chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004974: US-009507513-2005USA004973: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004984: US-009507513-2005USA004983: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992:
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Cough, Crying, Infantile spitting up, Irritability, Pyrexia
Clinical narrative: Fever of 101.8. Excessive and inconsolable crying for 7 hours straight. Irritability. Coughing. Spit up/vomiting.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Fever of 101.8. Excessive and inconsolable crying for 7 hours straight. Irritability. Coughing. Spit up/vomiting.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Dysphagia, Dyspnoea, Oxygen saturation decreased, Peripheral coldness, Swollen tongue
Clinical narrative: 1050  Patient states tongue feels swollen, hard time swollowing. 50mg benedryl given.  1105Patient complaining of more difficulty breathing. toes/hands are cold.  Dr called to room. RN  1120 Claritin given.   1130 Pulse ox down to 65; epi 0.3mg given. Dr called to room. O2 brought to room; Titrated up. Pulse ox up to 80 for a minute or two then down to 45. Dr in room. EMS called. IV tray brought in. 20G IV placed in RAC, NS bolus started. Pulse ox up to upper 80's low 90's on 9L 02. with Dr at bedside. 1155 EMS to bedside.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: caregiver reported noticing raised red areas to her right arm and trunk/back the following day post vaccination on the same side the vaccine was given
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was administered an expired vaccine. Exp 5.02.2020. Pt had no adverse reactions. Tolerated injection well.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Tremor
Clinical narrative: 5-19-2020 Developed chills, fever, shaking at 12:30 am.                           Muscle aches, fatigue, 11 am
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Generalised tonic-clonic seizure, Irritability
Clinical narrative: Patient received 12 month vaccines on 4/29/2020 as listed above.  On 5/9/2020 patient developed URI symptoms and fever.  Patient presented to ED at 901am on 5/11/2020 for febrile seizure at home.  ED report states seizure lasted 4 minutes, pt witnessed to have had a generalized tonic-clonic seizure accompanied by cyanosis and postictal somnolence and irritability.   Temp recorded at 104 F and  was treated in the ED with acetaminophen at 0939 and ibuprofen at 1043.  Pt was discharged home.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Postictal state, SARS-CoV-2 test negative, Somnolence
Clinical narrative: Patient received 12 month vaccines on 4/29/2020 as listed above.  On 5/9/2020 patient developed URI symptoms and fever.  Patient presented to ED at 901am on 5/11/2020 for febrile seizure at home.  ED report states seizure lasted 4 minutes, pt witnessed to have had a generalized tonic-clonic seizure accompanied by cyanosis and postictal somnolence and irritability.   Temp recorded at 104 F and  was treated in the ED with acetaminophen at 0939 and ibuprofen at 1043.  Pt was discharged home.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: patient claims the swelling and pain have not gone away, seven months after being administered the vacination.  The arm she showed me was the left arm, claims it is tender about a two inch diameter around injection site, and swollen., i did not oberve a rash or any irritaion to the skin.  The documentation, however, shows patient had injection in right arm, and patient is complaining in left arm
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Injection site red and sore, redness size of an orange, the area is hard and itchy
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired immunization. Patient will return to clinic for additional dose
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: soreness and pain at injection site and shoulder
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Productive cough, Pyrexia
Clinical narrative: fever of 102, chills, spitting up phlem, shakiness, headache, upset stomach for about 4 hours post-vaccine, has subsided 12-18 hours later
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: fever of 102, chills, spitting up phlem, shakiness, headache, upset stomach for about 4 hours post-vaccine, has subsided 12-18 hours later
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Crying uncontrollably and like never before for hours
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Otitis media, Rash erythematous, Rash macular
Clinical narrative: This is a 12 month old, spoke WITH MotheR on 3/26/2020. Toddler started with Rash - red flaT, NON-PRUITIC. He had been vaccinated on 3/18/2020 with MMR. No congestion, fever, Playful, good appetite. Told mother Reaction to MMR- Rash IS Self-lIMITINg. On 3/30/2020, video TeleVISIT. Rash was REd macular over body - No scratch marks. Mother states Rash is Resolving No other symptoms. Toddler is feeling WELL. Pt was diagnosed with BOM on 3/18/2020 finished amox on 3/28/2020. No hives.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events were reported.; first shot of GARDASIL 9 on 11/14/2019 and second dose of GARDASIL 9 on 12/12/2019; This spontaneous report has been received from the patient's father referring to a male patient of unknown age. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 14-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis at a health center. On 12-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) (inappropriate schedule of product administration). No additional adverse events were reported.
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient did not receive his second dose of GARDASIL 9 on an unspecified date in April 2020; This spontaneous report was received from a pharmacist referring to a 31 years old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On an unspecified date in February 2020, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. He did not receive his second dose of GARDASIL 9 on an unspecified date in April 2020 (inappropriate schedule of product administration).
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: was also diagnosed with intussusception again on 24-APR-2020.; The patient was diagnosed with intussusception on 15-APR-2020.; This spontaneous report was received from a Registered Nurse, referring to a 6-month-old male patient. The patient did not have any pertinent medical history, drug reactions, allergies, or concomitant medications.  On 12-DEC-2019, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 tube, administered orally (lot number S001101 which has been verified to be valid, expiration date reported and validated as 21-OCT-2020). On 13-FEB-2020, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 tube, administered orally (lot number 1660685 which has been verified to be valid, expiration date reported and validated as 21-MAR-2021). On 15-APR-2020, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 tube, administered orally (lot number S013436 which has been verified to be valid, expiration date reported and validated as 30-JAN-2021). All the vaccines administered as prophylaxis.    On 15-APR-2020, after he received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (also reported as later in the afternoon), the patient visited the emergency department, an ultrasound was performed and was diagnosed with intussusception. On an unspecified day in April 2020, the patient recovered from intussusception. On 24-APR-2020, a second visit to the emergency department was reported,  an ultrasound was performed, and he was also diagnosed with intussusception, and then, the same day, the patient status was reported as recovered.   The patient was not admitted to the hospital on either of the visits. The events resolved without treatment both times. The causal relationship between the suspect vaccine, and the intussusception was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  In 2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for  long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (subsequent to inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she 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 for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   By the time of this report, the patient had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects being reported; a patient received unspecified dose in VARIVAX innnunization series that was improperly stored.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 12-MAY-2020, the patient received unspecified dose in varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S031495, expiration date reported as 07-OCT-2022, but upon internal validation established as 07-OCT-2021; dose, strength and route were unknown) immunization series for prophylaxis that was improperly stored. The sterile diluent (lot#S026377 with expiration date: 06-MAY-2022) was properly stored. No symptoms or adverse effects being reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under 6.3 degrees fahrenheit (F) for 30 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: Sore Arm; This spontaneous report was received from a lawyer and a consumer regarding herself, a female patient of unknown age. The patient was married and was retired. The patient was a non-tobacco user. The patient's concurrent conditions included dry eye, high blood pressure (HBP), arthritis (foot), high cholesterol. The patient's historical medications included zoster vaccine live (Oka/Merck) (ZOSTAVAX), pregabalin (LYRICA), influenza virus vaccine (unspecified) and tetanus vaccine toxoid (reported as flu and tetnus vaccine). Additionally; the patient had received steroids or corticosteroids. The patient's concurrent medications included cyclosporine (RESTASIS) and metoprolol.  On an unspecified day in May 2014, the patient became aware of the symptoms of shingles and hypoaesthesia (captured in MARRS# 2002USA003299).   On unspecified dates between 2016 and 2019, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown); which caused on an unspecified date, an adverse reaction/side effects as the patient experienced sore arm (Injection site pain).   Outcome of the event was not provided, and causal relationship was reported as related to pneumococcal vaccine (manufacturer unknown); Sender's Comments:  US-009507513-2002USA003299:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (subsequent to inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she 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 for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. By the time of this report, the patient had not recovered from shingles.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; received the first dose ofGARDASIL 9 on an unspecified date in November, 2019, and received the second dose ofGARDASIL 9 on 4/16/2020; The patient received the first dose ofGARDASIL 9 on an unspecified date in November, 2019; This spontaneous report was received from a 44 year old female patient. Information regarding the patient´s medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date in November, 2019, the patient received the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, lot # and expiration date were not provided) and received the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, route, frequency, lot # and expiration date were not provided)  on 04-APR-2020. No additional adverse event.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adversse effect reported; patient was administered a dose of properly stored but expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 18-MAY-2020, the patient was vaccinated with a dose of properly stored but expired hepatitis a vaccine, inactivated(VAQTA) lot # S002459 with expiration date 15-MAY-2020 (dose, route and anatomical location were not reported) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002459; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Pediarix vaccine at 2 months and 4 months old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the doctor advised to give patient Kinrix instead of Pediarix, which led to inappropriate schedule of vaccine administered. No further details were provided. This case has been linked with case US2020045975, reported for same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Carpal tunnel syndrome, Cerebral infarction, Coordination abnormal, Dysphagia
Clinical narrative: Cerebral infarction unspecified; Unspecified mononeuropathy of bilateral upper limbs; Neuralgic amyotrophy/Parsonage-Turner syndrome; neuromuscular disease; neuropathy of the upper extremities; idiopathic brachial plexopathy; coordination issues; numbness; tremor; moderate right/Carpal tunnel syndrome; Vaccine reaction; This case was reported by a lawyer and described the occurrence of cerebral infarction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included turner's syndrome and drug allergy (The patient was allergic to shingrix (varicella-zoster)).   The initial information was received on 13 May 2020, via medical records (The case was medically confirmed). As per pharmacy records the patient used Shingrix powder for suspension from 12 July 2018 to 14 September 2018. As per medical records the patient had used varicella-zoster gE-AS01B, PF, (SHINGRIX, PF) injection with frequency once 10 July 2018 to 1 occurrence. As per medical records, the patient was allergic to shingrix (varicella-zoster). On 11 May 2016 the patient was hospitalized with diagnosis Cerebral infarction, unspecified. On 22 November 2019 the medical records stated patient had diagnosis of parsonage Turner syndrome which caused neuropathy of the upper extremities which was caused progressive weakness of the upper extremities and pain, She continued to have reduced functionality of her arms at that time, the patient was positive for coordination issues and numbness. As per medical records the patient was hospitalized on 29 November 2019 with diagnosis Neuralgic amyotrophy and Unspecified mononeuropathy of bilateral upper limbs, the patient also had medical history of bilateral motor neuropathy of upper extremities. As per medical records on 16 January 2020 the patient had problems with swallowing has neuropathy on both her arms and her muscles on side of neck were started to be affected by it. As per medical records, the patient stated the symptoms started about 1 year ago after receiving the Shingrix vaccination. As per medical records, the patient underwent Nerve conduction test and EMG, that study was performed on an EDX neurophysiology instrument for evaluation of complaints of bilateral upper extremity weakness and tremor following shingles vaccine showed Nerve conduction studies were consistent with a moderate right carpal tunnel syndrome and a mild left carpal tunnel syndrome and vaccine reaction. The patient must have a neuromuscular disease on 03 December 2019. As per medical records reviewed, the patient suffered from Parsonage-Turner syndrome (aka idiopathic brachial plexopathy or neuralgic amyotropy).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Electromyogram, Hypoaesthesia, Mononeuropathy, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Cerebral infarction unspecified; Unspecified mononeuropathy of bilateral upper limbs; Neuralgic amyotrophy/Parsonage-Turner syndrome; neuromuscular disease; neuropathy of the upper extremities; idiopathic brachial plexopathy; coordination issues; numbness; tremor; moderate right/Carpal tunnel syndrome; Vaccine reaction; This case was reported by a lawyer and described the occurrence of cerebral infarction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included turner's syndrome and drug allergy (The patient was allergic to shingrix (varicella-zoster)).   The initial information was received on 13 May 2020, via medical records (The case was medically confirmed). As per pharmacy records the patient used Shingrix powder for suspension from 12 July 2018 to 14 September 2018. As per medical records the patient had used varicella-zoster gE-AS01B, PF, (SHINGRIX, PF) injection with frequency once 10 July 2018 to 1 occurrence. As per medical records, the patient was allergic to shingrix (varicella-zoster). On 11 May 2016 the patient was hospitalized with diagnosis Cerebral infarction, unspecified. On 22 November 2019 the medical records stated patient had diagnosis of parsonage Turner syndrome which caused neuropathy of the upper extremities which was caused progressive weakness of the upper extremities and pain, She continued to have reduced functionality of her arms at that time, the patient was positive for coordination issues and numbness. As per medical records the patient was hospitalized on 29 November 2019 with diagnosis Neuralgic amyotrophy and Unspecified mononeuropathy of bilateral upper limbs, the patient also had medical history of bilateral motor neuropathy of upper extremities. As per medical records on 16 January 2020 the patient had problems with swallowing has neuropathy on both her arms and her muscles on side of neck were started to be affected by it. As per medical records, the patient stated the symptoms started about 1 year ago after receiving the Shingrix vaccination. As per medical records, the patient underwent Nerve conduction test and EMG, that study was performed on an EDX neurophysiology instrument for evaluation of complaints of bilateral upper extremity weakness and tremor following shingles vaccine showed Nerve conduction studies were consistent with a moderate right carpal tunnel syndrome and a mild left carpal tunnel syndrome and vaccine reaction. The patient must have a neuromuscular disease on 03 December 2019. As per medical records reviewed, the patient suffered from Parsonage-Turner syndrome (aka idiopathic brachial plexopathy or neuralgic amyotropy).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve conduction studies abnormal, Neuralgic amyotrophy, Neuromyopathy, Neuropathy peripheral, Pain in extremity
Clinical narrative: Cerebral infarction unspecified; Unspecified mononeuropathy of bilateral upper limbs; Neuralgic amyotrophy/Parsonage-Turner syndrome; neuromuscular disease; neuropathy of the upper extremities; idiopathic brachial plexopathy; coordination issues; numbness; tremor; moderate right/Carpal tunnel syndrome; Vaccine reaction; This case was reported by a lawyer and described the occurrence of cerebral infarction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included turner's syndrome and drug allergy (The patient was allergic to shingrix (varicella-zoster)).   The initial information was received on 13 May 2020, via medical records (The case was medically confirmed). As per pharmacy records the patient used Shingrix powder for suspension from 12 July 2018 to 14 September 2018. As per medical records the patient had used varicella-zoster gE-AS01B, PF, (SHINGRIX, PF) injection with frequency once 10 July 2018 to 1 occurrence. As per medical records, the patient was allergic to shingrix (varicella-zoster). On 11 May 2016 the patient was hospitalized with diagnosis Cerebral infarction, unspecified. On 22 November 2019 the medical records stated patient had diagnosis of parsonage Turner syndrome which caused neuropathy of the upper extremities which was caused progressive weakness of the upper extremities and pain, She continued to have reduced functionality of her arms at that time, the patient was positive for coordination issues and numbness. As per medical records the patient was hospitalized on 29 November 2019 with diagnosis Neuralgic amyotrophy and Unspecified mononeuropathy of bilateral upper limbs, the patient also had medical history of bilateral motor neuropathy of upper extremities. As per medical records on 16 January 2020 the patient had problems with swallowing has neuropathy on both her arms and her muscles on side of neck were started to be affected by it. As per medical records, the patient stated the symptoms started about 1 year ago after receiving the Shingrix vaccination. As per medical records, the patient underwent Nerve conduction test and EMG, that study was performed on an EDX neurophysiology instrument for evaluation of complaints of bilateral upper extremity weakness and tremor following shingles vaccine showed Nerve conduction studies were consistent with a moderate right carpal tunnel syndrome and a mild left carpal tunnel syndrome and vaccine reaction. The patient must have a neuromuscular disease on 03 December 2019. As per medical records reviewed, the patient suffered from Parsonage-Turner syndrome (aka idiopathic brachial plexopathy or neuralgic amyotropy).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral motor neuropathy, Tremor
Clinical narrative: Cerebral infarction unspecified; Unspecified mononeuropathy of bilateral upper limbs; Neuralgic amyotrophy/Parsonage-Turner syndrome; neuromuscular disease; neuropathy of the upper extremities; idiopathic brachial plexopathy; coordination issues; numbness; tremor; moderate right/Carpal tunnel syndrome; Vaccine reaction; This case was reported by a lawyer and described the occurrence of cerebral infarction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included turner's syndrome and drug allergy (The patient was allergic to shingrix (varicella-zoster)).   The initial information was received on 13 May 2020, via medical records (The case was medically confirmed). As per pharmacy records the patient used Shingrix powder for suspension from 12 July 2018 to 14 September 2018. As per medical records the patient had used varicella-zoster gE-AS01B, PF, (SHINGRIX, PF) injection with frequency once 10 July 2018 to 1 occurrence. As per medical records, the patient was allergic to shingrix (varicella-zoster). On 11 May 2016 the patient was hospitalized with diagnosis Cerebral infarction, unspecified. On 22 November 2019 the medical records stated patient had diagnosis of parsonage Turner syndrome which caused neuropathy of the upper extremities which was caused progressive weakness of the upper extremities and pain, She continued to have reduced functionality of her arms at that time, the patient was positive for coordination issues and numbness. As per medical records the patient was hospitalized on 29 November 2019 with diagnosis Neuralgic amyotrophy and Unspecified mononeuropathy of bilateral upper limbs, the patient also had medical history of bilateral motor neuropathy of upper extremities. As per medical records on 16 January 2020 the patient had problems with swallowing has neuropathy on both her arms and her muscles on side of neck were started to be affected by it. As per medical records, the patient stated the symptoms started about 1 year ago after receiving the Shingrix vaccination. As per medical records, the patient underwent Nerve conduction test and EMG, that study was performed on an EDX neurophysiology instrument for evaluation of complaints of bilateral upper extremity weakness and tremor following shingles vaccine showed Nerve conduction studies were consistent with a moderate right carpal tunnel syndrome and a mild left carpal tunnel syndrome and vaccine reaction. The patient must have a neuromuscular disease on 03 December 2019. As per medical records reviewed, the patient suffered from Parsonage-Turner syndrome (aka idiopathic brachial plexopathy or neuralgic amyotropy).
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone normal, Culture urine negative, Fatigue, Full blood count normal, Glycosylated haemoglobin normal
Clinical narrative: hot flashes, persistent fevers, headaches and arm pain with general fatigue and myalgias for several weeks and the hot flashes and fatigue lasting months ( through office visit 5/13)
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hot flush, Metabolic function test normal, Myalgia, Pain in extremity
Clinical narrative: hot flashes, persistent fevers, headaches and arm pain with general fatigue and myalgias for several weeks and the hot flashes and fatigue lasting months ( through office visit 5/13)
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vitamin B12 normal
Clinical narrative: hot flashes, persistent fevers, headaches and arm pain with general fatigue and myalgias for several weeks and the hot flashes and fatigue lasting months ( through office visit 5/13)
Age: 1.08
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Feeling hot, Irritability, Pyrexia, Rash
Clinical narrative: My son received the vaccine around 10:00am on 5/13/2020, he started to feel warm at 6pm and by 9pm he had a fever of 103.1 (rectal). For the next 48 hrs + he had a temperature between 100.6 and 103.1. Sleeping a lot, decreased appetite (he was taking milk and some water), irritable. No cough, no runny nose, no congestion. He was making urine and having bowel movements. He was given ibuprofen when necessary and we put him in a cool wet onesie and hat to draw the heat away from his body. In the morning of 2/23/2020 he woke up without a fever and never had one again. He then developed a diffuse rash that started on this trunk and spread to his arms and legs. This rash does not seem to bother him. It is now 5/20/20, he continues to be intermittently irritable, putting his head down on the floor and sucking his thumb and then getting back up (did not do this before), easily distracted, rash still there. Although we were in contact with the pediatrician, over the phone, we did not need to bring our son in as the fever did not make it to the 72 hr mark.
Age: 1.08
Sex: M
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: My son received the vaccine around 10:00am on 5/13/2020, he started to feel warm at 6pm and by 9pm he had a fever of 103.1 (rectal). For the next 48 hrs + he had a temperature between 100.6 and 103.1. Sleeping a lot, decreased appetite (he was taking milk and some water), irritable. No cough, no runny nose, no congestion. He was making urine and having bowel movements. He was given ibuprofen when necessary and we put him in a cool wet onesie and hat to draw the heat away from his body. In the morning of 2/23/2020 he woke up without a fever and never had one again. He then developed a diffuse rash that started on this trunk and spread to his arms and legs. This rash does not seem to bother him. It is now 5/20/20, he continues to be intermittently irritable, putting his head down on the floor and sucking his thumb and then getting back up (did not do this before), easily distracted, rash still there. Although we were in contact with the pediatrician, over the phone, we did not need to bring our son in as the fever did not make it to the 72 hr mark.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient received an improperly stored dose of proquad; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 13-MAY-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant human albumin (rHA)) of lot# S027462 and expiration date reported as 02-MAR-2021, 1 vial for prophylaxis (strength, dose, frequency, anatomical location and route were not reported) (product storage error). The concomitant medication included sterile diluent(STERILE DILUENT) (lot# T003594 and expiration date 07-JUL-2022). The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 6 degree Fahrenheit (F) to 14 degree F for a time frame of 16 hours and 17 minutes and 15 degree F to 46 degree F (16.7F) for a time frame of 1 hour and 21 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Age: 52.0
Sex: M
Vaccine: PNC
Symptoms: Electrocardiogram normal, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported to clinic 2 weeks after the vaccine with chief complaint of pain and swelling in right arm after receiving Prevnar 13. No visible signs of reaction. EKG done. Normal. Discharged with instructions to use warm compress.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed a reddened area on her left upper thigh area.  Mom attached a picture to the patient's portal to communicate.  Mom stated that it was itchy as first but has used hydrocortisone cream and it helped with the itchiness.  Mom states that it is still red and swollen but has not increased in size.  Provider was aware on 5/18/2020 and made the mom aware that this could last 4-6 weeks and if the patient develops a fever to call us back.  I checked on the patient today and no increase in swelling at this time.  Made aware again that if the child develops a fever to call us.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Joint swelling
Clinical narrative: Patient received second shot in Shingrix vaccination series on 2/21/20. Presented to outpatient facility as an Walk- in. Patient had erythema and swelling in left deltoid area . Size of area described as "hand size" and very slight swelling in wrist. Patient was told to ice the area, take Benadryl for itching and ibuprofen.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Blood glucose normal, Dizziness, Eye movement disorder, Foaming at mouth, Immediate post-injection reaction
Clinical narrative: SEIZURE IMMEDIATELY AFTER TRUMENBA WITH DIZZINESS, ARCHING OF THE BACK, ROLLING OF THE EYES, FOAMING AT THE MOUTH,RIGIDITY IN THE UPPER EXT B/L, NO INCONTINENCE, LASTING 5 MINS .  GLUCOSE 96(POST VACCINE). BP 101/64(PRE VACCINE), HEART RATE 65/MIN(PRE-VACCINE), PULSE OX 99 % ON 2 LITERS OF OXYGEN(POST VACCINE)
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Muscle rigidity, Opisthotonus, Seizure
Clinical narrative: SEIZURE IMMEDIATELY AFTER TRUMENBA WITH DIZZINESS, ARCHING OF THE BACK, ROLLING OF THE EYES, FOAMING AT THE MOUTH,RIGIDITY IN THE UPPER EXT B/L, NO INCONTINENCE, LASTING 5 MINS .  GLUCOSE 96(POST VACCINE). BP 101/64(PRE VACCINE), HEART RATE 65/MIN(PRE-VACCINE), PULSE OX 99 % ON 2 LITERS OF OXYGEN(POST VACCINE)
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Seizure
Clinical narrative: SEIZURE IMMEDIATELY AFTER TRUMENBA WITH DIZZINESS, ARCHING OF THE BACK, ROLLING OF THE EYES, FOAMING AT THE MOUTH,RIGIDITY IN THE UPPER EXT B/L, NO INCONTINENCE, LASTING 5 MINS .  GLUCOSE 96(POST VACCINE). BP 101/64(PRE VACCINE), HEART RATE 65/MIN(PRE-VACCINE), PULSE OX 99 % ON 2 LITERS OF OXYGEN(POST VACCINE)
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Blood glucose normal, Dizziness, Eye movement disorder, Foaming at mouth, Immediate post-injection reaction
Clinical narrative: Patient starting convulsing after 2nd vaccine which was Meningococcal B ,  Tumenba  , aunt told Medical assistant she had pass out in the past when she got 5 vaccines at health department, but did not mention she had convulsions, apparently she did not know the difference between fainting and convulsing and she had not all the history of child from parents
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Muscle rigidity, Opisthotonus, Seizure
Clinical narrative: Patient starting convulsing after 2nd vaccine which was Meningococcal B ,  Tumenba  , aunt told Medical assistant she had pass out in the past when she got 5 vaccines at health department, but did not mention she had convulsions, apparently she did not know the difference between fainting and convulsing and she had not all the history of child from parents
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, HEPA, MENB
Symptoms: Seizure
Clinical narrative: Patient starting convulsing after 2nd vaccine which was Meningococcal B ,  Tumenba  , aunt told Medical assistant she had pass out in the past when she got 5 vaccines at health department, but did not mention she had convulsions, apparently she did not know the difference between fainting and convulsing and she had not all the history of child from parents
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral ischaemia, Head titubation, Hyperacusis, Magnetic resonance imaging brain abnormal, Migraine
Clinical narrative: migraine disorder/Migraine headche; sensitivity to the light; moderate to severe white matter T2 hyperintensities; head tremor/shaking sensation of head; This case was reported by a lawyer and described the occurrence of migraine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received via medical record.(This case is medically confirmed now).As per medical record the patient had concurrent medical conditions included hypertension.On 30 July 2018, the patient received Shingrix. The patient visited on 9 July 2019 and the patient had head tremor began 2 weeks after getting shingrix last year per patient on 13 August 2018. Also the patient had migraine headache. The patient had sensitivity to the light sound and nausea and shaking sensation of head.She had been taking Topamax 75 mg 2 times daily. MRI of the brain which showed no acute abnormality, mild cerebral and cerebellar volume loss, moderate to severe white matter T2 hyperintensities, nonspecific due to microvascular ischemia dated 4 December 2018.      Lab Comments: MRI of the brain which showed no acute abnormality, mild cerebral and cerebellar volume loss, moderate to severe white matter T2 hyperintensities, nonspecific due to microvascular ischemia dated 4 December 2018.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Photophobia, Tremor, White matter lesion
Clinical narrative: migraine disorder/Migraine headche; sensitivity to the light; moderate to severe white matter T2 hyperintensities; head tremor/shaking sensation of head; This case was reported by a lawyer and described the occurrence of migraine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received via medical record.(This case is medically confirmed now).As per medical record the patient had concurrent medical conditions included hypertension.On 30 July 2018, the patient received Shingrix. The patient visited on 9 July 2019 and the patient had head tremor began 2 weeks after getting shingrix last year per patient on 13 August 2018. Also the patient had migraine headache. The patient had sensitivity to the light sound and nausea and shaking sensation of head.She had been taking Topamax 75 mg 2 times daily. MRI of the brain which showed no acute abnormality, mild cerebral and cerebellar volume loss, moderate to severe white matter T2 hyperintensities, nonspecific due to microvascular ischemia dated 4 December 2018.      Lab Comments: MRI of the brain which showed no acute abnormality, mild cerebral and cerebellar volume loss, moderate to severe white matter T2 hyperintensities, nonspecific due to microvascular ischemia dated 4 December 2018.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received one dose of a Shingles vaccine / developed a case of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. A Pharmacist reported that a patient received one dose of a Shingles vaccine and then developed a case of Shingles. The reporter was unsure which shingles vaccine was received by the patient. The reporter did not consent to follow up. The pharmacist declined to supply AE report details when requested.