chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Influenza like illness, Pyrexia
Clinical narrative: Patient reported possible adverse effect symptoms when patient was called to remind the second dose of SHINGRIX on 4/11/19. The symptoms of possible adverse reaction occurred approximately six hours after SHINGRIX 1st dose. Symptoms include flu like symptoms including fever, joint pain, difficulty in breathing that was lasted for the 2 days. Patient did not seek for the medical care and symptoms resolved its own.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Malaise
Clinical narrative: Patient stated she could not breath and was not feeling well at all told pt to go to nearest ER.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain in right arm, fever, chills, nausea, extreme tiredness all day April 9 to approximately 6 a.m. April 10; symptoms slowly improved through April 10, fever until early morning April 11, as of today pain in right arm and tiredness still an issue.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: localized pain and lump at site developed within 2 hours of administration then developed redness that extended from the deltoid to the elbow. Developed bruising at injection site 3 days after injection. Treatment: Tylenol, warm compresses, elevation.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor, Vomiting
Clinical narrative: Mother calling to report patient with sever vomiting and shakiness after menactra vaccine
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dyspnoea, Erythema, Injection site erythema, Pain
Clinical narrative: Within one hour my arm became very red and swollen in the next 4 hours my whole body ached. By 9pm i had a fever and chills and by the next morning i was struggling to breathe.  I needed to take several doses on Benadryl and use a nebulizer to be able to breathe without struggling.  It is now 4/11 and i am on antibiotics because the vaccination site is still extremely red, hot, and swollen.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Within one hour my arm became very red and swollen in the next 4 hours my whole body ached. By 9pm i had a fever and chills and by the next morning i was struggling to breathe.  I needed to take several doses on Benadryl and use a nebulizer to be able to breathe without struggling.  It is now 4/11 and i am on antibiotics because the vaccination site is still extremely red, hot, and swollen.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash generalised
Clinical narrative: Patient reported having rash around injection site approximately 5 days after receiving his SHINGRIX vaccine. He said the rash spread to most of his body as the days went by and no longer red around injection site. He reported this to the pharmacy on 4-11-2019. His doctor prescribed triamcinolone acetonide 0.1% lotion on 4/11/2019.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Approximately 15-20 minutes after receiving vaccines, child started breaking out with hives. Hives were on his trunk, arms, neck and face. Child was given 0.3 ml of diphenhydramine IM in the R thigh. Child was observed for approximately 40 minutes. During this time, the hives became noticeably less. Mother and child left the clinic.
Sex: F
Vaccine: VARZOS
Symptoms: Corneal endotheliitis, Emotional distress, Ophthalmic herpes zoster
Clinical narrative: Information has been received on 02-APR-2019 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 or around April 2017 the patient was inoculated with the ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX the patient suffered endotheliitis and herpes keratitis. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expensed; the loss of accumulations; and other economic and non-economic damages. Upon internal review herpes keratitis was considered medically significant. Endotheliitis and herpes keratitis were reported to be disabling. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: stored improperly; No adverse effect; This non-valid spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' relevant medical history, concomitant medications and concurrent conditions were not known.  On unknown dates, the patients were vaccinated subcutaneously with an unknown number of doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R013302, expiration date 08-MAY-2020 and lot # R017946 expiration date 24-JUN-2020 (strength and dose were not reported)) and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R003293, expiration date 31-JUL-2019, lot # R022572, expiration date 04-FEB-2020, lot # R011217, expiration date 15-OCT-2019 (strength and dose were not reported)), both for prophylaxis. It was unknown if sterile diluent was stored properly. No adverse effects were reported. There were previous temperature excursions. Data logger was not involved.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This initial spontaneous report was received from a licensed practical nurse (LPN) via a Company representative and refers to a 21 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient died in 2008 after receiving her third dose of GARDASIL (lot # not provided) (also reported that the patient died an unspecified time after receiving the third dose in 2008). Dates of the three doses were not provided.  Cause of death was not specified. The LPN said that patients at the office were asking questions about the event/incident because there have been multiple online posts being made about the event (also reported as reports of the death are being circulated on the internet). The Company employee stated that the "lawsuit just got settled" so that is why people were asking about it again. The LPN asked the Company employee what the Company had to say about the incident. Causality was not specified. Upon internal review, death was considered to be medically significant. The LPN did not want to be contacted for follow-up.; Reported Cause(s) of Death: died.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of urticaria in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (For tolerance of 1st dose refer case US2018GSK084164). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced urticaria and pruritus. On an unknown date, the outcome of the urticaria and pruritus were recovered/resolved. It was unknown if the reporter considered the urticaria and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced urticaria and pruritus for 16 hours. The reporter did not agree to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Migraine, Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pre-existing condition improved in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included migraine. 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 pre-existing condition improved and unexpected therapeutic effect. On an unknown date, the outcome of the pre-existing condition improved and unexpected therapeutic effect were unknown. It was unknown if the reporter considered the pre-existing condition improved and unexpected therapeutic effect to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient shared experience with the SHINGRIX drug. The patient had been getting around 30 migraines a month. The patient use to get migraines almost every day. After the patient's first injection, it was 8 days before the patient got a severe migraine. Something in the SHINGRIX positively affected the patient. The patient stated that the SHINGRIX was a really game changer. After the first shot, patient's migraines dropped to 3 a week. The patient reported the same to the company (GSK) however the email received by the patient was written by someone that did not read the patient's review. For patient to receive a single shot and drop 4 days of migraines was super. The patient advised that, GSK should pursue this affect and stated it was wondrous. The patient would get the second shot of SHINGRIX in about two months and the patient was hoping to get more of the same relief. The patient stated, this was not a complaint regarding the drug, but the response patient received.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient concerned that her 1st shot did not create an issue except the soreness of the shot. This case has been linked to the case US2019GSK059779.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 29th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, swelling arm, injection site erythema, extremities hot feeling of and muscle pain. On 30th March 2019, the patient experienced general body pain, fever, headache and injected limb mobility decreased. On an unknown date, the patient experienced chills and injection site induration. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site pain, swelling arm, injection site erythema, general body pain, extremities hot feeling of and muscle pain were not recovered/not resolved and the outcome of the fever, headache, chills and injection site induration were unknown and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the injection site pain, swelling arm, injection site erythema, general body pain, fever, headache, extremities hot feeling of, injected limb mobility decreased, muscle pain, chills and injection site induration to be related to SHINGRIX. Additional case details were reported as follows: This case was reported by the patient as well as physician separately. The patient received first dose of SHINGRIX on Friday in right arm at pharmacy and she experienced what she described as quite a reaction to the vaccine. The lot number or expiration date was not available. Less than a weeks after receiving SHINGRIX, the patient chills and induration at injection site. She reported that her right arm was sore and swelled up and was red and the area on her right arm that was red was the size of an orange. These symptoms started as the evening progressed and her arm became more and more sore. On 30th March 2019, 1 day after receiving SHINGRIX, the patient arm was beet red and she had body aches and by Saturday night she had a 101.8 fever with terrible body aches and a headache and she couldn't move her right arm. She used ice on her arm and she took ADVIL and went to bed at 7:00 PM. On 31st March 2019, her arm was painful and red but better. On 1st April 2019, her arm was better but the redness was still obviously there and the size of the redness was all the way across her arm and down her arm this morning and was still painful to the touch. On 1st April 2019, she could raise her arm above her head and her muscle in her arm was still hurting. Her arm was still hot which started the night she received the vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Myalgia, Pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 29th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, swelling arm, injection site erythema, extremities hot feeling of and muscle pain. On 30th March 2019, the patient experienced general body pain, fever, headache and injected limb mobility decreased. On an unknown date, the patient experienced chills and injection site induration. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site pain, swelling arm, injection site erythema, general body pain, extremities hot feeling of and muscle pain were not recovered/not resolved and the outcome of the fever, headache, chills and injection site induration were unknown and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the injection site pain, swelling arm, injection site erythema, general body pain, fever, headache, extremities hot feeling of, injected limb mobility decreased, muscle pain, chills and injection site induration to be related to SHINGRIX. Additional case details were reported as follows: This case was reported by the patient as well as physician separately. The patient received first dose of SHINGRIX on Friday in right arm at pharmacy and she experienced what she described as quite a reaction to the vaccine. The lot number or expiration date was not available. Less than a weeks after receiving SHINGRIX, the patient chills and induration at injection site. She reported that her right arm was sore and swelled up and was red and the area on her right arm that was red was the size of an orange. These symptoms started as the evening progressed and her arm became more and more sore. On 30th March 2019, 1 day after receiving SHINGRIX, the patient arm was beet red and she had body aches and by Saturday night she had a 101.8 fever with terrible body aches and a headache and she couldn't move her right arm. She used ice on her arm and she took ADVIL and went to bed at 7:00 PM. On 31st March 2019, her arm was painful and red but better. On 1st April 2019, her arm was better but the redness was still obviously there and the size of the redness was all the way across her arm and down her arm this morning and was still painful to the touch. On 1st April 2019, she could raise her arm above her head and her muscle in her arm was still hurting. Her arm was still hot which started the night she received the vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 29th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, swelling arm, injection site erythema, extremities hot feeling of and muscle pain. On 30th March 2019, the patient experienced general body pain, fever, headache and injected limb mobility decreased. On an unknown date, the patient experienced chills and injection site induration. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site pain, swelling arm, injection site erythema, general body pain, extremities hot feeling of and muscle pain were not recovered/not resolved and the outcome of the fever, headache, chills and injection site induration were unknown and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the injection site pain, swelling arm, injection site erythema, general body pain, fever, headache, extremities hot feeling of, injected limb mobility decreased, muscle pain, chills and injection site induration to be related to SHINGRIX. Additional case details were reported as follows: This case was reported by the patient as well as physician separately. The patient received first dose of SHINGRIX on Friday in right arm at pharmacy and she experienced what she described as quite a reaction to the vaccine. The lot number or expiration date was not available. Less than a weeks after receiving SHINGRIX, the patient chills and induration at injection site. She reported that her right arm was sore and swelled up and was red and the area on her right arm that was red was the size of an orange. These symptoms started as the evening progressed and her arm became more and more sore. On 30th March 2019, 1 day after receiving SHINGRIX, the patient arm was beet red and she had body aches and by Saturday night she had a 101.8 fever with terrible body aches and a headache and she couldn't move her right arm. She used ice on her arm and she took ADVIL and went to bed at 7:00 PM. On 31st March 2019, her arm was painful and red but better. On 1st April 2019, her arm was better but the redness was still obviously there and the size of the redness was all the way across her arm and down her arm this morning and was still painful to the touch. On 1st April 2019, she could raise her arm above her head and her muscle in her arm was still hurting. Her arm was still hot which started the night she received the vaccine.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast enlargement, Breast induration, Breast swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 78-year-old female patient who received SHINGRIX (batch number N72HZ, expiry date 9th June 2021) for prophylaxis. Concurrent medical conditions included breast cancer (diagnosed 4 months before the date of reporting) and lumpectomy (diagnosed left side or left breast lumpectomy 3 months before the date of reporting). On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2019, 4 days after receiving SHINGRIX, the patient experienced fever (serious criteria hospitalization), breast enlargement (serious criteria hospitalization), breast swelling (serious criteria hospitalization) and breast induration (serious criteria hospitalization). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown and the outcome of the breast enlargement, breast swelling and breast induration were not recovered/not resolved. It was unknown if the reporter considered the fever, breast enlargement, breast swelling and breast induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The SHINGRIX batch number was updated from N72H2 to N72HZ as per sales data sheet. On 31st March 2019, the patient was admitted to the emergency room with mild fever, swollen, enlarged, hard left breast. It was reported that there was nothing to drain at that time. It was unknown if the patient was hospitalized overnight or not. The patient was receiving Tylenol to manage mild fever. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast induration, Breast swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 78-year-old female patient who received SHINGRIX (batch number N72HZ, expiry date 9th June 2021) for prophylaxis. Concurrent medical conditions included breast cancer (diagnosed 4 months before the date of reporting) and lumpectomy (diagnosed left side or left breast lumpectomy 3 months before the date of reporting). On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2019, 4 days after receiving SHINGRIX, the patient experienced fever (serious criteria hospitalization), breast enlargement (serious criteria hospitalization), breast swelling (serious criteria hospitalization) and breast induration (serious criteria hospitalization). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown and the outcome of the breast enlargement, breast swelling and breast induration were not recovered/not resolved. It was unknown if the reporter considered the fever, breast enlargement, breast swelling and breast induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The SHINGRIX batch number was updated from N72H2 to N72HZ as per sales data sheet. On 31st March 2019, the patient was admitted to the emergency room with mild fever, swollen, enlarged, hard left breast. It was reported that there was nothing to drain at that time. It was unknown if the patient was hospitalized overnight or not. The patient was receiving Tylenol to manage mild fever. The reporter did not consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2017). On 27th September 2018, the patient received the 1st dose of SHINGRIX. On 26th December 2018, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX and 30 days after receiving SHINGRIX, the patient experienced generalized pruritus. In March 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 21st March 2019, the patient experienced papular rash, pain localized, pruritus and localized erythema. On an unknown date, the outcome of the vaccination failure, shingles, generalized pruritus, papular rash, pain localized, pruritus and localized erythema were unknown. It was unknown if the reporter considered the vaccination failure, shingles, generalized pruritus, papular rash, pain localized, pruritus and localized erythema to be related to SHINGRIX and SHINGRIX. Additional details were reported as follows: The batch number and expiry date were not known. Sometime in January 2019, the patient felt itchy and then resolved. Two weeks before the time of reporting, 85 days after 1st dose and 175 days after 2nd dose of SHINGRIX, the patient began to notice bumps on his arms, pain at those bumps, itching and red marks across his stomach. On 21st March 2019, 175 days after 2nd dose of SHINGRIX, the patient's physician diagnosed shingles and sent him for tests for such as a computed tomography (CT scan) to be sure. The patient wanted a compensation for being off work, doctor and lab bills. The reporter consented to follow up. This case was considered as a suspected vaccination failure since the details regarding laboratory confirmation was not provided.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2017). On 27th September 2018, the patient received the 1st dose of SHINGRIX. On 26th December 2018, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX and 30 days after receiving SHINGRIX, the patient experienced generalized pruritus. In March 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On 21st March 2019, the patient experienced papular rash, pain localized, pruritus and localized erythema. On an unknown date, the outcome of the vaccination failure, shingles, generalized pruritus, papular rash, pain localized, pruritus and localized erythema were unknown. It was unknown if the reporter considered the vaccination failure, shingles, generalized pruritus, papular rash, pain localized, pruritus and localized erythema to be related to SHINGRIX and SHINGRIX. Additional details were reported as follows: The batch number and expiry date were not known. Sometime in January 2019, the patient felt itchy and then resolved. Two weeks before the time of reporting, 85 days after 1st dose and 175 days after 2nd dose of SHINGRIX, the patient began to notice bumps on his arms, pain at those bumps, itching and red marks across his stomach. On 21st March 2019, 175 days after 2nd dose of SHINGRIX, the patient's physician diagnosed shingles and sent him for tests for such as a computed tomography (CT scan) to be sure. The patient wanted a compensation for being off work, doctor and lab bills. The reporter consented to follow up. This case was considered as a suspected vaccination failure since the details regarding laboratory confirmation was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 65-year-old 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 dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown. It was unknown if the reporter considered the dizziness and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiration date was not reported. The pharmacist reported that the patient felt dizzy, nauseated and faint after receiving SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient commented that, when he received SHINGRIX, it hurt. This case has been linked with case US2019GSK062708, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly 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 week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reporter gathered patient's information. The age at vaccination was not reported for this report. The patient's age group was captured as elderly from the release date of SHINGRIX and date of birth of patient. The patient experienced shingle in close proximity of getting 1st dose of SHINGRIX. The patient had a mild case. The doctor wanted to confirm if there was any relation between the vaccine and getting shingles and if it was safe to receive 2nd dose of SHINGRIX. The patient experienced shingles within a week of receiving 1st dose of SHINGRIX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Limb injury, Syncope, Tooth fracture
Clinical narrative: Patient fainted and fell injuring finger and breaking teeth.
Age: 51.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Injection site mass
Clinical narrative: On March 11, 2019 at 3:15 pm, I had an appointment to have the first in a series of two MMR vaccines administered.  I waited a while, so I'm estimating the time of the injection to have been 3:45 pm that day.  A gentleman took me to a room and injected the MMR in my left arm since I'm right-handed.  I was given no paperwork as to side effects or any other information regarding to take home.  On April 7th, I was rubbing the sight of the injection and found a quarter-sized lump under my skin.  I emailed Dr., my primary care physician.  She had employee from that location message me with the details of the immunizations as follows:  MMR Vaccine  Expiration: 10/2/2020 Lot:R028225 Manufacturer: Merck Sharp & Dohme NDC: 0006-4681-01   Diluent (which is used to reconstitute the MMR)  Lot: R033667  Expiration: 6/14/2021 NDC: 0006-4309-01
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash around the site, pain at site, and warm to touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site rash, Myalgia, Pain in extremity
Clinical narrative: The day after receiving the SHINGRIX vaccine I developed chills and had a fever of 99.5 degrees for two days. Other symptoms included headache and muscle soreness for two days. I took Tylenol and Ibuprofen for fever and headache which helped. The next day, my arm was very sore and a pale, raised rash appeared at the injection site. All symptoms seemed to appear about the next day after receiving the vaccine and lasted about two to three days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The day after receiving the SHINGRIX vaccine I developed chills and had a fever of 99.5 degrees for two days. Other symptoms included headache and muscle soreness for two days. I took Tylenol and Ibuprofen for fever and headache which helped. The next day, my arm was very sore and a pale, raised rash appeared at the injection site. All symptoms seemed to appear about the next day after receiving the vaccine and lasted about two to three days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Pt states "all over joint pain" starting the day of vaccination, continuing overnight into next day. APAP did not help, but Aleve did. Pt states she felt better after 48 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Injection site swollen, hot, and red. Nausea, headache, chills. Fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: Injection site swollen, hot, and red. Nausea, headache, chills. Fatigue.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Pt experienced rash on both arms, itchy started on 4/5/19. Saw dr 4/11 and dr started pt on prednisone for 5 days. Will check in on patient in a few days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Erythema, Fatigue, Pain
Clinical narrative: Swelling, redness, bruising,itching and pain for 8 days. Fever 101... chills and shivering for 2 days after vaccine.... persistent tiredness for a week..
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling, redness, bruising,itching and pain for 8 days. Fever 101... chills and shivering for 2 days after vaccine.... persistent tiredness for a week..
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Full blood count, Injection site papule, Injection site rash
Clinical narrative: Had 4 booster shots on 3/29/19.   Started with spots on legs 4 days ago.  No change.  No itch.  No fever.  no blister. Today at school they have gotten larger.  isolated papules and tiny clusters of papules on both legs..
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Client received SHINGRIX dose #2 on 01/28/2019. She called to report that her first dose was fine, but that after her second dose, she had a severe "blinding" headache, nausea, fever (no documented temperature), chills, and body aches. She states that the symptoms started about 12 hours after vaccination and lasted 2-3 days. She states that she took ibuprofen and that it helped with the pain and fever. She no longer has any of these symptoms.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Fungal infection, Rash, Rash morbilliform, Rash pruritic
Clinical narrative: My  stomach broke out in a very bad rash (looks like measles) about 90 days after I received the vaccination.  I went to the Dr. and he thought it was a fungus.  He treated me with Fluconazole 150mg (one tablet per week for 4 weeks).  This did not help but made the rash much worse.  Econazole nitrate cream was also prescribed to put on 2x/day.  Nothing helped.  This rash is painful and very itchy. It goes in and breaks out sporadically.  I received a letter from Traditional bank where I took the vaccination dated March 5, 2019 which said to call the Infectious Disease center for diagnosis and ongoing management.
Age: 30.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Anxiety, Blood glucose normal, Blood pressure decreased, Cold sweat, Dizziness
Clinical narrative: Within 5 minutes of administration of Boostrix and MMR, patient felt dizzy and had to lay on the bench by the pharmacy. A customer that was shopping close by said she saw him having a seizure and his eyes were rolled back. Rph did not see that and rph saw that patient was responsive, but was sweating profusely. Patient's skin felt clamy to the touch. Patient was given water and he needed help getting to a sitting position to drink his water. Management was called over and 911 was dialed. Rph stood by patient's side with immunization cart ready to administer CPR if necessary. EMS then arrived after about 10 minutes. They ran some tests on him and asked him to stand up. Patient could not stand up and he also stated now that he is nauseous. EMS then put him on stretcher and carted him off to hospital. Patient returned back to pharmacy 3 hours later, wanting to get a third vaccine, which this pharmacy did not have. He said the nurse at the hospital, told him the diagnosis was him having anxiety and his blood pressure dropped. He said they administered a few other tests on him, one of which was a blood sugar test, and that they did not find anything else wrong. Patient said he felt fine now and he is on his way to find the third vaccine, Varivax, in which he wants to get today.
Age: 30.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Dysstasia, Eye movement disorder, Hyperhidrosis, Nausea, Seizure
Clinical narrative: Within 5 minutes of administration of Boostrix and MMR, patient felt dizzy and had to lay on the bench by the pharmacy. A customer that was shopping close by said she saw him having a seizure and his eyes were rolled back. Rph did not see that and rph saw that patient was responsive, but was sweating profusely. Patient's skin felt clamy to the touch. Patient was given water and he needed help getting to a sitting position to drink his water. Management was called over and 911 was dialed. Rph stood by patient's side with immunization cart ready to administer CPR if necessary. EMS then arrived after about 10 minutes. They ran some tests on him and asked him to stand up. Patient could not stand up and he also stated now that he is nauseous. EMS then put him on stretcher and carted him off to hospital. Patient returned back to pharmacy 3 hours later, wanting to get a third vaccine, which this pharmacy did not have. He said the nurse at the hospital, told him the diagnosis was him having anxiety and his blood pressure dropped. He said they administered a few other tests on him, one of which was a blood sugar test, and that they did not find anything else wrong. Patient said he felt fine now and he is on his way to find the third vaccine, Varivax, in which he wants to get today.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient is a 54 yo M who presents to the office unaccompanied with symptoms of right upper extremity redness, swelling, tenderness x 2 days-- immediately adjacent to injection site of right deltoid.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Immediate post-injection reaction, Rash macular, Urticaria
Clinical narrative: Patient given immunization on right deltoid with immediate reaction, with a wheal with redness and splotchy rash. Patient was told to wait 15 minutes after being inspected by a provider and given an ice pack. Measurement of spot was 1.5 inches. Provider told to patient to wait 15 minutes and I re measured area and it went down significantly.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial Report Received on 21-Mar-2019 and 22-Mar-2019. A nurse reported that a newborn male patient (age and race not provided) was administered with 2 doses of HEPLISAV-B for hepatitis B immunization. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient received 2 injections of HEPLISAV-B (lot #, expiration date, and NDC # unknown) when he was born. On 21-Mar-2019, a nurse reported that a newborn patient received 2 doses of HEPLISAV-B when he was born. No further information was provided. 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 administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: More pain/redness at the injection site; More pain/redness at the injection site; This is a spontaneous report from a contactable pharmacist via a sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced more pain/redness at the injection site then normal on an unspecified date. Outcome of the events was recovered on an unspecified date.
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration
Clinical narrative: like a hard area at the injection/hardness; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received second dose pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient got his second pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) injection, two and a half days ago and he had like a hard area at the injection site and the doctor said that it could be normal at first. Reporter stated that the were like two and a half days in and just wanted to understand like how long they should expect the hardness to be there. The outcome of the event was unknown.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Crying, Immunisation, Syringe issue
Clinical narrative: cried; This is a spontaneous report from a contactable nurse. A 4-month-old male patient received the second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot no: W62465, expiration date: 31Jul2020), administered intramuscularly on right thigh on 21Mar2019 at 0.5 ml, single for routine vaccination in physician's office. The patient's medical history was not reported. Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) intramuscular on patient's left thigh, hib vaccine conj (ompc) (PEDVAXHIB) intramuscular on right thigh, and rotavirus vaccine live reassort oral 5v (ROTATEQ) oral, all administered in the physician's office on 21Mar2019 for immunization. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 10Jan2019 for immunization. The nurse reported that the patient was administered pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and the solution leaked out of the hub during administration on 21Mar2019. The nurse further stated that the solution leaked out of the hub during administration. Seriousness criteria verified as not serious, the nurse provided that there were no adverse events that occurred related to this event, he just cried. The first administration of this vaccine was on 10Jan2019. Therapy was ongoing because product was prescribed as a series of vaccinations. On 21Mar2019, administration was stopped during administration and a second dose of 0.5mL intramuscular injection to right thigh administered in response to this event. The patient was scheduled for additional administration in the future as part of routine vaccination series; this schedule has not been changed. Outcome of the event "cried" was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: severe swelling which radiated down her arm; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A 65-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling which radiated down her arm 5 months ago on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Food allergy, Hypersensitivity, Peripheral swelling
Clinical narrative: received one shot of pneumococcal 13-valent conjugate vaccine and had an allergic reaction; sensitivity to other allergens/she now has an allergy to nuts and fish; Arm Swelling; Asthma; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in Mar2018 at a single dose in the arm for immunization. The patient's medical history and concomitant medications were not reported. The patient received one shot of pneumococcal 13-valent conjugate vaccine and had an allergic reaction on an unspecified date. The allergic reaction was clarified as arm swelling for one week. However, it was not specified which arm. She also had asthma for two months since Mar2018 to 2018, unable to confirm which month ended and had sensitivity to other allergens that started and continuing. Since getting the shot, she now has an allergy to nuts and fish since an unspecified date. Outcome of the events arm swelling and asthma was recovered, for event sensitivity to other allergens/she now has an allergy to nuts and fish was not recovered and unknown for other event.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Fatigue, Injection site oedema, Injection site swelling
Clinical narrative: Swelling at site of injection within seconds of receiving vaccine in office; ice pack applied to area, observed for 30 minutes; no oral edema, wheezing, or respiratory distress, no other c/o sx by pt; Pt contacted office approximately 5 hrs later and came in for follow up same day. Injection site edema decreased; no respiratory distress noted; pt c/o chills and fatigue approximately 2-3 hrs after receiving vaccine while at work. Pt felt light headed and left work early. Pt examined at 3:30pm-vitals 99.8 ax temp, normal BP, 02 sats, and HR. Given acetaminophen 650mg in office. Reviewed common side effects again with patient. Follow up prn.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dysarthria, Dysphagia, Injection site rash, Rash, Swelling face
Clinical narrative: 3:55 PM pt started showing a patchy rash on her chest and then up her neck and at the site of injections. No SOB, No Tachycardia provider notified. 4 PM we gave 50 mg BENADRYL IM into L delt, no SOB no tachycardia cold compress was applied to R injection site. 4:10 PM pt complained of trouble swallowing and it was observed that she had swelling in her face. Pt was given 0.3 EPI PEN into L thigh and ambulance was called. BP was 138/80 HR was 112 with O2 of 100% on room air. 4:15 PM when ambulance arrived pt was noticed to have slurred speech and was transported to ER.
Age: 74.0
Sex: M
Vaccine: HEPA
Symptoms: Electromyogram, Mobility decreased, Pain, Pain in extremity, Seizure
Clinical narrative: Patient was given Hepatits A vaccine on 11/5/18.  Patient complained of soreness shortly after the vaccination (which I thought was normal).   I was unaware the patient was still having problems potentially related to the vaccine until his wife came into the pharmacy on 4/11/19.  I called the patient who said his arm still hurt and he was unable to lift his arm all the way up.  The patient also read online that Havrix could cause seizures and he said he had a seizure on 12/4/18.  The vaccine was given on 11/5/18.  He said he had been to physical therapy for 3 months (Dec, Jan, and Feb) but that did not resolve the pain and mobility problems of his arm/shoulder.  He said he also had an EMG scan done recently but did not have the results yet.