chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: fever; chills; flu like symptoms; sore throat; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number CX5BG, expiry date 30th April 2020) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd May 2019, 6 days after receiving Shingrix, the patient experienced fever, chills, flu like symptoms, sore throat and pain. On an unknown date, the outcome of the fever and pain were not recovered/not resolved and the outcome of the chills and flu like symptoms were unknown and the outcome of the sore throat was recovering/resolving.   It was unknown if the reporter considered the fever, chills, flu like symptoms, sore throat and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife.  The patient received the Shingrix vaccine into the left deltoid and before the night of the reporting, he began to have chills, sore throat, flu like symptoms.  The patient was achy on the day of reporting with continued fever but sore throat was not as bad. The reporter provided the consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Swelling
Clinical narrative: Pain at injection site; Myalgia; Swelling of armpit; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, myalgia and local swelling. On an unknown date, the outcome of the injection site pain, myalgia and local swelling were unknown.   It was unknown if the reporter considered the injection site pain, myalgia and local swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that after administration of Shingrix vaccine, the patient returned and complained of myalgia, pain at injection site and swelling in armpit for 4 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number C7B9P, expiry date 27th February 2021) for prophylaxis.   On 21st January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The nurse reported that the patient experienced left arm pain after receiving the Shingrix vaccine into the left deltoid.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: sore arm; chills; nausea; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th 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 pain in arm, chills, nausea and diarrhea. On an unknown date, the outcome of the pain in arm, chills, nausea and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, chills, nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient experienced sore arm, chills, nausea and diarrhea after receiving the Shingrix vaccine. The patient provided the consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness at injection site; warmth at injection site; pain at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported an adverse event to the caller (GlaxoSmithKline field employee) on behalf of his father (the patient).  The patient developed pain, redness, and warmth at the injection site. The patient consented to follow up. The caller did not provide the reporter's address at the time of the call and did not have any additional information regarding the patient or the event.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Rotavirus infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rotavirus infection in a 2-month-old male patient who received ROTARIX lyophilized formulation (batch number 2ZX4M, expiry date unknown) for prophylaxis. On 18th March 2019, the patient received the 1st dose of ROTARIX lyophilized formulation (oral) 1 ml. On 20th March 2019, 2 days after receiving ROTARIX lyophilized formulation, the patient experienced rotavirus infection (serious criteria hospitalization). On an unknown date, the outcome of the rotavirus infection was recovered/resolved.  It was unknown if the reporter considered the rotavirus infection to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The patient was admitted to the hospital. The patient initially came to the emergency room at the facility where the pharmacist works and then transferred to the hospital downtown. The reporter did not provide dates or number of days that patient stayed at the hospital.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel vaccine is given to a patient, no adverse event; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to cases 2019SA124198, 2019SA124197, 2019SA124199 and 2019SA124200 (same reporter).  This case involves a five-years old female patient who received an expired 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Suspension for injection) lot C5171AA, expiry date-23-Mar-2019 via unknown route in the left thigh on 05-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: none   It was a case of actual medication error due to expired vaccine used.  No side effects reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: 1) shortly after: major headache, nausea, extremely tired, continued throughout the day. Took 2 aspirin 2) Friday, May 10: point of entry mottled pink, warm and swollen, headache, nausea, very tired, itchiness on stomach - no visible rash, continued throughout day. Took 2 aspirin 3) Saturday, May 11: point of entry mottled pink, hot and swollen, warm nausea, mild rash on stomach, barely visible, but slightly itchy. Ate lunch at a restaurant, may have included some of my food intolerances 4) Sunday, May 12: point of entry no discoloration, warm and swollen, nausea, rash on stomach, tired but insomnia that night. Rested/read all day. 5) Monday, May 13: point of entry nausea warm but not swollen, rash more evident on stomach and more itchiness. Used some essential oils, called Dr.'s office. They suggested benadryl.  I had shingles before and this feels the same to me: I am uncomfortable but not in pain and I can ignore the itchiness. Plus I used essential oils at that time, which worked for me. Currently using Ancient Wisdom Painless, a blend of Birch (Betula alleghaniensis), helichrysum (Helichrysum italicum), clove (Syzygium aromaticum) and peppermint (Mentha piperita). I will be adding different blends, when I find the recipe for what I used previously.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Insomnia, Nausea, Pruritus, Rash
Clinical narrative: 1) shortly after: major headache, nausea, extremely tired, continued throughout the day. Took 2 aspirin 2) Friday, May 10: point of entry mottled pink, warm and swollen, headache, nausea, very tired, itchiness on stomach - no visible rash, continued throughout day. Took 2 aspirin 3) Saturday, May 11: point of entry mottled pink, hot and swollen, warm nausea, mild rash on stomach, barely visible, but slightly itchy. Ate lunch at a restaurant, may have included some of my food intolerances 4) Sunday, May 12: point of entry no discoloration, warm and swollen, nausea, rash on stomach, tired but insomnia that night. Rested/read all day. 5) Monday, May 13: point of entry nausea warm but not swollen, rash more evident on stomach and more itchiness. Used some essential oils, called Dr.'s office. They suggested benadryl.  I had shingles before and this feels the same to me: I am uncomfortable but not in pain and I can ignore the itchiness. Plus I used essential oils at that time, which worked for me. Currently using Ancient Wisdom Painless, a blend of Birch (Betula alleghaniensis), helichrysum (Helichrysum italicum), clove (Syzygium aromaticum) and peppermint (Mentha piperita). I will be adding different blends, when I find the recipe for what I used previously.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Reports headache, redness at injection site, nausea, and fever
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Anal haemorrhage, Chemical burn, Diarrhoea, Erythema, Rash
Clinical narrative: Day after the vaccination my child had diarrhea and within 15 minutes from BM to diaper change, developed rash so severe that it caused anal bleeding and severe redness of the skin. Prior to this event my child's bottom was clean without any signs of slightest skin irritation.  There were no new foods introduced in her diet in recent days, no increased intake of any particular food.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Throat irritation
Clinical narrative: Pt and grandmother contacted the after hours phone number due to patient stating he was having an itchy throat, and pain, redness and swelling at the site of injection in his right arm. After hours provider instructed guardian to take pt to the ER. Grandmother called 911 and pt was monitored and released and grandmother did not take pt to the ER. She gave pt Benadryl instead as discovered in follow up phone call.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Muscle soreness, shivering chills, sweating. Headache, fatigue ( flu like symptoms) did not verify fever with thermometer
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness, shivering chills, sweating. Headache, fatigue ( flu like symptoms) did not verify fever with thermometer
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Myalgia, Urticaria
Clinical narrative: Next day after vaccine: chills, headache, muscle pain Not capable of functioning normally 5 days after: hives along left lower back to side of buttock
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 24-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-009507513-1904USA012973: US-009507513-1904USA012974: 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-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: 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 12-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-009507513-1904USA012973: 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 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-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012979: US-009507513-1904USA01280: 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 16-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-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012980: US-009507513-1904USA012981:
Age: 0.58
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; PROQUAD was administered to a 7 month old child through the intramuscular route; PROQUAD was administered to a 7 month old child through the intramuscular route; This spontaneous report was received from a nurse and refers to a 7-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (lot # R017802, expiration date: 19-DEC-2019, dose was not provided) through the intramuscular route for prophylaxis. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Gait disturbance, Injection site rash
Clinical narrative: a rash on entire right upper thigh extending to the knee, patient does not want to walk on it; a rash on entire right upper thigh extending to the knee, patient does not want to walk on it; This spontaneous report was received from a physician via a company representative and refers to a 4-year-old female patient. Her concomitant therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX). The patient's historical vaccinations included measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) and varicella virus vaccine live (Oka/Merck) (VARIVAX) administered one year ago with no adverse reaction. Her concurrent conditions and medical history were not reported.  On 30-APR-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA), in right thigh, lot # R015742, expiry date: 02-DEC-2019 (dose and route of administration were not provided) for prophylaxis (reported as cdc schedule).   On 03-MAY-2019, the patient had a rash on the entire right upper thigh extending to the knee and she did not want to walk on it. The mother brought the patient to the physician's office on the same date for examination.  The outcome of the events was reported as recovered on an unknown date in May 2019. The relatedness between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Influenza like illness, Loss of consciousness, Malaise, Skin laceration
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of blackout in a female patient who received SHINGRIX for prophylaxis. In April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, 1 day after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), feeling unwell, fall, laceration of head and influenza-like symptoms. On an unknown date, the outcome of the blackout, feeling unwell, fall, laceration of head and influenza-like symptoms were unknown. It was unknown if the reporter considered the blackout, feeling unwell, fall, laceration of head and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient's age was between 50 and 52 years. The patient did not feel well after 2nd dose of SHINGRIX and called to ask if they had given her the same vaccine as last time. The next morning, the patient blacked out, fell, cut head and ended up in the emergency room. Flu like symptoms, etc. This occurrence took place about 3 to 3 and a half weeks ago, from the date of reporting but the reporter was informed at the morning of reporting date. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Diplopia, Dysgeusia, Immediate post-injection reaction
Clinical narrative: double vision; blurry vision; metallic tast in mouth; This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 11th April 2019, immediately after receiving Shingrix, the patient experienced taste metallic. On 13th April 2019, the patient experienced double vision and blurred vision. On 11th April 2019, the outcome of the taste metallic was recovered/resolved. On an unknown date, the outcome of the double vision and blurred vision were recovered/resolved.   It was unknown if the reporter considered the taste metallic, double vision and blurred vision to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on right arm. The patient reported that almost immediately, she tasted something metallic, which resolved later in the day.   On saturday, 2 days after vaccination the patient began to experience blurred and double vision.   The patient went to an urgent care and was referred to the hospital to rule out stroke.   The patient was not admitted, but had X-rays, CT scan, MRI scan, and blood work which was all normal.   The patient then follow up by her eye physician and was informed that everything looked normal.  The patient reported that the double and blurred vision has improved. The reporter consented to follow up.  The emergency room visit was required. The lot number was not available
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Vision blurred, X-ray normal
Clinical narrative: double vision; blurry vision; metallic tast in mouth; This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 11th April 2019, immediately after receiving Shingrix, the patient experienced taste metallic. On 13th April 2019, the patient experienced double vision and blurred vision. On 11th April 2019, the outcome of the taste metallic was recovered/resolved. On an unknown date, the outcome of the double vision and blurred vision were recovered/resolved.   It was unknown if the reporter considered the taste metallic, double vision and blurred vision to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on right arm. The patient reported that almost immediately, she tasted something metallic, which resolved later in the day.   On saturday, 2 days after vaccination the patient began to experience blurred and double vision.   The patient went to an urgent care and was referred to the hospital to rule out stroke.   The patient was not admitted, but had X-rays, CT scan, MRI scan, and blood work which was all normal.   The patient then follow up by her eye physician and was informed that everything looked normal.  The patient reported that the double and blurred vision has improved. The reporter consented to follow up.  The emergency room visit was required. The lot number was not available
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown.   It was unknown if the reporter considered the dizziness and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness and nausea after receiving Shingrix. The reporter permitted for follow up.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Pyrexia, Rash papular, Scab
Clinical narrative: Febrile illness associated with papular rash (1 vesicle that crusted) 10 days after receiving MMRV vaccine
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia, Skin ulcer
Clinical narrative: 10 weeks after Shingrix 1st shot I have shingles. Recieved treatment at my GP. It was very painfull with sores on my back and chest with burning  and tingles from head to legs
Age: 0.08
Sex: F
Vaccine: HIBV
Symptoms: Insomnia, Irritability, Sleep disorder
Clinical narrative: Within one hours of injection,child became irritable/fussy- not herself. She did not sleep that night. Irritability/fussiness and sleep problems lasted for 5 days and then resolved
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: Patient denied problems with previous immunizations. She stated on the day of vaccination she felt fine. The next day she began to feel chills, had body aches and her arm began to swell. She had swelling from the top of her shoulder to her elbow. No problems moving her arm but reported discomfort where the swelling was.  She spent 2 days in bed. The fever, chills, arm redness and swelling persisted for 2 days before she started to feel better. Is concerned about the persistent redness, swelling and heat from around her vaccination site. No longer having fevers and stated there is itching at the vaccination site. She has been taking ibuprofen and using cool packs on her arm. Reports that the swelling/redness has decreased in size.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient denied problems with previous immunizations. She stated on the day of vaccination she felt fine. The next day she began to feel chills, had body aches and her arm began to swell. She had swelling from the top of her shoulder to her elbow. No problems moving her arm but reported discomfort where the swelling was.  She spent 2 days in bed. The fever, chills, arm redness and swelling persisted for 2 days before she started to feel better. Is concerned about the persistent redness, swelling and heat from around her vaccination site. No longer having fevers and stated there is itching at the vaccination site. She has been taking ibuprofen and using cool packs on her arm. Reports that the swelling/redness has decreased in size.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Body temperature increased, Chest X-ray normal, Condition aggravated, Dizziness
Clinical narrative: Arm sore, swollen, painful at injection site on Tuesday (following day), began running temperature late Tuesday night and all day Wednesday (101.3 was highest), returned to work on Thursday.  About 1:25, started feeling lightheaded and recognized an SVT event coming on.  Coworkers called School Clinic personnel and ambulance.  BP was 70/40.  Approximately 30  minutes later, I began to rebound and I refused ambulance transport to the hospital and let my husband take me.   When I arrived at the ER at 2:30, my BP was 118/59.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Fatigue, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm sore, swollen, painful at injection site on Tuesday (following day), began running temperature late Tuesday night and all day Wednesday (101.3 was highest), returned to work on Thursday.  About 1:25, started feeling lightheaded and recognized an SVT event coming on.  Coworkers called School Clinic personnel and ambulance.  BP was 70/40.  Approximately 30  minutes later, I began to rebound and I refused ambulance transport to the hospital and let my husband take me.   When I arrived at the ER at 2:30, my BP was 118/59.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Supraventricular tachycardia
Clinical narrative: Arm sore, swollen, painful at injection site on Tuesday (following day), began running temperature late Tuesday night and all day Wednesday (101.3 was highest), returned to work on Thursday.  About 1:25, started feeling lightheaded and recognized an SVT event coming on.  Coworkers called School Clinic personnel and ambulance.  BP was 70/40.  Approximately 30  minutes later, I began to rebound and I refused ambulance transport to the hospital and let my husband take me.   When I arrived at the ER at 2:30, my BP was 118/59.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site abscess, Laboratory test, Ultrasound scan
Clinical narrative: Abscess right lateral thigh.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Apnoea, Coronavirus test positive, Enterovirus test positive, Human rhinovirus test positive, Lumbar puncture
Clinical narrative: Seizure like activity, stopped breathing momentarily at 6:40 am. Brought to hospital by ambulance had another seizure in e.r., admitted, had 3rd seizure and 4th seizure during spinal tap. Tested positive for coronavirus, rhinovirus/enterovirus. Stayed in hospital until released 5/3/17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Seizure, Seizure like phenomena
Clinical narrative: Seizure like activity, stopped breathing momentarily at 6:40 am. Brought to hospital by ambulance had another seizure in e.r., admitted, had 3rd seizure and 4th seizure during spinal tap. Tested positive for coronavirus, rhinovirus/enterovirus. Stayed in hospital until released 5/3/17
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypersensitivity, Rash
Clinical narrative: As part of my annual physical, I was administered a Shingrix vaccination. Forty-eight hours after the Shingrix injection, I developed a very painful rash (with blisters) on all sides of my left thigh. The next day I saw my doctor and he concluded that it was indeed a case of Shingles. I was prescribed 10mg of prednisone (on a declining daily dosage) and one gram of valacyclovir three times a day. While the rash and blisters have started to heal, I still have the same degree of pain and hypersersensitivity.
Sex: M
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported; The patient received PREVNAR on 5/22/2017 and then had a PNEUMOVAX on 11/29/2017; This spontaneous report has been received from a pharmacist referring to a 65 year old (currently 67 year old) male patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-MAY-2017, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). On 29-NOV-2017, after an inappropriate dosing interval, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported) (inappropriate schedule of product administration). No symptoms were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA010231:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a 57-year-old female consumer (also reported as employee), who was reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was not immunocompromised (to her knowledge).   On unknown date in March 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical site, lot # and expiration date were not provided) for prophylaxis.  On 24-APR-2019, the patient was diagnosed with shingles. The outcome of the event and the causality assessment between the event and the suspect vaccine were not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via skin contact, Occupational exposure to product, Product container issue
Clinical narrative: No adverse effects reported; the rubber stopper of the VARIVAX was punctured to reconstitute the product and it "dripped out" of the top of the vial; it "dripped out onto her hand through a hole in the top of the vial"; it "dripped out onto her hand through a hole in the top of the vial"; it "dripped out onto her hand through a hole in the top of the vial"; Could a full dose be withdrawn? NO; This spontaneous report was received from the field employee referring to a patient of unknown age or gender.  The patient's concurrent conditions, historical conditions, drug reactions, and allergies were not provided. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 02-MAY-2019, the patient, who was also the medical assistant, was aspirating a vial of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R022115 (expiration date 02-AUG-2020) (dose, frequency, strength, anatomical location or route of administration were not provided) and it "dripped out onto her hand through a hole in the top of the vial" (occupational exposure to product, accidental exposure to product, and exposure via skin contact).  The physician and medical assistant reported to the field employee that the rubber stopper of the varicella virus vaccine live (Oka/Merck) (VARIVAX) was punctured to reconstitute the product and it "dripped out" of the top of the vial (product container issue). It was reported tat a full dose could not be withdrawn, the quantity is unknown by reporter, but it was less than a full dose (circumstance or information capable of leading to medication error); however, the unspecified patient did not miss a dose. No more clarifying information was provided. Product would be able to be retrieved.  No adverse effects reported. No additional information provided.   The action taken regarding the event was not applicable.  The outcome of the event and causal relationship between the product container issue and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Sex: F
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: dose of expired diluent administerd; This spontaneous report was received from a nurse regarding to a 36-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-APR-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # N013296, expiry date: 28-APR-2019) 0.5 milliliter via subcutaneous route for prophylaxis along with one dose of expired sterile diluent(MERCK STERILE DILUENT) (lot# N013296, expiry date: 28-APR-2019) (expired product administered). It was reported that Merck diluent was stored in proper storage conditions according to nurse. No adverse effect reported. The outcome of expired product administered was unknown.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris, Arthralgia, Autoimmune disorder, Cardiac discomfort, Cardiac flutter
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 22nd April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced cardiac pain (serious criteria GSK medically significant), heart fluttering (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant), fatigue and heartbeats increased. On 22nd April 2019, the patient experienced pain in arm, skin warm, chills and joint pain. On 23rd April 2019, the patient experienced arousal difficult (serious criteria GSK medically significant), headache and sleep excessive. On an unknown date, the outcome of the cardiac pain, heart fluttering, autoimmune disorder, arousal difficult, pain in arm, skin warm, chills, joint pain, headache, fatigue, sleep excessive and heartbeats increased were not recovered/not resolved. It was unknown if the reporter considered the cardiac pain, heart fluttering, autoimmune disorder, arousal difficult, pain in arm, skin warm, chills, joint pain, headache, fatigue, sleep excessive and heartbeats increased to be related to SHINGRIX. Additional details were provided as follows: The patient's symptoms started about 6 hours after SHINGRIX injection that she got about 5pm. The patient's arm became extremely sore, hot and then she got the chills with severe aches all in her joints. The patient slept on a heating pad to get through the night. The next day, the patient could not get up and slept most of the day still having trouble with achy joints and a headache. One week later, the patient at the time of reporting had headaches and achy joints with fatigue. The patient had been diagnosed with an autoimmune disease so she thought this would be helpful information. The other major symptom the patient had experienced was heart flutters that come and go. The patient's heart was fluttering, heart was floppy and uncomfortable, painful but not like ouch kind of thing. The patient had multiple ones not all the time but 1 or 2 times during the day. When describing her side-effects, she also said she was having some effects from it, over a week later, at the time of reporting. The patient continued to have rapid heartbeats several times through the day. The patient was recommended to speak with her healthcare provider regarding event. This case was linked with US2019AMR083807, reported for patient's husband.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Hypersomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 22nd April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced cardiac pain (serious criteria GSK medically significant), heart fluttering (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant), fatigue and heartbeats increased. On 22nd April 2019, the patient experienced pain in arm, skin warm, chills and joint pain. On 23rd April 2019, the patient experienced arousal difficult (serious criteria GSK medically significant), headache and sleep excessive. On an unknown date, the outcome of the cardiac pain, heart fluttering, autoimmune disorder, arousal difficult, pain in arm, skin warm, chills, joint pain, headache, fatigue, sleep excessive and heartbeats increased were not recovered/not resolved. It was unknown if the reporter considered the cardiac pain, heart fluttering, autoimmune disorder, arousal difficult, pain in arm, skin warm, chills, joint pain, headache, fatigue, sleep excessive and heartbeats increased to be related to SHINGRIX. Additional details were provided as follows: The patient's symptoms started about 6 hours after SHINGRIX injection that she got about 5pm. The patient's arm became extremely sore, hot and then she got the chills with severe aches all in her joints. The patient slept on a heating pad to get through the night. The next day, the patient could not get up and slept most of the day still having trouble with achy joints and a headache. One week later, the patient at the time of reporting had headaches and achy joints with fatigue. The patient had been diagnosed with an autoimmune disease so she thought this would be helpful information. The other major symptom the patient had experienced was heart flutters that come and go. The patient's heart was fluttering, heart was floppy and uncomfortable, painful but not like ouch kind of thing. The patient had multiple ones not all the time but 1 or 2 times during the day. When describing her side-effects, she also said she was having some effects from it, over a week later, at the time of reporting. The patient continued to have rapid heartbeats several times through the day. The patient was recommended to speak with her healthcare provider regarding event. This case was linked with US2019AMR083807, reported for patient's husband.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 22nd April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced cardiac pain (serious criteria GSK medically significant), heart fluttering (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant), fatigue and heartbeats increased. On 22nd April 2019, the patient experienced pain in arm, skin warm, chills and joint pain. On 23rd April 2019, the patient experienced arousal difficult (serious criteria GSK medically significant), headache and sleep excessive. On an unknown date, the outcome of the cardiac pain, heart fluttering, autoimmune disorder, arousal difficult, pain in arm, skin warm, chills, joint pain, headache, fatigue, sleep excessive and heartbeats increased were not recovered/not resolved. It was unknown if the reporter considered the cardiac pain, heart fluttering, autoimmune disorder, arousal difficult, pain in arm, skin warm, chills, joint pain, headache, fatigue, sleep excessive and heartbeats increased to be related to SHINGRIX. Additional details were provided as follows: The patient's symptoms started about 6 hours after SHINGRIX injection that she got about 5pm. The patient's arm became extremely sore, hot and then she got the chills with severe aches all in her joints. The patient slept on a heating pad to get through the night. The next day, the patient could not get up and slept most of the day still having trouble with achy joints and a headache. One week later, the patient at the time of reporting had headaches and achy joints with fatigue. The patient had been diagnosed with an autoimmune disease so she thought this would be helpful information. The other major symptom the patient had experienced was heart flutters that come and go. The patient's heart was fluttering, heart was floppy and uncomfortable, painful but not like ouch kind of thing. The patient had multiple ones not all the time but 1 or 2 times during the day. When describing her side-effects, she also said she was having some effects from it, over a week later, at the time of reporting. The patient continued to have rapid heartbeats several times through the day. The patient was recommended to speak with her healthcare provider regarding event. This case was linked with US2019AMR083807, reported for patient's husband.