chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Paraesthesia
Clinical narrative: The patient states that about one week following her second shingrix vaccination, she started to have pain on her left side, including left upper arm (underside), left breast and left clavicle. She has been following with her PCP to rule out other causes. She continues to have pain and discomfort in these areas, as well as tingling and burning in her left clavicle area and down into her left upper arm and axilla area.  Has been taking oral anti-inflammatory medication with some relief. Her PCP has discussed with her that this could be due to the shingrix vaccine. The patient has had shingles in the past. Her PCP discussed the option of treatment with Elavil to help with nerve pain. This treatment has not been started yet. The patient has had symptoms now for about one month. The patient suspects that she may be  currently dealing with shingles.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain and tenderness on injection site beginning in the hours following injection that lasted approximately 4 days accompanied by redness swelling and hardness.  The maximal area of swelling was approximately 4 inches surrounding the injection site.  The tenderness and sswelling resolved over approximately 4 days  without treatment or sequelae.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Pt reported redness, swelling and pain in his left arm for approximately 12 hours the vaccination.  His symptoms slowly went away.  He reported his symptoms to his pcp, Dr. on 6/16/20.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Headache, Nasopharyngitis
Clinical narrative: sore arm and redness, swelling  and warmth (expected) not expected - extreme weakness, shivering, very cold, headache, fever 102.4
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Skin warm, Swelling
Clinical narrative: sore arm and redness, swelling  and warmth (expected) not expected - extreme weakness, shivering, very cold, headache, fever 102.4
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, some chills, tired Taking ibuprofen, resting
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Pt describes moderate myalgia 8pm night of vaccination, around 2am pt reports of sever myalgia and present was red/swollen in and around injection site. It has spread to cover the bicep and tricep as of 9am on 6/20/20.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash started on lower arm of vaccine arm on 6/16 (Day after vaccine) and another rash appeared near the vaccine site on 6/20. the rash is not itchy or painful. Patient is going to consult doctor on Monday on whether he should get the 2nd dose
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Eye ulcer, Urticaria
Clinical narrative: Ulcer inside lower right eyelid, hives, and diarrhea that lasted for one day. This all started at once. The hives are resolving. The ulcer is about 1mm in diameter. It does not cause pain. The patient is functional.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Celllulitis
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness, swelling and tenderness at injection site.  Systemic tiredness, chills.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Condition aggravated
Clinical narrative: possible allergic reaction to Pneumovax 23. The patient complained of chest pain. The patient is Asthmatic and used 3 pumps of albuterol HFA. The EMS told me to give 1 tablet of Aspirin 81 mg chewable EMS told me Not to use Epipen
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache
Age: 35.0
Sex: M
Vaccine: HPV9, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Pyrexia
Clinical narrative: Loca site induration (About 8 cm diameter), redness and localized pain associated with low grade fever started about 6 hours post vaccination, continued to worsen (to above size) on Day 2 and started to resolve on D3 post vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever, pain at shot site, headache - on and off for 2-3 days affecting my usual daily activities.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Feeling cold, Headache, Heart rate increased
Clinical narrative: Chills.Fever, headache.nausea, diarrhea, fatigue, rapid heart rate and high blood pressure, sore injection site
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Injection site pain, Nausea, Pyrexia
Clinical narrative: Chills.Fever, headache.nausea, diarrhea, fatigue, rapid heart rate and high blood pressure, sore injection site
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Diet refusal, Food intolerance, Hypophagia, Poor sucking reflex
Clinical narrative: High fever started 6/8/2020, 6 days after shot. Lasted 4 days. During this time, appetite decreased significantly & feeding refusals have continued to present time. Patient is primarily formula fed due to ongoing food intolerance issues (also older care of GI & allergist). Her intake has decreased & it is a huge struggle to get her to consume enough even to stay hydrated. Her suck on the bottle seems to have weakened significantly. She is losing weight at this  point.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Weight decreased
Clinical narrative: High fever started 6/8/2020, 6 days after shot. Lasted 4 days. During this time, appetite decreased significantly & feeding refusals have continued to present time. Patient is primarily formula fed due to ongoing food intolerance issues (also older care of GI & allergist). Her intake has decreased & it is a huge struggle to get her to consume enough even to stay hydrated. Her suck on the bottle seems to have weakened significantly. She is losing weight at this  point.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: After the two vaccinations, patient was crying, fell asleep soon after; but when woken she said her legs were in pain. There were extreme bruising, then the following day her legs were swollen. VERY swollen, the size of a baseball or bigger. This is not normal at all and not okay. The swollen part of her thighs (both of them) did not go down for about a week, and she was always in pain. The bruising was deep and also did not go away for over a week. I do have pictures of her legs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Headache, numbness/tingling in hands and feet, muscle weakness
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Skin warm
Clinical narrative: Cellulitis like crash with demarcated border and warm to the touch. Beginning evening of 6-17-2020 and persistent through 6-21-2020
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Pain in extremity, X-ray abnormal
Clinical narrative: When we called him for his second vaccine in the series, he said his arm was still sore and bothering him. He said that he had an xray done and they said it was arthritis.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Limb mass, Pain
Clinical narrative: huge lump on the arm with pain. with ice and ibuprofen it went down 80% over night and sore for 3 days.
Age: 1.25
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Blood test normal, Laboratory test normal, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Low grade fevers started the day after her vaccines were given. they were both given in her thighs. not sure which shot was put in which leg. first temp taken at around 930 A.M being 101.3.  No tylenol given at that time.  After about half an hour her temp spike to 103.6 Tylenol was given by mouth.  Temp went back down to 100.3 with in about 30 minutes.  Fever Spiked again at around 4:40 PM to 103.8 she was given motrin and a cool bath to try to get her temp down some. She was brought into Urgent care in around 5:30. We were transferred to Hospital where they ran labs and blood work and Covid swab. All test came back negative.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Feeling cold, Oropharyngeal pain, Pain
Clinical narrative: 36 weeks pregnant, estimate due date 07/17/2020. Healthy pregnancy.  Adverse events: extremely  noxious that after 4 days is still Going on, body aches, chills, sore throat.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: Fever, body aches, chills, unable to lift right arm
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: The patient's wife called during the evening on the day he had received the shot to report that he was complaining of a lot of arm pain. She had iced it and given him a dose of IBU. She also said he had some chills/had been shivering. I told her to monitor for fever, continue with the ice and IBU and to report back to me the next day. She called the following morning (6/21/2020) to report that he was still having a lot of muscular soreness/pain in the arm the shot was given but that there was not any redness or swelling at the injection site (she couldn't see where it had been given). She had taken his temperature and he did not have a fever. She was going to continue to monitor him for improvement over the next few days as I told her some patient's had reported similar findings that lasted 3-4 days after the injection.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Product administered at inappropriate site
Clinical narrative: Received the vaccination afternoon of April 2 and began experiencing intense pain in shoulder and hasn't subsided since. I am still experiencing severe pain and limited range of motion. The injection was administered high on the shoulder near the joint instead of the usual place in arm. I was not ever experiencing any shoulder pain before the injection.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Patient called reporting a soreness, fever, muscle and joint pain, nausea, and dry heaving.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: Patient called reporting a soreness, fever, muscle and joint pain, nausea, and dry heaving.
Age: 76.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Patient had extended reaction including chill, fatigue, headache, and injection site pain after vaccination given. Fever, myalgia, headache for 2-3 days. Per PCP, second series not recommended.  Headache & Fever
Age: 76.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient had extended reaction including chill, fatigue, headache, and injection site pain after vaccination given. Fever, myalgia, headache for 2-3 days. Per PCP, second series not recommended.  Headache & Fever
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: & Not documented
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: & Edema of arm
Age: 60.0
Sex: M
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: SkinRash
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Arthralgia
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus
Age: 69.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema multiforme, Swelling
Clinical narrative: ErythemaMultiform & swelling
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: nausea; headache; extreme tiredness; shivering; sore arm; sore arm up to my neck; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles once in May of 2018).   On 11th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced nausea, headache, fatigue, shivering, pain in arm and neck pain. On an unknown date, the outcome of the nausea, headache, fatigue, shivering, pain in arm and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the nausea, headache, fatigue, shivering, pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix vaccine and had awful reaction, nausea, headache, extreme tiredness, shivering, and sore arm up to neck.  The patient still had side effects. The reporter asked did the second dose vaccine cause the same degree of side effects reaction. If the patient did not get the second dose would the first dose give any level of protection from getting shingles in the future.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: nausea; headache; extreme tiredness; shivering; sore arm; sore arm up to my neck; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles once in May of 2018).   On 11th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced nausea, headache, fatigue, shivering, pain in arm and neck pain. On an unknown date, the outcome of the nausea, headache, fatigue, shivering, pain in arm and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the nausea, headache, fatigue, shivering, pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix vaccine and had awful reaction, nausea, headache, extreme tiredness, shivering, and sore arm up to neck.  The patient still had side effects. The reporter asked did the second dose vaccine cause the same degree of side effects reaction. If the patient did not get the second dose would the first dose give any level of protection from getting shingles in the future.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: nausea; headache; extreme tiredness; shivering; sore arm; sore arm up to my neck; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles once in May of 2018).   On 11th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced nausea, headache, fatigue, shivering, pain in arm and neck pain. On an unknown date, the outcome of the nausea, headache, fatigue, shivering, pain in arm and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the nausea, headache, fatigue, shivering, pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix vaccine and had awful reaction, nausea, headache, extreme tiredness, shivering, and sore arm up to neck.  The patient still had side effects. The reporter asked did the second dose vaccine cause the same degree of side effects reaction. If the patient did not get the second dose would the first dose give any level of protection from getting shingles in the future.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: nausea; headache; extreme tiredness; shivering; sore arm; sore arm up to my neck; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles once in May of 2018).   On 11th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced nausea, headache, fatigue, shivering, pain in arm and neck pain. On an unknown date, the outcome of the nausea, headache, fatigue, shivering, pain in arm and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the nausea, headache, fatigue, shivering, pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix vaccine and had awful reaction, nausea, headache, extreme tiredness, shivering, and sore arm up to neck.  The patient still had side effects. The reporter asked did the second dose vaccine cause the same degree of side effects reaction. If the patient did not get the second dose would the first dose give any level of protection from getting shingles in the future.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Woke up with 102.4 fever morning after vaccines. Left arm is very swollen, very red and hot to touch.  Swelling and redness goes from top of shoulder to elbow.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Red, hot, swelling, pains s itching. I gave him Tylenol for the pain. I was advised to give him Benadryl 5ml. So I gave him that. I was told to use a warm compress. But, I choose to use a cold compress. This is now 6/22/2020 and he?s still having the same complaints and issues.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Circumstance or information capable of leading to medication error, Ill-defined disorder, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: She is currentlyapplying for disability due to health conditions that limit her.; she has had a Pneumovax 23 vaccination, but not Prevnar 13.; she is not eligible for the Prevnar 13 at her age with her current diagnoses; she is not eligible for the Prevnar 13 at her age with her current diagnoses; This spontaneous report was received from a physician, via Pfizer, regarding a female patient of unknown age. The patient's concurrent conditions included severe asthma and bronchial hyperreactivity. The patient's medical history included very frequent and prolonged hospitalizations for respiratory issues (respiratory disorder) and respiratory distress. Concomitant medications were not provided.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) (lot # CW5295, expiration date was not provided) for prophylaxis.  On an unspecified date, at a recent office visit, it was found that she had had a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccination, but not pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) (Wrong product administered). Given her health situation with very frequent, prolonged hospitalizations for respiratory issues and distress, she needed both vaccinations to complete her protection. It was reported that she was not eligible for pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) at her age with her current diagnoses, however, knowing the severity of her asthma which had required multiple hospitalizations, the reporter considered she definitely needed it for her maximal protection (Product administered to patient of inappropriate age and Circumstance or information capable of leading to medication error). She was currently applying for disability due to health conditions (Ill-defined disorder) that limited her.  The outcome of Ill-defined disorder was unknown.   The causality assessment between Ill-defined disorder and therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.  The event Ill-defined disorder was considered to be a disabling event.
Sex: M
Vaccine: HPV9
Symptoms: Dysarthria, Electroencephalogram normal, Facial paralysis, Laboratory test normal, Magnetic resonance imaging brain normal
Clinical narrative: transient ischemic attack type events; an acute onset of slurred speech; facial paralysis and droopy face; This spontaneous report as received from a pediatrician via company representative and refers to a 12 year old male patient.    The patient's pertinent medical history and drug reactions or allergies were not reported. There were no concomitant medications.  On 02-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (indication reported as second dose in human papillomavirus (HPV) series).  The physician reported that on 04-JUN-2020, the patient had "transient ischemic attack type events, an acute onset of slurred speech, facial paralysis and droopy face" (transient ischaemic attack, facial paralysis and dysarthria). This lasted a few hours and the patient was airlifted to hospital on the same day. The patient had performed a magnetic resonance imaging (MRI) and a magnetic resonance angiography (MRA) of head, electroencephalogram (EEG), and unspecified labs, which were all negative. Also a COVID-19 testing was negative. On unspecified date in June 2020, the patient was sent home fully recovered. The physician reported that the patient was on an uspecified daily dose of aspirin and would have a neurology consult follow-up on an unspecified date. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was discontinued.    The reporting physician considered the that transient ischaemic attack, facial paralysis and dysarthria to be medically significant events.  The causal assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: SARS-CoV-2 test negative, Transient ischaemic attack
Clinical narrative: transient ischemic attack type events; an acute onset of slurred speech; facial paralysis and droopy face; This spontaneous report as received from a pediatrician via company representative and refers to a 12 year old male patient.    The patient's pertinent medical history and drug reactions or allergies were not reported. There were no concomitant medications.  On 02-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (indication reported as second dose in human papillomavirus (HPV) series).  The physician reported that on 04-JUN-2020, the patient had "transient ischemic attack type events, an acute onset of slurred speech, facial paralysis and droopy face" (transient ischaemic attack, facial paralysis and dysarthria). This lasted a few hours and the patient was airlifted to hospital on the same day. The patient had performed a magnetic resonance imaging (MRI) and a magnetic resonance angiography (MRA) of head, electroencephalogram (EEG), and unspecified labs, which were all negative. Also a COVID-19 testing was negative. On unspecified date in June 2020, the patient was sent home fully recovered. The physician reported that the patient was on an uspecified daily dose of aspirin and would have a neurology consult follow-up on an unspecified date. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was discontinued.    The reporting physician considered the that transient ischaemic attack, facial paralysis and dysarthria to be medically significant events.  The causal assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was vaccinated with only the liquid portion of Pentacel vaccine/No AE; Initial information was received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (office staff).  This case involves a seven months old female patient who received only the liquid (Dtap/IPV) portion 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ196ABA and expiry date 02-Mar-2021) via intramuscular route in the right thigh prophylactic vaccination on 15-Jun-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  Doctor wrote the order for the vaccination and patient was kept for observation afterwards.  It was an actual medication error case due to inappropriate reconstitution technique.  At a 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 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: 1.67
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: An expired Ipol was asministered to the patient, no AE; Initial information received on 16-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 20 months old female patient who was vaccinated with an expired 0.5 mL dose (4th dose) of IPV (VERO) [IPOL] (lot P1A251M and expiry date: 02-May-2020) via an intramuscular route in the left thigh on 16-Jun-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  It was an actual medication error case due to expired vaccine used.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site reaction, Irritability, Pyrexia
Clinical narrative: Fever; reaction at site; excessive crying/fussiness; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient of unknown age and gender who experienced fever (pyrexia), reaction at site (vaccination site reaction) and excessive crying/fussiness (crying), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number UJ214AAA) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever (pyrexia), reaction at site (vaccination site reaction) and excessive crying/fussiness (crying) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No laboratory data reported.  Final diagnosis was crying, vaccination site reaction and pyrexia.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown.  There will be no information on the batch number for this case.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient recieved an expired vaccine, no AE; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves male patient (age not reported) who received a dose of vaccine IPV (VERO) [IPOL], which was expired on 02-May-2020, (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  No adverse event was reported at the time of reporting.  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.  There will  be no information on the batch number for this case.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient develolped cellulitis and received antibiotic from dr.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Fatigue, Feeling abnormal, Formication
Clinical narrative: Aggravated tremor in right hand (shaking); swollen fingers on both hands; both feet: tingling (not Gout symptons); feeling of spiders crawling in my legs; profuse sweating; hot flashes; nausea; light headed; dizzy; I could feel every single joint in my body - especially hips and fingers; tired and "worn out"; spent Friday PM and all day Sat. in bed.  Last evening (Sunday, 6/21/2020) felt a tightness in throat - but drank plenty of liquids.  General feeling of something not right!!! Monday, 6/22/2020 - right hand is still shaking (typing w/two hands). Standard redness and swelling of area where injection was given
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Hyperhidrosis, Injection site erythema, Injection site swelling, Musculoskeletal discomfort
Clinical narrative: Aggravated tremor in right hand (shaking); swollen fingers on both hands; both feet: tingling (not Gout symptons); feeling of spiders crawling in my legs; profuse sweating; hot flashes; nausea; light headed; dizzy; I could feel every single joint in my body - especially hips and fingers; tired and "worn out"; spent Friday PM and all day Sat. in bed.  Last evening (Sunday, 6/21/2020) felt a tightness in throat - but drank plenty of liquids.  General feeling of something not right!!! Monday, 6/22/2020 - right hand is still shaking (typing w/two hands). Standard redness and swelling of area where injection was given
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Peripheral swelling, Throat tightness, Tremor
Clinical narrative: Aggravated tremor in right hand (shaking); swollen fingers on both hands; both feet: tingling (not Gout symptons); feeling of spiders crawling in my legs; profuse sweating; hot flashes; nausea; light headed; dizzy; I could feel every single joint in my body - especially hips and fingers; tired and "worn out"; spent Friday PM and all day Sat. in bed.  Last evening (Sunday, 6/21/2020) felt a tightness in throat - but drank plenty of liquids.  General feeling of something not right!!! Monday, 6/22/2020 - right hand is still shaking (typing w/two hands). Standard redness and swelling of area where injection was given
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Pain, Urticaria
Clinical narrative: woke up 9am next morning arm  was very sore to the touch but could move it and go about daily activities with minimal pain in movement. Redness the size of my palm around injection site. 24 hours after injection, multiple welts appeared approx. 3 finger lengths below injection site (no other welts or hives on my body just near injection site). Welts lasted another 24 hours and by Sunday evening had smoothed out and meshed together. Woke up Monday morning and site is a light pink and just sensitive to touch. Contacted my Dr. above information.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Mother calls to report reaction of redness, swelling and pain. This child was not seen in person to assess physically this reaction  was reported via telephone call.
Age: 2.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse effects reported; a patient was administered an expired dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a 2-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 04-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S002459, expiry date 15-MAY-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S002459; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was administered a 4th dose of GARDASIL 9; No additional adverse event; This spontaneous report was received from a nurse via a company representative referring to a 19 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On unknown dates, the patient completed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (strength, dose, route, lot # and expiration date were not reported) at medical practice for prophylaxis.         On an unknown date, the patient was administered a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)(strength, dose, route, lot # and expiration date were not reported)(extra dose administered) because there was no record of his vaccination history. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: felt faint while driving; This spontaneous report as received from an office manager via a company representative refers to a non-pregnant 19-year-old female patient. The patient had no pertinent medical history, concomitant therapies and drug reactions or allergies.  On 09-JUN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) to protect against human papillomavirus (HPV). On the same day, on 09-JUN-2020, the patient started therapy with levonorgestrel (KYLEENA) intrauterine device (IUD) (strength, dose, frequency, indication, lot # and expiration date were not reported).  On 09-JUN-2020, the patient felt faint while driving. It was reported that the patient pulled her car over and the patient was transported via an ambulance to an emergency room (ER). The patent was given something to eat and something to drink as treatment. No laboratory test were performed. The patient was not hospitalized, she was discharged home from the ER on the same day on 09-JUN-2020. The outcome of the event was reported as recovered/resolved on an unknown date in June 2020.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and levonorgestrel (KYLEENA) was not provided.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; inadvertently administered an expired dose of VAQTA; This spontaneous report as received from a physician refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R034339, expiration date 23-NOV-2019 (dose and route of administration was not reported) for prophylaxis. There was no adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R034339; expirationdate: 23-NOV-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; on 6/12/2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not provided.  On 12-JUN-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (vaccination scheme and anatomical site of administration were not reported; lot number T003833, which has been verified to be valid, expiration date reported and validated as 01-AUG-2021), administered subcutaneously as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number T000494, which has been verified to be valid, expiration date reported and validated as 06-JUL-2022).  The vaccine experienced a temperature excursion of 43.8 degrees Fahrenheit (F) for 29 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion. The patient experienced no symptoms.
Age: 33.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No known adverse effects; a 33 year old patient received a pediatric dose of VAQTA; This spontaneous report was received from a nurse referring to a 33 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 12-JUN-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) VIAL (lot # T001419 and expiration date 06-JAN-2021; strength, dose and route were not reported) for prophylaxis (product administered to patient of inappropriate age). No known adverse effects were reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported; patient received unspecified dose in ROTATEQ immunization series that was improperly stored.; Information has been received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication was not provided.       On 11-JUN-2020, the patient received unspecified dose in rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, lot # 1660948, expiration date 22-MAR-2021; strength and dose were unknown) immunization series for prophylaxis, that was improperly stored (product storage error). The vaccine was exposed to temperature excursion at 50 degrees Fahrenheit for 34 minutes. There was no previous temperature excursion. The call was due to digital data logger. No symptoms or additional adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; administered an improperly stored dose of PROQUAD; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown.   On 15-JUN-2020, the patients were vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) (lot # S030215 and expiration date: 25-MAR-2021; strength, dose, frequency, anatomical location were not reported) subcutaneously for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (lot # S038697 and expiration date: 10-AUG-2022). It was reported that the vaccine was exposed to a temperature of 6.8 degree Fahrenheit (F) for 20 minutes. There was previous temperature excursion for the vaccine. It was reported that digital data logger was involved. No additional symptoms reported (no adverse event).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Rash
Clinical narrative: vision loss; painful rash; Information has been received on 15-JUN-2020 from a lawyer, regarding a case in litigation, and refers to a currently approximately 64-year-old female patient (pt). No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 11-OCT-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for vision loss and painful rash, resulting from the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was considered to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; The patient was inadertently administered a dose of PROQUAD, that had been improperly stored; This spontaneous report was received from a nurse concerning to a 4-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    On 05-JUN-2020, there was previous temperature excursion of 6 Fahrenheit degrees to 14 Fahrenheit degrees  for 1 hour; 15 Fahrenheit degrees to 46 Fahrenheit degrees  for 4 hours. On 08-JUN-2020, 6 Fahrenheit degrees  to 14 Fahrenheit degrees  for 1 hour and 50 minutes and on 15-JUN-2020, 6 Fahrenheit degrees  to 14 Fahrenheit degrees  for 20 minutes.   On 16-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # S030215 expiration date not reported, but upon internal validation established as 25-MAR-2021, for prophylaxis (strength, dose schedule, anatomical site of injection and route of administration were not reported) (product storage error). The sterile diluent was properly stored.  The administered dose of the vaccine experienced a temperature of 7.2 Fahrenheit degrees  for 30 minutes recorded by a data logger. There was no additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Headache; Nausea; Arm is sore at the injection site also; This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th June 2020, the patient received the 2nd dose of Shingles vaccine. On 12th June 2020, 1 days after receiving Shingles vaccine, the patient experienced fever, chills, headache, nausea and injection site pain. On an unknown date, the outcome of the fever, chills, headache, nausea and injection site pain were unknown.   It was unknown if the reporter considered the fever, chills, headache, nausea and injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received shingles vaccine and experienced fever, chills, headache and nausea. Arm was sore at the injection site also. The reporter would not provide any name or contact information for themselves and then abandoned the chat did not had a chance to verify if it was GlaxoSmithKline Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Anaphylactic reaction
Clinical narrative: Similar to Anaphylaxis; Several severe reactions / Symptoms may be severe; This case was reported by a pharmacist via sales rep and described the occurrence of anaphylaxis in an unknown number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant) and adverse reaction. On an unknown date, the outcome of the anaphylaxis and adverse reaction were unknown.   It was unknown if the reporter considered the anaphylaxis and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that several severe reactions after receiving a 1st dose of Shingrix across multiple patients. The reporter described one reaction similar to anaphylaxis. The patient also stated that the day was shot after receiving a dose. The symptoms might be severe. The reporter consented to follow up. This case has been linked with the case US2020AMR102135 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR102135:2nd dose