chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Tinnitus, Vertigo
Clinical narrative: Loud, shrill constant ringing in my ears.  Went to ENT who could not determine cause but called it genetic.  Ringing in ears coincided EXACTLY with the start of extreme dizziness. light-headedness, vertigo.  Tinnitus has never stopped.  Vertigo came, remained for 6-7 months, was gone for several months, then recurred about 4 months ago and has remained ever since.
Age: 53.0
Sex: M
Vaccine: COVID19, FLUR4, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient stated he developed a rash and itching 3 days after received vaccinations. Patient reported rash disappeared after 24 hours. Itching still remains today; 10/04
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Nausea, Palpitations
Clinical narrative: Racing heart after walking the dog or simple tasks.  Weakness, nausea for a short time.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Malaise, Migraine
Clinical narrative: She got her vaccine, and in the middle of the night she started feeling feverish.  On Saturday morning she had 101 fever, chills, aches and pains, joint pains that were very very bad, and a very very bad migraine headache.  This continued all day Sunday.  Monday she called her PCP, her fever was then gone.  The joint pains started feeling better, the headache started feeling better.  Then she started with very very bad nausea, diarrhea and head congestion like a cold.  she has been feeling the nausea, diarrhea and head congestion since Monday.  She went to UC on Monday as her PCP suggested that she do that, and was told to get a PCR test.  This came back negative.  She did 3 rapid tests that were all negative. The UC feels it is due to the vaccine, and she is still sick, and she believes it is from the vaccine as well as she woke up in the middle of the night being sick.  They told her to take Tylenol if she had anymore fever or aches or pains, but that was gone by the time she went to the UC on Monday.   She does have migraines and was taking her migraine medicine, and she is so upset as she got the vaccine to make yourself not get sick and she is now sick, and she is not getting anymore in the future.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: She got her vaccine, and in the middle of the night she started feeling feverish.  On Saturday morning she had 101 fever, chills, aches and pains, joint pains that were very very bad, and a very very bad migraine headache.  This continued all day Sunday.  Monday she called her PCP, her fever was then gone.  The joint pains started feeling better, the headache started feeling better.  Then she started with very very bad nausea, diarrhea and head congestion like a cold.  she has been feeling the nausea, diarrhea and head congestion since Monday.  She went to UC on Monday as her PCP suggested that she do that, and was told to get a PCR test.  This came back negative.  She did 3 rapid tests that were all negative. The UC feels it is due to the vaccine, and she is still sick, and she believes it is from the vaccine as well as she woke up in the middle of the night being sick.  They told her to take Tylenol if she had anymore fever or aches or pains, but that was gone by the time she went to the UC on Monday.   She does have migraines and was taking her migraine medicine, and she is so upset as she got the vaccine to make yourself not get sick and she is now sick, and she is not getting anymore in the future.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: She got her vaccine, and in the middle of the night she started feeling feverish.  On Saturday morning she had 101 fever, chills, aches and pains, joint pains that were very very bad, and a very very bad migraine headache.  This continued all day Sunday.  Monday she called her PCP, her fever was then gone.  The joint pains started feeling better, the headache started feeling better.  Then she started with very very bad nausea, diarrhea and head congestion like a cold.  she has been feeling the nausea, diarrhea and head congestion since Monday.  She went to UC on Monday as her PCP suggested that she do that, and was told to get a PCR test.  This came back negative.  She did 3 rapid tests that were all negative. The UC feels it is due to the vaccine, and she is still sick, and she believes it is from the vaccine as well as she woke up in the middle of the night being sick.  They told her to take Tylenol if she had anymore fever or aches or pains, but that was gone by the time she went to the UC on Monday.   She does have migraines and was taking her migraine medicine, and she is so upset as she got the vaccine to make yourself not get sick and she is now sick, and she is not getting anymore in the future.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Pulse abnormal, Tachycardia
Clinical narrative: aware of tachycardia with pulse rate of 130 and regular.   This lasted 3 hours and then gradually decreased to normal pulse rate over the next 6 hours
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness
Clinical narrative: Became dizzy and clammy after vaccine while in observation area.  Stated he felt like he was going to faint
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: I experienced 100 2.temp; extremely sore arm at the injection site.; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I experienced 100 2.temp"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "extremely sore arm at the injection site."; CHILLS (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient just had 4th vaccine yesterday 27Sep2023 At (Pharmacy withheld) with Pfizer. Patient experienced 100 2.temp extremely sore arm at the injection site, chills was hit pretty hard.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an inapproved storage unit
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No reaction Dose expired on 9/30/23 and was given 10/02/2023 Given accidently 2 days after expiration date.
Age: 69.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Brain fog, Chills, Fatigue, Pain
Clinical narrative: chills, fatigue, brain fog. severe. body aches and pains. starting 09/29 till now. slight improvement 6 days later
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, PNC20, RSV
Symptoms: Abdominal pain upper
Clinical narrative: patient received the vaccines then sat down for the 15 minutes.   pt stated that his stomach was really hurting and that he was having ulcer problems the past few weeks and that it was acting up in the am.  He said it was not the vaccines but requested and ambulance about 5-10 minutes after receiving the vaccines.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: She was given the high dose but is not old enough. NO adverse event known.
Age: 1.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: none
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: PEDIATRIC FORMULATION WAS ADMINISTERED INSTEAD OF 12+ FORMULATION.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given high dose flu instead of regular flu
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PEDIATRIC FORMULATION WAS GIVEN TO PATIENT INSTEAD OF 12+ FORMULATION
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain
Clinical narrative: She woke up and was sitting in the kitchen and had aches and pain all over and she wasn't feeling good. She laid down to rest and took pain medication before laying down. Significant pain at the injection site on the left arm.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Oropharyngeal discomfort
Clinical narrative: after receiving the flu vaccine patient started to feel "funny in left side of throat" able to converse with staff thru whole process. Dr notified. patient has epi pen with her, she thought she might have a reaction since she is sensitive to alot of meds. has had flu shot in the past without reaction.  Patient felt like she needed the epi pen so she administered it. vitals taken within normal limits. appeared to be in no apparent distress , was conversing with staff and watching videos on her phone. was made aware by Dr she needed to go to ER, she refused to have 911 called. she had staff call her daughter. patient was one on one until daughter arrived. vital again in normal limits. patient left with daughter again no apparent distress ambulating and talking with staff and daughter
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Throat tightness
Clinical narrative: after receiving the flu vaccine patient started to feel "funny in left side of throat" able to converse with staff thru whole process. Dr notified. patient has epi pen with her, she thought she might have a reaction since she is sensitive to alot of meds. has had flu shot in the past without reaction.  Patient felt like she needed the epi pen so she administered it. vitals taken within normal limits. appeared to be in no apparent distress , was conversing with staff and watching videos on her phone. was made aware by Dr she needed to go to ER, she refused to have 911 called. she had staff call her daughter. patient was one on one until daughter arrived. vital again in normal limits. patient left with daughter again no apparent distress ambulating and talking with staff and daughter
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Full blood count, Neutrophil count decreased, White blood cell count decreased
Clinical narrative: White blood cell count plummeted from 5.8 to 3.3 within 2 months of receiving the Moderna vaccine, based on bloodwork taken Dec. 2021. Neutrophil count plummeted 4100 to 1310 as well. I am extremely healthy, young with no health conditions.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Condition aggravated, Dermal cyst, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Injection site reaction, redness and swelling with pain to touch. Pt Sebaceous cyst at the injection site.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: Injection site reaction, redness and swelling with pain to touch. Pt Sebaceous cyst at the injection site.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 76.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Heart rate irregular, Tachycardia
Clinical narrative: Reported adverse effects of tachycardia and irregular heartbeat about 72 hours after receiving vaccines. Patient states that he wacked himself in the chest 3 times and then it went away. He did not seek any medical care.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Hypoaesthesia, Vision blurred
Clinical narrative: Numbness in feet, legs, hands, and the right side of face, as well as blurry vision and disorientation occurred two to three days after an updated booster shot.
Age: 56.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Rash
Clinical narrative: Pimple like rashes all over the body, neck and upper extremities that he only noticed morning of 10/04/23. Patient was prescribed  Prednisone 20 mg PO, Calmoseptine cream, Diphenhydramine 25 mg  PO, Clotrimazole 1% topical cream.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: BOOSTRIX VACCINE EXPIRED 9/21/23 WAS ACCIDENTLY GIVEN TO PATIENT 10/2/23
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Induration, Inflammation, Skin warm, Tenderness
Clinical narrative: red, hot, hard, tender, inflamed arm from crux of arm to armpit and half way around arm.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry skin, Pityriasis rosea
Clinical narrative: I have had pityriasis rosea going on 6 months now.  I was diagnosed by Dr. in June of 2023, but had it since May 1.  This diagnosis was confirmed in August by a dermatologist who took a biopsy from two places, one from back of left shoulder and a very new one from my buttock.  Oddly, the one biopsy from the back of my shoulder had been there for about six months prior to May and only appeared as a small, rough spot on my skin which kept changing in size but had been dormant for six months.  Since it is a virus and there is no treatment for it and it predominantly occurs with babies, it seems very likely that the correlation may be one of the vaccines because babies are also receiving their vaccinations.  I have heard of a few other adults having this and their dermatologists have said they are seeing more and more cases of late.  Since it has been happening for so long, it is constantly in my thoughts, and this seems to be the most plausible, so I thought it would be prudent to pass this information along to the CDC.
Age: 60.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The Fluad HD NDC 70461-0123-03-  Patient is 60 years old and the patient recieved the flu vaccine for 65 year old plus.
Age: 33.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Breakthrough seizure (normally well-controlled with medication. The last one before this one was February 2019). There were no seizures after vaccinations in the past (flu or COVID). The difference this time was that the two were administered on the same day.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blood electrolytes, Blood pressure increased, Chest X-ray, Chest discomfort, Differential white blood cell count
Clinical narrative: Tightness R upper back, tightness in chest, radiating pain into R neck, jaw & ear.  Elevated blood pressure, diaphoresis.  Went to Emergency Room. Event lasted approximately 60 minutes.  Symptoms continued to come and go through evening and continued on 10/4/2023.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Electrocardiogram, Full blood count, Hyperhidrosis, Laboratory test
Clinical narrative: Tightness R upper back, tightness in chest, radiating pain into R neck, jaw & ear.  Elevated blood pressure, diaphoresis.  Went to Emergency Room. Event lasted approximately 60 minutes.  Symptoms continued to come and go through evening and continued on 10/4/2023.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle tightness, Neck pain, Pain, Pain in jaw, Troponin
Clinical narrative: Tightness R upper back, tightness in chest, radiating pain into R neck, jaw & ear.  Elevated blood pressure, diaphoresis.  Went to Emergency Room. Event lasted approximately 60 minutes.  Symptoms continued to come and go through evening and continued on 10/4/2023.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was injected with Moderna Spikevax when she did not request it. She had requested the Flu shot and was incorrectly given the COVID vaccine.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site nodule, Injection site pruritus
Clinical narrative: Donor stated that her Left leg started to cramp up. Her injection site was red/itchy with a lump/nodule that was <2x2 in size along with a purple bruise. Donor left before any recovery question can be asked.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms
Clinical narrative: Donor stated that her Left leg started to cramp up. Her injection site was red/itchy with a lump/nodule that was <2x2 in size along with a purple bruise. Donor left before any recovery question can be asked.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Patient called yesterday and informed me that since she had the vaccine two weeks ago, she had a 5-cm wide big bump on her arm, which was very painful and only resolved within the past two days. As of right now, patient reports only lingering soreness, but the swelling has subsided. Patient has already contacted her physician and she was present at the time I called to follow up on her well-being.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Patient had swollen lymph nodes from arm to neck on the left side where he received the vaccine.  He reported this to us several days after receiving the vaccine and stated it started the next day after being vaccinated.  He did state that the swelling was starting to decrease.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: I get double vision every day since the second shot I start the day with normal vision. As the day progresses I get double vision (vertical). It can reach the point of not being able to recognize faces. I can't sit down and read a book anymore because of this. I have seen Neurologists, Ophthalmologists and Neuro-Ophthalmologists for this for more than a year now with no resolution.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Lymph node pain, Lymphadenopathy
Clinical narrative: At 1 am on 10/3/23, I woke up due to chest pain. The pain worsened rapidly and affected my entire chest and neck. It felt like I could not breath. The pain was a 10 on a scale of 1-10. My entire chest wall felt very tight, like it could not move. I took some tylenol at 1:15am. The pain continued to come in waves of varying intensity from a 7 to 10. I was awake for 2 hours with the pain, and then it subsided and I fell back to sleep around 3am. The following day my chest continued to be sore from the inside out, but it was bearable. The lymph node in my left armpit swelled up and became painful. The chest pain and soreness has ceased as of the morning on 10/4, but the lymph node is still swollen and painful.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Sleep disorder
Clinical narrative: At 1 am on 10/3/23, I woke up due to chest pain. The pain worsened rapidly and affected my entire chest and neck. It felt like I could not breath. The pain was a 10 on a scale of 1-10. My entire chest wall felt very tight, like it could not move. I took some tylenol at 1:15am. The pain continued to come in waves of varying intensity from a 7 to 10. I was awake for 2 hours with the pain, and then it subsided and I fell back to sleep around 3am. The following day my chest continued to be sore from the inside out, but it was bearable. The lymph node in my left armpit swelled up and became painful. The chest pain and soreness has ceased as of the morning on 10/4, but the lymph node is still swollen and painful.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Blood glucose normal, Diarrhoea, Dizziness, Gait inability
Clinical narrative: I developed a fever the night after receiving the vaccine, which was expected based on previous COVID vaccine experience. I took my temperature this morning and had a fever of 101.4. I went downstairs and drank a small amount of water. Soon after, my hearing became muffled and I started feeling very lightheaded and sweating. I sat for a bit and then I started having severe lower abdominal pain. I had diarrhea and my hands were getting numb. I went to lay down on the couch and found that both of my hands had frozen in a spasm position and I couldn't move them. My lower legs had the pins and needles feeling but I could still walk. I felt like this for several minutes and eventually told my husband to call EMS. While waiting for the paramedics to arrive, I became nauseous and threw up several times. I still had the bad lower abdominal pain, light-headedness, couldn't move hands, sweating profusely. By the time the paramedics arrived, my symptoms started to subside quickly. I do not know if this was a life-threatening situation but I felt like I might die.  A similar thing happened after my first COVID vaccine (also Pfizer) back in early 2021 except that I didn't lose the ability to use my hands, and the feelings subsided sooner and EMS was not called that time.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Hypoaesthesia, Musculoskeletal disorder, Nausea
Clinical narrative: I developed a fever the night after receiving the vaccine, which was expected based on previous COVID vaccine experience. I took my temperature this morning and had a fever of 101.4. I went downstairs and drank a small amount of water. Soon after, my hearing became muffled and I started feeling very lightheaded and sweating. I sat for a bit and then I started having severe lower abdominal pain. I had diarrhea and my hands were getting numb. I went to lay down on the couch and found that both of my hands had frozen in a spasm position and I couldn't move them. My lower legs had the pins and needles feeling but I could still walk. I felt like this for several minutes and eventually told my husband to call EMS. While waiting for the paramedics to arrive, I became nauseous and threw up several times. I still had the bad lower abdominal pain, light-headedness, couldn't move hands, sweating profusely. By the time the paramedics arrived, my symptoms started to subside quickly. I do not know if this was a life-threatening situation but I felt like I might die.  A similar thing happened after my first COVID vaccine (also Pfizer) back in early 2021 except that I didn't lose the ability to use my hands, and the feelings subsided sooner and EMS was not called that time.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vomiting
Clinical narrative: I developed a fever the night after receiving the vaccine, which was expected based on previous COVID vaccine experience. I took my temperature this morning and had a fever of 101.4. I went downstairs and drank a small amount of water. Soon after, my hearing became muffled and I started feeling very lightheaded and sweating. I sat for a bit and then I started having severe lower abdominal pain. I had diarrhea and my hands were getting numb. I went to lay down on the couch and found that both of my hands had frozen in a spasm position and I couldn't move them. My lower legs had the pins and needles feeling but I could still walk. I felt like this for several minutes and eventually told my husband to call EMS. While waiting for the paramedics to arrive, I became nauseous and threw up several times. I still had the bad lower abdominal pain, light-headedness, couldn't move hands, sweating profusely. By the time the paramedics arrived, my symptoms started to subside quickly. I do not know if this was a life-threatening situation but I felt like I might die.  A similar thing happened after my first COVID vaccine (also Pfizer) back in early 2021 except that I didn't lose the ability to use my hands, and the feelings subsided sooner and EMS was not called that time.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Employee reported hives arms and chest, no shortness of breath 10/3/2023 @ approx. 1500. Employee reported taking 4x Benadryl last night and  1 this morning and hives down to about 50% of body this morning.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Vaginal haemorrhage
Clinical narrative: Patient has had an IUD placed for about 13 months and has not had a period in over a year.  Starting on 10/1 around 7:00pm, about 6-7 hours after vaccination, they began to experience abdominal cramps, then around 10:00pm, they experienced vaginal bleeding which has not stopped yet after 4 days.
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Syncope
Clinical narrative: Wife said he was fine after receiving the vaccines but the next day he collapsed and went to the hospital
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: C-reactive protein, Differential white blood cell count, Dysstasia, Fall, Full blood count
Clinical narrative: Wife said he was fine after receiving the vaccines but the next day he collapsed and went to the hospital
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Gait inability, Hypoaesthesia, Immunisation reaction, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Wife said he was fine after receiving the vaccines but the next day he collapsed and went to the hospital
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Respiratory pathogen panel, Urine analysis
Clinical narrative: Wife said he was fine after receiving the vaccines but the next day he collapsed and went to the hospital
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Blood test, Hypoaesthesia
Clinical narrative: Wife said he was fine after receiving the vaccines but the next day he collapsed and went to the hospital
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: GAVE VARICELLA AND MMRV. SHOULD HAVE GIVEN VARICELLA AND MMR.  NO ADVERSE EFFECTS NOTED AT TIME OF INJECTION.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: patient is reporting her left arm where she received 2 vaccines made her arm with big red band around it looked about 3 inches in width and very noticeable and warm to touch.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Immunisation, Syringe issue
Clinical narrative: When depressing vaccine into muscle the vaccine rolled down the arm.  Looked like it came from the neck of syringe just below luer lock.  Gave patient another dose  Fluzone.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to get a Hepatitis B vaccine and MA documented vaccine as Hep B but the lot# is for a Men B. Pt did not experience any adverse reactions
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Herpes zoster, Malaise, Nausea
Clinical narrative: Patient felt sick on 09/29/23 after getting the vaccine.  Was very tired and nauseous.  Claimed she almost fainted several times that night.  Developed a rash on her left side.  Was diagnosed with shingles on 10/4/23.  Was given valacyclovir 1g 1 tid for 7 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient felt sick on 09/29/23 after getting the vaccine.  Was very tired and nauseous.  Claimed she almost fainted several times that night.  Developed a rash on her left side.  Was diagnosed with shingles on 10/4/23.  Was given valacyclovir 1g 1 tid for 7 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Groin pain
Clinical narrative: pain in the groin area, and was not able to walk with right leg. severe soreness.  patient went to urgent care, and was given toradol shot.  monday evening symptoms subsided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive TDaP and MA gave Men B according to Lot# documented. NO adverse events from Men B
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antibody test, Blood test, Campylobacter test, Diarrhoea, Full blood count
Clinical narrative: He had fever, vomiting and diahrrea the same evening. from that time on the fever was intermittent and the vomiting was intermittent and the diarrhea has been consistent. over 9 diarrheas in a day in the beginning and now its about 3 per day.  First ER visit (outpatient service) on 9/23 and got IV fluids. Blood work was done. Second ER visit at Hospital on 9/26 and he was given more IV fluids. Blood work was done. He also needed magnesium by IV and by mouth.  Weight loss of about 12lbs minimum
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Giardia test, Laboratory test, Metabolic function test, Pyrexia, Salmonella test
Clinical narrative: He had fever, vomiting and diahrrea the same evening. from that time on the fever was intermittent and the vomiting was intermittent and the diarrhea has been consistent. over 9 diarrheas in a day in the beginning and now its about 3 per day.  First ER visit (outpatient service) on 9/23 and got IV fluids. Blood work was done. Second ER visit at Hospital on 9/26 and he was given more IV fluids. Blood work was done. He also needed magnesium by IV and by mouth.  Weight loss of about 12lbs minimum
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vomiting, Weight decreased
Clinical narrative: He had fever, vomiting and diahrrea the same evening. from that time on the fever was intermittent and the vomiting was intermittent and the diarrhea has been consistent. over 9 diarrheas in a day in the beginning and now its about 3 per day.  First ER visit (outpatient service) on 9/23 and got IV fluids. Blood work was done. Second ER visit at Hospital on 9/26 and he was given more IV fluids. Blood work was done. He also needed magnesium by IV and by mouth.  Weight loss of about 12lbs minimum
Age: 12.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: According to the lot # Pt was given PCV 15 but was supposed to get HPV. No adverse effects noted
Age: 16.0
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Wrong product administered
Clinical narrative: According to the lot# pt was given PCV 15 but supposed to get HPV. NO adverse reactions noted
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: 08:40am: vaccine administered, Patient was monitored x15 minutes post administration in office, no adverse reaction noted. Patient contacted clinic at 12:40pm stating she took a nap and woke up unable to move left arm and having pain throughout body. Triage nurse had patient report to the ER for emergency medical attention.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Peripheral swelling, Pruritus
Clinical narrative: Right arm/knuckle swelling, itchiness
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration
Clinical narrative: Patient called store to report a discoloration with no pain or discomfort at vaccine site.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: Swelling, redness, and tingling that had gotten worse over the time period
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to touch, and pain
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash on neck trunk.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Loss of consciousness, Muscle rigidity, Syncope
Clinical narrative: Patient and 4 other siblings were each getting their flu shots. Patient got hers, was surprised it didnt hurt, and didnt show any signs of distress. She popped up happy with her ice cream ticket and seemed completely fine. Nurse moved on to the siblings and finished the last sibling when patient face planted to the ground face first all of a sudden. Nurse thought maybe she tripped while getting up or that a sibling pushed but quickly realized that she had fainted. Patients arms were very rigid. Could not determine with absolute certainty that a seizure did not occur but the rigid arms were cause for concern. Patient lifted to recumbent chair where she came back to with ammonia. Patient laid recumbent and drank juice and ate crackers. NP assessed patient vitals and asked A&O questions along with assessing face and head. No obvious injuries other than a bruised ear cartilage. A&O x4 and vital signs all WNL.
Age: 65.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Allergy to vaccine, Erythema, Pruritus, Swelling
Clinical narrative: patient has 20x10cm red area on right arm. following vaccinations.  She experienced mild itching and swelling but condition has not worsened for 5 days.  Patient returned to the clinic 8 days following vaccinations and was examined by medical doctor.  Patient allergy profile was updated to include pneumococcal conjugate vaccine. (No reaction in the left arm where the Shingrix was administered)
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site swelling
Clinical narrative: Patient had a reaction immediately after receiving the vaccination.  The injection site location swelled and there was discoloration.
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Cold sweat, Palpitations
Clinical narrative: While ushering at a church service, I felt clammy and that my heart was racing. I checked my heart rate at 4:27 PM using a smart watch and found that my heart rate was at 148 to 154 BPM that lasted about 2 minutes.  During the episode, I took deep long breaths which reduced my heart rate to normal.    At about 4:37 PM my heart rate went back to about 152 to 156 BPM that lasted about 4 minutes.  I sat down and once again took long deep breaths and my heart rate reduced.  No additional problems after the second occurrence or since.
Age: 58.0
Sex: F
Vaccine: FLUA4
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Administrated the incorrect flu vaccine on 10/3/23. This individual received the high dose Fluad meant for individuals 65 and older instead of the Flucelvax 6 months and older flu vaccine accidently. Patient has been notified. Administrator has been notified and re-educated on proper administration and has reported the error. No adverse reactions, signs or symptoms from the recipient reported.
Age: 31.0
Sex: F
Vaccine: FLUA4
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administrated the incorrect flu vaccine on 10/3/23. This individual received the high dose Fluad meant for individuals 65 and older instead of the Flucelvax 6 months and older flu vaccine accidently. Patient has been notified. Administrator has been notified and re-educated on proper administration and has reported the error. No adverse reactions, signs or symptoms from the recipient reported.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV5
Symptoms: No adverse event
Clinical narrative: No adverse reactions after vaccines given nor 45 min later after vaccinations.  Per mom will keep an eye on infant.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Caller reporting that doses of PROQUAD were administered to a patient who is older than 12 years old (14 years and 8 months). Their vaccination status prior to this recent vaccination was unknown by parents and patient as they are from another unspec; This spontaneous report was received from a nurse practitioner, referring to a 14-year-old (reported as 14 years and 8 months old) of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  The reporter stated that the patient who was older than 12 years old (inappropriate age at vaccine administration). It was also confirmed that their vaccination status prior to this recent vaccination was unknown by parents and patient as they were from another unspecified country and there were no records.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; HBP calling to report adverse event regarding a 13 month old patient who was inadvertently administered PROQUAD and VARIVAX at the same time.  HBP stated that the doses were administered today, 9/25/2023, due to an administration error.  Both doses o; This spontaneous report was received from an other refers to a 13-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 25-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot number X012148, expiration date 28-OCT-2024, 0.5 milliliter (route of administration not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot number X010531, expiration date 11-APR-2025, 0.5 milliliter (route of administration not reported) (extra dose administered). No adverse event was reported.  "Lot number X012148 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative
Clinical narrative: Nurse is reporting that an adult patient came to the office with low titer for varicella and measles, mumps, and rubella.  The patient possibly received MMR II and VARIVAX in the past.    No additional AEs were reported. No further information provid; This spontaneous report was received from a nurse refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient's concomitant therapies included ADIPEX.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for vaccination.  On an unknown date, the patient experienced antibody test negative. On unknown date, the titer test was performed and showed low title. The outcome of antibody test negative was unknown.  The causality assessment was not provided.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: The needle and broken neck/hub got stuck to child's leg/no injury involved/there was no injury involved the neck/hub came out seamlessly from the involved patient; Reporter called on behalf of a Nurse to report a PQC on 2 VAXNEUVANCE syringes from the same lot number that broke; Second breakage occurred on 9/22/2023 and it broke at the neck after administering it; First breakage occurred on 9/15/2023 and broke at the neck when the needle was being put on prior to administration; This spontaneous report was received from a nurse referring to a child of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.   On 15-SEP-2023 a pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe broke into two separate pieces (hub/neck and barrel) at the neck when the needle/hub was being put on, twisting on the needle, attempting to attach the needle, prior to administration and the nurse confirmed that she did not use the product (Syringe issue). On 22-SEP-2023, the patient was vaccinated with a dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection, at a dose of 0.5 milliliter administered in the leg (reported as received full injection), lot # X012044 with expiration date 10-JAN-2025, for prophylaxis (vaccination scheme frequency, route of administration and specific anatomical location were not reported). It was reported that after the nurse administered the vaccine to the patient, the syringe broke off at the neck when removing the needle and the broken neck/hub got stuck to the child's leg (Syringe issue & poor quality device used) but no injury occurred (also reported as child was "ok") as the neck/hub came out seamlessly from the involved patient (No adverse event). The nurse confirmed there were no cracks, no evidence of damage, liquid in syringe tray, box was normal with no damage, and cellophane cover was intact.
Age: 11.0
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HCP called to get information on GARDASIL 9 alternative dosing schedules. HCP stated GARDASIL 9 was given to a patient   at age 11 (1st dose administered on 8/13/2019), at age 15 (2nd dose, 8/08/2023), at age15 (3rd dose on 9/21/2023). No other infor; No additional AE reported. No PQC reported; This spontaneous report was received from Other Health Professional and refers to a paient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #W026151, expiration date: 20-OCT-2024 (strength, route of administration, and indication were not provided). On 13-AUG-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1s dose, lot #R029512, expiration date: 08-JUL-2021, administered for prophylaxis (strength, and route of administration were not provided). On 21-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 3rd dose, lot #X005044, expiration date: 02-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced HCP called to get information on GARDASIL 9 alternative dosing schedules. HCP stated GARDASIL 9 was given to a patient at age 11 (1st dose), at age 15 (2nd dose), at age 15 (3rd dose). No other information. No additional AE reported. No PQC reported.
Age: 0.17
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product confusion, Wrong product administered
Clinical narrative: No AE; Nurse reported on Sep 28, 2023, a two month old patient was accidently administered a dose of GARDASIL 9. Nurse stated no adverse events have been reported as of now, but she has still not called the patients parents. The patient was suppose to recei; Nurse reported on Sep 28, 2023, a two month old patient was accidently administered a dose of GARDASIL 9. Nurse stated no adverse events have been reported as of now, but she has still not called the patients parents.; The patient was suppose to receive Prevnar 13. Nurse stated the HCP who administered the product must have gotten the products confused because GARDASIL 9 was not ordered.; This spontaneous report was received from a nurse and refers to a 2-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-SEP-2023, the patient was accidently administered a dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, once, valid lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Wrong product administered) (Product administered to patient of inappropriate age). The patient was supposed to receive pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). Nurse stated the healthcare provider (HCP) who administered the product must have gotten the products confused because HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not ordered (Product confusion). Nurse stated no adverse events have been reported as of now, but she had still not called the patients parents. No further information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding VARIVAX. Product had undergone TE and it was administered after the TE. No reported adverse reactions. Permission to contact HCP was given. No additional AE/no PQC.; No reported adverse reactions.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #w039294, expiration date: 11-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP called regarding VARIVAX. Product had undergone TE and it was administered after the TE. No reported adverse reactions. Permission to contact HCP was given. No additional AE/no PQC.; Sender's Comments:  US-009507513-2310USA000671:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Inbound call from HCP requesting evaluation of temperature excursion. Caller stated that 1 of their patient's received the VARIVAX after the excursion.  No symptoms reported.  Vaccine was administered by a RN who is a repeat user. No additional AE/P; This spontaneous report was received from administrator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis lot#X011424, expiration date: 19-APR-2025(strength and route of administration were not provided). This vaccine underwent temperature excursion for 1 hour 21 minutes in 11.37 Farenheit (Product storage error). No additional adverse event was reported.