chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Facial paralysis, Headache, Nausea, Pain
Clinical narrative: Next day pt felt achy, chest, back, felt dizzy, sharp chest pain, weak, mild nausea, felt like face was drooping, no fever at time, felt very weak, had bad headache, stomach ache, mostly upper epigastric area, no emesis, no rash, had diarrhea, to ED (had fever that night, and next am, none since) 8-6 - admitted x 2 days- normal CT brain, normal CSF, ultrasound kidneys normal, CXR normal, positive rapid strep but had no sore throat, no adenopathy, no rash - released on KEFLEX, TYLENOL, omeprazole, had normal urine culture - after release presents today still some achiness, no weakness in gait, normal exam, but for upper chest wall costochondritis features.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Streptococcus test positive, Ultrasound kidney normal
Clinical narrative: Next day pt felt achy, chest, back, felt dizzy, sharp chest pain, weak, mild nausea, felt like face was drooping, no fever at time, felt very weak, had bad headache, stomach ache, mostly upper epigastric area, no emesis, no rash, had diarrhea, to ED (had fever that night, and next am, none since) 8-6 - admitted x 2 days- normal CT brain, normal CSF, ultrasound kidneys normal, CXR normal, positive rapid strep but had no sore throat, no adenopathy, no rash - released on KEFLEX, TYLENOL, omeprazole, had normal urine culture - after release presents today still some achiness, no weakness in gait, normal exam, but for upper chest wall costochondritis features.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Gait disturbance, Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Extreme pain, unable to walk without difficulty, swelling at injection site. On day 2 (today, 8/10) - there is a huge red welt at the site of the Polio injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Extreme pain, unable to walk without difficulty, swelling at injection site. On day 2 (today, 8/10) - there is a huge red welt at the site of the Polio injection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site oedema, Migraine, Pain
Clinical narrative: About 12 hours after vaccination, patient reports TMAX 103 from 10pm to 7am when it broke and declined to about 101 degrees, bodyaches and headache. Patient reports a low grade fever entire day of 8/9 until about 4pm when it finally broke. Currently has been afebrile since 4pm on 8/9.  Left arm injection side erythematous and edematous and firm. Dimension of redness 5.5 in x 2 in and outlined to continue to monitor spread of redness. Patient reports onset of Migraine about 12 hours after vaccination as well.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: About 12 hours after vaccination, patient reports TMAX 103 from 10pm to 7am when it broke and declined to about 101 degrees, bodyaches and headache. Patient reports a low grade fever entire day of 8/9 until about 4pm when it finally broke. Currently has been afebrile since 4pm on 8/9.  Left arm injection side erythematous and edematous and firm. Dimension of redness 5.5 in x 2 in and outlined to continue to monitor spread of redness. Patient reports onset of Migraine about 12 hours after vaccination as well.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Patient reported fever (100.6) and 1 case of diarrhea upon waking on 8/10/2018. There was no redness, swelling, or pain at injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, shivers, headache, body ache.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Blood urine present, Henoch-Schonlein purpura, Injection site swelling, Protein urine present, Urine albumin/creatinine ratio increased
Clinical narrative: Mother called the day after vaccines were administered stating that patient had a swollen right knee and was unable to bear weight. He was treated conservatively at first without improvement and was eventually admitted to hospital with IgA Vasculitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: Mother called the day after vaccines were administered stating that patient had a swollen right knee and was unable to bear weight. He was treated conservatively at first without improvement and was eventually admitted to hospital with IgA Vasculitis.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 35-month-old patient. There was no information about the patient's pertinent medical history or drug reactions and allergies provided. On an unknown date in 2000 (reported as at age of 15 months), the patient was vaccinated with the first dose of M-M-R II injection for prophylaxis (exact dose, vaccination site, rout of administration, lot and expiration date were not provided). On an unknown date in 2002 (reported as at age of 2 years 11 months), the patient was vaccinated with the second dose of M-M-R II injection for prophylaxis (exact dose, vaccination site, rout of administration, lot and expiration date were not provided). Concomitant therapies included STERILE DILUENT. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JAN-2015, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around August 2016, the patient was treated by a physician for herpes zoster or shingles and zoster related injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Initial information received on 01-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves 05 patients (gender unknown) who received vaccines ADACEL and TENIVAC and while treated with TUBERSOL after an extreme temperature of (-4.2) Celsius. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient started taking TUBERSOL dosage unknown (with an unknown batch number) for Tuberculin test. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported. It was a case of actual medication error due to product storage error. Vaccines were improperly stored and they reached an extreme temperature of (-4.2) Celsius. It was unknown whether patients had any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 01-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case is associated to the case 2018SA138593 (same reporter). This case involves a 61 years old male patient who experienced pain that would be 3 out of 10 (10 being the most pain) (Pain in extremity), while he received vaccine TENIVAC (lot number: U565688, expiry date, dose, dose in series, route of administration was not reported) in the left shoulder on 13-Nov-2017 at a family health center. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient developed a pain which would be 3 out of 10 (10 being the most pain) when he was to catch a ball following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. No lab test reported. Final diagnosis was pain which would be 3 out of 10 (10 being the most pain) when he was to catch a ball. The patient was advised to take either ADVIL OR TYLENOL as corrective treatment. The patient outcome is reported as unknown for the event. List of documents held by sender: none.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash
Clinical narrative: Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 15 years old male patient who experienced rash on both arms and legs, while he received vaccines Diphtheria, Tetanus And Acellular Pertussis Vaccine and Menactra. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number, exp date and dosing details not reported via unknown route in the arm nos and a dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer lot number not reported via unknown route in the arm nos. On an unknown date, in the same evening, following vaccination, the patient developed a non-serious rash on both arms and legs. No lab data was reported. Final diagnosis was rash on both arms and legs. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for rash on both arms and legs.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash
Clinical narrative: Initial unsolicited valid non-serious case received from a physician via Sales Representative on 06-Aug-2018. This case involves a 15 years old male patient who experienced rash on both arms and legs, while he received vaccines MENACTRA and ADACEL. The patients past medical history, medical treatment, vaccination and family history were not provided. On an unknown date in 2011, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious rash on both arms and legs (rash), same day (in the evening) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Other relevant tests were not reported. Final diagnosis was rash on both arms and legs. It was not reported if the patient received a corrective treatment. On an unknown date, patient was recovered from event.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14-day old male patient who was vaccinated with a dose of 0.5 ml PENTACEL (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: YF
Symptoms: Allergy test negative, Granuloma, Immune system disorder, Rash, Rash erythematous
Clinical narrative: Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves a patient (age and gender not reported) who experienced broke out with a skin rash, round, red circles, white centers and sometimes in clusters so that they overlap, md described them as "granuloma", an immune system response and a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf, while he/she received vaccine YF-VAX. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 11-Aug-2017, the patient received a dose of suspect YELLOW FEVER VACCINE lot M51761V (expiry date: 28-Feb-2018, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious broke out with a skin rash (rash) (unknown latency) 48 hours following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious round, red circles, white centers and sometimes in clusters so that they overlap (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious md described them as "granuloma" (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious an immune system response (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf (tissue injury) (unknown latency) following the administration of YELLOW FEVER VACCINE. It was reported that lesions are not itchy, and there is no seepage. Generally they are not painful unless directly impacted by something with a sharp angle. Other relevant tests included Patient had been tested for sensitivity to poultry and eggs, with results being negative. Final diagnosis was a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf, an immune system response, md described them as "granuloma", round, red circles, white centers and sometimes in clusters so that they overlap and broke out with a skin rash. The patient was treated with PREDNISONE. Topical steroid creams have no effect, and in some cases exacerbate the problem. Forty doses of oral prednisone eased some of the symptoms. The patient outcome is reported as Unknown for skin rash, as Unknown for "granuloma", as Unknown for an immune system response. List of documents held by the sender: None.
Age: 68.0
Sex: M
Vaccine: YF
Symptoms: Tissue injury
Clinical narrative: Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves a patient (age and gender not reported) who experienced broke out with a skin rash, round, red circles, white centers and sometimes in clusters so that they overlap, md described them as "granuloma", an immune system response and a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf, while he/she received vaccine YF-VAX. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 11-Aug-2017, the patient received a dose of suspect YELLOW FEVER VACCINE lot M51761V (expiry date: 28-Feb-2018, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious broke out with a skin rash (rash) (unknown latency) 48 hours following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious round, red circles, white centers and sometimes in clusters so that they overlap (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious md described them as "granuloma" (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious an immune system response (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf (tissue injury) (unknown latency) following the administration of YELLOW FEVER VACCINE. It was reported that lesions are not itchy, and there is no seepage. Generally they are not painful unless directly impacted by something with a sharp angle. Other relevant tests included Patient had been tested for sensitivity to poultry and eggs, with results being negative. Final diagnosis was a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf, an immune system response, md described them as "granuloma", round, red circles, white centers and sometimes in clusters so that they overlap and broke out with a skin rash. The patient was treated with PREDNISONE. Topical steroid creams have no effect, and in some cases exacerbate the problem. Forty doses of oral prednisone eased some of the symptoms. The patient outcome is reported as Unknown for skin rash, as Unknown for "granuloma", as Unknown for an immune system response. List of documents held by the sender: None.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever of 100.1F for 2 days. Painful red circle at injection site and muscle ache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient stated the evening after he received his second dose (2 days ago on August 8th. 2018) of the SHINGRIX vaccine, he spiked a 101 fever. He also reported vomiting, nausea, and diarrhea. He states this was moderately bothersome. However, it lasted 1 evening and resolved. He is feeling better today.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood pressure decreased, Presyncope
Clinical narrative: Near syncopal episode following administration of GARDASIL 9 and MENACTRA. BP prior to vaccine 108/69. Following vaccine BP 88/60. Other vitals WNL. Pt assisted to exam room, recumbent for 15 mins, symptoms resolved spontaneously. Pt experienced near syncopal event in July 2017 following blood draw, unrelated to vaccine administration.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large hot red spot on arm around the injection site. Extremely painful.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia, Tendonitis, X-ray limb normal
Clinical narrative: Shoulder pain, soreness, tendonitis.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Patient states she began having trouble breathing on August 6th.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Computerised tomogram head normal, Dizziness, Electrocardiogram normal
Clinical narrative: Fainting, nausea, chills, dizziness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Syncope
Clinical narrative: Fainting, nausea, chills, dizziness.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. From 23-JUL-2018 to 31-JUL-2018, the patients were vaccinated with incorrectly stored ROTATEQ, orally, lot # N030150 with expiration date on 29-AUG-2019 (dose was not reported) for prophylaxis. The vaccines were stored for 2 hours in temperature of 47 Fahrenheit degrees to 77 Fahrenheit degrees. No adverse event was reported. Digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an online article. On unknown dates, numerous people (demographics not provided) were vaccinated with ZOSTAVAX (lot numbers, dosages and routes of administration not provided). It was noted that the ZOSTAVAX vaccine to prevent varicella, the adult version of chickenpox was causing numerous people who got the shot to suffer injuries and/or death. The causes of death were not provided. It is unknown if autopsies were performed. It was alleged that the vaccine for shingles wasn't safe and could cause serious adverse effects. It was reported that patient injuries from the ZOSTAVAX ranged from shingles itself, which the vaccine was supposed to prevent, to serious personal injuries such as blindness and paralysis. Other reports of adverse effects from ZOSTAVAX included brain damage and death. "But the thousands of people who took the shot [ZOSTAVAX] and are now permanently injured or dead...." According to data compiled by a law firm, ZOSTAVAX "is only effective in about 51% of people who get the shot. And many of those who receive the [ZOSTAVAX] vaccine end up getting shingles anyway." "There is some indication that the vaccination is linked to death." "The NCIS (The National Vaccine Information Center) analysis indicates that there were more than 1,100 serious adverse event reports made to the Vaccine Adverse Events Reporting System from 1990 until September 2015 related to shingles-containing vaccinations. Of these reports, 90 were for deaths associated with the shingles vaccine." The outcome of injuries and/or death is fatal, and the outcome of the blindness, paralysis, brain damage, and shingles is unknown. Upon internal review, injuries and/or death, blindness, paralysis, and brain damage were determined to be medically significant. Blindness, paralysis, brain damage, and shingles were considered to be disabling. Additional information is not expected.; Reported Cause(s) of Death: Death.
Age: 17.0
Sex: F
Vaccine: HPVX, MENB, VARCEL
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17-year-old female patient received TRUMENBA, HPV vaccine, and varicella zoster vaccine, via unspecified routes of administration on 01Aug2018 (at approximately noon) at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bad headache around 3pm (reported as today) along with some chills on an unspecified date in Aug2018. Per nurses instruction, the patient was given ibuprofen and was resting. Outcome of the events was unknown. No follow-up attempts are possible; information about the batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Blood cholesterol increased, Diabetes mellitus, Hypertension, Nodule, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An 81-year-old female patient received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization given at the pharmacy. The patient's medical history and concomitant medications were not reported. On an unspecified date after immunization, the patient contacted her physician with concern over side effect experienced such as pain, swelling, itching, rash 6 cm diameter that started as knot, was diabetic, had hypertension (HTN) and high cholesterol. The outcome of the events was unknown. The events occurred after use of product. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Being diabetic, having hypertension and high cholesterol are not related to the use of PREVNAR 13 in the advanced old patient but represent the patient's underlying medical conditions. 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.
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An 81-year-old female patient received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization given at the pharmacy. The patient's medical history and concomitant medications were not reported. On an unspecified date after immunization, the patient contacted her physician with concern over side effect experienced such as pain, swelling, itching, rash 6 cm diameter that started as knot, was diabetic, had hypertension (HTN) and high cholesterol. The outcome of the events was unknown. The events occurred after use of product. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Being diabetic, having hypertension and high cholesterol are not related to the use of PREVNAR 13 in the advanced old patient but represent the patient's underlying medical conditions. 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: 87.0
Sex: M
Vaccine: TDAP
Symptoms: Biopsy lung, Blood test abnormal, Bordetella test positive, Cough, Pertussis
Clinical narrative: Initial information received on 03-Aug-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 87 years old male patient who was positive for whooping cough, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a Booster dose of suspect TDaP lot number not reported via unknown route in the arm nos. The patient developed a serious whooping cough (pertussis) following the administration of TDaP. This event was assessed as medically significant. Patients blood test was positive for whooping cough (pertussis). Patient also had cough since February and needed a lung biopsy. (Other relevant tests included No lab test.) Final diagnosis was blood test was positive for whooping cough. Patient received antibiotic for one month. The patient outcome is reported as Unknown for whooping cough. Sender's Comments: This case concerns an elderly patient who presented with pertussis after and despite vaccination with a Pertussis containing vaccine. The time to onset is not known. Moreover, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: DAY 1/ Chills, fever, very tired,, after about 3-4 hours. DAY 2/ complete loss of appetite, somnolence, headache. DAY 3 / wake up with a swollen face, still somewhat evident on. the 8/10 Appetite has returned on day 3, still a bit tired on day 5.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Swelling face
Clinical narrative: DAY 1/ Chills, fever, very tired,, after about 3-4 hours. DAY 2/ complete loss of appetite, somnolence, headache. DAY 3 / wake up with a swollen face, still somewhat evident on. the 8/10 Appetite has returned on day 3, still a bit tired on day 5.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient reports redness, swelling, and welting starting ~2 inches below the injection site one day following injection. 2 days following injection, patient reports it has spread (enlarged). She has been advised to notify her PCP and monitor if the reaction is continuing to spread or now.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Streptococcus test positive, Tremor, Vaccination complication, Vomiting
Clinical narrative: About 30min after injections were administered patient started shaking and vomiting. Patient was very pale, so mom immediately called the check-in employees for help. A medical assistant was nearby when the incident occurred and took the patient back to a room where they check all vitals. Pulse Ox 97, BP 100/72 L arm, Pulse 75, and Temp. 97.6 Patient was treated by our CPNP, whom strongly agrees that this reaction was caused by the Dtap. Provider ordered a Strep Test which came back positive. Patient stayed in observation for approximately 1hr 30min and was able to be discharged once he felt better.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-FEB-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In 2015, the patient was treated by physicians for shingles and zoster related injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Headache, chills, stiffness redness around injection, arm pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oral herpes, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Severe red itchy rash/blisters on right arm and right hand, fever blisters on lips.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Below patients left arm where shot was given, the day after immunization was given the area became very red and sore. The patient followed up with her PCP and Dr. determined that the patient had cellulitis from the vaccine. The patient had no previous reaction with the first dose of the vaccine.
Age: 12.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Right arm swollen and red, slightly warm/tender to touch. Went to Urgent Care, was told by PMD that probably local reaction to MCV4, and was told to take OTC BENADRYL by mouth and topically. Shots were given on 08/07/2018 and reaction occurred 08/09/2018. Went to urgent care this a.m. 08/10/2018. Phone call to pt./Mom to check on child, child eating and doing okay. No c/o nausea/vomiting or fever.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had fever present 5 hours post injections. Patient had pain in both arms that night, was unable to move arms. pain in left arm still present at 1300 8/10/2018 with redness and swelling down to elbow, painful to touch. Armpits also painful per patient Pain has reduced since then, but still present. Patient took a tramadol, and pain was relieved. Pharmacist recommended ibuprofen.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient had fever present 5 hours post injections. Patient had pain in both arms that night, was unable to move arms. pain in left arm still present at 1300 8/10/2018 with redness and swelling down to elbow, painful to touch. Armpits also painful per patient Pain has reduced since then, but still present. Patient took a tramadol, and pain was relieved. Pharmacist recommended ibuprofen.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: About ~18 hours after vaccine administration, patient called the pharmacy to report Bilateral Knee Replacement Pain.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had soreness and red area under where the immunization was given to him 2 days after being given the vaccine. This was his 2nd dose from us for the SHINGRIX vaccine and he did not have a problem the first time he was given the immunization.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Patient has a sore, warm, red rash that she reported to her doctor. The patient was prescribed Cephalexin when a week passed and the rash was still there. Patient reported the prescriber had thought she may possibly have a bacterial infection from the vaccine, and according to the patient, the doctor also said they had seen a couple similar cases of the same vaccine.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain upper, Asthenia, Headache, Nausea, Somnolence
Clinical narrative: Weakness, a headache, stomachache, sleepiness and nausea.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cyanosis, Dizziness, Dyspnoea, Wheezing
Clinical narrative: Pt received Flu shot with no issue. She mentioned she needed a pneumonia shot, looked in her profile and she received PREVNAR 13 in April 2017. Did paperwork and few minutes later administered PNEUMOVAX. Pt stood up and was ok. She started walking away from the immunization area and sat down. My techs alerted me that her caretaker/family member said she was dizzy and couldn't breathe. I start talking to the patient and caretaker asking if she was ok and said she couldn't breathe. Was wheezing, SOB, face/lips turning blue/purple. Called 911, went back to the waiting room, gave her some water. Administered epinephrine 0.3 mg pen (expired May 2018), left thigh IM. Her face, had color and her breathing improved. Paramedics arrived rather quickly after 911 call (maybe 5 minutes?). They took over the scene, told them what happened and summary of events. She was given a breathing treatment and was then transported to the ER. Have not heard any follow up. She was in good spirits and was feeling better.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Only adjuvant suspension component administered without lyophilized component of vaccine (SHINGRIX). Pt will be revaccinated per GSK and CDC recommendation.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray normal, Crying, Dyspnoea, Erythema, Irritability
Clinical narrative: Baby took ROTATEQ fine. Then cried and held his breath during 2nd injection(PREVNAR). It lasted a few seconds. He received PENTACEL first and did fine. He checked out and parents returned secondary baby crying, getting a rash, and having difficulty breathing. Baby was extremely fussy on return to room. Bandaids removed from legs which were a red and blotchy. Pt had oral secretions and would not take TYLENOL or bottle. He had petechiae developing on face. He was worse with laying down. Oxygen 98% and HR 190s, baby stayed very fussy. Pt watched in office x 30 min and would not calm. Ambulance was called to transport to Hospital for reaction from vaccines. Discussed with ED. Recommend monitoring for allergic reaction, checking chest xray to R/O aspiration and CBC secondary to petechiae. Pt returned to office at 520 ambulance called at 545.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Petechiae, Rash macular
Clinical narrative: Baby took ROTATEQ fine. Then cried and held his breath during 2nd injection(PREVNAR). It lasted a few seconds. He received PENTACEL first and did fine. He checked out and parents returned secondary baby crying, getting a rash, and having difficulty breathing. Baby was extremely fussy on return to room. Bandaids removed from legs which were a red and blotchy. Pt had oral secretions and would not take TYLENOL or bottle. He had petechiae developing on face. He was worse with laying down. Oxygen 98% and HR 190s, baby stayed very fussy. Pt watched in office x 30 min and would not calm. Ambulance was called to transport to Hospital for reaction from vaccines. Discussed with ED. Recommend monitoring for allergic reaction, checking chest xray to R/O aspiration and CBC secondary to petechiae. Pt returned to office at 520 ambulance called at 545.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Pale, fainted required laying down, elevating feet, waiting 20 minutes before standing.
Age: 0.75
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No known adverse events. Unable to reach parent on phone. None reported to clinic.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient voiced nausea and dizziness within 2 minutes after vaccines administered. Code blue called at 4:40, patient vomited mild amount of emesis. Remained conscious BP 90/54 at 4:44pm, 100/44 at 4:47 pm. EMS called and responded at 4:48pm. Left health dept. ambulating with steady gait, no acute distress, unlabored breathing with parents.
Age: 13.0
Sex: M
Vaccine: HEPA, MMRV, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site induration, Injection site irritation
Clinical narrative: Redness, irritation over the left deltoid. Bruise/discoloration around injection site. Warm, hard, red to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site warmth
Clinical narrative: Redness, irritation over the left deltoid. Bruise/discoloration around injection site. Warm, hard, red to the touch.
Sex: F
Vaccine: VARZOS
Symptoms: Lung infection, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around October 2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or about November 2016, the patient was treated at a hospital for lung infection, which was diagnosed as zoster-related pneumonia. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful zoster-related pneumonia and neurological injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Upon internal review, lung infection, zoster related pneumonia was determined to be medical significant. Additional information has been requested.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial unsolicited report received from other health professional on 03-Aug-2018. This case involves a 16 years old male patient who was vaccinated with 0.5ml suspect MENACTRA, Batch number: U5948AB, expiration date: 02-Jul-2019, route intramuscular and site of administration right deltoid (dose was not reported) on 03-Aug-2018 and on 27 Jul 2018. The patients medical history was not reported. Concomitant medications was HEPATITIS A VACCINE on 23-Jul-2018. It was an actual medication error due to extra dose administered. Patient is not experiencing any adverse reactions at the moment. It has been approximately 45 minutes since the vaccine was administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain in extremity, Pyrexia, Skin discolouration, Tremor
Clinical narrative: Per patient, patient experienced high fever 101-102, chills, and shakes. Per pt arm is sore and turned purple. Vaccines were administered in same arm 1" a part.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient started to get a red, itchy rash covering her entire upper arm the day after vaccination (2nd dose). Called her to check in today (8/10/18) 10 days after vaccination to see if it has resolved. She is still having the rash and itching but it has faded considerably. She is just using anti-itch cream for it. She had no reaction to the first dose.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Severe arm pain, nausea, sweating. Nausea and sweating went away.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Patient's husband reported in the morning of August 10 that the patient has experienced a severe pain which started to develop from the left arm and radiated to the entire body over the night after receiving FLUZONE and PREVNAR 13 shots on August 9. The pain was severe enough to keep patient awake all night. I called and spoke with patient at 12:00 PM on August 10. Patient says she is still in severe body pain. She says her pain prevents her from leaving home to see her doctor. I instructed her to take either Motrin or Tylenol for the pain.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Pain, Paraesthesia, Pruritus
Clinical narrative: Redness spreading around the arm and in armpit, itching, numbness, tingling sensation in arm, extreme pain. lasted for weeks.
Age: 0.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Newborn infant was ordered to received birth dose of hepatitis B vaccine. Nurse accidentally removed a dose of Tdap from the automated dispensing machine and administered to the baby instead.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling abnormal, Nausea, Salivary hypersecretion
Clinical narrative: Dizziness, salivating, nausea and feeling of "spaciness".
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Influenza like illness
Clinical narrative: Swelling and soreness in entire upper arm-right. Large red area 5 to 6 inches below injection site wrapping 1/2 way around the arm and it is hot to the touch. Joint, bone & muscle pain similar to flu symptom. Shivering chills and extreme tiredness.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Swelling and soreness in entire upper arm-right. Large red area 5 to 6 inches below injection site wrapping 1/2 way around the arm and it is hot to the touch. Joint, bone & muscle pain similar to flu symptom. Shivering chills and extreme tiredness.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema to injection site with pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching
Clinical narrative: Patient reported leg/foot twitching, that did not begin until more than 48 hours after vaccination.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Fatigue, Grip strength decreased, Lymphadenopathy, Malaise, Muscular weakness
Clinical narrative: Per client's mother Hep A and Meningitis given on 08/07/2018 three hours after receiving shot client became ill. Feeling "fatigue, not able to hold plate dropped it on the table due to arm weakness. Also per patient she is not able to keep any food down" "glands swollen under both jaws". Client states she can only drink water but still unable to eat anything at this time. Client presented today at 2:45 pm. Referred for follow-up of care. Per mother we will go to an Urgent care because patient has to be at University on Saturday at 9:00 am.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Vomiting
Clinical narrative: Per client's mother Hep A and Meningitis given on 08/07/2018 three hours after receiving shot client became ill. Feeling "fatigue, not able to hold plate dropped it on the table due to arm weakness. Also per patient she is not able to keep any food down" "glands swollen under both jaws". Client states she can only drink water but still unable to eat anything at this time. Client presented today at 2:45 pm. Referred for follow-up of care. Per mother we will go to an Urgent care because patient has to be at University on Saturday at 9:00 am.