chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dysphonia, Injected limb mobility decreased, Injection site pain, Musculoskeletal chest pain
Clinical narrative: My sinuses started draining  (10 minutes after getting the shot) in my throat & making me voice hoarse & I had to keep tying to clear my throat. Then the severe pain started setting in from my left shoulder all the way down to my wrist & fingers. I couldn't move my arm with holding it with my other hand. The pain in my wrist y felt like I fractured it. The following morning I was able to move my arm just a little. At the same time the pain went into the upper left front rib cage of my chest also felt like I fractured some ribs  & was so sore even to touch or breath.  Also the inside roof of my mouth was sensitive & felt like it was burnt & raw like I had burned my mouth from eating something  hot. I had this sensitivity for at least 3 to 4 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Pain in extremity, Painful respiration, Paranasal sinus hypersecretion, Tenderness
Clinical narrative: My sinuses started draining  (10 minutes after getting the shot) in my throat & making me voice hoarse & I had to keep tying to clear my throat. Then the severe pain started setting in from my left shoulder all the way down to my wrist & fingers. I couldn't move my arm with holding it with my other hand. The pain in my wrist y felt like I fractured it. The following morning I was able to move my arm just a little. At the same time the pain went into the upper left front rib cage of my chest also felt like I fractured some ribs  & was so sore even to touch or breath.  Also the inside roof of my mouth was sensitive & felt like it was burnt & raw like I had burned my mouth from eating something  hot. I had this sensitivity for at least 3 to 4 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: My sinuses started draining  (10 minutes after getting the shot) in my throat & making me voice hoarse & I had to keep tying to clear my throat. Then the severe pain started setting in from my left shoulder all the way down to my wrist & fingers. I couldn't move my arm with holding it with my other hand. The pain in my wrist y felt like I fractured it. The following morning I was able to move my arm just a little. At the same time the pain went into the upper left front rib cage of my chest also felt like I fractured some ribs  & was so sore even to touch or breath.  Also the inside roof of my mouth was sensitive & felt like it was burnt & raw like I had burned my mouth from eating something  hot. I had this sensitivity for at least 3 to 4 days
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Headache, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: Immediately after vaccination patient developed a headache. Within 30-45 min after vaccinations, patient had a syncope episode where patient was unconscious for less than 1 minute. Patient had pallor which did not return to normal for about 30 minutes.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse event; adult patient was inadvertently administered a pediatric dose; adult patient was inadvertently administered a pediatric dose; This spontaneous report was received from a nurse and refers to an adult female patient of unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 08-JAN-2020, the patient was inadvertently vaccinated with a pediatric (instead of adult) dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal free, injection, pediatric dose (0.5 ml), lot number R031056, expiration date 04-JUN-2021 (route of administration was not provided) for prophylaxis. On that day, the patient experienced incorrect dose administered and accidental underdose, as administered dose was pediatric. No adverse events was reported.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, IPV, RV5
Symptoms: Rash
Clinical narrative: rash; This spontaneous report was received from a nurse and refers to a 6 month old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 2, orally, for immunisation (strength, frequency, lot# and expiration date were not reported). On the same day, the patient received diphtheria toxoid, pertussis acellular vaccine (unspecified); and poliovirus vaccine inactivated (unspecified), both for immunization (dose, strength, frequency, lot# and expiration date were not reported).      Later that day, the patient developed a rash. An appointment was made with the physician's office to address the rash, but it had resolved by the following morning. Causal relationship between the suspect therapies and the event rash was not reported.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported.; a patient received a dose of improperly stored PEDVAX; This spontaneous report was received from a nurse referring to a 13 months old male patient. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.   On 09-JAN-2020, the patient received a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006470, expiration date 15-JAN-2022) intramuscularly for prophylaxis (product storage error). The vaccine underwent temperature of 30.7 Fahrenheit for a duration of 16 hours and 24 minutes. There was no previous temperature excursion and the call was because of data logger. No symptoms reported.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chest pain, Throat irritation
Clinical narrative: chest pain; itch in the throat; chest pain radiating to the patient's back; This spontaneous report was received from a pharmacist and refers to a 75-year-old male patient. The patient's current condition included hypertension. The patient's concomitant medication included enalapril. The patient had none allergies or previous drug reactions.   On 29-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R022232, expiration date 16-APR-2020, intramuscular (dose and strength were not provided) to prevent pneumococcal disease. On 29-DEC-2019 (reported as later that same day), the patient experienced an itch in the throat. On an unknown date after that, the patient received unspecified antibiotics as a treatment. On 06-JAN-2020 (reported as 4 days ago), the patient experienced chest pain. On 09-JAN-2020, the pain began radiating to the patient's back. The patient sought medical attention and saw the pharmacist.  The outcome of the events was reported as not recovered. The causality assessment between the therapy and the events was not provided.
Sex: U
Vaccine: FLUX
Symptoms: Drug hypersensitivity
Clinical narrative: drug allergy; This case was reported by a nurse via other manufacturer and described the occurrence of drug allergy in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included hypertension, osteoporosis, hypercholesterolemia and breast cancer. Previously administered products included Ibrance (for breast cancer). Concurrent medical conditions included allergic reaction to analgesics and penicillin allergy. Concomitant products included losartan potassium, metoprolol tartrate and chlortalidone (Chlorthalidone).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced drug allergy. The patient was treated with meclozine (Meclizine), ondansetron, levofloxacin and fluticasone propionate. On an unknown date, the outcome of the drug allergy was unknown.   It was unknown if the reporter considered the drug allergy to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix and had drug allergy. The patient received Ibrance and feel tried. The patient allergy to opioids.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Got many of the major side effects; This case was reported by a physician via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The case was reported by patient's friend. The reporter stated that after vaccination the patient got many of the major side effects. The reporter stated that the side effects seemed to improve but approximately 6 days later side effects were worse again. The reporter asked is there ant treatment and how long will this last is this an arthus reaction igm or igg.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The reporter was the concerned patient. The patient received Shingrix in early November 2019 and had arm soreness which lasted 2 days and has resolved. The reporter consented to follow up. For tolerances of 2nd dose refer case US2020AMR003595, reported by same reporter for the same patient and  case US2019209511, reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included sepsis (sepsis infection requiring 23 days of hospitalization 6 months before the time of reporting).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in early November 2019 and had arm soreness which lasted 2 days. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2020AMR003593, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid rash, Headache, Herpes zoster, Pain, Pain of skin
Clinical narrative: the rash is on her face, eye lid and ear/ painful; the rash is on her face, eye lid and ear/ painful; Suspected vaccination failure; Shingles; headach only on the left side; needle pain in her scalp/scalp prickly pain; needle pain in her scalp/ scalp prickly pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3Z4KL, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number AS9CM, expiry date unknown) for prophylaxis.   On 18th March 2018, the patient received the 1st dose of Shingrix. On 18th May 2018, the patient received the 2nd dose of Shingrix. On 4th January 2020, 657 days after receiving Shingrix, 596 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, scalp pain and prick pain. On 5th January 2020, the patient experienced painful rash and eyelid rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, headache, scalp pain, prick pain, painful rash and eyelid rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, scalp pain, prick pain, painful rash and eyelid rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was pervious GSK employee. The patient developed a headache only on the left side of her head on Saturday 4th January 2020. The patient also had needle pain in her scalp. The rash appeared on Sunday on 5th January 2020 and she went to urgent care. The patient was given generic Valtrex 1 gram three times daily for 7 days. It was reported that the rash was on her face, eye lid and ear. The patient denied any in her eye. It was painful. The patient stated that she has an appointment with her primary care physician. Emergency room visit required. The reporter consented to follow up. This case was considered as suspected vaccination failure as details laboratory confirmation was unknown at the time of reporting.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: the rash is on her face, eye lid and ear/ painful; the rash is on her face, eye lid and ear/ painful; Suspected vaccination failure; Shingles; headach only on the left side; needle pain in her scalp/scalp prickly pain; needle pain in her scalp/ scalp prickly pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3Z4KL, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number AS9CM, expiry date unknown) for prophylaxis.   On 18th March 2018, the patient received the 1st dose of Shingrix. On 18th May 2018, the patient received the 2nd dose of Shingrix. On 4th January 2020, 657 days after receiving Shingrix, 596 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, scalp pain and prick pain. On 5th January 2020, the patient experienced painful rash and eyelid rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, headache, scalp pain, prick pain, painful rash and eyelid rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, scalp pain, prick pain, painful rash and eyelid rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was pervious GSK employee. The patient developed a headache only on the left side of her head on Saturday 4th January 2020. The patient also had needle pain in her scalp. The rash appeared on Sunday on 5th January 2020 and she went to urgent care. The patient was given generic Valtrex 1 gram three times daily for 7 days. It was reported that the rash was on her face, eye lid and ear. The patient denied any in her eye. It was painful. The patient stated that she has an appointment with her primary care physician. Emergency room visit required. The reporter consented to follow up. This case was considered as suspected vaccination failure as details laboratory confirmation was unknown at the time of reporting.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Lethargy, Malaise, Pyrexia
Clinical narrative: allergic reaction to Shingrix; red blotchy rash over her legs, arms chest torso and neck; red blotchy rash over her legs, arms chest torso and neck; fever; felt lethargic all day; headache; didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Allergy shot. Concurrent medical conditions included allergic to dogs and allergy to plants.   On 2nd January 2020, the patient received the 1st dose of Shingrix. On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced fever, lethargy, headache and feeling unwell. On 4th January 2020, the patient experienced allergic reaction, blotchy rash and red rash. The patient was treated with prednisone. On 4th January 2020, the outcome of the fever, lethargy, headache and feeling unwell were recovered/resolved. On an unknown date, the outcome of the allergic reaction was recovering/resolving and the outcome of the blotchy rash and red rash were unknown.   The reporter considered the allergic reaction to be related to Shingrix. It was unknown if the reporter considered the fever, lethargy, headache, feeling unwell, blotchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: The patient got her first dose of Shingrix last Thursday.  The patient had allergies to dogs and trees, she takes allergy shots for that. On friday morning the patient had a fever, felt lethargic all day, headache and didn't feel well. On saturday she felt fine, those issues had resolved but late in the day she noticed red blotchy rash over her legs and then on her arms, that she had noticed earlier. On sunday the rash was all over her chest, torso and neck. The patient was seen at Clinic and the physician diagnosed her with Stephen's Johnson Syndrome. The patient was sent to the Emergency Room, who changed the diagnosis to an allergic reaction to the Shingrix.  She was started on prednisone. The patient went to her primary physician office, who confirmed the reaction to Shingrix diagnosis. The patient noted things are looking better, but her legs are the worst and remain with the rash. The patient had referred to a Dermatologist for the continued rash on her legs. She noted no allergy to any ingredients in Shingrix. The reported consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: allergic reaction to Shingrix; red blotchy rash over her legs, arms chest torso and neck; red blotchy rash over her legs, arms chest torso and neck; fever; felt lethargic all day; headache; didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Allergy shot. Concurrent medical conditions included allergic to dogs and allergy to plants.   On 2nd January 2020, the patient received the 1st dose of Shingrix. On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced fever, lethargy, headache and feeling unwell. On 4th January 2020, the patient experienced allergic reaction, blotchy rash and red rash. The patient was treated with prednisone. On 4th January 2020, the outcome of the fever, lethargy, headache and feeling unwell were recovered/resolved. On an unknown date, the outcome of the allergic reaction was recovering/resolving and the outcome of the blotchy rash and red rash were unknown.   The reporter considered the allergic reaction to be related to Shingrix. It was unknown if the reporter considered the fever, lethargy, headache, feeling unwell, blotchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: The patient got her first dose of Shingrix last Thursday.  The patient had allergies to dogs and trees, she takes allergy shots for that. On friday morning the patient had a fever, felt lethargic all day, headache and didn't feel well. On saturday she felt fine, those issues had resolved but late in the day she noticed red blotchy rash over her legs and then on her arms, that she had noticed earlier. On sunday the rash was all over her chest, torso and neck. The patient was seen at Clinic and the physician diagnosed her with Stephen's Johnson Syndrome. The patient was sent to the Emergency Room, who changed the diagnosis to an allergic reaction to the Shingrix.  She was started on prednisone. The patient went to her primary physician office, who confirmed the reaction to Shingrix diagnosis. The patient noted things are looking better, but her legs are the worst and remain with the rash. The patient had referred to a Dermatologist for the continued rash on her legs. She noted no allergy to any ingredients in Shingrix. The reported consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Mobility decreased
Clinical narrative: flu-like symptoms; not feeling well; not able to move around for 15 to 18 hours; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, feeling unwell and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling unwell and mobility decreased to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient experienced flu like symptoms such that she was not feeling well and not able to move around for 15 to 18 hours.  The symptoms were resolved.  The reporter did not have any further details. This is 1 of 3 cases reported by the same reporter for different patients. The outcome of influenza-like symptoms and feeling unwell were reported as recovered/resolved however in source document, it was mentioned as recovered/resolved with sequel.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased
Clinical narrative: flu-like symptoms; could not move for 12-14 hours; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult 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 influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient felt flu like symptoms such that he could not move for 12 to 14 hours. The symptoms were resolved.  The reporter did not have any further details. This is 1 of 3 cases reported by the same reporter for different patients. The outcome of influenza-like symptoms was reported as recovered/resolved in the Argus however in source document, it was mentioned as recovered/resolved with sequel.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased
Clinical narrative: flu-like symptoms; could not move for 12-14 hours; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult 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 influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the mobility decreased was resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient felt flu like symptoms such that he could not move for 12 to 14 hours. The symptoms were resolved.  The reporter did not have any further details. This is 1 of 3 cases reported by the same reporter for different patients. The outcome of influenza-like symptoms was reported as recovered/resolved however in source document, it was mentioned as recovered/resolved with sequel.
Age: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 12 year old patient received a dose of Flubok, no AE; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Office Staff).  This case is linked to case 2019SA337479 (same reporter).  This case involves a 12 years old patient (gender not reported) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that nurse gave the Flubok to 12 year old patient.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  Information on the batch number was requested.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Nonspecific reaction
Clinical narrative: had a reaction to the product and the product has gluten in it; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient with unknown demographics who experienced reaction to the product and the product has gluten in it (reaction nonspecific), while patient received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and other dosing details were not reported) via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect TRUMENBA (not produced by Sanofi Pasteur) (lot number and other dosing details were not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious had a reaction to the product and the product has gluten in it (reaction nonspecific) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA.  It was unknown TRUMENBA has been prescribed to the patient who had a reaction to a product with gluten in it  Details of laboratory data not reported.  Final diagnosis was reaction nonspecific.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for reaction nonspecific.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: shipment was received late and one dose was given to a patient, no AE; shipment was received late and one dose was given to a patient, no AE; Initial information received on 03-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 31 years old male patient who was vaccinated with a 0.5 mL dose of suspect vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: UJ313AA and expiry date 30-Jun-2020) via intramuscular route in the right arm on 02-Jan-2020, which was not stored properly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not reported.  It is a case of actual medication error due to incorrect product storage and product shipment delay.  It was reported that the shipment was received late and one dose was given on 02jan2020 to a patient during a regular clinic visit. (Shipment date was 30-Dec-2019 but received on 02-Jan-2020).  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 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.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: a hib dose from a pentacel carton was given to a patient with sterile water instead of the supplied diluent, no advese event; Initial information received on 06-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 5 month and 21 days old male patient who was vaccinated with a first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ084AAA and expiration date 24-Jul-2020) via an intramuscular route at an unknown administration site on 30-Dec-2019.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong solution used in drug reconstitution as Hib dose from a pentacel carton was given with sterile water instead of the supplied diluent.  No known symptoms were reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient receiving Flublok instead of Fluzone Quadrivalent / no AE; patient received Flublok vaccine instead of Fluzone Quadrivalent vaccine/No AE; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA006402. (Same reporter)  This case involves a 11 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  it was reported that 11 year old patient receiving  FLUBLOK QIV (Product administered to patient of inappropriate age)   It was a case of actual medication error wrong vaccine administered and Inappropriate age at vaccine administration.  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.
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Restless legs syndrome, Tremor, Vomiting
Clinical narrative: shaking; vomiting; diarrhea; his legs had locked up; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 67 years old male patient who experienced shaking (tremor), vomiting (vomiting), diarrhea (diarrhoea) and his legs had locked up (restless legs syndrome), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Influenza vaccine.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 14-Dec-2019 at 11 am, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: U306AA and expiry date: not reported) via unknown route in the left arm.  On 14-Dec-2019 at 16:30 pm the patient developed a non-serious shaking (tremor), vomiting (vomiting), diarrhea (diarrhoea) 5 hours 35 minute following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, patient wife called the ambulance and when the ambulance arrived at the house the patient wife said he could barely get up out of bed. Caller stated his legs had locked up (Restless legs syndrome) and could move his legs with assistance. He went to the Emergency Department and received IV fluids.  Final diagnosis was stated his Restless legs syndrome, diarrhea, vomiting and shaking.   An unknown corrective treatment was received (IV fluids).  The patient outcome was reported as unknown for all events.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: 11/8/2019 -Approx 11:30 AM  I had sudden weakness from base of my skull, across both shoulders, down both arms to fingers. This was bilateral and simultaneous. It lasted several minutes. No nausea, dizziness, or pain. Just felt weak all over. Arms then had the sensation of being heavy or over-fatigued for several hours.  The exact episode and symtoms occured again November 19 around 4:30 PM.    11/21/2019 Approx 9:00am I felt like the same thing was about to happen, but the symptoms only traveled to my upper arms.  Not as extreme. 12/2/2019 6pm I felt a slight weakness in both upper arms that only lasted a few seconds.  Throughout this entire time perion I had occassional headaches, pressure in the sinus area and upper forehead.  I felt lightheaded at times, moreso when driving a car.  No episodes since 12/4/2019
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Limb discomfort, Magnetic resonance imaging brain normal, Muscular weakness, Paranasal sinus discomfort
Clinical narrative: 11/8/2019 -Approx 11:30 AM  I had sudden weakness from base of my skull, across both shoulders, down both arms to fingers. This was bilateral and simultaneous. It lasted several minutes. No nausea, dizziness, or pain. Just felt weak all over. Arms then had the sensation of being heavy or over-fatigued for several hours.  The exact episode and symtoms occured again November 19 around 4:30 PM.    11/21/2019 Approx 9:00am I felt like the same thing was about to happen, but the symptoms only traveled to my upper arms.  Not as extreme. 12/2/2019 6pm I felt a slight weakness in both upper arms that only lasted a few seconds.  Throughout this entire time perion I had occassional headaches, pressure in the sinus area and upper forehead.  I felt lightheaded at times, moreso when driving a car.  No episodes since 12/4/2019
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal, Ultrasound Doppler, Ultrasound scan normal
Clinical narrative: 11/8/2019 -Approx 11:30 AM  I had sudden weakness from base of my skull, across both shoulders, down both arms to fingers. This was bilateral and simultaneous. It lasted several minutes. No nausea, dizziness, or pain. Just felt weak all over. Arms then had the sensation of being heavy or over-fatigued for several hours.  The exact episode and symtoms occured again November 19 around 4:30 PM.    11/21/2019 Approx 9:00am I felt like the same thing was about to happen, but the symptoms only traveled to my upper arms.  Not as extreme. 12/2/2019 6pm I felt a slight weakness in both upper arms that only lasted a few seconds.  Throughout this entire time perion I had occassional headaches, pressure in the sinus area and upper forehead.  I felt lightheaded at times, moreso when driving a car.  No episodes since 12/4/2019
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Right side Bell's Palsy
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: 1/8/20 Per triage: "Received vaccines 1/3/20. Her left arm where she got her HPV the day after started with some redness. The redness over the past few days has worsened and is almost the whole length of her upper arm, not going past either joint. She also broke out in hives just on the upper portion of arm.  Mom gave benadryl, hives went away, but came back."  Patient presents today with her mother. Patient was seen by Dr. pediatrics on 1/3/2020 for her 11 year WCC. Patient received her meningococcal and HPV vaccinations in her LEFT deltoid. Mother reports redness on the patient LEFT arm that appeared the day following the vaccinations. Mother reports the redness exacerbated and that the patient developed hives on the upper portion of her LEFT arm. Patient denies the affected area in painful. She notes the affected area occasionally itches. Mother reports treating the patient's symptoms with benadryl. Mother reports benadryl temporarily improved the patient's symptoms but notes the hives later returned.   Mother reports the patient has a history of hives. Patient reports getting hives after rubbing her skin in the past.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Magnetic resonance imaging, Pain in extremity, X-ray normal
Clinical narrative: Patient reported experiencing left arm and shoulder pain since his flu shot on 10/21/19. He did not report the pain to Department of Public Health Services until 12/20/19. He stated that he believed the nurse injected the flu shot too high on his arm and caused the injury. He went to see a doctor just a few days before coming in to report it to the clinic and that he had an MRI scheduled.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Rash
Clinical narrative: rash on trunk and swollen lip
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Right arm pain, reported not being able to move her arm for the first 24 hours
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Dysacusis, Ear, nose and throat examination normal, Hypoacusis, Nerve injury
Clinical narrative: Woke up on 10/12/19 with reduced hearing & constant echo in right ear. Primary physician couldn't find any thing wrong - recommended Alegra D-10 days. No change in hearing or echo. ENT P.A. performed hearing test & exam. Only found reduced hearing - prescribed Prednisone for 14 days. ENT performed hearing test & exam two weeks later - no change - diagnosed Later-no change-diagnosed permanent nerve damage in rt. ear. No change in hearing or echo to date. My primary physician - found no sign of a cold, sinus infection, swollen glands, cough, earache, or wax in rt. ear. ENT P.A. also found no other illness or conditions except reduce reduced hearing in rt. ear. Left ear hearing was fine. I have never had a loss of hearing or echo in either ear or ear infections in my Life. I life. I am not around loud noises at anytime. I don't use ear buds.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient stated recieved Gardasil vaccine 9/11/19. On Saturday 10/5/19 it began getting red, now warm to touch, firm in area. Patient has felt chilled like since Saturday. Patient reports chills (since Saturday) but reports no fatigue and no fever. Skin:: left upper arm at area of tatoo and giardisil injection with swelling and tenderness. She reports no dyspnea / shortness of breath. She reports no abdominal pain, no nausea, no vomiting, and no diarrhea. She reports no urinary difficulties.  Cellulitis of upper arm - 10/7/19 - doxycycline 100 mg po bid x 7d; heating pad; ibuprofen as needed allergic to penicillin L03.119: Cellulitis of unspecified part of limb doxycycline hyclate 100 mg tablet - Take 1 tablet(s) twice a day by oral route for 7 days.     Qty: 14 tablet(s)
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient stated recieved Gardasil vaccine 9/11/19. On Saturday 10/5/19 it began getting red, now warm to touch, firm in area. Patient has felt chilled like since Saturday. Patient reports chills (since Saturday) but reports no fatigue and no fever. Skin:: left upper arm at area of tatoo and giardisil injection with swelling and tenderness. She reports no dyspnea / shortness of breath. She reports no abdominal pain, no nausea, no vomiting, and no diarrhea. She reports no urinary difficulties.  Cellulitis of upper arm - 10/7/19 - doxycycline 100 mg po bid x 7d; heating pad; ibuprofen as needed allergic to penicillin L03.119: Cellulitis of unspecified part of limb doxycycline hyclate 100 mg tablet - Take 1 tablet(s) twice a day by oral route for 7 days.     Qty: 14 tablet(s)
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash erythematous, Rash macular
Clinical narrative: Received the vaccine in the late morning. That evening develop pain, swelling, and a rash to arm. It was very pain. The rash was splotchy, red, itchy. Started in the upper arm and is moving down. The swelling was significant initially but is better today. Started on antihistamine, motrin, warm compresses. Is due to f/u tomorrow.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Received the vaccine in the late morning. That evening develop pain, swelling, and a rash to arm. It was very pain. The rash was splotchy, red, itchy. Started in the upper arm and is moving down. The swelling was significant initially but is better today. Started on antihistamine, motrin, warm compresses. Is due to f/u tomorrow.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Vaccination site pain
Clinical narrative: PAIN AROUND VACCINATION - LARGE DARK PINK  COLOR LEFT ARM - ALL IS FINE 0  01/10/2020
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In 2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, route, lot number, expiration date, and anatomical location were not provided) at physician's office, for long-term prevention of Shingles and zoster-related conditions. Subsequently, the patient was treated by the physician for shingles. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient had and would continue to 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 of 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. At the reporting time, the patient had not recovered from the event. The reporter considered the event as related.
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Cerebrovascular accident, Deafness neurosensory, Dyskinesia, Sudden hearing loss
Clinical narrative: severe to profound sensorineural hearing loss; cerebrovascular accident; spontaneous movement of the left arm; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 24-JUN-2016, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a sudden onset hearing loss and was diagnosed with severe to profound sensorineural hearing loss. On an unknown date, a few weeks later, the patient was unable to speak and experienced spontaneous movement of the left arm and was diagnosed with cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms resulted in physical limitations not present prior to the vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, the events of sensorineural hearing loss and cerebrovascular accident were considered to be medically significant.  The events of sensorineural hearing loss, spontaneous movement of the left arm and cerebrovascular accident were considered to be disabling.