chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Flushing, Headache, Injection site paraesthesia, Paraesthesia
Clinical narrative: The patient came into the health department at approximately 1:00 PM for her last Rabies vaccine to complete the series of 3 doses. About 10 minutes after receiving the vaccine, the patient began to feel "light headed" and her face became flushed. She reported feeling a "tingling" sensation in her left arm that ran from the injection site in the deltoid all the way down her arm. At 1:10 the patient's blood pressure was 139/78, heart rate was 80. The patient reported a headache as well located to the frontal area and rated her pain a 3/10. Patient reports her left arm is still tingling and was provided with apple juice and reclined back in chair. Patient denies any history of allergies or previous reaction to Vitals taken at 1:20 PM: BP 132/78, HR 83. Patient reports continued headache and tingling in left arm. Bilateral grip to hand strong, no weakness noted. Patient is stable but states her vision is slightly blurry and she feels dizzy. At 13:30 the patient's blood pressure is 140/76, HR 74. Patient reports tinging sensation has slightly improved and headache is about the same. Patient reports history of anxiety attacks. Patient kept in office until 2:15 PM and was continuously monitored. At 2:15 the patients BP is 118/72 and she states her headache is a 1/10 on the pain scale. Left arm has no redness or edema. She reports some continued tingling in the Left arm. The patient stands with assistance and is monitored. No acute distress is noted. The patient's guardian came to pick up the patient and escort patient home. The patient was escorted out of the building by RN and gets in the vehicle with her guardian. Patient was instructed to go to ER or Urgent care if any symptoms change or worsen. Patient to see Doctor if tingling does not resolve.   4/26/19: Phone call made by RN to follow up with patient. Patient states all her symptoms have resolved and she returned to work today. Patient denies headache, dizziness, or tingling in left arm.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Vision blurred
Clinical narrative: The patient came into the health department at approximately 1:00 PM for her last Rabies vaccine to complete the series of 3 doses. About 10 minutes after receiving the vaccine, the patient began to feel "light headed" and her face became flushed. She reported feeling a "tingling" sensation in her left arm that ran from the injection site in the deltoid all the way down her arm. At 1:10 the patient's blood pressure was 139/78, heart rate was 80. The patient reported a headache as well located to the frontal area and rated her pain a 3/10. Patient reports her left arm is still tingling and was provided with apple juice and reclined back in chair. Patient denies any history of allergies or previous reaction to Vitals taken at 1:20 PM: BP 132/78, HR 83. Patient reports continued headache and tingling in left arm. Bilateral grip to hand strong, no weakness noted. Patient is stable but states her vision is slightly blurry and she feels dizzy. At 13:30 the patient's blood pressure is 140/76, HR 74. Patient reports tinging sensation has slightly improved and headache is about the same. Patient reports history of anxiety attacks. Patient kept in office until 2:15 PM and was continuously monitored. At 2:15 the patients BP is 118/72 and she states her headache is a 1/10 on the pain scale. Left arm has no redness or edema. She reports some continued tingling in the Left arm. The patient stands with assistance and is monitored. No acute distress is noted. The patient's guardian came to pick up the patient and escort patient home. The patient was escorted out of the building by RN and gets in the vehicle with her guardian. Patient was instructed to go to ER or Urgent care if any symptoms change or worsen. Patient to see Doctor if tingling does not resolve.   4/26/19: Phone call made by RN to follow up with patient. Patient states all her symptoms have resolved and she returned to work today. Patient denies headache, dizziness, or tingling in left arm.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Nephrolithiasis, Renal pain
Clinical narrative: ON THIRD DAY AFTER VACINE INJECTION I EXPERIENCED PASSING A KIDNEY STONE FOR THE FIRST TIME IN MY 88 YEARS. EXCURCIATING PAIN FOR 1 1/2 DAYS & IT CAME OUT. ON 1ST DAY AFTER SHOT, SOME INTERNAL ORGAN DISCOMFORT.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Local swelling + pain at site of injection 8x10cm area (L) upper arm.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: The injection site was swollen, hard to touch and warm. Pt also complained it hurted when she raised her arm. Recommended: Hydrocortisone 1% cream, Benadryl tab & IBU for pain.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Acute urticarial - Elevated pink patches on upper & lower extremities
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Erythema, Rash macular, Swelling, Urticaria
Clinical narrative: patients hives from head to toe red raised blotchy hives; that patients hives from head to toe red raised blotchy hives; This report was identified from a line listing obtained on request by the Company from FDA under the Freedom of Information Act (HA # 716317). The reporter referred to a 12-year-old female patient. The patient's medical history included anorexia, sinus allergies and an emergency department (ED) visit on 21-SEP-2017 for contusion of right elbow. No concomitant therapy was reported.  On 20-SEP-2017, the patient was vaccinated with a first dose pf hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), in left leg, intramuscularly, lot # N019923, expiration date 28-APR-2019, for prophylaxis and with the third dose of influenza virus split virion 4v vaccine inactivated (FLUZONE), in left arm, intramuscularly, reported lot # UI825AD (expiration date was not provided) for prophylaxis. On 22-SEP-2017, the patient experienced hives from head to toe, red, raised, blotchy hives. The outcome of the events was reported as recovered. The causality assessment was not provided.  Follow-up information was identified from a line listing obtained on request by the Company from FDA under the Freedom of Information Act (HA # 716317). Information of another two reporters was provided. The patient was white. The patient was not pregnant. The patient had no known drug allergies. The patient had not ever had an adverse event following any previous vaccine.  It has been determined that case # US-009507513-1802USA001192 is a duplicate of case # US-009507513-1802USA000271. Therefore, case # US-009507513-1802USA001192 is being deleted from our files and the cases are consolidated into case # US-009507513-1802USA000271.  Follow-up information has been received on 16-APR-2019.  The reporter was unable to complete the report due to lack of patient name.
Age: 0.83
Sex: M
Vaccine: HEP
Symptoms: Irritability, Keratosis pilaris, Rash
Clinical narrative: I noticed patient's irritability the night of the injection; another adverse reaction was a mild rash that looks like keratosis pilaris on his legs, which started on 5/12.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling face
Clinical narrative: PATIENT DEVELOPED FACIAL SWELLING 2 HOURS AFTER INJECTION WAS ADMINISTERED. WENT TO ER GIVEN SOL MEDROL, BENADRYL AND PEPCID, WAS ADMITTED FOR OBSERVATION.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported.; a patient was inadvertently administered with one expired dose of VAQTA; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-APR-2019 the patient was inadvertently vaccinated with one expired dose of hepatitis a vaccine, inactivated (VAQTA) injection 25/0.5 (units not provided) (route unknown; lot#R006471, expiration date was 02-APR-2019) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) involved.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Crying
Clinical narrative: was crying; pulling legs up to chest; seemed to be in pain; This spontaneous report was received from a medical assistant via a company representative and refers to a 2 months old female patient. There was no information about the patient's concomitant medications, pertinent medical history and drug reactions or allergies provided. On 11-MAR-2019, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027272, expiration date: 07-JUN-2020, orally for rotavirus prevention, a dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (route of administration, anatomical location, lot# and expiration date were not reported) and a dose of hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (route of administration, anatomical location, lot# and expiration date were not provided). On 11-MAR-2019, the patient was crying, pulling legs up to chest and seemed to be in pain. The patient sought medical attention by visiting an emergency room on 11-MAR-2019, however it was unknown if she received any treatment for the events. On the same day, the patient was sent home and the symptoms were resolved.  The causality assessment between the events and the suspect therapies was not provided.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse effect reported; received PROQUAD instead of MMR II; This spontaneous report was received from a medical assistant and refers to a 30-month-old patient of unknown gender. No information on the patient's pertinent medical history, concomitant medications, drug refractions or allergies was provided. On 16-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R020816, expiration date 16-JAN-2010, recombinant Human albumin (rHA) (dose number, route of administration, anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERLIE DILUENT) injection (dose, route of administration, lot # and expiration date were not reported). The vaccine was administered instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, albumin status, route of administration, lot # and expiration date were not reported). The reason for vaccines substitution was not provided. The patient did not experience any adverse event.  The outcome of the events was unknown.
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; 25 year old female patient was administered one dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 25-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-APR-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA), lot # R014354, expiration date: 18-NOV-2019 for prophylaxis (route of administration and vaccination site were not reported) reconstituted with sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; a patient received an epxired dose of M-M-R II; a patient received an expired dose of M-M-R II via intramuscular route; This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (recombinant human albumin) lot # M029229, expiration date: 08-JUN-2018, intramuscularly (exact dose was not provided). No known adverse effects were reported.
Age: 1.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; MMR II administered 2 weeks after VARIVAX; Information has been received from a nurse referring to a 13 months old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  On 08-APR-2019, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (route of administration, lot number and expiration date were not reported) for prophylaxis. On 26-APR-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number R027999, expiration date 01-OCT-2020 and therapy type: rHA (recombinant Human albumin); route of administration was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported. No product quality complaint (PQC) was involved.  Lot number R027999 has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live.
Sex: U
Vaccine: MMR
Symptoms: Contraindication to vaccination, No adverse event, Product use issue
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient was immunocompromised due to therapy with adalimumab (HUMIRA). The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided. On 28-APR-2019, the patient was administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live M-M-R II (lot number R036582, expiration date 17-DEC-2020) with sterile diluent (lot number S002624 and expiration date 05-NOV-2021) subcutaneously for prophylaxis. The pharmacist was unaware the patient was on therapy with adalimumab (HUMIRA) until after Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was administered (product use issue). No adverse events were reported. No product quality complaint (PQC) was involved.   Lot No. S002624 has been verified to be a valid lot number for sterile diluent.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient was administered a dose of MMRII which was improperly stored; Information has been received from a healthcare worker/medical assistant referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  On 02-MAY-2019, the patient was administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number R031680, expiration date 01-NOV-2020 and therapy type: rHA (recombinant Human albumin, data logger); route of administration was not reported) for prophylaxis, which was improperly stored (product storage error). No adverse events were reported. There was no previous temperature excursion. No product quality complaint (PQC) was involved.  Lot number R031680 has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chest X-ray abnormal, Influenza, Laboratory test abnormal, Pneumococcal infection
Clinical narrative: This spontaneous report was received from female consumer under her 65-years-old referring to herself via company representative. The patient's concurrent conditions, drug reactions, allergies and concomitant therapies were unknown by the reporter. Her medical history included an unspecified cancer that was diagnosed ten years ago. In 2018 (reported as "on an unspecified date last year" ; the patient was vaccinated with the PNEUMOVAX 23 injection, for prophylaxis for an unknown indication (doses number where not reported; routes and anatomical locations of vaccination, lot numbers and expiration dates were unknown by the reporter; a she was vaccinated with the influenza vaccine for an unknown indication (doses number where not reported; routes and anatomical locations of vaccination, lot numbers and expiration dates were unknown by the reporter). On unknown date (reported as "approximately three months after receiving the vaccines"), the consumer was admitted to the hospital , where she was performed a chest X-Ray and a full diagnostic work-up, and was diagnosed with the flu (Influenza) and a pneumococcal disease (pneumococcal infection). The patient received treatment for the events according to the reporter. The outcome of the events was reported as resolved. The causal relationship between PNEUMOVAX 23 and influenza vaccine administration and the occurrence of the events not provided by the reporter. Upon internal review, the event pneumoccocal infection was determined to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Administered to pregnant patient; This spontaneous prospective pregnancy report was received from an immunization coordinator via company representative concerning a female patient of an unknown age.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (dosage regimen, route of administration, lot number and expiry date were not reported) for prophylaxis. It was reported the patient notified she was pregnant. Last menstrual period (LMP) or date of conception were not provided. No product quality complaint was involved. At the time of reporting, the outcome of exposure during pregnancy was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; an expired dose of MMR II (N009168, 3/20/2019) which was administered to a patient; Information has been received from a nurse, referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.    On 03-MAY-2019, the patient was vaccinated an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) (strength unknown; lot # N009168 and expiration date 20-MAR-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects reported.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: she "got inadvertent exposure in her eye to one droplet of one dose" of VARIVAX; she "got inadvertent exposure in her eye to one droplet of one dose" of VARIVAX; she "got inadvertent exposure in her eye to one droplet of one dose" of VARIVAX; This spontaneous report was received from a nurse referring to a female patient of unknown age or gender.  The patient's concurrent conditions, historical conditions, drug reactions, allergies, concomitant medications were not provided. The patient was not pregnant.  On 02-MAY-2019, the patient, who was also the nurse, got inadvertent exposure in her eye to one droplet of one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R026548 (expiration date 17-SEP-2020) (dose, frequency, strength, were not provided) (occupational exposure to product, accidental exposure to product, and exposure via eye contact). No additional information provided.
Sex: M
Vaccine: HEPA
Symptoms: HIV infection, Hepatitis A, Vaccination failure
Clinical narrative: Vaccination failure; acute HAV infection;   This literature marketed report was received from authors of a published article, titled as above.  It refers to a 29 year old male patient. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient completed a 2-dose series vaccination with hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. After 3 years, the patient was diagnosed the human immunodeficiency virus (HIV) infection. After 7 years, the patient experienced acute hepatitis A virus (HAV) infection. Previous vaccination for hepatitis did not reliably provide protection among some persons with HIV infection (Vaccination failure). The patient did not received postexposure prophylaxis. The outcome of vaccination failure and hepatitis A was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of the several reports received from the same literature (link reports # 1905USA005761, 1905USA005762).; Sender's Comments:  US-009507513-1905USA005761: US-009507513-1905USA005762:
Sex: F
Vaccine: MMR, MMRV
Symptoms: Urticaria, Wrong product administered
Clinical narrative: 3 dimensional hives all over her cheeks / had breakouts o hives intermittently over 4 days; the patient received a dose of PROQUAD instead of MMR II; This spontaneous report was received from a consumer (the patient's mother) and refers to a 5.5 years old female patient. The patient had no concomitant medications, pertinent medical history and no drug reactions or allergies. She was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) when she was supposed to have them (at 1-year-old).  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (exact dose, route of administration, albumin status, vaccination site, lot # and expiry date were not specified) for prophylaxis. On 01-MAY-2019, at the doctor's office, the patient was supposed to receive the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) due to measles outbreak, however she received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (exact dose, route of administration, albumin status, vaccination site, lot # and expiry date were not reported) instead.  On 02-MAY-2019, the patient was seen in the physician's office due to 3 dimensional hives all over her cheeks. The consumer reported that the patient had breakouts of hives intermittently over 4 days. No lab diagnostics or studies were performed. The patient received an unspecified treatment due to the event. Product quality complaint (PQC) was not involved.  The outcome of urticaria was reported as recovered/resolved on approximately 06-MAY-2019. The relatedness between the event and the suspect vaccines was not provided.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Rash
Clinical narrative: This spontaneous report was received from a nurse refers to a child of unknown age. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. The nurse reported that  a few weeks ago, she saw on the news a case of measles in a child who had a horrible rash on unspecified date. The nurse reported that the mother of the child said her child was completely up to date on vaccines and on an unknown date,  the patient was vaccinated with M-M-R II (dose, strength, route and administration, lot number and expiration date unknown) for prophylaxis. The nurse reported that the mother said she had her child "genotype tested" and the child was "positive for attenuated measles" (measles post vaccine). The nurse reported that, the mother of the patient was accused of being an anti-vaxer and it ruined her daycare business. A sterile diluent was used to reconstitute M-M-R II (lot number and expiration date unknown).The outcome of measles post vaccine was unknown. The causality assessment of measles post vaccine was not reported. No product quality complaints were involved. Upon internal review, measles post vaccine was determined to be medically significant. This is one of the two reports from the same reporter.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received doses of vaccines after a temperature excursion; No adverse effect were reported; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history.   On unknown date, the patient was vaccinated with a dose after a temperature excursion (product storage error ) of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R033660, expiration date 20-NOV-2020, and R029517, expiration date 14-OCT-2020 for prophylaxis (strength, dosage, route of administration, and anatomical site were not reported). Therefore, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (strength, dosage, route of administration, anatomical site, lot number and expiration date were not reported). No adverse effects were reported. Administered doses of both vaccines experienced the temperature excursion of 35.9 degrees Fahrenheit (F) for 5 hours 54 minutes. Data logger was involved. There were no previous excursions reported.  This is one of three several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005428: US-009507513-1905USA005429:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received doses of vaccines after a temperature excursion; No adverse effect were reported; This spontaneous report was received from a medical assistant and refers to a currently 5-year-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided.   The medical assistant reported that, on an unknown date, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (dose number and anatomical location of administration were not provided; witch lot number R029517, expiration date 14-OCT-2020 and R033660, expiration date 20-NOV-2020) for prophylaxis.   The doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to a temperature excursion of 35.9 degrees Fahrenheit (°F) for a time frame of 5 hours and 54 minutes, which was detected by the Digital Data Logger. There was no a previous temperature excursion. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005428: US-009507513-1905USA005327:
Age: 1.0
Sex: U
Vaccine: PNC13, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported; was inadvertently administered a dose of PNEUMOVAX 23 instead of PREVNAR 13; Information has been received from a medical assistant reporting on a 1-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 07-MAY-2019, the patient was inadvertently administered an unspecified dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot# R018731 and expiration date 27-FEB-2020 (route of administration was not reported) instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005505: US-009507513-1905USA005504: US-009507513-1905USA005507: US-009507513-1905USA005503:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R013127, expiration date: 04-NOV-2019 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005505: US-009507513-1905USA005504: US-009507513-1905USA005507: US-009507513-1905USA005488:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 19-APR-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA (recombinant human albumin))(PROQUAD) lot # R026351, expiration date 15-MAR-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-APR-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA (recombinant human albumin))(PROQUAD) lot # R026351, expiration date 15-MAR-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 23-APR-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA (recombinant human albumin))(PROQUAD) lot # R026351, expiration date 15-MAR-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
Sex: M
Vaccine: HEPA
Symptoms: HIV infection, Hepatitis A, Vaccination failure
Clinical narrative: Vaccination failure; acute HAV infection;  This literature marketed report was received from authors of a published article, titled as above.  It refers to a 31 year old male patient with human immunodeficiency virus (HIV) infection. Information about concomitant medication and medical history was not provided. On an unknown date the patient completed a 2-dose series vaccination with hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. After 5 years, the patient experienced acute hepatitis A virus (HAV) infection. Previous vaccination for hepatitis did not reliably provide protection among some persons with HIV infection (Vaccination failure). CD4 count before first HAV vaccine dose was 358 cells per cubic millimeter. HIV viral load before first HAV vaccine dose was 1886 copies per milliliter. CD4 count before HAV infection was 243 cells per cubic millimeter. HIV viral load before HAV infection was 28474 copies per milliliter. The patient did not received postexposure prophylaxis. The outcome of vaccination failure and hepatitis A was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of the several reports received from the same literature (link reports # 1905USA003825, 1905USA005762).; Sender's Comments:  US-009507513-1905USA003825:
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A, Vaccination failure
Clinical narrative: Vaccination failure; acute HAV infection; Incomplete course of vaccination;   This literature marketed report was received from authors of a published article, titled as above.  It refers to a 30 year old male patient with human immunodeficiency virus (HIV) infection. Information about concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis (incomplete course of vaccination). After 13 days, the patient experienced acute hepatitis A virus (HAV) infection. Previous vaccination for hepatitis did not reliably provide protection among some persons with HIV infection (Vaccination failure). CD4 count before first HAV vaccine dose was 887 cells per cubic millimeter. HIV viral load before first HAV vaccine dose was 154 copies per milliliter. CD4 count before HAV infection was 779 cells per cubic millimeter. HIV viral load before HAV infection was 20 copies per milliliter. The patient received postexposure prophylaxis (PEP) consisting of 1 dose of monovalent vaccine at 7 days and immune globulin (IG) at 14 days after the latest possible exposure but developed illness 6 days after PEP was completed. The outcome of vaccination failure and hepatitis A was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of the several reports received from the same literature (link reports # 1905USA003825, 1905USA005761).; Sender's Comments:  US-009507513-1905USA003825:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: vaccination site mass; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site lump in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that the patient complained about a lump on the arm after receiving shingrix on unspecified dates. No clarification information was provided, no further information was provided. This is 1 of the 5 patient case linked through same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: vaccination site mass; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site lump in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that the patient complained about a lump on the arm after receiving shingrix on unspecified dates. No clarification information was provided, no further information was provided. This is 1 of the 5 patient case linked through same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site mass, Injection site pain
Clinical narrative: Wrong Route of Administration; Injection site knot; Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 1st February 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site lump and injection site pain. On an unknown date, the outcome of the injection site lump and injection site pain were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site lump and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine on her left arm underneath the skin as a subcutaneous injection, which led to intramuscular formulation administered by other route. The patient developed a knot and pain at the injection site on left arm which lasted for 4 days. The reporter consented to follow up. No further details were provided.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: Fatigue; Ringing of the ears; Fever; Vomiting; Headache; Rash; Weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix. On 22nd March 2019, 10 hrs after receiving Shingrix, the patient experienced fever, vomiting, headache, rash, weakness, fatigue and ringing in ears. On an unknown date, the outcome of the fever, vomiting, headache, rash and weakness were recovered/resolved and the outcome of the fatigue and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the fever, vomiting, headache, rash, weakness, fatigue and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The reporter was patient. On 22nd March 2019, about 10 hours later post vaccination in the left arm, in the evening, the patient experienced fever, vomiting, headache, rash, weakness, fatigue and ringing in the ears. All adverse events lasted for about 1 to 2 days, except fatigue and ringing of the ears which were still ongoing at the time of reporting. The patient had been to the doctor twice and also had seen the nurse at the county health department where he received the vaccine. He had scheduled an appointment with an Ear, Nose, Throat (ENT) doctor at the end of this month. The reporter consented to follow up. No further details were provided. The caller did not have doctor's information handy.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus, Vomiting
Clinical narrative: Fatigue; Ringing of the ears; Fever; Vomiting; Headache; Rash; Weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix. On 22nd March 2019, 10 hrs after receiving Shingrix, the patient experienced fever, vomiting, headache, rash, weakness, fatigue and ringing in ears. On an unknown date, the outcome of the fever, vomiting, headache, rash and weakness were recovered/resolved and the outcome of the fatigue and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the fever, vomiting, headache, rash, weakness, fatigue and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The reporter was patient. On 22nd March 2019, about 10 hours later post vaccination in the left arm, in the evening, the patient experienced fever, vomiting, headache, rash, weakness, fatigue and ringing in the ears. All adverse events lasted for about 1 to 2 days, except fatigue and ringing of the ears which were still ongoing at the time of reporting. The patient had been to the doctor twice and also had seen the nurse at the county health department where he received the vaccine. He had scheduled an appointment with an Ear, Nose, Throat (ENT) doctor at the end of this month. The reporter consented to follow up. No further details were provided. The caller did not have doctor's information handy.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: redness at injection site; pain in left arm and hand/ pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and pain in extremity. On an unknown date, the outcome of the injection site erythema and pain in extremity were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and pain in extremity to be related to Shingrix.  Additional details were provided as follows: After receiving the first dose of Shingrix on left deltoid, the patient returned to the pharmacy the next day and reported to his pharmacist that he was experiencing pain and redness that has radiated from the injection site down to the bicep and hand.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hepatitis, Lymphocyte morphology abnormal, Malaise, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hepatitis in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 1st May 2019, the patient received SHINGRIX. In May 2019, less than a week after receiving SHINGRIX, the patient experienced hepatitis (serious criteria GSK medically significant), malaise, fatigue, fever and atypical lymphocytes. On an unknown date, the outcome of the hepatitis, malaise, fatigue, fever and atypical lymphocytes were unknown. It was unknown if the reporter considered the hepatitis, malaise, fatigue, fever and atypical lymphocytes to be related to SHINGRIX. Additional details were provided as follows: The reporter wants to know whether SHINGRIX causes hepatitis like syndrome or not. The reporter did not consent to follow-up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past expiration date by mistake
Age: 76.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Rash
Clinical narrative: Approximately 48 hours after administration of Shingrix and Havrix, a rash developed on upper back (bilateral).  The rash was associated with itching, no pain, no tingling.  Rash then went down back and progressed to hand (palms), soles of feet.  The rash would last about 24 to 48 hours and then disappear.  New rashes continue to appear and disappear in different parts of body.  Myalgias reported.  The patient has consulted two MDs and hydrocortisone was recommended.  At current time, patient is still having issues.  Patient also has ALS and taking riluzole as part of a study. Unknown if this occurence is related to vaccines, riluzole, or combination of both.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Pain, Pain in extremity
Clinical narrative: PATIENT'S WIFE CAME TO PHARMACY AND REPORTED PATIENT EXPERIENCING ARM PAIN AND SIGNIFICANT PAIN WITH ARM MOVEMENT AROUND 3 DAYS AFTER GETTING VACCINE. SHE STATED THAT THE PATIENT WAS STILL EXPERIENCE MILD TENDERNESS/BRUISING FEELING AROUND THE INJECTION SITE APPROXIMATELY 6 WEEKS LATER UPON TOUCH. SHE DENIED VISIBLE REDNESS OR SWELLING AROUND THE INJECTION SITE. SHE DENIED ANY CONTACT WITH A MEDICAL PROFESSIONAL FOR FURTHER EVALUATION.