chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest X-ray normal, Computerised tomogram normal, Deafness unilateral, Dizziness
Clinical narrative: Received my 2nd shingle shot (Shingrix) on Thursday 3/5/2020. Woke up next morning at 6:00 am with a horrible headache starting at my right shoulder.  In the evening of 3/6/2020 about 8:00 pm my right ear popped and could not hear anything out of it. On Sunday  I felt weak all day.  On Monday 3/9/2020 I woke up at 3:00 am with dizziness and vomiting.  Went to the ER at around  8:00 am (after contacting doctors office and not able to get in until late afternoon). Blood pressure was very high.  At hospital an MRI, CScan, chest xray and a heart sonagram was performed.   Nothing on any of them to indicate a reason for hearing loss or high blood pressure.  The hospital kept me overnight.  I followed up with my doctor on 3/12/2020. Nothing  stands out as to my hearing or high blood pressure.  At her request I made an appointment with the ENT doctor at the same clinic on 3/19/2020 .  With the tests at hospital he did not have a reason for the  hearing loss since stroke and heart issues were ruled out.  He does want me to  go in for a hearing test to measure the loss I have now.  The shingle shot was the only thing out of the ordinary in my life.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Headache, Hypertension, Magnetic resonance imaging normal, Ultrasound scan
Clinical narrative: Received my 2nd shingle shot (Shingrix) on Thursday 3/5/2020. Woke up next morning at 6:00 am with a horrible headache starting at my right shoulder.  In the evening of 3/6/2020 about 8:00 pm my right ear popped and could not hear anything out of it. On Sunday  I felt weak all day.  On Monday 3/9/2020 I woke up at 3:00 am with dizziness and vomiting.  Went to the ER at around  8:00 am (after contacting doctors office and not able to get in until late afternoon). Blood pressure was very high.  At hospital an MRI, CScan, chest xray and a heart sonagram was performed.   Nothing on any of them to indicate a reason for hearing loss or high blood pressure.  The hospital kept me overnight.  I followed up with my doctor on 3/12/2020. Nothing  stands out as to my hearing or high blood pressure.  At her request I made an appointment with the ENT doctor at the same clinic on 3/19/2020 .  With the tests at hospital he did not have a reason for the  hearing loss since stroke and heart issues were ruled out.  He does want me to  go in for a hearing test to measure the loss I have now.  The shingle shot was the only thing out of the ordinary in my life.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Received my 2nd shingle shot (Shingrix) on Thursday 3/5/2020. Woke up next morning at 6:00 am with a horrible headache starting at my right shoulder.  In the evening of 3/6/2020 about 8:00 pm my right ear popped and could not hear anything out of it. On Sunday  I felt weak all day.  On Monday 3/9/2020 I woke up at 3:00 am with dizziness and vomiting.  Went to the ER at around  8:00 am (after contacting doctors office and not able to get in until late afternoon). Blood pressure was very high.  At hospital an MRI, CScan, chest xray and a heart sonagram was performed.   Nothing on any of them to indicate a reason for hearing loss or high blood pressure.  The hospital kept me overnight.  I followed up with my doctor on 3/12/2020. Nothing  stands out as to my hearing or high blood pressure.  At her request I made an appointment with the ENT doctor at the same clinic on 3/19/2020 .  With the tests at hospital he did not have a reason for the  hearing loss since stroke and heart issues were ruled out.  He does want me to  go in for a hearing test to measure the loss I have now.  The shingle shot was the only thing out of the ordinary in my life.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 07-JUL-2015, patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. Patient was prescribed acetaminophen (+) oxycodone hydrochloride (PERCOCET) and lidocaine for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX on 2/26/2020; This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.   On 26-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028920, expiration date 19-SEP-2021 (route of administration, dose and frequency not reported) for prophylaxis.   The vaccine was reconstituted with a properly stored sterile diluent. Digital Data logger was involved. The vaccine was stored at the temperature reported as from 6 degrees of F to 14 degrees of F (5.69 degrees of F), the time frame as 1 second. There was a previous temperature excursion: reported as from 6 degrees of F to 14 degrees of F (5.81 degrees of F) for 28 minutes.   No adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 18-MAR-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) ) injection, lot # S028920, expiration date 16-SEP-2021 (route of administration was not reported) for prophylaxis. Concomitant therapies included sterile diluent. No adverse symptoms were reported.  On an unknown date, there was unknown temperature excursion for a time frame of 1 second. Previous temperature excursion was from 6 to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes. The digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX on 03/18/2020; This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.     On 18-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028920, expiration date 19-SEP-2021 (route of administration, dose and frequency not reported) for prophylaxis.   The vaccine was reconstituted with a properly stored sterile water diluent. Digital Data logger was involved. The vaccine was stored at the temperature reported as from 6 degrees of F to 14 degrees of F (5.81 degrees of F), the time frame as 28 minutes.  No adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: swelling; redness for 5-6 days; pain for 5-6 days; This case was reported by a consumer via sales rep and described the occurrence of swelling in a patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date unknown) for prophylaxis.   On 30th January 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema and pain were recovered/resolved.   It was unknown if the reporter considered the swelling, erythema and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced swelling, erythema and pain after vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: rash on her arms, which has now spread to her neck.; Dose 1 of Shingrix was given 14 months prior; This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 14 months prior from the date of reporting ).   On 5th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th February 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 12th February 2020, the patient experienced rash. On an unknown date, the outcome of the rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The patient reported that she had dose 2 of Shingrix.  no events were noted with dose 1.  The patient reports that 7 days after dose 2, she developed a rash on her arms, which has now spread to her neck. The interval was more than recommended, which led to lengthening of vaccination schedule.  The reporter consented to follow up. The reporter had no other contact information for physician at time of report.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: 1st shot on 10/9/2019 in left arm.  He received the 2nd shot in right arm on 10/29/2019; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cyst (on 29th October 2019). Concomitant products included Herpes zoster (Shingrix).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On 29th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient received the 1st shot on 9th Oct 2019 in left arm.  He received the 2nd shot in right arm on 29th Oct 2019 .  He reported pain at injection site with second shot that lasted 3 to 4 days, the duration was less than recommended schedule, which led to lengthening of vaccination schedule. He also had surgery to remove cysts in his back on the same day he received the 2nd shot. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: chills / shivering; fever; headache; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2020, the patient received the 1st dose of Shingrix. On 9th March 2020, 1 days after receiving Shingrix, the patient experienced chills, fever, headache and upset stomach. On an unknown date, the outcome of the chills, fever, headache and upset stomach were unknown.   It was unknown if the reporter considered the chills, fever, headache and upset stomach to be related to Shingrix.  Additional case details were reported as follows: The patient after vaccination had chills, fever, headache and upset stomach. The patient  wanted to know how long the events may last. The Prescribing Information was reviewed and offered. The patient also referred to his physician. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Mild rash on chest; This case was reported by a nurse via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experience a mild rash on her chest after receiving Shingrix. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Dermatitis contact, Injection site pain, Rash pruritic
Clinical narrative: Soreness at the site after getting the vaccine; The rash is a contact dermatitis; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of contact dermatitis in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hormone replacement therapy. Concurrent medical conditions included fibromyalgia.   On 24th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced contact dermatitis and itchy rash. On an unknown date, the patient experienced injection site pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the contact dermatitis and itchy rash were recovering/resolving and the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the contact dermatitis, itchy rash and injection site pain to be related to Shingrix.  Additional details were received as follows: This case was reported by patient herself. The patient received the first dose of Shingrix and had some soreness at the site after getting the vaccine. Within week after vaccination, the patient developed an itchy rash. The patient had been seen a provider about her rash and a biopsy was taken. The patient stated that the rash was a contact dermatitis from either Shingrix or her hormone replacement therapy. The patient did not consent to follow up.      Lab Comments: on an unknown date biopsy was done
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was give a double dose of HiB. Pt mother as not reported any adverse events.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Constipation, Fatigue, Headache
Clinical narrative: Pain on the right side, fast heartbeat, headache, unable to sleep, some swelling around the mouth and fever.  These didn't last too long but unset stomach, feeling tired and weak lasted a week and being constipated and trouble sleeping  lasted three weeks.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Insomnia, Mouth swelling, Pain, Pyrexia
Clinical narrative: Pain on the right side, fast heartbeat, headache, unable to sleep, some swelling around the mouth and fever.  These didn't last too long but unset stomach, feeling tired and weak lasted a week and being constipated and trouble sleeping  lasted three weeks.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased, Joint swelling, Medical device site joint pain, Myalgia
Clinical narrative: 24 hours after 2nd dose of shingles shot. All my muscles & joints had sharp pain. 48 hours still very painful. Knee replacement is most painful, unable to bend knee. 72 hrs still swollen knees & Leg pain
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 24 hours after 2nd dose of shingles shot. All my muscles & joints had sharp pain. 48 hours still very painful. Knee replacement is most painful, unable to bend knee. 72 hrs still swollen knees & Leg pain
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Body temperature increased, Erythema, Injection site cellulitis
Clinical narrative: Left arm cellulitis. Began 24 hours later w/ temp to 102. at 48 hours, redness spreading.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Altered state of consciousness, Blood glucose normal, Crying, Eye movement disorder, Flushing
Clinical narrative: Sanofi fluzone 0.5ml administered to left deltoid. Trumenba 0.5ml administered IM 2 inches below fluzone administration site. Bleeding from trumenba IM administration observed. Patient states "my arm really hurts, my fingers are tingly, my fingers hurt, i feel like im going to pass out". Pallor noted. Patient head rolled back and forward, eyes rolled back. Patient moaned with eyes closed then open eyes and cried. Skin appeared flushed. Dr. notified. Per MD, CBG performed. CBG 101. Mom states patient has not eaten today. Juice administered to patient. Patient states "I feel better". BP 106/78, HR 69. RR 20 and unlabored. Pt instructed to wait 15 minutes or more for monitoring.  0916 Pt sitting upright in chair, cheeks pink and smiling. Pt states she feels fine and wants to go eat. Pt and mother given ER precautions, no further questions or concerns. LVN 3/17/2020 8:55 AM: Called to examine patient who appeared to have a vaccine related adverse event 5 mins after both Influenza and Trumemba vaccine was given O/E conscious and alert, oriented to place and time, appear tired, normal color, not pale or flushed, responded to verbal commands, with normal neurological, cardiovascular and respiratory exams. Stable vital signs Impression: Vasovagal syncope following immunizations Plan: Observe for 15-20 mins and discharge home if patient remains stable.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site haemorrhage, Moaning, Pain in extremity, Pallor, Paraesthesia
Clinical narrative: Sanofi fluzone 0.5ml administered to left deltoid. Trumenba 0.5ml administered IM 2 inches below fluzone administration site. Bleeding from trumenba IM administration observed. Patient states "my arm really hurts, my fingers are tingly, my fingers hurt, i feel like im going to pass out". Pallor noted. Patient head rolled back and forward, eyes rolled back. Patient moaned with eyes closed then open eyes and cried. Skin appeared flushed. Dr. notified. Per MD, CBG performed. CBG 101. Mom states patient has not eaten today. Juice administered to patient. Patient states "I feel better". BP 106/78, HR 69. RR 20 and unlabored. Pt instructed to wait 15 minutes or more for monitoring.  0916 Pt sitting upright in chair, cheeks pink and smiling. Pt states she feels fine and wants to go eat. Pt and mother given ER precautions, no further questions or concerns. LVN 3/17/2020 8:55 AM: Called to examine patient who appeared to have a vaccine related adverse event 5 mins after both Influenza and Trumemba vaccine was given O/E conscious and alert, oriented to place and time, appear tired, normal color, not pale or flushed, responded to verbal commands, with normal neurological, cardiovascular and respiratory exams. Stable vital signs Impression: Vasovagal syncope following immunizations Plan: Observe for 15-20 mins and discharge home if patient remains stable.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Posture abnormal, Syncope
Clinical narrative: Sanofi fluzone 0.5ml administered to left deltoid. Trumenba 0.5ml administered IM 2 inches below fluzone administration site. Bleeding from trumenba IM administration observed. Patient states "my arm really hurts, my fingers are tingly, my fingers hurt, i feel like im going to pass out". Pallor noted. Patient head rolled back and forward, eyes rolled back. Patient moaned with eyes closed then open eyes and cried. Skin appeared flushed. Dr. notified. Per MD, CBG performed. CBG 101. Mom states patient has not eaten today. Juice administered to patient. Patient states "I feel better". BP 106/78, HR 69. RR 20 and unlabored. Pt instructed to wait 15 minutes or more for monitoring.  0916 Pt sitting upright in chair, cheeks pink and smiling. Pt states she feels fine and wants to go eat. Pt and mother given ER precautions, no further questions or concerns. LVN 3/17/2020 8:55 AM: Called to examine patient who appeared to have a vaccine related adverse event 5 mins after both Influenza and Trumemba vaccine was given O/E conscious and alert, oriented to place and time, appear tired, normal color, not pale or flushed, responded to verbal commands, with normal neurological, cardiovascular and respiratory exams. Stable vital signs Impression: Vasovagal syncope following immunizations Plan: Observe for 15-20 mins and discharge home if patient remains stable.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dermatitis allergic, Injection site erythema, Injection site warmth
Clinical narrative: Allergic dermatitis with Rt upper arm redness;warm to touch, itchiness. Treatment: Tylenol 500mg, Benadryl 25mg ,Claritin 10mg
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash, Rash vesicular
Clinical narrative: zoster-like rash across the chest; This spontaneous report as received from a lawyer refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 24-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a severe inflammatory reaction and was diagnosed with a painful, zoster-like rash across the chest. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of rash vesicular was reported as not recovered/not resolved. The reporter considered rash vesicular to be related to Zoster Vaccine Live (ZOSTAVAX).  Zoster-like rash across the chest was considered to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received one improperly stored dose of VARIVAX on 06-MAR-2020; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 06-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S028920 and expiration date: 16-SEP-2021) for prophylaxis (dose and anatomical location were not reported). Properly stored sterile diluent (lot#, expiration date were not reported) was used to reconstitute improperly stored vaccine. There was no adverse effect reported The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature excursion of 6 degrees of Fahrenheit (F) to 14 degrees of F (5.69 degrees of F) during a time frame of 1 second. There was previous temperature excursion reported: from 6 degrees of F to 14 degrees of F (5.81 degrees of F) for 28 minutes. Digital Data Logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Insomnia
Clinical narrative: severe shivering all night long; couldn't sleep; too cold to get up; i guess i had fever; bad headache; feeling exhausted the entire next day; This case was reported by a consumer via sales rep and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivering, sleeplessness, feeling cold, fever, headache and exhaustion. On an unknown date, the outcome of the shivering, sleeplessness, feeling cold, fever, headache and exhaustion were unknown.   It was unknown if the reporter considered the shivering, sleeplessness, feeling cold, fever, headache and exhaustion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the first Shingrix shot and had pretty horrible side effects severe shivering all night long and could not sleep and too cold to get up and take temperature but had fever, bad headache the next morning, and felt exhausted the entire next day after vaccination. The patient stated that had a due for the second shot and was really dreading the side effects. The patient was wondering if waiting longer after the first shot (6 months) or shorter (3 months) to get the second shot effects how severe the side effects are the second time. The patient asked if you have severe side effects the first time, are they likely to be as severe the second time or could they be even worse. The patient realize everyone reacts differently but would like to know what the odds are.      Lab Comments: On an unknown date body temperature was recorded
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: severe shivering all night long; couldn't sleep; too cold to get up; i guess i had fever; bad headache; feeling exhausted the entire next day; This case was reported by a consumer via sales rep and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivering, sleeplessness, feeling cold, fever, headache and exhaustion. On an unknown date, the outcome of the shivering, sleeplessness, feeling cold, fever, headache and exhaustion were unknown.   It was unknown if the reporter considered the shivering, sleeplessness, feeling cold, fever, headache and exhaustion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the first Shingrix shot and had pretty horrible side effects severe shivering all night long and could not sleep and too cold to get up and take temperature but had fever, bad headache the next morning, and felt exhausted the entire next day after vaccination. The patient stated that had a due for the second shot and was really dreading the side effects. The patient was wondering if waiting longer after the first shot (6 months) or shorter (3 months) to get the second shot effects how severe the side effects are the second time. The patient asked if you have severe side effects the first time, are they likely to be as severe the second time or could they be even worse. The patient realize everyone reacts differently but would like to know what the odds are.      Lab Comments: On an unknown date body temperature was recorded
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nausea
Clinical narrative: queasy; tired; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced nausea and tiredness. On an unknown date, the outcome of the nausea and tiredness were unknown.   It was unknown if the reporter considered the nausea and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced nausea and tiredness after vaccination. The patient asked how long the side effects last.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via other manufacturer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days 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 case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced shingles after vaccination.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: itchy blister on the forearm of the same arm as I had my 2nd Shingrix shot; this could be considered a rash; Itch; This case was reported by a consumer via call center representative and described the occurrence of blister in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received Shingrix. On 3rd March 2020, 1 days after receiving Shingrix, the patient experienced blister, rash and pruritus. On an unknown date, the outcome of the blister, rash and pruritus were unknown.   It was unknown if the reporter considered the blister, rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient had a itchy blister on forearm on the same side of vaccination. The patient at a stretch could be considered a rash.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced muscle pain right after taking the first dose. This case has been linked to US2020041868, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: myalgia; This case was reported by a nurse via sales rep and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown 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 case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient had experienced myalgia after vaccination. This case has been linked with case US2020AMR043347, reported for same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: myalgia; This case was reported by a nurse via sales rep and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown 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 case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced myalgia after vaccination. This case has been linked with case US2020AMR043345, reported for same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: i am having side effects of the vaccine; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced adverse drug reaction after vaccination. The patient asked if it is ok to be around infants and pregnant women after having the shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site / pain; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site muscle pain after vaccination. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Soreness; Nausea; Fatigue; Headache; Joint pain; This case was reported by a physician via call center representative and described the occurrence of pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included vascular disorder. Concomitant products included prednisone.   On 20th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain, nausea, fatigue, headache and joint pain. On an unknown date, the outcome of the pain, nausea, fatigue, headache and joint pain were recovered/resolved.   It was unknown if the reporter considered the pain, nausea, fatigue, headache and joint pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's husband. The reporter stated that the patient experienced soreness, nausea, fatigue, headache, join pain, for more than a week after vaccination. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Insomnia, Peripheral swelling
Clinical narrative: pain at injection site; left hand swelling; left hand numbness; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis.   On 29th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th March 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, hand swelling, numbness in hand and difficulty sleeping. On an unknown date, the outcome of the injection site pain, hand swelling, numbness in hand and difficulty sleeping were recovering/resolving.   It was unknown if the reporter considered the injection site pain, hand swelling, numbness in hand and difficulty sleeping to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced injection site pain, hand swelling, numbness in hand and difficulty sleeping after vaccination and was seen by her physician, and was referred to a neurologist. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Pain
Clinical narrative: joint pain all over her body/ beginning in the feet and working its way upwards towards the rest of the body; began to experience flu like symptoms; fatigue; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 30th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th September 2019, 8 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue and general body pain. On 2nd October 2019, the patient experienced joint pain. On an unknown date, the outcome of the influenza-like symptoms, fatigue and general body pain were resolved with sequelae and the outcome of the joint pain was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, general body pain and joint pain to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced  flu like symptoms described as body aches and fatigue that resolved after a few days. The patient also began to experienced joint pain all over her body, which was described as intermittent, beginning in the feet and working its way upwards towards the rest of the body. The patient consented to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: Patient received Prevnar 13 exposed to temperature excursion; Patient received Prevnar 13 exposed to temperature excursion; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient received Prevnar 13 exposed to temperature excursion. It was reported that temperature excursion occurred in Sep2019.   The information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020123171 Same reporter/drug/event, different patient
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: PAIN STARTED IN L) UPPER ARM IN 24 HRS AFTER INJECTION CONTINUED WITH LEFT UPPER DELTOID PAIN RADIATING INTO HIS LEFT SHOULDER - SXS WORSE WITH ACTIVITY/MOVEMENT - PAIN WITH EXTENSION OF THE SHOULDER + ABDUCTION MAKES WORSE - HE DENIED INJURY TO LEFT SHOULDER @ TIME OF VACCINATION
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acupuncture, Back pain, Chest pain, Herpes zoster, Injection site erythema
Clinical narrative: * I'd had shingles from back to chest left side Oct. 2017 - pain continued in back and chest area until approx. Feb 2019 - when my G.P. advised that I should have the vaccine, not to get shingles again. The day after the vaccination pain came back and has persisted since. I'm now taking acupuncture to try stop it!! the arm where the vaccine was administered - was red, painful and hot for several days
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: * I'd had shingles from back to chest left side Oct. 2017 - pain continued in back and chest area until approx. Feb 2019 - when my G.P. advised that I should have the vaccine, not to get shingles again. The day after the vaccination pain came back and has persisted since. I'm now taking acupuncture to try stop it!! the arm where the vaccine was administered - was red, painful and hot for several days
Age: 0.42
Sex: F
Vaccine: DTAP
Symptoms: Muscle spasms, Myoclonus
Clinical narrative: Benign Myoclonic spasms
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient with immediate left shoulder pain after injection, and has since that time experienced continued pain and decreased ROM of shoulder consistent with Shoulder Injury Related to Vaccine Administration (SIRVA).
Age: 1.67
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Adult Hep. A vaccine was inadvertently given to a 20 month old. Child should have received Pediatric Hep A. This was child's 1st Hep A vaccine. Parent was notified that child was given a double dose of Hep. A. Advised of any outward signs/symptoms to look. No adverse reaction a this time - will F/U with mom before I Leave at 5pm.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Nausea, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Nausea, Hives (L) arm red, swollen, warm to touch
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given the 3rd dose of HPV vaccine too early based on recommended tracking schedule/interval. Parent (mother) and patient made aware of incident. Parent instructed to bring patient back to clinic for 3rd dose of HPV on or after 07/02/2020. Parent and patient made appointment for 07/06/2020 to receive the 3rd dose of HPV within the appropriate time frame. Patient denies previous reactions to vaccine. Instructed parent and patient to return to clinic or go to Emergency Room if side effects occur. Parent and patient verbalize understanding.
Age: 51.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event.; administered a dose of PNEUMOVAX 23 that was expired; This initial spontaneous report was received from a pharmacy student and refers to a 51-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided. The report concerned 1 patient and 1 combination product.  On 11-MAR-2020, the patient was inadvertently vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R012632, expiration date 15-JAN-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: TYP
Symptoms: Ear infection, Ear pain
Clinical narrative: EAR INFECTION; EAR PAIN; This spontaneous case report was received from a pharmacist (PVX2019-020) on 03-Jan-2019. The report describes a 19-year-old adult female consumer who experienced ear pain and ear infection following the intake of Vivotif for an unknown indication.  The consumer did not have any medical history and not taking any concomitant medication.  It was reported that the consumer felt ear pain on 28-Dec-2018. She took the last dose of Vivotif on 29-Dec-2018. She also had an ear infection which started on an unknown date.   The action taken with Vivotif with respect to the event ear pain was dosage maintained, while with respect to the event ear infection was unknown.  The clinical outcome of the events ear pain and ear infection was unknown.  Company's Comment: In this case, a female consumer developed an ear pain and ear infection after receiving Vivotif vaccine.The consumer stated that she did not know specifically which day the ear infection started. Hence temporal association of event with Vivotif cannot be established. Also ear infection is an infectious condition so the causality of the events with Vivotif was assessed as not related.; Sender's Comments: Company's Comment: In this case, a female consumer developed an ear pain and ear infection after receiving Vivotif vaccine. The consumer stated that she did not know specifically which day the ear infection started. Hence temporal association of event with Vivotif cannot be established. Also ear infection is an infectious condition so the causality of the events with Vivotif was assessed as not related.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: ABDOMINAL PAIN; This spontaneous case (PVX2019-1395) report was received from a nurse on 31-May-2019. It describes a male consumer who experienced abdominal pain, after the administration of Vivotif (lot no: 3003253) for an unknown indication.  Case report: The consumer experienced abdominal pain after the first dose of Vivotif.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer had abdominal pain, after the administration of Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had abdominal pain, after the administration of Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash vesicular
Clinical narrative: 6 x 6 cm area of erythema and swelling around injection site that appeared the day after administrations.  There was a central  2x2cm area of vesicular rash.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Erythema, Papule
Clinical narrative: Tiny erythematous papules over face, forehead, hairline. No swelling or angioedema. No resp distress.