chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; constant pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: constant pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.   Additional Information: GSK received date: 26-Feb-2024 This case was reported by a patient via interactive digital media. Patient got the shingles six years ago. Patient had constant pain. Patient stated that no Doctor could give the patient anything to stop the pain. Patient also had the two shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain). The outcome of the injection site pain was resolved.   The reporter considered the injection site pain to be related to Arexvy.     The company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-FEB-2024 The reporter was physician assistant. The consent to follow up granted.
Sex: U
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Underdose/vaccine was partially administered; syringe leaked from the barrel; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number MX2Z9, expiry date 03-MAY-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: Underdose/vaccine was partially administered), syringe leak (Verbatim: syringe leaked from the barrel) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the underdose, syringe leak and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:22-FEB-2024 The reporter reported that one Boostrix syringe leaked from the barrel, during administration, after partial use of a multi pack, which led to syringe leak. The vaccine was partially administered which led to underdose. The vigorously mixing/shaking performed after reconstitution and/or re-suspension. The syringe was leak at barrel, near the luer lock device.  The leak appears to be from the glass, not the plastic luer lock device. (To verify, prior to calling GlaxoSmithKline the health care professional filled the syringe with water to determine where leak was.) The syringe was not pre-assembled with needle some time before administration. The 23G size gauge needle was used and blister and/or carton not damaged. If leaking from plunger stopper, there was no any liquid traces observed on the plunger stopper rings. The luer lock not damaged and used needle was not available, it was discarded. There were no any damage/breakage on the syringe barrel,  picture was not taken as no damage/defect is visible. The syringe and box would be returned to GlaxoSmithKline.  The product quality complaint and related adverse events were filed under the same case. Nothing else was reported. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of Boostrix on 16-FEB-2024. Vaccine expired on 18-JAN-2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 16-FEB-2024, the patient received Boostrix. On 16-FEB-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received expired dose of Boostrix on 16-FEB-2024. Vaccine expired on 18-JAN-2024.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date:22-FEB-2024 The registered pharmacist reported that a patient administered with expired dose of Boostrix, which led to expired vaccine used. The reporter did not wish to provide patient details at this time, other than gender. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: hives (red bumps) around injection site; injection site warm to touch; redness at injection site; swollen arm at injection site; upset stomach; pain at top of right shoulder; Fever; Pain radiates to chest muscles/has pain at the top of her right shoulder which moves to her chest; arm pain has intensified; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st Shingrix vaccination about 3 months ago in 2023).   On 13-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 13-FEB-2024, less than a day after receiving Shingrix, the patient experienced injection site hives (Verbatim: hives (red bumps) around injection site), injection site warmth (Verbatim: injection site warm to touch), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swollen arm at injection site), upset stomach (Verbatim: upset stomach), shoulder pain (Verbatim: pain at top of right shoulder) and fever (Verbatim: Fever). In FEB-2024, the patient experienced musculoskeletal chest pain (Verbatim: Pain radiates to chest muscles/has pain at the top of her right shoulder which moves to her chest) and pain in arm (Verbatim: arm pain has intensified). The outcome of the injection site hives, upset stomach and fever were resolved and the outcome of the injection site warmth, injection site erythema, injection site swelling, shoulder pain, musculoskeletal chest pain and pain in arm were not resolved.   It was unknown if the reporter considered the injection site hives, injection site warmth, injection site erythema, injection site swelling, upset stomach, shoulder pain, fever, musculoskeletal chest pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site hives, injection site warmth, injection site erythema, injection site swelling, upset stomach, shoulder pain, fever, musculoskeletal chest pain and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2024 The patient self-reported this case. The patient received her 2nd dose and on the same day she began having fever, upset stomach, arm swelling at injection site, redness at injection site, injection site warm to touch, and hives (red bumps) near the injection site.   Her arm pain had intensified, and she now (during the reporting days) had pain at the top of her right shoulder which moved to her chest muscles. All other symptoms had recovered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Musculoskeletal chest pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: hives (red bumps) around injection site; injection site warm to touch; redness at injection site; swollen arm at injection site; upset stomach; pain at top of right shoulder; Fever; Pain radiates to chest muscles/has pain at the top of her right shoulder which moves to her chest; arm pain has intensified; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st Shingrix vaccination about 3 months ago in 2023).   On 13-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 13-FEB-2024, less than a day after receiving Shingrix, the patient experienced injection site hives (Verbatim: hives (red bumps) around injection site), injection site warmth (Verbatim: injection site warm to touch), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swollen arm at injection site), upset stomach (Verbatim: upset stomach), shoulder pain (Verbatim: pain at top of right shoulder) and fever (Verbatim: Fever). In FEB-2024, the patient experienced musculoskeletal chest pain (Verbatim: Pain radiates to chest muscles/has pain at the top of her right shoulder which moves to her chest) and pain in arm (Verbatim: arm pain has intensified). The outcome of the injection site hives, upset stomach and fever were resolved and the outcome of the injection site warmth, injection site erythema, injection site swelling, shoulder pain, musculoskeletal chest pain and pain in arm were not resolved.   It was unknown if the reporter considered the injection site hives, injection site warmth, injection site erythema, injection site swelling, upset stomach, shoulder pain, fever, musculoskeletal chest pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site hives, injection site warmth, injection site erythema, injection site swelling, upset stomach, shoulder pain, fever, musculoskeletal chest pain and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2024 The patient self-reported this case. The patient received her 2nd dose and on the same day she began having fever, upset stomach, arm swelling at injection site, redness at injection site, injection site warm to touch, and hives (red bumps) near the injection site.   Her arm pain had intensified, and she now (during the reporting days) had pain at the top of her right shoulder which moved to her chest muscles. All other symptoms had recovered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administered a patient only adjuvant of Shingrix; administered a patient only adjuvant of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 5595T, expiry date 12-DEC-2025) for prophylaxis.   On 22-FEB-2024, the patient received Shingrix. On 22-FEB-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered a patient only adjuvant of Shingrix) and inappropriate dose of vaccine administered (Verbatim: administered a patient only adjuvant of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The physician assistant (PA) reported that nurse administered a patient only adjuvant of Shingrix today (on the reporting day), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: already received her 2 doses of Shingrix/received extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 21-FEB-2024, the patient received the 3rd dose of Shingrix. On 21-FEB-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: already received her 2 doses of Shingrix/received extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-FEB-2024 The pharmacist stated that he had the patient that came in to get her Shingrix vaccine and it was administered without knowing she already received her 2 doses of Shingrix at another pharmacy, which led to extra dose administered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Incorrect route of product administration, Induration, Pain
Clinical narrative: Shingrix administered subcutaneously; Pain; Induration; Bruising; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-FEB-2024, the patient received the 1st dose of Shingrix (subcutaneous, left arm). In FEB-2024, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Pain), induration (Verbatim: Induration) and contusion (Verbatim: Bruising). On 20-FEB-2024, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix administered subcutaneously). The outcome of the pain and contusion were not resolved and the outcome of the induration was resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pain, induration and contusion to be related to Shingrix.     It was unknown if the company considered the pain, induration and contusion to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-FEB-2024 The patient was a nurse practitioner and reported that a Shingrix vaccine was administered subcutaneously, which led to intramuscular formulation administered by other route. The patient had pain, induration and bruising. The patient reported that, it had less induration now (at the time of reporting), and it was fading but it still hurts.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: vertigo; she felt dizzy; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of vertigo in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-AUG-2023, the patient received the 1st dose of Shingrix. On 29-AUG-2023, immediately after receiving Shingrix, the patient experienced vertigo (Verbatim: vertigo), dizziness (Verbatim: she felt dizzy) and nausea (Verbatim: Nausea). The outcome of the vertigo, dizziness and nausea were resolved (duration 2 weeks).   It was unknown if the reporter considered the vertigo, dizziness and nausea to be related to Shingrix.     It was unknown if the company considered the vertigo, dizziness and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-FEB-2024 The patient self reported this case. The patient stated that within minutes she felt dizzy (like she had vertigo) and nauseated.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: discovered a vaccine error where a 5-month-old was given a Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 01-DEC-2023, the patient received Kinrix. On 01-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: discovered a vaccine error where a 5-month-old was given a Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-FEB-2024 The healthcare provider discovered a vaccine error where a patient below than the recommended age limit was given a Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administration of an expired Boostrix dose to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 24-FEB-2024, the patient received Boostrix. On 24-FEB-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Boostrix dose to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-FEB-2024 The Health Care Professional called to report the administration of an expired Boostrix dose to a patient, which led to expired vaccine used. The health care professional asked for guidance on this situation. The reporter consented to follow up.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired product used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old male patient who received HBV (Engerix B) (batch number 29RN7, expiry date 25-FEB-2024) for prophylaxis.   On 27-FEB-2024, the patient received the 2nd dose of Engerix B. On 27-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired product used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The patient was administered a dose of Engerix B, which had an expiration date of earlier date, which led to expired vaccine used.  At the time of reporting, the dose had not been repeated. The reporter stated the mistake happened because he inverted the 24 and the 25 in the expiration date.  The vaccine administration facility was the same as primary reporter.
Age: 48.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered four Arexvy vaccines to patients under the age of 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX3T4, expiry date 20-AUG-2025) for prophylaxis.   On 26-FEB-2024, the patient received Arexvy. On 26-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered four Arexvy vaccines to patients under the age of 60). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The pharmacist reported one of the locations that reporter works for inadvertently administered Arexvy vaccine to patient under the age of 60 which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This was 1 of 4 linked report, reported by same reporter, different patient.; Sender's Comments:  US-GSK-US2024025758:Same reporter / different patient US-GSK-US2024025764:SAME REPORTER/DIFFERENT PATIENT US-GSK-US2024025761:Same reporter / different patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; COVID-19; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 29-JAN-2024 was received on 29-JAN-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: hashimoto's thyroiditis, anxiety, mixed connective tissue, and autoimmune disease. The patient was previously treated with citrus x aurantium, and levofloxacin. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-APR-2021 for covid-19 prophylaxis. Non-company suspect vaccine included: tozinameran (coded as Revaccination with different COVID-19 vaccine) (dose number in series 2) ( form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 12-NOV-2021 to Left Arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included escitalopram oxalate for anxiety, and levothyroxine sodium for thyroid. On 15-JAN-2024, treatment medications included: nirmatrelvir/ritonavir. On 21-JAN-2024, Laboratory data included: COVID-19 virus test Negative. On 24-JAN-2024, Laboratory data included: COVID-19 virus test Positive. On 24-JAN-2024 12:00, the patient experienced covid-19 (dose number in series 2). Rebound COVID effect - tested negative 21-JAN-2024 and tested positive on 24-JAN-2024 with return of symptoms (stuffy nose and tiredness). On an unspecified date, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the covid-19 and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: administered only the liquid component of PENTACEL. It was not reconstituted and the lyophilized component was not administered with no reported AE; Initial information received on 27-Feb-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15-month-old male patient who was administered only the liquid component of diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)]; it was not reconstituted, and the lyophilized component was not administered with no reported adverse event.  The patient's past vaccination(s) included Vaxelis (3 doses). The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant: No other vaccines.  On 15-Feb-2024, the patient received 0.5 mL dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection (Frequency: once; Strength: standard) (lot number: UJ974AC; expiry date: 25-Nov-2024) via intramuscular route in the left thigh for Immunization; was administered only the liquid component as it was not reconstituted and the lyophilized component was not administered with no reported ae (product preparation error) (same day latency).  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 the 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: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK received date: 26-Feb-2024 This case was reported by a consumer via interactive digital media. Reporter knew 3 people who got shingles bad after getting shingles vax, they also had the other jab. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR026040:Same reporter different patient US-GSK-US2024AMR026035:Same reporter different patient
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Boostrix extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M7445) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix).   On 19-FEB-2024, the patient received the 2nd dose of Boostrix. On 19-FEB-2024, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Boostrix extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-FEB-2024 The pharmacist reported that a second dose of Boostrix was administered to the patient after the first dose, which led to extra dose administered.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: a nurse mistakenly gave Arexvy adjuvant only, not reconstituted vaccine; a nurse mistakenly gave Arexvy adjuvant only, not reconstituted vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7357L, expiry date 26-MAR-2025) for prophylaxis.   On 27-FEB-2024, the patient received Arexvy (intramuscular). On 27-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: a nurse mistakenly gave Arexvy adjuvant only, not reconstituted vaccine) and inappropriate dose of vaccine administered (Verbatim: a nurse mistakenly gave Arexvy adjuvant only, not reconstituted vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-FEB-2024 The reporter reported that a nurse mistakenly gave Arexvy adjuvant only, not reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Nothing else was reported. The reporter consented to follow-up.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Ear swelling, Headache, Myalgia, Peripheral swelling
Clinical narrative: Swelling of the entire face including ears. Swelling of the arms and hands, worse on the right side. Rash on face and right hand. Headache, joint and muscle pain of the upper body. Swelling of the tongue and neck
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Swelling, Swelling face, Swollen tongue
Clinical narrative: Swelling of the entire face including ears. Swelling of the arms and hands, worse on the right side. Rash on face and right hand. Headache, joint and muscle pain of the upper body. Swelling of the tongue and neck
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given, not age appropriate. called mother no symptoms were noticeable.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Arthropathy, Injection site movement impairment, Pain in extremity, Tearfulness
Clinical narrative: Mother returned to the HU on Feb 27, 2024 with an unknown companion to report an injury to son after the administration of vaccines. Companion explained that after he received the vaccines on 2/12/24 mother noticed that he could not use his left arm for apprx. 24 hours, once the use of the arm returned the she noticed that his thumb was bent and would not straighten; this was no  more than 2 days after the administration of the vaccines. Upon assessment left thumb is bent when he is in a relaxed position. Child tearful upon approach and would not allow for further evaluation. Mom reports she can massage it during bedtime and he does not seem to be in pain at that time,
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: N./A
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, COVID-19, Gait disturbance, Joint swelling, Pyrexia
Clinical narrative: She got her vaccine, which was not painful and no problem and went home.  20 minutes later she is getting dinner ready her ankle swells up and is painful.  It was very painful to walk on it, but if she sat down it was not bad.  She actually got a walker to walk.  A few hours she took 2 antihistamines and eventually she took 1/2 of a regular aspirin.  This did not help much.  The next morning the pain was better after resting all night.  It was still there, and the ankle swelling looked like it went down.  The next day it was still a little bit painful feeling like there was some wear and tear of the ankle itself.  She was able to walk on it better.  So far this morning it is fine, but she did notice yesterday she had to go up a small ladder and felt a slight pull on the ankle itself.  Last night she could feel some pulling on the ankle as well.   She woke up yesterday with a terrible toothache, and thinks that maybe she was grinding her teeth when she slept but it eventually went away.  She has peripheral neuropathy, but she never has issues with her ankles.   She had COVID and had a fever of 103.3, and had a dinner party and then tested positive a few days later.  Her friends did not get COVID from it.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: SARS-CoV-2 test positive, Toothache
Clinical narrative: She got her vaccine, which was not painful and no problem and went home.  20 minutes later she is getting dinner ready her ankle swells up and is painful.  It was very painful to walk on it, but if she sat down it was not bad.  She actually got a walker to walk.  A few hours she took 2 antihistamines and eventually she took 1/2 of a regular aspirin.  This did not help much.  The next morning the pain was better after resting all night.  It was still there, and the ankle swelling looked like it went down.  The next day it was still a little bit painful feeling like there was some wear and tear of the ankle itself.  She was able to walk on it better.  So far this morning it is fine, but she did notice yesterday she had to go up a small ladder and felt a slight pull on the ankle itself.  Last night she could feel some pulling on the ankle as well.   She woke up yesterday with a terrible toothache, and thinks that maybe she was grinding her teeth when she slept but it eventually went away.  She has peripheral neuropathy, but she never has issues with her ankles.   She had COVID and had a fever of 103.3, and had a dinner party and then tested positive a few days later.  Her friends did not get COVID from it.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: N/ A
Age: 1.75
Sex: F
Vaccine: HEPA, PNC15
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 104 fever, pain and swelling at injection site. Warm to touch. Red/bruising
Age: 1.75
Sex: F
Vaccine: HEPA, PNC15
Symptoms: Pyrexia
Clinical narrative: 104 fever, pain and swelling at injection site. Warm to touch. Red/bruising
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Inflammatory marker increased, Rash
Clinical narrative: Joint pain, facial rash, inflammation.
Age: 17.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: No adverse event noted, no treatment needed.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood culture, Blood thyroid stimulating hormone, C-reactive protein, Cytomegalovirus test, Differential white blood cell count abnormal
Clinical narrative: Had vaccine given in left thigh and 2 weeks later developed fevers for 10 days, 2 vesicles in mouth and severe left thigh myositis/fasciitis reported on MRI study and left knee effusion- neg bacterial cultures from blood, urine and synovial fluid, no viral cultures were sent.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Epstein-Barr virus test, Fasciitis, Full blood count normal, Human rhinovirus test positive, Joint effusion
Clinical narrative: Had vaccine given in left thigh and 2 weeks later developed fevers for 10 days, 2 vesicles in mouth and severe left thigh myositis/fasciitis reported on MRI study and left knee effusion- neg bacterial cultures from blood, urine and synovial fluid, no viral cultures were sent.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Magnetic resonance imaging joint, Myositis, Parvovirus B19 test, Platelet count increased, Pyrexia
Clinical narrative: Had vaccine given in left thigh and 2 weeks later developed fevers for 10 days, 2 vesicles in mouth and severe left thigh myositis/fasciitis reported on MRI study and left knee effusion- neg bacterial cultures from blood, urine and synovial fluid, no viral cultures were sent.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Red blood cell sedimentation rate increased, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative, Synovial fluid analysis
Clinical narrative: Had vaccine given in left thigh and 2 weeks later developed fevers for 10 days, 2 vesicles in mouth and severe left thigh myositis/fasciitis reported on MRI study and left knee effusion- neg bacterial cultures from blood, urine and synovial fluid, no viral cultures were sent.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Thyroxine free, Urine analysis
Clinical narrative: Had vaccine given in left thigh and 2 weeks later developed fevers for 10 days, 2 vesicles in mouth and severe left thigh myositis/fasciitis reported on MRI study and left knee effusion- neg bacterial cultures from blood, urine and synovial fluid, no viral cultures were sent.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Burning sensation, Chills, Electric shock sensation
Clinical narrative: March 15, 2021 Vomiting in the evening, achy with chills  March 16, 2021: Continued achiness with chills all day Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  March 17, 2021: Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  April 12, 2021: Pain progressed to pinched nerve-like feeling in shoulder and shoulder-blade area.  Made a chiropractor appointment to see if this would help to alleviate the pain.  After 3 visits, there was no improvement.    April 16, 2021: One month after administration of the Zoster, Recombinant Adjuvanted Shingrix (2nd dose), the pain intensity has become progressively worse and feels like I am carrying dead weight, where I need to hold my arm up like it is in a sling.  Burning sensation on fingertips, IV like feeling persists throughout right arm.  Outreached arm feels like it is being shocked. Feeling of extreme shock when attempted to apply shaving cream on legs.  Washing hands or showering difficult due to water/shock sensitivity. Unable to use fingertips on right hand.  Reported Adverse reaction to AHN Primary Care at 9:30am.    April 19, 2021: Appointment at 2:20pm with Primary Care, MD.  EMG ordered.  May 18, 2021: EMG scheduled with Medical, location at 1:00pm.  EMG showed no large nerve damage or other underlying condition.  May and June 2021: All above symptoms continued at the same pain intensity.  Tried Gabapentin twice. Medication triggered migraines and vertigo.    July & August 2021: Blistering rash along the waistline, just below bra-line, down thigh and up calf beginning on the ankle.  A few appeared as large single blisters: one on finger and two others on the foot.   These blisters continued to appear for approximately five weeks.  It took another three weeks for all to be completely healed over.   September 2021: While out for my daily hour-long walk on Sept. 14,2021, I felt a jolt under my right breast.  It was strong enough to stop me in my tracks.  Ten minutes later, I felt another jolt.  The following day, on Sept. 15, 2021, I experienced another chicken-pox like rash in a line from the top of my right breast around to the bottom of the breast.  I contacted the doctor on Sept. 16, 2021 to ask for the lot# of the Shingrix vaccine to see if it had been re-called for any reason.  March 4, 2024: Now going on 3 years, the chronic burning pain in my right hand and extreme sensitivity in the fingertips still persists, in addition to a generalized weakness and recurring pain in my right arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electromyogram normal, Feeling cold, Hypoaesthesia, Injection site pain, Limb discomfort
Clinical narrative: March 15, 2021 Vomiting in the evening, achy with chills  March 16, 2021: Continued achiness with chills all day Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  March 17, 2021: Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  April 12, 2021: Pain progressed to pinched nerve-like feeling in shoulder and shoulder-blade area.  Made a chiropractor appointment to see if this would help to alleviate the pain.  After 3 visits, there was no improvement.    April 16, 2021: One month after administration of the Zoster, Recombinant Adjuvanted Shingrix (2nd dose), the pain intensity has become progressively worse and feels like I am carrying dead weight, where I need to hold my arm up like it is in a sling.  Burning sensation on fingertips, IV like feeling persists throughout right arm.  Outreached arm feels like it is being shocked. Feeling of extreme shock when attempted to apply shaving cream on legs.  Washing hands or showering difficult due to water/shock sensitivity. Unable to use fingertips on right hand.  Reported Adverse reaction to AHN Primary Care at 9:30am.    April 19, 2021: Appointment at 2:20pm with Primary Care, MD.  EMG ordered.  May 18, 2021: EMG scheduled with Medical, location at 1:00pm.  EMG showed no large nerve damage or other underlying condition.  May and June 2021: All above symptoms continued at the same pain intensity.  Tried Gabapentin twice. Medication triggered migraines and vertigo.    July & August 2021: Blistering rash along the waistline, just below bra-line, down thigh and up calf beginning on the ankle.  A few appeared as large single blisters: one on finger and two others on the foot.   These blisters continued to appear for approximately five weeks.  It took another three weeks for all to be completely healed over.   September 2021: While out for my daily hour-long walk on Sept. 14,2021, I felt a jolt under my right breast.  It was strong enough to stop me in my tracks.  Ten minutes later, I felt another jolt.  The following day, on Sept. 15, 2021, I experienced another chicken-pox like rash in a line from the top of my right breast around to the bottom of the breast.  I contacted the doctor on Sept. 16, 2021 to ask for the lot# of the Shingrix vaccine to see if it had been re-called for any reason.  March 4, 2024: Now going on 3 years, the chronic burning pain in my right hand and extreme sensitivity in the fingertips still persists, in addition to a generalized weakness and recurring pain in my right arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Nerve conduction studies, Pain, Pain in extremity, Paraesthesia
Clinical narrative: March 15, 2021 Vomiting in the evening, achy with chills  March 16, 2021: Continued achiness with chills all day Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  March 17, 2021: Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  April 12, 2021: Pain progressed to pinched nerve-like feeling in shoulder and shoulder-blade area.  Made a chiropractor appointment to see if this would help to alleviate the pain.  After 3 visits, there was no improvement.    April 16, 2021: One month after administration of the Zoster, Recombinant Adjuvanted Shingrix (2nd dose), the pain intensity has become progressively worse and feels like I am carrying dead weight, where I need to hold my arm up like it is in a sling.  Burning sensation on fingertips, IV like feeling persists throughout right arm.  Outreached arm feels like it is being shocked. Feeling of extreme shock when attempted to apply shaving cream on legs.  Washing hands or showering difficult due to water/shock sensitivity. Unable to use fingertips on right hand.  Reported Adverse reaction to AHN Primary Care at 9:30am.    April 19, 2021: Appointment at 2:20pm with Primary Care, MD.  EMG ordered.  May 18, 2021: EMG scheduled with Medical, location at 1:00pm.  EMG showed no large nerve damage or other underlying condition.  May and June 2021: All above symptoms continued at the same pain intensity.  Tried Gabapentin twice. Medication triggered migraines and vertigo.    July & August 2021: Blistering rash along the waistline, just below bra-line, down thigh and up calf beginning on the ankle.  A few appeared as large single blisters: one on finger and two others on the foot.   These blisters continued to appear for approximately five weeks.  It took another three weeks for all to be completely healed over.   September 2021: While out for my daily hour-long walk on Sept. 14,2021, I felt a jolt under my right breast.  It was strong enough to stop me in my tracks.  Ten minutes later, I felt another jolt.  The following day, on Sept. 15, 2021, I experienced another chicken-pox like rash in a line from the top of my right breast around to the bottom of the breast.  I contacted the doctor on Sept. 16, 2021 to ask for the lot# of the Shingrix vaccine to see if it had been re-called for any reason.  March 4, 2024: Now going on 3 years, the chronic burning pain in my right hand and extreme sensitivity in the fingertips still persists, in addition to a generalized weakness and recurring pain in my right arm.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash vesicular, Tenderness, Vomiting
Clinical narrative: March 15, 2021 Vomiting in the evening, achy with chills  March 16, 2021: Continued achiness with chills all day Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  March 17, 2021: Tenderness at site, cold sensation down arm (IV-like feeling). Numbness and tingling in right hand and fingers. Pins & needles and extreme tenderness in fingertips.  April 12, 2021: Pain progressed to pinched nerve-like feeling in shoulder and shoulder-blade area.  Made a chiropractor appointment to see if this would help to alleviate the pain.  After 3 visits, there was no improvement.    April 16, 2021: One month after administration of the Zoster, Recombinant Adjuvanted Shingrix (2nd dose), the pain intensity has become progressively worse and feels like I am carrying dead weight, where I need to hold my arm up like it is in a sling.  Burning sensation on fingertips, IV like feeling persists throughout right arm.  Outreached arm feels like it is being shocked. Feeling of extreme shock when attempted to apply shaving cream on legs.  Washing hands or showering difficult due to water/shock sensitivity. Unable to use fingertips on right hand.  Reported Adverse reaction to AHN Primary Care at 9:30am.    April 19, 2021: Appointment at 2:20pm with Primary Care, MD.  EMG ordered.  May 18, 2021: EMG scheduled with Medical, location at 1:00pm.  EMG showed no large nerve damage or other underlying condition.  May and June 2021: All above symptoms continued at the same pain intensity.  Tried Gabapentin twice. Medication triggered migraines and vertigo.    July & August 2021: Blistering rash along the waistline, just below bra-line, down thigh and up calf beginning on the ankle.  A few appeared as large single blisters: one on finger and two others on the foot.   These blisters continued to appear for approximately five weeks.  It took another three weeks for all to be completely healed over.   September 2021: While out for my daily hour-long walk on Sept. 14,2021, I felt a jolt under my right breast.  It was strong enough to stop me in my tracks.  Ten minutes later, I felt another jolt.  The following day, on Sept. 15, 2021, I experienced another chicken-pox like rash in a line from the top of my right breast around to the bottom of the breast.  I contacted the doctor on Sept. 16, 2021 to ask for the lot# of the Shingrix vaccine to see if it had been re-called for any reason.  March 4, 2024: Now going on 3 years, the chronic burning pain in my right hand and extreme sensitivity in the fingertips still persists, in addition to a generalized weakness and recurring pain in my right arm.