chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient recevied first menactra in June 2018 and on 03Jan20 instead of his 3rd dose of Trumemba he was given a Menactra, No AE; Initial information received on 04-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 20 years old female patient who was vaccinated first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in June 2018 and on 03-Jan-2020 instead of his third dose of MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] he was given a Menactra.  It was actual medication error due to wrong vaccine administered.  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 holders 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.  Information on the batch number was requested.
Age: 73.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Asthenia, Gait inability, Hepatic enzyme increased
Clinical narrative: had side effects; liver enzymes way out of site; he could not walk; weak,He felt like he lost all strength in his right arm and right side; Initial information received on 16-Jan-2020 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 73 years old male patient (169 cm and 84.82 kg) who experienced had side effects; liver enzymes way out of site (hepatic enzyme abnormal), he could not walk and (gait disturbance), weak, he felt like he lost all strength in his right arm and right side (asthenia), while he received vaccine INFLUENZA VACCINE and while treated with CRIZOTINIB [XALKORI].  The patient's past medical history included Cholecystectomy in 2019.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Lung neoplasm malignant which was diagnosed maybe 3 years ago.   On an unknown date, the patient started taking XALKORI (CRIZOTINIB) dosage unknown route unknown (with an unknown batch number) for Neoplasm malignant. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  In Nov-2019, the patient developed a serious side effects; liver enzymes way out of site (hepatic enzyme abnormal), he could not walk (gait disturbance), weak,he felt like he lost all strength in his right arm and right side (asthenia) (Unknown latency) following the first dose intake and (Unknown latency) following the last dose intake of CRIZOTINIB and unknown latency following the administration of INFLUENZA VACCINE The patient was hospitalized for this event in Nov-2019. The patient was discharged in November 2019 (admitted for 5 days).  (Other relevant tests included no laboratory data reported.)  Final diagnosis was weak,he felt like he lost all strength in his right arm and right side, he could not walk and had side effects; liver enzymes way out of site.  CRIZOTINIB (XALKORI) was discontinued on an unknown date for a month (not sure permanent or temporary). The patient was switched to Rozlyrtek and he felt better.  Corrective treatments not reported.  The patient was recovering from all events at the time of report.  Batch number was requested.; Sender's Comments: This case concerns a 73 years old male patient who presented with hepatic enzyme abnormal, gait disturbance and asthenia (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were reported as Cholecystectomy and Lung neoplasm malignant. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: six year old patient patient received Flublok vaccine/NO AE; patient received Flublok vaccine instead of Fluzone Quadrivalent vaccine/No AE; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from a Consumer.  This case involves a six years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered)  Medical history, medical treatment, vaccination and family history were not provided.  On 16-Jan-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot QFAA1913, expiry date: 29-JUN-2020] in her left thigh instead of INFLUENZA QUADRIVAL A-B VACCINE via an unknown route.  This was a case of actual medication error due to inappropriate age at vaccine administration and wrong product administered.  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: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A 18 month old female baby got Pentacel and Acthib same time on 15 Jan 2020, baby accidentally got two doses of ActHIB/No AE; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 18 months old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] same time on 15-Jan -2020, baby accidentally got two doses of Acthib.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and INFLUENZA VACCINE (FLU).  On 15-Jan-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ053AAA, expiry date: 02-Oct-20 via intramuscular route in the right thigh and HIB (PRP/T) VACCINE lot UJ078AAA, expiry date: 27-Oct-20 via intramuscular route in the left thigh.  It was an actual medication error due to Extra dose administered.  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 holders 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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered the Hib portion of Pentacel in his right thigh today. The Hib portion was diluted in error with sterile diluent from  Merck, no AE; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received a 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ187AAA and expiry date: 16-Feb-2021) via unknown route in the right thigh, on 16-Jan-2021.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue). It was reported that patient was administered the Hib portion of Pentacel in his right thigh today. The Hib portion was diluted in error with "sterile diluent from Merck, Sharpe, and Dome Company" further described as sterile water with no preservatives. The DTaP-IPV portion of Pentacel was not administered.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Mobility decreased, Pain in extremity
Clinical narrative: trouble lifting arm; pain in arm; Rph said there was only maybe 1 drop of blood at site when she did the injection; Initial information received on 17-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 years old female patient who experienced rph said there was only maybe 1 drop of blood at site when she did the injection (vaccination site haemorrhage), pain in arm (vaccination site pain) and trouble lifting arm (mobility decreased), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ311AA (Expiry date 30-Jun-2020) via intramuscular route in the left arm.  On 20-Nov-2019, the patient developed a non-serious rph said there was only maybe 1 drop of blood at site when she did the injection (vaccination site haemorrhage) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious pain in arm (vaccination site pain) and trouble lifting arm (mobility decreased) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Detailed laboratory examination was not provided.  Final diagnosis Vaccination site pain, Mobility decreased and Vaccination site bleeding.  An anti inflammatories use as corrective treatment.  The event outcome is reported as Not Recovered for pain in arm, as Unknown for trouble lifting arm and as Unknown for Mobility decreased and Vaccination site bleeding.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Woke up at 1:30 am with severe chills, shivering uncontrollably.  Had to put layers of clothes and blankets on to get warm.  As of 5:30 am he is running a fever.  Temperature unknown, due to thermometer not working.  Chills and shivering have abated, and ibruprophen was given for fever.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: accidently administered two Adacel vaccines/no AE; Initial information received on 17-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 46 years old male patient who accidently received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] twice on 17-Jan-2020.(lot U6539AA via intramuscular route in the left deltoid).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for Immunisation.  It was an actual medication error due to extra dose administered.  It was unknown whether adverse event was noted or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Analgesic drug level, Audiogram abnormal, Blood test normal, Borrelia test, C-reactive protein
Clinical narrative: Woke up Saturday morning and could not hear in my right ear.  Went to Urgent Care and was referred to Hospital ER.  Visual exam, blood work and CAT scan all normal.  Given Prednisone and referred to Otolaryngologist.  Auditory test confirmed significant loss of hearing in right ear, especially at higher frequencies.  Given MRI scan with contrast with no abnormalities.  Attributed to non-specific ototoxicity possibly due to virus.  Little to no improvement since.  Follow up scheduled for May 2020.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Computerised tomogram head, Computerised tomogram normal, Deafness neurosensory, Deafness unilateral, Differential white blood cell count
Clinical narrative: Woke up Saturday morning and could not hear in my right ear.  Went to Urgent Care and was referred to Hospital ER.  Visual exam, blood work and CAT scan all normal.  Given Prednisone and referred to Otolaryngologist.  Auditory test confirmed significant loss of hearing in right ear, especially at higher frequencies.  Given MRI scan with contrast with no abnormalities.  Attributed to non-specific ototoxicity possibly due to virus.  Little to no improvement since.  Follow up scheduled for May 2020.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Full blood count, International normalised ratio, Magnetic resonance imaging normal, Metabolic function test, Prothrombin time
Clinical narrative: Woke up Saturday morning and could not hear in my right ear.  Went to Urgent Care and was referred to Hospital ER.  Visual exam, blood work and CAT scan all normal.  Given Prednisone and referred to Otolaryngologist.  Auditory test confirmed significant loss of hearing in right ear, especially at higher frequencies.  Given MRI scan with contrast with no abnormalities.  Attributed to non-specific ototoxicity possibly due to virus.  Little to no improvement since.  Follow up scheduled for May 2020.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Red blood cell sedimentation rate, Scan with contrast normal, Treponema test
Clinical narrative: Woke up Saturday morning and could not hear in my right ear.  Went to Urgent Care and was referred to Hospital ER.  Visual exam, blood work and CAT scan all normal.  Given Prednisone and referred to Otolaryngologist.  Auditory test confirmed significant loss of hearing in right ear, especially at higher frequencies.  Given MRI scan with contrast with no abnormalities.  Attributed to non-specific ototoxicity possibly due to virus.  Little to no improvement since.  Follow up scheduled for May 2020.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Audiogram abnormal, Computerised tomogram normal, Deafness unilateral, Magnetic resonance imaging normal, Scan with contrast normal
Clinical narrative: Woke up Saturday morning and could not hear in my right ear.  Went to Urgent Care and was referred to Hospital ER.  Visual exam, blood work and CAT scan all normal.  Given Prednisone and referred to Otolaryngologist.  Auditory test confirmed significant loss of hearing in right ear, especially at higher frequencies.  Given MRI scan with contrast with no abnormalities.  Attributed to non-specific ototoxicity possibly due to virus.  Little to no improvement since.  Follow up scheduled for May 2020.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Influenza like illness
Clinical narrative: There was only one day of a flu-like syndrome, which was mild. However, hoarseness of the voice continued. I am a serious and trained amateur singer, and my singing voice was badly affected for over a month. It didn't fully recover for about 4 months. The symptoms were similar to laryngeal reflux I have had in the past, but which has been well-controlled for several years. The treatment used was voice therapy exercises. The voice very gradually improved.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: On 01/23/20, 63 yo M presented to clinic for scheduled appointment. During this visit, pt was ordered and administered the second-in-series Varicella-Zoster vaccine IM (Shingrix). Per immunization record, 0.5 mL was injected in left deltoid at 0839 (Lot #EE924). Pt was discharged in stable condition. At ~2348, pt called nurse triage line and reported fever, body aches and shivering. Pt did not own a thermometer, so temperature was unknown. Pt was advised to go to ED. Per documentation, pt was transported to ED on early morning of 01/24. Per ED MD documentation, pt had "..no hives, no shortness of breath, no swelling, vitals and labs are reassuring." Vitals documented at 0115 included T: 37.9 °C (100.2°F). The only intervention documented included acetaminophen 650 mg PO at 0152. No other interventions were documented. Pt was discharged with instructions to follow up with PCP.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Severe Pain in left arm beginning the night of the vaccine and continuing 2 days.  I could not move my arm. After 2 days I could move the arm slowly to pull a shirt over my head but still could not sleep on that arm. After 2 weeks the pain remains at a reduced severity .If I use the arm for lifting or sleep on it the pain intensifies.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematochezia
Clinical narrative: Patient stated he had to go to the emergency room due to "severe" bloody stools.  ER doctor stated it was unlikely related to vaccination but couldn't rule it out.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: body and muscle aches, last night had fever 102, nausea, low appetite 101 today, took Advil other symptoms have stayed the same fever controlled with medications arm also sore at vaccine site, but no warmth, redness or swelling denies SOB, difficulty swallowing or breathing
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: body and muscle aches, last night had fever 102, nausea, low appetite 101 today, took Advil other symptoms have stayed the same fever controlled with medications arm also sore at vaccine site, but no warmth, redness or swelling denies SOB, difficulty swallowing or breathing
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: the site of injection was "hard and warm"; the site of injection was "hard and warm"; This spontaneous report was received from a medical assistant and refers to a 64-year-old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On 15-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot number: S029265, expiration date: 31-MAR-2021 (strength, exact dose and route of administration were not provided) for prophylaxis.  On 15-JAN-2020, the patient's site of injection was "hard and warm". She sought medical attention, coming back to the reporter's office on 16-JAN-2020. The patient received prescription for an unspecified antibiotic.  The outcome of the events was not recovered/not resolved (reported as ongoing).  The relatedness between the events and the suspect vaccine was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: patient is pregnant; no adverse event; inadvertently administered a dose of GARDASIL 9 instead of a dose of Tdap; This spontaneous prospective pregnancy report was received from a nurse referring to a 29 year old female patient. Information about patient's concurrent condition, concomitant medication, medical history, drug allergy/reaction was not reported.   The nurse reported that the patient was 28 weeks and 6 days of gestation at the time of vaccination with last menstrual period of 14-JUN-2019. On 02-JAN-2020, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R005341, expiry date 06-DEC-2020 (strength, dose number, route, anatomical location was not reported) for prophylaxis, instead of a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (exposure during pregnancy, wrong product administered). No adverse symptoms were reported (no adverse event). The estimated date of delivery of the patient was 20-MAR-2020. The pregnancy outcome was outcome pending. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: May have received 1 or 2 doses prior; May have received 1 or 2 doses prior; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 28-OCT-2019, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, anatomical location, route was not reported) with a lot number S000618 has been verified to be a valid lot number for zoster vaccine live, expiration date not reported, but upon internal validation established as 06-APR-2020. The pharmacist reported that the patient "may have received 1 or 2 doses" of zoster vaccine live(ZOSTAVAX) prior to 28-OCT-2019 (extra dose administered and circumstance or information capable of leading to medication error). No product quality complaint was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: had a sore arm that lasted 2 days; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 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 details were received as follows: The age at vaccination was not reported but could be 86 or 87 years. The patient had a sore arm that lasted 2 days after vaccination. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2020009814.
Sex: M
Vaccine: VARZOS
Symptoms: Nodular rash, Pain, Pain in extremity, Rash, Skin warm
Clinical narrative: nodular type of rash or bumps; Nodular rash; warm to the touch; Pain; bumps; arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced pain in arm, raised rash, nodular rash, skin warm, pain and rash. On an unknown date, the outcome of the pain in arm, raised rash and nodular rash were recovered/resolved and the outcome of the skin warm, pain and rash were unknown.   It was unknown if the reporter considered the pain in arm, raised rash, nodular rash, skin warm, pain and rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient developed arm pain that lasted about 4 days. The patient also had raised nodular type of rash or bumps and they were warm to the touch and slightly sore. The reporter did not confirm any other adverse events from the vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain of skin, Sensitive skin
Clinical narrative: fatigue; have muscle soreness though entire body; headache; painful/sensitive skin; sKIN PAIN; This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced generalized muscle aches, headache, sensitive skin and skin pain. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the generalized muscle aches, headache, sensitive skin, skin pain and fatigue were unknown.   It was unknown if the reporter considered the generalized muscle aches, headache, sensitive skin, skin pain and fatigue to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had muscle soreness throughout entire body, headache, painful and sensitive skin and fatigue after vaccination. The primary physician told never had a patient experience side effects so long. The reporter was asking adviced regarding event.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; have body aches; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were unknown.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who was health care professional. The patient received second Shingrix shot and had body aches and a sore arm all Day. The patient asked how long the patient would experience ache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Generalized body and face rash; This case was reported by a nurse via sales rep and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date unknown) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Generalized body and face rash.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles from vaccine/suspected vaccination failure; got shingles from vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced shingles after receiving Shingrix. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event confirmation at the time of reporting were unknown. This is 1 of the 4 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Blood pressure systolic increased, Headache, Hypertensive crisis
Clinical narrative: Hypertensive crisis; Elevated systolic pressure; Headache; Anxiety; This case was reported by a pharmacist and described the occurrence of hypertensive crisis in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 weeks before receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced hypertensive crisis (serious criteria GSK medically significant), blood pressure systolic increased, headache and anxiety. The patient was treated with antihypertensives nos (Antihypertensive). Shingrix was discontinued. On an unknown date, the outcome of the hypertensive crisis was recovered/resolved and the outcome of the blood pressure systolic increased, headache and anxiety were unknown.   The reporter considered the hypertensive crisis, blood pressure systolic increased, headache and anxiety to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 8 weeks apart from 1st dose. After receiving Shingri, the patient was repeatedly reporting elevated systolic pressure (more than 3 readings) in 180's at home and was symptomatic- headache, anxiety. The patient was taken to emergency room for hypertensive crisis, which resolved after treatment with an antihypertensive. The reporter was consented to follow up.      Lab Comments: Lab test performed on an unknown date
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Encephalitis, Herpes zoster, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: encephalitis; VZV; shingles; experiencing confusion; This case was reported by a physician via sales rep and described the occurrence of encephalitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), varicella zoster virus infection (serious criteria hospitalization), shingles and confusion. On an unknown date, the outcome of the encephalitis, varicella zoster virus infection, shingles and confusion were unknown.   It was unknown if the reporter considered the encephalitis, varicella zoster virus infection, shingles and confusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient developed shingles. The patient was experiencing confusion, so she recommended pcp send patient to emergency room. The patient was hospitalized with encephalitis and confirmed varicella zoster virus infection.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles outbreaks were on the face and arm; not yet received the second dose in the series; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included meningitis and shingles.   In February 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that the got the first shot of the Shingrix series but  did not know for sure that the injection was given intramuscularly but she assumes that the person administering it gave it correctly. The patient after vaccination got shingles. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter stated that the patient gets shingles 2 to 3 times per year. The reporter stated that the shingles outbreaks were on the face and arm, not always the chest. The reporter did not have the patient's MD information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: endocrinologist diagnosed her with shingles; spot on her back; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, 48 hrs after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows:  The patient developed a spot on her back 48 hours after she received a dose of Shingix. The endocrinologist diagnosed it with shingles. The spot went away without any antiviral treatment. Consented to follow up was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: have been sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of patients 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The reporter briefly mentioned that so many of her friends received the Shingrix vaccine and couple of them had been sick. No other information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a slight soreness in arm after receiving 1st dose of Shingrix. Consent to follow up was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: pain in the left arm; does not have full range of motion of his left arm; difficulty putting the arm up past his head; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm, joint range of motion decreased and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm, joint range of motion decreased and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, joint range of motion decreased and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in the left arm after receiving 2nd dose of Shingrix.  It still hurts but not as much. The patient did not have full range of motion of his left arm.  The patient had difficulty putting the arm up past his head. No further details were provided.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Muscle spasms
Clinical narrative: chills /shivering; Fatigue; sleepy; muscle spasms; headache; stomach doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix .5 ml. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort. On an unknown date, the outcome of the chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort were recovering/resolving.   It was unknown if the reporter considered the chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort to be related to Shingrix.  Additional details were reported as follows: The patient got the first dose of Shingrix and experienced chills, tired, sleepy, muscle spams, headache, shivering and stomach did not feel great. The patient did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: chills /shivering; Fatigue; sleepy; muscle spasms; headache; stomach doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 1st dose of Shingrix .5 ml. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort. On an unknown date, the outcome of the chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort were recovering/resolving.   It was unknown if the reporter considered the chills, tiredness, sleepiness, muscle spasm, headache and abdominal discomfort to be related to Shingrix.  Additional details were reported as follows: The patient got the first dose of Shingrix and experienced chills, tired, sleepy, muscle spams, headache, shivering and stomach did not feel great. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: painful; red; swollen; warm; itchy; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain, erythema, swelling, feeling of warmth and pruritus. On an unknown date, the outcome of the pain, erythema, swelling, feeling of warmth and pruritus were unknown.   It was unknown if the reporter considered the pain, erythema, swelling, feeling of warmth and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. GSK employee reports that he received an email communication where someone shared that they were having a prolonged reaction to the dose of Shingrix they received last week.  The reaction was described as painful, red, swollen, warm, and itchy. The reporter did not give consent to follow up. No additional details are available for this adverse event, the person report their reaction declined follow up.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Flushing, Wheezing
Clinical narrative: He was in a line at clinic (ortho resident), got his shot, and then walked out. Within 30 seconds he felt dizzy and flushed. He leaned over thinking he was having a vasovagal event. He then started wheezing. He went back into the clinic said he could barely breathe. A code was called. A nurse had her child's epinephrine autoinjector and used it on him (they did not have epinephrine readily available). He improved and had no further symptoms.
Age: 29.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Unevaluable event
Clinical narrative: hospitalized 2 days in the emergency room, solumedrol 125mg, Benadryl IV
Age: 29.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Dermatitis, Erythema, Rash
Clinical narrative: hospitalized 2 days in the emergency room, solumedrol 125mg, Benadryl IV
Age: 29.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Unevaluable event
Clinical narrative: Rash, red skin, inflamation of skin
Age: 29.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Dermatitis, Erythema, Rash
Clinical narrative: Rash, red skin, inflamation of skin
Age: 26.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Dizziness
Clinical narrative: Upon receiving vaccinations, patient became dizzy and lightheaded. Lasted approximately 5 minutes.  Treated with juice, and rest Outcome: patient recovered without incident
Age: 26.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Event: Syncope  Duration: 1 minute  Treatment: Juice, snack, ice pack and rest  Outcome: patient recovered with treatment above within 10 minutes
Age: 16.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 1/22/2020 I inadvertently administered an MMR vaccine that expired on 01/17/2020. No adverse effects were noted or reported by patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Chills, Decreased appetite, Headache
Clinical narrative: Soreness at vaccination site, shivering, muscle and joint aches over entire body, headache, rash on entire RIGHT arm, no appetite.  Spent two days bedridden.  Used acetaminophen to treat symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash, Vaccination site pain
Clinical narrative: Soreness at vaccination site, shivering, muscle and joint aches over entire body, headache, rash on entire RIGHT arm, no appetite.  Spent two days bedridden.  Used acetaminophen to treat symptoms.
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Muscle spasms, Nausea
Clinical narrative: Cramping; Diarrhea; Nausea; This spontaneous report was received from a physician via company representative referring to a male patient of an unknown age.  The information regarding patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was unknown.  On 20-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiry date, anatomical location, route of administration were unspecified) for prophylaxis. On the same day, the patient later experienced nausea, diarrhea and cramping afterwards. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did not experience any symptoms; one dose of pediatric V AQTA was inadvertently administered to a 5-week old infant; This spontaneous report was received from a medical assistant and refers to a 5-week-old infant of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies, or concomitant therapies was provided. On 23-JAN-2020, the patient was inadvertently vaccinated with pediatric hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit not reported; lot # S007769, expiration date 24-JUL-2020) 1 dose, intramuscularly for prophylaxis. The patient did not experience any symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain, Headache
Clinical narrative: bad headache on the left side; Hurting my left eye; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache and eye pain. On an unknown date, the outcome of the headache and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and eye pain to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient was vaccinated on left arm. The patient had bad headache on the left side and hurted his/her left eye too.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: headache; shivering; feel awful; Heart rate elevated last night to 93; myalgia; fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknwon date).   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue. On an unknown date, the outcome of the headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue were unknown.   It was unknown if the reporter considered the headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient experienced headache, shivering, feeling awful, myalgia and fatigue after receiving 2nd dose of Shingrix. The patients heart rate elevated to 93 on the night before reporting. Further information was not reported.