chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Dysarthria, Gait disturbance, Monoplegia, Seizure like phenomena, Syncope
Clinical narrative: Fainting, seizure like symptoms, limp/paralyzed limbs, slurred speech that lasted about 1 minute. With him in my arms went downstairs to get my cell phone to call 911 and all of the sudden he started acting normal again. Monitored him for the rest of the day and over night as the on call Dr had recommended. Made an appt with his pediatricians office following morning. They said it could have been a seizure and we made an appt to see a neurologist but appt isn?t until May 15!
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Rash
Clinical narrative: Swelling at injection site Rash L upper chest
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash on injection site of 2 inches, maybe a bit more. Described as a big bump and redness. Also with smaller bumps on rash. Starting to itch and painful to the touch.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Pain on the left arm; Swelling on the left arm; Injected on the left forearm; This is a spontaneous report from a contactable consumer.  A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot #: X90022), via an unspecified route of administration on the left forearm arm on an unspecified date at single dose for immunization.  The patient's medical history and concomitant medications were not reported. The patient was injected 1 vaccine of pneumococcal 13-val conj vac (dipht crm197 protein) on the left forearm arm and she returned days after claiming pain and swelling on the left arm on 16Mar2019 since the date vaccine was administered. The outcome of the events was unknown.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: injuries resulting from Zostavax use: Herpes Zoster; Herpes Zoster; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 76 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-JUL-2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient experienced injuries resulting from zoster vaccine live(ZOSTAVAX) use: herpes zoster and was treated at clinic. The reporter also claimed the product's liability - defective design; manufacturing defect. The outcome of events was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer refers to a currently 79-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date in 2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for long-term prevention of shingles and zoster-related conditions.         On an unknown date, the patient experienced shingles and she received treatment for this adverse event.       The outcome of the singles was unknown.  The causality assessment between the event and the suspect therapy was reported as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer refers to a currently 75-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 29-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for long-term prevention of shingles and zoster-related conditions.         On an unknown date, the patient experienced herpes zoster infection for which she received treatment.   The outcome of the herpes zoster was unknown.  The causality assessment between the event and the suspect therapy was reported as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer refers to a currently 67-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On or about 25-JAN-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for long-term prevention of shingles and zoster-related conditions.         On an unknown date, the patient experienced shingles for which she received treatment.      The outcome of the shingles was unknown.  The causality assessment between the shingles and the suspect therapy was reported as related.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sickness, injection site swelling and injection site warmth. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sickness, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sickness, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient expereinced stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sick and hot swollen arm at the vaccination site after 2nd dose of SHINGRIX. This case is linke dto case US2019000403, same patient.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sickness, injection site swelling and injection site warmth. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sickness, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sickness, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient expereinced stomach pain, injection site pain, injection site erythema, fever, chills, exhaustion, sick and hot swollen arm at the vaccination site after 2nd dose of SHINGRIX. This case is linke dto case US2019000403, same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly male patient who received SHINGRIX (batch number JE45P, expiry date 29th May 2021) for prophylaxis. 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Catheterisation cardiac normal, Chest pain, Injection site discomfort, Injection site erythema, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 73-year-old male patient who received SHINGRIX (batch number 4X733, expiry date 8th March 2021) for prophylaxis. On 1st April 2019, the patient received SHINGRIX (intramuscular). On 1st April 2019, less than a day after receiving SHINGRIX, the patient experienced pain (serious criteria hospitalization), chest pain (serious criteria hospitalization), injection site erythema and injection site discomfort. The patient was treated with nitroglycerine (Nitroglycerin). On an unknown date, the outcome of the pain and chest pain were recovered/resolved and the outcome of the injection site erythema and injection site discomfort were unknown. It was unknown if the reporter considered the pain, chest pain, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional details were reported as follows: On Monday, the patient received a dose of SHINGRIX on the left arm. At the vaccination night, the patient experienced severe pain in his left side and down through his chest. The pain was improved on Tuesday, but was worsened on Wednesday. On Thursday, on 4th April 2019, the patient was hospitalized for the pain with concerns that it might be related to his heart.  n Monday, 8 April 2019, the patient had a catheterization with did not show anything. The patient was given nitroglycerin while in the hospital. The emergency room visit required.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site hives in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced injection site hives. On an unknown date, the outcome of the injection site hives was recovered/resolved. It was unknown if the reporter considered the injection site hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced injection site hives which was recovered after two days. The reporter did not consented to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. An 8- year-old patient of an unspecified gender received 4 doses of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient was hospitalized for pneumonia for 8 days on an unspecified date. The patient underwent lab tests included ran strep pneumonia antibody serotypes test: some of the serotypes were below protective levels. The outcome of the event 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: Discomfort, Erythema, Pain, Swelling
Clinical narrative: Severe swelling; Redness; pain and discomfort; pain and discomfort; This is a spontaneous report from a contactable pharmacist received via a sales representative. An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were 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 patient experienced severe swelling, redness, pain and discomfort on Apr2018. The outcome of the events was unknown.  The information on the batch/lot number and expiration date has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Pain, Swelling
Clinical narrative: Severe swelling; Redness; Pain; Discomfort; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), 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 severe swelling, redness, pain and discomfort on an unspecified date.  The outcome of the events was unknown.  Information on the batch number has been requested.
Age: 43.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Other-HCP on behalf of Physician. A 43-year-old male patient received PREVNAR 13, (lot number: X49142, Expire Date: 30Nov2020, NDC number 0005197101) via an unspecified route of administration at left deltoid on 11Mar2019 04:25 at single dose for immunisation. Medical history included hypothyroidism and not a smoker. There were no concomitant medications. The patient phoned in on 13Mar2019, and stated his arm was very red and sore, all the way down his arm to his elbow. The patient brought a picture and his whole arm turned red with swelling, and a month later it was all gone. The events occurred within 48 hours after the injection (13Apr2019). The events arm red and arm swollen were considered serious due to medically significant. The patient did not visit emergency room or physician office due to events. Relevant tests was reported as none. The patient had completely recovered from the events, in about a month. The reporter considered the event arm red and arm swollen were related to pneumococcal 13-val conj vac (dipht crm197 protein). 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 vaccination site erythema/swelling/pain are related to PREVNAR 13 administration cannot be excluded.
Age: 23.0
Sex: M
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of right anterolateral thigh 7cm at injection site of Varicella, treated with Cephalexin 500mg BID for 10 days starting 18APR2019. The lot number is presumed to be R023737. It is the only opened box in our current stock. The other unopened boxes in stock are R024265 and R030609.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site induration, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: 26 y/o M, anthrax vaccine reaction, x2 days. Pt states he had the vaccine Wednesday, and started noticing reaction Wednesday night. Pt states Wednesday night he started noticing a small, hard bump at injection site. Pt states that the bump has been getting larger, and red spots around injection site. Arm is warm to the touch and red. Pt states there is no radiation of pain down the arm. Pt states he has not had any fevers, nausea, vomiting, body aches or chills. Pt states this is his fourth vaccine and has not had any reaction to the previous vaccines.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Skin warm
Clinical narrative: 26 y/o M, anthrax vaccine reaction, x2 days. Pt states he had the vaccine Wednesday, and started noticing reaction Wednesday night. Pt states Wednesday night he started noticing a small, hard bump at injection site. Pt states that the bump has been getting larger, and red spots around injection site. Arm is warm to the touch and red. Pt states there is no radiation of pain down the arm. Pt states he has not had any fevers, nausea, vomiting, body aches or chills. Pt states this is his fourth vaccine and has not had any reaction to the previous vaccines.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Ear pain, Fatigue
Clinical narrative: First, I felt extremely fatigued and my arm where I received the shot hurt so badly that I couldn't lift it up to shoulder height. Then I felt muscle aches throughout my whole body. I began to feel sick to my stomach and nauseated. I went to bed early and woke up in the night shivering. I couldn't get warm and my whole body hurt. Headache, sick stomach, and shivering. The next morning I took my temperature and it was 101.8. All day yesterday I had a fever, could barely eat, and felt like I had the flu. The muscle soreness continued - especially in my neck. My ears hurt. My skin hurt-a pins-and-needles sensation. I barely made it through the workday. By last night my temperature was down to 100.3. I took a TYLENOL PM and went to bed early. Today I feel somewhat better, although the soreness in my neck and ears continues, and I still don't have my usual energy. But my temperature is back to normal and I no longer have the chills.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Influenza like illness, Injected limb mobility decreased, Injection site pain
Clinical narrative: First, I felt extremely fatigued and my arm where I received the shot hurt so badly that I couldn't lift it up to shoulder height. Then I felt muscle aches throughout my whole body. I began to feel sick to my stomach and nauseated. I went to bed early and woke up in the night shivering. I couldn't get warm and my whole body hurt. Headache, sick stomach, and shivering. The next morning I took my temperature and it was 101.8. All day yesterday I had a fever, could barely eat, and felt like I had the flu. The muscle soreness continued - especially in my neck. My ears hurt. My skin hurt-a pins-and-needles sensation. I barely made it through the workday. By last night my temperature was down to 100.3. I took a TYLENOL PM and went to bed early. Today I feel somewhat better, although the soreness in my neck and ears continues, and I still don't have my usual energy. But my temperature is back to normal and I no longer have the chills.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: First, I felt extremely fatigued and my arm where I received the shot hurt so badly that I couldn't lift it up to shoulder height. Then I felt muscle aches throughout my whole body. I began to feel sick to my stomach and nauseated. I went to bed early and woke up in the night shivering. I couldn't get warm and my whole body hurt. Headache, sick stomach, and shivering. The next morning I took my temperature and it was 101.8. All day yesterday I had a fever, could barely eat, and felt like I had the flu. The muscle soreness continued - especially in my neck. My ears hurt. My skin hurt-a pins-and-needles sensation. I barely made it through the workday. By last night my temperature was down to 100.3. I took a TYLENOL PM and went to bed early. Today I feel somewhat better, although the soreness in my neck and ears continues, and I still don't have my usual energy. But my temperature is back to normal and I no longer have the chills.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: First, I felt extremely fatigued and my arm where I received the shot hurt so badly that I couldn't lift it up to shoulder height. Then I felt muscle aches throughout my whole body. I began to feel sick to my stomach and nauseated. I went to bed early and woke up in the night shivering. I couldn't get warm and my whole body hurt. Headache, sick stomach, and shivering. The next morning I took my temperature and it was 101.8. All day yesterday I had a fever, could barely eat, and felt like I had the flu. The muscle soreness continued - especially in my neck. My ears hurt. My skin hurt-a pins-and-needles sensation. I barely made it through the workday. By last night my temperature was down to 100.3. I took a TYLENOL PM and went to bed early. Today I feel somewhat better, although the soreness in my neck and ears continues, and I still don't have my usual energy. But my temperature is back to normal and I no longer have the chills.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Swollen and red left shoulder area, raised rash on left arm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reports a bilateral lower extremity rash, slight rash on bilateral arms as well, started today, 6 days after administration. No changes in detergents/soaps/lotions. Has not been doing yardwork or near poison ivy. Does not itch. Rash not elevated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV5
Symptoms: Abdominal distension, Blood lactic acid increased, Diarrhoea haemorrhagic, Enema administration, Intestinal obstruction
Clinical narrative: Intussusception vs pyloric stenosis, suspected, at day of presentation to our hospital on 4/16/2019, with chief complaint of projectile emesis that persisted, with bloody diarrhea on day of presentation. Symptoms started 3 days prior as emesis, that became more projectile in nature. Intussusception caught on ultrasound on 4/18/2019 when patient had bilious emesis with adnominal distension. Successfully reduced via contrast enema by interventional radiology on 4/18/2019. Patient remained stable the following day.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vomiting, Vomiting projectile, X-ray gastrointestinal tract abnormal
Clinical narrative: Intussusception vs pyloric stenosis, suspected, at day of presentation to our hospital on 4/16/2019, with chief complaint of projectile emesis that persisted, with bloody diarrhea on day of presentation. Symptoms started 3 days prior as emesis, that became more projectile in nature. Intussusception caught on ultrasound on 4/18/2019 when patient had bilious emesis with adnominal distension. Successfully reduced via contrast enema by interventional radiology on 4/18/2019. Patient remained stable the following day.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: acute local reaction of left deltoid. Deltoid area was red, warm and pruritic.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid area became very red, swollen and warm to touch.  Area marked by pen to determine if it increased. Dad sent picture to Dr's phone last evening and this morning. Area was larger than his deltoid area. Parents gave Benadryl and Motrin
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Gave Dtap instead of Tdap
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Cold sweat, Dizziness, Headache, Injected limb mobility decreased
Clinical narrative: I became very weak, nauseous, my skin hurt to touch, dizzy with a headache the day after the injection.  My left arm is so sore that I am still having difficulty lifting it over my head now 2 days after the injection.  This morning I broke out in an extreme cold sweat and it felt like needles were coming through my skin.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Nausea, Pain, Pain in extremity, Pain of skin
Clinical narrative: I became very weak, nauseous, my skin hurt to touch, dizzy with a headache the day after the injection.  My left arm is so sore that I am still having difficulty lifting it over my head now 2 days after the injection.  This morning I broke out in an extreme cold sweat and it felt like needles were coming through my skin.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Rash generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced generalized rash, injection site swelling, injection site erythema and pain in arm. The patient was treated with dexamethasone, BENADRYL and SOLU-MEDROL. On an unknown date, the outcome of the generalized rash, injection site swelling, injection site erythema and pain in arm were unknown. It was unknown if the reporter considered the generalized rash, injection site swelling, injection site erythema and pain in arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. Approximately 24 hours after vaccination, the patient experienced rash in all body, swelling, redness, erythema and puffiness in vaccine administration site. The patient went to the emergency room and they administered BENADRYL and SOLU-MEDROL. The day before reporting, the patient went to physician office and was administered Dexamethasone. The reporter consented to follow up.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced Herpes Zoster. The outcome of the event was not reported. The event of Herpes Zoster was resulting from zoster vaccine live (ZOSTAVAX).
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Products liability: manufacturing defect/defective design; This Information has been received regarding a case in litigation from a lawyer and refers to a currently 79-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 31-JUL-2012 9also reported as on about that date), the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date the patient experienced herpes zoster and was treated by a physician due to that event. The patient claimed damages as a result of: injury to themselves; economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown.  The reporter consider the event of herpes zoster to be related to the suspect vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was nor provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a currently 89-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of herpes zoster to be related to the suspected vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was nor provided.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; products liability - defective design/ manufacturing defect; Information has been received regarding a case in litigation from a lawyer and refers to a currently 66-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 22-JAN-2016 (also reported as on about that date), the patient was vaccinated by the pharmacist with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient experienced shingles and was treated by a healthcare provider due to that event. The patient claimed damages as a result of: injury to themselves; economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown.  The reporter consider the event of shingles to be related to the suspect vaccine.  The relatedness between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old female patient. No information was received regarding medical history, concurrent conditions, or concomitant medications.  On approximately 01-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided for long-term prevention of shingles and zoster-related conditions. The vaccine was administered by a pharmacist at the pharmacy. The patient was approximately 73 years old at the time of the vaccination. On an unknown date, the patient experienced shingles and was treated by a physician for the injuries.  The outcome of the event was unknown.  The reporter considered the event to be related to the zoster vaccine live (ZOSTAVAX).
Age: 85.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 90-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. The outcome of the event was not reported. The event of shingles was resulting from zoster vaccine live (ZOSTAVAX).
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. The outcome of the event was not reported. The event of shingles was resulting from zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient still experiencing deep ache at injection site for the last 2 months, experienced within first few days. Since event had been stable, not better nor worse. The vaccine was not administered at their facility, no information regarding patient not vaccine available. The healthcare professional reported local GlaxoSmithKline representative was informed of the adverse event. The reporter did not give consent to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: patient received ActHIB. Which was incorrectly reconstituted with a Merck diluent; Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case is linked to cases 2019SA036959 and 2019SA036960, same reporter.  This case involves a 4 months old patient (gender unknown) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patients past medical history and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL).  On 04-Jan-2019, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI914AA, expiry date 28-Nov-2018 via unknown route in the left thigh.  It was an actual medication error due to wrong solution used in drug reconstitution.  It was reported that patient received ActHIB. Which was incorrectly reconstituted with a Merck diluent.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a 67 year old patient a Adacel; Initial information received on 15-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 67 years old patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Daptacel; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a physician by phone.   This case involves a 24 months old patient (gender not reported) who was vaccinated with an expired 0.5 ml fourth dose of  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5169AA and expiry date: 16-Mar-2019) in the left thigh on 09-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15 month old patient was given expired Daptacel/ no AE; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a 15 months old female patient who was vaccinated with 0.5 ml expired fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5171AA and expiry date: 23-Mar-2019) via intramuscular route in the left thigh on 16-Apr-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  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: 10.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: 10 years old patient received 5th dose of expired Daptacel vaccine; 10 years old patient received 5th dose of expired Daptacel vaccine; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone.   This case involves a 10 years old patient (gender not reported) who was vaccinated with expired 0.5 ml fifth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number: C517AA and expiry date: 23-Mar-2019) on 16-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration.  It was unknown if any adverse event was occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Adacel that expired 6 days earlier was administered to a patient in error/ No AE; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves male patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported, expiry date- 05-04-2019 via intramuscular route in unknown administration site on 11-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used. Adacel was given to patient 6 days after expiration date.  No Adverse Event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pentacel was ordered for the 6 month old patient but Adacel was administered; Pentacel was ordered for the 6 month old patient but Adacel was administered; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 6 months old patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that Pentacel was ordered for the 6 month old patient but Adacel was administered.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administered.  It was not reported if any adverse event occurred or not.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dysphemia
Clinical narrative: At 2AM mom called the doctor on call Dr. Mom stated patient developed a stutter while playing video games and was concerned. Per mom patient was alert and aware of time and place. Mom was advised to observe patient and see how he is doing in the morning. I called mom this morning at 11:45am. Per mom stuttering had stopped and patient was fine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Patient received the shot on 02-13-19. Two to three days later patient started to get hives and itching throughout the body. Patient came to the pharmacy and the pharmacist gave him some cooling gel. Patient still has hives and itching today 04-19-19. Patient went to another pharmacy today 041919 and the pharmacist there recommended BENADRYL and for him to call his doctor. Pharmacist from pharmacy called me here and explained the situation and gave me the patient's phone number. I called the patient and he had called his doctor and was waiting to hear back. I told the patient he did the right thing. Should be seen by his doctor and I would fill out a VAERS report. I would follow up with him on Saturday 042019.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Peripheral swelling
Clinical narrative: Patient called 04/19/19 stating she had reaction to the SHINGRIX vaccine received on 04/17/19. She said her left arm became very swollen, red, hard, "indurated". She stated she took BENADRYL. As of this AM, she stated swelling has gone down but still red at injection site. She denied any shortness of breath or swelling anywhere else. I paged her Dr. who was on call for the office she advised that patient go to urgent care for evaluation. I called patient back and she said she appreciated the call and that she is a nurse and knows what to look for.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Influenza virus test negative, Pyrexia, Respiratory symptom, Respiratory syncytial virus test negative, Upper respiratory tract infection
Clinical narrative: Patient received shots at approximately 1:50pm on 4/11/19, that evening at 6pm spiked fever to 102. Brought in to office. Did have some respiratory symptoms though flu and rsv negative. Considered URI vs. vaccine reaction. Fever resolved within 48hrs and pt was back to baseline