chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired dose of M-M-R II; No adverse effects; This spontaneous report was received from a nurse concerning a 51 year-old patient of unknown gender and race. There was no information about the patient's medical history, drug reactions, allergies, concurrent conditions or concomitant medications to be reported.   It was reported that on an unspecified date, the patient was administered an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot number: N010496 (expiration date: 31-MAR-2019) (strength, formulation, dose, route and anatomical location not reported) for prophylaxis (expired product administered). No adverse effects were reported. The outcome of this event was not reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse effects reported; One expired dose of MMR II was administered to a patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 19-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(rHA) lot # M045400 with expiration date of 14-NOV-2019, intramuscularly for prophylaxis (dose was not provided).
Sex: M
Vaccine: HEP
Symptoms: Viral titre decreased
Clinical narrative: The primary reporter reported that the patient had "titers drawn on an unknown date which showed that the patient was not protected against hepatitis B.; This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's current conditions included diabetes and hypertension. Patient allergies included statins.   On unspecified date, an unknown patient was vaccinated with an unknown hepatitis B vaccine (manufacturer unknown) series at unknown facility for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported).  On unknown date, the patient had titers drawn which showed that the patient was not protected against hepatitis B (viral titre decreased). The reporter states that patient went to doctor's office on 19-APR-2019, however no treatment was provided at that time.  At the time of this report the patient had not recovered from the adverse event viral titre decreased.  The causal relationship with hepatitis B vaccine (manufacturer unknown) and the adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patients were administered improperly stored doses; no adverse effect; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown.  On 02-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R017626 and expiration date 18-DEC-2019 for prophylaxis (dose, strength, frequency and route of administration were unknown).    The patient experienced no adverse effects. It was reported that the vaccine was stored at a temperature of -9C to 8C (1C) during a time frame of 1 hour, 44 minutes. The vaccine had not experienced previous temperature excursions. Digital data logger was involved.; Sender's Comments:  US-009507513-1904USA010118: US-009507513-1904USA010119:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No adverse effects reported.; The patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.    On 22-APR-2019, the patient as inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) with lot # N030111 and expiration date 21-APR-2019  for prophylaxis.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patients were administered improperly stored doses; no adverse effect; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown.  On 28-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R024022 and expiration date 22-AUG-2019 for prophylaxis (dose, strength, frequency and route of administration were unknown).    The patient experienced no adverse effects. It was reported that the vaccine was stored at a temperature of -9C to 8C (1C) during a time frame of 1 hour, 44 minutes. The vaccine had not experienced previous temperature excursions. Digital data logger was involved.; Sender's Comments:  US-009507513-1904USA009984: US-009507513-1904USA010119:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patients were administered improperly stored doses; no adverse effect; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown.  On 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R024022 and expiration date 22-AUG-2019 for prophylaxis (dose, strength, frequency and route of administration were unknown).    The patient experienced no adverse effects. It was reported that the vaccine was stored at a temperature of -9C to 8C (1C) during a time frame of 1 hour, 44 minutes. The vaccine had not experienced previous temperature excursions. Digital data logger was involved.; Sender's Comments:  US-009507513-1904USA010118: US-009507513-1904USA009984:
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleep excessive in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sleep excessive. On an unknown date, the outcome of the sleep excessive was recovered/resolved. It was unknown if the reporter considered the sleep excessive to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, the patient was slept for 9 hours after vaccination. The reporter did not consent to follow-up. This case has been linked with case US2019069987, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On 16th April 2019, the patient received the 1st dose of SHINGRIX. On 16th April 2019, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, tiredness and injection site lump. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved and the outcome of the tiredness was recovered/resolved and the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, tiredness and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX on right arm. Two to three hours after vaccination, the patient experienced the arm became sore and swollen at the injection site. A small lump also presented at the site and the patient felt tired. The patient had gone shopping for a few hours after the vaccination and when the patient arrived home, the patient felt more tired than usual. The reporter also stated that, there was other customer at the pharmacy who said they had received SHINGRIX also but had no adverse reactions. The reporter did not consent to follow-up. This case has been linked with case US2019GSK073055, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 18th April 2019, the patient received the 1st dose of SHINGRIX. On 18th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported to have sore, painful arm at the injection site after receiving the SHINGRIX vaccine on the date of reporting. The patient also had difficulty raising her arm. The patient did not specify if it was dose 1 or 2, however the representative got the impression it was her first dose due to the nature of the call. The patient did not give consent to be followed up. The patient declined healthcare professional (HCP) consent and date of birth and provided limited capturing information.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Caesarean section, Exposure during pregnancy, Foetal disorder, Foetal therapeutic procedure
Clinical narrative: This is a spontaneous case reported by other non-health professional (consumer) and initially received on 12-Apr-2019, concerning a 28-year-old adult female pregnant patient. The patient had one previous pregnancy. The patient had no history of offspring with major congenital malformation neither had still birth or miscarriage. Also, the patient had no maternal or paternal history with major congenital malformations. The patient had no medical history. The patient did not receive any concomitant medications. The patient's last menstrual period (LMP) date was 19-May-2018. On an unspecified date, ultrasound was performed, and the baby's lungs were clear. On 04-Sep-2018, 15 weeks gestation period, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for active immunization against influenza. On an unspecified date in Sep-2018, 2 weeks after vaccination, the foetus was diagnosed with chylothorax (fluid around the lungs). It stayed consistent for many weeks but when the patient was at 29 weeks of the pregnancy, the volume increased so they decided to drain it by thoracentesis. The week before the patient delivered the infant, there was a little bit of fluid (explicitly coded as foetal disorder). 37 weeks and 4 days gestational period, the patient delivered a male infant. The delivery method was caesarean. Infant head circumference was 33 cm, infant body length was 19.5-inch, infant body weight was 7 lb 6 oz and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 8 at minute 1 and 10 at minute 5. It was reported that, chylothorax (foetal disorder) resolved and baby was born with no other complications other than hypospadias (tip of the urethra is lower than it is supposed to be). At the moment it was minor, they would re-evaluate at 6 months to see if he need surgery to resolve it. The patient's estimated date of delivery (EDD) was reported as 23-Feb-2019. The reporter assessed the case as serious (medically significant). The patient was willing to enroll in pregnancy registry for AFLURIA QUAD and FLUCELVAX QUAD. This case was linked to case: 201903041 (baby case).; Reporter's Comments: A 28-year-old pregnant patient was administered AFLURIA QUADRIVALENT vaccine (considered as vaccine exposure during pregnancy) at 15 weeks of gestation. The foetus was diagnosed with chylothorax (foetal disorder) in-utero, 2 weeks post vaccination which required thoracentesis. Despite the plausible temporal relationship between vaccination and reported event, considering the lack of biological evidence with vaccination, the event chylothorax (foetal disorder) assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Apgar score normal, Aspiration pleural cavity, Caesarean section, Chest X-ray normal, Chylothorax
Clinical narrative: This is a spontaneous case reported by other non-health professional (consumer) and initially received on 12-Apr-2019, concerning a neonate male patient. The patient's mother had one previous pregnancy. The patient had no history of offspring with major congenital malformation neither had still birth or miscarriage. Also, the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother had no medical history. The patient's mother did not receive any concomitant medications. The patient's mother's last menstrual period (LMP) date was 19-May-2018. On an unspecified date, ultrasound was performed, and the baby's lungs were clear. On 04-Sep-2018, at 15 weeks gestation age, the patient was exposed to AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: transplacental, parent's route of administration: intramuscular, batch number and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for active immunization against influenza. On an unspecified date, 2 weeks after vaccination, the foetus was diagnosed with chylothorax (fluid around the lungs). It stayed consistent for many weeks but when the foetus was at 29 weeks gestational age, the volume increased so thoracentesis was performed to drain the fluid. The week before the patient delivered the infant, there was a little bit of fluid. 37 weeks and 4 days gestational period, the male infant was born. The delivery method was caesarean. Infant head circumference was 33 cm, infant body length was 19.5-inches, infant body weight was 7 lb 6 oz and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 8 at minute 1 and 10 at minute 5. The patient was born with hypospadias and when x-rayed after the birth, no fluid was found (recovery of chylothorax). The hypospadias was minor and depending upon the situation, six months later, surgery would be performed to resolve it. The patient's mother's estimated date of delivery (EDD) was reported as 23-Feb-2019. The patient had recovered from the event chylothorax and had not recovered from the event hypospadias. The reporter assessed the case as serious (medically significant). This case was linked to case: 201903028 (mother case).; Reporter's Comments: A male neonate patient was exposed to AFLURIA QUADRIVALENT vaccine (considered as foetal exposure during pregnancy) after maternal receipt at 15 weeks of gestation and was diagnosed with chylothorax in-utero, 2 weeks post vaccination which required thoracentesis. The patient was also diagnosed with hypospadias, at birth. Despite the plausible temporal relationship between vaccination and reported events, considering the lack of biological evidence with vaccination, the event chylothorax and hypospadias assessed as not related to suspect vaccine. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Foetal exposure during pregnancy, Hypospadias
Clinical narrative: This is a spontaneous case reported by other non-health professional (consumer) and initially received on 12-Apr-2019, concerning a neonate male patient. The patient's mother had one previous pregnancy. The patient had no history of offspring with major congenital malformation neither had still birth or miscarriage. Also, the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother had no medical history. The patient's mother did not receive any concomitant medications. The patient's mother's last menstrual period (LMP) date was 19-May-2018. On an unspecified date, ultrasound was performed, and the baby's lungs were clear. On 04-Sep-2018, at 15 weeks gestation age, the patient was exposed to AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: transplacental, parent's route of administration: intramuscular, batch number and expiry date: not reported) (explicitly coded as foetal exposure during pregnancy) for active immunization against influenza. On an unspecified date, 2 weeks after vaccination, the foetus was diagnosed with chylothorax (fluid around the lungs). It stayed consistent for many weeks but when the foetus was at 29 weeks gestational age, the volume increased so thoracentesis was performed to drain the fluid. The week before the patient delivered the infant, there was a little bit of fluid. 37 weeks and 4 days gestational period, the male infant was born. The delivery method was caesarean. Infant head circumference was 33 cm, infant body length was 19.5-inches, infant body weight was 7 lb 6 oz and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 8 at minute 1 and 10 at minute 5. The patient was born with hypospadias and when x-rayed after the birth, no fluid was found (recovery of chylothorax). The hypospadias was minor and depending upon the situation, six months later, surgery would be performed to resolve it. The patient's mother's estimated date of delivery (EDD) was reported as 23-Feb-2019. The patient had recovered from the event chylothorax and had not recovered from the event hypospadias. The reporter assessed the case as serious (medically significant). This case was linked to case: 201903028 (mother case).; Reporter's Comments: A male neonate patient was exposed to AFLURIA QUADRIVALENT vaccine (considered as foetal exposure during pregnancy) after maternal receipt at 15 weeks of gestation and was diagnosed with chylothorax in-utero, 2 weeks post vaccination which required thoracentesis. The patient was also diagnosed with hypospadias, at birth. Despite the plausible temporal relationship between vaccination and reported events, considering the lack of biological evidence with vaccination, the event chylothorax and hypospadias assessed as not related to suspect vaccine. The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Hypoaesthesia, Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Almost 30 hours after shot given, patient woke up with tingle feeling in left pinky finger. Pins and needles feeling and touch sensation felt numb like wearing a glove. Hand was still functioning properly with proper grip strength. Almost 48 hours after shot given, patient said left ring finger and outer palm as well as pinky finger were feeling pins and needles. Sensation of left hand - outer palm, pinky finger and ring finger has remained numb touch sensation like wearing a glove. Grip strength still remained normal and function of hand is normal. Pins and needles sensation is constant. This sensation is still present at day 9 after shot administered. Day 9 has started sharp pained feeling sensation in left hand coming and going, not constant. Day 4 after shot, patient woke with a fever and nausea. Fever lasted three days. Nausea still present at day 9. Patient missed school due to symptoms. Hard to concentrate with nausea waves.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: High fever-102; extreme body aches and muscle pain; uncontrollable chills; headache; extreme fatigue; extreme tiredness.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever-102; extreme body aches and muscle pain; uncontrollable chills; headache; extreme fatigue; extreme tiredness.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Myalgia, Nausea
Clinical narrative: muscle pain, stomach pain, nausea
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: Swollen, reddened and bruised left arm. No treatment at time of this reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 16-APR-2019 from a lawyer regarding a case in litigation concerning a female patient (age and history not provided). In or around 12-AUG-2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). Five days after the vaccination the patient suffered a rash under her breast and increased around to her back and was diagnosed with herpes zoster. As a direct and proximate result of ZOSTAVAX the patients symptoms resulted in physical limitations nor present prior to use of the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries, serious progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result the patient has suffered and incurred damages including medical expenses, the loss of accumulation, and other economic and non economic damages. Outcome of herpes zoster was not recovered. Herpes zoster was considered to be disabling.   Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: FLUC4, HEP, HEPA, HEPA, PPV, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Selected Peds/adolescent  dose of Hep A and administered. Noted error and contacted Immunization coordinator who directed to give Hep A adult dose as well. No adverse outcome  noted at this time. Client tolerated vaccine administration without difficulty.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash pruritic, Varicella post vaccine
Clinical narrative: Rash started on 04/13/19 on back.  Itchy rash continued to spread to abdomen and to other areas on the body.  Clinically diagnosed with varicella rash related to vaccine on 04/23/19.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 04/17/2019- Child had a cat scratch to the Rt side of the forehead that had heavy bleeding and swelling.  Seen in the ER and encouraged to come in and get a DTaP.  Mother follows her own vaccine schedule per Dr.  Child came in and was given Daptacel only to the LVL per mother's request.   04/24/19- Mother calls this morning around 9:30am and states she noticed that he had a rash and was slightly raised and warm to touch to LVL where injection was given apx. the size of a baseball.  Child denies the area being painful.  Denies any respiratory distress or other complications.  Phone call message left with PCP, Dr to update him on local reaction.  Encouraged mother to ice the area for about 20 minutes 3-4 times a day and give a Benadryl orally.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: within 6 hrs, baseball size area of redness, warmth and hard area of swelling with itching at injection site- swelling extended down to elbow and including entire upper arm lasting 3 days.  12-14 hrs after injection nausea, severe headache and fever with profound nausea - vomiting shortly thereafter. Temp of 100.2 at that time- may have been higher but wasn't taken immediately.  Dizziness, nausea, muscle aches, and severe headache for at least 36 hrs with intermittent heart palpitations.  Symptoms slowly resolved after 3-4 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea, Palpitations
Clinical narrative: within 6 hrs, baseball size area of redness, warmth and hard area of swelling with itching at injection site- swelling extended down to elbow and including entire upper arm lasting 3 days.  12-14 hrs after injection nausea, severe headache and fever with profound nausea - vomiting shortly thereafter. Temp of 100.2 at that time- may have been higher but wasn't taken immediately.  Dizziness, nausea, muscle aches, and severe headache for at least 36 hrs with intermittent heart palpitations.  Symptoms slowly resolved after 3-4 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: within 6 hrs, baseball size area of redness, warmth and hard area of swelling with itching at injection site- swelling extended down to elbow and including entire upper arm lasting 3 days.  12-14 hrs after injection nausea, severe headache and fever with profound nausea - vomiting shortly thereafter. Temp of 100.2 at that time- may have been higher but wasn't taken immediately.  Dizziness, nausea, muscle aches, and severe headache for at least 36 hrs with intermittent heart palpitations.  Symptoms slowly resolved after 3-4 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Fatigue, Myalgia
Clinical narrative: Redness, swelling, pain in Left arm, nausea and stomach pain, fatigue, fever, chills, general myalgia. 6/11/2019: Follow up received from patient: Lot number unavailable.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Redness, swelling, pain in Left arm, nausea and stomach pain, fatigue, fever, chills, general myalgia. 6/11/2019: Follow up received from patient: Lot number unavailable.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Otitis media, Rash maculo-papular
Clinical narrative: PATIENT DIAGNOSED WITH BILATERAL OTITIS MEDIA ON APRIL22, 2019, PRESCRIBED CEFDNIR. PATIENT DEVELOPED MACULOPAPULAR RASH ON FACE, TRUNK, EXTREMITIES ON APRIL 24, 2019.
Age: 75.0
Sex: F
Vaccine: YF
Symptoms: Cardiac function test, Ear pain, Eye pain, Headache, Palpitations
Clinical narrative: Headache, heart palpations, rash, pain in eyes and ears
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Eye pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Numbness/tingling to fingers, burning sensation in palm of hand in arm injection was given, redness, swelling and pain at injection site, nausea, fatigue, light sensitivity/soreness to L eye with tingling to area near eye, headache.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Paraesthesia
Clinical narrative: Numbness/tingling to fingers, burning sensation in palm of hand in arm injection was given, redness, swelling and pain at injection site, nausea, fatigue, light sensitivity/soreness to L eye with tingling to area near eye, headache.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Photophobia
Clinical narrative: Numbness/tingling to fingers, burning sensation in palm of hand in arm injection was given, redness, swelling and pain at injection site, nausea, fatigue, light sensitivity/soreness to L eye with tingling to area near eye, headache.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Eye pain, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Numbness/tingling to fingers, burning sensation in palm of hand in arm injection was given, redness, swelling and pain at injection site, nausea, fatigue, light sensitivity/soreness to L eye with tingling to area near eye, headache.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Numbness/tingling to fingers, burning sensation in palm of hand in arm injection was given, redness, swelling and pain at injection site, nausea, fatigue, light sensitivity/soreness to L eye with tingling to area near eye, headache.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; one expired dose of PROQUAD (N028447, Expiration: 9-APR-2019) was administered to one patient; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 10-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), subcutaneously, lot # N028447, with expiration date 09-APR-2019, for prophylaxis (strength, dose and frequency were not provided). No adverse effects were reported.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large area (>3 inches) of redness, swelling and warmth at injection site developing several hours after injection and continuing 24 hours later.
Age: 25.0
Sex: F
Vaccine: FLU4, IPV, MNQ, TDAP
Symptoms: Angioedema, Pruritus, Urticaria
Clinical narrative: On 29 Friday, at appx 0100, several hours after receiving influenza, Tdap, MCV4P and IPV vaccines, pt presented to the Emergency Center for symptoms of angioedema of the cheeks, lips, associated with hives on her arms and chest. Denies associated lightheadedness, syncope, shortness of breath, wheezing, cough, conjunctivitis, rhinitis, vomiting, abdominal pain or diarrhea. She received IV BENADRYL, and symptoms resolved in 3-4 hours. She then followed with the trainee health clinic on 1 April and was given ZYRTEC, prednisone, and ZANTAC. However she only took one of these, she is unsure which, on one occasion d/t itching. Her symptoms have not since recurred.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction
Clinical narrative: Local reaction R/O cellulitis.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Unevaluable event
Clinical narrative: Immunocompromised patient wanted to have Prevenar 13 already received the Pneumovax 23; This spontaneous report was received from a pharmacist, referring to a 62 year old patient of unknown gender with leukemia. No information was provided regarding the patient's medical history and concomitant medications.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). Other suspect therapy included pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) both vaccines were for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date, the immunocompromised patient wanted to have pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) already received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(off label use).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from an attorney and refers to an elderly, currently 71 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not reported) by a healthcare provided for long-term prevention of shingles and zoster-related conditions. On an unspecified date in 2014, the vaccine was administrated by a pharmacist.  On an unknown date, the patient experienced shingles, which was treated by a healthcare provider.  The outcome of the event was unknown.  The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia, Rash
Clinical narrative: Information was received from a lawyer on 16-APR-2019 regarding a case in litigation, concerning a female patient who on an unknown date was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). On an unknown date the patent suffered sensations of burning, tingling, and sudden sharp localized pains accompanied by a rash. As a result of her symptoms, patient presented to a medical provider and was ultimately diagnosed with shingles. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using the product. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result the patient sustained severe and permanent personal injuries and serious progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles was determined to be disabling. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 25 year old patient. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On 22-APR-2019 the patient experienced inappropriate schedule of product administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of product administration and no adverse event is unknown. The reporter considered inappropriate schedule of product administration and no adverse event to be not assessed to GARDASIL 9.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pounding in head in a 53-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pounding in head, influenza-like symptoms, feels awful and product supply issue. On an unknown date, the outcome of the pounding in head, influenza-like symptoms and feels awful were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pounding in head, influenza-like symptoms and feels awful to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient felt awful for 3 days after getting the vaccine with a pounding headache and flu-like symptoms. At the time of this report, the patient had not been able to get the 2nd dose of SHINGRIX because her physician could not get any in stock. The patient gave consent to be followed up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Myalgia, Pyrexia
Clinical narrative: Patient states the adverse reaction started on the next day and told me that she had: ultra sensitive skin, fever, chills, headache, muscle pain, slept for 24 hours straight.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: Patient states the adverse reaction started on the next day and told me that she had: ultra sensitive skin, fever, chills, headache, muscle pain, slept for 24 hours straight.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site haematoma, Middle insomnia, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: 2 days after receiving the Tdap vaccine she woke up with a lot of painin her left arm and and was unable to lift her arm.  This condition  has persisted and the pain during the day is 4/10 and she is awaken at night with a 10/10  that is only relieved by pain medication.  Currently being treated by a neurologist.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site mass, Skin discolouration
Clinical narrative: Mom states that a few hours after the immunization she noticed an area of redness on the inner aspect of patient?s left thigh. She reports that patient did not seem particularly bothered by the area of redness. Mom states that over the last 24 hours after receiving the immunizations, the area has became brownish, like a bruise.The area on the leg appeared to be a bruise with the presence of a hematoma just under the bruise. The bruise is medial to the injection site. although doubt given the pressure that would need to be applied to this area to cause a hematoma of that size. The vaccine administration was performed by a novice medical assistant, under the supervision of an experienced medical assistant--The technique for vaccination was reviewed with both medical assistants, none of whom reported any unusual nor forceful application of pressure to the leg during vaccine administration. Medial aspect of the left thigh noted to have an irregular shaped brownish bruise measuring between 12 mm to 20mm (horizontally) X 25 mm (vertically). There is a palpable 5 mm to 7 mm mobile lump under the bruise.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Migraine, Myalgia
Clinical narrative: Fever, chills, SEVERE muscle and joint aches, migraine, nausea. Onset was in the early evening around 10 hours after receiving the vaccine. Lasted for the next 48 hours. Felt weak and shaky until the 72nd hour.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Fever, chills, SEVERE muscle and joint aches, migraine, nausea. Onset was in the early evening around 10 hours after receiving the vaccine. Lasted for the next 48 hours. Felt weak and shaky until the 72nd hour.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient describes significant swelling of the arm beginning the evening after receiving the vaccine.  Arm was still swollen the following day when she saw md
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Exposure to communicable disease, Scratch, Viral infection
Clinical narrative: Pt was exposed to chicken pox at school from fellow peer. Pt has been vaccinated and he received the recommended doses on schedule. On Sunday afternoon mom noticed that he was scratching and she applied calamine lotion to his skin and now the virus has spread over his body.   Dates of Immunization: 03/23/2009 12/18/2013  Tx- Acyclovir 200 mg/5 mL oral suspension
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, Product storage error
Clinical narrative: MMR was drawn up and screening not completed. medical assistant placed mixed vaccine in freezer while asking questions so as not to leave at room temp vs placing in fridge. frozen MMR then given to patient, but could not be fully administered as it was frozen. When injection removed, about 1/2 of 0.5mL had been given.  No adverse outcome, patient ok. Given a full dose of MMR on same day per county health department
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Autism spectrum disorder, Crying, Fall, Gait disturbance, Injection site rash
Clinical narrative: The pediatrician gave our son a single dose of the DTaP vaccine on the morning of 12/26. (I am unsure if it was "DAPTACEL" or "INFANRIX" as our medical records do not indicate as such). On the afternoon of 12/26, our son developed a rash in the area where the vaccine was given. On the evening of 12/26, within 12 hours of receiving the vaccine, our son was vomiting all over his crib. That evening as well as the next day and week following the vaccine, our son had uncontrollable and nonstop crying.  The next day, on 12/27 as well as each day after that, our son started stumbling and falling down A LOT. I'd also like to note that in the months leading up to his vaccine, he was starting to say actual words and had a solid 5-6 words down in his vocabulary. Since the vaccine, he has never said those words again nor has he spoken any new words since. We are now in the beginning stages of working with a Speech Therapist and are also exploring working with an Autism Specialist because it has been suggested that our son's lack of development may be on the spectrum for Autism. I called the pediatrician on 12/27 to report the symptoms and they claimed there is no way it could have been the vaccine and that maybe he caught the flu since we had family visiting. However, nobody in the family was sick and we just knew it was the result of the vaccine but the pediatrician did not want to take responsibility for it. I'd also like to note that in 2017, our son received a single dose of the Polio vaccine in which he developed chronic eczema following the vaccine. I was able to treat it with various remedies over the course of several months following the vaccine, and we made sure not to vaccinate him again for another year. The next vaccine he received was the one above, DTaP, which resulted in different vaccine injury symptoms.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder developmental, Vomiting
Clinical narrative: The pediatrician gave our son a single dose of the DTaP vaccine on the morning of 12/26. (I am unsure if it was "DAPTACEL" or "INFANRIX" as our medical records do not indicate as such). On the afternoon of 12/26, our son developed a rash in the area where the vaccine was given. On the evening of 12/26, within 12 hours of receiving the vaccine, our son was vomiting all over his crib. That evening as well as the next day and week following the vaccine, our son had uncontrollable and nonstop crying.  The next day, on 12/27 as well as each day after that, our son started stumbling and falling down A LOT. I'd also like to note that in the months leading up to his vaccine, he was starting to say actual words and had a solid 5-6 words down in his vocabulary. Since the vaccine, he has never said those words again nor has he spoken any new words since. We are now in the beginning stages of working with a Speech Therapist and are also exploring working with an Autism Specialist because it has been suggested that our son's lack of development may be on the spectrum for Autism. I called the pediatrician on 12/27 to report the symptoms and they claimed there is no way it could have been the vaccine and that maybe he caught the flu since we had family visiting. However, nobody in the family was sick and we just knew it was the result of the vaccine but the pediatrician did not want to take responsibility for it. I'd also like to note that in 2017, our son received a single dose of the Polio vaccine in which he developed chronic eczema following the vaccine. I was able to treat it with various remedies over the course of several months following the vaccine, and we made sure not to vaccinate him again for another year. The next vaccine he received was the one above, DTaP, which resulted in different vaccine injury symptoms.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; products liability - defective design/ manufacturing defect; Information has been received regarding a case in litigation from a lawyer and refers to a currently 76-year-old patient of unspecified gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.  On approximately 21-MAR-2014 (reported as on or about March 21, 2014), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route and site of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided. The causality between the event and the suspect therapy was reported as related. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; products liability - defective design/ manufacturing defect; Information has been received regarding a case in litigation from a lawyer and refers to a currently 79-year-old patient of unspecified gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.  On approximately 27-DEC-2013 (reported as on or about December 27, 2013), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route and site of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated due to the event at a medical center. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided. The causality between shingles and the suspect therapy was reported as related. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Cough, Nail discolouration, Skin discolouration, Urticaria, Wheezing
Clinical narrative: Wheezy cough 9pm hives on face, stomach and chest dark purple dots on palms of hands purple fingernails
Age: 1.5
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling  at the injection sites.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster
Clinical narrative: Patient received SHINGRIX on 04/12/2019 and came to the pharmacy counter on 4-24-19 and reported the adverse event. Patient stated redness along arm vaccine was given in as well as down to the breast and back. Patient was seen by a doctor and informed us the doctor diagnosed the patient shingles.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Chronic arm pain