chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient was seen in the office today for her first visit. She reports she started having hives and itching on her upper and lower extremities 5/6/18- 5 days after MMR and Varicella vaccines were administered. She was taking BENADRYL OTC 25 mg twice a day with relief. She stopped BENADRYL 2 days ago. Her symptoms are improving. Continues with itching. NO shortness of breath, chest pain, palpitations, facial swelling, throat swelling. Denies rash on back, chest, abdomen. She will take Cetirizine 10 mg daily OTC and Hydrocortisone 1% topical OTC as needed. I will see her back for follow up in 1 week. She reports she was told by her mother she had a possible reaction to Varicella vaccine as child with hives several days after the vaccine was given. MMR and Varicella vaccines were given due to "low titers".
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: 05/16/2018 08:08 AM patient presents to clinic with C/O pain, swelling, itching x 2 days post Tdap immunization. Patient reports she experienced "warm, red, hard, itching area" surrounding the injection site (R deltoid). Soreness and redness confined to bicep area. Patient reports she is feeling better now but wanted the nurse to check it prior to her leaving for vacation. Pain: 0/10. Meds: ZYRTEC. NKDA. T: 98.3. R deltoid area noted to have 4 in X 4 in ecchymosis, inflammation and slight firmness. Slight erythema noted to R deltoid. Area warm to touch. Patient advised to ice area to decrease inflammation. NP prescribed KEFLEX TID x 7 days. Patient instructed to take medication with food. Patient to return if symptoms persist or worsen. Pharmacovigilence notified. Signed by RN on 5/16/2018 at 8:35 AM.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site warmth, Pain, Pruritus, Swelling
Clinical narrative: 05/16/2018 08:08 AM patient presents to clinic with C/O pain, swelling, itching x 2 days post Tdap immunization. Patient reports she experienced "warm, red, hard, itching area" surrounding the injection site (R deltoid). Soreness and redness confined to bicep area. Patient reports she is feeling better now but wanted the nurse to check it prior to her leaving for vacation. Pain: 0/10. Meds: ZYRTEC. NKDA. T: 98.3. R deltoid area noted to have 4 in X 4 in ecchymosis, inflammation and slight firmness. Slight erythema noted to R deltoid. Area warm to touch. Patient advised to ice area to decrease inflammation. NP prescribed KEFLEX TID x 7 days. Patient instructed to take medication with food. Patient to return if symptoms persist or worsen. Pharmacovigilence notified. Signed by RN on 5/16/2018 at 8:35 AM.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: It was reported in a published article, that a 12 month old patient with severe immunodeficiency was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed disseminated varicella confirmed to be due to vaccine strain VZV. It was also reported that the patient's father developed a rash after exposure to the patient (WAES # 0803USA03578). The article also discussed the experiences of two other patients while on therapy with varicella virus vaccine live (Oka/Merck) (WAES numbers 0803USA04454 and 0803USA04484). Additional information has been requested. This is an amended report. The serious criterion of death was deleted from the report. This is a downgraded report. The serious criterion of death was deleted from the report.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 08-MAY-2018, the patient received an expired dose of VARIVAX injection, subcutaneously (lot # M006729, expiration date 08-FEB-2018) for prophylaxis. Concomitant therapy included sterile diluent (STERILE DILUENT). No adverse effect was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 11-MAY-2018 the patient was vaccinated with expired dose of ROTATEQ (dose, units and frequency not reported) (lot# unknown and expiration date: 28-APR-2018), orally. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. On 10-MAY-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021581 with an expiration date 09-AUG-2019 for prophylaxis (dose, route of administration anatomical location were not reported). Concomitant therapies included properly stored sterile diluent (MERCK). Administered dose of VARIVAX experienced the temperature excursion form -9 degrees Celsius to 8 degrees Celsius for 192 hours. There was no previous temperature excursion. A digital data logger was not involved. Product quality complaint (PQC) was not reported.
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-JUN-2015, the patient was inoculated with ZOSTAVAX at a clinic for routine adult health maintenance and for the prevention of shingles (route, dose, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-JUN-2016, the patient was treated at the same clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 12-APR-2018, the patient was vaccinated with VARIVAX lot# M033214, expiration date 13-JUL 2018, route of administration reported as "injection" (strength, dose and frequency were not reported) instead of ZOSTAVAX. No adverse effects reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 15-MAY-2018, the patient was vaccinated with an expired dose of M-M-R II injection, lot # M006544, expiry date 03-FEB-2018 (exact dose and route of administration were not reported) for prophylaxis. The lot# of the sterile diluent used was N011475, expiry date 08-AUG-2019 (also reported as 31-AUG-2019). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of stroke in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced stroke (serious criteria GSK medically significant) and numbness of upper extremities. On an unknown date, the outcome of the stroke and numbness of upper extremities were not recovered/not resolved. The reporter considered the stroke and numbness of upper extremities to be unrelated to SHINGRIX. Additional information was received as follows: The patient's arm became numb, and he was referred to emergency room,  where  the  physician  believed  that  the  patient  suffered  a  mild  stroke.  On  an  unknown  date,  the  patient  went  to  the  emergency  room and was sent to a rehabilitation facility. Neither the physician nor the patient's wife were attributing the stroke to the  SHINGRIX vaccine. The reporter searched the literature, and did not found anything concerning stroke. The incident had been reported VAERS. The reporter imagined that the numbness was due to the stroke and not due to the SHINGRIX vaccine.
Age: 97.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Wheelchair user
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of lower extremities weakness of in a 93-year-old male patient who received SHINGRIX. Concurrent medical conditions included congestive heart failure (with multiple comorbidities) and fatigue. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced lower extremities weakness of (serious criteria disability). The patient was treated with Steroid Pack (NOS). On an unknown date, the outcome of the lower extremities weakness of was recovered/resolved. It was unknown if the reporter considered the lower extremities weakness of to be related to SHINGRIX. Additional details were provided as follows: This case was received from Office Manager and Nurse Practitioner. The patient was on multiple comorbidities and on many medications (unknown). On Thursday, the patient received dose of SHINGRIX vaccine at a local pharmacy. The patient was seen the next day in the physician office for weakness in his legs that required wheelchair use. The exact dates of the vaccination and events were unknown but the patient stated that he was vaccinated on a Thursday and saw the Nurse Practitioner the next day on Friday initially in the office and given the steroid pack. The patient was seen back on Tuesday and was back to his normal. The Nurse Practitioner stated he was not convinced the weakness was from the vaccination. The patient however was convinced it was the vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest pain, Dizziness, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: 5/2/18 P.M. soreness at injection site - hurt more than usual in evening - nothing visible - hurt to move his arms to brush his teeth next morning. 9:30A 5/3/18 hurt across his chest - trouble breathing. 11:10Am in ribs 1:30-2PM - water play day - hurting even more - hurt entire body. Restless at home.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain, Restlessness
Clinical narrative: 5/2/18 P.M. soreness at injection site - hurt more than usual in evening - nothing visible - hurt to move his arms to brush his teeth next morning. 9:30A 5/3/18 hurt across his chest - trouble breathing. 11:10Am in ribs 1:30-2PM - water play day - hurting even more - hurt entire body. Restless at home.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Burning sensation, Erythema, Erythrodermic psoriasis, Inflammation
Clinical narrative: It started at the end of September as a small rash on my chest but within a month quickly moved to my back, torso, arms, hands, feet and legs. The rash was extremely itchy and burning. By the end of October 95% of my arms and legs were inflamed and red, along with the itching and burning, as well as shedding skin, large patches and small flakes. During this time I had been to several dermatologists and emergency room. I was told nothing could be done, it had to run it's course and was prescribed various topical lotions, Triamcinolone, Desoximetasone, Desonide, Betamethasone Dipropionate, KERA-42 and HUMIRA. Thanks to a Dr. I started HUMIRA Dec 1, 2017, it started to clear up the rash but lost it's efficacy and the rash stared coming back, I'm now on TREMFYA, just had my second shot. I was told I basically contracted erythrodermic psoriasis from the vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash pruritic, Vaccination complication
Clinical narrative: It started at the end of September as a small rash on my chest but within a month quickly moved to my back, torso, arms, hands, feet and legs. The rash was extremely itchy and burning. By the end of October 95% of my arms and legs were inflamed and red, along with the itching and burning, as well as shedding skin, large patches and small flakes. During this time I had been to several dermatologists and emergency room. I was told nothing could be done, it had to run it's course and was prescribed various topical lotions, Triamcinolone, Desoximetasone, Desonide, Betamethasone Dipropionate, KERA-42 and HUMIRA. Thanks to a Dr. I started HUMIRA Dec 1, 2017, it started to clear up the rash but lost it's efficacy and the rash stared coming back, I'm now on TREMFYA, just had my second shot. I was told I basically contracted erythrodermic psoriasis from the vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Chills, Computerised tomogram, Dizziness
Clinical narrative: Passed out the following morning, muscles paralyzed, severe leg tremors, slight fever, severe pain in right arm, dizziness, weakness, shivering.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Pain in extremity, Paralysis, Pyrexia, Tremor
Clinical narrative: Passed out the following morning, muscles paralyzed, severe leg tremors, slight fever, severe pain in right arm, dizziness, weakness, shivering.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site soreness, redness and swelling, headache, muscle aches: onset approximately 2 hours post injection and continuing as of time of this report. Fever (100), chills and night sweats: onset approximately 5 hours post injection and continuing for approximately 12 hours. Has resolved. Treatments: Ibuprofen. I experienced the same reactions to the first injection received 13Mar2018.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Night sweats, Pyrexia
Clinical narrative: Injection site soreness, redness and swelling, headache, muscle aches: onset approximately 2 hours post injection and continuing as of time of this report. Fever (100), chills and night sweats: onset approximately 5 hours post injection and continuing for approximately 12 hours. Has resolved. Treatments: Ibuprofen. I experienced the same reactions to the first injection received 13Mar2018.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm pain-sharp pain and soreness. Not going away (several weeks out now).
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Antibody test abnormal, Areflexia, Arthralgia, Asthenia, Ataxia
Clinical narrative: 11-15-17 Tingling in thumb and first two fingers-both hands-within week progressed to severe pain in both hands and wrists-EMG showed myotonia also had absence of reflexes in both arms and legs. Dec. 13th legs gave out-unable to walk. Hospitalized 12-13-17 -> 2-12-18. Severe electrolyte abnormalities. Cardiac issues from those. Extremity weakness-especially left side. Too weak to walk for some time. No feeling in both hands. Atrophy and contractures of both hands. Extreme pain in both feet. Numbness on bottom of both feet. Poor balance. Ataxia. Altered voice sound. Thrombocytopenia. Treated with SOLU-MEDROL January 2018 caused blurry vision. Treated with IVIG in December 2017 and Plasma Exchange February 2018. Not much improvement. Consulted with Clinic March 5-9-2018 and April 5-6-2018. Recommended IVIG for 12 weeks-started treatment March 30, 2018. Also recommended IMURAN to start 5-7-18.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Atrophy, Balance disorder, Biopsy muscle abnormal, Biopsy peripheral nerve abnormal, Blood magnesium abnormal
Clinical narrative: 11-15-17 Tingling in thumb and first two fingers-both hands-within week progressed to severe pain in both hands and wrists-EMG showed myotonia also had absence of reflexes in both arms and legs. Dec. 13th legs gave out-unable to walk. Hospitalized 12-13-17 -> 2-12-18. Severe electrolyte abnormalities. Cardiac issues from those. Extremity weakness-especially left side. Too weak to walk for some time. No feeling in both hands. Atrophy and contractures of both hands. Extreme pain in both feet. Numbness on bottom of both feet. Poor balance. Ataxia. Altered voice sound. Thrombocytopenia. Treated with SOLU-MEDROL January 2018 caused blurry vision. Treated with IVIG in December 2017 and Plasma Exchange February 2018. Not much improvement. Consulted with Clinic March 5-9-2018 and April 5-6-2018. Recommended IVIG for 12 weeks-started treatment March 30, 2018. Also recommended IMURAN to start 5-7-18.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Cardiac disorder, Dysphonia, Electrocardiogram abnormal, Electrolyte imbalance, Electromyogram abnormal
Clinical narrative: 11-15-17 Tingling in thumb and first two fingers-both hands-within week progressed to severe pain in both hands and wrists-EMG showed myotonia also had absence of reflexes in both arms and legs. Dec. 13th legs gave out-unable to walk. Hospitalized 12-13-17 -> 2-12-18. Severe electrolyte abnormalities. Cardiac issues from those. Extremity weakness-especially left side. Too weak to walk for some time. No feeling in both hands. Atrophy and contractures of both hands. Extreme pain in both feet. Numbness on bottom of both feet. Poor balance. Ataxia. Altered voice sound. Thrombocytopenia. Treated with SOLU-MEDROL January 2018 caused blurry vision. Treated with IVIG in December 2017 and Plasma Exchange February 2018. Not much improvement. Consulted with Clinic March 5-9-2018 and April 5-6-2018. Recommended IVIG for 12 weeks-started treatment March 30, 2018. Also recommended IMURAN to start 5-7-18.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Full blood count abnormal, Gait inability, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: 11-15-17 Tingling in thumb and first two fingers-both hands-within week progressed to severe pain in both hands and wrists-EMG showed myotonia also had absence of reflexes in both arms and legs. Dec. 13th legs gave out-unable to walk. Hospitalized 12-13-17 -> 2-12-18. Severe electrolyte abnormalities. Cardiac issues from those. Extremity weakness-especially left side. Too weak to walk for some time. No feeling in both hands. Atrophy and contractures of both hands. Extreme pain in both feet. Numbness on bottom of both feet. Poor balance. Ataxia. Altered voice sound. Thrombocytopenia. Treated with SOLU-MEDROL January 2018 caused blurry vision. Treated with IVIG in December 2017 and Plasma Exchange February 2018. Not much improvement. Consulted with Clinic March 5-9-2018 and April 5-6-2018. Recommended IVIG for 12 weeks-started treatment March 30, 2018. Also recommended IMURAN to start 5-7-18.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Muscle contracture, Muscular weakness, Myotonia, Pain in extremity, Paraesthesia
Clinical narrative: 11-15-17 Tingling in thumb and first two fingers-both hands-within week progressed to severe pain in both hands and wrists-EMG showed myotonia also had absence of reflexes in both arms and legs. Dec. 13th legs gave out-unable to walk. Hospitalized 12-13-17 -> 2-12-18. Severe electrolyte abnormalities. Cardiac issues from those. Extremity weakness-especially left side. Too weak to walk for some time. No feeling in both hands. Atrophy and contractures of both hands. Extreme pain in both feet. Numbness on bottom of both feet. Poor balance. Ataxia. Altered voice sound. Thrombocytopenia. Treated with SOLU-MEDROL January 2018 caused blurry vision. Treated with IVIG in December 2017 and Plasma Exchange February 2018. Not much improvement. Consulted with Clinic March 5-9-2018 and April 5-6-2018. Recommended IVIG for 12 weeks-started treatment March 30, 2018. Also recommended IMURAN to start 5-7-18.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Plasmapheresis, Renal function test abnormal, Sensory loss, Thrombocytopenia, Vision blurred
Clinical narrative: 11-15-17 Tingling in thumb and first two fingers-both hands-within week progressed to severe pain in both hands and wrists-EMG showed myotonia also had absence of reflexes in both arms and legs. Dec. 13th legs gave out-unable to walk. Hospitalized 12-13-17 -> 2-12-18. Severe electrolyte abnormalities. Cardiac issues from those. Extremity weakness-especially left side. Too weak to walk for some time. No feeling in both hands. Atrophy and contractures of both hands. Extreme pain in both feet. Numbness on bottom of both feet. Poor balance. Ataxia. Altered voice sound. Thrombocytopenia. Treated with SOLU-MEDROL January 2018 caused blurry vision. Treated with IVIG in December 2017 and Plasma Exchange February 2018. Not much improvement. Consulted with Clinic March 5-9-2018 and April 5-6-2018. Recommended IVIG for 12 weeks-started treatment March 30, 2018. Also recommended IMURAN to start 5-7-18.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: In the evening I got very weak and achy, then had severe chills (very scary, never had this before). I got into bed with electric blanket turned to the highest level. I continued to shake badly for over an hour later. Got a headache and didn't sleep. The next day still felt bad, headache, tired and achy. Layed around. It took until the following morning before I felt better. I don't have reactions to medication and this one scared me.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Tremor
Clinical narrative: In the evening I got very weak and achy, then had severe chills (very scary, never had this before). I got into bed with electric blanket turned to the highest level. I continued to shake badly for over an hour later. Got a headache and didn't sleep. The next day still felt bad, headache, tired and achy. Layed around. It took until the following morning before I felt better. I don't have reactions to medication and this one scared me.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: Dizziness, Nausea, Injection Site pain. Lasted a few hours after returning home.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site started after injection and continued. Seen on 5/16/18. Diagnosed with Cellulitis of Rt. upper arm. Started on Cefdinir 300mg, 2 caps daily x 10 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus, Tenderness
Clinical narrative: Developed irregularly round erythematous, warm, slightly firm ~5in in diameter area on R upper arm with top point being at site of HPV injection. No fluctuance, drainage, minimal tenderness. Pruritic. Tx: ibuprofen, ice, BENADRYL, monitoring. Patient seen today so unsure of how long reaction will continue.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2018-05-11.
Age: 64.0
Sex: F
Vaccine: MNQ
Symptoms: Adverse event, Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-05-08.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-05-11.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling cold, Migraine, Myalgia
Clinical narrative: I started getting insanely tired, then every joint and my muscle started hurting, I got really cold and have a migraine headache. It all started going really downhill around 4 pm the day of. It is now 9:30 am the following morning and everthing from my teeth and hair to my toes hurts.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Toothache
Clinical narrative: I started getting insanely tired, then every joint and my muscle started hurting, I got really cold and have a migraine headache. It all started going really downhill around 4 pm the day of. It is now 9:30 am the following morning and everthing from my teeth and hair to my toes hurts.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 18 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2018, the patient was inadvertently vaccinated with a fourth dose of GARDASIL 9 (dose, site of administration, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-APR-2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 31-MAY-2016, the patient was treated by a health professional for a severe vesicular outbreak, which was diagnosed as 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: U
Vaccine: PNC13
Symptoms: Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. It was reported that a currently 4 and half year-old patient of unknown gender and ethnicity received the first dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation, at 2 months of age. The patient received the second dose at 4 months of age, at single dose for immunisation, the third dose at 6 months at single dose for immunisation and the fourth dose at 12 months at single dose for immunisation. The patient medical history and concomitant medications were not reported. After receiving all four doses of PREVNAR 13 the patient had no immune response to the vaccine. The reporter is wondering how to revaccinate the patient. The information on the batch number has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Laboratory test normal, Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on the deltoid, on 04May2018 at a single dose; and MENACTRA, via an unspecified route of administration on the same arm as meningococcal group b rlp2086, on 04May2018 at an unspecified dose, both for immunization. The patient had no underlying conditions. The patient's concomitant medications were not reported. In May2018, after the patient left the office, the patient fainted and was taken to the ER. It was reported that the event took place after use of the product. In May2018, the lab results were normal - no issues. The outcome of the event was unknown. Information on the batch number has been requested.; 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: MENB
Symptoms: Decreased immune responsiveness
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age, ethnicity and gender, received TRUMENBA (lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician was concerned over the patient's sharp decline of immunity after 12 months after completing series on an unspecified date. The outcome of the event of "sharp decline of immunity" was unknown. The information on the batch/lot number has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered
Clinical narrative: PROQUAD vaccine was one day expired. Pt was notified and will be revaccinated. Incident reported to Merck as well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: PROQUAD vaccine was one day expired. Pt was notified and will be revaccinated. Incident reported to Merck as well.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had a reaction on right side of face along neck. (Rash like symptoms).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Nodule, Rash, Rash pruritic, Swelling
Clinical narrative: Orange sized knot and bruise at the injection site, angry itchy rash around the side and swelling, rash subsided after the 4th day after injection. Knot has diminished after 4 days but bruise is still prevalant after 4 days post injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Patient called pharmacy to report ringing in the ears. She described it as tolerable and not severe. No further action taken.
Age: 0.17
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Body temperature increased, Rash morbilliform
Clinical narrative: Baby developed a morbiliform rash, temperature of 100.4. Presume viral and not related.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Blood calcium decreased, Blood creatine phosphokinase, Brain natriuretic peptide increased, C-reactive protein increased, Chest pain
Clinical narrative: Patient developed chest pain, went to ER, diagnosed with Myocarditis, stayed inpatient for 2 days.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Fibrin D dimer decreased, High density lipoprotein decreased, Lymphocyte count increased, Myocarditis, Red blood cell sedimentation rate normal
Clinical narrative: Patient developed chest pain, went to ER, diagnosed with Myocarditis, stayed inpatient for 2 days.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Toxicologic test normal, Troponin T increased
Clinical narrative: Patient developed chest pain, went to ER, diagnosed with Myocarditis, stayed inpatient for 2 days.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Frequent bowel movements, Rash vesicular, Vomiting
Clinical narrative: Patient's mother described mucous watery diarrhea, 6-8 times a day for 5 days, with one episode of vomiting, slightly crabby. Was eating and sleeping fine otherwise. Seen 5/16/18 and stool is a bit firmer now. Did have blistery diaper rash with increased stools, healing now. No fevers, no other s/s.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Patient reports she received the vaccine 10:30am on 5/14 and had some injection site soreness. By 10pm on 5/15, there was a warm, raised, red area 5-6 inches below the injection site on her left arm. Patient reports it does not hurt and denies any difficulty breathing, etc.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Tremor
Clinical narrative: Severe total body shaking & shivering with normal body temperature - lasting about 2 hours. Total body aches & pains - lasting about 36 hours. Treated with rest & fluids. No ongoing issues.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous
Clinical narrative: Right back of arm on subcutaneous area has oval, 5x15cm, red rash. No satellite lesions. Indurated to palpitation. No warmth, swelling of arm, streaking or bruising. Denies SOB, wheezing or throat closing.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abnormal behaviour, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash that started last night. Has about 3 large spots on abdomen size of quarter and starting to form blisters in the center. No fevers. Areas red and itchy. Received immunizations on Monday. Also has 7 spots that are red on abdomen without blisters. No breathing difficulties or wheezing. No bluishness to skin. Is acting hungry but not wanting to eat. Patient has a papular rash in patches on her abdomen and under both armpits. 1-2 lesions on her upper back. Surrounding erythema.  They all appear at the same stage. No scabbing of lesions. Mom said is just not acting her normal self.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Rash that started last night. Has about 3 large spots on abdomen size of quarter and starting to form blisters in the center. No fevers. Areas red and itchy. Received immunizations on Monday. Also has 7 spots that are red on abdomen without blisters. No breathing difficulties or wheezing. No bluishness to skin. Is acting hungry but not wanting to eat. Patient has a papular rash in patches on her abdomen and under both armpits. 1-2 lesions on her upper back. Surrounding erythema.  They all appear at the same stage. No scabbing of lesions. Mom said is just not acting her normal self.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Infection transmission via personal contact, Myalgia, Rash, Skin disorder
Clinical narrative: Contact transmission. Skin changes began 9 May. Previously vaccinated in 2008. Symptoms: HEADACHE (R51), RASH and OTH NON-SPEC SKIN ERUPTION (R21), MYALGIA (M791).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical center for a blistering 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, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 25-NOV-2009, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy (by an unspecified health care professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster.  On or about 25-AUG-2014, the patient was treated by a physician at a family group medical office for a persistent and severe vesicular rash, which was diagnosed as shingles. On or about 25-AUG-2014, the patient sough(t) subsequent treatment from a physician (name was the same as the physician's name at the family group medical office; unclear if it was the same physician) at an ophthalmology office for the diagnosis of Herpes zoster ophthalmmicus (shingles with interference in the eyes). On or about the dates of 02-SEP-2014 and 08-SEP-2014 the patient sought additional treatment from the physician (same name) at the family group medical office for a persistent and severe vesicular rash, which was diagnosed as shingles. On or about 14-NOV-2014, the patient was further treated by the physician (same name) for ongoing and worsening symptoms of zoster infections. The patient was prescribed famciclovir  (FAMVIR), methylprednisolone (MEDROL), gabapentin and hydrocortisone for management of her painful and persistent symptoms. 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, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.   Upon internal review, the event of Herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from contactable Pharmacist via a Pfizer Sales Representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling on an unspecified date with outcome of unknown.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Periorbital oedema
Clinical narrative: Periorbital edema, treated with prednisolone.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Abdominal pain with nausea and vomiting 3-4 days.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital rash, Rash
Clinical narrative: Patient reported spotty rash on chest, back, stomach, genitals. No fever, pain, or itchiness. No other symptoms besides rash. MD prescribed OTC cortisone and BENADRYL. Still red at this time but has improved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Injection was given wrong route. It should have been IM not SQ.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on torso and back.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt states that starting the next morning after receiving her vaccines, the injection site became swollen, red, itchy, tender, and warm to the touch. Over the next few days the reaction began to spread out from the injection site and formed a large red band all the way around her upper left arm. Pt presented to the pharmacy to determine what she should do. Pharmacist recommended OTC BENADRYL and a visit to her PCP, since pt reported a history of adverse reaction to a tetanus vaccine.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Rash generalised
Clinical narrative: 5/12/18 golf ball size rash around injection site; 5/13/18 new onset wide spread rash and injection site; Nothing done in the ER, follow up with PCP told to patient.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain, Swelling
Clinical narrative: Raised bulge at injection site. Red streak extending to elbow and forearm, ending close to the wrist. Reaction was described as painful and swollen. Symptoms began the day of the injection and subsided 5 days later (5/15/18).
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Muscular weakness, Peripheral swelling, Skin warm
Clinical narrative: Pt states her arm felt weak and had difficulty moving or lifting her arm. Pt RTC today and her arm is red, warm and swollen.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash pruritic
Clinical narrative: Patient called to inform us that : he developed an itchy rash/ blisters within 3 days after the shot around the abdominal area - from one side to the other; the rash is still remaining after more than a week passed. The rash is also above the naval area lower chest region; Appearance: small red blisters 1/16th to 1/8th of an inch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: First really noticed increased aching of arm near injection site about 5 hours after the injection, which was evening. Awoke the next morning with bad headache, feeling tired, with a lack of appetite. Increasingly got occasional chills, as the day went on. Suspected fever (which I haven't had in probably over a decade), and took my temperature in mid-afternoon, which was about 24 hours after I'd gotten the vaccine: 101 degrees. I then read of the possible side-effects. Slept and rested the rest of the day, but I basically "lost" a day. Totally fine the next day, except for residual bit of ache at the injection site. Not looking forward to the recommended 2nd injection in a few months.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: First really noticed increased aching of arm near injection site about 5 hours after the injection, which was evening. Awoke the next morning with bad headache, feeling tired, with a lack of appetite. Increasingly got occasional chills, as the day went on. Suspected fever (which I haven't had in probably over a decade), and took my temperature in mid-afternoon, which was about 24 hours after I'd gotten the vaccine: 101 degrees. I then read of the possible side-effects. Slept and rested the rest of the day, but I basically "lost" a day. Totally fine the next day, except for residual bit of ache at the injection site. Not looking forward to the recommended 2nd injection in a few months.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccines given to patient (was not supposed to get the Hep A or the Hib).
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: About 6pm in the evening of the vaccination date, the patient noticed swelling at the elbow on the vaccination arm. The arm continued to swell, it became hard on the outside of the elbow and was bulbous on the inside of the elbow. Redness spread from the tricep down to the wrist. The injection site was not actually showing signs of adverse events. The morning after vaccination the patient woke up with very achy joints all over body. The patient went to the emergency room and was treated with IV antibiotics then sent home with oral KEFLEX 500mg 1 QID. The patient stated pain was never higher than a 1 on pain scale but inflammation was a 10. There were no fevers, nausea, vomiting, diarrhea or upset stomach. Patient was given ibuprofen 600mg tablets for pain/swelling, he only used this for a day then D/C the medication after it was messing up his stomach. After 6 days, the patient is finishing the antibiotic and the swelling as reduced but the redness persists, although getting better.
Age: 78.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Patient reports discomfort directly at injection site at first and had trouble lifting arm. Pain moved up to the shoulder and it persists. He reports that it is getting better but still has occasional pain in the shoulder area. Two shots were given in the deltoid. PNEUMOVAX was higher and SHINGRIX was lower, separated by greater than 1 inch.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: I was helping down in walk-in's tonight where typically immunizations are given by all clinical support staff (CSS) instead of paging the Imm's Specialist. Patient was due for his second doses of MCV4 and Hep A. I confirmed the dose, insurance's and made sure I was pulling from VFC correctly with another CSS. When I pulled from the box of vaccines in the fridge the boxes facing me were the pre-drawn up vaccines, and right there in big letters was, HEP A. So, I took the pre drawn hep A out of the box, and got the correct MCV4. Gave the vaccines. Everything went very smoothly until I went to document the vaccines and I couldn't find the lot number in the list the EHR was giving me. When I walked back down and looked into what box the I pulled from, I pulled the pre drawn Hep A, that is 1.0 mL, not 0.5 ml that the patient was supposed to receive. So, I gave the patient 1 mL of Hepatitis A in his right arm, along with MCV4, in his right arm. The patient had left by the time I had realized my error. I notified Manager On Duty. I also sent an email to RN and my manager. As of Friday night, the patient had not been notified. I contacted the patient on 5-15-2018 and informed him of the adult Hepatitis A vaccine that he received. Teaching was done. Patient had no complaints.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient had swelling and redness at site of injection, however chief complaint was itching...mostly on stomach..kind of all over she said.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 5/14/18 in the evening of the injection, the patient started to experience dizziness, chills, fever, redness at the site along with swelling and warmth at the site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: On 5/14/18 in the evening of the injection, the patient started to experience dizziness, chills, fever, redness at the site along with swelling and warmth at the site
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypoaesthesia, Nausea, Pyrexia
Clinical narrative: Fever of 100.9 for 12 hours after administration of two Extra Strength TYLENOL every 6 hours, Shaking Chills, Numbness of upper legs, Nausea, Somnolence, Headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Tremor
Clinical narrative: Fever of 100.9 for 12 hours after administration of two Extra Strength TYLENOL every 6 hours, Shaking Chills, Numbness of upper legs, Nausea, Somnolence, Headache.