chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from 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 3, (booster) single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN) (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional information: Causality: 1) Tinnitus   Action(s) taken with drug: Not applicable  Causality as per reporter (Drug/Vaccine): Possible   Causality as per Mfr. (Drug/Vaccine): Possible  Dechallenge: N/A Rechallenge: N/A Seq.No.: 2 Drug: Tozinameran (TOZINAMERAN), UNKNOWN (TOZINAMERAN) Causality: 1) Tinnitus   Action(s) taken with drug: Not applicable  Dechallenge: N/A Rechallenge: N/A   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I have a swollen lymph node behind my left ear since Jun2021 after taking my second shot on 31Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jun2021, outcome "unknown", described as "I have a swollen lymph node behind my left ear since Jun2021 after taking my second shot on 31Mar2021". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient had been to primary care doctor twice and they have not prescribed any medication to reduce the swelling. Also took the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Feeling abnormal, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Occasional brain fog; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4325345-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jan2022 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single, intramuscular, administration date 31Jul2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1154587) at unk (citrate free). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "COVID-19"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "recovering", described as "Occasional brain fog". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the ["covid-19" and "occasional brain fog"] with the suspect product was not provided at the time of this report. Since related determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: experienced chest pain after taking the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "experienced chest pain after taking the vaccine".  Additional information: It was reported that, he experienced chest pain after taking the vaccine. He wanted to know if it's normal to experience chest pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Lymphadenopathy, Migraine, Pyrexia
Clinical narrative: Worst migraine ever.; Can't even see; Fever 101 with motrin; Dizziness; Swollen lymph node on right side of neck; Vomiting; This is a spontaneous report from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 18Mar2022 at 17:30 (Lot number: FK9896) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FA7475, Anatomical location: Right arm, Administration time: 17:00), administration date: 30Jul2021, when the patient was 46 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FA7484, Anatomical location: Left arm, Administration time: 17:00), administration date: 20Aug2021, when the patient was 46 years old, for COVID-19 immunisation.  The following information was reported: MIGRAINE (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Worst migraine ever"; VISUAL IMPAIRMENT (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Can't even see"; PYREXIA (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Fever 101 with motrin"; DIZZINESS (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Dizziness"; LYMPHADENOPATHY (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Swollen lymph node on right side of neck"; VOMITING (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Vomiting". The events "Worst migraine ever.", "Can't even see", "Fever 101 with motrin", "Dizziness", "Swollen lymph node on right side of neck" and "Vomiting" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, visual impairment, pyrexia, dizziness, lymphadenopathy and vomiting.  Additional Information: The patient reported that it was day 6 of events at the time of this report. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment included motrin for pyrexia and steroids for migraine, visual impairment, pyrexia, dizziness, lymphadenopathy and vomiting.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Visual impairment, Vomiting
Clinical narrative: Worst migraine ever.; Can't even see; Fever 101 with motrin; Dizziness; Swollen lymph node on right side of neck; Vomiting; This is a spontaneous report from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 18Mar2022 at 17:30 (Lot number: FK9896) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FA7475, Anatomical location: Right arm, Administration time: 17:00), administration date: 30Jul2021, when the patient was 46 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FA7484, Anatomical location: Left arm, Administration time: 17:00), administration date: 20Aug2021, when the patient was 46 years old, for COVID-19 immunisation.  The following information was reported: MIGRAINE (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Worst migraine ever"; VISUAL IMPAIRMENT (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Can't even see"; PYREXIA (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Fever 101 with motrin"; DIZZINESS (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Dizziness"; LYMPHADENOPATHY (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Swollen lymph node on right side of neck"; VOMITING (non-serious) with onset 18Mar2022 at 23:00, outcome "not recovered", described as "Vomiting". The events "Worst migraine ever.", "Can't even see", "Fever 101 with motrin", "Dizziness", "Swollen lymph node on right side of neck" and "Vomiting" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, visual impairment, pyrexia, dizziness, lymphadenopathy and vomiting.  Additional Information: The patient reported that it was day 6 of events at the time of this report. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment included motrin for pyrexia and steroids for migraine, visual impairment, pyrexia, dizziness, lymphadenopathy and vomiting.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: since my second shot which was back in Nov I have been having headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "since my second shot which was back in Nov I have been having headaches".  Additional information: The patient had received both dose of the Pfizer covid vaccine and ever since patient second shot which was back in Nov, patient have been having headaches all day everyday and it never was like this until after could this be a side-effect of the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: The first shot I was tired and I felt like I was in a fishbowl.; The first shot I was tired and I felt like I was in a fishbowl.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2022 (Lot number: Fj6369) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gerd" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "The first shot I was tired and I felt like I was in a fishbowl.".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination and since the vaccination the patient did not tested for Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Vaccination site pruritus
Clinical narrative: It is the second shot I had the issue with. I had the same feeling tired and the fishbowl feeling but my arm would not stop itching where I got the shot; It is the second shot I had the issue with. I had the same feeling tired and the fishbowl feeling but my arm would not stop itching where I got the shot; It is the second shot I had the issue with. I had the same feeling tired and the fishbowl feeling but my arm would not stop itching where I got the shot; Covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2022 (Lot number: Fm0698) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gerd" (unspecified if ongoing); "IBS" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19 Pfizer, lot number: Fj6369,, administration date=07Feb2021, dose number=1, location=Left arm), administration date: 07Feb2022, when the patient was 31 years old, for Covid-19 immunization, reaction(s): "The first shot I was tired and I felt like I was in a fishbowl.", "The first shot I was tired and I felt like I was in a fishbowl." The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Mar2022, outcome "recovering", described as "Covid arm"; FATIGUE (non-serious), outcome "unknown", FEELING ABNORMAL (non-serious), outcome "recovering" and all described as "It is the second shot I had the issue with. I had the same feeling tired and the fishbowl feeling but my arm would not stop itching where I got the shot"; VACCINATION SITE PRURITUS (non-serious) with onset 01Mar2022, outcome "recovering", described as "It is the second shot I had the issue with. I had the same feeling tired and the fishbowl feeling but my arm would not stop itching where I got the shot". Therapeutic measures were taken as a result of pain in extremity, vaccination site pruritus. Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: Facility type vaccine: Pharmacy or Drug Store. It was the second shot patient had the issue with. He had the same feeling tired and the fishbowl feeling but his arm would not stop itching where he got the shot. After about two weeks, he went back to the pharmacy and asked. The pharmacist said that it sounded like COVID arm. He had tried heating pad, ice, and rubbing it. He also started using some hydrocortisone cream. It was getting better and not as itching him. No COVID prior vaccination. Not tested COVID post vaccination. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: brain bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Feb2021, for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for Covid-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (death, medically significant) with onset 29Dec2021, outcome "fatal", described as "brain bleed". He was 82 years old and in great shape. The patient date of death was 29Dec2021. The reported cause of death was cerebral haemorrhage. It was unknown if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: brain bleed
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Pain in extremity, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Extensive DVT of left leg; pulmonary embolism in both lungs; SOB; Calf pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 19Aug2021 15:00 (Lot number: FC3181) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0191), administration date: 29Jul2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant, life threatening) with onset Nov2021, outcome "unknown", described as "Extensive DVT of left leg"; PULMONARY EMBOLISM (medically significant, life threatening) with onset Nov2021, outcome "unknown", described as "pulmonary embolism in both lungs"; DYSPNOEA (life threatening) with onset Nov2021, outcome "unknown", described as "SOB"; PAIN IN EXTREMITY (life threatening) with onset Nov2021, outcome "unknown", described as "Calf pain". The events "extensive DVT of left leg", "pulmonary embolism in both lungs", "sob" and "calf pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. Therapeutic measures were taken as a result of deep vein thrombosis, pulmonary embolism, dyspnoea, pain in extremity. Additional information: The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Events treatment included direct oral anticoagulants (DOAC) medications. COVID test post vaccination with nasal swab. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: suffered a full body allergic reaction to her lotion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 13Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer , Unknown dose), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "suffered a full body allergic reaction to her lotion".  Additional information: Patient had a massage from therapist and suffered a full body allergic reaction to lotion. Two weeks ago patient had another massage with the same results. She has not changed her formula for her lotion and patient been going to her for over a year with no reaction. patient wondering if the booster somehow messed with my immune system causing the allergic reaction.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 83 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 12:45 (Lot number: EW017) as dose 3 (booster), single, administered in arm left, administration date 09Feb2021 16:00 (Lot number: EM9809) as dose 2, single and administered in arm left, administration date 19Jan2021 12:30 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "bronchiectasis" (unspecified if ongoing), notes: Other medical history: bronchiectasis. Concomitant medication(s) included: LUTEIN, start date: Jan2020, stop date: Feb2022; VITAMIN D3, start date: Jan2020, stop date: Feb2022; CALCIUM 600 + D, start date: Jan2020, stop date: Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: tested positive / covid test result=Positive; tested positive / covid test result=Positive; Mild cold symptoms; lost taste and smell; lost taste and smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 (Lot number: EF2593) at the age of 18 years as dose 3, booster for covid-19 immunisation. Relevant medical history included: "Autoimmune-Hashimoto" (unspecified if ongoing); "Juvenile idiopathc arthritis" (unspecified if ongoing); "DGBI" (unspecified if ongoing); "known allergies; Bees" (unspecified if ongoing). Concomitant medication(s) included: TOCILIZUMAB; CELEBREX; CYMBALTA. Past drug history included: Enbrel, reaction(s): "known allergies;Enbrel". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9809, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 09Apr2021, when the patient was 17 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9810, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 17 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Mar2022, outcome "recovered with sequelae" and all described as "tested positive / covid test result=Positive"; NASOPHARYNGITIS (non-serious) with onset 18Mar2022, outcome "recovered with sequelae", described as "Mild cold symptoms"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 18Mar2022, outcome "recovered with sequelae" and all described as "lost taste and smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (23Mar2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasopharyngitis, ageusia, anosmia.  Clinical Course: Facility type vaccine: Pharmacy. Post vaccination COVID test was performed.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: tested positive / covid test result=Positive; tested positive / covid test result=Positive; Mild cold symptoms; lost taste and smell; lost taste and smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 (Lot number: EF2593) at the age of 18 years as dose 3, booster for covid-19 immunisation. Relevant medical history included: "Autoimmune-Hashimoto" (unspecified if ongoing); "Juvenile idiopathc arthritis" (unspecified if ongoing); "DGBI" (unspecified if ongoing); "known allergies; Bees" (unspecified if ongoing). Concomitant medication(s) included: TOCILIZUMAB; CELEBREX; CYMBALTA. Past drug history included: Enbrel, reaction(s): "known allergies;Enbrel". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9809, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 09Apr2021, when the patient was 17 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9810, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 17 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Mar2022, outcome "recovered with sequelae" and all described as "tested positive / covid test result=Positive"; NASOPHARYNGITIS (non-serious) with onset 18Mar2022, outcome "recovered with sequelae", described as "Mild cold symptoms"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 18Mar2022, outcome "recovered with sequelae" and all described as "lost taste and smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (23Mar2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasopharyngitis, ageusia, anosmia.  Clinical Course: Facility type vaccine: Pharmacy. Post vaccination COVID test was performed.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: got my period a week earlier than it's suppose to come; because it's 11 days now and I am still bleeding; 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 female patient received bnt162b2 (BNT162B2), administration date 12Mar2022 (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: MENSTRUATION IRREGULAR (non-serious) with onset 14Mar2022, outcome "not recovered", described as "got my period a week earlier than it's suppose to come"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14Mar2022, outcome "not recovered", described as "because it's 11 days now and I am still bleeding". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding.  Additional information: Patient always had her period tracker and was surprised to get her period 2 days after she got the shot. It was 11th day and patient was still bleeding. Patient was not on any medication, haven't change anything in her lifestyle except 12Mar when she took the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.    ~
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Swelling
Clinical narrative: receiving covid booster/having more discomfort and swelling; receiving covid booster/having more discomfort and swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 75 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Sep2021 (Batch/Lot number: unknown) at the age of 75 years as dose number unknown booster, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SWELLING (non-serious), DISCOMFORT (non-serious), outcome "recovered" and all described as "receiving covid booster/having more discomfort and swelling". Therapeutic measures were taken as a result of swelling, discomfort.  Additional information: Patient reported some time around Sep2021 receiving covid booster. She was off of Xeljanz for 9 days for the booster as instructed by MD. During time off of Xeljanz, she reported having more discomfort and swelling. After getting back on Xeljanz, the symptoms went away.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Hypersensitivity, Illness, Suspected COVID-19
Clinical narrative: Drug ineffective; COVID-19; Sickness; ALLERGIES; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4327620-00.  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single and intramuscular, administration date 15Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "not recovered", described as "COVID-19"; DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Drug ineffective"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "ALLERGIES". The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of Sickness (Illness) was reported as Possible and COVID-19 (COVID-19), Allergy  (Hypersensitivity)  Causality as per reporter (Drug/Vaccine):  Not Reported  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Muscle spasms
Clinical narrative: cramps; headache; lower back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "cramps"; HEADACHE (non-serious), outcome "unknown", described as "headache"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain".  Additional Information: I was at withheld Hospital (withheld (Hospital address) to have bloodwork done (I'm fine it's just for a checkup). The doctor or nurse whom conducted this had a (Country name Withheld) accent / was originally from (Country name Withheld). I didn't catch her name. She told me that when she received the COVID vaccine (I think first dose) she had cramps, headache and lower back pain - she did have her period but hadn't had cramps during period for some time so chalked it up to the vaccine. She said her husband was sick for around 24 hours and threw up. She said for other doses / booster they were fine. Note even though she's originally from (Country name Withheld) my impression is both she and her husband are living here in the United states and would have received the vaccine here. They are both fine and it sounds like most of her family had the Pfizer vaccine which was encouraged by her and her husband. She was not seeking to complain or report - I just felt that I should relay. I'm just relaying what she said - she wasn't looking to complain or report it. In fact, after I told her I worked for Pfizer she said they had filled out some form after having the vaccine but it wasn't clear to me if both she & her husband filled it out and if it was the reactions to the dose she had relayed to me or another dose that she had no symptoms. I tried filling out this form Pfizer's Adverse Event Reporting Portal (withheld) but I'm presuming patient details is the person relaying this information and I don't have her name or date of birth etc.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal disorder, Suspected COVID-19, Vaccination failure
Clinical narrative: had a throat problem; he just had many of the classic symptoms; he just had many of the classic symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 32030BD) at the age of 81 years as dose 3 (booster), single, administered in arm left, administration date 01Mar2021 (Lot number: EN6202) as dose 2, single and administered in arm left, administration date 08Feb2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Over weight" (unspecified if ongoing), notes: over-weight he lost 16lbs last time he went to the doctor. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 31Jan2022, outcome "unknown" and all described as "he just had many of the classic symptoms"; PHARYNGEAL DISORDER (non-serious), outcome "unknown", described as "had a throat problem". Clinical course: Reporter doesn't know if her husband ever got tested for COVID. He just thought he had covid, he had a throat problem, then found out the caller, his wife had covid, he just had many of the classic symptoms. Patient Height: he has shrunk, before having COVID, he has had back surgeries, spacers in disks. Concomitant meds was no medications, remarkably healthy. Description of Product Complaint, patient thought he had Covid after his Covid-19 Vaccines. Reporter clarifies she does not know if patient ever got tested for Covid, but patient had the classic Covid symptoms.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: sick for around 24 hours; Threw up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick for around 24 hours"; VOMITING (non-serious), outcome "recovered", described as "Threw up".  Additional information: It was reported that, she said her husband was sick for around 24 hours and threw up. She said for other doses/booster. They were fine. Note even though she was originally from country her impression was both she and her husband are living here in other country and would have received the vaccine here. They are both fine and it sounds like most of her family had the Pfizer vaccine which was encouraged by her and her husband. She was not seeking to complain or report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I have gotten a cold sore on my lip sometimes 2 at a time, pretty much every 4 weeks; 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 left, administration date 14Jun2021 10:00 (Lot number: EW0180) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Cold sore" (unspecified if ongoing), notes: Before the vaccine I got cold sores but 1-2 every 18 months or so. The patient took concomitant medications. Past drug history included: Indocin, reaction(s): "known allergies: indocin", notes: known allergies: indocin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 24May2021, when the patient was 37 years old, for COVID-19 Immunization.  The following information was reported: ORAL HERPES (non-serious) with onset 23Jun2021 12:00, outcome "recovered with sequelae", described as "I have gotten a cold sore on my lip sometimes 2 at a time, pretty much every 4 weeks". Therapeutic measures were not taken as a result of oral herpes.  Additional Information: No other vaccine in four weeks. Adverse event: Every month since 2nd dose i have gotten a cold sore on my lip sometimes 2 at a time, pretty much every 4 weeks. Before the vaccine I got cold sores but 1-2 every 18 months or so. My mom got shingles after Pfizer vaccine too (she had the shingles vaccine about 2 years ago), maybe the gene, she has already filled out this form. Just thought I would let you know, it was not life threatening but it was a pain to have them all the time it seems like, the last as long as a normal cold sore 5-7 days or so. but before my COVID vaccine I never in my life have 2 at one time. It started about a week after my 2nd dose.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: My mom got shingles after Pfizer vaccine too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "My mom got shingles after Pfizer vaccine too".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Hypoaesthesia oral
Clinical narrative: I have lost my sense of taste across the middle part of my tongue. It also feels a bit numb; I have lost my sense of taste across the middle part of my tongue. It also feels a bit numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2022 09:30 (Lot number: FJ6369) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID prior vaccination: Yes" (unspecified if ongoing), notes: COVID prior vaccination: Yes; "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. Vaccination history included: Bnt162b2 (prev dose product= COVID 19,, prev dose brand= Pfizer,, prev dose lot number= ER8737,, prev dose administration time= 08:30 AM,, prev dose-dose number= 1,, prev dose vaccine location= Left arm), administration date: 07Apr2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (prev dose product= COVID 19,, prev dose brand= Pfizer,, prev dose lot number= EW0176,, prev dose administration time= 08:30 AM,, prev dose-dose number= 2,, prev dose vaccine location= Right arm), administration date: 28Apr2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA ORAL (non-serious), AGEUSIA (non-serious) all with onset 24Mar2022 09:00, outcome "not recovered" and all described as "I have lost my sense of taste across the middle part of my tongue. It also feels a bit numb". Therapeutic measures were not taken as a result of hypoaesthesia oral, ageusia.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: I have lost my sense of taste across the middle part of my tongue.  It also feels a bit numb. AE resulted in: None of the above. Since the vaccination, has the patient been tested for COVID-19: No. Known allergies: No  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I developed Tinnitus after the first two doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0171) at the age of 48 years as dose 2, single and administered in arm left, administration date 08Apr2021 (Lot number: ER8737) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Relapsing Remitting Multiple Sclerosis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Droperidol, reaction: "Allergy". The following information was reported: TINNITUS (disability) with onset Jun2021, outcome "not recovered", described as "I developed Tinnitus after the first two doses". The event "i developed tinnitus after the first two doses" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus including Course of high dose steroids.  Follow up information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Type I hypersensitivity
Clinical narrative: experienced reactivity (IgE type); Initial information received on 21-Mar-2022 regarding an unsolicited valid  serious case received from a pharmacist via call center.  This case involves an unknown age and unknown gender patient who experienced reactivity (ige type) while receiving vaccine influenza quadrival a-b vaccine [Fluzone qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Latex allergy.   On an unknown date, the patient received a  dose of suspect influenza quadrival a-b vaccine [fluzone qiv].(batch lot UI433AA;expiry date :23-Sep-2015)(unknown dosage strength, route of administration, formulation) in unknown administration site. for immunization.  On an unknown date the patient developed a serious experienced reactivity (ige type) (Type I hypersensitivity ) (unknown latency) following the administration of influenza quadrival a-b vaccine. This event was assessed as medically significant.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced reactivity (IgE type)).  At time of reporting, the outcome was Unknown for the event (experienced reactivity (IgE type).; Sender's Comments: Sanofi Company Comment dated (24-Mar-2022) This case involves an unknown age and unknown gender patient who experienced reactivity (ige type) while receiving vaccine influenza quadrival a-b vaccineAdditional information regarding condition at the time of vaccination, medical history, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: patient received FLUBLOK that was under the age of 18 with no reported adverse event; Initial information received  on 22-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who received flublok that was under the age of 18 with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Mar-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine 0.5 ml Single-dose prefilled syringe at a dose of 0.5 ml total once (lot : QFAA2126; expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 01-MAR-2022, the patient received influenza quadrivalent recombinant vaccine that was under the age of 18 with no reported adverse event (off label use) (latency: same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.
Age: 0.5
Sex: F
Vaccine: IPV
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: if she needs to give another dose of IPOL as she has given the last dose from a MDV of IPOL that is the 11th dose from the vial and it is only half filled with no reported adverse event; Initial information received on 24-Mar-2022 regarding an unsolicited valid non-serious case from a nurse via call center.  This case involves a 6months old female, and it was reported that "if she needs to give another dose of ipol as she has given the last dose from a mdv of ipol that is the 11th dose from the vial and it is only half filled no reported adverse event" while receiving vaccine IPV (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) for Immunisation.  On 23-Mar-2022, the patient received a 3rd dose of suspect IPV (VERO) (batch number: T1E872M) at a dose of 0.5 ml via intramuscular route in the left thigh (formulation, strength, expiration date: unknown) for immunization.  On 23-Mar-2022, it was reported that "if she needs to give another dose of ipol as she has given the last dose from a mdv of ipol that is the 11th dose from the vial and it is only half filled with no reported adverse event" (incorrect dose administered) following the administration of IPV (VERO).  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event (incorrect dose administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.