chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Cystitis interstitial, Cystoscopy, Drug interaction, Echocardiogram, Ejection fraction decreased
Clinical narrative: My daughter had UTI symptoms starting in March of 2016. Had third dose of GARDASIL in June of 2016. Doctor kept treating her with antibiotics even though no bacteria showed up in urine. She was better until July of 2016 when she thought she had another UTI and was given more antibiotics. Was ok until Dec of  2016 when the symptoms came roaring back. More antibiotics to no avail and GP told her to see a urologist. Urologist paid basically no attention to her but gave her more antibiotics even though no bacteria and also URIBEL. The pain and frequency was so horrendous that she went to her GP for something for her anxiety. The mixture of the URIBEL and PROZAC sent her into serotonin syndrome causing seizures and possible death. She was hospitalized for 6 days and had an EF fraction of 30. As soon as I got her out of hospital I took her to Clinic for heart and bladder. Her heart function is still low and she was diagnosed with interstitial cystitis. The doctor could not believe that a 19 year old would have this condition.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Nuclear magnetic resonance imaging heart, Pain, Seizure, Serotonin syndrome
Clinical narrative: My daughter had UTI symptoms starting in March of 2016. Had third dose of GARDASIL in June of 2016. Doctor kept treating her with antibiotics even though no bacteria showed up in urine. She was better until July of 2016 when she thought she had another UTI and was given more antibiotics. Was ok until Dec of  2016 when the symptoms came roaring back. More antibiotics to no avail and GP told her to see a urologist. Urologist paid basically no attention to her but gave her more antibiotics even though no bacteria and also URIBEL. The pain and frequency was so horrendous that she went to her GP for something for her anxiety. The mixture of the URIBEL and PROZAC sent her into serotonin syndrome causing seizures and possible death. She was hospitalized for 6 days and had an EF fraction of 30. As soon as I got her out of hospital I took her to Clinic for heart and bladder. Her heart function is still low and she was diagnosed with interstitial cystitis. The doctor could not believe that a 19 year old would have this condition.
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: My daughter had UTI symptoms starting in March of 2016. Had third dose of GARDASIL in June of 2016. Doctor kept treating her with antibiotics even though no bacteria showed up in urine. She was better until July of 2016 when she thought she had another UTI and was given more antibiotics. Was ok until Dec of  2016 when the symptoms came roaring back. More antibiotics to no avail and GP told her to see a urologist. Urologist paid basically no attention to her but gave her more antibiotics even though no bacteria and also URIBEL. The pain and frequency was so horrendous that she went to her GP for something for her anxiety. The mixture of the URIBEL and PROZAC sent her into serotonin syndrome causing seizures and possible death. She was hospitalized for 6 days and had an EF fraction of 30. As soon as I got her out of hospital I took her to Clinic for heart and bladder. Her heart function is still low and she was diagnosed with interstitial cystitis. The doctor could not believe that a 19 year old would have this condition.
Sex: M
Vaccine: TDAP
Symptoms: Limb mass, Nodule
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of upper extremity mass in a adult male patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a month after receiving dTpa vaccine, the patient experienced upper extremity mass. On an unknown date, the outcome of the upper extremity mass was unknown. The reporter considered the upper extremity mass to be possibly related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient's daughter's Obstetrics and Gynaecology told the reporter and her husband to go and get the TDAP injection since; the Obstetrics and Gynaecology would keep her daughter when she went back to work. The patient got vaccinated at work. Since he worked at the hospital, it was mandatory but it had been about a month since he got the vaccination and still has a knot on his arm. The reporter guessed she would have to go to the health department to get the vaccination.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Blister at injection site. Band Aid brand Curad Latex fee SANS free cloth Band Aid.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received FLUARIX at the pharmacy on 9/12/17. She "stopped by" on 9/14/17 since she was in the store to show me her arm which had a softball sized, unraised red area that was a little warm to the touch. She stated she was not concerned, but she has had flu shots in the past and never any problems. I asked her if it seemed to be getting worse at this point and she stated it did not. I told her it seemed very localized and did not seem to be anything to cause great alarm at this time, to try applying a cold compress and if it seems to get worse instead of better, to give her PCP a call. She states no allergies. I plan to give her a follow-up call tomorrow.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Nausea
Clinical narrative: Patient had a warmed, itchy, and reddened area to the right deltoid. Patient denies fever and chills. Patient reports nausea this morning. Patient was sent to Emergency Department for follow up.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash
Clinical narrative: Pt has a rash that has been expanding.  She is also feeling a lot of pain.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: In arm where pt received TDaP and PNEUMOVAX the arm became really red and swollen, said doing better on Monday and taking MOTRIN. On Tuesday 10 AM, said going to MD to get something to bring swelling down. Described it as a large red band around his left arm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: Within 4 hours, my left arm below the injection site became swollen, red, and warm to the touch. Arm was uncomfortable due to the stretching of the skin. Redness, swelling, and warmth continued to move down the arm to below the elbow. By day four after the vaccine, the systems have nearly resolved.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Within 4 hours, my left arm below the injection site became swollen, red, and warm to the touch. Arm was uncomfortable due to the stretching of the skin. Redness, swelling, and warmth continued to move down the arm to below the elbow. By day four after the vaccine, the systems have nearly resolved.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006040: US-009507513-1709USA006041: US-009507513-1709USA006042: US-009507513-1709USA006043: US-009507513-1709USA006044: US-009507513-1709USA006045: US-009507513-1709USA006057: US-009507513-1709USA006047: US-009507513-1709USA006048: US-009507513-1709USA006049: US-009507513-1709USA006050: US-009507513-1709USA006051: US-009507513-1709USA006052: US-009507513-1709USA006053: US-009507513-1709USA006054: US-009507513-1709USA006055: US-009507513-1709USA006056: US-009507513-1709USA006039: US-009507513-1709USA006038: US-009507513-1709USA006046.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # L014427 with expiry date on 09-MAR-2018, lot # L030869 with expiry date on 08-JUN-2018, lot # L042836 with expiry date on 24-AUG-2018, and lot # N001348 with expiry date on 31-OCT-2019 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit for 15 days. Data logger was involved in recording the excursion details. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007335: US-009507513-1709USA007336.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with VARIVAX injection, lot # N012488 with expiration date on 20-APR-2019; lot # M038857 with expiration date on 14-SEP-2018 and lot # N007930 with expiration date on 08-MAR-2019 (dose and route of administration were not reported). The doses of vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of VARIVAX experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 14 hours and 54 minutes. There were no previous temperature excursions. Digital data logger was involved in recording the excursion. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with ROTATEQ lot # M041768, expiration date 25-JUN-2018, orally (dose unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 6 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. From 03-SEP-2017 (also reported as "starting on or after 03-SEP-2017"), the patients were vaccinated with improperly stored doses of VARIVAX lot # M047662 with expiration date 02-DEC-2018, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included STERILE DILUENT. No adverse effect was reported. It was stated that the temperature was between 15 and 46 Fahrenheit degrees with a time frame of 2 hours and 50 minutes. The call was made because a data logger. No previous temperature excursion was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored ROTATEQ (strength, lot # and expiration date were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004085: US-009507513-1709USA007306: US-009507513-1709USA007304: US-009507513-1709USA007305.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored PEDVAXHIB (strength, lot #, expiry date and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007303: US-009507513-1709USA007306: US-009507513-1709USA004085: US-009507513-1709USA007305.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a  multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of VAQTA (strength, route, lot # and expiration date  were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Farenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007303: US-009507513-1709USA007306: US-009507513-1706USA002054: US-009507513-1709USA004085:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored RECOMBIVAX HB (strength, lot #, expiration date and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Farenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007303: US-009507513-1709USA004085: US-009507513-1709USA007304: US-009507513-1709USA007305:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # M036059 with expiry date on 03-JUN-2019, lot # M044717 with expiry date on 19-JUL-2019, lot # N000326 with expiry date on 14-OCT-2019, and lot # N013276 with expiry date on 21-JAN-2020 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit for 15 days. Data logger was involved in recording the excursion details. There were no previous excursions reported. This is one of several reports received from the same reporter. Lot number N013276 has been verified to be a valid lot number for GARDASIL 9. Sender's Comments: US-009507513-1709USA004696: US-009507513-1709USA007336.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot # M037533 with expiry date on 07-MAY-2018, and lot # N010109 with expiry date on 20-NOV-2018 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit for 15 days. Data logger was involved in recording the excursion details. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007335: US-009507513-1709USA004696.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site induration, Nausea
Clinical narrative: 8 cm area of induration and erythema (L) deltoid. Decreased ROM of (L) arm due to pain. No adenopathy palpated in axilla and cervical regions. C/o nausea, headache and photophobia. Afebrile, VS stable. No nuchal rigidity. Denied fainting, dizziness, seizure, vomiting.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Pain in extremity, Photophobia
Clinical narrative: 8 cm area of induration and erythema (L) deltoid. Decreased ROM of (L) arm due to pain. No adenopathy palpated in axilla and cervical regions. C/o nausea, headache and photophobia. Afebrile, VS stable. No nuchal rigidity. Denied fainting, dizziness, seizure, vomiting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Skin lesion
Clinical narrative: Patient returned to the pharmacy three days after receiving ZOSTAVAX vaccine with an obvious and classical shingles infection. The infection followed a dermatome from the right side of her neck down her arm to the palms of her right hand. There were several painful lesions and patient has had cold chills. The patient was told she needs to be seen by a doctor for the infection.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: The patient came in for a Dtap vaccine. I gave a Tdap unintentionally. The patient  had no symptoms and tolerated injection well. I spoke with two doctors at our office who researched the vaccines and stated to me that the patient would not need another dose of dtap and should have no adverse reaction to the vaccine. the patients mother was notified.
Age: 10.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient develop big red circle around injection area, keep getting bigger warm to the touch.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Patient was given the vaccine around 9 am on 08/29/2017 during a routine office visit then sent home - no complaints when administered vaccine tolerated well. Patient presented to the office around 3 pm same day complaining of red swollen area on arm where the vaccine was given. Patient was seen by the provider treated with Benadryl and send home.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient was given the vaccine around 9 am on 08/29/2017 during a routine office visit then sent home - no complaints when administered vaccine tolerated well. Patient presented to the office around 3 pm same day complaining of red swollen area on arm where the vaccine was given. Patient was seen by the provider treated with Benadryl and send home.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Cyanosis, Death, Fatigue, Immediate post-injection reaction
Clinical narrative: Immediately during and after the shots, she was crying. Right after, she was very tired and drowsy. She fell asleep in the car on the way home. Napped for a very short time during the evening and was kind of fussy which was not normal for her. She was fed at around 9:30 PM that evening and fell asleep right after so she was laid down on her back in her crib. She was checked on at 11:30 and 12, still sleeping on her side. She was checked on at 6 the following morning and was face down. When she was flipped over she was all blue/discolored with fluids coming out of her nose. When EMS arrived, no resuscitation attempts were made.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Resuscitation, Rhinorrhoea, Skin discolouration, Somnolence
Clinical narrative: Immediately during and after the shots, she was crying. Right after, she was very tired and drowsy. She fell asleep in the car on the way home. Napped for a very short time during the evening and was kind of fussy which was not normal for her. She was fed at around 9:30 PM that evening and fell asleep right after so she was laid down on her back in her crib. She was checked on at 11:30 and 12, still sleeping on her side. She was checked on at 6 the following morning and was face down. When she was flipped over she was all blue/discolored with fluids coming out of her nose. When EMS arrived, no resuscitation attempts were made.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: Inconsolable crying and screaming after the vaccine was given.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: ON TUESDAY - 9/12/17 SHE C/O MINOR POST FLU VACCINNATION REACTIONS - SORE ARM, MUSCLE ACHES, HEADACHE ; ON WEDNESDAY - 9/13/17 C/O MORE SEVERE REACTION = NAUSEA / DIZZINESS / HEAD SPINNING / TONGUE SWELLING -- > DENIED DIFFICULTY BREATHING IN THE THROAT OR SWALLOWING, BUT FELT TIGHTNESS IN THE CHEST WITH DEEP INSPIRATION.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Swollen tongue, Vertigo
Clinical narrative: ON TUESDAY - 9/12/17 SHE C/O MINOR POST FLU VACCINNATION REACTIONS - SORE ARM, MUSCLE ACHES, HEADACHE ; ON WEDNESDAY - 9/13/17 C/O MORE SEVERE REACTION = NAUSEA / DIZZINESS / HEAD SPINNING / TONGUE SWELLING -- > DENIED DIFFICULTY BREATHING IN THE THROAT OR SWALLOWING, BUT FELT TIGHTNESS IN THE CHEST WITH DEEP INSPIRATION.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, tenderness, redness three days after injection.
Age: 0.75
Sex: M
Vaccine: PNC13
Symptoms: Head banging, Speech disorder
Clinical narrative: Banging head on crib rails that evening and for a few days after vaccine. Decrease in speech that day and for a few days later. His behavior resumed back to normal about a few days after vaccine.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: AFTER PT WAS INJECTED WITH THE IMMUNIZATION, HE BLACKED OUT FOR A FEW SECONDS.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: The next morning the patient had experienced cramping in the stomach, severe nausea, and vomiting. The abdominal cramps lasted for 2 days...
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Complained of soreness at injection site at 7:30 PM on day of injection (9/13/17). On morning of 9/14/17, prior to school at about 6:55AM, complained of soreness and heaviness, stated she was unable to lift arm. Mom looked at site, stated there was no redness or swelling, not hot to touch. At 12:30PM on 9/14/17, communicated with mom via text that arm was "a little" better, still felt heavy and could not lift. Stated that she was staying for basketball open gym.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: Constant itching at the injection site.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Injection site pruritus, Swollen tongue
Clinical narrative: Patient reports itching at vaccine site, followed by swelling of tongue and eyes. Itching started in the evening after vaccination. Swelling of tongue and eyes occurred while patient was sleeping.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received the vaccine on 09/13/2017 at 945 am tolerated injection well, sent home. Called the clinic around 4 pm that afternoon complaining of sore, swollen arm. Instructed to use ice to area and take pain reliever for the pain and call back in the am with an update. Patient presented to the clinic on 09/14/2017 with a red, swollen, warm painful arm from the injection. Patient was examined by out provider and instructed to use Benadryl and ice and elevation follow up in the am.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received the vaccine on 09/13/2017 at 945 am tolerated injection well, sent home. Called the clinic around 4 pm that afternoon complaining of sore, swollen arm. Instructed to use ice to area and take pain reliever for the pain and call back in the am with an update. Patient presented to the clinic on 09/14/2017 with a red, swollen, warm painful arm from the injection. Patient was examined by out provider and instructed to use Benadryl and ice and elevation follow up in the am.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis: treated with Prednisone 30mg & Acyclovir 800mg.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has red and swollen lower arm, well below the injection site and on the inside of the upper arm.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Eye pain, Headache, Photophobia
Clinical narrative: Pt complained with having severe headaches, vision pain, light sensitivity.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm is red, hot and swollen about 5 inches in diameter. Patient was at her dermatologist who first noticed it (patient did not have any discomfort). Dermatologist dismissed it. Patient called and was right next to Dr.'s office, I told her to have him take a look at it. I spoke to the nurse who stated Dr. said to use a cold compress and some advil if needed. I asked if I should report it via VAERS and she stated no. Patient came into pharmacy at 2:30 and due to the large area, I feel it needs to be reported.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Feeling hot, Paraesthesia, Paraesthesia oral
Clinical narrative: PATIENT REPORTED LIGHT-HEADEDNESS AND DIFFICULTY BREATHING (BUT NOT SWELLING IN THE FACE, MOUTH, OR THROAT) STARTING ABOUT 5 MINUTES AFTER VACCINE ADMINISTRATION. NO VISIBLE RASH OR HIVES BUT PATIENT REPORTED FEELING WARM AND THAT HER HANDS AND LATER LIPS WERE TINGLY. 911 WAS CALLED, FIRST RESPONDERS MONITORED BLOOD PRESSURE, PULSE RATE, AND O2 SATURATION. ADMINISTERED IV DIPHENHYDRAMINE. PATIENT REPORTED FEELING BETTER SHORTLY THEREAFTER. PATIENT WAS MONITORED ABOUT 30 MINUTES AND THEN RETURNED TO WORK.
Age: 33.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Musculoskeletal pain
Clinical narrative: Vaccine x2 as above on 9Sept17, soreness to arm and shoulder began 10Sept17 mid-afternoon and progressively got worse through the evening. Woke up 11Sept w limited to no ROM of Left arm/shoulder. Job is construction work. Unable to function in his line of work and called in sick Mon and Tues (12Sept). On Mon took MOTRIN OTC and used ICY HOT topically with cool compresses to shoulder, without relief. C/O nausea on Mon and Tues as well w/o vomiting. Pain started to subside on Tues mid-afternoon and was able to return to work on 13Sept17. Today c/o pain at injection sites and tenderness to touch, but ROM has returned to normal. No medical tx sought for above conditions. NKDA/NKA, no meds and no significant PMH as identified above. Verified site locations with patient, states injection sites are at least 1 inch apart and approx. 2-3 finger widths from the bony prominence on shoulder. States this Anthrax shot felt different than previous Anthrax vaccines, c/o "numbing sensation" after insertion vs the normal stinging sensation he had remembered in the past. Technician told patient what med he was injecting each time prior to his vaccination (Anthrax vs Typhoid). Information on the Program provided to patient as he was inquiring about any compensation for lost work time d/t requirement. Encouraged to seek medical care if symptoms do not fully resolve.
Age: 33.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Nausea, Pain in extremity
Clinical narrative: Vaccine x2 as above on 9Sept17, soreness to arm and shoulder began 10Sept17 mid-afternoon and progressively got worse through the evening. Woke up 11Sept w limited to no ROM of Left arm/shoulder. Job is construction work. Unable to function in his line of work and called in sick Mon and Tues (12Sept). On Mon took MOTRIN OTC and used ICY HOT topically with cool compresses to shoulder, without relief. C/O nausea on Mon and Tues as well w/o vomiting. Pain started to subside on Tues mid-afternoon and was able to return to work on 13Sept17. Today c/o pain at injection sites and tenderness to touch, but ROM has returned to normal. No medical tx sought for above conditions. NKDA/NKA, no meds and no significant PMH as identified above. Verified site locations with patient, states injection sites are at least 1 inch apart and approx. 2-3 finger widths from the bony prominence on shoulder. States this Anthrax shot felt different than previous Anthrax vaccines, c/o "numbing sensation" after insertion vs the normal stinging sensation he had remembered in the past. Technician told patient what med he was injecting each time prior to his vaccination (Anthrax vs Typhoid). Information on the Program provided to patient as he was inquiring about any compensation for lost work time d/t requirement. Encouraged to seek medical care if symptoms do not fully resolve.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt called 2 days after he got the PNEUMOVAX 23 in his left arm, stating that the arm was warm, red and swollen. He is resting the arm and applying a cold compress. He also marked the outline of the area in order to monitor if it is getting bigger or improving. After 4 hours he said he felt better and that it had not gotten bigger at this time.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site haemorrhage
Clinical narrative: Patient stopped back several days after injection. He mentioned that the night he was given the injection he has bleeding in that arm. Patient is on blood thinner. Pt had a tiny drop of blood from the PREVNAR injection at time given and no bleeding from FLUZONE injection. Patient stated that the blood had dried up and he had no bleeding 1-2 hours after he was given the injection. Later night prior to bed he said his arm was bleeding and was unable to determine if it had been from the vaccine site or something else.  He continued bleeding on and off for 1 day. Two days after getting the injection he stopped by the pharmacy, the pharmacist inspected the site and there was no bleeding at that time. The pharmacist called the patient to follow up the next day and no bleeding at that time.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Body temperature increased, Muscle contracture
Clinical narrative: Temp greater than 105 and muscle contractures.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Dizziness, Heart rate increased, Lip swelling
Clinical narrative: My doctor ordered for me to get a shingles vaccination. I received Rx at pharmacy. Less than an hour later, already at home, I started getting dizzy, got chills, and rapid heart beat. I called my allergist and was recommended to take 5 mg Prednisone and BENADRYL. Next day, September 2, my lips got swollen. My BP went up to 187/110. I took another Prednisone (only 5 mg) and BENADRYL x2 for three more days. It took me a week to finally start feeling better. I checked with pharmacy and my doctor and was told that I needed to report my reaction.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Confusional state, Headache, Pyrexia, Respiratory distress
Clinical narrative: 8-31-17 (315pm) administered FLUZONE by Pharmacy. 9-1-17 adverse effect low grade fever, chills, headache, slight respiratory distress. Slight confusion. Symptoms ceased 9-5-17. First time I received this new vaccine over 65 yr old.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 24-AUG-2017 from a pharmacist regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unspecified dates in August 2017, an unspecified number of patients were vaccinated with doses of ZOSTAVAX lot # N012615 expiration 16-MAR-2018, subcutaneous for prophylaxis which were improperly stored. Concomitant therapies included sterile diluent (STERILE DILUENT) which was stored properly. The vaccines were stored at temperatures between 15 degrees Fahrenheit to 46 degrees Fahrenheit for the cumulative time of 10 hours and 8 minutes. The vaccines were stored at temperatures between 15 degrees Fahrenheit to 46 degrees Fahrenheit for the time frame of 5 hours and 30 minutes and a previous temperature excursion of temperatures between 15 degrees Fahrenheit to 46 degrees Fahrenheit (36.3 degrees Fahrenheit) for 4 hours and 38 minutes. The call was made due to a data logger. No adverse effects were reported. No further information provided. Additional information is not expected. No permission to contact.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Information was received on 25-AUG-2017 from a field representative reporting for a physician regarding a 14-year-old female with no known medical history and no concomitant medications who received a dose of GARDASIL 9 (Lot# M014929, exp. 27-MAY-2017) on 23-AUG-2016 and a second dose of GARDASIL 9, (Lot# M016193, exp. 24-APR-2018) on 10-OCT-2016 for prophylaxis. It was reported that a few days after the second dose the patient reported "breaking out in hives on her arms and belly." No treatment was provided. The patient recovered from this event. The patient no longer has the hives. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On 12-SEP-2017, the patient was vaccinated with an expired dose of VARIVAX 0.5 ml, once, subcutaneously, lot number L002216, expiration date 21-JAN-2017, for prophylaxis. Concomitant therapies included a sterile diluent (lot number M001834, expiration date 08-MAR-2018), which was used to reconstitute the vaccine. At the reporting time, no adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's age, medical history and concurrent conditions were not provided. On or about 23-AUG-2012, at a pharmacy the patient was vaccinated with ZOSTAVAX, (route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 24-MAY-2016, the patient was treated by a physician at a medical center for a vesicular outbreak that was diagnosed as shingles. The patient has been prescribed VALTREX to attempt to manage and relieve her painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuritis, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 01-FEB-2007, at the Department of Public Health, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 13-MAR-2007, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles accompanied by post-herpetic neuritis. The patient was prescribed mupirocin calcium (BACTROBAN), valacyclovir hydrochloride (VALTREX) and Lidocaine cream for the management of her painful symptoms and herpetic complications. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information was from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 23-APR-2013, at a pharmacy, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles.  It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster.  On or about 07-APR-2016, the patient was treated by a physician for a painful outbreak that was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient came back with complaint of pain and swelling in arm. Md prescribed hydrocortisone 0.5% ointment to apply over area.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Patient received HPV #3 and Flu today and fainted shortly after.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Mucous stools, Pyrexia, Urticaria
Clinical narrative: He developed a low-grade fever that evening (5/9/17) after his shot (which I understand is a normal reaction). However, that morning he pooped mucous. Shortly after the odd mucous type of bowel movement, he developed hives that was all over his body and face. The hives lasted for three weeks. After two weeks of no improvement Dr. advised I apply hydrocortisone to help him with the hives. A week later they subsided.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reported having arm pain in her left arm that was shooting dorn her entire arem and into her neck. She tried ice on the site of injection and hot packs as well so see if the pain is relieved. She contacted her friend who was a nurse and the nurse expained the patient that sometimes when the nerve is hit in the process of injecting the vaccination this can happen.  Pt has been feeling better as of 09/14/2017.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient reported having arm pain in her left arm that was shooting dorn her entire arem and into her neck. She tried ice on the site of injection and hot packs as well so see if the pain is relieved. She contacted her friend who was a nurse and the nurse expained the patient that sometimes when the nerve is hit in the process of injecting the vaccination this can happen.  Pt has been feeling better as of 09/14/2017.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Loss of consciousness, Peripheral swelling, Syncope, Urticaria
Clinical narrative: Reaction to PNEUMOVAX 23. Pt reporting pain at site of vaccination approx. 7hrs after receiving. The next morning pt's arm was swollen, red w/ hives and unconscious after fainting. EMS responded to pt.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain
Clinical narrative: Reaction to PNEUMOVAX 23. Pt reporting pain at site of vaccination approx. 7hrs after receiving. The next morning pt's arm was swollen, red w/ hives and unconscious after fainting. EMS responded to pt.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Mobility decreased, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Patient reported severe arm soreness, "hardly able" to raise arm for two days. Hives and area warm to the touch, malaise for several hours.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Dysphonia, Throat irritation, Throat tightness
Clinical narrative: Patient reported prior to getting vaccinated that the last time she had these vaccines (10AUG2017) she had an anaphylactic reaction 24 hours after. Pt states that she saw an allergist and was tested for food allergies. Pt states all allergy tests came back negative, but the doctor was doubtful that the reaction was caused by the MMR and Varicella vaccinations that she received because the reaction was so delayed. Upon hearing this from the patient I told her that she needed to sit in the lobby for 30 minutes after vaccine was administered. The vaccine was given at 0928. At 1000, she reported feeling itchiness in her throat. Patient was coughing mildly. Patient's voice was getting hoarse. Patient was brought to the acute care area. Patient started to cough more, and was complaining of more itchiness and feeling more constricted. Patient's voice was very hoarse at this point. Duty RN approved the administration of auto-inject epinephrine. The EPIPEN was administered by myself at 1010. Emergency services were called so that she could be transported via ambulance to the emergency room. Paramedics arrived and approved administration of 1ML of 50 MG BENADRYL, which was administered by myself at 1020 in the left arm IM deltoid. Patient was then turned over to the paramedics for transport.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Decreased appetite, Pain in extremity, Peripheral swelling
Clinical narrative: Stomach upset leading to loss of appetite, Arm pain with swelling lasting for days. Symptoms started the day of vaccine administration, when they did not stop patient chose to visit doctor. She was given a medrol pack to help with symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site irritation, Rash vesicular
Clinical narrative: Vesicle rash on left face, neck, chest and left arm. 1" redness and irritation at injection site left arm. Patient also complains of dizziness today.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Large knot, redness, and warmth at site.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Patient experienced some facial swelling to the left side of her face along the jawline, where her jawline meets her ear. Patient came back to the pharmacy to purchase some Benadryl as she was advised to do by her doctor's office.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3 inch swelling, puffy, red areas around injection.