chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash macular, Swelling face
Clinical narrative: Face and eye swelling and blotchy rash to face.  Localized reaction with redness, warmth, and swelling to left thigh.  No wheezing or distressed breathing, no vomiting, no lip or tongue swelling.  Vitals remained stable.  Treated with oral Benadryl, oral Decadron, and oral Tylenol.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: GOT LARGE RED KNOT, HOT, SWOLLEN ABOUT SIZE OF GRAPEFRUIT TO LEFT THIGH WITH DTAP
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Feeling cold, Tongue movement disturbance
Clinical narrative: On Wednesday following vaccine child had 1 episode of tongue clicking in conjunction with spontaneous head rotation and shoulder lift. On Thursday the child played with friends and went swimming, she stated that she felt cold and noticed that the tongue clicking and head rotation and shoulder lift occurred spontaneously until she felt warm. She experienced these symptoms throughout the weekend whenever she felt chilled. Per parents report she was seen my natural path physician 6/22 and a 24 hr urine is being collected. She has slept better approximately 13 hrs through Monday night until today. She denies HA, fever, N/V/D or stomach pain.  Parents state that she rotates her head different directions and lifts different shoulders, the child states that she doesn't have control over these episodes. The parents deny that she has seizure or loss of consciousness. No loss of bowel or bladder control.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Fatigue, Irritability
Clinical narrative: REALLY, REALLY FUSSY X 1 FULL WEEK AFTER DTAP AND HIB VACCINE; WAS ALSO REALLY TIRED FOR A FEW DAYS
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Swelling face
Clinical narrative: Face puffy. Eyes swollen. No swelling of the mouth tongue or throat. No difficulty breathing. Taking Benadryl 25mg every 6 hours. Monitoring for signs of hives swelling and difficulty breathing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Malaise, Nausea, Pain
Clinical narrative: PATIENT HAS FEVER,  SERVERE BODY ACHE, NAUSEA AND HEADACHE 24 HOURS AFTER GETTING THE VACCINE.  PATIENT FEELS BETTER 4 DAYS AFTER.  BUT THEN 3 DAYS LATER PATIENT CAN NOT SLEEP.  PATIENT DOES NOT FEEL WELL THE WHOLE WEEK.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PATIENT HAS FEVER,  SERVERE BODY ACHE, NAUSEA AND HEADACHE 24 HOURS AFTER GETTING THE VACCINE.  PATIENT FEELS BETTER 4 DAYS AFTER.  BUT THEN 3 DAYS LATER PATIENT CAN NOT SLEEP.  PATIENT DOES NOT FEEL WELL THE WHOLE WEEK.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Patient noticed a rash on her arms at 10:30 PM on the day she received her vaccine. She showed her mother and discovered it also covered the trunk of her body, neck, and face. She woke up the next day and the rash had spread to her full body. The rash did not itch and was not painful. Her mother made an appointment to be seen again that same day. Patient mentioned having had her wisdom teeth removed on 6/15/2020, and she was still taking Amoxicillin 500mg every 8 hours. Her last dose was the evening on the day after the vaccination. The rash may have been related to a reaction from the antibiotic per the provider who examined her (NP), and recommended she did not take the last dose that evening. She was told to call the office if the rash did not subside within three days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Fatigue, fever, muscle aches, nausea
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Bloody stools the night of the immunization, about 5 bouts of diarrhea and 2 bouts of blood.
Age: 17.0
Sex: F
Vaccine: DTAP, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The adverse event was to the HPV vaccine, which was the second dose in a series started when I was much younger and administered in my left arm. The day after the injection site was red, slightly swollen and painful to the touch.  Some time after, some type of slightly raised painful bump formed in the injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever to 101.7, approx. 24 hours afterwards lasting x 1 day with spreading erythema around site of injection.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt experience redness and swelling at the injection site. the size of red spot had increased over the week, pt did speak with provider and then came in to the pharmacy for us to look at. through discussion she was monitoring the size of rash and has been increasing. pt did also state she took Benadryl without improvement.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Blood magnesium normal, Differential white blood cell count normal, Eye movement disorder, Full blood count normal
Clinical narrative: Patient reported not feeling well  with nausea at home less than 1.5 hours after receiving 2 vaccines in our office, then had witnessed  tonic clonic seizure ( loss of consciousness with eyes rolling back and convulsive movements of upper extremities and torso for 2 minutes, then sleepy and lethargic ) and brought to by ambulance to ER in post ictal state. No previous history of seizures. Patient discharged home form the ER same day w. Instructions to see Neurologist and Pediatric PCP for follow up. Seen by Neurologist 6/22/20, has not had any further seizure activity since and patient is feellng well. MRI and EEG to be performed, no medications started except  rectal Diastat hould patient have another seizure.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure, Lethargy, Malaise, Nausea, Pregnancy test urine negative
Clinical narrative: Patient reported not feeling well  with nausea at home less than 1.5 hours after receiving 2 vaccines in our office, then had witnessed  tonic clonic seizure ( loss of consciousness with eyes rolling back and convulsive movements of upper extremities and torso for 2 minutes, then sleepy and lethargic ) and brought to by ambulance to ER in post ictal state. No previous history of seizures. Patient discharged home form the ER same day w. Instructions to see Neurologist and Pediatric PCP for follow up. Seen by Neurologist 6/22/20, has not had any further seizure activity since and patient is feellng well. MRI and EEG to be performed, no medications started except  rectal Diastat hould patient have another seizure.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: SARS-CoV-2 test negative, Seizure, Somnolence, Toxicologic test normal, Urine analysis normal
Clinical narrative: Patient reported not feeling well  with nausea at home less than 1.5 hours after receiving 2 vaccines in our office, then had witnessed  tonic clonic seizure ( loss of consciousness with eyes rolling back and convulsive movements of upper extremities and torso for 2 minutes, then sleepy and lethargic ) and brought to by ambulance to ER in post ictal state. No previous history of seizures. Patient discharged home form the ER same day w. Instructions to see Neurologist and Pediatric PCP for follow up. Seen by Neurologist 6/22/20, has not had any further seizure activity since and patient is feellng well. MRI and EEG to be performed, no medications started except  rectal Diastat hould patient have another seizure.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Per patient, she had a rash on both legs with welts. She is not sure, wether this is due to vaccine, but she got rash the next day after receiving vaccine and show would like it reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: No additional adverse effect reported.; patient was administered PROQUAD and VARIVAX on 05-JUN-2020; patient was administered PROQUAD and VARIVAX on 05-JUN-2020; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 05-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA) (lot # S027467 had been verified to be a valid number; expiration date 02-MAR-2021) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R035223 had been verified to be a valid number; expiration date 04-DEC-2020); both vaccines for prophylaxis (strengths, doses, routes of administration, and anatomical site of vaccinations were not reported) (inappropriate schedule of product administration and duplicate therapy error). It was mention a used of sterile diluent (MERCK STERILE DILUENT). No additional adverse effect reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse effect reported.; patient was administered PROQUAD and VARIVAX on 05-JUN-2020; patient was administered PROQUAD and VARIVAX on 05-JUN-2020; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 05-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA) (lot # S027467 had been verified to be a valid number; expiration date 02-MAR-2021) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R035223 had been verified to be a valid number; expiration date 04-DEC-2020); both vaccines for prophylaxis (strengths, doses, routes of administration, and anatomical site of vaccinations were not reported) (inappropriate schedule of product administration and duplicate therapy error). It was mention a used of sterile diluent (MERCK STERILE DILUENT). No additional adverse effect reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no additional adverse event; inadvertently administering a dose of PROQUAD by the intramuscular rather than subcutaneous route; This spontaneous report as received from a physician refers to a 4 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 16-JUN-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S031705, expiration date: 06-APR-2021 (Albumin status: recombinant Human albumin (rHA))(strength and dosing schedule were not reported) intramuscular rather than subcutaneous route, for prophylaxis. No additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis, Visual impairment
Clinical narrative: diagnosed with Bell's palsy; suffered from impaired vision; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 25-MAY-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt was diagnosed with Bell's palsy and suffered from impaired vision. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to physical limitations and seriousness of the pt's condition. The pt sustained severe and permanent personal injuries and 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 pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was considered to be not recovered. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of diagnosed with Bell's palsy and suffered from impaired vision were considered to be disabling.  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to toxic agent, Herpes zoster, Musculoskeletal pain, Pain in extremity, Rash
Clinical narrative: Contacted poison ivy two months later; Shingles with rash and pain from shoulder blade to the elbow; This spontaneous report was received from a 65-year-old female patient referring to herself. The patient's medical history, concurrent conditions, drug allergies or reactions and concomitant therapy were not provided.      On an unspecified date in 2014, the patient was vaccinated with initial dose of zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, frequency and anatomical location were not provided), route of administration reported as injection for prevention of shingles (prophylaxis). On an unspecified date (reported as two months later), the patient got contacted with poison ivy (exposure to toxic agent) and 4 months after the initial zoster vaccine live (ZOSTAVAX) injection, she experienced shingles with rash and pain from shoulder blade to the elbow (herpes zoster). She sought medical attention from the physician's office and was prescribed with an unspecified medication for treatment. The patient declined to participate fully and to provide full demographics. No further symptoms or specifics were provided. Product quality complaint (PQC) was not associated with this report. The patient was not sure how long the events lasted, but on an unknown date, the events were recovered eventually. The causality assessment was not provided by the reporter.
Sex: M
Vaccine: CHOL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Has been taking the cholera vaccine up until age 73; Spontaneous report received on 14MAY2020.  A male consumer reported that he "has been taking the cholera vaccine up until age 73" (PT: Product use issue). The consumer was receiving Vaxchora for immunisation. On 14MAY2020, the patient was informed that the cholera vaccine would not be provided to him because centers for disease control and prevention (CDC) does not recommend it over the age of 62. Although, he was taking the cholera vaccine until age 73. Action taken with Vaxchora with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer had been taking the cholera vaccine (Vaxchora) up until the age of 73 (Drug use in unapproved age group). Further details of the event is limited. Vaxchora is indicated for use in adults (18 to 64 years of age) who are traveling to cholera affected regions, and the causality of the event is assessed as not applicable to Vaxchora.; Sender's Comments: It was reported that a consumer had been taking the cholera vaccine (Vaxchora) up until the age of 73 (Drug use in unapproved age group). Further details of the event is limited. Vaxchora is indicated for use in adults (18 to 64 years of age) who are traveling to cholera affected regions, and the causality of the event is assessed as not applicable to Vaxchora.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: continued achiness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix the patient experienced continued achiness, tiredness The patient asked how long do shingles vaccine side effects last. For tolerance after 2nd dose of Shingrix, refer case US2020AMR103218.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR103218:Same Patient
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: immobile/being immobile during the night; pain on the interior of his left arm  / sore, stiff and painful; sore, stiff and painful; pain in the arm pit; sore/painful; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm, stiffness, axillary pain and pain. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, stiffness, axillary pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, stiffness, axillary pain and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported pain on the interior of his left arm toward the arm pit but not all the way up to the armpit.  It was not near the injection site and was not a burning pain.   It was sore, stiff and painful. The symptoms presented a week after receiving the vaccine.   It presents in the morning after being immobile during the night and said he sometimes forgets about it during the day. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Neck pain, Pain, Swelling
Clinical narrative: Headache; Chills; Neck Ache; Soreness; Swelling; Low White Blood Cells; This case was reported by a consumer via call center representative and described the occurrence of white blood cell decreased in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen (Advil).   On 7th June 2020, the patient received Shingrix. On 7th June 2020, less than a day after receiving Shingrix, the patient experienced pain and swelling. On 8th June 2020, the patient experienced headache, chills and neck pain. In June 2020, the patient experienced white blood cell decreased. On an unknown date, the outcome of the white blood cell decreased was unknown and the outcome of the headache was not recovered/not resolved and the outcome of the pain, swelling, chills and neck pain were recovered/resolved.   It was unknown if the reporter considered the white blood cell decreased, headache, pain, swelling, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the white blood cell count was lower and desired to know if Shingrix could cause this.   The reporter stated that into the night and next day he had headache, soreness, swelling, and chills and had mild headache every but other symptoms were gone.   The reporter also received phone number to Medical information to provide to his doctor. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count decreased
Clinical narrative: Headache; Chills; Neck Ache; Soreness; Swelling; Low White Blood Cells; This case was reported by a consumer via call center representative and described the occurrence of white blood cell decreased in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen (Advil).   On 7th June 2020, the patient received Shingrix. On 7th June 2020, less than a day after receiving Shingrix, the patient experienced pain and swelling. On 8th June 2020, the patient experienced headache, chills and neck pain. In June 2020, the patient experienced white blood cell decreased. On an unknown date, the outcome of the white blood cell decreased was unknown and the outcome of the headache was not recovered/not resolved and the outcome of the pain, swelling, chills and neck pain were recovered/resolved.   It was unknown if the reporter considered the white blood cell decreased, headache, pain, swelling, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the white blood cell count was lower and desired to know if Shingrix could cause this.   The reporter stated that into the night and next day he had headache, soreness, swelling, and chills and had mild headache every but other symptoms were gone.   The reporter also received phone number to Medical information to provide to his doctor. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Eating disorder
Clinical narrative: Flu-like Symptoms; Dizziness; Fatigue; Injection Site Pain; Difficulty Eating; Shivers; Diarrhea; Weakness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, dizziness, fatigue, injection site pain, eating disorder, chills, diarrhea and weakness. On an unknown date, the outcome of the influenza-like symptoms, dizziness, eating disorder, chills, diarrhea and weakness were recovered/resolved and the outcome of the fatigue and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, dizziness, fatigue, injection site pain, eating disorder, chills, diarrhea and weakness to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix in left arm muscle. The patient experienced diarrhea, weakness, shivers, difficulty eating, injection site pain, fatigue, dizziness, and flu-like symptoms.  The patient declines to provide health care provider information for follow-up due to not having a current doctor.  The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Flu-like Symptoms; Dizziness; Fatigue; Injection Site Pain; Difficulty Eating; Shivers; Diarrhea; Weakness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, dizziness, fatigue, injection site pain, eating disorder, chills, diarrhea and weakness. On an unknown date, the outcome of the influenza-like symptoms, dizziness, eating disorder, chills, diarrhea and weakness were recovered/resolved and the outcome of the fatigue and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, dizziness, fatigue, injection site pain, eating disorder, chills, diarrhea and weakness to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix in left arm muscle. The patient experienced diarrhea, weakness, shivers, difficulty eating, injection site pain, fatigue, dizziness, and flu-like symptoms.  The patient declines to provide health care provider information for follow-up due to not having a current doctor.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient had shingles after 1st dose of Shingrix. The patient was due for 2nd dose. The reporter asked, if the patient waits one month is it still ok to get then 2nd shot at 7 months. The reporter consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash
Clinical narrative: has not yet received the second dose of Shingrix; rashes on their cheeks, neck, and anterior chest; This case was reported by a physician via call center representative and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 31st October 2019, less than a month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received Shingrix and experienced rashes on their cheeks, neck, and anterior chest.  Reaction occurred within a few days of getting the shot, which was given back in October 2019 and rashes had since resolved.  The patient has not yet received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Vaccination failure
Clinical narrative: She had pneumovax and prevnar not working; This is a spontaneous report from two contactable physicians from a Pfizer-sponsored program. A 69-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation, pneumococcal vaccine polysacch 23v (PNEUMOVAX), via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she had pneumovax and prevnar not working  on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: The association between the event "prevenar not working" with pneumococcal 13-valent conjugate vaccine can not be fully excluded.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient received IPOL at 2-months prior to age 4 / no AE; the patient received 5th dose of IPOL at 4 years of age / no AE; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 3 years 10 months old male patient who received IPV (VERO) [IPOL] at 2-months prior to age 4 (Inappropriate schedule of product administration) and received 5th dose of IPOL at 4 years of age  (Extra dose administered).  Past vaccinations: a dose of Pentacel (dose 1 of IPOL) at 2 months and a dose of Pentacel (dose 2 of IPOL) at 4 months and a dose of Kinrix (dose 3 of IPOL) at 6 months of age.  The patient's past medical history, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a fourth dose and a fifth dose of IPV (VERO) [IPOL] (lot number and Exp. Date not reported) via unknown route, in unknown administration site for Prophylactic vaccination.  It was an actual medication error case due to extra dose administered and Inappropriate schedule of vaccine administered.  At the time of reporting no adverse reaction was reported.  The caller stated that a patient received 5 polio vaccinations. He received them at 2 months, 4 months, 6 months, and 2 months before 4th birthday. He also received one on his 4th birthday. The caller wants to know if he should receive a 6th vaccination as booster.  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 and Module VI of the 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra was given to patient, no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 17 year old male patient who received 0.5 ml dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6207AA, Exp. Date 25-May-2020) via an intramuscular route in the deltoid on 19-Jun-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Fever, sore And red at injection area. Dizzy, nausea. Tired. Weak. Listless.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Listless, Nausea, Pyrexia
Clinical narrative: Fever, sore And red at injection area. Dizzy, nausea. Tired. Weak. Listless.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Computerised tomogram, Dizziness, Pain in extremity, Syncope
Clinical narrative: blood pressure 75/60 pulse 132 fainted dizziness weakness arm pain.added fluids still alive
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: blood pressure 75/60 pulse 132 fainted dizziness weakness arm pain.added fluids still alive
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Patient report breaking out in a rash.  Very itchy, very painful, large red blotchy area on her right trunk. This occured a few days after the vaccine. It became drier and then flared up again.  Came to see Dr. on 6/23/2020. Dr. recommended report adverse reaction. Started patient on an anti viral med valtrex.
Age: 10.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Feeling abnormal, Muscle rigidity, Presyncope
Clinical narrative: Within 30 seconds of receiving vaccines, patient was walking towards mom and stated "she felt funny." She then appeared as though she was going to faint but Medical assistant caught her from behind before she fell. Patient went rigid for a few seconds in Medical assistant's arms but then within 15 seconds had improved and returned to baseline. When she went rigid, her face and front side was not visualized. She was briefly examined by another provider who asked her a few follow-up questions and everything was normal.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: While in clinic employee noted with localized swelling  after injection. Site massaged with guaze and cool compress applied for approximately 10 minutes. Site secured with Medi Rip bandage and cool compress. Employee was advised to remove compress once she got into her car directly after leaving clinic.  Employee spoke with NP at approximately 9:27am and reported  arm being swollen, painful with mild numbness and tingling in her fingers after Hep B vaccine was administered. NP advised "to take Ibuprofen and keep cool compress over arm and to give us an update in 2-3 hrs. If worsen, will modify recommendation. Also advised her to call at 3-4pm prior to her shift for additional precaution".
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Malaise, Pain, Pyrexia
Clinical narrative: Patient called the next morning (6/24/2020) and stated she has a lump where the injection occurred. Also experiencing fever, malaise, and severe pain. Instructed her to ice the area and take acetaminophen. Call MD if fever does not subside in 24 hours.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site plaque, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccine was administered in the morning and by afternoon patient had developed a red pruritic non-scaly, warm flat plaque in area of vaccination. The following morning the site doubled in size to approx. 5cmx5cm and became pruritic/slightly painful. No other symptoms or concerns. This is not her first flu vaccine, has never had a reaction before. Plan to treat with Zyrtec and ibuprofen for symptoms with return precautions.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site warmth
Clinical narrative: Vaccine was administered in the morning and by afternoon patient had developed a red pruritic non-scaly, warm flat plaque in area of vaccination. The following morning the site doubled in size to approx. 5cmx5cm and became pruritic/slightly painful. No other symptoms or concerns. This is not her first flu vaccine, has never had a reaction before. Plan to treat with Zyrtec and ibuprofen for symptoms with return precautions.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Injection site movement impairment, Rash erythematous, Rash macular
Clinical narrative: patient had red blotchy rash. patient had trouble walking on that leg.
Age: 1.75
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Febrile convulsion, Urine analysis normal
Clinical narrative: Simple febrile seizure - temp up to 103, 13 days after vaccines. Other vaccines were given with this dose of MMRV: DTaP #4, PCV13#4, Hib #4, and Hep A #1 - as the child was behind on vaccines.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported; 17-year-old patient is in office 6/16/2020 for GARDASIL 9 after was administered first dose of GARDASIL 9 when 14 years old; This spontaneous report as received from a registered nurse concerning a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  In approximately 2017 (reported as "when 14 years old"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis. On 16-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, lot# and expiration date were unknown), intramuscularly for prophylaxis (inappropriate schedule of vaccine administered). No additional adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 04-MAY-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider at a physician's medical office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at a walk-in-clinic for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information was provided regarding the pt's past medical history, concurrent conditions and concomitant medications. On an unknown day in 2016, the pt was vaccinated at the medical office with the dose of zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at the medical office for shingles. On an unknown day, the pt was hospitalized due to shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the pt suffered and would 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 shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of PROQUAD on 6/16/2020, that had been improperly stored.; This spontaneous report was received from a licensed practical nurse referring to a 13 years old male patient. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.  On 16-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant Human albumin)) (lot # S030215, expiration date 25-MAR-2021; vaccine dosage detail and route of administration not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (STERILE DILUENT) (product storage error). The storage temperature was 7.2 Fahrenheit degrees for 30 minutes. Previous temperature excursion included:  On 05-JUN-2020, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 1 hour and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 4 hours; On 08-JUN-2020, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 1 hour 50 minutes; On 15-JUN-2020, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 20 minutes. No additional adverse event. Data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unspecified age and unknown gender. Information about concurrent condition, concomitant medication or medical history was not provided. On or about 23-JUN-2014 the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a pharmacist for the long term prevention of shingles and/or zoster-related conditions. At the time of pt's vaccination, pt relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the pt to be vaccinated.  On an unspecified date (reported as subsequent to inoculation), the pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live(ZOSTAVAX) vaccine, pt 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 shingles was considered as not recovered. The causality was assessed as related by the lawyer and the patient.
Sex: F
Vaccine: HPV4, HPV9, UNK
Symptoms: Inappropriate schedule of product administration, Injection site pain, Interchange of vaccine products
Clinical narrative: patient is experiencing soreness at the injection site; his daughter completed a three dose GARD A SIL vaccination series, two to three years ago. patient received a dose of GARDASIL 9, on 6/18/2020,; his daughter completed a three dose GARD A SIL vaccination series, two to three years ago. patient received a dose of GARDASIL 9, on 6/18/2020,; This spontaneous report was received from a pharmacist referring to his daughter, a 15-year-old female patient with coeliac disease and raynaud's phenomenon. The patient was not pregnant. The patient had no concomitant medication or drug reactions/ allergies.        In approximately 2017 (reported as two to three years ago), the patient completed a three dose quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) vaccination series (dose detail, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 18-JUN-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 mL, once, lot# 1637642 with expiration date unknown but upon internal validation established as 28-MAY-2022) intramuscularly for prophylaxis when it was believed that she had not completed the initial series with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (inappropriate schedule of product administration and interchange of vaccine products). On the same day, the patient experienced soreness at the injection site.   The patient did not seek medical attention. No treatment was given for the event. The outcome of the event was not recovered. The causality assessment between two suspect vaccines and the event was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 2.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; inadvertently adrninistered a dose of PNEUMOVAX 23, that was expired; This spontaneous report as received from a physician refers to a 2-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-JUN-2020, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R031961, expiration date 09-JUN-2020 (dose and route of administration) for prophylaxis. There was no adverse event reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R031961; expirationdate: 09-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability