chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red and sore to injection site first night. Next day increased swelling, redness more and a lot more sore. I also had body aches that felt like authritis and a headache.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Swollen, red and sore to injection site first night. Next day increased swelling, redness more and a lot more sore. I also had body aches that felt like authritis and a headache.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Discomfort, Erythema, Irritability, Pruritus, Pyrexia
Clinical narrative: Fever starting Afternoon of 8/21/2020 - morning Of 8/24/2020, ranging from 102.4 and 99.4 degrees.   Red spots started forming the evening of 8/24/2020 and by the following day a rash was visible on back, neck and face. She was fussy all day and uncomfortable. By 8/26/2020 it covered her entire back, neck, face, butt and lightly on arms and legs. The lower back/buttocks was the most concerning. She was clearly fussy, uncomfortable and trying to itch her body.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Fever starting Afternoon of 8/21/2020 - morning Of 8/24/2020, ranging from 102.4 and 99.4 degrees.   Red spots started forming the evening of 8/24/2020 and by the following day a rash was visible on back, neck and face. She was fussy all day and uncomfortable. By 8/26/2020 it covered her entire back, neck, face, butt and lightly on arms and legs. The lower back/buttocks was the most concerning. She was clearly fussy, uncomfortable and trying to itch her body.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: The day after extremely painful. Last night it was throbbing. Not as painful has developed bad rash on her arm that has spread a little up her arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left Deltoid: Induration, warmth and tenderness. TReated with cephalexin on 7/31/20 Sx completely resolved on 8/07/2020.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: -Redness/warmth at The site swelling -fever/chills, body aches & fatigue -Cellulitis was started on Cephalexin 500 mg 8-18-20
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: -Redness/warmth at The site swelling -fever/chills, body aches & fatigue -Cellulitis was started on Cephalexin 500 mg 8-18-20
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: headache; Fever got up to 102-103; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID:818931) referring to a  14 year old male patient.  At the time of vaccination, the patient had no chronic or long-standing health conditions, no illness and no known allergies to medication, food or other products. The patient had not ever had an adverse event following any previous vaccine.  There were no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken.  On 04-JUN-2018, at 10:01am, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N025429 (expiration date not reported, but upon internal validation established as 21-JUL-2020), intramuscularly in the left deltoid for prophylaxis.        Starting in the evening that the vaccine was given, the patient experienced fever and headache.  Fever got up to 102-103 (units not provided).  Non medical tests or laboratory results were provided.  The patient was seen at the doctor's office two days after vaccination and had a normal examination. The symptoms lasted about a week.  At the time of reporting the patient had recovered from the events.  The agency considered this case as non-serious.  The reporter did not assess the causal relationship between suspect therapies and the patient's events.  Follow up information has been received from other reporter on 19-AUG-2020. The patient's pertinent concurrent conditions included acne and blood pressure increased and the patient recovered from the events on 10-JUN-2020.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; MMR II after an excursion / temperature (-15°C); This spontaneous report was received from a nurse referring to a 4 year old female patient. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.  On an unknown date in July 2020, the patient was vaccinated with an incorrect stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  (recombinant human albumin rHA) (Lot # S020161, expiration date 30-JUN-2021); dosage, frequency, route of administration, anatomical location were not provided for prophylaxis. The reporting nurse asked about the stability for incorrect stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) after an excursion and stated that two lots of the vaccine were administered to two patients. The excursion occurred on 26-JUL-2020. Temperature (-15°C), time frame 48 minutes, no previous temperature excursion was reported, the call was due to data logger. No additional adverse event or Product quality complaint (PQC) were reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 06-AUG-2020, the patient was vaccinated an improperly store dose of  with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # S020160, expiration date 30-JUN-2021, frequency reported as "1" (dose, route and vaccination site were not reported) for prophylaxis.       Temperature- 50F Time frame - 6°F to 14°F for 1 hour and 15 minutes; 15°F to 46°F (44.SF) for 1 hour and 30 minutes; 47°F to 77°F for 2 hours and 30 minutes Previous temperature excursion? N Was call because ofa "data logger"? Y
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Went backward develomentally; High fever; This spontaneous report was received from an other reporter, concerning an unspecified child of unknown age and gender. Information regarding patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient presented high fever, the parents swear that the child went backward developmentally after the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), however the physician did not agree with the parents assessment.   At the time of reporting, the outcome of high fever and backward developmentally was unknown.   The causal relationship between the vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and the adverse event was not provided by the reporter.
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events.; on 7/1/2020 an 18 year old patient was inadvertently administered PROQUAD.; This spontaneous report was received from a registered nurse, referring to an 18-year-old male patient.  The patient's pertinent medical history, previous drug reactions, or allergies, were not reported.   On 01-JUL-2020, the adult patient was inadvertently vaccinated with  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, as prophylaxis (strength, dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported; lot number S012533, which has been verified to be valid, the expiration date was unknown by the reporter, but upon internal review was determined as 20-OCT-2020) (product administered to patient of inappropriate age). As concomitant therapy, sterile diluent (MERCK STERILE DILUENT) was used to reconstitute the vaccine. No additional events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No ae reported; expired PNEUMOVAX23 given; This spontaneous report has been received from a health care professional referring to a 66 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R022249 with expiration date of 16-APR-2020 (strength, indication, dose, route, frequency, and anatomical location were not provided) for prophylaxis. No adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R022249; expirationdate: 16-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Pharmacy student called in to report that a patient who was vaccinated on 05-AUG-2020 with varivax and developed a injection site skin rash on the right upper arm; This spontaneous report has been received from pharmacy student concerning a 38 year old female patient. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.    On 05-AUG-2020, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection in the right arm Lot # S025914, expiration date 20-AUG-2021 for prophylaxis.   On 17-AUG-2020, the patient developed an injection site skin rash on the right upper arm.      It was reported that the patient did not seek medical attention and no laboratory tests or diagnostic studies were performed.  At the time of reporting, the patient had  not recovered from injection site skin rash on the right upper arm and the causal relationship between varicella virus vaccine live (oka/merck)(VARIVAX) and the injection site rash was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; Expired vaccine given to patient; This spontaneous report has been received from a registered nurse concerning a  5 year-old patient of unknown gender.The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.         On 13-AUG-2020,  the patient was administered an expired but properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # S003864, expiration date 08-AUG-2020 for prophylaxis (dosage regimen was not provided). No additional adverse effects were reported and a temperature excursion did not occur..
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; expired PROQUAD (Ext date 8/8/2020) was inadvertently administered to a patient; This spontaneous report was received from a nurse rand refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On 19-AUG-2020, the patient inadvertently received an expired measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rha) (PROQUAD) injection, lot # S003865, expiry date 08-AUG-2020, for prophylaxis (concentration, dose, dose number, route of administration and frequency were not reported). No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; Caller stated that on 8/18/2020, the patient was administered improperly stored PROQUAD (reconstituted with properly stored Merck STERILE DILUENT).; This spontaneous report was received from a nurse, referring to a 5-year-old female patient. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.     On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number T001187, which has been verified to be valid, expiration date reported and validated as 11-JUL-2021), subcutaneously administered, as prophylaxis (product storage error) (dose, dose number, vaccination scheme, and anatomical site of vaccination was not provided). The suspect vaccine was reconstituted with a properly stored Merck sterile diluent (lot number and expiration date were not provided).  Additionally, it was reported that the vaccine was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F (10.9 degrees F) for a time frame of 2 hours and 30 minutes, as recorded by digital data logger. There was no previous temperature and no additional adverse effects were reported.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; the patient was administered improperly stored VARlVAX; This spontaneous report was received from a nurse, referring to a 12-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously (strength, vaccination scheme, anatomical site of injection were not reported; lot number S032352, expiration date: 14-OCT-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effects reported.  On an unknown date, the vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.9F) for 2 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; the patient was administered improperly stored VARlVAX (reconstituted with properly stored Merck STERILE DILUENT).; This spontaneous report was received from a nurse, referring to a 12-months-old female patient. The patient's pertinent medical history, drug reactions, or allergies were not reported.   On 18-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously, as prophylaxis (strength, dose, vaccination scheme frequency and anatomical site of vaccination were not reported; lot number S032352, expiration date 14-OCT-2021, which were verified to be valid) (product storage error) which was concomitantly reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine was exposed to a temperature of 6 to 14 degrees Fahrenheit (F) for a time frame of 2 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion, nor additional events were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: an improperly stored and administered ROTATEQ; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-AUG-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally (strength, vaccination scheme and anatomical site of injection were not reported; lot number 1676322, expiration date: 21-APR-2021) as prophylaxis (product storage error).  On an unknown date, the vaccine underwent a temperature excursion between 2 degrees Celsius (C) to 8C (8.4C) for 34 hours and 41 minutes and above 9C (10.5C) for 6 hours, as recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported administration of 1 dose of V ARIV AX that was involved in temperature excursion; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender.      There was not information about patient's concurrent conditions, medical history or concomitant medications.  On 20-AUG-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022758 with expiration date of 22-JUL-2021) that was involved in temperature excursion at 7.8 °F during 45 minutes, for prophylaxis (dose and route of administration were not reported). There was not previous temperature excursion and it was called because of a data logger. No adverse events were reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was administered improperly stored PROQUAD; This spontaneous report as received from a nurse refers to a 4 year old male patient.  The patient's concurrent conditions and medical history were not provided.   On 18-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T001187 with expiration date of 11-JUL-2021, subcutaneously, for prophylaxis (dose not provided), which was reconstituted with properly stored sterile diluent (DILUENT MRK INJ) (dose, lot# and expiration date were not provided). The vaccine had temperature excursion of 6 °F to 14 °F (10.9 °F) during 2 hours 30 minutes. There was not previous temperature excursion. The report was called because of a data logger. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional adverse effects reported; expired product used; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 13-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)  (dose, frequency, route and vaccination site were not provided), for prophylaxis that was reconstituted with expired diluent (lot# reported as "N030411", expiration date  04-JUL-2020, on 13-AUG-2020.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: developed a rash on one side of her body shortly after receiving ZOSTAVAX / Diagnosed the rash as Shingles; This spontaneous report was received from the patient's neighbor, referring to a 63 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter.  On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) to prevent shingles (strength, dose, route, frequency, lot# and expiration date were not reported).  On an unknown date, the patient developed a rash on one side of her body shortly after receiving Zoster Vaccine Live (ZOSTAVAX), subsequently, the patient sought medical attention and was diagnosed with Shingles (herpes zoster).  At the time of reporting, the outcome of shingles was unknown reported as "doing great now". The causality assessment between herpes zoster with Zoster Vaccine Live (ZOSTAVAX) was not provided.
Sex: F
Vaccine: BCG, UNK
Symptoms: Therapeutic response unexpected
Clinical narrative: she received BCG vaccine she did not get the COVID; Information has been received from a pharmacist, regarding a female patient born in a different country from the country of incident (age not provided). The patient's concurrent conditions, drug reactions/allergies, medical history and concomitant medications were not provided.  It was reported that on unspecified date, the patient received a dose of BCG live (BCG vaccine) (dose, frequency, route, lot # and expiration date were not provided), for prophylaxis. The vaccine was administered in the patient's country of birth.   Subsequently, the patient was adopted for a family in the reporter's country. Her extended and nuclear family got infected with COVID, however, she did not get the COVID and was the only person in her family (besides her grandfather on hydroxychloroquine). According to that, the pharmacist considered the BCG vaccine could be beneficial against COVID (therapeutic response unexpected). The patient's outcome was uknown and the reporter considered the event to be related to suspect therapy.  The pharmacist was also aware of cases where people from other countries benefited from receiving BCG vaccine tested negative for COVID (non-valid case MARRS US-009507513-2008USA012450). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); manufacturername: Organon Teknika Corporation LLC; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA012450:
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site bruising
Clinical narrative: bruising at the site of the GARDASIL 9 injection; Pharmacist reported that she administered the third dose of GARDASIL 9 to the patient in the patients right deltoid / patient stated her concern to the pharmacist that the GARDASIL 9 was not administered in the deltoid region.; Patient Age: 33 year old; This spontaneous report has been received from a pharmacist concerning a 33 year old female patient. The patient had no pertinent medical history nor drug reactions or allergies. Her concomitant therapies included unspecified birth control medication. Her concurrent conditions were not reported.  On 18-AUG-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, intramuscularly in her right deltoid (product administered to patient of inappropriate age) along with an unspecified flu shot; and a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) in her left arm. Dose, lot number and expiration date were not reported for both suspect vaccines.  On 22-AUG-2020, the patient complained of bruising at the site of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (injection site bruising). It was reported that no treatment was given for the event. Moreover, the patient stated her concern to the pharmacist that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not administered in the deltoid region (wrong technique in product usage process).  At the time of reporting, the patient had not recovered from injection site bruising (reported as Present Status: Ongoing).  The causal relationship between injection site bruising and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: she took her first dose 01/05/2015 and the second dose 07/30/2015. She had not received the 3rd dose. Physician davised her to ask if she could receive the 3rd dose years later; This spontaneous report was received from a 25 year old female patient who was reporting on herself. Patient had not any pertinent medical history, concurrent conditions, drug reactions/allergies and was not taking any concomitant medication.  On 05-JAN-2015, patient took her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and on 30-JUL-2015, she received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) both given as a shot in the arm.   Patient explained she had not received the 3rd dose and the doctor in charge of her first two doses was now retired. She currently was seeing a new physician who advised her to call to the company and ask if she could receive the 3rd dose years later or had to start a new dosing schedule. No treatment was given, no laboratory studies were performed and no medical attention was sought. Therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was discontinued in 2015.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA012541:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given DTaP IPV portion of Pentacel without the Hib/No Ae; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a 6 months old female patient who was given DTaP IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without the Hib (product preparation issue)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 21-Aug-2020, the patient received a 0.5 mL third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AA and expiry date 22-Jun-2021) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  Case details: reporter stated that the DTaP IPV portion was given but not mixed into the dry powder. She would like to know if the dose was valid and what to do regarding missed Hib.   It was an actual medication error case due to inappropriate reconstitution technique.  At a time of reporting 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, DTAPIPVHIB, PNC13
Symptoms: Chest X-ray, Computerised tomogram head, Culture, Febrile convulsion, Pyrexia
Clinical narrative: Sleeping soundly, then spiked a fever of 104.1 within a minute, no warning, no prior sickness. Severe febrile seizure lasting 3 minutes
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB, PNC13
Symptoms: Toxicologic test
Clinical narrative: Sleeping soundly, then spiked a fever of 104.1 within a minute, no warning, no prior sickness. Severe febrile seizure lasting 3 minutes
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Albumin globulin ratio normal, Anion gap, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: Patient presented with complaint of vomiting  for almost 12 hours and approximately 10 episodes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Patient presented with complaint of vomiting  for almost 12 hours and approximately 10 episodes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal
Clinical narrative: Patient presented with complaint of vomiting  for almost 12 hours and approximately 10 episodes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematocrit normal, Haemoglobin normal, Lipase increased, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Patient presented with complaint of vomiting  for almost 12 hours and approximately 10 episodes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Mean platelet volume normal, Platelet count normal, Protein total normal, Red blood cell count normal, Red cell distribution width increased
Clinical narrative: Patient presented with complaint of vomiting  for almost 12 hours and approximately 10 episodes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: Patient presented with complaint of vomiting  for almost 12 hours and approximately 10 episodes.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction, Polymyalgia rheumatica
Clinical narrative: PMR (Polymyalgia rheumatica); awful; This case was reported by a consumer and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant) and feels awful. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica and feels awful were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that shortly after second Shingrix shot the patient came down with PMR (Polymyalgia rheumatica).  It had taken one year to get better after a long regiment of Prednisone. The patient asked if any other reported cases of PMR after taking Shingrix? The patient reported that It was an awful experience.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Arthralgia, Diarrhoea, Drug hypersensitivity, Fatigue
Clinical narrative: Rheumatoid arthritis; agitated; patient is very sensitive to medication, oversensitive, also to other injections; severe diarrhea; extremely tired; severe headache; joint pain; vomiting; Tremors, all body shaking / hands shaking; This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date 25th March 2022) for prophylaxis.   Concurrent medical conditions included drug hypersensitivity (very sensitive to medication, oversensitive, also to other injections).   On 17th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced agitation, vomiting and tremor. On 17th August 2020, the patient experienced joint pain. On 18th August 2020, the patient experienced diarrhea, tiredness and headache. On an unknown date, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant) and drug hypersensitivity. The patient was treated with paracetamol (Tylenol). In August 2020, the outcome of the agitation was recovered/resolved. On 21st August 2020, the outcome of the vomiting, diarrhea, tiredness, headache and joint pain were recovered/resolved and the outcome of the tremor was not recovered/not resolved. On an unknown date, the outcome of the rheumatoid arthritis and drug hypersensitivity were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, agitation, vomiting, tremor, diarrhea, tiredness, headache, joint pain and drug hypersensitivity to be related to Shingrix.  Additional information was provided as follows: The same evening of receiving vaccine, the patient had joint pain, and then took Tylenol. On Tuesday, 18th August 2020, the patient woke up with severe headache, extremely tired. During afternoon, she had severe diarrhea. Pharmacist also reported that the patient had tremors, all body shaking. She couldn't even use her phone because her hands were shaking, also she was vomiting.  On Thursday, 20th August 2020, patient was feeling better, only agitated. On Friday (on the day of reporting), 21st August 2020, patient was feeling better, all symptoms stopped, only her hands were still shaking. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rheumatoid arthritis, Tremor, Vomiting
Clinical narrative: Rheumatoid arthritis; agitated; patient is very sensitive to medication, oversensitive, also to other injections; severe diarrhea; extremely tired; severe headache; joint pain; vomiting; Tremors, all body shaking / hands shaking; This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date 25th March 2022) for prophylaxis.   Concurrent medical conditions included drug hypersensitivity (very sensitive to medication, oversensitive, also to other injections).   On 17th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced agitation, vomiting and tremor. On 17th August 2020, the patient experienced joint pain. On 18th August 2020, the patient experienced diarrhea, tiredness and headache. On an unknown date, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant) and drug hypersensitivity. The patient was treated with paracetamol (Tylenol). In August 2020, the outcome of the agitation was recovered/resolved. On 21st August 2020, the outcome of the vomiting, diarrhea, tiredness, headache and joint pain were recovered/resolved and the outcome of the tremor was not recovered/not resolved. On an unknown date, the outcome of the rheumatoid arthritis and drug hypersensitivity were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, agitation, vomiting, tremor, diarrhea, tiredness, headache, joint pain and drug hypersensitivity to be related to Shingrix.  Additional information was provided as follows: The same evening of receiving vaccine, the patient had joint pain, and then took Tylenol. On Tuesday, 18th August 2020, the patient woke up with severe headache, extremely tired. During afternoon, she had severe diarrhea. Pharmacist also reported that the patient had tremors, all body shaking. She couldn't even use her phone because her hands were shaking, also she was vomiting.  On Thursday, 20th August 2020, patient was feeling better, only agitated. On Friday (on the day of reporting), 21st August 2020, patient was feeling better, all symptoms stopped, only her hands were still shaking. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Deafness
Clinical narrative: Hearing loss; All of the listed adverse events (as per reported); This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix. On 19th August 2020, 1 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and adverse reaction. In August 2020, the outcome of the adverse reaction was recovered/resolved. On an unknown date, the outcome of the hearing loss was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss and adverse reaction to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but could be 71 or 72 years old. The patient reported that after Shingrix adminsitration he had developed all of the adverse events listed in the prescribing information (as per patient and reporter words). Also, patient had developed hearing loss and though all other adverse events had diminished, the hearing loss had persisted. Patient was concerned about this. The reporter consented to follow up.
Sex: U
Vaccine: FLUX, FLUX, PPV
Symptoms: Autoimmune disorder, Hypersensitivity, Malaise, Nerve injury
Clinical narrative: auto immune disease; nerve damage; got sick; had a allergic reaction to it; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Influenza vaccine Quadrivalent 2019-2020 season and PNEUMONIA SHOT. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced autoimmune disorder (serious criteria disability and GSK medically significant), nerve damage (serious criteria disability), malaise and allergic reaction. On an unknown date, the outcome of the autoimmune disorder, nerve damage, malaise and allergic reaction were unknown.   It was unknown if the reporter considered the autoimmune disorder and nerve damage to be related to Influenza vaccine Quadrivalent unspecified season. The reporter considered the malaise and allergic reaction to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient took the flu vaccine last year and for the time got sick and had a allergic reaction to it .  The patient used to take the flu shot every year and the pneumonia shot every 3 or 4 years because of low immune system and other health issues.  The patient experienced enough Auto Immune Diseases and Permanent Disability/Nerve Damage.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Inflammation
Clinical narrative: Left arm inflammation and redness radiating to elbow. Made his left arm feel numb. Happened on next day or day after next. Pt had keflex course and inflammation reduced and had some sensation back.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MNQ, TDAP, VARCEL
Symptoms: Condition aggravated, Dermatitis contact, Pruritus, Rash
Clinical narrative: days ago, which was just an small area on the leg. Pt recieved varicella, hep B, IPV, menactra and Tdap vaccines about 3 days later on 8/21. As of 1 day ago, the rash has worsened, and is now on the upper legs, arms and both hands, and back. She has been trying clamine, tecnu ointment, and just started triamcinolone 0.1% cream today. She has been using benadryl once a day which seems to help with the itching some. It has not been oozing. It is itchy but not painful.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; on 08/19/2020 a patient was administered a dose of PNEUMOVAX 23 (lot R010724 expiration 06/13/2020); This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R010724, expiration date: 13-JUN-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; inadvertently administered an expired PNEUMOVAX 23; This spontaneous report as received from a pharmacist refers to a 72-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapy were not reported.  On 19-AUG-2020, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # R033080, expiration date 06-JUN-2020, route of administration and anatomical location were not reported), for prophylaxis. The vaccine had no prior temperature excursions. No adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R033080; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: 69 year old female patient came into get PNEUMOVAX 23 at the pharmacy on 8/18/20, but informed pharmacist today 8/19/20 that she received the same vaccine at the doctor's office 6 months ago.; This spontaneous report was received from a pharmacist and refers to a 69-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in approximately February 2020 (reported as 6 months ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 18-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled-syringe, lot # T009744, expiration date was reported as January 2020, but upon internal verification was established as 28-JAN-2022 (exact dose, injection site and route of administration were not provided). On the next day, the patient informed the pharmacist that she received the same vaccine at the doctor's office 6 months ago. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; manufactureraddress: manufacturercity: manufacturerstate:  manufacturercountry: devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; dose of expired but properly stored PROQUAD was administered to a female patient; This spontaneous report was received from a nurse rand refers to a female patient of unknown age.  Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On 20-AUG-2020, the patient inadvertently received a dose of expired but properly stored measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rha) (PROQUAD) injection, lot # S005074, expiry date 18-AUG-2020, for prophylaxis (concentration, dose, dose number, route of administration and frequency were not reported). The vaccine was reconstituted with properly stored sterile diluent. No additional adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Skull fracture, Syncope
Clinical narrative: passed out; skull fracture; syncopal episode; This spontaneous report was received from a nurse prescriber and refers to a 16-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On an unknown date  (reported as recent), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for prophylaxis (dose, site of administration, lot# and expiration date were not reported).  Upon check-out at the office, the patient passed out, had a syncopal episode and experienced a skull fracture.   The outcome of the events and relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported.  Upon internal review, the all of the events were considered to be medically significant.
Sex: U
Vaccine: TDAP
Symptoms: Malaise
Clinical narrative: Violently ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in an unspecified number of patients who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter knew several adult people that got violently ill when getting the vaccine. The reporter asked what had done with these vaccines to make them so unhealthy.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Oedema
Clinical narrative: cellulitis; Edema; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a adult female 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 cellulitis (serious criteria GSK medically significant) and edema. On an unknown date, the outcome of the cellulitis and edema were unknown.   It was unknown if the reporter considered the cellulitis and edema to be related to Shingrix.  Additional details were provided as follows: The age ar vaccination was not reported. The age group of the patient was selected as an adult as per vaccine indication. The reporter stated that, after vaccination with dose of Shingrix, the patient experienced cellulitis and edema. The reporter did not consent to follow up.