chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number XN4FP, expiry date 19th March 2022) for prophylaxis.   The patient's past medical history included shingles.   On 10th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient contacted the pharmacy on the day of reporting and stated that she had broken out in shingles. The patient previously had shingles and the new case of shingles was in the same place. The outcome of the event was reported as recovering hoowever in argus it was captured  as not recovered. No other information was reported
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: experienced occasional headaches and still have them.; This case was reported by a pharmacist via call center representative and described the occurrence of intermittent headache in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, immediately after receiving Shingrix, the patient experienced intermittent headache. On an unknown date, the outcome of the intermittent headache was not recovered/not resolved.   It was unknown if the reporter considered the intermittent headache to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient received the second dose of Shingrix and immediately started to experienced occasional headaches. The reporter consented to follow up.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Rash papular
Clinical narrative: erythema and raised papular rash over area of vaccine, approximately 2cm
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles on right side of stomach and waist.  Shooting pain has stopped today.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysstasia, Nausea, Syncope
Clinical narrative: Patient experienced severe syncope and nausea almost vomited and couldn't stand up for almost 15 minutes. I applied ice to the back of neck and gave her orange juice. She left with her dad about 20 minutes later.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal tenderness, Chills, Decreased appetite, Headache
Clinical narrative: About 10 hours after the injection, I got slammed with the following: fever, chills, headache, upset stomach, malaise, sore injection site, no appetite, uncontrollable shivering and body aches.  I slept as much as I was able to.  These lasted over 24 hours.  Then it was reduced to sore injection site, malaise, no appetite and very tender entire abdomen area; sternum to pubic bone, pelvis to pelvis.  That was another 24 hours.  By Saturday I was feeling better.  Still needed a nap in the afternoon to recover from very little activity.  All is good now.  With my first injection, in December, I just had a sore injection site that was very red and hot to the touch, body aches and malaise that lasted about 48 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: About 10 hours after the injection, I got slammed with the following: fever, chills, headache, upset stomach, malaise, sore injection site, no appetite, uncontrollable shivering and body aches.  I slept as much as I was able to.  These lasted over 24 hours.  Then it was reduced to sore injection site, malaise, no appetite and very tender entire abdomen area; sternum to pubic bone, pelvis to pelvis.  That was another 24 hours.  By Saturday I was feeling better.  Still needed a nap in the afternoon to recover from very little activity.  All is good now.  With my first injection, in December, I just had a sore injection site that was very red and hot to the touch, body aches and malaise that lasted about 48 hours.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse event; The patient was inadvertently administered a 4th does of GARDASIL 9.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 27-MAR-2020, the patient was vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (extra dose administered) (concentration, vaccination scheme frequency, route and anatomical location of administration were not reported; lot number R030456 and expiration date: 23-JUL-2021). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; TOOK DOSES INAPPROPRIATELY; This spontaneous case report was received from a nurse (PVX2019-072) on 07-Jan-2019. The report describes a 70-year-old elderly female consumer who had diarrhoea following the intake of oral Vivotif for typhoid vaccine. The consumer also "took doses inappropriately".  The consumer's concomitant medication included probiotics. The past medications included Vaxchora (cholera Vaccine Live Oral), Hepatitis A and B and Tdap (tetanus, diphtheria, and pertussis) vaccines, which she received on 17-Dec-2018.  It was reported that the consumer started Vivotif on 26-Dec-2018 and finished it by 02-Jan-2019 and diarrhoea happened about a week after the consumer finished the entire course of Vivotif. She also stated that the consumer did not receive any treatment and she was fine. The reporter further stated that she denies fever, chills or abdominal pain. The consumer took no medications for the events.  The action taken with Vivotif with respect to the events diarrhoea and "took doses inappropriately" was not applicable.  The clinical outcome of the event diarrhoea was resolved while with the event "took doses inappropriately" was unknown.  Company's Comment: In this case, it was reported that 70-year-old adult female consumer had diarrhoea one week after the completion of full course of Vivotif. Her medical history of using probiotics concomitantly suggests some gastrointestinal problem. Diarrhoea is labelled as per CCDS. Hence, in view of the above information the causality of the event with Vivotif is assessed as not related. The causality of the event "took doses inappropriately" with Vivotif was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that 70-year-old adult female consumer had diarrhoea one week after the completion of full course of Vivotif. Her medical history of using probiotics concomitantly suggests some gastrointestinal problem. Diarrhoea is labelled as per CCDS. Hence, in view of the above information the causality of the event with Vivotif is assessed as not related. The causality of the event  "took doses inappropriately" with vivotif was considered as not applicable.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: ringing in ear; This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 6th January 2020, less than a week after receiving Shingrix, the patient experienced ringing in ears. The patient was treated with antibiotics nos, prednisone, otologicals (Ear Drops {Nos}), bioflavonoids (Flavonoid) and ginkgo biloba (Ginkobil). On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient experienced ringing in ears 5 to 7 days after receiving Shingrix vaccine. The patient tried 2 antibodics, prednisone pack , ear drops, Flavonoid & Ginko Biblio nothing had helped.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Muscular weakness
Clinical narrative: Muscle weakness; Headache; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness and headache. On an unknown date, the outcome of the muscle weakness and headache were unknown.   It was unknown if the reporter considered the muscle weakness and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know that how long did the muscle weakness and headache last after the dose of Shingrix.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: developed shingles in the weeks following his first dose /diagnosed with herpes zoster; development of a blistering rash on the left forearm; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included meloxicam unknown for product used for unknown indication.   On 6th June 2018, the patient received the 1st dose of Shingrix .5 ml. In June 2018, the patient started meloxicam at an unknown dose and frequency. In June 2018, less than 3 weeks after receiving Shingrix, the patient experienced shingles and blistery rash. The action taken with meloxicam was unknown. On an unknown date, the outcome of the shingles and blistery rash were unknown.   It was unknown if the reporter considered the shingles and blistery rash to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose and developed blistering rash on the left forearm and visited the clinic on 24th June 2018 The patient then diagnosed with herpes zoster at an urgent care and patient believed it was due to the vaccine. Patient also stated that he had just started meloxicam one week prior to the event and believed that contributed to the shingles. The patient was due for the 2nd dose of Shingrix on 6th December 2018. It was unknown if the reporter considered the shingles and blistery rash to be related to meloxicam .
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Is diarrhea a side effect of shingles shot; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 89-year-old 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 diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced diarrhea after receiving shingle vaccine. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph gland; This case was reported by a other health professional via interactive digital media and described the occurrence of enlargement of lymph nodes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced swollen lymph gland after receiving Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Dysstasia, Injection site erythema, Injection site swelling
Clinical narrative: The injection site is  swollen; The injection site is red; she couldn't hold herself up; she was weak; sick on her stomach; sleep all; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received Shingrix. On 17th March 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness. On an unknown date, the outcome of the injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness to be related to Shingrix.  Additional details were reported as follows: The patient shingrix vaccine and next day she was unable to hold herself up, she was weak, and her stomach was upset and patient slept all. The patient also experienced injection site redness and injection site swelling after vaccination. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: The injection site is  swollen; The injection site is red; she couldn't hold herself up; she was weak; sick on her stomach; sleep all; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2020, the patient received Shingrix. On 17th March 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness. On an unknown date, the outcome of the injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, difficulty in standing, weakness, stomach discomfort and sleepiness to be related to Shingrix.  Additional details were reported as follows: The patient shingrix vaccine and next day she was unable to hold herself up, she was weak, and her stomach was upset and patient slept all. The patient also experienced injection site redness and injection site swelling after vaccination. No other information was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer via patient support programs and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient called and stated that he had flu like symptoms after the first dose six months ago. The patient was due for the second dose at the time of reporting.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Injection site vesicles
Clinical narrative: blisters at the injection site; blisters around her nose and below her chin; fatigue; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site blisters in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 5S43T, expiry date 5th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2019).   On 31st January 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 2 days after receiving Shingrix, the patient experienced injection site blisters and blister. In February 2020, the patient experienced fatigue and erythema. On an unknown date, the outcome of the injection site blisters, blister, fatigue and erythema were unknown.   It was unknown if the reporter considered the injection site blisters, blister, fatigue and erythema to be related to Shingrix.  Additional details were reported as follows: The patient experienced blisters at the injection site as well as around her nose and below her chin after receiving 2nd dose of Shingrix. The patient also experienced fatigue and erythema. The patient was not seen her physician or pharmacist, but spoken with her pharmacist. Consent to follow up was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Paraesthesia, Pruritus
Clinical narrative: itch on back, arms, legs with pin pricks; itch on back, arms, legs with pin pricks; Headache; Fever; Pain; Nausea; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 22nd April 2022) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 14th February 2020, 13 days after receiving Shingrix, the patient experienced pruritus and tingling skin. In February 2020, the patient experienced headache, fever, generalized aching and nausea. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the fever, generalized aching, nausea, pruritus and tingling skin were unknown.   It was unknown if the reporter considered the headache, fever, generalized aching, nausea, pruritus and tingling skin to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed headache, generalized pain , nausea and fever. The patient also developed an itch on back, arms, legs with pin pricks.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: itch on back, arms, legs with pin pricks; itch on back, arms, legs with pin pricks; Headache; Fever; Pain; Nausea; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 22nd April 2022) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 14th February 2020, 13 days after receiving Shingrix, the patient experienced pruritus and tingling skin. In February 2020, the patient experienced headache, fever, generalized aching and nausea. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the fever, generalized aching, nausea, pruritus and tingling skin were unknown.   It was unknown if the reporter considered the headache, fever, generalized aching, nausea, pruritus and tingling skin to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed headache, generalized pain , nausea and fever. The patient also developed an itch on back, arms, legs with pin pricks.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot
Clinical narrative: Local reaction of Erythema; Local reaction of warmth; This case was reported by a nurse via call center representative and described the occurrence of localized erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. On 4th March 2020, less than a day after receiving Shingrix, the patient experienced localized erythema and feeling of warmth. On an unknown date, the outcome of the localized erythema and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the localized erythema and feeling of warmth to be related to Shingrix.  Additional details were reported as follows: The patient experienced local reactions of erythema and warmth that has persisted for a week and one day. No other information was reported. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms; Fever; Chills; Body Aches; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills and general body pain to be related to Shingrix.  Additional details were reported as follows: The Chief Administrative Officer stated that they were hesitant in administering Shingrix to patient's in the sense that the side effects from the vaccine could be confused with symptoms of COVID-19. The reporter stated that the they administered hundreds of doses of Shingrix and patients have experienced normal or expected side effects, such as flu like symptoms which includes fever, chills, and body aches. No other information was reported. The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over his body including his scalp; itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included losartan.   On 24th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th February 2020, 3 days after receiving Shingrix, the patient experienced hives and pruritus. On 1st March 2020, the outcome of the hives and pruritus were recovered/resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine in right arm. The patient experienced hives all over his body including his scalp and itching. No other information was reported. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: tiredness; chills; muscle ache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (when patient was young).   On 26th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced tiredness, chills and muscle pain. On an unknown date, the outcome of the tiredness, chills and muscle pain were recovered/resolved.   It was unknown if the reporter considered the tiredness, chills and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she received the first dose of the Shingrix vaccine in her left arm and she did have some chills, tiredness and muscle aches. For the tolerability of 2nd dose, refer case US2020AMR057149 reported for same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Pain in extremity, Rash, Sciatica
Clinical narrative: shingles; schedule for MRI to rule out sciatica; pain in the left thigh area/constant pain in the left leg; rash on the left thigh area; first dose of the Shingrix vaccine on 07/02/2019 and then the second dose on 2/27/2020; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 8 years after receiving Zostavax, had an episode of shingles on the left side of her body). Previously administered products included Zostavax (approximately 12 years before the date of reporting) and Shingrix (1st dose received on 2nd July 2019). Concurrent medical conditions included sjogren's.   On 27th February 2020, the patient received the 2nd dose of Shingrix. On 27th February 2020, unknown after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles, sciatica, leg pain and rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir), hydrocodone and steroids nos (Steroids). On an unknown date, the outcome of the shingles, sciatica, leg pain, rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles, sciatica, leg pain, rash and drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The patient received 2nd dose of Shingrix in the left arm later than recommended schedule, which led to lengthening of vaccination schedule.  Few days after vaccination, the patient was complaining of pain in the left thigh area and few days later noticed rash on the left thigh area and severe, constant pain in the left leg.  The patient was schedule for magnetic resonance imaging (MRI) to rule out sciatica. The patient was started on steroid dose pack, Hydrocodone and Valacyclovir.  Husband stating approximately 12 years ago wife received the Zostavax vaccine and about 8 years after receiving that vaccine, she had an episode of shingles on the left side of her body. The reporter consented to follow up. This case has been linked to US2020053225, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult female 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's sister in law. The age at vaccination was not reported. The patient received Shingrix and she did not feel well for a day after the shot.  No additional details were available. The reporter consented to follow up. This case has been linked to US2020053228 and US2020053230, reported by the same reporter.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Patient is seen in Occ. Health for adverse reation to her Varicella vaccine. She has a red area 4" round that is warm and itchy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 64-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis at a physician office. On an unspecified date in June 2015, the patient suffered shingles (herpes zoster). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 61-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 10-SEP-2013, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis. On an unspecified date in September 2013, the patient suffered shingles (herpes zoster). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Per patient presented with a low grade fever 3/26/20 of 99.1.  Temperature was taking with the highest temperature documented at 100.9.  Pt presented with no other symptoms other than elevated temperature.  After hospital visit patient was diagnosed with pneumonia.r
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: one hour after vaccine given pt broke out in hives, redness and puffiness to face.  parent given instruction to give Benadryl 2.5 ml now.  called parent 30 min after phone call,  hives had started to disappear
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: no adverse event- drew u p the diluent and did not put it into the HIB component.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site rash, Rash
Clinical narrative: moderate rash on injection arm which developed a few hours after injection. Happened each injection, but 2nd injection was much worse than initial. It wasnt bad enough for me to not want to get vaccinated again, but it was severe enough to go down my entire arm + couldn't lift arm.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling and tenderness at injection site that was expected initially, but took a few weeks to resolve. Large swelling and sharp pain in shoulder for 3 weeks after injection.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Joint swelling
Clinical narrative: Mild ache at site of injection; swelling at site of injection lasting about 3 days.  Redness, mild itching from just below the site of injection and extending downward over the lower deltoid muscle lasting 5 days.  No treatment required.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site reaction, Mass, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received flu-zone vaccine on 12/10/2019. Pt came in on 3/20/20 to complain about pain, swelling, numbness to her three fingers and a lump on her left shoulder. I have advised pt to contact her family doctor. Patient was contacted by rph, from store on 3/27/20. Per rph, pt told him that her pain is getting better. I contacted pt on 3/30/20 pt stated that she was hospitalized a week ago and her symptoms are getting better. I contacted patient's doctor, Dr on 3/30/20 and again on 3/31/20. Md's office manager contacted me on 3/31/20 at 5:27 PM told me that he has touched the patient's injection site and he told patient that the side effect will go away eventually. Md's office manager, contacted me on 3/31/20 at 5:27 and informed me that Md has discussed the side effects with the patient. He told patient that the side effects will eventually go away.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on torso front and back
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Bursal fluid accumulation, Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: On October 21, 2019 an influenza vaccination I received at the Drugs noted above, was not appropriately administered into my left deltoid muscle as intended. As a result I have a shoulder injury related to the misplaced injection (SIRVA). I remain in active treatment as of this date. Over my lifetime, I have received many types of vaccinations at various care facilities without concern or complication - including previously a this location. However, I believe this particular injection was not appropriately administered into my left deltoid muscle. The individual who gave me the influenza vaccination stood when administering my injection while I was seated in a chair. The actual injection of the needle in my arm caused immediate and significant pain - not the slight "prick" of pain normally experienced. I said, "Ow!" but thought nothing more of it until the morning of October 24, 2019, when I began to experienced severe pain and range of motion limitations to my left shoulder and arm. Since that time, the symptoms have been chronic and have negatively impacted my quality of life. Initially, I tried relieving pain with over-the-counter medications. When those did not provide relief I pursued medical attention - multiple visits with providers and multiple MRI's.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Magnetic resonance imaging abnormal, Magnetic resonance imaging spinal, Product administration error, Quality of life decreased, Shoulder injury related to vaccine administration
Clinical narrative: On October 21, 2019 an influenza vaccination I received at the Drugs noted above, was not appropriately administered into my left deltoid muscle as intended. As a result I have a shoulder injury related to the misplaced injection (SIRVA). I remain in active treatment as of this date. Over my lifetime, I have received many types of vaccinations at various care facilities without concern or complication - including previously a this location. However, I believe this particular injection was not appropriately administered into my left deltoid muscle. The individual who gave me the influenza vaccination stood when administering my injection while I was seated in a chair. The actual injection of the needle in my arm caused immediate and significant pain - not the slight "prick" of pain normally experienced. I said, "Ow!" but thought nothing more of it until the morning of October 24, 2019, when I began to experienced severe pain and range of motion limitations to my left shoulder and arm. Since that time, the symptoms have been chronic and have negatively impacted my quality of life. Initially, I tried relieving pain with over-the-counter medications. When those did not provide relief I pursued medical attention - multiple visits with providers and multiple MRI's.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: redness, swelling, Pt. did a follow up visit on 3/14/2020 and given Ibuprofen & advise to - to do cool compression.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: DIARRHOEA; VOMITING; NAUSEA; This spontaneous case report was extracted through VAERS database (785711-1) on 15-Feb-19. The case was reported by a consumer via health authority. The report describes a female consumer who had diarrhea, nausea, and vomiting following the intake of oral Vivotif (one dose every other day) (lot no: 3003215) for an unknown indication.  The consumer was allergic to amoxicillin.  The consumer's concomitant medications included Flonase (fluticasone) and Zyrtec (cetirizine and pseudoephedrine) for unknown indications. The consumer also taking Lillow (levonorgestre and ethinyl estradiol) as oral contraceptive.  It was reported that the consumer took the first dose of Vivotif on Monday (05-Nov-2018) and at 1 pm same day she experienced nausea and vomited one time and diarrhea two time between 3 to 5 pm. Next day there was no side effect. On Wednesday, the consumer took the second dose and again experienced nausea which resolved on Thursday. On Friday, she took the third dose and nausea began at noon and worsened throughout afternoon and she had diarrhea two times in early evening. Then on Saturday, she experienced diarrhea six plus times from late morning to early afternoon. On Sunday, she took the last dose and there were no side effects. On the days with side effects she ate only cheerios, noodle soup, saltines, bananas, and ginger ale.  The action taken with Vivotif with respect to the events diarrhea, nausea, and vomiting was dosage maintained.  The clinical outcome of the event diarrhea, nausea, and vomiting was resolved.  Company's Comment: In this case, it was reported that a female consumer had diarrhea, nausea, and vomiting following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, nausea, and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer had diarrhea, nausea, and vomiting following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, nausea, and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Vomiting
Clinical narrative: VOMITING; ABDOMINAL PAIN; WEAKNESS; STOMACH PAIN; This spontaneous case report was extracted through VAERS database (785960-1) on 15-Feb-2019. This case was reported by consumer via health authority. The report describes a 66-year-old female consumer who had vomiting, abdominal pain, stomach pain, and weakness following the intake of oral Vivotif (lot number: 3003215) for an unknown indication.  The consumer had no medical history and not taking any concomitant medication.  It was reported that the consumer took the first dose of Vivotif on 06-Nov-2018 and on the same day, she experienced severe abdominal pain which began 2 hours after ingestion, vomiting began 4 hours after ingestion. Vomiting persisted for several hours and stomach pain gradually subsided over 5 days. The consumer was on bed rest for two days following with stomach pain and weakness.  The action taken with Vivotif with respect to the events vomiting, abdominal pain, stomach pain, and weakness was dosage maintained.  The clinical outcome of the events vomiting, abdominal pain, stomach pain, and weakness was resolved.  Company's Comment: In this case, it was reported that a 66-year-old female consumer had vomiting, abdominal pain, stomach pain, and weakness following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, vomiting, abdominal pain, stomach pain, and weakness are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a 66-year-old female consumer had vomiting, abdominal pain, stomach pain, and weakness following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, vomiting, abdominal pain, stomach pain, and weakness are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: HEP, TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Fatigue, Headache
Clinical narrative: FATIGUE; HEADACHE; ABDOMINAL DISCOMFORT; STOMACH PAIN; VOMITING; LOOSE STOOLS; This spontaneous case (798713-1) was extracted through VAERS database on 26-Apr-2019. The case was reported by a consumer. It describes a 53-year-old female consumer who had fatigue, headache, abdominal discomfort, stomach pain, vomiting, and loose stools, after the administration of oral Vivotif (company suspect) (lot no: 3003220) for an unknown indication. She also received intramuscular Engerix-B (non-company suspect) (lot number: 2KJ42) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 24-Jan-2019 and Engerix-B. After 1 hour, she had a headache and abdominal discomfort. She took Tylenol (paracetamol) for it but got no relief. Approximately three hours later, she had a massive headache and severe stomach pain. In the late morning, she had vomiting and loose stools, which persist for hours. Next morning, she felt fatigued but condition was improved.   The consumer's past medical history included stomach bug (December 2018). She had no allergy.   The consumer had no concomitant medication.  The consumer had no laboratory tests.  Action taken with Vivotif was unknown.  The consumer had recovered from the events of fatigue, headache, abdominal discomfort, stomach pain, vomiting, and loose stools on 25-Jan-2019.  Company's Comment: In this case, the consumer experienced "sore throat", "headache", "influenza like symptoms", "high fever" and "body pain" following administration of Vivotif and intramuscular Engerix-B. There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides a plausible explanation for the reported events.; Sender's Comments: Company's Comment: In this case, the consumer experienced "sore throat", "headache", "influenza like symptoms", "high fever" and "body pain" following administration of Vivotif and intramuscular Engerix-B. There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides a plausible explanation for the reported events.
Sex: F
Vaccine: HEP, TYP
Symptoms: Vomiting
Clinical narrative: FATIGUE; HEADACHE; ABDOMINAL DISCOMFORT; STOMACH PAIN; VOMITING; LOOSE STOOLS; This spontaneous case (798713-1) was extracted through VAERS database on 26-Apr-2019. The case was reported by a consumer. It describes a 53-year-old female consumer who had fatigue, headache, abdominal discomfort, stomach pain, vomiting, and loose stools, after the administration of oral Vivotif (company suspect) (lot no: 3003220) for an unknown indication. She also received intramuscular Engerix-B (non-company suspect) (lot number: 2KJ42) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 24-Jan-2019 and Engerix-B. After 1 hour, she had a headache and abdominal discomfort. She took Tylenol (paracetamol) for it but got no relief. Approximately three hours later, she had a massive headache and severe stomach pain. In the late morning, she had vomiting and loose stools, which persist for hours. Next morning, she felt fatigued but condition was improved.   The consumer's past medical history included stomach bug (December 2018). She had no allergy.   The consumer had no concomitant medication.  The consumer had no laboratory tests.  Action taken with Vivotif was unknown.  The consumer had recovered from the events of fatigue, headache, abdominal discomfort, stomach pain, vomiting, and loose stools on 25-Jan-2019.  Company's Comment: In this case, the consumer experienced "sore throat", "headache", "influenza like symptoms", "high fever" and "body pain" following administration of Vivotif and intramuscular Engerix-B. There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides a plausible explanation for the reported events.; Sender's Comments: Company's Comment: In this case, the consumer experienced "sore throat", "headache", "influenza like symptoms", "high fever" and "body pain" following administration of Vivotif and intramuscular Engerix-B. There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides a plausible explanation for the reported events.