chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Anti-thyroid antibody increased, Autoimmune thyroiditis, Blood aluminium increased, Blood lead increased
Clinical narrative: Goiter, Elevated thyroglobulin and thyroperoxidase antibodies, elevated levels of mercury, aluminum, and lead.  Two miscarriages due to chromosomal abnormalities.  Diagnoses of hashimotos thyroiditis.  After a spike protein detox and heavy metal detox, ovaries are perfect.  Overall health has improved immensely.  Energy improved.  Digestion improved.  Goiter has gone away.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood mercury abnormal, Goitre, Thyroglobulin increased
Clinical narrative: Goiter, Elevated thyroglobulin and thyroperoxidase antibodies, elevated levels of mercury, aluminum, and lead.  Two miscarriages due to chromosomal abnormalities.  Diagnoses of hashimotos thyroiditis.  After a spike protein detox and heavy metal detox, ovaries are perfect.  Overall health has improved immensely.  Energy improved.  Digestion improved.  Goiter has gone away.
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported arm soreness post administration - has continued to have arm soreness/pain and limited range of motion for the last 6 months in arm at site of administration.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Haematemesis, Laboratory test normal, White blood cell count increased
Clinical narrative: hospital admission with vomiting blood.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: PATIENT WAS OVERVACCINATED.   PATIENT HAD ALREADY RECEIVED A PREVNAR 20 VACCINE ON 10/23/2023. AND RECEIVED A SECOND DOSE ON 7/19/2025
Age: 71.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient called today stating that shortly after she received her RSV vaccine on her left arm the site of the injection got swollen to the size of a golf ball.  Patient then stated that the swollen arm subsided but the site of the injection is still itchy. The patient did not try to treat the reaction in any way and stated she decided to inform the pharmacy about the reaction today. The patient also stated they had no reaction on their right arm where they received the Pneumonia vaccine.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Ear pain, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: 2-5-24 dry cough, has not been resolved; 3 inch diameter bright red spot on right arm where vaccination was received and rash on both arms (disappeared within 48 hours); lymph node in right armpit swollen to size of racquetball; lymph node in left armpit swollen to size of golf ball; lymph nodes in neck and groin area also swollen; as of today lymph nodes are all still swollen, armpit nodes have decreased to golf ball size on right armpit and marble size on left armpit; lymph node on left groin area has increased to egg size; severe inflammation and swelling especially in legs and ankles; severity has decreased, but some days the swelling returns; 2-5-24 thru 2-10-24 headaches 2-5-24 thru 3-5-24 night sweats of the same intensity of valley fever night sweats (i.e. I woke up in middle of night drenched from head to toe and had to change clothes) 2-19-24   sinus issues, watery eyes, but did not develop into respiratory illness and resolved within about two weeks; severe hip pain for two days making it hard to walk; this symptom was identical to known side effect of disseminated valley fever case where I could hardly walk from July-October 2014; I also had hip pain when I became allergic to Macrobid; allergies to antibiotics are also a result of having valley fever 7-8-24   had six night sweats about one per hour 9-19-24   ocular event which my eye doctor diagnosed as an ocular migraine without the migraine; he scheduled me for a return visit to monitor on 11-4-24; (Dr. had dealt with severe infections of my eyes due to valley fever which began in October 2024)  12-5-24   Was called by provider and told that I needed to immediately start doing nasal rinses to resolve sinusitis; she was extremely concerned because sinus infections in valley fever are dangerous 12-5-24 thru 12-17-24   sinus rinses were not effective until 12-17-24 when massive amounts of blood and green mucus were finally released; I became so ill that I called to make appt with PCP, but she was out of town; by 12-21-24 the severe earaches and headaches and difficulty breathing sent me to an urgent care center where I was given only a 7-day prescription of Amox-Clav when it should have been a 14-day prescription 1-2-25   saw provider and she was alarmed that I had not been given a 14 day treatment of antibiotics; she prescribed me another 7 day prescription 12-17-24 thru 6-17-25   had nightly sweats; during this period it was difficult to exert myself, exercise or take a walk of any distance due to breathing difficulties and dry coughing fits;  6-13-25 ? I learned from a friend and paralegal that she was involved in legal cases addressing the fact that the RSV vaccine should never be given to valley fever survivors; evidently all the adverse events I have suffered have also occurred to other valley fever patients; to my knowledge the medical profession has not been informed of this information   7-15-25 ? scheduled appt. with PCP to get an inhaler and was prescribed Albuterol and given a sample of AirSupra which is not covered by my insurance company
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Ultrasound Doppler, Ultrasound lymph nodes, White matter lesion
Clinical narrative: 2-5-24 dry cough, has not been resolved; 3 inch diameter bright red spot on right arm where vaccination was received and rash on both arms (disappeared within 48 hours); lymph node in right armpit swollen to size of racquetball; lymph node in left armpit swollen to size of golf ball; lymph nodes in neck and groin area also swollen; as of today lymph nodes are all still swollen, armpit nodes have decreased to golf ball size on right armpit and marble size on left armpit; lymph node on left groin area has increased to egg size; severe inflammation and swelling especially in legs and ankles; severity has decreased, but some days the swelling returns; 2-5-24 thru 2-10-24 headaches 2-5-24 thru 3-5-24 night sweats of the same intensity of valley fever night sweats (i.e. I woke up in middle of night drenched from head to toe and had to change clothes) 2-19-24   sinus issues, watery eyes, but did not develop into respiratory illness and resolved within about two weeks; severe hip pain for two days making it hard to walk; this symptom was identical to known side effect of disseminated valley fever case where I could hardly walk from July-October 2014; I also had hip pain when I became allergic to Macrobid; allergies to antibiotics are also a result of having valley fever 7-8-24   had six night sweats about one per hour 9-19-24   ocular event which my eye doctor diagnosed as an ocular migraine without the migraine; he scheduled me for a return visit to monitor on 11-4-24; (Dr. had dealt with severe infections of my eyes due to valley fever which began in October 2024)  12-5-24   Was called by provider and told that I needed to immediately start doing nasal rinses to resolve sinusitis; she was extremely concerned because sinus infections in valley fever are dangerous 12-5-24 thru 12-17-24   sinus rinses were not effective until 12-17-24 when massive amounts of blood and green mucus were finally released; I became so ill that I called to make appt with PCP, but she was out of town; by 12-21-24 the severe earaches and headaches and difficulty breathing sent me to an urgent care center where I was given only a 7-day prescription of Amox-Clav when it should have been a 14-day prescription 1-2-25   saw provider and she was alarmed that I had not been given a 14 day treatment of antibiotics; she prescribed me another 7 day prescription 12-17-24 thru 6-17-25   had nightly sweats; during this period it was difficult to exert myself, exercise or take a walk of any distance due to breathing difficulties and dry coughing fits;  6-13-25 ? I learned from a friend and paralegal that she was involved in legal cases addressing the fact that the RSV vaccine should never be given to valley fever survivors; evidently all the adverse events I have suffered have also occurred to other valley fever patients; to my knowledge the medical profession has not been informed of this information   7-15-25 ? scheduled appt. with PCP to get an inhaler and was prescribed Albuterol and given a sample of AirSupra which is not covered by my insurance company
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: I had a rare side effects from the covid vaccine. I applied for insurance back in May and unfortunately they did not hurry and approve my application and now I am still suffering from unusual side effects and can?t get medical care. This feels like neglect as many are aware of this and I did notify  a doctor. A pediatrician during a office visit, Please contact me right away as this is an ongoing issue, I?m even having a housing crisis.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Headache, Injection site erythema, Injection site rash, Malaise, Pyrexia
Clinical narrative: severe malaise, fever, headache. redness at the injection site, rash at the injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dysstasia, Loss of consciousness, Pallor, Paraesthesia
Clinical narrative: Patient passed out and face turned white along with lips had tingling in hands and feet and could not stand for 10 minutes was able to stand after but kept them at pharmacy sitting down for an extra 20 minutes to observe.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling that feels warm at injection site that is worsening after four days. No pain or fever associated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Cardiac arrest and death
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Vaccination error
Clinical narrative: Given in error
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: symptoms: pain of needle like needle is still in his body and cant lift arm and its on right arm
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain. Heaviness in arms and legs. Could not get out of bed for 2 days.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Hardness in the left deltoid at injection site. A clear defined red ring 3 inches in diameter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Rash, Rash macular, Rash pruritic
Clinical narrative: Pt developed rash all over body in patch-like formations.  Started at back.  Itchy, splotchy rash.  Patient thought it was shingles appearing but rash did not form the painful blisters commonly seen with the rash.  Rash/itchy scaly section is still present in the scalp.  Has continued but slowed down in progression over the last 5 weeks
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 2 was administered 3 days too soon.
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose #2 of Heplisav was administered 3 days before recommended
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site one week later. Patient then went to an urgent care and was prescribed antibiotics.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Ended pregnancy because of spontaneous membrane rupture on 04/13/ 2022, 18 weeks pregnant
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC15, RV5
Symptoms: Feeding disorder, Infant irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Developed bright red erythematous, tender, warm rash from lower abdomen and along both legs to feet evolving within 1 hour of immunization.  Had fever up to 101 and fussiness and poor feeding for 20 hrs after immunization.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC15, RV5
Symptoms: Skin warm, Tenderness
Clinical narrative: Developed bright red erythematous, tender, warm rash from lower abdomen and along both legs to feet evolving within 1 hour of immunization.  Had fever up to 101 and fussiness and poor feeding for 20 hrs after immunization.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site hypersensitivity, Injection site rash, Rash erythematous
Clinical narrative: Red Rash, blistering and sensitivity at the injection site
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: rash, blisters on stomach and back right side. started next day after vaccine. continues even after taking antiviral medication and applying  cream. 5 days now
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PT  had rash  the next day , and it gradually  spread   to the whole body. Pt said she has to go to the hospital. She is ok today when she came tin to report the  adverse effect
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: muscle aches; fever of 102; extreme fatigue; expiration date: 31Jan2021, vaccination date: 18Mar2021; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 18Mar2021 as dose number unknown, single (Lot number: EP7534, Expiration Date: 31Jan2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 18Mar2021, outcome "unknown", described as "expiration date: 31Jan2021, vaccination date: 18Mar2021"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; PYREXIA (non-serious), outcome "unknown", described as "fever of 102"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue".  Additional information: Patient reported that patient gets terribly sick (muscle aches, fever of 102 and extreme fatigue) when patient got the COVID shot every time. Patient wanted to know what was error in the medicine.  Follow-up (14Jul2025): This is a spontaneous follow-up report received from a consumer.Updated information included: New events (muscle ache, fever, fatigue) and additional information.  Amendment: This follow-up report is being submitted to amend previous information: Removed at-risk classification.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500065348 Same patient/vaccine, different dose/event;
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Fatigue, Myalgia, Pyrexia
Clinical narrative: muscle aches; fever of 102; extreme fatigue; expiration date: 31Jan2021, vaccination date: 18Mar2021; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 18Mar2021 as dose number unknown, single (Lot number: EP7534, Expiration Date: 31Jan2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 18Mar2021, outcome "unknown", described as "expiration date: 31Jan2021, vaccination date: 18Mar2021"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; PYREXIA (non-serious), outcome "unknown", described as "fever of 102"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue".  Additional information: Patient reported that patient gets terribly sick (muscle aches, fever of 102 and extreme fatigue) when patient got the COVID shot every time. Patient wanted to know what was error in the medicine.  Follow-up (14Jul2025): This is a spontaneous follow-up report received from a consumer.Updated information included: New events (muscle ache, fever, fatigue) and additional information.  Amendment: This follow-up report is being submitted to amend previous information: Removed at-risk classification.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500065348 Same patient/vaccine, different dose/event;
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Restless arm syndrome
Clinical narrative: Patient reported that pain at the injection site began almost immediately upon administration. She reported sharp, stabbing pain in her shoulder and very limited mobility. CNM referred patient to physical therapy and patient saw her PCP as well. Patient reported that her PCP also gave a referral for Physical Therapy and she has an appointment on 7/23/25.  Patient is currently pregnant and due on 9/29/25.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Injection site pain, Mobility decreased
Clinical narrative: Patient reported that pain at the injection site began almost immediately upon administration. She reported sharp, stabbing pain in her shoulder and very limited mobility. CNM referred patient to physical therapy and patient saw her PCP as well. Patient reported that her PCP also gave a referral for Physical Therapy and she has an appointment on 7/23/25.  Patient is currently pregnant and due on 9/29/25.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot at injection site; Injection site redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). In JUL-2025, less than a week after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Hot at injection site) and injection site erythema (Verbatim: Injection site redness). The outcome of the injection site warmth and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site warmth and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2025 The patient received her first dose of Shingrix in her right arm on 08 JUL 2025.  Consumer reports the injection site was hot and red. No further information was provided/obtained.
Age: 3.0
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult dose(Harvix) to a pediatric patient; adult dose(Harvix) to a pediatric patient; Upon review two other doses were also given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-year-old patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis.   On 23-MAY-2025, the patient received Havrix 1440 adult. On 23-MAY-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: adult dose(Harvix) to a pediatric patient), adult product administered to child (Verbatim: adult dose(Harvix) to a pediatric patient) and extra dose administered (Verbatim: Upon review two other doses were also given). The outcome of the overdose, adult product administered to child and extra dose administered were not applicable.   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: 07-JUL-2025 The reporter reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old)and upon review two other doses were also given, which led to adult product administered to child and overdose and extra dose administered. Also asked if that dose was valid or not.  Any side effects need to advise the parents of as well.  This case was 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2025085083:Same reporter/Diffrent patient US-GSK-US2025087636:Same reporter/Diffrent patient
Age: 1.0
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: adult dose(Harvix) to a pediatric patient (19 Month Old); adult dose(Harvix) to a pediatric patient (19 Month Old); upon review two other doses were also given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-month-old patient who received HAV (Havrix 1440) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis.   On 23-MAY-2025, the patient received Havrix 1440. On 23-MAY-2025, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: adult dose(Harvix) to a pediatric patient (19 Month Old)), adult product administered to child (Verbatim: adult dose(Harvix) to a pediatric patient (19 Month Old)) and extra dose administered (Verbatim: upon review two other doses were also given). The outcome of the overdose, adult product administered to child and extra dose administered were not applicable.   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: 07-JUL-2025 The reporter reported that they gave an adult dose (Harvix) to a pediatric patient (19-Month-Old)and upon review two other doses were also given, which led to adult product administered to child and overdose and extra dose administered. Also asked if that dose was valid or not.  Any side effects need to advise the parents of as well.  This case was 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2025087634:Same reporter/Diffrent patient US-GSK-US2025085083:Same reporter/Diffrent patient
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: administered a dose of Priorix in intramuscular route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 65-year-old female patient who received MMR (Priorix) (batch number 49M2F, expiry date 01-DEC-2026) for prophylaxis.   On 10-JUL-2025, the patient received the 2nd dose of Priorix (intramuscular). On 10-JUL-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: administered a dose of Priorix in intramuscular route). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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: 10-JUL-2025 On 10th July 2025, a pharmacist called to inform that earlier that day, he had administered a dose of Priorix in intramuscular route which led to subcutaneous injection formulation administered by other route. No further details were provided.
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: A patient received a tetanus vaccine (Boostrix) 5 months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: A patient received a tetanus vaccine (Boostrix) 5 months apart). The outcome of the extra dose administered was not applicable.   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: 10-JUL-2025 On 10th July 2025 a pharmacist called to ask for a patient who received a tetanus vaccine (Boostrix) 5 months apart which led to extra dose administration, and wanted to know if was there anything that they need to do?
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage administration (6 month old patient); 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 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis.   On 10-JUL-2025, the patient received Kinrix. On 10-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration (6 month old patient)). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 10-JUL-2025 The Certified Medical Assistant called asking for recommendations/advise since a six month old patient was given a Kinrix vaccine at the time of reporting, which led to inappropriate age at vaccine administration. The vaccination date, vaccine detail and patient demographics were obtained in this call.  No further information was obtained in this call. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of vaccine in May 2018) and Twinrix (received 2nd dose of vaccine in June 2018).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was not applicable.   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: 14-JUL-2025 The pharmacist had called to report that a patient had been administered two doses of Twinrix back in May and June of Twenty-eighteen.  It was unclear whether the vaccination series needed to be restarted, as no specific vaccination dates or vaccine details had been obtained during the call. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received a first dose in September 2023 and 2nd dose in October 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   In OCT-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Received a first dose in September 2023 and 2nd dose in October 2023). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK Receipt Date: 15-JUL-2025 The pharmacist reported that a patient received a first dose of the Shingrix vaccine and received the second dose a little bit early in October 2023.  She wanted to know if that was a problem and asked if she needs to get another dose or what was the advice if somebody received the second dose of Shingrix too early. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient were given ADACEL after the excursions with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who were given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] after the excursions with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received Unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection of standard strength (Unknown expiry date) with lot U8232AA via unknown route in unknown administration site for Immunization after the excursions with no reported adverse event (poor quality product administered) (Latency same day)  Reportedly, The previous report stated the vaccines were not administered after the excursions that deemed them no longer suitable for use, but after investigating further she found that 3 patients were given adacel after the excursions  Action taken was not applicable.   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.
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain in extremity, Pyrexia, Rash papular, Rash pruritic
Clinical narrative: PATIENT EXPERIENCED FEVER AND SORE ARM FEW HOURS AFTER VACCINATION.  ON 7/20 NOTICED WIDESPREAD (FROM SHOULDER TO MORE THAN HALF WAY DOWN TO ELBOW) RED, RAISED RASH WITH SOME ITCHINESS.  PATIENT NOT SURE IF SHE GOT IT BEFORE TODAY BUT ONLY NOTICED IT TODAY.  ON AND OFF FEVER AND PAIN MANAGED BY TYLENOL.  MADE APPOINTMENT TO SEE DR BUT NOT UNTIL AUGUST.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine with aura
Clinical narrative: Migraine with aura
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The powdered Shingrix was mixed with a sterile diluent (sterile water) instead of the liquid vial that came in the box. Patient has had no adverse reaction.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: 3rd Dose of HPV vaccine given after previously receiving completed series.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: Patient received shingrix vaccination on 6/6/25. On 7/21/25, the husband reported to me that shortly after the vaccination she began to have shoulder pain and restricted mobility in that arm. She went to the doctor and they referred her to an orthopedic MD. The orthopedic MD diagnosed her with SIRVA and suspects that the cause was due to the vaccine potentially being given too high.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Two weeks post injection (7/11/25) parent called office to report patient complaints of arm throbbing when she's trying to sleep, hurts during the day, and hurts when she lifts her arm. Patient seen 3 days later (7/14/2025) in office for examination as pain was still present.  There was no point tenderness, swelling or redness in her deltoid muscle near site of injection. No pain with passive range of motion.  Treatment with naproxen sodium 220mg AM and 440mg PM since pain was worse in the evening.  Recommended gentle stretching exercises to prevent stiffness, heat and ice depending which makes it feel better.  7/18/2025 Mom called back stating patient was still in discomfort.  Patient was taking naproxen sodium 440mg qhs which helped but not taking the 220mg qam regularly.  Still complaints of "pinching/burning" pain intermittently. Recommended increasing naproxen sodium to 440 mg BID, starting Medrol dose pack and range of motion exercises 2x/day.  Recommended ortho evaluation if not improving.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Laboratory test normal, Mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: Patient experienced severe arm pain with inability to lift arm 1 day after receiving vaccine which continued through 7/14/2025 when evaluated in office
Age: 54.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Burning sensation, Erythema, Limb discomfort, Peripheral swelling, Pruritus
Clinical narrative: 1 week after vaccinations patient came to show us her arms. Left arm had a slight rash with no fever or swelling. Right arm was red, slightly swollen, and feverish. Patient stated that her arms have felt heavy with burning and itching sensations in both.
Age: 54.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: 1 week after vaccinations patient came to show us her arms. Left arm had a slight rash with no fever or swelling. Right arm was red, slightly swollen, and feverish. Patient stated that her arms have felt heavy with burning and itching sensations in both.
Age: 57.0
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Erythema, Fatigue, Headache, Pain
Clinical narrative: extreme low energy, fatigue, weakness, body ache, headache, fever, arm swelling, redness and tenderness
Age: 57.0
Sex: M
Vaccine: PNC20
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: extreme low energy, fatigue, weakness, body ache, headache, fever, arm swelling, redness and tenderness
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Received 0.5 mL dose of Pfizer's Pneumoccal Vaccine (Prevnar-20) IM on 7/16/2025. Slight fever and small rash appeared on 7/17/2025. Then 7/18/2025-7/21/2025, the rash expanded but still only at the area of the administered vaccine. Rash becomes itchy and red. Called primary care doctor about symptoms on 7/21/2025. Doctor office instructed to take Benadryl and ice the area and monitor additional symptoms (must see urgent care if shortness of breath symptoms appear). First dose of Benadryl taken on 7/21/2025 and to monitor symptoms. No evidence of shortness of breath.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hemiparesis, Immediate post-injection reaction, Injection site irritation, Pyrexia
Clinical narrative: Pt had immediate muscle weakness and site irritation. Next morning, pt had fever, headache and more significant muscle weakness on her right side.  By 7/18/25, all symptoms had resolved.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, PNC20, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Client did not experience any adverse events or treatments. The Prevnar 20 Vaccine was inadvertently given instead of the Meningococcal ACWY Vaccine.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Patient presented to the clinic 5 days after receiving PCV20 vaccine in the left upper arm. Noted area had swelling, redness, painful, and itchy. Area measured 3x2 3/4 inches in diameter. No fever, no rash/hives, no SOB, and no N/V noted at the time of her assessment. Ice pack applied. Patient seen by Dr. for further evaluation. Per his orders, patient is to continue applying ice and follow up as needed. No further actions indicated at this time. BP 131/76, Pluse 89, Respirations 18, and Temp. 98.4 oral. O2 pulse Ox 96%.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, PNC20, TDAP, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Prevnar 20 was administered, when the client should have received Meningococcal ACWY vaccines. Client has not experienced any adverse reactions, events, treatments or outcomes.
Age: 59.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Myalgia, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patients states that 3 days after receiving the vaccinations, she started experiencing pain and tingling sensation in her Left Arm from her shoulder down to her wrist (no fingers). Patient also complains of neck pain and pain in the muscle between her shoulder and neck.  Patient has difficulty raising her left arm up without pain. Patient states that it is very difficult for her to sleep because of the pain. She is still experiencing the pain now.
Age: 59.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Sleep disorder
Clinical narrative: Patients states that 3 days after receiving the vaccinations, she started experiencing pain and tingling sensation in her Left Arm from her shoulder down to her wrist (no fingers). Patient also complains of neck pain and pain in the muscle between her shoulder and neck.  Patient has difficulty raising her left arm up without pain. Patient states that it is very difficult for her to sleep because of the pain. She is still experiencing the pain now.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema
Clinical narrative: Pt reported to pharmacy that her arm has a 3 inch diameter red spot.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Activated partial thromboplastin time normal, Blood glucose normal, Full blood count normal, Loss of consciousness, Oral mucosal discolouration
Clinical narrative: 5 minutes after receiving vaccine patient had an episode of vasovagal syncope. Patient lost complete consciousness for 20-30 seconds. Vitals were reassessed. After third attempt was able to obtain BP reading 82/45, blood sugar 94. EMS was called but mom denied transport and stated she would monitor at home. 12 hours after vaccine patient developed a non blanching rash on the anterior rash, petechial in size, given the history of HPV vaccination yesterday, will workup for any reason for petechiae. CBC and PT and PTT ordered which came back normal. About 30 hours after vaccine patient was advised to go to ED due to rash spreading to whole face and black dislocation in the mouth.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Petechiae, Prothrombin time normal, Rash, Syncope
Clinical narrative: 5 minutes after receiving vaccine patient had an episode of vasovagal syncope. Patient lost complete consciousness for 20-30 seconds. Vitals were reassessed. After third attempt was able to obtain BP reading 82/45, blood sugar 94. EMS was called but mom denied transport and stated she would monitor at home. 12 hours after vaccine patient developed a non blanching rash on the anterior rash, petechial in size, given the history of HPV vaccination yesterday, will workup for any reason for petechiae. CBC and PT and PTT ordered which came back normal. About 30 hours after vaccine patient was advised to go to ED due to rash spreading to whole face and black dislocation in the mouth.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Local red reaction on skin. Not treated
Age: 67.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: One day after receiving the vaccines the patient reported swelling, redness, and itching from her shoulder to her elbow. She stated it was very painful. It was recommended that she use OTC Tylenol, Advil, and Benadryl to treat her condition. She has a follow up visit with her PCP on 7/24/25.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram normal, Dizziness, Magnetic resonance imaging normal, Nausea
Clinical narrative: Extreme dizziness and nausea. Dizziness was almost paralyzing. Any movement at all would make me want to throw up. Symptoms occurred almost daily for a week or two. All test results (CT scans, MRIs, etc) were negative. Went to the ER one time.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Unresponsive to stimuli
Clinical narrative: Patient presented to office for a well-child visit.  Patient was finished with exam and visit.  Patient was leaving to go to check out when she stated that she does not feel so good and the clinician that had given patient her vaccine had quickly ran over the patient and lowered her to the floor.  Patient did not hit her head but was unresponsive for a period of time.  911 was called and presented to office to take patient to ED to be evaluated.  Patient did start responding to the provider.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: RASH STARTED 2 DAYS AFTER VACCINATION NO TREATMENT NECESSARY.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Abnormal behaviour, Dyspnoea, Moaning, Pyrexia, Seizure like phenomena
Clinical narrative: Patient was seen today for catch up of 4 month shots. He received vaxelis, pcv 20, and rotovirus around 9:30 AM. Dad stated he woke up from nap at 1pm and was acting "strange", couldn't breath, groaning, fever, would only look one way, seemed like he as in another planet, shaking, acted like a seizure. ER doctor was thinking it was a febrile seizure due to vaccine that was given. Doctor stated to continue to monitor for the next 24 hours and to alternate between tylenol and motrin. Doctor also stated to give one vaccine at a time next visit to see if the reaction happened again and to what vaccine it would happen to.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Staring, Tremor
Clinical narrative: Patient was seen today for catch up of 4 month shots. He received vaxelis, pcv 20, and rotovirus around 9:30 AM. Dad stated he woke up from nap at 1pm and was acting "strange", couldn't breath, groaning, fever, would only look one way, seemed like he as in another planet, shaking, acted like a seizure. ER doctor was thinking it was a febrile seizure due to vaccine that was given. Doctor stated to continue to monitor for the next 24 hours and to alternate between tylenol and motrin. Doctor also stated to give one vaccine at a time next visit to see if the reaction happened again and to what vaccine it would happen to.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: Patient received PCV 21 per report
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia
Clinical narrative: prolonged muscular soreness in arm without paresthesia, sensation changes, or neurovascular compromise
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second today/ Wrong schedule; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 28-APR-2023).   On 14-JUL-2025, the patient received the 2nd dose of Shingrix (right arm). On 14-JUL-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the second today/ Wrong schedule). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 14-JUL-2025 The Registered Nurse reported on behalf of a patient who received her first Shingrix vaccine on April 28th of 2023 and the second dose today which led to drug dose administration interval too long
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: The patient never went back for the second dose of the series; shingles on the back of his left leg hamstring area; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in an elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In AUG-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, the patient received the 2nd dose of Shingrix. In AUG-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: The patient never went back for the second dose of the series). In SEP-2024, the patient experienced shingles (Verbatim: shingles on the back of his left leg hamstring area). In OCT-2024, the outcome of the shingles was resolved (duration 1 month). The outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JUL-2025 The patient received his first dose of Shingrix in August of 2024 left arm. One month later he developed shingles on the back of his left leg hamstring area. The shingles resolved one month after getting the rash. The patient never went back for the second dose of the series which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-JUL-2025, the patient received Shingrix. On 08-JUL-2025, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2025 Patient received the Shingrix vaccine on July 7th 2025 and instantly developed shingles within 24 hours. Patient wanted to know why did this happen as the vaccine is supposedly 100 percent not supposed to cause this. Patient visited their doctor and he was able to explain it. This case was reported by a patient via interactive digital media.
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: i got the Shingrix vaccine in 2019 and mistakenly got the vaccine again today (1st shot); This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 on an unknown date).   On 14-JUL-2025, the patient received Shingrix. On 14-JUL-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: i got the Shingrix vaccine in 2019 and mistakenly got the vaccine again today (1st shot)). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 14-JUL-2025 The patient received the Shingrix vaccine in 2019 and mistakenly got the vaccine again on the reporting day (1st shot), which led to extra dose administered.