chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient stated that he received one vaccine in his left arm too high. He said that the vaccine was painful at the time of administration and that it is still painful 12 days later.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Feeling cold, Hot flush, Hyperhidrosis, Nausea
Clinical narrative: I took both shots not too far paced from eachother into the upper left arm. About 10 minutes after I felt nauseous, light-headed, had a warm ?flushing sensations? go over me like what all over the body and then it turned ice cold. I never broke out in sweats. About 5 minutes after that the cold feeling slowed down and I felt in both hands a ?rumbling/tingling? sensation everywhere in my hands for about 10 minutes. Over that time since about 26 hours later I feel the usual and expected symptoms of the shots and NO neurological side effects to my knowledge. That has subsided.
Age: 31.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Paraesthesia
Clinical narrative: I took both shots not too far paced from eachother into the upper left arm. About 10 minutes after I felt nauseous, light-headed, had a warm ?flushing sensations? go over me like what all over the body and then it turned ice cold. I never broke out in sweats. About 5 minutes after that the cold feeling slowed down and I felt in both hands a ?rumbling/tingling? sensation everywhere in my hands for about 10 minutes. Over that time since about 26 hours later I feel the usual and expected symptoms of the shots and NO neurological side effects to my knowledge. That has subsided.
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Parent stated that 3 days after receiving Covid vaccine, child had low grade fever and hives all over body.  Was taken to urgent care and prescribed Zyrtec.  Did well and hives went away.  Had follow up visit with PCP and Zyrtec was stopped but hives did return.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Chills, Fatigue, Induration, Injection site erythema
Clinical narrative: Swelling, heat, redness that spread to most of upper left arm. Swollen lymph nodes left armpit. Fatigue, malaise, chills, achiness. Doctor said it was cellulitis and prescribed Doxycycline. Started 12/12/2024. Still taking. Arm is getting better slowly. Still some redness and induration after 4 days of abx.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy, Malaise, Pain
Clinical narrative: Swelling, heat, redness that spread to most of upper left arm. Swollen lymph nodes left armpit. Fatigue, malaise, chills, achiness. Doctor said it was cellulitis and prescribed Doxycycline. Started 12/12/2024. Still taking. Arm is getting better slowly. Still some redness and induration after 4 days of abx.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Swelling, redness and slight itching of upper arm which started at the injection site and grew down the arm in time.  Day after injection patient noticed upper arm was extremely sore and remained sore for first few nights.  Patient said he first noticed the rash on Saturday.  he's not sure when it first appeared.  He said it became rock hard and swollen and the rash itched slightly.  Patient can not take NSAIDS so recommended Tylenol for any further pain and advised Benadryl for the rash and to seek medical attention if the symptoms got worse instead of improving or he developed additional symptoms.  Patient also reported night sweats of upper body  12/14 and 12/15.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Injection site swelling, Night sweats, Rash pruritic
Clinical narrative: Swelling, redness and slight itching of upper arm which started at the injection site and grew down the arm in time.  Day after injection patient noticed upper arm was extremely sore and remained sore for first few nights.  Patient said he first noticed the rash on Saturday.  he's not sure when it first appeared.  He said it became rock hard and swollen and the rash itched slightly.  Patient can not take NSAIDS so recommended Tylenol for any further pain and advised Benadryl for the rash and to seek medical attention if the symptoms got worse instead of improving or he developed additional symptoms.  Patient also reported night sweats of upper body  12/14 and 12/15.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood uric acid increased, Dysstasia, Gait disturbance, Gait inability, Inflammation
Clinical narrative: Inflamation, gait instability, unable to stand nor walk, tinnitus.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Magnetic resonance imaging abnormal, Soft tissue disorder, Tinnitus
Clinical narrative: Inflamation, gait instability, unable to stand nor walk, tinnitus.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine administration error. No adverse event. MA went into the wrong patient's room. MA failed to identify patient and Pt received a flu vaccine that had not been ordered for her and was not needed. Pt received a flu vaccine in September.
Age: 60.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Contusion, Erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: still has redness/bruising, fever, swelling and sore muscle at injection site
Age: 1.5
Sex: M
Vaccine: DTPPVHBHPB, FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: SWELLING AND REDNESS TO RIGHT THIGH
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle spasms, Pain in extremity
Clinical narrative: Can not lay on arm. Can not reach behind me or reach higher than shoulder. Arm cramps up and hurts badly and slowly goes away.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Headache, Ocular hyperaemia, Pain
Clinical narrative: # hours after vaccination, developed head ache, generalized body aches, redness and swelling of eyes face and neck, no respiratory distress. Redness and swelling of face and neck lasted for 4 days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Swelling face
Clinical narrative: # hours after vaccination, developed head ache, generalized body aches, redness and swelling of eyes face and neck, no respiratory distress. Redness and swelling of face and neck lasted for 4 days.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure 1 week later
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Abscess drainage, Blood test, Injection site abscess, Ultrasound abdomen
Clinical narrative: Abscess formed at the site. I&D completed.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Asthenia, Chills, Cough, Dizziness
Clinical narrative: Received the annual Flu vaccine at Hospital's employee health department on Monday and immediately that day got very sick. First day had fever, chills, congestion, headache, body aches. Second day no more fever, but all other symptoms worsened, and began to be raspy, lost my voice, had throat pain and coughing, with sweats. 3rd and 4th day same symptoms, no improvement. 5th day, Friday, had to call in sick from work because of sever dizziness and headache, with generalized weakness, and feeling of exhaustion. yesterday, day 7 I developed severe hives on arms, chest and back. all of these symptoms and more occurred last year from the flu shot with documentation from my PCP and allergist. Still, with all that, I was not able to obtain a medical exemption for this year. Am still currently sick from it 1 week later, congestion and loss of voice with cough, headache and fatigue still present. Spoke with manger and employee health prior to explain that I have had a reaction the year prior and still could not avoid getting vaccinated. Employee health department asked to submit an ERA, complete symptoms form on their website, and report this to the national reporting agency in the hopes that with all this I am able to obtain a medical exemption.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Fatigue, Headache, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Received the annual Flu vaccine at Hospital's employee health department on Monday and immediately that day got very sick. First day had fever, chills, congestion, headache, body aches. Second day no more fever, but all other symptoms worsened, and began to be raspy, lost my voice, had throat pain and coughing, with sweats. 3rd and 4th day same symptoms, no improvement. 5th day, Friday, had to call in sick from work because of sever dizziness and headache, with generalized weakness, and feeling of exhaustion. yesterday, day 7 I developed severe hives on arms, chest and back. all of these symptoms and more occurred last year from the flu shot with documentation from my PCP and allergist. Still, with all that, I was not able to obtain a medical exemption for this year. Am still currently sick from it 1 week later, congestion and loss of voice with cough, headache and fatigue still present. Spoke with manger and employee health prior to explain that I have had a reaction the year prior and still could not avoid getting vaccinated. Employee health department asked to submit an ERA, complete symptoms form on their website, and report this to the national reporting agency in the hopes that with all this I am able to obtain a medical exemption.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Received the annual Flu vaccine at Hospital's employee health department on Monday and immediately that day got very sick. First day had fever, chills, congestion, headache, body aches. Second day no more fever, but all other symptoms worsened, and began to be raspy, lost my voice, had throat pain and coughing, with sweats. 3rd and 4th day same symptoms, no improvement. 5th day, Friday, had to call in sick from work because of sever dizziness and headache, with generalized weakness, and feeling of exhaustion. yesterday, day 7 I developed severe hives on arms, chest and back. all of these symptoms and more occurred last year from the flu shot with documentation from my PCP and allergist. Still, with all that, I was not able to obtain a medical exemption for this year. Am still currently sick from it 1 week later, congestion and loss of voice with cough, headache and fatigue still present. Spoke with manger and employee health prior to explain that I have had a reaction the year prior and still could not avoid getting vaccinated. Employee health department asked to submit an ERA, complete symptoms form on their website, and report this to the national reporting agency in the hopes that with all this I am able to obtain a medical exemption.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Urticaria
Clinical narrative: Received the annual Flu vaccine at Hospital's employee health department on Monday and immediately that day got very sick. First day had fever, chills, congestion, headache, body aches. Second day no more fever, but all other symptoms worsened, and began to be raspy, lost my voice, had throat pain and coughing, with sweats. 3rd and 4th day same symptoms, no improvement. 5th day, Friday, had to call in sick from work because of sever dizziness and headache, with generalized weakness, and feeling of exhaustion. yesterday, day 7 I developed severe hives on arms, chest and back. all of these symptoms and more occurred last year from the flu shot with documentation from my PCP and allergist. Still, with all that, I was not able to obtain a medical exemption for this year. Am still currently sick from it 1 week later, congestion and loss of voice with cough, headache and fatigue still present. Spoke with manger and employee health prior to explain that I have had a reaction the year prior and still could not avoid getting vaccinated. Employee health department asked to submit an ERA, complete symptoms form on their website, and report this to the national reporting agency in the hopes that with all this I am able to obtain a medical exemption.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This RN gave Moderna dosed for  12 years and older instead of 6-11 year dose.  No adverse reaction noted.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient did have some injection site pain with the first vaccine, however on the second vaccine she developed extreme erythema a few inches under the vaccine site in a circular pattern that is staying consistent in size.  It is itchy and the patient states some small blisters are developing.  It appears to be a localized reaction.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Itchiness, rash, warmth at injection site, started same day as injection.  Symptoms persist to date with some relief of itch with OTC hydrocortisone cream.    Employee had started dupixent 7/2024.  This was the only noted change compared to previous years when she had received flu shots with no issues.   Plans to see her primary care provider due to the length of time without resolution of symptoms.
Age: 22.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Fear, Feeling abnormal, Galactorrhoea, Infertility female, Mammogram normal
Clinical narrative: Woke up the next morning completely paralyzed, couldn't move my legs for a good few minutes I can't remember how long exactly but it was scary, then when I did finally move, my legs hurt and my body felt completely different.  I noticed different changes happening with my body a couple days later.  My boobs lactate , I've went to doctors about this in county I have health records showing tests including a mammogram and they have no idea why it's happening to me. They were never able to find me answer especially because I never been pregnant . I still can't get pregnant to this day, I still have the same health issues.  I also want to point out here that this clinic would not let me have the copy of the vaccine paper until 2023 recently. I previously made a report and I couldn't get back into that to change the date I submitted.  Thank you this is just awful of the long term damage from the vaccine. If I could go back in time, I would have never got the Gardasil vaccine.
Age: 22.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pain in extremity, Paralysis
Clinical narrative: Woke up the next morning completely paralyzed, couldn't move my legs for a good few minutes I can't remember how long exactly but it was scary, then when I did finally move, my legs hurt and my body felt completely different.  I noticed different changes happening with my body a couple days later.  My boobs lactate , I've went to doctors about this in county I have health records showing tests including a mammogram and they have no idea why it's happening to me. They were never able to find me answer especially because I never been pregnant . I still can't get pregnant to this day, I still have the same health issues.  I also want to point out here that this clinic would not let me have the copy of the vaccine paper until 2023 recently. I previously made a report and I couldn't get back into that to change the date I submitted.  Thank you this is just awful of the long term damage from the vaccine. If I could go back in time, I would have never got the Gardasil vaccine.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave expired MMR. No adverse reaction noted.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Eye swelling
Clinical narrative: L eye swelling, not painful, no vision changes, no other associated sx.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: NONE WERE WITNESSED
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Dyspnoea, Dyspnoea exertional, Pulmonary function test
Clinical narrative: Extreme shortness of breath that has been ongoing.  For the first couple of months I would only have to walk a few steps to be completely out of breath and have to sit and catch my breath.  I was previously in good physical health and not overweight.  I have been on a nebulizer and inhaler the last 3.5 years to help control the symptoms.  Getting the vaccine has been the worst decision of my life.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Extreme shortness of breath that has been ongoing.  For the first couple of months I would only have to walk a few steps to be completely out of breath and have to sit and catch my breath.  I was previously in good physical health and not overweight.  I have been on a nebulizer and inhaler the last 3.5 years to help control the symptoms.  Getting the vaccine has been the worst decision of my life.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Magnetic resonance imaging, Muscular weakness, Rash
Clinical narrative: Drs office (Family Medical) called us back Friday and told us the pt had the typical rash that developed, but a few weeks later experienced loss of strenght in arm the shingrix vaccine was given in. The drs office reached out to the Shingrix rep and and they said no shots are supposed to be given with the shingrix and all vaccines should be spaced 2 weeks before and after any shingrix vaccines.
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Hives upper right arm, redness, swollen, itchy.  Symptoms lasted approximately 3 days. No other problems
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: 34-year-old male presenting to clinic with a 3-week history of lightheadedness, dizziness, and vertigo symptoms.  Patient states he had the flu vaccine approximately 3 weeks ago.  The following day he experienced a mild headache, dizziness, lightheadedness, and vertigo.  He states that since then he continues to have intermittent symptoms primarily the dizziness.  He denies any patterns or triggers for his symptoms.  He denies any recent changes to his diet, exercise, or medications.  He has received the flu vaccine previously and denies any known allergies.  He denies any current medications.  He denies any numbness, tingling, or weakness.  He describes a sensation as "if he goes to sit up too fast."  He states he may have had an illness around the time when he got the vaccine and has intermittent congestion particularly on his right side of his face.  He tried Dramamine and decongestions with partial relief for short time. Pt has had his CPAP for about 2 months, but will sometimes remove the device as it irritates his nose/face.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and fever at injection site noted morning after IMZ. Still observed at 72 hours after immunization. Patient advised to monitor for any further increase in swelling and to continue treatment with acetaminophen and ibuprofen as needed.
Age: 12.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Underdose
Clinical narrative: Patient received the pediatric version of the covid vaccine instead of the 12 and above
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AE; Nurse calling to report inadvertently recontinuing PEDVAX HIB with sterile diluent and administering to a patient. Caller stated patient has not reported any symptoms. Permission to contact HCP was granted. No additional information provided. No addi; This spontaneous report has been received from a Nurse, referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 10-DEC-2024, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), intramuscular injection (Lot No. X021054 has been verified to be a valid lot number for [haemophilus b conjugate vaccine (meningococcal protein conjugate)], expiration date reported and upon internal validation established as 18-MAY-2026) (strength, dose number, exact dose quantity volume, anatomical location of administration and vaccination scheme frequency were not provided), inadvertently reconstituted with sterile diluent, solution for injection/ infusion (Lot No, expiration date, dose, route of administration and anatomical location were not reported) (product preparation error)  It was stated that the patient had not reported any symptoms. No additional adverse event (no adverse event)
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptomatic adverse events; HCP called to report that the patient was inadvertently administered ROTATEQ before 6 weeks of age.; This spontaneous report was received from a medical assistant and refers to a 3-week-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 10-DEC-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, 2 milliliter, lot #2032354, expiration date: 12-NOV-2025, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) (Inappropriate age at vaccine administration).   No symptomatic adverse events were reported.
Sex: F
Vaccine: MMR
Symptoms: Vaccination failure
Clinical narrative: patients not immune to measles, rubella, and varicella, had been vaccinated against these viruses in the past; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with measles, mumps, and rubella vaccine (manufacturer unknown) injection, administered for prophylaxis (dose, strength, lot #, expiry date, site and route of administration were not provided).  On unknown date, the patient was not immune to measles or rubella (serological titer test for immunity to measles, or rubella was below13.5 IU/mL for measles, and below 0.9 IU/mL for rubella). The patient was vaccinated against these viruses in the past. The outcome of the event vaccination failure was not provided.  The event of vaccination failure was considered to be related to suspect vaccine.  This is one of 3 reports derived from the same literature article (cross referenced with MARRS# 2412USA003005, 2412USA004537)  Literature Report:  Lot # is being requested and will be provided if available.; Sender's Comments:  US-009507513-2412USA003005: US-009507513-2412USA004537:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: patients not immune to measles, rubella, and varicella, had been vaccinated against these viruses in the past; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with varicella vaccine (manufacturer unknown) injection, administered for prophylaxis (dose, strength, lot #, expiry date, site and route of administration were not provided).  On unknown date, the patient was not immune not immune to varicella (serological titer test for immunity to varicella was below 135 IU/mL). The patient was vaccinated against this virus in the past. The outcome of the event vaccination failure was not provided.  The event of vaccination failure was considered to be related to suspect vaccine.  This is one of 3 reports derived from the same literature article (cross referenced with MARRS#2412USA003005, 2412USA004536)  Literature Report:   Lot # is being requested and will be provided if available,; Sender's Comments:  US-009507513-2412USA003005: US-009507513-2412USA004536:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding PROQUAD. Vaccine was administered after a TE. No reported signs/symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC; No adverse event; This spontaneous report was received from a customer (reported as ''other'') to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On unknown dates, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), formulation: injection (lot # and expiration date was unknown (also reported as: multiple), exact dose, route of administration and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion (product storage error). There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: RVX
Symptoms: Tinnitus
Clinical narrative: Annoying sound; This serious case was reported by a consumer and described the occurrence of ear discomfort in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ear discomfort (Verbatim: Annoying sound) (serious criteria hospitalization). The outcome of the ear discomfort was resolving.   It was unknown if the reporter considered the ear discomfort to be related to RSV vaccine.     The company considered the ear discomfort to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient self-reported this case for herself/himself. The reporter was in hospital for Annoying sound.; Sender's Comments: Ear discomfort is an unlisted event which is considered unrelated to GSK  RSV vaccine.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: I noticed my 15-month-old daughter was given 4 pediarix; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (received 3 doses of pediarix on an unknown date).   On an unknown date, the patient received the 4th dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: I noticed my 15-month-old daughter was given 4 pediarix). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-NOV-2024 Reporter reported that he/she noticed his/her 15-month-old daughter was given 4 pediarix vaccines from her healthcare provider instead of 3 according to her record. Reporter questioned that how will this affect her since this was supposed to be a 3-dose series. Reporter worried about potential harm to her.  At the time of reporting, the patient had received the 4th dose of pediarix which had led to extra dose administered.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and Influenza vaccine. On an unknown date, 2 weeks after receiving RSV vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to RSV vaccine.     It was unknown if the company considered the shingles to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-NOV-2024 This case was reported by a patient via interactive digital media. Patient had RSV shot and Flu shot together. Two weeks later he/she got shingles. It was unknown if the reporter considered the shingles to be related to Flu shot (Influenza vaccine).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; bad shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: bad shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-DEC-2024 This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine a year and a half ago in 2023 and she had shingles in 2024 and it was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: vaccines that don't work; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (vaccines that don't work) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (vaccines that don't work). At the time of the report, VACCINATION FAILURE (vaccines that don't work) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2024: Live non-significant follow-up received: reference ID was added.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, ringing in ears; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus, ringing in ears) in a 54-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 03-Dec-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced TINNITUS (Tinnitus, ringing in ears). At the time of the report, TINNITUS (Tinnitus, ringing in ears) had not resolved.            No concomitant medication was reported.  It was reported that patient experienced tinnitus, ringing in ears, which started 1-2 days after vaccination. Increased in intensity over the next week. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
Sex: U
Vaccine: RSV
Symptoms: Blood blister, Device difficult to use
Clinical narrative: cannot get to activate, when presses down on the rubber stopper while mixing the vaccine it requires significant force, very hard to press; getting blood blisters on hands trying, is not going; A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LN5489, Expiration Date: Oct2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DIFFICULT TO USE (non-serious), outcome "unknown", described as "cannot get to activate, when presses down on the rubber stopper while mixing the vaccine it requires significant force, very hard to press"; BLOOD BLISTER (non-serious), outcome "unknown", described as "getting blood blisters on hands trying, is not going".  Additional information: NDC number of Abrysvo: 00069-2465-10. Cannot get to activate, when presses down on rubber stopper while mixing vaccine it requires significant force, very hard to press. All are very hard to press while mixing. Getting blood blisters on hands trying, is not going. Asking about replacement. Clarified and confirmed a total of 3 Abrysvo Act-O-Vial vaccines had this issue. All 3 came from same box, one lot number. Count size of box is 10 total. Sample of the product is available to be returned, if requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wound
Clinical narrative: after each and every shot my mother wound up in the hospital for at least 2-3 weeks.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation, reaction(s): "after each and every shot my mother wound up in the hospital for at least 2-3 weeks.". The following information was reported: WOUND (hospitalization), outcome "unknown", described as "after each and every shot my mother wound up in the hospital for at least 2-3 weeks.". Clinical course: Reporter's mother received all 5 of the Covid-19 shots (name withheld) they first came out even though reporter begged her not to. 2-3 days after each and every shot reporter mother wound up in the hospital for at least 2-3 weeks.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400161742 same patient and reporter, different dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wound
Clinical narrative: after each and every shot my mother wound up in the hospital for at least 2-3 weeks.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "after each and every shot my mother wound up in the hospital for at least 2-3 weeks."; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "after each and every shot my mother wound up in the hospital for at least 2-3 weeks.". The following information was reported: WOUND (hospitalization), outcome "unknown", described as "after each and every shot my mother wound up in the hospital for at least 2-3 weeks.". Clinical course: Reporter's mother received all 5 of the Covid-19 shots (name withheld) they first came out even though reporter begged her not to. 2-3 days after each and every shot reporter mother wound up in the hospital for at least 2-3 weeks.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400161742 same patient and reporter, different dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wound
Clinical narrative: after each and every shot my mother wound up in the hospital for at least 2-3 weeks.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WOUND (hospitalization), outcome "unknown", described as "after each and every shot my mother wound up in the hospital for at least 2-3 weeks.". Clinical course: Reporter's mother received all 5 of the Covid-19 shots (Name withheld) they first came out even though reporter begged her not to. 2-3 days after each and every shot reporter's mother wound up in the hospital for at least 2-3 weeks.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400323042 same patient and reporter, different dose;US-PFIZER INC-202400323041 same patient and reporter, different dose;US-PFIZER INC-202400323043 same patient and reporter, different dose;US-PFIZER INC-202400323044 same patient and reporter, different dose;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID infection; COVID infection; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID infection".; Sender's Comments: Based on the known drug safety profile, the reported events Drug ineffective, Covid 19  are assessed as related to suspect drug .
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Flu shot killed my father in 4 days; Initial information received on 11-Dec-2024 regarding an unsolicited valid serious case received from a Non health care professional.  This case involves, unknown age Adult male patient who received INFLUENZA VACCINE and died (death NOS) (not otherwise specified).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination reporter reported, flu shot killed the patient in 4 days (death) (unknown-4 days).  Final diagnosis was (fatal).  Reportedly, Caller said ''flu shot killed the patient in 4 days''.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Fatal for the event.  Seriousness criteria: This event was assessed as medically significant and was leading to death.; Sender's Comments: Sanofi company comment dated 16-Dec-2024:This case involves, Unknown age Adult male patient who received INFLUENZA VACCINE and died (death NOS) (not otherwise specified). Additionally, cause of death was not reported, and it was unknown if an autopsy was performed. Further information on allergy history, previous laboratory investigations, autopsy reports excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Flu shot killed my father in 4 days
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Products were put incorrectly in a frozen coolerMax /low temperature reached: 26.2F - 34.7 FDuration out of labelled range: 1 hour with no reported adverse event; Products were put incorrectly in a frozen coolerMax /low temperature reached: 26.2F - 34.7 FDuration out of labelled range: 1 hour and administered with no reported adverse event; Initial information received on 28-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who opened influenza USP TRIVAL A-B subvirion vaccine [Fluzone] were put incorrectly in a frozen cooler max /low temperature reached: 26.2f - 34.7 f duration out of labelled range: 1 hour and administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, opened influenza USP TRIVAL A-B subvirion vaccine Suspension for injection (strength, lot number and expiry date not reported) were put incorrectly in a frozen cooler max /low temperature reached: 26.2f - 34.7 f duration out of labelled range: 1 hour and administered with no reported adverse event (product storage error) (latency: unknown) (Poor quality product administered) (latency: same day). Human error was involved.  Information on the batch number was requested corresponding to the one at time of event occurrence.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Based on data previously received, the following information [added classification of valid ICSR with no AE as requested] has been amended.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached 47°F for 5 minutes and administered to patient with no reported adverse event; Max/low temperature reached 47°F for 5 minutes and administered to patient with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that exposed to max/low temperature reached 47° F for 5 minutes and administered to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect unsuitable IPV (VERO) Suspension for injection (Unknown strength) with lot W1C741M and expiry date 17-Nov-2025  via unknown route in unknown administration site for Immunization with no reported adverse event (poor quality product administered) (Latency same day) .  On an unknown date the suspect IPV (VERO) exposed to max/low temperature reached 47°f for 5 minutes with no reported adverse event (product storage error)   Reportedly, Previous excursion was on 02-Aug-2024: 34°F for 3 hours (already punctured), Human error involved. Administered post excursion Between August and October, 4 doses were given to 4 patients in the previous excursion. Reporter said she does not have the patients' information at the time of the call, but there were 4 doses given to 4 patients according to the medical assistant.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This non-serious case was reported by a other health professional and described the occurrence of taste metallic in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number L7445, expiry date 22-NOV-2025) for prophylaxis.   On 26-NOV-2024, the patient received Shingrix (intramuscular) .5 ml. On 26-NOV-2024, less than a day after receiving Shingrix, the patient experienced taste metallic (Verbatim: Metallic taste in mouth). The outcome of the taste metallic was not resolved.   It was unknown if the reporter considered the taste metallic to be related to Shingrix.     It was unknown if the company considered the taste metallic to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-NOV-2024 The healthcare professional reported that the patient experienced the metallic taste in mouth and was ongoing
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (batch number LC757, expiry date 21-AUG-2024) for prophylaxis.   On 26-NOV-2024, the patient received the 2nd dose of Shingrix. On 26-NOV-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-NOV-2024 The pharmacy technician reported that the patient was inadvertently given an expired 2nd dose of Shingrix on the reporting day, which led to expired vaccine used.