chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot
Clinical narrative: This case was reported by a consumer and described the occurrence of red face in a elderly female patient who received SHINGRIX. On 11th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 1 days after receiving SHINGRIX, the patient experienced red face and feeling of warmth facial. On 13th April 2018, the outcome of the red face and feeling of warmth facial were recovered/resolved. It was unknown if the reporter considered the red face and feeling of warmth facial to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX vaccine administered by the pharmacist. On 12th April 2018 morning, the patient awoke with beet red face, hot face and no temperature. It was persisted whole day. On 13th April 2018 morning, the patient's face was back to normal and she informed her physician, who had prescribed the vaccine and was advised not to have the 2nd dose. The patient also informed the Center of Disease Control.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling to (L) upper arm starting the day after Men and Tdap injection; initially was about palm size; taken to ER and started on P.O. KEFLEX, now swelling and redness up to above elbow; not painful to touch but still red and warm.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of tiredness in a male patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the tiredness and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that, the patient received SHINGRIX in the deltoid last Saturday before the date of reporting. The patient felt tired for a few days and his arm hurt so they had given his arm a good rub. At the time of this report, the patient stated that he was feeling better and he was glad that he received the vaccine.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swelling, and warm at left arm injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 16-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-MAY-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a medical group as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles. On or about 19-MAY-2016, the patient was treated by a physician at a medical clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 23-MAY-2016 the patient sought further treatment from a health care professional at a medical clinic for ongoing and worsening symptoms of shingles outbreaks and zoster infections. The patient has been prescribed acyclovir and gabapentin for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Cough, Dyspnoea, Influenza virus test negative, Injection site induration, Injection site nodule
Clinical narrative: Later that night after receiving the first dose of Dtap, he became a bit lethargic with extreme hard knot under skin where injection was giving with red blotch that was very large at injection site. By the next day lethargy continued on and he developed a fever, then developed a cough and congestion in lungs, stuffy/runny nose, trouble breathing from coughing so much in a whoop like sound on some coughing fits, high fevers, very lethargic, and nausea with some vomiting of some liquids. This lasted almost 2 weeks. Cough lasted for a longer time as well as the very hard welt and red blotch on skin. He also seemed to stop responding to his name after this incident and lagged behind in speech development after this. He received the second dose 6/23/2017, his age was 9 months old, he didn't develop a huge fever, but had a slight one with cough, as well as a more severe welt and red blotch rash at site of injection that last for a few weeks. Again some of the progress made into getting him to respond to his name left and verbally delayed further. He is now to this day, delayed in speech by 47%, and now sometimes responds to his name being called.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site urticaria, Lethargy, Nasal congestion, Nausea
Clinical narrative: Later that night after receiving the first dose of Dtap, he became a bit lethargic with extreme hard knot under skin where injection was giving with red blotch that was very large at injection site. By the next day lethargy continued on and he developed a fever, then developed a cough and congestion in lungs, stuffy/runny nose, trouble breathing from coughing so much in a whoop like sound on some coughing fits, high fevers, very lethargic, and nausea with some vomiting of some liquids. This lasted almost 2 weeks. Cough lasted for a longer time as well as the very hard welt and red blotch on skin. He also seemed to stop responding to his name after this incident and lagged behind in speech development after this. He received the second dose 6/23/2017, his age was 9 months old, he didn't develop a huge fever, but had a slight one with cough, as well as a more severe welt and red blotch rash at site of injection that last for a few weeks. Again some of the progress made into getting him to respond to his name left and verbally delayed further. He is now to this day, delayed in speech by 47%, and now sometimes responds to his name being called.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Pulmonary congestion, Pyrexia, Rash macular, Respiratory syncytial virus test negative, Rhinorrhoea
Clinical narrative: Later that night after receiving the first dose of Dtap, he became a bit lethargic with extreme hard knot under skin where injection was giving with red blotch that was very large at injection site. By the next day lethargy continued on and he developed a fever, then developed a cough and congestion in lungs, stuffy/runny nose, trouble breathing from coughing so much in a whoop like sound on some coughing fits, high fevers, very lethargic, and nausea with some vomiting of some liquids. This lasted almost 2 weeks. Cough lasted for a longer time as well as the very hard welt and red blotch on skin. He also seemed to stop responding to his name after this incident and lagged behind in speech development after this. He received the second dose 6/23/2017, his age was 9 months old, he didn't develop a huge fever, but had a slight one with cough, as well as a more severe welt and red blotch rash at site of injection that last for a few weeks. Again some of the progress made into getting him to respond to his name left and verbally delayed further. He is now to this day, delayed in speech by 47%, and now sometimes responds to his name being called.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder developmental, Unresponsive to stimuli, Vomiting
Clinical narrative: Later that night after receiving the first dose of Dtap, he became a bit lethargic with extreme hard knot under skin where injection was giving with red blotch that was very large at injection site. By the next day lethargy continued on and he developed a fever, then developed a cough and congestion in lungs, stuffy/runny nose, trouble breathing from coughing so much in a whoop like sound on some coughing fits, high fevers, very lethargic, and nausea with some vomiting of some liquids. This lasted almost 2 weeks. Cough lasted for a longer time as well as the very hard welt and red blotch on skin. He also seemed to stop responding to his name after this incident and lagged behind in speech development after this. He received the second dose 6/23/2017, his age was 9 months old, he didn't develop a huge fever, but had a slight one with cough, as well as a more severe welt and red blotch rash at site of injection that last for a few weeks. Again some of the progress made into getting him to respond to his name left and verbally delayed further. He is now to this day, delayed in speech by 47%, and now sometimes responds to his name being called.
Age: 25.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Pulmonary physical examination, Pyrexia
Clinical narrative: Pt describes reproducible likely non-IgE mediated reactions to influenza vaccinations received in 2009, 10, 11, 13, 14, and 15. Two weeks following vaccine on each occasion, fevers 101-104, body aches, upper and lower resp. congestion, and cough - with cough persisting for several weeks thereafter. Reproducible with subsequent vaccinations, of approximately same severity. Because works as an RN in hospital, did not decline yearly vaccinations until recently.
Age: 25.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Upper respiratory tract congestion
Clinical narrative: Pt describes reproducible likely non-IgE mediated reactions to influenza vaccinations received in 2009, 10, 11, 13, 14, and 15. Two weeks following vaccine on each occasion, fevers 101-104, body aches, upper and lower resp. congestion, and cough - with cough persisting for several weeks thereafter. Reproducible with subsequent vaccinations, of approximately same severity. Because works as an RN in hospital, did not decline yearly vaccinations until recently.
Age: 25.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: Pt describes reproducible likely non-IgE mediated reactions to influenza vaccinations received in 2009, 10, 11, 13, 14, and 15. Two weeks following vaccine on each occasion, fevers 101-104, body aches, upper and lower resp. congestion, and cough - with cough persisting for several weeks thereafter. Reproducible with subsequent vaccinations, of approximately same severity. Because works as an RN in hospital, did not decline yearly vaccinations until recently.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Coronary artery occlusion, Myocardial infarction, Vaccination complication
Clinical narrative: In bed day after shot due to reaction; two days later heart attack coronary artery blocked ; may or may not be related; possibly due to stress from shot?
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm became significantly swollen, red, warm to touch.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-MAR-2018, the patient was concomitantly vaccinated with PROQUAD (lot # N021728, expiry date: 06-FEB-2019) and VARIVAX (lot # M035142, expiry date: 03-AUG-2018) (dose and frequency were not reported) subcutaneously for prophylaxis. No adverse effects reported. No product quality complaint involved. Albumin status for PROQUAD is recombinant human albumin (rHA). This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown demographics. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-MAR-2018 the patient was concomitantly vaccinated with PROQUAD (lot # N021728, expiry date: 06-FEB-2019) and VARIVAX (lot # M035142, expiry date: 03-AUG-2018) (dose and frequency were not reported) subcutaneously for prophylaxis. No adverse effects reported. No product quality complaint involved. Albumin status for PROQUAD is recombinant human albumin (rHA). This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patients involved were not reported. The reporter informed that on an unspecified date, unspecified patients were vaccinated with an improperly stored dose of GARDASIL 9, lot number: M040412 (expiration date: 30-JUN-2019), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: Temperature: 47°F to 77°F for 7 hours, Previous temperature excursion: 47°F to 77°F for 1 hour 30 minutes. No adverse events were reported. Follow up has been received from the same reporter on 16-APR-2018. She reported that the doses of GARDASIL 9 were administered to unspecified number of patients aged 19 and above.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue
Clinical narrative: This spontaneous report as received from a physician via company representative and a nurse refers to a female patient of unknown age. The information regarding medical history, drug reactions/allergies, concurrent conditions and concomitant medications was not reported. On 05-APR-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose, route and site of administration, lot number and expiration date were not reported). On the same day, after sitting 15 to 20 minutes post vaccination, she required further resting. She had to lay down on exam table for several additional minutes. It was unknown if any further treatment was given (also reported as no treatment given). The outcome of the event was reported as not recovered at the time of the reporting. There had been no further adverse events reported. The causality between the event and GARDASIL 9 was not reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse referring to an 11 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 20-MAR-2017, the patient was vaccinated with first dose of GARDASIL 9 injection series (dose and route of administration were not reported) (lot # M033583 and expiration date: 14-APR-2019) for preventative of cervical cancer. On 20-MAR-2017, after the injection, patient had a severe injection site reaction. The reporter stated that the patient experienced severely swollen and red. The outcome of events was reported as recovered/resolved (reported as resolved on its own). The causality was not reported. No further clarifying information was provided by the reporter. There was no product quality complaint (PQC) reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 year old male patient. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant therapy included sterile diluent (MRK). On 22-MAR-2018 the patient was vaccinated with expired dose of PROQUAD injection (lot # M038228, expiry date: 06-MAR-2018) (dose, frequency and route were not reported) for prophylaxis. The reporter confirmed that, the expired PROQUAD had no temperature excursions prior to being administered. No adverse effects reported. No product quality complaint was involved. Albumin status for PROQUAD is recombinant human albumin (rHA).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (MRK INJ). On 10-APR-2018 the patient was vaccinated with dose of expired M-M-R II injection (dose, frequency and route were not reported) (lot # M016234, expiry date: 31-MAR-2018) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Albumin status for M-M-R II is recombinant human albumin (rHA).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (strength, dose, route of administration were not reported) (lot # N022728 expiry date: 31-MAY-2020) for prophylaxis. The vaccine was stored in 32 degrees Fahrenheit (F) up to 35 F (32.3 F) for 1 hour 45 minutes and 30.2 F for 37 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1804USA005778: US-009507513-1804USA005779.
Age: 0.42
Sex: U
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 5 months old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medication were not reported. On 13-APR-2018, the patient was vaccinated with a dose of unidentified HPV vaccine (name and lot number not provided) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
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, drug reactions and allergies were unknown. Concomitant therapy included sterile diluent (MRK INJ). On 12-APR-2018 the patient was vaccinated with improperly stored dose in PROQUAD immunization series (dose, units and frequency unknown) (lot # M043306 and expiration date 24-APR-2018). The sterile diluent (MRK INJ) used to reconstitute PROQUAD was properly stored. The temperature excursion was at 9F (degree Fahrenheit), for time frame of 288 hours cumulatively, multiple excursions. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complaint was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAY-2016, the patient was treated at a medical center, for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Chest X-ray normal, Chest wall mass, Echocardiogram abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old male patient. The patient's concurrent condition included asthma. The patient had no drug reactions/allergies. On 03-DEC-2017, the patient was vaccinated with GARDASIL 9 intramuscularly (lot # N017686, Expiry date: 02-FEB-2020) for prophylaxis. There was no concomitant medications administered. On 05-DEC-2017 (reported as within 2 days), the patient developed a hard mass in the chest which was causing the rib cage and overlying flesh to protrude outwards. On an unknown date, an x-ray was performed and the mass was not found by x-ray. Thus, an echocardiogram was performed on an unknown date and the mass was found to be 5 cm by 8 cm and located between the heart and the rib cage. There was no treatment given for the adverse event. The outcome of mass was reported as not recovered/not resolved. The reporter did not provide the causality assessment for the event. There was no product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to a 5 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 17-APR-2018, the patient was vaccinated with an expired dose of PROQUAD lot # M017335 with expiration date of 05-OCT-2017, 5 ml, by subcutaneous route for prophylaxis. No adverse events were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an other professional (office manager) regarding a pediatric patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2018 and 12-MAR-2018, an unspecified dose of M-M-R II and VARIVAX went out of range. It was unknown if any of those vaccine was administered to unspecified pediatric patients. An adverse event report was taken as a precaution.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: Arm swelling, chills, fever.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Mobility decreased, Pain
Clinical narrative: Client in for annual flu vaccine. Related to vaccinating nurse concerns that occurred following her 11/18/2016 vaccinations. Client states the next day from her 2016 vaccines, she developed a "red spot" and had "a lot of pain" with limited movement associated with elevation. (Client reported opposite sites for vaccine administration from EMR and 2016 vaccinating nurse's documentation of those vaccines). States she used warm compresses which help, but the pain lasted until after the holiday. States pain was constant but now "ebbs and flows". Described pain as aching, muscular pain with a red spot 2" in diameter at shot area. At 12/15/17 visit, states pain has gotten "tons and tons better". Now has full range of motion but has twinge type pain when she elevates her left arm half way; also states the aching continues.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches, chills.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Later that night after receiving the vaccine patient began to feel flu like symptoms that lasted throughout the night and into the morning. He also described that he arm was very sore but no redness or swelling. Today, he feels much better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Rash vesicular, Scab, Skin lesion
Clinical narrative: Diffuse vesicular rash w/crusted lesions in various phases, on erythematous bases mainly on back mainly on back of torso, some lesions present scattered on extremities and face/scalp, no evidence of secondary infection.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (strength, dose, route of administration were not reported) (lot # N022728 expiry date: 31-MAY-2020) for prophylaxis. The vaccine was stored in 32 degrees Fahrenheit (F) up to 35 F (32.3 F) for 1 hour 45 minutes and 30.2 F for 37 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1804USA005184: US-009507513-1804USA005779.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-MAY-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-MAY-2016, the patient was treated at a family medicine facility for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Sleep apnoea syndrome, Somnambulism
Clinical narrative: This spontaneous report as received from a physician assistant via company representative, referring to a 13 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 for human papillomavirus prevention (HPV) (strength, dose, route, frequency, lot# and expiration date were not reported). On 16-APR-2018, the patient was vaccinated with the second dose of GARDASIL 9 for human papillomavirus prevention (HPV) (strength, dose, route, frequency, lot# and expiration date were not reported). On the same date, around 8:00 PM, the patient complained of headache. On 17-APR-2018, around 2:30 AM, the patient was discovered sleepwalking. The patient did not receive any treatment and was unknown if the diagnostic laboratories were performed. At the time of reporting, the outcome of headache and sleepwalking was unknown. Additionally, the causality assessment between headache and sleepwalking with GARDASIL 9 was not provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Exfoliative rash, Flushing, Hyperhidrosis, Myalgia
Clinical narrative: Pt called on 4/7/18. She received a shingles vaccine on Wednesday 4/4/18. She was told of mild side effects including muscle aches, but she had major achiness "all down left side of body". Pt states it was "extremely painful" was nauseated and vomited 4-5 times on the Friday and felt flushed and sweaty at times. When she went online to check out concerns because they were so severe, at that time she found there was a "class action lawsuit" so she thought it would be best for her to call in and report her symptoms. She does admit that no vomiting today, and feeling better. On 4/8/18, pt called at 4 am with new onset of rash or hives. She states about 25 whelps "like a horror show" itchy. No swelling of lips or tongue, no change in breathing. Nurse instructed to take BENADRYL and monitor. If hives worsen or other changes to call back and can be seen in urgent care. On 4/9/18 pt called back and stated rash is resolving, states is now dry and scaly, asking if SHINGRIX #2 is recommended.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pruritus, Rash, Urticaria
Clinical narrative: Pt called on 4/7/18. She received a shingles vaccine on Wednesday 4/4/18. She was told of mild side effects including muscle aches, but she had major achiness "all down left side of body". Pt states it was "extremely painful" was nauseated and vomited 4-5 times on the Friday and felt flushed and sweaty at times. When she went online to check out concerns because they were so severe, at that time she found there was a "class action lawsuit" so she thought it would be best for her to call in and report her symptoms. She does admit that no vomiting today, and feeling better. On 4/8/18, pt called at 4 am with new onset of rash or hives. She states about 25 whelps "like a horror show" itchy. No swelling of lips or tongue, no change in breathing. Nurse instructed to take BENADRYL and monitor. If hives worsen or other changes to call back and can be seen in urgent care. On 4/9/18 pt called back and stated rash is resolving, states is now dry and scaly, asking if SHINGRIX #2 is recommended.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pt called on 4/7/18. She received a shingles vaccine on Wednesday 4/4/18. She was told of mild side effects including muscle aches, but she had major achiness "all down left side of body". Pt states it was "extremely painful" was nauseated and vomited 4-5 times on the Friday and felt flushed and sweaty at times. When she went online to check out concerns because they were so severe, at that time she found there was a "class action lawsuit" so she thought it would be best for her to call in and report her symptoms. She does admit that no vomiting today, and feeling better. On 4/8/18, pt called at 4 am with new onset of rash or hives. She states about 25 whelps "like a horror show" itchy. No swelling of lips or tongue, no change in breathing. Nurse instructed to take BENADRYL and monitor. If hives worsen or other changes to call back and can be seen in urgent care. On 4/9/18 pt called back and stated rash is resolving, states is now dry and scaly, asking if SHINGRIX #2 is recommended.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Pallor, Skin discolouration
Clinical narrative: Right arm is discolored with purple tint. Blanches on touch. Discoloration from right shoulder down to right wrist. Can see where the bandaids were placed (white colored where band aids were placed).
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Tender lump right biceps at injection area, no redness or itch. Immunization site documented as left, lump is right, patient reports getting it in the right arm and noticing at the time is was charted as in the left arm.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Grandmother of patient stated Right arm severely swollen, red and rash.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Hypotonia, Lethargy, Pallor, Skin warm
Clinical narrative: Went to ER last night because she was very pale. Mom said she felt slightly warm but she wasn't sure if she had fever. Shots were given around 3:30, this occurred around 8-8:30. After shots was eating/active but sleepier in evening she was crying but calmed down after eating and then when they arrived at the house and went to take her out of her car seat, she was pale, limp and not responding. They took baby to ER around 9 PM and mom said they took vitals and that vitals were stable and baby was more responsive and lethargic but improving. ER records show that they left before midnight and that she was not seen by a physician. Pt's mom does not speak English and perhaps thought that she was free to leave.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: Went to ER last night because she was very pale. Mom said she felt slightly warm but she wasn't sure if she had fever. Shots were given around 3:30, this occurred around 8-8:30. After shots was eating/active but sleepier in evening she was crying but calmed down after eating and then when they arrived at the house and went to take her out of her car seat, she was pale, limp and not responding. They took baby to ER around 9 PM and mom said they took vitals and that vitals were stable and baby was more responsive and lethargic but improving. ER records show that they left before midnight and that she was not seen by a physician. Pt's mom does not speak English and perhaps thought that she was free to leave.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Delayed (7 days) redness, warmth, and swelling at injection site.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Neuralgia, Peripheral swelling
Clinical narrative: Patient came back 2 weeks later saying her arm flared up with redness, shooting nerve pain for the whole arm and it was swollen. The symptoms lasted for a week and she mentioned to her doctor at a doctor's visit but the doctor had no comment and didn't prescribe any medications for the symptoms because they were almost all resolved per patient. Patient said she didn't apply ice pack or take any pain meds when she experienced the symptoms. She didn't do anything. Patient declined to provide doctor's name and contact info because doctor didn't give any comment nor treat her for it. Patient indicated she's fine at the time when she first notified us 2 weeks after the vaccine.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: She woke this am with raised, red, itchy rash on trunk, back, thighs, and scalp. No fever. No respiratory symptoms. She states her glands may feel slightly swollen, like she has a sore throat.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Delirium, Fatigue, Feeding disorder
Clinical narrative: Upon given the shot, I immediately had a painful left arm which I could barely move throughout the day. I gradually started feeling run down and by 7 PM on 4/17/18 (the day I received the vaccine), I felt sick. My symptoms included headache, chills, upset stomach, sensitivity to sounds. I could not sleep probably because of my thoughts. I can best describe as being delirious - restless and incoherent. By morning (4/18), I could barely move to even go to the bathroom and started vomiting from about 1 PM the following day until 7 PM. Therefore, I could not eat anything the entire day. Slept a little better that evening and feel better and I'm able to eat although not entirely recovered today (4/19). Overall, no one should have to suffer from these side effects. I can honestly say the suffering was worse than getting the shingles. (Maybe not as long, but worse!). I had the shingles!
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperacusis, Incoherent, Insomnia, Malaise
Clinical narrative: Upon given the shot, I immediately had a painful left arm which I could barely move throughout the day. I gradually started feeling run down and by 7 PM on 4/17/18 (the day I received the vaccine), I felt sick. My symptoms included headache, chills, upset stomach, sensitivity to sounds. I could not sleep probably because of my thoughts. I can best describe as being delirious - restless and incoherent. By morning (4/18), I could barely move to even go to the bathroom and started vomiting from about 1 PM the following day until 7 PM. Therefore, I could not eat anything the entire day. Slept a little better that evening and feel better and I'm able to eat although not entirely recovered today (4/19). Overall, no one should have to suffer from these side effects. I can honestly say the suffering was worse than getting the shingles. (Maybe not as long, but worse!). I had the shingles!
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Restlessness, Vomiting
Clinical narrative: Upon given the shot, I immediately had a painful left arm which I could barely move throughout the day. I gradually started feeling run down and by 7 PM on 4/17/18 (the day I received the vaccine), I felt sick. My symptoms included headache, chills, upset stomach, sensitivity to sounds. I could not sleep probably because of my thoughts. I can best describe as being delirious - restless and incoherent. By morning (4/18), I could barely move to even go to the bathroom and started vomiting from about 1 PM the following day until 7 PM. Therefore, I could not eat anything the entire day. Slept a little better that evening and feel better and I'm able to eat although not entirely recovered today (4/19). Overall, no one should have to suffer from these side effects. I can honestly say the suffering was worse than getting the shingles. (Maybe not as long, but worse!). I had the shingles!
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient initially was seen in ED and treated with ibuprofen, sling and ice pack which patient reported resolved the adverse reaction. Myalgia and Right shoulder muscle pain, inability to lift arm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Insomnia, Pain, Rash macular
Clinical narrative: Patient reported to PCC on 4/4/18: Per RN Note: Left deltoid with blotchy reddened area to entire deltoid, site of injection raised, appearing like a bug bite. Denies any itching to site. Patient reports improvement to rash since appearing Monday 4/2/18 evening. He states that Monday night he had significant pain, making it difficult to sleep. Pain currently 1/10 he reports as tender.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient reported to PCC on 4/4/18: Per RN Note: Left deltoid with blotchy reddened area to entire deltoid, site of injection raised, appearing like a bug bite. Denies any itching to site. Patient reports improvement to rash since appearing Monday 4/2/18 evening. He states that Monday night he had significant pain, making it difficult to sleep. Pain currently 1/10 he reports as tender.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Mouth swelling, Pruritus, Rash
Clinical narrative: Bumps and itching under hands and feet. Bumps on stomach, shoulder and around belly button (Wednesday 4/18/2018. Swelling of mouth Thursday 4/19/2018.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever after 4y imms to 103.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 03-APR-2018, the patient was ordered to receive a dose of M-M-R II and a dose of VARIVAX. Inadvertently, the patient received a dose of PROQUAD therapy type; rHA, (Lot number: N015621, Expiration date: 15-JAN-2018) subcutaneously (dose not reported) for prophylaxis and a dose of VARIVAX (Lot number: M049125, Expiration date: 15-DEC-2018) (dose not reported) for prophylaxis. Other concomitant therapy included sterile diluent (MRK) (lot#, expiry date and dosage details were not reported). No adverse effects reported. No product quality complaint (PQC) was involved.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased
Clinical narrative: Temp to 103 after vaccines. Afebrile 24 hours later.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, Redness, Tenderness 3 days post-vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Differential white blood cell count, Full blood count, Measles antibody, Polymerase chain reaction, Pyrexia
Clinical narrative: Child presented to the clinic with maculopapular eruption to entire body and fever on 4-16-2018. Rash occured 14 days after vaccinations were administered. As of today 4-19-2018 rash is completely gone.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Child presented to the clinic with maculopapular eruption to entire body and fever on 4-16-2018. Rash occured 14 days after vaccinations were administered. As of today 4-19-2018 rash is completely gone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Suspected acute disseminated encephalomyelitis.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Continued left deltoid pain at site of injection.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Suspected acute disseminated encephalomyelitis.
Age: 81.0
Sex: F
Vaccine: FLUC4
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Suspected acute disseminated encephalomyelitis.
Age: 92.0
Sex: F
Vaccine: FLUC4
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Suspected acute disseminated encephalomyelitis. It is unknown if the vaccine was actually given- an order was placed, but record of administration unclear.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin exfoliation
Clinical narrative: Skin peeling around injection site and a 3 to 4 inches away from injection site.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Eye swelling, Headache, Ocular hyperaemia, Oropharyngeal pain, Rash
Clinical narrative: Mother reported symptoms of headache; sore throat; rash to face, stomach, and both legs; redness to white part of both eyes; and swollen eyes on 4/10/2018. Presented to Public Health Department on 4/18/2018 with red raised rash to medial chin, and one raised white spot to medial upper sternal area near neck. Generalized examination performed and no evidence of any additional rash; no redness to throat; no redness to bilateral sclera; no edema bilateral periorbital. Denied complaint of Headache. Referred to Health Center or local ER for further evaluation and assessment.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Rash erythematous
Clinical narrative: Mother reported symptoms of headache; sore throat; rash to face, stomach, and both legs; redness to white part of both eyes; and swollen eyes on 4/10/2018. Presented to Public Health Department on 4/18/2018 with red raised rash to medial chin, and one raised white spot to medial upper sternal area near neck. Generalized examination performed and no evidence of any additional rash; no redness to throat; no redness to bilateral sclera; no edema bilateral periorbital. Denied complaint of Headache. Referred to Health Center or local ER for further evaluation and assessment.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Impaired work ability, Myalgia
Clinical narrative: Developed severe pain in my teeth and generalized myalgia, had fever and chills, headache, and some mental fuzziness, nausea, but no vomiting. Also had pain at the vaccination site. Symptoms worsened on the 16th of April into the 17th of April and I was unable to go to work on April 17th. I spent most of that day in bed, but by the end of the day I was able to get up for a few hours. I kept taking ADVIL every 6-8 hours as needed (which was ongoing for Sunday, Monday, Tuesday, and Wednesday and Thursday 4/15-19).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Toothache, Vaccination site pain
Clinical narrative: Developed severe pain in my teeth and generalized myalgia, had fever and chills, headache, and some mental fuzziness, nausea, but no vomiting. Also had pain at the vaccination site. Symptoms worsened on the 16th of April into the 17th of April and I was unable to go to work on April 17th. I spent most of that day in bed, but by the end of the day I was able to get up for a few hours. I kept taking ADVIL every 6-8 hours as needed (which was ongoing for Sunday, Monday, Tuesday, and Wednesday and Thursday 4/15-19).
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from the patient's mother who is also a company representative and refers to 12-year-old male patient. The patient's concurrent conditions included haemolytic uraemic syndrome (HUS), kidney failure, dialysis, blood transfusion and asthma. On 09-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for human papilloma virus (HPV) prevention. Concomitant therapies included probiotics (unspecified), vitamins (unspecified), ASMANEX TWISTHALER or ASMANEX HFA; reported as ASMANEX. On the same day, reported as after receiving the dose and last night, the patient experienced 4 bouts of vomiting. The patient did not seek medical attention and did not receive any treatment for the reported event. The outcome of vomiting was reported as recovering. Causality assessment was not provided. This is one of two reports refers to the same patient. Sender's Comments: US-009507513-1804USA004780.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Systemic lupus erythematosus
Clinical narrative: This spontaneous report has been received from a registered nurse, via a field representative, concerning a 30 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On unknown dates, at age 27 years old, the patient received three doses of GARDASIL (concentration, dose, anatomical location, lot number and expiration date were not provided), administered intramuscularly for prophylaxis. On an unknown date, at age 30 years old, the patient was diagnosed with systemic lupus erythematosus. It was reported that the patient sought medical attention and an unspecified treatment was given for the event, however, it was unknown if lab diagnostics or studies were performed. At the time of reporting, the patient's outcome for systemic lupus erythematosus and the causal relationship between GARDASIL and the event were unknown. Upon internal review, systemic lupus erythematosus was determined to be medically significant.