chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: experienced swelling, warmth and redness at the injection site; experienced swelling, warmth and redness at the injection site; experienced swelling, warmth and redness at the injection site; This spontaneous report was received from a nurse refers to a 78 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. Her drug reactions and allergies included allergy to sulfa drugs that gave her sore mouth. On 09-OCT-2019, patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, anatomical location, lot # and expiration date were unknown) via an intramuscular route for prophylaxis. On 25-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, anatomical location were unknown) with lot # S006777 and expiration date 28-NOV-2020 via an intramuscular route for prophylaxis. On 26-NOV-2019, the patient experienced swelling (injection site swelling), redness (injection site erythema) and warmth (injection site warmth). The reporter stated that the area of redness measured "17 cm X 19 cm". The patient received antibiotics as treatment for the events. The patient sought medical attention from physician office. The reporter stated that the "patient had no fever". The outcome of the events of injection site swelling, injection site erythema and injection site warmth was reported as not recovered. Causality assessment was not provided. There was no product quality complaint associated with the case.
Age: 4.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: proquad administered intramuscularly; No adverse effect; This spontaneous report was received from a Licensed Vocational Nurse (LVN) via medical assistant referring to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug allergies/ reactions were not reported.      On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection (strength, dose, anatomical location not reported) with lot # S021623 and expiry date 09-JAN-2021, intramuscularly (incorrect route of product administration) for prophylaxis. Co-suspect therapy included sterile diluent (STERILE DILUENT) with lot # S029574 and expiry date 29-MAY-2022. No adverse symptoms reported. No product quality complaint was involved in this report.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event information provided; Improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported.  On 25-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S013715, expiry date: 01-NOV-2020) (dose, frequency and route were not reported) for prophylaxis.  The sterile diluent(DILUENT MRK INJ) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. Multiple excursions were involved with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) with unspecified temperature and time frame. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Achy; Fever; This case was reported by a consumer via sales rep and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the fever was recovered/resolved.   The reporter considered the pain and fever to be possibly related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced fever and achy. The events got better within 24 hours but still achy. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate increased, Injection site pain
Clinical narrative: I only experienced soreness at the injection site; had a racing pulse during the night; Earlier this am I felt body aches; somenauseated.; I woke up feeling feverish. Now I just am feeling weak and generally tired; I woke up feeling feverish. Now I just am feeling weak and generally tired; I'm also feeling mildly dizzy and weak now; generally tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, pulse rapid, general body pain, nausea, fever, feelings of weakness, dizziness and tiredness. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, general body pain, nausea, fever, feelings of weakness, dizziness and tiredness were unknown and the outcome of the pulse rapid was recovered/resolved.   It was unknown if the reporter considered the injection site pain, pulse rapid, general body pain, nausea, fever, feelings of weakness, dizziness and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced racing pulse during the night which had subsided.  On reporting day, early in morning the patient felt body aches and took Advil and went back to bed. The patient felt mildly nauseated. The patient woke up with feeling feverish and at the day of reporting in morning felt weak and generally tired. The patient also reported soreness at the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I only experienced soreness at the injection site; had a racing pulse during the night; Earlier this am I felt body aches; somenauseated.; I woke up feeling feverish. Now I just am feeling weak and generally tired; I woke up feeling feverish. Now I just am feeling weak and generally tired; I'm also feeling mildly dizzy and weak now; generally tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, pulse rapid, general body pain, nausea, fever, feelings of weakness, dizziness and tiredness. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, general body pain, nausea, fever, feelings of weakness, dizziness and tiredness were unknown and the outcome of the pulse rapid was recovered/resolved.   It was unknown if the reporter considered the injection site pain, pulse rapid, general body pain, nausea, fever, feelings of weakness, dizziness and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced racing pulse during the night which had subsided.  On reporting day, early in morning the patient felt body aches and took Advil and went back to bed. The patient felt mildly nauseated. The patient woke up with feeling feverish and at the day of reporting in morning felt weak and generally tired. The patient also reported soreness at the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Lethargy, Pyrexia
Clinical narrative: side effects; low-grade fever; lethargy; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2019, the patient received the 1st dose of Shingrix. In February 2019, less than a week after receiving Shingrix, the patient experienced adverse drug reaction, low grade fever and lethargy. On an unknown date, the outcome of the adverse drug reaction, low grade fever and lethargy were unknown.   It was unknown if the reporter considered the adverse drug reaction, low grade fever and lethargy to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix saturday morning and experienced common side effect with low-grade fever and some lethargy.
Sex: U
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Muscle spasms, Nausea
Clinical narrative: gastrointestinal problems; nausea; cramps; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced gastrointestinal disorder, nausea and cramp. Shingrix was discontinued. On an unknown date, the outcome of the gastrointestinal disorder, nausea and cramp were unknown.   It was unknown if the reporter considered the gastrointestinal disorder, nausea and cramp to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on 11th September 2019, ever since then patient had experienced various gastrointestinal problems, including nausea and cramps. The patient certainly not going to do a 2nd shot. The patient was enquiring if there was anything that could be done to offset these gastro issue in the way of medication or food or anything else.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Pyrexia
Clinical narrative: FEVER; CHILLS; UPSET STOMACH; This case was reported by a pharmacist via other manufacturer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced fever, chills and upset stomach. On an unknown date, the outcome of the fever, chills and upset stomach were recovered/resolved.   It was unknown if the reporter considered the fever, chills and upset stomach to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. No other information available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: ain in arm that has lasted a year; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced Pain in arm which lasted for a year. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: pain to my shoulder blade on the side of the injection; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient had Shingrix vaccine 2 weeks ago and was still having pain to the shoulder blade on the side of the injection.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Mild headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 2nd dose of Shingrix. On 19th November 2019, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional information was received as follows: The patient had the second dose of Shingrix yesterday and have a mild headache this morning. The patient enquired whether to take aspirin or ibuprofen to relieve headache.
Sex: U
Vaccine: MENB
Symptoms: Malaise, Pyrexia
Clinical narrative: Malaise; Fever; This case was reported by a nurse via sales rep and described the occurrence of malaise in a 19-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced malaise and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the malaise and fever were unknown.   The reporter considered the malaise and fever to be related to Bexsero.  Additional information was received as follows: The patient experienced malaise and fever when vaccinated with Bexsero.The reporter felt symptoms related to vaccine. The patient took ibuprofen for symptoms. The reporter did not agreed to follow up. This was 1 out of 2 cases reported by same reporter.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is very painful; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 2nd dose of Shingrix. On 19th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was received as follows: The patient had 2nd shot of Shingrix this morning and the patient's arm was very painful. The patient could barely use the arm due to pain was 10. The patient asked whether heat would be helpful.      Lab Comments: On an unknown date lab test was performed.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Soar arm where the shot was given; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2019, the patient received Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was going to get side effects from the 1st shot or 2nd and asked how long would it be. The patient received Shingrix and had sore arm where the shot was given but not much else yet. The patient was not comfortable giving the rest information.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site pain, Pain in extremity
Clinical narrative: Painful Injection; Diarrhea; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and diarrhea. The patient was treated with loperamide hydrochloride (Imodium). On an unknown date, the outcome of the pain in arm and diarrhea were recovered/resolved.   It was unknown if the reporter considered the pain in arm and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and in her left upper arm and complains of painful injection that lasted for approximately 3 days. Approximately 12 hours following vaccination caller reports starting to have diarrhea that lasted another 12 hours while taking Immodium AD for relief. The reporter consented to follow up. The caller was a GlaxoSmithKline employee. GlaxoSmithKline employee was not a field representative.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: shingles/rash most likely like shingles/ rash on differrent site from injection; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a elderly male patient who received Herpes zoster (Shingrix) (batch number 3D53C, expiry date 11th December 2021) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix, 3 months before the reporting date. The patient developed a rash on a different site from injection, most likely like Shingles. The reporter provided all patients identifiers as well as batch number and expiration date.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: soreness; Sore; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema 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 injection site erythema and pain. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the injection site erythema and pain 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 has experienced redness at site of injection for three weeks and soreness. Reporter consented to follow up. This case has been linked with US2019209062, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Left arm injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported but it could be 62 or 63 years. The patient received Shingrix on left arm. After receiving Shingrix, the patient experienced left arm injection site pain which resolved in 1.5 days. The patient did not provide address, phone number or date of birth.  The reporter did not consent to follow up. This case was linked with case US2019209767, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site pain; Injection site with redness; Injection site is warm to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows The age at vaccination was not reported but it could be 62 or 63 years. The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced injection site pain, which was warm to touch and with redness. The reporter did not provide address, phone number or any contact information. No additional information provided. The reporter did not consent to follow up. This case was linked with case US2019209765, reported by the same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Sensitive skin
Clinical narrative: Burning sensation; Sensitive skin; Does not feel the area unless something is touching the area; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, between 1 and 2 weeks after receiving Shingrix, the patient experienced burning sensation, sensitive skin and numbness localized. On an unknown date, the outcome of the burning sensation was not recovered/not resolved and the outcome of the sensitive skin and numbness localized were unknown.   It was unknown if the reporter considered the burning sensation, sensitive skin and numbness localized to be related to Shingrix.  Additional case details were reported as follows: The patient reported for himself. The patient had the Shingrix vaccine in the right arm, approximately at the end of October 2019 or early part of November 2019. He did not know exact date. About 8 to 10 days before the reporting date, the patient developed sensitive skin about a quarter inch below his rib cage. The patient described it as, the area was about four inches wide and run horizontal. The area was a football shape cut in half that tapered to a point along the sides of his body. It was in the center of his rib cage area. The patient also stated that, he did not feel the area unless something touch it such as his shirt or sheet.  He described these symptoms as a burning sensation, the area was not red and did not itch. He further stated that, the sensation moved down his rib cage. The patient mentioned this to his physician but his physician did not know what it could be. The patient did not have lot number. The patient consented to follow up and provided his physician's details also.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: extreme pain at the injection site; difficulty raising arm and lifting objects; Sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 30-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site erythema
Clinical narrative: Diagnosed with shingles on left arm; Injection site redness; Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date 8th March 2022) for prophylaxis.   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 9th November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and influenza-like symptoms. On 20th November 2019, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site erythema and influenza-like symptoms were unknown.   It was unknown if the reporter considered the shingles, injection site erythema and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter statesd that, the improvement of these symptoms on 12th November 2018, but did not know if these symptoms have resolved at this time.  The reporter stated that the patient was diagnosed with shingles on his left arm on 20th November 2019 at a walk-in clinic. The emergency visit was required. The healthcare professional did not consent to follow up of this case.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: all over body rash; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 76-year-old male 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 months after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: Six weeks before the time of reporting, the patient received 1st dose of Shingrix and since then he has sustained an all over body rash. They have looked at possible allergens, such as food allergies or detergents, but had not been able to find a culprit. The responsible physician or any details regarding vaccine were not reported. The reporter consented to follow up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, VIth nerve paralysis
Clinical narrative: Diagnosed with palsy of the sixth nerve of the right eye; Double vision in right eye; This case was reported by a nurse via call center representative and described the occurrence of vith nerve palsy in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th November 2019, 57 days after receiving Shingrix, the patient experienced vith nerve palsy (serious criteria GSK medically significant) and double vision. On an unknown date, the outcome of the vith nerve palsy and double vision were unknown.   It was unknown if the reporter considered the vith nerve palsy and double vision to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient was a retired who develop double vision in her right eye. On 8th November 2019, she was seen by an ophthalmologist who diagnosed her with palsy of the sixth nerve of the right eye. Additional information was not provided. The reporter did not consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 102F; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cough (had cough prior to receiving vaccine).   On 25th November 2019, the patient received the 2nd dose of Shingrix. On 25th November 2019, less than a day after receiving Shingrix, the patient experienced fever. The patient was treated with antibiotics nos and paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the physician's assistant reported on behalf of her father. The patient received dose of Shingrix in an unknown arm. On 25th November 2019, less than 12 hours after vaccination, the patient experienced fever of 102F. The reporter stated that, the patient had cough prior to receiving the vaccine and when the patient developed fever, the reporter called the doctor. The doctor prescribed antibiotics and also recommended to took Tylenol. The reporter stated that, the patient called his doctor to inform about his symptoms,  however, the patient did not visit the doctor's office. The reporter did not consent to folllow up.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: delayed transit of Fluzone Quad 0.5mL pre-filled syringes and administered to a patient, no AE; delayed transit of Fluzone Quad 0.5mL pre-filled syringes and administered to a patient, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA287365, 2019SA287366 and 2019SA287333 (same reporter).  This case involves a 47 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe, lot: UT6686JA, expiry date: 30-Jun-2020), via intramuscular route in the right arm on 14-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to the incorrect product storage and Product shipment delay.  It was reported that there was delayed transit of Fluzone Quad 0.5mL pre-filled syringes and shipment was to be delivered on 10-Oct-2019 and was not received until 14-Oct-2019 and inadvertently administered to 1 patient prior to being aware of delayed shipment.  At the time of reporting, the patient had no adverse event.  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: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: most of the dose was lost through the end of the plunger with no AE; dose dribbled down the patient's arm with no AE; something with the needle or barrel was wrong, no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA312488.  This case involves 79 year old female patient for whom most of the dose was lost through the end of the plunger [Underdose] and dose dribbled down the arm [Exposure via skin contact], while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Patients Medical history, concomitant medication were not reported.   On 18-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot UJ285AB, exp date: 02Jun2020] via intramuscular route in right arm for prophylactic vaccination.  It was reported that pharmacist went to administer a Fluzone High Dose shot on Friday and something with the needle or barrel was wrong so a good portion of the dose sprayed back at me and dribbled down the patient's arm. The patient is fine, but most of the dose was lost through the end of the plunger. The Pharmacist reported that a consumer did not receive their full dose of Fluzone High-Dose due to the vaccine sprayed from the end of the plunger; that she does not know if the needle was screwed on correctly; that the needle went on as normal; that she has disposed of the syringe and needle; that she has used the same needles; that there were no other issue with other doses from the same LOT; and that per store policy patient identifiers are not available.  It was a case of Exposure via skin contact and vaccine underdose. It was also a case of Syringe issue.   At the time of this 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: 0.08
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Patinet received the vaccine which was delay in shipment with no AE; Patinet received the vaccine which was delay in shipment with no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 1 month old patient of unknown gender who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686LA, expiry date: 30-Jun-2020), via intramuscular route in the left thigh, on 17-Oct-2019.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the incorrect product storage and product shipment delay.   It was reported that the shipment of Fluzone QID received late. On Thursday morning the office had already given 5 children vaccines from this shipment before they realized that the vaccines were not viable.  At the time of reporting, the patient had no adverse event.  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: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: the plunger down during the injection, it was leaking from somewhere; reporter saw a little (liquid) on patients arm; Reporter don't if it was injected or how much was injected; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 73 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE] (lot: UJ285AB, expiry date: 02-Jun-2020), via intramuscular route in the Left deltoid after injecting something leaked on an unknown date.   The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to vaccine underdose and Exposure via skin contact. It was reported that some of the Fluzone High-Dose leaked out, when reporter started to push the plunger down during the injection (PT- Syringe issue), it was leaking from somewhere (PT- Incorrect dose administered by device). Reporter am not sure from where it was leaking. Reporter checked the needle tip and it was screwed on tight. Reporter could not see any crack or anything. Reporter don't if it was injected or how much was injected (PT- Underdose). Reporter felt a little (liquid) on my glove and reporter saw a little (liquid) on her arm (PT- Exposure via skin contact). No, the syringe is not available to be returned. Reporter put it in the sharps container because reporter did inject her. The syringe was clear. It didn't look like anything was off.  At the time of reporting, the patient had no adverse event.  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: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to 15 year old patient with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist  This case involves a 15 years old female patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1933, expiry date: 30-Jun-2020) via intramuscular route on 21-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Flublok Quadrivalent was administered to 15 year old patient.  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: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort
Clinical narrative: had a reaction which she describes as her chest feeling funny; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 74 years old female patient who experienced a reaction which she describes as her chest feeling funny (Chest discomfort) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past treatment, vaccination and concomitant medication were unknown.  medical condition: allergic to everything including mycins, sulfa, phosphates, penicillin (drug allergy) and has food allergies (food allergy). It was reported that patient had annifilactic allergies.  On an unknown date in 2018, the patient received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot and expiry date: unknown), via unknown route and site of administration.  On an unknown date, who experienced a reaction which she describes as her chest feeling funny (Chest discomfort)unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Lab data not reported.  Corrective treatment included allergy pill..  At the time of reporting, event outcome was unknown.  Batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 2 patients of unknown demographics who had sore arm (pain in extremity), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient's received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient's developed a non-serious sore arm (pain in extremity), unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was sore arm.   It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as unknown.  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received a dose of expired Flublok, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA301296, 2019SA301057 and 2019SA301297 (same reporter).  This case involves a 76 years old patient who received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK QIV) (lot QFAA1827, 30-Jun-2019) via intramuscular route in the left deltoid on 26-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to two 11 year old female, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked with 2019SA301738 (same reporter)  This case involves a 11 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1963, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid, on 24-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  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: 3.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given expired Daptacel; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3-year-old patient (gender unknown) who was administered with an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] (PT: expired product administered).  The patient's past medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included hepatitis A vaccine.  On 24-Oct-2019, the patient received expired diphtheria-15/tetanus/5 ac pertussis vaccine (lot number: C5281AA; expiry date: 05-Oct-2019), at a dose of 0.5 ml via intramuscular route, in left thigh, for prophylactic vaccination (PT: expired product administered).  At the time of this report, no adverse event was reported.  Information on the batch number is available.  d adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error