chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: female child received her M-M-R II on 6/30/2014 and less than 28 days later her VARIVAX; No adverse effects reported; This spontaneous report was received from a registered nurse and  refers to a female patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.          On 30-JUN-2014, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported).    On 14-JUL-2014, less than 28 days later the patient was vaccinated varicella virus vaccine live (oka/merck)(VARIVAX)(inappropriate schedule of product administration) (dosage schedule, route, anatomical location, lot number and expiration date were not reported).   No adverse effects reported.   The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Brain injury, Cardiac arrest, Cortical visual impairment, Encephalopathy, Hypotonia
Clinical narrative: This initial spontaneous report was received via an article and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The article discusses that the patient was awarded compensation by the compensation program. On 13-FEB-2013, the patient was administered measles (+) mumps (+) and rubella (reported as MMR; manufacturer not specified), haemophilus influenza type B (manufacturer not specified), PREVNAR, hepatitis A vaccine (manufacturer not specified), and varicella vaccine (manufacturer not specified). That evening following vaccination, the patient became feverish and irritable, prompting her mother to contact the doctor. The doctor advised the patient's mom to administer BENADRYL and TYLENOL for her symptoms. That fever persisted for several days and was followed by a severe seizure resulting in cardiac and respiratory arrest. The cardiac arrest and seizures caused the patient to develop encephalopathy, kidney failure, severe brain injury, low muscle tone, and cortical vision impairment. The outcome of the events were unknown. The events were considered related to M-M-R II. Causality was not specified for the other vaccines. Upon internal review, cardiac arrest, respiratory arrest, encephalopathy, seizure, kidney failure, severe brain injury, and cortical vision impairment were considered to be medically significant events.
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Renal failure, Respiratory arrest, Seizure
Clinical narrative: This initial spontaneous report was received via an article and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The article discusses that the patient was awarded compensation by the compensation program. On 13-FEB-2013, the patient was administered measles (+) mumps (+) and rubella (reported as MMR; manufacturer not specified), haemophilus influenza type B (manufacturer not specified), PREVNAR, hepatitis A vaccine (manufacturer not specified), and varicella vaccine (manufacturer not specified). That evening following vaccination, the patient became feverish and irritable, prompting her mother to contact the doctor. The doctor advised the patient's mom to administer BENADRYL and TYLENOL for her symptoms. That fever persisted for several days and was followed by a severe seizure resulting in cardiac and respiratory arrest. The cardiac arrest and seizures caused the patient to develop encephalopathy, kidney failure, severe brain injury, low muscle tone, and cortical vision impairment. The outcome of the events were unknown. The events were considered related to M-M-R II. Causality was not specified for the other vaccines. Upon internal review, cardiac arrest, respiratory arrest, encephalopathy, seizure, kidney failure, severe brain injury, and cortical vision impairment were considered to be medically significant events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient recieved improperly stored dose of VARIVAX; no adverse effects; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R010468, expiration date: 10-APR-2020, subcutaneously for prophylaxis. The sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit (7.9F) for 3 hours 9 minutes. Data logger was involved. There were no previous excursions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic myeloid leukaemia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chronic myeloid leukemia in a male patient who received 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 chronic myeloid leukemia (serious criteria GSK medically significant). On an unknown date, the outcome of the chronic myeloid leukemia was unknown. It was unknown if the reporter considered the chronic myeloid leukemia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with chronic myeloid leukemia (CML) after receiving a dose of SHINGRIX. The health care professional was interested on safety data to make decision on 2nd dose. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to case US2019GSK057841, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX for prophylaxis. On 2nd April 2019, the patient received SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and hives. On an unknown date, the outcome of the pain in arm and hives were unknown. It was unknown if the reporter considered the pain in arm and hives to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient's arm hurt very badly and had hives. The patient denied to provide contact details as the patient was living with daughter and cannot give her address or her phone number.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received 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 fever, pain in arm, headache, tiredness, pruritus and pins and needles. On an unknown date, the outcome of the fever, pain in arm, headache, tiredness, pruritus and pins and needles were unknown. It was unknown if the reporter considered the fever, pain in arm, headache, tiredness, pruritus and pins and needles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's fingers feel like pins and needles poking the fingers and they itch bad. The patient also had many of the other problems that come with that headache, tired, sore arm and fever, this was all from shingles booster shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received 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 fever, pain in arm, headache, tiredness, pruritus and pins and needles. On an unknown date, the outcome of the fever, pain in arm, headache, tiredness, pruritus and pins and needles were unknown. It was unknown if the reporter considered the fever, pain in arm, headache, tiredness, pruritus and pins and needles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's fingers feel like pins and needles poking the fingers and they itch bad. The patient also had many of the other problems that come with that headache, tired, sore arm and fever, this was all from shingles booster shot.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized tingling in a female patient who received 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 localized tingling, numbness facial and pimples. On an unknown date, the outcome of the localized tingling, numbness facial and pimples were recovered/resolved. It was unknown if the reporter considered the localized tingling, numbness facial and pimples to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported  After receiving 1st dose of SHINGRIX, the patient reported tingling, numbness and pimples on the right side of her face from the temple to her lips. The call center representative informed the patient that she was misdirected to medical Information but the patient was hostile and stated that she would not give any additional information until her questions were answered. The patient was directed to the GRC for further guidance and reporting. No additional details could be provided. This case has been linked to the case US2019061250, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 69-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received when patient was 60 years of age) and SHINGRIX with an associated reaction of injection site pain (1st case refer case US2019GSK064202 ). On 6th February 2019, the patient received the 2nd dose of SHINGRIX. On 6th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the injection site muscle pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on left arm. The patient experienced deep significant pain in the muscle where the vaccine was administered, since receiving the 2nd dose of SHINGRIX. The patient had received 1st dose on 14th December 2018. The patient was evaluated by physical therapist and it was found that there was no bubble. The pharmacy manager who administered the vaccine informed the patient that he utilized correct technique for administration. The patient was not able to lift her arm. The pain was deep, achy throbbing pain like the pain which gets during shingles. The patient also had some pain with 1st injection. The patient has used all kinds of balms and arnica on the site. The patient also exercises and tries to move the arm as much as possible but it hurts to even lift it.
Sex: M
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: rash / diffuse maculopapular rash over torso, back and upper extremities as well as lower extremities; This case was reported by a physician via call center representative and described the occurrence of maculopapular rash in a 26-year-old male patient who received HBV (Engerix B adult) (batch number J2J9R, expiry date 14th September 2021) for prophylaxis.   On 25th March 2019, the patient received the 1st dose of Engerix B adult (intramuscular). On 27th March 2019, 2 days after receiving Engerix B adult, the patient experienced maculopapular rash. On an unknown date, the outcome of the maculopapular rash was unknown.   It was unknown if the reporter considered the maculopapular rash to be related to Engerix B adult.  Additional details were provided as follows: The age at vaccination was not reported but it could be 25 years or 26 years. The patient experienced diffuse maculopapular rash over torso, back and upper extremities as well as lower extremities. The patient did not experience rash on palms or soles of feet or mucosa.
Age: 0.17
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody abnormal, Inappropriate schedule of product administration, Therapeutic response decreased
Clinical narrative: Low Titers; Drug dose administration interval too long; Inappropriate schedule of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 2-month-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 3rd October 1995, the patient received the 1st dose of Engerix B. On 23rd February 1996, the patient received the 2nd dose of Engerix B. On 12th August 1996, the patient received the 3rd dose of Engerix B. On 23rd February 1996, not applicable after receiving Engerix B and Engerix B, unknown after receiving Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long. On 12th August 1996, the patient experienced drug dose administration interval too long. On 1st April 2019, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased, drug dose administration interval too long and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the therapeutic response decreased to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The batch number and expiration date was not reported. The health care professional reported that the patient received Hepatitis B series. On 1st April 2019, the titers were tested and they were resulted low. The patient received the 2nd dose late, which led to lengthening of schedule. The patient received the 3rd dose late, which led to lengthening of schedule.      Lab Comments: The titers of the hepatitis B antibody was low.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 70-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) and (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th January 2019, the 2nd dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were reported as follows: The patient received 2nd dose of SHINGRIX in mid January, intramuscularly on right deltoid. The event bruising was still present at the injection site. The patient did not take any blood thinning medications, no pain, no issues, just bruising. The reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient had local reaction included injection site area was very red and itchy with mild swelling about 6 to 8 inches in diameter.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Hypoaesthesia, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized tingling in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of paraesthesia (for tolerance of 1st dose, refer case US2019GSK065540). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced localized tingling, numbness facial and pimples. The patient was treated with antivirals for systemic use. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the localized tingling, numbness facial and pimples were unknown. It was unknown if the reporter considered the localized tingling, numbness facial and pimples to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. After receiving 2nd dose of SHINGRIX, the patient reported tingling, numbness and pimples on the right side of her face from the temple to her lips. The patient was under the care of her doctor and they had prescribed an Antiviral. The call center representative informed the patient that she was misdirected to medical Information but the patient was hostile and stated that she would not give any additional information until her questions were answered. The patient was directed to the GRC for further guidance and reporting. No additional details could be provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The reporter called to report that, patient had fever for a few hours after SHINGRIX immunization. The batch number reported for SHINGRIX (5MG5F), did not exist and was updated to 5MG5E, as per sales database.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Ear pain, Feeling cold, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sinus pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. On 5th April 2019, 1 days after receiving SHINGRIX, the patient experienced sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat. On an unknown date, the outcome of the sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat were recovering/resolving. It was unknown if the reporter considered the sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX the patient experienced sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat. The reporter stated that, the patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sinus pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. On 5th April 2019, 1 days after receiving SHINGRIX, the patient experienced sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat. On an unknown date, the outcome of the sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat were recovering/resolving. It was unknown if the reporter considered the sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX the patient experienced sinus pain, cough, arthritic pains, feeling cold, ear pain and sore throat. The reporter stated that, the patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: accidentally gave a Fluzone 0.5 ml pre-filled syringe to a patient yesterday with the expiration date of 2018; Initial information received on 04-Apr-2019 regarding an unsolicited valid non-serious case received from an- other healthcare professional by phone.  This case involves adult patient of unknown demographics who was accidentally vaccinated with 0.5 ml expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Batch number: UT5911KA and expiry date: 30-Jun-2018, dose in series, route and site of administration were not reported) on an unspecified date for the 2017-2018 season.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by the sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Lymphadenopathy, Peripheral swelling
Clinical narrative: Client states her left arm swelled and lymphnodes in L axilla swelled. States she was diagnosed with cellulitis by her primary care Physician on 4/10/19.
Age: 70.0
Sex: F
Vaccine: CHOL
Symptoms: Chills, Fatigue, Pain
Clinical narrative: chills, sore body an fatique
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient was vaccinated on 04/04/2019. The morning of 04/06/2019 redness, warm to touch, and swelling were noted at right upper arm at the injection site. Patient was seen in the ER on 04/06/2019. Patient was give Prednisolone and Benadryl. Patient had immediate improvement after given the treatment. Patient's mother was called on 04/09/2019, and mother reports arm is much better with a barely visible rash.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Eyelid function disorder, Facial pain, Facial paralysis, Pain in jaw
Clinical narrative: On the morning of April 4th 2019, around ~11:00am, give or take 15 minutes, I began to notice a slight abnormality in my ability to conjure facial expressions on command. The noticeable lack of voluntary control of my facial muscles on the left side of my face worsened into the evening by which I time I researched how to check myself how for a stroke. Upon awakening the following morning, the symptoms were still present and have not changed since - near complete paralysis of the left side of my face with the small benefit of being able to close, but not blink, my left eye. As of Wednesday April 10, and at the time of writing this on the 11th, I am feeling an onset of pain in the muscular attachment sites around the left side of my face and along the bones of the upper and lower jaw, as though I have been punched or impacted my face upon a wall.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Asthenia, Back pain, Blood test normal, Chest X-ray normal
Clinical narrative: Severe headache, jaw pain, neck,  back, buttocks, thighs, calf, right ankle and right big toe.  Severe pain in all muscles. Partly debilitating, not able to climb in bed, tie shoes, bath legs in shower, climb in and out of his vehicle.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Electrocardiogram normal, Headache, Loss of personal independence in daily activities, Musculoskeletal pain, Myalgia
Clinical narrative: Severe headache, jaw pain, neck,  back, buttocks, thighs, calf, right ankle and right big toe.  Severe pain in all muscles. Partly debilitating, not able to climb in bed, tie shoes, bath legs in shower, climb in and out of his vehicle.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Severe headache, jaw pain, neck,  back, buttocks, thighs, calf, right ankle and right big toe.  Severe pain in all muscles. Partly debilitating, not able to climb in bed, tie shoes, bath legs in shower, climb in and out of his vehicle.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; two patients received PROQUAD that was improperly stored; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 03-APR-2019, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously for prophylaxis (dose, lot # and expiration date were not reported). It was unknown whether sterile diluent that was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. No adverse effects were reported.  Administered dose of vaccine experienced the temperature excursion of minus 13 degrees Celsius for 5 minutes. Data logger was involved. There were no previous excursions reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA004557:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; two patients received PROQUAD that was improperly stored; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 03-APR-2019, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously for prophylaxis (dose, lot # and expiration date were not reported). It was unknown whether sterile diluent that was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. No adverse effects were reported.  Administered dose of vaccine experienced the temperature excursion of minus 13 degrees Celsius for 5 minutes. Data logger was involved. There were no previous excursions reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003295:
Sex: F
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: Developed a 3 inch in diameter lump at the unspecified injection site; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (the dosage regimen information was not reported) for prophylaxis.  On an unknown date, the patient developed a 3 inch in diameter lump at the injection site.  At the time of the report, the outcome of injection site mass was unknown. No causality assessment was provided.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2019GSK065385). On 2nd April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced headache, feeling hot, muscle pain, shivering and pain. On an unknown date, the outcome of the headache, feeling hot, muscle pain, shivering and pain were not recovered/not resolved. It was unknown if the reporter considered the headache, feeling hot, muscle pain, shivering and pain to be related to SHINGRIX. Additional details were provided as follows: The patient had a pounding headache, feel feverish, muscle aches, shivering and achy. The patient wanted to know should she be concerned about these symptoms as did not experience after 1st dose of SHINGRIX. The patient reported she would monitor it and if she saw no improvement would contact her physician.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2019GSK065385). On 2nd April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced headache, feeling hot, muscle pain, shivering and pain. On an unknown date, the outcome of the headache, feeling hot, muscle pain, shivering and pain were not recovered/not resolved. It was unknown if the reporter considered the headache, feeling hot, muscle pain, shivering and pain to be related to SHINGRIX. Additional details were provided as follows: The patient had a pounding headache, feel feverish, muscle aches, shivering and achy. The patient wanted to know should she be concerned about these symptoms as did not experience after 1st dose of SHINGRIX. The patient reported she would monitor it and if she saw no improvement would contact her physician.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 58-year-old patient who received SHINGRIX for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient felt like hit by a bus. The patient asked to the reporter how long do the side effects from Shinglex last. The patient was asked to provide the contact details, however the patient refused it and told that the patient will call to their physician. The patient refused to provide the prescribing doctor's contact details.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included open heart surgery and arm operation. Previously administered products included Shingles vaccine (received in July 2010). On 18th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: For tolerance to further doses, refer case US2019GSK065334 (2nd dose). This case has been linked with the case US2019025070, (pharma case) reported by the same reporter and same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included open heart surgery and arm operation. Previously administered products included Shingles vaccine (received in July 2010) and SHINGRIX (1st dose received on 18 July 2018, refer case US2019GSK065308.). Concomitant products included SHINGRIX. On 8th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her right arm. The patient described that it was zapping her strength and energy. The patient provided to follow up which her nurse practitioner. This case has been linked with the case US2019025070, (case) reported by the same reporter and same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Pain of skin, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in the past but still got shingles afterward). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in November 2018, refer case US2019GSK061315) and ZOSTAVAX (in the past but still got shingles afterward). On 6th January 2019, the patient received the 2nd dose of SHINGRIX. On 24th March 2019, 77 days after receiving SHINGRIX, the patient experienced scalp pain. On an unknown date, the patient experienced pain in arm and drug dose administration interval too short. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the scalp pain was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the pain in arm and scalp pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and 7-8 days ago she started to experience some pain on her scalp in the exact spot where shingles had presented numerous times prior to getting SHINGRIX. There was no rash and the pain was substantially less than it was in the past prior to SHINGRIX. She also mentioned that her arm was sore. The patient received the 1st dose in late November 2018 and the 2nd dose somewhere around 6th January 2019, which led to shortening of vaccination schedule.
Sex: F
Vaccine: DTAP
Symptoms: Chest discomfort, Insomnia, Product administered to patient of inappropriate age
Clinical narrative: Chest tightness; Unable to sleep; Inappropriate Age for vaccine; This case was reported by a consumer via call center representative and described the occurrence of chest tightness in a adult female patient who received DTPa (Infanrix) for prophylaxis.   Concomitant products included DTPa (Infanrix), PNEUMOCOCCAL VACCINE (PREVNAR-13), PNEUMOCOCCAL VACCINE (PREVNAR-13) and protonix (nos) (Protonix).   In January 2019, the patient received the 2nd dose of Infanrix. On an unknown date, less than a year after receiving Infanrix, the patient experienced chest tightness, sleeplessness and inappropriate age at vaccine administration. On an unknown date, the outcome of the chest tightness, sleeplessness and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the chest tightness and sleeplessness to be related to Infanrix.  Additional details were reported as follows: The age at vaccination was not reported. The member of public reported that she received a puncture from a rusty nail and was given Dtap and Prevnar 13 in November and then again in January.   The patient reported that she had been unable to sleep and that she had tightness in the chest since the 2nd dose of the vaccines.  The patient stated there were other symptoms but did not supply them when requested. The patient reported being seem medically but not hospitalization for symptoms.   No additional details were provided. MOP had a hard time sticking to the patient and wanted medical advice or for someone to call her physician to make them state they gave 2 doses of the vaccine.  The primary care physician (PCP) information was not given when requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received the 2nd dose of SHINGRIX. On 30th March 2019, less than a day after receiving SHINGRIX, the patient experienced headache, general body pain, chills and injection site pain. On 2nd April 2019, the patient experienced rash and blister. On an unknown date, the patient experienced dizziness. On an unknown date, the outcome of the headache, general body pain, dizziness, chills and injection site pain were unknown and the outcome of the rash and blister were not recovered/not resolved. It was unknown if the reporter considered the headache, general body pain, dizziness, chills, injection site pain, rash and blister to be related to SHINGRIX. Additional details were provided as follows: The Physician reported that the patient received the SHINGRIX shot in the left arm and reported to him that she had the normal side effects including headache, body aches and chills with pain at the injection site, however 3 days after receiving vaccination, the patient experienced a rash on her left leg with fine blisters which started in morning the day of reporting. The reporter gave consent to follow up. The reporter reported that GlaxoSmithKline could follow up with the physician directly. However, the reporter did not want to provide any additional details during phone conversation.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received the 2nd dose of SHINGRIX. On 30th March 2019, less than a day after receiving SHINGRIX, the patient experienced headache, general body pain, chills and injection site pain. On 2nd April 2019, the patient experienced rash and blister. On an unknown date, the patient experienced dizziness. On an unknown date, the outcome of the headache, general body pain, dizziness, chills and injection site pain were unknown and the outcome of the rash and blister were not recovered/not resolved. It was unknown if the reporter considered the headache, general body pain, dizziness, chills, injection site pain, rash and blister to be related to SHINGRIX. Additional details were provided as follows: The Physician reported that the patient received the SHINGRIX shot in the left arm and reported to him that she had the normal side effects including headache, body aches and chills with pain at the injection site, however 3 days after receiving vaccination, the patient experienced a rash on her left leg with fine blisters which started in morning the day of reporting. The reporter gave consent to follow up. The reporter reported that GlaxoSmithKline could follow up with the physician directly. However, the reporter did not want to provide any additional details during phone conversation.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site lump were unknown. It was unknown if the reporter considered the injection site erythema, injection site rash and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX intramuscularly on left arm and later a red baseball size spot developed at the injection site. On 15 February 2019, the patient reported that they developed little bumps or sores at the site. No additional details given.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 22nd March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 25th March 2019, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient provided limited information, as he did not want to answer question regarding his experience. The patient did not consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An adolescent female patient started to receive TRUMENBA on 08Mar2019 and MENACTRA on an unspecified date, both via an unspecified route of administration at a single dose for an immunization. Medical history was none. The patient's concomitant medications were not reported. On 08Mar2019, the reporter stated that the patient experienced dizziness after taking meningococcal group brlp2086. The patient was on day 4 of dizziness. The outcome of the event was not recovered.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Red, swollen L leg, warm to the touch, painful to walk or touch area.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: After she received shot on 04/01/2019 she got reaction on 04/04/2019 on her right Arm. Its swollen  with pain and red inflamed big bruise . she taking Advil and rubbing Ice as of Today 04/11/2019 she is doing better and swollen is down and less pain according to her.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills,body aches,headache.
Age: 0.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Received PPSV23 on her left deltoid yesterday around 12:30 pm. The arm hurt when she left, just felt achy. Noticed that it was starting to swell around 2 pm. By 6 pm, when she got home, it was very swollen, hot. She took 2 tylenol, put ice on it. The swelling has gone down since yesterday. Will continue to ice and provide supportive care. Denies rash, denies any difficulty breathing.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site plus severe body aches from head to toe, shivering, headache, nausea, and fatigue started in the afternoon and worsened in the evening. Could not move without pain and difficulty. Normal activities extremely limited. Took 3 extra strength TYLENOL at 9 pm. Slept 10 pm-5 am and woke up feeling much better, but still some body aches. Took 2 extra strength TYLENOL at 6 am. Pain at injection site and some redness continues. After 24 hours from injection, most symptoms are better. I'm reporting this incident just to add to the statistics about the number of patients experiencing problems that limit normal activities.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Nausea, Pain
Clinical narrative: Pain at injection site plus severe body aches from head to toe, shivering, headache, nausea, and fatigue started in the afternoon and worsened in the evening. Could not move without pain and difficulty. Normal activities extremely limited. Took 3 extra strength TYLENOL at 9 pm. Slept 10 pm-5 am and woke up feeling much better, but still some body aches. Took 2 extra strength TYLENOL at 6 am. Pain at injection site and some redness continues. After 24 hours from injection, most symptoms are better. I'm reporting this incident just to add to the statistics about the number of patients experiencing problems that limit normal activities.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site warmth, Pain in extremity
Clinical narrative: Very sore/painful and hard at the arm. Very red. Felt like heat coming from the injection site.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash, Rash erythematous
Clinical narrative: Patient developed flu like symptoms as well as a red discoloration/rash on neck and both forearms.