chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: After going to the gym 2 days after receiving the Shingrix shot, I developed a rash on areas of my body where I sweated a lot - inside of upper arm, under breasts, around waist where waistband of gym pants hit. The rash was red and itched and was like those I have suffered from in the past due to wearing black clothes without washing them first. In the past when under stress, I have had a similar rash when I have been hot and have sweated and seemed to be allergic to my onw sweat.  I treated the rash with OTC hydrocortisone rather than using stronger prescription-strength steroid cream as it covered large areas of my body and I did not want to put so much steroids on my skin at one time.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient had visible redness which radiated down her arm about 3 inches from where the vaccine was given. Patient takes a daily meloxicam which helped with the inflammation response. Recommended patient start diphenhydramine as well to limit the injection site reaction.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash macular
Clinical narrative: Patient states she woke up next morning after vaccine and had blotches on her chest and arms that were raised and itchy. She spoke with her doctor today and was advised to take Benadryl 3 times a day because symptoms were not resolving.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Paraesthesia, Pyrexia
Clinical narrative: 24 hours later, at about 2:00 PM,  I began to run a fever which reached 102 by about 6:00 PM.  It began to subside about 10:00 PM and temperature was normal the next day. Five days after the injection a raised red rash with some itchiness, developed around the injection site.  It's almost gone now, the next day.  I have some mild itchiness persisting and I have some random, infrequent pin prick sensations on some recurrent sites of my body.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient had contacted his healthcare provider the day following his vaccination stating that his left arm was numb from the shoulder down to his hand and he was in a lot of pain. He states it started a few hours after the vaccination. They instructed him to go to walk in care, but patient said he is not able due to the pain in his arm and has no way for someone to get him there as he lives in an assisted living/senior center. They were going to call him back and advise him to call 911 if symptoms got worse, etc. We called the patient a few times in the days following the incident, each time he stated it is slowly getting better, although still somewhat stiff and slightly painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Feeding disorder, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Patient described the event:  the next morning and all day on the 17th not being able to move or eat.  Bedridden in body pain for the whole day, says she couldn't even feed herself.  She also threw up.  She had to have her son help her out by feeding her.  Then after a day some of  her strength returned, but entire right arm is still terribly sore 5 days later.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Patient described the event:  the next morning and all day on the 17th not being able to move or eat.  Bedridden in body pain for the whole day, says she couldn't even feed herself.  She also threw up.  She had to have her son help her out by feeding her.  Then after a day some of  her strength returned, but entire right arm is still terribly sore 5 days later.
Age: 79.0
Sex: M
Vaccine: TD
Symptoms: Mobility decreased, Swelling
Clinical narrative: Swelling of the shoulder and immobility upon lifting the arm upward starting after the vaccination and persisting to 07/21/2019. Patient advised to follow up with primary care provider.
Age: 26.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The Tdap vaccine was administered intravenously instead of intramuscularly on 7/17/19 @ 1742. The patient did not experience any adverse events. Patient advised to see his primary care physician in the next week to receive a Tdap intramuscularly.
Age: 26.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: The Tdap vaccine was administered intravenously instead of intramuscularly on 7/17/19 @ 1742. The patient did not experience any adverse events. Patient advised to see his primary care physician in the next week to receive a Tdap intramuscularly.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: left shoulder pain
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: local reaction consisting of warmth to the touch, redness at injection site. clinic instructed to take benadryl and ice to area. suspected allergic reaction
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient developed a rash from head to toe the day after receiving the immunization. He went to an urgent care and was prescribed both oral and topical steroids.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Fall, Feeling abnormal, Heart rate decreased, Incoherent
Clinical narrative: Not sure if related to vaccine but wonder.  After falling on right knee got very nauseous, faint, blurred vision. Felt like having a stroke. Could not respond, incoherent with eyes open.  911 called and took me to er.  Blood pressure extremely low.  Bottom number was around 40.  Don't remember top number.  Heart beat very low as well.  After laying me downand giving fluids in ambulance went back to normal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury, Laboratory test, Nausea, Syncope, Vision blurred
Clinical narrative: Not sure if related to vaccine but wonder.  After falling on right knee got very nauseous, faint, blurred vision. Felt like having a stroke. Could not respond, incoherent with eyes open.  911 called and took me to er.  Blood pressure extremely low.  Bottom number was around 40.  Don't remember top number.  Heart beat very low as well.  After laying me downand giving fluids in ambulance went back to normal.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Fatigue, Initial insomnia
Clinical narrative: Day 1 - sore arm and becoming ill by night (maybe near midnight).  Day 2  Temperature elevated 2 degrees, chills, itching Left forearm outside in mid area, tired but hard to get to sleep ; Day 3 Rash on both sides of forearm (left backside and right forearm inside near crease in arm with  raised bumps and skin very pink both above and below the crease - and areas were about an inch to 1 1/2 inches), chills continued, had to cover up and fell asleep off and on (naps are not something I do) and went to bed early, tired, very achy body.  Day 4  Although feeling better, the rash on the right inside arm near the crease is continues and lightens the pinkness a bit but other spots are appearing.  NOTE: My husband won't send in a report but he had the two VERY BAD DAYS like I did but no chills but his  rash was in small splotches and the entire length of his  one inside forearm.  I am wondering if this vaccine was not inactivated enough?  I hope the rash will eventually go away.  I knew not to scratch it.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Day 1 - sore arm and becoming ill by night (maybe near midnight).  Day 2  Temperature elevated 2 degrees, chills, itching Left forearm outside in mid area, tired but hard to get to sleep ; Day 3 Rash on both sides of forearm (left backside and right forearm inside near crease in arm with  raised bumps and skin very pink both above and below the crease - and areas were about an inch to 1 1/2 inches), chills continued, had to cover up and fell asleep off and on (naps are not something I do) and went to bed early, tired, very achy body.  Day 4  Although feeling better, the rash on the right inside arm near the crease is continues and lightens the pinkness a bit but other spots are appearing.  NOTE: My husband won't send in a report but he had the two VERY BAD DAYS like I did but no chills but his  rash was in small splotches and the entire length of his  one inside forearm.  I am wondering if this vaccine was not inactivated enough?  I hope the rash will eventually go away.  I knew not to scratch it.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash/hives break out on face, al over body. Lasted 3 days.  Child?s father had a similar reaction after receiving MMR vaccine as a child (approximately 1988)
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate decreased, Hypotension, Sensitive skin
Clinical narrative: Severe headache with  intermittent sharp pains lasting 7+ hours: hypotension (88/50) : decreased pulse (56): decreased body temperature (97): epidermal contact sensitivity
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: hives on stomach and upper thigh (left). injection on 07/18/2019 and noticed hives around 7pm. still present today 07/21/2019
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Fatigue, Headache
Clinical narrative: I have been sick for 18 days now.  I called the pharmacy and got no support there.  Red, hot, swollen arm, fever, chills, tossing & turning in bed, mild nausea, headache, hart to sleep, exhausted, ringing in ears, then more severe nausea, fatigue, malaise, no energy...  I'm sick of being sick!  I thought maybe Shingrix contained thermiasol, but was told no.  But I MUST have been allergic to something in the shot!  I have no idea what I'm sensitive to~ I'm usually healthy and active, and this sucks!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: I have been sick for 18 days now.  I called the pharmacy and got no support there.  Red, hot, swollen arm, fever, chills, tossing & turning in bed, mild nausea, headache, hart to sleep, exhausted, ringing in ears, then more severe nausea, fatigue, malaise, no energy...  I'm sick of being sick!  I thought maybe Shingrix contained thermiasol, but was told no.  But I MUST have been allergic to something in the shot!  I have no idea what I'm sensitive to~ I'm usually healthy and active, and this sucks!
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Skin warm, Tinnitus
Clinical narrative: I have been sick for 18 days now.  I called the pharmacy and got no support there.  Red, hot, swollen arm, fever, chills, tossing & turning in bed, mild nausea, headache, hart to sleep, exhausted, ringing in ears, then more severe nausea, fatigue, malaise, no energy...  I'm sick of being sick!  I thought maybe Shingrix contained thermiasol, but was told no.  But I MUST have been allergic to something in the shot!  I have no idea what I'm sensitive to~ I'm usually healthy and active, and this sucks!
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Increased redness and swelling of thighs.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: The first Shingrix shot was given on 10/22/2018 and caused muscle soreness that lasted about 7 weeks. A few days after the soreness went away, I went back to get the second Shingrix shot on 12/30/2018, but this time the same type of soreness has persisted to this day, i.e., for over 6 months. The pain is mild for most activities but is moderate for a few things like a workout on an elliptical trainer. The soreness is severe when I try to reach behind my back or if I must suddenly use my arm to steady myself on the bus.  The first shot on 12/22/2018 had lot number N79Z5.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's arm was red and warm to the touch at injection site. Arm was also swollen and sore.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site reaction of redness, hot, swollen and painful. After 3 days improvement seen but still red and hot feeling
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Next day patient got redness & some swelling on arm of injection where she received Pneumovax and shingles shot (2 inches apart). Redness has decreased with benadryl OTC but spread slightly about 1 inch. Looks better day #2
Age: 15.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Dyskinesia, Syncope
Clinical narrative: SYNCOPE; DYSKINESIA; Information has been received via the Freedom of Information Act (FOI) on 21-FEB-2018.  This spontaneous report was received from a regulatory authority and refers to a 15-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 20-NOV-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose wa snot reported, lot # N021572, expiration date 01-MAY-2020), intramuscularly in the left arm for prophylaxis.  On 20-NOV-2017, the patient had syncopal like episode with movement of all 4 limbs, which lasted less than 10 seconds. Afterwards, she had completely normal exam results and vitals. The outcome of dyskinesia and syncope was reported as recovered on 20-NOV-2017.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow-up information was received on 19-JUN-2019 from a healthcare professional via the Agency. The patient had no history of adverse event following any vaccination. The patient was vaccinated on 20-NOV-2017 at 13.00. At the time of the vaccination the patient was 15 years old and not pregnant. The patient experienced dyskinesia and syncope on 20-NOV-2017 at 13.00.  Follow-up information was received from the health professional on 15-JUL-2019. On 20-NOV-2017, the patient was also vaccinated with unspecified influenza virus vaccine, intramuscularly in left deltoid, lot # B3ZA5 (formulation, dose, indication and expiration date were not reported). It was reported that physician assistant examined patient 10 minutes and 30 seconds after the incident and vital signs were totally normal. There was no prescription drug required for the experience.  Upon internal review, the event of syncope was considered to be medically significant.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site pain
Clinical narrative: Forearm started swelling rapidly & developed a huge lump & was extremely painful. Started turning black & blue. Took Benadryl & used ice packs but swelling was there even next day. Slowing swelling went down but lump was still there & bruising spread to the whole forearm. MD advised pt to call toll free no. Pt called & left a message & was told they will mail her questionnaire pt came down with shingles now after taking 2 shingles shots.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Herpes zoster, Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: Forearm started swelling rapidly & developed a huge lump & was extremely painful. Started turning black & blue. Took Benadryl & used ice packs but swelling was there even next day. Slowing swelling went down but lump was still there & bruising spread to the whole forearm. MD advised pt to call toll free no. Pt called & left a message & was told they will mail her questionnaire pt came down with shingles now after taking 2 shingles shots.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: 1) Fever, swelling, heat on cite, redness whole upper arm. Sulfamethoxazole 800-160 for 5 days. All symptoms started to come down upon start on 6/21/2019. Most symptoms gone 5 days later. Weak one week later. (1) 99.5 cellulitis
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 1) Fever, swelling, heat on cite, redness whole upper arm. Sulfamethoxazole 800-160 for 5 days. All symptoms started to come down upon start on 6/21/2019. Most symptoms gone 5 days later. Weak one week later. (1) 99.5 cellulitis
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: 1) Fever, swelling, heat on cite, redness whole upper arm. Sulfamethoxazole 800-160 for 5 days. All symptoms started to come down upon start on 6/21/2019. Most symptoms gone 5 days later. Weak one week later. (1) 99.5 cellulitis
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Malaise, Neck pain
Clinical narrative: Headache, body aches, high fever, pain in entire arm on side of injection (left arm), unable to move arm due to extreme throbbing pain, gradually regained use of arm over the next four days, pain radiated into shoulder and upper neck area, felt extremely sick and nonfunctional for about three days. Applied heat to sore arm and took Tylenol for fever and pain.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, body aches, high fever, pain in entire arm on side of injection (left arm), unable to move arm due to extreme throbbing pain, gradually regained use of arm over the next four days, pain radiated into shoulder and upper neck area, felt extremely sick and nonfunctional for about three days. Applied heat to sore arm and took Tylenol for fever and pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Pain during injection-initially dull pain as vaccine was dispensed followed by VERY sharp pain until needle was withdrawn.  Sometime during the next few hours a golf-ball size red area with a clearly defined border appeared, and a knot developed at the injection site.   It was only painful when I touched the area.  I took some acetaminophen.  The following day the red area had doubled in diameter (still with a defined border)and the painful knot was still present.   Other symptoms this day included fatigue and chills.  I took more acetaminophen. The third day (today) the red area appears the same size but with blurry edges and the area is a little less painful.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 13-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 10-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000862: US-009507513-1906USA011674:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 05-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 17-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 28-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012223: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012231: US-009507513-1907USA012222: US-009507513-1907USA012221: US-009507513-1907USA012219: US-009507513-1907USA012220:
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 90-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 06-JUN-2014, the patient was vaccinated by a pharmacist in pharmacy with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) prescribed by a health care provider for the long-term prevention of shingles and zoster-related conditions by healthcare provider. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: The patient had bad rash all over the body and fever; bad rash all over the body and fever; This spontaneous report was received from a medical assistant and refers to a currently 6-year-old female patient. The patient's medical history, concurrent conditions and concomitant medication were unknown to the reporter. The patient had previously experienced an unspecified allergy/drug reaction on measles, mumps and rubella virus vaccine (reported as MMR) (manufacturer unknown) (captured in case # 1907USA012574). On an unspecified date in 2014, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dosing details, route of administration, lot number, and expiry date were not reported) for prophylaxis (reported as vaccine). On an unspecified date in 2014, the patient experienced bad rash all over body (rash generalised) and fever (pyrexia), which lasted for one week. The patient took diphenhydramine hydrochloride (BENADRYL) to treat the events. The patient visited the physician's office and sought medical attention. It was unknown to the reporter, if any lab diagnostics/studies were performed. The patient had recovered from rash generalised and pyrexia on an unspecified date in 2014 (reported as lasted for 1 week). The causality assessment was not reported. No product quality complaint was involved.; Sender's Comments:  US-009507513-1907USA012574:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: unspecified patient received an unspecified dose of GARDASIL 9 "while she was pregnant in her first trimester" on an unknown date; No adverse effects; This spontaneous prospective pregnancy report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On an unknown date, while she was pregnant in her first trimester, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route, site of adminstration, lot# and expiration date were not reported) for prophylaxis. The last menstrual period (LMP) date and estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. No adverse effect were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was vaccinated with a dose of improperly stored GARDASIL 9; No adverse effects reported; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-US-009507513-1907USA007468: US-US-009507513-1907USA007439: US-US-009507513-1907USA005368: US-US-009507513-1907USA010550: US-US-009507513-1907USA010551: US-US-009507513-1907USA010552: US-US-009507513-1907USA010553: US-US-009507513-1907USA010554: US-US-009507513-1907USA010555: US-US-009507513-1907USA010556: US-US-009507513-1907USA010557: US-US-009507513-1907USA010557:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Full blood count, Injection site pain, Injection site reaction
Clinical narrative: his wife "experienced a "fever of 100.5 F, chills, and disorientation; his wife "experienced a "fever of 100.5 F, chills, and disorientation; experienced the same swelling and tenderness in her arm where the shot was given; his wife had a severe, whole body reaction; his wife "experienced a "fever of 100.5 F, chills, and disorientation; experienced the same swelling and tenderness in her arm where the shot was given; experienced a "mild, localized reaction" at the injection site with "swelling and tenderness at the site; experienced a "mild, localized reaction" at the injection site with "swelling and tenderness at the site"; experienced a "mild, localized reaction" at the injection site; This spontaneous report was received from the patient's husband and concerns to a 58 year old female patient. Concomitant therapies included rosuvastatin calcium(CRESTOR). The patient's drug reactions or allergies included penicillin and erythromycin. And the patient don't referred pertinent medical history.   On 18-MAR-2019, the patient was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) as shingles prevention (route of administration, anatomical location, lot number and expiration date were not reported).   On the same date, upon receiving the first dose of zoster vaccine live (ZOSTAVAX) the patient experienced a mild  localized reaction at the injection site (injection site reaction) with swelling (injection site swelling) and tenderness at the site (injection site pain).   On 10-JUL-2019  at 10 or 11 A.M., the patient was vaccinated with the second dose of zoster vaccine live (ZOSTAVAX) as shingles prevention (route of administration, anatomical location, lot number and expiration date were not reported).      On the same day (reported as around 9 P.M), the patient had a delayed reaction, she experienced a severe whole body reaction (injection site reaction),  fever of 100.5° Fahrenheit (F)(pyrexia), chills and disorientation. Also, the patient experienced the same swelling and tenderness in her arm where the shot was given (injection site pain and injection site swelling).  The patient was admitted to the hospital and given intravenous (IV) saline fluid, acetaminophen (TYLENOL), diphenhydramine hydrochloride (BENADRYL), anti-nausea medication, and potassium.  A complete blood count was performed however, the results were not provided.  At the time of the report, the patient was recovering from all events.   The causality between the aforementioned events and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Limb discomfort, Pyrexia, Skin reaction
Clinical narrative: his wife "experienced a "fever of 100.5 F, chills, and disorientation; his wife "experienced a "fever of 100.5 F, chills, and disorientation; experienced the same swelling and tenderness in her arm where the shot was given; his wife had a severe, whole body reaction; his wife "experienced a "fever of 100.5 F, chills, and disorientation; experienced the same swelling and tenderness in her arm where the shot was given; experienced a "mild, localized reaction" at the injection site with "swelling and tenderness at the site; experienced a "mild, localized reaction" at the injection site with "swelling and tenderness at the site"; experienced a "mild, localized reaction" at the injection site; This spontaneous report was received from the patient's husband and concerns to a 58 year old female patient. Concomitant therapies included rosuvastatin calcium(CRESTOR). The patient's drug reactions or allergies included penicillin and erythromycin. And the patient don't referred pertinent medical history.   On 18-MAR-2019, the patient was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) as shingles prevention (route of administration, anatomical location, lot number and expiration date were not reported).   On the same date, upon receiving the first dose of zoster vaccine live (ZOSTAVAX) the patient experienced a mild  localized reaction at the injection site (injection site reaction) with swelling (injection site swelling) and tenderness at the site (injection site pain).   On 10-JUL-2019  at 10 or 11 A.M., the patient was vaccinated with the second dose of zoster vaccine live (ZOSTAVAX) as shingles prevention (route of administration, anatomical location, lot number and expiration date were not reported).      On the same day (reported as around 9 P.M), the patient had a delayed reaction, she experienced a severe whole body reaction (injection site reaction),  fever of 100.5° Fahrenheit (F)(pyrexia), chills and disorientation. Also, the patient experienced the same swelling and tenderness in her arm where the shot was given (injection site pain and injection site swelling).  The patient was admitted to the hospital and given intravenous (IV) saline fluid, acetaminophen (TYLENOL), diphenhydramine hydrochloride (BENADRYL), anti-nausea medication, and potassium.  A complete blood count was performed however, the results were not provided.  At the time of the report, the patient was recovering from all events.   The causality between the aforementioned events and zoster vaccine live (ZOSTAVAX) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Biopsy, Biopsy muscle normal, C-reactive protein normal, Computerised tomogram abnormal, Fasciotomy
Clinical narrative: case of an immunization resulting in a large local reaction after vaccination; pain, swelling, and erythema at the injection site; pain, swelling, and erythema at the injection site; pain, swelling, and erythema at the injection site; Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus; Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus; extensive edema of the brachialis muscle and subcutaneous tissue causing complete stenosis of the basilic vein with less pronounced edema involving the surrounding muscles;   Information has been received from the authors in a published literature article entitled as stated above.  This case concerns to a 26-year-old female with a history of refractory idiopathic thrombocytopenic purpura status post splenectomy presented to an immunization clinic for Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) immunization nine weeks after receiving the 13-valent pneumococcal vaccine (PCV13). Three hours after immunization in her right deltoid, the patient experienced pain, swelling, and erythema at the injection site. Her symptoms increased in severity leading her to seek care in the emergency department. Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus. Laboratory evaluation showed a leukocyte count of 17.8 X10^9/L, hemoglobin of 11.7 g/dL, and a latelet count of 92 X10^9/L, C-reactive protein was 0.50 mg/dL, and erythrocyte sedimentation rate was within normal limits. Contrasted axial CT imaging of the right humerus demonstrated extensive edema of the brachialis muscle and subcutaneous tissue, causing complete stenosis of the basilic vein with less pronounced edema involving the surrounding muscles. These adverse events led to hospitalization of the patient on an unspecified date. Orthopedic surgery was consulted for a diagnosis of possible necrotizing fasciitis. The patient was treated with multiple intravenous antibiotics and underwent fasciotomy with excisional biopsies of the deltoid fascia and muscle. Findings included healthy-appearing tissue without evidence of necrotizing fasciitis. Negative gram-stain preceded deep wound cultures that failed to isolate any organisms. The patient fully recovered with resolution of edema two days after surgery.  The authors presented a case of an immunization resulting in a large local reaction that concerned multiple providers for necrotizing fasciitis, but ultimately revealing healthy subcutaneous tissue, so the clinicians should remember that localized infection following immunization could be rare, while large local reactions could be common, so as to avoid unnecessary medical treatments surgical interventions.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: PPV
Symptoms: Haemoglobin decreased, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: case of an immunization resulting in a large local reaction after vaccination; pain, swelling, and erythema at the injection site; pain, swelling, and erythema at the injection site; pain, swelling, and erythema at the injection site; Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus; Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus; extensive edema of the brachialis muscle and subcutaneous tissue causing complete stenosis of the basilic vein with less pronounced edema involving the surrounding muscles;   Information has been received from the authors in a published literature article entitled as stated above.  This case concerns to a 26-year-old female with a history of refractory idiopathic thrombocytopenic purpura status post splenectomy presented to an immunization clinic for Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) immunization nine weeks after receiving the 13-valent pneumococcal vaccine (PCV13). Three hours after immunization in her right deltoid, the patient experienced pain, swelling, and erythema at the injection site. Her symptoms increased in severity leading her to seek care in the emergency department. Physical examination revealed tenderness to palpation, erythema, and edema extending from the right deltoid to mid-humerus. Laboratory evaluation showed a leukocyte count of 17.8 X10^9/L, hemoglobin of 11.7 g/dL, and a latelet count of 92 X10^9/L, C-reactive protein was 0.50 mg/dL, and erythrocyte sedimentation rate was within normal limits. Contrasted axial CT imaging of the right humerus demonstrated extensive edema of the brachialis muscle and subcutaneous tissue, causing complete stenosis of the basilic vein with less pronounced edema involving the surrounding muscles. These adverse events led to hospitalization of the patient on an unspecified date. Orthopedic surgery was consulted for a diagnosis of possible necrotizing fasciitis. The patient was treated with multiple intravenous antibiotics and underwent fasciotomy with excisional biopsies of the deltoid fascia and muscle. Findings included healthy-appearing tissue without evidence of necrotizing fasciitis. Negative gram-stain preceded deep wound cultures that failed to isolate any organisms. The patient fully recovered with resolution of edema two days after surgery.  The authors presented a case of an immunization resulting in a large local reaction that concerned multiple providers for necrotizing fasciitis, but ultimately revealing healthy subcutaneous tissue, so the clinicians should remember that localized infection following immunization could be rare, while large local reactions could be common, so as to avoid unnecessary medical treatments surgical interventions.  A copy of the published article is attached as further documentation of the patient's experience.