taken no more than four times a day. This treatment alleviated the itching for the most part, however the hives continued to break out the same as originally described. After the treatment, the patient put up with the hives. At the end of the third week, the number of outbreaks began to lessen.  On 15-Oct-2021, one month and one day after receiving influenza virus vaccine polyvalent, the patient recovered from the events.    The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: A 63-year-old female patient developed pruritus, urticaria and erythema two days after receiving influenza virus vaccine polyvalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 63-year-old female patient developed pruritus, urticaria and erythema two days after receiving influenza virus vaccine polyvalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Chest pains on left side above the heart; Feels like pressure and throbbing; Shortness of breath; 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 28Oct2021 10:00 (Lot number: FF8841) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose brand=PFIZER , Lot No: 30145BA, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 07Oct2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 29Oct2021 01:00, outcome "not recovered", described as "Chest pains on left side above the heart"; CHEST DISCOMFORT (non-serious) with onset 29Oct2021 01:00, outcome "not recovered", described as "Feels like pressure and throbbing"; DYSPNOEA (non-serious) with onset 29Oct2021 01:00, outcome "not recovered", described as "Shortness of breath". Therapeutic measures were not taken as a result of chest pain, chest discomfort, dyspnoea.  Additional Information: Chest pains on left side above the heart. Feels like pressure and throbbing. This is only on the left side. Issue occurs often but usually at night or in the morning. Shortness of breath. This currently occurs often. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. It was reported that, there were no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dyspnoea, Ear pruritus, Pruritus, Urticaria
Clinical narrative: ITCHING ALL OVER THE BODY; DIFFICULTY BREATHING; HIVES; ITCHING IN EARS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height and weight were not reported. The patient's past medical history included: hives and concurrent conditions include: asthma, hypothyroidism, diabetes mellitus type 2, sulpha allergy, non-alcohol user, and non-smoker, and the patient was allergic to grape leaves. The patient did not have any drug abuse or illicit drug use. The patient was previously received with covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination (dose number in series 1). The patient did not have side effects with the initial vaccine dose (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 15-NOV-2021 for prophylactic vaccination on the left arm (dose number in series 2). No concomitant medications were reported.  On 16-NOV-2021 (the day after the booster dose), the patient experienced itching in ears. On 17-NOV-2021, the patient experienced hives, itching all over body, and difficulty breathing (dose number in series 2). The patient went to the emergency room on the same day but was not admitted. She was treated and released with prednisone, and given pills to take for a few days upon discharge that day. On 19-NOV-2021, Laboratory data included: Blood glucose (not provided) Increased. The patient stated that due to increased blood glucose level she did not take the last prednisone. On 24-NOV-2021, Laboratory data included: Blood glucose (not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching in ears on 17-NOV-2021, itching all over the body, and difficulty breathing on 19-NOV-2021, and hives on 18-NOV-2021. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Postpartum disorder, Postpartum haemorrhage
Clinical narrative: The bleeding was subsiding again after the first when I received the shots and it quickly returned; My postpartum lochia returned after having diminished immediately after both Covid vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 11:00 (Lot number: FF2590) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, start date: 19Nov2021, stop date: 19Nov2021. The following information was reported: POSTPARTUM HAEMORRHAGE (non-serious) with onset 05Nov2021 18:00, outcome "not recovered", described as "The bleeding was subsiding again after the first when I received the shots and it quickly returned"; POSTPARTUM DISORDER (non-serious) with onset 05Nov2021 18:00, outcome "not recovered", described as "My postpartum lochia returned after having diminished immediately after both Covid vaccines". Therapeutic measures were not taken as a result of postpartum haemorrhage, postpartum disorder.  Additional information: Patient received other vaccine in four weeks. Patient had no COVID prior vaccination and not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: left arm at the injection site she had itching, redness, swelling and a rash; left arm at the injection site she had itching, redness, swelling and a rash; left arm at the injection site she had itching, redness, swelling and a rash; left arm at the injection site she had itching, redness, swelling and a rash; Headache; Tiredness; Caller states she is calling about the Pfizer Covid Vaccine Booster Dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FJ8757) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: Lot: EN6202), administration date: 26Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "Headache", "Tiredness"; Bnt162b2 (Second Dose: Lot: ER2613), administration date: 19Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "Headache", "Tiredness". The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Caller states she is calling about the Pfizer Covid Vaccine Booster Dose"; HEADACHE (non-serious) with onset 11Dec2021, outcome "recovered" (12Dec2021), described as "Headache"; FATIGUE (non-serious) with onset 11Dec2021, outcome "recovered" (12Dec2021), described as "Tiredness"; VACCINATION SITE PRURITUS (non-serious) with onset 12Dec2021, outcome "recovered" (2021), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 12Dec2021, outcome "recovering" and all described as "left arm at the injection site she had itching, redness, swelling and a rash". Therapeutic measures were taken as a result of headache. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101781350 same patient, same reporter, different dose, similar event
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: left arm at the injection site she had itching, redness, swelling and a rash; left arm at the injection site she had itching, redness, swelling and a rash; left arm at the injection site she had itching, redness, swelling and a rash; left arm at the injection site she had itching, redness, swelling and a rash; Headache; Tiredness; Caller states she is calling about the Pfizer Covid Vaccine Booster Dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FJ8757) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: Lot: EN6202), administration date: 26Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "Headache", "Tiredness"; Bnt162b2 (Second Dose: Lot: ER2613), administration date: 19Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "Headache", "Tiredness". The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Caller states she is calling about the Pfizer Covid Vaccine Booster Dose"; HEADACHE (non-serious) with onset 11Dec2021, outcome "recovered" (12Dec2021), described as "Headache"; FATIGUE (non-serious) with onset 11Dec2021, outcome "recovered" (12Dec2021), described as "Tiredness"; VACCINATION SITE PRURITUS (non-serious) with onset 12Dec2021, outcome "recovered" (2021), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 12Dec2021, outcome "recovering" and all described as "left arm at the injection site she had itching, redness, swelling and a rash". Therapeutic measures were taken as a result of headache. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101781350 same patient, same reporter, different dose, similar event
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation
Clinical narrative: booster; 6 patients received the Pfizer COVID-19 vaccine adult formulation (purple cap)- booster dose past the expiry date; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A 64 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 10Dec2021 14:13 (Lot number: FE3592, Expiration Date: 03Dec2021) at the age of 64 years as dose 3 (booster), 0.3 ml single for covid-19 immunization.The patient had no relevant medical history.There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Pfizer Covid 19 Vaccine, 1st dose received on 29Apr2021,Lot: Unknown, Expiry: Unknown), administration date: 29Apr2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Pfizer Covid 19 Vaccine, 2nd dose received on 20May2021., Lot: ER8729, Expiry: Unknown), administration date: 20May2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 14:13, outcome "unknown", described as "booster"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 10Dec2021 14:13, outcome "unknown", described as "6 patients received the Pfizer COVID-19 vaccine adult formulation (purple cap)- booster dose past the expiry date".  Follow-up (16Dec2021): New information received from a Pfizer-sponsored program [159558] included Patient characteristics and Suspect Drug information was updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101804356 same reporter/drug/AE with different patient
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder, Spondylitis, Testicular injury, Thrombosis
Clinical narrative: blood clots; Damaged testicle area; Back arthritis; lung issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; TESTICULAR INJURY (non-serious), outcome "unknown", described as "Damaged testicle area"; SPONDYLITIS (non-serious), outcome "unknown", described as "Back arthritis"; LUNG DISORDER (non-serious), outcome "unknown", described as "lung issues".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Inner ear disorder, Tinnitus
Clinical narrative: Ringing in right ear with pressure behind and inside ear; Ringing in right ear with pressure behind and inside ear; Ringing in right ear with pressure behind and inside ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 (Lot number: EP7533) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa allergy" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534), administration date: 18Mar2021, when the patient was 36 years old, for COVID-19 immunization.The following information was reported: TINNITUS (non-serious), EAR DISCOMFORT (non-serious), INNER EAR DISORDER (non-serious) all with onset 09Apr2021, outcome "not recovered" and all described as "Ringing in right ear with pressure behind and inside ear". The event "ringing in right ear with pressure behind and inside ear", "ringing in right ear with pressure behind and inside ear" and "ringing in right ear with pressure behind and inside ear" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, ear discomfort, inner ear disorder.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Multifocal motor neuropathy, Muscular weakness
Clinical narrative: One of  the current working diagnoses is possible Multifocal Motor Neuropathy; she developed sudden onset of weakness of the upper extremities; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 90 years 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 (First Dose, (MANUFACTURER UNKNOWN)), for COVID-19 Immunization. The following information was reported: MULTIFOCAL MOTOR NEUROPATHY (medically significant) with onset 23Feb2021, outcome "unknown", described as "One of  the current working diagnoses is possible Multifocal Motor Neuropathy"; MUSCULAR WEAKNESS (non-serious) with onset 23Feb2021, outcome "unknown", described as "she developed sudden onset of weakness of the upper extremities". The clinical course was reported as follows: My wife received her second dose of the Pfizer vaccine on 13Feb2021 Approximately 10 days  later, she developed sudden onset of weakness of the upper extremities. It has been relentless in its progression. This was something she never previously experienced in any way. One of the current working diagnoses is possible Multifocal Motor Neuropathy.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Multifocal Motor Neuropathy and muscles weakness 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysstasia, Presyncope, Pyrexia
Clinical narrative: almost fainted; two episodes of extreme dizziness (almost fainted); low grade fever; Chills; could not stand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 14:00 (Lot number: Fd7218) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gerd" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; PEPCID [FAMOTIDINE]; LEXAPRO. Past drug history included: Bactroban, reaction(s): "Known allergies"; Keflex, reaction(s): "Known allergies"; Amoxicillin, reaction(s): "Known allergies"; Erythromycin, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose 1, single, at 02:00 PM administered in arm left, Lot Number: Ew0183), administration date: 18Nov2021, when the patient was 34 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PRESYNCOPE (medically significant) with onset 20Dec2021 05:45, outcome "unknown", described as "almost fainted"; DIZZINESS (non-serious) with onset 20Dec2021 05:45, outcome "unknown", described as "two episodes of extreme dizziness (almost fainted)"; PYREXIA (non-serious) with onset 20Dec2021 05:45, outcome "unknown", described as "low grade fever"; CHILLS (non-serious) with onset 20Dec2021 05:45, outcome "unknown", described as "Chills"; DYSSTASIA (non-serious) with onset 20Dec2021 05:45, outcome "recovered" (20Dec2021 20:45), described as "could not stand". The patient could not stand about 15 hours after 2nd dose. Therapeutic measures were not taken as a result of presyncope, dizziness, pyrexia, chills, dysstasia. The patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.