chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012977: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 22-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient received one dose of VAQTA (lot number R013857, expiration date 4/22/2019) on 05/06/2019; This spontaneous report was received from a medical assistant (inconsistent information as it was also reported as nurse), concerning a patient of unknown age or gender.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.   On 06-MAY-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R013857 with expiration date 22-APR-2019, administered intramuscularly (strength, frequency, dose, and anatomical location were not provided) for prophylaxis.  No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Red on his entire body; rash is itchy; raised rash on body/bumpy rash; This case was reported by a other health professional via call center representative and described the occurrence of red rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced red rash, itchy rash and raised rash. On an unknown date, the outcome of the red rash and itchy rash were not recovered/not resolved and the outcome of the raised rash was unknown.   It was unknown if the reporter considered the red rash, itchy rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter had a part-time co-worker that received Shingrix vaccine 10 days ago. He has broken out in a red, bumpy, raised rash over his entire body. He reported that the rash was itchy.  The reporter consented to follow up. The reporter was unable to provide additional information.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient reported that he experienced a sore arm which was not going away after receiving Shingrix. The reporter consented to follow up.  No information was available. The outcome reported for AE in the structured field is recovering instead of not resolved (outcome uploaded).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site soreness/pain; injection site swelling; injection site warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows:  The patient reported this case. The age at vaccination was not reported. Approximately two weeks ago (of date of reporting), the patient received the 1st dose of the Shingrix vaccine in left arm.   The patient had soreness, pain, warmth and swelling around the injection site.   These symptoms lasted for almost a week. The patient did not consent to follow-up. Unable to obtain additional information at this time.
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Broke out in a rash; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. A contactable consumer reported for a female patient that:  Description: The Office Manager reported that "a female patient received a PREVNAR 13 shot in her left arm and broke out in a rash the same day". Manufacturer information for PREVNAR 13 is Pfizer. No PQC involved. No further AE information provided.  Product: Product: Prevnar Product Circular#: Not Applicable Lot Number: X13882 Expiration Date: 30Sep2020 Dose/Frequency: Refused to Answer Manufacturer (if available): Pfizer  The information listed above is all data we have received. Please do not contact Merck & Co., Inc. for additional information. Any follow-up information received by Merck & Co., Inc. regarding this case will be forwarded to you upon receipt.  Please note that this information has not been reported to the FDA.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Intense swelling from injection sight.
Age: 59.0
Sex: F
Vaccine: MENB, MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient developed localized redness, swelling, and tenderness over her L deltoid (MenACWY and MenB injection sites) 3-4hours after injections.  Patients arm was swollen, warm, tender and pt had low grade fever (as high as 100.9F). Seen in ER.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza, Memory impairment
Clinical narrative: severe flu symptoms  headaches  memory problems
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dysphagia, Dyspnoea, Pallor, Vomiting
Clinical narrative: PT TURNED PALE, AND BEGAN STATING THAT HE COULD NOT SWALLOW AND WAS HAVING A HARD TIME BREATHING. VOMITING 1-2 TIMES. EMS WAS CALLED
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Antinuclear antibody positive, Laboratory test normal, Rash
Clinical narrative: Developed facial rash that Dermatology is concerned for Lupus.
Age: 54.0
Sex: F
Vaccine: PPV, UNK, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Headache, body aches, fatigue, chills, low-level fever, loss of appetite, sporadic mild nausea, soreness at injection site, minor redness at injection site, Had to lay in bed all day on 5/9/19 and somewhat in 5/10/19. I had a similar reaction to the first Shingrix vaccine in this 2-part series. One factor might be that I never had chicken pox (which was verified by a blood test). (But I did have the chicken pox vaccine.) I have never had a reaction to the tetanus vaccine.
Age: 54.0
Sex: F
Vaccine: PPV, UNK, VARZOS
Symptoms: Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Headache, body aches, fatigue, chills, low-level fever, loss of appetite, sporadic mild nausea, soreness at injection site, minor redness at injection site, Had to lay in bed all day on 5/9/19 and somewhat in 5/10/19. I had a similar reaction to the first Shingrix vaccine in this 2-part series. One factor might be that I never had chicken pox (which was verified by a blood test). (But I did have the chicken pox vaccine.) I have never had a reaction to the tetanus vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Influenza like illness, Myalgia, Nausea
Clinical narrative: About 1 hour later, noticed that ears started hissing and ringing.  Before the vaccine, patient had history of auditory issues but were under control.  The noise started getting louder and louder by midnight; it was frightening and awful.   Patient took Valium to relax but did not help.  Patient also reports severe arm pain at vaccination site.  Next day patient reports muscle aches, dizziness, nausea, and flu-like symptoms.   Patient took Oxycondin on Wednesday; medicine did not help with symptoms.    On Thursday, patient called the doctor and was told to give it a few day and to call back by Monday if symptoms continued.   Patient reported to the pharmacist as well. By Monday 5/6, auditory symptoms lessened but came back. Patient has been using Valium to keep symptoms down.  Doctor specified that there is nothing they can do about it.   Last night, auditory symptoms were very strong.  At this point, patient not planning to take the next Shingrix dose due to the aggravated auditory issues it caused.  Patient still has not recovered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: About 1 hour later, noticed that ears started hissing and ringing.  Before the vaccine, patient had history of auditory issues but were under control.  The noise started getting louder and louder by midnight; it was frightening and awful.   Patient took Valium to relax but did not help.  Patient also reports severe arm pain at vaccination site.  Next day patient reports muscle aches, dizziness, nausea, and flu-like symptoms.   Patient took Oxycondin on Wednesday; medicine did not help with symptoms.    On Thursday, patient called the doctor and was told to give it a few day and to call back by Monday if symptoms continued.   Patient reported to the pharmacist as well. By Monday 5/6, auditory symptoms lessened but came back. Patient has been using Valium to keep symptoms down.  Doctor specified that there is nothing they can do about it.   Last night, auditory symptoms were very strong.  At this point, patient not planning to take the next Shingrix dose due to the aggravated auditory issues it caused.  Patient still has not recovered.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian failure
Clinical narrative: a patient experienced "Primary Ovarian Failure after being vaccinated with GARDASIL".; This spontaneous report was received from a physician, via company representative, referring to a 17-year-old female patient.     The patient's concurrent conditions, medical history, previously drug reactions, drug allergies and concomitant medications were unknown by the reporter.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not provided) as prophylaxis.   The physician had written an article regarding primary ovarian failure (POF) and was later contacted by patient's mother, who stated that her daugther experienced primary ovarian failure after being vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). At the reporting time, the outcome of the event POF, as well as, if patient sought medical attention, or received treatment, or if laboratory diagnostics or studies were performed, were unknown.   Relatedness between the event POF and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Patient have taken the shingle vaccine and had a reaction to it; Information has been received from a female patient of unknown age via Novartis, referring to herself. Information of concurrent condition, medical history and concomitant therapy was not provided.    On an unknown date, the patient taken zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.      On an unknown date, the patient had a reaction to it. The outcome of the event was unknown. The relationship between the event and zoster vaccine live (ZOSTAVAX) was related.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 27-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; shivers; fever of 101.8 F; sore neck; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a week after receiving Shingrix, the patient experienced pain in arm, shivers, fever and neck pain. On an unknown date, the outcome of the pain in arm, shivers, fever and neck pain were unknown.   It was unknown if the reporter considered the pain in arm, shivers, fever and neck pain to be related to Shingrix.  Additional details were provided as follows:  The reporter was the concerned patient. The patient experienced sore arm, shivers and fever of 101.8 degrees F and a sore neck. The patient did not consent to follow-up.
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Malaise, Pyrexia
Clinical narrative: had a fever; decreased appetite; sick; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 13-month-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced had a fever, decreased appetite. It was also reported that patient received several vaccines and was sick on an unspecified date. Events took place after use of product. The outcome of the events was unknown.
Age: 2.08
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose of Hep A vaccine was given. Advised Dr no further action require. Spoke with mom and was advise, as per mom patient is doing okay and has no symtoms.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Patient received the shot on Saturday and on sunday she developed severe pain and soreness at the injection site. Three days later on Thursday she noticed a red bump and it was warm to touch. On Thursday 05/09, she was advised by the pharmacist to take Benadryl 50mg. She did but it did not help. She called back on Friday and said it was not getting better. I told her to try taking Ibuprofen for pain and inflammation. Also advised her to see her doctor if it does not improve in a few days or if it gets better. Patient denied having any shortness of breath or any other symptoms other than localized reaction.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: On Saturday, April 27, 2019 I went to Emergency Triage because my painfully, swollen ejection sight needed to be seen as soon as possible by a healthcare provider for advice.  It took approximately 7 days from Thursday, April 25, 2019 day of injection for my pain and swelling to reduce.  However, today Friday, May 10, 2019 my upper left deltoid has no pain or swelling present.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Within 3 minutes of getting vaccine patient began to have itching, redness, and hive noted in area of injection site on Right Lateral Thigh area. Only MMR given in that leg. Benadryl (12.5mg/5ml) 4ml dose administered in office and observed. No worsening symptoms. Patient released and parent advised to monitor site and to call for worsening symptoms.
Age: 57.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Emotional distress, Wrong product administered
Clinical narrative: This 57 year old woman was given an MMRV instead of MMR and was taking ASA at the time.  The error was not found until she called asking questions about the number of vaccines she received versus what her husband received. It was discovered at that time, that she received the wrong vaccine.  She was advised to call her primary doctor to see if she should stop her ASA for the next 5 days.  She was rightfully upset about not being notified.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site discolouration, Injection site reaction, Injection site urticaria, Injection site warmth
Clinical narrative: Erythematous wheal 2 cm x 3 cm coalesced with a 2 cm wheal on (R) upper lateral arm over deltoid. A 4 cm wheal inferior and medial to the above. White rim, warm to touch, blanching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Urticaria
Clinical narrative: Erythematous wheal 2 cm x 3 cm coalesced with a 2 cm wheal on (R) upper lateral arm over deltoid. A 4 cm wheal inferior and medial to the above. White rim, warm to touch, blanching.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: the third dose of VAQTA; using another unspecified vaccine for Hepatitis Bat that time; HAVRIX on 5/22/2018; Information has been received from a pharmacist referring to a 73 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  The initial dose of Hepatitis A vaccination was hepatitis a virus vaccine inactivated (HAVRIX) (lot number PZ353, expiration date 21-NOV-2020) administered on 22-MAY-2018, and the second dose was Hepatitis A Vaccine, Inactivated (VAQTA) (lot number R 027987, expiration date 09-AUG-2019) intramuscularly for prophylaxis on 18-DEC-2018 (reported as 7 months later) (inappropriate schedule of product administration). On 20-FEB-2019, the patient received the third dose of Hepatitis A vaccine, which was VAQTA (lot number R031045, expiration date 18-NOV-2019) (inappropriate schedule of product administration). There was a medical error as per pharmacist, the office was using another unspecified vaccine for Hepatitis B at that time (wrong product administered). No product quality complaint (PQC) was involved.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abscess drainage, Culture, Injection site abscess
Clinical narrative: The patient developed an abscess at the injection site; The patient developed an abscess at the injection site (on the opposite arm); This spontaneous report was received from a physician via company representative regarding a 13-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.   On an unknown date, the patient developed an abscess at the injection site (injection site abscess), she sought medical attention and the abscess was lanced and cultured on unspecified date (result not provided). Then, on an unknown date, the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis and she developed an abscess at the injection site (injection site abscess) on the opposite arm which was lanced and cultured on unspecified date (result not provided). The patient received unspecified treatment.  At the time of the report, the outcome of the events was unknown.  The relatedness between the events and therapy with of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: injection site swollen; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 80-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the injection site swelling to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection kind of bubbled Up, it was not anything that went anywhere and it stayed localized. This case has been linked with case US2019077746, reported by the same reporter for adverse event following Shingrix.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperacusis, Mobility decreased, Musculoskeletal chest pain, Myalgia
Clinical narrative: Headache; Muscle aches (predominantly in chest and leg); Sensitivity to noise; light sensity; pain in leg; Muscle aches (predominantly in chest and leg); This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced headache, myalgia of lower extremities, hyperacusis, photophobia, leg pain and musculoskeletal chest pain. On an unknown date, the outcome of the headache and musculoskeletal chest pain were recovering/resolving and the outcome of the myalgia of lower extremities was unknown and the outcome of the hyperacusis, photophobia and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, myalgia of lower extremities, hyperacusis, photophobia, leg pain and musculoskeletal chest pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscularly on left deltoid and experienced headache, muscle aches (predominately in the chest and legs), sensitivity to light, and sensitivity to noise.  The muscle aches made the patient feel like she could not move.   These symptoms started out mild in the evening prior to when she went to bed and worsened overnight.   The symptoms were less the morning at the time of reporting, although the reporter was trying to decide if he should take her to the emergency room.   The chest pain was less and the headache was a little better.  The patients legs were really sore.   The light and noise sensitivity was unchanged. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Photophobia
Clinical narrative: Headache; Muscle aches (predominantly in chest and leg); Sensitivity to noise; light sensity; pain in leg; Muscle aches (predominantly in chest and leg); This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced headache, myalgia of lower extremities, hyperacusis, photophobia, leg pain and musculoskeletal chest pain. On an unknown date, the outcome of the headache and musculoskeletal chest pain were recovering/resolving and the outcome of the myalgia of lower extremities was unknown and the outcome of the hyperacusis, photophobia and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, myalgia of lower extremities, hyperacusis, photophobia, leg pain and musculoskeletal chest pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscularly on left deltoid and experienced headache, muscle aches (predominately in the chest and legs), sensitivity to light, and sensitivity to noise.  The muscle aches made the patient feel like she could not move.   These symptoms started out mild in the evening prior to when she went to bed and worsened overnight.   The symptoms were less the morning at the time of reporting, although the reporter was trying to decide if he should take her to the emergency room.   The chest pain was less and the headache was a little better.  The patients legs were really sore.   The light and noise sensitivity was unchanged. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: extreme pain; This case was reported by a physician via call center representative and described the occurrence of pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced extreme pain with the first dose of Shingrix and as a result  she would not be completing the two dose series. The batch number and date of birth not provided.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Injected limb mobility decreased, Myalgia
Clinical narrative: mal-administration; headache; muscle aches; limited range of motion; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2018, the patient received the 1st dose of Shingrix. In April 2019, the patient received the 2nd dose of Shingrix. In July 2018, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced headache, muscle pain and injected limb mobility decreased. In April 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the headache, muscle pain and injected limb mobility decreased were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, muscle pain and injected limb mobility decreased to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on left arm. In April 2019, the patient received the 2nd dose of Shingrix, which led to lengthening of the vaccination schedule. The patient experienced the side effects 24 hours after her first dose. The effects lasted for 5 days and resolved.  The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On 25th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: In 2019, the patient experienced upset stomach. The reporter gave consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Pain
Clinical narrative: Having the cold; Chills; Low grade fever; Achy; Exhausted; Sore arm; Joint aches / Arthritic feeling / arthritic feeling in her knuckles; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eye dryness.   On 15th March 2019, the patient received the 1st dose of Shingrix .5 ml. On 15th March 2019, less than a day after receiving Shingrix, the patient experienced joint pain. On 16th March 2019, the patient experienced feeling cold, chills, fever, pain, exhaustion and pain in arm. On 16th March 2019, the outcome of the feeling cold, chills, fever, pain, exhaustion and pain in arm were recovered/resolved. On an unknown date, the outcome of the joint pain was recovered/resolved.   It was unknown if the reporter considered the joint pain, feeling cold, chills, fever, pain, exhaustion and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient got the first Shingrix dose in the morning of 15th March 2019 and patient started having the symptoms that same night, joint aches (like arthritic feeling in her knuckles).  The next day 1 day after receiving Shingrix, the patient woke up with the following symptoms: feeling like having the cold, chills, low grade fever, achy, exhausted, arm was sore.  The symptoms were disappeared within a day or so except for the sore arm, which lasted a longer time. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Having the cold; Chills; Low grade fever; Achy; Exhausted; Sore arm; Joint aches / Arthritic feeling / arthritic feeling in her knuckles; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eye dryness.   On 15th March 2019, the patient received the 1st dose of Shingrix .5 ml. On 15th March 2019, less than a day after receiving Shingrix, the patient experienced joint pain. On 16th March 2019, the patient experienced feeling cold, chills, fever, pain, exhaustion and pain in arm. On 16th March 2019, the outcome of the feeling cold, chills, fever, pain, exhaustion and pain in arm were recovered/resolved. On an unknown date, the outcome of the joint pain was recovered/resolved.   It was unknown if the reporter considered the joint pain, feeling cold, chills, fever, pain, exhaustion and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient got the first Shingrix dose in the morning of 15th March 2019 and patient started having the symptoms that same night, joint aches (like arthritic feeling in her knuckles).  The next day 1 day after receiving Shingrix, the patient woke up with the following symptoms: feeling like having the cold, chills, low grade fever, achy, exhausted, arm was sore.  The symptoms were disappeared within a day or so except for the sore arm, which lasted a longer time. The reporter did not consent to follow up.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Immediate post-injection reaction, Injection site haemorrhage, Injection site mass
Clinical narrative: muscle aches; freezing; not feeling well; fever; nausea; fatigue; patient was prescribed Shingrix by her physician; inappropriate age at vaccine administration; bled at the injection site; pain at the injection site/ soreness at the injection site; bump at the injection site; knuckle at the injection site; problems sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 30-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2019) for prophylaxis.   The patient's past medical history included shingles.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st May 2019, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage, injection site pain, injection site swelling, injection site lump, sleep problem, off label use and inappropriate age at vaccine administration. On 2nd May 2019, the patient experienced muscle pain, feeling cold, feeling unwell, fever, nausea and fatigue. On an unknown date, the outcome of the injection site hemorrhage, injection site swelling, injection site lump and sleep problem were recovered/resolved and the outcome of the injection site pain, muscle pain, feeling cold, feeling unwell, fever, nausea and fatigue were not recovered/not resolved and the outcome of the off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site hemorrhage, injection site pain, injection site swelling, injection site lump, sleep problem, muscle pain, feeling cold, feeling unwell, fever, nausea and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient was prescribed Shingrix by her physician. The patient bled at the injection site, she had little bump that came up immediately after having the injection. It was a knuckle at the injection site and patient also experienced pain and soreness at the injection site. The patient reported having problems sleeping last night and woke up with muscle aches, feeling like freezing and not feeling well. At the day of reporting, the patient complained of having soreness at the injection site and also complained low grade fever, nausea and fatigue.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Myalgia, Nausea
Clinical narrative: muscle aches; freezing; not feeling well; fever; nausea; fatigue; patient was prescribed Shingrix by her physician; inappropriate age at vaccine administration; bled at the injection site; pain at the injection site/ soreness at the injection site; bump at the injection site; knuckle at the injection site; problems sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 30-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2019) for prophylaxis.   The patient's past medical history included shingles.   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st May 2019, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage, injection site pain, injection site swelling, injection site lump, sleep problem, off label use and inappropriate age at vaccine administration. On 2nd May 2019, the patient experienced muscle pain, feeling cold, feeling unwell, fever, nausea and fatigue. On an unknown date, the outcome of the injection site hemorrhage, injection site swelling, injection site lump and sleep problem were recovered/resolved and the outcome of the injection site pain, muscle pain, feeling cold, feeling unwell, fever, nausea and fatigue were not recovered/not resolved and the outcome of the off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site hemorrhage, injection site pain, injection site swelling, injection site lump, sleep problem, muscle pain, feeling cold, feeling unwell, fever, nausea and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient was prescribed Shingrix by her physician. The patient bled at the injection site, she had little bump that came up immediately after having the injection. It was a knuckle at the injection site and patient also experienced pain and soreness at the injection site. The patient reported having problems sleeping last night and woke up with muscle aches, feeling like freezing and not feeling well. At the day of reporting, the patient complained of having soreness at the injection site and also complained low grade fever, nausea and fatigue.