chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product physical issue
Clinical narrative: DID NOT TAKE THE FOURTH DOSE OF VIVOTIF AS CAPSULE WAS BROKEN AND THE CONTENTS WERE MISSING; This spontaneous case report (PVX2019-2947, PTC-000105) was received from a pharmacist on 02-Dec-2019. It described a female consumer who "did not take the fourth dose of Vivotif as capsule was broken and the contents were missing" (PT: Incomplete course of vaccination). She was receiving Vivotif capsule (lot number: 3003303; expiry date: Sep 2020) for typhoid prophylaxis.  Case report: The consumer had taken three doses of Vivotif and the third dose was taken either on 24-Nov-2019 or 25-Nov-2019. Then, she noticed that the fourth capsule was broken and the contents were missing. Thus, she did not take the last dose. It was reported that she will be traveling to the endemic area on 12-Dec-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer did not take the fourth dose of Vivotif as capsule was broken and the contents were missing (Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer did not take the fourth dose of Vivotif as capsule was broken and the contents were missing ( Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: BIT THE VIVOTIF CAPSULE AND SWALLOWED SOME OF IT AND SPIT SOME OF IT OUT; This spontaneous case report (PVX2019-2935) was received from consumer on 27-Nov-2019. It described a 7-year-old female consumer who "bit the Vivotif capsule and swallowed some of it and spit some of it out" (PT: Wrong technique in product usage process), while being on oral Vivotif capsule for typhoid fever.  Case report: The consumer took the first dose of Vivotif on 26-Nov-2019 and bit the Vivotif capsule and swallowed some of it and spit some of it out. It was reported that she did not have any swallowing problem.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer bit the Vivotif capsule and swallowed some of it and spit some of it out (Wrong technique in product usage process). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer bit the Vivotif capsule and swallowed some of it and spit some of it out (Wrong technique in product usage process). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-2951) was received from a pharmacist on 27-Nov-2019. It described a 6-year-old male consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took the first dose of Vivotif on 23-Nov-2019 and then he did not take the second dose of Vivotif according to schedule, and took it one day late on 26-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: It was reported that a patient did not take Vivotif according to the schedule (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: It was reported that a patient did not take Vivotif according to the schedule (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE VIVOTIF ACCORDING TO THE SCHEDULE; This spontaneous case report (PVX2019-2961) was received from a nurse on 03-Dec-2019. It described a 26-year-old female consumer who "did not take Vivotif according to the schedule" (PT: Inappropriate schedule of product administration). She was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first two doses of Vivotif according to the schedule and then waited three days to take the third dose. It was reported that she did not take the fourth dose yet.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer took the first two doses of Vivotif according to the schedule and then waited three days to take the third dose (Inappropriate schedule of Vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took the first two doses of Vivotif according to the schedule and then waited three days to take the third dose (Inappropriate schedule of Vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED A DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2962) was received from a nurse on 03-Dec-2019. It described a female consumer who "missed a dose of Vivotif" (PT: Product dose omission). She was receiving Vivotif for an unknown indication.  Case report: The consumer missed a dose of Vivotif. The nurse stated that she was not sure which dose was missed or when it was missed.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer had missed a dose of Vivotif. Information on the which dose of Vivotif was missed by the consumer was limited. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. ; Sender's Comments: A consumer had missed a dose of Vivotif. Information on the which dose of Vivotif was missed by the consumer was limited. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF EVERY DAY; This spontaneous case report (PVX2019-2964) was received from a nurse on 03-Dec-2019. It described a male consumer who "took Vivotif every day" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took all four doses of Vivotif on every day instead of every other day. The doses were taken on 23-Oct-2019, 24-Oct-2019, 25-Oct-2019, and 26-Oct-2019.  The action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of reported event was unknown.  Company Comment: A consumer took one dose of Vivotif every day for four days instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took one dose of Vivotif every day for four days instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED AND PROMPTLY TOOK THE THIRD DOSE WHEN REMEMBERED; This spontaneous case report (PVX2019-2971) was received from a healthcare professional on 03-Dec-2019. It described a consumer who "missed and promptly took the third dose when remembered" (PT: Inappropriate schedule of product administration) while being on Vivotif for typhoid fever.  Case report: The consumer took the first two doses of Vivotif according to schedule but the consumer missed the third dose and promptly took it when remembered.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer missed third dose of Vivotif and promptly took it when remembered ( Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer missed third dose of Vivotif and promptly took it when remembered ( Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVELING; This spontaneous case report (PVX2019-2955) was received from a consumer on 02-Dec-2019. It described a female consumer who "did not complete immunization one week prior to traveling" (PT: Inappropriate schedule of product administration), while being on oral Vivotif (lot number: 3003277) for typhoid fever.  Case report: The consumer took first dose of Vivotif two days before reporting. She would be traveling to the endemic area before completing Vivotif and would be taking the last dose of Vivotif on the flight to the endemic area.  The action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of reported event was unknown.  Company Comment: A consumer did not complete four doses of Vivotif one week prior to traveling to endemic area (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer did not complete four doses of Vivotif one week prior to traveling to endemic area (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Labelled drug-drug interaction medication error
Clinical narrative: DID NOT WAIT THREE DAYS AFTER HIS LAST DOSE OF VIVOTIF TO START TAKING ANTIBIOTICS; This spontaneous case report (PVX2019-2978) was received from a consumer on 04-Dec-2019. It described 25-year-old male consumer who "did not wait three days after his last dose of Vivotif to start taking antibiotics" (PT: Labelled drug-drug interaction medication error). She was receiving oral Vivotif for typhoid fever and antibiotics (unknown) for prophylaxis for wisdom teeth removal.  Case report: The consumer completed the course of Vivotif and after a day, he started taking antibiotics because he got his wisdom teeth taken out. It was reported that it occurred about a month ago.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer did not wait three days after his last dose of Vivotif to start taking antibiotics (Labelled drug-drug interaction medication error). The causality of the event is assessed as not related to Vivotif.  .; Sender's Comments: A consumer did not wait three days after his last dose of Vivotif to start taking antibiotics (Labelled drug-drug interaction medication error). The causality of the event is assessed as not related to Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter wanted to know was it safe to get a Shingrix shot when it's possible he/she could catch Covid-19 (or already have it). The patient was due for second shot of the shingles vaccine but it gave flu-like symptoms for several days last time. This made the patient worried that if it happen to catch Covid-19 the same week of getting the shot the patient might get sicker than otherwise would if he/she did not get the vaccine, since immune system was already responding to one invader. If the vaccine causes an immune response to create shingles anti-bodies while Covid-19 causes an immune response to create coronavirus antibodies at the same time, was it possible that there would be a cascade effect. Or that might have a greater than normal inflammatory response to one or the other (or both) as a result. Or that response to Covid-19 might be weaker as a result of being exposed to a different invader at the same time.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: No energy; Felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of loss of energy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced loss of energy and feeling bad. On an unknown date, the outcome of the loss of energy and feeling bad were unknown.   It was unknown if the reporter considered the loss of energy and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that he experienced no energy and felt bad after second shingrix dose. Did not consent to follow-up. This case was 1 of 8 cases, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Rash
Clinical narrative: Flare up of the arm; Felt bad; 7 patients for a late second dose of Shingrix over 6 months / one of those patient being due today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rash, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and feeling bad to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient flare up of the arm and felt bad after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Rash
Clinical narrative: Flare up of arm; felt bad; 7 patients late second dose of Shingrix over 6 months, with one of those patient being due today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rash, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and feeling bad to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient flare up of the arm and felt bad after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Rash
Clinical narrative: Flare up of the arm; Felt bad; 7 patients for a late second dose of Shingrix over 6 months, with one of those patient being due today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rash, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and feeling bad to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient flare up of the arm and felt bad after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event, Incomplete course of vaccination
Clinical narrative: Experienced a problem after first dose; late second dose of Shingrix over 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced adverse event and incomplete course of vaccination. On an unknown date, the outcome of the adverse event and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had problem after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 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 a year after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was recovered/resolved.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A patient received the 1st dose of Shingrix about a year ago and was later diagnosed with cancer. She was cancer -free now and would like to get the 2nd dose. The pharmacist did not have any of the patient demographic information at the time of report.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: high fever, chills, severe body aches
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Incomplete course of vaccination, Rotavirus infection, Rotavirus test positive
Clinical narrative: Dose # 3 at 6 months of age was never administered for unspecified reason (therapy discontinued: NO); Stool swab was done and was positive for rotavirus; This spontaneous report was received from a nurse practitioner via company representative regarding a 20-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2018 (reported as at 2 months of age), the patient was vaccinated with 1st dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot # N030996, expiration date was 08-SEP-2019, via oral route as normal childhood vaccination (prophylaxis) (strength and dose were not reported). On an unknown date in 2018 (reported as at 4 months of age), the patient was vaccinated with 2nd dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025733, expiration date 30-MAR-2020 via oral route for prophylaxis (strength and dose were not reported). The other vaccines administered along with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at 2 months and 4 months included Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), pneumococcal 13v conj vaccine (crm197)(PREVNAR 13), and diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) for prophylaxis (dose, route, lot # and expiry date were not reported). The third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at 6 months of age was never administered due to an unspecified reason (however, was reported as not discontinued) (Inappropriate schedule of product administration). On 26-MAR-2020, the patient experienced mild diarrhea without fever and vomiting. The patient sought medical attention. The stool swab was performed on 26-MAR-2020 and the result revealed on unknown date in March 2020 was positive for rotavirus (rotavirus infection). The patient was treated with oral hydration and ibuprofen if fever occurred. No product quality complaint (PQC) was involved. The outcome of the event rotavirus infection was resolving (as of 27-MAR-2020 patient was mostly recovered as the diarrhea had improved). The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: had fever; had chills; had myalgia; only the bilateral hip pain did not not go away after 2nd dose; This case was reported by a pharmacist and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 1st dose of Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, myalgia and pain in hip. On an unknown date, the outcome of the fever, chills, myalgia and pain in hip were recovered/resolved.   It was unknown if the reporter considered the fever, chills, myalgia and pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that they developed fever, chills, myalgias and bilateral hip pain. For the tolerability of 2nd dose, refer case US2020AMR063465 reported for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: I've developed polymyagia rheumatica after my 2nd Shingrix shot; had fever; had chills; had myalgia; only the bilateral hip pain did not not go away after 2nd dose; "It then spread to bilateral shoulders and my neck; It then spread to bilateral shoulders and my neck; This case was reported by a pharmacist and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), fever, chills, myalgia, pain in hip, shoulder pain and neck pain. The patient was treated with prednisone (Prednison). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the polymyalgia rheumatica was recovering/resolving and the outcome of the fever, chills and myalgia were recovered/resolved and the outcome of the pain in hip, shoulder pain and neck pain were unknown.   The reporter considered the polymyalgia rheumatica to be related to Shingrix. It was unknown if the reporter considered the fever, chills, myalgia, pain in hip, shoulder pain and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The hospital pharmacist stated that they developed polymyalgia rheumatica after their 2nd Shingrix shot. The patient had fever, chills and myalgias 1 day after their first dose 8th December 2019 and the same their 2nd dose only the bilateral hip pain did not go away after 2nd dose. It then spread to bilateral shoulders and their neck. Currently on Prednisone and improved but polymyalgia rheumatica seems triggered by Shingrix shot. For the tolerability of 1st dose, refer case US2020AMR063397 reported for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica, Pyrexia, Vaccine positive rechallenge
Clinical narrative: I've developed polymyagia rheumatica after my 2nd Shingrix shot; had fever; had chills; had myalgia; only the bilateral hip pain did not not go away after 2nd dose; "It then spread to bilateral shoulders and my neck; It then spread to bilateral shoulders and my neck; This case was reported by a pharmacist and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), fever, chills, myalgia, pain in hip, shoulder pain and neck pain. The patient was treated with prednisone (Prednison). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the polymyalgia rheumatica was recovering/resolving and the outcome of the fever, chills and myalgia were recovered/resolved and the outcome of the pain in hip, shoulder pain and neck pain were unknown.   The reporter considered the polymyalgia rheumatica to be related to Shingrix. It was unknown if the reporter considered the fever, chills, myalgia, pain in hip, shoulder pain and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The hospital pharmacist stated that they developed polymyalgia rheumatica after their 2nd Shingrix shot. The patient had fever, chills and myalgias 1 day after their first dose 8th December 2019 and the same their 2nd dose only the bilateral hip pain did not go away after 2nd dose. It then spread to bilateral shoulders and their neck. Currently on Prednisone and improved but polymyalgia rheumatica seems triggered by Shingrix shot. For the tolerability of 1st dose, refer case US2020AMR063397 reported for same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Rash
Clinical narrative: Flare up of the arm; felt bad; 7 patients late second dose of Shingrix over 6 months, with one of those patient being due today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rash, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and feeling bad to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient flare up of the arm and felt bad after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Headache, Loss of consciousness, Malaise
Clinical narrative: Patient presented to health dept. on 2/4/2020 for 2nd dose of Trumenba and states he had difficulty breathing about 1 hour after being vaccinated with Trumenba on 7/25/19. He said he was very ill for about 3 hours with excruciating headache as well as the difficulty breathing. Patient states symptoms eventually went away and he did not seek medical treatment. Notes on the patient's card from the administering RN show that he did pass out when he received his vaccines on 7/25/19. The health dept. was notified of this reaction on 2/4/2020 when patient presented for the 2nd dose of Trumenba. Patient was not vaccinated with the 2nd dose of Trumenba and was advised to follow up with his primary doctor should he be required to have this series for college admission.
Age: 40.0
Sex: M
Vaccine: FLU4, HEP, HEPA, MMR, PPV, TDAP
Symptoms: Hyperhidrosis, Myalgia, Neck pain
Clinical narrative: Sweating, myalgias, sore neck
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Cold sweat, Dizziness, Mental impairment, Skin warm
Clinical narrative: Patient became lightheaded & not able to think clearly; BP elevated to 150/84 mmHg.  Patient given benadryl 50mg IM at 845am.  Skin noted to be clammy and warm.  Patient seen by MD and given epipen injection at 913am.  Patient reported that her head cleared and was able to think better after epipen injection.  BP noted to be 140/80 mmHg and HR 75 beats/min.  O2 sat stable at 97-99%. Patient transported to ER.  No further interventions needed.
Age: 86.0
Sex: U
Vaccine: VARZOS
Symptoms: Disorientation, Incomplete course of vaccination, Middle insomnia
Clinical narrative: Box 18 - Woke up in the middle of the night disoriented. Didn't know where I was. First time I've experienced this type of reaction to anything. No medical attn. sought. Advised against receiving 2nd dose per Dr.
Age: 59.0
Sex: M
Vaccine: FLU4, HEP, HEPA, PPV, TDAP
Symptoms: C-reactive protein increased, Chills, Fatigue, Headache, Influenza A virus test negative
Clinical narrative: Chills, fatigue, myalgias and headache,  during the evening hours of 3/17/2020. Developed fever 103.2 on 3/19/2020
Age: 59.0
Sex: M
Vaccine: FLU4, HEP, HEPA, PPV, TDAP
Symptoms: Influenza B virus test, Influenza virus test negative, Myalgia, Neutrophil count increased, Pyrexia
Clinical narrative: Chills, fatigue, myalgias and headache,  during the evening hours of 3/17/2020. Developed fever 103.2 on 3/19/2020
Age: 59.0
Sex: M
Vaccine: FLU4, HEP, HEPA, PPV, TDAP
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, White blood cell count increased
Clinical narrative: Chills, fatigue, myalgias and headache,  during the evening hours of 3/17/2020. Developed fever 103.2 on 3/19/2020
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Head titubation, Musculoskeletal stiffness, Seizure, Unresponsive to stimuli
Clinical narrative: Patient received the vaccine in the morning. Later in the evening, I was holding her, and she flung herself backwards into a seizure. Her body stiffened, head nodding, and she was non-responsive. I took her to the emergency room after she came back to herself. The doctors checked her, and said it's possible she had a seizure, but said the only way to verify it was for sure a seizure was to do a brain scan, which they do not recommend in babies after only one seizure following a vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Drug hypersensitivity
Clinical narrative: allergies; This case was reported by a other health professional via sales rep and described the occurrence of drug allergy in a 43-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown.   It was unknown if the reporter considered the drug allergy to be related to Influenza vaccine.  Additional details were reported as follows: The patient received flu vaccine on unknown date and experienced allergies. No other information was reported. This is 1 of the 3 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Palpitations
Clinical narrative: I had heart palpitations; I had shortness of breath / have breathing issues where it feels difficult to breath/I get out of breath fast; I exert myself a little; This case was reported by a consumer and described the occurrence of palpitation in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In March 2020, the patient received Shingles vaccine. In March 2020, 1 day after receiving Shingles vaccine, the patient experienced palpitation, shortness of breath and fatigue. On an unknown date, the outcome of the palpitation, shortness of breath and fatigue were unknown.   It was unknown if the reporter considered the palpitation, shortness of breath and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 62 or 63 year old. The patient stated that they received a Shingles vaccine about 5 weeks ago. The next day they had heart palpitations and shortness of breath. Anytime they exert themselves even a little, they had breathing issues where it feels difficult to breath as if they was breathing through a towel. If they still exert themselves, they get out of breath fast. Just days before the vaccine, they rode an exercise bike every day with zero issues. The patient took an EKG and it was perfect.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Chest discomfort, Pain in extremity, Palpitations
Clinical narrative: her heart began to race / have palpitations; felt very anxious for a couple of hours; reports having arm pain within 5 minutes of the vaccine; felt her chest tightening; This case was reported by a consumer via call center representative and described the occurrence of heart racing in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received Influenza vaccine (intramuscular). On an unknown date, 60 sec after receiving Influenza vaccine, the patient experienced heart racing, anxiety, pain in arm and chest tightness. On an unknown date, the outcome of the heart racing, anxiety, pain in arm and chest tightness were recovered/resolved.   It was unknown if the reporter considered the heart racing, anxiety, pain in arm and chest tightness to be related to Influenza vaccine.  Additional details were reported as follows: The patient received flu vaccine approximately 3 years ago in 2017 in her left arm at a pharmacy and within 60 seconds her heart began to race she had palpitations and she felt very anxious for a couple of hours. The patient reported arm pain within 5 minutes of the vaccine that was on and off for approximately 4 to 6 hours. She also described a moment when she sat in her car to call her physician and felt her chest tightening but eventually everything subsided. The reporter did not consent to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: lower extreme urticaria, increase of hives, redness and itching; lower extreme urticaria, increase of hives, redness and itching; lower extreme urticaria, increase of hives, redness and itching; lower extreme urticaria, increase of hives, redness and itching; Based on information previously received, the following information patient information, dosing details, vaccination dated, event onset corrective have been amended   Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 29 years old male patient (194 cm and 104.5 kg) who experienced lower extreme urticaria, increase of hives, redness and itching (hypersensitivity) (urticaria) (erythema) (pruritus), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the right deltoid for prophylactic vaccination.  On 19-Oct-2020, the patient developed a non-serious lower extreme urticaria, increase of hives, redness and itching (hypersensitivity) (urticaria) (erythema) (pruritus) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was hypersensitivity.  Corrective treatment: IV steroid and antihistamine.  The outcome of the events was unknown at the time of reporting.  Follow-up information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  No new information received.  Addendum: Based on information previously received, the following information patient information, dosing details, vaccination dated, event onset corrective have been amended
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Product storage error, Wheezing
Clinical narrative: severe asthma; gradually kept getting worse with wheezing; Fluzone High-Dose, patient received had been stored improperly; Initial information received on 08-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 65 years old female patient who experienced severe asthma (asthma) and gradually kept getting worse with wheezing (wheezing), 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.  The patient stated in the past when she has gotten vaccines the only side effect she can think of was being tired.  On 25-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe asthma (asthma) and gradually kept getting worse with wheezing (wheezing), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also a case of actual medication error due to incorrect product storage. The consumer received a letter form the office that the Fluzone High-Dose she received had been stored improperly; that she was made aware of this on 07-Apr-2020; that the letter stated that he efficacy of the dose but not the safety might be an issue since it was improperly stored.  Other relevant tests were not reported.  Final diagnosis was severe asthma.   Corrective treatment: The consumer reported that the asthma began right away described as not knowing the exact day but soon after the injection; that she gradually kept getting worse with wheezing; that she then went to the clinic and was prescribed Prednisone and a rescue inhaler. Later, she saw pulmonologist and was placed on a 3 month regiment of high dose BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) after the asthma became severe; that she was still on the Symbicort.  The outcome of the event was not reported.  The information on the batch number will not be available for this case.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Migraine, Nausea, Vomiting
Clinical narrative: Migraines, nausea, vomiting, tiredness,weakness
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: day 1 post vaccination: swelling, erythema and tenderness at injection site; severe headache, chills, fever 101 oral, arthralgias and body aches; fatigue; in bed most of the day. day 2 post vaccination: swelling, erythema and tenderness at injection site; severe headache, chills, fever 101 oral, arthralgias and body aches; fatigue; in bed most of the day; took acetaminophen 650 mg q 4 hours x 4; defervesce day 3 post vaccination; swelling and erythema ay injection site  improved; mild general malaise but other symptoms resolved. .
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: day 1 post vaccination: swelling, erythema and tenderness at injection site; severe headache, chills, fever 101 oral, arthralgias and body aches; fatigue; in bed most of the day. day 2 post vaccination: swelling, erythema and tenderness at injection site; severe headache, chills, fever 101 oral, arthralgias and body aches; fatigue; in bed most of the day; took acetaminophen 650 mg q 4 hours x 4; defervesce day 3 post vaccination; swelling and erythema ay injection site  improved; mild general malaise but other symptoms resolved. .
Sex: M
Vaccine: VARZOS
Symptoms: Ataxia, Atrophy, Dysarthria, Mental status changes, Pneumonia
Clinical narrative: hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; severe respiratory infection; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  Approximately, on 18-APR-2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered a severe respiratory infection, and the patient was hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.  As a direct and proximate result of her receipt of vaccination, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient had not recovered from the aforementioned events, and the reporter considered them to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered the events of pneumonia, mental status changes, atrophy, dysarthria, ataxia and respiratory tract infection to be disabling.  Upon internal review, the event of pneumonia was considered medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory tract infection
Clinical narrative: hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.; severe respiratory infection; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  Approximately, on 18-APR-2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered a severe respiratory infection, and the patient was hospitalized with altered mental status, atrophy, dysarthria, ataxia and left lobe pneumonia.  As a direct and proximate result of her receipt of vaccination, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient had not recovered from the aforementioned events, and the reporter considered them to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered the events of pneumonia, mental status changes, atrophy, dysarthria, ataxia and respiratory tract infection to be disabling.  Upon internal review, the event of pneumonia was considered medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Breast swelling, Erythema, Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (age not provided). Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  Approximately, on 26-JUL-2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered redness, swelling and soreness of her left breast and she was diagnosed with herpes zoster. As a direct and proximate result of her receipt of vaccination, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient outcome regarding shingles was unknown, and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX) and disabling.