chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant took the wrong vaccine out of the fridge and administered it to the baby.  There have been no reported adverse side effects reported by parent.  Patient should have received a Hib vaccine
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dyskinesia, Feeling abnormal, Loss of consciousness, Muscle rigidity
Clinical narrative: Within 15 minutes of receiving vaccine, pt reported dizziness and stated that he did not feel good. Pt's skin tone turned ashen gray and had syncopal episode with tonic clonic movements. Pt regained consciousness within 10-15 seconds with a few moments of rigidity and repetitive right facing head movement. Vital signs were monitored for 30 minutes and pt was released home once vital signs were stable and pt reported feeling better.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Skin discolouration, Syncope, Tonic clonic movements
Clinical narrative: Within 15 minutes of receiving vaccine, pt reported dizziness and stated that he did not feel good. Pt's skin tone turned ashen gray and had syncopal episode with tonic clonic movements. Pt regained consciousness within 10-15 seconds with a few moments of rigidity and repetitive right facing head movement. Vital signs were monitored for 30 minutes and pt was released home once vital signs were stable and pt reported feeling better.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pt was given pediatric dose
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, UNK, UNK, UNK
Symptoms: Death
Clinical narrative: death
Age: 51.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Bullseye itchy  raised  rash around injection site of the LT arm. (Shingrix Vaccine) The raised rash then exceeded 3cm out  towards the inner part of the arm.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: the adult patient was administered two pediatric doses of VAQTA, instead of one adult dose.; the adult patient was administered two pediatric doses of VAQTA, instead of one adult dose.; No adverse effects occurred.; Information has been received from a nurse referring to an unknown gender adult patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 intramuscular (lot # R024007, expiration date: 12-OCT-2019, frequency were not reported) for prophylaxis instead of one adult dose. (incorrect dose administered, product administered to patient of inappropriate age). No adverse effects occurred.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: temperature of 99.6; severe shivering; Muscle ache; Back ache; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix, the patient experienced fever, shivering, muscle pain, back pain and headache. On an unknown date, the outcome of the fever, shivering, muscle pain, back pain and headache were recovered/resolved.   It was unknown if the reporter considered the fever, shivering, muscle pain, back pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 69 years or 70 years. About 10 hours after vaccination, the patient experienced a temperature of 99.6 degree F and severe shivering, muscle and back aches, and headache which were lasting for about 6 to 8 hours. The patient wanted to know, how common was this reaction? The patient was wondering if 2nd dose would be the same. If so, she need to time the second dose for a time when she had nothing to attend to.      Lab Comments: On an unknown date, the patient's body temperature was recorded as 99.6 degree F.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: soreness in right shoulder; This case was reported by a pharmacist via sales rep and described the occurrence of shoulder pain in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2017-2018 season) for prophylaxis.   In August 2017, the patient received Fluarix Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Fluarix Quadrivalent 2017-2018 season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Fluarix Quadrivalent 2017-2018 season.  Additional details were provided as follows: The age at vaccination was not reported. In this case the reporter is the pharmacist and patient also. The patient received Fluarix Quadrivalent 2017-2018 season and had intermittent soreness in right shoulder after vaccination that lasted up to 30 days. Maybe 3 other colleagues who got shot at same time reported similar. The reporter would like to request, if possible, the health care professional address for the case attached. The reporter has agreed to follow up. This case linked with US2019GSK104482, reported by same reporter.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Inadvertently administered Proquad instead of MMR II. Therefore pt mistakenly received 2 doses of Varicella Antigen on same day. Notified mother. Advised to look for signs such as fever, rash, appetite loss, mental status changes
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site erythema, Injection site pain
Clinical narrative: Arm red, sore, pulsating around injection site, and Elbow pain about 24 hours after injection.  Took ibuprofen and was not better by Monday so went to urgent care for evaluation
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Muscle twitching
Clinical narrative: Syncopal event. Patient was laughing with her sister, and felt fine about 1-2 minutes after the shot. Stood up and continued to joke with her sister. Suddenly felt faint, and collapsed to the floor, hitting the side of her head on the sink. Had brief twitching of upper extremities, and then regained consciousness after <1 minute. Immediately endorsed feeling fine, and no longer light-headed with no headache or nausea. No neurological findings and normal neuro exam. BP immediately after event 80s/50s. Patient was moved to a chair and observed for 15 minutes. Continued to deny any confusion, light-headedness, headache, nausea. Repeat BP 110/67. Patient was given strict return precautions.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Neurological examination normal, Syncope
Clinical narrative: Syncopal event. Patient was laughing with her sister, and felt fine about 1-2 minutes after the shot. Stood up and continued to joke with her sister. Suddenly felt faint, and collapsed to the floor, hitting the side of her head on the sink. Had brief twitching of upper extremities, and then regained consciousness after <1 minute. Immediately endorsed feeling fine, and no longer light-headed with no headache or nausea. No neurological findings and normal neuro exam. BP immediately after event 80s/50s. Patient was moved to a chair and observed for 15 minutes. Continued to deny any confusion, light-headedness, headache, nausea. Repeat BP 110/67. Patient was given strict return precautions.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The day after the injection the site of the injection was sore, swollen and red.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Full Body Hives-Responded well to oral BENADRYL
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Influenza like illness, Pain in extremity
Clinical narrative: Both my wife and I received the first dose of the Shringix vaccine and were adversely affected much more than we expected or heard about from other people who got the same vaccine. Our arms were sore on the day of the vaccine. On the second day we both felt like we had the flu and laid around all day on the couches/rockers sleeping and watch TV. On the third day we still felt weak, but returned to normal activities on the light side. From all indications, we expected soreness at the sight of the vaccine, but didn't expect to feel like we caught the flu.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain lower, Arthralgia, Chills, Diarrhoea, Disturbance in attention
Clinical narrative: injection site erythema, injection site induration and heat, injection site swelling, tenderness around injection site, chills causing sleeplessness, pyrexia, fatigue, arthralgia in both knees, mild lower abdominal pain, difficulty with mental focus, erythema spreading around and over most of upper arm - some areas bright red irritability, diarrhea, ear pain  These are listed in order of onset, with the first four that evening, continuing through the next day and night, the chills and pyrexia occuring Monday night, fatigue, arthralgia, abdominal pain, focus difficulty, and spreading erythema  beginning Tuesday,  diarrhea beginning and ending Wednesday (the rest gradually faded as the week progressed), and ear pain beginning over the weekend and increasing through 6/10/19 (took an antihistamine to clear up any fluid) - not yet totally gone.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: injection site erythema, injection site induration and heat, injection site swelling, tenderness around injection site, chills causing sleeplessness, pyrexia, fatigue, arthralgia in both knees, mild lower abdominal pain, difficulty with mental focus, erythema spreading around and over most of upper arm - some areas bright red irritability, diarrhea, ear pain  These are listed in order of onset, with the first four that evening, continuing through the next day and night, the chills and pyrexia occuring Monday night, fatigue, arthralgia, abdominal pain, focus difficulty, and spreading erythema  beginning Tuesday,  diarrhea beginning and ending Wednesday (the rest gradually faded as the week progressed), and ear pain beginning over the weekend and increasing through 6/10/19 (took an antihistamine to clear up any fluid) - not yet totally gone.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Irritability, Pyrexia
Clinical narrative: injection site erythema, injection site induration and heat, injection site swelling, tenderness around injection site, chills causing sleeplessness, pyrexia, fatigue, arthralgia in both knees, mild lower abdominal pain, difficulty with mental focus, erythema spreading around and over most of upper arm - some areas bright red irritability, diarrhea, ear pain  These are listed in order of onset, with the first four that evening, continuing through the next day and night, the chills and pyrexia occuring Monday night, fatigue, arthralgia, abdominal pain, focus difficulty, and spreading erythema  beginning Tuesday,  diarrhea beginning and ending Wednesday (the rest gradually faded as the week progressed), and ear pain beginning over the weekend and increasing through 6/10/19 (took an antihistamine to clear up any fluid) - not yet totally gone.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Speech disorder
Clinical narrative: The patient and family members who received this vaccine report speech impediment, possible seizure events
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever on 5/31/19 On 6/6/19 started with hives.  Seen in our office on 6/6/19, in the ER on 6/7/19 and again in our office on 6/8/19
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aphasia, Autism spectrum disorder, Blood test, Brain injury, Cognitive disorder
Clinical narrative: At first high fever an inconsolable crying. Then his left thigh swelled up so large I thought I'd have to go to the emergency room. In the following weeks he lost his ability to speak, started drooling nonstop, only screamed and lost his ability to make eye contact. He then stopped playing with toys or acknowledging his sister, he stopped mimicking sounds and facial movements for play. Shortly after this he stopped waving,  clapping or acknowledging any sounds. He began walking around the house in his own world unaware of anyone. Simply licking the walls and screaming with nothing to help. Within weeks our nuero typical son had become cognitively impaired and
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Cytogenetic abnormality, Decreased eye contact, Drooling, Ear tube insertion
Clinical narrative: At first high fever an inconsolable crying. Then his left thigh swelled up so large I thought I'd have to go to the emergency room. In the following weeks he lost his ability to speak, started drooling nonstop, only screamed and lost his ability to make eye contact. He then stopped playing with toys or acknowledging his sister, he stopped mimicking sounds and facial movements for play. Shortly after this he stopped waving,  clapping or acknowledging any sounds. He began walking around the house in his own world unaware of anyone. Simply licking the walls and screaming with nothing to help. Within weeks our nuero typical son had become cognitively impaired and
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site swelling, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Screaming
Clinical narrative: At first high fever an inconsolable crying. Then his left thigh swelled up so large I thought I'd have to go to the emergency room. In the following weeks he lost his ability to speak, started drooling nonstop, only screamed and lost his ability to make eye contact. He then stopped playing with toys or acknowledging his sister, he stopped mimicking sounds and facial movements for play. Shortly after this he stopped waving,  clapping or acknowledging any sounds. He began walking around the house in his own world unaware of anyone. Simply licking the walls and screaming with nothing to help. Within weeks our nuero typical son had become cognitively impaired and
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Cyanosis, Dyspnoea, Eye movement disorder, Hypotonia, Injection site haemorrhage
Clinical narrative: The nurse was putting a bandage on her arm which was bleeding.  My daughter fainted, her head went back, her eyes rolled into her head and her whole body went stiff.  After this, she went limp and her face turned a very dark blue then went pale.  Her lips were so blue, they almost looked black. When she came to, she said she remembered having a hard time taking a breath.  She also couldn't focus and didn't even know I was in the room holding her hand.  She has never had any other type of reaction to an injection.  She gets a yearly flu shot.  She is also current with her MCV4, and Tdap.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Pallor, Syncope, Vision blurred
Clinical narrative: The nurse was putting a bandage on her arm which was bleeding.  My daughter fainted, her head went back, her eyes rolled into her head and her whole body went stiff.  After this, she went limp and her face turned a very dark blue then went pale.  Her lips were so blue, they almost looked black. When she came to, she said she remembered having a hard time taking a breath.  She also couldn't focus and didn't even know I was in the room holding her hand.  She has never had any other type of reaction to an injection.  She gets a yearly flu shot.  She is also current with her MCV4, and Tdap.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Patient developed an injection site skin reaction 24 hours after receiving the 2nd dose of Shingrix.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was inadvertently administered PROQUAD instead of VARIVAX; The patient was inadvertently administered PROQUAD instead of VARIVAX; No adverse reaction; This spontaneous report was received from a registered nurse referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated for prophylaxis with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously (dosage regimen, anatomical location, lot number and expiration date were not reported). It was reported that the patient was inadvertently administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) instead of varicella virus vaccine live (Oka/Merck) (VARIVAX) (interchange of vaccine products and wrong drug administered). No adverse reactions reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Shivers; muscular pain; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd April 2019 03:30, the patient received Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced shivering and muscle pain. On an unknown date, the outcome of the shivering and muscle pain were unknown.   It was unknown if the reporter considered the shivering and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine on left arm. Within 12 hours of vaccination the patient awoke to shivering and muscular pain.
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Skin disorder
Clinical narrative: PAPULAR LESION; red lesion; skin disorder; This case was reported by a physician via sales rep and described the occurrence of papular rash in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced papular rash, red rash and skin disorder. On an unknown date, the outcome of the papular rash, red rash and skin disorder were unknown.   It was unknown if the reporter considered the papular rash, red rash and skin disorder to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician stated that the patients experienced lesions that were popular, red, and pulsating with touch 2 weeks after receiving dose of Shingrix.  The physician had referred patient to dermatology.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: side effects hit hard; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 3 years ago).   On 13th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The patient stated that side effects really hit hard. The patient would plan better for 2nd shot of Shingrix. The reporter advised to the patient to refer Healthcare provider as a primary resource for patient care. The reporter asked to the patient with respect to what experienced after receiving the first Shingrix shot.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site redness; injection site swelling; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number T4952, expiry date unknown) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix .5 ml. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The redness and swelling at injection site went from quarter size in diameter to deck of cards size. On 23rd May 2019, redness was improving. Nurse asked if the patient should receive second dose. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: not feeling well; fever; soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd June 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell and fever. In June 2019, the patient experienced pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling unwell, fever and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: In the morning, the patient received Shingrix in the left arm and developed a fever of 101 degree F in the afternoon. The patient also stated that she was not feeling well and that started in afternoon of vaccination day. The patient's fever increased to 102.9 degree F in the morning of reporting day. The patient was taking Tylenol for the fever. The outcome of adverse events were reported as recovering resolving while it was discrepantly captured as not recovered. The reporter gave consent to follow up.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Face oedema, Hypersensitivity, Oral pain
Clinical narrative: allergy; Facial edema; mouth hurt; crying; This case was reported by a other health professional via call center representative and described the occurrence of allergy in a 30-month-old female patient who received DTPa (Infanrix) (batch number 5553K, expiry date 1st February 2021) for prophylaxis.   On 26th December 2018 10:51, the patient received the 4th dose of Infanrix (intramuscular) .5 ml. On 26th December 2018, less than a day after receiving Infanrix, the patient experienced allergy (serious criteria hospitalization), face edema (serious criteria hospitalization), oral pain (serious criteria hospitalization) and crying (serious criteria hospitalization). Infanrix was discontinued. On an unknown date, the outcome of the allergy, face edema, oral pain and crying were unknown.   It was unknown if the reporter considered the allergy, face edema, oral pain and crying to be related to Infanrix.  Additional information was provided as follows: The patient received Infanrix on the left thigh. Same day, the patient started with crying because the mouth hurt and patient had facial edema. The patient was seen at the emergency room on the same day at 11:52 pm and was admitted for 12 hours and then discharged the next day. The emergency room provided a diagnosis of allergy, unspecified. The patient's mother also reported to the physician's office that the patient would not be completing the vaccination series later on (5th dose or 2nd booster dose).
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: they gave daptacel on yesterday and just discovered that the vaccine had expired; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that they gave Daptacel on yesterday and just discovered that the vaccine had expired.  The patient's past vaccination(s) included PEDIARIX. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5206AA and expiry date: 17-May-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Feeling cold, Malaise, Pyrexia
Clinical narrative: I woke up with chills; I could not get warm enough, I started running a high fever; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demography who experienced malaise, pyrexia and chills while he received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Flu shot. Patient never had a reaction ever to a flu shot.  The patient's past medical history, concomitant therapy, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date , the patient woke up with chills (chills) could not get warm enough, started running a high fever, (pyrexia) and was sick all night following the administration of INFLUENZA VACCINE.  The patient mentioned that flu shot was too strong for my body. I need some help with this flu shot since they gave it to me too strong. The pharmacist, he was a partner, he gave me the wrong flu shot or something. I've never had a reaction ever to a flu shot.  No lab test was reported.  Final diagnosis was malaise and pyrexia.   It was not reported if the patient received a corrective treatment.  The patient outcome was Unknown for all events.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: male patient was administered Daptacel on 03-May-2019 that expired 23-Mar-2019/not had any side effects; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old male patient who was administered a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]on 03-may-2019 that expired 23-mar-2019 lot C5171AA via intramuscular route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB).  It was an actual medication error due to expired vaccine used.  The patient did not experience any signs of any side effects.  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.  List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Injection site reaction, Insomnia
Clinical narrative: Employee/patient presented himself at the pharmacy today, 6/11/19, with complaint of left shoulder pain and immobility that appears related to his receiving a Td (tetanus/diphtheria) vaccine from the pharmacy on 5/28/19. The evening of the day that he received the vaccine, he noticed overall muscle soreness including ligament/joint pain in the left shoulder. He took ibuprofen the day after for the pain and a fever that he experienced, and daily thereafter for the pain only, thinking that it was temporary and a normal reaction to the vaccine. For the first few days it was still quite painful, then became bearable but still painful. He tried working it out by lifting weights but found it quite painful in the joint. It has progressed to the point where it limits his motion, not painful to the touch, but keeps him awake and interrupts sleep. He was seen in the employee clinic in building on 6/10/19 and he received a prescription for naproxen 500mg for the pain. No apparent redness or inflammation at the injection site, just overall soreness and joint pain with movement, and aches at rest. He then came to the pharmacy to seek guidance on his next steps as the nurse practitioner has sent in an order to receive an x-ray and to choose an orthopedist for follow up. He will contact Risk Management/Office of Patient Experience as to whether he can seek any help with insurance copayments, etc.
Age: 23.0
Sex: M
Vaccine: TD
Symptoms: Ligament pain, Myalgia, Pain, Pyrexia
Clinical narrative: Employee/patient presented himself at the pharmacy today, 6/11/19, with complaint of left shoulder pain and immobility that appears related to his receiving a Td (tetanus/diphtheria) vaccine from the pharmacy on 5/28/19. The evening of the day that he received the vaccine, he noticed overall muscle soreness including ligament/joint pain in the left shoulder. He took ibuprofen the day after for the pain and a fever that he experienced, and daily thereafter for the pain only, thinking that it was temporary and a normal reaction to the vaccine. For the first few days it was still quite painful, then became bearable but still painful. He tried working it out by lifting weights but found it quite painful in the joint. It has progressed to the point where it limits his motion, not painful to the touch, but keeps him awake and interrupts sleep. He was seen in the employee clinic in building on 6/10/19 and he received a prescription for naproxen 500mg for the pain. No apparent redness or inflammation at the injection site, just overall soreness and joint pain with movement, and aches at rest. He then came to the pharmacy to seek guidance on his next steps as the nurse practitioner has sent in an order to receive an x-ray and to choose an orthopedist for follow up. He will contact Risk Management/Office of Patient Experience as to whether he can seek any help with insurance copayments, etc.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Peripheral swelling
Clinical narrative: SWELLING OF LEFT ARM POST VACCINATION. NO FEVER, SWELLING, PAIN, OR DECREASED USE OF ARM WHEN SEEN IN CLINIC 6/11/19 AT 1345.  OBS FOR NOW.
Age: 18.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Loss of consciousness, Pain, Syncope
Clinical narrative: Patient expressed that this vaccine "hurt more than the first" and stated that she felt she was going to pass out.  Patient experienced syncope and lost consciousness for approximately 10 seconds.  Patient was sitting at the time of the vaccination and was supported by the pharmacist until she regained consciousness.  Patient stated that she would like to lie on the floor.  She felt improvement within 2-3 minutes.  Patient was given a cool drink and felt improvement.  Patient was monitored for approximately 10 minutes and left under her own will under the care of a guardian.  Patient stated that she has passed out when she had bloodwork done in the past.  She stated that she felt ok to leave after observation.  I informed her that she should follow up with her PCP and inform them of the incident.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia
Clinical narrative: Extreme Shivering, Headache,  insominia
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Sore throat, runny nose, head ache, fatigue, coughing, nausea, diarrhea, chills with shaking. Symptoms started 3 days post, improving but still present.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Oropharyngeal pain, Rhinorrhoea, Tremor
Clinical narrative: Sore throat, runny nose, head ache, fatigue, coughing, nausea, diarrhea, chills with shaking. Symptoms started 3 days post, improving but still present.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: weakness, and numbness in arm and hand on right side started few days after injection given
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling on Rt arm redness & itching going below area of vaccine 2 days later swelling down & pt ok.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Mother specifies "pain, redness, warm to touch in the area of the left deltoid. The doctor prescribed cephalexin 500mg every 8 hrs x 7 days.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Oropharyngeal pain, Peripheral swelling, Polyarthritis
Clinical narrative: Approx. 2 days after MMR pt. developed severe polyarthritis of multiple joints. The patient is a 56 year old female who presents with a hip problem. Note for "Hip problem": R hips is swollen. Went to ER after getting MMR a couple of weeks ago with swelling in both hips. Now just both hips/ mostly upper leg area/ elbows and knees. Additional reasons for visit: Sore throat is described as the following: The sore throat has been occurring for 1 week. The course has been worsening. There had been no associated chills or fever. Note for "Sore throat": Patient says it felt like a lymph node on R side of neck.
Sex: U
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Warm and hot injection site area; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced warm and hot injection site area on an unspecified date. Outcome of the event was unknown.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: female patient was given an expired Daptacel injection/ no specific symptoms; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from other a non-health professional (office staff).  This case involves a 4 months 18 days old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that female patient was given an expired Daptacel injection.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 31-May-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA and expiry date: 23-Mar-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to expired product administered.  No specific symptoms were 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.  List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: ActHIB was reconstitued with a sterile water diluent not supplied in ActHIB packaging; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demography who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that ActHib was reconstitued with a sterile water diluent.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of potential medication error due to wrong solution used in drug reconstitution.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose Menactra administered to patient; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Quality manager).  This case involves a 25 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patients past medical history and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) on unknown date.  On 30-May-2019, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5833AA, expiry date 25-Feb-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that expired dose Menactra administered to patient.  It was unknown whether patient experienced any adverse reaction after the injection.   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.  List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: rash around the injection site; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 8 years old male patient who experienced rash around the injection site, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patients past vaccination(s) included Fluzone Quadrivalent year 2015- 2016, 0.5 ml prefilled syringe, Lot number- UI493AB, Expiry date: 30-Jun-2016. Had received Fluzone Quadrivalent with no issues for years.  The patient did not receive any concomitant medication.   On 07-Sep-2017, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI839AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid.  On 07-Sep-2017, the patient developed a non-serious rash around the injection site (vaccination site rash) few hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was rash around the injection site.   No corrective treatment was received.  The patient outcome is reported as Recovered / Resolved on its own, on an unknown date for rash around the injection site.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 25 months old patient was given an expired Daptacel vaccine/No AE; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 25 months old male patient who was given an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL vaccine lot C5202AA,expiry date: 16-May-2019 via right quad route on 31-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error due to expired vaccine used.  No adverse event symptoms mentioned at the time of the call.   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.  List of documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: IPV, UNK
Symptoms: Wrong product administered
Clinical narrative: accidental administration of Ipol intradermally instead of Tubersol; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 26 years old female patient who was vaccinated with a 0.5 ml dose of vaccine IPV (VERO) [IPOL] (lot N1K93 and Exp. Date 18-Nov-2019) instead of TUBERCULIN TEST [TUBERSOL] via intradermal route in unknown administration site on 04-Jun-2019.  The patient did not received any concomitant medications and medical history not reported.  It was an actual medication error case due to wrong vaccine administered.  It was unknown whether the patient experienced any adverse event post vaccination.  No corrective treatment received.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: patients's last 2 Imovax vaccinations were given in the gluteous/ no AE; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 27 years old male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] in gluteous region.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-May-2019 the patient received a first dose of the suspect RABIES (HDC) VACCINE (formulation: unknown) via intramuscular route in unknown administration site. On 24-May-2019 he also received a second dose and on 28-May-2019, the patient received a third dose of the same vaccine (formulation: unknown, lot: N1G4O/M0308) via intramuscular route in Gluteus. On 04-Jun-2019, the patient received a fourth dose of (formulation: unknown) via intramuscular route in the upper arm.  It was an actual medication error due to vaccine administered at inappropriate site (last 2 Imovax vaccinations were given in the gluteous).  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 error.  Information on the batch number was requested for 1st and 4th dose.  List of document held by sender: none.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: received vaccine that was had taken too long in shipping; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 75 years old male patient who was vaccinated with a 0.5 ml dose of vaccine IPV (VERO) IPV (VERO) lot PIA124 (Expiry date 26-Apr-2020) via unknown route in the right thigh.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It is an actual medication error due to incorrect product storage. It was reported that vaccine that was not valid, it had taken too long in shipping.  It was not reported that if any adverse reaction was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  List of documents held by sender: none.