chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site reaction, Rash, Rash erythematous, Skin discolouration
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. This pharmacist reported similar event for two patients. This is the first of two reports. A 79-year-old female patient received, on 04Oct2018, PREVNAR 13 (Lot. W51924, Expiration date: Jul2020, NDC number: 0005-1971-02) at single dose, for immunization (prevention of Pneumonia). Relevant medical history included diabetes, thyroid disorder and blood pressure. Concomitant medications included oral atorvastatin 20 mg, daily (one tablet daily by mouth), from an unspecified date (ongoing); oral glipizide 5 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for diabetes; oral levothyroxine 0.075 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for thyroid disorder; oral losartan 25 mg, once daily (one tablet, once a day, by mouth), from 02Aug2018 (ongoing), for blood pressure; oral metformin, tablet, 1000 mg, twice daily, for diabetes and oral sitagliptin phosphate (JANUVIA) 100 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for diabetes. After the vaccination, the patient experienced the following delayed reaction: on 05Oct2018, the patient's arm was blue and green. On 10Oct2018, the patient experienced little red bumps on arm and her arm was red and warm with a circle at the site. The adverse events were assessed as serious (Medically Significant). The events, vaccination site mass and vaccination site discoloration were considered related to pneumococcal 13-val conj vac (dipht crm197 protein). The patient did not recover from the adverse events at time of this report.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "vaccination site red/ warmth/discoloration and little red bumps" cannot be fully excluded considering the known adverse event profile of PREVNAR 13 and apparent time association.  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.,Linked Report(s) : US-PFIZER INC-2018421167 same reporter/drug, different patient/events.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Vaccination site discolouration, Vaccination site mass
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. This pharmacist reported similar event for two patients. This is the first of two reports. A 79-year-old female patient received, on 04Oct2018, PREVNAR 13 (Lot. W51924, Expiration date: Jul2020, NDC number: 0005-1971-02) at single dose, for immunization (prevention of Pneumonia). Relevant medical history included diabetes, thyroid disorder and blood pressure. Concomitant medications included oral atorvastatin 20 mg, daily (one tablet daily by mouth), from an unspecified date (ongoing); oral glipizide 5 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for diabetes; oral levothyroxine 0.075 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for thyroid disorder; oral losartan 25 mg, once daily (one tablet, once a day, by mouth), from 02Aug2018 (ongoing), for blood pressure; oral metformin, tablet, 1000 mg, twice daily, for diabetes and oral sitagliptin phosphate (JANUVIA) 100 mg, once daily (one tablet, once a day, by mouth), from an unspecified date (ongoing), for diabetes. After the vaccination, the patient experienced the following delayed reaction: on 05Oct2018, the patient's arm was blue and green. On 10Oct2018, the patient experienced little red bumps on arm and her arm was red and warm with a circle at the site. The adverse events were assessed as serious (Medically Significant). The events, vaccination site mass and vaccination site discoloration were considered related to pneumococcal 13-val conj vac (dipht crm197 protein). The patient did not recover from the adverse events at time of this report.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "vaccination site red/ warmth/discoloration and little red bumps" cannot be fully excluded considering the known adverse event profile of PREVNAR 13 and apparent time association.  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.,Linked Report(s) : US-PFIZER INC-2018421167 same reporter/drug, different patient/events.
Sex: M
Vaccine: PNC13
Symptoms: Neoplasm malignant
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 2 patients (Husband and wife). This is 1st of 2 reports. A 93-year-old male patient received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included immunocompromised. The concomitant medications were not reported. The patient experienced cancer on an unspecified date with outcome of unknown.  The reporter wanted to know the patients should receive a second dose of PREVNAR 13, since  immunocompromised. Information on the batch number has been requested.; Sender's Comments: Cancer is not related to the vaccination with PREVNAR 13 representing an intercurrent malignancy.  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.,Linked Report(s) : US-PFIZER INC-2018423295 same reporter/product/event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Facial paralysis
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. An adolescent female patient received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, few weeks after vaccination, the patient was treated by hospital neurologist for Bell's palsy. The outcome of the event was unknown. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: FLU4
Symptoms: Device use issue, Wrong technique in product usage process
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from another healthcare professional. This case is linked to case 2018SA290867. This case involves an unknown demographics patient who was vaccinated with FLUZONE QUADRIVALENT with a 5/8th inch needle rather than a 1-inch needle which is recommended for intramuscular administration (lot number not reported via intramuscular route in unknown administration site). The patients past medical history, medical treatments, vaccinations and family history were not provided. It was as actual medication error case due to wrong technique in product usage process. It was unknown whether the patient has any adverse reaction. 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 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 17 year old male patient who received vaccine 0.5 ml MENACTRA (Batch no: U5917AA, expiry date 30 June 2019) in right thigh on 02-Aug-2018 and again received on 17 Oct 2018 (batch number U5986AA, expiry date 24-AUG-2019) in right arm. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Extra dose administered. It was unknown if any adverse event occurred. 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.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Crying, Incorrect dose administered, Irritability, Pyrexia
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA284822. This case involves a 33 months old male patient who experienced fever, irritability, uncontrolled crying and shivering, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious fever (pyrexia), irritability (irritability), uncontrolled crying (crying), shivering (chills) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was an actual medication error due to overdose. (Other relevant tests included No lab data.) Final diagnosis was fever, irritability, uncontrolled crying and shivering. It was not reported if the patient received a corrective treatment. On an unknown date, the event outcome was reported as Unknown for fever, irritability, uncontrolled crying and shivering. 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: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient for whom vaccinated in their office on 19sep2018 with FLUZONE QUADRIVALENT 0.5ml and was then given second dose of influenza vaccine was reported, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation. On 17-Oct-2018, the patient received a dose 2 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On 19-Sep-2018 he also received a 0.5 ml dose 1 of the same vaccine with an unknown batch number via intramuscular route in the left arm. The patient developed a non-serious vaccinated in their office on 19sep2018 with FLUZONE QUADRIVALENT 0.5ml and was then given second dose of influenza vaccine (inappropriate schedule of drug administration) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was vaccinated in their office on 19sep2018 with FLUZONE QUADRIVALENT 0.5ml and was then given second dose of influenza vaccine. It was unknown whether patient experienced any adverse reaction after vaccination. Outcome of the event was not applicable. 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. Documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Facial paralysis, Speech disorder
Clinical narrative: 2 days after receiving vaccine, face drooping, seeing from (R) eye, speech garbled. Bell's Palsy.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear pain, Ear swelling, Erythema, Lymphadenopathy, Neck pain
Clinical narrative: 10-16-18 Ear pain, swollen gland (L) side, ear swelling. 10/17/18 Ear swelling increasing, red painful neck. 10/18/18 Ear pain swelling increasing, gland swelling increasing. Swelling persists.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Skin discolouration
Clinical narrative: Pt received 2 month vaccines on 10/15/18. On 10/16/18 mom gave TYLENOL. She states child experienced brief seconds of a color change and a question of a breathing pause. Went to ER. Child was in no distress at the ER.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: C/O of (R) arm pain the arm that he got the Flu vaccine, no temp, no trauma, pain in arm thru the elbow to half way down the forearm, worse with FUU extension. Onset of Flu Vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Aphthous ulcer, Injection site mass, Injection site reaction, Rash generalised, Rash maculo-papular
Clinical narrative: Pt. with vaccines 9/13/18. (R) thigh with large mass at upper area with fine pink, papular rash at same site. Pt with maculopap rash the body, esp at hands/palms and feet. Canker sores t/o mouth. (Coxsackie-like reaction).
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash papular
Clinical narrative: Pt. with vaccines 9/13/18. (R) thigh with large mass at upper area with fine pink, papular rash at same site. Pt with maculopap rash the body, esp at hands/palms and feet. Canker sores t/o mouth. (Coxsackie-like reaction).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysphonia, Fatigue, Gingivitis, Headache
Clinical narrative: Soreness at injection site, hoarseness, fever, severe chills, aches over entire body, severe headache, sporadic itching, could not sleep all night, fatigues for several days, gum infection on 3rd day.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pain, Pruritus, Pyrexia
Clinical narrative: Soreness at injection site, hoarseness, fever, severe chills, aches over entire body, severe headache, sporadic itching, could not sleep all night, fatigues for several days, gum infection on 3rd day.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: PREVNAR-13 given 10/08/18. Pt. presented to pharmacy on 10/15/18 with swollen rash at injection site. Referred pt to PCP who administered steroid shot.
Age: 17.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Induration, Rash macular
Clinical narrative: (L) arm red, blotchy with induration, red streak. Concern with cellulitis. Put on oral KEFLEX 500mg TID x 10days.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within one hour of receiving injection started with pain and redness at injection site. Continued with increased pain, redness, warm to touch, swelling over next 12 hours. Arm red from injection site to 2 inches above elbow on outside of upper arm. Using cool intermittent compress. Ibuprofen 12.5 ml q 6-8 hr. and BENADRYL 12.5 mg/5ml-10 ml q 6-8.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotonia
Clinical narrative: Pt came in for flu vaccine-received vaccine without any issues-mom left office and approx 5 mins. later mom returned with child limp in her arms. Pt was fully conscious when returned to office-no jerking/stiffing. No loss bowel/bladder.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient forgot that he had completed SHINGRIX series. He received 2 doses 2 months apart, but forgot about the second dose. Pharmacist also thought patient is waiting for second dose to be available. Patient does not have any adverse effect from any of the SHINGRIX dose. Patient has no complains from SHINGRIX vaccine. 1 st dose: 04-06-2018, 2nd dose: 06-06-2018, 3rd dose: 09-22-2018.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Abnormal behaviour, Asthma, Crying, Dyspnoea
Clinical narrative: Per mother, was with father doing farm work. Refused to make decisions/irrational/had tantrum/ tried to get out of the truck while Dad was driving down gravel road. Child called mother, crying, said that Dad was rude. When mother got there he refused to get out of the truck, held on to dash. Mom got him into her vehicle; and he tried to climb out of her vehicle while she was driving.  Mother described as extreme behavior for 45 minutes; told her they were mean, he wanted to die more than once and used language that he had never used before. He was crying; mother got him into shower and that seemed to "reset" him.  He was "down" and remorseful during the evening.  Prior to the event; had c/o stomach ache; but no other complaints. No known fever, shortness of breath, muscle aches, etc. Had similar episode in February 2018 after receiving Tamiflu. Had been sick with flu symptoms/fever for 24 hours; saw dr.; tested positive for Influenza B and was put on Tamiflu. Had been on Tamiflu for 2 days and has what mother described as a "behavioral reaction". States she had sat down with him to do homework; became irrational and could not do homework.  He was "set off" ; threw papers and books, cried for hours over homework. Had pneumonia before having flu/labored breathing/Oxygen level dropped below 80 - seen at Urgent Care. Mother thinks he has had flu vaccine in the past; but, not consistently. Late August 2018, had asthma attack; was sent to ER from Urgent Care. Received epinephrine, breathing treatments, sent home with breathing Tx / albuterol. Saw pediatrician the next day; was sent to allergy-asthma specialist.  QVAR was started at that time. Other than these two occasions; child has not had similar behavioral episodes.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Influenza B virus test positive, Loss of personal independence in daily activities, Oxygen saturation decreased, Pneumonia
Clinical narrative: Per mother, was with father doing farm work. Refused to make decisions/irrational/had tantrum/ tried to get out of the truck while Dad was driving down gravel road. Child called mother, crying, said that Dad was rude. When mother got there he refused to get out of the truck, held on to dash. Mom got him into her vehicle; and he tried to climb out of her vehicle while she was driving.  Mother described as extreme behavior for 45 minutes; told her they were mean, he wanted to die more than once and used language that he had never used before. He was crying; mother got him into shower and that seemed to "reset" him.  He was "down" and remorseful during the evening.  Prior to the event; had c/o stomach ache; but no other complaints. No known fever, shortness of breath, muscle aches, etc. Had similar episode in February 2018 after receiving Tamiflu. Had been sick with flu symptoms/fever for 24 hours; saw dr.; tested positive for Influenza B and was put on Tamiflu. Had been on Tamiflu for 2 days and has what mother described as a "behavioral reaction". States she had sat down with him to do homework; became irrational and could not do homework.  He was "set off" ; threw papers and books, cried for hours over homework. Had pneumonia before having flu/labored breathing/Oxygen level dropped below 80 - seen at Urgent Care. Mother thinks he has had flu vaccine in the past; but, not consistently. Late August 2018, had asthma attack; was sent to ER from Urgent Care. Received epinephrine, breathing treatments, sent home with breathing Tx / albuterol. Saw pediatrician the next day; was sent to allergy-asthma specialist.  QVAR was started at that time. Other than these two occasions; child has not had similar behavioral episodes.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Thinking abnormal
Clinical narrative: Per mother, was with father doing farm work. Refused to make decisions/irrational/had tantrum/ tried to get out of the truck while Dad was driving down gravel road. Child called mother, crying, said that Dad was rude. When mother got there he refused to get out of the truck, held on to dash. Mom got him into her vehicle; and he tried to climb out of her vehicle while she was driving.  Mother described as extreme behavior for 45 minutes; told her they were mean, he wanted to die more than once and used language that he had never used before. He was crying; mother got him into shower and that seemed to "reset" him.  He was "down" and remorseful during the evening.  Prior to the event; had c/o stomach ache; but no other complaints. No known fever, shortness of breath, muscle aches, etc. Had similar episode in February 2018 after receiving Tamiflu. Had been sick with flu symptoms/fever for 24 hours; saw dr.; tested positive for Influenza B and was put on Tamiflu. Had been on Tamiflu for 2 days and has what mother described as a "behavioral reaction". States she had sat down with him to do homework; became irrational and could not do homework.  He was "set off" ; threw papers and books, cried for hours over homework. Had pneumonia before having flu/labored breathing/Oxygen level dropped below 80 - seen at Urgent Care. Mother thinks he has had flu vaccine in the past; but, not consistently. Late August 2018, had asthma attack; was sent to ER from Urgent Care. Received epinephrine, breathing treatments, sent home with breathing Tx / albuterol. Saw pediatrician the next day; was sent to allergy-asthma specialist.  QVAR was started at that time. Other than these two occasions; child has not had similar behavioral episodes.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus generalised, Urticaria
Clinical narrative: Patient stated that she received the flu shot here at the pharmacy and picked up a prescription for smz/tmp ds for a UTI yesterday. She stated that she left the pharmacy and went straight home and took the antibiotic. She stated that later in the evening yesterday she started to break out in hives and itch all over. She then took 25mg of BENADRYL. She also stated that there was NO redness or swelling at the injection site. I explained that her allergic reaction was probably due to the antibiotic, but I instructed her to continue taking the BENADRYL and call her dr.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Lumbar puncture, Paraesthesia
Clinical narrative: 11/22/2018 Second hand notification from Employer. Patient admitted to hospital and doing spinal tap 10/22/18. Complained last week tingling of extremities and working up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient is complaining of redness, warmth and swelling at site of injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Patient presented to pharmacy 10/23/18 to state shoulder still very sore and having issues with range of motion which started after receiving influenza immunization in pharmacy 10/11/2018.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Pericarditis
Clinical narrative: Pericarditis.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Full blood count, Hypersensitivity, Injection site rash, Metabolic function test
Clinical narrative: Mother states on 10/19/2018, one day after flu injection patient had rash to arm at injection site.  On date 10/21/2018 patient report to ER due to hives/rash all over body, dyspnea, Itching/stinging. At home was given Hydroxyzine before coming to hospital. Was admitted to hospital stay x 1 day due to allergic reaction, hives, dyspnea. Release from hospital on 10/22/2018.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pruritus, Rash generalised, Urticaria
Clinical narrative: Mother states on 10/19/2018, one day after flu injection patient had rash to arm at injection site.  On date 10/21/2018 patient report to ER due to hives/rash all over body, dyspnea, Itching/stinging. At home was given Hydroxyzine before coming to hospital. Was admitted to hospital stay x 1 day due to allergic reaction, hives, dyspnea. Release from hospital on 10/22/2018.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Joint stiffness, radiating from shoulder to spine and jaw. Relieved by benadryl. Occured for 3 days before ceasing.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Anxiety, Asthenia, Balance disorder, Cough
Clinical narrative: Sinus infection with cough, dizzy spells, loss of balance, weakness, anxiety, ear pain, abdominal pain, and nausea,legs give out, brain fog, sea legs, rapid heart beat, high blood pressure, nasal polyps.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Ear pain, Feeling abnormal, Heart rate increased, Hypertension
Clinical narrative: Sinus infection with cough, dizzy spells, loss of balance, weakness, anxiety, ear pain, abdominal pain, and nausea,legs give out, brain fog, sea legs, rapid heart beat, high blood pressure, nasal polyps.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of control of legs, Nasal polyps, Nausea, Sinusitis
Clinical narrative: Sinus infection with cough, dizzy spells, loss of balance, weakness, anxiety, ear pain, abdominal pain, and nausea,legs give out, brain fog, sea legs, rapid heart beat, high blood pressure, nasal polyps.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Weight bearing difficulty
Clinical narrative: Could not bear weight with the arm that was vaccinated in for 15 days. Pain began in the left deltoid the evening of the exam & for the next 15 days. There was no warmth or erythema.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling arm at site of injection, went to local ED.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Monoplegia
Clinical narrative: Pt had severe pain at injection site at time of injection. Starting about 6 hours later and lasting just over 24 hours, she reports complete paralysis of arm injection was given in. (I am reporting because 2 other patient with SHINGRIX have reported numbness or neurogeic pain for < 1 week following same vaccine).
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Eye swelling, Feeling abnormal, Nausea
Clinical narrative: 10 min. after receiving shot; patient stated she was feeling "funny", then started stating her vision was blurry; then minute after onset began to complain of SOB, lightheadedness and nausea; then her eyes and face began to swell and cont. shortness of breath.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face, Vision blurred
Clinical narrative: 10 min. after receiving shot; patient stated she was feeling "funny", then started stating her vision was blurry; then minute after onset began to complain of SOB, lightheadedness and nausea; then her eyes and face began to swell and cont. shortness of breath.
Age: 11.0
Sex: F
Vaccine: FLU4, IPV, TDAP
Symptoms: Malaise, Vomiting
Clinical narrative: AFTER PATIENT RECEIVED VACCINES SUCCESSFULLY SHE LEFT CLINIC WITH PARENT WITHOUT COMPLAINTS. MOTHER RETURNED TO WINDOW AND REPORTED PATIENT HAD VOMITED IN THE PARKING LOT. EMPLOYEES WENT TO CAR WITH MOTHER AND TOOK VITALS: P 118/66; HR 90; TEMP 98.2; PATIENT REPORTED NOT FEELING ILL ANY MORE. HAD EATEN A MEATBALL SUB AT SCHOOL CAFETERIA WHICH SHE HAS NOT HAD IN THE PAST.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Migraine
Clinical narrative: Pt went home and noticed that evening that they had full body joint pain and a migraine headache within 6 hours of the shot. The pt is still having full body joint pain 4 weeks after the shot.
Age: 43.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Pain
Clinical narrative: SEVERE PAIN.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Pt presented in my office on 10/18/2018 with an acute pruritic rash which appeared to be hives to both arms, posterior trunk, and scalp. Pt reported the rash initially began on RUE between 10/14/2018 to 10/15/2018, and progressively spread to other areas as noted above. Pt mentioned having pre-travel vaccinations on 10/11/2018 for preparation for trip at clinic as listed. Other than the recent vaccinations, we cannot pinpoint any relative causes for the signs and symptoms described.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Flushing, Neurological examination normal, Vertigo
Clinical narrative: Patient began having  episodes of vertigo 4 hours after the influenza vaccine was given. This was associated by feeling flush.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Night sweats, Pain, Pyrexia
Clinical narrative: Local soreness, insomnia, fever, night sweats, fatigue.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersomnia, Inflammation, Lethargy, Nodule
Clinical narrative: Pt was lethargic for about 72 hours. Described "sleeping almost all day Saturday following the vaccine". She also described a red nodule on her bicep that was warm to the touch that dissipated over the course of 72 hours including extreme soreness and inflammation.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Skin warm
Clinical narrative: Pt was lethargic for about 72 hours. Described "sleeping almost all day Saturday following the vaccine". She also described a red nodule on her bicep that was warm to the touch that dissipated over the course of 72 hours including extreme soreness and inflammation.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Swelling, Ultrasound Doppler normal, Ultrasound scan normal, X-ray normal
Clinical narrative: 3 inches X 3 inches puffy swollen firm area over the glenohumeral joint, injection site 8.9cm below the swollen area, limited ROM.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: Patient had pneumococcal vaccine with development of erythema and induration. This is not centralized around the injection site and there is development of cellulitis.  here may be some aspect of local reaction component as well.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient had 2 inch diameter around injection site that was red, swollen, warm to touch. Started in the evening after receiving her flu shot. Patient took TYLENOL 10/22/18 to treat the pain. When she came into pharmacy, nurse instructed patient to use ibuprofen and a cold compress to help with swelling and to refer to primary doctor if symptoms worsened.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Wrong product administered
Clinical narrative: THIS VACCINE ADMINISTERED ALONG WITH 0.50 ML IPV (POLIO) VACCINE  IN ERROR
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse food reaction, Allergy test positive, Anaphylactic reaction, Asthma, Blood immunoglobulin E increased
Clinical narrative: Constant severe atopic dermatitis, hives/skin reactions from food, increasing number of food allergies documented through blood labs/skin testing/observation, skin infections (fungal and bacterial) asthma, elevated IGE labs and diagnosed immune disorder. Heightened severe eczema and food reactions started within a few days of shot and continued for 2 years now.  Molluscum started after shot and failed 7 rounds (?) of treatment before EUCRISA and immune activation drug finally cured 11 months later. She's had several bacterial skin infections in addition to that. She had an anaphylactic reaction to coconut on 12/13/16. Patient had no history of food reactions/anaphylactic reaction prior to 10/27 flu shot. We have patient also has been fighting candida yeast infection and parasites. We are finally starting to make some head way with those issues on a new diet. We have seen allergist, Dermatology (skin), Allergy/Immunology, Dermatology and several holistic doctors over the past 2 years. We are currently working with 2 functional medicine doctors to work towards re-building patient's gut/immune system/lymphatic system. So far, she has seen slight progress after one month on a new diet. She is immune compromised now, though, so it is hard to make forward progress when she reacts to external stimuli so frequently (hives) and develops secondary infections and has to go back on antibiotics. This has been the pattern for 2 years now.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Candida infection, Chronic granulomatous disease, Dermatitis atopic, Eczema, Food allergy
Clinical narrative: Constant severe atopic dermatitis, hives/skin reactions from food, increasing number of food allergies documented through blood labs/skin testing/observation, skin infections (fungal and bacterial) asthma, elevated IGE labs and diagnosed immune disorder. Heightened severe eczema and food reactions started within a few days of shot and continued for 2 years now.  Molluscum started after shot and failed 7 rounds (?) of treatment before EUCRISA and immune activation drug finally cured 11 months later. She's had several bacterial skin infections in addition to that. She had an anaphylactic reaction to coconut on 12/13/16. Patient had no history of food reactions/anaphylactic reaction prior to 10/27 flu shot. We have patient also has been fighting candida yeast infection and parasites. We are finally starting to make some head way with those issues on a new diet. We have seen allergist, Dermatology (skin), Allergy/Immunology, Dermatology and several holistic doctors over the past 2 years. We are currently working with 2 functional medicine doctors to work towards re-building patient's gut/immune system/lymphatic system. So far, she has seen slight progress after one month on a new diet. She is immune compromised now, though, so it is hard to make forward progress when she reacts to external stimuli so frequently (hives) and develops secondary infections and has to go back on antibiotics. This has been the pattern for 2 years now.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Fungal skin infection, Hypersensitivity, Immune system disorder, Immunodeficiency, Impetigo
Clinical narrative: Constant severe atopic dermatitis, hives/skin reactions from food, increasing number of food allergies documented through blood labs/skin testing/observation, skin infections (fungal and bacterial) asthma, elevated IGE labs and diagnosed immune disorder. Heightened severe eczema and food reactions started within a few days of shot and continued for 2 years now.  Molluscum started after shot and failed 7 rounds (?) of treatment before EUCRISA and immune activation drug finally cured 11 months later. She's had several bacterial skin infections in addition to that. She had an anaphylactic reaction to coconut on 12/13/16. Patient had no history of food reactions/anaphylactic reaction prior to 10/27 flu shot. We have patient also has been fighting candida yeast infection and parasites. We are finally starting to make some head way with those issues on a new diet. We have seen allergist, Dermatology (skin), Allergy/Immunology, Dermatology and several holistic doctors over the past 2 years. We are currently working with 2 functional medicine doctors to work towards re-building patient's gut/immune system/lymphatic system. So far, she has seen slight progress after one month on a new diet. She is immune compromised now, though, so it is hard to make forward progress when she reacts to external stimuli so frequently (hives) and develops secondary infections and has to go back on antibiotics. This has been the pattern for 2 years now.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Infection parasitic, Laboratory test, Laboratory test abnormal, Localised infection, Milk allergy
Clinical narrative: Constant severe atopic dermatitis, hives/skin reactions from food, increasing number of food allergies documented through blood labs/skin testing/observation, skin infections (fungal and bacterial) asthma, elevated IGE labs and diagnosed immune disorder. Heightened severe eczema and food reactions started within a few days of shot and continued for 2 years now.  Molluscum started after shot and failed 7 rounds (?) of treatment before EUCRISA and immune activation drug finally cured 11 months later. She's had several bacterial skin infections in addition to that. She had an anaphylactic reaction to coconut on 12/13/16. Patient had no history of food reactions/anaphylactic reaction prior to 10/27 flu shot. We have patient also has been fighting candida yeast infection and parasites. We are finally starting to make some head way with those issues on a new diet. We have seen allergist, Dermatology (skin), Allergy/Immunology, Dermatology and several holistic doctors over the past 2 years. We are currently working with 2 functional medicine doctors to work towards re-building patient's gut/immune system/lymphatic system. So far, she has seen slight progress after one month on a new diet. She is immune compromised now, though, so it is hard to make forward progress when she reacts to external stimuli so frequently (hives) and develops secondary infections and has to go back on antibiotics. This has been the pattern for 2 years now.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Molluscum contagiosum, Pharyngitis streptococcal, Pruritus, Pyrexia, Respiratory tract infection
Clinical narrative: Constant severe atopic dermatitis, hives/skin reactions from food, increasing number of food allergies documented through blood labs/skin testing/observation, skin infections (fungal and bacterial) asthma, elevated IGE labs and diagnosed immune disorder. Heightened severe eczema and food reactions started within a few days of shot and continued for 2 years now.  Molluscum started after shot and failed 7 rounds (?) of treatment before EUCRISA and immune activation drug finally cured 11 months later. She's had several bacterial skin infections in addition to that. She had an anaphylactic reaction to coconut on 12/13/16. Patient had no history of food reactions/anaphylactic reaction prior to 10/27 flu shot. We have patient also has been fighting candida yeast infection and parasites. We are finally starting to make some head way with those issues on a new diet. We have seen allergist, Dermatology (skin), Allergy/Immunology, Dermatology and several holistic doctors over the past 2 years. We are currently working with 2 functional medicine doctors to work towards re-building patient's gut/immune system/lymphatic system. So far, she has seen slight progress after one month on a new diet. She is immune compromised now, though, so it is hard to make forward progress when she reacts to external stimuli so frequently (hives) and develops secondary infections and has to go back on antibiotics. This has been the pattern for 2 years now.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Skin bacterial infection, Skin reaction, Swelling face, Urticaria, Wheezing
Clinical narrative: Constant severe atopic dermatitis, hives/skin reactions from food, increasing number of food allergies documented through blood labs/skin testing/observation, skin infections (fungal and bacterial) asthma, elevated IGE labs and diagnosed immune disorder. Heightened severe eczema and food reactions started within a few days of shot and continued for 2 years now.  Molluscum started after shot and failed 7 rounds (?) of treatment before EUCRISA and immune activation drug finally cured 11 months later. She's had several bacterial skin infections in addition to that. She had an anaphylactic reaction to coconut on 12/13/16. Patient had no history of food reactions/anaphylactic reaction prior to 10/27 flu shot. We have patient also has been fighting candida yeast infection and parasites. We are finally starting to make some head way with those issues on a new diet. We have seen allergist, Dermatology (skin), Allergy/Immunology, Dermatology and several holistic doctors over the past 2 years. We are currently working with 2 functional medicine doctors to work towards re-building patient's gut/immune system/lymphatic system. So far, she has seen slight progress after one month on a new diet. She is immune compromised now, though, so it is hard to make forward progress when she reacts to external stimuli so frequently (hives) and develops secondary infections and has to go back on antibiotics. This has been the pattern for 2 years now.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 26-SEP-2018, the patient was vaccinated with VARIVAX (dose, frequency and route were unknown, lot number N020013 and expiration date 17-JUL-2019) for prophylaxis. On the same day, the patient was also vaccinated with M-M-R II rHA (recombinant Human albumin) (dose, frequency and route were unknown, lot number M047302 and expiration date 30-NOV-2018) for prophylaxis. Both VARIVAX and M-M-R II were reconstituted with sterile diluent (manufacture unknown) (lot number reported as R010090 and expiration date 29-NOV-2018), respectively. It was reported that "medication drawn into plastic syringe (which was supplied by HCP) had needle and barrel of syringe come apart during injection. So the reporter was unsure the amount of medication received. Product quality complaint (PQC) was ruled out as the nurse reported using needle supplied by HCP and did not use prefilled syringe. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist via a field representative referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, schedule, route, lot # and expiration date unknown) for prophylaxis. On an unknown date, the patient developed an unspecified reaction to the injection. The outcome of the event was reported as recovering. The causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot # and route unknown) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-SEP-2015, the patient was treated at a medical center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-MAY-2008, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-SEP-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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.