chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling abnormal, Somnolence
Clinical narrative: felt like a vegetable/wet washcloth; slept most of the day; fatigue; arm is red; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 2 years ago).   On 28th August 2019, the patient received Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced feeling abnormal, sleepiness, fatigue and erythema of extremities. On 30th August 2019, the outcome of the feeling abnormal was recovered/resolved. On an unknown date, the outcome of the sleepiness was recovered/resolved and the outcome of the fatigue was unknown and the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal, sleepiness, fatigue and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and felt like a vegetable, wet washcloth, she slept most of the day. The 2nd day she was still fatigued, but able to walk outside for 25 minutes. At the time of reporting she was feeling better. Her arm was red. The reporter did not consent to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Iritis, Ocular hyperaemia
Clinical narrative: Iritis; blood shot eyes; This case was reported by a pharmacist via call center representative and described the occurrence of iritis in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number YA724, expiry date unknown) for prophylaxis.   Concomitant products included triamcinolone (Triamcinolone Cream).   On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th August 2019, 9 days after receiving Shingrix, the patient experienced iritis and bloodshot eye. The patient was treated with steroids nos (Oral Steroid (Brand Unknown)) and difluprednate (Durezol Eye Drops). On an unknown date, the outcome of the iritis was not recovered/not resolved and the outcome of the bloodshot eye was unknown.   The reporter considered the iritis and bloodshot eye to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced blood shot eyes (may had been a little before this date, but this was the date it was diagnosed) and progressed into iritis, which was pretty severe. The patient's eye doctor believes it was related to the Shingrix. The patient was prescribed an oral steroid and Durezol 0.05 percent eye drops, 1 drop each eye four times a day until resolved. The patient was also using topical triamcinolone cream all over body (for a previous diagnosis, which they held for the vaccine but had been using this month a lot). The oral medication was unknown. The reporter consented to follow up. The expiry date was unknown.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a Flublok to a 14 year old; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1906 via unknown route.  It was a case of potential medication error due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: gave expired Menactra to a patient and was expired 3 days; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an 18 years old female patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]   The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 27-Aug-2019, the patient received a single 0.5 ml booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5986AA (expiry date: 24-Aug-2019) via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced by the patient or not. .  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.
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was administered to a 7 years old/no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 23-Aug-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5635AA via intramuscular route in the right deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration.   Patient experienced no adverse event.  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.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Fluzone Highdose was administered on august 27th 2019 to patient, however doctor realize the dose was expired/No AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 82 years old female patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (pre-filled syringe).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication.  On 27-Aug-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ036AB (expiry date: 09-May-2019) via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was reported that no adverse event was experienced.  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.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient received Menactra twice within a week apart/ NO AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old female patient who received 0.5 mL dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] twice within a week apart lot U6365AA, expiry date: 23-FEB-2021 via intramuscular route in the left deltoid on 20-Aug-2019 and 28-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines received.   It was a case of actual medication error due to extra dose administered.  It was unknown whether the patient had any adverse event.  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: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute disseminated encephalomyelitis, Ageusia, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Borrelia test negative
Clinical narrative: Ultimate diagnosis:  acute disseminated encephalitis  Event Details July 1, 2019, 9:20 PM ? Headache behind left eye came on over the course of about 10 minutes, followed by intense nausea, beginning about an hour later.  About mid-way through the nausea, left facial numbness began, starting at left tip of tongue, and progressing over the course of less than an hour to the left upper palate, upper and lower left teeth, nose, check, forehead, scalp, and jaw, to the front of the left ear.  Sense of taste on the left side of the tongue disappeared, as well.  Headache abated at or before start of numbness.  No loss of coordination, loss of strength, confusion, slurring, drooping of muscles or other symptoms beyond those described above.  Went to urgent care after finding that the numbness persisted into the following morning.  Urgent care staff directed me to the emergency room.  Will begin a course of 4 days of IV steroid.  Currently pending insurance coordination and facility scheduling.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Ehrlichia test, Electrocardiogram ambulatory abnormal, Headache, Hypoaesthesia
Clinical narrative: Ultimate diagnosis:  acute disseminated encephalitis  Event Details July 1, 2019, 9:20 PM ? Headache behind left eye came on over the course of about 10 minutes, followed by intense nausea, beginning about an hour later.  About mid-way through the nausea, left facial numbness began, starting at left tip of tongue, and progressing over the course of less than an hour to the left upper palate, upper and lower left teeth, nose, check, forehead, scalp, and jaw, to the front of the left ear.  Sense of taste on the left side of the tongue disappeared, as well.  Headache abated at or before start of numbness.  No loss of coordination, loss of strength, confusion, slurring, drooping of muscles or other symptoms beyond those described above.  Went to urgent care after finding that the numbness persisted into the following morning.  Urgent care staff directed me to the emergency room.  Will begin a course of 4 days of IV steroid.  Currently pending insurance coordination and facility scheduling.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Immunology test, Laboratory test normal, Lumbar puncture, Magnetic resonance imaging brain abnormal
Clinical narrative: Ultimate diagnosis:  acute disseminated encephalitis  Event Details July 1, 2019, 9:20 PM ? Headache behind left eye came on over the course of about 10 minutes, followed by intense nausea, beginning about an hour later.  About mid-way through the nausea, left facial numbness began, starting at left tip of tongue, and progressing over the course of less than an hour to the left upper palate, upper and lower left teeth, nose, check, forehead, scalp, and jaw, to the front of the left ear.  Sense of taste on the left side of the tongue disappeared, as well.  Headache abated at or before start of numbness.  No loss of coordination, loss of strength, confusion, slurring, drooping of muscles or other symptoms beyond those described above.  Went to urgent care after finding that the numbness persisted into the following morning.  Urgent care staff directed me to the emergency room.  Will begin a course of 4 days of IV steroid.  Currently pending insurance coordination and facility scheduling.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Red blood cell sedimentation rate increased, Scan with contrast abnormal, Sinus bradycardia, Supraventricular tachycardia
Clinical narrative: Ultimate diagnosis:  acute disseminated encephalitis  Event Details July 1, 2019, 9:20 PM ? Headache behind left eye came on over the course of about 10 minutes, followed by intense nausea, beginning about an hour later.  About mid-way through the nausea, left facial numbness began, starting at left tip of tongue, and progressing over the course of less than an hour to the left upper palate, upper and lower left teeth, nose, check, forehead, scalp, and jaw, to the front of the left ear.  Sense of taste on the left side of the tongue disappeared, as well.  Headache abated at or before start of numbness.  No loss of coordination, loss of strength, confusion, slurring, drooping of muscles or other symptoms beyond those described above.  Went to urgent care after finding that the numbness persisted into the following morning.  Urgent care staff directed me to the emergency room.  Will begin a course of 4 days of IV steroid.  Currently pending insurance coordination and facility scheduling.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound Doppler normal, Vitamin B12 normal
Clinical narrative: Ultimate diagnosis:  acute disseminated encephalitis  Event Details July 1, 2019, 9:20 PM ? Headache behind left eye came on over the course of about 10 minutes, followed by intense nausea, beginning about an hour later.  About mid-way through the nausea, left facial numbness began, starting at left tip of tongue, and progressing over the course of less than an hour to the left upper palate, upper and lower left teeth, nose, check, forehead, scalp, and jaw, to the front of the left ear.  Sense of taste on the left side of the tongue disappeared, as well.  Headache abated at or before start of numbness.  No loss of coordination, loss of strength, confusion, slurring, drooping of muscles or other symptoms beyond those described above.  Went to urgent care after finding that the numbness persisted into the following morning.  Urgent care staff directed me to the emergency room.  Will begin a course of 4 days of IV steroid.  Currently pending insurance coordination and facility scheduling.
Age: 65.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Feeling hot, Headache
Clinical narrative: Reports redness to palms f both hands that went up each arm to chest. Also reports  headache and sensation of feeling very hot.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site starting about 3 hours after injection. By 7 hours after injection, redness and swelling was present at the injection site. Large localized reaction appreciated on exam 2 days after vaccine was administered. Headache, subjective fever, fatigue and nausea began several hours after the injection was given and resolved by the next day.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Local reaction, Nausea, Pyrexia
Clinical narrative: Pain at injection site starting about 3 hours after injection. By 7 hours after injection, redness and swelling was present at the injection site. Large localized reaction appreciated on exam 2 days after vaccine was administered. Headache, subjective fever, fatigue and nausea began several hours after the injection was given and resolved by the next day.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; patient received improperly stored dose of VARN AX; This spontaneous report was received from an office manager referring to an unspecified patient of unknown age and unknown gender. Information of concurrent condition, medical history, and drug reactions/allergies were not provided. Concomitant therapy included sterile diluent.  On 03-JAN-2019, the patient received improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # N014368 with expiration date 09-MAY-2019, dose detail and route were not reported), for prophylaxis. No adverse effects were reported. The vaccine was stored at 15 to 46 Fahrenheit degrees (-9 Celsius degree to 8 Celsius degree) (1.93 Celsius degree) for 34.5 hours. There was no previous temperature excursion and data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a unknown age female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unspecified date in 2016 , the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related condition.  On an unknown date, the patient was treated for shingles. The event caused the patient hospitalization. As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The reporter considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a unknown age female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On or about 08-MAR-2011, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related condition.  On an unknown date, the patient was treated for shingles. The event caused the patient hospitalization. As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The reporter considered herpes zoster to be related to zoster vaccine live(ZOSTAVAX).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: facial swelling/cheek swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling face (1st dose received on 7th May 2019, refer linked case US2019159156).   On 28th August 2019, the patient received the 2nd dose of Shingrix .5 ml. On 29th August 2019, 1 days after receiving Shingrix, the patient experienced facial swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the facial swelling was not recovered/not resolved.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The day after receiving Shingrix, the patient experienced facial swelling on her left cheek. This exact same event and onset time happened after the 1st and 2nd dose. Both injections were administered in the left arm. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on face; This case was reported by a other health professional via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The pharmacy intern stated that the physician's office contacted the pharmacy and stated that the patient received Shingrix and then had a rash on their face. The reporter consented to follow up. The pharmacy intern stated no further details were provided by the physician's office, so she was unable to provide additional details at the time of this call.  The pharmacy intern consented to follow up from safety.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash
Clinical narrative: Muscle Aches; Rash; This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced muscle pain and rash. On an unknown date, the outcome of the muscle pain and rash were unknown.   It was unknown if the reporter considered the muscle pain and rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient called the next day of vaccination to report muscle aches and a rash. It was unknown how long adverse reactions lasted. The reporter was a field representative and was at physician's office on day of reporting and notified of adverse event. The field representative had very limited information (i.e. vaccinated arm).  The physician office okay with receiving follow-up for additional details. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th June 2019, 1 days after receiving Shingrix, the patient experienced fatigue. On 28th June 2019, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The day after vaccination, the patient felt very fatigued. The symptoms resolved after 1 day. The reporter did not consent to follow-up. This case has been linked with US2019AMR159652, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: Fever; Weakness/Lack of energy; Fatigue; Muscle ache; Limited daily life activities; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, weakness, fatigue, muscle pain and activities of daily living impaired. On an unknown date, the outcome of the fever, weakness, fatigue, muscle pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, weakness, fatigue, muscle pain and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever, weakness, fatigue, lack of energy and muscle aches. His daily life activities were limited for 3 to 4 days. Call  The caller did not want to provide any additional details in regards to the adverse event, therefore limited data was available.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Chills, Discomfort, Dizziness postural, Feeling hot, Headache
Clinical narrative: About 12 hours after the two shots, I got very cold and shivering. Once I warmed up, my face got very hot. My entire body felt terrible; my back ached, I felt dizzy upon standing, and my head would throb and ache whenever I moved my neck. Some of the time, I felt like throwing up. I slept restlessly for 11.5 hours, feeling immense pain every time I moved. The next morning, I felt pain behind my ears when I turned my head and my head throbbed when bending down. I was also sensitive to loud noises and bright lights.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Hyperacusis, Nasopharyngitis, Nausea, Opisthotonus, Pain
Clinical narrative: About 12 hours after the two shots, I got very cold and shivering. Once I warmed up, my face got very hot. My entire body felt terrible; my back ached, I felt dizzy upon standing, and my head would throb and ache whenever I moved my neck. Some of the time, I felt like throwing up. I slept restlessly for 11.5 hours, feeling immense pain every time I moved. The next morning, I felt pain behind my ears when I turned my head and my head throbbed when bending down. I was also sensitive to loud noises and bright lights.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Photophobia, Poor quality sleep
Clinical narrative: About 12 hours after the two shots, I got very cold and shivering. Once I warmed up, my face got very hot. My entire body felt terrible; my back ached, I felt dizzy upon standing, and my head would throb and ache whenever I moved my neck. Some of the time, I felt like throwing up. I slept restlessly for 11.5 hours, feeling immense pain every time I moved. The next morning, I felt pain behind my ears when I turned my head and my head throbbed when bending down. I was also sensitive to loud noises and bright lights.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: MOTHER CALLED 08/14/2019 STATING PATIENT HAD A RAISED RED INJECTION SITE (HALF DOLLAR SIZE) WITH NO OTHER SYMPTOMS.  WAS ADVISED TO DRAW A LINE AROUND INJECTION SITE AND CALL BACK IF IT HAD SPREAD OUTSIDE OF THE LINE THE NEXT DAY.  CALLED BACK 08/15 THE REDNESS HAD GOTTEN WORSE REDNESS HAD SPREAD OUTSIDE OF THE MARKINGS ON HER INJECTION SITE AND WAS RX'D CEPHALEXIN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Chest X-ray normal, Chills, Full blood count normal
Clinical narrative: Last Thursday she received her second vaccine for Shingrix. She tells me within 1 hour she developed a fever, aches, pains and chills. She says that her temperature was 102. She says during the day she has low grade temp 99 and at bedtime it went to 102.1. She went to the hospital on September 3rd. She had an IV and labs and was sent home.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Red blood cells urine positive, Urine ketone body present, Urine leukocyte esterase
Clinical narrative: Last Thursday she received her second vaccine for Shingrix. She tells me within 1 hour she developed a fever, aches, pains and chills. She says that her temperature was 102. She says during the day she has low grade temp 99 and at bedtime it went to 102.1. She went to the hospital on September 3rd. She had an IV and labs and was sent home.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site pain, Lethargy
Clinical narrative: Very sore and painful at site of injection; 2-3 days duration Elevated temperature (99.4) for 24 hours Lethargy 24 hours
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: I had the higher dose because I just turned 65.  I have never had a reaction to a flu shot before.  About 5 - 6 hours after getting it I had aches, fever, and chills for several hours.  It was better in the morning, but I felt ill occasionally for the next 2 days. I do not have a primary physician right now because I recently moved here.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; one patient received one dose of improperly stored ROTATEQ; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.         On 27-JUN-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R025713, expiration date 20-JUN-2020; dose and route were not reported) for prophylaxis (improper storage of product in use). No additional doses were administrated. No adverse effects were reported.   The administrated vaccine experienced the following temperature excursion: total time and lowest temperature below 36 degree Fahrenheit (33.9 Fahrenheit) for 40 minutes. The digital data logger was involved. Previous temperature excursions included total time and lowest temperature below 36 degree Fahrenheit (30.3 Fahrenheit) for 90 hours and 7 minutes, total time and lowest temperature below 36 degree Fahrenheit (30.5 Fahrenheit) for 1 hour and 45 minutes and total time and lowest temperature below 36 degree Fahrenheit (35.2 Fahrenheit) for 2 hours and 5 minutes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in arm not in the same spot but around where the shot was given'; This case was reported by a consumer and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included non-alcoholic steatohepatitis (stage 4 NASH a hereditary liver disease), renal disease (stage 3), diabetes, fibromyalgia and sleep apnea.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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: The patient was 68 years old at the time of reporting. The age at vaccination was not reported. The patient had so many physician appointments, etc. due to having "Stage 4 Nash"(a hereditary liver disease), a "Stage 3" kidney disease, diabetis, fibromyalgia, sleep apnea, among other things, she needed medicine for, so it was hard to remember when she had the shot or when she got the letter. The patient was wondering if there was any solution for the pain in her arm. The patient requsted response. The patient thought that she received Shingrix 3 years ago from the physician and then at one of follow up visits, the patient told the physician that since vaccination, the patient's arm hurt every day, not in the same spot but around where the shot was given. The patient thought that the physician contacted GSK and GSK response (she believed) was a letter from GSK to the patient. When the patient received the letter she could not think what it was about and did not finish even reading it and what it concerned, due to the fact of receiving so much junk mail.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Injection site redness; Injection site with a rash-like appearance; Burning; Itchy; Blotches of red; Swelling; Sore arm; Difficult to raise her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site burning, injection site itching, red blotches and swelling. On 24th August 2019, the patient experienced pain in arm and movements reduced. On an unknown date, the outcome of the pain in arm, movements reduced, red blotches and swelling were recovered/resolved and the outcome of the injection site erythema, injection site rash, injection site burning and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, movements reduced, injection site erythema, injection site rash, injection site burning, injection site itching, red blotches and swelling to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of the Shingrix vaccine and within 1 hour, her arm became sore and she noted it was difficult to raise her arm. These symptoms resolved within 2 to 3 days. Approximately 2 to 3 days after receiving the vaccination, the injection site became red with a rash-like appearance.  The patient estimated the area was approximately 5 inches long and 3 to 4 inches wide, but in blotches of red. The patient noted that the redness had gotten darker and more prominent over time. It was reported that, the red area had became itchy and it burns. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash macular, Swelling
Clinical narrative: Injection site redness; Injection site with a rash-like appearance; Burning; Itchy; Blotches of red; Swelling; Sore arm; Difficult to raise her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site burning, injection site itching, red blotches and swelling. On 24th August 2019, the patient experienced pain in arm and movements reduced. On an unknown date, the outcome of the pain in arm, movements reduced, red blotches and swelling were recovered/resolved and the outcome of the injection site erythema, injection site rash, injection site burning and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, movements reduced, injection site erythema, injection site rash, injection site burning, injection site itching, red blotches and swelling to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of the Shingrix vaccine and within 1 hour, her arm became sore and she noted it was difficult to raise her arm. These symptoms resolved within 2 to 3 days. Approximately 2 to 3 days after receiving the vaccination, the injection site became red with a rash-like appearance.  The patient estimated the area was approximately 5 inches long and 3 to 4 inches wide, but in blotches of red. The patient noted that the redness had gotten darker and more prominent over time. It was reported that, the red area had became itchy and it burns. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: soreness at injection site; rash at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer (left side).   On 28th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th August 2019, 1 days after receiving Shingrix, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. The patient planned to follow up with the physician on an unknown date. The patient consented to follow up. There was discrepancy in the event outcome reported in source document(Recovering) and in system (Not recovered).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: facial swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix .5 ml. On 8th May 2019, 1 days after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was recovered/resolved.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were reported as follows: The patient experienced Shingrix in the left arm. The patient experienced facial swelling on her left cheek the day after she received the vaccine.  The patient consented to follow up. This case has been linked to the case US2019AMR159589, reported by same reporter for same patient.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Head discomfort
Clinical narrative: Trouble breathing; Dizziness; Heaviness in head; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 8th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced difficulty breathing, dizziness and heaviness of head. On an unknown date, the outcome of the difficulty breathing, dizziness and heaviness of head were unknown.   It was unknown if the reporter considered the difficulty breathing, dizziness and heaviness of head to be related to Shingrix.  Additional case details were reported as follows: The patient came in to get her 2nd dose of Shingrix on day of reporting but reported having trouble breathing, dizziness, and her head felt heavy after receiving the first dose. The reporter enquired if there were any recommendations/safety precautions on a patient receiving the 2nd dose after having adverse reactions to the first dose. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: left upper thigh erythema, edema ( lump and bruise )  and pain, extending to the midthigh about 10 cm .
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: Injection site reactoin and medrol dose pack needed from MD 9 days later
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: significant arm swelling, redness, and tenderness upper half of left arm initially, lasting for 4 days, then generalized joint aches, chills, fatigue, and myalgias for the next 11 days as of today
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: significant arm swelling, redness, and tenderness upper half of left arm initially, lasting for 4 days, then generalized joint aches, chills, fatigue, and myalgias for the next 11 days as of today
Age: 11.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient given the wrong vaccine: Trumenba. She should have been given Menactra due to age. No adverse reaction.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Arthralgia, Headache, Joint injury, Nausea
Clinical narrative: Went for an afternoon walk and experienced previously ankle injury agitation. Started on right ankle then progressed upwards with joint pain. Also had some nausea and headache. Experienced frequent urination throughout the night.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pollakiuria
Clinical narrative: Went for an afternoon walk and experienced previously ankle injury agitation. Started on right ankle then progressed upwards with joint pain. Also had some nausea and headache. Experienced frequent urination throughout the night.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia
Clinical narrative: Peripheral nerve pain Taking Gabapentin
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Fever of 101 degrees Achy muscles Large red hot area of 3inch diameter around the injection site
Age: 48.0
Sex: M
Vaccine: HEP, HEP, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given two doses of Pediatric Hep B, same manufacture and lot number, at the same appt in place of giving one adult dose of Hep B. No adverse events or reactions reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient inadvertently received an expired dose of GARDASIL 9 on 8/20/2019; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.  On 20-AUG-2019, the patient was inadvertently vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency and route of administration not reported) (lot #: M042853, expiration date: 17-JUL-2019) (expired product administered) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: feeling tired; fever; pain left arm; weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever, pain in arm and weakness. On an unknown date, the patient experienced tiredness. On an unknown date, the outcome of the fever, pain in arm, weakness and tiredness were recovering/resolving.   It was unknown if the reporter considered the fever, pain in arm, weakness and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient received dose of Shingrix in the left arm. The patient reported that, currently had fever, pain in the left arm, weakness and also felt tired. The patient did not provide any additional information and disconnected the call before date of birth and address could be obtained. The patient did not consent to follow up. There was discrepancy in the event outcome reported in source document (recovering and resolving) and in system (not recovered and not resolved).
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3 days after received vaccines, student noticed left deltoid area became red, swollen, hard, and tender to touch. Student proceeded with warm compress for three days. Yet, the swollen, warm, and hardness did not decrease.  9/9/2019, when student came to the clinic, provider noticed left deltoid are is still slightly swollen but no redness no warm and no longer hard to touch. Student indicated: area is not tender to touch at this time. Left arm would get really sore after the game that had never happened.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Crying, Decreased appetite, Eye movement disorder, Feeling abnormal, Insomnia
Clinical narrative: Patient's mother states that patient was crying and nauseous and had loss of appetite. She was not able to sleep and was shaking and feeling nervous and her eyes were rolling back. There was no loss on consciousness. No reaction at the site of injection. Symptoms presented on and off for 3 days. Patient was examined on 09/09/2019 and is feeling better.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Nervousness, Tremor
Clinical narrative: Patient's mother states that patient was crying and nauseous and had loss of appetite. She was not able to sleep and was shaking and feeling nervous and her eyes were rolling back. There was no loss on consciousness. No reaction at the site of injection. Symptoms presented on and off for 3 days. Patient was examined on 09/09/2019 and is feeling better.