chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Muscular weakness, Mycobacterium tuberculosis complex test negative, Paralysis, Polyneuropathy
Clinical narrative: 10/13/2019 - 12 days after flu shot, he developed numbness of face, feet, and then hands,  and "abnormal hot and cold sensations."  Taken to ER, had negative stroke work up (Head CT, MRA) and stroke ruled out so he left and went home. Next morning awoke and was having diplopia,  was paralyzed in both  his feet, was unable to walk, both hands became more numb, unable to grasp objects, areflexia, returned to ER, was diagnosed with Guillain Barré. Became confused, speech garbled, developed left facial paralysis and eyelid droop, and right sided facial weakness, was lethargic for couple days. LP showed increased number of lymphocytes, elevated protein; Was transferred to higher level of care on 10/18/2019 to Medical Center. Truncal ataxia was noted at that time, reflexes absent, unable to sit up,  still unable to walk. Had further work up,  lots of lab tests, repeat LP similar; CXR showed some old calcified nodes, so underwent bronchoscopy looking for  possible sarcoid but no granulomas were seen in specimens.  Was treated with 5 days of IVIG with signs of slight improvement over that period of time, continued to very slowly improve, , diplopia and Facial CN findings resolved, continued with numbness and weakness of all 4 extremities with very slow improvement.  Given IV steroids after the IVIG, and then switched to oral prednisone. Was hospitalized until November 6, 2019, then transferred to Skilled Nursing Facility, to receive physical therapy, continued on  prednisone.  Final diagnosis was Acute inflammatory polyneuropathy.   Still in Skilled Nursing Facility, very slow recovery of function, still unable to walk independently, somewhat slurred speech, some word finding difficulty. My impression (Not the attending )   Diagnosis is consistent with Bickenstaff's  Brainstem encephalitis with Guillain Barré following Flu shot..
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Posture abnormal, Speech disorder
Clinical narrative: 10/13/2019 - 12 days after flu shot, he developed numbness of face, feet, and then hands,  and "abnormal hot and cold sensations."  Taken to ER, had negative stroke work up (Head CT, MRA) and stroke ruled out so he left and went home. Next morning awoke and was having diplopia,  was paralyzed in both  his feet, was unable to walk, both hands became more numb, unable to grasp objects, areflexia, returned to ER, was diagnosed with Guillain Barré. Became confused, speech garbled, developed left facial paralysis and eyelid droop, and right sided facial weakness, was lethargic for couple days. LP showed increased number of lymphocytes, elevated protein; Was transferred to higher level of care on 10/18/2019 to Medical Center. Truncal ataxia was noted at that time, reflexes absent, unable to sit up,  still unable to walk. Had further work up,  lots of lab tests, repeat LP similar; CXR showed some old calcified nodes, so underwent bronchoscopy looking for  possible sarcoid but no granulomas were seen in specimens.  Was treated with 5 days of IVIG with signs of slight improvement over that period of time, continued to very slowly improve, , diplopia and Facial CN findings resolved, continued with numbness and weakness of all 4 extremities with very slow improvement.  Given IV steroids after the IVIG, and then switched to oral prednisone. Was hospitalized until November 6, 2019, then transferred to Skilled Nursing Facility, to receive physical therapy, continued on  prednisone.  Final diagnosis was Acute inflammatory polyneuropathy.   Still in Skilled Nursing Facility, very slow recovery of function, still unable to walk independently, somewhat slurred speech, some word finding difficulty. My impression (Not the attending )   Diagnosis is consistent with Bickenstaff's  Brainstem encephalitis with Guillain Barré following Flu shot..
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, headache beginning the morning after vaccine was administered. Symptoms were largely alleviated with rest and over the counter fever reducer/pain reliever
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Cough, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Red inflamed bump where injection was given, 104 fever loss of breathe  rash  cough  runny nose  body weakness
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Rash, Respiratory arrest, Rhinorrhoea
Clinical narrative: Red inflamed bump where injection was given, 104 fever loss of breathe  rash  cough  runny nose  body weakness
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Biopsy skin, Computerised tomogram, Dysphagia, Electromyogram
Clinical narrative: Within a month of the dose noted core weakness, difficulty in swallowing, rash to face and chest, itching to skin and scalp
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Mammogram, Pruritus, Rash
Clinical narrative: Within a month of the dose noted core weakness, difficulty in swallowing, rash to face and chest, itching to skin and scalp
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Pt looked palor, felt very dizzy and fainty. Pt was assisted to sitting/lying position to help elevate blood pressure. Pt mother and a friend trauma nurse, were present at scene to provide child with first aid care. Pt recover after 15-20 minutes and color return to face.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Magnetic resonance imaging, Pain
Clinical narrative: - VACCINATED 11/4/19, PAIN ARRIVED AND CONSISTENT THE NEXT DAY. MORE PAIN CONTINUED 14 DAYS LATER, SAW MD. CURRENTLY IN PT. STATE SHOT WAS PREVIOUSLY IN DELTOID, CONCERN WITH ROTATOR CUFF + BICEP - IN PHYSICAL THERAPY.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: According to pt, he experienced numbness after shot, it disappeared gradually. He has minor pain when he rites things with his (L) arm. He didnt see a doctor for that
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Renal disorder, Renal transplant
Clinical narrative: shingles; Kidney Disease; Information has been received on 06-DEC-2019, from a lawyer and an approx. 62-year-old male patient (pt) via a Plaintiff Fact Sheet. The pt had a history of chicken pox diagnosed in 1960s, at approx. 6-8 years of age. He has never received chicken pox vaccine. The pt was a former smoker (cigarettes, 1-2 pack a day) from 1970s to 2003. In the seven (7) years preceding his zoster vaccine live (ZOSTAVAX)-vaccination to the present he received inpatient or outpatient care for the throat cancer from January 2003 to December 2003. His other medical conditions diagnosed by a healthcare provider, other than those alleged to be caused by zoster vaccine live (ZOSTAVAX), for which the pt required hospitalization or recurrent medical care and treatment or medication at any time during the seven (7) years preceding his vaccination to the present included high blood pressure and high cholesterol from 1990s, back surgery in early 2000s and throat cancer in 2003. His prescription medication taken on a regular basis in the seven years preceding zoster vaccine live (ZOSTAVAX) vaccination to the present included: nifedipine 30-90 mg, from 1990s, for high blood pressure and fenofibrate 54 mg, from 1990s, for high cholesterol. Before receiving zoster vaccine live (ZOSTAVAX), he was treated with radiation therapy for throat cancer in 2003. On 03-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) injection, in the arm (dose, route of administration, exact vaccination site, lot # and expiry date were not specified) at a pharmacy for prophylaxis as prescribed by a physician. The pt claimed he suffered the following injuries caused by zoster vaccine live (ZOSTAVAX): shingles (herpes zoster). He first became aware of the injury in the end of July 2016, when his scalp was sensitive and then on 02-AUG-2016, he noticed a rash and went to the doctor. On 02-AUG-2016, he was diagnosed with shingles by a physician and received treatment with lidocaine patches. The physician said that with everything considered it was probably the vaccine that caused the pt to have the outbreak. The pt did not know if a test was performed to determine if the rash was wild type or vaccine strain varicella zoster virus. The HCP did not tell him that he had vaccine strain varicella zoster virus. His other vaccinations included yearly flu shot and pneumonia vaccine (with no side effects).   Information received on 06-DEC-2019, contained the following adverse event: kidney disease (treated in 2016 with kidney transplant, steroids (prednisone 5 mg), mycophenolate mofetil (CELLCEPT) 500 mg, tacrolimus 0.5 mg and since 2019, tacrolimus (ENVERSUS) 0.75 mg).  Upon internal review, the event of kidney disease was determined to be medically significant due to the kidney transplant.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, PPV, UNK
Symptoms: Fatigue, Injection site erythema, Injection site pain, Limb discomfort
Clinical narrative: Developed (LOCALIZED RASH) (a big reD arm band) around my upper Left arm where he gave me the two shots about 1 1/2 INches apart from each other. I felt sore - tired and ill after getting the two shots. I begged him to give me just one shot AND I would be back NEXT week for the other. He INstisted I get both shots.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, PPV, UNK
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Malaise, Pain
Clinical narrative: Developed (LOCALIZED RASH) (a big reD arm band) around my upper Left arm where he gave me the two shots about 1 1/2 INches apart from each other. I felt sore - tired and ill after getting the two shots. I begged him to give me just one shot AND I would be back NEXT week for the other. He INstisted I get both shots.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, PPV, UNK
Symptoms: Rash
Clinical narrative: Developed (LOCALIZED RASH) (a big reD arm band) around my upper Left arm where he gave me the two shots about 1 1/2 INches apart from each other. I felt sore - tired and ill after getting the two shots. I begged him to give me just one shot AND I would be back NEXT week for the other. He INstisted I get both shots.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Within several hours developed soreness, hardness at injection site.  By late afternoon/early evening I began feeling very tired.  Developed headache and muscle soreness by 7 p.m.  As evening progressed became increasingly tired, headache worsened (sinus back of head).  Felt weak.  Began shivering (fever).  My wife took my temperature several times and it was 100.4. Overnight I was miserable with the headache, muscle soreness (everywhere) and by morning still had the fever (100.2).  As the day (Saturday) progressed began to feel somewhat better. The headache had mostly subsided, some  soreness persisted, felt stronger.  By Sunday morning felt much better.  No specific treatment for the symptoms other than fluids.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Within several hours developed soreness, hardness at injection site.  By late afternoon/early evening I began feeling very tired.  Developed headache and muscle soreness by 7 p.m.  As evening progressed became increasingly tired, headache worsened (sinus back of head).  Felt weak.  Began shivering (fever).  My wife took my temperature several times and it was 100.4. Overnight I was miserable with the headache, muscle soreness (everywhere) and by morning still had the fever (100.2).  As the day (Saturday) progressed began to feel somewhat better. The headache had mostly subsided, some  soreness persisted, felt stronger.  By Sunday morning felt much better.  No specific treatment for the symptoms other than fluids.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Malaise, Pain
Clinical narrative: Body aches, chills, headache, malaise (significant enough for me to be unable to work) began within 24 hrs after injection and lasted 36 hrs.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; the patient was inadvertently administered a dose of PROQUAD, that was expired.; This spontaneous report as received from registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 20-NOV-2019, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R013575 (therapy type: recombinant Human albumin (rHA)), expiration date 10-NOV-2019; strength, vaccine dosage detail, route of administration were not reported) for prophylaxis (expired product administered). No additional adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; a patient was administered an improperly stored VARIVAX that was reconstituted with properly stored DILUENT.; a patient was administered an improperly stored VARIVAX that was reconstituted with properly stored DILUENT.; This spontaneous report was received from a medical assistant referring to a 3 week old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not reported.    On 02-DEC-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength and route were not provided; lot# S020464, expiration date reported as 21-JUL-2021, but internal generated as 02-JUL-2021; lot# S021928, expiration date 15-JUL-2021) for prophylaxis (product storage error and product administered to patient of inappropriate age). The vaccine was reconstituted with properly stored diluent. The temperature/time frame included 15 degree fahrenheit to 46 degree fahrenheit (35.7 F) for 2 hours. There was no previous temperature excursion. No data logger was involved. No additional adverse events were reported.
Age: 0.17
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the patient did not experience any symptoms; the patient, who is 2 months old, was administered one dose each of MMR II and VARIVAX.; the patient, who is 2 months old, was administered one dose each of MMR II and VARIVAX.; This spontaneous report was received from a registered nurse, referring to a 2-month-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported, and concomitant medications included hib conj vaccine (ompc)(PEDVAXHIB), pneumococcal 13v conj vaccine (crm197)(PCV 13), rotavirus g1 p1 vaccine live (89-12)(ROTARIX) and hepatitis a virus vaccine inactivated (HAVRIX).      On 04-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) the first dose, administered subcutaneously as prophylaxis (anatomical location, lot number S005248 has been verified to be a valid, expiration date not reported but validated as 20-FEB-2021) and varicella virus vaccine live (oka/merck)(VARIVAX) the first dose, administered subcutaneously (anatomical location, lot number S021320 has been verified to be a valid, expiration date not reported but validated as 09-JUL-2021) (product administered to patient of inappropriate age and inappropriate schedule of vaccine administered).   The patient did not experienced any symptoms.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; an improperly stored dose of ROTATEQ was administered to a patient on 12/3/2019.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 03-DEC-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R016790, expiration date 20-APR-2020; dosage detail and strength were not reported) orally for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 53 degrees Fahrenheit (F) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect; the patient was inadvertently administered a dose of VARIVAX on 12/3/2019 that had been improperly stored; This spontaneous report was received from a physician concerning  a patient of unknown age and gender.  Concomitant therapy included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug allergies or reactions were not reported.     On 03-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S020464 and expiration date 02-JUL-2021 ) for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of 9.3°C degrees Fahrenheit for 1 hour as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Vaccine was inadvertently administered; This spontaneous information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  In 10-DEC-2019, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (lot number: 1621934 with expiration date: 29-JAN-2022) (strength and route of administration were not reported) (incorrect product storage).  The reporter was unable to provide the temperature excursion timeframe or estimated temperature the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was exposed to. The call was not because of the data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No additional adverse event.; less than the full recommended dose of VARIVAX (Lot#S024363/Exp:8/6/2021) was administered, because the patient moved".; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 11-DEC-2019, the patient was vaccinated with less than the full recommended dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S024363, expiration date 06-AUG-2021; strength, dose and route were not reported) for prophylaxis, because the patient moved (incorrect dose administered). No additional adverse event was reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events; Administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 10-DEC-2019, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, anatomical location were unknown) with lot # 1621934 and expiration date 29-JAN-2022 for prophylaxis (product storage error). Reporter stated that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) shipment was received on 09-DEC-2019 and "received by date" was 06-DEC-2019. Reporter unable to provide temperature excursion timeframe or estimated temperature the vaccine was exposed to. No additional adverse events were reported. There was no previous temperature excursion. Data logger was not involved. There was no product quality complaint associated with the case.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events; a 6 months old patient was administered proquad; This spontaneous report as received from a medical assistant refers to a 6 month old patient. The patient's medical history and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent.   On 13-NOV-2019, a 6 months old patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # and expiry date was not reported) for prophylaxis (product administered to patient of inappropriate age).  No additional adverse events were reported.
Age: 0.33
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No symptoms being reported from patient/ family; inadvertently received dose of Gardasil 9 in error as Prevnar 13 was ordered; This spontaneous report was received from a health professional (medical assistant) referring to a 4 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies were not reported. Concomitant therapies included diphtheria toxoid, hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) and rotavirus g1 p1 vaccine live (89-12) (ROTARIX). On 28-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) once, lot number 1614898 and expiry date 15-NOV-2021, (strength, route of administration and anatomical location were not reported) for prophylaxis in error, as PREVANAR 13 was ordered (wrong product administered). The reporter confirmed that it was a human error and not product confusion. No adverse events were reported. No product quality complaint (PQC) was reported.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong vaccine administered; wrong vaccine administered; soreness where the injection of SHINGRIX; This case was reported by a consumer and described the occurrence of injection site pain in a 43-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 9th November 2019, the patient received Shingrix .5 ml. On 9th November 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. In November 2019, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: Shingrix was administered in left arm and Boostrix was administered in right arm. The patient was accidentally administered by Shingrix instead of Boostrix at the age of 43 years, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient went to the reporter's pharmacy to get a Boostrix injection and the pharmacist inadvertently administered Shingrix instead. As expected, I am experiencing only (so far) soreness where the injection of Shingrix was administered.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain, Red blood cell count decreased, Vaccine positive rechallenge
Clinical narrative: Patient is also feeling extremely tired; Muscle aches; Pains; Low red blood cell count; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of red blood cell count decreased (received 1st dose in August 2019 and experienced red bllod count decreased, feeling extremely tired, with muscle aches and pains, refer case US2019202816).   On 23rd October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tiredness, muscle pain, pain and red blood cell count decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, muscle pain, pain and red blood cell count decreased were recovering/resolving.   It was unknown if the reporter considered the tiredness, muscle pain, pain and red blood cell count decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The reporter stated that the patient red blood cell count was lower than it should be, and also felt extremely tired, with muscle aches and pain. The endocrinologist recommended the patient to the hematologist because the blood cell count was low enough that it merits an hematologist. The reporter stated that the patient thinks the red blood cell count was around 110,000. This case has been linked with cases US2019202829 and US2019202816 reported by the same reporter.      Lab Comments: lab test done on unknown date
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Back pain, Chills, Erythema, Headache
Clinical narrative: injection site rash; numerous red blemishes on body; body ache; headache; Back ache; Canker sores; Tooth pain; Sore throat; Chills; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (received 1st dose on 30th August 2019 and experienced Numerous red blemishes on body body aches head ache back ache canker sores tooth pain sore throat chills).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills were unknown.   It was unknown if the reporter considered the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe reaction, rash at injection site, numerous red blemished on body, body aches, headache, backache, canker sore, tooth pain and sore throat chills. It was unknown if the reporter consented to follow up.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Oropharyngeal pain, Pain, Toothache, Vaccine positive rechallenge
Clinical narrative: injection site rash; numerous red blemishes on body; body ache; headache; Back ache; Canker sores; Tooth pain; Sore throat; Chills; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site rash (received 1st dose on 30th August 2019 and experienced Numerous red blemishes on body body aches head ache back ache canker sores tooth pain sore throat chills).   On 29th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills were unknown.   It was unknown if the reporter considered the injection site rash, localized erythema, general body pain, headache, back pain, aphthous stomatitis, toothache, sore throat and chills to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe reaction, rash at injection site, numerous red blemished on body, body aches, headache, backache, canker sore, tooth pain and sore throat chills. It was unknown if the reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: head and body aches; head and body aches; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, general body pain and shivering. On an unknown date, the outcome of the headache, general body pain and shivering were unknown.   It was unknown if the reporter considered the headache, general body pain and shivering to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced head and body and shivering. The patient asked if contagious to any children who have not had chicken pox or the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Rash
Clinical narrative: rashes on their hands; Accidental Exposure/reported rashes on their hand from accidentally gettig vaccine on them; Accidental Exposure; This case was reported by a nurse via call center representative and described the occurrence of rash in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the rash, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was received as follows: The age group was not reported but was captured as Adult as per vaccine indication. Nurse on the chat reported some of their coworkers who give the vaccine had reported rashes on their hand from accidentally getting the vaccine on them.This led to exposure via skin contact and inadvertent exposure to vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: feet were tingling at bottom of sole of the feet; numbness has moved up to the calf and then it it continued moving up to her thigh and pelvic area; difficulty using the restroom; This case was reported by a nurse via sales rep and described the occurrence of tingling in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 3425X, expiry date 18th December 2021) for prophylaxis.   On 21st November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced numbness in leg and activities of daily living impaired. On 21st November 2019, the patient experienced tingling. On an unknown date, the outcome of the tingling was unknown and the outcome of the numbness in leg and activities of daily living impaired were recovering/resolving.   It was unknown if the reporter considered the tingling, numbness in leg and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 21st November 2019, late morning, the patient received the 1st dose of Shingrix vaccine and later that evening, patient reported that her feets were tingling at bottom of sole of the feet. The patient also reported that the numbness has moved up to the calf and then it it continued moving up to her thigh and pelvic area. The patient said that based on where the numbness was located, she had difficulty using the restroom..
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Nausea, Pain in extremity
Clinical narrative: upset stomach; sore arm; queasy; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced upset stomach, pain in arm and queasy. On an unknown date, the outcome of the upset stomach, pain in arm and queasy were recovering/resolving.   It was unknown if the reporter considered the upset stomach, pain in arm and queasy to be related to Shingrix.  Additional details were received as follows: The patient experienced upset stomach, he was queasy and had a sore arm. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: two bumps behind his ear; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient broke out with two bumps behind his ear after receiving the Shingrix vaccine. The reporter was unwilling to provide any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: light redness, about 2 inches in diameter around the injection sit; pain; This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were resolved with sequelae.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient noticed light redness, about 2 inches in diameter around the injection site and also had pain in her arm for 4 to 5 days.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but it was taken as an adult as per vaccine indicatiion. The pharmist reported that there was a possible Gullian barre syndrome post shingrix in the area. No additional information was provided. The reporter did not consent to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: injection site redness; Injection site swelling; shoulder pain; knots in shoulder muscle; decreased arm mobility; difficulty with daily activities; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine (received vaccine dose years ago from  reporting date). Concomitant products included LEVOTHYROXINE.   On 11th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, shoulder pain, local swelling, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the shoulder pain and local swelling were not recovered/not resolved and the outcome of the mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, shoulder pain, local swelling, mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: On 11th October 2019, The patient received first dose of Shingrix and experienced injection site redness and swelling that has resolved. The patient also experienced shoulder pain and knots in her shoulder muscle that persisted and resulted in decreased arm mobility and difficulty with daily activities. This case has been linked with US2019AMR225727, reported by same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: injection site redness; Injection site swelling; shoulder pain; knots in shoulder muscle; decreased arm mobility; difficulty with daily activities; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine (received vaccine dose years ago from  reporting date). Concomitant products included LEVOTHYROXINE.   On 11th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, shoulder pain, local swelling, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the shoulder pain and local swelling were not recovered/not resolved and the outcome of the mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, shoulder pain, local swelling, mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: On 11th October 2019, The patient received first dose of Shingrix and experienced injection site redness and swelling that has resolved. The patient also experienced shoulder pain and knots in her shoulder muscle that persisted and resulted in decreased arm mobility and difficulty with daily activities. This case has been linked with US2019AMR225727, reported by same reporter.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cardiac arrest, Generalised tonic-clonic seizure, Headache, Limb discomfort
Clinical narrative: Grand Mal Seizure; Ventricular arrythmia; Cardiac Arrest; Sore arm; Sore joints; Headache; This case was reported by a physician via call center representative and described the occurrence of grand mal seizure in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, 3 days after receiving Shingrix, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant), ventricular arrhythmia (serious criteria hospitalization and GSK medically significant) and cardiac arrest (serious criteria hospitalization and GSK medically significant). In December 2019, the patient experienced pain in arm (serious criteria hospitalization), soreness of joint (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the outcome of the grand mal seizure, ventricular arrhythmia, cardiac arrest, pain in arm, soreness of joint and headache were unknown.   It was unknown if the reporter considered the grand mal seizure, ventricular arrhythmia, cardiac arrest, pain in arm, soreness of joint and headache to be related to Shingrix.  Additional case details were reported as follows: Less than a week after vaccination the patient complained of sore arm, sore joints, headache. On Monday 9th December 2019, 3 days after vaccination patient had a grand mal seizure, ventricular arrhythmia, and cardiac arrest. The patient was currently hospitalized. The reporter did not have lot or expiration date of Shingrix as it was given elsewhere. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Ventricular arrhythmia
Clinical narrative: Grand Mal Seizure; Ventricular arrythmia; Cardiac Arrest; Sore arm; Sore joints; Headache; This case was reported by a physician via call center representative and described the occurrence of grand mal seizure in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, 3 days after receiving Shingrix, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant), ventricular arrhythmia (serious criteria hospitalization and GSK medically significant) and cardiac arrest (serious criteria hospitalization and GSK medically significant). In December 2019, the patient experienced pain in arm (serious criteria hospitalization), soreness of joint (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the outcome of the grand mal seizure, ventricular arrhythmia, cardiac arrest, pain in arm, soreness of joint and headache were unknown.   It was unknown if the reporter considered the grand mal seizure, ventricular arrhythmia, cardiac arrest, pain in arm, soreness of joint and headache to be related to Shingrix.  Additional case details were reported as follows: Less than a week after vaccination the patient complained of sore arm, sore joints, headache. On Monday 9th December 2019, 3 days after vaccination patient had a grand mal seizure, ventricular arrhythmia, and cardiac arrest. The patient was currently hospitalized. The reporter did not have lot or expiration date of Shingrix as it was given elsewhere. The reporter consented to follow up.
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre' Syndrome; Initial information received on 05-Dec-2019 and additional information received on 06-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves adult male patient who experienced Guillain-barre' syndrome (Guillain-Barre syndrome), while received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ249AA (Expiry date Apr-2020) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious Guillain-barre' syndrome (Guillain-barre syndrome) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event during 11 days. (hospitalization during 11 days).  Final diagnosis was Guillain-barre' syndrome.   Patient received 5 days of infusion treatment  in hospital.  The patient outcome is reported as recovering for Guillain-barre' syndrome.; Sender's Comments: This case involves an adult male patient who presented with Guillain-Barre syndrome after vaccination FLUZONE HIGH DOSE. Time to onset is compatible with the role of vaccine. However, patient's medical condition at the time of vaccination and lab tests ruling were not reported. Based on available information the role of individual vaccine cannot be assessed.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Patients MMRV was administered IM instead of SQ
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Right arm was very swollen and red. Pt stated it was itchy, and warm to the touch. Slightly Painful. Started 12/14/219 (day after vaccine was received)
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Incorrect route of product administration
Clinical narrative: Patient was given Tdap SQ instead of IM which caused cellulitis
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever, fatigue
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Magnetic resonance imaging brain normal, Muscular weakness
Clinical narrative: At one week, right deltoid weakness which progressed for one month.  MRI of brain with no stroke.  Physical therapy with improvement but still with significant weakness of deltoid function.  We are about one month out from peak weakness.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None noted
Age: 34.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Patient received both Influenza and PCV13 on 12/3/2019.  Returned to clinic on 12/5/2019 with cellulites of the upper left arm. Treated with doxycycline
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: patient had bone chilling chills,pain in her left arm for one week, very fatigued, achy felt like bad flu for 3 days