chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Patient "got to feeling funny" had some tightness in chest.  After resting she was able to daily activities without further incident.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: APPROXIMATELY 24 HOURS AFTER INJECTION PATIENT BROKE OUT IN FULL BODY HIVES AND WAS EXTREMELY ITCHY. PATIENT'S MOTHER TOOK HER TO LOCAL ER AND SHE ALSO HAD TO GO TO A DERMATOLOGIST.  WAS GIVEN SPRINALACTONE 50 MG BID, HYDROXINE, AND FEXOFINADINE. FINALLY, WEEKS LATER HIVES ARE STARTING TO CLEAR UP.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Developed severe nausea approximately one hour after dose was administered. Had overwhelming fatigue and muscle pain starting upon waking on 1/5/24, which lasted until midday on 1/7/24.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Chromatopsia
Clinical narrative: Vaccines given approximately 3:57pm. Patient presented to ED after seeing red and green lights for 1.5 hours after waking up. She has never seen like this before, no headache, walking normally, would see them when her eyes per shut. Denies auditory hallucinations. According to ED report- neuroexam repeated at 0802 and was normal. Patient was discharged from ED to follow-up for any new or repeat neurologic symptoms
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Headache, Nausea, Pruritus
Clinical narrative: Patient received vaccination and within 12 hours started getting a pounding headache with nausea and joint pain. The following day her arm presented with swelling, itchiness, and redness.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Patient received vaccination and within 12 hours started getting a pounding headache with nausea and joint pain. The following day her arm presented with swelling, itchiness, and redness.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site mass
Clinical narrative: Patient reports that she developed a knot at the injection site 3 to 4 hours after the injections. She reports having no energy at all and no appetite for a couple of days post injection and says she forgot to tell the nurse about the burning in her mouth that she had been having for weeks prior to the 12/14/23 dose of Moderna COVID-19 vaccine. She is feeling better now but wanted to know if her mouth issue is what caused her to react the way she did after reciving this dose of COVID-19 vaccine since she didn't do that with the prior 5 COVID-19 injections that she received.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Client reports redness to neck and chest that started 2 hours after injection. Area is itching area is still reddened and itching. She has tried Aveno, that has helped.
Age: 70.0
Sex: M
Vaccine: FLU4, PNC20, RSV
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site nodule, Injection site pain, Pain
Clinical narrative: He got his vaccine, didn't notice anything for the first day and then he started noticing that he his arm was a little sore, then it would continue to get a little worse.  The pain went into the muscle and that started getting pretty intense and now just doing nothing and there is a knot under the skin now where there was no knot before.  The knot is in the muscle at the injection site.  He hasn't taken anything other than his regular medicines, and Aspercreme is about the only thing that seems to be helping him, and also Ibuprofen.  You can feel it to touch under the skin when his wife rubs the Aspercreme on it.  There is a bump that is visible on the skin.  He has complained about his movement in his arm, and not able to move it due to the pain when he moves it.    His doctor did not feel anything when he showed it to him, and felt that the pharmacist may have hit the bone, but did not see any kind of reaction or anything showing that there should have been any problem.  He saw his doctor on December 20th, and since then the knot has gotten worse and more noticeable.  He has a FU appointment with him on 1/18/24.  His wife circled it last night and noticed it last night.    He also had 2 other vaccines in his right arm that day, but not having any issues with that arm, just the left one.
Age: 70.0
Sex: M
Vaccine: FLU4, PNC20, RSV
Symptoms: Pain in extremity
Clinical narrative: He got his vaccine, didn't notice anything for the first day and then he started noticing that he his arm was a little sore, then it would continue to get a little worse.  The pain went into the muscle and that started getting pretty intense and now just doing nothing and there is a knot under the skin now where there was no knot before.  The knot is in the muscle at the injection site.  He hasn't taken anything other than his regular medicines, and Aspercreme is about the only thing that seems to be helping him, and also Ibuprofen.  You can feel it to touch under the skin when his wife rubs the Aspercreme on it.  There is a bump that is visible on the skin.  He has complained about his movement in his arm, and not able to move it due to the pain when he moves it.    His doctor did not feel anything when he showed it to him, and felt that the pharmacist may have hit the bone, but did not see any kind of reaction or anything showing that there should have been any problem.  He saw his doctor on December 20th, and since then the knot has gotten worse and more noticeable.  He has a FU appointment with him on 1/18/24.  His wife circled it last night and noticed it last night.    He also had 2 other vaccines in his right arm that day, but not having any issues with that arm, just the left one.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: viral measles like rash. no fever. otherwise well
Age: 0.67
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: PCV 20 WAS ORDERED BUT GARDASIL9 WAS GIVEN INSTEAD BY MISTAKE. GARDIAN TO WATCH PATIENT AND CALL WITH ANY FEVER, RASH, SWELLING AND TO TAKE TO ER WITH ANY RESPRIRATORY ISSUES.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 15X13 cm erythematous indurated area around injection site
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received third dose of Shingrix vaccine (given on 06/25/2018, 08/27/2018, and 10/27/2023). Patient denied adverse effects due to extra dose and did not require medical attention. Incident was discovered when a pharmacist checked the Immunization Registry when he came in for what he thought was his second dose. He had received the previous two doses at a different pharmacy.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Peripheral coldness, Tremor
Clinical narrative: Severe shivering  My whole body was shaking violently, My feet, hand, nose  and ears felt like they were frozen
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: patient felt pain in arm after injection site continued to get worse and worse and she eventually looked it up and stated it might be sirva which is shoulder injury related to vaccines. patient believes the vaccine was given too high causing damage. she has had to go to pt and many doctors visits and still does not have full mobility in her arm. cannot hold it up to do her hair without pain
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Incorrect route of product administration, Pain, Product administered at inappropriate site, X-ray
Clinical narrative: Per patient, she received a Covid vaccine on October 2nd. Within 3 days she got Covid. She said the pharmacist who gave the vaccine put the vaccine high up in her arm in her shoulder joint. She had never had this issue before or pain like this before. While it isn't as bad as it was before, she still has pain and it is strong. She said that on October 2nd she received a Covid vaccine. Within 3 days she got Covid. She said the pharmacist who gave the vaccine put the vaccine high up in her arm "in her shoulder joint". She had never had this issue before or pain like this before. While it isn't as bad as it was before, she still has pain and it is strong. She went to her doctor and told her what happened. The doctor took an x-ray to find out what was wrong. She said she has 83-year-old joints and anything can happen
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Arm is sore and stiff
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states left arm is swollen and painful, the site of injection is raised with a red circle around it.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given spikevax today and we discovered it was given after beyond use date.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: MMR vaccine was expired.  Error was discussed with parent and parent will bring child back in 4 weeks to receive valid vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Arthralgia, Chills, Diarrhoea, Dizziness
Clinical narrative: Sore arm and muscles. 2 hours later my neck both arms, back, buttocks, thighs were all hurting. I had a terrible headache. Later I saw colorful spots briefly. Then I got extreme chills and shaking during the evening and all day the next day. I had some chills the day after that too. 12 hours after the vaccine I was nauseous and having dry heaving and I had foaming and mucus-like diarrhea through the night. The second day was the worst with waves of dizziness. The injection site was red and sore but not rashy. I had a little bit of a fever. 24 hours after the injection I tried to eat and everything tasted metallic and weird and had dry mouth. Yesterday I felt much better, I had a little chills but everything else was resolved. I did have some joint and muscle pain and fatigue though with some of the metallic taste.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Fatigue, Headache, Injection site erythema
Clinical narrative: Sore arm and muscles. 2 hours later my neck both arms, back, buttocks, thighs were all hurting. I had a terrible headache. Later I saw colorful spots briefly. Then I got extreme chills and shaking during the evening and all day the next day. I had some chills the day after that too. 12 hours after the vaccine I was nauseous and having dry heaving and I had foaming and mucus-like diarrhea through the night. The second day was the worst with waves of dizziness. The injection site was red and sore but not rashy. I had a little bit of a fever. 24 hours after the injection I tried to eat and everything tasted metallic and weird and had dry mouth. Yesterday I felt much better, I had a little chills but everything else was resolved. I did have some joint and muscle pain and fatigue though with some of the metallic taste.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, Nausea, Neck pain
Clinical narrative: Sore arm and muscles. 2 hours later my neck both arms, back, buttocks, thighs were all hurting. I had a terrible headache. Later I saw colorful spots briefly. Then I got extreme chills and shaking during the evening and all day the next day. I had some chills the day after that too. 12 hours after the vaccine I was nauseous and having dry heaving and I had foaming and mucus-like diarrhea through the night. The second day was the worst with waves of dizziness. The injection site was red and sore but not rashy. I had a little bit of a fever. 24 hours after the injection I tried to eat and everything tasted metallic and weird and had dry mouth. Yesterday I felt much better, I had a little chills but everything else was resolved. I did have some joint and muscle pain and fatigue though with some of the metallic taste.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Retching, Taste disorder, Tremor
Clinical narrative: Sore arm and muscles. 2 hours later my neck both arms, back, buttocks, thighs were all hurting. I had a terrible headache. Later I saw colorful spots briefly. Then I got extreme chills and shaking during the evening and all day the next day. I had some chills the day after that too. 12 hours after the vaccine I was nauseous and having dry heaving and I had foaming and mucus-like diarrhea through the night. The second day was the worst with waves of dizziness. The injection site was red and sore but not rashy. I had a little bit of a fever. 24 hours after the injection I tried to eat and everything tasted metallic and weird and had dry mouth. Yesterday I felt much better, I had a little chills but everything else was resolved. I did have some joint and muscle pain and fatigue though with some of the metallic taste.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Sore arm and muscles. 2 hours later my neck both arms, back, buttocks, thighs were all hurting. I had a terrible headache. Later I saw colorful spots briefly. Then I got extreme chills and shaking during the evening and all day the next day. I had some chills the day after that too. 12 hours after the vaccine I was nauseous and having dry heaving and I had foaming and mucus-like diarrhea through the night. The second day was the worst with waves of dizziness. The injection site was red and sore but not rashy. I had a little bit of a fever. 24 hours after the injection I tried to eat and everything tasted metallic and weird and had dry mouth. Yesterday I felt much better, I had a little chills but everything else was resolved. I did have some joint and muscle pain and fatigue though with some of the metallic taste.
Sex: F
Vaccine: HPV9
Symptoms: Ill-defined disorder
Clinical narrative: she noticed a gradual change / acceleration in her daughters development; This spontaneous report was received from a patient's mother via Vendor and refers to a female patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, dose #, anatomical location, lot #, expiry date, and route of administration were not provided).  On an unknown date, the reported stated she noticed a gradual change / acceleration in her daughter's development (ill-defined disorder) that she attributed to the vaccine. She said this is the reason why she did not vaccinate her younger daughter, now 13. The outcome of the event was not reported. Action taken with suspect vaccine was assessed as not applicable.  The reporter considered the event to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 57.0
Sex: F
Vaccine: PNC15, PPV, VARZOS
Symptoms: Asthenia, Chills, Feeding disorder, Influenza like illness, Malaise
Clinical narrative: not feeling good; has not been able to move; mucus; weakness; chills; unable to eat; This spontaneous report was received from a consumer via other company and refers to a 57-year-old female .  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in September 2023, the patient was vaccinated with with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 04-DEC-2023 (reported as 4 days ago from 08-DEC-2023), the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); or pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and with a second dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in December 2023, consumer stated that she was not feeling good at all and has not been able to move for the past few days. On an unknown date in December 2023, she also experienced mucus, weakness, chills, and was unable to eat. Consumer stated, that she knew from these vaccines that flu like symptoms may be experienced, but consumer advised that what she was experiencing was worse than that. She was supposed to start her first dose of secucinumab (COSENTYX) 300 mg/ml on 08-DEC-2023. She was going to be taking secucinumab (COSENTYX) weekly. The consumer knew, there were some side effects taking secucinumab (COSENTYX), while having received live vaccines and feeling sick, therefore she wanted further information as to if there was specific timeframe, that she should wait to start her secucinumab (COSENTYX) medication. At the time of reporting, the outcome of the events secretion discharge, asthenia, chills were not reported. It was also reported that the patient advised that at the time of report was the first day that she felt a little better and was able to move around and eat breakfast therefore the outcome of  malaise, movement disorder  feeding disorder was recovering.   The causal relationship between malaise, movement disorder, secretion discharge, asthenia, chills and feeding disorder and suspected vaccines was not provided.
Age: 57.0
Sex: F
Vaccine: PNC15, PPV, VARZOS
Symptoms: Mobility decreased, Secretion discharge
Clinical narrative: not feeling good; has not been able to move; mucus; weakness; chills; unable to eat; This spontaneous report was received from a consumer via other company and refers to a 57-year-old female .  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in September 2023, the patient was vaccinated with with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 04-DEC-2023 (reported as 4 days ago from 08-DEC-2023), the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); or pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and with a second dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in December 2023, consumer stated that she was not feeling good at all and has not been able to move for the past few days. On an unknown date in December 2023, she also experienced mucus, weakness, chills, and was unable to eat. Consumer stated, that she knew from these vaccines that flu like symptoms may be experienced, but consumer advised that what she was experiencing was worse than that. She was supposed to start her first dose of secucinumab (COSENTYX) 300 mg/ml on 08-DEC-2023. She was going to be taking secucinumab (COSENTYX) weekly. The consumer knew, there were some side effects taking secucinumab (COSENTYX), while having received live vaccines and feeling sick, therefore she wanted further information as to if there was specific timeframe, that she should wait to start her secucinumab (COSENTYX) medication. At the time of reporting, the outcome of the events secretion discharge, asthenia, chills were not reported. It was also reported that the patient advised that at the time of report was the first day that she felt a little better and was able to move around and eat breakfast therefore the outcome of  malaise, movement disorder  feeding disorder was recovering.   The causal relationship between malaise, movement disorder, secretion discharge, asthenia, chills and feeding disorder and suspected vaccines was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma stage 0
Clinical narrative: FBE calling on behalf of HCP to report adverse event regarding GARDASIL.  FBE reporting that the HCP stated that a patient in their care was vaccinated with the complete series of GARDASIL 17 years ago, and the patient has recently been diagnosed wit; This spontaneous report was received from a physician and a company representative refers to a female patient with unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as 17 years ago), the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5 ml/ two dose series, administered intramuscularly (IM) for prophylaxis (strength, lot #, and expiry date were not provided).  On an unknown date (reported as recently), the patient was diagnosed with carcinoma in situ uterine cervix (Cervix carcinoma stage 0). At the time of reporting, the outcome of the event was not known. No additional information provided. The action taken was not applicable.   The causal relationship between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown. Upon internal review, the event Cervix carcinoma stage 0 was determined to be medically significant.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No side effects or adverse reactions were reported with the administration; A HCP called to report a TE that occurred on 12/23/2023 for ROTATEQ that was also administered to a patient post-excursion on 01/02/2024.; This spontaneous report was received from a medical assistant referring to a 4-month-old patient of unknown gender. The patient's medial history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 02-JAN-2024, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid vial (lot#: 19339111, expiration date: 18-APR-2024; strength was not provided) by a healthcare professional orally for prophylaxis. The administered vaccine experienced a temperature excursion (TE) at 52.7 F for an unknown length of time on 23-DEC-2023 (product storage error). No previous excursion occurred. No side effects or adverse reactions were reported with the administration (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash with blisters; Rash that still continues to move throughout my body; This non-serious case was reported by a consumer and described the occurrence of generalized rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (rash trunk). Concomitant products included loratadine, pseudoephedrine sulfate (Claritin-D).   On 09-AUG-2023, the patient received Shingrix. On 02-SEP-2023, 24 days after receiving Shingrix, the patient experienced generalized rash (Verbatim: Rash that still continues to move throughout my body). On an unknown date, the patient experienced blistery rash (Verbatim: Rash with blisters). The patient was treated with cortisone and hydrazine. The outcome of the generalized rash was not resolved and the outcome of the blistery rash was not reported.   It was unknown if the reporter considered the generalized rash and blistery rash to be related to Shingrix.     It was unknown if the company considered the generalized rash and blistery rash to be related to Shingrix.   Additional Information: GSK receipt date: 05-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient self-reported this case. The patient used Cortisone cream, Steroid pills, Hydrazine and multiple other creams. The seriousness for rash that still continued to move throughout my body and rash with blisters was reported as intervention required. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: received Arexvy instead of Abrysvo; This non-serious case was reported by a consumer and described the occurrence of wrong vaccine administered 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 wrong vaccine administered (Verbatim: received Arexvy instead of Abrysvo). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 05-JAN-2024 The reporter had a mother who just delivered a baby and had received Arexvy instead of Abrysvo, which led to wrong vaccine administered. The reporter wanted to know if there were any concerns he/she need to watch in the infant.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: swelling and rash that went down the length of her upper arm; Rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   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 swelling arm (Verbatim: swelling and rash that went down the length of her upper arm) and rash (Verbatim: Rash). The outcome of the swelling arm and rash were unknown.   It was unknown if the reporter considered the swelling arm and rash to be related to Shingrix.     It was unknown if the company considered the swelling arm and rash to be related to Shingrix.   Additional Information: GSK Receipt date: 2-JAN-2024 The reporter reported that the patient received the Shingrix vaccine a few years ago and had a reaction to the vaccine that swelling and rash that went down the length of her upper arm. Patient's doctor of medicine advised her not to get the second dose. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule, Nerve injury, Pain in extremity
Clinical narrative: the reporter stated she had knot in the upper right arm; felt like nerve damage down the arm to the wrist area; Pain in bilateral arms/ pain down to her wrist; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site mass in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site mass (Verbatim: the reporter stated she had knot in the upper right arm), nerve damage (Verbatim: felt like nerve damage down the arm to the wrist area) and pain in arm (Verbatim: Pain in bilateral arms/ pain down to her wrist). The outcome of the injection site mass, nerve damage and pain in arm were not resolved.   It was unknown if the reporter considered the injection site mass, nerve damage and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site mass, nerve damage and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR001145   Additional Information: GSK Receipt date: 03-JAN-2024 The reporter was the patient who received her 1st dose of Shingrix vaccine. Immediately following her vaccine to the right upper arm, she stated that she suffered from what felt like nerve damage down the arm to the wrist area. Patient also stated that she had knot in the upper right arm that had not resolved and pain down to her wrist. The adverse event was not resolved. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2024AMR001145:Original Case : US2024000677
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Administered to pregnant patient; maladministered Arexvy instead of Abrysvo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9J7TT, expiry date 06-JUL-2025) and (batch number J7G30, expiry date 09-MAY-2026) for prophylaxis.   On 31-DEC-2023, the patient received Arexvy. On 31-DEC-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: maladministered Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Administered to pregnant patient). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 3-JAN-2024 A pharmacist requested data on the safety and efficacy of Arexvy in pregnant women.  A pregnant patient was maladministered Arexvy instead of Abrysvo, which led to vaccine exposure during pregnancy and wrong vaccine administered. The reporter asked for any data on use in pregnancy. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix was reconstituted with sterile water instead of the provided diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution 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 wrong solution used in drug reconstitution (Verbatim: Shingrix was reconstituted with sterile water instead of the provided diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-JAN-2024. The Health care professional reported that she had a patient received shingrix that was reconstituted with sterile water instead of the provided diluent and wanted to check on its efficacy when given that way or if the patient should receive an additional dose.  The patient received Shingrix that was reconstituted with sterile water instead of the provided diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received his first dose of SHINGRIX on 28-AUG-19 now wants second one today. Second dose has not yet been administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th August 2019, with batch hy4gt).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received his first dose of SHINGRIX on 28-AUG-19 now wants second one today. Second dose has not yet been administered.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA receipt date: 03-JAN-2024 CMA called stating patient who received his first dose of Shingrix and now wanted second dose one today (on the day reporting).  The second dose had not yet been administered, which led to incomplete  course of vaccination. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered two doses of Flulaval less than 30 days apart; 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 short in a 15-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 7PB23, expiry date 30-JUN-2024) for prophylaxis.   Previously administered products included Flulaval quadrivalent (one dose of Flulaval quadrivalent for last season on 16th January2023). Concomitant products included Influenza vaccine inact split 4v (Flulaval quadrivalent).   On 26-OCT-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 26-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced drug dose administration interval too short (Verbatim: administered two doses of Flulaval less than 30 days apart). The outcome of the drug dose administration interval too short 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-2024 The clinical supervisor reported that they administered two doses of Flulaval less than 30 days apart, which led to shortening of vaccinations schedule. The Vaccine Administration Facility was the same as Primary Reporter. The clinic address in health care professional's details was reported. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Therapeutic response unexpected
Clinical narrative: genital herpes were gone; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included genital herpes ((HSV-1)).   On 29-DEC-2023, the patient received Arexvy (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Arexvy, the patient experienced unexpected therapeutic effect (Verbatim: genital herpes were gone). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt date: 03-JAN-2024. The reporter was a patient. The patient got the Arexvy vaccine injected into her upper left arm and the next day her genital herpes were gone. Patient stated that it was a pretty bad outbreak and does not usually just clear up like that so she felt it may be related to the vaccine and wanted to let GSK know about this outcome. Patient stated she was unsure if her primary health care provider was aware of her herpes, so provided her gynecologist who was aware of the conditions information as well. The reporter consented to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Redness Left arm from elbow to shoulder (on injection side); Swollen Left arleft arm from elbow to shoulder pain (on injection side); Shoulder pain; left Pain Left arm from elbow to shoulder (on injection side); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 3DK7E, expiry date 25-JAN-2026) for prophylaxis.   On 28-DEC-2023, the patient received Shingrix (left arm). On 28-DEC-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: left Pain Left arm from elbow to shoulder (on injection side)) and shoulder pain (Verbatim: Shoulder pain). On 29-DEC-2023, the patient experienced erythema of extremities (Verbatim: Redness Left arm from elbow to shoulder (on injection side)) and swelling arm (Verbatim: Swollen Left arleft arm from elbow to shoulder pain (on injection side)). The outcome of the pain in arm, erythema of extremities, swelling arm and shoulder pain were resolving.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and shoulder pain to be related to Shingrix.     It was unknown if the company considered the pain in arm, erythema of extremities, swelling arm and shoulder pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JAN-2024 The patient experienced whole left arm from elbow to shoulder pain, redness and swelling on day after Shingrix vaccine, vaccine was administered.  The pharmacist advised over the counter (OTC) medications like, Ibuprofen and Benadryl to treat.  The pharmacist reported that on yesterday (the day before reporting), patient return to pharmacy and reported that symptoms were getting better. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Overdose; the adult dose of Engerix-B to a 5 year old child.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   On 03-JAN-2024, the patient received Engerix B adult. On 03-JAN-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: the adult dose of Engerix-B to a 5 year old child.). The outcome of the overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the overdose and adult product administered to child to be related to Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the overdose and adult product administered to child to be related to Engerix B 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: 03-JAN-2023 The health care professional (HCP) reported giving the adult dose of Engerix-B to a 5 year old child, which led to overdose and adult product administered to child. Limited information available. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness
Clinical narrative: first dose of Shingrix in 2019/reporter is going to receive her 2nd dose of the Shingrix series January of 2024; Flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old 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 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, 4 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms) and incomplete course of vaccination (Verbatim: first dose of Shingrix in 2019/reporter is going to receive her 2nd dose of the Shingrix series January of 2024). The outcome of the influenza-like symptoms was resolved (duration 4 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt date: 03-JAN-2024 The patient self-reported this case. The patient received her first dose of Shingrix in 2019 and stated that she received 1st dose at 11 am and developed flu like symptoms 4 hours after administration. Flu like symptoms resolved 4 days after they began. Patient was going to receive her 2nd dose of Shingrix series in January 2024. Product information recommended that the second dose of Shingrix should be given 2 to 6 months after the 1st dose.  The patient was not under physician's care. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: 2-inch puffy red area around the injection site; 2-inch puffy red area around the injection site; Tired; Chills; Headache; Upset stomach; Fever of 100 degrees that lasted 4 hours; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 26-DEC-2023, 6 hrs after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and upset stomach (Verbatim: Upset stomach). On 30-DEC-2023, the patient experienced tiredness (Verbatim: Tired) and chills (Verbatim: Chills). On 01-JAN-2024, the patient experienced fever (Verbatim: Fever of 100 degrees that lasted 4 hours). On 03-JAN-2024, the patient experienced injection site erythema (Verbatim: 2-inch puffy red area around the injection site) and injection site swelling (Verbatim: 2-inch puffy red area around the injection site). On 01-JAN-2024, the outcome of the headache was resolved (duration 6 days). The outcome of the injection site erythema, injection site swelling, upset stomach, tiredness and chills were not resolved and the outcome of the fever was resolved (duration 4 hrs).   It was unknown if the reporter considered the injection site erythema, injection site swelling, headache, upset stomach, tiredness, chills and fever to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, headache, upset stomach, tiredness, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-Jan-2024 The patient was self-reported this case. The patient reported that the patient received Shingrix vaccine and on same day experienced a headache that resolved 6 days later.  The reporter stated that an upset stomach that was still not completely resolved. The reporter stated that on 30th December 2023 he felt tired and had chills which had not completely resolved On Monday, 11st January 2024. The reporter stated that a fever of 100 degrees that lasted 4 hours then resolved.  The reporter reported that on 3rd January 2024 he had a 2-inch puffy red area around the injection site.  The patient will contact healthcare professional as he felt this is an allergic reaction to the adjuvant. The reporter did not consent to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: 2-inch puffy red area around the injection site; 2-inch puffy red area around the injection site; Tired; Chills; Headache; Upset stomach; Fever of 100 degrees that lasted 4 hours; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 26-DEC-2023, 6 hrs after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and upset stomach (Verbatim: Upset stomach). On 30-DEC-2023, the patient experienced tiredness (Verbatim: Tired) and chills (Verbatim: Chills). On 01-JAN-2024, the patient experienced fever (Verbatim: Fever of 100 degrees that lasted 4 hours). On 03-JAN-2024, the patient experienced injection site erythema (Verbatim: 2-inch puffy red area around the injection site) and injection site swelling (Verbatim: 2-inch puffy red area around the injection site). On 01-JAN-2024, the outcome of the headache was resolved (duration 6 days). The outcome of the injection site erythema, injection site swelling, upset stomach, tiredness and chills were not resolved and the outcome of the fever was resolved (duration 4 hrs).   It was unknown if the reporter considered the injection site erythema, injection site swelling, headache, upset stomach, tiredness, chills and fever to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, headache, upset stomach, tiredness, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-Jan-2024 The patient was self-reported this case. The patient reported that the patient received Shingrix vaccine and on same day experienced a headache that resolved 6 days later.  The reporter stated that an upset stomach that was still not completely resolved. The reporter stated that on 30th December 2023 he felt tired and had chills which had not completely resolved On Monday, 11st January 2024. The reporter stated that a fever of 100 degrees that lasted 4 hours then resolved.  The reporter reported that on 3rd January 2024 he had a 2-inch puffy red area around the injection site.  The patient will contact healthcare professional as he felt this is an allergic reaction to the adjuvant. The reporter did not consent to follow up.
Sex: M
Vaccine: RSV
Symptoms: Wrong technique in product usage process
Clinical narrative: patient had received a dose of Arexvy at 4:25 pm, but that dose had been reconstituted at 9:35 am; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in product usage process in a 61-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 344ND) for prophylaxis.   On 02-JAN-2024, the patient received Arexvy. On 02-JAN-2024, an unknown time after receiving Arexvy, the patient experienced wrong technique in product usage process (Verbatim: patient had received a dose of Arexvy at 4:25 pm, but that dose had been reconstituted at 9:35 am). The outcome of the wrong technique in product usage process was unknown.   Additional Information: GSK receipt date: 03-JAN-2024 A nurse informed that on 2nd January 2024 a patient had received a dose of Arexvy at 4:25 pm, but that dose had been reconstituted at 9:35 am, which led to wrong technique in product usage process. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.