chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Within 48-72 hours following vaccine receipt, patient noted swelling, redness, itching, warmth, and tenderness surrounding anthrax vaccination site.  She tried applying ice to the area to reduce pain and swelling, but felt it was not effective. The area affected went from her vaccination site to her elbow and was almost encircling her whole upper arm.  By 3 Sep, there was no significant improvement at her vaccination site, so she sought evaluation. Patient denied hives, fever, sore throat, cough, difficulty breathing, hoarseness, lump in throat, enlarged lymph nodes, headache, chest pain, abdominal pain, nausea, vomiting, diarrhea, difficulty with urination, and joint pain. On exam, the skin was described as: Warm and dry. Normal color. No rash. Normal turgor, small area of erythema with tenderness and warmth to right arm. No swelling or lymphangitis.  She was diagnosed with normal reaction to anthrax vaccine.  Acetaminophen or Motrin were recommended. On 5 Sep 2019, patient returned for medical evaluation after there was no significant improvement of her RUE. She reported redness, warmth, itching and tenderness affecting vaccination site on RUE. She denied fever, chills, headache, sore throat, skin rash, enlarged lymph nodes, abdominal pain, nausea, vomiting, and diarrhea. On exam, description of extremities noted:  Upper extremity signs of infection present (Right deltoid (faint erythema), No purulent drainage, serous drainage, lymphangitis, or fluctuance. No axillary adenopathy. Upper extremity capillary refill no prolonged.  She was diagnosed with right deltoid/bicep cellulitis, and was prescribed Keflex, Motrin and Benadryl.  Patient does not recall when RUE returned to normal, but it was by the end of the second week in Sep 2019. Patient denies significant restriction or limitations of ADLs and work-related duties due to vaccine reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Constipation, Depression, Fatigue, Feeling abnormal
Clinical narrative: Fever and aches for next day, feeling so awful had to stay in bed the next day, tiredness lasting a week, pain in arm where shot administered, rash at site of shot (might have had to do with the antiseptic bandaid), pain in lymph node in armpit lasting a couple days, canker sore 2 days after, constipation on the day after, depression lasting at least a week after.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Lymph node pain, Pain, Pyrexia
Clinical narrative: Fever and aches for next day, feeling so awful had to stay in bed the next day, tiredness lasting a week, pain in arm where shot administered, rash at site of shot (might have had to do with the antiseptic bandaid), pain in lymph node in armpit lasting a couple days, canker sore 2 days after, constipation on the day after, depression lasting at least a week after.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Nearly fainted morning after vaccine after rising. Dizziness and lightheadedness. Nausea and sweating. Tingling in fingers. Episode lasted about 10-15 mins followed by chills and fatigue.  Slept for about two hours. Less severe episode upon rising again. Felt headachey, tired, and feverish throughout day and day after.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Presyncope, Pyrexia
Clinical narrative: Nearly fainted morning after vaccine after rising. Dizziness and lightheadedness. Nausea and sweating. Tingling in fingers. Episode lasted about 10-15 mins followed by chills and fatigue.  Slept for about two hours. Less severe episode upon rising again. Felt headachey, tired, and feverish throughout day and day after.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Patient reports having a severe headache and dizziness.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event.; The patient inadvertently received an expired dose of MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 21-JAN-2020, the patient inadvertently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) (strength, route, dose, frequency, and anatomical location were unknown) with lot # R001659 and expiration date on 17-JAN-2020, reconstituted with sterile diluent(MERCK STERILE DILUENT) for prophylaxis. No additional adverse event were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patinet was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 09-DEC-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) (albumin status: recombinant Human albumin (rHA)) lot # R026722, expiration date 17-MAR-2020 for prophylaxis (exact dose, dose number and route of administration were not provided). Sterile diluent used to reconstitute vaccine was properly stored.  The temperature excursion was from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.6 F) for 8 hours 14 minutes. There were no previous excursions reported. The digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiomyopathy, Cerebrovascular disorder, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: chest pains/discomfort, shortness of breath / diagnosed with cardiomyopathy and acute cerebrovascular disease; chest pains/discomfort, shortness of breath / diagnosed with cardiomyopathy and acute cerebrovascular disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for and for its intended purpose: the prevention of shingles (dose, route of administration, and lot # not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered chest pains/discomfort, shortness of breath, and was diagnosed with cardiomyopathy and acute cerebrovascular disease. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms resulted in physical limitations not present prior to use of the suspect vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. As a further tragic consequence of Company's wrongful conduct, 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, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The events were considered to be related to the suspect vaccine.   Cardiomyopathy and acute cerebrovascular disease were considered to be disabling events. Upon internal review cardiomyopathy was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: herpes zoster; Information has been received from an attorney regarding a case in litigation. This case refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In or around 20-OCT-2017, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX), (dosage, route, anatomical location, lot number and expiration date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered a severe rash on her lateral chest wall and extended around the vertebrae of the back. The patient was diagnosed with herpes zoster. As a direct and proximate result of patient's vaccination, the symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, and physical impairment and injury. At the time of the report, the patient's outcome was unknown. The reporter considered the event to be related to suspect therapy.  The reporter considered the event of herpes zoster as disabling since resulted on severe and permanent personal injuries.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The patient experienced headache after receiving Shingrix. The patient wanted to know whether is it advisable to take advil for headache.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm where the injection took place is still painful; Keeps me awake at night; It throbs and keeps me awake at night; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a month after receiving Shingrix, the patient experienced pain in arm, sleep disturbance and throbbing pain. On an unknown date, the outcome of the pain in arm, sleep disturbance and throbbing pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, sleep disturbance and throbbing pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine and experienced pain in arm where the injection took place. It throbs and kept patient awake at night. The patient wanted to know when will pain stop. The patient was not sure about receiving 2nd dose.
Age: 82.0
Sex: U
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Lethargy, Myalgia
Clinical narrative: Lethargy; My reaction fits the symptons you describe abovee; My reaction fits the symptons you describe abovee/ chills; My reaction fits the symptons you describe abovee; My reaction fits the symptons you describe abovee; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 82-year-old patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   Concomitant products included pyridostigmine bromide (Mestinon).   In January 2020, the patient received the 1st dose of Zoster vaccine. In January 2020, less than a week after receiving Zoster vaccine, the patient experienced lethargy, headache, shivering, myalgia and fatigue. On an unknown date, the outcome of the lethargy, headache, shivering, myalgia and fatigue were unknown.   It was unknown if the reporter considered the lethargy, headache, shivering, myalgia and fatigue to be related to Zoster vaccine.  Additional details were reported as follows: The patient received vaccine and experienced lethargy, headache, shivering, myalgia and fatigue. The patient would check with primary care physician. The reporter wanted to know what would be the recommendation to get 2nd zoster shot
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: painful; Shingles/an outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 29th January 2020, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient received Shingrix at least a year and couple of months ago in an unknown arm, but the reporter assumed left arm. The reporter could not remember vaccination facility information during call. Consumer intends to receive 2nd dose after forgetting about it. During call, consumer mentioned 2 days ago she started having an outbreak of shingles and mentioned she may not be able to receive 2nd dose at this time. Caller described shingles course as becoming worse and being in a little bit of arc. After probing, caller defines that as the feeling when shingles is about to start and then shingles becoming painful. No further description of outbreak provided. The reporter consented to follow up. Consumer consented to HCP follow-up but mentioned her physician at her clinic recently retired and she does not know who new provider was yet. Agreed to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced Shingles after receiving the first of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AS54, expiry date 15th May 2022) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than 2 weeks 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 provided as follows: The patient received Shingrix and experienced Shingles. The followup consent was granted.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: It hurt; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and lymph node excision (lymph nodes removed due to breast cancer).   On 21st October 2019, the patient received the 1st dose of Shingrix. On 21st October 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and stated it hurt. The patient was due for the 2nd dose which she did not wanted in her left arm and was unable to receive in her right arm due to history of lymph nodes removed due to breast cancer. The patient would like to receive the 2nd dose at an alternative site. The reporter consented to follow up.
Age: 9.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: injection site pain; chills; fever; didn't use their arm for 3 days; bexsero at an age younger than recommended; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 9-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than a year after receiving Bexsero, the patient experienced injection site pain, chills, fever, injected limb mobility decreased and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site pain, chills, fever, injected limb mobility decreased and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered a dose of Bexsero at an age younger than recommended which led to inappropriate age at vaccine administration. The patient was recommended to receive Bexsero due to them having no spleen. The patient experienced injection site pain, chills, and fever and didn't use the arm for 3 days. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. No further details were available. The follow up consent was not granted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: bruising at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3EE55, expiry date 31st December 2020) for prophylaxis.   On 23rd January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was recovering/resolving.   It was unknown if the reporter considered the injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and on the day of reporting the patient came back to the pharmacy complaining about bruising all around the site of injection.  The pharmacist said that it looks like someone punched her all around the site of injection.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: redness; soreness; This case was reported by a consumer via call center representative and described the occurrence of erythema 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 erythema and pain. On an unknown date, the outcome of the erythema and pain were recovered/resolved.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced redness and soreness that resolved quickly. Reporter did not consent to follow-up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pain, Swelling
Clinical narrative: pain; swelling; lump on collar bone; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. On 22nd October 2019, less than a day after receiving Shingrix, the patient experienced pain, swelling and mass. On 26th October 2019, the outcome of the pain, swelling and mass were recovered/resolved.   It was unknown if the reporter considered the pain, swelling and mass to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain, swelling and lump on collar bone. The reporter was left a sticky note from another pharmacist. The pharmacist stated that, she did not normally work at that particular store The reporter consented to follow up
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: She states that she received Shingrix "about two years ago." She states that she now has an out break of shing; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included VARICELLA ZOSTER VIRUS VACCINE, LIVE, OKA STRAIN (ZOSTAVAX) for prophylaxis.   The patient's past medical history included shingles (had history since 8 years).   On an unknown date, the patient received Shingrix and ZOSTAVAX at an unknown dose. On an unknown date, 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with "both shingles vaccines as soon as they were available" and that it was both vaccines that were on the market. The reporter stated that she received Shingrix "about two years ago and she now had an outbreak of shingles at the time of reporting. It was unknown if the reporter considered the vaccination failure and shingles to be related to Zostavax. The reporter did not consent to followup.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Influenza like illness, Ocular discomfort, Ophthalmological examination normal, Photopsia
Clinical narrative: In addition to the normal flu like symptoms that are typically reported, I had a reaction in my Right Eye.   I saw Flashes of light and it felt like I was punched in the eye.  After about a week of discomfort, the eye started to feel better, but I now have a floating "floater" in my eye when look up and down.  It is particularly noticeable when driving during bright light.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: In addition to the normal flu like symptoms that are typically reported, I had a reaction in my Right Eye.   I saw Flashes of light and it felt like I was punched in the eye.  After about a week of discomfort, the eye started to feel better, but I now have a floating "floater" in my eye when look up and down.  It is particularly noticeable when driving during bright light.
Age: 64.0
Sex: F
Vaccine: HEPA, TYP, VARZOS
Symptoms: Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Per the patient "36 hours after the shot, I woke up itching at my ankles/lower legs (I had assumed at the time it was just dry skin) but also in the waist area on both sides which seemed very peculiar.   I have a pinkish rash at my waist that looks like the area indicated on the shingles CDC statement for where  shingles appears on a body.   Also the itching on my legs has a bumpy rash, but it is not red.  None of it looks dramatic like I would think "hives" would be and I am not experiencing any of the serious symptoms of an allergic reaction.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Balance disorder
Clinical narrative: Child had significant balance issues starting the day after the vaccine was administered. He will walk a few steps and then loses his balance out, which was not happening prior to vaccine. Pt. continues to have these symptoms as of today.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle pain, slight fever, joint pain very week or tired. Kept me in bed for 24 hours. This did not happen with the first dose.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthritis, Injection site discomfort, Insomnia, Joint range of motion decreased, Limb discomfort
Clinical narrative: Severe pain in upper arm, limitation to movement of left arm.  Still feel spot where injection was administered,  Range of motion limited at times.  Unable to sleep on left side, painful to move in bed,  sitting in chair uncomfortable as to where to put my arm to prevent pain. Brought up to my Doctor Feb. 21, 2019 (at regular visit).
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain, Pain in extremity, X-ray limb abnormal
Clinical narrative: Severe pain in upper arm, limitation to movement of left arm.  Still feel spot where injection was administered,  Range of motion limited at times.  Unable to sleep on left side, painful to move in bed,  sitting in chair uncomfortable as to where to put my arm to prevent pain. Brought up to my Doctor Feb. 21, 2019 (at regular visit).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On morning of 6 Feb 2020, Mother of patient noted increased redness, swelling, and warmth at vaccination sites. Reported area felt "firm" . Patient had no fever, chills,  headaches, body aches, and N/V/D. Seen in Medical Home Clinic on afternoon of 6 Feb:  Redness and swelling of right upper arm 2 days following vaccine receipt. Area warm to touch. Patient denies pain at site. Normal ROM and no numbness. On Exam: 12.5 x 8 cm on upper right arm.  Temp 97.6 Treated with antihistamines and NSAID Follow up on 8 Feb - symptoms at vaccination site almost completely resolved
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Pt was given the wrong vaccine and the vaccine was also expired. Pt was to be given the shringrix vaccine, but was given zostavax vaccine instead. The zostavax expired on 1-18-2018. Pt has been notified on this mistake, and hasnt exhibited any reaction to the vaccine. Pt was instructed to call the clinic if she has any unusual symptoms. Pt was also instructed to come back to the clinic in two months to receive the first shringrix vaccine, and then come back when the time is due for the second shringrix vaccine. Pt verbalized understanding when this information was given to her by the doctor.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Blister rupture, Injection site erythema, Injection site vesicles, Pain in extremity, Peripheral swelling
Clinical narrative: Patient returned to clinic for PPD reading on 1-10-2020. Patient C/O (L) arm pain & swelling and took off bandaid it was a 5mm blister that had been broken. Mom concerned about Blister & upper arm redness. Physician looked at arm & blister under bandaid approx. 4mm from inj site. Patient did not return Monday to re-evaluate. Given ABX ointment & wrap.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Malaise, Middle insomnia, Mobility decreased
Clinical narrative: FelT like I was dying! AT 12MN awakened from sleep on (L) side unable To move, felt paralyzed could not turn To (R) side To reach for phone or waste basket due To severe nausea, severe shivering, felt like I was on fire buT could noT move To Take my Temp. Lasted from MN until 4am Than sTopped as fast as It sTarTed. STill have off & on Low grade Temp Told by pharmacist ThaT I should geT The second shoT. (aT $163.09) Told by my Dr. absolutely noT geT iT. I have never had a reaction To any vaccine in my life and I have everyone ThaT comes ouT. (Except for Travel shoTs) Thank you for interest in This matter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: FelT like I was dying! AT 12MN awakened from sleep on (L) side unable To move, felt paralyzed could not turn To (R) side To reach for phone or waste basket due To severe nausea, severe shivering, felt like I was on fire buT could noT move To Take my Temp. Lasted from MN until 4am Than sTopped as fast as It sTarTed. STill have off & on Low grade Temp Told by pharmacist ThaT I should geT The second shoT. (aT $163.09) Told by my Dr. absolutely noT geT iT. I have never had a reaction To any vaccine in my life and I have everyone ThaT comes ouT. (Except for Travel shoTs) Thank you for interest in This matter.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Vaccination site pain
Clinical narrative: On Friday, around 6:00 pm, February 7, 2020, the patient presented burning, itching and pain in both arms where she was vaccinated. The area was red and swollen.
Age: 28.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Eyelid function disorder, Facial asymmetry, Facial paresis, Sensory loss
Clinical narrative: Patient reported to ER 05 February 2020 with left-sided facial weakness, difficulty closing his eye, asymmetric smile and decreased sensation to the left side of his face.  Patient received vaccines on 05 February 2020
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: On 02/07/2020 generalized red itchy rash started on forearms, by 02/08/2020 patient woke to hives all over body except face, by 02/09/2020 hive came and went despite over the counter Benadryl use.  02/10/2020 all rash is resolved.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Myalgia, Nausea, Vertigo
Clinical narrative: Severe vertigo, weakness, loss of appetite, muscle ache, nausea
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cardiac arrest, Death, Hypoxia, Influenza, Respiratory failure
Clinical narrative: Client passed away on 2/4/2020 at 0832 AM. Cause of death states hypoxia, respiratory failure, cardiac arrest and influenza. Unknown if the vaccines were linked to death in anyway. Reported due to close timing the vaccines were administered  to death.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, frequency and route of administration) lot # R026722 and expiration date: 17-MAR-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No additional adverse event information was provided.  The vaccine was stored in between 6 Fahrenheit degrees (F) to 14 F for 8 hours and 14 minutes. There was no previous temperature excursion. The storage was recorded by digital data logger.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Quadracel instead of Pediarix, no AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 months old male patient who received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5635AA and expiry date: 18-Jun-2021) via an intramuscular route in right lateral thigh on 27-Jan-2020 for prophylactic vaccination, instead of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), as the office did not have PEDIARIX.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B) for Immunisation.  It was actual medication error due to wrong vaccine administered.   It was reported that 10 month old male patient had a medication error by receiving Quadracel and not the Pediarix. The nurse reported that the vaccine was given due to the office did not have the Pediarix; that the administrator of the vaccine was a medical asssitant who decided to administer the Quadracel and a sperate dose of ENGERIX-B (Hepatitis B).  At the time of reporting, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.58
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Adacel was given to a 19 month old male patient instead of Daptacel / no AE; Adacel was given to a 19 month old male patient instead of Daptacel / no AE; Initial information was received on 03-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 19 months old male patient who received a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, past medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of concomitant HEPATITIS A VACCINE (HEPATITIS A) and INFLUENZA VACCINE (FLUZONE) (lot number and expiry date not reported) via unknown route and administration site.  On 31-Jan-2020, the patient received a 0.5 mL dose (forth dose of DTP) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6307AA, expiry date: 31-May-2021), via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and inappropriate age at vaccine administration.  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: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave expired Daptacel to a child, no ae; Initial information was received on 03-Feb-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 16 month old female patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 03-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE once (lot C5367AA, Expiry date 30-Jan-2020) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  The staff member just gave an expired Daptacel to the patient. The medication expired on 30-Jan-2020.  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: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Daptacel was given to a patient/no AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 year 7 month old male patient who was vaccinated with an 0.5 mL expired dose (fourth dose) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5367AA and expiry date: 30-Jan-2020, frequency once) via an intramuscular route in the left vastus lateralis on 03-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used. It was reported that patient was given the DAPTACEL vaccine, which was expired on 30-Jan-2020.  At the time of reporting, 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 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: 43.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received exspired dose of Tenivac, No AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 43 years old female patient who was vaccinated with expired 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: UF854AA and expiry date: 25-Jan-2020) via intramuscular on 31-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patint was given a expired dose of Tenivac/no AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from the other health professional.  This case involves a 25 year old female patient who was vaccinated with an 0.5 mL expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number U5854AB and expiry date: 25-Jan-2020, frequency once) via an intramuscular route in the left deltoid on 29-Jan-2020.  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  It was a case of actual medication error due to expired vaccine used. It was reported that patient was given an expired dose of TENIVAC vaccine for prophylactic vaccination.  At the time of reporting, 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 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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion due to human error to Ipol, and Tenivac maximum 37.6F due to the refrigerator went out of range for about 30 minutes, no AE; Temperature excursion with stability data not reported. Hence considered as non case.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel was given 4 days after the Expiry date/no ae; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 month old female patient who received 0.5 mL expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA, of Expiration date: 30-Jan-2020) via intramuscular route in the right thigh for prophylactic vaccination on 04-Feb-2020 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient recieved HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired Daptacel/no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient ( unknown demographics) who received expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]/no AE(expired product administered) for prophylactic vaccination [batch number, dosing details, route and site of administration not reported].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was of actual medication error case due to expired vaccine used.  At the time of reporting, adverse event was not 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 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.  Information on the batch number was requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: a patient received a dose of Acthib that had been resconstituted with normal saline 0.9 percent (rather than the 0.4 percent saline diluent supplied with the vials)/No AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographics patient who received HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) that had been reconstituted with normal saline 0.9 percent (rather than the 0.4 percent saline diluent supplied with the vials) (lot number and expiration date reported) via an unknown route in an unknown administration site for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.   It was an actual medication error due to wrong solution used in drug reconstitution.  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.  Information on the lot number was requested.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of Daptacel, no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 15 months old female patient who received an 0.5 mL fourth dose expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 03-FEB-2020.  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to expired vaccine used. It was reported that child received expired dose of Daptacel. Medication expired on 30Jan2020.  At the time of reporting, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.