chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Disability, Ear pain, Eyelid function disorder, Facial paralysis
Clinical narrative: Experience earaches, jaw aches, and numbness on the right side of her face/unable to close her right eye and was diagnosed with Bell's Palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around 04-MAY-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).   On 04-JUN-2016 (reported as "Approximately one (1) month after"), the pt began to experience earaches, jaw aches, and numbness on the right side of her face. The pt was unable to close her right eye and was diagnosed with Bell's Palsy on or about 30-JUN-2016. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental risks, mental anguish, including diminished enjoyment of life, and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and suffered incurred other losses and damages. The outcome of Bell's Palsy was not recovered, the pt continued to suffer from right side facial paralysis. The event was considered to be related to the suspect vaccine and to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in jaw
Clinical narrative: Experience earaches, jaw aches, and numbness on the right side of her face/unable to close her right eye and was diagnosed with Bell's Palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around 04-MAY-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).   On 04-JUN-2016 (reported as "Approximately one (1) month after"), the pt began to experience earaches, jaw aches, and numbness on the right side of her face. The pt was unable to close her right eye and was diagnosed with Bell's Palsy on or about 30-JUN-2016. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental risks, mental anguish, including diminished enjoyment of life, and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and suffered incurred other losses and damages. The outcome of Bell's Palsy was not recovered, the pt continued to suffer from right side facial paralysis. The event was considered to be related to the suspect vaccine and to be disabling.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE reported; HCP called to report T/E for PROQUAD. PROQUAD outcome was Supported. HCP stated it was administered to a patient. No additional AE reported. No PQC reported.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 29-SEP-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number  X009733, expiration date 02-SEP-2024 (dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP called to report T/E for VARIVAX. VARIVAX outcome was Supported. HCP stated it was administered to a patient. No additional AE reported. No PQC reported.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 29-SEP-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number X006983, expiration date 07-MAR-2025 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no side effects; an expired dose of PNEUMOVAX23 that was administered. It expired on 01-OCT-2023 but was administered to a patient today 02-OCT-2023; This spontaneous report was received from Pharmacist referring to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #W021636, expiration date: 01-OCT-2023 (Expired product administered), administered for prophylaxis (strength, and route of administration were not provided). Confirmed no prior temperature excursion, no side effects, no symptoms.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Product expired on 09/30/2023 and was administered on 10/03/2023. No additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 30-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, unk, lot #W019533, expiration date: 30-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 03-OCT-2023, HCP called to report inadvertent administration of expired PNEUMOVAX 23 to a patient. Product expired on 30-SEP-2023 and was administered on 03-OCT-2023. No additional AE/PQC.
Sex: F
Vaccine: FLUR3, PPV, VARZOS
Symptoms: Blister, Blister rupture, Bone disorder, Chills, Erythema
Clinical narrative: morning of 9/21/2023 "not feeling right."; turned into a knot on her left arm; fever; headache; body ache; chills; "felt like their bones were cracking"; the patient developed red mark; patient reported that they had bleeding at the site on left arm immediately after the injections; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; This spontaneous report was received from a pharmacist and refers to a 60-year-old female.  The patient's medical history included  pulmonary hypertension,  osteoporosis, and herniated disc. The patient's concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided); varicella zoster vaccine rge (cho) (SHINGRIX), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided); and  influenza vaccine rha 3v (baculovirus) (FLUBLOK), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided).  On 20-SEP-2023, the patient developed bleeding at site on the left arm immedistely after the injection. Then on morning on 21-SEP-2023, she woke up "not feeling right". On the same date at the afternoon, patient had developed a red mark that turned into a knot on her left arm and had a fever, headache, body ache, chills, and "felt like their bones were cracking." Caller stated the patient reported that the knot continued to get bigger for several days and cold and warm compresses only made it worse. Patient then reported that after several days she developed a blister on top of the knot on the left arm which has now "popped and is peeling." Caller stated that in her opinion the site appears to be improving and the patient stated "it is still a big knot but it is smaller than it was before." At the time of reporting, the patient was recovering from the all adverse events.    The causal relationship between all adverse events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: F
Vaccine: FLUR3, PPV, VARZOS
Symptoms: Feeling abnormal, Headache, Immediate post-injection reaction, Injection site haemorrhage, Nodule
Clinical narrative: morning of 9/21/2023 "not feeling right."; turned into a knot on her left arm; fever; headache; body ache; chills; "felt like their bones were cracking"; the patient developed red mark; patient reported that they had bleeding at the site on left arm immediately after the injections; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; This spontaneous report was received from a pharmacist and refers to a 60-year-old female.  The patient's medical history included  pulmonary hypertension,  osteoporosis, and herniated disc. The patient's concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided); varicella zoster vaccine rge (cho) (SHINGRIX), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided); and  influenza vaccine rha 3v (baculovirus) (FLUBLOK), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided).  On 20-SEP-2023, the patient developed bleeding at site on the left arm immedistely after the injection. Then on morning on 21-SEP-2023, she woke up "not feeling right". On the same date at the afternoon, patient had developed a red mark that turned into a knot on her left arm and had a fever, headache, body ache, chills, and "felt like their bones were cracking." Caller stated the patient reported that the knot continued to get bigger for several days and cold and warm compresses only made it worse. Patient then reported that after several days she developed a blister on top of the knot on the left arm which has now "popped and is peeling." Caller stated that in her opinion the site appears to be improving and the patient stated "it is still a big knot but it is smaller than it was before." At the time of reporting, the patient was recovering from the all adverse events.    The causal relationship between all adverse events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: F
Vaccine: FLUR3, PPV, VARZOS
Symptoms: Pain, Pyrexia, Skin exfoliation
Clinical narrative: morning of 9/21/2023 "not feeling right."; turned into a knot on her left arm; fever; headache; body ache; chills; "felt like their bones were cracking"; the patient developed red mark; patient reported that they had bleeding at the site on left arm immediately after the injections; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; he developed a blister on top of the knot on the left arm which has now "popped and is peeling; This spontaneous report was received from a pharmacist and refers to a 60-year-old female.  The patient's medical history included  pulmonary hypertension,  osteoporosis, and herniated disc. The patient's concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided); varicella zoster vaccine rge (cho) (SHINGRIX), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided); and  influenza vaccine rha 3v (baculovirus) (FLUBLOK), 1 dose, administered intramuscularly for prophylaxis (strength, formulation, lot #, and expiry date were not provided).  On 20-SEP-2023, the patient developed bleeding at site on the left arm immedistely after the injection. Then on morning on 21-SEP-2023, she woke up "not feeling right". On the same date at the afternoon, patient had developed a red mark that turned into a knot on her left arm and had a fever, headache, body ache, chills, and "felt like their bones were cracking." Caller stated the patient reported that the knot continued to get bigger for several days and cold and warm compresses only made it worse. Patient then reported that after several days she developed a blister on top of the knot on the left arm which has now "popped and is peeling." Caller stated that in her opinion the site appears to be improving and the patient stated "it is still a big knot but it is smaller than it was before." At the time of reporting, the patient was recovering from the all adverse events.    The causal relationship between all adverse events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: F
Vaccine: HEPAB
Symptoms: Injury
Clinical narrative: suffered injuries due to the Twinrix Vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injury in a female patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced injury (Verbatim: suffered injuries due to the Twinrix Vaccine). The outcome of the injury was not reported.   The reporter considered the injury to be related to Twinrix and hepatitis A and hepatitis B vaccine pre-filled syringe device.     The company considered the injury to be related to Twinrix and hepatitis A and hepatitis B vaccine pre-filled syringe device.   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: 25-SEP-2023  The patient self-reported this case. The patient who was alleging that she suffered injuries due to the Twinrix vaccine administered at pharmacy location.  Through their initial investigation, they have determined the above-referenced that GlaxoSmithKline manufactured the Twinrix vaccine that administered to the patient, resulting in side-effects for the patient.  The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site swelling
Clinical narrative: injection site large; Shingles; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (on 12th July, 2023 received 1st dose, reference case US2023131685). Concurrent medical conditions included hypertension and cholesterol. Concomitant products included amlodipine, atorvastatin, finasteride, tamsulosin and losartan.   On 22-SEP-2023, the patient received the 2nd dose of Shingrix. On 23-SEP-2023, 1 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). On 25-SEP-2023, the patient experienced injection site swelling (Verbatim: injection site large).  The outcome of the injection site swelling was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the injection site swelling and shingles to be related to Shingrix.     It was unknown if the company considered the injection site swelling and shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2023131685   Additional Information: GSK receipt date: 25-SEP-2023 The patient had the site was as large as a silver dollar. The (Shingles) symptoms were treated. The reporter consented to follow up. The case is linked with US2023131685, by same reporter.; Sender's Comments:  US-GSK-US2023131685:Original Case : US2023131685 US-GSK-US2023131685:Original Case : US2023131685 US-GSK-US2023AMR136610:2nd dose case
Sex: M
Vaccine: RVX
Symptoms: Myalgia, Streptococcus test positive
Clinical narrative: muscle pain; Elevated Antistreptolysin O (ASO); This non-serious case was reported by a consumer via sales rep and described the occurrence of muscle pain in a elderly male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Additional patient notes included No symptoms of strep throat.   On an unknown date, the patient received RSV vaccine. On an unknown date, less than a week after receiving RSV vaccine, the patient experienced muscle pain (Verbatim: muscle pain) and antistreptolysin o increased (Verbatim: Elevated Antistreptolysin O (ASO)).  The outcome of the muscle pain was not reported and the outcome of the antistreptolysin o increased was unknown.   It was unknown if the reporter considered the muscle pain and antistreptolysin o increased to be related to RSV vaccine.     It was unknown if the company considered the muscle pain and antistreptolysin o increased to be related to RSV vaccine.   Additional Information: GSK Receipt date: 25-SEP-2023 Reporter was uncertain of patient's exact age, but thought he was in 70 to 79 year age range. The reporter reported that the older adult patient went for well check one week after RSV vaccine (brand not reported) and reported muscle pain, elevated or high ASO level. No symptoms of strep throat. Reporter reported that physician ordered bloodwork for patient. Reporter worked at GSK and asked about her friend's results. The follow-up could not be possible as the as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: since Shingrix vaccination, phantom pains were significantly reduced; This non-serious case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included amputee and phantom pain.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: since Shingrix vaccination, phantom pains were significantly reduced).  The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt date: 25-SEP-2023 The patient was self-reported. After his initial vaccine with Shingrix, he had a noticeable decrease in incidents of phantom pain which  always suspected may had been a result of a virus.  This product could be a potential help with these symptoms among some amputees.  The patient was amputee, since Shingrix vaccination, phantom pains were significantly reduced. The symptoms was not treated. The reporter had permission to contact.
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain, Erythema, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle soreness; Low fever; Abdominal pain; Tiredness; Redness on neck and face;; This non-serious case was reported by a other health professional via sales rep and described the occurrence of muscle soreness in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle soreness (Verbatim: Muscle soreness), fever (Verbatim: Low fever), abdominal pain (Verbatim: Abdominal pain), tiredness (Verbatim: Tiredness) and erythema (Verbatim: Redness on neck and face;).  The outcome of the muscle soreness, fever, abdominal pain, tiredness and erythema were resolved (duration 1 day).   It was unknown if the reporter considered the muscle soreness, fever, abdominal pain, tiredness and erythema to be related to Arexvy.     It was unknown if the company considered the muscle soreness, fever, abdominal pain, tiredness and erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter reported that the patient received Arexvy vaccine and experienced low fever for a few hours, muscle soreness, abdominal pain, tiredness, redness on neck and face all recovered the following day of the adverse events onset. The reporter did not consent to follow up.
Sex: U
Vaccine: RVX
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: sore arm; achy joints; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm) and joint pain (Verbatim: achy joints).  The outcome of the pain in arm and joint pain were resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm and joint pain to be related to RSV vaccine.     It was unknown if the company considered the pain in arm and joint pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-SEP-2023 The patient got RSV vaccine and for 3 days had a sore arm and achy joints.
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Arthritis, Condition aggravated
Clinical narrative: Reporter experienced flare up of arthritis after receiving the vaccine; Reporter experienced joint pain after receiving the vaccine; This non-serious case was reported by a consumer via sales rep and described the occurrence of flare up of arthritis in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced flare up of arthritis (Verbatim: Reporter experienced flare up of arthritis after receiving the vaccine) and joint pain (Verbatim: Reporter experienced joint pain after receiving the vaccine).The outcome of the flare up of arthritis and joint pain were resolved (duration 5 days).   It was unknown if the reporter considered the flare up of arthritis and joint pain to be related to Arexvy.   It was unknown if the company considered the flare up of arthritis and joint pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter experienced flare up of arthritis and joint pain after receiving the Arexvy vaccine. This resolved over the next 5 days. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was administered with the  Covid Vaccine 2023-2024.  The vaccine is a 3 dose multi dose vial.  This was not diluted with the Sodium Chloride.  Pt received .3  ml of the Covid vaccine of the vial undiluted.    Patient's mother was notified and patient did not have any adverse reactions.
Sex: M
Vaccine: RVX
Symptoms: Mobility decreased
Clinical narrative: he lost movement of his arm for 24 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced mobility decreased (Verbatim: he lost movement of his arm for 24 hours).  The outcome of the mobility decreased was resolved (duration 24 hrs).   It was unknown if the reporter considered the mobility decreased to be related to RSV vaccine.     It was unknown if the company considered the mobility decreased to be related to RSV vaccine.   Additional Information: GSK Receipt date: 25-SEP-2023 This case was reported by patient via interactive digital media. The reporter reported that her husband got ours and he lost movement of his arm for 24 hours. Follow up was not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR133372:same reporter, different patient
Sex: M
Vaccine: VARZOS
Symptoms: Brain fog, Fatigue, Headache
Clinical narrative: headache; fatigue; brain fog; This non-serious case was reported by a physician via sales rep and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced headache (Verbatim: headache), fatigue (Verbatim: fatigue) and brain fog (Verbatim: brain fog).  The outcome of the headache, fatigue and brain fog were not reported.   It was unknown if the reporter considered the headache, fatigue and brain fog to be related to Shingrix.     It was unknown if the company considered the headache, fatigue and brain fog to be related to Shingrix.   Additional Information: GSK receipt date: 25-Sept-2023 The physician reported that the patient had headache, fatigue and brain fog after getting Shingrix vaccine. The case was linked with case US2023132524, reported by the same reporter for patient's wife. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023132524:wife case
Sex: U
Vaccine: FLUX, RVX
Symptoms: Malaise, Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   Previously administered products included Covid vaccine.   On an unknown date, the patient received RSV vaccine and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving RSV vaccine and FLU VACCINE (NAME UNKNOWN), the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 28-SEP-2023 This case was reported by the patient via interactive digital media. The patient got the RSV shot and Flu shot and had sore arm for a couple of days. Patient felt that it was better to did, then being very sick or in hospitalization, racked up huge medical bills. Patient did not get the new booster shot for Covid. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itches; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension and cholesterol. Concomitant products included amlodipine, atorvastatin, finasteride, tamsulosin and losartan.   On 12-JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: itches).  The patient was treated with calamine (nos) (Calamine Lotion). The outcome of the pruritus was not reported.   It was unknown if the reporter considered the pruritus to be related to Shingrix.     It was unknown if the company considered the pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 25-SEP-2023 The patient stated that one place on his lower back, left side that itches unless he apply calamine lotion.  The itching began prior to the second shot as possibly a bug bite.  The reporter consented to follow up. For tolerance of 2nd dose, refer case US2023131685.; Sender's Comments:  US-GSK-US2023131685:2nd dose case
Age: 43.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra Dose; rceived 2nd dose on 29 Aug 2018 and 3rd dose on 09 Sep 2019; received 1st dose on 30th Aug 2016 and 2nd dose on 29th August 2018; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 43-year-old female patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 30th August 2016).   On 19-SEP-2023, the patient received the 4th dose of Twinrix. On 09-SEP-2019, the patient received the 3rd dose of Twinrix. On 29-AUG-2018, the patient received the 2nd dose of Twinrix. On 29-AUG-2018, not applicable after receiving Twinrix and Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose on 30th Aug 2016 and 2nd dose on 29th August 2018). On 09-SEP-2019, the patient experienced drug dose administration interval too long (Verbatim: rceived 2nd dose on 29 Aug 2018 and 3rd dose on 09 Sep 2019). On 19-SEP-2023, the patient experienced extra dose administered (Verbatim: Extra Dose).The outcome of the drug dose administration interval too long, drug dose administration interval too long and extra dose administered 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: 25-SEP-2023 The reporter was medical assistant. The reporter reported that office had patient that received Twinrix doses outside of the recommended timeframe (they had late doses), so they were administered another dose in September when they were seen in clinic.  The doses prior to the 2023 dose were given at another location. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 4th dose of Twinrix on 19th September 2023, which led to extra dose administered. The case had been linked to US2023131774, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023131774:2nd report
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Somnambulism
Clinical narrative: sleepwalking, fever, bodyaches
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: Sore arm, aches - 24 hours Posterior neck stiffness with pain on flexion and limited range of motion - 72 hours
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was administered with the Covid Vaccine 2023/2024. The Vaccine is 3 dose multi dose vial. This was not diluted with the Sodium Chloride.  Patient received the full vial that was unconcentrated.
Age: 31.0
Sex: M
Vaccine: DTAP
Symptoms: Incorrect dose administered
Clinical narrative: Was given a infanrix and should have been the adult dose. A boosterix
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pentacel has an expiration date of Sept. 16, 2023.  Patient did not have reaction or symptoms.  Expiration date was noticed/documented after administration.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness/bruising, very warm to touch - prescribed Bactrim DS in case of infection
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given pediatric Pfizer Biotech Covid 19 2023-2024 6mos-4year dose.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient administered an expired DTaP vaccine. Vaccine expired on 9/16/23 and administered on 10/04/23.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Lip pruritus, Lip swelling, Urticaria
Clinical narrative: -10/2/23: Patient returned to the clinic with report of 2 or 3 hives on her right arm about 2 hours after her injection.  Denied any additional symptoms, recent contact with anything new or ingestion of anything new.  Patient advised to take diphenhydramine 25-50mg  and be seen in ER if any respiratory or worsening of symptoms occurred.  -10/5/23:  Patient returned to clinic stating that she has been taking diphenhydramine 25-50 mg since 10/2/23.  Reports that the hives have gone away but last night she developed some lip swelling/itching that has continued this morning despite taking 50mg of diphenhydramine last night.  Denies any respiratory difficulties or any other symptoms and denies eating anything new or different than her usual diet.  Pt advised that she could also take a famotidine tablet and should be seen in the ER due to continued allergic reaction type symptoms. No acutely visible lip or facial swelling noted by provider but patient states she can feel that her upper lip is swollen as is the area above her lip and into her nose.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Hot flush, Lethargy, Musculoskeletal stiffness
Clinical narrative: 1st day: hot flashes 2nd day: low-grade headache, stiff neck, lightheadedness with the feeling of passing out accompanied by lethargy
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: This is the latest, Spikevax.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Fatigue, Nervousness
Clinical narrative: Fatigue, shaky, lightheaded
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient presented to receive an influenza vaccination.  The vaccinator documented giving her a COVID vaccination of Moderna Lot 3030342, exp 3/25/2024.  Patient received a copy for her records and later questioned what she received.  The vaccinator is unsure if her documentation is incorrect, or if she gave an incorrect vaccine.  Patient contacted public health department and we were made aware of this on the evening of 10/3/2023.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on left forearm which developed to right bicep area.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU4, VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: After administered the vaccines, patent was advised to wait for 15 to 20 minutes. And the other patient signal that Pt was experiencing reaction. She was initially not responding when called her name. But later she started responding slightly. It seems as if she was sleeping with her eyes closed
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Bone pain, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Pain in right hip bone, later extending into back of both legs. Groin discomfort. Still ongoing at 10 days in.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body ache, chills, and headache
Age: 49.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient presented to clinic and requested RSV vaccine be given. Provider educated patient that this vaccine is recommended beginning at age 60. She also clarified that patient does not have a immunocompromised status. Despite this information, patient insisted on vaccine being administered outside of CDC and guidelines.  No known adverse reaction.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Fall, Pain in extremity, Rhinorrhoea, Tenderness
Clinical narrative: She got her vaccine, she had no reactions at first, and fine when she left the pharmacy.  When she came home and about 10:00 her arm started to get sore, not real sore but she could feel it.  She went to bed around 12:00 PM, and was in bed and about 2:05 AM on the 19th and all of a sudden, she does not know if she started rolling or if she had some sort of allergic reaction, she fell out of bed, and there was an end table near her bed, she hit her arm pretty hard as a part of her forearm was bruised.  When she had the regular flu vaccine the only thing she had was a little run nose and a sore arm.  She is still trying to recuperate from this, the bruising is going away and the arm is still sore.  She did on the 24th, she went to Well and she had x-rays and there were no signs of that.  She has osteoporosis in February and her mother and sister both had it.   She went to the ER and they took some x-rays and no fracture or broken bones.  She is concerned about this.  She stayed up after this, it was a small fall but enough that it did some injury to her.  That same morning she put ice on the arm, was not bruised and did not start hurting her until he day after that continuing until her arm was black and blue above the area where her watch is.  It is sort of like a yellowish bruise and is still very sore.  She has been putting on his arnica (Arniflora), cream.  She is still recovering from that injury, and she knows it related to the shot as prior to that she was fine.    It's a long process and it's been.  She did not hit her elbow and it's black and blue behind there.  She showed her arm to the pharmacist and told him what happened and going to go back to the pharmacy today to see if there was something they can tell her.    She is allergic to Latex, and wanting to know the ingredients.  I did give her the manufacturers area.  She is hoping the bruised area is going to get better.  She was diagnosed as contusion of left forearm.  She has been soaking her arm in warm epsome salts and does help to some degree.    She is still having tenderness, and was going to go to an orthopedist group if it does not feel better.  X-rays do not tell everything.  She has bruising above her elbow and goes down to her wrist.  She has not slept since this has happened.  Has slept better in the last couple of days, but was a little bit frazzled by the incident.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: She got her vaccine, she had no reactions at first, and fine when she left the pharmacy.  When she came home and about 10:00 her arm started to get sore, not real sore but she could feel it.  She went to bed around 12:00 PM, and was in bed and about 2:05 AM on the 19th and all of a sudden, she does not know if she started rolling or if she had some sort of allergic reaction, she fell out of bed, and there was an end table near her bed, she hit her arm pretty hard as a part of her forearm was bruised.  When she had the regular flu vaccine the only thing she had was a little run nose and a sore arm.  She is still trying to recuperate from this, the bruising is going away and the arm is still sore.  She did on the 24th, she went to Well and she had x-rays and there were no signs of that.  She has osteoporosis in February and her mother and sister both had it.   She went to the ER and they took some x-rays and no fracture or broken bones.  She is concerned about this.  She stayed up after this, it was a small fall but enough that it did some injury to her.  That same morning she put ice on the arm, was not bruised and did not start hurting her until he day after that continuing until her arm was black and blue above the area where her watch is.  It is sort of like a yellowish bruise and is still very sore.  She has been putting on his arnica (Arniflora), cream.  She is still recovering from that injury, and she knows it related to the shot as prior to that she was fine.    It's a long process and it's been.  She did not hit her elbow and it's black and blue behind there.  She showed her arm to the pharmacist and told him what happened and going to go back to the pharmacy today to see if there was something they can tell her.    She is allergic to Latex, and wanting to know the ingredients.  I did give her the manufacturers area.  She is hoping the bruised area is going to get better.  She was diagnosed as contusion of left forearm.  She has been soaking her arm in warm epsome salts and does help to some degree.    She is still having tenderness, and was going to go to an orthopedist group if it does not feel better.  X-rays do not tell everything.  She has bruising above her elbow and goes down to her wrist.  She has not slept since this has happened.  Has slept better in the last couple of days, but was a little bit frazzled by the incident.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: 13 hours after the injections, developed Fever, chills, shaking that lasted several hours (overnight)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient reported flu-like symptoms that began the night following vaccination. These included: fatigue, headache, body aches and fever.  On 10/2/23, patient developed a rash near the injection site. Initially started with a red spot at the injection site which then spread to the lower arm. Area is painful to touch, swelling present, mild itching.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient reported flu-like symptoms that began the night following vaccination. These included: fatigue, headache, body aches and fever.  On 10/2/23, patient developed a rash near the injection site. Initially started with a red spot at the injection site which then spread to the lower arm. Area is painful to touch, swelling present, mild itching.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reported flu-like symptoms that began the night following vaccination. These included: fatigue, headache, body aches and fever.  On 10/2/23, patient developed a rash near the injection site. Initially started with a red spot at the injection site which then spread to the lower arm. Area is painful to touch, swelling present, mild itching.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient ordered influenza vaccine but received high dose influenza vaccine.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received dose one of Twinrix in 2019, dose two in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2019) and Twinrix (received 2nd dose in 2020).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received dose one of Twinrix in 2019, dose two in 2020). The outcome of the incomplete course of vaccination 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: 25-SEP-2023 The reporter could not provide exact dates of administration, lot numbers or expiration dates of Twinrix.  No additional information was provided. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix, which led to incomplete course of vaccination.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: administered expired dose pregnant female patient; administered expired dose of FluLaval QIV; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 35-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number CA52L, expiry date 30-JUN-2023) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 25-SEP-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 25-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administered expired dose of FluLaval QIV). On an unknown date, the patient experienced exposure during pregnancy (Verbatim: administered expired dose pregnant female patient).  The outcome of the expired vaccine used and exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (FluLaval Quadrivalent 2022-2023 season): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023131803   Additional Information: GSK Receipt Date: 25-SEP-2023 The Obstetrics and Gynecology Office Supervisor reported to a Medical Assistant that expired dose of FluLaval QIV was administered to pregnant female patient which led to expired vaccine used and exposure during pregnancy. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The reporter gave permission for follow up. This case is linked with US2023131803, same reporter.; Sender's Comments:  US-GSK-US2023131803:Same reporter, different patient