chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Epigastric discomfort, Hernia, Herpes zoster, Nausea
Clinical narrative: decreased therapeutic effect; irritates her stomach; missed dose; Hernia; throwing up; sick to her stomach; abdominal pain; Shingles; Information has been downloaded from regulatory authority (US-GLAXOSMITHKLINE-US2014GSK020480) on 06-JUL-2020.  This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's current conditions included high blood pressure high (hypertension), diabetes and gallstones removal (cholelithotomy). Information regarding the patient's medical history, concomitant therapies, drug allergies or reactions, and historical drugs were not provided.  On an unknown date in 2012, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine) (indication, dose, and lot number were reported as unknown; concentration, dose number, frequency of vaccination scheme, anatomical location of vaccination, and expiry date were not reported). Other suspect therapies included eltrombopag olamine (PROMACTA) tablet, which was started on an unknown date in 2012 at a dose of 50 milligram (mg) every other day (qod) via oral and also at a dose of 2 dosage forms a day from an unknown date (conflicting information as also reported as twice a day (bid) for this dose) for platelet count decreased (strength, and expiry date were not reported; lot number reported as unknown).      On 01-SEP-2014, the patient experienced shingles (herpes zoster).  On 01-OCT-2014, the patient experienced hernia.  On an unknown day in October 2014, the patient developed abdominal pain, felt sick to her stomach (nausea) and was throwing up (vomiting). The patient recovered from the nausea and vomiting on 01-NOV-2014.  On 08-SEP-2015 the patient missed a dose (product dose omission).    On an unknown date, the patient experienced a decreased therapeutic effect and she had an irritable stomach (epigastric discomfort).  These events caused the patient to be hospitalized on an unknown date.    The action taken with eltrombopag olamine (PROMACTA) was reported as unknown.  The outcome of herpes zoster, abdominal pain and hernia was reported as resolving. The outcome of therapeutic response decreased, product dose omission and epigastric discomfort was reported as unknown.     The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the occurrence of all the events was not reported.  The causal relationship between eltrombopag olamine (PROMACTA) and the occurrence of herpes zoster, and hernia was considered not related; and for vomiting, nausea, abdominal pain, decreased therapeutic effect, and epigastric discomfort, the relatedness was reported as unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Product dose omission, Therapeutic product effect decreased, Vomiting
Clinical narrative: decreased therapeutic effect; irritates her stomach; missed dose; Hernia; throwing up; sick to her stomach; abdominal pain; Shingles; Information has been downloaded from regulatory authority (US-GLAXOSMITHKLINE-US2014GSK020480) on 06-JUL-2020.  This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's current conditions included high blood pressure high (hypertension), diabetes and gallstones removal (cholelithotomy). Information regarding the patient's medical history, concomitant therapies, drug allergies or reactions, and historical drugs were not provided.  On an unknown date in 2012, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine) (indication, dose, and lot number were reported as unknown; concentration, dose number, frequency of vaccination scheme, anatomical location of vaccination, and expiry date were not reported). Other suspect therapies included eltrombopag olamine (PROMACTA) tablet, which was started on an unknown date in 2012 at a dose of 50 milligram (mg) every other day (qod) via oral and also at a dose of 2 dosage forms a day from an unknown date (conflicting information as also reported as twice a day (bid) for this dose) for platelet count decreased (strength, and expiry date were not reported; lot number reported as unknown).      On 01-SEP-2014, the patient experienced shingles (herpes zoster).  On 01-OCT-2014, the patient experienced hernia.  On an unknown day in October 2014, the patient developed abdominal pain, felt sick to her stomach (nausea) and was throwing up (vomiting). The patient recovered from the nausea and vomiting on 01-NOV-2014.  On 08-SEP-2015 the patient missed a dose (product dose omission).    On an unknown date, the patient experienced a decreased therapeutic effect and she had an irritable stomach (epigastric discomfort).  These events caused the patient to be hospitalized on an unknown date.    The action taken with eltrombopag olamine (PROMACTA) was reported as unknown.  The outcome of herpes zoster, abdominal pain and hernia was reported as resolving. The outcome of therapeutic response decreased, product dose omission and epigastric discomfort was reported as unknown.     The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the occurrence of all the events was not reported.  The causal relationship between eltrombopag olamine (PROMACTA) and the occurrence of herpes zoster, and hernia was considered not related; and for vomiting, nausea, abdominal pain, decreased therapeutic effect, and epigastric discomfort, the relatedness was reported as unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: extreme pain all over; headache; tiredness; This case was reported by a consumer via call center representative and described the occurrence of generalized aching in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching, headache and tiredness. On an unknown date, the outcome of the generalized aching, headache and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the generalized aching, headache and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had extreme pain all over, headache, tiredness. The reporter asked how long did the vaccine side effects last. The reporter asked could you get shingles and not had any rash.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising
Clinical narrative: bruising in other areas other than the injection site; injection site bruising; This case was reported by a other health professional via interactive digital media and described the occurrence of contusion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced contusion and injection site bruising. On an unknown date, the outcome of the contusion and injection site bruising were unknown.   It was unknown if the reporter considered the contusion and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter asked, was the bruising common in other areas than the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: itch; pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus and pain. On an unknown date, the outcome of the pruritus and pain were unknown.   It was unknown if the reporter considered the pruritus and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, after vaccination, the patient had itch and pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: body shakes; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th February 2020, 12 hrs after receiving Shingrix, the patient experienced tremor, chills and fever. On an unknown date, the outcome of the tremor, chills and fever were recovered/resolved.   It was unknown if the reporter considered the tremor, chills and fever to be related to Shingrix.  Additional case details were reported as follows: The patient experienced 12 hours after vaccination fever, chills, and body shakes. All events resolved within 24 hours after the injection. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain and swelling at the injection site; Intense itching at injection site; Swelling at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site itching and injection site swelling. The patient was treated with non-drug therapy (Ice-Cold Compresses (Nos)) and hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site pain, injection site itching and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site itching and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient experienced pain and swelling at the injection site after receiving Shingrix.  She also experienced intense itching at injection site.  The patient treated with ice compresses and icy hot. She also used hydrocortisone cream.  The reactions were intense for a day or two. By day 3, the reactions had begun to resolve. At time of report, reactions had resolved completely. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Malaise, Pain
Clinical narrative: Headache; Itchy area on the abdomen / felt itchy on the abdomen like a shingles; Felt sick; achy; felt itchy on the abdomen like a shingles; chills; like a bite; This case was reported by a nurse via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. On 1st July 2020, immediately after receiving Shingrix, the patient experienced headache, pruritus, malaise, pain, vesicular rash, chills and scratch. On an unknown date, the outcome of the headache, pruritus, malaise, pain, vesicular rash, chills and scratch were unknown.   It was unknown if the reporter considered the headache, pruritus, malaise, pain, vesicular rash, chills and scratch to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix about 1 week ago and right after the administration she experienced headache, felt sick and an itchy area on the abdomen. The patient also experienced felt itchy on the abdomen like a bite like shingles. She also reported that she felt sick, achy, and had chills. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular, Scratch
Clinical narrative: Headache; Itchy area on the abdomen / felt itchy on the abdomen like a shingles; Felt sick; achy; felt itchy on the abdomen like a shingles; chills; like a bite; This case was reported by a nurse via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. On 1st July 2020, immediately after receiving Shingrix, the patient experienced headache, pruritus, malaise, pain, vesicular rash, chills and scratch. On an unknown date, the outcome of the headache, pruritus, malaise, pain, vesicular rash, chills and scratch were unknown.   It was unknown if the reporter considered the headache, pruritus, malaise, pain, vesicular rash, chills and scratch to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix about 1 week ago and right after the administration she experienced headache, felt sick and an itchy area on the abdomen. The patient also experienced felt itchy on the abdomen like a bite like shingles. She also reported that she felt sick, achy, and had chills. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Rash, Rash vesicular
Clinical narrative: rash; rash appears to be Varicella (Chicken pox); This case was reported by a nurse via call center representative and described the occurrence of rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and varicella-like rash. On an unknown date, the outcome of the rash and varicella-like rash were unknown.   It was unknown if the reporter considered the rash and varicella-like rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced a rash after dose of Shingrix.  The rash appears to be Varicella (Chicken pox) but the provider was uncertain. On 7th July 2020, the patient had a biopsy done to determine if the rash was Varicella or not.  No outcome was provided. No additional information was provided. The reporter consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Malaise, Social problem
Clinical narrative: sick; tired; because of the COVID-19 has not the second dose; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, 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 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, tiredness and social problem. On an unknown date, the outcome of the sickness, tiredness and social problem were unknown.   It was unknown if the reporter considered the sickness and tiredness to be related to Shingrix.  Additional case details were reported as follows: On 19th November 2020, the patient experienced Shingrix. The patient stated after she got the first dose, she remembers being tired and sick. The patient did not remember if she experienced fever or shiver while feeling sick. Due to COVID-19, pharmacy was not administering the vaccine, hence the patient not yet gotten the 2nd dose. The reporter consent to follow up.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 9 month old male patient received an expired dose of Fluzone vaccine,No AE; Initial information received on 07-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a nine month old male patient who received an expired 0.5 mg dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number not reported and expiry date: 30-Jun-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  Past vaccination included flu vaccine (with first dose at his 6 month visit in April).  Medical history, concomitant therapy, medical treatment and family history were not provided.  It was a case of an actual medication error due to expired vaccine used. It was reported that a 9 month patient visit yesterday and he received the flu vaccine. After he received the dose they found that the vaccine was expired.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 60.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Ipol was administered to patient, No AE; Initial information received on 07-Jul-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case involves a 60 year old male patient who received a 0.5 ml second dose of vaccine IPV (VERO) [IPOL] (lot number: P1A461M) via subcutaneous route in the left arm for prophylactic vaccination on 07-Jul-2020, that was expired on 03-May-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TETANUS VACCINE and HIB VACCINE (HIB) for prophylactic vaccination on 07-Jul-2020.  It was an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse effects; PNEUMOVAX23 was inadvertantly administered insteas of Prevenar13; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.    On 24-JUN-2020 the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, frequency, route of administration anatomical location, lot # and expiration date were not reported) instead of pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) (lot # and expiration date were not reported) for prophylaxis. No additional adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in ligitation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2015, the pt 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 pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: MMR, UNK
Symptoms: Circumstance or information capable of leading to medication error, Eye irrigation, Eye pruritus, Occupational exposure to product
Clinical narrative: Nurse Practitioner reported while she was administering a dose of MMR II to a patient on 7/7/2020, the patient moved and a "small amount" of MMR II "went into" Nurse Practitioner's eye; she is experiencing "slight" itching in the eye; Information has been received from a nurse practitioner referring to a 45 years old female patient. The patient had no pertinent medical history. The patient's concomitant medication included loratadine (CLARITIN). The patient's drug reactions/allergies included seasonal allgergies.  On 07-JUL-2020, while the nurse practitioner was administering a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # S015427  and expiration date 20-MAY-2021; strength and dose were unknown) to a patient, the patient moved and a small amount of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) went into the nurse practitioner's eye (occupational exposure to product). The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot # S022090 and expiration date 21-FEB-2022; strength, dose were unknown). The nurse practitioner immediately flushed unspecified eye with water. On the same day, the nurse practitioner was experiencing slight itching in the eye. The nurse practitioner reported itching was probably related to seasonal allergies. The outcome of the event slight itching in the eye was not recovered.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003205:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no known adverse effects; a patient received an expired dose of ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 07-JUL-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R034103, expiration date: 26-JUN-2020 (strength and dose number were not provided) orally for prophylaxis. No known adverse effects.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 5 unspecified patients experienced syncope/3 of the unspecified patients were male; This spontaneous report was received from a physician via a company representative and refers to 2 female patients, at the age range between 11 to 16 years old. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot# and expiration date were not provided) for prophylaxis. After administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patients experienced syncope.  The outcome of the event was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as dose not changed. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003299:
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed case of shingles / Herpes zoster; This spontaneous report was received from an other health professional and refers to a 80-year-old female patient. The patient's concurrent conditions included depression, osteoporosis and dementia. There was no information about patient's concomitant therapies or medical history provided.  On 14-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), subcutaneously in the right arm (strength, dose, indication, lot# and expiration date were not provided). On the same date, the patient was also vaccinated with influenza virus split virion 3v vaccine inactivated (AFLURIA) intramuscular injection in the right arm, lot# U57907 (strength, dose and expiration date were not provided) for unknown indication and pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) intramuscularly in the right arm (strength, dose, indication, lot# and expiration date were not provided).  On 22-OCT-2015, the patient experienced herpes zoster. The outcome of the event was unknown.  Causality assessement was not provided.  Upon internal review, the event od herpes zoster was determined as medically significant.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Terrible pain; Rash across her right abdomen, side, and around her back; Shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US059987).    This spontaneous report was received from a health professional referring to a 63 years old female patient. The patient's concomitant medications included losartan potassium (+) hydrochlorothiazide (HYZAAR), amitriptyline hydrochloride, fish oil, potassium, vitamin d and aspirin. No information regarding the patient's concurrent conditions and medical history was provided.   On 11-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 dosage form, lot # K018176, has been verified to be a valid lot number, expiration date was not reported, but upon internal validation established as 10-JAN-2016, strength and exact dose were not reported) subcutaneously for immunization and influenza virus sag 3v vaccine inactivated (FLUVIRIN) (1 dosage form, lot # 146604, strength, expiration date and exact dose were not reported) intramuscularly for immunization.   On 17-FEB-2015, the patient experienced rash across her right abdomen, side, and around her back (rash) and shingles. On an unknown date, the patient experienced terrible pain. The outcome of all events was reported as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was not provided. The primary reporter suspected all the events related to influenza virus sag 3v vaccine inactivated (FLUVIRIN).      The events of rash, shingles and pain were considered as medical significant by the agency.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Incidence of dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experinced dizziness. The reporter did not consent to follow-up.   Upon an internal check, the following corrections were performed: The concomitant was deleted was capture inadvertanly.
Age: 53.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Only to right deltoid (where pneumococcal vaccine as injected). Patient stated that the night of the vaccine his arm hurt badly and could not lay on that arm. The next day the whole upper arm was swollen red and hot to touch
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Rash
Clinical narrative: SkinRash  ZOSTER VACCINE 0.5 ML ONCE
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Facial asymmetry, Pruritus, Swelling face
Clinical narrative: Facial swelling and itching presented on left side of face including facial asymmetry
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant redness, swelling, and pain around the injection site.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Headache, Hypersensitivity, Injection site urticaria, Throat tightness
Clinical narrative: Patient received Bexsero on 7/6/2020.  On 7/11/2020 patient reports she woke up with severe headache, severe shortness of breath, felt like her throat was closing, and hives at injection site. Patient  then went to the ER  and was treated for severe allergic reaction.  Interestingly, this was her second dose and did not have same reaction to her her first dose.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Left arm swelling which resolved without intervention
Age: 68.0
Sex: M
Vaccine: PNC
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect; patient was administered GARDASIL 9 on 8/6/2018, 10/9/2018, 6/7/2019 and 6/30/2020; patient was administered GARDASIL 9 on 8/6/2018, 10/9/2018, 6/7/2019 and 6/30/2020; This spontaneous was report as received from a nurse via a field representative and refers to a 18-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 06-AUG-2018, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 09-OCT-2018, the patient was vaccinated with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 07-JUN-2019, the patient was vaccinated with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 30-JUN-2020, the patient was vaccinated with the fourth dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). No additional adverse effect reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: injection site felt warm; fever; fatigue; redness at injection site; pain in arm/injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 9th February 2020, refer case US2020AMR123816). Concomitant products included acyclovir.   On 3rd July 2020, the patient received the 2nd dose of Shingrix. On 3rd July 2020, less than a day after receiving Shingrix, the patient experienced injection site warmth, fever, fatigue and injection site erythema. In July 2020, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site warmth, fever, fatigue and injection site erythema were unknown.   It was unknown if the reporter considered the pain in arm, injection site warmth, fever, fatigue and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and felt fatigue, redness at injection site, pain at injection site, injection site warmth and a sore arm. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR123816:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: injection site felt warm; fever; fatigue; redness at injection site; pain in arm/injection site pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 9th February 2020, refer case US2020AMR123816). Concomitant products included acyclovir.   On 3rd July 2020, the patient received the 2nd dose of Shingrix. On 3rd July 2020, less than a day after receiving Shingrix, the patient experienced injection site warmth, fever, fatigue and injection site erythema. In July 2020, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site warmth, fever, fatigue and injection site erythema were unknown.   It was unknown if the reporter considered the pain in arm, injection site warmth, fever, fatigue and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and felt fatigue, redness at injection site, pain at injection site, injection site warmth and a sore arm. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR123816:same reporter
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: A refrigerator malfunction caused the temperature excursion of vaccine which reached -.8 C for 14 hours and 22 minutes and was administered, no AE; Initial information was received on 08-Jul-2020 regarding an unsolicited valid non-serious case from a pharmacist  This case involves a 21 year old female patient who received a 0.5 ml once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5655AA, Expiry date: 15-Aug-2021) once via intramuscular route in the left deltoid on 01-Jul-2020 for prophylactic vaccination  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. She recently had a baby.   It was a case of an actual medication error due to Product storage error temperature too low (Product storage error).   It was reported that on 01-Jul-2020, a 21 year-old woman came in for an Adacel vaccine as she just had a baby and her doctor was unsure of her immunization history. She received the vaccine, but it was later discovered that the Adacel had undergone an excursion in which the product went to a temperature less than 0 degree Celsius (-.8 C for 14 hours and 22 minutes) due to a mechanical problem. It was reported that she will be reimmunized.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 0th hour got the shot. 12th hour got a 99.9 degrees Fahrenheit fever. 36th hour fever gone.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Burning sensation, Complex regional pain syndrome, Condition aggravated, Grip strength decreased
Clinical narrative: 29 y/o male presents to clinic c/o a questionable Tdap injection site reaction x3 days. The injection was given on Monday, symptoms started on Saturday. Patient is experiencing numbness, burning, weakness, limited ROM and is so painful it woke him up. The site is not discolored or warm. He has not any issues with any vaccines. He can't hold a coffee cup with this hand and the pain is severe 9/10. He has been working out and working manual labor. Denies any known injury to arm. Pt received his TDAP for a cut that occurred at work on his right arm.        Per immunization record at this clinic, the Tdap vaccine was given in his right deltoid. Pt is c/o left arm pain. Denies fever.        He has been referred to Neurology and Physical Therapy - he has an appt with Neuro this Thursday, 7/9/2020.         His history is significant for complex regional pain syndrome. He uses lidocaine patches and medical marijuana to treat. Physical exam wnl. I have no concerns at this time. Pt will f/u with Neurology and PT for further evaluation. Discussed with pt that I suspect symptoms are secondary to complex regional pain syndrome.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Joint range of motion decreased, Middle insomnia, Pain in extremity
Clinical narrative: 29 y/o male presents to clinic c/o a questionable Tdap injection site reaction x3 days. The injection was given on Monday, symptoms started on Saturday. Patient is experiencing numbness, burning, weakness, limited ROM and is so painful it woke him up. The site is not discolored or warm. He has not any issues with any vaccines. He can't hold a coffee cup with this hand and the pain is severe 9/10. He has been working out and working manual labor. Denies any known injury to arm. Pt received his TDAP for a cut that occurred at work on his right arm.        Per immunization record at this clinic, the Tdap vaccine was given in his right deltoid. Pt is c/o left arm pain. Denies fever.        He has been referred to Neurology and Physical Therapy - he has an appt with Neuro this Thursday, 7/9/2020.         His history is significant for complex regional pain syndrome. He uses lidocaine patches and medical marijuana to treat. Physical exam wnl. I have no concerns at this time. Pt will f/u with Neurology and PT for further evaluation. Discussed with pt that I suspect symptoms are secondary to complex regional pain syndrome.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Hyperhidrosis, Skin discolouration
Clinical narrative: Patient became very grey and sweaty.  I laid him down and put a pillow under his head with an ice pack with feet up on the bench.  I gave him apple juice and graham crackers as he had not had lunch prior to his appointment today.  He remained laying down for approximately 15 minutes and drank two apple juice.  I them sat him up for a few minutes and then slowly had him stand.  He was able to leave with his mother, stating that he was feeling fine and felt he could leave.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: PNEUMOVAX 23 was expired and given to the patient; This solicited report was received from a pharmacist, concerning a female patient of unknown age, who was enrolled in a Patient Support Program (PSP). The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies, and concomitant medications were unknown by the reporter.      On 28-JUN-2020, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number R033079 with expiration date on 06-JUN-2020 as prophylaxis (strength, dose, frequency and anatomical location were not reported) (expired vaccine used).  Follow-up information was received in 08-JUL-2020.  It was reported that the call was deemed to be transferred from an internal group rather than a PSP. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R033079; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The patient experienced no symptoms.; A patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a Medical Assistant, 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 01-JUL-2020, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live  recombinant Human albumin (rHA)(PROQUAD) via subcutaneous route (strength,dose number, dose, frequency, and anatomical location, were unknown) with lot # S031704, and expiration date 06-APR-2021, reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT).     The administered dose of the vaccine experienced the temperature excursion of -13.3°C degrees Celsius for 1 hour and 15 minutes, and had a previous temperature excursion of ( -1.8°C) degrees Celsius for 4 hours and 27 minutes; and of (-13.4°C) degrees Celsius for 1 hour. There was a digital data logger involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer and a patient of unknown age and gender, regarding a case in litigation on 06-JUL-2020. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered an outbreak of shingles. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. The patient also sustained severe, permanent and incurable personal 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 results of zoster vaccine live (ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered shingles to be a disabling event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt 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 a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a physician's medical office for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Social problem
Clinical narrative: Neuropathy; Shingles; Didn't get it due to COVID-19; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular). 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 neuropathy (serious criteria GSK medically significant), shingles and social problem. On an unknown date, the outcome of the neuropathy, shingles and social problem were unknown.   It was unknown if the reporter considered the neuropathy and shingles to be related to Shingrix.  Additional information was provided as follows: The patient was due in February to get the second dose and she didn't get it due to COVID-19, which led to social problem. The patient got shingles during a vacation last summer and she experienced neuropathy. The reporter consented to follow up.