chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood magnesium, Blood magnesium increased, Blood osmolarity decreased, Blood phosphorus, Blood phosphorus normal
Clinical narrative: While on changing table mom noticed child staring blankly and then stiffened. She then had jerky of extremities and shallow breathing. Neighbors called EMS. Mom states episode lasted 4-5 minutes. EMS transferred patient to Hospital for evaluation  Temperature of 37.9 C on arrival to ED. Sleepy, but arousable. Pt. was observed. CXR results were normal. Obtained Bloodwork (CBC with Diff., CMP, Phosphorus level, magnesium level, urinalysis, & urine culture) ED consulted Neurology who recommended outpatient EEG and to return to ED with any repeated seizure activity. Discharged home. CBC normal except for: Neutrophils 68% - H Lymphocytes 19% - L Absolute Lymphocytes 1.50 k/ul - L CMP normal except: C02 1.9 - L osmolality 273 - L urine normal except: Ketones - 10 Mucous - rare Urine culture - Negative  Magnesium - 2.3 - Normal Phosphorus - 5.1 Normal  Per mom, seen at Urgent Care Clinic on 4/26/2020 for fever up to 103.4F and cough. Per notes, negative swabs for flu, strep throat, & RSV. Tested for COVID-19. Results pending.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Carbon dioxide, Chest X-ray normal, Cough, Culture urine, Culture urine negative
Clinical narrative: While on changing table mom noticed child staring blankly and then stiffened. She then had jerky of extremities and shallow breathing. Neighbors called EMS. Mom states episode lasted 4-5 minutes. EMS transferred patient to Hospital for evaluation  Temperature of 37.9 C on arrival to ED. Sleepy, but arousable. Pt. was observed. CXR results were normal. Obtained Bloodwork (CBC with Diff., CMP, Phosphorus level, magnesium level, urinalysis, & urine culture) ED consulted Neurology who recommended outpatient EEG and to return to ED with any repeated seizure activity. Discharged home. CBC normal except for: Neutrophils 68% - H Lymphocytes 19% - L Absolute Lymphocytes 1.50 k/ul - L CMP normal except: C02 1.9 - L osmolality 273 - L urine normal except: Ketones - 10 Mucous - rare Urine culture - Negative  Magnesium - 2.3 - Normal Phosphorus - 5.1 Normal  Per mom, seen at Urgent Care Clinic on 4/26/2020 for fever up to 103.4F and cough. Per notes, negative swabs for flu, strep throat, & RSV. Tested for COVID-19. Results pending.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Differential white blood cell count, Dyskinesia, Full blood count normal, Hypopnoea, Influenza virus test negative
Clinical narrative: While on changing table mom noticed child staring blankly and then stiffened. She then had jerky of extremities and shallow breathing. Neighbors called EMS. Mom states episode lasted 4-5 minutes. EMS transferred patient to Hospital for evaluation  Temperature of 37.9 C on arrival to ED. Sleepy, but arousable. Pt. was observed. CXR results were normal. Obtained Bloodwork (CBC with Diff., CMP, Phosphorus level, magnesium level, urinalysis, & urine culture) ED consulted Neurology who recommended outpatient EEG and to return to ED with any repeated seizure activity. Discharged home. CBC normal except for: Neutrophils 68% - H Lymphocytes 19% - L Absolute Lymphocytes 1.50 k/ul - L CMP normal except: C02 1.9 - L osmolality 273 - L urine normal except: Ketones - 10 Mucous - rare Urine culture - Negative  Magnesium - 2.3 - Normal Phosphorus - 5.1 Normal  Per mom, seen at Urgent Care Clinic on 4/26/2020 for fever up to 103.4F and cough. Per notes, negative swabs for flu, strep throat, & RSV. Tested for COVID-19. Results pending.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Lymphocyte count normal, Lymphocyte percentage decreased, Metabolic function test, Musculoskeletal stiffness, Neutrophil percentage decreased
Clinical narrative: While on changing table mom noticed child staring blankly and then stiffened. She then had jerky of extremities and shallow breathing. Neighbors called EMS. Mom states episode lasted 4-5 minutes. EMS transferred patient to Hospital for evaluation  Temperature of 37.9 C on arrival to ED. Sleepy, but arousable. Pt. was observed. CXR results were normal. Obtained Bloodwork (CBC with Diff., CMP, Phosphorus level, magnesium level, urinalysis, & urine culture) ED consulted Neurology who recommended outpatient EEG and to return to ED with any repeated seizure activity. Discharged home. CBC normal except for: Neutrophils 68% - H Lymphocytes 19% - L Absolute Lymphocytes 1.50 k/ul - L CMP normal except: C02 1.9 - L osmolality 273 - L urine normal except: Ketones - 10 Mucous - rare Urine culture - Negative  Magnesium - 2.3 - Normal Phosphorus - 5.1 Normal  Per mom, seen at Urgent Care Clinic on 4/26/2020 for fever up to 103.4F and cough. Per notes, negative swabs for flu, strep throat, & RSV. Tested for COVID-19. Results pending.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test, Somnolence, Staring
Clinical narrative: While on changing table mom noticed child staring blankly and then stiffened. She then had jerky of extremities and shallow breathing. Neighbors called EMS. Mom states episode lasted 4-5 minutes. EMS transferred patient to Hospital for evaluation  Temperature of 37.9 C on arrival to ED. Sleepy, but arousable. Pt. was observed. CXR results were normal. Obtained Bloodwork (CBC with Diff., CMP, Phosphorus level, magnesium level, urinalysis, & urine culture) ED consulted Neurology who recommended outpatient EEG and to return to ED with any repeated seizure activity. Discharged home. CBC normal except for: Neutrophils 68% - H Lymphocytes 19% - L Absolute Lymphocytes 1.50 k/ul - L CMP normal except: C02 1.9 - L osmolality 273 - L urine normal except: Ketones - 10 Mucous - rare Urine culture - Negative  Magnesium - 2.3 - Normal Phosphorus - 5.1 Normal  Per mom, seen at Urgent Care Clinic on 4/26/2020 for fever up to 103.4F and cough. Per notes, negative swabs for flu, strep throat, & RSV. Tested for COVID-19. Results pending.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Streptococcus test negative, Urine analysis, Urine ketone body present
Clinical narrative: While on changing table mom noticed child staring blankly and then stiffened. She then had jerky of extremities and shallow breathing. Neighbors called EMS. Mom states episode lasted 4-5 minutes. EMS transferred patient to Hospital for evaluation  Temperature of 37.9 C on arrival to ED. Sleepy, but arousable. Pt. was observed. CXR results were normal. Obtained Bloodwork (CBC with Diff., CMP, Phosphorus level, magnesium level, urinalysis, & urine culture) ED consulted Neurology who recommended outpatient EEG and to return to ED with any repeated seizure activity. Discharged home. CBC normal except for: Neutrophils 68% - H Lymphocytes 19% - L Absolute Lymphocytes 1.50 k/ul - L CMP normal except: C02 1.9 - L osmolality 273 - L urine normal except: Ketones - 10 Mucous - rare Urine culture - Negative  Magnesium - 2.3 - Normal Phosphorus - 5.1 Normal  Per mom, seen at Urgent Care Clinic on 4/26/2020 for fever up to 103.4F and cough. Per notes, negative swabs for flu, strep throat, & RSV. Tested for COVID-19. Results pending.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: How long does the fever and pain last?; How long does the fever and pain last?; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain and fever after vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Gastroenteritis viral, Nausea, Social problem, Vomiting
Clinical narrative: strong reaction to dose 1 , including vomiting; nausea; Reaction ( as if digestive virus) lasted several days.; Because of the covid 19 restrictions & concerns, I am not getting second shot in earliest timeframe.; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vomiting, nausea, stomach virus and social problem. On an unknown date, the outcome of the vomiting, nausea and social problem were unknown and the outcome of the stomach virus was recovered/resolved.   It was unknown if the reporter considered the vomiting, nausea and stomach virus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after 1st dose experienced vomiting, nausea and reaction as if digestive virus. The patient because of the covid 19 restrictions & concerns was not getting second shot in earliest timeframe.  The patient asked how far apart can have the 2 doses and have it effective.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Redness to injection site and small in duration of 1 cm x 1 cm with fever.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Cyanosis, Hypotonia, Seizure like phenomena, Tonic clonic movements
Clinical narrative: New onset seizure like movements after receiving vaccines. 2 Atonic events lasting 1-2 minutes with associated peri-oral cyanosis. 1 tonic-clonic event lasting 1-2 minutes.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: TEMPERATURE 100.4 TO 100.7 F. REDNESS AND SWELLING AT SITE. BODY ACHES
Sex: U
Vaccine: VARZOS
Symptoms: Arthropod sting, Burning sensation, Herpes zoster, Pruritus
Clinical narrative: What is important is that on 4/23/2020 I was stung (right temple/under right nose opening/right arm/right leg) by at least six-eight or more desert bees (based on stinger removal) after shingles and the shots.  I am not allergic to stings.  here was a VERY unusual reaction for me.  The shingles returned under the skin on the back with very aggressive burn-and-itch to the degree that caused concern. By Wed the shingle reaction to the bee stings subsided.  This was sufficiently curious that I thought sharing might be important if bee toxin and the shingle shots and the recombinant zoster were at odds with each other?  In any event, this may save someone else from the grief of bee stings and shingles.  Shingles is more than enough to deal with for a lifetime!
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Pain in extremity
Clinical narrative: Patient received a flu vaccine for the first time 10/17/2019. Patient has had residual pain in the arm that received the vaccination. Described pain as sharp in the elbow and bicep as well as weakness especially with movement.   Went to the doctor Dec. 6th  as pain was not getting better.  She has taken ibuprofen  but it was not helpful.    She has not had any tests or referrals at this time but will be following up with the doctor.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Consciousness fluctuating, Dizziness, Eye movement disorder, Fatigue, Pallor
Clinical narrative: syncope and collapse. started feeling faint and collapsed while sitting in car with dad. episode lasted 20-30min and she was in and out of consciousness during that time per dad. She was very pale at the time, eyes deviated back. no tonic clonic features. + emesis and dry heaving for 15-20min following the event. when she came to her underwear was wet, believe she may have lost continence of urine. no stool incontinence. Marked fatigue following the event. She did have WCC and vaccines earlier that day, Tdap, MCV, HPV. Hx of vasovagal responses to pain in the past, usually immediately following pain. did have emesis in response to pain from a bee sting in the past. No prior Hx of incontinence of urine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Retching, Syncope, Urinary incontinence, Vomiting
Clinical narrative: syncope and collapse. started feeling faint and collapsed while sitting in car with dad. episode lasted 20-30min and she was in and out of consciousness during that time per dad. She was very pale at the time, eyes deviated back. no tonic clonic features. + emesis and dry heaving for 15-20min following the event. when she came to her underwear was wet, believe she may have lost continence of urine. no stool incontinence. Marked fatigue following the event. She did have WCC and vaccines earlier that day, Tdap, MCV, HPV. Hx of vasovagal responses to pain in the past, usually immediately following pain. did have emesis in response to pain from a bee sting in the past. No prior Hx of incontinence of urine.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth, Peripheral swelling
Clinical narrative: Grossly swollen leg after administration. Warmth, erythema, hard nodule at injection site
Age: 61.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Contusion, Swelling, Tachycardia
Clinical narrative: Patient received both immunizations in the same arm. Later that night the patient woke up with tachycardia with HR in the 140s that persisted through the entire next day. He also mentioned that the entire upper half of his was bruised and swollen for several days following the immunizations.
Age: 38.0
Sex: M
Vaccine: HPV9
Symptoms: Discomfort, Feeling cold, Hyperhidrosis
Clinical narrative: I received the Guardasil-9 vaccine via shot in my arm on the morning of 11/26/19. That night, and every night thereafter since, I have been sweating swimming pools in my sleep. I have never had a problem with sleeping or sweating in my sleep prior to this. Given that this began occurring in the late fall/winter time, it was and has been highly uncomfortable for several months now. Initially, I had to change shirts multiple times and was awaken because of being soaked and freezing multiple times during the night. I informed Dr. of this very odd and uncomfortable issue when I returned for my follow-up appointment to receive my second Guardasil-9 shot on January 2nd, 2020. Nevertheless, I was given the 2nd vaccination shot of the series of 3 that day. The sweating had dissipated a bit, but still present, and then that night it came roaring back - and hasn't left since (has gotten slightly better with time). I have no question that my sweating at night was caused by whatever shots I was given on November 26, 2019 and then again on January 2nd, 2020. The only reason why I even inquired with Dr. about the Guardasil shot was because I had read a news article which stated that the shot was now considered safe to receive for men aged up to 45. I wish so badly now that I had not then gone to Dr. and inquired about whether I should get the shot. And then I wish even more so that after I voiced my apparent reaction to the first shot of 3, that I had not been given the 2nd shot. Last night (4/28/20), like every night since 11/26/19, I sweat a ton again. Needless to say, I never scheduled my 3rd shot.  Will this ever go away??
Age: 1.0
Sex: F
Vaccine: HEPAB, HIBV, MMRV, PNC13
Symptoms: Condition aggravated, Ear infection, Fungal infection, Gastrointestinal motility disorder, Insomnia
Clinical narrative: Patient had a minor cold for 2-3 days prior to the vaccines.  She had a runny nose, sniffle, and mild fever one night.  She was on the mend and doing better prior to the vaccines.  The doctor told me that it would be fine if her fever was more than 24 hours prior.  It was but she was still slightly stuffy.  She got the vaccines and within 24 hours afterward was not sleeping through the night like she had been for months prior.  She was screaming nearly non-stop.  She proceeded to regress into her cold again but this time worse.  She developed an ear infection.  She received an antibiotic.  This gave her diarrhea, a topical yeast infection on her vulva and groin and did not help the infection.  She then received another antibiotic from a different pediatrician for a double ear infection and a topical nystatin for her yeast infection on her vulva/groin.  This slowly improved over 14+ days.  She now has muscle spasms in her face (eyebrows and jaw) and has ongoing diarrhea and constipation alternating since this episode.
Age: 1.0
Sex: F
Vaccine: HEPAB, HIBV, MMRV, PNC13
Symptoms: Muscle spasms, Nasopharyngitis, Screaming
Clinical narrative: Patient had a minor cold for 2-3 days prior to the vaccines.  She had a runny nose, sniffle, and mild fever one night.  She was on the mend and doing better prior to the vaccines.  The doctor told me that it would be fine if her fever was more than 24 hours prior.  It was but she was still slightly stuffy.  She got the vaccines and within 24 hours afterward was not sleeping through the night like she had been for months prior.  She was screaming nearly non-stop.  She proceeded to regress into her cold again but this time worse.  She developed an ear infection.  She received an antibiotic.  This gave her diarrhea, a topical yeast infection on her vulva and groin and did not help the infection.  She then received another antibiotic from a different pediatrician for a double ear infection and a topical nystatin for her yeast infection on her vulva/groin.  This slowly improved over 14+ days.  She now has muscle spasms in her face (eyebrows and jaw) and has ongoing diarrhea and constipation alternating since this episode.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Burning sensation, Chills, Feeling cold
Clinical narrative: Started feeling cold and got chills around 9 PM. Started getting severe muscle pain EVERYWHERE. Took temp and it was ok at 98. Went to bed after taking 1000mg Tylenol.  Could not get warm, shivering and shaking. Extreme body pain in neck, back, toes, heels, hips, head. Burning pain sensations.  Had this same type reaction from the first shot in November but thought it could be flu.  Still in the midst of the reaction right now, but the other reaction ended with profuse sweating in the morning and then it was basically gone, except I did continue with the Tylenol.  Feeling extremely painful now so took Alka Seltzer. I can not tolerate NSAIDS, so could not take ibuprofen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Influenza virus test negative, Myalgia, Neck pain, Pain
Clinical narrative: Started feeling cold and got chills around 9 PM. Started getting severe muscle pain EVERYWHERE. Took temp and it was ok at 98. Went to bed after taking 1000mg Tylenol.  Could not get warm, shivering and shaking. Extreme body pain in neck, back, toes, heels, hips, head. Burning pain sensations.  Had this same type reaction from the first shot in November but thought it could be flu.  Still in the midst of the reaction right now, but the other reaction ended with profuse sweating in the morning and then it was basically gone, except I did continue with the Tylenol.  Feeling extremely painful now so took Alka Seltzer. I can not tolerate NSAIDS, so could not take ibuprofen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Started feeling cold and got chills around 9 PM. Started getting severe muscle pain EVERYWHERE. Took temp and it was ok at 98. Went to bed after taking 1000mg Tylenol.  Could not get warm, shivering and shaking. Extreme body pain in neck, back, toes, heels, hips, head. Burning pain sensations.  Had this same type reaction from the first shot in November but thought it could be flu.  Still in the midst of the reaction right now, but the other reaction ended with profuse sweating in the morning and then it was basically gone, except I did continue with the Tylenol.  Feeling extremely painful now so took Alka Seltzer. I can not tolerate NSAIDS, so could not take ibuprofen.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Viral titre
Clinical narrative: patient had negative titers for Varivax; This spontaneous report was received from a physician concerning to a 22 years old, non-pregnant female patient. The patient had no concurrent conditions, medical history and concomitant medications  On an unspecified date in 1998, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, (dose, frequency, lot# and expiration date were not provided) for prophylaxis (reported as vaccine). On an unspecified date in 2007, the patient was vaccinated with an additional dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # and expiration date not reported).  On 17-APR-2020, a bloodwork (serologic testing) was drawn and results showed that the patient had negative titers for varicella virus vaccine live (oka/merck)(VARIVAX). The patient sought for medical attention, however no treatment was administered for this event. At the time of the report, the outcome of the event was not recovered.  The causal relationship between the event and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: cellulitis; postherpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 04-FEB-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful burning rash on her foot and she was diagnosed with herpes zoster, cellulitis and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the all events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered all events to be disability. Upon internal review, the event of cellulitis was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; One patient received an improperly stored dose of VARIVAX; 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, drug/allergy reactions, and concomitant therapies were not reported.  On 20-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, vaccination scheme and anatomical site of administation were not reported;  lot number S022755, expiration date 22-JUL-21) as prophylaxis. Additionally, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was reported as "properly stored".  The administered dose of the vaccine was stored in a temperature between 6 degrees Fahrenheit (°F) to 14 °F, in a timeframe of 90 minutes, as recorded by a data logger. The previous temperature excursion reported was 15°F to 46 °F  in a timeframe of 36 hours.  No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA007458:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; that patient was administered an expired dose of MMR; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant therapies was provided.  On 20-APR-2020, the patient was vaccinated with  an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, albumin status (rHA), live (M-M-R II) (dose, route of administration, vaccination scheme and  anatomical site of vaccination, were not reported); lot number R011219, expiration date 17-APR-2020) as prophylaxis.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; One patient received an improperly stored dose of VARIVAX; 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, drug/allergy reactions, and concomitant therapies were not reported.  On 20-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, vaccination scheme and anatomical site of administation were not reported;  lot number S022755, expiration date 22-JUL-21) as prophylaxis. Additionally, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was reported as "properly stored".  The administered dose of the vaccine was stored in a temperature between 6 degrees Fahrenheit (°F) to 14 °F, in a timeframe of 90 minutes, as recorded by a data logger. The previous temperature excursion reported was 15°F to 46 °F  in a timeframe of 36 hours.  No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA006968:
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction reported; her son, inadvertently got a 4th dose of GARDASIL 9; This spontaneous report was received from a consumer who is the patient's mother, referring to a 20-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 24-APR-2020 earlier in the morning, the patient was inadvertently vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (strength, route of administration, and anatomical location was not reported; lot number and expiration date were unknown by the reporter) by a physician, who thought the patient had not received the third dose (extra dose administered). No adverse reaction reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Anaphylactic reaction
Clinical narrative: Patient was treated for anaphylaxis in an unspecified emergency room after administration of unspecified version of GARDASIL; This spontaneous report was received from a nurse practitioner (conflicting information also reported as nurse prescriber referring to a female patient of unknown age. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.     On an unknown date, the patient was vaccinated with unidentified Merck hpv vaccine administered (lot number not provided, name reported as unspecified version of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)) as prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical location of administration and expiration date were not reported).   On an unknown date, the patient experienced anaphylaxis (anaphylactic reaction) after vaccination, the patient was treated for the event in the emergency room.   At the time of this report, the outcome of anaphylactic reaction was not reported.     As the patient had an anaphylactic reaction to the unidentified Merck hpv vaccine administered therefore the causality was considered as related.  Upon internal review, anaphylactic reaction was determined to be medically significant.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; the patient was inadvertently administered a dose of Rotateq on 4/21/2020 that has been improperly stored; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 21-APR-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot #1660947, expiration date 16-FEB-2021 for prophylaxis (exact dose, dose # and route of administration were not provided). The temperature excursion was 47.7 degrees Fahrenheit (F) for 12 minutes. The previous excursion was 58.3 F for 14 hours. The digital data logger was involved. No adverse effect was reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Received HEPLISAV-B That Was Not Stored Properly; Initial Report Received on 11-Mar-2020  This report was received from the supervisor of a health center.  The reporter stated that on 10-Mar-2020 a 58-year-old female patient received HEPLISAV-B (lot # 933621) in the left deltoid.  The vaccine was reported to have not been stored properly and reached 48 degrees Fahrenheit for 13.5 hours.  The patient had not reported any adverse reactions at the time of report.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Received Heplisav-B That Was Not Stored Properly; Initial Report Received on 11-Mar-2020  This report was received from the supervisor of a health center.  The reporter stated that on 11-Mar-2020 a 52-year-old female patient received HEPLISAV-B (lot # 933621, expiration date 26-Jul-2021) in the right deltoid.  The vaccine was reported to have not been stored properly and reached 48 degrees Fahrenheit for 13.5 hours.  The patient had not reported any adverse reactions at the time of report.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: Missed second dose of Vivotif; Spontaneous report received on 30DEC2019.  A pharmacist reported that a male consumer "missed second dose of Vivotif" (PT: Product dose omission), while being on Vivotif for immunisation. The consumer missed the second dose of Vivotif, and three to four days had passed since his initial dose. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif. ; Sender's Comments: A consumer missed second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT SKIP A DAY BETWEEN FIRST AND SECOND DOSE; This spontaneous case report (PVX2019-2738) was received from a pharmacist on 05-Nov-2019. It described a female consumer who "did not skip a day between first and second dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took first and second dose of Vivotif on 04-Nov-2019 and 05-Nov-2019 respectively.  Action taken with Vivotif with respect reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not skip a day between first and second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not skip a day between first and second dose" was considered as not applicable.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: How long does the shivering side effect last; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient asked how long does the shivering side effect last.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Developed a very red and very large area at the injection site; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included axillary lymphadenectomy (lymph nodes removed from both armpits). Concurrent medical conditions included breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Last week from the date of reporting, the patient received Shingrix in an unknown arm. The patient was breast cancer survivor and had lymph nodes removed from both armpits.  The patient was at risk for lymphedema and avoided needles in the arms when possible.  The patient developed a very red and very large area at the injection site.  For the second injection in several months, the patient asked if there someplace else the vaccine might be injected besides the arm and still maintain the same percentage of protection.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: woke with chills during the night; has a bad headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced headache. On 22nd April 2020, the patient experienced chills. On an unknown date, the outcome of the headache and chills were unknown.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had his booster dose the day before reporting and woke with chills during the night. The patient now had a bad headache and wants to know if he could take Advil or Tylenol.
Sex: M
Vaccine: HEP, HEP
Symptoms: Coeliac disease, Hepatitis B antibody negative, Social problem, Therapeutic response decreased
Clinical narrative: later diagnosed with coeliac disease; Hepatitis B antibody; received a dose of Engerix B four months ago and was scheduled for a second dose tomorrow (this dose had to be rescheduled due to the COVID-19 pandemic; This case was reported by a consumer and described the occurrence of celiac disease in a adult male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received 4 months before reporting (December 2019)).   On an unknown date, the patient received Hepatitis B vaccine and the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Engerix B adult, the patient experienced celiac disease (serious criteria GSK medically significant), therapeutic response decreased and social problem. On an unknown date, the outcome of the celiac disease, therapeutic response decreased and social problem were unknown.   It was unknown if the reporter considered the celiac disease and therapeutic response decreased to be related to Hepatitis B vaccine.  Additional case details were reported as follows: The reporter was patient's mother. Age at vaccination was not reported. At the time of reporting patient was 18 years old. The patient had received his childhood hepatitis B immunizations but was later diagnosed with coeliac disease. As the consumer read online that coeliac patients might not get protective antibody responses, the patient´s physician tested for hep B antibodies which came back negative. Therefore, the patient received a dose of Engerix B four months before day of reporting and was scheduled for a second dose day after reporting (this dose had to be rescheduled due to the COVID-19 pandemic). The reporter requesting consent to follow up.      Lab Comments: on an unknown date lab test was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site soreness; little redness at sight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age could be 66 years or 67 years at the time of vaccination. The patient received Shingrix and had slight soreness at sight, and a little redness at sight.  For tolerances of 2nd dose, refer case US2020AMR070625, reported by same reporter for the same patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sores; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd March 2020, 9 days after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and around March 3 or 4, developed cold sores.  She has not had cold sores for years. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Sleep disorder
Clinical narrative: She noticed redness and itching at the injection site; She noticed redness and itching at the injection site; injection site became sore; She could not sleep on the arm for two days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2020, couple of hours after receiving Shingrix, the patient experienced injection site pain. On 5th March 2020, the patient experienced injection site erythema and injection site itching. In March 2020, the patient experienced sleeplessness. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching and sleeplessness to be related to Shingrix.  Additional case details were reported as follows: The patient reported that the injection site became sore within a couple of hours of receiving the vaccination. The patient could not sleep on the arm for two days after receiving the injection. Four days after receiving vaccination, the patient also noticed redness and itching at the injection site. The patient gave permission for her physician to be contacted. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: mild flu symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated they experienced mild flu like symptom after receiving a dose of Shingrix. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: "felt like I had a vaccine"; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were provide as follows: This case was reported by patient herself. The age at vaccination was not reported. After vaccination, the patient felt like she had a vaccine. The reporter declined to provide any additional details for this adverse event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Urticaria
Clinical narrative: she developed hives; had slight swelling at the site of the injections; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received Shingrix. On 24th February 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site swelling and hives were recovered/resolved.   The reporter considered the injection site swelling and hives to be related to Shingrix.  Additional details were provide as follows: The patient picked up the vaccine from the pharmacy and took it to a clinic where it was administered so limited information was available. The patient had slight swelling at the site of the injections.  The evening of vaccination or the next day, the patient developed hives that seemed to have a pattern.   The patient took a dose of Benadryl and the hives went away.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule
Clinical narrative: developed nodularities on the extensor sufaces of hand, upper extremities, feet and face.; This case was reported by a physician via call center representative and described the occurrence of nodule on extremity in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In March 2020, 2 days after receiving Shingrix, the patient experienced nodule on extremity. On an unknown date, the outcome of the nodule on extremity was unknown.   It was unknown if the reporter considered the nodule on extremity to be related to Shingrix.  Additional details were provided as follows: The patient had her first dose nine days ago. Seven days ago she developed nodularities on the extensor sufaces of hand, upper extremities, feet and face. Mouth was clear. He was not sure if it is hand, foot and mouth disease. The physician was in a hurry and did not have time to answer all questions. Did not have the lot number. Consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Peripheral swelling
Clinical narrative: Swollen right eye; Swollen left hand; This case was reported by a pharmacist via call center representative and described the occurrence of eye swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7A7H4, expiry date 10th December 2021) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, less than a week after receiving Shingrix, the patient experienced eye swelling and hand swelling. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the eye swelling and hand swelling were unknown.   It was unknown if the reporter considered the eye swelling and hand swelling to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced swollen right eye and left hand after vaccination. The reporter stated that when she was unable to withdraw the medication from the vial, so she had to open a new vial for reconstitution of a dose. The pharmacist also reported that the patient went to see her HCP and that he gave her 20 mg of Prednisone, in case she is allergic to Shingrix. The pharmacist reported that patients will potentially be late for the 2nd dose of Shingrix due to a reconstitution PQC and a supply issue with restocking the vaccine. The reporter consented to follow up. This case has been linked with case US2020042784(Husband's case), reported for same reporter.