chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Erythema, Rash erythematous, Scar
Clinical narrative: Broke out with big red spots on my body. My right arm had two red marks - raised like a blister type - not fluid from them but the mass, spread - now it's scarred (R arm). Red dots on my body and black and blue for no reason. Still having problems.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Broke out with big red spots on my body. My right arm had two red marks - raised like a blister type - not fluid from them but the mass, spread - now it's scarred (R arm). Red dots on my body and black and blue for no reason. Still having problems.
Age: 57.0
Sex: F
Vaccine: HEPAB, IPV, TDAP
Symptoms: Ear pruritus, Headache, Injection site pain
Clinical narrative: The day she received her hep A/B, IPV and TDaP, she experienced ear itching, headache and left shoulder pain. This resolved the next day.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Diarrhoea, Diet refusal, Dyskinesia
Clinical narrative: 2/15 11am- vaccines, evening-fussy. 2/16- fussy/sleepy. 2/17- sleepy 9pm-extreme fussiness, inconsolable screaming all night into the morning. 2/18 1am-100.3 temp, inconsolable crying/ screaming. 9am-100.4 temp/TYLENOL, 10am-called pediatrician nurse line and she said no need to take him in until 105 temp. (Ummm No thanks), 2pm-102.2 temp/ give TYLENOL, 2:45pm-100.6 temp 330pm- arrive at urgent care & Dr sends us straight to childrens ER due to HR in 200s. Would have been sent by ambulance but said I could take him since he was alert. 4pm-100 temp at ER, flu, rsv, uti test (all negative), HR gone down to 180s. 6pm-discharged saying it's probably viral. 9pm-101 temp, inconsolable, refuses to lift head from belly position. 2/19 11am-follow up appt at ped, said ears looked great, sent back to ER for labs. 12pm-ER says ears appear a little red and diagnose as viral ear infection, no rx and to follow up with ped, labs all normal. 8pm- inconsolable, gave TYLENOL, up all night crying, rapid/darting eye movements. Still refusing to lift head from belly position. 2/20 5am- 101.6 temp/TYLENOL. Fever continues through the day w/fussiness, diarrhea. I stop TYLENOL and use cool cloths and bath, fever gone by early evening. Night- fever free, extremely fussy, diarrhea. Refuses to lift head from belly position. 2/21-diarrhea, vomiting, fussy, sleepy. Cries at breast and refuses to nurse, jerky movements different than the typical newborn stuff, 6 wet diapers between 6am-9pm, tries to sleep at night but his body won't stop moving even if his eyes are closed trying to sleep, extremely gassy. 2/22 am- jerky movements, more alert, gassy, fussy. 2/23 follow up with pediatrician, no evidence of an ear infection, small appetite. 2/24 happy in the am, inconsolable crying afternoon/pm, just wants to sleep and nurse.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ear infection viral, Erythema, Eye movement disorder, Flatulence, Influenza virus test negative
Clinical narrative: 2/15 11am- vaccines, evening-fussy. 2/16- fussy/sleepy. 2/17- sleepy 9pm-extreme fussiness, inconsolable screaming all night into the morning. 2/18 1am-100.3 temp, inconsolable crying/ screaming. 9am-100.4 temp/TYLENOL, 10am-called pediatrician nurse line and she said no need to take him in until 105 temp. (Ummm No thanks), 2pm-102.2 temp/ give TYLENOL, 2:45pm-100.6 temp 330pm- arrive at urgent care & Dr sends us straight to childrens ER due to HR in 200s. Would have been sent by ambulance but said I could take him since he was alert. 4pm-100 temp at ER, flu, rsv, uti test (all negative), HR gone down to 180s. 6pm-discharged saying it's probably viral. 9pm-101 temp, inconsolable, refuses to lift head from belly position. 2/19 11am-follow up appt at ped, said ears looked great, sent back to ER for labs. 12pm-ER says ears appear a little red and diagnose as viral ear infection, no rx and to follow up with ped, labs all normal. 8pm- inconsolable, gave TYLENOL, up all night crying, rapid/darting eye movements. Still refusing to lift head from belly position. 2/20 5am- 101.6 temp/TYLENOL. Fever continues through the day w/fussiness, diarrhea. I stop TYLENOL and use cool cloths and bath, fever gone by early evening. Night- fever free, extremely fussy, diarrhea. Refuses to lift head from belly position. 2/21-diarrhea, vomiting, fussy, sleepy. Cries at breast and refuses to nurse, jerky movements different than the typical newborn stuff, 6 wet diapers between 6am-9pm, tries to sleep at night but his body won't stop moving even if his eyes are closed trying to sleep, extremely gassy. 2/22 am- jerky movements, more alert, gassy, fussy. 2/23 follow up with pediatrician, no evidence of an ear infection, small appetite. 2/24 happy in the am, inconsolable crying afternoon/pm, just wants to sleep and nurse.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Posture abnormal, Pyrexia, Respiratory syncytial virus test negative, Screaming
Clinical narrative: 2/15 11am- vaccines, evening-fussy. 2/16- fussy/sleepy. 2/17- sleepy 9pm-extreme fussiness, inconsolable screaming all night into the morning. 2/18 1am-100.3 temp, inconsolable crying/ screaming. 9am-100.4 temp/TYLENOL, 10am-called pediatrician nurse line and she said no need to take him in until 105 temp. (Ummm No thanks), 2pm-102.2 temp/ give TYLENOL, 2:45pm-100.6 temp 330pm- arrive at urgent care & Dr sends us straight to childrens ER due to HR in 200s. Would have been sent by ambulance but said I could take him since he was alert. 4pm-100 temp at ER, flu, rsv, uti test (all negative), HR gone down to 180s. 6pm-discharged saying it's probably viral. 9pm-101 temp, inconsolable, refuses to lift head from belly position. 2/19 11am-follow up appt at ped, said ears looked great, sent back to ER for labs. 12pm-ER says ears appear a little red and diagnose as viral ear infection, no rx and to follow up with ped, labs all normal. 8pm- inconsolable, gave TYLENOL, up all night crying, rapid/darting eye movements. Still refusing to lift head from belly position. 2/20 5am- 101.6 temp/TYLENOL. Fever continues through the day w/fussiness, diarrhea. I stop TYLENOL and use cool cloths and bath, fever gone by early evening. Night- fever free, extremely fussy, diarrhea. Refuses to lift head from belly position. 2/21-diarrhea, vomiting, fussy, sleepy. Cries at breast and refuses to nurse, jerky movements different than the typical newborn stuff, 6 wet diapers between 6am-9pm, tries to sleep at night but his body won't stop moving even if his eyes are closed trying to sleep, extremely gassy. 2/22 am- jerky movements, more alert, gassy, fussy. 2/23 follow up with pediatrician, no evidence of an ear infection, small appetite. 2/24 happy in the am, inconsolable crying afternoon/pm, just wants to sleep and nurse.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Somnolence, Urine analysis normal, Viral infection, Vomiting
Clinical narrative: 2/15 11am- vaccines, evening-fussy. 2/16- fussy/sleepy. 2/17- sleepy 9pm-extreme fussiness, inconsolable screaming all night into the morning. 2/18 1am-100.3 temp, inconsolable crying/ screaming. 9am-100.4 temp/TYLENOL, 10am-called pediatrician nurse line and she said no need to take him in until 105 temp. (Ummm No thanks), 2pm-102.2 temp/ give TYLENOL, 2:45pm-100.6 temp 330pm- arrive at urgent care & Dr sends us straight to childrens ER due to HR in 200s. Would have been sent by ambulance but said I could take him since he was alert. 4pm-100 temp at ER, flu, rsv, uti test (all negative), HR gone down to 180s. 6pm-discharged saying it's probably viral. 9pm-101 temp, inconsolable, refuses to lift head from belly position. 2/19 11am-follow up appt at ped, said ears looked great, sent back to ER for labs. 12pm-ER says ears appear a little red and diagnose as viral ear infection, no rx and to follow up with ped, labs all normal. 8pm- inconsolable, gave TYLENOL, up all night crying, rapid/darting eye movements. Still refusing to lift head from belly position. 2/20 5am- 101.6 temp/TYLENOL. Fever continues through the day w/fussiness, diarrhea. I stop TYLENOL and use cool cloths and bath, fever gone by early evening. Night- fever free, extremely fussy, diarrhea. Refuses to lift head from belly position. 2/21-diarrhea, vomiting, fussy, sleepy. Cries at breast and refuses to nurse, jerky movements different than the typical newborn stuff, 6 wet diapers between 6am-9pm, tries to sleep at night but his body won't stop moving even if his eyes are closed trying to sleep, extremely gassy. 2/22 am- jerky movements, more alert, gassy, fussy. 2/23 follow up with pediatrician, no evidence of an ear infection, small appetite. 2/24 happy in the am, inconsolable crying afternoon/pm, just wants to sleep and nurse.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives. Treated with Benadryl and oral steroids.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pyrexia, Rash, Rash erythematous
Clinical narrative: Low grade fever, stiffness in RUA, erythematous non-puritic rash on RUA. No weakness in BUE. Full ROM to RUE. Provided with ALEVE PRN, apply ice to RUA.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pt says arm is sore  over one month later.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Malaise, Nausea, Syncope
Clinical narrative: Patient was leaving the room, when she told her mom that she wasn't feeling well. Then mother noticed that she had stopped walking and "appeared as though she had fainted". Mom and MA caught her before falling to the floor.  She was taking to an exam room, where she had recovered.  She said that she felt a little nauseated. After 10 minutes, she was assessed again and stated that she felt better. She was then released to go home.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain/soreness.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Feeling hot
Clinical narrative: Severe joint pain throughout especially in back down my spine, fever-over 102, chills, then too hot, aches. Gross armpit (L) swelling the size of a large orange. Lymph swelling on the left side of my neck. Sweating, extreme malaise. Very tired, slept nearly two days- a very uneasy sleep. Fever blister on my lip the first in my life. Day three at approximately 2:30pm my fever broke, swelling in the armpit still very tender but could now move my arm. Injection site sore but wnl the entire time. Took 2000mg of TYLENOL q4-6h. Barely unable to leave my bed Saturday. On Sunday a little improvement, difficult night on Sunday. Was sweating with fever most of Monday with painful armpit swelling- unable to do my job to full capacity due to my left arm/hand. I am a DDS.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Impaired work ability, Injection site pain, Lymphadenopathy, Malaise
Clinical narrative: Severe joint pain throughout especially in back down my spine, fever-over 102, chills, then too hot, aches. Gross armpit (L) swelling the size of a large orange. Lymph swelling on the left side of my neck. Sweating, extreme malaise. Very tired, slept nearly two days- a very uneasy sleep. Fever blister on my lip the first in my life. Day three at approximately 2:30pm my fever broke, swelling in the armpit still very tender but could now move my arm. Injection site sore but wnl the entire time. Took 2000mg of TYLENOL q4-6h. Barely unable to leave my bed Saturday. On Sunday a little improvement, difficult night on Sunday. Was sweating with fever most of Monday with painful armpit swelling- unable to do my job to full capacity due to my left arm/hand. I am a DDS.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pain, Poor quality sleep, Pyrexia, Swelling
Clinical narrative: Severe joint pain throughout especially in back down my spine, fever-over 102, chills, then too hot, aches. Gross armpit (L) swelling the size of a large orange. Lymph swelling on the left side of my neck. Sweating, extreme malaise. Very tired, slept nearly two days- a very uneasy sleep. Fever blister on my lip the first in my life. Day three at approximately 2:30pm my fever broke, swelling in the armpit still very tender but could now move my arm. Injection site sore but wnl the entire time. Took 2000mg of TYLENOL q4-6h. Barely unable to leave my bed Saturday. On Sunday a little improvement, difficult night on Sunday. Was sweating with fever most of Monday with painful armpit swelling- unable to do my job to full capacity due to my left arm/hand. I am a DDS.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Severe joint pain throughout especially in back down my spine, fever-over 102, chills, then too hot, aches. Gross armpit (L) swelling the size of a large orange. Lymph swelling on the left side of my neck. Sweating, extreme malaise. Very tired, slept nearly two days- a very uneasy sleep. Fever blister on my lip the first in my life. Day three at approximately 2:30pm my fever broke, swelling in the armpit still very tender but could now move my arm. Injection site sore but wnl the entire time. Took 2000mg of TYLENOL q4-6h. Barely unable to leave my bed Saturday. On Sunday a little improvement, difficult night on Sunday. Was sweating with fever most of Monday with painful armpit swelling- unable to do my job to full capacity due to my left arm/hand. I am a DDS.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 26 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-JAN-2017 the patient was vaccinated with GARDASIL (dose, units, frequency, route, lot number, expiration date not reported), on 08-JUL-2017 with GARDASIL 9 and on 24-SEP-2017 with GARDASIL 9 (dose, units, frequency, route, lot number, expiration date not reported). The patient received an off schedule dosing of GARDASIL/GARDASIL 9. On 23-FEB-2018, the patient went to the pharmacy to receive another dose of GARDASIL 9. No adverse effects were reported. No further information was provided. No product quality compliant (PQC) was present.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 23-FEB-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M019706 with expiration date of 24-OCT-2017, orally for prophylaxis (dose was not reported).
Sex: U
Vaccine: MENB
Symptoms: Volvulus
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was hospitalized for a twisted intestine on an unspecified date. The outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: The information is limited. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus
Clinical narrative: SMALL BLISTER WITH ITCHING AND BURNING SENSATION. NO PAIN/ NO RASH/ NO FEVER. APPEAR 1 DAY AFTER VACCINE. 2/26/18- THE BLISTER GONE DOWN, NO OTHER SYMPTOM.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Injection site reaction, Peripheral swelling, Rash erythematous
Clinical narrative: Pt. return to clinic informed of adverse reaction to rt. arm from receiving Men-B on 2/22/2018. Nurse noted pt. arm red swollen with red rash at the injection site. Pt. stated it painful to touch.  Provider Dr. came to assess pt. Pt. state she had taken Claritin. Dr. informed pt. to continue taking the Claritin and apply cold compress when needed. Dr. informed pt. it could be a week or more for swelling to go down. Call clinic if she need further assistance.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine of PREVNAR-13. Vaccine expired 1/31/2018.
Age: 47.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dyspnoea, Fatigue, Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Client called clinic on 2/20/18 and 2/26/18 regarding symptoms she began experiencing after receiving these two vaccines. The symptoms included: racing heartbeat, difficulty catching her breath, numbness and tingling to both lower extremities, frequent headaches, generalized fatigue, nausea, and stiff and achy shoulder muscles.
Age: 47.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Myalgia, Nausea, Palpitations, Paraesthesia
Clinical narrative: Client called clinic on 2/20/18 and 2/26/18 regarding symptoms she began experiencing after receiving these two vaccines. The symptoms included: racing heartbeat, difficulty catching her breath, numbness and tingling to both lower extremities, frequent headaches, generalized fatigue, nausea, and stiff and achy shoulder muscles.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Patient said injection site was inflamed and sore for a few days. For a few weeks now the pain goes away during the day and shoulder pain occurs again later in the day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Fatigue, Headache, Impaired work ability
Clinical narrative: Patient reported significant adverse effects with the SHINGRIX. She had her shot on Wednesday afternoon, 2/21/2018. She reported waking up around 6am on Thursday feeling like she had the flu. She had a 102F temperature that she treated with TYLENOL. Patient also reported feeling tired, achy, had a headache, and had to leave work early at 1pm. Her arm was red and also swelled up significantly. All issues resolved the following day, but she felt tired and run down for several days. She was back to normal today, 2/26.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Peripheral swelling
Clinical narrative: Patient reported significant adverse effects with the SHINGRIX. She had her shot on Wednesday afternoon, 2/21/2018. She reported waking up around 6am on Thursday feeling like she had the flu. She had a 102F temperature that she treated with TYLENOL. Patient also reported feeling tired, achy, had a headache, and had to leave work early at 1pm. Her arm was red and also swelled up significantly. All issues resolved the following day, but she felt tired and run down for several days. She was back to normal today, 2/26.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Lethargy, Pain
Clinical narrative: Red, swollen firm area at injection site, low grade fever, body ache, lethargic. Treatment ADVIL and TYLENOL.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Red, swollen firm area at injection site, low grade fever, body ache, lethargic. Treatment ADVIL and TYLENOL.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Cognitive disorder, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: Symptoms started the day after the injection  with a headache, nausea, dizziness, malaise, fatigue, soreness at the injection site, and general flu like symptoms. Roughly one week after the shot my right hand felt tingly, similar to when a limb "falls asleep" this feeling slowly made its way up my right arm, then crossed to the left arm with the tingling starting from the shoulder then working its way down. Cognitive dysfunction, relentless lingering headache.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Laboratory test, Malaise, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: Symptoms started the day after the injection  with a headache, nausea, dizziness, malaise, fatigue, soreness at the injection site, and general flu like symptoms. Roughly one week after the shot my right hand felt tingly, similar to when a limb "falls asleep" this feeling slowly made its way up my right arm, then crossed to the left arm with the tingling starting from the shoulder then working its way down. Cognitive dysfunction, relentless lingering headache.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Symptoms started the day after the injection  with a headache, nausea, dizziness, malaise, fatigue, soreness at the injection site, and general flu like symptoms. Roughly one week after the shot my right hand felt tingly, similar to when a limb "falls asleep" this feeling slowly made its way up my right arm, then crossed to the left arm with the tingling starting from the shoulder then working its way down. Cognitive dysfunction, relentless lingering headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: Skin: right arm: 3 in. by 2.5 in erythema, skin feels warm, taut to touch, no fluctuance. Redness covers about 2/3 of outer arm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Skin: left outer deltoid: approx. 2 inch diameter raised erythematous area. Feels warm to touch, firm flat nodule. No fluctuance, no blisters.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Slightly, raised and warm w/redness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Unable to use arm for a few weeks with pain.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 26th January 2018, the patient received SHINGRIX. On 26th January 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported to a field representative that SHINGRIX was administered to the patient subcutaneously instead of intramuscular route, which led to inappropriate route of vaccine administration. Follow up information received from a nurse via sales representative on 22nd February 2018: The patient's demographic details were updated. On 25th January 2018, the patient received the 1st dose of SHINGRIX (0.5 ml dose) subcutaneously rather than intramuscularly. Less than a month, after receiving SHINGRIX, the patient experienced redness, swelling and tenderness at the injection. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site tenderness were not reported. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site tenderness to be related to SHINGRIX. The VAERS details were updated. It was a medication error associated with adverse event.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 26th January 2018, the patient received SHINGRIX. On 26th January 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported to a field representative that SHINGRIX was administered to the patient subcutaneously instead of intramuscular route, which led to inappropriate route of vaccine administration. Follow up information received from a nurse via sales representative on 22nd February 2018: The patient's demographic details were updated. On 25th January 2018, the patient received the 1st dose of SHINGRIX (0.5 ml dose) subcutaneously rather than intramuscularly. Less than a month, after receiving SHINGRIX, the patient experienced redness, swelling and tenderness at the injection. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site tenderness were not reported. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site tenderness to be related to SHINGRIX. The VAERS details were updated. It was a medication error associated with adverse event.
Sex: F
Vaccine: YF, YF
Symptoms: Erythema
Clinical narrative: Initial unsolicited report received from a health care professional on 15-Feb-2018. This case involves 38-year-old female patient who was vaccinated with a first dose of YELLOW FEVER VACCINE (YELLOW FEVER) (Batch number- UI668AD, expiration date- 04-JAN-2019, dose, route was not reported) subcutaneously in right arm and diluent U5679AA on 12-Feb-2018 at 10:00. Patient's medical history included Augmentin. Illness at the time of vaccination was also reported as none. Any other vaccinations within four weeks of vaccinations included- MENACTRA U5841AA intramuscularly in right deltoid on 11-Feb-2014 and 24-Feb-2014. On 15-Feb-2018 at 1:00 PM, three day following vaccination patient had right back of arm 2inx1in red area. No complaints of itching, afebrile, no numbness or tingling of extremity. Laboratory investigations were none and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthenia, Dizziness, Muscle spasms, Muscle tightness, Product quality issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of throat tightness in a male patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, 21 days after receiving RABAVERT, the patient experienced throat tightness. On an unknown date, the outcome of the throat tightness was not recovered/not resolved. The reporter considered the throat tightness to be almost certainly related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced tightness in throat that started about 3 weeks after he received his booster shot. He wanted to know what could be causing this, and representative informed the patient that he could not answer that question, but could go over the adverse reactions for RABAVERT. The patient states that he was aware of the adverse reactions, and would like to know if this had been reported. The representative informed the patient that he could only provide him with adverse reactions observed in trials, but the patient declined again. The patient doctor was aware of his symptom, but was also not sure of the cause. The patient was not yet hospitalized due this particular adverse reaction.
Sex: M
Vaccine: RAB, RAB
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of throat tightness in a male patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, 21 days after receiving RABAVERT, the patient experienced throat tightness. On an unknown date, the outcome of the throat tightness was not recovered/not resolved. The reporter considered the throat tightness to be almost certainly related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced tightness in throat that started about 3 weeks after he received his booster shot. He wanted to know what could be causing this, and representative informed the patient that he could not answer that question, but could go over the adverse reactions for RABAVERT. The patient states that he was aware of the adverse reactions, and would like to know if this had been reported. The representative informed the patient that he could only provide him with adverse reactions observed in trials, but the patient declined again. The patient doctor was aware of his symptom, but was also not sure of the cause. The patient was not yet hospitalized due this particular adverse reaction.
Sex: M
Vaccine: RAB, RAB
Symptoms: Throat tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of throat tightness in a male patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, 21 days after receiving RABAVERT, the patient experienced throat tightness. On an unknown date, the outcome of the throat tightness was not recovered/not resolved. The reporter considered the throat tightness to be almost certainly related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced tightness in throat that started about 3 weeks after he received his booster shot. He wanted to know what could be causing this, and representative informed the patient that he could not answer that question, but could go over the adverse reactions for RABAVERT. The patient states that he was aware of the adverse reactions, and would like to know if this had been reported. The representative informed the patient that he could only provide him with adverse reactions observed in trials, but the patient declined again. The patient doctor was aware of his symptom, but was also not sure of the cause. The patient was not yet hospitalized due this particular adverse reaction.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Inflammation, Injection site swelling
Clinical narrative: Vaccine given around 2 PM on Saturday. I noticed swelling at the injection site Sunday morning. Throughout the day the swelling got worse - and the area of redness grew. By Sunday night the maximum dimensions were 3.5" and 4". Arm was very itchy and painful. I want to add two comments. I read the package insert and it leaves me with uncertainty: a) The two large Phase 3 trials excluded people who had received ZOSTAVAX. I had ZOSTAVAX about five years ago. I am wondering if prior exposure to ZOSTAVAX leads to more intense reactions than would be experienced by someone without such exposure. b) the two studies only reported data from people who had taken both doses of vaccine and it doesn't give a clue about the severity of reaction to dose 2 as a function of severity of reaction to dose 1. Nor does it give any clue about the protection afforded by a single dose in people who mount a strong reaction to it. During the day I felt tired; in the evening I felt suddenly feverish and got chills. I took two TYLENOL to address the chills. The suddenness of the onset made me think it might have been the flu but I got better by the morning. On Monday, my arm was painful, itchy, and felt as if I had a constant bee sting. By Monday evening the area of the redness increased to 3.5" x 4.75" but the area seemed less inflamed. This morning (Tuesday), the area of redness is slightly larger than it was last night but much less inflamed. Still itchy but less painful. I don't know when the arm will be back to normal. My systemic symptoms were over yesterday (Monday).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Vaccine given around 2 PM on Saturday. I noticed swelling at the injection site Sunday morning. Throughout the day the swelling got worse - and the area of redness grew. By Sunday night the maximum dimensions were 3.5" and 4". Arm was very itchy and painful. I want to add two comments. I read the package insert and it leaves me with uncertainty: a) The two large Phase 3 trials excluded people who had received ZOSTAVAX. I had ZOSTAVAX about five years ago. I am wondering if prior exposure to ZOSTAVAX leads to more intense reactions than would be experienced by someone without such exposure. b) the two studies only reported data from people who had taken both doses of vaccine and it doesn't give a clue about the severity of reaction to dose 2 as a function of severity of reaction to dose 1. Nor does it give any clue about the protection afforded by a single dose in people who mount a strong reaction to it. During the day I felt tired; in the evening I felt suddenly feverish and got chills. I took two TYLENOL to address the chills. The suddenness of the onset made me think it might have been the flu but I got better by the morning. On Monday, my arm was painful, itchy, and felt as if I had a constant bee sting. By Monday evening the area of the redness increased to 3.5" x 4.75" but the area seemed less inflamed. This morning (Tuesday), the area of redness is slightly larger than it was last night but much less inflamed. Still itchy but less painful. I don't know when the arm will be back to normal. My systemic symptoms were over yesterday (Monday).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were unknown. On 08-FEB-2018, the patient was vaccinated with an expired dose of PROQUAD (strength, route, dose and frequency were not reported) (lot # M035690, expiration date: 06-FEB-2018) for prophylaxis. The reporter stated that PROQUAD did not have any temperature excursions prior to administration. No adverse event (reported as symptoms) were reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-MAY-2003 and 22-NOV-2006, the patient was vaccinated with first and second dose of M-M-R II (Lot # and expiry date was not reported) for prophylaxis. On 12-FEB-2018, the patient inadvertently received a third dose of with M-M-R II recombinant human albumin (rHA) 0.5 ml, subcutaneous (lot # N010495, Expiry date :31-MAR-2019) for prophylaxis. It was reconstituted with sterile diluent (Manufacturer Unknown) (Lot # N015479, Expiry date : 23-JUL-2019). The physician assistant reported that the patient was supposed to receive a dose of VARIVAX on 12-FEB-2018, but instead received the third dose of M-M-R II. Physician assistant reported the error occurred because of human error and that she "just grabbed the wrong vaccine" (wrong drug administered). No symptoms reported. There was no product quality compliant involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant student referring to a patient of unknown age and gender. The patients' concurrent conditions, concomitant therapy, medical history and historical drugs were not reported. On 13-FEB-2018, the patient was vaccinated with expired PNEUMOVAX 23, intramuscular, expiry date: 23-AUG-2017 (strength, dose, frequency, lot # were not reported) for prophylaxis (expired product administered). No adverse effects were reported. No product quality compliant was reported.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 25-AUG-2017 the patient was vaccinated with first dose of ROTATEQ (lot # M025563 expiry date 06-NOV-2017) (dose and frequency were not reported) orally for prophylaxis. On an unknown date in November 2017 the patient was vaccinated with second dose of ROTATEQ (lot # N013884 expiry date 05-DEC-2018) (dose and frequency were not reported) orally for prophylaxis. On 20-FEB-2018 the patient was vaccinated with third dose later than 10 weeks after the second dose of ROTATEQ (lot number N013884 expiry date 05-DEC-2018) (dose and frequency were not reported) orally for prophylaxis. No adverse effects were reported. No product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD recombinant human albumin (rHA) (lot # M048201, Expiry date : 05-JUN-2018 ) for prophylaxis reconstituted with properly stored sterile diluent (Manufacturer Unknown). It was reported that the vaccine experienced a temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (6.9 degrees Fahrenheit) for 1 hour (incorrect product storage). There was previous temperature excursion reported, temperature was reported as 6 degrees Fahrenheit up to 14 degrees Fahrenheit for 10 hours 30 minutes. There were no adverse effects reported. There was no product quality complaint reported. It was reported that this case was reported due to a digital data logger.
Sex: M
Vaccine: HPVX, MENB, MNQ
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a physician via company representative regarding a 15 or a 16 year old male patient with concurrent condition of epilepsy. Information regarding patient's medical history, drug reactions and allergies were reported as unknown. Information regarding patient's past therapies was not reported. On an unspecified date in January 2017, the patient was vaccinated with second dose of either GARDASIL (unidentified Merck hpv vaccine administered (name and lot number not provided)) or GARDASIL 9 (unidentified Merck hpv vaccine administered (name and lot number not provided)), via intramuscular route for prevention of human papilloma virus (HPV) (dose and expiry date were reported as unknown). On the same day, the patient was also vaccinated with TRUMENBA and possibly but not completely certain MENACTRA for prophylaxis (dose, route, lot number and expiry date were not reported). On an unspecified date in February 2017 (reported as about a year ago and about a month after receiving these vaccines), the patient experienced seizure. It was reported that patient went to an unspecified hospital but it was unknown if patient had visited emergency room or admitted to the hospital. It was unknown if patient had received any treatment for the adverse event. It was unknown if any lab diagnostics or any studies performed. The outcome of the event was reported as recovered on an unknown date. The reporter assessed the causal relationship of event to patient's pre-existing epilepsy. The causality with suspect therapies was unknown. It was reported that there was no product quality complaint (PQC) involved in the report. Upon internal review, the event seizure was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a health care professional, referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-FEB-2018 the patient was vaccinated with M-M-R II per subcutaneous route, lot # N025889, expiration date 18-APR-2018 (dose was not reported). The vaccine was reconstituted with a sterile saline, instead the supplied sterile diluent. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a nurse concerning  a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 15-JUL-2016, the patient was vaccinated with a dose of M-M-R II lot # L049316 with expiration date of 03-DEC-2017, subcutaneously (dose was not reported) and with a dose of PROQUAD lot # M012986 with expiration date of 12-SEP-2017 (dose and route of administration were not reported) for prophylaxis.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments: US-009507513-1801USA005992:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (Merck sterile diluent). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved.  This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments: US-009507513-1801USA005992:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of Merck sterile diluent). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments: US-009507513-1801USA005992: