chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered the shingrix vaccine to patient without reconstituting; only injected the liquid portion without mixing with the powder; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old patient who received Herpes zoster (Shingrix) (batch number FJA7, expiry date 16-JUL-2026) for prophylaxis.   On 18-SEP-2024, the patient received Shingrix. On 18-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered the shingrix vaccine to patient without reconstituting) and inappropriate dose of vaccine administered (Verbatim: only injected the liquid portion without mixing with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-SEP-2024 Reporter is a physician. He/She administered the Shingrix vaccine to a patient without reconstituting. Reporter also stated that he/she only  injected the liquid portion without mixing with the powder. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Cervical lymph node swelling and tenderness. Warm compress to site.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: The patient received the flu vaccine; she was waiting for her son to receive his vaccination when she fell to the floor. She appeared to hit her head on the door frame during the fall. She was awake and alert at first but then became unresponsive with seizure-like activity for approximately one minute. EMS arrived, and the patient was transported to the local Emergency Department.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: He received an unnecessary Hepatitis B vaccine on 9/30
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Flumist on 9-26-24 and we administered another Flumist on 10-4-24. Patient reported no adverse reaction. Patients mother was informed of incident as well as Dr.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Pain
Clinical narrative: Client is generally anxious about vaccines. 10/1/24, he did very well with the influenza vaccine despite being nervous. Client's mom was with during the visit and waited in waiting room while client received his seasonal flu vaccine.  When client got to work about 4:30 pm he started getting a headache. He works in the kitchen at he golf course in town. When he got home later that evening he took some Tylenol and took a shower. He went to bed. When he woke up he was achy and  described it difficult to breathe. Client's dad took him to the clinic soon after clinic open on 10/2/24. Client seen one of the PAs. No lab work or tests were done at the clinic appointment. Blood pressure, pulse, and oxygen saturation was taken and all appeared to be good according to dad's report to RN (writing this report). Client's dad mentioned that at the clinic, client went to the bathroom and felt much better after that. Client's dad described client has a chronic constipation problem and uses miralax daily. When client's dad dropped client off at school, client was feeling well.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: COVID pediatric  dose 0.25mL was given to a 14-year-old patient. Should have received the adult dose 0.5mL.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong vaccine was administered based on patient group of age.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient complained of severe painful arm 2 hours after injection and lasting on and off almost 3 weeks later. She stated her pain has improved but still comes on and off.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Wrong dose was administered base on age group. Patient received 5-11 yrs dose
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Blood test normal, Computerised tomogram head abnormal, Computerised tomogram spine abnormal, Electrocardiogram normal
Clinical narrative: pt states she noticed numbness in her left thumb and the next day the index finger and the tips of all of the fingers were numb. After a few days all of her fingers were numb. A week later her left arm was numb and in pain. Her entire left side of her body under and around her arm was painful.  She developed muscle spasms in left arm. She went to the ER. She and was prescibed prednisone, toradol, and gabapentin. She followed up with PCP. She increased gabapentin. She was referred to see a spine doctor and a neurologist. Appts are scheduled. Her appt with spine doctor is on 10/14/24. She says the pain is getting worse and makes her nauseated. She is in continuous pain.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Intervertebral disc degeneration, Intervertebral disc protrusion, Muscle spasms, Nausea
Clinical narrative: pt states she noticed numbness in her left thumb and the next day the index finger and the tips of all of the fingers were numb. After a few days all of her fingers were numb. A week later her left arm was numb and in pain. Her entire left side of her body under and around her arm was painful.  She developed muscle spasms in left arm. She went to the ER. She and was prescibed prednisone, toradol, and gabapentin. She followed up with PCP. She increased gabapentin. She was referred to see a spine doctor and a neurologist. Appts are scheduled. Her appt with spine doctor is on 10/14/24. She says the pain is getting worse and makes her nauseated. She is in continuous pain.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Spondylitis
Clinical narrative: pt states she noticed numbness in her left thumb and the next day the index finger and the tips of all of the fingers were numb. After a few days all of her fingers were numb. A week later her left arm was numb and in pain. Her entire left side of her body under and around her arm was painful.  She developed muscle spasms in left arm. She went to the ER. She and was prescibed prednisone, toradol, and gabapentin. She followed up with PCP. She increased gabapentin. She was referred to see a spine doctor and a neurologist. Appts are scheduled. Her appt with spine doctor is on 10/14/24. She says the pain is getting worse and makes her nauseated. She is in continuous pain.
Age: 1.92
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received a dose of flu vaccine. Flu vaccine for this season was given 09/07/2024
Age: 30.0
Sex: M
Vaccine: FLU3, YF
Symptoms: Syncope
Clinical narrative: PATIENT FAITED AFTER VACCINATION.  Two doses of epi-pen were administered for the adverse reaction. EMS called and Patient taken to the hospital. Patient was conscious when EMS arrived
Age: 1.67
Sex: M
Vaccine: HEPA
Symptoms: Device connection issue
Clinical narrative: Medical Assistant  gave injection, while pulling out the syringe/needle from patients leg, the entire needle came disconnected from the hub of the base of the needle and remained in patients thigh,   Medical Assistant had to pull out needle separately from patients thigh. The needle was in one apiece, it did not break, all of vaccine was given,there was no leakage at leg or from syringe/needle. No unusual bleeding at site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Spasms in left hand
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, MMR, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was behind on vaccines. In trying to get her caught up, mom wanted all but hep A. MA drew up all vaccines and upon charting, it was discovered that the patient got Pediarix and IPV, therefore giving her two Polio vaccines instead of one. Provider and Pharmacist both notified and instructions given on what to watch for, but that there should be no harm to the child. Provider attempted to contact mom, but she did not answer.
Age: 0.33
Sex: U
Vaccine: RVX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; 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 4-month-old patient who received Rotavirus vaccine (batch number 5f7l2, expiry date 08-MAY-2026) for prophylaxis.   Concomitant products included Rotavirus vaccine live oral 1v (Rotarix).   On 18-SEP-2024, the patient received the 2nd dose of Rotavirus vaccine. On 18-SEP-2024, an unknown time after receiving Rotavirus vaccine, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). 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: 19-SEP-2024 The reporter was the healthcare professional (medical assistant) who stated that the patient received doses of Rotarix vaccine to close together. The second dose was administered 2 weeks after the first dose (on 9-APR-2024 and lot number In425) instead of at least 4 weeks, which led to shortening of vaccination schedule.
Age: 14.0
Sex: F
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Eye swelling
Clinical narrative: Around 5 minutes post-vaccination the patient felt their right eye begin to swell. Patient was brought into the clinic room after notifying the staff their eye was swelling. Patient was brought into the clinic room and 0.3mg Epi Pen (Lot #: 3FM355) administered to the left thigh at 9:15am on 10/04/2024. Patient given cool ice pack over the eye. No tingling of the throat or difficulty breathing was endorsed by the patient.   Patient's eye swelling was decreasing during post epi- observation. An additional nurse monitored the rest of recovery and the eye swelling had returned to normal and remained normal until the group of all the students left the Health deparment around 10:45am.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This patient is 57 years of age. Fluzone HD approved for 65+ was administered. No reaction was observed or noted at time of vaccination but reporting as it was not indicated for this patient.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Aches and fatigue within 12-24 hours, then raised tender erythema injection site after 48 hours
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Immediately following the shot, my left upper arm was red and extremely painful.  On day 5, my left upper arm began to swell.  For two more days, the swelling continued down my left arm.  The redness and pain stayed.  I went to my primary care and saw Physician Assistance.  He prescribed clindamycin (CLEOCIN) and methyIPREDNISolone (Medrol DOSPACK).  The pharmacy was out of methyIPREDNISolone at the time so I started the CLEOCIN.  All adverse events stopped after 3 days with just the one medication.
Age: 85.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Headache, Injection site pain, Productive cough, Pyrexia
Clinical narrative: pt states he had muscle discomfort around the injection site. He developed productive cough, headache and slight fever that lasted about 4 hours. Still feels weak today but no longer has a cough or fever but continues to have a headache.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: Day of extreme pain, first overall pain the blood flow pain, fatigue, loss of appetite, sleepiness, continued excessive sleepiness, body aches, Thursday as above, slept 15 hours, head ache dizziness
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: Day of extreme pain, first overall pain the blood flow pain, fatigue, loss of appetite, sleepiness, continued excessive sleepiness, body aches, Thursday as above, slept 15 hours, head ache dizziness
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Choking, Fatigue, Headache, Impaired work ability, Malaise
Clinical narrative: Symptoms began 10/1/2024 with runny nose when I woke up, not feeling bad at all.  By 11:00 am, I began to notice that I wasn't thinking very well.  By 12:33 pm, I felt like I had a fever.  I went upstairs to use the bathroom and afterward, decided to lay down on our bed for about 15 minutes to see if I felt better.  I woke up about two hours later when my husband got in bed with me because he said he was feeling very tired.  My husband had NOT been vaccinated since 2023.  We both slept until around 6:30 pm.  Very unusual for us.  That evening, my head ached and I was feeling very congested in my nose.  I started coughing during the night.  10/2/2024 - 10/3/2024 I felt so ill I couldn't work.  Low grade temperature, fatigue, headache, congestion, lots of coughing and choking on mucous for two days.  I took a COVID test on 10/2/2024 and 10/3/2024 but they were negative.  I had just received these tests in the mail on 10/1/2024.  My husband didn't test but was feeling well enough on 10/3/2024 to keep his dentist appointment and go grocery shopping.  I began working today, 10/4/2024 but still don't feel good.  I take cough syrup at night so I can rest and daytime cough syrup this morning so I don't cough so hard.  No COVID testing today.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Nasal congestion, Productive cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Symptoms began 10/1/2024 with runny nose when I woke up, not feeling bad at all.  By 11:00 am, I began to notice that I wasn't thinking very well.  By 12:33 pm, I felt like I had a fever.  I went upstairs to use the bathroom and afterward, decided to lay down on our bed for about 15 minutes to see if I felt better.  I woke up about two hours later when my husband got in bed with me because he said he was feeling very tired.  My husband had NOT been vaccinated since 2023.  We both slept until around 6:30 pm.  Very unusual for us.  That evening, my head ached and I was feeling very congested in my nose.  I started coughing during the night.  10/2/2024 - 10/3/2024 I felt so ill I couldn't work.  Low grade temperature, fatigue, headache, congestion, lots of coughing and choking on mucous for two days.  I took a COVID test on 10/2/2024 and 10/3/2024 but they were negative.  I had just received these tests in the mail on 10/1/2024.  My husband didn't test but was feeling well enough on 10/3/2024 to keep his dentist appointment and go grocery shopping.  I began working today, 10/4/2024 but still don't feel good.  I take cough syrup at night so I can rest and daytime cough syrup this morning so I don't cough so hard.  No COVID testing today.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Symptoms began 10/1/2024 with runny nose when I woke up, not feeling bad at all.  By 11:00 am, I began to notice that I wasn't thinking very well.  By 12:33 pm, I felt like I had a fever.  I went upstairs to use the bathroom and afterward, decided to lay down on our bed for about 15 minutes to see if I felt better.  I woke up about two hours later when my husband got in bed with me because he said he was feeling very tired.  My husband had NOT been vaccinated since 2023.  We both slept until around 6:30 pm.  Very unusual for us.  That evening, my head ached and I was feeling very congested in my nose.  I started coughing during the night.  10/2/2024 - 10/3/2024 I felt so ill I couldn't work.  Low grade temperature, fatigue, headache, congestion, lots of coughing and choking on mucous for two days.  I took a COVID test on 10/2/2024 and 10/3/2024 but they were negative.  I had just received these tests in the mail on 10/1/2024.  My husband didn't test but was feeling well enough on 10/3/2024 to keep his dentist appointment and go grocery shopping.  I began working today, 10/4/2024 but still don't feel good.  I take cough syrup at night so I can rest and daytime cough syrup this morning so I don't cough so hard.  No COVID testing today.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC20, RSV, VARZOS
Symptoms: Fall, Head injury, Sepsis
Clinical narrative: Patient fell and hit head the evening after vaccinations, she was taken to the hospital and diagnosed with sepsis. She is still hospitalized and should be released tomorrow.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: High dose influenza vaccine given vs intended standard influenza dose
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: duplicate Shot given. Patient's school would not accept previous vaccination from July. Patient requested second vaccination in order to comply with school request.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given vaccine out of recommended age range.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Red, warm and bruise
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Our clinic stocks COVID vaccine for ages 6 months to 4 years and 364 days.  This child was given a dose of our current COVID vaccine.  She was underdosed for her age.  Patient parent was instructed to redose patient with correct dosage.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported 10-4-24 that last year when he received his flu shot, it ended up causing bursitis. He said his left arm was swollen and red and painful by the time he got home from getting the flu shot. He ended up seeking treatment from his general practitioner.  Dr gave him a kenalog shot on two different occasions and it took him awhile for it to feel better.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: second dose of Arexvy given to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: second dose of Arexvy given to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2024 The pharmacist called to ask information about a second dose of Arexvy given to a patient. The reporter mentioned it happened in a different zip code and was calling to help someone else. When asked about patient information stated didn't have any information about the event available and to treat the question as a hypothetical question. The pharmacist believed that patient received Arexvy 2 doses close to a year apart which led to extra dose administered.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5, UNK
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED RSV (BEYFORTUS) .50 ML INSTEAD OF 1 ML.
Age: 52.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: Painful right arm resulting in decreased ROM persisting as of 10/4/24
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given vaccine out of recommended age group for vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: "Broke out with tiny itchy and burning blisters all up and down my arms, on the tops and the backs of just my upper arms. Sensitive to touch and sun. Have dealt with it for a couple weeks - taken Benedryl and have use dtopical hydrocortisone with no relief."
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: "Broke out with tiny itchy and burning blisters all up and down my arms, on the tops and the backs of just my upper arms. Sensitive to touch and sun. Have dealt with it for a couple weeks - taken Benedryl and have use dtopical hydrocortisone with no relief."
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Dizziness, Feeling hot, Immediate post-injection reaction, Injection site reaction
Clinical narrative: Immediately after injection patients arm began to bruise and was very swollen right under the skin. Patients arm began to look blotchy with hives around the site of injection. Patient stated to me that he was not feeling very well and was warm and slightly dizzy.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria, Malaise, Peripheral swelling, Rash macular
Clinical narrative: Immediately after injection patients arm began to bruise and was very swollen right under the skin. Patients arm began to look blotchy with hives around the site of injection. Patient stated to me that he was not feeling very well and was warm and slightly dizzy.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Pt came to the pharmacy day after getting 2nd dose of Twinrix series, presenting with rash that was spread down her neck, on/side of nose (moving close to brow and eyes).  Pt stated she got shot in morning and rash/hives itching started happening at night around 9-10pm.  Patient had taken extra strength Benadryl to relieve itching.  Pt was counseled to monitor rash, if any severe breathing or swelling starts to seek emergency medical attention.
Age: 0.75
Sex: M
Vaccine: DTPPVHBHPB, FLU3, PNC20
Symptoms: Diarrhoea, Influenza like illness, Injection site reaction, Pyrexia, Rash
Clinical narrative: Vomiting, diarrhea, tactile fever, and rash started the evening of vaccination. Mom also sick with "flu-like illness" in the preceding days, but baby did not develop symptoms until after the vaccines. No rash or swelling at vaccination sites. 2 red bumps - one on lateral right thigh and one on back
Age: 0.75
Sex: M
Vaccine: DTPPVHBHPB, FLU3, PNC20
Symptoms: Rash erythematous, Vomiting
Clinical narrative: Vomiting, diarrhea, tactile fever, and rash started the evening of vaccination. Mom also sick with "flu-like illness" in the preceding days, but baby did not develop symptoms until after the vaccines. No rash or swelling at vaccination sites. 2 red bumps - one on lateral right thigh and one on back
Age: 1.5
Sex: F
Vaccine: COVID19, DTAP, FLU3, HEPA
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: There was not an adverse event. There was an administration error.  Pfizer 6mo to 4 years. Instructions are to dilute vial which then contained 3 doses. The vial was not diluted.  MA gave correct dose of 0.3ml undiluted.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Swollen tongue, Urticaria
Clinical narrative: Patient got Fluad vaccine 4pm tuesday 10/01, her arm started to get itching with small bumps appearing around injection site 8pm tuesday before she went to bed. Wednesday morning she woke up itchy, and it progressed to hives throughout the day. Patient thinks about 95% of body was covered in hives, she went to health clinic about 6pm wednesay 10/03. They gave her methylprednisolone doespak. She said the dosepak did not help her symptoms and wednesday night she was covered even more and went to the ER. Patient unsure of what they gave her at the ER. Thursday, patient not any better very late in the evening and stated her tongue started to swell. She went to the ER again Thursday around 11p.m. 10/03. She is unsure of what they gave her in the ER. Sent in prescriptions for famotidine and prednisone taper. Patient picked up these medications Friday morning 10/04. Her tongue was no longer swollen but she reported still feeling itchy.
Age: 3.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse gave Kinrix which is for age 4-6 to a 3 year old.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Rash, Rash macular
Clinical narrative: Red blotchy and flushed to areas of bilateral arms, neck, upper back, chest and face.  Started 45 min after receiving vaccine.
Age: 68.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Feeling cold, Hallucination, Headache, Hyperhidrosis, Pain
Clinical narrative: woke up around 6 am on 10/03/24 hallucinating stating to his wife "why are we both in the hospital" and that his wife was standing in his room looking at him through the window. very sweaty but cold, did not want to get out of bed and wanted to stay in bed, headache, body aches, could not consume anything not even water
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Our clinic stocks COVID vaccine for ages 6 months to  4 years.  The child was given a dose of our current COVID vaccine.  She was underdosed for her age.  Patient parent was instructed to redose patient with correct dose
Age: 76.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Dyspnoea, Headache, Palpitations, Sleep disorder
Clinical narrative: Patient came in to the pharmacy today 10/4/24 to report that he woke up in the middle of the night (on 9/14/24) after receiving both vaccines with a racing heartbeat, shortness of breath, pounding headache, and dizziness that lasted for approx 1 to 1.5 hours.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event noted
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient that had a first dose of SHINGRIX two years ago, the patient never completed the schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 04-OCT-2022).   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 that had a first dose of SHINGRIX two years ago, the patient never completed the schedule). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 The pharmacist reported that a patient had first dose of Shingrix two years ago, the patient never completed the schedule. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, was there any advise about restarting this patient series, or what should be done.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 2 flucelvax vaccinations this season, she is experiencing no side effects
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: On 10/1/24, patient received the following FLUZONE HD PF 2024-25 INJ and on 10/4/24, patient wife called us stating that the patient was experiencing severe flu like symptoms (fever chills) and they believe that the vaccine may have caused this. The patient's wife wanted to inform of us these side effects and to wanted report to VAERS.  I told her that we will be reporting these side effects to VAERS and that patient should follow up with PCP regarding his flu like symptoms.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pallor, Somnolence, Vomiting
Clinical narrative: presented with parents for flu shot only.  Screening questions negative per parents.  flu shot given at 1314.  patient sat in chair for 10 minutes.  Parents then state he routinely gets sick with vaccines.  He c/o nausea lightheaded, sleepy.  Assisted tolying position with feet elevated.  Color pale, symptoms continue.  Transferred to clinic bed at 1:35.  Vomited large amount fluid, vitals 114/58,pulse 80, O98 percent.   RN in to assist with patient.  Gradually symptoms reolved and and assisted to sitting then standing.  vitals continue stable.  Taking sips of apple juice.  to exit walking at 1:55
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site hypoaesthesia, Injection site pain, Pain
Clinical narrative: Patent reported pain with injection.  She awoke this morning with continued pain, fatigue and reported numbness at the injection site.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant was administering the COVID vaccine and gave patient, the pt age 4, the 12 and up vaccine.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Nausea, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Fever Nausea emesis sore throat flu like symptoms, ascending rash that started at ankles.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fever Nausea emesis sore throat flu like symptoms, ascending rash that started at ankles.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No signs or symptoms reported. Patient is a G3P1011 with an EDD 11/25/2024. She received a Tdap on 9/20/24 and again on 10/2/24.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Given pediatric dose vs adults dose
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Nervousness, Vomiting
Clinical narrative: Pt called approximately 2 hours after her vaccine with complaints of not feeling well. Specifically, nausea, vomiting and feeling shaky were here most prominent symptoms.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Allergy test, Asthenia, Blood test, Condition aggravated, Eye swelling
Clinical narrative: (Pt sees Dr. at the healthcare facility) Pt states the day she took the vaccine. On 8/28/24 she went to eye clinic because she developed a knot on her left eye. The knot is under the eyelid. She was prescribed eye drops. On 8/30/24 she went to the ER because her entire face, eyes, and nose was swelling. She was in alot of pain all over her body. She was given a shot of tremodol. She was prescribed prednisone and discharged. She already had some swelling of the nose and lips before the 28th but after the vaccine it because much more swollen and so much worse. She also saw an immulogist Dr.  outside of the healthcare facility. She was prescribed allegra and xylal. The swelling began after the flu vax last year that was reported. Medicine helps with the swelling but as soon as the medicine wears off, she has to take another pill. This last vax made all of the swelling from the last years vaccine aggrivated and much worse. She can hardly walk and became very weak. She continues to have this weakness and swelling.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Laboratory test, Lip swelling, Nodule, Pain
Clinical narrative: (Pt sees Dr. at the healthcare facility) Pt states the day she took the vaccine. On 8/28/24 she went to eye clinic because she developed a knot on her left eye. The knot is under the eyelid. She was prescribed eye drops. On 8/30/24 she went to the ER because her entire face, eyes, and nose was swelling. She was in alot of pain all over her body. She was given a shot of tremodol. She was prescribed prednisone and discharged. She already had some swelling of the nose and lips before the 28th but after the vaccine it because much more swollen and so much worse. She also saw an immulogist Dr.  outside of the healthcare facility. She was prescribed allegra and xylal. The swelling began after the flu vax last year that was reported. Medicine helps with the swelling but as soon as the medicine wears off, she has to take another pill. This last vax made all of the swelling from the last years vaccine aggrivated and much worse. She can hardly walk and became very weak. She continues to have this weakness and swelling.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Swelling face
Clinical narrative: (Pt sees Dr. at the healthcare facility) Pt states the day she took the vaccine. On 8/28/24 she went to eye clinic because she developed a knot on her left eye. The knot is under the eyelid. She was prescribed eye drops. On 8/30/24 she went to the ER because her entire face, eyes, and nose was swelling. She was in alot of pain all over her body. She was given a shot of tremodol. She was prescribed prednisone and discharged. She already had some swelling of the nose and lips before the 28th but after the vaccine it because much more swollen and so much worse. She also saw an immulogist Dr.  outside of the healthcare facility. She was prescribed allegra and xylal. The swelling began after the flu vax last year that was reported. Medicine helps with the swelling but as soon as the medicine wears off, she has to take another pill. This last vax made all of the swelling from the last years vaccine aggrivated and much worse. She can hardly walk and became very weak. She continues to have this weakness and swelling.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: No known adverse effects to first vaccine. We are attempting to notify patient that a 2nd duplicate vaccine was given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia test, Ear pain, Facial paralysis, Pain, Treatment failure
Clinical narrative: Started w/R ear pain and radiated to R clavicle on 9/18/24. Then developed R facial droop consistent w/7th facial nerve palsy. Negative lyme testing. completed valtrex and prednisone without improvement.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: About 12 hours after receiving the Moderna dose, she started to shake , as in shivering
Age: 67.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: Received shot on 9/30/2024.  Arm was sore for 2 days, no other reactions during that time,  On the evening of 10/3/2024, I noticed 3 red blothces on my upper right leg. The largest was almost the size of a dime. The other two were about half that size.  On the morning of 10/4/2024, they appeared redder with a slight bumpy feel.  Also started to experience itchy feeling around abdomen, both front and back, but there is no rash or bumps.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Asthenia, Brain fog, Fatigue, Gait inability, Memory impairment
Clinical narrative: Patient called and reported in the middle of the night she needed to use the restroom and was weak and not able to sit up. She laid down as she was tired, then tried again, and not able to sit up, lowered self to floor and scooted to the restroom. Today, 10/4/24, she is feeling ok, walking, a little foggy, forgetful today. Patient did have all three vaccines in her right arm due to lymphedema. Patient has had Influenza and COVID-19 vaccines in the past. RSV was new for her.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Mobility decreased
Clinical narrative: Patient called and reported in the middle of the night she needed to use the restroom and was weak and not able to sit up. She laid down as she was tired, then tried again, and not able to sit up, lowered self to floor and scooted to the restroom. Today, 10/4/24, she is feeling ok, walking, a little foggy, forgetful today. Patient did have all three vaccines in her right arm due to lymphedema. Patient has had Influenza and COVID-19 vaccines in the past. RSV was new for her.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: PATIENT REPORTED HAVING NUMBNESS IN HER RIGHT SIDE OF TONGUE STARTING ON THE MORNING OF 10/04/2024
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose normal, Blood pressure increased, Dizziness, Headache
Clinical narrative: Loss of balance, dizziness, vertigo, room spinning.  Lasted less than 1 minute. Very slight residual light headache behind right ear.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Loss of balance, dizziness, vertigo, room spinning.  Lasted less than 1 minute. Very slight residual light headache behind right ear.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: pt reported injection was in upper arm near shoulder joint, about 6 hours after administration pt's left arm went number, resolved within the day
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the administration of Kinrix to a 15 month old patient who is a male; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 17-JUL-2024, the patient received Kinrix. On 17-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: the administration of Kinrix to a 15 month old patient who is a male). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-SEP-2024 A phone call was transferred by a first line agent two second line where a medical assistant contacted GSK to request information about the administration of Kinrix as either the 3rd or 4th dose in the DTAP series and during the phone call, she also inquired about the administration of Kinrix to a 15 month old patient who was a male and whose initials, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.; Sender's Comments:  US-GSK-US2024119309:Same reporter
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap, Asthenia
Clinical narrative: Per discussion with son, patient woke up around midnight with generalized weakness, he called EMS and they noted him to be hypoxic with SPO2 88%, noted to have a fever at ER.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood calcium normal, Blood chloride increased
Clinical narrative: Per discussion with son, patient woke up around midnight with generalized weakness, he called EMS and they noted him to be hypoxic with SPO2 88%, noted to have a fever at ER.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood magnesium normal, Blood potassium normal, Blood sodium normal
Clinical narrative: Per discussion with son, patient woke up around midnight with generalized weakness, he called EMS and they noted him to be hypoxic with SPO2 88%, noted to have a fever at ER.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urea increased, Blood urea nitrogen/creatinine ratio increased, Carbon dioxide normal, Chest X-ray abnormal, Electrocardiogram abnormal
Clinical narrative: Per discussion with son, patient woke up around midnight with generalized weakness, he called EMS and they noted him to be hypoxic with SPO2 88%, noted to have a fever at ER.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Globulin, Glomerular filtration rate, Hypoxia, Protein total normal, Pulmonary congestion
Clinical narrative: Per discussion with son, patient woke up around midnight with generalized weakness, he called EMS and they noted him to be hypoxic with SPO2 88%, noted to have a fever at ER.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema, Pyrexia, Sinus tachycardia, Troponin I increased
Clinical narrative: Per discussion with son, patient woke up around midnight with generalized weakness, he called EMS and they noted him to be hypoxic with SPO2 88%, noted to have a fever at ER.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: warm / redness below the injection sites (pt noticed around 10/4/2024 afternoon)- doesn't bother patient but she was curious.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Employee has pain, redness and warmth at the injection site.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Neuralgia
Clinical narrative: Severe neuropathic pain
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Extra dose administered, Fall, Fatigue
Clinical narrative: The patient received a 2nd RSV vaccine in a year's time. She thought the vaccine was annual and we didn't notice in her shot records that she had already received the vaccine last year. She stated she was weak and tired and suffered a fall.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Redness, bruising, swelling to injection site.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RSV, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave baby Abrysvo instead of Breyfortus for RSV
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Throat irritation
Clinical narrative: Patient presented to the pharmacy on 10/2 (3 days following vaccination) reporting that approximately 6 hours after injection, patient began experiencing rash near and around injection site covering upper arm to top of shoulder. She experienced pain and itching at injection stie as well as itching in throat.  She was still experiencing side effects at time of presentation. Pharmacist advised patient to take antihistimine to help with itching and rash and to report to health care provider if symptoms do not improve or start to become worse  moving forward.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Employee reported feeling dizzy, headache, and lightheaded. She stated this is the symptoms she has normally from each of the prior injections.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Administered comirnaty 12+ to 9 year old patient
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Tachycardia
Clinical narrative: Donor with Tachycardia and anxiety
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Redness, bruising, swelling at injection site.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient received pfizer and moderna vaccine in error.  patient was wanting to get a flu and moderna.  no reaction at the time of talking to patient, but told him to call us with an issues that come up over the weekend.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: administered comirnaty 12+ to pt 11 years of age
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: PATIENT CAME FOR FLU AND COVID VACCINE, SHE WAS GIVEN 2 COVID SHOTS WITH SAME LOT NUMBER AND DOSE AT THE SAME TIME
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid component administered; Only liquid component administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   On 14-AUG-2024, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid component administered) and inappropriate dose of vaccine administered (Verbatim: Only liquid component administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 A pharmacist called to inform that they had an administration of a Menveo where only one vial, the which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vomiting
Clinical narrative: Vomiting every 30 to 60 minutes for 12 hours following joint flu and covid vaccine. Note that the flu vaccine was not documented in the provider visit summary so I am unsure which flu vaccine was given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Erythema, Feeling hot, Pain
Clinical narrative: Patient called to report that her arm was red hot painful and swollen from her joint to the bottom of her bicep and that her chronic back pain was also exacerbated she believes that it is improving
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient called to report that her arm was red hot painful and swollen from her joint to the bottom of her bicep and that her chronic back pain was also exacerbated she believes that it is improving
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electric shock sensation, Electrocardiogram, Feeling abnormal
Clinical narrative: 2-5 seconds after administration,  patient mentioned she felt weird, stated shortness of breath and shocking reaction through out her body.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose: 100mg dose given instead of 50mg dose. patient's weight 6.89 lbs
Age: 81.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a dose of both Fluad and Comirnaty at a pharmacy location on 9/26/24 and then received a second dose of both Fluad and Comirnaty at another Pharmacy immunization clinic on 10/3/24.  The patient was unable to be reached and therefore no adverse effects are known at the time of reporting.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: With most of the COVID vaccinations, I have experienced very mild symptoms (fatigue or slight headache). With the second dose (July 2021) and my fifth (September 29), I had a number of symptoms, but rigors were the most concerning and unpleasant. With last evening's vax, I got a headache within a few hours. That was manageable with Tylenol and is gone today. But the thing that is concerning to me is that the shot site is sort and has a red, swollen area about the size of a quarter. I haven't had that as red or as large before.