chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 week old female patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 31-MAY-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis (product storage error). The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments:US-009507513-1710USA012197: US-009507513-1805USA007925: US-009507513-1805USA007926: US-009507513-1805USA007927: US-009507513-1805USA007929.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old male patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-DEC-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis (product storage error). The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments: US-009507513-1710USA012197; US-009507513-1805USA007925; US-009507513-1805USA007926; US-009507513-1805USA007927; US-009507513-1805USA007928.
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered, Fatigue, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 66-year-old male patient who received TWINRIX (batch number B9H95, expiry date 29th November 2017). On an unknown date, the patient received the 3rd dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follow: On an unknown date, the patient was inadvertently administered a dose of TWINRIX, which was already expired on 29th November 2017. Follow up information was received from a pharmacist on 8th May 2018: The patient's demographic details were updated. On 4th April 2018, the patient received the 3rd dose of TWINRIX vaccine (1.0 ml) intramuscularly. After vaccination, the nurse realized that the vaccine was expired and the patient was contacted immediately, who stated no adverse event. The patient was followed up on 4th day, at the time he stated had fatigue and general malaise, for 3 days following vaccination. Latency for fatigue and general malaise was less than a week. The patient was advised to return for vaccination but he refused. No additional adverse effects were reported. It was unknown if the reporter considered the fatigue and general malaise to be related to TWINRIX. The VAERS details were added. This case was associated with a medication error with an adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not applicable for this report. It was reported that, everyone she knew that had received the SHINGRIX vaccine had an extremely sore arm that lasted for 3 days at the minimum. The caller refused to provide any additional details.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 4th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: After receiving the vaccine, the patient experienced headaches on and off. The headaches had not resolved till the date of reporting. Additional information was not provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Pain in extremity, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd May 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, axillary pain and headache. On 5th May 2018, the patient experienced skin discoloration. On 7th May 2018, the outcome of the pain in arm, axillary pain, skin discoloration and headache were recovering/resolving. It was unknown if the reporter considered the pain in arm, axillary pain, skin discoloration and headache to be related to SHINGRIX. Additional information was reported as follows: Concomitant medication included eye medicine. The patient reported that, after vaccination with SHINGRIX the patient's arm was sore to touch and she had a bad headache. The patient felt as if she had rash in her armpit but there was nothing there. On Saturday the patient's skin was red, black, blue and tender under her arm. By Monday the symptoms were better and almost gone.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was immunized at the pharmacy and experienced significant myalgias. The physician did not have any additional details regarding the patient. The reporter did not agree to receive mails of follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK082075 reported by the same reporter.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccines were administered on 05/16/18 at 2:30 PM Mom notice redness at the injection sites at 6:00 PM on the same day. On 05/17/18 Mom noticed redness had spread and there was some swelling temp. was taken with temporal scanner and read 96.0 F, as the progressed redness and swelling spread and pt. was itchy in the area and stated it was painful to touch Mom continued to monitor. On 05/18/18 Mom noticed redness and swelling has worsened so she called to schedule appointment, patient was scheduled for 05/18/18 at 11:15 AM. Dr. evaluated and prescribed AUGMENTIN ES-600 600 mg-42.9/5 mL oral suspension 7 ml PO BID for 10 days also recommended Ibuprofen for inflammation and pain. Patients follow up appt. is scheduled for 05/21/18. The redness was marked by Dr. and measure 260 cm length and 140 cm width Mom was advised to monitor and take patient to ER is swelling and redness worsened or new symptoms developed over the weekend Mom voiced understanding.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Cheilitis, Lip pain, Malaise, Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 55-year-old female patient who received SHINGRIX. The patient's past medical history included cold sores. Previously administered products included varicella vaccine (booster vaccine received before 2010). Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin, PRAVAXHOL, PROTONIX and SYNTHROID. On 26th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th April 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 27th April 2018, the patient experienced blood sugar increased. On 28th April 2018, the patient experienced cold sores, malaise, fever, tingling lips and tiredness. On an unknown date, the patient experienced bumps lip, scab and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the cold sores was recovering/resolving and the outcome of the pain in arm, blood sugar increased, malaise and fever were recovered/resolved and the outcome of the tingling lips, bumps lip, scab, pain and tiredness were unknown. The reporter considered the cold sores to be possibly related to SHINGRIX. The reporter considered the pain in arm, blood sugar increased, malaise and fever to be related to SHINGRIX. It was unknown if the reporter considered the tingling lips, bumps lip, scab, pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cold blisters. The patient received SHINGRIX vaccine in the right deltoid. The patient reported that she received the SHINGRIX vaccine on a Thursday around 7:30 PM and on Saturday she woke up with a tingling feeling on her upper lip on the right side. On Sunday she had a cold blister and she used Acyclovir cream and she still had the blister. The patient could feel the little white bumps and they were larger than normal and they hurt and then she got a scab and it crusted over. The blister did not really get that big as it was the size of a frozen pea. The patient still had the scab with white underneath the blister. She also experienced a low grade fever which lasted a day or two and then resolved. Her blood sugar went through the roof at 212. She claimed that her blood sugar started to creep up on Friday and leveled back down again. She increased her Metformin at the advice of her physician during this time. She had a hurt and sore arm after injection which resolved by Sunday. On Saturday she felt tired and by Saturday night she had a fever of 100.4 and then it went to 100.7 and by Monday it was gone.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia oral, Pyrexia, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 55-year-old female patient who received SHINGRIX. The patient's past medical history included cold sores. Previously administered products included varicella vaccine (booster vaccine received before 2010). Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin, PRAVAXHOL, PROTONIX and SYNTHROID. On 26th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th April 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 27th April 2018, the patient experienced blood sugar increased. On 28th April 2018, the patient experienced cold sores, malaise, fever, tingling lips and tiredness. On an unknown date, the patient experienced bumps lip, scab and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the cold sores was recovering/resolving and the outcome of the pain in arm, blood sugar increased, malaise and fever were recovered/resolved and the outcome of the tingling lips, bumps lip, scab, pain and tiredness were unknown. The reporter considered the cold sores to be possibly related to SHINGRIX. The reporter considered the pain in arm, blood sugar increased, malaise and fever to be related to SHINGRIX. It was unknown if the reporter considered the tingling lips, bumps lip, scab, pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cold blisters. The patient received SHINGRIX vaccine in the right deltoid. The patient reported that she received the SHINGRIX vaccine on a Thursday around 7:30 PM and on Saturday she woke up with a tingling feeling on her upper lip on the right side. On Sunday she had a cold blister and she used Acyclovir cream and she still had the blister. The patient could feel the little white bumps and they were larger than normal and they hurt and then she got a scab and it crusted over. The blister did not really get that big as it was the size of a frozen pea. The patient still had the scab with white underneath the blister. She also experienced a low grade fever which lasted a day or two and then resolved. Her blood sugar went through the roof at 212. She claimed that her blood sugar started to creep up on Friday and leveled back down again. She increased her Metformin at the advice of her physician during this time. She had a hurt and sore arm after injection which resolved by Sunday. On Saturday she felt tired and by Saturday night she had a fever of 100.4 and then it went to 100.7 and by Monday it was gone.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 59-year-old male patient who received SHINGRIX. On 17th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and weight bearing difficulty. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the weight bearing difficulty was unknown. It was unknown if the reporter considered the pain in arm and weight bearing difficulty to be related to SHINGRIX. Additional information was reported as follows: This case was reported by patient's wife. The patient was immunized with SHINGRIX on his right deltoid at his personal family doctor. The patient stated that, the shot was very painful and worst than anything else in the world. He stated that, for a week after receiving vaccination with SHINGRIX, he had difficulty lifting any weights at the gym, because it was hard to lift anything due to arm pain. The patient did not seek any medical attention and was fully recovered. The reporter had not agreed to follow-up with GlaxoSmithKline.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered
Clinical narrative: None known
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: PNEUMOVAX severe redness other side of arm from injection site, myalgias diffuse, exhaustion 5/9/18. SHINGRIX 2nd dose tactile fever and chills lasting over 24 hours 4/13/18.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: Prolonged Blister, which progressed despite appropriate care. Blister subsided for approximately 2 weeks and then reappeared.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Injection delivery-pain upon injection. Pain at injection site for approx. 8 hours, interrupting sleep. 12 hours after injection, awoke with nausea and joint pain severe enough that just getting out of bed and walking to the bathroom was painful. Because of nausea, could not take any pain medication. Headache approx. 14 hours after injection. Again, because of nausea, no pain medication could be taken.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Injection delivery-pain upon injection. Pain at injection site for approx. 8 hours, interrupting sleep. 12 hours after injection, awoke with nausea and joint pain severe enough that just getting out of bed and walking to the bathroom was painful. Because of nausea, could not take any pain medication. Headache approx. 14 hours after injection. Again, because of nausea, no pain medication could be taken.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient describing redness and pain at injection site more than normal reaction that has now spread to the other side of her arm. The area where the injection was given is now returning back to skin color, but the other side is still red and painful. She described it as slightly warm to the touch. Pharmacy recommended she contact her physician to have it evaluated for possible treatment.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt had pain and redness at the injection site after receiving the injection on 5/15/18. The pain subsided midday on 5/17/18 but the redness has gotten worse. The redness has spread down towards the patient elbow. He does not report pain at this time, but the redness is an issue of concern as it has gotten worse. Pt is starting to take BENADRYL 25 mg.
Age: 19.0
Sex: F
Vaccine: HEP, HIBV, IPV, MNQ, PNC13, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient receiving Hepatitis A (adult dose) and by age Hepatitis B (ped/adolescent dose) for 12 month Post Stem Cell revaccination and travel. Nurse administered HBV (adult dose). Patient will not be 20 yrs of age until 8/21/2018.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Induration, Tenderness
Clinical narrative: Patient developed area of redness and induration, approximately 8cm x 8cm and was evaluated in clinic. It was painful to palpation. Diagnosed as cellulitis by primary care provider.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia
Clinical narrative: Since administering vaccination 04/24/2018, pt has been experiencing soreness in muscle. Denies any fever, redness, warmth at injection site, or bruising.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema
Clinical narrative: Within 24 hours after receiving the SHINGRIX first dose, the pt had a hard area develop under the skin and then a very large red area appeared in the skin surrounding the vaccine site over that day and the next day (5/16-5/17/18).
Age: 39.0
Sex: F
Vaccine: HEP, TD, TYP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Myalgia
Clinical narrative: 5/14/18 Client was given oral typhoid vaccine at travel visit to take home on 5/3/2108. Client states she took her last dose on 5/10/18 at approx 5 AM. Client states on 5/11/18 at approx 10 pm she experienced stomach spasms, chills, muscle aches and diarrhea that lasted about 12 hours. Client states she did not take her temperature. Client states this AM (5/14/18) she still has a little bit of diarrhea but is better. PHN to call client in a few days to check health status and ensure sx are resolving. 5/18/18 Telephone call to client. Client states she is much better now and the diarrhea has resolved. No further follow-up needed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Retching
Clinical narrative: Fevers, chills and dry heaving for 24 hours following injection.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: History per mother: child was seen on 05/14 for 18mth wcc and states pt received shots that day (Hep A on right leg of concern, DTaP on left). On the day of the app pt would complain when touching. The day after the app pt began to "walk a bit funny". Yesterday area began to become red, was a bit swollen and was very hot. Temp Monday 101, Tuesday less than 100 F. MD assessment 5/18: No fever. Some mild tenderness in area. Only calor. No puss from injection site. No trauma. Patient eating normally. Child has not limped today. Walking funny on Tuesday. Rash on Wednesday, photo shown with significantly more redness ~2 times as big. Diagnosis: Rash at application site (R21). Patient Plan: Child with rash that developed 2 days after Hep A placed on right medial thigh, child had only 1 day of fever on initial day, but child currently afebrile and having improvement of rash without any medication today to ~50% original size from yesterday. Provided child with 2.5 mL of Benadryl now. Will schedule Cetirizine and PRN Children's Benadryl until rash resolves. No need for antibiotics at this time, will follow up tomorrow for repeat evaluation while monitoring off antibiotics.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: History per mother: child was seen on 05/14 for 18mth wcc and states pt received shots that day (Hep A on right leg of concern, DTaP on left). On the day of the app pt would complain when touching. The day after the app pt began to "walk a bit funny". Yesterday area began to become red, was a bit swollen and was very hot. Temp Monday 101, Tuesday less than 100 F. MD assessment 5/18: No fever. Some mild tenderness in area. Only calor. No puss from injection site. No trauma. Patient eating normally. Child has not limped today. Walking funny on Tuesday. Rash on Wednesday, photo shown with significantly more redness ~2 times as big. Diagnosis: Rash at application site (R21). Patient Plan: Child with rash that developed 2 days after Hep A placed on right medial thigh, child had only 1 day of fever on initial day, but child currently afebrile and having improvement of rash without any medication today to ~50% original size from yesterday. Provided child with 2.5 mL of Benadryl now. Will schedule Cetirizine and PRN Children's Benadryl until rash resolves. No need for antibiotics at this time, will follow up tomorrow for repeat evaluation while monitoring off antibiotics.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster disseminated
Clinical narrative: This spontaneous report was received from a physician via a company representative. The physician heard about this shingles case study which was presented during a meeting, referring a male patient of an unknown age. The patient was considered "immunosuppressed" and he had a transplant surgery in an unspecified date for an unspecified cause/reason. Information regarding drug reactions, allergies or concomitant medications was not mentioned. In an unspecified date in 2012, the patient was vaccinated with ZOSTAVAX (dose, anatomical location and patient route of administration, lot # and expiration date were not reported). On an unmentioned date, after getting vaccinated the patient experienced disseminated shingles virus. It was unknown which the outcome of shingles was. Furthermore, on an unspecified date due to an unspecified cause the patient died. It was not known if an autopsy was performed. The causal relationship between shingles and death, with vaccination with ZOSTAVAX was not reported. Upon internal review, the event Herpes zoster disseminated was considered to be medically significant.; Reported Cause(s) of Death: died due to an unspecified cause.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-FEB-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-FEB-2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 15-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster the very virus the ZOSTAVAX is intended to prevent. On or about 27-JUN-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 15-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a family practice as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster the very virus the ZOSTAVAX is intended to prevent. On or about 01-JUL-2015, the patient was treated at a family practice for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-AUG-2012, the patient was inoculated ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-OCT-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed cephalexin, gabapentin, valacyclovir, and aspirin for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-MAY-2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. On or about 27-AUG-2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed gabapentin and acyclovir for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: 2 days after the vaccine was given, pt experienced redness around the injection site which got larger in size and spread down her arm. Patient took benadryl as instructed by her doctor, and the redness did not go down. She has received an antibiotic for cephalexin and will be starting it today on 5/18/18. It has now been a week and I was informed of the event as of today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Pruritus
Clinical narrative: Injected subcutaneous instead of intramuscular. Patient developed red itchy area unclear at this time how soon. She called on 5/15/2018 12:49 stating circular, red, itchy area. Patient seen Dr. on 5/16/2018 placed on doxycycline hyclate 100 MG. Doxycycline hyclate 100 MG and prednisone 10 mg three times daily. Prednisone 10 MG Take one tab po tid.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Nausea, Pain
Clinical narrative: Patient started feeling tired around 8:00 and went to bed early. Throughout the night she woke up feeling hot and achy. She took her temperature and she did have a fever. She took ibuprofen and went back to sleep. When she woke on Friday 5/18, her arm hurt really bad, she felt feverish (hot and then chills), nauseous and extremely fatigued. Throughout the day her symptoms continued. She ended up leaving work early to go home and rest.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient started feeling tired around 8:00 and went to bed early. Throughout the night she woke up feeling hot and achy. She took her temperature and she did have a fever. She took ibuprofen and went back to sleep. When she woke on Friday 5/18, her arm hurt really bad, she felt feverish (hot and then chills), nauseous and extremely fatigued. Throughout the day her symptoms continued. She ended up leaving work early to go home and rest.
Age: 10.0
Sex: M
Vaccine: FLUX, HEP, HPV9, MMR, FLUX, HEP, HPV9, MMR
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pharyngeal oedema, Pyrexia, Ultrasound scan abnormal
Clinical narrative: On May 16th my son started with pain on the throat and with swelling that was painful to touch. Next day, at 3 AM started with more pain, more swelling and high fever. I took him to the emergency room.
Age: 10.0
Sex: M
Vaccine: FLUX, HEP, HPV9, MMR, FLUX, HEP, HPV9, MMR
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: On May 16th my son started with pain on the throat and with swelling that was painful to touch. Next day, at 3 AM started with more pain, more swelling and high fever. I took him to the emergency room.
Age: 10.0
Sex: M
Vaccine: FLUX, HEP, HPV9, MMR, FLUX, HEP, HPV9, MMR
Symptoms: Swelling, Tenderness, Ultrasound scan abnormal
Clinical narrative: On May 16th my son started with pain on the throat and with swelling that was painful to touch. Next day, at 3 AM started with more pain, more swelling and high fever. I took him to the emergency room.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at injection site, fever (101 F), headache, tired, nausea, muscle stiffness and soreness, light headed.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia
Clinical narrative: Pain and redness at injection site, fever (101 F), headache, tired, nausea, muscle stiffness and soreness, light headed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: Patient complained of diarrhea, extremely tired, stabbing pain on right side under the breast, nerve pain. She couldn't go into work on Monday and then went into work on Tuesday but had to leave within 3 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient complained of diarrhea, extremely tired, stabbing pain on right side under the breast, nerve pain. She couldn't go into work on Monday and then went into work on Tuesday but had to leave within 3 hours.
Age: 80.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Approximately 1 day after vaccination, patient experienced redness that started at the injection site, swelling of upper arm, low grade fever of 100.4, and chills. Fever/chills resolved within 24 hours, however swelling and redness move slightly to more inner elbow area of upper arm vs injection site where it started.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site cellulitis, Injection site oedema
Clinical narrative: Cellulitis at injection site w/edema.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Myalgia
Clinical narrative: Arm very, very sore even 48 hours later; Red, hard, sore injection site; Fatigue; Muscle aches.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm very, very sore even 48 hours later; Red, hard, sore injection site; Fatigue; Muscle aches.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site nodule, Irritability, Pain, Pyrexia
Clinical narrative: High fever, pain, shaking, loss of appetite, fussy, huge knot under injection site.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: High fever, pain, shaking, loss of appetite, fussy, huge knot under injection site.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient showed me her arm at 8:00 on 5/18. It was red, warm to the touch, and looked bruised around the injection site. She said she was dizzy, had nausea/vomiting(?), fever. I told her those are common injection site reactions, but if she would feel better, to call the doctor. She did and they told her to come in. She went in; the doctor said it was an injection site reaction, measuring 4x8 cm, and had developed into cellulitis. She gave her an rx for Bactrim DS and told her to come back on 5/22.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient showed me her arm at 8:00 on 5/18. It was red, warm to the touch, and looked bruised around the injection site. She said she was dizzy, had nausea/vomiting(?), fever. I told her those are common injection site reactions, but if she would feel better, to call the doctor. She did and they told her to come in. She went in; the doctor said it was an injection site reaction, measuring 4x8 cm, and had developed into cellulitis. She gave her an rx for Bactrim DS and told her to come back on 5/22.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Nausea, Vomiting
Clinical narrative: Hospitalized from shortness of breath, nausea/vomiting, generalized weakness patient has since recovered with supportive care and discharged.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Migraine, Pain
Clinical narrative: All over body aches, chills, migraine headache.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Heart rate decreased, Hypotension, Loss of consciousness, Oxygen saturation decreased, Seizure
Clinical narrative: Seizure within 10 minutes of administration of vaccines. Called doctor and was told he just passed out. Called paramedics when we got home due to low pulse, blood pressure, and oxygen. They told us to keep an eye on him and follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Fever, chill, severe headache, nausea, vomiting, redness and swelling at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, chill, severe headache, nausea, vomiting, redness and swelling at the injection site.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Epistaxis
Clinical narrative: Epistaxis lasting 30 minutes. No history of epistaxis or bleeding disorders.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Abdomen scan normal, Blood test normal, Diarrhoea haemorrhagic, Frequent bowel movements, Laboratory test normal
Clinical narrative: My daughter had her 6 month shots DTaP, Hib, Polio, Hep B and PCV13 on 5/15/15 at 10am. At 9pm on 5/15/15 she had severe bloody diarrhea. In 30 minutes she pooped 5 times. The first of 5 times was 10% blood. The 5th time was 90% blood. I took her to ER and blood tests, xrays and lab work were done, but the drs could not figure out what was causing the blood in the diarreah. They discharged her. She had bloody diarreah for 24 hours. The next day her pediatrician ordered additional lab work. We are still waiting for those results. There were no other out of the ordinary happenings the day of the 15th or leading up to the bloody diarreah, except the 3 vaccines.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Stool analysis, X-ray normal
Clinical narrative: My daughter had her 6 month shots DTaP, Hib, Polio, Hep B and PCV13 on 5/15/15 at 10am. At 9pm on 5/15/15 she had severe bloody diarrhea. In 30 minutes she pooped 5 times. The first of 5 times was 10% blood. The 5th time was 90% blood. I took her to ER and blood tests, xrays and lab work were done, but the drs could not figure out what was causing the blood in the diarreah. They discharged her. She had bloody diarreah for 24 hours. The next day her pediatrician ordered additional lab work. We are still waiting for those results. There were no other out of the ordinary happenings the day of the 15th or leading up to the bloody diarreah, except the 3 vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Erythema, Fatigue, Musculoskeletal pain
Clinical narrative: Left arm, shoulder, breast area, back were all swollen, red and painful for 8 days. Fatigue and Fever for 24 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Left arm, shoulder, breast area, back were all swollen, red and painful for 8 days. Fatigue and Fever for 24 hours.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Per patient's representative, after receiving the vaccine around 0230pm,  the patients arm began to swell and she was taken to an emergency room at 0800pm. While in the ER, the patient was given a steroid shot and an NSAID. The swelling in the patient's arm resolved.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Given the varicella vaccine in left upper arm, subcutaneous. I had recieved one dose of this vaccine as a baby, as well as had the chicken pox at age 3. My varicella titer was negative, so I required a new vaccine series for work. The first shot in the series was 02/2017 with no adverse events. The second shot was 04/31. The day following the vaccine, I developed a small rash on my arm and was told it was a "site reaction." two days later, the site became extremely red, swollen, hard to the touch, and warm. I returned to employee health and was told to go to urgent care immediately. Urgent care diagnosed cellulitis  and  prescribed Keflex antibiotics. I was told to return to Urgent care within 24 hours, and then again within 48 hours. I was switched from Keflex to Amoxicillin and given intramuscular Ceftriaxone. Over the course of 10 days the cellulitis resolved with antibiotic treatment.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Given the varicella vaccine in left upper arm, subcutaneous. I had recieved one dose of this vaccine as a baby, as well as had the chicken pox at age 3. My varicella titer was negative, so I required a new vaccine series for work. The first shot in the series was 02/2017 with no adverse events. The second shot was 04/31. The day following the vaccine, I developed a small rash on my arm and was told it was a "site reaction." two days later, the site became extremely red, swollen, hard to the touch, and warm. I returned to employee health and was told to go to urgent care immediately. Urgent care diagnosed cellulitis  and  prescribed Keflex antibiotics. I was told to return to Urgent care within 24 hours, and then again within 48 hours. I was switched from Keflex to Amoxicillin and given intramuscular Ceftriaxone. Over the course of 10 days the cellulitis resolved with antibiotic treatment.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Patient wife called and spoke to an LPN that was in the clinic-she reported to me that the wife told her husband was having a reaction to the ZOSTAVAX injection he received yesterday.She said he felt his throat was closing up.Icalled her right away-she told me her husband used an EPI-PEN that he had from 2008 and also took several BENADRYL tablets.He told her he still had the same feeling but it did not get worse.I advised her to take her husband to the nearest ER or to her PMD for eva.Iwill forward this not to the provider.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and pain. On an unknown date, the outcome of the swelling and pain were unchanged. It was unknown if the reporter considered the swelling and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On an unknown date, at 11, the patient received a dose of SHINGRIX. The reporter provided very limited information due to time constraint. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Product administered at inappropriate site, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain in arm, erythema of extremities, swelling arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the pain in arm, erythema of extremities and swelling arm were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the fever, pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported the adverse event information. The age at vaccination was not reported. The health care professional stated that the patient presented to his three days after receiving the SHINGRIX, the patient's body temperature was recorded as 102 degree F that was ongoing. Less than a year after receiving SHINGRIX, the patient experienced redness, swelling, and pain in his arm. The health care professional stated fever appears to be related to the vaccine. The patient received vaccine at location other than at physician's office and did not have vaccine information, just patient information. The health care professional stated that potential administration location error. The patient stated that vaccine was administered intramuscularly along the back of the upper extremity and not in the deltoid as well, which led to the inappropriate site of vaccination. The patient required emergency room visit.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal discomfort, Pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX. Concomitant products included Herbal Supplement. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache and muscle discomfort. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the headache and muscle discomfort were recovered/resolved. The reporter considered the pain in arm, headache and muscle discomfort to be related to SHINGRIX. Additional details were provided as follows: The concomitant medication also included unspecified vitamins. The patient stated that she received the Shingles vaccine on left arm, last week from reporting date and was almost certain it was the SHINGRIX vaccine. The patient states that she experienced headache, muscle discomfort and her left arm was painful to touch which was resolved. In the morning of reporting date, after swimming, the patient experienced shooting pain down her left arm.