chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dyspnoea, Fatigue, Palpitations
Clinical narrative: injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself.  This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself.  This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Ear discomfort
Clinical narrative: 16% loss of hearing; Fullness in ear on the injection side (left); This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 13Jan2021 at 11:30 at a single dose on left arm for COVID-19 immunisation. Medical history included breast cancer, lymphedema (right arm) and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR). The patient experienced 16% loss of hearing and fullness in ear on the injection side (left) on 14Jan2021 at 17:00. The patient underwent lab tests and procedures which included acoustic stimulation tests: 16 % (16% loss of hearing) on 14Jan2021. Therapeutic measures were taken as a result of 16% loss of hearing and fullness in ear on the injection side (left). The outcome of the events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Jaw disorder, Trismus
Clinical narrative: jaw spasms on the left side of face near TMJ; Involuntary jaw closing; This is a spontaneous report from a contactable consumer (patient) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 29Jan2021 17:45 at a single dose for covid-19 immunization. The vaccine was administered at the Health Department. The patient also received the first dose of other vaccine (reported as Pfizer brand) via an unspecified route of administration on the right arm on 29Jan2021. Medical history included tinnitus from an unknown date, and allergy from quinoa. Patient is not pregnant at the time of the vaccination. Concomitant medications included ergocalciferol (VIT D), and fexofenadine hydrochloride (ALLEGRA). The patient previously took, neosporin [neomycin sulfate;polymyxin b sulfate] and experienced drug allergy. On 02Feb2021 08:00, the patient experienced jaw spasms on the left side of face near TMJ, and involuntary jaw closing when teeth were very close to each other. The reported events was resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318; expiry date: not known), via an unspecified route of administration in the left arm on 01Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT) and allergies to sulfa drugs. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously took amoxicillin, clavulanate potassium (AUGMENTIN) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced atrial fibrillation on 01Feb2021 17:45. No treatment received for this event. The outcome of the event was recovered on an unspecified date in Feb2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Passed out and fell to the floor before daylight; Passed out and fell to the floor before daylight; Dizziness; This is a spontaneous report from a contactable consumer (patient's spouse).   A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265) on 01Feb2021 at 13:15 at single dose intramuscular COVID-19 immunization. Relevant medical history included Alzheimer's disease diagnosed about 5-6 years ago, seizure (diagnosed 40 years ago) and ongoing high blood pressure. Concomitant medications were not reported. On 02Feb2021 patient passed out and fell before daylight morning, it may be around 06:00-07:00 (as reported). Patient's spouse informed that  got up early and was already up when she called him to tell him she had fallen. She sleeps a lot anyway, so she was  just put back to bed. Reporter didn't known exactly when she was up again. It was also informed that several of the medications that she took have side effects like dizziness (as reported).  At the time of the reporting event outcome was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Eye pruritus, Eye swelling, Lip swelling, Mouth swelling
Clinical narrative: Face was swollen; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Itching around my neck ears and eyes; Itching around my neck ears and eyes; Itching around my neck ears and eyes; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 28Jan2021 14:00 at a single dose in the left arm for COVID-19 immunisation. Medical history included multiple sclerosis and environmental allerges. Concomitant medications included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC), montelukast, and other unspecified medications. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL3246) on 07Jan2021 11:00 on the left arm. After the first dose, the patient formed a sty on her right eye and it is still there three weeks later. After second dose, the patient started itching around her neck, ears, and eyes on the day after injection, on 29Jan2021 10:00. By the third day, on 30Jan2021, when she woke up, her face was swollen, especially eyes and then her mouth and lips started swelling and the itching worsened. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient recovered from the events on an unspecified date. Treatment received for the adverse events was Depo-Medrol Injection. The events were reported as non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: Face was swollen; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Itching around my neck ears and eyes; Itching around my neck ears and eyes; Itching around my neck ears and eyes; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 28Jan2021 14:00 at a single dose in the left arm for COVID-19 immunisation. Medical history included multiple sclerosis and environmental allerges. Concomitant medications included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC), montelukast, and other unspecified medications. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL3246) on 07Jan2021 11:00 on the left arm. After the first dose, the patient formed a sty on her right eye and it is still there three weeks later. After second dose, the patient started itching around her neck, ears, and eyes on the day after injection, on 29Jan2021 10:00. By the third day, on 30Jan2021, when she woke up, her face was swollen, especially eyes and then her mouth and lips started swelling and the itching worsened. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient recovered from the events on an unspecified date. Treatment received for the adverse events was Depo-Medrol Injection. The events were reported as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal death, Heart rate, Human chorionic gonadotropin, Off label use, Product use issue
Clinical narrative: embryonic demise/loss of pregnancy; patient was pregnant at the time of vaccination of the second dose; patient was pregnant at the time of vaccination of the second dose; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284), intramuscular in the left arm on 12Jan2021 at 08:00 at a single dose, received in the Doctor's office/urgent care for covid-19 immunisation. Medical history included anxiety and allergies: gets hives from anything cold (fluid, food, air) that touches her. Concomitant medication included venlafaxine for anxiety. The patient was pregnant at the time of vaccination of the second dose, last menstrual date was 23Nov2020, delivery date was 30Aug2021, gestation period was 7 weeks. The patient experienced embryonic demise/loss of pregnancy in Jan2021, patient was hospitalized for 1 day and treatment was received for the event. The patient underwent lab tests and procedures which included didn't see a fetal heartbeat at 6 week on u/s, and 7 weeks still no heartbeat on u/s, HCG didn't go down until second u/s, so fetal demise occurred between 6 -7 weeks, D&C performed and no genetic abnormalities were found in fetal tissue. Doctor and patient, who is a nurse, do not think the fetal demise is related to the vaccine, but wanted to document the loss for data in case they would start to see a trend. The patient does not intend to pursue further investigation into the vaccine as a cause. After the first dose (received on 21Dec2020 at 08:00, the patient had a sore arm and then two days later found out she was pregnant. The doctor discussed with patient and pharmacist whether to get second dose. Patient is a nurse and decided to get second dose. No major symptoms were reported after second dose until the miscarriage. The patient recovered from the event with lasting effects/sequel.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine dilation and curettage
Clinical narrative: embryonic demise/loss of pregnancy; patient was pregnant at the time of vaccination of the second dose; patient was pregnant at the time of vaccination of the second dose; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284), intramuscular in the left arm on 12Jan2021 at 08:00 at a single dose, received in the Doctor's office/urgent care for covid-19 immunisation. Medical history included anxiety and allergies: gets hives from anything cold (fluid, food, air) that touches her. Concomitant medication included venlafaxine for anxiety. The patient was pregnant at the time of vaccination of the second dose, last menstrual date was 23Nov2020, delivery date was 30Aug2021, gestation period was 7 weeks. The patient experienced embryonic demise/loss of pregnancy in Jan2021, patient was hospitalized for 1 day and treatment was received for the event. The patient underwent lab tests and procedures which included didn't see a fetal heartbeat at 6 week on u/s, and 7 weeks still no heartbeat on u/s, HCG didn't go down until second u/s, so fetal demise occurred between 6 -7 weeks, D&C performed and no genetic abnormalities were found in fetal tissue. Doctor and patient, who is a nurse, do not think the fetal demise is related to the vaccine, but wanted to document the loss for data in case they would start to see a trend. The patient does not intend to pursue further investigation into the vaccine as a cause. After the first dose (received on 21Dec2020 at 08:00, the patient had a sore arm and then two days later found out she was pregnant. The doctor discussed with patient and pharmacist whether to get second dose. Patient is a nurse and decided to get second dose. No major symptoms were reported after second dose until the miscarriage. The patient recovered from the event with lasting effects/sequel.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Muscle spasms, Nausea, Syncope, Vomiting
Clinical narrative: Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Dizziness
Clinical narrative: a loss of vision in left eye that lasted for about three minutes; Dizzy sell; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 12Jan2021 08:15 at single dose in left arm for COVID-19 immunisation. Medical history included had surgery for a torn rotator cuff on 07Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) only at night a few days before taking the shot for post-operative pain control. Two days after BNT162B2 (14Jan2021 14:00), patient had a loss of vision in left eye that lasted for about three minutes and had a dizzy sell that lasted for forty-five minutes after getting out of the hot tub. It was unknown if treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. Doctors had no explanation at this time and had no idea if it was related to the injection. Outcome of the events was resolved on 14Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; This is a spontaneous report from a contactable nurse (reporting for herself). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3302), at age 35 years, via an unspecified route of administration on the left arm, second dose on 29Jan2021, at single dose, for COVID-19 immunization. Medical history included breast feeding from an unknown date and unknown if ongoing, and COVID-19 on unspecified dates diagnosed prior to vaccination. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took BNT162B2 on 08Jan2021 at age 35 years for COVID-19 immunization. On 02Feb2021, 4 days after the second dose, the patient experienced dizziness, nausea and was diagnosed with vertigo when seen in ER. The adverse event resulted in emergency room/department or urgent care visit. Treatment received for the adverse event includes IV fluids and meclizine.  Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The outcome of the event was recovering/resolving. Case was reported as non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Immunoglobulins, Influenza like illness, Malaise, Off label use
Clinical narrative: has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; General feeling of malaise; Prickly feeling through body; General Flu-type feeling; Fever of 101 degrees; This is a spontaneous report from a contactable other healthcare professional (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9251), via an unspecified route of administration on 20Jan2021 07:00 at 0.3 mL, single on left arm to prevent COVID virus (COVID-19 immunization). Medical history included myasthenia gravis, and an ongoing autoimmune disorder. Patient has no family medical history. There were no concomitant medications. The patient did not receive any other vaccines 4 weeks prior to COVID vaccination. The patient did not receive additional vaccines on the same date as Pfizer suspect. On 20Jan2021, the patient experienced general feeling of malaise, prickly feeling through his body, which lasted a few hours and fever of 101 degrees. On the same day (20Jan2021), patient had general flu-type feeling that lasted the whole day. He was fine the next morning (21Jan2021), when he woke up. The events were considered serious and medically significant by the reporter. The events did not require a visit to a physician or to an emergency room. The patient underwent Gammunoglobulin blood test with unknown results on an unspecified date. The patient recovered from general malaise, prickly feeling through the body, general flu-type feeling, and fever of 101 degrees on 21Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Product use issue, Pyrexia
Clinical narrative: has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; has an autoimmune disease/Myasthenia gravis and was given bnt162b2 vaccine; General feeling of malaise; Prickly feeling through body; General Flu-type feeling; Fever of 101 degrees; This is a spontaneous report from a contactable other healthcare professional (patient). A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9251), via an unspecified route of administration on 20Jan2021 07:00 at 0.3 mL, single on left arm to prevent COVID virus (COVID-19 immunization). Medical history included myasthenia gravis, and an ongoing autoimmune disorder. Patient has no family medical history. There were no concomitant medications. The patient did not receive any other vaccines 4 weeks prior to COVID vaccination. The patient did not receive additional vaccines on the same date as Pfizer suspect. On 20Jan2021, the patient experienced general feeling of malaise, prickly feeling through his body, which lasted a few hours and fever of 101 degrees. On the same day (20Jan2021), patient had general flu-type feeling that lasted the whole day. He was fine the next morning (21Jan2021), when he woke up. The events were considered serious and medically significant by the reporter. The events did not require a visit to a physician or to an emergency room. The patient underwent Gammunoglobulin blood test with unknown results on an unspecified date. The patient recovered from general malaise, prickly feeling through the body, general flu-type feeling, and fever of 101 degrees on 21Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a lawyer in the.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that patient got one flu shot around seven years ago, never been that sick in life. Have not got a flu shot since and have not got that sick so.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: allergies; Initial information regarding an unsolicited valid non-serious case was received from physician (Reference number- 00448644) and transmitted to Sanofi on 27-Jan-2021.  This case involves patient (age and gender not specified) who had allergies (hypersensitivity), while patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergies (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild soreness at site of injection.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills and muscle aches about 16 hours after injection continued chills and myalgia along with headaches about 24 hours after injection  at 30 hours after injection symptoms  persist
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Started with slight itching Sunday afternoon.  By Monday evening swelling and warm to touch at injection site.  Tuesday morning,swelling area hard to touch and some pain around swelling.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Skin swelling, Skin warm
Clinical narrative: A red bump about 2 inches long and 1 inch wide. Hot to the touch. Its been over two weeks and I still have a bruise
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Received shot on Friday, February 12 around 1PM.  Saturday, February 13:Approximately 30 hours after receiving shot,  8:00 pm, Saturday, Feb 13, developed stomach cramps.   Over the next 4/5 hours, diarrhea, vomiting, cramps, chills.  Felt very hot at times, but never ran a fever.  Sunday, February 14,  felt tired and weak, periodic cramps. No nausea or diarrhea.  Monday, February 15, more energy, some cramps,  By
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Muscle spasms, Vomiting
Clinical narrative: Received shot on Friday, February 12 around 1PM.  Saturday, February 13:Approximately 30 hours after receiving shot,  8:00 pm, Saturday, Feb 13, developed stomach cramps.   Over the next 4/5 hours, diarrhea, vomiting, cramps, chills.  Felt very hot at times, but never ran a fever.  Sunday, February 14,  felt tired and weak, periodic cramps. No nausea or diarrhea.  Monday, February 15, more energy, some cramps,  By
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Chills, fever, fatigue
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: she had terrible hives; This spontaneous report was received from a female adult consumer of unknown age refering to herself. The patient'sconcurrent conditions included osteoporosis. The patient's concomitant therapies included metoprolol. Information regarding the patient's pertinent medical history, historical drugs and previous drug reactions or allergies was not reported.    On an unknown date (reported as "about 5 or 6 years ago"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot number and expiration date  were not reported). The patient stated that after the vaccine she had terrible hives (urticaria), had to go to the emergency room (ER), and got steroids to treat it. The outcome of urticaria was reported as recovered.         The causal relationship between urticaria and zoster vaccine live (ZOSTAVAX) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other AE/PQC identified; expired dose of MMR administered; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not provided.  On 20-JAN-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters intramuscular route, Lot number S001322 and expiration date 14-JAN-2021 as prophylaxis.  Lot number S001322 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) does not match any company product as confirmed by lot verification team.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE/PQC reported; VARlVAX had been administered via the IM route to a patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.  On 28-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not reported, lot # S031494, expiration date was 07-OCT-2021) intramuscularly (IM) for prophylaxis and sterile diluent (strength and dose were not reported, lot # T006500, expiration date was 16-SEP-2022) intramuscularly for prophylaxis (incorrect route of product administration).
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: she experienced Flu-like symptoms; and had a mild reaction; headache; tiredness; chills; mild fever of 99; she felt out of sorts; This spontaneous report was received from a 54-year-old female patient regarding herself. The patient's concurrent conditions included seasonal allergies, antifungal drug and allergy to iron infusion. The patient's medical history included heart attack.  Concomitant therapy included unspecified blood pression (BP) medicine, clopidogrel bisulfate(PLAVIX) and alprazolam (reported as generic for alprazolam(XANAX)).   On 19-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the arm, lot number T020639, expiration date not reported but upon internal validation established as 13-MAR-2022 (dose, route, and anatomical location were not reported) to prevent pneumonia.   On the same day six hours after vaccination with of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient experienced a mild reaction to the vaccine, flu-like symptoms, headache, tiredness, chills, and a mild fever of 99 (units not reported), she felt out of sorts for four days (influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache). The patient enquired for the ingredients of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because she had pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) the year before (19-OCT-2019) and she did not have any symptoms. The patient sought medical attention by informing the doctor's office and no treatment was given for the events.  At the time of the report, on 23-OCT-2020, the patient had recovered from mood altered and on an unspecified date, she had recovered from the events.  The relatedness between the events of influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: PPV
Symptoms: Mood altered, Pyrexia, Vaccination complication
Clinical narrative: she experienced Flu-like symptoms; and had a mild reaction; headache; tiredness; chills; mild fever of 99; she felt out of sorts; This spontaneous report was received from a 54-year-old female patient regarding herself. The patient's concurrent conditions included seasonal allergies, antifungal drug and allergy to iron infusion. The patient's medical history included heart attack.  Concomitant therapy included unspecified blood pression (BP) medicine, clopidogrel bisulfate(PLAVIX) and alprazolam (reported as generic for alprazolam(XANAX)).   On 19-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the arm, lot number T020639, expiration date not reported but upon internal validation established as 13-MAR-2022 (dose, route, and anatomical location were not reported) to prevent pneumonia.   On the same day six hours after vaccination with of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient experienced a mild reaction to the vaccine, flu-like symptoms, headache, tiredness, chills, and a mild fever of 99 (units not reported), she felt out of sorts for four days (influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache). The patient enquired for the ingredients of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because she had pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) the year before (19-OCT-2019) and she did not have any symptoms. The patient sought medical attention by informing the doctor's office and no treatment was given for the events.  At the time of the report, on 23-OCT-2020, the patient had recovered from mood altered and on an unspecified date, she had recovered from the events.  The relatedness between the events of influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other issues were reported; The patient received his 3rd dose of RECOMBIVAX HB on 03-FEB-2021 and it expired on 24-JAN-2021; This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 03-FEB-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) with expiration date of 24-JAN-2021 (dose, route, anatomical location and lot number were not reported) for prophylaxis. No other issues were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: a dose of expired Pneumovax 23 was administered to a patient; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 11-FEB-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, administered intramuscularly, as prophylaxis, lot number S012245, expiration date 09-FEB-2021 (expired product administered) (frequency and anatomical vaccination site were not provided). The reporter confirmed there were no previous temperature excursions. It was also reported that vaccine was "supported 1 month post expiration date per post expiry memo". Any decision for re-vaccination, would be up to the healthcare provider.  The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report as received from a nurse refers to her sister of unknown age.There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, the patient was vaccinated with 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, route of administration, lot number and expiration date were not reported), unidentified Merck hpv vaccine administered (name not provided).      On an unknown date, the patient experienced syncope. No treatment was given for the adverse event. The patient did not seek medical attention. The outcome of syncope was reported as recovered, on an unknown date.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), unidentified Merck hpv vaccine administered (name not provided) was not reported.No further information was provided    Upon internal review the event syncope was considered to be medically significant.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took last dose of Viviotif a day late; Spontaneous report received on 10JAN2020.  A male consumer "took last dose of Vivotif a day late" (PT: Inappropriate schedule of product administration), while being on Viviotif for immunization. The consumer took the final dose of Vivotif a day late. Action taken with Vivotif with respect to reported event was not applicable. The clinical outcome of the reported event was unknown.  Company Comment: A consumer took his last dose of Vivotif a day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took his last dose of Vivotif a day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Drank coffee within an hour after taking third dose of Vivotif; Spontaneous report received on 14JAN2020.  A nurse reported that a 49-year-old male consumer "drank coffee within an hour after taking third dose of Vivotif" (PT: Product administration error). He was receiving Vivotif for immunisation. The consumer took first two doses of Vivotif on an empty stomach on 10JAN2020 and 12JAN2020 respectively. On 14JAN2020 he drank coffee less than an hour after taking the third dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer drank coffee within an hour of taking his third dose of Vivotif (drug administration error). Vivotif should be taken on an empty stomach with cold or luke warm water and the person should not have a meal for at least one hour after taking Vivotif dose. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer drank coffee within an hour of taking his third dose of Vivotif (drug administration error). Vivotif should be taken on an empty stomach with cold or luke warm water and the person should not have a meal for at least one hour after taking Vivotif dose. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Ate food immediately after first dose and took some doses with coffee; Spontaneous report received on 16JAN2020.  A male consumer reported that he "ate food immediately after first dose and took some doses with coffee" (PT: Product administration error) while being on Vivotif capsule for immunisation. The consumer stated that, he took the first dose of Vivotif and ate food immediately afterwards. He also took some doses of Vivotif with coffee. He had completed the course of Vivotif on 16JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer ate food immediately after taking first Vivotif dose and also took some Vivotif doses with coffee (drug administration error). Vivotif dose should be taken one hour before a meal with cold or luke-warm water. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer ate food immediately after taking first Vivotif dose and also took some Vivotif doses with coffee (drug administration error). Vivotif dose should be taken one hour before a meal with cold or luke-warm water. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away with an hour to hour and 1/2 of receiving vaccine; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away with an hour to hour and 1/2 of receiving vaccine.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient passed away within an hour and a 1/2 of receiving the vaccine. Per the nursing home staff, they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given. The patient was 14+ days post COVID.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   The patient died on an unknown date. The cause of death was unknown.; Reporter's Comments: This case concerns a patient, who experienced event of death (unknown cause). The event occurred  an hour to hour and 1/2 after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.  However, Per the nursing home staff, the patient was 14+ days post COVID and they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given.; Reported Cause(s) of Death: unknown cause of death