chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Polymerase chain reaction, Serum ferritin increased
Clinical narrative: Feritine was found to be more than 40000 mcg/l/Extreme hyperferritinemia; Hypertriglyceridemia to 2285 mg/dl; Hepatocellular injury with deranged liver function tests; This is a literature case initially retrieved on 07-Oct-2019, concerning a 65-year-old, male patient.   A 65-year-old man presented to clinic with daily nausea, vomiting and diarrhea in the setting of 15 lbs weight loss, ferritin level more than 1000 mcg/L, cytopenias and mild liver function test (LFT) abnormalities. There was no lymphadenopathy on exam. Hemochromatosis DNA testing was negative. Magnetic Resonance Imaging of brain, Computed Tomography of chest, abdomen, pelvis, and upper and lower endoscopies were non-contributory. The patient had an unknown illness causing non-specific constitutional symptoms and derangement of acute phase reactants (APRs).  During this work-up, seasonal influenza trivalent adjuvant vaccine was given [influenza virus vaccine polyvalent; dose, batch number, route of administration, anatomical location and expiry date: not reported] for an unknown indication.  Less than 24 hours later, a routine ferritin was found to be more than 40,000 mcg/L, along with deranged LFTs and hypertriglyceridemia to 2285 mg/dL without cytopenia. Due to concern for rapidly escalating unknown illness, patient was admitted to hospital for monitoring and expedited work up. Tests including, but not limited to, blood culture, hepatitis panel, human immunodeficiency virus, acetaminophen level, stool culture, C. difficile polymerase chain reaction (PCR) as well as soluble CD25 returned negative. Liver biopsy showed hepatocellular injury but no hemophagocytosis. Bone marrow biopsy was also without hemophagocytosis and otherwise normocellular.   Hyperferritinemia and abnormal LFTs remained persistent for 3 to 4 days before spontaneous downtrend without antibiotics or immunosuppressive therapy (recovered).   The outcome for the event of 'hypertriglyceridaemia' was not provided.  The reporter's comment is as follows: Laboratory, imaging and pathology work up was non-contributory, and there was a close temporal relationship between vaccine administration and onset of hyperferritinemia', while the causality assessment for the other two events was not reported.; Sender's Comments: The patient experienced hyperferritinaemia, hypertriglyceridaemia and hepatocellular injury 24 h after vaccination with the suspect product seasonal influenza trivalent adjuvant vaccine. Chronology is suggestive. Medical history of unknown illness may have contributed to development of the events. No concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Computerised tomogram, Deafness unilateral, Ear, nose and throat examination, Electrocardiogram, Hypoaesthesia
Clinical narrative: Loss of hearing in left ear; Felt pains; Vertigo; Numbness in left side of face, including ear canal; Felt general malaise; This is spontaneous case, initially received from other health professional (nurse) via Communications (reference number: SEQ-04129) on 08-Oct-2019, concerning 59-year-old, female patient.  The patient's medical history included thyroid cancer and breast cancer in remission.  The patient concomitant medication included Synthroid (levothyroxine sodium), tamoxifen and cortisone; indication was not provided.  On 29-Sep-2019, the patient was administered Flucelvax Quadrivalent [Influenza vaccine, subunit influenza virus vaccine polyvalent; NDC: 70461-0319-03, dose: 0.5 ml; batch number, expiration date, route of administration and anatomical location: not reported] as influenza prophylaxis.  On 30-Sep-2019, one day after vaccination, the patient felt general malaise.  On 04-Oct-2019, five days after vaccination, the patient felt pains and experienced vertigo, numbness in left side of face, including the left canal and loss of hearing in left ear. On the same day, the patient was hospitalised due to the events. In hospital was ruled out the possibility of a stroke.  On an unknown date in Oct-2019, the patient underwent magnetic resonance imaging, electrocardiogram, computerised tomogram scan, carotid doppler study and ENT (ear, nose and throat examination). The results of these test were not provided.   On 05-Oct-2019, the patient was discharged from the hospital.  At the time of this report, the events of numbness in left side of face, including ear canal and loss of hearing in left ear were not resolved, while the outcome for malaise, pain and vertigo was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.; Sender's Comments: The patient experienced deafness unilateral, pain, vertigo, hypoaesthesia and malaise after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. Medical history of thyroid cancer and breast cancer may provide alternative aetiology for the events. Causality was also confounded by therapy with concomitant drugs, Synthroid (levothyroxine sodium), tamoxifen and cortisone. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging, Malaise, Pain, Ultrasound Doppler, Vertigo
Clinical narrative: Loss of hearing in left ear; Felt pains; Vertigo; Numbness in left side of face, including ear canal; Felt general malaise; This is spontaneous case, initially received from other health professional (nurse) via Communications (reference number: SEQ-04129) on 08-Oct-2019, concerning 59-year-old, female patient.  The patient's medical history included thyroid cancer and breast cancer in remission.  The patient concomitant medication included Synthroid (levothyroxine sodium), tamoxifen and cortisone; indication was not provided.  On 29-Sep-2019, the patient was administered Flucelvax Quadrivalent [Influenza vaccine, subunit influenza virus vaccine polyvalent; NDC: 70461-0319-03, dose: 0.5 ml; batch number, expiration date, route of administration and anatomical location: not reported] as influenza prophylaxis.  On 30-Sep-2019, one day after vaccination, the patient felt general malaise.  On 04-Oct-2019, five days after vaccination, the patient felt pains and experienced vertigo, numbness in left side of face, including the left canal and loss of hearing in left ear. On the same day, the patient was hospitalised due to the events. In hospital was ruled out the possibility of a stroke.  On an unknown date in Oct-2019, the patient underwent magnetic resonance imaging, electrocardiogram, computerised tomogram scan, carotid doppler study and ENT (ear, nose and throat examination). The results of these test were not provided.   On 05-Oct-2019, the patient was discharged from the hospital.  At the time of this report, the events of numbness in left side of face, including ear canal and loss of hearing in left ear were not resolved, while the outcome for malaise, pain and vertigo was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.; Sender's Comments: The patient experienced deafness unilateral, pain, vertigo, hypoaesthesia and malaise after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. Medical history of thyroid cancer and breast cancer may provide alternative aetiology for the events. Causality was also confounded by therapy with concomitant drugs, Synthroid (levothyroxine sodium), tamoxifen and cortisone. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.
Age: 59.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache, nausea, muscle aches
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Rash erythematous, Rash papular
Clinical narrative: 10/15/2019 pt presented to Clinic with temp of 100.0 and rash to cheeks. Provider noted faint slightly erthyematous papular rash to cheeks and forehead without pruritis.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus, Swelling
Clinical narrative: allergic type reaction with extreme pruritis, redness and swelling beginning in scalp and spreading to face, arms, trunk and back
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: allergic type reaction with extreme pruritis, redness and swelling beginning in scalp and spreading to face, arms, trunk and back
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Incorrect route of product administration
Clinical narrative: Given IV instead of IM- burning sensation
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth, Rash
Clinical narrative: Itchy rash that started on right shoulder of injection site. The site was fevered and the rash was itchy and hurt to touch. The rash spread down the chest to the abdomen. The further away from the site the rash got, the less itchy and painful it was. The rash was gone the next day.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoacusis, Hypotension, Lip discolouration, Loss of consciousness, Seizure
Clinical narrative: Within 10 minutes of receiving the vaccine, the patient passed out and began convulsing.  Convulsions lasted about 6-7 seconds and she was unconscious for about 10 seconds. She regained consciousness and was semi-alert for maybe 30 seconds and then passed out again and convulsed again for a longer period of time (approximately 10-20 seconds).  She turned whitish/green in color, lips were white and she reported that she could not hear.  I called 911 to our residence and she was assessed.  Her blood pressure was on the lower end. Her heart rate was within normal range for her age. The paramedics noted that her reaction was not typical for a flu vaccine.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Skin discolouration
Clinical narrative: Within 10 minutes of receiving the vaccine, the patient passed out and began convulsing.  Convulsions lasted about 6-7 seconds and she was unconscious for about 10 seconds. She regained consciousness and was semi-alert for maybe 30 seconds and then passed out again and convulsed again for a longer period of time (approximately 10-20 seconds).  She turned whitish/green in color, lips were white and she reported that she could not hear.  I called 911 to our residence and she was assessed.  Her blood pressure was on the lower end. Her heart rate was within normal range for her age. The paramedics noted that her reaction was not typical for a flu vaccine.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: PT SEEN IN CLINIC TODAY WITH LOCAL REACTION TO THE FLU SHOT, L ARM RED AND WARM TO TOUCH. REDNESS MEASURED BY PROVIDER 7.75 CM. PROVIDER ADVISED PT TO APPLY ICE AND TO TAKE IBUPROFEN. DENIES HA NO FEVER
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysphagia, Throat irritation, Throat tightness
Clinical narrative: Was pre-medicated with 25mg Benadryl per  request. has had mild throat irritation " scratchy"after vaccines in the past. Flu vaccine give at 8:33 AM 15 minutes after vaccine given developed throat scratching sensation, no airway swelling, no angioedema, no difficulty breathing. vss 45 minutes after vaccine stated felt like her throat felt "full" and mild difficulty swallowing. no difficulty breathing and no airway swelling noted. Was sent to ED department and was given an additional 25mg orally and 8 mg of Decardron IM. Was monitored in ED and discharged home at 12:50 pm
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted approximately one minute after receiving immunization upon standing.  She was out for about 5-10 seconds and came to.  No signs of injury to head or body.  Follow up with parents stated that patient was fully recovered and doing fine.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: did fall and hit head as part of fainting; did fall and hit head as part of fainting; This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On an unknown date (reported as within last few months), the patient was vaccinated with an unspecified dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiration date, strength and dose were not reported) administered intramuscularly for human papillomavirus (HPV) prevention. The patient fainted after the administered dose and was observed in the office after fainting. Treatment for fainting was not specified. It was also reported that the patient might have fallen and hit head as part of fainting. The office called 9-1-1 and patient was taken to unspecified medical facility (not believed to be a hospital) for an unspecified treatment and release. It was unknown if any laboratory tests were performed for the events. The outcome of faint was reported as recovered. The outcome of head injury was not provided.   The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, faint was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA008572:
Age: 13.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MMR, MNQ, TD, UNK, VARCEL
Symptoms: Syncope
Clinical narrative: Pt had a syncope after the 9th vaccine that lasted few seconds. Pt become complete alert/Oriented X4, cooperative. Pt ambulatory without complains at time of discharge.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Periorbital swelling, Pyrexia
Clinical narrative: About 5 hours after the vaccination symptoms: eyes puffy, muscle aches,  fever, malaise.  Took Tylenol and Benedryl.   did not seel Medical attention. symptoms resolved in 36 hours.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Head discomfort, Headache, Injection site pain, Nausea
Clinical narrative: sudden pain injection site, dizziness with things spinning, light headed with pressure in head and nausea
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Vertigo
Clinical narrative: sudden pain injection site, dizziness with things spinning, light headed with pressure in head and nausea
Age: 71.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Muscle spasms, Vomiting
Clinical narrative: cramps, diarrhea, vomiting
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Patient states she started having a red rash develop on her back that were itchy about 8 hours after she received the vaccine.  She used anti-itch lotion and diphenhydramine which helped with the itchiness.  The next morning she started to have red, itchy welts develop on her chest, however her back was improved.  She is still using the lotion and diphenhydramine for her symptoms.  Recommended she continue to use these therapies, and if her symptoms worsen then to contact her provider.  The patient also stated this was the second time in her life that she got a flu vaccine, the first time was in 2018.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Dyspnoea, Mobility decreased
Clinical narrative: Vax- Fluzone HD (unable to enter in box 17)  Returned from PCP and started to experience sudden chills. Used covers/blankets to keep warm and eventually fell asleep. Attempted to get up to pee, but I couldn't move. Body/muscles felt extremely heavy. Took aprox. 20-30 minutes to edge myself to edge of the bed so that I could fall to the floor. Urinated on floor since I was unable to move. Around 3am I was able to inch myself to onto a chair, where I proceeded to call my doctor. Sister took me to see the doctor every day after vaccination.  Complained of the above symptoms and labored breathing. Given albuterol.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Periorbital oedema, Pharyngeal swelling
Clinical narrative: periorbital edema both eyes, throat swelling; initial treatment after swelling became evident I took benedryl 50 mg , once the throat swelling was noted I took prednisone 10 mg by mouth. No progression of symptoms was noted after the prednisone was taken. The time was approximately 1;20 PM. Over the next 2 hours the throat swelling subsided but the periorbital edema lasted for three days.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Febrile convulsion, Septic screen
Clinical narrative: Febrile seizure, was seen at Medical Center ED
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Ammonia normal, Cerebellar ataxia, Coagulation test normal, Full blood count normal, Metabolic function test normal
Clinical narrative: developed acute cerebellar ataxia 8 days after flu vaccine. Normal labs. No imaging done yet since improving.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: 3? in diameter rash
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Multiple Hives on body; seen in urgent care; steroids ordered
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported.; administered MMR II via intramuscular route on 9/17/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 17-SEP-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, intramuscular for prophylaxis, lot # R030810, expiration date 24-OCT-2020 (exact dose was not provided) reconstituted with sterile diluent lot number S002638, expiration date 31-OCT-2021. The patient experienced incorrect route of product administration as intramuscular is not approved route of administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of PEDVAX was administered to the patient; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N024570, expiration date: 01-MAY-2020, dose, unit and route were not reported) for prophylaxis (product storage error). The haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed below 36 Fahrenheit (F) degrees (32.1F) for 8 hours. There were no previous temperatures excursion and the call was because of data logger involved. No adverse effects were reported. No product quality complaints involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; an unspecified patient was administered 1 dose of expired MMR II; This non-valid spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-OCT-2019, the patient was vaccinated with 1 expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rHA, lot # N025891, expiration date 19-SEP-2019 (exact dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse event reported.  This case is non-valid due to lack of the patient's identifiers.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; a second dose of Hepatitis A, VAQTA, at 5 months and 7 days after my first dose of HAVRIX instead of 6 months; This spontaneous report as received from a patient of unknown age and gender reporting on herself. No information regarding the patient's concurrent conditions and concomitant medications was reported.       On 30-SEP-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) injection (route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis. It was reported that the patient received a "second dose" of vaccine, inactivated (VAQTA), at 5 months and 7 days after the first dose of hepatitis A virus vaccine inactivated (HAVRIX) instead of 6 months. No adverse effects were reported. Product quality complaint was not involved.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; A patient received a dose of VAQTA on 01/29/2018, on 07/31/2018, and on 09/25/2019; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 29-JAN-2018, the patient received their fist dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). On 31-JUL-2018, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). On 25-SEP-2019, the patient was administered a third dose of  hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) (extra dose administered).    No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included properly stored sterile diluent.   On 13-AUG-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, dose number, route of administration and location of administration were not reported) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020 (the reporting nurse was unable to determine which lot was administered to the patient), administered for prophylaxis.   The vaccine was exposed to a temperature range of -14 degree Celsius to -10 degree Celsius (-9.74 degree Celsius) for an unknown time frame as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Reaction to excipient
Clinical narrative: Arm still itches below the injection site; Swatch that is stll reddened and discolored; discolored; Reaction to artificial sweeteners; This case was reported by a consumer and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site erythema, injection site discoloration and reaction to drug excipient. The patient was treated with benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the injection site itching, injection site erythema, injection site discoloration and reaction to drug excipient were not recovered/not resolved.   The reporter considered the injection site itching, injection site erythema, injection site discoloration and reaction to drug excipient to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient received Shingrix last Thursday and it said side effects are 2 to 3 days. The patient's arm was still itches below the injection site and there was a swath about 3 X 6 that was still reddened and discolored. The patient putting Benadryl cream on it. The patient wanted to know why the patient had reaction after 8 days. The patient asked if there was something in vaccine that giving a reaction, was there any latex involved in the packaging, vial top, or in the vaccine or any artificial sweetner? The patient did not see that it did not have preservatives and no phenol. The pharmacist stated that Shingrix does not contain preservatives. The vial stoppers were not made with natural rubber latex. Each dose also contains 20 mg of sucrose (as stabilizer), 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. The patient asked whether the virus itself causing the reaction. The pharmacist stated that unsolicited adverse events that occurred within 30 days following each vaccination were recorded on a diary card by all subjects. Unsolicited adverse events that occurred in more than 1percentof recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo included chills (3.5percentversus 0.2 percent), injection site pruritus (2.2percentversus 0.2 percent). The patient reported that polysorbate is a sorbitol derivative and that is an artificial sweetener and the patient had reactions to artificial sweeteners.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pruritus, Reaction to excipient
Clinical narrative: itchy at injection site; injection site sicolored; reactions to product; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th September 2019, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site discoloration and reaction to drug excipient. The patient was treated with benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the injection site itching, injection site discoloration and reaction to drug excipient were not recovered/not resolved.   The reporter considered the injection site itching, injection site discoloration and reaction to drug excipient to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient was talking to a pharmacist about ingredients and had to leave. The patient received Shingrix 8 days ago, the patient had swatch about 3 inches by 6 inches on the arm. The patient's arm was still itches below the injection site and still discolored. The patient putting Benadryl cream on it twice daily. It seems the diluent as it tried to absorb downward on the arm by gravity caused the reaction. The reported that the vaccine had Polysorbate in it and that is a Sorbitol derivative. The patient was concerned if it would be worse with the second one and if the patient get any other vaccines this year with that ingredient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Rash, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Rash that was extremely itchy; flu like symptoms; aching; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 26th September and experienced pain, flu like symptoms, refer case US2019183593).   On 26th September 2019, the patient received the 2nd dose of Shingrix. On 26th September 2019, 20 hrs after receiving Shingrix, the patient experienced influenza-like symptoms and pain. On 1st October 2019, the patient experienced itchy rash. The patient was treated with fexofenadine hydrochloride (Allegra). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain and itchy rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. Approximately 20 hours after receiving Shingrix, the patient experienced aching and flu like symptoms. These symptoms lasted for 24 hours. The patient developed a rash 5 days after receiving the 2nd dose of Shingrix. It was reported that, the rash started on both sides of the chest and spread to the left upper arm and both wrists. The rash was extremely itchy. The patient received Allegra for rash. The reporter consented to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired drug used in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number 49Z43, expiry date 30th June 2019) for an unknown indication.   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced expired drug used. The action taken with Fluarix Quadrivalent 2018-2019 season was unknown. On an unknown date, the outcome of the expired drug used was unknown.   It was unknown if the reporter considered the expired drug used to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were reported as follows: The age at vaccination was not reported.  Nurse on the line reporting the patient was accidentally given Fluarix that was already expired, which led expired drug used. The reporter consented to follow up. This case was linked with case US2019183549, reported by the same reporter.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypotension, Injection site pain, Nausea, Pallor, Vomiting
Clinical narrative: nauseous; threw up; blood pressure was relatively low; Looked pale; Sore at the injection site; This case was reported by a nurse via call center representative and described the occurrence of nausea in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   In August 2019, the patient received Bexsero and the 2nd dose of MENACTRA. In August 2019, less than a day after receiving Bexsero, the patient experienced nausea, vomiting, low blood pressure, pallor and injection site pain. On an unknown date, the outcome of the nausea, vomiting, low blood pressure, pallor and injection site pain were unknown.   It was unknown if the reporter considered the nausea, vomiting, low blood pressure, pallor and injection site pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero in unknown arm and dose of Menactra in other arm. The nurse treported that, after vaccination, the patient went and sat in the car. It was hot outside and the patient started to get nauseous and threw up. The patient came back in doctor's office and they took her blood pressure and it was relatively low. The patient also looked pale. The next day after vaccination, the nurse called to the patient and was still had soreness at the injection site. No additional details were provided. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: In the morning following the injection, I felt tired, there was some pain around the injection site, also felt chilled.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site pain, Rotator cuff syndrome, Tendonitis
Clinical narrative: 4 hours after vaccine given in left arm, patient reported increased pain in left should.  Over the next three days the pain and difficulty in moving her arm at the shoulder intensified.  She was seen by an orthopedic physician on site three days after vaccine administration and was diagnosed with Tendonitis versus Rotator Cuff Injury.  She was prescribed steroids.  She reported feeling much better but not 100% at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient came in on 10/14/2019  for flu shot.   Patient was given the flu vaccine in his left deltoid.  The next day, patient states mom had  noticed a small red area on his upper left deltoid.  Patient went to school in the school called dad the afternoon of 10/15/2019.  the school had said the patient had swelling with red reaction starting on his left deltoid.  When dad picked patient up,  he noticed about 2 in below the injection site red swelling.  Dad circled the reaction and over 1-2 hours  later dad  noticed that the  reaction had gotten larger.   Dad called pediatrician's office and spoke to the medical assistant.   He said he had given him Benadryl orally  and apply Benadryl cream to the red area.  Dad did not notice  a difference with the Benadryl.   Dad  e-mailed to pictures of patient's left deltoid.    dad said he got red swollen and hot he brought patient in.   when patient got here he had blisters on his left deltoid.  He was given a steroid shot a dexamethasone.  Mom states patient is better today but is still swollen.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Lethargy, Pain, Swollen tongue, Tongue erythema
Clinical narrative: about 24 hours after receiving patient felt achy all over and very lethargic for 3 days. On the 4th day her tongue swelled on outside of tongue with redness. The redness is still present but swelling has gone down.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Insomnia, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Patient contacted pharmacy morning (around 9:30am) of 10/16/19 reporting sore arm that was difficult to sleep on, welt was developing around injection site area, and red itch rash traveling down her arm about 6 inches.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient contacted pharmacy morning (around 9:30am) of 10/16/19 reporting sore arm that was difficult to sleep on, welt was developing around injection site area, and red itch rash traveling down her arm about 6 inches.
Age: 19.0
Sex: U
Vaccine: FLU4
Symptoms: Chest X-ray, Computerised tomogram head, Confusional state, Laboratory test, Lethargy
Clinical narrative: Patient was seen in the ED on 10/15-10/16 due to lethargy, fever, confusion. he was diagnosed with viral syndrome after having a Lumbar puncture, CT scan of head, labs, and chest xray. patient is new and did not mention he had flu vaccine on 10/14. he speaks different language.
Age: 19.0
Sex: U
Vaccine: FLU4
Symptoms: Lumbar puncture, Pyrexia, Viral infection
Clinical narrative: Patient was seen in the ED on 10/15-10/16 due to lethargy, fever, confusion. he was diagnosed with viral syndrome after having a Lumbar puncture, CT scan of head, labs, and chest xray. patient is new and did not mention he had flu vaccine on 10/14. he speaks different language.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Very itchy for a day an a half.  Huge painful welt about the size of the palm of my hand at the injection site.
Age: 71.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Cold sweat, Dizziness, Muscular weakness
Clinical narrative: PATIENT REPORTS WAKING THE MORNING AFTER RECEIVING VACCINES, EXPERIENCING COLD SWEAT, DIZZINESS, AND BILATERAL WEAKNESS IN LOWER EXTREMITIES. PATIENT REPORTS THAT SYMPTOMS RESOLVED AFTER LYING DOWN AGAIN FOR ABOUT AN HOUR.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Per patient report, shoulder pain in same arm as injection administered, right arm pinky was numb and next day burning pain reported.  Next day the numbness was gone but still a dull pain.  The burning pain was noted on day 2 on right side of neck.  Took tylenol every 4-5 hours with some noted improvement because that is what patient had on hand.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient states she has developed redness and swelling at the injection site and surrounding area
Age: 13.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Per Dr. Recommendation due to child's fear of needles and need to catch up on immunization, Pediarix was given. MD and legal guardian informed of questionable validity after.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: LOCALIZED PINK ROUND AREA, PAINFUL TO TOUCH, WARM TO HOT FEELING, SIZE IS GROWING IN A DAY.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: PATIENT STATES THAT THEY HAD LOWER BACK PAIN, JOINT PAIN ALL OVER THE BODY.  JOINT PAIN AND LOWER BACK HAS GOTTEN BETTER BUT SOMETIMES HAS A KNEE TO ANKLE SHOOTING PAIN ON THE LEFT LEG.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: I have not seen the patient all info via phone. Patient described pain and swelling at injection site in Left Deltoid, stated that 1.5 days after injection a rash appeared a few inches below injection site. I tried to clarify if rash or redness, she was unsure. Stated that it is about 2 x3 inch area or rash/redness and warm to touch.  Now the swelling is gone but the redness/rash persists.  Patient weighs 140 lbs and a 25g 1 inch needle was used. Patient has call in to her MD.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Induration, Local reaction, Tenderness
Clinical narrative: Local reaction with erythema, induration, and tenderness.  No fever, generalized aching, rash, hives.
Age: 49.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Loss of personal independence in daily activities, Malaise, Pain, Pain in extremity
Clinical narrative: Approximately 5 hours after receiving injection began having moderated right arm pain which gradually worsened. By next morning was having severe arm pain (unable to raise arm without pain, couldn't touch arm or lie on it), malaise, and slight headache. Did not notice swelling or redness at injection site. Other symptoms subsided but arm pain persists. Pain now less severe but still present ; less pain with ROM; still has activity limitations with right arm due to pain.
Age: 49.0
Sex: M
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Approximately 5 hours after receiving injection began having moderated right arm pain which gradually worsened. By next morning was having severe arm pain (unable to raise arm without pain, couldn't touch arm or lie on it), malaise, and slight headache. Did not notice swelling or redness at injection site. Other symptoms subsided but arm pain persists. Pain now less severe but still present ; less pain with ROM; still has activity limitations with right arm due to pain.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Chills, Headache, Influenza like illness
Clinical narrative: less than 12 hours after vaccination  flu like symptoms  fever chills, headache, joint pain  hands knees hips shoulders lower back and neck
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Neck pain, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor increased
Clinical narrative: less than 12 hours after vaccination  flu like symptoms  fever chills, headache, joint pain  hands knees hips shoulders lower back and neck
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Viral test negative
Clinical narrative: less than 12 hours after vaccination  flu like symptoms  fever chills, headache, joint pain  hands knees hips shoulders lower back and neck
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Hallucination, Hyperhidrosis, Pain, Pyrexia, Vomiting
Clinical narrative: At 12:30 am I woke up feverish and sweating for the rest of the night, threw up for about an hour then tried to go back to sleep but was hallucinating as I tried to sleep. Fever finally broke arounf 7am and I was able to sleep. Body remained achey for 48 hours after vaccine.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events that I am aware of.  Pt was informed after receiving high dose that pt should have received regular dose and the potential of increased local reactions.  Pt had stated understanding.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Allergy test, Antinuclear antibody, Full blood count, Influenza virus test, Mental status changes
Clinical narrative: Fever Myalgia Hives Alerted mental status
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Mononucleosis heterophile test, Myalgia, Mycoplasma test, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Fever Myalgia Hives Alerted mental status
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rheumatoid factor, Streptococcus test, Urticaria
Clinical narrative: Fever Myalgia Hives Alerted mental status
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Pruritus and hives, persisting for >24 hours following vaccine administration. Resolves with Benadryl. No anaphylaxis.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Breast pain, Chills, Injection site pain, Lethargy, Lymph node pain
Clinical narrative: Body aches fever chills lethargic sore throat moderate left breast pain moderate site pain moderate left arm to hand pain enlarged clavical lymph node  and pain
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches fever chills lethargic sore throat moderate left breast pain moderate site pain moderate left arm to hand pain enlarged clavical lymph node  and pain
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Was reported to me that by the teacher at the school where patient had received her vaccine, that patient had returned to class that afternoon and was becoming short of breath. Went to her doctors office. they gave her Benadryl and steroids.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: the patient passed out and went white when given the shot, she was unresponsive, pt's mother began calling her name, employee asked the mother if she wanted us to call 911, mother didn't respond, patient came around, was given a bottle of water and went on their way
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis, Hypertension, Pain, Pyrexia, Swelling
Clinical narrative: pt received both the pneumovax 23 and flublok  vaccine in the left arm.  By the evening the patient experienced extreme pain and swelling as well as reporting a fever of 100.2. She called her son, who then advised she be transported by ambulance to the hospital.  She was treated for bursitis and hypertension.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Fatigue, Headache, Muscle spasms
Clinical narrative: Joint pain, headache, chills, fatigue, nausea, muscle cramps & pain
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea
Clinical narrative: Joint pain, headache, chills, fatigue, nausea, muscle cramps & pain
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Injection site pain, Injection site swelling, Joint noise, Joint range of motion decreased
Clinical narrative: About 4-5 hours after injection I had pain and swelling at the injection site which was high on my left arm. Severe pain in shoulder and arm for one week then continued with moderate pain, weakness and limited range of motion due to pain. Crepitus with motion. Had orthopedic evaluation 10/4/19. Normal Xray
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity, X-ray normal
Clinical narrative: About 4-5 hours after injection I had pain and swelling at the injection site which was high on my left arm. Severe pain in shoulder and arm for one week then continued with moderate pain, weakness and limited range of motion due to pain. Crepitus with motion. Had orthopedic evaluation 10/4/19. Normal Xray
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: fever, swollen Arm, Redness on Arm (left) where pneumovax was administered.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury
Clinical narrative: Child was standing by the check out counter when she started to fall backwards. She hit the back of her head on the wall as she fell. Pt. was reseen by Dr. and a blood preasure was take.
Age: 13.0
Sex: F
Vaccine: FLUR4, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered was not Age appropriate. Patient was notified (Parents) & Pt had no adverse reaction.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered was not age appropriate. Parents were notified & they report no adverse reaction
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Pain
Clinical narrative: Patient called and said that he felt - after receiving the 2nd Shingrix shot, very tired and achy all over and had to leave work, He said that he had a similar reaction to the first Shingrix shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm upper deltoid with swelling no increased redness 8-9 hours after immunization and hot. Sx 4x has helped but cont swelling with redness 24 hr after injections. Benadryl prn helping.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week 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. The age group was not reported, but was selected as adult as per vaccine indication. The patient developed a case of shingles within 24 to 48 hours. The reporter was enquiring about what he should suggest to his patient about receiving 2nd dose and also if the dose administered to the patient given a case of the shingles to the patient, if so, what was the percentage chance of that happening. The reporter consented to follow up. This case had been linked to the case US2019186035, reported by the same reporter.