chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: The injection site & surrounding 3" in every direction is hot, red, hard, itchy, and sore to the touch. My cheeks also turned bright red, but that has subsided overnight.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Eye swelling, Rash
Clinical narrative: At approximately 6:15 pm patient started breaking out in a rash with eyes swelling, no difficulty breathing. Provider advised mom to give the patient Epi-Pen and 25mg of Benadryl PO and then call 911. Follow up with mom per phone at 8:30 am the next morning. EMS gave Hydroxizine, did not go to the ER. Rash gone this morning, no symptoms. Thinks rash was caused by a new blanket that patient used
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular, Rash pruritic, Rash vesicular
Clinical narrative: Patient  developed diffuse, erythematous  rash on legs, arms, torso, neck, face; very itchy rash that began 2 days after received the vaccine.   Tried  Benadryl and it helped a little, then rash changed and became bubble-like rash.  Finally resolved after 1 week.   Patient provided photos documenting a diffuse, significant erythematous macular rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Limb mass, Pain in extremity
Clinical narrative: Flu like symptoms, large lump and pain in arm
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: itching, right deltoid pain radiating to right arm and up into right shoulder, swelling and warmth locally
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Half dollar sized welts broke out on chest: 5 welts that would fit into half dollar circle: fiery red, itchy. No pain.  Just started to dry up and loose inflammatory response starting Monday 9/2
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia, Skin warm
Clinical narrative: Patient experienced flu-like symptoms including chills, fever, body ache, and hotness to touch for 5-6 days following the Shingrix vaccine administration. Patient self-treated with OTC acetaminophen.
Age: 52.0
Sex: M
Vaccine: TYP, UNK
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms, fever, body ache, lasting for 4 days now and still ongoing.
Sex: F
Vaccine: HIBV, HPV9, PNC
Symptoms: Crying, Irritability, Sleep terror, Wrong product administered
Clinical narrative: This error may have occured but (physician) was not certain; a lot of crying for 5 to 7 days; Child was also fussy; Had night terrors; Possible low grade fever; Physician stated a 1 year old female was inadvertently administered GARDASIL 9; Receive Hep A vaccine but instead may have received HPV in error; This spontaneous report was received from a physician and refers to a 1-year-old female patient. The patient had no concomitant medications and or pre-existing allergies, birth defects and medical conditions. She had no illnesses at the time of the vaccination. The patient was the only child and her bith weight was 7 ibs and 14 oz.  On 02-AUG-2019 the patient was inadvertently vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  The patient was supposed to receive an unspecified hepatitis a virus vaccine (reported as Hep A vaccine), but instead she might had received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (also reported as HPV) in error. The administration physician was not certain if that error had occurred.  On that same day, the patient was also administered with a fourth dose of hib conj vaccine (intramuscularly, lot # UJ077AA (formulation, strength, expiration date were not reported) and with a fourth dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) intramuscularly, lot # AF5647 (formulation, strength, expiration date were not reported).  On 02-AUG-2019, the patient's parents observed a lot of crying (also reported as cried more than usual) and for the next week (also reported as 5 to 7 days), the patient was fussy, had night terrors and a possible low grade fever.  Additionally, it was reported, that the patient's mother subsequently changed practices.  The patient recovered from the events on 09-AUG-2019 (reported as for 5 to 7 days). The causality assessment was not provided.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect reported; The patient was inadvertenlty administered a dose of MMRII via the intramuscular route rather than the recomended subcuataneous; The dose of MMRII was reconstituted with expired diluent; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHA (recombinant human albumin), lot # N032752, expiration date 20-NOV-2019 (exact dose was not reported) via the intramuscular route instead of the recommended subcutaneous route, for prophylaxis. The vaccine was reconstituted with an expired sterile diluent (STERILE DILUENT), with lot # M041689  has been verified to be a valid lot number for sterile diluent, expiration date reported as 20-JUN-2019, but upon internal validation established as 29-JUN-2019.  There were no adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient inadvertently received an expired dose of VAQTA; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 19-AUG-2019, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # R018775, expiration date 09-AUG-2019 (strength, exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects were reported; the patient was inadvertently administered one dose od expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-AUG-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, 1 dose, lot # N031294 and expiration date 21-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. The dose was stored in its recommended range through the date of administration. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation, referring to a patient (pt) of unknown age. Concurrent condition, medical history and concomitant therapy were not reported.   In 2013 the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, frequency, lot#, expiration date not known) for long-term prevention of shingles and/or zoster-related conditions, administered by a healthcare provider at a hospital. Subsequently, on an unknown date, pt experienced shingles, and was treated by a healthcare provider. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX). Pt 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 shingles was reported as not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a unknown age female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unspecified date in 2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related condition.  On an unknown date, the patient was treated for shingles. The event caused the patient hospitalization. As a direct and proximate result of Plaintiff's use of zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has 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 event was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: M
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 male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, patient was inoculated with Zoster Vaccine Live(ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not provided), as prescribed and/or administered by a healthcare provider at hospital, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to patient's Zoster Vaccine Live(ZOSTAVAX) inoculation, patient was treated by a healthcare provider at a hospital, for shingles. As a direct and proximate result of patient's use of the Zoster Vaccine Live(ZOSTAVAX) vaccine, 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.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: weakness; felt ill; low fever; chills; arm hurt; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic fatigue syndrome (has Chronic Fatigue syndrome).   On 14th February 2019, the patient received the 1st dose of Shingrix 50 µg. On 14th February 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell, fever, chills and pain in arm. On 24th February 2019, the patient experienced weakness. On an unknown date, the outcome of the feeling unwell, fever, chills, pain in arm and weakness were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fever, chills, pain in arm and weakness to be related to Shingrix.  Additional details were provided as follows: The caller stated the weakness she experienced 10 days after her 1st dose of Shingrix was what it felt like.  She states it lasted for months.  She noted she also felt ill the night of the shot.  She states she had a low lever and chills that resolved after three days.   Her arm hurt for 2 weeks, which started the same day as the vaccination.  She was concerned about getting the 2nd dose after the experience of the 1st. The reporter consented to follow up. The caller was offered for health care professional to call management information system to obtain information on 1st dose efficacy if data was available. There is discrepancy between the outcome reported in the structured field (recovered) and the outcome reported in the source document (recovered with sequel).
Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Pre-term birth; This is a serious retrospective pregnancy study case, initially received from other health professional on 26-Aug-2019, concerning a neonate, male subject.  The mother was a 35-year-old female, enrolled in a  prospective observational safety study.   The mother's medical history was not reported. Concomitant medications included prenatal vitamins.  The mother's obstetrical history included one previous pregnancy of full term live birth. Also, the subject's mother had no maternal or paternal history with major congenital malformations. The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was on 06-Dec-2018 and the pregnancy was singleton. The estimated delivery date (EDD) and the corrected estimated date of delivery (CEDD) were both on 12-Sep-2019.  On 29-Jan-2019, at gestation age of seven weeks, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, at a dose of 0.5 ml, batch number:252675, expiration date, route of administration, and anatomical location: not reported] (explicitly coded as foetal exposure during pregnancy') for influenza immunisation.  At gestational age of 36.1 weeks, the mother vaginally delivered a normal male neonate (explicitly coded as premature baby'). The neonate's birth weight was 2637 g, his head circumference was 34.3 cm and length 48.3 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.  This case is linked to 201904507, corresponding mother case.  Company Comment: Reportedly, the male neonate subject was delivered as premature baby 6 months and 18 days after foetal exposure during pregnancy with the suspect product Flucelvax QIV (influenza vaccine). Chronology is plausible. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event premature baby.; Reporter's Comments: Reportedly, the male neonate subject was delivered as premature baby 6 months and 18 days after foetal exposure during pregnancy with the suspect product Flucelvax QIV (influenza vaccine). Chronology is plausible. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event premature baby.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site streaking, Injection site vesicles
Clinical narrative: Blister at injection site with red streaking noted.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 13x8 cm area of erythema and warmth at and around the injection site
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Chest discomfort, Electrocardiogram normal, Eye swelling, Lip swelling
Clinical narrative: Hives over entire body, lip, eye, throat, face, neck swelling, heavy chest.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pharyngeal swelling, Swelling, Swelling face, Urticaria, X-ray normal
Clinical narrative: Hives over entire body, lip, eye, throat, face, neck swelling, heavy chest.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Eye swelling, Lip swelling, Oropharyngeal discomfort, Swelling
Clinical narrative: Hives over entire body, lip, eye, throat, face, neck swelling, heavy chest.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Throat tightness, Urticaria
Clinical narrative: Hives over entire body, lip, eye, throat, face, neck swelling, heavy chest.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Cough, Pyrexia
Clinical narrative: Fever 100-102F and cough
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, TD
Symptoms: Extra dose administered
Clinical narrative: Looked at digital medical record but did not see she already had a dose of  HEAV
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Severe vomiting and diarrhea
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Hyperhidrosis
Clinical narrative: Pain and soreness at injection site beginning approximately 3 hours after the injection.  Chills, shivering, sweating, fever, upset stomach, nausea, beginning approximately 11 hours after the injection (1:30 AM).  Felt tired and weak and had a fever (99.9 degrees F) the morning after the day of the injection.  The low grade fever lasted until approximately 30 hours after the injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Pain and soreness at injection site beginning approximately 3 hours after the injection.  Chills, shivering, sweating, fever, upset stomach, nausea, beginning approximately 11 hours after the injection (1:30 AM).  Felt tired and weak and had a fever (99.9 degrees F) the morning after the day of the injection.  The low grade fever lasted until approximately 30 hours after the injection.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm injection site red, warm, raised, and sore. Today the raised area is softer, but larger to 2-3 inches
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Unevaluable event
Clinical narrative: Checked clinic but did not notice the month last given for HEAV
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error
Clinical narrative: Shingrix vaccine was reconstituted with sterile water for injections diluent (used for Merck live vaccines such as Zostavax) instead of the diluent provided in the Shingrix box. Patient has not experienced any adverse effects. Patients will return for a correctly reconstituted vaccination.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Induration, Pain, Pruritus
Clinical narrative: At time of injection pt had no issues. On day 3 it started to get red and swollen and painful. She came to pharmacy on day 4, where her whole upper arm was dark red with a bruise/greenish center that she said was hard underneath. She said it was still painful and hot to the touch. Sometimes it is itchy.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Skin discolouration, Skin warm, Swelling
Clinical narrative: At time of injection pt had no issues. On day 3 it started to get red and swollen and painful. She came to pharmacy on day 4, where her whole upper arm was dark red with a bruise/greenish center that she said was hard underneath. She said it was still painful and hot to the touch. Sometimes it is itchy.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Sep. 4 - 1:00am - shivering and muscle pain in both arms, both legs and lower back Sep. 4 - 7:00am - all symptoms except shivering continuing, large redness area ( 4" by 6") at injection site, feverish at redness area, lower back pain became more extreme (about a 6).   Treated with acetaminophen and heat  Sep. 4 - 6:00pm - muscle pain decreased a great deal (about a 2) Sep. 6 - 7:00 am - muscle pain basically gone - redness and fever at injection site almost gone
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure - went to ER, had 104 fever.  Resolved on own
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever, Rash, and Vomiting.  Symptoms began approximately 24 hours after vaccination.
Age: 8.0
Sex: U
Vaccine: MMR, UNK, UNK, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse effects; the vaccine was inadvertently reconstituted with the incorrect diluent; the vaccine was inadvertently reconstituted with the incorrect diluent; This spontaneous report was received from a medical assistant and refers to a 8-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-AUG-2019, the patient was vaccinated with the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# S006646, expiration date 05-MAR-2021, exact dose and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot R035221, expiration date 04-DEC-2020, exact dose and route of administration were not reported), both for prophylaxis. One of the administered vaccines was reconstituted with sterile diluent (MENCYW 135 liquid) (lot AMXA072A, expiration date ??-MAR-2021), which was the diluent for meningococcal ACYW conj vaccine (CRM197) (MENVEO) and the second was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot S008564, expiration date 05-AUG-2021). It was unknown by reporter which vaccine was inadvertently reconstituted with the incorrect sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; An improperly stored dose of PEDVAX HIB administered to patient.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 23-AUG-2019 the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), lot # S00352, expiration date 17-OCT-2020 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 36°F/2°C (35.4F) degrees Fahrenheit for 27 minutes, as recorded by a data logger. No adverse effect reported. "Lot number S00352 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate)."
Sex: M
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 male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX), 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 herpes zoster was unknown.   Additional information is not expected.
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 medical history, concurrent conditions, or concomitant medications.   In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. And on an unknown date the patient was hospitalized. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has 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 of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
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 medical history, concurrent conditions, or concomitant medications.   In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. And on an unknown date, the patient was hospitalized. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has 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 of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
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 patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not provided), as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by Advanced Practice Registered Nurse (APRN), for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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.
Sex: M
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 male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-NOV-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a military facility, for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at a healthcare center, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received unspecified dose of ROTATEQ that was improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-AUG-2019, the patient was vaccinated with improperly stored unspecified number of doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020 orally (dose was not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 24.1 degrees Fahrenheit for 4 hours 33 minutes. Previous temperature excursions included 34.7 degrees Fahrenheit for 3 hours 2 minutes. The data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received unspecified dose of ROTATEQ that was improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-AUG-2019, the patient was vaccinated with improperly stored unspecified number of doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020, orally (dose was not reported) for prophylaxis. There was no adverse effect reported. On 13-AUG-2019 and 14-AUG-2019, the administered doses of vaccine experienced the temperature excursion of 34.1 degrees Fahrenheit for 4 hours 33 minutes. Previous temperature excursions included 34.7 degrees Fahrenheit for 3 hours 2 minutes. The data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was swelled to my elbow; Arm sore; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of Shingrix, the patient experienced arm swelling to the elbow and arm soreness. The patient stated that, could not remembered, if being this tired. .
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: slight fever; the area is sore; Tired; This case was reported by a consumer and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever, injection site pain and tiredness. On an unknown date, the outcome of the fever, injection site pain and tiredness were unknown.   It was unknown if the reporter considered the fever, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had slight fever, somewhat tired and area was sore after vaccination with dose of Shingrix.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach; This case was reported by a consumer and described the occurrence of upset stomach in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. On 28th August 2019, 1 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had upset stomach. The reporter asked how long should it last. The reporter asked would the side effects be the same for the 2nd dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Mammogram, Paraesthesia, Pruritus, Rash
Clinical narrative: Itchy welts; Rash across her chest wall, abdomen, back and groin area; Allergic reaction; pinching in her breast area; This case was reported by a other health professional via call center representative and described the occurrence of urticaria in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th August 2019, 1 days after receiving Shingrix, the patient experienced urticaria, rash, allergic reaction and paresthesia. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the urticaria, rash, allergic reaction and paresthesia were not recovered/not resolved.   It was unknown if the reporter considered the urticaria, rash, allergic reaction and paresthesia to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient received Shingrix and the following day she experienced an allergic reaction which included itchy welts with a rash across her chest wall, abdomen, back and groin area.   She had a mammogram on the same day as the vaccine and she felt some pinching in her breast area the next day and initially thought it was related to the mammogram.   Her physician started the patient on the Medrol pack and her symptoms are still unresolved. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Itchy welts; Rash across her chest wall, abdomen, back and groin area; Allergic reaction; pinching in her breast area; This case was reported by a other health professional via call center representative and described the occurrence of urticaria in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th August 2019, 1 days after receiving Shingrix, the patient experienced urticaria, rash, allergic reaction and paresthesia. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the urticaria, rash, allergic reaction and paresthesia were not recovered/not resolved.   It was unknown if the reporter considered the urticaria, rash, allergic reaction and paresthesia to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient received Shingrix and the following day she experienced an allergic reaction which included itchy welts with a rash across her chest wall, abdomen, back and groin area.   She had a mammogram on the same day as the vaccine and she felt some pinching in her breast area the next day and initially thought it was related to the mammogram.   Her physician started the patient on the Medrol pack and her symptoms are still unresolved. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: tinnitus; This case was reported by a physician via sales rep and described the occurrence of tinnitus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician reported to the sales representative the patient in the late 50s to early 60s developed tinnitus. No additional information was available regarding the patient. The reporter consented to follow up. This case has been linked with US2019AMR158102, having same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Vaccination complication
Clinical narrative: Rash around her navel and left side of stomach; Redness on her arm near the injection site; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2019, 1 days after receiving Shingrix, the patient experienced localized erythema. On 30th July 2019, the patient experienced rash. The patient was treated with prednisone. On an unknown date, the outcome of the localized erythema and rash were resolved with sequelae.   It was unknown if the reporter considered the localized erythema and rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced redness on her arm near the injection site. The patient also experienced big rash around her navel and left side of stomach. The patient went to a dermatologist and said it was a reaction to Shingrix. Dermatologist prescribed prednisone tablets and a spray. The patient did not consent to follow up. The patient stated that the primary care physician did not recommend 2nd dose. Dermatologist suggested to patient that 2nd dose reaction might be worse. This case has been linked with case US2019AMR158816, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: shingles; pain; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3P25J, expiry date 21st September 2021) for prophylaxis.   On 5th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced shingles, pain and rash. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was recovering/resolving and the outcome of the rash was resolved with sequelae.   It was unknown if the reporter considered the shingles, pain and rash to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed shingles, rash and pain. The rash had resolved but the pain was ongoing
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: body ache; flu like symptoms; not feeling well; diarrhea; soreness; nausea; headache; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 1 day after receiving Shingrix, the patient experienced nausea and headache. On 24th August 2019, the patient experienced pain in arm. On 27th August 2019, the patient experienced general body pain, influenza-like symptoms, feeling unwell and diarrhea. On 27th August 2019, the outcome of the pain in arm was recovering/resolving. On an unknown date, the outcome of the nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea were recovering/resolving.   It was unknown if the reporter considered the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced a sore arm for three days. The patient also experienced nausea and headache. On 27th August 2019, the patient experienced general body pain, influenza-like symptoms, feeling unwell and diarrhea. The patient overheard a co worker speaking about another patient who had similar side effects, however, she had no details to provide. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: body ache; flu like symptoms; not feeling well; diarrhea; soreness; nausea; headache; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 1 day after receiving Shingrix, the patient experienced nausea and headache. On 24th August 2019, the patient experienced pain in arm. On 27th August 2019, the patient experienced general body pain, influenza-like symptoms, feeling unwell and diarrhea. On 27th August 2019, the outcome of the pain in arm was recovering/resolving. On an unknown date, the outcome of the nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea were recovering/resolving.   It was unknown if the reporter considered the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced a sore arm for three days. The patient also experienced nausea and headache. On 27th August 2019, the patient experienced general body pain, influenza-like symptoms, feeling unwell and diarrhea. The patient overheard a co worker speaking about another patient who had similar side effects, however, she had no details to provide. The reporter consented to follow up.