chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Injection site reaction, Product administered to patient of inappropriate age, Product dispensing error, Product prescribing error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 37-year-old male patient who received ENGERIX B pediatric (batch number GX9X5, expiry date 25th February 2021) for prophylaxis. On 19th January 2019, the patient received the 2nd dose of ENGERIX B pediatric .5 ml. On 19th January 2019, unknown after receiving ENGERIX B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown. Additional details were reported as follows: The adult patient inadvertently administered with 0.5 ml dose of ENGERIX B, which led to accidental underdose and adult use of a child product. The reporter consented to follow up. Follow up information were received from pharmacist on 19th February 2019: The patient demographic details were updated. The patient received ENGERIX B pediatric by intramuscular route. In 2019, unknown after receiving ENGERIX B pediatric, the patient experienced injection site reaction. The patient came in to get the 20 mg dose of ENGERIX B adult. The paper was in for 20 mg but 10 mg was typed, reviewed, dispensed and administered to patient, this led to drug prescribing error and drug dispensing error. The patient had been contacted and aware of the situation. No reaction or side effect had occurred due to the result of this besides general localized injection site reaction. The outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to ENGERIX B pediatric. The VAERS details were updated.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 15th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced skin breakout. On 16th February 2019, the patient experienced shingles. On an unknown date, the outcome of the shingles and skin breakout were unknown. It was unknown if the reporter considered the shingles and skin breakout to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left deltoid. The reporter stated that a patient received the SHINGRIX and broke out and went to the emergency room on 16th February 2019. The doctor there told her that the patient had Shingles. The reporter did not provide any additional details.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Hepatitis B antibody negative
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of weakness in a 41-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included ENGERIX B (batch number 9X9ZT, expiry date 19th January 2021) for prophylaxis. Previously administered products included Hepatitis B vaccine (In 2015, the patient received 2 doses). On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On 19th February 2019, the patient received the 1st dose of ENGERIX B 20 µg. On 19th February 2019, not applicable after receiving Hepatitis B vaccine and less than a day after receiving ENGERIX B, the patient experienced weakness, dizziness and shortness of breath. On 20th February 2019, the patient experienced headache. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the weakness, dizziness and headache were recovering/resolving and the outcome of the shortness of breath was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the weakness, dizziness, shortness of breath and headache to be related to ENGERIX B. Additional details were received as follows: Till the time of reporting, the patient did not complete the series of Hepatitis B vaccine, which led to incomplete course of vaccination. At the time of reporting, titer showed that the patient was not immune to hepatitis B, so the first dose of ENGERIX-B was administered. On the same evening of the day of vaccination, the patient experienced weakness, dizziness, shortness of breath and almost fainted. At the time of reporting, the patient was weak, dizzy and after 1 day after vaccination the patient has a headache. The still had some shortness of breath, but it was better than yesterday.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, Incomplete course of vaccination, Presyncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of weakness in a 41-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included ENGERIX B (batch number 9X9ZT, expiry date 19th January 2021) for prophylaxis. Previously administered products included Hepatitis B vaccine (In 2015, the patient received 2 doses). On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On 19th February 2019, the patient received the 1st dose of ENGERIX B 20 µg. On 19th February 2019, not applicable after receiving Hepatitis B vaccine and less than a day after receiving ENGERIX B, the patient experienced weakness, dizziness and shortness of breath. On 20th February 2019, the patient experienced headache. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the weakness, dizziness and headache were recovering/resolving and the outcome of the shortness of breath was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the weakness, dizziness, shortness of breath and headache to be related to ENGERIX B. Additional details were received as follows: Till the time of reporting, the patient did not complete the series of Hepatitis B vaccine, which led to incomplete course of vaccination. At the time of reporting, titer showed that the patient was not immune to hepatitis B, so the first dose of ENGERIX-B was administered. On the same evening of the day of vaccination, the patient experienced weakness, dizziness, shortness of breath and almost fainted. At the time of reporting, the patient was weak, dizzy and after 1 day after vaccination the patient has a headache. The still had some shortness of breath, but it was better than yesterday.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Flu vaccine. Additional details were provided as follows: This case was reported by a pharmacy intern. The patient had a Guillian Barre reaction to a flu vaccine in 2005. The brand name of flu vaccine and other details were not available at time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vertigo in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown. It was unknown if the reporter considered the vertigo to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The patient received SHINGRIX and developed vertigo after receiving the vaccine. The reporter did not have any additional information regarding this event.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 23rd February 2019, the patient received SHINGRIX. On 24th February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, pain in arm and axillary pain. On 25th February 2019, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, pain in arm, injected limb mobility decreased and axillary pain were unknown.  It was unknown if the reporter considered the injection site pain, pain in arm, injected limb mobility decreased and axillary pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient developed injection site pain the day after the vaccination. He developed a pain that radiates from his armpit to his wrist on  25th February 2019 (Monday).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Patient described arm pain as well as weakness in the legs. She said her legs just gave out with no dizziness prior to falling. She woke up the day later with a self-reported fever of 101 F.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed swelling with a hard knot at injection site along with redness and fever at injection site.
Age: 44.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event from the vaccine, Incorrect vaccine given. Patient was given PREVNAR 13 should have received pneumococcal conjugate vaccine 23.
Age: 1.17
Sex: M
Vaccine: FLU4, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events noted. Patient received incorrect vaccine. Was due for MMR but received MMRV.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pt describes pain in left shoulder that kept her up the night after the vaccination. Has limited range of motion in left arm. On follow up as of 02/28/19 pt pain is markedly decreased, and range of motion is improving but not back at 100% Pt is concerned of bursitis in the left shoulder as a result of vaccine administration. The immunization site was inspected as she still had the bandage on from the administration. The site appears to be at the upper limit of the normal immunization site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Pt. called to ask about some blisters that appeared on skin a few days after vaccination. Pt. was instructed to seek medical attention for evaluation. Pt. was educated about most common ADE/SE of vaccines and the precaution he should have.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Shivering, fever 100.8 F, muscle aching entire body, headache lasted 24 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Fever for about 36 hours and as high as 101 degrees, chills, aches, headache, red rash at injection site of about 3" x 4", extreme swelling at the injection site and it was hot to the touch. After 9 days, I still have redness and itching at the site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever for about 36 hours and as high as 101 degrees, chills, aches, headache, red rash at injection site of about 3" x 4", extreme swelling at the injection site and it was hot to the touch. After 9 days, I still have redness and itching at the site.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Hallucination, Mental status changes, Pyrexia
Clinical narrative: Hallucinations, high fever (reached 105), altered mental status, occurred about a week after the vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Patient had muscular pain and aching at the site of the injection after receiving the SHINGRIX vaccine on February 6th. On February 8th, she described having worsening soreness, stiffness, and muscular pains/aches in her shoulder, arm, neck, and throughout her back. The pain escalated and started to involve a shooting pain on February 11th and 12th. Patient stated that the pain is constant--about a 3 or 4 out of 10. The pain gets worse to an 8 out of 10 at times--both provoked and unprovoked. Her pain worsens if she lays on her left side or in certain positions, such as bending over to pick something up off the ground. Other times the pain worsens with no apparent cause. Patient has tried to take ibuprofen, naproxen, and a leftover opioid medication with little to no improvement in pain. Her doctor prescribed her amitriptyline on the 18th, which also did not help. On the 25th she was prescribed gabapentin and has not had relief with this medication yet (she is still currently taking). She is scheduled to see an ortho hand specialist on March 7th.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Adverse Event: Redness, swelling, itching, hives, & soreness at & around the injection site. Tx: OTC Benadryl, Ibuprofen, cold compress over next 2-3 days. Outcome: symptoms resolved.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood bicarbonate decreased, Blood culture negative, Blood pH decreased, Congestive cardiomyopathy, Diarrhoea
Clinical narrative: Pt was seen on 3/28/18 for a well visit and received her 2 month imms that day. She was well appearing with normal growth. Within 24 hours developed, lethargy, diarrhea, poor feeding and presented to the ED the next day with profound metabolic acidosis. She was intubated and admitted to PICU where she was diagnosed with a severe dilated cardiomyopathy. She remained intubated and on high levels of inotropic support for the first 1-2 weeks and then gradually improved. A very extensive workup was done. At time of discharge there was no identifiable etiology for what was a presumed acute and very fulminant myocarditis including extensive metabolic, genetic, and infectious etiologies. She has continued to improve over the last 10 months and is entirely normal developmentally at this time. She is currently being very slowly weaned off all cardiac medications. Her most recent echo is normal. She remains on carnitine supplementation which was started the PICU after she was found to have minimally reduced levels (medical genetics did not feel this was the etiology). Awaiting input to d/c that from genetics. She has not received further vaccinations since her two month shots.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Echocardiogram abnormal, Ejection fraction normal, Endotracheal intubation, Intensive care, Left ventricular dilatation
Clinical narrative: Pt was seen on 3/28/18 for a well visit and received her 2 month imms that day. She was well appearing with normal growth. Within 24 hours developed, lethargy, diarrhea, poor feeding and presented to the ED the next day with profound metabolic acidosis. She was intubated and admitted to PICU where she was diagnosed with a severe dilated cardiomyopathy. She remained intubated and on high levels of inotropic support for the first 1-2 weeks and then gradually improved. A very extensive workup was done. At time of discharge there was no identifiable etiology for what was a presumed acute and very fulminant myocarditis including extensive metabolic, genetic, and infectious etiologies. She has continued to improve over the last 10 months and is entirely normal developmentally at this time. She is currently being very slowly weaned off all cardiac medications. Her most recent echo is normal. She remains on carnitine supplementation which was started the PICU after she was found to have minimally reduced levels (medical genetics did not feel this was the etiology). Awaiting input to d/c that from genetics. She has not received further vaccinations since her two month shots.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Metabolic acidosis, Mitral valve incompetence, Myocarditis, PCO2 increased
Clinical narrative: Pt was seen on 3/28/18 for a well visit and received her 2 month imms that day. She was well appearing with normal growth. Within 24 hours developed, lethargy, diarrhea, poor feeding and presented to the ED the next day with profound metabolic acidosis. She was intubated and admitted to PICU where she was diagnosed with a severe dilated cardiomyopathy. She remained intubated and on high levels of inotropic support for the first 1-2 weeks and then gradually improved. A very extensive workup was done. At time of discharge there was no identifiable etiology for what was a presumed acute and very fulminant myocarditis including extensive metabolic, genetic, and infectious etiologies. She has continued to improve over the last 10 months and is entirely normal developmentally at this time. She is currently being very slowly weaned off all cardiac medications. Her most recent echo is normal. She remains on carnitine supplementation which was started the PICU after she was found to have minimally reduced levels (medical genetics did not feel this was the etiology). Awaiting input to d/c that from genetics. She has not received further vaccinations since her two month shots.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Poor feeding infant, Viral test negative
Clinical narrative: Pt was seen on 3/28/18 for a well visit and received her 2 month imms that day. She was well appearing with normal growth. Within 24 hours developed, lethargy, diarrhea, poor feeding and presented to the ED the next day with profound metabolic acidosis. She was intubated and admitted to PICU where she was diagnosed with a severe dilated cardiomyopathy. She remained intubated and on high levels of inotropic support for the first 1-2 weeks and then gradually improved. A very extensive workup was done. At time of discharge there was no identifiable etiology for what was a presumed acute and very fulminant myocarditis including extensive metabolic, genetic, and infectious etiologies. She has continued to improve over the last 10 months and is entirely normal developmentally at this time. She is currently being very slowly weaned off all cardiac medications. Her most recent echo is normal. She remains on carnitine supplementation which was started the PICU after she was found to have minimally reduced levels (medical genetics did not feel this was the etiology). Awaiting input to d/c that from genetics. She has not received further vaccinations since her two month shots.
Sex: F
Vaccine: FLUX, HEPA, MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 16-year-old female patient received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation and co-administered with Hepatitis A and Flu. The patient medical history was not reported. The patient experienced fainted on an unspecified date. The outcome of event was unknown. Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that fainted is related to TRUMENBA administration cannot be excluded.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Rash
Clinical narrative: Information has been received on 21-FEB-2019 from a lawyer regarding a case in litigation, involving a male patient, age and medical history not reported. In and around 16-AUG-2017 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster). A few days after receiving the vaccine, the patient suffered a burning and stinging rash on his face spreading towards his left eye. The patient was diagnosed with herpes zoster on 30-AUG-2017. As a direct and proximate result of the ZOSTAVAX, the patients symptoms have resulted in physical limitations not present prior to the using the product. The patient also experiences mental and emotional distress due to physical limitations and the seriousness of his condition. The patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. The patient required and will continue to require healthcare and services, medical and related expenses, and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, diminished quality of life and other losses and damages. Herpes zoster was considered to be a disabling event. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal, Ear infection
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 10-year-old patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date to for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced recurring ear infections, allergist checked PREVNAR 13 titers, which came back low. The outcome of the events was unknown. The allergist recommended a booster of PREVNAR 13 and rechecking the titers in four weeks. The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: F
Vaccine: PNC13
Symptoms: Generalised erythema, Pruritus, Rash, Rash erythematous, Rash generalised
Clinical narrative: This is spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received PREVNAR 13, Lot # X13847, Expiry date Jul2020, NDC # 00005197102, UPC # 300051971022 via an unspecified route of administration at single dose on an unspecified date in Feb2019 (might be a week before this report) for immunisation. Medical history included pain. Concomitant medication included Tramadol, it has histamine release but she has been on that one, for pain. The patient has not taken anything since she got the vaccine. On an unspecified date the patient experienced redness all over her body, patches of rash and redness (these red bumps all over her body, they are pretty red), itching really bad, maybe she is allergic to one of the ingredients or something. Skin reaction is raised above. The outcome of the events was unknown. No treatment given by the reporter. Course of events: Pharmacist had a patient come by like 5 minutes before this report and gave her the PREVNAR dose may be a week before this report and the patient said she had these red bumps all over her body and Pharmacist looked at that them they are pretty red. She was itching really bad and but that was about a week, might be a week before this report. Pharmacist was not sure about the itching but the skin reaction was raised above. Causality: Pharmacist spoke to the patient and asking her for anything changed in her diet, if she started taking any other medications over the counter besides the one in the pharmacy. She said no and she said they were all over her body and she received the vaccination on the 16th so to me it has something to do with it, maybe she is allergic to one of the ingredients or something.
Sex: F
Vaccine: PNC13
Symptoms: Skin reaction
Clinical narrative: This is spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received PREVNAR 13, Lot # X13847, Expiry date Jul2020, NDC # 00005197102, UPC # 300051971022 via an unspecified route of administration at single dose on an unspecified date in Feb2019 (might be a week before this report) for immunisation. Medical history included pain. Concomitant medication included Tramadol, it has histamine release but she has been on that one, for pain. The patient has not taken anything since she got the vaccine. On an unspecified date the patient experienced redness all over her body, patches of rash and redness (these red bumps all over her body, they are pretty red), itching really bad, maybe she is allergic to one of the ingredients or something. Skin reaction is raised above. The outcome of the events was unknown. No treatment given by the reporter. Course of events: Pharmacist had a patient come by like 5 minutes before this report and gave her the PREVNAR dose may be a week before this report and the patient said she had these red bumps all over her body and Pharmacist looked at that them they are pretty red. She was itching really bad and but that was about a week, might be a week before this report. Pharmacist was not sure about the itching but the skin reaction was raised above. Causality: Pharmacist spoke to the patient and asking her for anything changed in her diet, if she started taking any other medications over the counter besides the one in the pharmacy. She said no and she said they were all over her body and she received the vaccination on the 16th so to me it has something to do with it, maybe she is allergic to one of the ingredients or something.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 19-years-old female patient received TRUMENBA (Lot#W95309 Expiration date Jan2020), via an unspecified route of administration on 15Feb2019 at single dose for immunisation. Medical history included ongoing food allergy to pork, beef & turkey, ongoing diarrhea if the patient eats too many eggs. There were no concomitant medications.  The patient stated her arm was really hurting more and there was a little redness around the area of administration. The onset of the event was unknown. The reported events were considered non serious. The outcome of the two events were unknown.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report received from a contactable Physician via Pfizer sales representative. A 72-year-old patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included diabetes mellitus, chronic heart disease and hypertension. The patient's concomitant medications were not reported. The patient previously took pneumococcal polysaccharide vaccine, 23-valent for immunisation. The patient developed pneumococcal pneumonia few months after being vaccinated with pneumococcal 13-val conjugate vaccine (dipht crm197 protein). The outcome of the event pneumonia was unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for her sister) from Pfizer sponsored program. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration from an unspecified date to an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced "I was remembering when I pneumonia and also my sister had the shot and still got pneumonia" (drug ineffective). The action taken in response to the event for the vaccine was not applicable. The clinical outcome for the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Mild headache, muscle ache, joint ache,low grade fever 99.9 lasting as of now 2 days, chills.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pain on left arm below deltoid. Pain has been there since vaccine was administered. Patient cannot do her exercise class.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash, Rash morbilliform
Clinical narrative: Patient was given the MMR vaccine on 2/11/19. On the morning of 2/28/19 dad called the office reporting that patient broke out in a rash last evening and they were not sure what it was, if a reaction to the change in the laundry detergent (as they did change this). Informed dad to send a picture via patient portal. The rash look suspicious and dad was informed that we should make an appointment to have patient seen. Appointment was made. Parents arrived with patient and they were immediately brought into the room. Patient's vitals were taken, parents denied any other symptoms other than the rash, denied itching. Rash was located to the abdomen, chest, back and some on the patient's neck. Parents stated rash started last evening. Dr. stated he felt the rash was a Measles like reaction (viral) and it just needed to run its course. Patient was sent home with the parents.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Limb mass, Tenderness
Clinical narrative: Palpable lump to left arm with pain with palpation. Happened 2 weeks after administration of vaccine but reports pain prevents her from lying on that aspect of her arm when she sleeps. Otherwise, not bothersome. Advised warm compresses and massaging are since lumps following vaccine administration can happen.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site discomfort, Lip blister, Ophthalmic herpes zoster, Oral herpes
Clinical narrative: The patient reported he got the second of 2 SHINGRIX vaccines on 2/9/19 at Pharmacy. I do not have the specifics for lot number. He presented to me for F/U of URI symptoms on 2/25/19 and I noted a blister above his left lip and near left nares. On further review he had a cluster of 3 blisters to the left eye on the lateral aspect. I brought that to his attention, he referred to them as "cold sores" and noted them first on 2/20/19. There was mild pain, no vision changes. He was outside of the 72 hr window for antivirals. He had some mild discomfort at the site but was not terribly bothered by the lesions. I was concerned given this occurred within 10-11 days of the date he had the second SHINGIX vaccine. I am not clear if the 2 are related, but I am concerned about the timing.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Upper respiratory tract infection
Clinical narrative: The patient reported he got the second of 2 SHINGRIX vaccines on 2/9/19 at Pharmacy. I do not have the specifics for lot number. He presented to me for F/U of URI symptoms on 2/25/19 and I noted a blister above his left lip and near left nares. On further review he had a cluster of 3 blisters to the left eye on the lateral aspect. I brought that to his attention, he referred to them as "cold sores" and noted them first on 2/20/19. There was mild pain, no vision changes. He was outside of the 72 hr window for antivirals. He had some mild discomfort at the site but was not terribly bothered by the lesions. I was concerned given this occurred within 10-11 days of the date he had the second SHINGIX vaccine. I am not clear if the 2 are related, but I am concerned about the timing.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Ammonia increased, Anxiety, Ascites
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Aspartate aminotransferase increased, Atrial fibrillation, Bacteraemia, Blood albumin decreased, Blood bilirubin increased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium decreased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood culture positive, Blood iron decreased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood lactate dehydrogenase increased, Blood potassium increased, Blood urea increased, Blood urine present, Bundle branch block left
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Carbon dioxide decreased, Cardiac failure congestive, Cardiomegaly, Cardiomyopathy, Cholelithiasis
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Complement factor C3 decreased, Compression fracture, Computerised tomogram abnormal, Confusional state, Death
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Delirium, Dysphagia, Dyspnoea, Eosinophil percentage decreased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Epstein-Barr virus antibody positive, Fall, Fatigue, Gait disturbance, Gastrointestinal oedema
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised oedema, Haematocrit decreased, Haematoma, Haemoglobin decreased, Hyponatraemia
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypovolaemia, Immunodeficiency, International normalised ratio increased, Iron binding capacity total decreased, Lethargy
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Leukocytosis, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin decreased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Memory impairment, Mental disorder, Metabolic encephalopathy, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Normocytic anaemia, Nuclear magnetic resonance imaging abnormal, Pain, Platelet count decreased, Pleural effusion
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Protein urine present, Prothrombin time prolonged, Pulmonary oedema, Red blood cell count decreased, Red blood cell sedimentation rate increased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Red cell distribution width increased, Restlessness, Sinus tachycardia, Transaminases increased, Transferrin saturation decreased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan abnormal, Ventricular extrasystoles, White blood cell count increased
Clinical narrative: The patient (my wife) died on Jan 25, 2019.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Burning sensation, Decreased appetite, Erythema, Feeling abnormal, Injection site erythema
Clinical narrative: Mom reports on day of vaccines around 6 pm cheeks and chin was red and injection site (lt arm) red and warm to touch. Pt c/o it burning Has not felt good  and has not wanted to eat since then. On left upper arm at injection site is red (8 cm x 9 cm). Seen by provider today and was place on Amoxicillin.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Skin warm
Clinical narrative: Mom reports on day of vaccines around 6 pm cheeks and chin was red and injection site (lt arm) red and warm to touch. Pt c/o it burning Has not felt good  and has not wanted to eat since then. On left upper arm at injection site is red (8 cm x 9 cm). Seen by provider today and was place on Amoxicillin.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site discomfort, Injection site erythema
Clinical narrative: Within 24 hours the patient developed redness and discomfort several inches below the vaccine site around the bicep with some redness up toward the axilla.
Age: 0.83
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on legs and face.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: High fever and related effects: prostration, shivering, fatigue. Fever started shortly after injection.  Left work at 3:30, went to bed. Fever broke next morning.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Malaise, Musculoskeletal stiffness
Clinical narrative: Pt showed larger than expected area of redness at left deltoid area, reported waking up with feeling of muscles being stiff "like iron" and general malaise. She thought she may have had a low-grade fever also. Muscle symptoms and fever are gone now but maybe 3-4 inch area of redness at injection site still present.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a 76 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 30-OCT-2015, the patient was administered the ZOSTAVAX by a healthcare professional at a clinic (lot number, dosage and route of administration not provided). On or about 25-AUG-2017, the patient was treated by a healthcare provider at a clinic for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles was unknown.  Causality assessment was considered related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-DEC-2014, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a physician at a physician's office. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Ear infection, Sinusitis, Wrong product administered
Clinical narrative: Initial information received on 23-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional (physician assistant/ patients mother) via other company (Pfizer) (Manufacturer Report Number: 2018314537) by phone. This case involves a 16 years old male patient who was vaccinated with a dose of TRUMENBA and BEXSERO instead of MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (same visit). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unspecified date of Jul-2018, the patient developed a non-serious sinus infection (sinusitis) and double ear infection (ear infection) a couple of days following the vaccination. It was also a case of actual medication error due to wrong vaccine administered because patient was about to receive MENACTRA but was given TRUMENBA instead because they pulled the wrong one. It was reported that the reporter wants to known when should the patient get the second dose of BEXSERO, and should he wait until he gets his MENACTRA. No Lab data was reported. Final diagnosis was double ear infection, sinus infection, a TRUMENBA and a BEXSERO were both given at the same time, same visit and supposed to get MENACTRA but was given TRUMENBA instead because they pulled the wrong one. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for sinus infection and double ear infection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old male patient who was vaccinated with vaccine reconstituted with sterile water, while he received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT; PREVNAR 13; and PEDIATRIX. On 22-Feb-2019, the patient received a 3rd dose of suspect 0.5 ml HIB (PRP/T) VACCINE (lot number: UI951AA and expiry date: 13-Jun-2020) (route and site of administration was not reported). It was a case of actual medication error due to inappropriate reconstitution technique. There were no side effects. 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: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a health professional. This case involves a patient of unknown demographics who received an expired dose of MENACTRA (lot number not reported via unknown route in unknown administration site) which was expired one month before. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if patient experienced adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a pediatrician via consumer (patient's mother). This case involves a female patient of unknown age who received 0.5 ml first dose of IPOL (lot number, expiry date, route and site of administration were not reported) which was stored outside the recommended range on 07-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP VACCINE for Immunisation. It was a case of actual medication error due to incorrect product storage. It was reported that patient's mother received a letter from the pediatrician that stated that the vaccine was stored outside the recommended range and 'may have' been ineffective and recommended re-vaccination. It was unknown whether adverse event was 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: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via other company (Pfizer) (Manufacturer Report Number: 2018266370). This case concerns a patient (age and gender not reported) who experienced tetanus toxoid allergy, while he/she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported. The patient developed a non-serious tetanus toxoid allergy (Unknown latency) following the administration of TETANUS TOXOID. (Other relevant tests included No lab data.) Final diagnosis was tetanus toxoid allergy. It was not reported if the patient received a corrective treatment. The patient outcome was Unknown for tetanus toxoid. List of document held by sender: none.