chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dizziness
Clinical narrative: Approximately 9 hours after injection, I started to get chills. They were not terrible, but sent me to bed at 9:00PM. Rough night sleeping, as I was waking every hour or so due to pain in my knee, back, head. I was still having chills. At about 2:00 AM, I got up because of a pain in my right ankle. I do tend to have an inflammatory response there from vaccines. It also happened with Covid shots. Other vulnerable areas that were painful was my lower back (dull pain), as well as another area I have post vaccine issues with, the ball of my left foot. However, I could deal with this, and probably not file this report, if it wasn't for the next issue. When I got up at around 4:30AM, I stood up, feeling weak, and moved to and moved towards my bedroom door. As I did, I started to faint. Fortunately, I was able to get back on the bed and avoid injury from fainting. I tried again an hour or so later, and the same thing happened. I had been close to completely passing out 3 times. I read things on the CDC site that said that fainting side effects were generally thought to be associated with the procedure itself, rather than the vaccine. The fact that I was fainting many hours later, calls that into question. I had a fever of 100 degrees at 4:30 AM. It's 9:15 AM on 2/1/12025, and I'm feeling better, to be sure. Back is still quite sore, and I am very fatigued. The last time my back got this sore was after my first Covid shot back in 2020.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Sleep disorder
Clinical narrative: Approximately 9 hours after injection, I started to get chills. They were not terrible, but sent me to bed at 9:00PM. Rough night sleeping, as I was waking every hour or so due to pain in my knee, back, head. I was still having chills. At about 2:00 AM, I got up because of a pain in my right ankle. I do tend to have an inflammatory response there from vaccines. It also happened with Covid shots. Other vulnerable areas that were painful was my lower back (dull pain), as well as another area I have post vaccine issues with, the ball of my left foot. However, I could deal with this, and probably not file this report, if it wasn't for the next issue. When I got up at around 4:30AM, I stood up, feeling weak, and moved to and moved towards my bedroom door. As I did, I started to faint. Fortunately, I was able to get back on the bed and avoid injury from fainting. I tried again an hour or so later, and the same thing happened. I had been close to completely passing out 3 times. I read things on the CDC site that said that fainting side effects were generally thought to be associated with the procedure itself, rather than the vaccine. The fact that I was fainting many hours later, calls that into question. I had a fever of 100 degrees at 4:30 AM. It's 9:15 AM on 2/1/12025, and I'm feeling better, to be sure. Back is still quite sore, and I am very fatigued. The last time my back got this sore was after my first Covid shot back in 2020.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Abrysvo on 11-13-2023 and again on 01-29-2025.  Shot was duplicated.  Spoke to patient on 01-29-25 and 01-30-25 and she reported NO adverse events.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red, warn injection site
Age: 63.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Pain, Sleep disorder, Tremor
Clinical narrative: Pt states he has uncontrollable shaking and can't sleep and has body aches.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Headache, Myalgia, Pain
Clinical narrative: January 24 around 1:00 PM - vaccine January 25 around 2:00 AM - chills, body aches, headache, chest tight and muscle like pain on the right side of my body continued throughout the day even taking 600 mg ibuprofen every six hours. That evening fever was 101.4.  Extreme fatigue during the day also. January 26 - Symptoms continued, especially severe headache and weakness. January 27 - Doctor s appointment.  Fever that morning 102 and now experiencing nausea with severe headache, body aches.  Fever blisters started appearing on the outside of mouth.  Doctor did flu and Covid test, both negative.  Said to alternate ibuprofen and Tylenol every 4 hours and told me to take Valacyclovir for fever blisters.  If not better call her on Wednesday. January 28 - Seemed to feel a little better but weak and still had headache. Fever blisters on outside of mouth and sores on inside of mouth. About 4:00 PM chills started again and brought fever, extreme headache, and bodyache.  Tylenol and ibuprofen were not helping much.  Temp got up to 105 at one point.  Unable to sleep and new pain developed under my right breast and radiated to my back. January 29 - Extremely weak by the ordeal and a little short of breath.  Called doctor and she scheduled bloodwork for the next day.  Did not miss Tylenol and ibuprofen and symptoms did improve.  Pain under right breast returning when I laid down.  Ate better today but very little. January 30 - No fever or body aches and better appetite.  Still had a noticeable headache and was weak but otherwise much better.  Pain under right breast woke me up several times in the night and had a little shortness of breath. January 31 - Doctor reported that bloodwork showed potassium was low and anemia.  She suggested I have a CT Scan about pain to check for blood clot.  Everything much improved, including headache.  Throughout night pain under right breast still persisted but not as pronounced. February 1 - Mouth is healing, normal appetite and more energy.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Erythema, Myalgia, Pyrexia
Clinical narrative: Got the Capvaxive shot,that night patient got fever,muscle pain and chill,fever gone in 2 days but the muscle pain and redness on the skin still there
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: PATIENT'S CAREGIVER ( DAD)  REPORTED PATIENT HAD  PAIN IN LEFT ARM FOR PAST FEW DAYS AFTER RECEIVING  VACCINE. HE ALSO ADDED  WITH PAINFUL ARM  PATIENT PRACTICED VOLLEYBALL GAME FOR PAST FEW DAYS, WHICH ELEVATED HER PAIN LEVEL. SHE WAS SEEN BY CLINIC TODAY. SHE WAS PRESCRIBED MUSCLE RELAXANTS , NSAIDS  BY THE CLINIC.
Age: 35.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccines administered 1/29/25, patient called the pharmacy 2/1/25 with c/c of local redness, swelling and warmth and headache. The headache resolved after 24 hours but the patient continues to have local injection site reactions. RPh advised patient to continue acetaminophen as directed and to apply ice.  Pt verbalized understanding.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: pt says on 1/31/25 injection site began slight swelling, redness and itching. he tried putting some alcohol on it. But no other symptoms or reactions.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. received dose of Pfizer Comirnaty (2024-25) vaccine in right deltoid. Pt had soreness, redness at injection site. Minor swelling at injection site.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Extreme pain causing limited mobility for approximately one month after immunization which subsided lighty to pain when raising arm in pressing motion or pulling light weights across body or over head.
Age: 1.58
Sex: M
Vaccine: HIBV, IPV
Symptoms: Hypersensitivity, Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: 3 hours after vaccination, pt started to have an allergic reaction at home with hives, itchiness and facial swelling. We gave benedryl and proceeded to the emergency department due to lip swelling. He was given more Benedryl, steroids and discharged with prescriptions for Benedryl, 3 day course of steroids and epi pens. He continued on the Benedryl as needed for another day and completed the course of steroids.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Wheezing
Clinical narrative: Wheezing, cough, tiredness
Age: 92.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Blood test, Cardiac failure congestive, Computerised tomogram, Laboratory test, Pneumonia
Clinical narrative: None stated.
Age: 92.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Sepsis
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not report any issues after vaccination; however this is a duplication. Patient just received a dose of Prevnar 20 on 12/03/2024 so they were not eligible for vaccination on 1/31/2025. It was overlooked when we searched state Shots and pt did not remember getting it in December
Age: 53.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Rash, Swelling face, Swelling of eyelid
Clinical narrative: patient had a rash that broke out on forehead and some facial swelling, especially right eyelid
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test, Disorientation, Dizziness, Hepatic enzyme increased, Hypertension
Clinical narrative: Dizziness disorientation.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Neuropathy peripheral, Retinal disorder, Sleep apnoea syndrome, Type 2 diabetes mellitus
Clinical narrative: Dizziness disorientation.
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy vaccine was give twice to the same patient
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy was given twice to the same patient
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 1/27/25 - Soreness & Redness at injection site; 1/28/25 - Itchy, Chills & Feverish; 1/29/25 - Swelling, redness, hotness, and itchy rash at injection site; 1/30/25 - Cold sore on outer right nostril; 1/31/25 - Swelling & rash spreading down to bicep; 2/1/15 - Swelling and rash down to elbow. 2/2/25 - Swelling past elbow & Itchy rash
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site warmth, Oral herpes, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: 1/27/25 - Soreness & Redness at injection site; 1/28/25 - Itchy, Chills & Feverish; 1/29/25 - Swelling, redness, hotness, and itchy rash at injection site; 1/30/25 - Cold sore on outer right nostril; 1/31/25 - Swelling & rash spreading down to bicep; 2/1/15 - Swelling and rash down to elbow. 2/2/25 - Swelling past elbow & Itchy rash
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Rash, Rash pruritic
Clinical narrative: 1/27/25 - Soreness & Redness at injection site; 1/28/25 - Itchy, Chills & Feverish; 1/29/25 - Swelling, redness, hotness, and itchy rash at injection site; 1/30/25 - Cold sore on outer right nostril; 1/31/25 - Swelling & rash spreading down to bicep; 2/1/15 - Swelling and rash down to elbow. 2/2/25 - Swelling past elbow & Itchy rash
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received two doses of Boostrix 6 months apart
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea, Vision blurred
Clinical narrative: patient reported that symptoms occurred 1 day after vaccination. she reports symptoms of a cold such as runny nose, congestion, and fatigue. she also reported having blurry vision that has continued.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Arm was initially sore and swollen. Patient states that the injection was administered too high in the deltoid muscle and did  hit the bone.  Patient did not see any doctor in regards to the extreme soreness. Patient went to seek advice from her local pharmacy a few times after 4 months of getting vaccine and was told that the soreness would go away, but it did not.
Age: 95.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Death, Resuscitation, Wheezing
Clinical narrative: 11-30-2024 resident was found at 0620 with audible wheezing. Blood glucose testing performed, with results of 65. PRN Albuterol jet nebulizer treatment administered. O2 saturation 93% ; pulse 96; respirations 22. At 0635 patient had no vital signs, CPR begun, 911 called and resident was pronounced at 0729.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The pt was given the moderna 6 month-11 yrs dose instead of spikevax
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: On the first day of vaccination, pt called to express she experienced redness and swelling at the injection site. She also started to experience some dizziness on the next day.  Her symptoms have since improved and she is feeling much better.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Hallucination, Moaning, Resuscitation
Clinical narrative: 11-26-2024 resident was diagnosed with a UTI and med prescribed for treatment. 11-27-2024 Resident was noted lying in bed moaning. Resident denied being in pain, resident was talking to person not in the room.  Later on in the day resident was noted to have SOB. O2 was placed on resident and during the night an order obtained to transfer resident to hospital for observation during. On 11-28-2024 resident was transferred from hospital to hospital. During transport CPR was initiated. Resident was pronounced at the hospital on 11-28-2024, time unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: 11-26-2024 resident was diagnosed with a UTI and med prescribed for treatment. 11-27-2024 Resident was noted lying in bed moaning. Resident denied being in pain, resident was talking to person not in the room.  Later on in the day resident was noted to have SOB. O2 was placed on resident and during the night an order obtained to transfer resident to hospital for observation during. On 11-28-2024 resident was transferred from hospital to hospital. During transport CPR was initiated. Resident was pronounced at the hospital on 11-28-2024, time unknown.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Pain
Clinical narrative: Achiness, soreness, throbbing, pain at injection site lasting more than 10 days
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Erythema, Lethargy, Mobility decreased, Pain in extremity
Clinical narrative: Swelling, redness tender and sore arm from shoulder to elbow. Unable to move arm 2x day following vaccine. Mild fever 38.1. X1 day following vaccine. Lethargy, loss of appetite. Following two days redness and swelling continues to grow and spread.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Swelling, redness tender and sore arm from shoulder to elbow. Unable to move arm 2x day following vaccine. Mild fever 38.1. X1 day following vaccine. Lethargy, loss of appetite. Following two days redness and swelling continues to grow and spread.
Age: 69.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Musculoskeletal stiffness, Skin discolouration
Clinical narrative: PATIENT COMPLAIN THAT HER RIGHT IS STIFF AND CANNOT MOVE AROUND. AREA LOOKS PURPLE AND IT HAS BEEN 2 WEEKS
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3, PNC20, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: On 2/2/2025 patient states she started experiencing redness and swelling of the left arm the evening of the vaccination (1/27/2025). Patient reported  (2/2/2025) that the swelling and redness was going around her whole arm and was painful and warm to touch. Advised patient to mark around area to make sure the redness wasn't spreading and to follow up with provider to determine next steps.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Extra dose administered
Clinical narrative: Patient administered a 5th, unnecessary dose of RabAbert for post-exposure secondary to a cat scratch. Only 4 post-exposure doses recommended in immunocompetent patient.
Age: 1.5
Sex: F
Vaccine: DTPPVHBHPB, MMR, VARCEL, DTPPVHBHPB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability
Clinical narrative: Measels 8/5/24; 1/31/25 ? should be birth and 4-5 years  old Chicken pox 8/5/24; 1/31/25 ? should be birth and 4-5 years old Combo ? Dtap, hib, HepB 9/23; 11/23; 1/2024; 10/31/24; 1/31/25 ? 4-5 years old (this last dose was not needed, and Dr. had given her the previous dose)  Medical records from another state were provided prior to first appointment, per clinic request. A paper copy of vaccine records was also brought to the first appointment, 10/31/2024.   During the appointment on 1/31/25 the provider, Dr., said patient was due for 4 shots as well as a Flu Shot.   Patient had already received a flu shot plus booster, as such the flu shot was declined. The provider was 35 mins late to the appointment and was very rushed. She kept referring to Patient as ?he? and also kept thinking that she was in for 15 month well check, instead of the 18 month well check. The evening of 1/31/25 Patient was generally not feeling well with a low grade fever.  By 6pm she developed a rash on her chest, face, and inner thighs.  The hotline was consulted and symptoms were managed with OTC medication. The day of 2/1/25 Patient continued to be unwell, generally fussy, poor appetite, and vomited mid day.  She developed a high fever >103 later in the day, as well as a reoccurrence of the rash on her chest and face.  The fever was controlled with OTC medications The hotline was consulted multiple times. It was discovered that Patient was improperly dosed with MMR, Chicken Pox, and the combo.   2/2/25 Patient woke up and was doing better. Temperature was 98-99 deg F for the morning.  She took a nap and again developed a fever of 101.6 in the afternoon. Fever was managed with OTC meds and the hotline was consulted again, as Patient was seeming improved, but quickly developed another fever.  Dr. recommended that we follow up with a pediatrician tomorrow, 2/3/25 morning (he said he would be speaking with Dr. and recommended we call at 730AM to make an appointment with him) Patient is sleeping as I complete this form. She still had a fever of 101 tonight when she went to bed, despite tylenol and ibuprofen dosage. Hotline provider was Dr.- very helpful Provider that administered unnecessary vaccinees: Dr.
Age: 1.5
Sex: F
Vaccine: DTPPVHBHPB, MMR, VARCEL, DTPPVHBHPB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Malaise, Pyrexia, Rash, Vomiting
Clinical narrative: Measels 8/5/24; 1/31/25 ? should be birth and 4-5 years  old Chicken pox 8/5/24; 1/31/25 ? should be birth and 4-5 years old Combo ? Dtap, hib, HepB 9/23; 11/23; 1/2024; 10/31/24; 1/31/25 ? 4-5 years old (this last dose was not needed, and Dr. had given her the previous dose)  Medical records from another state were provided prior to first appointment, per clinic request. A paper copy of vaccine records was also brought to the first appointment, 10/31/2024.   During the appointment on 1/31/25 the provider, Dr., said patient was due for 4 shots as well as a Flu Shot.   Patient had already received a flu shot plus booster, as such the flu shot was declined. The provider was 35 mins late to the appointment and was very rushed. She kept referring to Patient as ?he? and also kept thinking that she was in for 15 month well check, instead of the 18 month well check. The evening of 1/31/25 Patient was generally not feeling well with a low grade fever.  By 6pm she developed a rash on her chest, face, and inner thighs.  The hotline was consulted and symptoms were managed with OTC medication. The day of 2/1/25 Patient continued to be unwell, generally fussy, poor appetite, and vomited mid day.  She developed a high fever >103 later in the day, as well as a reoccurrence of the rash on her chest and face.  The fever was controlled with OTC medications The hotline was consulted multiple times. It was discovered that Patient was improperly dosed with MMR, Chicken Pox, and the combo.   2/2/25 Patient woke up and was doing better. Temperature was 98-99 deg F for the morning.  She took a nap and again developed a fever of 101.6 in the afternoon. Fever was managed with OTC meds and the hotline was consulted again, as Patient was seeming improved, but quickly developed another fever.  Dr. recommended that we follow up with a pediatrician tomorrow, 2/3/25 morning (he said he would be speaking with Dr. and recommended we call at 730AM to make an appointment with him) Patient is sleeping as I complete this form. She still had a fever of 101 tonight when she went to bed, despite tylenol and ibuprofen dosage. Hotline provider was Dr.- very helpful Provider that administered unnecessary vaccinees: Dr.
Age: 1.5
Sex: F
Vaccine: DTPPVHBHPB, MMR, VARCEL, DTPPVHBHPB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Measels 8/5/24; 1/31/25 ? should be birth and 4-5 years  old Chicken pox 8/5/24; 1/31/25 ? should be birth and 4-5 years old Combo ? Dtap, hib, HepB 9/23; 11/23; 1/2024; 10/31/24; 1/31/25 ? 4-5 years old (this last dose was not needed, and Dr. had given her the previous dose)  Medical records from another state were provided prior to first appointment, per clinic request. A paper copy of vaccine records was also brought to the first appointment, 10/31/2024.   During the appointment on 1/31/25 the provider, Dr., said patient was due for 4 shots as well as a Flu Shot.   Patient had already received a flu shot plus booster, as such the flu shot was declined. The provider was 35 mins late to the appointment and was very rushed. She kept referring to Patient as ?he? and also kept thinking that she was in for 15 month well check, instead of the 18 month well check. The evening of 1/31/25 Patient was generally not feeling well with a low grade fever.  By 6pm she developed a rash on her chest, face, and inner thighs.  The hotline was consulted and symptoms were managed with OTC medication. The day of 2/1/25 Patient continued to be unwell, generally fussy, poor appetite, and vomited mid day.  She developed a high fever >103 later in the day, as well as a reoccurrence of the rash on her chest and face.  The fever was controlled with OTC medications The hotline was consulted multiple times. It was discovered that Patient was improperly dosed with MMR, Chicken Pox, and the combo.   2/2/25 Patient woke up and was doing better. Temperature was 98-99 deg F for the morning.  She took a nap and again developed a fever of 101.6 in the afternoon. Fever was managed with OTC meds and the hotline was consulted again, as Patient was seeming improved, but quickly developed another fever.  Dr. recommended that we follow up with a pediatrician tomorrow, 2/3/25 morning (he said he would be speaking with Dr. and recommended we call at 730AM to make an appointment with him) Patient is sleeping as I complete this form. She still had a fever of 101 tonight when she went to bed, despite tylenol and ibuprofen dosage. Hotline provider was Dr.- very helpful Provider that administered unnecessary vaccinees: Dr.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Peripartum cardiomyopathy
Clinical narrative: Peripartum Cardiomyopathy
Age: 0.5
Sex: M
Vaccine: COVID19, DTPPVHBHPB, PNC20, RV5
Symptoms: Incorrect dose administered, Irritability, Pyrexia
Clinical narrative: Inadvertent administration of higher than recommended dose for pfizer COVID-19 vaccine given on 9/30/24. Parent informed same day. VAERS and Pfizer informed. Patient had fever and irritability x 24 hours which is now improved. Patient can continue on current recommended Pfizer dose schedule and this dose is considered valid.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Dry eye, Ear pain, Endocrine ophthalmopathy
Clinical narrative: she ended up getting covid; she ended up getting covid; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 1, single (Lot number: EW0158) and on 13Aug2021 as dose 2, single (Lot number: EW0169) for covid-19 immunisation. The patient's relevant medical history included: "throwing up" (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset 13Aug2021, outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "she ended up getting covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) positive. Clinical course: The vaccine from what she understands is supposed to prevent her from getting covid or that is what they said to dupe us all into getting it and she ended up getting covid.  She got covid and it is a serious issue and has so much records from clinic and spoke to so many doctors. She tested positive for covid on 06Jan2022 and the vaccines were before that which is strange as she was not supposed to get covid right away but had the vaccines then and thinks it takes a few weeks to kick in and the covid was diagnosed but probably began in Dec2021 but the positive test was not until 06Jan2022 and she thinks she contracted it in Dec2021. So about 4 months later she got covid which is strange and the data suggested the vaccine could actually cause covid which is distressing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Graves' disease, Inappropriate schedule of product administration, Influenza like illness, Ocular discomfort
Clinical narrative: she ended up getting covid; she ended up getting covid; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 1, single (Lot number: EW0158) and on 13Aug2021 as dose 2, single (Lot number: EW0169) for covid-19 immunisation. The patient's relevant medical history included: "throwing up" (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset 13Aug2021, outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "she ended up getting covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) positive. Clinical course: The vaccine from what she understands is supposed to prevent her from getting covid or that is what they said to dupe us all into getting it and she ended up getting covid.  She got covid and it is a serious issue and has so much records from clinic and spoke to so many doctors. She tested positive for covid on 06Jan2022 and the vaccines were before that which is strange as she was not supposed to get covid right away but had the vaccines then and thinks it takes a few weeks to kick in and the covid was diagnosed but probably began in Dec2021 but the positive test was not until 06Jan2022 and she thinks she contracted it in Dec2021. So about 4 months later she got covid which is strange and the data suggested the vaccine could actually cause covid which is distressing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Thyroid function test, Thyroxine
Clinical narrative: she ended up getting covid; she ended up getting covid; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 1, single (Lot number: EW0158) and on 13Aug2021 as dose 2, single (Lot number: EW0169) for covid-19 immunisation. The patient's relevant medical history included: "throwing up" (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset 13Aug2021, outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "she ended up getting covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) positive. Clinical course: The vaccine from what she understands is supposed to prevent her from getting covid or that is what they said to dupe us all into getting it and she ended up getting covid.  She got covid and it is a serious issue and has so much records from clinic and spoke to so many doctors. She tested positive for covid on 06Jan2022 and the vaccines were before that which is strange as she was not supposed to get covid right away but had the vaccines then and thinks it takes a few weeks to kick in and the covid was diagnosed but probably began in Dec2021 but the positive test was not until 06Jan2022 and she thinks she contracted it in Dec2021. So about 4 months later she got covid which is strange and the data suggested the vaccine could actually cause covid which is distressing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: she ended up getting covid; she ended up getting covid; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 1, single (Lot number: EW0158) and on 13Aug2021 as dose 2, single (Lot number: EW0169) for covid-19 immunisation. The patient's relevant medical history included: "throwing up" (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing); "sick with asthma attacks", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset 13Aug2021, outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "she ended up getting covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) positive. Clinical course: The vaccine from what she understands is supposed to prevent her from getting covid or that is what they said to dupe us all into getting it and she ended up getting covid.  She got covid and it is a serious issue and has so much records from clinic and spoke to so many doctors. She tested positive for covid on 06Jan2022 and the vaccines were before that which is strange as she was not supposed to get covid right away but had the vaccines then and thinks it takes a few weeks to kick in and the covid was diagnosed but probably began in Dec2021 but the positive test was not until 06Jan2022 and she thinks she contracted it in Dec2021. So about 4 months later she got covid which is strange and the data suggested the vaccine could actually cause covid which is distressing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported.; HCP called to report a Temperature Excursion  on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROPQUAD was inadvertently administered after suffering from a T; This spontaneous report was received from a registered nurse (RN) concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (reported as "Diluent MRK".)  On 09-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) injection, 0.5ml/series, lot #Y010050, expiration date 25-NOV-2025 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis. The vaccine was inadvertently administered after suffering from a temperature excursion (product storage error.)  It was reported that the product reached -11.6 degrees Celsius (c) and was out of range for 3 hours 5 minutes 0 seconds. Previous excursions could not be confirmed and at the reporting time, temperature excursion was ongoing and it was not possible to confirm if the products were still supported.  No symptomatic adverse events were reported (no adverse event). No additional information available.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2501USA007066: US-009507513-2501USA008866: US-009507513-2501USA008885: US-009507513-2501USA008880: US-009507513-2501USA008935: US-009507513-2501USA008877: US-009507513-2501USA008882: US-009507513-2501USA007047: US-009507513-2501USA007446: US-009507513-2501USA008861:
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that a 14 year old female patient was administered a dose of the PROQUAD vaccine. HCP did not report any side effects from the administration of the PROQUAD vaccine. HCP did not; HCP did not report any side effects from the administration of the PROQUAD vaccine.; This spontaneous report was received from registered nurse (RN) concerning to a 14-year-old female patient.  Her medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) injection, lot #Y012077, expiration date 05-JAN-2026 (exact dose, dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product administered to patient of inappropriate age.)  The reporter did not inform any side effects from the administration of the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine (no adverse event), did not state the reason for the administration of the vaccine and provided limited pertinent information and demographic data.
Sex: U
Vaccine: MMR
Symptoms: Device connection issue, No adverse event
Clinical narrative: No additional AE; Nurse called to report that the needle "popped off" a prefilled DILUENT syringe after it was used to administer a dose of MMR II.; Nurse called to report that the needle "popped off" a prefilled DILUENT syringe after it was used to administer a dose of MMR II.; Nurse called to report that the needle "popped off" a prefilled DILUENT syringe after it was used to administer a dose of MMR II.; This spontaneous report was received from nurse and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-JAN-2025, the patient was vaccinated with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, unk, valid lot #1973259, expiration date: 03-MAR-2026 (strength, route of administration, and indication were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, valid lot #X026222, expiration date: 06-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that the needle popped off a diluent syringe after it was used to administered a vaccine. The problem occurred when the staff member tried to engage the safety on the needle and it instead came off the syringe and caused a needle stick in the staff member left hand (needle issue, device connection issue and poor quality device used). The reporter stated that the patient received full dose and no issue was noted prior to or during administration. The reporter stated that no patient symptoms have been reported.  No additional adverse event (AE) was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical Assistant called to report expired GARDASIL 9 administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JAN-2025, the patient was vaccinatedwith hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, valid lot #W029724, expiration date: 08-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered).  No symptoms reported. No additional adverse event (AE).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No events were reported; Nurse calling to report that a dose of VARIVAX and PROQUAD were administered concomitantly to a 1 year old patient. No clinical events were reported. No PQC. No additional information.; This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 21-JAN-2025, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X028613, expiration date: 13-DEC-2025 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis concomitantly with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) # Y011215, expiration date: 18-DEC-2025 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis .   No clinical events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC reported; Medical Assistant calling with a report of an adverse event regarding an expired dose of PNEUMOVAX 23 that was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 30-JAN-2025, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, lot #X018273, expiration date: 07-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Medical Assistant confirmed the patient involved had not had any medical concerns or symptoms after the administration of the expired dose of the vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025. No PQC. No additional information.; This spontaneous report was received from a nurse and 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 23-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) injection, 0.5 milliliter, lot #Y010050, expiration date: 25-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 23-JAN-2025, the patient experienced Customer calling to report temperature excursion (Product storage error ). PROQUAD dose was administered on 1/23/2025. No PQC. No additional information.. At the time of reporting, the outcome of the event Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025. No PQC. No additional information. was not known. The action taken with PROQUAD regarding Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025. No PQC. No additional information. was reported as Not Applicable.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Customer calling to report temperature excursion. PROQUAD dose was administered on 1/29/2025. No PQC. No additional information.; This spontaneous report was received from registered Nurse referred 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 29-JAN-2025, the patient started therapy with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y010050, expiration date: 25-NOV-2025, administered for prophylaxis (strength, dose number, frequency, scheme, route of administration, and anatomical location were not reported). The vaccine underwent a temperature excursion (Improper storage of product in use). The duration of temperature excursion, and if there were previous temperature excursions were not reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Conversion disorder, Syncope
Clinical narrative: diagnosed with functional neurological disorder/Doctors are saying the fainting is the result of this diagnosis; toothache; Drug reactions: AMOXYCILLIN/she broke out in hives; This spontaneous report was received from the patient's mother regarding her approximately 13-year-old daughter (female).  The patient's medical history was not reported. Historical drugs included lurasidone hydrochloride (LATUDA). The patient's concurrent conditions included  seasonal allergy and allergy to lurasidone hydrochloride (LATUDA). Concomitant medications included aripiprazole (ABILIFY) and topiramate (reported as ''topirmate'').   On 08-NOV-2024, the patient was vaccinated with the second dos of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 virus like particle (VLP) vaccine (yeast) (GARDASIL 9) injection, lot #X024251 (expiration date was not provided but upon validation it was found to be 15-MAY-2026), administered intramuscularly to prevent HPV (strength was not provided).  On an unknown date, the patient started therapy with amoxicillin, administered for toothache (strength, formulation, dose, lot #, expiry date, and route of administration were not provided). After which she broke out in hives   On an unknown date (after the second dose of the suspect vaccine), the patient began to experience side effects with the suspect vaccine, such as fainting, that was later diagnosed as functional neurological disorder (Conversion disorder), as the doctors thought was the cause of fainting. Therefore, the patient was admitted to the hospital (date of admission not reported), to seek medical attention, but no treatment was given for this event. The action taken with amoxicillin regarding the events was not reported. At the time of this report the patient ad not recovered from conversion disorder; the outcome of the remaining events was not provided.   The causal relationship between amoxicillin and hives was not reported, but given wording and company guidelines it was considered as related; the causality between this suspect drug and toothache was considered as not related; and for conversion disorder was not reported. The causal  relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and all the events was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: administered after temperature excursions; no adverse event; This spontaneous report was received from Other Health Professional and refers to a currently 22-month-old patient of unknown 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 an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #Y007585, expiration date: 31-OCT-2025, administered for prophylaxis (strength, dose, dose number, frequency, scheme, anatomical location, and route of administration were not provided) (Improper storage of product in use). The vaccine underwent a temperature excursion during 1h 30 m under 60 Fahrenheit Degrees. No previous temperature excursions.   No adverse event reported.   This case was previously reported as non-valid due to lack of individual patient identifiers, but upon follow-up information on 17-JAN-2025, was updated to valid.   This case was one of three from the same reporter. ; Sender Comments: Keywords : MUL US-009507513-2502USA000139:Original Case : 2501USA004754 US-009507513-2501USA004754:Original Case : 2501USA004754