chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Oestradiol normal, Red blood cell morphology abnormal, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: This patient was vaccinated by this reporter at a community flu shot outreach event on November 6th, 2018. At the time, the patient reported no contraindications to receiving the influenza vaccine and she did not report any adverse events at the time of administration. This patient reached out to the Clinic in February of 2019 to report that the day after she received her flu vaccine, she developed severe and persistent vertigo. According to the patient, these symptoms were severe enough that she had to take medical leave from her undergraduate program and undergo physical therapy. As of February 2019, the patient was still in physical therapy, still experiencing severe vertigo, and still unable to attend classes. The patient reported that she had been diagnosed with vertibular neuritis. She also reported that her neurologist, who made this diagnosis, told her that he believed her condition had been triggered by the flu vaccine. Dr. is not affiliated with the Clinic and we do not have access to this patient's medical records, so he is the best person to contact if you need further information.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Serum ferritin decreased, Tinnitus, Vitamin B12 normal
Clinical narrative: This patient was vaccinated by this reporter at a community flu shot outreach event on November 6th, 2018. At the time, the patient reported no contraindications to receiving the influenza vaccine and she did not report any adverse events at the time of administration. This patient reached out to the Clinic in February of 2019 to report that the day after she received her flu vaccine, she developed severe and persistent vertigo. According to the patient, these symptoms were severe enough that she had to take medical leave from her undergraduate program and undergo physical therapy. As of February 2019, the patient was still in physical therapy, still experiencing severe vertigo, and still unable to attend classes. The patient reported that she had been diagnosed with vertibular neuritis. She also reported that her neurologist, who made this diagnosis, told her that he believed her condition had been triggered by the flu vaccine. Dr. is not affiliated with the Clinic and we do not have access to this patient's medical records, so he is the best person to contact if you need further information.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Loss of personal independence in daily activities, Vertigo, Vestibular neuronitis
Clinical narrative: This patient was vaccinated by this reporter at a community flu shot outreach event on November 6th, 2018. At the time, the patient reported no contraindications to receiving the influenza vaccine and she did not report any adverse events at the time of administration. This patient reached out to the Clinic in February of 2019 to report that the day after she received her flu vaccine, she developed severe and persistent vertigo. According to the patient, these symptoms were severe enough that she had to take medical leave from her undergraduate program and undergo physical therapy. As of February 2019, the patient was still in physical therapy, still experiencing severe vertigo, and still unable to attend classes. The patient reported that she had been diagnosed with vertibular neuritis. She also reported that her neurologist, who made this diagnosis, told her that he believed her condition had been triggered by the flu vaccine. Dr. is not affiliated with the Clinic and we do not have access to this patient's medical records, so he is the best person to contact if you need further information.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 26-year-old female patient who received HAVRIX (batch number D94MK, expiry date 5th July 2021) for prophylaxis. Co-suspect products included BOOSTRIX (batch number 42PT4, expiry date 5th October 2019) for prophylaxis. On 15th February 2019, the patient received HAVRIX (intramuscular) 1 ml and BOOSTRIX (intramuscular) .5 ml. On 17th February 2019, 2 days after receiving HAVRIX and BOOSTRIX, the patient experienced itchy rash and skin discoloration. On an unknown date, the outcome of the itchy rash and skin discoloration were recovered/resolved. It was unknown if the reporter considered the itchy rash and skin discoloration to be related to HAVRIX and BOOSTRIX. Additional details were provided as follows: The patient received HAVRIX on left deltoid and BOOSTRIX on left deltoid. The patient experienced a purple rash that appeared on her hip and axilla along with mild itching. On 25th February 2019, the rash traveled to the right armpit, right buttock and right hand, left hand, and the middle finger on her right hand. On the day of reporting, the patient visited the nurse practitioner, and the rash had changed from purple color to light deep brown color. The patient was doing fine, and had no other adverse events. No further details were provided.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Rash pruritic, Skin discolouration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 26-year-old female patient who received HAVRIX (batch number D94MK, expiry date 5th July 2021) for prophylaxis. Co-suspect products included BOOSTRIX (batch number 42PT4, expiry date 5th October 2019) for prophylaxis. On 15th February 2019, the patient received HAVRIX (intramuscular) 1 ml and BOOSTRIX (intramuscular) .5 ml. On 17th February 2019, 2 days after receiving HAVRIX and BOOSTRIX, the patient experienced itchy rash and skin discoloration. On an unknown date, the outcome of the itchy rash and skin discoloration were recovered/resolved. It was unknown if the reporter considered the itchy rash and skin discoloration to be related to HAVRIX and BOOSTRIX. Additional details were provided as follows: The patient received HAVRIX on left deltoid and BOOSTRIX on left deltoid. The patient experienced a purple rash that appeared on her hip and axilla along with mild itching. On 25th February 2019, the rash traveled to the right armpit, right buttock and right hand, left hand, and the middle finger on her right hand. On the day of reporting, the patient visited the nurse practitioner, and the rash had changed from purple color to light deep brown color. The patient was doing fine, and had no other adverse events. No further details were provided.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX (batch number N72HZ, expiry date 9th June 2021) for prophylaxis. On 26th February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 27th February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the patient received SHINGRIX. The next day she developed redness at the injection site and it is hot to the touch. On the day of reporting, It was still red and hot. The patient also had a fever for a day. The reported batch number W72H2 was corrected to N72HZ as per sales data sheet.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX (batch number N72HZ, expiry date 9th June 2021) for prophylaxis. On 26th February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 27th February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and fever to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the patient received SHINGRIX. The next day she developed redness at the injection site and it is hot to the touch. On the day of reporting, It was still red and hot. The patient also had a fever for a day. The reported batch number W72H2 was corrected to N72HZ as per sales data sheet.
Age: 67.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Sore arm.
Age: 67.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pain in extremity
Clinical narrative: Sore arm.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dermatitis in a 83-year-old male patient who received SHINGRIX (batch number 9277N, expiry date 27th June 2021) for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2019, 7 days after receiving SHINGRIX, the patient experienced dermatitis, erythema, pruritus and rash. On an unknown date, the outcome of the dermatitis, erythema, pruritus and rash were unknown. It was unknown if the reporter considered the dermatitis, erythema, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that the patient received SHINGRIX about a week later post vaccination, patient was experiencing topical dermatitis rash associated with redness and itching about 4 inches above and 4 inches below the injection site on the outer forearm.  The rash started fading away one week after, but it was at the time of reporting coming back. No further details were provided.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site dermatitis, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dermatitis in a 83-year-old male patient who received SHINGRIX (batch number 9277N, expiry date 27th June 2021) for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2019, 7 days after receiving SHINGRIX, the patient experienced dermatitis, erythema, pruritus and rash. On an unknown date, the outcome of the dermatitis, erythema, pruritus and rash were unknown. It was unknown if the reporter considered the dermatitis, erythema, pruritus and rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that the patient received SHINGRIX about a week later post vaccination, patient was experiencing topical dermatitis rash associated with redness and itching about 4 inches above and 4 inches below the injection site on the outer forearm.  The rash started fading away one week after, but it was at the time of reporting coming back. No further details were provided.
Age: 22.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Tremor
Clinical narrative: Ten minutes after administration right arm was involuntarily tremoring or shaking. Onsite personnel were notified. Patient was referred to urgent care facility although unknown if she visited a facility for follow up.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Rash generalised, Urticaria
Clinical narrative: Hives or complete body rash.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an other health care professional (administrator) referring to multiple unspecified patients of unknown age and gender. Concomitant medication included sterile diluent. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. On multiple unspecified dates, the patients were administered improperly stored doses of M-M-R II (rHA) (lot #: R000551, expiration date: 08-JAN-2020; dose, strength, route, and frequency were not reported) or VARIVAX (lot #: R017641, expiration date: 20-JUN-2020; dose, strength, route, and frequency were not reported) for prophylaxis. The M-M-R II and VARIVAX both reconstituted with properly stored Merck sterile diluent. No adverse effects reported. The vaccines were expose to the temperature of 64 F for 9 hours 30 minutes. There was previous temperature excursion with unspecified temperature for an unspecified amount of time. The data logger was included. This is a non-valid report with no patient identifiers; Sender's Comments: US-009507513-1902USA005226.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immunisation reaction
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 24-FEB-2017, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose:  the prevention of shingles (herpes zoster). One week after receiving the ZOSTAVAX, the patient suffered an immunization reaction and was diagnosed with Herpes zoster, which affected his right side from anterior mid-axillary line around side toward the spine. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the ZOSTAVAX, patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were not resolved. Causality assessment was related. Immunization reaction and Herpes zoster were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2016 the patient was inoculated with ZOSTAVAX (lot# and route unk.) vaccine by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, 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 direct and proximate result of these malfunctions, the patient suffered painful injures 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.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse refers to a 19 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. The patient's concomitant medications included vitamins. On 29-JAN-2019 the patient was vaccinated with first dose of GARDASIL 9 (lot, expiry date and dose were not reported) intramuscularly to prevent Human papilloma virus(prophylaxis) during pregnancy. The second dose of GARDASIL 9 was administered on 27-FEB-2019(inappropriate schedule of product administration). On an unknown date, urine pregnancy test was performed. The patient became pregnant with last menstrual period of 21-DEC-2018(also reported as about 10 weeks on date of report) and estimated date of delivery (EDD) of 27-SEP-2019. Initial exposure to GARDASIL 9 was at 5 weeks. The pregnancy outcome was pending. Patient sought medical attention by visiting office. No product quality complaint was filed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was prescribed ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-SEP-2014, the patient was administered the ZOSTAVAX vaccine by a pharmacist. The patient was treated by a physician for the flowing injury resulting from the patient's use of ZOSTAVAX: shingles.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 01-MAR-2019 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a healthcare provider.  The patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 01-MAR-2019 regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-SEP-2012, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. The patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female patient referring to herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered the ZOSTAVAX by a healthcare provider at a medical office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a medical office for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a male patient referring to himself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The male patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26 FEB 2015, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a clinic by an unspecified healthcare provider for the following injury resulting from the ZOSTAVAX use: Herpes zoster. The patient claims damages including: injury to self, loss of consortium, loss of services, and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative, referring to an unknown number of unidentified teenagers of unknown age and gender. Information about patient's historical conditions, current conditions, drug reactions or allergies and concomitant medications. were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9 for prophylaxis (dose schedule, anatomical location, route of administration, lot number and expiration date were not provided). On an unspecified date in 2015, the patients experienced syncope episodes after their vaccination. At reporting time, the outcome of the event was not provided. The causality assessment between GARDASIL 9 and syncope was not provided. Upon internal review, the syncope was determined to be medically significant.
Age: 25.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager regarding a 25 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot number N020139 and 14-FEB-2020 expiration date for prophylaxis (dose, strength, frequency and route of administration was not reported), on 29-AUG-2018, was vaccinated with the second dose of GARDASIL 9 lot number N019104 and 03-FEB-2020 expiration date for prophylaxis (dose, strength, frequency and route of administration was not reported) and on 05-MAR-2019 was vaccinated with the third dose of GARDASIL 9 lot number R017249 and 04-MAY-2021 expiration date for prophylaxis (dose, strength, frequency and route of administration was not reported). No adverse effect reported.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 58-year-old female patient (race not provided) was administered with HEPLISAV-B that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the first injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor, Distributor, on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on Distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patients experienced influenza-like symptoms, fever and pain. On an unknown date, the outcome of the influenza-like symptoms, fever and pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that lot of patients experienced reactions to SHINGRIX vaccine such as flu like reactions, fever and pain. The reporter did not know the specific details about the patients and no further details were provided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea, Peripheral coldness
Clinical narrative: I just wanted to report that I awoke at 11 p.m. and had severe chills, fever, shaking, feet were ice cold. Later developed a severe headache with nausea, vomiting. Took the weekend to recover and gain energy back. The first injection I had in January I developed severe tiredness that lasted for a week, but my reaction to the vaccine for the second shot was very severe and felt I needed to report it.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: I just wanted to report that I awoke at 11 p.m. and had severe chills, fever, shaking, feet were ice cold. Later developed a severe headache with nausea, vomiting. Took the weekend to recover and gain energy back. The first injection I had in January I developed severe tiredness that lasted for a week, but my reaction to the vaccine for the second shot was very severe and felt I needed to report it.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Vaccine given 11:01 3-9-2019. At approx. 10 pm of 3-9-2019, started with all over body aches and general malaise. Took Ibuprofen, relaxed awhile and went to bed. Slept until 7:30 a.m. 3/10/2019 (unusual for me). Got up feeling weak, took shower and attempted to get dressed for church, all the while feeling worse with nausea starting (had not eaten or taken any medications at this point). At 9:20 a.m. went back to bed and slept solid for 2 hours. Continued to feel poorly most of day with low grade temp of 99-100 degrees F. Rested several times during the day, noting achy muscle areas and just plain weakness. Slept fairly well and arose Monday a.m. 3-11-2019 feeling better without any temperature elevation, nausea or general malaise. Of note, the fever was not exceptionally elevated, as would be with the flu, no headache, diarrhea or vomiting. Body aches subsided after Sunday 3-10-2019 p.m. was just tired after that time.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Vaccine given 11:01 3-9-2019. At approx. 10 pm of 3-9-2019, started with all over body aches and general malaise. Took Ibuprofen, relaxed awhile and went to bed. Slept until 7:30 a.m. 3/10/2019 (unusual for me). Got up feeling weak, took shower and attempted to get dressed for church, all the while feeling worse with nausea starting (had not eaten or taken any medications at this point). At 9:20 a.m. went back to bed and slept solid for 2 hours. Continued to feel poorly most of day with low grade temp of 99-100 degrees F. Rested several times during the day, noting achy muscle areas and just plain weakness. Slept fairly well and arose Monday a.m. 3-11-2019 feeling better without any temperature elevation, nausea or general malaise. Of note, the fever was not exceptionally elevated, as would be with the flu, no headache, diarrhea or vomiting. Body aches subsided after Sunday 3-10-2019 p.m. was just tired after that time.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: Small satellite erythematous papules throughout both arms, back, chest, right wrist and right foot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: On 2-28-19 per mom via telephone L arm is warm to touch underneath injection site and earlier in am was red but is no longer red, no lump - advised to monitor - On 3-1-18 area has gotten bigger (tender, warm, itches) on exam L upper arm below deltoid with large cellulitis (stops about 2 in above elbow). 9x9cm, warm, +edema, tender w/movement but has full ROM, no streaking.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: On 2-28-19 per mom via telephone L arm is warm to touch underneath injection site and earlier in am was red but is no longer red, no lump - advised to monitor - On 3-1-18 area has gotten bigger (tender, warm, itches) on exam L upper arm below deltoid with large cellulitis (stops about 2 in above elbow). 9x9cm, warm, +edema, tender w/movement but has full ROM, no streaking.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nausea, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Patient reports N, V, high fever, swollen lymph nodes that started approximately 1 day after IM injection. Patient reports s/s fever, N, V decreased within 24 hours with anti nausea medication and OTC TYLENOL. She denies local reax s/s skin infection of injection site. She reports on this date (03/11/19) that her lymph nodes remain swollen and she has a mild ST.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, CSF protein increased, Gait inability, Lumbar puncture normal, Muscular weakness
Clinical narrative: 80 y/o male that underwent lumbar fusion on 1/22. Initially did very well. Was discharged home and was recovering well. Ambulating normally. Approximately 4 days ago he began noticing his leg giving out and parasthesias. Was seen in the ED on 2/1 and discharged home. Rerutned on 2/2 unable to walk. Surgical Wound was explored but did not demonstrate any unexpected findings - normal post-operative hematoma and seroma. Nerve roots were all inspected. Hardware was in place. POD#1 his weakness had worsened. POD#2 LP was performed which was normal except for a protein of appx 110. MRI showed mild enhnacement along the anterior surface of the lumbar roots. There was concern for GBS and patient was transferred in stable condition.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Post procedural haematoma, Seroma
Clinical narrative: 80 y/o male that underwent lumbar fusion on 1/22. Initially did very well. Was discharged home and was recovering well. Ambulating normally. Approximately 4 days ago he began noticing his leg giving out and parasthesias. Was seen in the ED on 2/1 and discharged home. Rerutned on 2/2 unable to walk. Surgical Wound was explored but did not demonstrate any unexpected findings - normal post-operative hematoma and seroma. Nerve roots were all inspected. Hardware was in place. POD#1 his weakness had worsened. POD#2 LP was performed which was normal except for a protein of appx 110. MRI showed mild enhnacement along the anterior surface of the lumbar roots. There was concern for GBS and patient was transferred in stable condition.
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This literature marketed report has been received from the authors of a published literature article and refers to 14 elderly patients of unknown age and gender. There was no information about the patients' concomitant therapies or medical history provided. Concurrent conditions included hospitalization. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 followed by pneumococcal 13v conj vaccine (CRM197) (dose, route of administration, lot # and expiration date were not provided for both) for prevention of pneumococcal diseases. The vaccines were administered out of sequence (patients should have received PNEUMOVAX 23). This is one of three reports received from the same authors.; Sender's Comments: US-009507513-1903USA004221: US-009507513-1903USA004220:
Sex: U
Vaccine: PNC13, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a practice administrator referring to a 4 months old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 28-FEB-2019, the patient was inadvertently administered VARIVAX (Lot: R023737; expiry date: 20-AUG-2020) 0.5 ml once subcutaneously instead of PREVNAR 13 (wrong product administered). Concomitant medication included sterile diluent (manufacturer unknown) (lot: N028745; expiry date: 15-MAR-2020). Practice administrator reported that the patient received PREVNAR 13 at the same visit after the error was discovered. No adverse effects reported.
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This literature marketed report has been received from the authors of a published literature article and refers to 2 elderly patients of unknown age and gender. There was no information about the patients' concomitant therapies or medical history provided. Concurrent conditions included hospitalization. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided for both) for prevention of pneumococcal diseases. The patients had less than 12 months elapse following a pneumococcal 13v conj vaccine (CRM197) dose (inappropriate time between vaccines). This is one of three reports received from the same authors.; Sender's Comments: US-009507513-1902USA011509: US-009507513-1903USA004221:
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 4 elderly patients of unknown age and gender. There was no information about the patients' concomitant therapies or medical history provided. Concurrent conditions included hospitalization. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 followed by pneumococcal 13v conj vaccine (CRM197) (dose, route of administration, lot # and expiration date were not provided for both) for prevention of pneumococcal diseases. The patients received a second, duplicate dose of PNEUMOVAX 23 after the age of 65. A copy of the published article is attached as further documentation of the patients' experience. This is one of three reports received from the same authors. Sender's Comments: US-009507513-1903USA004220; US-009507513-1902USA011509.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 54-year-old male patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received SHINGRIX. On 1st March 2019, less than a day after receiving SHINGRIX, the patient experienced dizziness and tiredness. On an unknown date, the outcome of the dizziness and tiredness were unknown. It was unknown if the reporter considered the dizziness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received a shingles shot and experiencing dizziness and tiredness and was asking if he should be concerned.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling, erythema and pruritus. On an unknown date, the outcome of the swelling, erythema and pruritus were unknown. It was unknown if the reporter considered the swelling, erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient had the shot three days ago before date of reporting. The shot was administered at a pharmacy, not in the doctor's office. The patient asked how long after a dose of SHINGRIX, the swelling and redness take to relieve itself. The patient asked whether any suggestion as to hot or cold compresses to relieve, the redness, itching and swelling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and skin warm. The patient was treated with Cold Compresses and TYLENOL. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and skin warm were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on Tuesday. The patient's arm at the time of reporting was sore, red, and a little swollen also warm to the touch and seemed to be traveling down her arm. The patient tried calling her physician's office but they were closed. The patient would try cold compresses and TYLENOL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, 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 a 72-year-old female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: Two weeks ago from the reporting date, the patient received a dose of SHINGRIX. The patient concerned about her pain in the arm as it lasted more than 2 weeks. The patient informed to her physician about the adverse event she experienced and he said, it was too new to have a lot of data. It had been advised to the patient that, her physician or pharmacist can contact to medical information department regarding questions on SHINGRIX and provided the contact details for the same. At the time of this report, the patient could not raise her arm without pain. The patient had been advised to contact her Heath Care Provider (HCP), if she continued to experience the arm pain, or it bothered to her.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Tenderness, Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tremor in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tremor and forehead headache. On an unknown date, the outcome of the tremor and forehead headache were recovered/resolved. It was unknown if the reporter considered the tremor and forehead headache to be related to SHINGRIX. Additional details were provided as follows: The date of birth and age of the patient was unknown. The age at vaccination was not reported. The patient did not know when he received SHINGRIX. The patient reported severe shaking and a tender forehead that lasted 8 to 10 hours. All the patient told that he was due for his 2nd dose of SHINGRIX. It was not known if it had been 2 months or 6 months since the 1st dose of SHINGRIX. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th October 2018, 2 hrs after receiving SHINGRIX, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was recovered/resolved. It was unknown if the reporter considered the heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The anatomical location was left arm. After experiencing a fast heartbeat, the patient went to bed, and awoke the next morning and it was still present. Later in the morning, the fast heart rate stopped and was resolved. The reporter did not give consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Skin burning sensation
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tingling in a adult patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced tingling and burning sensation skin. On an unknown date, the outcome of the tingling and burning sensation skin were unknown. It was unknown if the reporter considered the tingling and burning sensation skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. No patient demographics or other information was provided. The reporter had a question if a patient received SHINGRIX two doses and then developed shingles, was it considered a failure if it is within a few months of receiving the second injection. The question at the time of reporting was general but there was tingling and burning but no rash. The reporter confirmed that there was a patient and the healthcare professional states that she was not certain that the definitive diagnosis was shingles but there was tingling and burning in a previous area of shingles after receiving the SHINGRIX vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eye irritation in a male patient who received 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 eye irritation, inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the eye irritation was not recovered/not resolved and the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown. It was unknown if the reporter considered the eye irritation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. During administration of SHINGRIX to the patient, some of the vaccine leaked out and squirted in the administering pharmacist's eye. The pharmacist was experiencing ongoing mild eye irritation. The pharmacist was no longer present in the pharmacy at the time of reporting. The lot and expiration was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Muscular weakness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle weakness in a female patient who received 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 muscle weakness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the muscle weakness, exhaustion and influenza-like symptoms were unknown. It was unknown if the reporter considered the muscle weakness, exhaustion and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter reported via chat. The age at vaccination was not reported. No information about lot or expiry was available. The pharmacist reported that the patient stated that she had all of the side effects from a dose of SHINGRIX and experienced muscle weakness, feeling exhausted, and like she had the flu. She felt so terrible that she did not want another one. Pharmacist stated, the patient did not receive the vaccine at her facility.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included shingles (received 7 years ago before the date of reporting). In October 2017, the patient received the 1st dose of SHINGRIX. In December 2017, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient having an episode of Shingles in May as well as a second episode that is currently ongoing. The batch number was unavailable as the reporter was the patient. Adeverse event obtained through chat, in which both consumer and agent had connection issues. During reconnection consumer stated that, the patient was the greatest advocate of shingles vaccines because she had the old vaccines 7 years ago but she would no longer encourage people to go through the expense of getting the new vaccines. The agent requested full demographics and consent to follow up. Follow-up consent provided however only an email address and telephone number was provided.