chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Mental impairment, Movement disorder, Pain, Pyrexia
Clinical narrative: a foggy feeling in my head that made it hard to think; woke up with my eyes crusted shut; my whole body aching so severely that I could barely move; my whole body aching so severely that I could barely move; a foggy feeling in my head that made it hard to think; severe dizziness that affected my ability to drive; severe dizziness that affected my ability to drive; loss of appetite; I also experienced some bruising at the injection site; I experienced a fever of 101.1; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: FF2587), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 2, single for COVID-19 immunisation. The patient's medical history included IBS, asthma, cholecystectomy since an unknown date. The patient did not have covid prior to the vaccination. The patient did not have any known allergies. Concomitant medication(s) included dicycloverine hydrochloride (BENTYL) and ferrous sulphate since an unknown date. The patient previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: 30145BA), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 1, single for COVID-19 immunisation and experienced moderate dizziness, low grade fever, arm aches, and mild swelling at the injection site. No other vaccine was taken in in four weeks. The patient experienced her symptoms the day after the shot. She woke up with her eyes crusted shut, her whole body aching so severely that she could barely move, loss of appetite, a foggy feeling in her head that made it hard to think, and she experienced a fever of 101.1 and severe dizziness that affected her ability to drive. She also experienced some bruising at the injection site but that was to be expected. These adverse effects however only lasted 1 to 3 days and afterward she was fine. The patient did not take any treatment for the events. The patient underwent lab tests and procedures which included body temperature as 101.1 on an unknown date. The patient was not tested for COVID-19 post vaccination. The outcome of all the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: a foggy feeling in my head that made it hard to think; woke up with my eyes crusted shut; my whole body aching so severely that I could barely move; my whole body aching so severely that I could barely move; a foggy feeling in my head that made it hard to think; severe dizziness that affected my ability to drive; severe dizziness that affected my ability to drive; loss of appetite; I also experienced some bruising at the injection site; I experienced a fever of 101.1; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: FF2587), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 2, single for COVID-19 immunisation. The patient's medical history included IBS, asthma, cholecystectomy since an unknown date. The patient did not have covid prior to the vaccination. The patient did not have any known allergies. Concomitant medication(s) included dicycloverine hydrochloride (BENTYL) and ferrous sulphate since an unknown date. The patient previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: 30145BA), via an unspecified route of administration, in arm left on an unspecified date at 10:00 as dose 1, single for COVID-19 immunisation and experienced moderate dizziness, low grade fever, arm aches, and mild swelling at the injection site. No other vaccine was taken in in four weeks. The patient experienced her symptoms the day after the shot. She woke up with her eyes crusted shut, her whole body aching so severely that she could barely move, loss of appetite, a foggy feeling in her head that made it hard to think, and she experienced a fever of 101.1 and severe dizziness that affected her ability to drive. She also experienced some bruising at the injection site but that was to be expected. These adverse effects however only lasted 1 to 3 days and afterward she was fine. The patient did not take any treatment for the events. The patient underwent lab tests and procedures which included body temperature as 101.1 on an unknown date. The patient was not tested for COVID-19 post vaccination. The outcome of all the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: shortness of breath; asthma; This is a spontaneous report from a contactable other HCP. This 32-year-old female other HCP (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in right arm on 31Oct2021 at 11:15 (at the age of 32 years) as dose 1, single for covid-19 immunisation. Patient's was not pregnant at the time of vaccination. Medical history included known allergies. Patient had other medications in two weeks. Patient had other vaccine in four weeks. Concomitant medication(s) included influenza vaccine (Influenza Quadrivalent Preservative Free) via intramuscular (IM) at left arm taken for an unspecified indication from 29Oct2021 at 12:00 PM. No covid prior and post vaccination. The patient experienced shortness of breath with asthma on 31Oct2021 at 12:00. Shortness of breath-trigger asthma reaction which was not resolving. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The seriousness of events was non-serious. Therapeutic measures were taken as a result of events included Ventokin HFA inhaler prescriber. The outcome of events was not recovered.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Off label use
Clinical narrative: she started bleeding as if she has a period and it hasn't stopped.; her 8 year old daughter got her first dose on nov 5th; This is a spontaneous report from a contactable consumer or other non health care professional . A 8-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 05Nov2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccine in four weeks. It was unknown if the patient had covid-19 prior to vaccination and it was unknown if the patient had tested for covid-19 post vaccination. It was reported that, the patient got her first dose on nov 5th and next day (06Nov2021) she started bleeding as if she had a period and it has not stopped. It was unknown if the patient received any treatment for the events. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: She has a superficial clot, not a deep vein clotted, not in the vascular system; This is a spontaneous report from a contactable pharmacist reported for a female patient. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported; NDC/ UPC number/ Expiry date: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported that (patient) she has a superficial clot, not a deep vein clotted, not in the vascular system on an unspecified date. Additional information included reporter (pharmacist, United States) from a pharmacy stated that they have had a patient to get her second Pfizer COVID Vaccine. Reported, patient has a superficial clot, not a deep vein clotted, not in the vascular system. So, wanted to know the protocol. When asked about date of first vaccination, pharmacist replied as they don't have that right in front and wanted to know the recommendation if they should proceed with the vaccine or not. When probed, pharmacist said no information about lot number was available. The outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Gotten her third dose; contracting COVID-19; contracting COVID-19; This is a spontaneous report from a contactable other HCP. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 (booster) via an unspecified route of administration on an unspecified date (at the age of 44 years) (Batch/Lot number was not reported) as a single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient contracted COVID-19. She has completed 2 doses of Pfizer and has gotten her third dose as well. Outcome of the events was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Covid-19 and Drug ineffective cannot be completely excluded. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for SARS CoV 2 RNA; collected on 15Nov2021; Resulted on 17Nov2021; Tested Positive for SARS CoV 2 RNA; collected on 15Nov2021; Resulted on 17Nov2021; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), intramuscular on 24Mar2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. Past drug included Macrobid and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The historic vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), intramuscular on 02Mar2021 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient tested positive for sars cov 2 rna; collected on 15nov2021; resulted on 17nov2021. No treatment was received due to adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Nov2021. Outcome of the event was Recovering.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure has significantly increased / Started seeing high blood pressure after June 145/90 / seeing high from June; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included low blood pressure until Feb2021. On an unknown date in Feb2021, the patient had her physicals done and her blood pressure was normal 120/80 (unspecified units). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Jun2021, the patient's blood pressure had significantly increased and she started seeing high blood pressure; she had high blood pressure of 145/90 (unspecified units) after Jun2021; nothing else changed other than the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On an unknown date in Jun2021, the patient underwent blood pressure test and the result was 145/90 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blood pressure had significantly increased, she started seeing high blood pressure and started seeing high blood pressure of 145/90 (unspecified units) after Jun2021 was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Retinal tear, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test type post vaccination:Blood test, covid test result:Positive; covid test type post vaccination:Blood test, covid test result:Positive; Torn retina in left eye; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at the age of 80-years-old) (Batch/Lot Number: E19262) as DOSE 2, SINGLE for covid-19 immunisation. There was no medical history and were no concomitant medications. On 10Feb2021, the patient experienced BNT162B2 for COVID-19 immunisation (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left). On 11May2021, the patient experienced torn retina in left eye (disability, life threatening). On 04Oct2021, the patient covid test type post vaccination:Blood test, covid test result:Positive (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Oct2021. Therapeutic measures were taken as a result of torn retina in left eye (retinal tear). The outcome of the event Torn retina in left eye was not recovered, while unknown for the other events.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chest pain, Chills, Ear pain
Clinical narrative: Headache; Earache; Upper and lower backache; Chills; Muscle pain from head to toe; Sensitive to light; Super sore arm; Pain down my right arm near the injection site; Pain down my right arm near the injection site as well as on the opposite side of arm into armpit; Fatigue; Foggy head; Random chest pains; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 16Nov2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included norethisterone (NORETHINDRONE) for an unknown indication, from an unknown date and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 25Jan2021 at 15:30 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 15Feb2021 at 15:30 (at the age of 39-years-old); both as single dose for COVID-19 immunisation and did not have any symptoms with the first two vaccines. On 17Nov2021 at 06:00, the patient experienced headache, earache, upper and lower backache, chills, muscle pain from head to toe, was sensitive to light, had super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit. The pains continued for 48 hours (as reported). The patient also had fatigue and a foggy head and random chest pains. The patient was concerned and worried that this could be more serious. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, earache, upper and lower backache, chills, muscle pain from head to toe, sensitive to light, super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit, fatigue and a foggy head and random chest pains was resolving at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Immunisation, Myalgia
Clinical narrative: Headache; Earache; Upper and lower backache; Chills; Muscle pain from head to toe; Sensitive to light; Super sore arm; Pain down my right arm near the injection site; Pain down my right arm near the injection site as well as on the opposite side of arm into armpit; Fatigue; Foggy head; Random chest pains; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 16Nov2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included norethisterone (NORETHINDRONE) for an unknown indication, from an unknown date and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 25Jan2021 at 15:30 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 15Feb2021 at 15:30 (at the age of 39-years-old); both as single dose for COVID-19 immunisation and did not have any symptoms with the first two vaccines. On 17Nov2021 at 06:00, the patient experienced headache, earache, upper and lower backache, chills, muscle pain from head to toe, was sensitive to light, had super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit. The pains continued for 48 hours (as reported). The patient also had fatigue and a foggy head and random chest pains. The patient was concerned and worried that this could be more serious. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, earache, upper and lower backache, chills, muscle pain from head to toe, sensitive to light, super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit, fatigue and a foggy head and random chest pains was resolving at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Photosensitivity reaction, Vaccination site pain
Clinical narrative: Headache; Earache; Upper and lower backache; Chills; Muscle pain from head to toe; Sensitive to light; Super sore arm; Pain down my right arm near the injection site; Pain down my right arm near the injection site as well as on the opposite side of arm into armpit; Fatigue; Foggy head; Random chest pains; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 16Nov2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included norethisterone (NORETHINDRONE) for an unknown indication, from an unknown date and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 25Jan2021 at 15:30 (at the age of 39-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 15Feb2021 at 15:30 (at the age of 39-years-old); both as single dose for COVID-19 immunisation and did not have any symptoms with the first two vaccines. On 17Nov2021 at 06:00, the patient experienced headache, earache, upper and lower backache, chills, muscle pain from head to toe, was sensitive to light, had super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit. The pains continued for 48 hours (as reported). The patient also had fatigue and a foggy head and random chest pains. The patient was concerned and worried that this could be more serious. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, earache, upper and lower backache, chills, muscle pain from head to toe, sensitive to light, super sore arm, pain down right arm near the injection site as well as on the opposite side of arm into armpit, fatigue and a foggy head and random chest pains was resolving at the time of this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: Immediate sweating; Dizziness; Shortness of breath; Rash developed within the next 12 hours; Face swelling; Arm swelling at injection site; Body aches; Chills; Headache; Nausea following next 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0514) via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) and asthma. The patient was allergic to multiple medications, lactose, bees, and multiple environmental factors. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 18Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 08Jan2021, the patient experienced immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling, arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling and arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours was resolved on an unknown date in 2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rash, SARS-CoV-2 test, Swelling face
Clinical narrative: Immediate sweating; Dizziness; Shortness of breath; Rash developed within the next 12 hours; Face swelling; Arm swelling at injection site; Body aches; Chills; Headache; Nausea following next 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0514) via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) and asthma. The patient was allergic to multiple medications, lactose, bees, and multiple environmental factors. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 18Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 08Jan2021, the patient experienced immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling, arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling and arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours was resolved on an unknown date in 2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Immediate sweating; Dizziness; Shortness of breath; Rash developed within the next 12 hours; Face swelling; Arm swelling at injection site; Body aches; Chills; Headache; Nausea following next 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0514) via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD) and asthma. The patient was allergic to multiple medications, lactose, bees, and multiple environmental factors. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 18Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 08Jan2021, the patient experienced immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling, arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events immediate sweating, dizziness, shortness of breath, rash developed within the next 12 hours, face swelling and arm swelling at injection site, body aches, chills, headache, and nausea following next 24 hours was resolved on an unknown date in 2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness of right arm; Tingling of right arm and right side of face; Feeling dizzy or faint like; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PH8028) via an unspecified route of administration in the right arm on 20Nov2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not take any concomitant medication. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Nov2021 at 14:45, the patient experienced numbness and tingling of right arm and right side of face after feeling dizzy or faint like. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness and tingling of right arm and right side of face after feeling dizzy or faint like was not resolved at the time of the report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Feeding disorder, Headache
Clinical narrative: Chest pain; Elevated BP; Nausea; Headache; Vaccine location=Left leg; 2 heart attacks; Couldn't eat; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162B2 (COMIRNATY, Lot EW6175, second dose) solution for injection intramuscular in left thigh on 30Aug2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunization. Medical history included AAA (abdominal aortic aneurysm) repair and had several stents. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EW0182) for Covid-19 immunization on 30Jul2021 and experienced increase joint pain, tired, weak and no energy. On 30Aug2021, the patient experienced chest pain, elevated BP (blood pressure), nausea, and headache. In 2021, the patient experienced 2 heart attacks and couldn't eat. Treatment for events chest pain included nitro and elevated BP medication.  The outcome of the events chest pain, elevated BP, nausea, and headache was recovered on 18Sep2021. The outcome of the events heart attacks and couldn't eat was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Nausea, Product administered at inappropriate site
Clinical narrative: Chest pain; Elevated BP; Nausea; Headache; Vaccine location=Left leg; 2 heart attacks; Couldn't eat; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162B2 (COMIRNATY, Lot EW6175, second dose) solution for injection intramuscular in left thigh on 30Aug2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunization. Medical history included AAA (abdominal aortic aneurysm) repair and had several stents. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EW0182) for Covid-19 immunization on 30Jul2021 and experienced increase joint pain, tired, weak and no energy. On 30Aug2021, the patient experienced chest pain, elevated BP (blood pressure), nausea, and headache. In 2021, the patient experienced 2 heart attacks and couldn't eat. Treatment for events chest pain included nitro and elevated BP medication.  The outcome of the events chest pain, elevated BP, nausea, and headache was recovered on 18Sep2021. The outcome of the events heart attacks and couldn't eat was unknown.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Induration, Rash
Clinical narrative: chicken pox type reaction/white red blister/red spots; This spontaneous report was received from a 69-year-old patient via Glaxosmithkline GlaxoSmithKline,reporting on herself. Medical history included that she had a total of 4 Shingles outbreaks, starting in the 1970's. Information regarding concurrent conditions and concomitant medication was not provided.  In September 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dosage information, route, lot number and expiration date were not reported).  On 26-AUG-2021, at at 12:30 PM, the patient was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 (unk) (dosage information, route, lot number and expiration date were not reported).     On 26-AUG-2021, at 11:30 PM that evening, she had 10 or 11 red spots all over her body (one or two spots on each arm, one or two on each leg and one of her chest), then she developed a firm red, whitish raised blister, called the doctor and she said it was a chicken pox type reaction. The patient took diphenhydramine  (BENADRYL) by mouth and used hot and ice compress, all the spots and the blister went away in 6 or 7 days. The outcome of rash vesicular was unknown. The causality assessment was not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: chicken pox type reaction/white red blister/red spots; This spontaneous report was received from a 69-year-old patient via Glaxosmithkline GlaxoSmithKline,reporting on herself. Medical history included that she had a total of 4 Shingles outbreaks, starting in the 1970's. Information regarding concurrent conditions and concomitant medication was not provided.  In September 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dosage information, route, lot number and expiration date were not reported).  On 26-AUG-2021, at at 12:30 PM, the patient was vaccinated with the first dose of varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 (unk) (dosage information, route, lot number and expiration date were not reported).     On 26-AUG-2021, at 11:30 PM that evening, she had 10 or 11 red spots all over her body (one or two spots on each arm, one or two on each leg and one of her chest), then she developed a firm red, whitish raised blister, called the doctor and she said it was a chicken pox type reaction. The patient took diphenhydramine  (BENADRYL) by mouth and used hot and ice compress, all the spots and the blister went away in 6 or 7 days. The outcome of rash vesicular was unknown. The causality assessment was not provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired dose of RECOMBIVAX HB was administered; No adverse event; This spontaneous report as received from a Nurse referrin to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.  On 02-NOV-202, the patient was vaccinated with an expired dose of Hepatitis B vaccine (recombinant)(RECOMBIVAX HB) (Lot # S022584, expiration date 31-OCT-2021) dosage, route of administration and anatomical location were not provided used to prevent hepatitis B.  No additional Adverse events and no product quality complaints (PQCs) were reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA000981:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a patient via a social media via a company representative concerned multiple patients of unknown race and ethnicity. 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 not reported, batch number: unknown, expiry: unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On17-NOV-2021, it was reported on that 3 patients died after being fully vaccinated. Reporter stated that "I know three who died. All fully vaxd". The cause of death was unknown. It was unknown if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.   This report was serious (Death).; Sender's Comments: V0: 20211142701-Covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Magnetic resonance imaging, Neurosensory hypoacusis, Tinnitus
Clinical narrative: Sudden Sensorineural Hearing Loss / mild hearing loss; tinnitus/roaring sound; This spontaneous case was reported by a consumer and describes the occurrence of NEUROSENSORY HYPOACUSIS (Sudden Sensorineural Hearing Loss / mild hearing loss) and TINNITUS (tinnitus/roaring sound) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced TINNITUS (tinnitus/roaring sound). On 05-Oct-2021, the patient experienced NEUROSENSORY HYPOACUSIS (Sudden Sensorineural Hearing Loss / mild hearing loss). At the time of the report, NEUROSENSORY HYPOACUSIS (Sudden Sensorineural Hearing Loss / mild hearing loss) and TINNITUS (tinnitus/roaring sound) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2021, Acoustic stimulation tests: abnormal (abnormal) abnormal. On an unknown date, Magnetic resonance imaging: normal (normal) she had a MRI to rule out a tumor and result was normal with no findings..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced tinnitus which was described as a roaring sound like a clothes dryer running all the time and never goes away.  On 05-Oct-2021 the caller stated she went to see an ENT Doctor and was diagnosed with Sudden Sensorineural Hearing Loss after having a hearing test. She stated it was a mild hearing loss and didn't need a hearing aid.  The caller also reported she had Multiple Sclerosis and the results were normal with no findings. The caller did not receive the second Moderna COVID-19 dose. Concomitant product use was not provided by reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; Developed rash on her arm, chest and stomach; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH (Developed rash on her arm, chest and stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching) and RASH (Developed rash on her arm, chest and stomach). At the time of the report, PRURITUS (Itching) and RASH (Developed rash on her arm, chest and stomach) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Muscular weakness
Clinical narrative: Felt weak in arms (and fingers) and leg; Stuck between bed and nightstand for extended periods/ thinks she was stuck until the morning/ could not seek help as she could not move; Headache; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULAR WEAKNESS (Felt weak in arms (and fingers) and leg), MOBILITY DECREASED (Stuck between bed and nightstand for extended periods/ thinks she was stuck until the morning/ could not seek help as she could not move) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 011620A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Varicose vein (On observation, no treatment or follow up.), Type 2 diabetes mellitus, Hypertension, Edema and Hypothyroidism. Concomitant products included GLICLAZIDE (DIAZIDE [GLICLAZIDE]) for Edema, PROPRANOLOL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, METFORMIN for Type 2 diabetes mellitus.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Felt weak in arms (and fingers) and leg) and MOBILITY DECREASED (Stuck between bed and nightstand for extended periods/ thinks she was stuck until the morning/ could not seek help as she could not move). In November 2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. On 14-Nov-2021, MUSCULAR WEAKNESS (Felt weak in arms (and fingers) and leg) and MOBILITY DECREASED (Stuck between bed and nightstand for extended periods/ thinks she was stuck until the morning/ could not seek help as she could not move) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 8 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 8 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 8 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 8 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the vial was kept under Moderna recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date . No treatment medication was reported.