chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Confusional state, Fall
Clinical narrative: Here for Kindergarten Immunizations. Approximately 5 minutes after immunization received patient stood up and fell to the ground. Patient landed anterior and made an arch position was some eye fluttering noted briefly and while holding shoulders no seizure like activity noted. Lasted about 30 sec. then patient started to answer question but still extremely confused. Mom picked child up. Mom was obviously very nervous and scared. Patients Pupils Equal and reactive to light right after incident. Had patient squeeze my hands, push feet against my hands then pull feet towards my hands. Patients strength equal bilaterally in all extremities. After mom and patient calmed down patient was able to tell us where he was "Doctors Office", Asked who was holding him he said "My Mom", Asked him what sport we were talking about before the incident and he said baseball which was correct. Patient denies any pain anywhere at this time besides where he received his shots. Head palpated no bumps or lacerations noted to head. While assessing patient head he denies any painful areas. Explained to mom that things like this occasionally happen. Mom still extremely nervous. Told her if it would make her feel better to take him to a doctor to have him checked out I think that would ease her mind a little. Pupils checked prior to leaving and remain equal and reactive to light. Patient did not want to walk so mom carried him out of the office. Advised mom to keep us updated on patient and that if the doctor had any questions about the incident to give me a call. All of mom's questions answered as best as they could be. Assessment and Plan. Create Assessment Group.
Age: 17.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Diarrhoea, Erythema, Headache, Mobility decreased, Pain in extremity
Clinical narrative: Woke up the next day with a low grade fever, H/A and diarrhea. His right upper arm had a red raised area 3 in wide and 8 inches long. It was also itching. His arm was painful and he could not lift it up. Mom gave him BENADRYL and TYLENOL. It was redder on Sunday but no itching. Mom called the office on Monday am to report it. It was resolving on its own.
Age: 17.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Pruritus, Pyrexia
Clinical narrative: Woke up the next day with a low grade fever, H/A and diarrhea. His right upper arm had a red raised area 3 in wide and 8 inches long. It was also itching. His arm was painful and he could not lift it up. Mom gave him BENADRYL and TYLENOL. It was redder on Sunday but no itching. Mom called the office on Monday am to report it. It was resolving on its own.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Patient ended up getting shingles that went up her back entirely with blisters creating immense pain and itching for the patient following the immunization.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Insomnia, Pyrexia
Clinical narrative: Patient states the day after receiving the vaccine (4/21) at around 9-10pm she developed a fever (unsure of temp), chills, and started shivering. This kept her awake until about 3am when she fell asleep. She said the following day (4/22) the fever and chills were gone but she didn't have any energy. The next day (4/23) she said she was fully recovered and felt fine.
Age: 0.75
Sex: F
Vaccine: HPV9
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: There were two vaccinations for two separate rooms laid out, and I accidentally grabbed the wrong vaccine and gave to the wrong patient. There were no adverse reactions in office, or reported by parent as of 6/20/18 3:30 pm thus far. As part of Dr's request, we still felt the need to fill out this form.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Hot flush, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, and swelling of injection site, hot and cold flashes, and body aches. Symptoms for about 3 days, controlled with OTC acetaminophen 1000mg q6 hours. Symptoms then resolved completely with no long-term effects.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Redness, pain, and swelling of injection site, hot and cold flashes, and body aches. Symptoms for about 3 days, controlled with OTC acetaminophen 1000mg q6 hours. Symptoms then resolved completely with no long-term effects.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Lethargy, Pyrexia, Rash, Rash pustular
Clinical narrative: Pt called this afternoon at 430pm stating this morning about 8am (appox 12 hours after vaccination) she began to feel week, lethargic and had a slight fever that peaked at 100.4 degrees. These symptoms were consistent with expected adverse events of the vaccine. Patient stated that as the day has gone one, she has felt a little better in regards to those symptoms. However, patient also stated that pustules/bumps began forming on her torso this morning. This symptom was not consistent with reported adverse events and is believed to be a possible allergic reaction.  Patient stated it has not spread beyond initial area. Advised patient to take oral BENADRYL and will follow-up with her to see how she is feeling.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Influenza, Lethargy, Pain
Clinical narrative: Pt called this afternoon at 430pm stating this morning about 8am (appox 12 hours after vaccination) she began to feel week, lethargic and had a slight fever that peaked at 100.4 degrees. These symptoms were consistent with expected adverse events of the vaccine. Patient stated that as the day has gone one, she has felt a little better in regards to those symptoms. However, patient also stated that pustules/bumps began forming on her torso this morning. This symptom was not consistent with reported adverse events and is believed to be a possible allergic reaction.  Patient stated it has not spread beyond initial area. Advised patient to take oral BENADRYL and will follow-up with her to see how she is feeling.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt called this afternoon at 430pm stating this morning about 8am (appox 12 hours after vaccination) she began to feel week, lethargic and had a slight fever that peaked at 100.4 degrees. These symptoms were consistent with expected adverse events of the vaccine. Patient stated that as the day has gone one, she has felt a little better in regards to those symptoms. However, patient also stated that pustules/bumps began forming on her torso this morning. This symptom was not consistent with reported adverse events and is believed to be a possible allergic reaction.  Patient stated it has not spread beyond initial area. Advised patient to take oral BENADRYL and will follow-up with her to see how she is feeling.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an adult patient (reported as 11 years old on 19-JUN-2009) of unknown gender. On 19-JUN-2009, the patient was vaccinated with a dose of VAQTA for prophylaxis (dose, route and site of administration were not reported). On 10-NOV-2017 and 14-MAY-2018, the patient was given two more pediatric doses of VAQTA (dose, route and site of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 07-JUN-2018, the patient was vaccinated with a dose of oral ROTATEQ, for prophylaxis; and with the valid lot # M041181, which expired on 31-MAY-2018. The dose was inadvertently given to the patient. No adverse effects were reported in the patient after the vaccine was administered. No product quality complaint was filed.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial test negative, Malaise, Nasopharyngitis, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a registered nurse referring to her 3.5 year old daughter. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that the patient was not pregnant. On an unknown date in the past, the patient had an episode of pink eye, which was treated with eye drops that contained NEOSPORIN, and she had reactions to the eye drops (red spots and trouble breathing), which were treated by her mother with BENADRYL. Likewise, the patient's mother felt that she had used neomycin ointment on her daughter in the past but not sure if daughter had a reaction to that. On 07-NOV-2015, the patient was vaccinated with a first dose of VARIVAX (lot # 1010146; strength, dose, route, anatomical location and expiration date were not provided), for prophylaxis. On an unknown date, after receiving a dose of VARIVAX, every time that the patient got sick, had a cold or got a virus, she experienced chicken pox, clarified as red bumps. The registered nurse reported that her daughter got one or two bumps on groin, belly and maybe neck. It was also reported that the patient's physician stated that the bumps look like a bug bite. In addition, on an unspecified day in June 2018 (reported as this week), the patient got the bumps on the neck, abdomen and groin, that look scabbed over and there were 30 to 50 bumps and this time the bumps were itchy. Therefore, an unspecified culture showed a came back of negative bacterial. Moreover, the patient's mother was waiting for results of viral culture from patient's pediatrician. On an unknown day in July 2018 (reported as next month), the patient had an appointment with an allergist. In addition, the patient's mother was wondering if there was any relationship to neomycin in VARIVAX to episodic rashes that daughter was experiencing. The registered nurse was not sure if the patient should have received the second recommended dose of VARIVAX. The patient's mother felt certain that those rashes were repeated bouts of breakthrough varicella. It was also reported that on an unspecified date, the patient had episode of a respiratory illness, which was treated with inhaled corticoid steroids. At the time of reporting, the outcome of varicella, viral infection, nasopharyngitis, malaise and respiratory disorder was unknown. The causal relationship between varicella, viral infection, nasopharyngitis, malaise, rash and respiratory disorder with the VARIVAX was not reported. Lot number 1010146 is an invalid lot number for varicella virus vaccine live (oka/merck).
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Respiratory disorder, Scab, Viral infection, Viral test
Clinical narrative: This spontaneous report was received from a registered nurse referring to her 3.5 year old daughter. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that the patient was not pregnant. On an unknown date in the past, the patient had an episode of pink eye, which was treated with eye drops that contained NEOSPORIN, and she had reactions to the eye drops (red spots and trouble breathing), which were treated by her mother with BENADRYL. Likewise, the patient's mother felt that she had used neomycin ointment on her daughter in the past but not sure if daughter had a reaction to that. On 07-NOV-2015, the patient was vaccinated with a first dose of VARIVAX (lot # 1010146; strength, dose, route, anatomical location and expiration date were not provided), for prophylaxis. On an unknown date, after receiving a dose of VARIVAX, every time that the patient got sick, had a cold or got a virus, she experienced chicken pox, clarified as red bumps. The registered nurse reported that her daughter got one or two bumps on groin, belly and maybe neck. It was also reported that the patient's physician stated that the bumps look like a bug bite. In addition, on an unspecified day in June 2018 (reported as this week), the patient got the bumps on the neck, abdomen and groin, that look scabbed over and there were 30 to 50 bumps and this time the bumps were itchy. Therefore, an unspecified culture showed a came back of negative bacterial. Moreover, the patient's mother was waiting for results of viral culture from patient's pediatrician. On an unknown day in July 2018 (reported as next month), the patient had an appointment with an allergist. In addition, the patient's mother was wondering if there was any relationship to neomycin in VARIVAX to episodic rashes that daughter was experiencing. The registered nurse was not sure if the patient should have received the second recommended dose of VARIVAX. The patient's mother felt certain that those rashes were repeated bouts of breakthrough varicella. It was also reported that on an unspecified date, the patient had episode of a respiratory illness, which was treated with inhaled corticoid steroids. At the time of reporting, the outcome of varicella, viral infection, nasopharyngitis, malaise and respiratory disorder was unknown. The causal relationship between varicella, viral infection, nasopharyngitis, malaise, rash and respiratory disorder with the VARIVAX was not reported. Lot number 1010146 is an invalid lot number for varicella virus vaccine live (oka/merck).
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-Jan-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX "did function as intended," and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-FEB-2016 the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as shingles. The outcome of the events is unknown. 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.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in October 2017 (reported that from 10-OCT-2017 to 12-OCT-2017), the patients were vaccinated with improperly stored doses of  PEDVAXHIB (lot # L051124, expiration date: 14-OCT-2018, lot # M046133, expiration date: 26-SEP-2019), PNEUMOVAX 23 (lot # N003997 expiration date: 20-OCT-2018) and GARDASIL 9 (lot # L036301 expiration date: 20-DEC-2017, lot # M028323, expiration date: 26-SEP-2018 and lot # N017686, expiration date: 2-FEB-2020) (for all vaccines doses and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius (C) to 25C (11.4C) for 1 hours. Data logger was involved. Follow-up information has been received from the nurse on 11-JUN-2018. She provided that the temperature excursion took place on 10-OCT-2017. The patient identification information was not readily available. Follow-up information has been received from the nurse on 11-JUN-2018 concerning a patient of unknown age and gender. The patient was vaccinated with GARDASIL 9 (lot # N017686, expiration date: 02-FEB-2020) of temperature excursion which took place on 10-OCT-2017 from 16:32 until 19:02 (maximum temperature 11.4C). No adverse effects were reported. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is valid because the patient's identifier was received. Sender's Comments: US-009507513-1710USA007686.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: No reaction on previous exposure to drug, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A child male patient received at the age of 11-year-old the 1st dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included the 3rd dose of GARDASIL at the same time on an unspecified date for immunisation. On an unspecified date after receiving TRUMENBA, the patient vomited and developed low grade fever with outcome of unknown. The nurse stated patient had not had any problems with first two doses of GARDASIL. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash on the skin over her entire upper body 2 days after receiving the second dosage of the SHINGRIX vaccine. Patient was recommended an BENADRYL and topical anti-itch medication as needed. Patient was also advised to follow up with primary care provider.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Lymphadenopathy, Rash generalised
Clinical narrative: Patient developed a rash on the skin over her entire upper body 2 days after receiving the second dosage of the SHINGRIX vaccine. Patient was recommended an BENADRYL and topical anti-itch medication as needed. Patient was also advised to follow up with primary care provider.
Age: 18.0
Sex: M
Vaccine: TD, TYP
Symptoms: Neck pain, Rash generalised, Rash pruritic
Clinical narrative: Mom reported on 6/20/18 (when she was being seen for travel vaccinations) that her son developed a sore neck and body rash later in the day on 6/5/18. Rash was described as being all over his body; itchy but not painful. She did call the pediatrician; they recommended use of OTC topical steroid ointment. He was not evaluated in person by the pediatrician. Per mom, the symptoms resolved within 12-18 hours. No residual effects reported at this time.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient came to the pharmacy on 06/18/18. She had been to the doctor. She said she originally had one bump (which she thought was a spider bite) on the right upper back which developed 1 week after receiving SHINGRIX on 06/06/2018. The next day she had a "splotch" on the groin area about 2 inches long. Later that day she had 4-5 bumps on her waist area and on her right arm. The patient said the doctor told her to take ZYRTEC for itching. She stated the doctor still wants her to get the second dose. The nurse at her doctor's office faxed over the doctor's notes which says if the rash has totally resolved and it is time for her second SHINGRIX, ok to continue. Her rash did not appear immediately with SHINGRIX, and I (the doctor) don't believe it was related. The risk/benefit would support getting SHINGRIX (per doctor's notes). Talked to patient 06/20/2018 (today). She says she is still breaking out and she went to a dermatologist who sent in a prescription for triamcinolone.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Began itching about 30min to 1 hour after injection and has continued to itch, now over a week later. Has blisters on the back of his legs behind his knees and itchy whelps.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site discolouration, Skin discolouration
Clinical narrative: Purple coloration of lower limbs.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported injection-site reaction (redness and soreness of injection site which is warm to touch).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Started to feel nauseous about 6 hours after the vaccination. Proceeded to experience extremely sore muscles and joints, fever, chills, headache and fatigue. This continued a full 24 hours after the vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Started to feel nauseous about 6 hours after the vaccination. Proceeded to experience extremely sore muscles and joints, fever, chills, headache and fatigue. This continued a full 24 hours after the vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain
Clinical narrative: Large amount of brusing and pain (current pain level  (1-10)=2), did not experience this with first dose of series.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: An area of 3 cm diameter of erythema appeared at the injection site of the MMR vaccine 10 minutes after it was administered. No dyspnea. Told mom to watch and to give diphenhydramine syrup ordered at the pharmacy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient experienced 4 large welts on arm where she received PNEUMOVAX 23 vaccine.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced severe redness, pain, and some swelling around injection site and running down arm from deltoid to elbow. Persisted for several days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site swelling, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient initially felt a little short of breath but went away quickly. Patient called and came in 6/20/18 and stated arm has been warm to touch and it is visbually swollen around injection site. Patient states arm has been sore to move. Patient states she is feeling better. Symptoms are going away slowly.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Insomnia, Malaise
Clinical narrative: Feeling of impending doom. Not feeling well at all, sat up in bed troubled and concerned. Couldn't sleep. I am otherwise a healthy adult with a recent excellent EEG/EKG and stress test, normotensive, active 6' and 188lbs adult male. Symptoms lasted 2 days and the third day a bit better but still troubled. Took about 5-6 days to feel normal again.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: The patient stated that on 6/19/18, he woke up with a rash underneath his breast area. He stated that the rash was bumpy, red and slightly itched. As of today, 6/20/18, he stated that the rash is starting to clear up-it doesn't itch and there are less bumps.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: The patient stated that on 6/19/18, he woke up with a rash underneath his breast area. He stated that the rash was bumpy, red and slightly itched. As of today, 6/20/18, he stated that the rash is starting to clear up-it doesn't itch and there are less bumps.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red upper bicep on LUE at injection site. Circumferential erythema around site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Malaise, Pruritus, Pyrexia
Clinical narrative: I had fever, chills, and malaise the next day. I also developed itching and redness on both palms and soles. Symptoms resolved over 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient has experienced the shingles a month later of getting the vaccine, Patient is on Valacyclovir and Prednisolone AC eye drops.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Myalgia
Clinical narrative: Nausea, muscle aches, fever, mild fever, headache, fatigue, overall sick feeling, and pain at the site of injection for approximately 12 hours.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, muscle aches, fever, mild fever, headache, fatigue, overall sick feeling, and pain at the site of injection for approximately 12 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Soreness and mild swelling at injection site within 4 hours, lasting 2 days. Severe fatigue and headache at 12 hours, lasting 12 hours, treated with ibuprofen.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bradyphrenia, Injection site pain, Insomnia, Night sweats
Clinical narrative: Fever, night sweats, pain in all joints, unable to sleep due to joint pain and sweating, very sore arm at injection site. Mentally, I felt like I was unable to think clearly and quickly. Lasting for three days. Feeling better on fourth day but arm still sore.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, night sweats, pain in all joints, unable to sleep due to joint pain and sweating, very sore arm at injection site. Mentally, I felt like I was unable to think clearly and quickly. Lasting for three days. Feeling better on fourth day but arm still sore.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Syncope
Clinical narrative: Pt had a lot of fatigue, soreness, and stated that she collapsed into bed.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Anti-Muellerian hormone level decreased, Blood follicle stimulating hormone increased, Hormone level abnormal, Infertility female
Clinical narrative: Infertility secondary to Primary Ovarian Failure resulting in premature menopause at 27 years old.   Onset of symptoms at 26 when it became difficult to carry a pregnancy. 5 miscarriages as a result of imbalance of hormones and high levels of Follicular Stimulating Hormone (FSH), decreased Anti Mullerian Hormone (AMH) and poor egg quality.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Oestradiol decreased, Ovarian failure, Premature menopause
Clinical narrative: Infertility secondary to Primary Ovarian Failure resulting in premature menopause at 27 years old.   Onset of symptoms at 26 when it became difficult to carry a pregnancy. 5 miscarriages as a result of imbalance of hormones and high levels of Follicular Stimulating Hormone (FSH), decreased Anti Mullerian Hormone (AMH) and poor egg quality.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Fever, chills, flu-like symptoms including muscle and joint pain the first 24 hours. Second day my underarm on the arm of the injection is very swollen. Arm is very sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever, chills, flu-like symptoms including muscle and joint pain the first 24 hours. Second day my underarm on the arm of the injection is very swollen. Arm is very sore.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Nausea, Vomiting
Clinical narrative: I threw up last night and nausea and exhaustion have continued all day today. I slept 12 hours last night.
Age: 57.0
Sex: F
Vaccine: MMR, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: MILD REDNESS AT AND AROUND THE INJECTION SITE WITH MILD ITCHING.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Immunisation, Product administered at inappropriate site
Clinical narrative: Infant was born to a mother who is Hep B positive. Infant was given the HBIG injection and the Hep B vaccination in the same left thigh, instead of giving each one if a different thigh/leg. Therefore, the Hep B vaccine had to be repeated in the opposite thigh/leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient came in on 6/19/18 afternoon with concerns of her adverse reactions after the vaccine. Patient stated that she started having pain at injection site the day after the injection, then itchy and warmth remains. On the 4th day she starting having redness and swelling at injection site, as well as upper lip swelling. On the 5th-6th day she started having headache and heaviness of head. The patient did not appears to be in acute stress and was alert and oriented. Although some of the adverse events seemed common as listed per package insert, lip swelling and warmth at injection site were not. I made a follow up phone call on 6/20/18 but was unable to reach the patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lip swelling
Clinical narrative: Patient came in on 6/19/18 afternoon with concerns of her adverse reactions after the vaccine. Patient stated that she started having pain at injection site the day after the injection, then itchy and warmth remains. On the 4th day she starting having redness and swelling at injection site, as well as upper lip swelling. On the 5th-6th day she started having headache and heaviness of head. The patient did not appears to be in acute stress and was alert and oriented. Although some of the adverse events seemed common as listed per package insert, lip swelling and warmth at injection site were not. I made a follow up phone call on 6/20/18 but was unable to reach the patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash, Rash papular
Clinical narrative: Fever - max temp 103.7, loss of appetite, erythematous papular rash on trunk, buttocks, limbs.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: A few hours after receiving the vaccine I became nauseous and began vomiting. The next day I developed a large, red and tender bump at the injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, headache, muscle aches.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: R shoulder swelling: warm/calor; armpit swelling R side. Local warmth in R arm has subsided. R shoulder and armpit swelling for 6 days, since administration of vaccine.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness, advised to continue taking ibuprofen/OTC pain medication PRN.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: I had SHINGRIX vaccination on June 8 and experienced headaches the following day, I had the same thing in when I took first dose in March, but did not report at the time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea
Clinical narrative: Began having abdominal pain and diarrhea after shingles vaccine going on over 8 days now. Diarrhea,chills, abdomenpain.
Sex: F
Vaccine: HPV4
Symptoms: Apathy, Arthralgia, Asthenia, Blood cholesterol increased, Blood glucose normal
Clinical narrative: My life changed forever in 2012. My mother and I thought we were making the right choice. I received the 3 part series of the GARDASIL vaccine starting in February of 2012 and through August of 2012. After the vaccine, I started sleeping so much and my menstrual cycles worsened. I had massive mood swings and I never felt good or had energy the same ever again. In February of 2013, I was diagnosed with Chronic Fatigue Syndrome. I have been tested negative for Lyme and all other autoimmune diseases, as well as blood panels and CBC counts. After visiting several doctors, they asked if I got the GARDASIL vaccine and determined from other reports of side effects in the area that my CFS was a result of a vaccine injury from the GARDASIL. Over the years this has gotten worse, into my college years now I experience severe joint pain, muscle aches, exhaustion after completing simple tasks, lack of motivation, etc. I am still being tested every year for things such as autoimmune diseases and they still don't have an answer, just that it's chronic fatigue syndrome. Ever since I got this vaccine I have not been the same person. My family had to sit back and watch me change from an energy filled girl to someone who could sleep forever and has joint pain so bad sometimes she can't move. Diet changes, exercise and pills haven't helped. None of this was ever present until AFTER I received the GARDASIL vaccine.
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Borrelia test negative, Chronic fatigue syndrome, Fatigue, Feeling abnormal
Clinical narrative: My life changed forever in 2012. My mother and I thought we were making the right choice. I received the 3 part series of the GARDASIL vaccine starting in February of 2012 and through August of 2012. After the vaccine, I started sleeping so much and my menstrual cycles worsened. I had massive mood swings and I never felt good or had energy the same ever again. In February of 2013, I was diagnosed with Chronic Fatigue Syndrome. I have been tested negative for Lyme and all other autoimmune diseases, as well as blood panels and CBC counts. After visiting several doctors, they asked if I got the GARDASIL vaccine and determined from other reports of side effects in the area that my CFS was a result of a vaccine injury from the GARDASIL. Over the years this has gotten worse, into my college years now I experience severe joint pain, muscle aches, exhaustion after completing simple tasks, lack of motivation, etc. I am still being tested every year for things such as autoimmune diseases and they still don't have an answer, just that it's chronic fatigue syndrome. Ever since I got this vaccine I have not been the same person. My family had to sit back and watch me change from an energy filled girl to someone who could sleep forever and has joint pain so bad sometimes she can't move. Diet changes, exercise and pills haven't helped. None of this was ever present until AFTER I received the GARDASIL vaccine.
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Hypersomnia, Immunology test normal, Menstrual disorder, Mobility decreased
Clinical narrative: My life changed forever in 2012. My mother and I thought we were making the right choice. I received the 3 part series of the GARDASIL vaccine starting in February of 2012 and through August of 2012. After the vaccine, I started sleeping so much and my menstrual cycles worsened. I had massive mood swings and I never felt good or had energy the same ever again. In February of 2013, I was diagnosed with Chronic Fatigue Syndrome. I have been tested negative for Lyme and all other autoimmune diseases, as well as blood panels and CBC counts. After visiting several doctors, they asked if I got the GARDASIL vaccine and determined from other reports of side effects in the area that my CFS was a result of a vaccine injury from the GARDASIL. Over the years this has gotten worse, into my college years now I experience severe joint pain, muscle aches, exhaustion after completing simple tasks, lack of motivation, etc. I am still being tested every year for things such as autoimmune diseases and they still don't have an answer, just that it's chronic fatigue syndrome. Ever since I got this vaccine I have not been the same person. My family had to sit back and watch me change from an energy filled girl to someone who could sleep forever and has joint pain so bad sometimes she can't move. Diet changes, exercise and pills haven't helped. None of this was ever present until AFTER I received the GARDASIL vaccine.
Sex: F
Vaccine: HPV4
Symptoms: Mood swings, Myalgia
Clinical narrative: My life changed forever in 2012. My mother and I thought we were making the right choice. I received the 3 part series of the GARDASIL vaccine starting in February of 2012 and through August of 2012. After the vaccine, I started sleeping so much and my menstrual cycles worsened. I had massive mood swings and I never felt good or had energy the same ever again. In February of 2013, I was diagnosed with Chronic Fatigue Syndrome. I have been tested negative for Lyme and all other autoimmune diseases, as well as blood panels and CBC counts. After visiting several doctors, they asked if I got the GARDASIL vaccine and determined from other reports of side effects in the area that my CFS was a result of a vaccine injury from the GARDASIL. Over the years this has gotten worse, into my college years now I experience severe joint pain, muscle aches, exhaustion after completing simple tasks, lack of motivation, etc. I am still being tested every year for things such as autoimmune diseases and they still don't have an answer, just that it's chronic fatigue syndrome. Ever since I got this vaccine I have not been the same person. My family had to sit back and watch me change from an energy filled girl to someone who could sleep forever and has joint pain so bad sometimes she can't move. Diet changes, exercise and pills haven't helped. None of this was ever present until AFTER I received the GARDASIL vaccine.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This Spontaneous case, initially received on 17-Apr-2017, was reported by pharmacist and concerns a 74-years-old elderly female patient. The patient's drug history included unspecified pneumococcal vaccine (route of administration, anatomical location, dosage, batch number: not reported). Indication was not reported. Administration of Company suspect drug: On 14-Nov-2016, the patient was administrated by AFLURIA (TIV) (route of administration, dosage, batch number, expiration date: not reported and anatomical location: arm). Administration of Co-suspect drugs: On 14-Nov-2016, the patient was administrated by PNEUMOVAX 23 (batch number: M037669, expiration date: 05-Sep-2018, route of administration, dosage: not reported and anatomical location: arm). On an unspecified date, the patient was administrated by PREVNAR 13 (route of administration, anatomical location, dosage, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On 14-Nov-2016, after administration PNEUMOVAX 23, the patient was also administered AFLURIA (TIV) on the same day, in the same arm, the patient experienced redness at injection site, pain at the injection site, swelling at the injection site, hardness at the injection site. Symptoms has spread to the joint in her inner elbow and patient has not been sleeping well because of symptoms. The action taken with influenza vaccine was not reported. The outcome of the events was Not recovered/Not resolved. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and events. This report was not serious.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint stiffness, Joint swelling, Poor quality sleep
Clinical narrative: This Spontaneous case, initially received on 17-Apr-2017, was reported by pharmacist and concerns a 74-years-old elderly female patient. The patient's drug history included unspecified pneumococcal vaccine (route of administration, anatomical location, dosage, batch number: not reported). Indication was not reported. Administration of Company suspect drug: On 14-Nov-2016, the patient was administrated by AFLURIA (TIV) (route of administration, dosage, batch number, expiration date: not reported and anatomical location: arm). Administration of Co-suspect drugs: On 14-Nov-2016, the patient was administrated by PNEUMOVAX 23 (batch number: M037669, expiration date: 05-Sep-2018, route of administration, dosage: not reported and anatomical location: arm). On an unspecified date, the patient was administrated by PREVNAR 13 (route of administration, anatomical location, dosage, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On 14-Nov-2016, after administration PNEUMOVAX 23, the patient was also administered AFLURIA (TIV) on the same day, in the same arm, the patient experienced redness at injection site, pain at the injection site, swelling at the injection site, hardness at the injection site. Symptoms has spread to the joint in her inner elbow and patient has not been sleeping well because of symptoms. The action taken with influenza vaccine was not reported. The outcome of the events was Not recovered/Not resolved. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and events. This report was not serious.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Right upper leg redness noted day after vaccines administered. Also 2 blistered areas noted in the reddened area on Right upper anterior leg. Treated with cephalexin 250 mg/5 mg suspension 10ml. by mouth 2 times a day for 7 days. This 4 year old male is brought in by his father this morning for concerns of redness and blistering of his right anterior thigh. Patient was given DTAP/IPV vaccinations on Wednesday. Dad noticed the following morning some redness about the size of his palm. This redness increased circumferentially throughout the day and two blisters appeared. This morning he is seeking recommendations. Patient has no complaints of pain, itching, fever, cough, runny nose, sore throat, nausea, vomiting or diarrhea. He is sleeping well. Appetite unchanged. Activity level is unchanged. No outpatient prescriptions have been marked as taking for the 6/16/18 encounter (Office Visit) with PA. No known allergies.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Erythema, Lip swelling, Pruritus, Vomiting
Clinical narrative: Within 5 minutes of vaccines, had vomiting, redness to skin, swollen lip and itching, gave EPI and BENADRYL and sent to ER for anaphylaxis reaction.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 6/20/18 1515 Mom phoned today stating patient starting vomiting yesterday afternoon. Mom states she had just given a small amount of applesauce prior to the vomiting. No fever, no rash. Acting normally between episodes of vomiting. Having normal wet diapers. Mom will offer PEDIALYTE, monitor wet diapers, and have patient seen for any worsening.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Headache, Lethargy, Malaise
Clinical narrative: Dizziness-neck and head pain-falling-lethargy-general malaise.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Dizziness-neck and head pain-falling-lethargy-general malaise.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Skin warm, X-ray normal
Clinical narrative: Arm very sore for 6 months. Lost some movement of arm for some time. Fever in arm for several days. Still hurts at times now. 2 rounds of steroids 1 wk, 1 month-X-ray.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 696416) on 08-Aug-2017, concerns a 52-year-old male patient. The patient had no medical history and current illness. On 28-Sep-2016, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 29-Sep-2016, after 1 day of vaccination, the patient experienced sore shoulder, limited shoulder mobility and was diagnosed with adhesive capsulitis of shoulder on the same day by primary care physician. At the time of this report, the patient had not yet recovered from the event. The health authority assessed the report as non-serious. Significant case correction received on 17-Aug-2017: The as determined causality for the event (adhesive capsulitis of shoulder) was corrected from unassessable to related.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dizziness postural, Nausea, Vomiting
Clinical narrative: This initial spontaneous case, received from other non-health care professional via regulatory authority (VAERS ID: 696831) on 07-Aug-2017, concerning a 24-year-old female patient. The patient had no relevant medical history and current illness. On an unspecified date (5 years ago), the patient had received AFLURIA vaccine and had been receiving intranasal flu vaccine very year (since on an unspecified date until this year). It was reported that, the patient had no known drug allergy. 04-Nov-2016, approximately 10:30 hours, the patient had received AFLURIA vaccine (dose: 0.5 (reported as 1), route of administration: intramuscular, anatomical location, batch number, expiry date: not reported). On the same day, after vaccination, approximately between 11:00 to 11:15 hours, the patient felt dizzy, lightheaded with nausea and had approximately 6 episodes of vomiting. Vomitus was non-bilious and non-blood. Her dizziness got worsened on standing. The patient had no wheezing, shortness of breath or feeling of her throat closing, hives, urticaria and swelling of tongue or lip. It was reported approximately at 14:00 hours, the patient went to clinic. The outcome of the events was recovered. The health authority assessed the case as non-serious.