chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Two generalized, tonic-clonic seizures while febrile on 5/1/2018, several hours apart. He was admitted overnight for observation after the second febrile seizure.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Pain
Clinical narrative: This case was reported by a other health professional and described the occurrence of shingles in a 68-year-old patient who received SHINGRIX. On 24th April 2018, the patient received SHINGRIX 50 mcg/mg. On 19th May 2018, 25 days after receiving SHINGRIX, the patient experienced shingles, pain and sleeplessness. On an unknown date, the outcome of the shingles, pain and sleeplessness were unknown. It was unknown if the reporter considered the shingles, pain and sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient never had shingles previously. The patient received SHINGRIX and diagnosed with shingles (diagnosed by the patient's doctor). It was very painful and the patient cannot sleep. The patient wanted to know that how this happened besides vaccination. The patient said that since the vaccine was supposed to be the newest and best and no one told the patient that the SHINGRIX would give the shingles not even literature. The patient would have never got the vaccine. The patient want $168 back for the shot, and said that who knows how much work the patient would miss. The patient would be posting this on GlaxoSmithKline website and social media unless GlaxoSmithKline could show literature where it said the vaccine could give the shingles.
Sex: F
Vaccine: HPV9
Symptoms: Food allergy, Malaise
Clinical narrative: This spontaneous report was received from an unspecified office manager who is also the patient's relative via company representative and refers to a 18-year-old female patient. The patient's pertinent medical history was not reported. Concomitant therapies were not provided. In 2015 and 2016, the patient was vaccinated with all three doses of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). In 2015, reported as "after the first vaccination ", the patient was getting very sick and had a mushroom allergy. She sought physical attention and went to many unspecified physician. The outcome of the event was reported as recovering. The reporter considered a mushroom allergy to be related to GARDASIL 9. The relatedness between the event of getting very sick and the suspect therapy was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 28 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-MAY-2018, the patient received an expired dose of PROQUAD, subcutaneously, lot # M042500 and expiration date on 17-APR-2018, for prophylaxis (anatomical location was not reported). There were no adverse effects reported.   .
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Wrong drug administered
Clinical narrative: This initial spontaneous report was received from the mother of an 18 year old female patient. The patient had no drug reactions/allergies. No information regarding medical history, concurrent conditions, or concomitant medications was provided. Historical drug included first dose of meningococcal conjugate vaccine (reported as MCV4) in 2011 (manufacturer not specified). On 13-JUN-2016, the patient received her first dose in the human papilloma virus (HPV) series with GARDASIL 9 (lot # not provided). On 30-JAN-2017, she received her second dose in the series with GARDASIL (lot # not provided). The reporter did not specify whether her daughter received the third dose in the HPV series. On 05-JUN-2018, the patient inadvertently received GARDASIL 9 in the left upper arm (unknown route) (lot # N019104; expiration 02-MAR-2020), but she was supposed to receive the second dose of MCV4 (manufacturer not specified) "because she is going to university and needed the MCV4 vaccine." Since an hour and a half after receiving GARDASIL 9 on 05-JUN-2018, the patient was having severe anxiety. The patient did not seek medical attention and no treatment was given. The anxiety was not recovered at the time of the report. Causality assessment was specified. The reporter asked if NDC 0006412101, lot N019104 and expiration 02-MAR-2018 was a Merck vaccine. The reporter was informed that the lot # matches a lot of GARDASIL 9. Subsequently, the reporter stated she would hire an attorney because her daughter inadvertently received GARDASIL 9 instead of the MCV4. She stated that "the doctor's office put that she received the MCV4 vaccine but the lot number indicated GARDASIL 9. The attorney will handle everything both with Merck and with the doctor." The reporter did not provide consent for her daughter's physician to be contacted.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Rash pruritic, Skin discolouration
Clinical narrative: In patient's words, typed as written: Broke out in a rash with itching and dark spots all over my body, also had dark purple bruise from my ankle to the calf of my leg had to to go urgent care.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Irritability, Mucous stools, Occult blood positive
Clinical narrative: Infant with fussiness since vaccines. In past 2-3 days has developed bloody, mucousy stools, fussiness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Scattered erythematous macules on chest, back, abdomen, arms, face, sparing legs.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Gastrointestinal pain, Myalgia, Pyrexia
Clinical narrative: Fever (100), overall muscle soreness ache, stomach/gut pain -- the reaction was similar to having an unpleasant flu. Very unpleasant on 6/5/2018. Improved, but still present 6/6/2018.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Redness, swelling, black ring around arm, stiffness, painful, traveling up towards neck and down arm, veins in hand were very purple, like a rubber band around my arm cutting off circulation going down my arm, very painful like a 10, dizziness, nausea. In office shot of steroids 40mgs and to take 40mgs there after for 5 days. After shot within 24 hours pain was gone, swelling was gone.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin discolouration, Vein discolouration
Clinical narrative: Redness, swelling, black ring around arm, stiffness, painful, traveling up towards neck and down arm, veins in hand were very purple, like a rubber band around my arm cutting off circulation going down my arm, very painful like a 10, dizziness, nausea. In office shot of steroids 40mgs and to take 40mgs there after for 5 days. After shot within 24 hours pain was gone, swelling was gone.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Oedema, Pain, Pruritus, Skin warm
Clinical narrative: 1 day later with large local reaction of edema, warmth and pain with mild itching.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Upon administration of the second dose of the SHINGRIX vaccine in the left deltoid the patient said his arm hurt and he had pain down his arm into his left hand. Pharmacist immediately checked the site of administration and it was correct in the left deltoid region (not too high or low). One week later the patient comes back to the pharmacy and said he still has a burning pain in his left hand/thumb. About 2 weeks after vaccination the patient still has a burning sensation in his left hand/thumb and is seeking treatment.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Local reaction
Clinical narrative: Large local reaction - edema, erythema and pain 7cm x 6cm around injection sites start 24 hours after injection.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: EXTREME PAIN AT INJECTION SITE -- IMMOBILIZED ARM FOR 3 DAYS.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Injected limb mobility decreased, Injection site pain
Clinical narrative: EXTREME PAIN AT INJECTION SITE -- IMMOBILIZED ARM FOR 3 DAYS.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient had vaccines on 6/4/18 KINRIX given IM right thigh. Varicella sub Q right flank. Tuesday she had a warm red swollen and painful area. Mom has done ice and TYLENOL, BENADRYL given. No relief to symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Patient states that her right knee down to her foot has swollen. She states that her foot is so swollen that she can barely wear a shoe.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count, Headache, Myalgia, Pyrexia, White blood cell count normal
Clinical narrative: Symptoms- fever greater than 100.4F, myalgia, headache; Treatment- Ibuprofen q4hrs prn, 64+ fl.oz. of water daily, monitor for worsening sx's; Outcome- unknown, treatment advised this AM.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Headache muscle ache low grade fever severe malaise 24 hours.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: 3 hour after injection pt noticed headache, nausea, fever and fatigue. Pt did take ibuprofen and sx stopped. 12 hours after administration sx started again. Severe chills and fever 100.5-101.5.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site indentation, Injection site pain
Clinical narrative: Patient called 06/06/2018 340 pm stating pain at injection site and an indent where the shot was administered. Patient stated they are going to make an appointment with doctor to get x-ray.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Allodynia, Condition aggravated, Facial pain, Neuropathy peripheral, Pain
Clinical narrative: Recurrence of painful right facial neuropathy, at the same site of previous post-herpetic neuropathy. Has lasted about 3 weeks, and is gradually getting better but not gone yet. Patient describes allodynia on the right cheek and right ear, very painful to even light touch.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Recurrence of painful right facial neuropathy, at the same site of previous post-herpetic neuropathy. Has lasted about 3 weeks, and is gradually getting better but not gone yet. Patient describes allodynia on the right cheek and right ear, very painful to even light touch.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer
Clinical narrative: Aphthous ulcer in throat, currently being treated with Prednisolone solution gargle, still not healed after 6 days of treatment.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Day after the shot-headache, tired, spiked a fever, achy, chills, shaking. Ever since, injection site swollen, itchy, painful.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia, Tremor
Clinical narrative: Day after the shot-headache, tired, spiked a fever, achy, chills, shaking. Ever since, injection site swollen, itchy, painful.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient briefly passed out after vaccines were given. We gave him water and a cold pack and had him sit with his father for about 30 minutes. Took blood pressure. Pt began to feel better on his own and was able to walk out unassisted.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a Physician on 17-MAY-2018. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (reported as last fall, September-October) at a pharmacy. Patient's medical history and concomitant medication were not reported. On an unknown date, within one to two-hour post vaccination, patient developed anaphylactic reaction. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: anaphylactic reaction. Documents held by sender: none.; Sender's Comments: This is poorly documented case which involves a female patient who received FLUZONE HD vaccine and experienced anaphylactic reaction one- two hours after vaccination. Time to onset is compatible with the role of vaccine and the diagnosis. Anaphylactic reaction is an expected event following FLUZONE HD administration. However, additional information, including patient's medical history, allergic history, medical condition at the time of vaccination and immunization history (tolerance to previous vaccination) are needed for further assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Pruritus, Skin warm
Clinical narrative: Hives stated on 5/31/18 on neck, chest, stomach, back, legs and arms. Hives were itchy and warm to touch and did not change much with BENADRYL or cool compresses. 6/2/18- hives not any better spreading. 6/3/18-- still has hives, not spreading at this point 6/5/18- hives starting to subside but pt developed a large whelp at injection site, approximately the size of a hand print and is warm to touch. 6/6/18- hives are pretty much gone but now he has a red strawberry mark where injections were given. Dr. believes it is an adverse reaction to MMRV vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Hives stated on 5/31/18 on neck, chest, stomach, back, legs and arms. Hives were itchy and warm to touch and did not change much with BENADRYL or cool compresses. 6/2/18- hives not any better spreading. 6/3/18-- still has hives, not spreading at this point 6/5/18- hives starting to subside but pt developed a large whelp at injection site, approximately the size of a hand print and is warm to touch. 6/6/18- hives are pretty much gone but now he has a red strawberry mark where injections were given. Dr. believes it is an adverse reaction to MMRV vaccine.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Myalgia
Clinical narrative: Patient developed erythema at the injection site, generalized myalgia and arthralgia the day following vaccination.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patients states that his arm is swollen and hurts.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Full blood count normal, Macule, Petechiae, Platelet count normal, Purpura
Clinical narrative: Patient is a 12 month old girl who presents to clinic for evaluation of rash and suspicion for vaccine reaction vs. Measles. Patient received her 12 month vaccines, including MMR, Varicella, HiB, and PCV13, about 2 weeks ago (5/21/18). A couple of days after the immunizations she developed fever that ranged from 101-102F and persisted for 3 days. The fever resolved, but 5 days after the immunizations she developed a rash. The rash started on her face and subsequently spread, involving her entire body. But unfortunately this was all occurring while on vacation. They presented to an urgent care center at the onset of rash, and were told that this was most likely a vaccine reaction, but that it also had an appearance that could be consistent with Measles. Though, at that time she did not have conjunctivitis, coryza, or cough. After a few more days, now about 8 days after the immunizations, she seemed to be improving, was afebrile, and the rash was resolving. Then, about 11-12 days after the immunizations, the rash recurred. The second phase of the rash was similar in appearance to the first time, but was clearly more morbiliform (parents have photos). She still did not have fever, conjunctivitis, coryza, or cough. They were seen by an Infectious Diseases specialist who thought that the rash was most likely due to a vaccine reaction and gave them clearance to take a plane and return home. Since returning home patient has been overall doing well, but the rash seems to be resolving, now with a few scattered petechiae and larger non-blanching macules/purpura in her diaper area. PCP obtained a CBC which was normal; in particular, her platelets were 252. She was referred to clinic for further evaluation. Today, patient is overall doing well. She is active and playful. She is taking PO well. However, she continues to have rash; though, per parents report it is stable and evolving/improving. She is afebrile. There is no conjunctivitis, mouth sores, nasal congestion, cough, vomiting, diarrhea, or joint swelling/pain. There have been no known sick contacts. No known tick exposures; though, the family has been hiking. No recent antibiotics.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular, Rash morbilliform, Vaccination complication
Clinical narrative: Patient is a 12 month old girl who presents to clinic for evaluation of rash and suspicion for vaccine reaction vs. Measles. Patient received her 12 month vaccines, including MMR, Varicella, HiB, and PCV13, about 2 weeks ago (5/21/18). A couple of days after the immunizations she developed fever that ranged from 101-102F and persisted for 3 days. The fever resolved, but 5 days after the immunizations she developed a rash. The rash started on her face and subsequently spread, involving her entire body. But unfortunately this was all occurring while on vacation. They presented to an urgent care center at the onset of rash, and were told that this was most likely a vaccine reaction, but that it also had an appearance that could be consistent with Measles. Though, at that time she did not have conjunctivitis, coryza, or cough. After a few more days, now about 8 days after the immunizations, she seemed to be improving, was afebrile, and the rash was resolving. Then, about 11-12 days after the immunizations, the rash recurred. The second phase of the rash was similar in appearance to the first time, but was clearly more morbiliform (parents have photos). She still did not have fever, conjunctivitis, coryza, or cough. They were seen by an Infectious Diseases specialist who thought that the rash was most likely due to a vaccine reaction and gave them clearance to take a plane and return home. Since returning home patient has been overall doing well, but the rash seems to be resolving, now with a few scattered petechiae and larger non-blanching macules/purpura in her diaper area. PCP obtained a CBC which was normal; in particular, her platelets were 252. She was referred to clinic for further evaluation. Today, patient is overall doing well. She is active and playful. She is taking PO well. However, she continues to have rash; though, per parents report it is stable and evolving/improving. She is afebrile. There is no conjunctivitis, mouth sores, nasal congestion, cough, vomiting, diarrhea, or joint swelling/pain. There have been no known sick contacts. No known tick exposures; though, the family has been hiking. No recent antibiotics.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Viral rash
Clinical narrative: Patient is a 12 month old girl who presents to clinic for evaluation of rash and suspicion for vaccine reaction vs. Measles. Patient received her 12 month vaccines, including MMR, Varicella, HiB, and PCV13, about 2 weeks ago (5/21/18). A couple of days after the immunizations she developed fever that ranged from 101-102F and persisted for 3 days. The fever resolved, but 5 days after the immunizations she developed a rash. The rash started on her face and subsequently spread, involving her entire body. But unfortunately this was all occurring while on vacation. They presented to an urgent care center at the onset of rash, and were told that this was most likely a vaccine reaction, but that it also had an appearance that could be consistent with Measles. Though, at that time she did not have conjunctivitis, coryza, or cough. After a few more days, now about 8 days after the immunizations, she seemed to be improving, was afebrile, and the rash was resolving. Then, about 11-12 days after the immunizations, the rash recurred. The second phase of the rash was similar in appearance to the first time, but was clearly more morbiliform (parents have photos). She still did not have fever, conjunctivitis, coryza, or cough. They were seen by an Infectious Diseases specialist who thought that the rash was most likely due to a vaccine reaction and gave them clearance to take a plane and return home. Since returning home patient has been overall doing well, but the rash seems to be resolving, now with a few scattered petechiae and larger non-blanching macules/purpura in her diaper area. PCP obtained a CBC which was normal; in particular, her platelets were 252. She was referred to clinic for further evaluation. Today, patient is overall doing well. She is active and playful. She is taking PO well. However, she continues to have rash; though, per parents report it is stable and evolving/improving. She is afebrile. There is no conjunctivitis, mouth sores, nasal congestion, cough, vomiting, diarrhea, or joint swelling/pain. There have been no known sick contacts. No known tick exposures; though, the family has been hiking. No recent antibiotics.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Discomfort, Dysgeusia, Injection site swelling, Lethargy
Clinical narrative: Normal day on Saturday. On Sunday morning stiff neck started and general body malaise. Called pharmacist by Sunday afternoon; pharmacist advised to take Tylenol but did not have any. On Sunday did not go out as planned because did not feel well. Experienced fever all day up to 99.5 (2 degrees up than normal), felt lethargic, and uncomfortable. Patient did not take any medicine for the fever. By Monday fever was gone, had unpleasant taste in mouth, and body stiffness. Went to water aerobics class to stretch to help with stiffness. Today doing well; still don't have a lot of energy and there is a bit of swelling at the site of the injection.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Normal day on Saturday. On Sunday morning stiff neck started and general body malaise. Called pharmacist by Sunday afternoon; pharmacist advised to take Tylenol but did not have any. On Sunday did not go out as planned because did not feel well. Experienced fever all day up to 99.5 (2 degrees up than normal), felt lethargic, and uncomfortable. Patient did not take any medicine for the fever. By Monday fever was gone, had unpleasant taste in mouth, and body stiffness. Went to water aerobics class to stretch to help with stiffness. Today doing well; still don't have a lot of energy and there is a bit of swelling at the site of the injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Within hours upper arm became red and swollen. Progressed to involve lower arm extending to just at the wrist. Sore to touch. She went to urgent care 5/1/18, placed on antibiotics. I saw her 5/2/18, no change in therapy. Patient phoned 5/3/18- improving.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture, Blood test, Chest X-ray, Computerised tomogram head, Confusional state
Clinical narrative: Confusion, inability to walk, incoherence (9+ hours). hingles began 06/04 (current as of 06/06).
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture urine, Gait inability, Herpes zoster, Incoherent, Urine analysis
Clinical narrative: Confusion, inability to walk, incoherence (9+ hours). hingles began 06/04 (current as of 06/06).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Discomfort, Gingival discomfort, Lip swelling, Lymph node pain
Clinical narrative: Patient received first Shingles dose 8-10 weeks prior. For 2nd dose, by evening and early next morning arm was a little more tender and sore than after 1st dose. Then left arm became more sore and developed tenderness in armpit--from armpit radiating to pectoral muscle. On next day felt malaise and took it easy but late that day had 100.9 fever; it was gone by the next morning. By 5/29 developed sore on lower lip on left side (the size of a nickel); area was initially swollen with lot of pressure, and very uncomfortable. Next day felt sore developing inside mouth even on the roof of mouth and gums were irritated. Patient tried to manage the sore are by putting peroxide and keeping it moist so it would not crack. During scheduled dental cleaning dentist confirmed that there were no nuclei on the blisters, no bleeding but there was inflammation, irritation and tenderness. Patient went back to pharmacist who suggested follow-up with doctor. Called doctor on 6/4 and they will call manufacturer; doctor  did not recommend a course of action yet. On 6/3, lymph node under jaw in right side tender and inflamed. Today tenderness under armpit subsided and only has residual tender spots. Patient notes that he has not had sores since he was a teenager.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Noninfective sialoadenitis, Oral discomfort, Pain in extremity, Pyrexia
Clinical narrative: Patient received first Shingles dose 8-10 weeks prior. For 2nd dose, by evening and early next morning arm was a little more tender and sore than after 1st dose. Then left arm became more sore and developed tenderness in armpit--from armpit radiating to pectoral muscle. On next day felt malaise and took it easy but late that day had 100.9 fever; it was gone by the next morning. By 5/29 developed sore on lower lip on left side (the size of a nickel); area was initially swollen with lot of pressure, and very uncomfortable. Next day felt sore developing inside mouth even on the roof of mouth and gums were irritated. Patient tried to manage the sore are by putting peroxide and keeping it moist so it would not crack. During scheduled dental cleaning dentist confirmed that there were no nuclei on the blisters, no bleeding but there was inflammation, irritation and tenderness. Patient went back to pharmacist who suggested follow-up with doctor. Called doctor on 6/4 and they will call manufacturer; doctor  did not recommend a course of action yet. On 6/3, lymph node under jaw in right side tender and inflamed. Today tenderness under armpit subsided and only has residual tender spots. Patient notes that he has not had sores since he was a teenager.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis, Tenderness
Clinical narrative: Patient received first Shingles dose 8-10 weeks prior. For 2nd dose, by evening and early next morning arm was a little more tender and sore than after 1st dose. Then left arm became more sore and developed tenderness in armpit--from armpit radiating to pectoral muscle. On next day felt malaise and took it easy but late that day had 100.9 fever; it was gone by the next morning. By 5/29 developed sore on lower lip on left side (the size of a nickel); area was initially swollen with lot of pressure, and very uncomfortable. Next day felt sore developing inside mouth even on the roof of mouth and gums were irritated. Patient tried to manage the sore are by putting peroxide and keeping it moist so it would not crack. During scheduled dental cleaning dentist confirmed that there were no nuclei on the blisters, no bleeding but there was inflammation, irritation and tenderness. Patient went back to pharmacist who suggested follow-up with doctor. Called doctor on 6/4 and they will call manufacturer; doctor  did not recommend a course of action yet. On 6/3, lymph node under jaw in right side tender and inflamed. Today tenderness under armpit subsided and only has residual tender spots. Patient notes that he has not had sores since he was a teenager.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Every muscle aches, low grade fever (100.7), chills, no appetite, fatigue, necessary to stay in bed for two days now.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: Very sore arm and large red rash on left shoulder/behind injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warm to touch. No fever.
Age: 27.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Dizziness, Feeling abnormal, Pallor
Clinical narrative: Patient was sitting in chair beside this RN as she was finishing up paperwork, patient started to look pale and kind of blinked his eyes hard, this RN asked if he was ok, patient stated that he was feeling "funny" like lightheaded. This RN said lets get you in another room and lay you down. Patient went with RN and friend who was with him. Patient laid down and vitals were taken at 5 minute interval until vital were within normal range and patient stated he was feeling better. This started at 16:30 and Patient was able to leave on his own accord at 16:50.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Joint swelling
Clinical narrative: Redness, and joint swelling of both hands and elbows.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got a shingles rash on his abdomen, confirmed by a dermatologist and treated with Valtrex.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed a rash on his neck about 3 to 4 days after. He went to his doctor, who diagnosed it as Shingles. He was started on anti-viral therapy right away. His symptoms are mild.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at injection site on right thigh. Fever. Mother took patient to emergency room on 6/5/2018.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Fever (101F), severe chills and sweating, headache.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient had severe headache first and then later that evening she got body aches, pain in arm, fever and chills. She took Tylenol and symptoms subsided 1.5 days later.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Paraesthesia, Pyrexia, Vaccination site reaction
Clinical narrative: Fever, chills and fatigue for 24 hours. Frequent episodes of tingling, pins and needles that shoots down the vaccinated arm from vaccination site down through the thumb. Still occurring 2 1/2 months after shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Peripheral swelling, Pyrexia
Clinical narrative: My arm became very swollen, red, and stung several hours after receiving the vaccination. I have never had a reaction to a shot, so this concerned me. The next morning (this morning) I woke feeling icky and slightly feverish. Symptoms increased, and by 1pm, I decided to take an Ibuprofen tablet. By 6pm, my arm was bothering me more, I showed it to my husband, who said it not only looked worse, but was bright red. As it was too late to go to the Dr., so at 6:30, we went to an urgent care facility to check it out. NP told me it was an adverse reaction to the vaccination.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Laziness, Somnolence, Vomiting
Clinical narrative: Vomiting, sleepy and lazy.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 85-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 21st October 2020). The patient's past medical history included shingles (recurring shingles). On 8th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 4 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. In May 2018, the outcome of the shingles was recovered/resolved. The reporter considered the shingles to be unlikely related to SHINGRIX. Additional information was received as follows: The other healthcare professional did not believe that the shingles was caused by SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGIRX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced severe pain for a couple of days at the injection site after receiving SHINGRIX vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Oral discomfort
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of burning lips in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced burning lips. On an unknown date, the outcome of the burning lips was unknown. It was unknown if the reporter considered the burning lips to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional stated that, the patient was suffering from burning lips 24 to 48 hours, following vaccination after SHINGRIX. The adverse event was submitted via Webform.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of blepharospasm in a 79-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced blepharospasm. On an unknown date, the outcome of the blepharospasm was unknown. It was unknown if the reporter considered the blepharospasm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced twitching and flapping of left eye about a day after receiving a dose of SHINGRIX. The symptoms were reported to last for about 3 weeks after the injection. No further information was reported regarding the event.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash n a 61-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020). On 26th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th May 2018, 3 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was not recovered/not resolved. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid at 10:15 hours. The patient experienced a red rash on the lower back a few days after receiving the SHINGRIX vaccine. It was reported that, the rash seemed to get worse after the patient exercised.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Grip strength decreased, Headache, Hypotonia, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. The patient's past medical history included neurological disorder NOS. On 29th May 2018, the patient received SHINGRIX (intramuscular). On 29th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 30th May 2018, the patient experienced headache, nerve pain, insomnia, hypotonia and eye pain. On an unknown date, the outcome of the injection site pain, headache, nerve pain, insomnia, hypotonia and eye pain were not recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, nerve pain, insomnia, hypotonia and eye pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported this case for herself. The patient reported that she was on many other medications, but did not have her list available at time of report. It was reported that, the patient she received her SHINGRIX injection at around 3 PM. Less than a day after receiving SHINGRIX, the patient experienced pain at the injection site, but had no redness or marks. At 1 AM, the patient was still wide awake and could not sleep. The patient was experiencing nerve pain, which began on her hands and arms and spread to her entire body. The patient could not specify further. The patient also reported that she had difficulty gripping her walker. The patient has denied permission to contact their physician.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. The patient's past medical history included neurological disorder NOS. On 29th May 2018, the patient received SHINGRIX (intramuscular). On 29th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 30th May 2018, the patient experienced headache, nerve pain, insomnia, hypotonia and eye pain. On an unknown date, the outcome of the injection site pain, headache, nerve pain, insomnia, hypotonia and eye pain were not recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, nerve pain, insomnia, hypotonia and eye pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported this case for herself. The patient reported that she was on many other medications, but did not have her list available at time of report. It was reported that, the patient she received her SHINGRIX injection at around 3 PM. Less than a day after receiving SHINGRIX, the patient experienced pain at the injection site, but had no redness or marks. At 1 AM, the patient was still wide awake and could not sleep. The patient was experiencing nerve pain, which began on her hands and arms and spread to her entire body. The patient could not specify further. The patient also reported that she had difficulty gripping her walker. The patient has denied permission to contact their physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, fever, chills and malaise. On an unknown date, the outcome of the injection site erythema, fever, chills and malaise were recovering/resolving. The reporter considered the injection site erythema, fever, chills and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: At 13:15, the patient received SHINGRIX on right deltoid. The healthcare professional was unsure of symptoms onset day, but believed it was within 24 hours of administration.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 89-year-old male patient who received SHINGRIX. On 22nd May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and tenderness. On an unknown date, the outcome of the pain in arm and tenderness were recovering/resolving. The reporter considered the pain in arm and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported, but it could be either 89 or 90 year old. The patient experienced a sore arm that lasted for about 3 days, but it still hurt if she touches the area for 5 days. The patient had denied permission to contact their physician. This case has been linked with case US2018096131, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Gastric disorder, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 25th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, gastric disorder, headache, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, gastric disorder, headache, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, gastric disorder, headache, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced gastro issues after receiving SHINGRIX. The patient did not elaborate as to what the gastro issues were. The patient declined to participate in the report.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received SHINGRIX. On 22nd May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and tenderness. On an unknown date, the outcome of the pain in arm and tenderness were recovering/resolving. The reporter considered the pain in arm and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be either 81 or 82 years old. The patient experienced a sore arm that lasted for about 3 days, but it still hurt if she touches the area for 5 days. The patient had denied permission to contact their physician. This case has been linked with case US2018096132, reported by the same reporter.
Age: 1.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Diarrhoea, Faeces discoloured, Vomiting
Clinical narrative: Child began vomiting in lobby, was given acetaminophen 160/5ML oral SOLN 3.8ML. Pt. spit the medication out, would not take. Pt seen in ER, 5/31/18 at 04:39. Reported green and brown diarrhea throughout the night.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Syncope
Clinical narrative: Fainted at home day following vaccine administration, fatigued from Friday evening until Saturday evening.
Age: 26.0
Sex: F
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: (5/30/18) Pt reports 2 days after getting vaccines listed below 6.1.18 that her left foot became swollen and red and very itchy. Pt states today 6/6/18 swelling and redness improved; still itchy.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Skin discolouration
Clinical narrative: Red below site of injection, 3 days after vaccine. Discoloured and bruising above inject. site after 3 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Herpes zoster, Ligament sprain, Occipital neuralgia, Pain of skin
Clinical narrative: 16 April about 1330 received SHINGRIX. 19th of April my scalp became very tender. So much so, that I called my Doctor to get it checked out. My Doctor didn't have clinic so I saw another Doctor. No rash was present at this time, but he gave me a Rx for Prednisone, (he called it Occipital neuralgia). I took the series of pills for 6 days and was going to call the Doctor because I felt a painful rash on my scalp and nothing eased the pain. I took a pill for pain I had (4 years ago). I helped by made me a little lightheaded, I twisted my ankle and my husband took me to the ER. They looked at my head and diagnosed shingles. They gave me an RX for ten day and said to see my family Dr. when I was finished with them. He looked at my scalp and said to take 800mg MOTRIN three times a day. Not much he could say. I had crusted sores across my head and I still can't lay my head down on the right side. Today is May 26th and I still have at least 3 clusters of scabs. I found "TERRASIL" on line and use it on the rash at least three times a day. (It's for Shingles skincare). It does ease the pain and itching. No allergies except TEGRETOL, which I took about 10 years ago. I had a routine check up with my family doctor on the 12th of April. That's when he gave me the script for SHINGRIX which I got around to getting the following Monday. No illness prior to the shot. At hospital medication ordered; Acyclovir 800 mg and a RX for the next 10 days, then follow up with family Doctor. This paper with all the other documents says it all. The scabs have gone however, the scalp pain continues. Vaccination given by the Pharmacist, I don't know anything about the actual injection except it was given in my Rt arm. Which is also the side of my head that was affected with the pain and rash.