chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling, Rash macular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of red blotches in a female patient who received SHINGRIX (batch number 45539 ?, expiry date 20th January 2020). On 18th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th February 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling. On 20th February 2018, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was unchanged and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the red blotches to be related to SHINGRIX. The reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The Pharmacy intern reported that a patient received SHINGRIX last week. The patient came in today with flat red blotches about the size of a dime down both arms. The patient stated the spots started about 2-3 days after getting the vaccine. The health care professional did speak with an individual earlier, who filled initial adverse event. This report just supplements his report, as had a discussion with the health care professional as well. Some of this information may be repetitive, as initially unaware that it had already been collected.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reports shingles outbreak and supposedly confirmed by patient's physician that it is shingles.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed case of the shingles.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: 7cm localized reaction erythema, warmth, and swelling starting on 3/14/18, treated with cephalexin, ZYRTEC, and ice on 3/15/18.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Ataxia, Demyelination, Exposure during pregnancy, Hypoaesthesia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 23 year old young lady, 20 weeks pregnant, who presented with symptoms 2 weeks after her flu vaccination. Symptoms include numbness/tingling on right from armpit down the right side of her body, ataxia, She gradually after that developed what she describes as block of blue discoloration in her central vision in left eye, decreased vision (20/200) in L eye first, which then also occurred in her R eye this occurred approximately within the past 3 weeks. MRI is showing patterns and distribution most concerning of MS with active demyelination. Based on Neurology consult, they feel it could be related to the flu vaccination she had on January 5.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Visual field defect, Visual impairment
Clinical narrative: 23 year old young lady, 20 weeks pregnant, who presented with symptoms 2 weeks after her flu vaccination. Symptoms include numbness/tingling on right from armpit down the right side of her body, ataxia, She gradually after that developed what she describes as block of blue discoloration in her central vision in left eye, decreased vision (20/200) in L eye first, which then also occurred in her R eye this occurred approximately within the past 3 weeks. MRI is showing patterns and distribution most concerning of MS with active demyelination. Based on Neurology consult, they feel it could be related to the flu vaccination she had on January 5.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a male patient who received SHINGRIX. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On 6th March 2018, 40 min after receiving SHINGRIX, the patient experienced myalgia, fever, tiredness, sleeplessness and general body pain. On an unknown date the outcome of the myalgia, fever, tiredness, sleeplessness and general body pain were unknown. It was unknown if the reporter considered the myalgia, fever, tiredness, sleeplessness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient complained of myalgia and stated his body hurt all over, including his hair. He also said he had a fever and was extremely tired but also not sleeping. No further information was provided.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concurrent medical conditions included irritable bowel syndrome and hyperlipidemia. Concomitant products included CYMBALTA, IMITREX, VALIUM, vitamin D, CELEXA, AMBIEN, LINZESS, PERCOCET, VAGIFEM and VICODIN. On 30th January 2018, the patient received SHINGRIX (intramuscular). On 1st February 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unchanged. The reporter considered the shingles to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient required emergency room visit. The patient received SHINGRIX vaccine on left arm. Shingles occurred 2 days after the SHINGRIX was administered. At the time of reporting the patient again had shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. GlaxoSmithKline representative was notified that a patient experienced a reaction after receiving the SHINGRIX vaccine. No additional details were available.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Urticaria
Clinical narrative: C/O hives both arms, face and inner wrist (B/L). Hives are intermittent.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given PROQUAD instead of regular MMR. The patient did not have any adverse reactions.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a currently 87-year old female patient. On an unknown date in 1941 (also reported as when the patient was 11-years-old) she had an allergic reaction to an unspecified sulfa medication which caused her face to swell. On an unknown date in 2004 or 2005, the patient was participated in a clinical trial (There isn't enough information in the case details to determine the clinical trial referenced by the patient/subject) and vaccinated with ZOSTAVAX 19400 PFU for preventing shingles (unknown lot and expiry date). Other suspect therapies included sterile diluent (MRK INJ). On an unknown date after 2005 but before 2010, the patient had an outbreak of shingles. The painful rash started on the left side of her back between her waist up to and above her shoulder blade. The size of the rash was 8 inches by 11.5 inches the same size as typing paper. The patient sought medical treatment from her doctor, 5 days after the rash appeared. The doctor performed an unspecified blood test and treated her with prescription pain medication consisting of ADVIL and codeine with little relief. The patient reported that she walked around her apartment topless because she was not able to wear clothes that would cover the rash during the total recovery period which was "5 weeks". No further clarifying information provided. The outcome of herpes zoster was reported as recovered. Causality assessment was not provided. No PQC was involved.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Patient here for OV to update Immunizations and discuss B/P. Patient was ordered a PNEUMOVAX per Provider. Pt is autoimmune and it was advised she received another PNEUMOVAX 3 mos after 1st one.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Localized reaction to right deltoid 11 x7 cm erthema, induration, warmth.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Skin lesion, Swelling, Tenderness, Vaccination site reaction
Clinical narrative: Call to patient after receiving my chart message with picture included or round raised lesion and blistering at site of vaccination. Reports swelling started Tuesday evening after vaccination was given. The area is tender to the touch but not painful without touching it. She does not feel it has increased in size since Wednesday evening. Denies: facial swelling, breathing issues, drainage of the blisters, fever, hives over body, illness in the past month. Reviewed VAERS form data.  Patient is not taking any prescription medications, herbal or vitamin supplements.  She took some otc tylenol yesterday. No known allergy to egg or medications. No chronic health conditions.  No recent illness in the past month.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site vesicles
Clinical narrative: Call to patient after receiving my chart message with picture included or round raised lesion and blistering at site of vaccination. Reports swelling started Tuesday evening after vaccination was given. The area is tender to the touch but not painful without touching it. She does not feel it has increased in size since Wednesday evening. Denies: facial swelling, breathing issues, drainage of the blisters, fever, hives over body, illness in the past month. Reviewed VAERS form data.  Patient is not taking any prescription medications, herbal or vitamin supplements.  She took some otc tylenol yesterday. No known allergy to egg or medications. No chronic health conditions.  No recent illness in the past month.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Adverse event
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2018-03-13.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Paralysis, Peripheral swelling
Clinical narrative: ARM SWELLING TRAVELED BELOW THE ELBOW AND MUSCLE PARALYSIS WITH TEMPERATURE OF 99.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Paralysis, Peripheral swelling
Clinical narrative: ARM SWELLIN TRAVELED BELOW THE ELBOW AND MUSCLE PARALYSIS WITH TEMP OF 99.
Age: 8.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-03-08.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Localized swelling and bumps on bilateral thighs.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2018-03-07.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Axillary pain, Body temperature increased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Temp up to 100 on 3/14. That night developed right upper arm pain and swelling. Pain extended to right axilla. Symptoms worsened the following morning. Also has some warmth in right upper arm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Full body joint pain.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Cervix carcinoma, Colposcopy, Maternal exposure before pregnancy, Uterine dilation and curettage
Clinical narrative: This spontaneous retrospective pregnancy report was received from a 25 year old female patient, who was medical assistant and reporting on herself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2008, the patient was vaccinated with 3 doses of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported. On an unknown date in 2010, (reported as at age 17), the patient delivered a baby (details unknown) (captured in MARRS# 1803USA006531). On an unknown date in October 2017, the patient was diagnosed with cervical cancer with strain HPV (human papillomavirus )-16. On an unknown date (reported as recently), the patient experienced a miscarriage. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. On unspecified dates, the patient had colposcopy and dilation and curettage (D&C) as a treatment. Unspecified lab diagnostics and studies were performed. The significant disability or incapacity was reported and not specified. The outcome of the events was unknown (reported also as "Not"). The causality assessment was not provided. Upon internal review, the events of cervical cancer and miscarriage were considered to be medically significant.; Sender's Comments: US-009507513-1803USA006531 :
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a 15 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in December 2017, reporrted as "at the 12 month old visit", the patient was vaccinated with PROQUAD (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On 08-MAR-2018, reported as "at the 15 month old visit", the patient was vaccinated againg in error with PROQUAD lot number N019250 with expiration date on 20-DEC-2018 for prophylaxi (dose, route of administration and anatomical location were not reported). On the same date, the patient also was vaccinated with an unspecified GSK Hepatitis A vaccine. There was no adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-MAR-2018, the patient was vaccinated with an expired dose of VAQTA (lot number M039202 with expiration date on 11-MAR-2018) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effect were reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Pt. requested Shingles vaccine at time of visit and wrote on history form that she had never received it. When Dr. went to document exam notes she saw Immunization Record showing Shingles had been given in 2015. Pt. developed rash on trunk 10 days after vaccine. Rash symmetrical but limited to trunk. Itches, no blisters, no pain, no burning, No fever, no redness or rash at vaccine site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Incorrect route of drug administration, Injection site erythema, Skin striae
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX. Concurrent medical conditions included asthma and hypertension. Concomitant products included SINGULAIR, Levothyroxine, valsartan, hydrochlorothiazide and metoprolol. On 2nd March 2018, the patient received SHINGRIX. On 2nd March 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In March 2018, the patient experienced injection site erythema and striae. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the injection site erythema and striae were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema and striae to be related to SHINGRIX. Additional details were provided as follows: The reporting physician stated that a patient who received SHINGRIX on 2nd March 2018 developed 15 to 16 blisters or vesicles on injection site over the weekend, which was most likely (according to physician) her non-dominant arm (left arm). The reporting physician stated symptoms were better today than yesterday. The physician stated he believed this was extremely likely to have been caused by SHINGRIX. The physician stated that medical intervention has included ADVIL or TYLENOL, and that the patient's other physician was considering prescribing VALTREX. The reporting physician did not have lot number or expiration date. But in follow up narrative they reported that, the patient presented to the physician's office after receiving dose 1 of SHINGRIX from another provider. Prior to being seen, she told the physician she had vesicles at the injection site. Upon further evaluation, the provider deems there are no vesicles but a large erythematous area with striae, at least 90 mm in diameter. The patient also believed that she was given the injection subcutaneously but had yet to confirm, which led to inappropriate route of vaccination. The health care professional follow up on his question about the adverse event noted in the prior. It was then that he informed to representative that the patient had just come in and left and she did not have vesicles, which were reported previously. Her adverse event seemed more in line with grade 3 injection site reactions. She also told the health care professional that she was almost certain she got the vaccine subcutaneously, but has yet to confirm, which led to incorrect route of drug administration. This case has been linked with US2018037473, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included naproxen, AVAPRO, FEMHRT and alprazolam. On 3rd January 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2018, 41 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with prednisone. On an unknown date, the outcome of the hives were recovered/resolved. The reporter considered the hives to be unrelated to SHINGRIX. Additional details were reported as follows: The patient developed hives that started around her eyes. The reporter states that the hives were absolutely not related to SHINGRIX. She was concerned that the prednisone would affect her response to SHINGRIX and also because she was going on vacation on 19th May 2018 and would be taking prednisone prior to leaving because of her arthritis. This was around the time she would receive the 2nd dose, so was concerned that prednisone would interfere with her 2nd dose as well. The patient has denied permission to contact their physician.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Pain at injection site that resolved, and "tingling' that goes down to the elbow and forearm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain, Swelling face
Clinical narrative: Right cheek swelling (mild) 13 days after MMRV and KINRIX. Mildly painful to touch; Afebrile and otherwise asymptomatic.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: As overnight approached, I got a severe headache, stiff neck, fever of 100.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain upper, Anxiety, Condition aggravated, Metabolic function test normal, Pain in extremity
Clinical narrative: Patient stated that the same night he had some momentary tremors in his hands, and felt soreness in the arms. He had stomach ache and had palpitations that lasted a short while. He has had tremors 2 more times albeit short lasting. He does have anxiety and my opinion was that this was anxiety related. He however stated that these started on the same night and hence I am reporting this.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Palpitations, Thyroid function test normal, Tremor
Clinical narrative: Patient stated that the same night he had some momentary tremors in his hands, and felt soreness in the arms. He had stomach ache and had palpitations that lasted a short while. He has had tremors 2 more times albeit short lasting. He does have anxiety and my opinion was that this was anxiety related. He however stated that these started on the same night and hence I am reporting this.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Chest pain, Chills, Gait inability, Guillain-Barre syndrome
Clinical narrative: After having a wellness physical I received the flu shot on 10/20/17. Within 24 hrs. I had flu like symptoms - chills and fever. Within 48 hrs. I had sudden lower back pain on my right side going up my back and pain in chest. After a visit to ER heart was checked to rule out heart attack. I was discharged with diagnosis of SARS virus and muscle spasms. Four days later (8 days after receiving flu shot) I returned to the ER with severe legs weakness and incontinence. Paralysis began in toes and continued through torso. After MRI surgery was performed to remove abscess on spine. After five weeks of acute rehab and two weeks of subacute rehab. I continue to learn to to walk going to rehab. 3 days a week.  I am still unable to return to work.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired work ability, Incontinence, Influenza like illness, Muscle spasms, Muscular weakness
Clinical narrative: After having a wellness physical I received the flu shot on 10/20/17. Within 24 hrs. I had flu like symptoms - chills and fever. Within 48 hrs. I had sudden lower back pain on my right side going up my back and pain in chest. After a visit to ER heart was checked to rule out heart attack. I was discharged with diagnosis of SARS virus and muscle spasms. Four days later (8 days after receiving flu shot) I returned to the ER with severe legs weakness and incontinence. Paralysis began in toes and continued through torso. After MRI surgery was performed to remove abscess on spine. After five weeks of acute rehab and two weeks of subacute rehab. I continue to learn to to walk going to rehab. 3 days a week.  I am still unable to return to work.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Severe acute respiratory syndrome, Spinal cord abscess, Surgery
Clinical narrative: After having a wellness physical I received the flu shot on 10/20/17. Within 24 hrs. I had flu like symptoms - chills and fever. Within 48 hrs. I had sudden lower back pain on my right side going up my back and pain in chest. After a visit to ER heart was checked to rule out heart attack. I was discharged with diagnosis of SARS virus and muscle spasms. Four days later (8 days after receiving flu shot) I returned to the ER with severe legs weakness and incontinence. Paralysis began in toes and continued through torso. After MRI surgery was performed to remove abscess on spine. After five weeks of acute rehab and two weeks of subacute rehab. I continue to learn to to walk going to rehab. 3 days a week.  I am still unable to return to work.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Dyskinesia, Electroencephalogram normal, Exaggerated startle response, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Per parents, she received her routine 4-month immunizations (DTaP-IPV-HBV, PCV, Rotavirus, Hib) on 1/30/18 and she seemed sleepier than usual that night. On 02/01, she started having episodes where her whole body would tense up, her mouth would turn downwards into a frown, her eyes would widen, and she would then seem to startle and let out a cry afterwards. These episodes typically only last for 1-5 seconds. She has no extremity jerking and has no post-ictal period afterwards where she appears very tired. They occurred multiple times on 02/01.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Somnolence, Tension
Clinical narrative: Per parents, she received her routine 4-month immunizations (DTaP-IPV-HBV, PCV, Rotavirus, Hib) on 1/30/18 and she seemed sleepier than usual that night. On 02/01, she started having episodes where her whole body would tense up, her mouth would turn downwards into a frown, her eyes would widen, and she would then seem to startle and let out a cry afterwards. These episodes typically only last for 1-5 seconds. She has no extremity jerking and has no post-ictal period afterwards where she appears very tired. They occurred multiple times on 02/01.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: On the evening of the 12th, I developed the shingles virus rash on my right side and back..  I went to urgent care the next morning, was diagnosed and prescribed an antiviral.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Blood test normal, Gastrointestinal pain, Hyperhidrosis, Loss of consciousness
Clinical narrative: Became very sweaty, no fever, passed out on floor, blood pressure was 83/56, heart rate was in 90's. This went on for about 4 hours, then felt progressively better. Stomach/intestinal pains for part of this time.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Became very sweaty, no fever, passed out on floor, blood pressure was 83/56, heart rate was in 90's. This went on for about 4 hours, then felt progressively better. Stomach/intestinal pains for part of this time.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Dizziness, Heart rate increased, Hypotension, Nausea
Clinical narrative: Became very sweaty, no fever, passed out on floor, blood pressure was 83/56, heart rate was in 90's. This went on for about 4 hours, then felt progressively better. Stomach/intestinal pains for part of this time.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness, Fall, Heart rate increased, Hyperhidrosis
Clinical narrative: Became very sweaty, no fever, passed out on floor, blood pressure was 83/56, heart rate was in 90's. This went on for about 4 hours, then felt progressively better. Stomach/intestinal pains for part of this time.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypotension, Motion sickness, Muscular weakness, Nausea
Clinical narrative: Became very sweaty, no fever, passed out on floor, blood pressure was 83/56, heart rate was in 90's. This went on for about 4 hours, then felt progressively better. Stomach/intestinal pains for part of this time.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Circumstance or information capable of leading to medication error, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a pregnant female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-MAR-2018, the patient was holding her child during administration of VARIVAX (dose, route of administration, lot #, expiration date) for prophylaxis and the child moved causing a drop of VARIVAX to splash in the woman's eye. It was reported that the exact amount of VARIVAX that was splashed in the eye was unknown. No adverse effects were reported. The patient's last menstrual period and estimated date of delivery were not reported. The pregnancy outcome was pending.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting, ondansetron orally, oral rehydration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Local reaction - redness, swelling, pain, heat.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cough, Erythema, Pyrexia
Clinical narrative: Redness, fever, cough.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Eye pain, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediately: left arm pain at injection site lasting a couple of days and went away next day: left side headache continuously for 2 days then on and off runny nose left ear pain started 3/14/18 left earlobe very red, hot to touch 3/15/18 am left jaw pain, left eye pain patient called doctor and sent picture he told patient to go to urgent care 3/15/18, because he may have mastoiditis.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in jaw, Rhinorrhoea, Skin warm
Clinical narrative: Immediately: left arm pain at injection site lasting a couple of days and went away next day: left side headache continuously for 2 days then on and off runny nose left ear pain started 3/14/18 left earlobe very red, hot to touch 3/15/18 am left jaw pain, left eye pain patient called doctor and sent picture he told patient to go to urgent care 3/15/18, because he may have mastoiditis.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Rash, Rash pruritic
Clinical narrative: Pruritic burning rash on bilateral arms and legs. Given prednisone by provider.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red at injection site, sore.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Seizure, Syncope
Clinical narrative: My son fainted and began to seizure for 5-10 seconds immediately following the injection. He came to and was given a popsicle and some cold water. Watched for 15 minutes and then released.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus generalised, Rash, Urticaria
Clinical narrative: Recipient of vaccination began having a reaction 30 minutes after receiving the shot. He presents with red welts and rash on back, RT AC site, redness to face and generalized itching to body. He was advised to go home and take diphenhydramine and shower and seek medical attention if symptoms worsen.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Eye pain, Limb mass, Pruritus, Swelling
Clinical narrative: Silver dollar size lump in arm, bright red. Swollen, red, itchy, painful eyes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: Patient presented to Pharmacy today 03/15/18 which a lateral rash on right arm near injection site. Area is red, minimal inflammation, and no itch. Rash developed several days after vaccine per patient's memory. Advised to apply ice to cool area down and use hydrocortisone to help with inflammation. If doesn't resolve in a few days patient will see her doctor.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: Patient received IM AFLURIA vaccine Lot XT35709 exp 6/30/18 in left arm on 2/7/18. Today pt states that she has nerve pain that radiates from the site of injection all the way down her arm starting approximately 1 week after receiving vaccine that prevents her from exercising. Stated she has appointment with her doctor but has not been seen yet.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Exactly those listed as possible by the CDC with the addition of thoughts swirling around my mind very fast. "Some people felt tired, had muscle pain, a headache, shivering, fever, stomach pain, or nausea (I experienced both though nausea was worse).
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Thinking abnormal
Clinical narrative: Exactly those listed as possible by the CDC with the addition of thoughts swirling around my mind very fast. "Some people felt tired, had muscle pain, a headache, shivering, fever, stomach pain, or nausea (I experienced both though nausea was worse).
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash generalised
Clinical narrative: She has a severe rash from her face to her toes. Also has a fever.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Face oedema, Oedema peripheral, Pruritus, Rash, Serum sickness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of serum sickness in a 7-year-old male patient who received HAVRIX. The patient's past medical history included leg pain (the day before getting the vaccine). Concurrent medical conditions included seasonal allergy (the child is generally healthy). On 27th February 2018, the patient received the 1st dose of HAVRIX .5 ml. On 5th March 2018, 6 days after receiving HARVIX, the patient experienced rash. On 7th March 2018, the patient experienced face edema, edema hands, pruritus and urticaria. In March 2018, the patient experienced serum sickness. The patient experienced serum sickness. The patient was treated with ZYRTEC and BENADRYL. On an unknown date, the outcome of the serum sickness, face edema, edema hands, pruritus, rash and urticaria were not recovered/not resolved. The reporter considered the serum sickness, face edema, edema hands, pruritus, rash and urticaria to be possibly related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. At 16:22, the patient received full dose of HAVRIX in left deltoid. Six days after receiving HAVRIX, the patient experienced serum sickness. On 7th March 2018, 8 days after receiving HAVRIX, the patient developed a rash on his thigh that was spreading and had some edema in his face and hands. Also had pruritus and urticaria. He was playful at the time of reporting. The patient was not taking treatment.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of serum sickness in a 7-year-old male patient who received HAVRIX. The patient's past medical history included leg pain (the day before getting the vaccine). Concurrent medical conditions included seasonal allergy (the child is generally healthy). On 27th February 2018, the patient received the 1st dose of HAVRIX .5 ml. On 5th March 2018, 6 days after receiving HARVIX, the patient experienced rash. On 7th March 2018, the patient experienced face edema, edema hands, pruritus and urticaria. In March 2018, the patient experienced serum sickness. The patient experienced serum sickness. The patient was treated with ZYRTEC and BENADRYL. On an unknown date, the outcome of the serum sickness, face edema, edema hands, pruritus, rash and urticaria were not recovered/not resolved. The reporter considered the serum sickness, face edema, edema hands, pruritus, rash and urticaria to be possibly related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. At 16:22, the patient received full dose of HAVRIX in left deltoid. Six days after receiving HAVRIX, the patient experienced serum sickness. On 7th March 2018, 8 days after receiving HAVRIX, the patient developed a rash on his thigh that was spreading and had some edema in his face and hands. Also had pruritus and urticaria. He was playful at the time of reporting. The patient was not taking treatment.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX. On 7th March 2018, the patient received SHINGRIX. On 7th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and slight temperature. In March 2018, the patient experienced poor sleep. On an unknown date, the outcome of the injection site pain, poor sleep and slight temperature were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, poor sleep and slight temperature to be related to SHINGRIX. Additional details were provided as follows: The patient received her SHINGRIX injection and said that it hurt at the injection site and it still hurts at the time of reporting. The patient was running a slight temperature, it was running 99 and she normally had 97. On the day of reporting, the patient also said that she did not sleep well last night because of the pain.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional information was received as follows: The reporting physician stated that three patients experienced expected side effects of SHINGRIX. The reporting physician stated that he and his wife are two of three patients who experienced expected side effects of SHINGRIX. The patient in this report is the third patient. The patient experienced a fever after vaccination. The age at vaccination was not reported. This case was one of three cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication was unknown. The physician reported to the field representative that the patient developed shingles a few days after receiving SHINGRIX. The field representative thought, it was the patient's 1st dose, but was not certain. The physician also commented that, it was a weird coincidence, but did not seem alarmed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX. On 2nd March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, injection site pain and feeling unwell. On 6th March 2018, the outcome of the headache and injection site pain were recovered/resolved. On an unknown date, the outcome of the feeling unwell was recovering/resolving. The reporter considered the headache and injection site pain to be probably related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe injection site pain and headache, which were resolved by day 3 after vaccination. The patient still felt under the weather almost 1 week after vaccination. The healthcare professional (HCP) who reported the event was not associated with the HCP who vaccinated the patient and therefore was unable to provide lot number or expiry date of the vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received several years ago before the time of reporting). On 7th March 2018, the patient received SHINGRIX .5 ml. On 9th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site induration, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling and injection site itching were not recovered/not resolved and the outcome of the injection site induration, injection site erythema and injection site warmth were unknown. The reporter considered the injection site swelling and injection site itching to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site induration, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received a SHINGRIX in the left arm and there were no issues with the vaccination. On 9th March 2018, the patient called to report that she has a hard, red bump at the injection site the size of a silver dollar. The area was hot and itchy.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient told provider he feet, legs, and hips hurt so bad that he could not get out of bed to eat of drink.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, fever and swelling. On an unknown date, the outcome of the pain, fever and swelling were unknown. It was unknown if the reporter considered the pain, fever and swelling to be related to SHINGRIX. Additional information was received as follows: The reporting physician stated that three patients experienced expected side effects of SHINGRIX including aches, fever, and swelling. The age at vaccination was not reported. The reporting physician stated that he and his wife are two of three patients who experienced expected side effects of SHINGRIX. The reporting physician stated that one patient experienced a fever. This case was one of three cases, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Pruritus, Rash, Urticaria
Clinical narrative: Rash, urticaria, pruritus and also bruising.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash on face four days after vaccination.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swollen, red, warm to touch from her shoulders down to her elbows. Patient was advised to see her PCP, which she did on 3/15/18 morning. PCP prescribed antibiotics in case of possible infection from injection site reaction.
Age: 1.92
Sex: M
Vaccine: RV5
Symptoms: Anxiety, Cardiomegaly, Chromaturia, Condition aggravated, Echocardiogram
Clinical narrative: Kawasaki disease complete vascular system swollen his body attacks itself he was in the hospital for 2 weeks he received two treatments of IVIG treatment he was on high-dose aspirin to control the swelling in his heart he couldn't walk he couldn't talk he couldn't eat his urine look like orange juice he had started off with a rash and it started for me very quickly throughout his whole body even his testicles were peeling off skin and feet peeling off layers of skin his tongue was extremely swollen lips swollen can it started the beginning of February of 2015 and we got him in the hospital but it was a very long process he suffers extreme anxiety because obviously he was young when he started it it was a very traumatizing event for him and for I especially when not much is known about Kawasaki disease his vaccines were received in December and he started getting sick like I said about the beginning of February the high fevers cause them to have rheumatoid arthritis he has bad sleeping patterns it's just been very bad he still goes for echograms of his heart he can't do a lot of activities because his legs begin to hurt and his heart begins to pound because he was going to have an aneurysm in his heart these magazines are filled with poisons that are killing our children.
Age: 1.92
Sex: M
Vaccine: RV5
Symptoms: Feeding disorder, Gait inability, Immunoglobulin therapy, Kawasaki's disease, Lip swelling
Clinical narrative: Kawasaki disease complete vascular system swollen his body attacks itself he was in the hospital for 2 weeks he received two treatments of IVIG treatment he was on high-dose aspirin to control the swelling in his heart he couldn't walk he couldn't talk he couldn't eat his urine look like orange juice he had started off with a rash and it started for me very quickly throughout his whole body even his testicles were peeling off skin and feet peeling off layers of skin his tongue was extremely swollen lips swollen can it started the beginning of February of 2015 and we got him in the hospital but it was a very long process he suffers extreme anxiety because obviously he was young when he started it it was a very traumatizing event for him and for I especially when not much is known about Kawasaki disease his vaccines were received in December and he started getting sick like I said about the beginning of February the high fevers cause them to have rheumatoid arthritis he has bad sleeping patterns it's just been very bad he still goes for echograms of his heart he can't do a lot of activities because his legs begin to hurt and his heart begins to pound because he was going to have an aneurysm in his heart these magazines are filled with poisons that are killing our children.
Age: 1.92
Sex: M
Vaccine: RV5
Symptoms: Pain in extremity, Palpitations, Pyrexia, Rash, Rheumatoid arthritis
Clinical narrative: Kawasaki disease complete vascular system swollen his body attacks itself he was in the hospital for 2 weeks he received two treatments of IVIG treatment he was on high-dose aspirin to control the swelling in his heart he couldn't walk he couldn't talk he couldn't eat his urine look like orange juice he had started off with a rash and it started for me very quickly throughout his whole body even his testicles were peeling off skin and feet peeling off layers of skin his tongue was extremely swollen lips swollen can it started the beginning of February of 2015 and we got him in the hospital but it was a very long process he suffers extreme anxiety because obviously he was young when he started it it was a very traumatizing event for him and for I especially when not much is known about Kawasaki disease his vaccines were received in December and he started getting sick like I said about the beginning of February the high fevers cause them to have rheumatoid arthritis he has bad sleeping patterns it's just been very bad he still goes for echograms of his heart he can't do a lot of activities because his legs begin to hurt and his heart begins to pound because he was going to have an aneurysm in his heart these magazines are filled with poisons that are killing our children.