chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: First dose of Shingrix on 9/11/2019 / Second dose of Shingrix not administered yet; Difficulty breathing; Asthma exacerbation; Redness on her left arm around injection site; Affected area was described as itchy; affected area was described was raised; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included seasonal allergy, asthma and rhinorrhoea (which typically occurs every fall). Concomitant products included antihistamine (Antihistamines).   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 12th September 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced difficulty breathing, asthma aggravated, injection site erythema, injection site itching and injection site swelling. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with prednisone. On 15th September 2019, the outcome of the difficulty breathing and asthma aggravated were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site itching, injection site swelling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the difficulty breathing, asthma aggravated, injection site erythema, injection site itching and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient said that the day before Shingrix vaccination had a runny nose which typically occurs every fall due to seasonal allergies from tree. At the time of vaccination the patient has being on anithistamines due to this. The patient reported medical history significant for acute asthma and bronchiole airways that overreacted. The patient received 1st dose of Shingrix and next day after vaccination, had difficulty breathing and an asthma exacerbation that lasted approximately 3 to 4 days. The patient went to an urgent care to undergo treatment and was prescribed Prednisone 60 milligram for 10 days. The reporter also reported redness on her left arm around the injection site that was approximately the size of a softball. The affected area was described as itchy and raise approximately 1/16th to 1/8th of an inch. The redness reportedly lasted over one week. The patient did not received 2nd dose of Shingrix till the time of report, which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020209434:same reporter US-GLAXOSMITHKLINE-US2020209436:same reporter US-GLAXOSMITHKLINE-US2020209432:same reporter
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Flu vaccine from last year that was inadvertently injected to a patient with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other healthcare professional and transmitted to Sanofi on 09-Oct-2020 .  This case was linked with 2020SA283093 and 2020SA283092 (Same reporter).  This case involved a 37-year-old female patient who received a 0.5 mL dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number- UJ247AA, expiration date- 30-Jun-2020) via intramuscular route in left deltoid for prophylactic vaccination on 07-Oct-2020 (Expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medication was reported as none.  It was a case of actual medication error as expired vaccine was administered (Latency: Same day).  It was reported that 3 boxes of Fluzone QD NP (no preservative) which was from last year. Each box had 10 syringes.One box was open. There were 3 Flu vaccines from last year that were inadvertently injected to 3 different patients. One of the patient was a doctor.  At the time of reporting it was unknown if the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Malaise, Mobility decreased, Muscular weakness
Clinical narrative: patient had Guillain Barre Syndrome; lost use of one arm; slight weakness in my left arm; sicker; Initial information received on 20-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves patient of unknown demography who had Guillain Barre syndrome, lost use of one arm (mobility decreased), sicker (malaise) and slight weakness in left arm (muscular weakness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date In 1978, the patient received a first ever dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious event of Guillain Barre syndrome, within 48 hours following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient lost use of one arm (mobility decreased) ,slight weakness in my left arm (muscular weakness) (serious events) and sicker (malaise) (non serious) (unknown latency) following the administration of INFLUENZA VACCINE. Mobility decreased and muscular weakness were assessed as medically significant.  Reporter stated that more than one doctor told that the syndrome is actually what has protected her from the flu for years now  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for malaise and other events considered not recovered as it was reported that  the patient still have slight weakness in left arm.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient who had Guillain Barre syndrome, mobility decreased, malaise and muscular weakness, after vaccination with INFLUENZA VACCINE. The time to onset is compatible for Guillain Barre syndrome. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired dose of flu vaccine was inadvertently injected to a patient/no adverse event; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked with 2020SA283093 and 2020SA283083 (Same reporter).  This case involves a 53 year-old female patient who was inadvertently vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which had already expired (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was reported.   On 07-Oct-2020, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ247AA and expiry date 30-Jun-2020) via intramuscular route at the left deltoid for prophylactic vaccination.  Case Detail: It was reported that 3 boxes of Fluzone Quadrivalent NP (no preservative) which was from last year. Each box had 10 syringes. One box was open. There were 3 Flu vaccines from last year that were inadvertently injected to 3 different patients. One of the patient was a doctor.  It was a case of actual medication error due to expired vaccine used (Latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: 2 year old was given expired Pentacel with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from nurse via Medical Information (Reference number- 00309771) and transmitted to Sanofi on 09-Oct-2020.  This case involved a 2 years old male received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number- UJ060AA, expiration date- 04-Oct-2020) (Expired product administered) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, family history were not provided.   Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) and MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (MMRV) for prophylactic vaccination.  It was actual medication error as expired vaccine was administered to a patient (Latency: Same day).  At the time of reporting it was not reported that the patient had experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Crying, Hypertonia, Hypotonia, Infantile apnoea, Syncope
Clinical narrative: just stopped breathing; syncope; hypertonic; limp; crying uncontrollably; Initial information regarding an unsolicited valid serious case was received from a physician (Pediatrician) via Medical Information (Reference number- 00323540) and transmitted to Sanofi on 20-Oct-2020.  This case involves a 2 month old male patient who just stopped breathing (apnoea), had syncope, limp (gait disturbance) was hypertonic (hypertonia), and crying uncontrollably (crying), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), past vaccination(s) and family history was not provided.  At the time of the event, the patient had ongoing abdominal pain and irritability (the patient was generally a cranky colicky baby).  Concomitant vaccinations included POLIO VACCINE (POLIO) and HIB VACCINE (HIB) for prophylactic vaccination (not sure if they were given on same day).  On an unknown date (in Jun or Jul-2020), the patient received a 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported, strength: standard) once via intramuscular route in the left leg for prophylactic vaccination.  On an unknown date, the patient just stopped breathing (apnoea) and had a syncope (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  On an unknown date, the patient was hypertonic (hypertonia), went limp (gait disturbance) and was crying uncontrollably (crying) (unknown latency, non-serious events) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   The doctor was able to immediately stimulate him and he came back very fast. She did not have his chart with her and was at home. She had given Daptacel to other children and they were fine. She was asking if she should give the patient his next Daptacel dose and was concerned and unsure if she should. The patient is due for his next dose.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events were unknown.  The information on batch number was requested for this case.; Sender's Comments: This case concerns a 2 month old male patient who had apnoea, syncope, hypertonia, gait disturbance and was crying after vaccination with DAPTACEL. The time to onset is compatible. At the time of the event, the patient had ongoing abdominal pain and irritability. Concomitant vaccinations included POLIO and HIB VACCINE. Additional information regarding medical history and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: complete immobilization of left hand; Initial information regarding an unsolicited valid non-serious case was received from a nurse.  This case involves a 71 year old male patient who experienced complete immobilization of left hand (mobility decreased), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    It was reported, patient received no other vaccine.  On 19-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ511AA, expiry date: 30-Jun-2021] via an intramuscular route at a left deltoid administration site for prophylactic vaccination.  On 19-Oct-2020, the patient developed a non-serious complete immobilization of left hand (mobility decreased) 12 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.   Date of emergency room/doctor visit reported as 23-Oct-2020.  It was not reported if the patient received any corrective treatment.  Product use was reported as used.  At the time of reporting, the patient was recovering from event.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Chest pain, Haematoma, Injection site mass, Injection site pain
Clinical narrative: She received the HPV vaccine on 9/29/2020. She reported on 10/29/2020 that 2 weeks after receiving the vaccine (10/13/2020), she noticed a hard lump which she described as golf ball sized where the vaccine was given. This lump continued to be there and around 10/25/2020 she began having more pain at the site which began radiating into her shoulder and left chest when she bent her arm "like a chicken wing".She was advised to go to the ER for evaluation. She called after ER visit on 10/29/2020  and said an ultrasound showed the lump is a 2.25 cm  hematoma, and they told her to use heat and take ibuprofen.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Ultrasound scan
Clinical narrative: She received the HPV vaccine on 9/29/2020. She reported on 10/29/2020 that 2 weeks after receiving the vaccine (10/13/2020), she noticed a hard lump which she described as golf ball sized where the vaccine was given. This lump continued to be there and around 10/25/2020 she began having more pain at the site which began radiating into her shoulder and left chest when she bent her arm "like a chicken wing".She was advised to go to the ER for evaluation. She called after ER visit on 10/29/2020  and said an ultrasound showed the lump is a 2.25 cm  hematoma, and they told her to use heat and take ibuprofen.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea
Clinical narrative: Date of vax, a few mins later, started feeling short of breath. Could not get air into lungs and air out of his lungs. Sit in vehicle with no face mask on gasping for air. Few minutes went by and it went away. That was end of adverse event. Felt like lungs stopped working. Only lasted for 1 min. Called Pharmacy, and they gave VAERS info to report it.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Laboratory test, Paraesthesia, Wrong technique in product usage process, X-ray
Clinical narrative: Patient had numbness and tingling in arm after vaccine. Continued to get worse over the course of the week. Mother took son to doctor after continued to worsen on 10/23/2020. She reported to pharmacy that they had to get multiple x-rays and tests and MD confirmed issue is due to incorrectly given flu vaccine
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Erythema, Influenza like illness, Joint range of motion decreased
Clinical narrative: My entire arm from elbow up was red and swollen. Extremely painful.  It has been a year now and I still cannot bring myself to get the second shot.  I also had all the flu like symptoms and I had alot of ringing in my ears and since then I now have a pulsing in my ear and sometimes dizziness since that shot. It feels like my ear is full sometimes.  It comes and goes.   When my arm is resting I can still feel a dull pain in that arm and also noticed is doesn't have the same range of motion I used to have in it.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tinnitus
Clinical narrative: My entire arm from elbow up was red and swollen. Extremely painful.  It has been a year now and I still cannot bring myself to get the second shot.  I also had all the flu like symptoms and I had alot of ringing in my ears and since then I now have a pulsing in my ear and sometimes dizziness since that shot. It feels like my ear is full sometimes.  It comes and goes.   When my arm is resting I can still feel a dull pain in that arm and also noticed is doesn't have the same range of motion I used to have in it.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient reported having redness and swelling from injection site radiating down to her elbow starting roughly 5 hours after vaccine administration. Reported a fever and pain. Went to ER and received an antibiotic and pain medication
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Condition aggravated, Decreased appetite, Heart rate increased, Injection site reaction
Clinical narrative: Stiff/swollen injection site( 5-6 days), loss of appetite(1 .5 days), fever(100 degrees for 1.5 days), rapid heart rate and elevated blood pressure(somewhere around 174/93.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiff/swollen injection site( 5-6 days), loss of appetite(1 .5 days), fever(100 degrees for 1.5 days), rapid heart rate and elevated blood pressure(somewhere around 174/93.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
Clinical narrative: shoulder pain
Age: 38.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT REPORTED OF PAIN, REDNESS, AND SWELLING AT INJECTION SITE
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Injection site warmth, Lip pruritus, Pruritus, Rash
Clinical narrative: Started with itching. Immunization given in left deltoid.  Left deltoid swollen and hot to touch.  Lips itching, wheezing.  Chest and neck rash.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Wheezing
Clinical narrative: Started with itching. Immunization given in left deltoid.  Left deltoid swollen and hot to touch.  Lips itching, wheezing.  Chest and neck rash.
Age: 48.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Blood thyroid stimulating hormone, Laboratory test, Muscular weakness, Radial nerve palsy, Red blood cell sedimentation rate increased
Clinical narrative: Left  extensor wrist drop and weakness in the forearm and brachioradialis muscle weakness  as well
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Began with soreness at injection site, fatigue, body aches, shivers. No sign of fever. Then rash developed at the site the next day, which progressed to other upper arm, shoulders, back, lower face, and some on legs. Rash continues. There also continues a light itch at the site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Began with soreness at injection site, fatigue, body aches, shivers. No sign of fever. Then rash developed at the site the next day, which progressed to other upper arm, shoulders, back, lower face, and some on legs. Rash continues. There also continues a light itch at the site.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 24 hours after receiving vax. appetite decreased, by noon, started feeling nauseous, then immediately became really nauseous. Then began uncontrollably shivering, having to vomit and covered in blankets, then immediately turn to sweating. Did not check for fever. Does not have symptoms at time of call. Pt used anti nauseous meds to control her nauseous meds. Was too sick to drive to ER.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Gait inability, Muscular weakness
Clinical narrative: The pt states at night time legs started feeling weak and then for like 2 hours or maybe a little more he could not walk. He stated he felt completly paralyzed. He came in the next day and he could walk but he spoke to his dr and he  told him to report to us.
Age: 5.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a 5 year old received dose number 2 and dose number 3 in the series approximately 6weeks and 5 days apart; This spontaneous report was received from a physician referring to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent condition and drug reactions or allergies were not reported.      On unknown dates, the patient received dose number 2 and dose number 3 of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscularly (dose, strength, frequency, lot number and expiration date were unknown) for hep B prevention in the series approximately 6 weeks and 5 days apart (inappropriate schedule of product administration). No lab diagnostics/studies were performed.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: pain in her shoulder (75 percent of motion)/ in her left shoulder/ pain in left arm as 3/10; pain in her shoulder (75 percent of motion)/ in her left shoulder; not being able to lift much weight; This spontaneous report was received from an administrator who was reporting on 35-year-old female patient. She has no pertinent medical history, no known drug reactions or allergies, she was not in pregnant and had no concomitant therapies. Her concurrent conditions were not reported.   On 10-JUL-2020, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter administered intramuscularly in the left deltoid (strength was not provided; lot number R030453 was confirmed to be valid, expiration date 23-JUL-2021 was confirmed) for HPV prevention. On 09-SEP-2020, she received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) also intramuscularly in the left deltoid (strength, exact dose, lot number and expiration date were not reported) for the same indication.  On 15-SEP-2020, after second dose of the vaccine, she reported pain in her shoulder (75 percent range of motion), on an unknown date in 2020 she also complain that she is not able to lift much weight. She sought medical attention and on examination, the patient had full range of motion but the doctor is ruling it vaccine related injury. It was recommended that the patient use warm compresses and oral acetaminophen (TYLENOL) or ibuprofen for pain management, but she preferred to use "ARNICA" (it was unknown if it was topical or oral "ARNICA"). On 12-OCT-2020 the patient was brought in for examination, she continued to complain on 75 percent range of motion with left arm and not being able to lift much weight. Patient pain rating was 3 of 10 with movement. Health business partner reported that there was no inflammation or discharge noted at left deltoid injection site. On 16-OCT-2020, the patient was feeling much better, and recovered from the above-mentioned events.   The reporter did not provide a causal assessment between the events of pain in shoulder, 75 percent range of motion and being not able to lift much weight and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: an expired, administered dose of ROTATEQ; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 22-OCT-2020, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (once, lot# S004397 and expiration date 19-OCT-2020; strength, dose, route of administration, were not reported) for prophylaxis (expired product administered). The product never underwent a temperature excursion, and the administration was supported via the post-expiry table.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Diarrhoea, Feeling abnormal, Pyrexia
Clinical narrative: Diarrhea; No energy; Cough; Fever; Feeling terrible; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2020AMR211574).   On 6th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced fever and feels awful. On 22nd October 2020, the patient experienced diarrhea, loss of energy and cough. On an unknown date, the outcome of the fever and feels awful were recovered/resolved and the outcome of the diarrhea was recovering/resolving and the outcome of the loss of energy and cough were not recovered/not resolved.   It was unknown if the reporter considered the fever, feels awful, diarrhea, loss of energy and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A patient received her 2nd dose on 06th October 2020 and within 36 hours of receiving it she got a fever and was in bed for a couple of days feeling terrible.  That had resided but still currently had diarrhea that had slightly improved but not much along with no energy and a cough.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211574:same patient, 1st dose
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Chromaturia, Inappropriate schedule of product administration
Clinical narrative: dark yellow urine on 18-Oct-2020; received / first dose / one year before this report / second dose on 13-Oct-2020; This case was reported by a physician via call center representative and described the occurrence of urine coloring yellow in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included metal poisoning (cobalt metallosis after a joint replacement failure) and myopathy (myopathy after a treatment with statins). Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received approximately 1 year before this report, refer case- US2020211174). Concomitant products included rosuvastatin calcium (Crestor).   On 13th October 2020, the patient received the 2nd dose of Shingrix. On 13th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 18th October 2020, the patient experienced urine coloring yellow. On an unknown date, the outcome of the urine coloring yellow was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the urine coloring yellow to be related to Shingrix.  Additional information was provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced dark yellow urine and c- reactive protien increased to 37 after receiving the 2nd dose of Shingrix. On 16th October 2020, the patient had a bloodtest and all the values were within normal range except for c-protien which was increased to 37. The patient was expecting to undergo further laboratory investigations including more specific muscle damage markers. The reporter consented to follow up.; Sender's Comments:  US2020211174:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Arm be red; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient asked how long should arm red after receiving dose of Shingrix shot. No other information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: skin reaction; This case was reported by a consumer via interactive digital media and described the occurrence of skin reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction 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 it was selected as adult as per the vaccine indication. The patient received Shingrix and had skin reactions.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: Been hit by the flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 2nd dose of Shingrix. On 26th October 2020, less than a day after receiving Shingrix, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza 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 captured as an adult as per vaccine indication.  The patient had received the 2nd part of Shingrix vaccine day before reporting date, and on the night of vaccination date, felt like had been hit by the flu. The reporter has questioned whether this was a common reaction.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling cold, Herpes zoster, Hyperhidrosis
Clinical narrative: back as appearing to have zits and potentially shingles./shingles; left side of back became very itchy; in pain; sweat; freezing; fever; Weak; Ill; Tired; sore Arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st October 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm. On 2nd October 2020, the patient experienced unwell, tiredness, fever and weakness. On 3rd October 2020, the patient experienced sweating and feeling cold. On 21st October 2020, the patient experienced shingles, pruritus and pain. The patient was treated with dermatologicals nos (Lotion) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, weakness, pruritus and pain were not recovered/not resolved and the outcome of the pain in arm, unwell, tiredness, sweating, fever and feeling cold were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, unwell, tiredness, sweating, fever, weakness, feeling cold, pruritus and pain to be related to Shingrix.  Additional information was provided as follows: The reporter states that have no known allergy to medications and having chickenpox as a child. The patient received the 1st dose of Shingrix and experienced sore arm an hour after vaccination and lasted for one week. The patient felt ill, weak and tired and that night developing a fever, sweat and was freezing, which was recovered recovered till the time of reporting all symptoms On 21st October 2020, the reporter stated that the left side of back became very itchy. The patient asked his wife to rub lotion on his back and his wife described his back as appearing to have zits and potentially shingles. The patient visited physician office on 22nd October 2020 and the patient was diagnosed with shingles. The patient was prescribed for antiviral medication for shingles. The patient complains of being in pain. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: back as appearing to have zits and potentially shingles./shingles; left side of back became very itchy; in pain; sweat; freezing; fever; Weak; Ill; Tired; sore Arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st October 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm. On 2nd October 2020, the patient experienced unwell, tiredness, fever and weakness. On 3rd October 2020, the patient experienced sweating and feeling cold. On 21st October 2020, the patient experienced shingles, pruritus and pain. The patient was treated with dermatologicals nos (Lotion) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, weakness, pruritus and pain were not recovered/not resolved and the outcome of the pain in arm, unwell, tiredness, sweating, fever and feeling cold were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, unwell, tiredness, sweating, fever, weakness, feeling cold, pruritus and pain to be related to Shingrix.  Additional information was provided as follows: The reporter states that have no known allergy to medications and having chickenpox as a child. The patient received the 1st dose of Shingrix and experienced sore arm an hour after vaccination and lasted for one week. The patient felt ill, weak and tired and that night developing a fever, sweat and was freezing, which was recovered recovered till the time of reporting all symptoms On 21st October 2020, the reporter stated that the left side of back became very itchy. The patient asked his wife to rub lotion on his back and his wife described his back as appearing to have zits and potentially shingles. The patient visited physician office on 22nd October 2020 and the patient was diagnosed with shingles. The patient was prescribed for antiviral medication for shingles. The patient complains of being in pain. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Myalgia
Clinical narrative: after receiving / first dose / experienced mild myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included myopathy (myopathy after treatment with statins), metal poisoning (cobalt metallosis after a joint replacement failure in 2012) and joint replacement (failure in 2012). Concomitant products included rosuvastatin calcium (Crestor).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced myalgia. The patient was treated with naproxen. On an unknown date, the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional information was provided as follows: The patient who was also a rheumatologist and the reporter. The age at vaccination was not reported. The patient received 1st dose of Shingrix approximately one year before the date reporting. Shortly after receiving the first dose of Shingrix, the patient experienced mild myalgia (exact dates were not provided). The patient took Naproxen as a treatment to myalgia. The patient was expecting to undergo further laboratory investigations including more specific muscle damage markers. The reporter consented to follow up. For the tolerance of 2nd dose, refer the case US2020AMR211918, reported by the same reporter; Sender's Comments:  US2020AMR211918:same reporter
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Malaise
Clinical narrative: Not feeling well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and PNEUMOCOCCAL VACCINE for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, Influenza vaccine Quadrivalent unspecified season and PNEUMOCOCCAL VACCINE. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received first dose of Shingrix at an unspecified time along with flu and pneumonia shot and was not feeling well for two days. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020AMR212682. This was 1 of the 4 cases, reported by same reporter. Caller declined to provide PII. Limited information provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212040:same reporter US-GLAXOSMITHKLINE-US2020AMR212682:same reporter
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Eye irritation, Eye pain, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Horrible eye pain / in both eyes / thought that her eyes were going to explode / shooting pain on the inside of the eye; Watering eyes; Beat red eyes; It felt like acid on the front of the eye; Seeing double; shooting pain on the inside of the eye; This case was reported by a consumer via call center representative and described the occurrence of eye pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 24 hrs after receiving Shingrix, the patient experienced eye pain, watering eyes, eye red, burning in eyes, double vision and pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the eye pain, watering eyes, eye red and double vision were recovered/resolved and the outcome of the burning in eyes and pain were unknown.   It was unknown if the reporter considered the eye pain, watering eyes, eye red, burning in eyes, double vision and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and reported horrible eye pain. The pain occurred in both eyes and thought that eyes were going to explode.   The pain lasted for 8 hours and then resolved after taking 4 Benadryl.   The patient reported watering eyes, beat red eyes, shooting pain on the inside of the eye and it felt like acid on the front of the eye.   The patient also reported seeing double.   All the symptoms have since resolved. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Horrible eye pain / in both eyes / thought that her eyes were going to explode / shooting pain on the inside of the eye; Watering eyes; Beat red eyes; It felt like acid on the front of the eye; Seeing double; shooting pain on the inside of the eye; This case was reported by a consumer via call center representative and described the occurrence of eye pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 24 hrs after receiving Shingrix, the patient experienced eye pain, watering eyes, eye red, burning in eyes, double vision and pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the eye pain, watering eyes, eye red and double vision were recovered/resolved and the outcome of the burning in eyes and pain were unknown.   It was unknown if the reporter considered the eye pain, watering eyes, eye red, burning in eyes, double vision and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and reported horrible eye pain. The pain occurred in both eyes and thought that eyes were going to explode.   The pain lasted for 8 hours and then resolved after taking 4 Benadryl.   The patient reported watering eyes, beat red eyes, shooting pain on the inside of the eye and it felt like acid on the front of the eye.   The patient also reported seeing double.   All the symptoms have since resolved. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash, Vaccine positive rechallenge
Clinical narrative: Muscle pain at the injection site; Rash on the bicep; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 26th July 2020, refer case US2020AMR213680).   On 20th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced injection site muscle pain and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site muscle pain and rash on the bicep that was 4 to 5 inches. The 2nd dose was given in the lower deltoid and rash was still there. The reporter did not consent to follow up. Not all information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213680:1st dose, same patient
Sex: F
Vaccine: MENB, MNQ
Symptoms: Migraine
Clinical narrative: Headache / migraine; This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Bexsero and Menveo. On an unknown date, less than a month after receiving Bexsero and Menveo, the patient experienced migraine headache. On an unknown date, the outcome of the migraine headache was not recovered/not resolved.   It was unknown if the reporter considered the migraine headache to be related to Bexsero and Menveo.  Additional details were provided as follows: The patient meningitis vaccine a month ago and was not sure if the vaccine was Bexsero or Menveo, believes was Bexsero since the patient started college and had headache migraine since then.  The reporter was not sure about the onset date and mentioned did not know if it was or not related to the vaccine.  The reporter mentioned the patient was still had headache.  No other information was provided. Th reporter did not consent to follow up.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Tendonitis
Clinical narrative: spasms on his hand, like they are moving by their own; tendinitis on his hand; This case was reported by a pharmacist via call center representative and described the occurrence of spasms in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 27th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, several hours after receiving Shingrix, the patient experienced spasms and tendonitis. On an unknown date, the outcome of the spasms and tendonitis were unknown.   It was unknown if the reporter considered the spasms and tendonitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and few hours later experienced tendinitis on his hand and spasms on his hand, like they are moving by their own.  The patient was still had this symptom. The reporter consented to follow up. No further information was provided and agreed to follow up.