chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Vaccines given on Friday the 20th, no complications at that time. Parents noticed red, itchy, splotchy pattern forming on left thigh around the upper left thigh around Prevnar 13th injection site in the morning of Tuesday around 10am. Increased in size before being seen 9/25, where an antibiotic was given for suspected soft tissue infection. F/u scheduled Friday 9/27/24
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Anaphylactic shock, Dizziness, Dysphagia, Dysphonia
Clinical narrative: Intial site burning, extremely hot, swelled 1inX1in within 10 minutes. At 10 minutes lips began getting tingly. About 30 minutes I became flushed on the chest, arms, face, and legs. At 40 minutes after injection my throat got itchy, my voice began to go hoarse, my tongue started to swell. At 1 hour after injection I experienced difficulty breathing, dizziness, nausea, hard time swallowing, injection site was 2inX3in and the size of a golfball. At 2 hours I was in full blown Anaphylactic shock. I arrived at the hospital at 2 hours after injection and received Epi, benadryl, pepcid, duo neb treatment, 1000 ml of fluid, and a steroid. Symptoms resolved immediately and I was monitored and released. 24 hours after injection I had a biphasic Anaphylaxis reaction and went back to the ER where I received benadryl, prednisone, pepcid, and another 1000ml of fluid. I am now 72 hours post injection and on Prednisone, pepcid, and benadryl due to a continuous reaction.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Intial site burning, extremely hot, swelled 1inX1in within 10 minutes. At 10 minutes lips began getting tingly. About 30 minutes I became flushed on the chest, arms, face, and legs. At 40 minutes after injection my throat got itchy, my voice began to go hoarse, my tongue started to swell. At 1 hour after injection I experienced difficulty breathing, dizziness, nausea, hard time swallowing, injection site was 2inX3in and the size of a golfball. At 2 hours I was in full blown Anaphylactic shock. I arrived at the hospital at 2 hours after injection and received Epi, benadryl, pepcid, duo neb treatment, 1000 ml of fluid, and a steroid. Symptoms resolved immediately and I was monitored and released. 24 hours after injection I had a biphasic Anaphylaxis reaction and went back to the ER where I received benadryl, prednisone, pepcid, and another 1000ml of fluid. I am now 72 hours post injection and on Prednisone, pepcid, and benadryl due to a continuous reaction.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia oral, Swollen tongue, Throat irritation
Clinical narrative: Intial site burning, extremely hot, swelled 1inX1in within 10 minutes. At 10 minutes lips began getting tingly. About 30 minutes I became flushed on the chest, arms, face, and legs. At 40 minutes after injection my throat got itchy, my voice began to go hoarse, my tongue started to swell. At 1 hour after injection I experienced difficulty breathing, dizziness, nausea, hard time swallowing, injection site was 2inX3in and the size of a golfball. At 2 hours I was in full blown Anaphylactic shock. I arrived at the hospital at 2 hours after injection and received Epi, benadryl, pepcid, duo neb treatment, 1000 ml of fluid, and a steroid. Symptoms resolved immediately and I was monitored and released. 24 hours after injection I had a biphasic Anaphylaxis reaction and went back to the ER where I received benadryl, prednisone, pepcid, and another 1000ml of fluid. I am now 72 hours post injection and on Prednisone, pepcid, and benadryl due to a continuous reaction.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Neck pain, Pain
Clinical narrative: 5 days of overall aching and lethargy.  Subsequently, and at present, Pain in shoulders and neck when moving arms
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Vomiting
Clinical narrative: After receiving HPV vaccine the patient complained that the vaccine was painful and then immediately vomited several times.  He was observed for 15 minutes, then stated he felt completely fine, drank water and juice, had a snack, and asked to go back to his classroom.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever of 102, shivers, headache
Age: 13.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Decreased appetite, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: parent states that on 9/20/24 (6 days after vaccination) patient had  rash all over body (appears to be similar to chickenpox), fevers on and off (up to 103), fatigue, decreased appetite, and headaches---they have been on and off. The provider they see thinks it was the varivax vaccination that is causing the symptoms and family was advised to report as adverse event
Age: 13.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: parent states that on 9/20/24 (6 days after vaccination) patient had  rash all over body (appears to be similar to chickenpox), fevers on and off (up to 103), fatigue, decreased appetite, and headaches---they have been on and off. The provider they see thinks it was the varivax vaccination that is causing the symptoms and family was advised to report as adverse event
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever of 101, headache
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: Patient's Mom requested son receive Influenza vaccine at flu clinic at School Vaccine Clinic. Patient was seated during vaccination with Mother in direct contact with son.  Patient was calm and answered name and dob correctly.  Mom was asked if any adverse reaction after vaccination and she stated no.  Patient received Fluzone tri-valent in left arm.  Patient did not exhibit any pain or discomfort during vaccination. Pharmacist applied band-aid to the site.  Patient was seated for a few seconds.  He then was told everything complete with vaccination and to wait 15 minutes in the chairs post-vaccination.  At that time, he went to stand up and fell to the floor.  His Mom was behind him and caught him during the fall.  He was non-responsive for a few seconds and then he became alert after 10-15 seconds. Ice was applied to his chest and back.  He then told us he is fine but stayed seated on the floor and gently got up to a seated position.  He then drank water and was feeling much better.  Mom and son decided to walk around near the vaccination area so we could monitor him.  After 15 minutes, he left with his Mother and he was alert and responsive to commands.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Rash
Clinical narrative: The following day in the evening after receiving the Fluad vaccine, the patient reports a full body rash and a significant drop in blood pressure.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cardiac monitoring, Heart rate increased, Treatment failure
Clinical narrative: Patient experienced an increased heart rate following vaccine administration and cardiologist believes it is due to the covid vaccine.  Patient saw Dr that morning around 11:45am and his HR was 68bpm.  Following his vaccine appointment, his HR doubled to 120bpm and has remained elevated despite his cardiologist switching carvedilol to metoprolol.  The patient said his HR seems to be in "reverse" as when he is resting his HR is at 120bpm and while exercising it drops back into the 60s.  This is opposite to what he previously experienced.  The patient is being monitored and is otherwise doing well.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Peripheral coldness, Pharyngeal swelling, Pruritus
Clinical narrative: Patient was in the parking garage shortly after getting the flu vaccine when she had the following symptoms, itching, cold hands, throat swelling, numbness. She was brough to the ED and evaluated at our hospital and then transferred to a nearby ED since we are a hospital. She said she was given steroids and antihistamines and discharged.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash/hives/itchiness, onset 4 hours after injection and ongoing until now (48 hours later and possibly longer)
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient came in and requested a flu shot. Realized only after the fact that she received flu shot in July 2024 also.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age for vaccine
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient came in and requested a flu shot. Realized only after the fact that he received flu shot in July 2024 also.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age for vaccine
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site rash, Myalgia, Rash, Rash erythematous
Clinical narrative: Pt presented to the pharmacy counseling window about 115p on 9/26/24. He informed me that he received two immunizations (SpikeVax and Fluzone HD) on 9/23/24 and he was concerned about the rash he had on his left shoulder, left breast and left upper arm. The rash was red and blotchy and exclusive to his left side. There was a clear difference in color between his skin and the rash. He said the rash was itchy and oozed a little bit when he scratched it. He experienced so much pain in his left shoulder, trapezius muscle that ?he could hardly sleep? the night of 9/25 to 9/26 in the morning so he decided to report the reaction to the pharmacy. I told him if his symptoms worsen that he should go to the Dr and let me know the outcome.   I called the patient about 7p on 9/26 and he said that he was not experiencing any pain and he did not see a Dr. He said he would see how he is doing in the morning and keep me posted.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic, Skin discolouration, Skin weeping, Sleep disorder
Clinical narrative: Pt presented to the pharmacy counseling window about 115p on 9/26/24. He informed me that he received two immunizations (SpikeVax and Fluzone HD) on 9/23/24 and he was concerned about the rash he had on his left shoulder, left breast and left upper arm. The rash was red and blotchy and exclusive to his left side. There was a clear difference in color between his skin and the rash. He said the rash was itchy and oozed a little bit when he scratched it. He experienced so much pain in his left shoulder, trapezius muscle that ?he could hardly sleep? the night of 9/25 to 9/26 in the morning so he decided to report the reaction to the pharmacy. I told him if his symptoms worsen that he should go to the Dr and let me know the outcome.   I called the patient about 7p on 9/26 and he said that he was not experiencing any pain and he did not see a Dr. He said he would see how he is doing in the morning and keep me posted.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on right arm after visiting the beach. Applied aloe but made worse.
Age: 98.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: Patient received both vaccines on Monday, 9/23/2024.  Noticed a rash beginning on Tuesday, 9/24/2024. Rash continued to spread on Wednesday, 9/25/2024 and Thursday, 9/26/2024. Patient called the pharmacy to report the reaction.  States that rash is "all over her body.  There is no itching or pain.  No shortness of breath or dizziness, rapid heartbeat or syncope. No facial or tongue swelling or throat closure.  Advised the patient that these were signs of a serious allergic reaction, and if she experience any of these symptoms she should go the the emergency room immediately.  Advised the patient that her doctor should be notified immediately.  Patient stated that she has never had an adverse reaction to any vaccine before, and that she has taken diphenhydramine safely in the past.  Patient stated that the rash is improving. Advised her that she could take diphenhydramine and use hydrocortisone cream, and remphasized that she must contact her doctor.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Feeling hot, Insomnia
Clinical narrative: The patient reports that on the same night that she received the vaccination, she started having  "excruciating" body aches, joint pain everywhere and it was to the point that she could not sit up in bed.  The patient also reports that she had a cough and felt hot as well. The patient reported that she could not sleep at all that night.  She said that she tried Tylenol, but it did not help.  The patient reports that the pain subsided the next morning and she continued to feel fatigued for the next few days.  The patient said that she feels fine now.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, SARS-CoV-2 test negative
Clinical narrative: The patient reports that on the same night that she received the vaccination, she started having  "excruciating" body aches, joint pain everywhere and it was to the point that she could not sit up in bed.  The patient also reports that she had a cough and felt hot as well. The patient reported that she could not sleep at all that night.  She said that she tried Tylenol, but it did not help.  The patient reports that the pain subsided the next morning and she continued to feel fatigued for the next few days.  The patient said that she feels fine now.
Age: 51.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood test, Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Had severe pain at injection site from the beginning. Also had limited mobility in arm. This has not gone away except for 2 days out of a total of 4 weeks time. The 2 days it went away, there was still an aching feeling at the injection site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Fatigue, Muscular weakness
Clinical narrative: Patient felt fatigued, weakness in legs, had a fall.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cervix haemorrhage uterine, Exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: 16 weeks pregnant (healthy pregnancy) when Moderna COVID booster given. Estimated date of delivery is March 8, 2025. Following vaccination, patient woke up in the morning with vaginal bleeding. OBGYN believes blood is coming from cervix. There was no known stress or injury to the cervix prior to vaccination. There was no intercourse or heavy lifting that would have triggered bleeding. Bleeding has slowed but light bleeding has continued throughout the day.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3, RSV
Symptoms: Vertigo
Clinical narrative: Vertigo,
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Pallor, Staring, Syncope, Unresponsive to stimuli
Clinical narrative: Prior to getting the shots, Patient received the vaccines before her Dad and was informed to have a seat outside the vaccination room for 15 minutes and called the brother in, but patient came back into the room and was standing leaning against the wall while the brother was getting the vaccine. The patient fell sideway fainted but was still has her eyes open and just looked like she was zoning out.  She was able to sit back up when her Dad had her sit up on the ground first and looked pale. We offered to call 911 to call for help.  For a few minutes she was zoning out and we did not see her respond. We had her sit up and offered her water and got some apple juice. Her brother informed us that she just got out of sports too afterwards and she probably did not have anything to eat. She was able to respond and tell us her name and date of birth and age. We informed her we would follow up and fill out a report. We advised the father to check and monitor her for injury or any concussion symptoms. We also advised to check with a doctor.  We had the patient sat down for at least another 15 minutes.
Age: 61.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pallor, Pulse abnormal, Seizure, Syncope
Clinical narrative: After receiving both vaccines, patient became pale and fainted on chair (did not fall off chair). Wife and I caught him on time and patient woke up after a few seconds. We provided water for the patient and checked his pulse. Pulse was faint so I suggested to call paramedics. Patient said no, to give him some time to recover. After 10 minutes, patient fainted again but also was seizing (5 seconds). We decided to call paramedics per his and his wife's request. She said he has fainted before during his tattoo session, but never seized. After speaking with paramedics, patient seized again (around 5-10 seconds). Paramedics arrived, checked patient, and took patient with them.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Localised oedema
Clinical narrative: Large local reaction of erythema and edema, treatment cool compress and monitoring, recheck 9/26/24 with noted improvement
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Pain, soreness at injection site - 48 hrs Fatigue for 24 hrs Headache for 24 hrs Chills in fingertips - intermittent  No treatment administered
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Rash, Rash erythematous, Skin discolouration
Clinical narrative: Real bad rash. Up the back of both legs from knees upwards. Day4 still painful, now a solid pink, purple in color.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia
Clinical narrative: Severe joint pain, severe muscle pain, numbness in feet
Age: 86.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Malaise, Pain in extremity, Syncope
Clinical narrative: Patient started to feel unwell the night of 9-23-24. Patient also reported severe achy arm in L arm that received covid shot. Patient reported fainting the morning of 9-24-24.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: Rash began behind Left knee, and inside Left elbow area, itching became more uncomfortable by Saturday, 9/21/24. It has not resolved as of this report.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: Fever, chills, joint pain, fatigue, general malaise
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On his left arm (where he received the high dose Fluzone), just around and slightly below injection site, area is pink and warm. He denies pain except if he presses on it. The other arm, where he received the COVID vaccine, there is no reaction at all.  He thinks it may be getting smaller at this point.  He takes daily cetirizine, which apparently has not cleared it.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Developed a rash on r ar Site injection - looks like a bug bite. Red to area some swelling.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Immediate symptoms:  severe pain in left arm, inability to fully lift left arm, and loss of range of motion in left arm.   Treatment included:  consultation with neurologist on October 28, 2021, three day course of prednisone and physical therapy to address left arm weakness.   Ongoing symptoms include:  left arm weakness, inability to type at computer for more than 15 minutes without left shoulder pain and inability to perform household tasks such washing dishes and putting away groceries.  Still being seen in physcial therapy.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Limb injury, Loss of personal independence in daily activities, Nerve injury, Pain in extremity
Clinical narrative: Immediate symptoms:  severe pain in left arm, inability to fully lift left arm, and loss of range of motion in left arm.   Treatment included:  consultation with neurologist on October 28, 2021, three day course of prednisone and physical therapy to address left arm weakness.   Ongoing symptoms include:  left arm weakness, inability to type at computer for more than 15 minutes without left shoulder pain and inability to perform household tasks such washing dishes and putting away groceries.  Still being seen in physcial therapy.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity
Clinical narrative: Immediate symptoms:  severe pain in left arm, inability to fully lift left arm, and loss of range of motion in left arm.   Treatment included:  consultation with neurologist on October 28, 2021, three day course of prednisone and physical therapy to address left arm weakness.   Ongoing symptoms include:  left arm weakness, inability to type at computer for more than 15 minutes without left shoulder pain and inability to perform household tasks such washing dishes and putting away groceries.  Still being seen in physcial therapy.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: paralyzed from the neck down; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (hospitalization), outcome "unknown", described as "paralyzed from the neck down". The patient was paralyzed from the neck down, clarified patient also had the COVID vaccine, and is now in hospital and can't move. Call handler attempted to clarify the manufacturer of the COVID vaccine the patient received, caller unknown, caller stated probably Pfizer, but caller unable to confirm. Made life bad, caller stated killed a very nice man, pleasant, caller then clarified and confirmed maybe did not kill this person, but this person is paralyzed from the neck down.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Fall, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: paralyzed from the neck down; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (hospitalization), outcome "unknown", described as "paralyzed from the neck down". The patient was paralyzed from the neck down, clarified patient also had the COVID vaccine, and is now in hospital and can't move. Call handler attempted to clarify the manufacturer of the COVID vaccine the patient received, caller unknown, caller stated probably Pfizer, but caller unable to confirm. Made life bad, caller stated killed a very nice man, pleasant, caller then clarified and confirmed maybe did not kill this person, but this person is paralyzed from the neck down.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed from the neck down; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (hospitalization), outcome "unknown", described as "paralyzed from the neck down". The patient was paralyzed from the neck down, clarified patient also had the COVID vaccine, and is now in hospital and can't move. Call handler attempted to clarify the manufacturer of the COVID vaccine the patient received, caller unknown, caller stated probably Pfizer, but caller unable to confirm. Made life bad, caller stated killed a very nice man, pleasant, caller then clarified and confirmed maybe did not kill this person, but this person is paralyzed from the neck down.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Asthenia, Exposure during pregnancy, Feeling hot, Impaired work ability
Clinical narrative: administration of varicella vaccine while pregnant; severe itching,; she felt hot; had a racing heart,; felt weak; and had so much anxiety; This prospective pregnancy report was received from a female patient of 27-year-old regarding herself. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapy included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(TDAP) and other unspecified medications.  On 12-SEP-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported) for prevention.  The patient stated that she experienced severe itching, she felt hot, had a racing heart, felt weak and had so much anxiety. No rash was reported with the itching. The patient also reported that was abnormal for her to have such bad anxiety. Patient reports she had to leave work because the symptoms she was feeling were so intense (pruritus, anxiety, asthenia, palpitations and feeling hot), she got a ride home, took 1 or 2 ammonium chloride, diphenhydramine hydrochloride(BENADRYL) and laid in bed. The patient did not seek medical attention and just waited for the symptoms to subside. In addition, she did not know how far along she was on 12-JUN-2024 but she was 16 weeks and 3 days pregnant today 17-SEP-2024 (exposure during pregnancy).  At the time of the report, the patient had recovered from the events described as the symptoms gradually went away and were gone by the end of the next day 13-JUN-2024.   The relatedness between the events and therapy with varicella virus vaccine live (oka/merck)(manufacturer unknown) was not reported.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Palpitations, Pruritus
Clinical narrative: administration of varicella vaccine while pregnant; severe itching,; she felt hot; had a racing heart,; felt weak; and had so much anxiety; This prospective pregnancy report was received from a female patient of 27-year-old regarding herself. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapy included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(TDAP) and other unspecified medications.  On 12-SEP-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported) for prevention.  The patient stated that she experienced severe itching, she felt hot, had a racing heart, felt weak and had so much anxiety. No rash was reported with the itching. The patient also reported that was abnormal for her to have such bad anxiety. Patient reports she had to leave work because the symptoms she was feeling were so intense (pruritus, anxiety, asthenia, palpitations and feeling hot), she got a ride home, took 1 or 2 ammonium chloride, diphenhydramine hydrochloride(BENADRYL) and laid in bed. The patient did not seek medical attention and just waited for the symptoms to subside. In addition, she did not know how far along she was on 12-JUN-2024 but she was 16 weeks and 3 days pregnant today 17-SEP-2024 (exposure during pregnancy).  At the time of the report, the patient had recovered from the events described as the symptoms gradually went away and were gone by the end of the next day 13-JUN-2024.   The relatedness between the events and therapy with varicella virus vaccine live (oka/merck)(manufacturer unknown) was not reported.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Consumer called to inquire whether she needs to restart the series of GARDASIL 9. Consumer reports she received only 1 injection of GARDASIL 9, 2 years ago at 38 years old, exact date unknown. Consumer reports she never received the next 2 doses; No adverse event; This spontaneous report was received from a consumer, referring to herself a 40-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2022 (also reported as 2 years ago), the patient was vaccinated with 1 injection of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided). Consumer reported she never received the next 2 doses of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) due to switching insurance providers and her physician at the time never said it was a series. Consumer was going to "pharmacy" today to inquired about HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and to received vaccination (Inappropriate schedule of product administration). No additional adverse events reported.  Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: he felt tired; injection site was sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included rivaroxaban (Xarelto) and valaciclovir (Valacyclovir).   On 12-SEP-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 12-SEP-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site was sore). On 13-SEP-2024, the patient experienced tiredness (Verbatim: he felt tired). The outcome of the injection site pain and tiredness were resolved.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.     It was unknown if the company considered the injection site pain and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 This case was self-reported by patient. On the day of Shingrix vaccination and the next day. the patient experienced injection site was sore. Nothing else was reported.
Age: 6.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given Adacel instead of DtaP at immunization appointment with no reported adverse event; Initial information received on 11-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 years old male patient (18.14 kg) who was given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine at immunization appointment with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jan-2024, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: 2CA18C1) (strength; expiry date unknown) via intramuscular route in unknown administration site for Immunisation instead of dtap at immunization appointment with no reported adverse event (wrong product administered) (latency: same day).  Reportedly, event occurred 8 months ago and had been addressed with the clinical staff member that performed this administration of the vaccine. No adverse reactions or side effects were reported by the patient's parent.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: giving the DTAP-IPV component of Pentacel without mixing it with the HIB component with no reported adverse event; Initial information received on 11-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was given the dtap-ipv component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without mixing it with the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received dtap-ipv component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date unknown) without mixing it with the hib component with no reported adverse event (single component of a two-component product administered) (same day latency). Information on batch number corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: vaccine was administered to a twomonth old baby on accidentally with no reported adverse event; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 months old male patient who was administered with Influenza usp trival a-b subvirion no preservative vaccine [Fluzone] accidentally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2024, the patient received 0.5 ml dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection (strength- standard) (lot- UP8415MA and expiry date- 30-JUN-2025) via intramuscular route in unknown administration site for Immunisation and vaccine was administered to a twomonth old baby on accidentally with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: medication error/an inappropriate use due to administering an expired vaccine with no reported adverse event; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient with medication error/an inappropriate use due to administering an expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2024, the patient received expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Suspension for injection, 0.5 ml (x1 (once)) expiry-23-Jun-2024, lot U7092AA via unknown route in unknown administration site for Immunization (strength unknown) with medication error/an inappropriate use with no reported adverse event (expired product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient received a flu shot today at a flu clinic at her medical group. I don?t know which flu vaccine it was. Two hours later she started vomiting. It?s 2200 hours now and she has not stopped vomiting. She vomited continually throughout the evening/night. I gave her 4 mg of zofran at 6 pm and she still vomited.
Sex: U
Vaccine: FLU3
Symptoms: Blood lactate dehydrogenase increased, C-reactive protein, Eye pain, Fluorescence angiogram normal, Iridocyclitis
Clinical narrative: Bilateral anterior uveitis, R>L.  Onset 11 am on Tue 9/24/2024 with red, painful right eye, significant photophobia, and fixed right pupil.  Symptoms a little better 9/25/2024, started cyclopentolate & prednisolone eyedrops later that day.  May or may not be vaccine-related vs consequence of URI two weeks prior, and may or may not be influenced by hx psoriasis.  However, given the proximity to vaccination and that we are still early in the vaccination season, I did want to report this early in case this turns out to be an idiosyncratic feature of this season's adjuvanted flu vaccine, and flu vaccine has had a stronger link with uveitis than other vaccines.
Sex: U
Vaccine: FLU3
Symptoms: Iris adhesions, Mycobacterium tuberculosis complex test negative, Photophobia, Pupil fixed, Slit-lamp tests abnormal
Clinical narrative: Bilateral anterior uveitis, R>L.  Onset 11 am on Tue 9/24/2024 with red, painful right eye, significant photophobia, and fixed right pupil.  Symptoms a little better 9/25/2024, started cyclopentolate & prednisolone eyedrops later that day.  May or may not be vaccine-related vs consequence of URI two weeks prior, and may or may not be influenced by hx psoriasis.  However, given the proximity to vaccination and that we are still early in the vaccination season, I did want to report this early in case this turns out to be an idiosyncratic feature of this season's adjuvanted flu vaccine, and flu vaccine has had a stronger link with uveitis than other vaccines.
Sex: U
Vaccine: FLU3
Symptoms: Treponema test, Upper respiratory tract infection
Clinical narrative: Bilateral anterior uveitis, R>L.  Onset 11 am on Tue 9/24/2024 with red, painful right eye, significant photophobia, and fixed right pupil.  Symptoms a little better 9/25/2024, started cyclopentolate & prednisolone eyedrops later that day.  May or may not be vaccine-related vs consequence of URI two weeks prior, and may or may not be influenced by hx psoriasis.  However, given the proximity to vaccination and that we are still early in the vaccination season, I did want to report this early in case this turns out to be an idiosyncratic feature of this season's adjuvanted flu vaccine, and flu vaccine has had a stronger link with uveitis than other vaccines.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood lactate dehydrogenase increased, C-reactive protein, Eye pain, Fluorescence angiogram normal, Iridocyclitis
Clinical narrative: Bilateral anterior uveitis, R>L. Onset 11 am on Tue 9/24/2024 with red, painful right eye, significant photophobia, and fixed right pupil. Symptoms a little better 9/25/2024, started cyclopentolate & prednisolone eyedrops later that day. May or may not be vaccine-related vs consequence of URI two weeks prior, and may or may not be influenced by hx psoriasis. However, given the proximity to vaccination and that we are still early in the vaccination season, I did want to report this early in case flu vaccine-associated uveitis turns out to be more than sporadic with this season's adjuvanted flu vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Iris adhesions, Mycobacterium tuberculosis complex test negative, Photophobia, Pupil fixed, Slit-lamp tests abnormal
Clinical narrative: Bilateral anterior uveitis, R>L. Onset 11 am on Tue 9/24/2024 with red, painful right eye, significant photophobia, and fixed right pupil. Symptoms a little better 9/25/2024, started cyclopentolate & prednisolone eyedrops later that day. May or may not be vaccine-related vs consequence of URI two weeks prior, and may or may not be influenced by hx psoriasis. However, given the proximity to vaccination and that we are still early in the vaccination season, I did want to report this early in case flu vaccine-associated uveitis turns out to be more than sporadic with this season's adjuvanted flu vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Treponema test
Clinical narrative: Bilateral anterior uveitis, R>L. Onset 11 am on Tue 9/24/2024 with red, painful right eye, significant photophobia, and fixed right pupil. Symptoms a little better 9/25/2024, started cyclopentolate & prednisolone eyedrops later that day. May or may not be vaccine-related vs consequence of URI two weeks prior, and may or may not be influenced by hx psoriasis. However, given the proximity to vaccination and that we are still early in the vaccination season, I did want to report this early in case flu vaccine-associated uveitis turns out to be more than sporadic with this season's adjuvanted flu vaccine.
Age: 34.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: misuse AE for PROQUAD: 34-year-old patient one dose of the PROQUAD; No additional AE; This spontaneous report has been received from a nurse practitioner, regarding to a 34-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, the patient (at 34-years-old) was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number and expiration date were not reported) (Product administered to patient of inappropriate age).  No additional adverse events were reported in the patient.  Additional information is not expected, the reporter declined permission to contact.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Muscle soreness, chills, achiness, sweating, nausea, headache, ear ache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Muscle soreness, chills, achiness, sweating, nausea, headache, ear ache
Age: 23.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Eczema-like rash at joints. Large blotches. Worst on right arm at elbow, but present on both elbows, wrist, and knuckles. Rash is speckled with elevated bumps, itchy. Lasting over 24 hours. Anti-histamines and hydrocortisone do not bring down the rash. Rash appears to be spreading from initial site, but still localized only at joints.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Sudden onset of arthritic pain in right shoulder, neck and right scapula . Lasted 4 days. Very sore compared to usual arthritic pain in past. Right arm was almost unusable for 2 days, super sore for two more. Impossible to sleep well, no sleep first 2 nights, very poor sleep next 2. 5th day fell better, 6th day much better about 95% good. On day 8, woke up middle of night with severe arthritic pain in right elbow and arm. So, at this time reporting and still in severe arm pain this next morning. My arthritus is well managed and I take only tylenol to manage as needed. I have never felt this much pain from it or such sudden unexplained onset.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Sudden onset of arthritic pain in right shoulder, neck and right scapula . Lasted 4 days. Very sore compared to usual arthritic pain in past. Right arm was almost unusable for 2 days, super sore for two more. Impossible to sleep well, no sleep first 2 nights, very poor sleep next 2. 5th day fell better, 6th day much better about 95% good. On day 8, woke up middle of night with severe arthritic pain in right elbow and arm. So, at this time reporting and still in severe arm pain this next morning. My arthritus is well managed and I take only tylenol to manage as needed. I have never felt this much pain from it or such sudden unexplained onset.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Vertigo
Clinical narrative: Bottom lip swelled  48 hours after administering. Vertigo as also. Top lip swelled 72 hours , vertigo persisted.
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Bad cough, fever, headache, tiredness lack of appetite , no energy
Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Pyrexia
Clinical narrative: Bad cough, fever, headache, tiredness lack of appetite , no energy
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on the right deltoid after influenza vaccine
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: Patient became lightheaded and syncopied in elevator. Brought back in office, gave water and something to eat, did blood pressure, laid down, patient vomited. Monitored for 45 minutes until he felt well and could leave. Assisted to car. Patient to go to ER.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: BYFORTUS  given in error.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Byfortus given in error
Age: 1.33
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Byfortus given in error