chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in the right arm
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given a dose of Hep B, Pentacel and PCV20 erroneously. She was given the same vaccines at 15 months - due to a change in the well child visit schedule this was an oversight
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Rash, Urticaria
Clinical narrative: Mom reported to this writer. Onset of generalized rash ~90 min after immunization. Hives starting on trunk w/ spread to ears, chest, face. Gave OTC
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: Mom reports >24 hr after vaccination, child's arm swollen.
Age: 28.0
Sex: M
Vaccine: ANTH, FLU3, MNQ, YF
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Mouth swelling, Paraesthesia
Clinical narrative: Approximately 15 minutes after receipt of these vaccines patient experienced dizziness and blurred vision. Approximately 1 hour after receipt patient experienced numbness/tingling to face and mouth and felt as if his mouth and throat were swelling. Symptoms improved following receipt of Benadryl 50mg IV x 1 and EpiPen 0.3mg IM x 1.
Age: 28.0
Sex: M
Vaccine: ANTH, FLU3, MNQ, YF
Symptoms: Paraesthesia oral, Pharyngeal swelling, Vision blurred
Clinical narrative: Approximately 15 minutes after receipt of these vaccines patient experienced dizziness and blurred vision. Approximately 1 hour after receipt patient experienced numbness/tingling to face and mouth and felt as if his mouth and throat were swelling. Symptoms improved following receipt of Benadryl 50mg IV x 1 and EpiPen 0.3mg IM x 1.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: fever tmax 104F temporal at home and vomiting
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Hypersomnia, Malaise, Somnolence
Clinical narrative: pt says after about 2 hours after getting the RSV vaccine she became very sleepy. She had malaise and felt very ill with no upper respiratory issues. She took tylenol extended release and went to bed. She has slept alot and her symptoms are better but she has still not totally recovered. She has never felt so bad after getting vaccinated before.
Age: 0.67
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was due for Hep B but was given Hep A
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Vomiting projectile
Clinical narrative: Patient reported severe chills, severe diaphoresis, projectile vomiting, the evening of the vaccination day followed by extreme weakness lasting for 3 days.  Patient did not notify us of these side effects until today (1/23/25) which was over 2 months past the date of vaccination.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: My left upper arm swelled up terribly, bruised, and developed a very hard egg-size knot beside the injection site.  Over the egg-size knot area, my skin was red & hot to touch.   The circumference of the swelling initially was the size of a small grapefruit.  I experienced & continue to experience severe pain and limited range of motion in my left arm.  I keep icing the area and keeping an eye on the injury.  I have never had a reaction like this before.  It wasn't due to my Pharmacy immunizing tech, he did a wonderful job.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: My left upper arm swelled up terribly, bruised, and developed a very hard egg-size knot beside the injection site.  Over the egg-size knot area, my skin was red & hot to touch.   The circumference of the swelling initially was the size of a small grapefruit.  I experienced & continue to experience severe pain and limited range of motion in my left arm.  I keep icing the area and keeping an eye on the injury.  I have never had a reaction like this before.  It wasn't due to my Pharmacy immunizing tech, he did a wonderful job.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Heart rate increased, Hypoaesthesia oral, Pain in extremity, Paraesthesia
Clinical narrative: HAD A SORE ARM FOR THE FIRST 3 DAYS. ON DAY 3 HE NOTICED A RASH ON HIS TORSO, WITH TINGLY HANDS AND A NUMB UPPER LIP. THE PATIENT ALSO HAD MILD CHEST PAIN AND AN INCREASED HEART RATE. TODAY IS DAY 6 AND HE SAYS THAT HE STILL HAS THE SYMPTOMS BUT THEY ARE MILDER THAN WHAT THEY WERE BEFORE.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: HAD A SORE ARM FOR THE FIRST 3 DAYS. ON DAY 3 HE NOTICED A RASH ON HIS TORSO, WITH TINGLY HANDS AND A NUMB UPPER LIP. THE PATIENT ALSO HAD MILD CHEST PAIN AND AN INCREASED HEART RATE. TODAY IS DAY 6 AND HE SAYS THAT HE STILL HAS THE SYMPTOMS BUT THEY ARE MILDER THAN WHAT THEY WERE BEFORE.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Injection Reaction. Started the same day. Large Bruise. As of 01/20/2025, bruise has not cleared.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dry mouth, Hyperhidrosis, Respiratory tract congestion
Clinical narrative: Sweating, dry mouth within 1 hour of receiving vaccine. Patient went into hospital. Had chest congestion and required antibiotics. Had cough.
Age: 62.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chest pain, Ear pain
Clinical narrative: December 10th:  I began having left sided neck pain which progressed into left shoulder, chest and back pain over the next few days to the point I couldn?t sleep.   December 14th:  I called MD Live and completed a virtual visit for the left shoulder, arm, pectoral, and scapula pain.  At that time I had full range of motion and no loss of strength in the left arm.  I received and started a medrol dose pack that afternoon.   I was taking Tylenol round the clock for pain with little relief and was also using Voltaren cream on the affected shoulder.  The pain was excruciating and constant..December 16th: in the evening I began applying the Voltaren cream to my shoulder and felt what appeared to be a rash which covered my left shoulder, ran across the top of the left side of my back and down past my antecubital area on my left arm.  I also began to lose muscle strength in my left arm and the pain extended into the left side of my face and external left ear. December 17th:  I came to the office and saw Dr who confirmed the muscle weakness in the left arm and indicated the rash looked liked shingles.  She sent me to the ER for further evaluation and MRI.  The MRI confirmed Parsonage Turner syndrome.  I was started on Acyclovir for the shingles, pain and sleeping meds. The rash subsided over the course of the next 2 weeks but the pain and weakness persisted. January 8:  I saw the Neurologist and had a nerve conduction test performed which confirmed the upper brachial plexus was ?75%? gone but also indicated the nerves were already beginning to regenerate.  She prescribed Amyltriptiline for the nerve pain and  physical therapy.  She recommended I return in 6 weeks.  January 14:  I began having some relief from the nerve pain January 20:  Most of the pain has subsided, continue to have weakness but feel like I?m regaining some strength in the left arm.
Age: 62.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Facial pain, Inflammation, Magnetic resonance imaging abnormal, Muscle strain, Muscular weakness
Clinical narrative: December 10th:  I began having left sided neck pain which progressed into left shoulder, chest and back pain over the next few days to the point I couldn?t sleep.   December 14th:  I called MD Live and completed a virtual visit for the left shoulder, arm, pectoral, and scapula pain.  At that time I had full range of motion and no loss of strength in the left arm.  I received and started a medrol dose pack that afternoon.   I was taking Tylenol round the clock for pain with little relief and was also using Voltaren cream on the affected shoulder.  The pain was excruciating and constant..December 16th: in the evening I began applying the Voltaren cream to my shoulder and felt what appeared to be a rash which covered my left shoulder, ran across the top of the left side of my back and down past my antecubital area on my left arm.  I also began to lose muscle strength in my left arm and the pain extended into the left side of my face and external left ear. December 17th:  I came to the office and saw Dr who confirmed the muscle weakness in the left arm and indicated the rash looked liked shingles.  She sent me to the ER for further evaluation and MRI.  The MRI confirmed Parsonage Turner syndrome.  I was started on Acyclovir for the shingles, pain and sleeping meds. The rash subsided over the course of the next 2 weeks but the pain and weakness persisted. January 8:  I saw the Neurologist and had a nerve conduction test performed which confirmed the upper brachial plexus was ?75%? gone but also indicated the nerves were already beginning to regenerate.  She prescribed Amyltriptiline for the nerve pain and  physical therapy.  She recommended I return in 6 weeks.  January 14:  I began having some relief from the nerve pain January 20:  Most of the pain has subsided, continue to have weakness but feel like I?m regaining some strength in the left arm.
Age: 62.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Nerve conduction studies abnormal, Neuralgia
Clinical narrative: December 10th:  I began having left sided neck pain which progressed into left shoulder, chest and back pain over the next few days to the point I couldn?t sleep.   December 14th:  I called MD Live and completed a virtual visit for the left shoulder, arm, pectoral, and scapula pain.  At that time I had full range of motion and no loss of strength in the left arm.  I received and started a medrol dose pack that afternoon.   I was taking Tylenol round the clock for pain with little relief and was also using Voltaren cream on the affected shoulder.  The pain was excruciating and constant..December 16th: in the evening I began applying the Voltaren cream to my shoulder and felt what appeared to be a rash which covered my left shoulder, ran across the top of the left side of my back and down past my antecubital area on my left arm.  I also began to lose muscle strength in my left arm and the pain extended into the left side of my face and external left ear. December 17th:  I came to the office and saw Dr who confirmed the muscle weakness in the left arm and indicated the rash looked liked shingles.  She sent me to the ER for further evaluation and MRI.  The MRI confirmed Parsonage Turner syndrome.  I was started on Acyclovir for the shingles, pain and sleeping meds. The rash subsided over the course of the next 2 weeks but the pain and weakness persisted. January 8:  I saw the Neurologist and had a nerve conduction test performed which confirmed the upper brachial plexus was ?75%? gone but also indicated the nerves were already beginning to regenerate.  She prescribed Amyltriptiline for the nerve pain and  physical therapy.  She recommended I return in 6 weeks.  January 14:  I began having some relief from the nerve pain January 20:  Most of the pain has subsided, continue to have weakness but feel like I?m regaining some strength in the left arm.
Age: 62.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Neuralgic amyotrophy, Osteoarthritis, Pain in extremity, Rash, Rash vesicular
Clinical narrative: December 10th:  I began having left sided neck pain which progressed into left shoulder, chest and back pain over the next few days to the point I couldn?t sleep.   December 14th:  I called MD Live and completed a virtual visit for the left shoulder, arm, pectoral, and scapula pain.  At that time I had full range of motion and no loss of strength in the left arm.  I received and started a medrol dose pack that afternoon.   I was taking Tylenol round the clock for pain with little relief and was also using Voltaren cream on the affected shoulder.  The pain was excruciating and constant..December 16th: in the evening I began applying the Voltaren cream to my shoulder and felt what appeared to be a rash which covered my left shoulder, ran across the top of the left side of my back and down past my antecubital area on my left arm.  I also began to lose muscle strength in my left arm and the pain extended into the left side of my face and external left ear. December 17th:  I came to the office and saw Dr who confirmed the muscle weakness in the left arm and indicated the rash looked liked shingles.  She sent me to the ER for further evaluation and MRI.  The MRI confirmed Parsonage Turner syndrome.  I was started on Acyclovir for the shingles, pain and sleeping meds. The rash subsided over the course of the next 2 weeks but the pain and weakness persisted. January 8:  I saw the Neurologist and had a nerve conduction test performed which confirmed the upper brachial plexus was ?75%? gone but also indicated the nerves were already beginning to regenerate.  She prescribed Amyltriptiline for the nerve pain and  physical therapy.  She recommended I return in 6 weeks.  January 14:  I began having some relief from the nerve pain January 20:  Most of the pain has subsided, continue to have weakness but feel like I?m regaining some strength in the left arm.
Age: 62.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Sleep disorder
Clinical narrative: December 10th:  I began having left sided neck pain which progressed into left shoulder, chest and back pain over the next few days to the point I couldn?t sleep.   December 14th:  I called MD Live and completed a virtual visit for the left shoulder, arm, pectoral, and scapula pain.  At that time I had full range of motion and no loss of strength in the left arm.  I received and started a medrol dose pack that afternoon.   I was taking Tylenol round the clock for pain with little relief and was also using Voltaren cream on the affected shoulder.  The pain was excruciating and constant..December 16th: in the evening I began applying the Voltaren cream to my shoulder and felt what appeared to be a rash which covered my left shoulder, ran across the top of the left side of my back and down past my antecubital area on my left arm.  I also began to lose muscle strength in my left arm and the pain extended into the left side of my face and external left ear. December 17th:  I came to the office and saw Dr who confirmed the muscle weakness in the left arm and indicated the rash looked liked shingles.  She sent me to the ER for further evaluation and MRI.  The MRI confirmed Parsonage Turner syndrome.  I was started on Acyclovir for the shingles, pain and sleeping meds. The rash subsided over the course of the next 2 weeks but the pain and weakness persisted. January 8:  I saw the Neurologist and had a nerve conduction test performed which confirmed the upper brachial plexus was ?75%? gone but also indicated the nerves were already beginning to regenerate.  She prescribed Amyltriptiline for the nerve pain and  physical therapy.  She recommended I return in 6 weeks.  January 14:  I began having some relief from the nerve pain January 20:  Most of the pain has subsided, continue to have weakness but feel like I?m regaining some strength in the left arm.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient and her wife came in together and asked for an RSV vaccine because their adult daughter has been severely ill with RSV for a month. They are under 75 years old, so I informed them that it was no longer indicated unless they had increased risk. They both said they were diabetic and in their late 60's so wanted to go ahead and get vaccinated. I asked if they had ever gotten an RSV shot, both indicated that they had not, and our pharmacy software also did not show that they had gotten it as far back as our profiles show. We administered the vaccine to each of them. The next day, we were informed by our corporate that they both had already received this vaccine on 10/7/23. I informed the patients. They did not realize they had ever received it. They were not upset, and they were not experiencing any adverse reactions. They are doing well but know to follow up if anything changes.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient expressed concern after the immunization that it was provided too high (provided by a technician under RPH guidance).  On 1/22/25 patient reported to us that she had significant arm pain beginning the next day along with numbness from the shoulder to the fingers.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; an infant received their first dose of ROTATEQ at 19 weeks of age instead of the recommended 6-12 weeks; This spontaneous report was received from a nurse and refers to a 19-week-old (also reported as 5-month-old) patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-DEC-2024, at 19 weeks of age instead of the recommended 6-12 weeks as outlined in the prescribing information, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml / series, administered orally for prophylaxis (lot #2032353, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 21-OCT-2025; strength was not provided) (Inappropriate schedule of product administration). No symptomatic events were reported. No additional information was provided. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: dose of expired Engerix-B was administered to the pateint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (expiry date 01-AUG-2024) for prophylaxis.   On 26-DEC-2024, the patient received Engerix B. On 26-DEC-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: dose of expired Engerix-B was administered to the pateint). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-DEC-2024 The manager of an urgent care reported that a dose of Engerix-B was expired, and a medical assistant administered it to a patient which led to, expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had a shingrix 2019 and last in 2024.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Had a shingrix 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Had a shingrix 2019 and last in 2024.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-JAN-2025 The reporter had a Shingrix 2019 and last in 2024.  The reporter asked does he/she still need a third shot. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Only dministered the shingrix vaccine as solution with no powder; Only dministered the shingrix vaccine as solution with no powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: Only dministered the shingrix vaccine as solution with no powder) and inappropriate dose of vaccine administered (Verbatim: Only dministered the shingrix vaccine as solution with no powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-DEC-2024  The reporter had visited with the patient and went to administer the Shingrix but only administered the solution with no powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter said that it was a general question as however when asking if a patient was administered and she was defensive when asking for safety data.  No further data was collected.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix 2 years ago/ Can she get the second dose now; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago on an unknown date).   On an unknown date, the did not  patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix 2 years ago/ Can she get the second dose now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-DEC-2024  The pharmacist called to ask if a patient could get the second dose of Shingrix, if the first dose was 2 years ago. The reporter wanted to know did patient needs to repeat the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site swelling, Pain in extremity, Peripheral swelling, Vertigo
Clinical narrative: Bump where the injection was given; Swollen arm; Very painful arm, arm is a little sore; Spinning; Dizziness/when she would lie down and close her eyes, the dizziness did not stop; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax on an unknown date ). Concurrent medical conditions included herpes zoster.   On 21-DEC-2024, the patient received the 1st dose of Shingrix (right arm). In DEC-2024, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Bump where the injection was given), swelling arm (Verbatim: Swollen arm), pain in arm (Verbatim: Very painful arm, arm is a little sore), spinning sensation (Verbatim: Spinning) and dizziness (Verbatim: Dizziness/when she would lie down and close her eyes, the dizziness did not stop). The outcome of the injection site swelling, swelling arm and pain in arm were not resolved and the outcome of the spinning sensation and dizziness were resolved.   It was unknown if the reporter considered the injection site swelling, swelling arm, pain in arm, spinning sensation and dizziness to be related to Shingrix.     It was unknown if the company considered the injection site swelling, swelling arm, pain in arm, spinning sensation and dizziness to be related to Shingrix.   Additional Information: GSK receipt date: 30-DEC-2024 The patient received the first dose of Shingrix and experienced a very painful arm, swollen arm, and a bump where the injection was given. On this day, the patient stated the arm was a little sore, a little swollen, and a little bump where the injection was given. About 3 to 4 days after the vaccine was given, that patient experienced dizziness, and spinning, night time was worse. Even when she would lie down and close her eyes, the dizziness does not stop and the dizziness had since resolved.
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 6 month old patient received an adult dose of Havrix; 6 month old patient received an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HAV (Havrix) (batch number Z27PB, expiry date 27-AUG-2026) for prophylaxis.   On 27-DEC-2024, the patient received Havrix. On 27-DEC-2024, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: 6 month old patient received an adult dose of Havrix) and adult product administered to child (Verbatim: 6 month old patient received an adult dose of Havrix). The outcome of the overdose and adult product administered to child 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: 07-JAN-2025 The nurse reported a 6 month old patient received an adult dose of Havrix which led to adult product administered to child and overdose. The vaccine administration facility was the same as primary reporter.
Age: 67.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo 1 vial was administered to a patient  over 55years of age; 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 67-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 7gf79, expiry date 31-DEC-2025) for prophylaxis.   On 15-NOV-2024, the patient received Menveo. On 15-NOV-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo 1 vial was administered to a patient  over 55years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2025 The pharmacist called reporting Menveo 1 vial was administered to a patient over 55 years of age. The patient received it because she was going to be starting on a complement inhibitor. The pharmacist did not know if patient started treatment with this medication as she was waiting on the vaccines.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: pin in left arm injection site; shivering; achiness; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 15-JAN-2025, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pin in left arm injection site), shivering (Verbatim: shivering), pain (Verbatim: achiness) and headache (Verbatim: headache). The outcome of the injection site pain, shivering, pain and headache were not resolved.   It was unknown if the reporter considered the injection site pain, shivering, pain and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, shivering, pain and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2022174220   Additional Information: GSK Receipt Date: 15-JAN-2025 Patient received his second Shingrix vaccine on 14-JAN-2025 and experienced symptoms 24 hours later of shivering, achiness, headache and left arm painful.  These symptoms were not resolved. For tolerance of first dose refer case US2022174220.; Sender's Comments:  US-GSK-US2022174220:Same patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune disorder, Interstitial lung disease
Clinical narrative: autoimmune disease; autoimmune disease with interstitial lung disease; This serious case was reported by a pharmacist via call center representative and described the occurrence of autoimmune disorder in a elderly female 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 autoimmune disorder (Verbatim: autoimmune disease) (serious criteria GSK medically significant) and interstitial lung disease (Verbatim: autoimmune disease with interstitial lung disease) (serious criteria GSK medically significant). The patient was treated with rituximab (Rituxan). The outcome of the autoimmune disorder and interstitial lung disease were unknown.   It was unknown if the reporter considered the autoimmune disorder and interstitial lung disease to be related to Shingrix and Shingrix.     The company considered the autoimmune disorder and interstitial lung disease to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2025 Pharmacist stated she had a patient that completed Shingrix series in 2020.  The patient had an autoimmune disease with interstitial lung disease and was receiving Rituxin infusions. Pharmacist stated she really was not sure if the autoimmune disease was present before Shingrix series was administered, but she thought it was a newer development as the Rituxin was new for the patient.  The pharmacist could no longer recall the name of the patient, so she was unable to look in the patient's records to locate the exact date of Shingrix doses.  The only patient specific information the pharmacist could provide was that this was a female patient in her 80s. The patient decided to not receive any further Shingrix dosing. The pharmacist was inquiring about recommendations on repeating the series in patients receiving Rituxin, as the patient's physician had mentioned finding guidelines that advised repeating.  Following an internal meeting on 15-January-2025, it was realized that clarification was needed to determine if the autoimmune condition with interstitial lung disease was pre-existing, or occurred after the Shingrix series, so an outbound call was placed back to the pharmacist on 15- January -2025. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Autoimmune disorder and Interstitial lung disease are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever/ started fever within one hour and could not break it; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever/ started fever within one hour and could not break it) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/ started fever within one hour and could not break it) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever/ started fever within one hour and could not break it) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had no medical history, concomitant disease or risk factor.  Reporter causality was not reported. The patient did not experience any additional symptoms or events. There were no lab data or results available.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2025: Live significant follow-up information received contains reporter's state, event verbatim and event seriousness criteria added as medically significant, and additional references were added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: the glass tip broke so they were not able to draw it from the vial; The initial case was missing the following minimum criteria: no adverse event (Product complaint only - the vaccine was not administered to the patient). Upon receipt of follow-up information on 10Jan2025, this case now contains all required information to be considered valid (reportability assessment received).  This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  An 83-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), described as "the glass tip broke so they were not able to draw it from the vial".  Additional information: A pharmacist reporter reported that he would like to get a replacement for an Abrysvo vaccine because when trying to administer it, the glass tip broke so they were not able to draw it from the vial and the patient was not able to get vaccinated because this was their only remaining dose. The presentation of this Abrysvo was the little sealed vacuum one with the vial and one cap and one syringe and it was not the pack of five. The reporter discarded the antigen vial, vial adaptor, diluent syringe and has no lots, expiry dates, NDC numbers or manufacturer names to provide from those components to provide; however, the reporter kept the box with the box lot number. The box was not damaged and was not squished. The complaint sample was not available to return.  The reporter considered "the glass tip broke so they were not able to draw it from the vial" not related to rsv vaccine prot.subunit pref 2v. Causality for "the glass tip broke so they were not able to draw it from the vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller mentioned she has had Covid before and taken Paxlovid; Caller mentioned she has had Covid before and taken Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0161) and on 03May2021 as dose 2, single (Lot number: EW0176) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (regular vitamins and hormone replacement therapy). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller mentioned she has had Covid before and taken Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2025) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chills, Computerised tomogram, Monoplegia, Somnolence
Clinical narrative: chills; falling asleep; tried to get up but had no function in left leg; strokes; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure", start date: 2019 (ongoing). The patient's concomitant medications were not reported. The following information was reported: MONOPLEGIA (medically significant) with onset Jan2021, outcome "unknown", described as "tried to get up but had no function in left leg"; CHILLS (non-serious) with onset 26Jan2021, outcome "unknown"; SOMNOLENCE (non-serious) with onset 26Jan2021, outcome "unknown", described as "falling asleep"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "strokes". The events "tried to get up but had no function in left leg", "chills" and "falling asleep" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Feb2021) Two strokes. Clinical course: The patient was one of the first to get the shot, when they said it was safe to take. The patient had two strokes from the Pfizer COVID shot. It all started on 26Jan2021, the day after taking the first Pfizer COVID shot. The patient was sitting and started having chills and drove home. He was falling asleep and had chills driving home. It was freezing, so he put a blanket around. The patient didn't get up for three days, tried to get up but had no function in left leg. They missed the stokes when the patient went to emergency room, they were looking for Guillain-Barre, so they didn't catch a stroke. Patient's doctor sent him to neurologist,who did CT scan on the first week in Feb2021 and found two strokes.  The lot number for BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administering an expired Engerix-B vaccine to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-day-old female patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 03-JAN-2025, the patient received Engerix B pediatric. On 03-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: administering an expired Engerix-B vaccine 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: 03-JAN-2025 Reporter requested information and reported adverse events after administering an expired Engerix-B vaccine to a patient on 03-JAN-2025 which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have Covid; I have Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A 53-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunisation; Bnt162b2 (DOSE 2), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have Covid". Clinical course: The patient was requesting financial assistance to get PAXLOVID for Covid. She got Covid at work after she got 2 Pfizer shots and a booster.  The lot number for BNT162b2 omicron (kp.2), was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: I have been nauseous and vomiting since the injection
Age: 0.58
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Cough, Gastrooesophageal reflux disease, Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: This was for pneumococcal vaccine and flu booster.Vomiting, high fever (102), runny nose, coughing, reflux and shaking
Age: 0.58
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Vomiting
Clinical narrative: This was for pneumococcal vaccine and flu booster.Vomiting, high fever (102), runny nose, coughing, reflux and shaking
Age: 2.17
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Decreased appetite, Extra dose administered
Clinical narrative: New patient to clinic. Record ahowed one Hep A dose given on 11/10/23. Dose given 1/14/25. Upon receipt of vaccine record, patient already had second Hep A on 5/24/24. Discussed case with employee at Health Dept and she emailed literature for mother to review. Patient doing well although she had a decresed appetite and complained that she had occasional abdominal pain for 2-3 days. This report is to document that patient had a third Hep A vaccine.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Pain at arm,  pain at muscle at other parts of body,  headache, fever,  nasal discharge ,taking Tylenol 500mg two times so far, all symptoms still persistent  at end of second day.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Erythema, Induration, Malaise, Pyrexia
Clinical narrative: pt states she had a fever/chills start at 2 am in the morning after vaccine. arm became red and hard. By Wednesday she developed hives  all over her body , all over malaise for about 1 week. pt had virtual appoint with MD on 1/19/25. md dis not want to give pt steroids as to not interfere with immune response
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Urticaria
Clinical narrative: pt states she had a fever/chills start at 2 am in the morning after vaccine. arm became red and hard. By Wednesday she developed hives  all over her body , all over malaise for about 1 week. pt had virtual appoint with MD on 1/19/25. md dis not want to give pt steroids as to not interfere with immune response
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was given dose IM, not SQ. No adverse reactions reported as of 4  hours after administration
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested to receive an RSV vaccination.  Pharmacist did not realize that patient had already received an  RSV shot (Arexvy on 11/25/2023).  So patient has now received two RSV shots when only one is recommended.  Patient has not reported any adverse events from either shot.  Reporting because patient received two RSV shots when one is recommended.
Age: 73.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: There was not an actual event. Patient received 2 doses of Prevnar20 within 1.5 years of each other. We were not aware that he had gotten a Prevnar20 shot on 5/26/2023 and patient had requested to get same shot on 1/17/2025.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Pain for over 24 hours followed by large red swelling covering over half her thigh
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Provider stated that she had a patient syncopize on exam table after a dose of gardasil 9 this past year. She said the patient remained alert and recovered. No injury noted.; This spontaneous report was received from Physician via Company Representative referred to a 16-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, dose number, frequency, scheme, lot #, expiry date, route of administration, and anatomical location were not provided).  On an unknown date in 2024, the reporter stated that she had a patient syncopize on exam table after the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (syncope), and reported that the patient remained alert and recovered on an unknown date; it was also reported that no injury was noted.   The reporter did not assess the causal relationship between the syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection.   Upon internal review syncope was determined to be medically significant event.  Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: third dose received on 24-mar2004; 2nd dose received on 13-nov-2002; first dose received on 27-SEP-2002; This spontaneous report was received from other health care professional  from a medical record, from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (MARRS # 2501USA005583) and concerns male patient (transgender) of 11 weeks old. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-SEP-2002, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). On 13-NOV-2002, the patient received  2nd dose administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered) On 24-MAR-2004, the patient received the third dose administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered).  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2501USA005583: