chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Blister rupture, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Within two hours after the PPSV 23, injection, on arriving home and changing back into normal clothes, I noticed she had a strange mark on her right side chest. At first, I thought it may have been from her bra strap but then I checked the two do not match up. It looked like a cigarette burn mark. Over the next couple of days, this turned into a blister. The blister broke, then scabbed over and took a long time to heal up, as all of these eruptions have.  In the next day or so she started to break out with an extremely itchy rash on her arms and legs. I was applying hydrocortisone cream but that was not enough to control the severe itching, and since her stroke, she has a hard time with control issues. Continued. Within two hours after the PPSV 23, injection, on arriving home and changing back into normal clothes, I noticed she had a strange mark on her right side chest. At first, I thought it may have been from her bra strap but then I checked the two do not match up. It looked like a cigarette burn mark. Over the next couple of days, this turned into a blister. The blister broke, then scabbed over and took a long time to heal up, as all of these eruptions have.In the next day or so she started to break out with an extremely itchy rash on her arms and legs. I was applying hydrocortisone cream but that was not enough to control the severe itching, and since her stroke, she has a hard time with control issues. I contacted her Dr and informed her of the rash going on, and that this was a reaction to the pneumonia vaccine she had the other day and would probably be needing prednisone to help with this rash break out and the severe itching, (yes, I asked for the prednisone).  I was giving my wife the prednisone by her peg tube for a month until the itching finally subsided, and was able to be controlled with the hydrocortisone cream. The rash calmed down but has not stopped, as now she is getting blisters. During this, I did keep in touch with her doctor and also took my wife in to have this looked at by the doctor in December. The numerous rash areas with pop-up small blisters at the time, that, of course, would be scratched open because of the itching, then scab over and take a long time to heal up and fall off. Now February 11, the marks are still very obvious from where most of the rash areas were.Now she is occasionally popping out with larger blisters from the vaccine because there is no other reason for her to develop these blisters on her body.  She has had a couple of these blisters on her lower legs, and now has a large one with two associated smaller blisters on her hip. So this is still an ongoing thing for my poor wife after 3 1/2 months, almost 4 months.  I do have photos of these recent blisters if anyone should be interested.  *** My Wifes Dr. may of also filed on this reaction. Thank you, Husband
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Anxiety, Cardiac flutter, Heart rate increased, Insomnia, Neck pain
Clinical narrative: Her pulse was high 178 and her Blood pressure was 168/112, heart palpitations  fever of 101.8 all this maintained for well over a day. she could not sleep from the pain she had in her neck, and whole left arm, she also became very anxious from all this. this all started within 6 hours of receiving the vaccination. I called the online emergency number for the doctors office where they told me that these symptoms could be one of the rare side effects and that I should not be worried but if it continued past 3 days then take her into ER. we was up all night because her heart was beating so fast and fluttering
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Palpitations, Pyrexia
Clinical narrative: Her pulse was high 178 and her Blood pressure was 168/112, heart palpitations  fever of 101.8 all this maintained for well over a day. she could not sleep from the pain she had in her neck, and whole left arm, she also became very anxious from all this. this all started within 6 hours of receiving the vaccination. I called the online emergency number for the doctors office where they told me that these symptoms could be one of the rare side effects and that I should not be worried but if it continued past 3 days then take her into ER. we was up all night because her heart was beating so fast and fluttering
Age: 18.0
Sex: M
Vaccine: FLU4, HEPAB, SMALL, TYP
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Full blood count, HIV test, Lymphadenopathy
Clinical narrative: 18-year-old active male with supraclavicular lymphadenopathy to the left side x 4 days, smallpox vaccination on 29 January 2020 on ipsilateral shoulder. 3 nodules approximately 1 cm each at supraclavicular region, they are nontender, rubbery and mobile.  No axillary lymphadenopathy noted on exam and patient has a otherwise benign physical exam. Per  NOVEMBER 2010 article , will monitor for 4 weeks.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPAB, SMALL, TYP
Symptoms: Metabolic function test, Nodule
Clinical narrative: 18-year-old active male with supraclavicular lymphadenopathy to the left side x 4 days, smallpox vaccination on 29 January 2020 on ipsilateral shoulder. 3 nodules approximately 1 cm each at supraclavicular region, they are nontender, rubbery and mobile.  No axillary lymphadenopathy noted on exam and patient has a otherwise benign physical exam. Per  NOVEMBER 2010 article , will monitor for 4 weeks.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; an unspecified patient received doses of improperly stored VARIVAX and PROQUAD; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The administrator reported that on 04-FEB-2020, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S020465 (expiration date 02-JUL-2021), and 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S021623,  frequency and route of administration not reported, has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 09-JUN-2021 (also reported as 09-JUN-2021), recombinant human albumin (rHA)), both administered for prophylaxis. The vaccines were incorrectly stored for 5 hours and 39 minutes within a temperature of minus (-) 9 Celsius degrees (°C) to 8°C (3.6°C ), with no previous temperature excursion. Sterile diluent (1 dose) used for reconstitution of varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. The error was identified due to a data logger. No additional adverse event (AE) information. No further details provided  This case was considered non-valid due to lack of patient identifiers.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a male patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2016, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, and route were unknown) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; other zoster-related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-NOV-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a physician at the physician office for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the patient was treated by a physician for hearing loss and other zoster-related injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, hearing loss was considered to be medically significant.
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-NOV-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions (dose, route, and lot # not provided). Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles (herpes zoster) was not recovered. The event was considered to be related to the suspect vaccine.
Age: 16.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; Information has been downloaded from Regulatory Authority (US-GlaxoSmithKline-A0878178A).  This spontaneous retrospective pregnancy report was received from an unspecified health professional and refers to a 16-year-old female patient. There were no concomitant medications and no relevant medical history. The patient had not experienced adverse events following previous vaccinations.  On 18-AUG-2010, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown), 0.5 milliliter, as a single dose, subcutaneously, lot # 0226Z has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 28-JAN-2012 (anatomical location was not reported), diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX), dosage reported as 0.5 CC, as a single dose, via intramuscular route, lot # AC52B045BCA (anatomical location and expiration date were not reported), hepatitis a virus vaccine inactivated (HAVRIX), dosage reported as 0.5 CC, as a single dose, via intramuscular route, lot # AHABV379AA (anatomical location and expiration date were not reported), poliovirus vaccine inactivated (unspecified), 0.5 milliliter, as a single dose, via intramuscular route, lot # D0674, anatomical location and expiration date were not reported) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), 0.5 milliliter, as a single dose, via intramuscular route, lot # U3335AA, anatomical location and expiration date were not reported) all for prophylaxis. The patient was pregnant at the time of vaccines administration, last menstrual period (LMP) was reported as 24-JUL-2010 and estimated due date (EDD) was 30-APR-2011. Initial exposure to vaccines was at the first trimester.  The pregnancy outcome was unknown.  The Agency considered the event of vaccine exposure during pregnancy to be medically significant.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Dysphonia, Lip pain, Oral discomfort, Oropharyngeal pain
Clinical narrative: Hoarseness; burning and soreness in throat; burning and soreness in throat; inappropriate dose of vaccine administered; burning and soreness in lips; burning and soreness in lips; Backache; little dot on buccal mucosa in soft palate; This is a spontaneous report from a contactable physician.   A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/lot number: 70865, Expiry Date: 31Dec2020) via an unspecified route of administration at 0.5 ml, single in the left deltoid on 23Jan2020 for immunisation. Medical history included ongoing diabetes mellitus (diagnosed several years ago), ongoing arthritis (has had for many years). There were no concomitant medications. The patient previously took Pneumovax 23 and Prevnar 13, both on unknown date for immunization without any adverse event. She had allergies to Ceftin, Ciprofloxacin, Dolobid, Fluconazole, Lasix, Levaquin, Macrobid, Metformin, Motrin and Sulfa drugs. The patient experienced burning and soreness in lips on 23Jan2020 with outcome of not recovered, backache on 23Jan2020 with outcome of recovered, little dot on buccal mucosa in soft palate in Jan2020 with outcome of recovered, hoarseness on 03Feb2020 with outcome of unknown, burning and soreness in throat on 23Jan2020 with outcome of not recovered. Therapeutic measures were taken as a result of little dot on buccal mucosa in soft palate.  The events were described as follows: After receiving the vaccine, about an hour and a half later she developed burning and soreness with her lips and throat. After 11 days she still has the same symptoms. She did not have a fever, angioedema or chills. She had a backache at that time as well. She developed a little dot on the buccal mucosa on 23Jan2020 or 24Jan2020. She applied Orajel to the dot. On 03Feb2020  she had hoarseness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Throat irritation
Clinical narrative: Hoarseness; burning and soreness in throat; burning and soreness in throat; inappropriate dose of vaccine administered; burning and soreness in lips; burning and soreness in lips; Backache; little dot on buccal mucosa in soft palate; This is a spontaneous report from a contactable physician.   A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/lot number: 70865, Expiry Date: 31Dec2020) via an unspecified route of administration at 0.5 ml, single in the left deltoid on 23Jan2020 for immunisation. Medical history included ongoing diabetes mellitus (diagnosed several years ago), ongoing arthritis (has had for many years). There were no concomitant medications. The patient previously took Pneumovax 23 and Prevnar 13, both on unknown date for immunization without any adverse event. She had allergies to Ceftin, Ciprofloxacin, Dolobid, Fluconazole, Lasix, Levaquin, Macrobid, Metformin, Motrin and Sulfa drugs. The patient experienced burning and soreness in lips on 23Jan2020 with outcome of not recovered, backache on 23Jan2020 with outcome of recovered, little dot on buccal mucosa in soft palate in Jan2020 with outcome of recovered, hoarseness on 03Feb2020 with outcome of unknown, burning and soreness in throat on 23Jan2020 with outcome of not recovered. Therapeutic measures were taken as a result of little dot on buccal mucosa in soft palate.  The events were described as follows: After receiving the vaccine, about an hour and a half later she developed burning and soreness with her lips and throat. After 11 days she still has the same symptoms. She did not have a fever, angioedema or chills. She had a backache at that time as well. She developed a little dot on the buccal mucosa on 23Jan2020 or 24Jan2020. She applied Orajel to the dot. On 03Feb2020  she had hoarseness.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bone pain, Dizziness, Fall, Nausea
Clinical narrative: Patient became very nauseous & put head between knees while trying to get it under control while sitting & ended up tipping forward & falling & too weak/dizzy to get up so spent night on floor, slept all evening & night. Was shaky & weak & said bones hurt. Next day started getting better. Wanted us to be sure to report this.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness
Clinical narrative: Patient became very nauseous & put head between knees while trying to get it under control while sitting & ended up tipping forward & falling & too weak/dizzy to get up so spent night on floor, slept all evening & night. Was shaky & weak & said bones hurt. Next day started getting better. Wanted us to be sure to report this.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Muscle and joint aches, headache, fatigue (flu-like symptoms)
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus
Clinical narrative: Pt had itching that continued 1 week after immunization. She said that she has some redness since she was scratching it but no other reactions.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Feeling cold, Feeling hot
Clinical narrative: from chart: "Pt reports arm really hurt yesterday after injection. After coming home from work yesterday, felt so cold. Sat in hot tub - felt cold and hot after. Woke in middle of the night w/ fever, vomiting and diarrhea. Fever did not go over 101. States fever is gone now. Has had 3 episodes each of vomiting and diarrhea. Last vomited 1 hour ago. Still nauseated. Has some abd pain prior to vomiting/diarrhea that resolves after. Drinking water which is staying down. Is tired, has been sleeping. Head is killing her but not the worst HA ever - feels like it's turning into a migraine. Did not have her coffee this morning. Arm still hurts, aches, is uncomfortable. Denies dizziness, lightheadedness, body aches or any other sxs. "
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Limb discomfort, Migraine, Nausea, Pain in extremity
Clinical narrative: from chart: "Pt reports arm really hurt yesterday after injection. After coming home from work yesterday, felt so cold. Sat in hot tub - felt cold and hot after. Woke in middle of the night w/ fever, vomiting and diarrhea. Fever did not go over 101. States fever is gone now. Has had 3 episodes each of vomiting and diarrhea. Last vomited 1 hour ago. Still nauseated. Has some abd pain prior to vomiting/diarrhea that resolves after. Drinking water which is staying down. Is tired, has been sleeping. Head is killing her but not the worst HA ever - feels like it's turning into a migraine. Did not have her coffee this morning. Arm still hurts, aches, is uncomfortable. Denies dizziness, lightheadedness, body aches or any other sxs. "
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: from chart: "Pt reports arm really hurt yesterday after injection. After coming home from work yesterday, felt so cold. Sat in hot tub - felt cold and hot after. Woke in middle of the night w/ fever, vomiting and diarrhea. Fever did not go over 101. States fever is gone now. Has had 3 episodes each of vomiting and diarrhea. Last vomited 1 hour ago. Still nauseated. Has some abd pain prior to vomiting/diarrhea that resolves after. Drinking water which is staying down. Is tired, has been sleeping. Head is killing her but not the worst HA ever - feels like it's turning into a migraine. Did not have her coffee this morning. Arm still hurts, aches, is uncomfortable. Denies dizziness, lightheadedness, body aches or any other sxs. "
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Herpes zoster, Hypoaesthesia, Rash
Clinical narrative: Approximately three weeks after receiving first Shingrix vaccine, I developed painful rash on my left hand and left elbow, mild numbness on my left arm, and mild pain in my armpit.  It was diagnosed as shingles this morning.  I was given Valacyclovir, 1 gram tablet (3x a day for 7 days).
Age: 10.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Wrong product administered
Clinical narrative: Pt was given the Prevnar in error
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient received Shingrix #2 at 11:35am in left deltoid. Monitored patient X15mins. At 11:50am states she feels tingling in left index and middle fingertips. Referred patient to Dr., MD. Patient assessed and states tingling was starting to feel better. Doctor instructed patient to continue to monitor and if it tingling gets worse to return to clinic.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Body temperature increased, Cough, Diarrhoea, Gastrointestinal disorder, Injection site erythema
Clinical narrative: 2/11/2020 Noticed 2x3cm erythematous patch with central induration left left thigh. No crusting, no discharge. No streaking. Described: Tiny pinpoint eryth. papules medially. No vesiculatiions, no pustules. Patient is a 1 year old female. Flu and varivax vaccines given 13d ago. First noted bump on the leg just this morning. No pain, no itch, no d/c. She feels fine OTW. She had had GI Sx's with loose stools 1-3x/day for sev days like her buddies at school. Vomited after coughing x 2d last week. She had temps to 101.4 3d ago her vaccines - those lasted one day. She also had otorrhea at that time.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site induration, Injection site papule, Injection site rash, Otorrhoea, Vomiting
Clinical narrative: 2/11/2020 Noticed 2x3cm erythematous patch with central induration left left thigh. No crusting, no discharge. No streaking. Described: Tiny pinpoint eryth. papules medially. No vesiculatiions, no pustules. Patient is a 1 year old female. Flu and varivax vaccines given 13d ago. First noted bump on the leg just this morning. No pain, no itch, no d/c. She feels fine OTW. She had had GI Sx's with loose stools 1-3x/day for sev days like her buddies at school. Vomited after coughing x 2d last week. She had temps to 101.4 3d ago her vaccines - those lasted one day. She also had otorrhea at that time.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Mother brought child to clinic on 2/10/20 d/t reaction to vaccines given on 2/6/20. Mother states both of the child's legs started bruising and a red rash appeared around the injection sites the same day of vaccination. Child also ran a fever of 101 the next day on 2/7/20 and she gave Tylenol which helped with the fever. Her temperature ran 99.9 throughout the day on 2/7/20 and eventually came down. The mother called an aunt who works with a pediatrician and also talked to an ER nurse who told her to bring child to clinic to report reaction to the vaccines. Upon examining the child both of her legs had redness, swelling, and was hard to touch. The right leg had more redness and swelling than the right leg. She was not running a fever and the child said she was not hurting. Instructed mother to continue to monitor for any more signs & symptoms and call us if they do not go away. Mother verbalized understanding.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Mother brought child to clinic on 2/10/20 d/t reaction to vaccines given on 2/6/20. Mother states both of the child's legs started bruising and a red rash appeared around the injection sites the same day of vaccination. Child also ran a fever of 101 the next day on 2/7/20 and she gave Tylenol which helped with the fever. Her temperature ran 99.9 throughout the day on 2/7/20 and eventually came down. The mother called an aunt who works with a pediatrician and also talked to an ER nurse who told her to bring child to clinic to report reaction to the vaccines. Upon examining the child both of her legs had redness, swelling, and was hard to touch. The right leg had more redness and swelling than the right leg. She was not running a fever and the child said she was not hurting. Instructed mother to continue to monitor for any more signs & symptoms and call us if they do not go away. Mother verbalized understanding.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Measles, Pallor, Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: Koplik's spots in the mouth; rash with red blanching dots on the trunk, extremities, stomach, back, and face; runny nose; rash with red blanching dots on the trunk, extremities, stomach, back, and face; This spontaneous report was received from a nurse and refers to a 12-month-old female patient. There was none pertinent medical history and drug reactions or allergies. No information about the patient's concomitant medications was provided.  On 10-JAN-2020 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant human albumin)) (PROQUAD) lot number: S013711, expiration date: 01-NOV-2020 (exact dose was not provided) subcutaneously as 1 year wellness visit vaccines. Other suspect therapies included sterile diluent (STERILE DILUENT) (dose, route of administration, indication, lot # and expiration date were not reported).  On 20-JAN-2020, the patient had runnny nose and rash with red blanching dots on the trunk, extremities, stomach, back, and face, and Koplik's spots in the mouth (considered as mild case of measles). The patient sought medical attention. No treatment was given for the events and no lab diagnostics or studies were performed. Lot check was requested. The reporter was interested in Varicella Zoster Virus (VZV) analysis by Polymerase Chain Reaction (PCR) and wanted to send viral isolates.  The outcome of the events was reported as resolved on an unknown date.  The relatedness between the events and the suspect vaccine was not provided.  Upon internal review, the event of Koplik's spots in the mouth was considered to be medically significant.  Additional information has been requested.  This is one of five cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA001548: US-009507513-2002USA001507: US-009507513-2002USA001496: US-009507513-2002USA001134:
Sex: M
Vaccine: MMRV, UNK
Symptoms: Influenza virus test negative, Pallor, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities; fever; macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities; This spontaneous report as received from a nurse refers to a 12-month-old male patient. His concomitant therapies included pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and hepatitis a virus vaccine inactivated (HAVRIX). The patient had none pertinent medical history, drug reactions or allergies.  On 08-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant human albumin)) (PROQUAD) subcutaneously, lot # S013711, expiration date 01-NOV-2020 (exact dose was not reported) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (dose, route of administration, indication, lot# and expiration date were not reported).  On 20-JAN-2020, the patient experienced fever, macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities. On 22-JAN-2020, the patient was seen and diphenhydramine hydrochloride (BENADRYL) was prescribed. Lot check was requested by reporter. Samples would be possibly sent for polymerase chain reaction (PCR) analysis to the Varicella Zoster Virus Identification Program (VZVIP). On an unknown date, the flu test was performed and the result was negative. It was reported that the patient sought medical attention and the intervention to prevent serious criteria was needed.   The outcome of the events was reported as resolved on an unknown date. The causality assessment between the events and suspect therapies was not reported.  Upon internal review the events of "fever, macular, papular red blanching rash on the scalp, soles of the feet, palms, diaper area, trunk, face, and extremities" were considered to be medically significant since required intervention to prevent serious criteria.  This is one of five cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA001425: US-009507513-2002USA001507: US-009507513-2002USA001496: US-009507513-2002USA001134:
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Low titer/received the results Rubella 4.89, Measles was 84.3 and Mumps IGG less than 9 showed immunity from infection or vaccination; Low titer/received the results Rubella 4.89, Measles was 84.3 and Mumps IGG less than 9 showed immunity from infection or vaccination; Low titer/received the results Rubella 4.89, Measles was 84.3 and Mumps IGG less than 9 showed immunity from infection or vaccination; This spontaneous report was received from a currently 33-year-old male patient, referring to himself.  The patient did not have any medical history and drug reactions/allergies. The patient's concurrent conditions and concomitant therapies were unknown.  On 01-OCT-1987, the patient was vaccinated with the last dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot/batch # and expiry date were not reported) for prophylaxis (reported as "doctor recommendation"). The patient reported that he recently had titers drawn and results revealed Rubella 4.89 (units not provided), Measles 84.3 (units not provided) and Mumps Immunoglobulin G (IgG) less than 9 (units not provided) which showed immunity from infection or vaccination (rubella antibody negative, mumps antibody test negative and measles antibody negative). Additionally, tuberculosis (TB) test, varicella and quantiferon TB tests were performed and the results were not reported. The patient sought medical attention and he did not receive any treatment. No product quality complaint (PQC) was involved. The outcome of all the events was unknown. The causality assessment was not provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Autonomic nervous system imbalance
Clinical narrative: dysautonomia; This spontaneous report has been received from the patient's mother via social media and website "Dependent" via vendor, referring to a 12-year-old female patient. Her pertinent medical history, drug reactions, allergies or concomitant medication were not reported.   On an unknown date, the patient was vaccinated with unidentified Merck hpv vaccine unclear if it was HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection (route, dose, anatomical location of vaccination, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient was diagnosed with dysautonomia. It was reported that typically, people with dysautonomia did not perform well in the morning as it took hours for their bodies to function and bagin their day. The patient was started on blood pressure medication, followed by a vasoconstrictor medicine, followed by a medicine used for people with Attention Deficit Disorder. These medicines all helped push more blood to the heart and brain, thus making her illness less violent. It was reported that despite treatment, the patient could not get back to functioning like a teenager. The reporter requested a second and third opinion and a doctor finally admitted that they had seen an increase in dysautonomia since the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine (unclear which one) was introduced. By the reporting time, the patient had not recovered from the event.   The reporter considered dysautonomia to be related to unidentified Merck hpv vaccine (HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)).  Upon internal review, dysautonomia was considered to be a disabling event as the patient could not get back to functioning like a teenager.
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 female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown day in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider in a clinic for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequent to patient's zoster vaccine live (ZOSTAVAX), she was treated by the physician for shingles. As a direct and proximate result of patient's use of the suspect vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was reported as not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: (first dose was on 31-Jul-2019 and second dose was on 13-Oct-2019) had a "flare up" on 05-Dec-2020; (first dose was on 31-Jul-2019 and second dose was on 13-Oct-2019) had a "flare up" on 05-Dec-2020; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date 22nd October 2021) and (batch number 92NA4, expiry date 22nd November 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 249DB, expiry date 8th November 2021) and (batch number 92NA4, expiry date 22nd November 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On 31st July 2019, the 1st dose was an unknown dose. On 13th October 2019, the patient received the 2nd dose of Shingrix. On 13th October 2019, the 2nd dose was an unknown dose. On 5th December 2019, 127 days after receiving Shingrix and 53 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient received 2 doses of vaccine and had a flare up. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol was given to a patient/ no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received expired 0.5 ml fourth dose of suspect IPV (VERO) lot N1K921M (Expiry date 14-Nov-2019) via unknown route in the left thigh for prophylactic vaccination, on 03-Feb-2020.  medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of reporting no adverse was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Daptacel given, No AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a one years old male patient who vaccinated with 0.5 ml expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5367AA and expiry date: 30-Jan-2020) via intramuscular route in the right vastus lateralis on 03-Feb-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given today another dose of Menactra by mistake / No AE; Initial information was received on 05-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an 18 years old female patient who on 11-Jun-2018 received a first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported via unknown route in an unknown administration site and on 05-Feb-2020 was mistakenly given second 0.5 ml dose of same vaccine (lot U6586BA and expiry date 20-APR-2020) via intramuscular route in the left deltoid for prophylactic vaccination.     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that on 11-Jun-2018 patient got her initial first dose of Menactra when she was 17 years old and on 05-Feb-2020 was given another dose by mistake .   It was an actual medication error case due extra dose administered.  No adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested for first dose.
Age: 57.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave a adult patient an expired Daptacel instead of Adacel, no advesre event; gave a adult patient an expired Daptacel instead of Adacel, no advesre event; gave a adult patient an expired Daptacel instead of Adacel, no advesre event; Initial information was received on 05-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 57-year-old female patient who was vaccinated with a 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5367AA and expiration date 30-Jan-2020) via an intramuscular route in the left deltoid on 03-Feb-2020.  Medical history was not reported and the patient did not receive any concomitant medications.  It was an actual medication error case due to expired vaccine used, wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient only received the diluent, no harm came to patient
Age: 14.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt given the Prevnar in error
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Severe swelling and pain throughout entire arm after PSV 23 vaccination in clinic, high fever, nausea/vomiting, took several days to improve
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Severe swelling and pain throughout entire arm after PSV 23 vaccination in clinic, high fever, nausea/vomiting, took several days to improve