chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Skin lesion
Clinical narrative: About 2 hours after Hep B vaccine given in right thigh, this NP was called to examine rash on infant's right thigh.  Right anterior thigh appeared to have scattered flat erythematous macules.  Per infant's nurse, it was unclear if this rash/lesion was present prior to vaccine administration, but parents did not notice the rash prior to vaccine.  1% Hydrocortisone ordered to the affected area per recommendation of dermatology team.   Examined the following day and the area appeared unchanged.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Pruritus, Swelling
Clinical narrative: Patient's Left arm started hurting and was red beginning the next day 04202020 after the Shingrix shot was administered.The arm started itching the next day 04212020.The arm has continued to itch and has remained red.The patient will take a Benadryl to hopefully help with the itching and swelling.The patient will call her Doctor to tell her what has happened.I told the patient I will call her on Sunday to see how she is doing.I will follow up with her.Patient has reported no signs of fever but has a off and on headache which she believes is due to her sinuses.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pruritus, Injection site swelling, Listless
Clinical narrative: In January 2020 I received immunizations for shingles and flu at Pharmacy. Reactions to shots is that they were painful afterwards which that was expected.Follow up shingles shot in March 2020 was painful afterwards with swelling and itching at site, headache, tired, listlessness.Shortly, days afterwards I started feeling tingling in both hands. Most noticeable in the early morning on rising. As the day progresses the tingling abated more and more until slight by bedtime. This has occurred daily since the immunization on 3-16-2020. Less for a few days following the shot, then growing in intensity the next few days.Have put off reporting this mostly because of the Corona Virus alerts.At first I didnt know what may be the cause and have been trying to recall medical events that may have contributed to this condition.On researching the events and reviewing side effects of medications and procedures I think I have narrowed it down to the SINGRIX shingles immunizations.At this time it seems to be slightly lessening in its intensity as the days progress..I am going to be sending this information to the pharmacy, urologist, and drug manufacture.     SHINGRIX50MCG INJ(IM)SNGL DSE  1VL
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: In January 2020 I received immunizations for shingles and flu at Pharmacy. Reactions to shots is that they were painful afterwards which that was expected.Follow up shingles shot in March 2020 was painful afterwards with swelling and itching at site, headache, tired, listlessness.Shortly, days afterwards I started feeling tingling in both hands. Most noticeable in the early morning on rising. As the day progresses the tingling abated more and more until slight by bedtime. This has occurred daily since the immunization on 3-16-2020. Less for a few days following the shot, then growing in intensity the next few days.Have put off reporting this mostly because of the Corona Virus alerts.At first I didnt know what may be the cause and have been trying to recall medical events that may have contributed to this condition.On researching the events and reviewing side effects of medications and procedures I think I have narrowed it down to the SINGRIX shingles immunizations.At this time it seems to be slightly lessening in its intensity as the days progress..I am going to be sending this information to the pharmacy, urologist, and drug manufacture.     SHINGRIX50MCG INJ(IM)SNGL DSE  1VL
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Condition aggravated, Fatigue, Gastrointestinal disorder, Irritable bowel syndrome
Clinical narrative: Medicine for IBS was working wonderfully for three months. A few days later I descended again into having the worst IBS flare ups ( worse than pre-meds). I've had a myriad of gastrointestinal issues since along with extreme fatigue that developed days afterward.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab, Skin lesion
Clinical narrative: 9 months post-vaccination with MMR and VAR vaccines, patient developed vesicular rash limited in distribution to L4 dermatome on right side only. Clinically consistent with zoster. Spread in this distribution over 5 days, with initial lesions scabbed over at day 5. Patient was otherwise well at time of visit for rash. Interestingly, the rash did not seem to bother patient, though mom kept her in pants to keep her from being able to touch the rash. We do have photo documentation of rash, if would be helpful. No samples taken or labs done at this time, will be doing CBC in follow-up with delayed due to pandemic.
Age: 27.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Client was given his first dose of Hepatitis A and HPV on 11/05/2019. On 3/2/2020 Hepatitis A #2 and HPV #2 were given. Dose #2 of Hepatitis A was given too early and the ACIP minimum interval was not met. . Client was notified on 4/20/2020. No adverse reactions were reported from the client.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Lethargy, Myalgia
Clinical narrative: Muscle pains, chills, dizziness, lethargy, headache, nystagmus
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Nystagmus
Clinical narrative: Muscle pains, chills, dizziness, lethargy, headache, nystagmus
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large swelling and redness, approximately 2.5 x 4? in size, hot to the touch, states it?s painful
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain in extremity, Tinnitus
Clinical narrative: Shingrix Vaccine was administered in my left arm/shoulder at 10 am on 2/26/2020.  At 6:00pm that day my left ear started ringing. My ear is still ringing and has gotten worse the last 3 weeks. The pain in my left are went away after the vaccine but started hurting more 3 weeks ago. The pain has moved down to my forearm at times. There have been muscle spasms at times also. I did not have any of these issues prior to the vaccine. I regret getting this vaccine. I would rather have Shingles right now than have taken the vaccine. Todays date is 2 months later. 4/26/2020
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever Nausea  Three days
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Fatigue, Malaise, Pain in extremity
Clinical narrative: PRESENTING WITH A FEVER.  HAD SHINGRIX IMMUNIZATION ON Friday./  ARM SWELLING, ERYTHEMA, PAIN, TENDERNESS.  HAD SYSTEMIC SYMPTOMS OF FEVERS, FATIGUE, DIZZINESS, AND MALAISE.    NO COUGH, CHANGE IN BOWEL OR BLADDER HABITS. NO HEADACHE.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: PRESENTING WITH A FEVER.  HAD SHINGRIX IMMUNIZATION ON Friday./  ARM SWELLING, ERYTHEMA, PAIN, TENDERNESS.  HAD SYSTEMIC SYMPTOMS OF FEVERS, FATIGUE, DIZZINESS, AND MALAISE.    NO COUGH, CHANGE IN BOWEL OR BLADDER HABITS. NO HEADACHE.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: 100.7 FEVER DAY AFTER SHINGRIX. DEVELOPED LEFT SIDED NECK PAIN DAY AFTER THAT. NO HEADACHE.   NO COUGH, WHEEZE, OR ANGIOEDEMA.    Sore muscles left shoulder and neck have persisted.   No weakness, rash, or numbness.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Joint range of motion decreased, Paraesthesia
Clinical narrative: Left shoulder pain, limited range of motion, and paresthesia to posterior shoulder starting the day of injection. Worse at night and upon waking this next morning. Symptoms have improved since onset.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red, swollen, hot to touch, diameter of reaction was over 3 inches
Age: 4.0
Sex: F
Vaccine: FLUA3
Symptoms: Allergy to metals, Allergy to vaccine, Anaphylactic reaction
Clinical narrative: Anaphylaxis  Went to er with o2 level In Low 80
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram, Electroencephalogram, Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: I was unable to function for 4 days. Puked for the first days.
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: I was unable to function for 4 days. Puked for the first days.
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Myalgia, Rash
Clinical narrative: MUSCLE ACHE; RASH; This spontaneous case report was extracted through VAERS database (787033-1) on 15-Feb-2019. The case was reported by a consumer via health authority. The report describes a 42-year-old male consumer who experienced muscle ache and had rash following the intake of oral Vivotif (company suspect), Havrix (Hepatitis A) and Stamaril (yellow fever vaccine) (non-company suspects) for unknown indications.  The consumer had a history of psoriasis and his concurrent medical condition included bronchitis.  It was reported that the consumer took the first dose of Vivotif on 09-Nov-2018. On 13-Nov-2018, he experienced muscle aches and developed rash on arms, chest, torso, and back. The consumer also took Havrix and Stamaril on an unknown date.  The action taken with Vivotif with respect to the events muscle ache and rash was dosage maintained.  The action taken with Havrix and Stamaril with respect to the events muscle ache and rash was unknown.  The clinical outcome of the events muscle ache and rash was not resolved.  Company's Comment: In this case a 42-year-old male consumer experienced muscle ache and had rash following the intake of oral Vivotif (company suspect), Havrix (Hepatitis A) and Stamaril (yellow fever vaccine) (non-company suspects).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 a 42-year-old male consumer experienced muscle ache and had rash following the intake of oral Vivotif (company suspect), Havrix (Hepatitis A) and Stamaril (yellow fever vaccine) (non-company suspects).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: M
Vaccine: TYP
Symptoms: Arthralgia, Chills, Malaise, Muscle spasms, Nausea
Clinical narrative: MUSCLE SPASMS; JOINT PAIN; CHILLS; MALAISE; SEVERE NAUSEA; VOMITING; This spontaneous case (793970-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by consumer via health authority. It describes a 72-year-old male consumer who experienced severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm while being on oral Vivotif (lot no: 3003239) for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 26-Dec-2018. On 27-Dec-2018, she experienced severe nausea, vomiting (three times), and joint pain. After taking the third dose, he experienced chills with muscle spasm, and malaise.  The consumer's medical history included hypertension and restless leg syndrome. He also had allergy from finned fish.  Concomitant medication at the time of events included lisinopril, pramapexol, ropinerol, tramadol, zolpidem, Vitamin C (ascorbic acid), Preservision (multivitamin), and aspirin for an unknown indication.  Action taken with Vivotif was dosage maintained   The clinical outcome of the events severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm while was not resolved.   Company's Comment: In this case, it was reported that a 72-year-old male consumer experienced severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm following intake of oral Vivotif vaccine. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events is assessed as possible to vivotif. However, the event is confounded by consumer's past medical history and intake of multiple concomitant medications.; Sender's Comments: Company's Comment: In this case, it was reported that a 72-year-old male consumer experienced severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm following intake of oral Vivotif vaccine. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events is assessed as possible to vivotif. However, the event is confounded by consumer's past medical history and intake of multiple concomitant medications.
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: MUSCLE SPASMS; JOINT PAIN; CHILLS; MALAISE; SEVERE NAUSEA; VOMITING; This spontaneous case (793970-1) was extracted through VAERS database on 29-Mar-2019. The case was reported by consumer via health authority. It describes a 72-year-old male consumer who experienced severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm while being on oral Vivotif (lot no: 3003239) for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 26-Dec-2018. On 27-Dec-2018, she experienced severe nausea, vomiting (three times), and joint pain. After taking the third dose, he experienced chills with muscle spasm, and malaise.  The consumer's medical history included hypertension and restless leg syndrome. He also had allergy from finned fish.  Concomitant medication at the time of events included lisinopril, pramapexol, ropinerol, tramadol, zolpidem, Vitamin C (ascorbic acid), Preservision (multivitamin), and aspirin for an unknown indication.  Action taken with Vivotif was dosage maintained   The clinical outcome of the events severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm while was not resolved.   Company's Comment: In this case, it was reported that a 72-year-old male consumer experienced severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm following intake of oral Vivotif vaccine. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events is assessed as possible to vivotif. However, the event is confounded by consumer's past medical history and intake of multiple concomitant medications.; Sender's Comments: Company's Comment: In this case, it was reported that a 72-year-old male consumer experienced severe nausea, vomiting, joint pain, malaise, chills, and muscle spasm following intake of oral Vivotif vaccine. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events is assessed as possible to vivotif. However, the event is confounded by consumer's past medical history and intake of multiple concomitant medications.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Myalgia
Clinical narrative: ABDOMINAL CRAMPING; UPSET STOMACH; SEVERE MUSCLE ACHE ACROSS THE SHOULDER AND NECK AREA; This spontaneous case (795340-1) was extracted through VAERS database on 26-Apr-2019. The case was reported by a consumer. It describes a 34-year-old female consumer who had severe muscle ache across the shoulder and neck area, upset stomach, and abdominal cramping, after the administration of oral Vivotif (lot number: 3003237) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 02-Jan-2019. She experienced severe muscle ache across the shoulder and neck area. After the dose, events got worsened for 24 hours and then improved till the next dose. On day 3, she experienced upset stomach and abdominal cramping for 48 hours.  The consumer's past medical history included injection site reaction, mostly in upper arm area which caused in 2005, when she took Yellow Fever shot. Other medical history included migraine headaches and depression. She was allergic to amoxicillin, dairy product, and eggs.  Concomitant medication at the time of events included fluoxetine, topiramate, loratadine, and Vitamin D for unknown indications.  Action taken with Vivotif was dosage maintained.  The consumer had recovered from the events of severe muscle ache across the shoulder and neck area, upset stomach, and abdominal cramping.  Company's Comment: In this case, it was reported that the consumer had severe muscle ache across the shoulder and neck area, upset stomach, and abdominal cramping, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. 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 the consumer had severe muscle ache across the shoulder and neck area, upset stomach, and abdominal cramping, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: LOSS OF APPETITE; NAUSEA; STOMACH PAIN; DIARRHEA; This spontaneous case (799750-1) was extracted through VAERS database on 24-May-2019. It describes a 30-year-old female consumer who had nausea, stomach pain, diarrhea, and loss of appetite, after the administration of oral Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 26-Jan-2019, and after a few hours, she had nausea, stomach pain, diarrhea, and loss of appetite. All the events were continued for the entire dosing period.   Action taken with Vivotif was dosage maintained.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer had nausea, stomach pain, diarrhea, and loss of appetite after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, stomach pain, diarrhea, and loss of appetite 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 the consumer had nausea, stomach pain, diarrhea, and loss of appetite after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, stomach pain, diarrhea, and loss of appetite are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Hypersomnia
Clinical narrative: LIGHT DIARRHEA; CHILLS; STOMACH PAIN; HEADACHE; NAUSEA; SLEEP ALL OF THE DAY; This spontaneous case report (804889-1) was extracted through VAERS database on 21-Jun-2019. The case was reported by a consumer. It describes a 34-year-old male consumer who experienced chills, nausea, stomach pain, headaches, light diarrhea, and sleep all of the day, after the administration of oral Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif and had light diarrhea. Then, he took the second dose on 04-Mar-2019 and on 05-Mar-2019, he experienced chills, nausea, stomach pain, and headaches. He also reported that he had to sleep all day after taking the second dose of Vivotif.   Action taken with Vivotif with respect to the light diarrhea was dosage maintained while with respect to the events chills, nausea, stomach pain, headaches and sleep all of the day was unknown.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a 34-year-old male consumer experienced chills, nausea, stomach pain, headaches, light diarrhea, and sleep all day, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, chills, nausea, stomach pain, headaches, and diarrhea 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 34-year-old male consumer experienced chills, nausea, stomach pain, headaches, light diarrhea, and sleep all day, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, chills, nausea, stomach pain, headaches, and diarrhea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: LIGHT DIARRHEA; CHILLS; STOMACH PAIN; HEADACHE; NAUSEA; SLEEP ALL OF THE DAY; This spontaneous case report (804889-1) was extracted through VAERS database on 21-Jun-2019. The case was reported by a consumer. It describes a 34-year-old male consumer who experienced chills, nausea, stomach pain, headaches, light diarrhea, and sleep all of the day, after the administration of oral Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif and had light diarrhea. Then, he took the second dose on 04-Mar-2019 and on 05-Mar-2019, he experienced chills, nausea, stomach pain, and headaches. He also reported that he had to sleep all day after taking the second dose of Vivotif.   Action taken with Vivotif with respect to the light diarrhea was dosage maintained while with respect to the events chills, nausea, stomach pain, headaches and sleep all of the day was unknown.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a 34-year-old male consumer experienced chills, nausea, stomach pain, headaches, light diarrhea, and sleep all day, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, chills, nausea, stomach pain, headaches, and diarrhea 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 34-year-old male consumer experienced chills, nausea, stomach pain, headaches, light diarrhea, and sleep all day, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, chills, nausea, stomach pain, headaches, and diarrhea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Fatigue, Nausea, Somnolence
Clinical narrative: SLEPT FOR 5 HOURS ON AND OFF WITH ABDOMINAL PAIN; ABRUPT ONSET OF FATIGUE; ABDOMINAL PAIN WITH PAINFUL CRAMPING; TRANSIENT EPISODES OF NAUSEA; This spontaneous case report (804931-1) was extracted through VAERS database on 21-Jun-2019. The case was reported by a consumer. It describes a 62-year-old female consumer who experienced abdominal pain with painful cramping, transient episodes of nausea, abrupt onset of fatigue, and slept for 5 hours on and off with abdominal pain, after the administration of oral Vivotif (lot number: 3003241) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 09-Mar-2019. Ten hours later on 10-Mar-2019, she had continuous abdominal pain with painful cramping. 4 to 5 out of 10 on a pain scale, along with transient episodes of nausea, abrupt onset of fatigue, and slept for 5 hours (after good night's sleep) on and off with abdominal pain the entire time.  The consumer was lactose intolerant.  The consumer had sore throat with cough 2 weeks earlier.  Concomitant medication included lisinopril, calcium, Vitamin C (ascorbic acid), magnesium, Vitamin D (ergocalciferol), senior women's multiple vitamin, senior probiotic and fish oil (eicosapentaenoic acid and docosahexaenoic acid).  Action taken with Vivotif was unknown.  The consumer had recovered from the events on 10-Mar-2019.  Company's Comment: In this case, it was reported that a female consumer who experienced abdominal pain with painful cramping, transient episodes of nausea, abrupt onset of fatigue, and slept for 5 hours on and off with abdominal pain, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, abdominal pain, nausea and fatigue 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 who experienced abdominal pain with painful cramping, transient episodes of nausea, abrupt onset of fatigue, and slept for 5 hours on and off with abdominal pain, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, abdominal pain, nausea and fatigue are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Muscle spasms, Nausea, Vomiting
Clinical narrative: CRAMPS; NAUSEA; SEVERAL HOURS OF STOMACH ACHE; VOMITING; This spontaneous case report (828589-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. It described a 20-year-old female consumer who had cramps (PT: Muscle spasms), several hours of stomach ache (PT: Abdominal pain upper), nausea (PT: Nausea), and vomiting (PT: Vomiting), after receiving of oral Vivotif for an unknown indication.  Case report: The consumer completed the course of Vivotif from 25-Jul-2019 to 31-Jul-2019. On 05-Aug-2019, the consumer vomited once and felt better afterwards. On 10-Aug-2019, she experienced several hours of stomachache, nausea and cramps and vomited again on 11-Aug-2019 followed by several hours of stomachache.  Consumer's concomitant medications included oral contraceptives.   Action taken with Vivotif with respect to reported events was not applicable.  The consumer had recovered from the reported events.  Company Comment: A consumer completed four dose of Vivotif and after a few days had cramps (muscle spasms), abdominal pain upper, nausea and vomiting. All of the events were resolved without any treatment. Considering the case information and the potential of Vivotif to cause abdominal pain, nausea and vomiting, the causality of all the reported events is assessed as possible with Vivotif. The event (Muscle spasms) is unlisted as per CCDS.; Sender's Comments: A consumer completed four dose of Vivotif and after a few days had cramps (muscle spasms), abdominal pain upper, nausea and vomiting. All of the events were resolved without any treatment. Considering the case information and the potential of Vivotif to cause abdominal pain, nausea and vomiting, the causality of all the reported events is assessed as possible with Vivotif. The event (Muscle spasms) is unlisted as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Balance disorder, Diarrhoea, Dizziness, Dysstasia, Mobility decreased
Clinical narrative: UNABLE TO STAND OR MOVE WITHOUT ASSISTANCE; UNABLE TO STAND OR MOVE WITHOUT ASSISTANCE; EXTREME VERTIGO; DIZZINESS; DIARRHEA; LINGERING BALANCE ISSUES/ DISEQUILIBRIUM; This spontaneous case report (831469-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. The report described a 50-year-old female consumer who had lingering balance issues/ disequilibrium (PT: Balance disorder), dizziness (PT: Dizziness), diarrhea (PT: Diarrhoea), unable to stand or move without assistance (PT: Dysstasia and Gait disturbance) and extreme vertigo (PT: Vertigo), while being on oral Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 05-Aug-2019. On the same day, she had disequilibrium and on 06-Aug-2019, she was unable to stand or move without assistance due to extreme dizziness. She also had diarrhea. Moreover, she experienced extreme vertigo which was lasted for a full day. It was reported that she had lingering balance issues for about a week.  Action taken with Vivotif with respect to the reported events was unknown.  The consumer had recovered from the reported events.  Company Comment: A consumer took the first dose of Vivotif and then developed disequilibrium in the late evening with lingering balance issues (balance disorder), along with dizziness, diarrhea, vertigo, dysstasia, and gait disturbance. All of the events were resolved. Considering the consumer experienced the events after taking Vivotif, and potential of Vivotif to cause dizziness and diarrhea, the role of Vivotif cannot be ruled out, and the causality of all of the events is assessed as possible with Vivotif.; Sender's Comments: A consumer took the first dose of Vivotif and then developed disequilibrium in the late evening with lingering balance issues (balance disorder), along with dizziness, diarrhea, vertigo, dysstasia, and gait disturbance. All of the events were resolved. Considering the consumer experienced the events after taking Vivotif, and potential of Vivotif to cause dizziness and diarrhea, the role of Vivotif cannot be ruled out, and the causality of all of the events is assessed as possible with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Vertigo
Clinical narrative: UNABLE TO STAND OR MOVE WITHOUT ASSISTANCE; UNABLE TO STAND OR MOVE WITHOUT ASSISTANCE; EXTREME VERTIGO; DIZZINESS; DIARRHEA; LINGERING BALANCE ISSUES/ DISEQUILIBRIUM; This spontaneous case report (831469-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. The report described a 50-year-old female consumer who had lingering balance issues/ disequilibrium (PT: Balance disorder), dizziness (PT: Dizziness), diarrhea (PT: Diarrhoea), unable to stand or move without assistance (PT: Dysstasia and Gait disturbance) and extreme vertigo (PT: Vertigo), while being on oral Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 05-Aug-2019. On the same day, she had disequilibrium and on 06-Aug-2019, she was unable to stand or move without assistance due to extreme dizziness. She also had diarrhea. Moreover, she experienced extreme vertigo which was lasted for a full day. It was reported that she had lingering balance issues for about a week.  Action taken with Vivotif with respect to the reported events was unknown.  The consumer had recovered from the reported events.  Company Comment: A consumer took the first dose of Vivotif and then developed disequilibrium in the late evening with lingering balance issues (balance disorder), along with dizziness, diarrhea, vertigo, dysstasia, and gait disturbance. All of the events were resolved. Considering the consumer experienced the events after taking Vivotif, and potential of Vivotif to cause dizziness and diarrhea, the role of Vivotif cannot be ruled out, and the causality of all of the events is assessed as possible with Vivotif.; Sender's Comments: A consumer took the first dose of Vivotif and then developed disequilibrium in the late evening with lingering balance issues (balance disorder), along with dizziness, diarrhea, vertigo, dysstasia, and gait disturbance. All of the events were resolved. Considering the consumer experienced the events after taking Vivotif, and potential of Vivotif to cause dizziness and diarrhea, the role of Vivotif cannot be ruled out, and the causality of all of the events is assessed as possible with Vivotif.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Diplopia
Clinical narrative: 2/2/20 low grade fever, malaise, slight headache chills, very sore upper (Lt) arm redness, swelling 2/14 DOUBLE VISION 2/15 Imbalance
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Cough, Diplopia, Headache, Injection site pain
Clinical narrative: 2/2/20 low grade fever, malaise, slight headache chills, very sore upper (Lt) arm redness, swelling 2/14 DOUBLE VISION 2/15 Imbalance
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test abnormal, Malaise, Nephropathy, Optic nerve injury, Pain in extremity
Clinical narrative: 2/2/20 low grade fever, malaise, slight headache chills, very sore upper (Lt) arm redness, swelling 2/14 DOUBLE VISION 2/15 Imbalance
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Productive cough, Pyrexia
Clinical narrative: 2/2/20 low grade fever, malaise, slight headache chills, very sore upper (Lt) arm redness, swelling 2/14 DOUBLE VISION 2/15 Imbalance
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Chills, Diplopia, Headache, Injection site erythema
Clinical narrative: 2/2/20 low grade fever, malaise, slight headache chills, very sore upper (Lt) arm redness, swelling 2/14 DOUBLE VISION 2/15 Imbalance
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Laboratory test, Magnetic resonance imaging normal, Malaise
Clinical narrative: 2/2/20 low grade fever, malaise, slight headache chills, very sore upper (Lt) arm redness, swelling 2/14 DOUBLE VISION 2/15 Imbalance
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: 2/2/20 low grade fever, malaise, slight headache chills, very sore upper (Lt) arm redness, swelling 2/14 DOUBLE VISION 2/15 Imbalance
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia, Somnolence
Clinical narrative: soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old 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, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced injection site pain after 1st dose of Shingrix. This case has been linked with case US2020AMR039090, reported for same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old 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, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced injection site pain after 1st dose of Shingrix. This case has been linked with case US2020AMR039090, reported for same reporter.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling,  redness,  pain
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEP, HIBV, MMRV
Symptoms: Mental disorder
Clinical narrative: Mental disorder
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 days old patient was administered; This spontaneous report as received from a physician refers to a 2-day-old neonate patient.     The patient's medical history, current condition, drug reactions/allergies and concomitant medications were not reported On 23-APR-2020, an unspecified 2 days old patient was administered the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot#S017631, expiry date: 08-DEC-2020, strength, dosage information were not reported) for prophylaxis (product administered to patient of inappropriate age). The outcome of product administered to patient of inappropriate age was unknown. No additional AE information. No further information provided. No product quality complaint (PQC).
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON DAY 9; This spontaneous case report was received from a pharmacist (PVX2019-002) on 02-Jan-2019. The report describes a 27-year-old adult male consumer who "took third dose on day 9". The consumer was receiving oral Vivotif capsule (every other day) for typhoid prevention.  It was reported that the consumer took two doses of Vivotif and then forgot to take it for 5 days and then took the remaining two doses. The doses were taken on 20-Dec-2018, 22-Dec-2018, 28-Dec-2018, and 30-Dec-2018, respectively.  The action taken with Vivotif with respect to the event "took third dose on day 9" was not applicable.  The clinical outcome of the event "took third dose on day 9" was unknown.  Company's Comment: The causality of the event "took third dose on day 9" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 9" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT COMPLETE VIVOTIF ONE WEEK PRIOR TO TRAVEL; This spontaneous case report was received from a pharmacist (PVX2019-009) on 02-Jan-2019 and a follow-up was received on 04-Jan-2019. The report describes an adult female consumer who "did not complete Vivotif one week prior to travel". The consumer was receiving Vivotif (one dose every other day) for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 02-Jan-2019 and left to travel on Thursday (03-Jan-2019).   The action taken with Vivotif with respect to the event "did not complete Vivotif one week prior to travel" was not applicable.  The clinical outcome of the event "did not complete Vivotif one week prior to travel" was unknown.  Company's Comment: The causality of the event "did not complete Vivotif one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete Vivotif one week prior to travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED A DOSE; This spontaneous case report was received from a pharmacist (PVX2019-022) on 03-Jan-2019. The report describes a 32-year-old adult male consumer who "missed a dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on Saturday (29-Dec-2018) and forgot to take the second dose which was due on Monday (31-Dec-2018). The pharmacist stated he advised the consumer to take the next dose on Wednesday, 02-Jan-2019, and continue every other day to finish the course.  The action taken with Vivotif with respect to the event "missed a dose" was not applicable.  The clinical outcome of the event "missed a dose" was unknown.  Company's Comment: The causality of the event "missed a dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report was received from a pharmacist (PVX2019-024) on 03-Jan-2019. The report describes a 50-year-old female consumer who "took unrefrigerated Vivotif". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the unrefrigerated doses of Vivotif but not sure how many doses she took.  The action taken with Vivotif with respect to the event "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the event "took unrefrigerated Vivotif" was unknown.  Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT TAKE THE VERY LAST DOSE; This spontaneous case report was received from a nurse (PVX2019-116) on 14-Jan-2019. The report describes a female consumer who "did not take the very last dose". The consumer was receiving oral typhoid for a foreign trip.   It was reported that the oral typhoid vaccine in the past (Jan 2018) for a trip, but she forgot to take the very last dose.   The action taken with oral typhoid vaccine with respect to the event "did not take the very last dose" was not applicable.  The clinical outcome of the event "did not take the very last dose" was unknown.  Company's Comment: The causality of the event "did not take the very last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the very last dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain upper, Back pain, Diarrhoea, Dizziness
Clinical narrative: DIZZINESS; STOMACH BLOATING; EXTREME MUSCLE PAIN IN HIS NECK AND BACK; FEVER; NAUSEA; STOMACH PAIN; DIARRHEA; This spontaneous case (PVX2019-750) was received from a consumer on 28-Mar-2019. It describes a 42-year-old adult male consumer (height: 72 inches/ 182 cm and weight: 210 pounds/ 95 kg) who experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea, while receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took Vivotif doses on 18-Mar-2019, 20-Mar-2019, 22-Mar-2019, and 24-Mar-2019, respectively. On 25-Mar-2019, he had a fever (about 100 degree Fahrenheit), nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea for 4 days. He did not receive any treatment for nausea, stomach bloating, dizziness, stomach pain, and diarrhea. The muscle pain was mostly in his neck and back, which got worse at the time of this report. He took Tylenol (paracetamol) and oral Advil (ibuprofen) one tablet every 6 hours from 25-Mar-2019 for fever and muscle pain. He also stated that out the events stomach bloating, dizziness, and stomach pain were the worst symptoms.  The consumer had no medical history or allergy. He smoked half pack per day and consumed about four drinks per week.  Concomitant medication at the time of the events included Zyrtec (cetirizine) (once daily for last few months). He was taken regular strength of Tylenol (paracetamol or acetaminophen) and oral Advil (ibuprofen) in every 6 hours on 25-Mar-2019 for fever and muscle pain.  Action taken with Vivotif was not applicable.   The consumer had recovered from the fever on 26-Mar-2019 but did not recover from nausea, stomach bloating, dizziness, stomach pain, diarrhea, and extreme muscle pain in his neck and back.  Company's Comment: In this case, it was reported that a 42-year-old adult male consumer experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea 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 42-year-old adult male consumer experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: DIZZINESS; STOMACH BLOATING; EXTREME MUSCLE PAIN IN HIS NECK AND BACK; FEVER; NAUSEA; STOMACH PAIN; DIARRHEA; This spontaneous case (PVX2019-750) was received from a consumer on 28-Mar-2019. It describes a 42-year-old adult male consumer (height: 72 inches/ 182 cm and weight: 210 pounds/ 95 kg) who experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea, while receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took Vivotif doses on 18-Mar-2019, 20-Mar-2019, 22-Mar-2019, and 24-Mar-2019, respectively. On 25-Mar-2019, he had a fever (about 100 degree Fahrenheit), nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea for 4 days. He did not receive any treatment for nausea, stomach bloating, dizziness, stomach pain, and diarrhea. The muscle pain was mostly in his neck and back, which got worse at the time of this report. He took Tylenol (paracetamol) and oral Advil (ibuprofen) one tablet every 6 hours from 25-Mar-2019 for fever and muscle pain. He also stated that out the events stomach bloating, dizziness, and stomach pain were the worst symptoms.  The consumer had no medical history or allergy. He smoked half pack per day and consumed about four drinks per week.  Concomitant medication at the time of the events included Zyrtec (cetirizine) (once daily for last few months). He was taken regular strength of Tylenol (paracetamol or acetaminophen) and oral Advil (ibuprofen) in every 6 hours on 25-Mar-2019 for fever and muscle pain.  Action taken with Vivotif was not applicable.   The consumer had recovered from the fever on 26-Mar-2019 but did not recover from nausea, stomach bloating, dizziness, stomach pain, diarrhea, and extreme muscle pain in his neck and back.  Company's Comment: In this case, it was reported that a 42-year-old adult male consumer experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea 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 42-year-old adult male consumer experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.