chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Herpes simplex test negative, Hypophagia, Influenza virus test negative, Lung consolidation, Lymphocyte count decreased
Clinical narrative: Received HPV vaccine on 8/13/18. Develop headache on 9/16/18, fever on 9/17/18, vaginal ulcers on 9/19/18. Seen on 9/18/18 - diagnosed with pneumonia by chest x-ray - started Augmentin. Seen on 9/19/18 for vaginal ulcers. Admitted to the hospital 9/21/18 - 9/23/18 for pneumonia and vaginal ulcers, and poor PO intake. She was diagnosed with mycoplasma pneumonia and Lipschutz ulcers. Had follow up on 9/26/18 - all symptoms were improving. Also complained of right shoulder pain during the illness. (Vaccine given in left shoulder and pneumonia was in left upper lung.)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Mycoplasma test positive, Pneumonia, Pneumonia mycoplasmal, Polymerase chain reaction
Clinical narrative: Received HPV vaccine on 8/13/18. Develop headache on 9/16/18, fever on 9/17/18, vaginal ulcers on 9/19/18. Seen on 9/18/18 - diagnosed with pneumonia by chest x-ray - started Augmentin. Seen on 9/19/18 for vaginal ulcers. Admitted to the hospital 9/21/18 - 9/23/18 for pneumonia and vaginal ulcers, and poor PO intake. She was diagnosed with mycoplasma pneumonia and Lipschutz ulcers. Had follow up on 9/26/18 - all symptoms were improving. Also complained of right shoulder pain during the illness. (Vaccine given in left shoulder and pneumonia was in left upper lung.)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Streptococcus test negative, Treponema test negative, Urine ketone body present, Vaginal ulceration
Clinical narrative: Received HPV vaccine on 8/13/18. Develop headache on 9/16/18, fever on 9/17/18, vaginal ulcers on 9/19/18. Seen on 9/18/18 - diagnosed with pneumonia by chest x-ray - started Augmentin. Seen on 9/19/18 for vaginal ulcers. Admitted to the hospital 9/21/18 - 9/23/18 for pneumonia and vaginal ulcers, and poor PO intake. She was diagnosed with mycoplasma pneumonia and Lipschutz ulcers. Had follow up on 9/26/18 - all symptoms were improving. Also complained of right shoulder pain during the illness. (Vaccine given in left shoulder and pneumonia was in left upper lung.)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Varicella virus test negative, White blood cells urine positive
Clinical narrative: Received HPV vaccine on 8/13/18. Develop headache on 9/16/18, fever on 9/17/18, vaginal ulcers on 9/19/18. Seen on 9/18/18 - diagnosed with pneumonia by chest x-ray - started Augmentin. Seen on 9/19/18 for vaginal ulcers. Admitted to the hospital 9/21/18 - 9/23/18 for pneumonia and vaginal ulcers, and poor PO intake. She was diagnosed with mycoplasma pneumonia and Lipschutz ulcers. Had follow up on 9/26/18 - all symptoms were improving. Also complained of right shoulder pain during the illness. (Vaccine given in left shoulder and pneumonia was in left upper lung.)
Age: 54.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Axillary pain, Headache, Injection site erythema, Injection site inflammation, Nausea
Clinical narrative: Patient reports developing severe headache the evening after vaccination. Patient reports nausea/vomiting. Patient reports pain in unilateral under arm area (side of vaccination). Symptoms improved with time and have now (48 hours post vaccination) resolved. Patient has small red/inflamed patch on inner portion of the injection site arm. This redness appears to be localized around anatomic sites of lymph nodes.
Age: 54.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vomiting
Clinical narrative: Patient reports developing severe headache the evening after vaccination. Patient reports nausea/vomiting. Patient reports pain in unilateral under arm area (side of vaccination). Symptoms improved with time and have now (48 hours post vaccination) resolved. Patient has small red/inflamed patch on inner portion of the injection site arm. This redness appears to be localized around anatomic sites of lymph nodes.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Pain
Clinical narrative: Pharmacist unsure of which vaccine administered in (R) arm. Patient has body ache and chills next day. Currently has 5 cm erythema to (R) arm surrounding injection site. Hardness palpated under skin.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Nausea headache and sore arm. Arm - swelling and redness worse on 26Sep18 and improving on 27Sep18.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient says he had itching and bumps around his elbows and forearms.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Fatigue, Headache, Myalgia, Oral discomfort
Clinical narrative: About 1 hour after the FLUARIX injection I began to have itchiness and tightness in my throat. I also had a burning sensation in my mouth and throat. I took 25mg BENADRYL and wasn't feeling relief so I took another 25mg tablet about 30minutes after 1st dose. I began to feel some relief after about 30 minutes. I did continue to take BENADRYL 25mg-50mg every 6 hours for the next 48 hours. I also had the usual symptoms that I usually have after my yearly flu vaccination----extreme muscle and body aches, headache, fatigue, and low grade temperature for which I took Acetaminophen.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Throat irritation, Throat tightness
Clinical narrative: About 1 hour after the FLUARIX injection I began to have itchiness and tightness in my throat. I also had a burning sensation in my mouth and throat. I took 25mg BENADRYL and wasn't feeling relief so I took another 25mg tablet about 30minutes after 1st dose. I began to feel some relief after about 30 minutes. I did continue to take BENADRYL 25mg-50mg every 6 hours for the next 48 hours. I also had the usual symptoms that I usually have after my yearly flu vaccination----extreme muscle and body aches, headache, fatigue, and low grade temperature for which I took Acetaminophen.
Age: 67.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Local injection site pain, full body myalgia, arthralgia incapacitating for 36 hours post SHINGRIX injection with concomitant influenza vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site
Clinical narrative: Does not recall observing where vax was given in arm (possibly too high).
Age: 80.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Pain, Pruritus
Clinical narrative: Blisters and itching from middle of stomach to middle of back, very painful for 3 week reaction to shingle shot: SHINGRIX 50mcg inj (IM) sngdse vl 10pk. At same time given flu shot: FLUZONE HIGH DOSE 2018-19 0.5ml syr at same time in left arm. At pharmacy by MD.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Pt mother states leg has a large area of redness, warm and inflamed. Appointment with Provider to assess. Treatment cool moist compress.
Age: 56.0
Sex: U
Vaccine: FLU4, PPV, TDAP
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Patient got PNEUMOVAX, flu vaccine and Tdap. She preferred all vaccines on one arm and 2 days later she had pain on her upper arm soreness and increased temperature.
Age: 39.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site pain, Pain
Clinical narrative: (L) arm still hurts at site of Tdap (ADACEL) injection, 1 1/2 months later. Has not been using analgesics PO, but has been using topical lavender essential oil and "DEEP BLUE" liniment, to which she denies a reaction. Pain (L) shoulder 5-5/10 w/ lifting.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Peripheral swelling
Clinical narrative: Swelling of arm from shoulder to elbow which started the morning after the vaccine was given. Pt contacted doctor and no treatment was given. 10 days later patient is still experiencing redness and subcutaneous fluid buildup in bicep region of arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Arms red slightly swollen and itchy at injection site.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Neck pain, Paraesthesia, Toothache
Clinical narrative: Symptom start Sunday morning, severe aching "toothache type" of pain but no redness or visual sign, pain from neck to elbow and tingling fingers. Pain has not abated with Ibuprofen 800 mg. Pt follow up with ER visit on 9/27/18.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she contracted shingles due to the SHINGRIX vaccine administered. The patient was upset with the way this was handled on her previous call to the pharmacy. The lawyer requested that to GlaxoSmithKline that to contact the customer (patient) and advice on the companies liability with an explanation. The customer had informed if resolution was not made promptly, then the patient would be turning this over to an attorney. The reporter requested the written indemnification within fifteen (15) days. This case was considered as suspected vaccination failure as basic immunization schedule and time to onset for the event (TTO) was not provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she contracted shingles due to the SHINGRIX vaccine administered. The patient was upset with the way this was handled on her previous call to the pharmacy. The lawyer requested that to GlaxoSmithKline that to contact the customer (patient) and advice on the companies liability with an explanation. The customer had informed if resolution was not made promptly, then the patient would be turning this over to an attorney. The reporter requested the written indemnification within fifteen (15) days. This case was considered as suspected vaccination failure as basic immunization schedule and time to onset for the event (TTO) was not provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she contracted shingles due to the SHINGRIX vaccine administered. The patient was upset with the way this was handled on her previous call to the pharmacy. The lawyer requested that to GlaxoSmithKline that to contact the customer (patient) and advice on the companies liability with an explanation. The customer had informed if resolution was not made promptly, then the patient would be turning this over to an attorney. The reporter requested the written indemnification within fifteen (15) days. This case was considered as suspected vaccination failure as basic immunization schedule and time to onset for the event (TTO) was not provided.
Age: 68.0
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 68-year-old female patient who received Shingrix (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 11th September 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2018, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. In September 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the injection site warmth was recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix. Additional information was reported as follows: The healthcare professional stated that the symptoms had improved at the time of reporting.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of transient ischemic attack in a 78-year-old male patient who received SHINGRIX (batch number 9349T, expiry date 7th March 2021) for prophylaxis. On 12th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 16th September 2018, 4 days after receiving SHINGRIX, the patient experienced transient ischemic attack (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the transient ischemic attack was unknown. It was unknown if the reporter considered the transient ischemic attack to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient experienced multiple transient ischemic attacks and was admitted to the hospital and discharged on 19th September 2018. This case has been linked with case US2018172576, reported by same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Shingrix for prophylaxis. On 12th September 2018, the patient received the 1st dose of Shingrix. On 13th September 2018, 1 days after receiving Shingrix, the patient experienced shingles, back pain and leg pain. In September 2018, the patient experienced blister and pain. On 18th September 2018, the patient experienced rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the shingles, back pain, leg pain and rash were not recovered/not resolved and the outcome of the blister and pain were unknown. It was unknown if the reporter considered the shingles, back pain, leg pain, rash, blister and pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix at 12:00. After the vaccination patient developed the developed shooting pain in his back and legs, pain that had not improved. On 17th September 2018, the patient saw his chiropractor due to back and leg pain. On 18th September 2018, the reporter discovered the rash on his left leg. This rash spread to his whole left leg and extended into his groin. The patient stated that he had put cortisone cream on the rash thinking he had poison ivy. The patient saw his healthcare professional. On 20th September 2018, the reporter discovered the rash on his left leg, who diagnosed him with shingles. The patient reported that he had blisters on his chin, neck and face and behind his right ear and they were all painful. The caller expressed multiple life stressors during call and was offered the National Suicide Prevention Lifeline phone number. The patient did not take the number and denied the need to talk with someone. Unable to obtain further information from caller. The patient gave permission to be contacted to physician and provided contact details of the same.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Shingrix for prophylaxis. On 12th September 2018, the patient received the 1st dose of Shingrix. On 13th September 2018, 1 days after receiving Shingrix, the patient experienced shingles, back pain and leg pain. In September 2018, the patient experienced blister and pain. On 18th September 2018, the patient experienced rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the shingles, back pain, leg pain and rash were not recovered/not resolved and the outcome of the blister and pain were unknown. It was unknown if the reporter considered the shingles, back pain, leg pain, rash, blister and pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix at 12:00. After the vaccination patient developed the developed shooting pain in his back and legs, pain that had not improved. On 17th September 2018, the patient saw his chiropractor due to back and leg pain. On 18th September 2018, the reporter discovered the rash on his left leg. This rash spread to his whole left leg and extended into his groin. The patient stated that he had put cortisone cream on the rash thinking he had poison ivy. The patient saw his healthcare professional. On 20th September 2018, the reporter discovered the rash on his left leg, who diagnosed him with shingles. The patient reported that he had blisters on his chin, neck and face and behind his right ear and they were all painful. The caller expressed multiple life stressors during call and was offered the National Suicide Prevention Lifeline phone number. The patient did not take the number and denied the need to talk with someone. Unable to obtain further information from caller. The patient gave permission to be contacted to physician and provided contact details of the same.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Shingrix for prophylaxis. On 12th September 2018, the patient received the 1st dose of Shingrix. On 13th September 2018, 1 days after receiving Shingrix, the patient experienced shingles, back pain and leg pain. In September 2018, the patient experienced blister and pain. On 18th September 2018, the patient experienced rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the shingles, back pain, leg pain and rash were not recovered/not resolved and the outcome of the blister and pain were unknown. It was unknown if the reporter considered the shingles, back pain, leg pain, rash, blister and pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix at 12:00. After the vaccination patient developed the developed shooting pain in his back and legs, pain that had not improved. On 17th September 2018, the patient saw his chiropractor due to back and leg pain. On 18th September 2018, the reporter discovered the rash on his left leg. This rash spread to his whole left leg and extended into his groin. The patient stated that he had put cortisone cream on the rash thinking he had poison ivy. The patient saw his healthcare professional. On 20th September 2018, the reporter discovered the rash on his left leg, who diagnosed him with shingles. The patient reported that he had blisters on his chin, neck and face and behind his right ear and they were all painful. The caller expressed multiple life stressors during call and was offered the National Suicide Prevention Lifeline phone number. The patient did not take the number and denied the need to talk with someone. Unable to obtain further information from caller. The patient gave permission to be contacted to physician and provided contact details of the same.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Seizure
Clinical narrative: Seizure, muscle weakness.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Unknown.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient complained of  numbness at the very tip of her left index finger. Patient was advised to consult family physician Dr. who she saw for this situation on 09/27/2018.
Sex: U
Vaccine: HEP, HIBV, HPV4, MMR, MMRV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. From on an unknown date in February 2018 to 25-JUN-2018, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, PEDVAXHIB, GARDASIL, ROTATEQ orally, M-M-R II, VARIVAX and PROQUAD (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. The vaccines were reconstituted with properly stored STERILE DILUENT. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. Clarification has been received on 26-SEP-2018 stating that the case concerned temperature excursion and no adverse event. There was no event of seizure.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Information has been received from two physicians referring to a 2 months old male infant. Information about concurrent condition, concomitant medication medical history, drug reactions or allergies was unknown. On 11-SEP-2018, the patient was vaccinated with ROTATEQ (lot# R007991, expiration date 18-OCT-2019) (strength, dose were not reported) orally for vaccination. On the same date, the patient vomited after administration the vaccine. It was also reported that the patient had been fed right before receiving the ROTATEQ and before the ROTATEQ was fully ingested, the patient vomited once. The patient also received other vaccinations after vomiting. The patient was fully recovered prior to leaving the office. One of the report physicians felt the vomiting was due to the feeding, and not the vaccine. Information about treatment given for the event and lab diagnostics/studies was unknown by the reporter. The patient had sought medical attention and seen by physician.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Crying, Intussusception, Stomach mass
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. His concomitant medication included other two vaccines (unspecified) indicated as prophylaxis (also reported as for 2 months old babies). On 13-SEP-2017, the patient was vaccinated with ROTATEQ (dose, lot number and expiration date were not reported), administered orally as prophylaxis. In September 2018, " (also reported as "about a week later"), the patient experienced intussusception, had a lump in is stomach and he did not stop crying. On an unspecified date, the patient was sent to a hospital for evaluation; it was not specified if the patient was hospitalized. On an unspecified day in September 2018, the patient recovered from the events. The reporter stated that there were no long term issues and no other doses of ROTATEQ were administered. The causal relationship between the events and ROTATEQ were not reported. Upon internal review, the event intussusception was considered to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On17-SEP-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, for prophylaxis lot number R006466 and expiration date of 24-OCT-2019. The administered dose of the vaccine experienced a temperature excursion of 47 degrees F to 77 degrees F during 1 hour and 6 minutes, as recorded by a data logger. There was no adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Influenza
Clinical narrative: This spontaneous report was received from a 67-year-old female registered nurse, referring to herself. The patient's medical history included heart transplant. The patient's concurrent condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date in approximately 2013 (reported as about 5 years ago), the patient was vaccinated with PNEUMOVAX 23 (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for prevention of pneumonia. On an unknown date, the patient experienced flu, due to which, she was hospitalized. The patient sought medical attention and an unspecified treatment was given for the event. The outcome of the flu was reported as recovered. The relatedness between the event and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-AUG-2018, the patient was vaccinated with a dose of M-M-R II, lot # N009171 and expiration date: 20-MAR-2019 (exact dose, frequency and route of administration were not reported). On 14-SEP-2018, the was vaccinated with a dose of VARIVAX, lot # N019127 and expiration date: 22-JUN-2019 (exact dose, frequency and route of administration were not reported). Both vaccines were reconstituted with properly stored sterile diluent. No adverse effect was reported. No causality assessment was provided.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 30 year old female patient referring to herself. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unspecified date, in September 2018 the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. No adverse reaction was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Actinic keratosis, Asthenia, Fatigue, Herpes zoster, Neuralgia
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about late 2015, the patient was inoculated with ZOSTAVAX (route of administration, site of administration, lot number and expiration date were not reported) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash on her left arm, which was accompanied by pain, weakness, and fatigue. In response to these complaints, the patient presented to her primary care physician and was diagnosed as suffering from herpes zoster, neuropathic pain, pain syndrome and actinic keratosis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about late 2015, the patient was inoculated with ZOSTAVAX (route of administration, site of administration, lot number and expiration date were not reported) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash on her left arm, which was accompanied by pain, weakness, and fatigue. In response to these complaints, the patient presented to her primary care physician and was diagnosed as suffering from herpes zoster, neuropathic pain, pain syndrome and actinic keratosis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD albumin status: recombinant human albumin (rHA), lot# R009616, expiration date 30-SEP-2020 (exact dose, frequency, site and route of administration were not reported), reconstituted with properly stored sterile diluent lot# N035973, expiration date: 07-AUG-2020. Administered dose of vaccine was exposed to a temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -12.3 degrees Celsius) for 7 hours and 52 minutes. There was a previous temperature excursion on 07-SEP-2018, between -9 degrees Celsius to 8 degrees Celsius (also reported as -1.8 degrees Celsius) for 7 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA013368.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an adult patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 21-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (lot number: R010724, expiration date: 07-JUN-2020) for prophylaxis using a with a 5/8 inch needle that might had been intradermal administration (strength and dosage schedule were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 25-SEP-2018, the patient was vaccinated with a dose of M-M-R II (Albumin status, rHA), intramuscularly; the valid lot number was R000555, with an expiration date of 01-JAN-2020, (unknown dose, and strength) for prophylaxis. And the vaccine was reconstituted with the sterile diluent (manufacturer unknown). The pharmacist reported that the patient received the M-M-R II via intramuscular route instead of subcutaneous (incorrect route of drug administration). No adverse effects reported. No further information was provided.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from an office manager, via a company representative, referring to a 10 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 05-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 06-JUL-2018, the patient developed a knot around the injection site, redness and pain. It was unknown by the reporter whether the patient received treatment, sought medical attention or if any laboratory tests were carried out. The outcome of injection site nodule, injection site erythema and infusion site pain was unknown. Causality assessment was not provided.
Age: 61.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 61 year old male patient with an unspecified immunocompromising condition. The patient's drug reactions/allergies and concomitant medication were not reported. On an unknown date in 1994, the patient was vaccinated with the first dose of PNEUMOVAX 23 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). Then in 2001, he was revaccinated with the second dose and in 2014, he received a third dose. Additionally on an unknown date in 2015, the patient received a dose of PREVNAR 13 (strength, route, dosage schedule, indication, lot number and expiration date were not reported). No adverse effect was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA012952.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-SEP-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # N000175, expiration date 20-SEP-2018, orally (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of PROQUAD albumin status: recombinant human albumin (rHA), lot# R009616, expiration date 30-SEP-2020 (exact dose, frequency, site and route of administration were not reported), reconstituted with properly stored sterile diluent lot# N035973, expiration date: 07-AUG-2020. Administered dose of vaccine was exposed to a temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -12.3 degrees Celsius) for 7 hours and 52 minutes. There was a previous temperature excursion on 07-SEP-2018, between -9 degrees Celsius to 8 degrees Celsius (also reported as -1.8 degrees Celsius) for 7 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA011525.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Influenza like illness, Oropharyngeal pain, Pain, Sinus congestion
Clinical narrative: Got flu like symptoms of headache and aches around body as well as sore throat and sinus congestion. Moderately severe, like a normal course of a bad cold. Starting to clear up by morning of 06/28.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Mobility decreased
Clinical narrative: Swelling, redness, sore arm (unable to raise above shoulder), headaches, shivering, fatigue.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness, sore arm (unable to raise above shoulder), headaches, shivering, fatigue.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Allergic reaction and cellulitis.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Syncope. Dizziness, hypotension. Rest, hydration.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Severe headache lasting from 5pm on 9/26 to 8am on 9/28. Constant itching, slight swelling, redness spreading approximately 2 inches from injection site.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Client developed hives (reported by client's mom via phone) approximately 24 hours after administration.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Oral herpes, Pain, Pyrexia
Clinical narrative: Redness and swelling at site. Achy feeling. Feverish feeling. All these symptoms occurred on the Saturday after the Thursday I received the vaccine. And also 3 days after I developed a cold sore on my left lip. I have not had a cold sore in a very long time.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Within approximately an hour of administration, patient developed raised, red hives on trunk, extremities, back, neck.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash papular
Clinical narrative: Red bumps going across back and over the shoulders. The bumps are not itchy but patient can feel them if shirt rubs across them.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site.
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Pruritus generalised, Slow response to stimuli, Throat irritation, Wheezing
Clinical narrative: About an hour after her flu shot she had a tickle in her throat. Then she started itching all over, and said she might need some BENADRYL. As employee was opening the cupboard to get the BENADRYL, pt started slowly going to the ground. Employee yelled for help and the PA came around and saw pt on the floor. I heard nurse ask for the EPIPEN which is when I went to see what was going on. At that point Dr and her resident were in the lab starting O2 with a neb. Pt has upper wheezes, could not talk, and making short gasping breaths. We offered to call 911 but pt wanted us to wait. As Dr was asking questions her responses got slower and we thought she was going to pass out but she came back  We did 2 neb treatments with O2, then saline with O2. Kept her sitting in a room until the end of the day.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified adult patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently administered doses of pediatric hepatitis b vaccine (recombinant)manufacturer unknown (dose, frequency, site of administration, route of administration, lot# and expiration date were not specified) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased activity, Decreased appetite, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in either June or July, refer linked case US2018GSK175505). On 4th September 2018, the patient received the 2nd dose of Shingrix. On 4th September 2018, immediately after receiving Shingrix, the patient experienced pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity and somnolence. On 5th September 2018, the patient experienced feeling abnormal. In September 2018, the patient experienced weight loss, stomach pain and gastric disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder were unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder to be related to Shingrix. Additional details were provided as follows: At 10 am, the patient received 2nd dose of Shingrix on left arm. The patient stated that with the second dose of the vaccine, when the injection was being given, it hurt. Later in the afternoon about 6:00 pm,8 hours after receiving Shingrix, the patient started having cold shakes that lasted for about three hours. Less than a day after receiving Shingrix , the patient's stomach felt like it was churning and was unable to eat or drink and just laid around all day. Several hours after receiving Shingrix, the patient tried to went to sleep that night and was able to sleep all night long which she said was not normal for her. One day after receiving Shingrix, the patient woke up the next morning and said that her body felt like it had been turned inside out. The patient could not think of any other way to describe what she was feeling but her stomach was still a problem. Most of the side effects had subsided but she still had stomach problems that lasted two weeks. The patient was able to eat and drink normally at the time of reporting. Less than 2 weeks after receiving Shingrix, the patient lost four pounds over three days after getting the second dose of the vaccine and she only weighed 100 pounds. The patient did not have a primary physician. She went to a clinic only when she needs to and at the time of reporting she was in good health.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fluid intake reduced, Gastric disorder, Immediate post-injection reaction, Nausea, 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 65-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in either June or July, refer linked case US2018GSK175505). On 4th September 2018, the patient received the 2nd dose of Shingrix. On 4th September 2018, immediately after receiving Shingrix, the patient experienced pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity and somnolence. On 5th September 2018, the patient experienced feeling abnormal. In September 2018, the patient experienced weight loss, stomach pain and gastric disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder were unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder to be related to Shingrix. Additional details were provided as follows: At 10 am, the patient received 2nd dose of Shingrix on left arm. The patient stated that with the second dose of the vaccine, when the injection was being given, it hurt. Later in the afternoon about 6:00 pm,8 hours after receiving Shingrix, the patient started having cold shakes that lasted for about three hours. Less than a day after receiving Shingrix , the patient's stomach felt like it was churning and was unable to eat or drink and just laid around all day. Several hours after receiving Shingrix, the patient tried to went to sleep that night and was able to sleep all night long which she said was not normal for her. One day after receiving Shingrix, the patient woke up the next morning and said that her body felt like it had been turned inside out. The patient could not think of any other way to describe what she was feeling but her stomach was still a problem. Most of the side effects had subsided but she still had stomach problems that lasted two weeks. The patient was able to eat and drink normally at the time of reporting. Less than 2 weeks after receiving Shingrix, the patient lost four pounds over three days after getting the second dose of the vaccine and she only weighed 100 pounds. The patient did not have a primary physician. She went to a clinic only when she needs to and at the time of reporting she was in good health.