chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 04-OCT-2024).   On 03-MAR-2025, the patient received the 2nd dose of Twinrix. On 03-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-APR-2025 The pharmacist reported that the patient received a first dose of Twinrix and then the second dose was given late.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received second dose of Twinrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: needs restart the series or if the patient just need one more dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27-JAN-2018 with batch number 1S534 and lot expiry 27-JAN-2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: needs restart the series or if the patient just need one more dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 08-APR-2025 The pharmacist reported that a patient received one dose (Shingrix) in 2018, and requested information about whether the patient needs restart the series or if the patient just need one more dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: The patient received the vaccine and then a couple of minutes later said he felt 'funny' and he passed out. An epipen was administered and 911 was called. He was coherent and responding to ems when he was taken away.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Bump where vaccine was administered. Upper arm swollen, now resolved.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Migraine, Oropharyngeal discomfort, Pain of skin, Pyrexia
Clinical narrative: throat scratchy like closing, skin became red and sore to touch all over body, fever, vertigo, migraine
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: throat scratchy like closing, skin became red and sore to touch all over body, fever, vertigo, migraine
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Influenza virus test negative, Lymphadenopathy, Mononucleosis heterophile test negative, SARS-CoV-2 test negative
Clinical narrative: Patient woke up the next day following the vaccine administration with a swollen posterior cervical lymph node and a cough. Saw her PCP, tested for strep, covid, mono, and influenza which were all negative. Patient treated for URI and sinusitis with a course of abx.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Streptococcus test negative
Clinical narrative: Patient woke up the next day following the vaccine administration with a swollen posterior cervical lymph node and a cough. Saw her PCP, tested for strep, covid, mono, and influenza which were all negative. Patient treated for URI and sinusitis with a course of abx.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Cyanosis, Fall, Hypoaesthesia, Loss of consciousness
Clinical narrative: Patient received flu immunization and then had blood work done in room. When patient was getting ready to leave the patient's room in health center patient stood up and told her mother" I don't feel my legs" and then started to fall. At this time the patient's mother called out for the doctor. Dr., LPN and MA went to patient's room and assisted with patient at 8:50 am. First 911 call was made at 8:50 am. Patient was on the floor, extremely pale skin, blue lips, and not conscious. BP within normal range, pulse within normal range, Oxygen was placed on patient. Patient was being spoke to which made her aware of her surroundings. alert and orientated to time and location.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Patient received flu immunization and then had blood work done in room. When patient was getting ready to leave the patient's room in health center patient stood up and told her mother" I don't feel my legs" and then started to fall. At this time the patient's mother called out for the doctor. Dr., LPN and MA went to patient's room and assisted with patient at 8:50 am. First 911 call was made at 8:50 am. Patient was on the floor, extremely pale skin, blue lips, and not conscious. BP within normal range, pulse within normal range, Oxygen was placed on patient. Patient was being spoke to which made her aware of her surroundings. alert and orientated to time and location.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Blood culture, Blood glucose, Blood lactic acid, Brain natriuretic peptide
Clinical narrative: was seen in Dr's office on 3/20/25 for acute visit. c/o cough, nasal congestion. respiratory PCR testing done. was positive for "Human Metapneumonvirus".  called our office on 3/27/25. c/o symptoms getting worse and being very short of breath, weak and not eating. Dr. advised her to go to ER.  She did go to ER, and was placed under observation. She was discharged on 3/29/25. Clinical Impressions were; "unspecified Dyspnea: and "unspecified community acquired pneumonia".
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray, Computerised tomogram thorax, Cough, Culture urine, Decreased appetite
Clinical narrative: was seen in Dr's office on 3/20/25 for acute visit. c/o cough, nasal congestion. respiratory PCR testing done. was positive for "Human Metapneumonvirus".  called our office on 3/27/25. c/o symptoms getting worse and being very short of breath, weak and not eating. Dr. advised her to go to ER.  She did go to ER, and was placed under observation. She was discharged on 3/29/25. Clinical Impressions were; "unspecified Dyspnea: and "unspecified community acquired pneumonia".
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Differential white blood cell count, Dyspnoea, Electrocardiogram, Full blood count, Legionella test
Clinical narrative: was seen in Dr's office on 3/20/25 for acute visit. c/o cough, nasal congestion. respiratory PCR testing done. was positive for "Human Metapneumonvirus".  called our office on 3/27/25. c/o symptoms getting worse and being very short of breath, weak and not eating. Dr. advised her to go to ER.  She did go to ER, and was placed under observation. She was discharged on 3/29/25. Clinical Impressions were; "unspecified Dyspnea: and "unspecified community acquired pneumonia".
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Liver function test, Metabolic function test, Nasal congestion, Pneumonia, Prothrombin time
Clinical narrative: was seen in Dr's office on 3/20/25 for acute visit. c/o cough, nasal congestion. respiratory PCR testing done. was positive for "Human Metapneumonvirus".  called our office on 3/27/25. c/o symptoms getting worse and being very short of breath, weak and not eating. Dr. advised her to go to ER.  She did go to ER, and was placed under observation. She was discharged on 3/29/25. Clinical Impressions were; "unspecified Dyspnea: and "unspecified community acquired pneumonia".
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Scan with contrast, Troponin, Urine analysis
Clinical narrative: was seen in Dr's office on 3/20/25 for acute visit. c/o cough, nasal congestion. respiratory PCR testing done. was positive for "Human Metapneumonvirus".  called our office on 3/27/25. c/o symptoms getting worse and being very short of breath, weak and not eating. Dr. advised her to go to ER.  She did go to ER, and was placed under observation. She was discharged on 3/29/25. Clinical Impressions were; "unspecified Dyspnea: and "unspecified community acquired pneumonia".
Age: 11.0
Sex: M
Vaccine: DTAPIPV, HPV9, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Provider ordered DTap to be given, I didn't catch it should have been TDap given pts age. thought I gave what was ordered, but gave Kinrix instead.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 27-year-old patient received a pediatric dose of Engerix-B; Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number M2RH3) for prophylaxis.   On 04-APR-2025, the patient received the 1st dose of Engerix B pediatric. On 04-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 27-year-old patient received a pediatric dose of Engerix-B) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-APR-2025 The registered nurse stated that a 27-year-old patient received a pediatric dose of Engerix-B, first dose, which led to adult use of a child product and underdose.  No side effects or adverse reactions noted.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Resident passes away while on hospice.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Lymph node pain, Scleroderma, Skin disorder
Clinical narrative: COVID Vaccine #1:  03/26/21 at (redacted) COVID Vaccine #2: 04/16/21 at (redacted), COVID Vaccine #3 at (redacted) Pharmacy.   I had a pretty bad reaction to Vaccine #1.  Fatigue, muscle pain, and difficulty breathing for a few days afterwards.  Vaccine #2 went OK.  A few days after Vaccine #3 I developed pain in my lymph nodes under both of my arms which lasted about 3 to 5 months.  A couple of months later I started noticing changes in my skin.  I went to several dermatologists for diagnosis but no one could figure out what it was.  When I moved to (redacted) from (redacted) I went to a new Primary Care Physician in 2024 who said she thought it looked like Scleroderma.  I went to see another Dermatologist in (redacted) in 2025 who took a biopsy and confirmed Scleroderma Morphia.
Age: 33.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Injection site pain, Pain, Pain in extremity
Clinical narrative: DAY OF: JOLT - LIKE FEELING IN LEFT THIGH WHEN WALKING: INTERMEDIATE 3 HOURS. JOINT PAIN, FATIGUE, INJECTION SITE PAIN, SHOULDER MOBILITY
Age: 44.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Bell's palsy, Eye pain, Hypoaesthesia oral, Lacrimation increased, Vision blurred
Clinical narrative: Spoke with patient's wife.  She states that patient began having tongue numbness on Saturday 4/5/25 into Sunday 4/6/25.  Went to ER Monday night 4/7/25 with eye pain of level 9, blurry vision and watering of eye.  Doc at ER told them it was believed to be viral Bells Palsy and could not link to vaccines but wife cannot think of anything that had changed.  Doc prescribed anti-viral medication and a steroid.  The right side has been affected and patient is having difficulty with eating/drinking.  Does not have PCP at this time and does not establish with one until next month.  Has neuro appt in 2 weeks.  ER doc advised family that some pts fully recover, some partially recover and some don't at all.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress
Clinical narrative: patient states around 2-3 months after receiving last dose of shingrix vaccine she developed shingles. Patient states that she has continued to breakout with shingles anytime she becomes stressed. Patient has been to her physician and has been prescribed valtrex to take at onset of shingles breakout. Patient states she has to take medication average every couple of months.
Age: 40.0
Sex: M
Vaccine: HPV9
Symptoms: Dermatitis, Herpes zoster, Rash
Clinical narrative: Recurrent breakout of either shingles or herpetic dermatitis after gardisil shot.  I received the first gardisil shot in January of 2025, and 2 weeks later I broke out in a severe rash all over my body.  I took antivirals and the rash went away.  Less than 1 week after the second gardisil shot the same rash came back again.  I believe it's related.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT DID RECEIVE A DTAP VACCINE AT THE AGE OF 7 Y/O. FOR THIS AGE 7 THE PATIENT SHOULD HAVE RECEIVED TDAP.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is only 10 years old and was given the higher dose (12+ year) vaccination.
Age: 81.0
Sex: F
Vaccine: RSV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complain of swelling, redness, itching and lump at injection site
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: Child on catch up schedule for vaccines. Received 1 HIB vaccine 09/06/2022. Protocol reads Vaxelis cannot be given for booster but other HIB containing vaccine can  be. Apparently misread other protocol which states if received at 15 month or older no further doses needed.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was inadvertently given a Proquad and Varivax same day. No adverse reaction noted as of yet.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Pyrexia, Use of accessory respiratory muscles
Clinical narrative: Per Mother child had retractions and a fever the next day and was admitted to Hospital for a few days
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Pyrexia, Use of accessory respiratory muscles
Clinical narrative: Per mother child had fever and retractions; she spoke with child's doctor.  No hospital visit at this time.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dermatomyositis, Pruritus, Rash
Clinical narrative: Rash with itching, treated by dermatologist; later determined to be Dermatomyositis
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered HPV vaccine during clinic visit, but after Medical Assistant was documenting the vaccine, it was discovered that the vaccine expired on 03/07/2025. Per clinic staff, the patient had no adverse effects or symptoms.
Age: 17.0
Sex: F
Vaccine: MNP
Symptoms: Rash
Clinical narrative: developed mildly painful bumps on bilaterally knees and left elbow day after receiving vaccine (4/1/25). 3 on knees and 1 on elbow. exam suspicious for possible erythema nodosum. no other systemic symptoms or recent illnesses. Seen on 4/10/25 with nodules still present.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Electrocardiogram normal, Hypotension, Syncope, Vomiting
Clinical narrative: Monday, 4/14/2025 evening Patient went to emergency room for vomiting and low blood pressure. Patient was released that evening and emergency room diagnosed patient with "syncopal episode."   Patient returned to emergency room on Wednesday, 4/9/2025 with chest pain. Patient was released from emergency room and referred to cardiologist.
Age: 75.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Influenza vaccine was given for a second time for the season. The first time was 9/20/2024.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient requested Hepatitis B vaccine (Engerix) but pharmacy vaccinated patient with Hepatitis A (Havrix). No adverse events reported by patient.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Lot number U8115AA.  Adacel given around 2 pm.  Next afternoon noted hive on abdomen.  Awoke the next day with diffuse hives sparing mouth palms and soles.  No other symptoms
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Circumstance or information capable of leading to medication error, Injected limb mobility decreased, Injection site haematoma, Injection site pain, Product administered at inappropriate site
Clinical narrative: She reports that when she received her pneumonia vax she feels like her bone was hit, she pulled her arm back and then the vax was put back in 1 inch below and the rest was injected.  Pt then lost range of motion in the arm - she had NP in Cardiology where she works look at it - they are afraid the injection got into the Bursa. There is bruising, a hematoma, and she thinks the capsule is broken.  Pt left work to go home and put ice on her arm as she can not move it - Advised pt go to ED for evaluation as we would be unable to treat this in the office at this time. Pt declined ED evaluation - scheduled an office visit with her PCP for the next morning, pt accepted. Pt seen next day in PCP office 4/10.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Pyrexia
Clinical narrative: Per mother child had a fever.     (Per mother child had a reaction to his previous vaccines on 2/14/2024 - retractions and fever and was hospitalized.)
Age: 40.0
Sex: F
Vaccine: IPV, JEV1
Symptoms: Immediate post-injection reaction, Petechiae
Clinical narrative: In  my office today (4/10/2025) for 2nd Japanese Encephalitis vaccine for her upcoming trip overseas. States had a mild non-hive rash after vaccines last visit (3/19/2025) to L upper arm and upper L chest near neck, mild itching but not severe. Had Polio IPV and JE (IXIARO) in that arm. States noticed it while driving home (15-20 mins post vaccines). States took Benadryl and rash was gone in <15 mins (carries Benadryl with her). Did not go to medical provider or urgent care.  States is hypersensitive to many things and has had a "reaction to all her Covid vaccines, including golfball sized enlargement to axilla, my lymph nodes".  States still gets Covid vaccines but "I just take benadryl now before I get them". I called Valneva Rep on speaker for client to hear and inquired about risk with a second dose, he was not able to reach their "medical team" but said even a mild case of an actual allergic reaction is not a contraindication for a second dose, only severe.                                                                                                                                                                                                                                   Client states is comfortable going ahead with a 2nd JE vaccine today. States has never had vaccine reactions before and "is not worried about it today", "I brought some Benadryl with me in case". Denies other changes to medical Hx, allergies or meds since last visit. Looks and states feels well today.                                                                                                                                                                                                                JE #2 given and mild flat scattered petechiae-type rash (not hives) developed immediately after today's vaccine, 3" diameter area above but not on the vaccine site (took a picture). States no itching. Did not spread, and began to fade within 3-5 minutes. Client did take her oral benadryl, but rash was already receding by then. Kept client for 30 mins post-vaccine. Client was pleasant, friendly and talkative, not alarmed by event and stated she felt ready to go and that she fine. Understands to go to ER if it redevelops, worsens or other symptoms occur.
Age: 21.0
Sex: M
Vaccine: COVID19, MENB, UNK
Symptoms: Syncope
Clinical narrative: He left the room and sat down in the waiting area and fainted for a moment. He did not fall out of seat or have injury after fainting. After waiting a few minutes he left without problem.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3, HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: Grandma came in today and was at the other window. She then came to our window and stated she had vomiting and fever after shots were given 3/10/25. She just now reported it.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Received both vaccines on March 25th, 4 days later (March 29) started with rash on one arm where a vaccine was given, then spread to entire body.  Mom was concerned about allergic reaction so was seen at Urgent Care on March 30th for Urticaria and pruritic rash, where he was given atarax, hydrocortisone cream, and a 5 day course of prednisone. Rash resolved 4/2.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia, Use of accessory respiratory muscles
Clinical narrative: Per mother child had a fever.   Also reported by mother that child had a reaction to prior vaccines on 2/14/2024 and 4/10/2024.   Please see VAERS reports:  1055347, 1055348 and 1055358.  Per mother the child had fever and retractions the day after the 2/14/2024 vaccines and was hospitalized for a few days and retractions/fever but no hospitalization from the January 8, 2025 vaccines.     Per mother child had fevers after all his vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction to any of the vaccines. Reason for VAERS report is MMRV (component) vaccine was expired LOT: X019303  EXP: 01/14/2025. NDC: 00006-4309-01. Sterile Diluent used LOT: W036927  EXP: 08/18/2025  NDC: 00006-4309-01.
Age: 72.0
Sex: F
Vaccine: FLU3, COVID19, FLU3
Symptoms: Injected limb mobility decreased, Rash
Clinical narrative: Patient states she is still having severe pain in right arm. 16 days since vaccination. She has been unable to use arm since getting vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3, COVID19, FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient states she is still having severe pain in right arm. 16 days since vaccination. She has been unable to use arm since getting vaccine.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Eye movement disorder, Immediate post-injection reaction, Loss of consciousness, Presyncope, Wrong product administered
Clinical narrative: My infant daughter upon receiving the vaccination immediately had her eyes roll back and she passed out. She came to about 30 seconds later. The doctors tried to assure me it was a vasovagal reaction where she was scared of the needle, which makes no sense for an infant who is unaware of what is going on. I also had only signed for the DTaP vaccine, but the nurse administered Pediarix, which combined DTaP, Hep B, and Polio, which again was not what I signed for.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: visible red rash below the injection site, patient stated it is not itching. rash area is about the size of a small fist ball and rash is not anywhere else on body.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging head, Paraesthesia
Clinical narrative: Tingling and numbness in great toe
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Malaise, Night sweats, Pyrexia
Clinical narrative: Customer said she was in-between jobs and was no longer insured.  She went to get a flu shot and the explained that the cost was $89.  She explained that she didn't have insurance and the pharmacist then offered a cheaper version of the flu shot.  She said the next day, she started feeling bad, and then started getting sick.  She said the following Sunday, and started getting really tired and felt really weird.  She went to bed, started sweating, had a fever, and she called her neighbor who is a doctor.  Around 5:00 a.m., she started having a seizure.  EMS was called and she was rushed to the hospital.  She spent a few days there and now has a $8,900 bill.  She said she feels that pharmacy gave her a cheaper version of the flu shot and this really made her sick.  She said that she's not sure why they would give this to people if it would make them sick and wants her bill paid and to be compensated for her trouble.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Customer said she was in-between jobs and was no longer insured.  She went to get a flu shot and the explained that the cost was $89.  She explained that she didn't have insurance and the pharmacist then offered a cheaper version of the flu shot.  She said the next day, she started feeling bad, and then started getting sick.  She said the following Sunday, and started getting really tired and felt really weird.  She went to bed, started sweating, had a fever, and she called her neighbor who is a doctor.  Around 5:00 a.m., she started having a seizure.  EMS was called and she was rushed to the hospital.  She spent a few days there and now has a $8,900 bill.  She said she feels that pharmacy gave her a cheaper version of the flu shot and this really made her sick.  She said that she's not sure why they would give this to people if it would make them sick and wants her bill paid and to be compensated for her trouble.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient and Mom came to clinic for dental care and agreed for patient to have HPV vaccine while they were here. We pulled a report and report showing patient had NOT received HPV vaccine. Gave Mom the VIS for HPV, discussed process, administered HPV vaccine per PHN protocol, monitored patient for 15 minutes, patient tolerated well. They started to leave and Mom asked if patient needed any other vaccines, I advised her we don't show her having   the Tdap vaccine. Mom then states patient has lived elsewhere. Mom gets on her phone and pulls up a shot record. She showed me her phone, first vaccine on list was Tdap, so I asked Mom to email the record to me and we will update our records. Mom and patient left. I received the email an hour later, and I reviewed it and it showed patient had already received both doses of HPV vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Pain, Rash, Skin warm, Swelling
Clinical narrative: Rash,  swelling, warmth and pain. Thigh is also hard/firm
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: LVN administered incorrect dose to patient, MD and Manager notified, MD contacted Infectious Disease and confirmed no harm to patient -- patient may continue next dose in series, as scheduled
Age: 10.0
Sex: F
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Two sisters were scheduled to have vaccines and the older sister was inadvertently given the younger sister's injections. The mistake was realized the the younger sister received the correct vaccinations.  No adverse symptoms or signs were observed.
Age: 19.0
Sex: F
Vaccine: HEP, MMR, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Client received adult Engerix -B formulation instead of the pediatric/ adolescent Engerix-B as a 19-year-old. No adverse side effects observed nor reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Comirnaty vaccine given 4/9/2025 has expired on 03/28/2025.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Alopecia, Biopsy skin abnormal, Inflammation, Laboratory test normal, Scalp biopsy
Clinical narrative: Hair began to fall out in a small patch on September 19 after receiving vaccines.  Total hair loss occurred by October 28.  I saw a dermatologist who did lab work and scalp biopsy. All labs negative for anything autoimmune.  Scalp biopsy showed inflammation.
Age: 67.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Periarthritis
Clinical narrative: Patient called pharmacy and said after his vaccinations his arm was sore each day, but beginning on 4/9/2025 he had significant pain and couldn't move his arm at all.  He believes he has frozen shoulder.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions. Patient received the vaccine but had already received the Prevnar 20 on 5/14/2022.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: fatigue & injection site soreness same day, chills started third day
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Comirnaty COVID vaccine was administered 10 days after the expiration date. No adverse effects reports thus far
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patinet reported localised pain and soreness in the arm , but  developed low grade fever and slept for about 2-3 hours after she reached home. But she was ok after that . She did not reported any treatment that she needed
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a female patient of an unknown age 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) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication was not reported.  Reporter stated that in 3 years, she lost 7 family members (7 people were dead in caller's family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sisters-in-law, and several brothers-in-law.  Treatment medication was not reported.  This case was created for reporter's sister.   This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 08-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: Company comment: Very limited information provided at this time. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784180:Master case; Reported Cause(s) of Death: Dead
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Administered IM vs SQ
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 25.0
Sex: M
Vaccine: COVID19, FLU3, HEP, MMR, TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: I noticed when doing a routine chart audit for vaccines that the Priorix MMR vaccine was given intramuscularly, when it should only be given subcutaneously. When I asked the nurse who administered the vaccines about this, she did not report any adverse events or outcomes at the time of vaccination. I called GSK and they had internal studies suggesting it is still more than 96% effective when given IM and immunize.org suggests that the dose does not need to be repeated. We did attempt to contact the patient to follow-up and have not yet gotten a hold of them. I also noticed when auditing the chart that the nurse gave two vaccines (influenza and Tdap) in the gluteus muscle. This is not a preferred site, but per immunize.org should still count as valid. I reviewed vaccination technique with this nurse, including how to give up to three IM injections in each deltoid. I also reviewed that Priorix should only be give subcutaneously.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Given IM vs SQ
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Erythema, Induration, Malaise
Clinical narrative: Large, hard, flat lump and burning red area. Fever. Notified  primary doctor and pharmacy on March 31. Told to monitor. Redness grew and worsened. Teleconference with primary doctor on April 3. Notified pharmacy that I was diagnosed with Cellulitis. Doctor prescribed antibiotics.  Today, April 10, redness is gone but discoloration remains. Still feel ill but improving.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pyrexia
Clinical narrative: Large, hard, flat lump and burning red area. Fever. Notified  primary doctor and pharmacy on March 31. Told to monitor. Redness grew and worsened. Teleconference with primary doctor on April 3. Notified pharmacy that I was diagnosed with Cellulitis. Doctor prescribed antibiotics.  Today, April 10, redness is gone but discoloration remains. Still feel ill but improving.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Given IM vs SQ
Age: 31.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tremor
Clinical narrative: Tremors; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors) and FATIGUE (fatigue) in a 39-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremors) and FATIGUE (fatigue). At the time of the report, TREMOR (Tremors) and FATIGUE (fatigue) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       This case contains information about 2nd patient out of 4 patients as described by reporter.  No concomitant medications were reported.  The patient had reduced his work hours due to severe tremors and fatigue that developed after receiving his Moderna shot. Previously, the physician had dismissed that it was long COVID, but the patient believed his symptoms were due to the vaccine, and now the patient who was a formerly active outdoorsman struggled with his daily family life.  No treatment medications were reported.   This case was linked to AU-MODERNATX, INC.-MOD-2025-784512 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2025: Live significant follow-up received. RA was updated to 07-Apr-2025. On 08-Apr-2025: Live significant follow-up received. country of incidence updated.; Sender's Comments:  AU-MODERNATX, INC.-MOD-2025-784512:Same Report, patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling abnormal, Tinnitus
Clinical narrative: Chronic tinnitus; debilitating heart issues; Spidey senses; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Chronic tinnitus), CARDIAC DISORDER (debilitating heart issues) and FEELING ABNORMAL (Spidey senses) in a 57-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Chronic tinnitus), CARDIAC DISORDER (debilitating heart issues) and FEELING ABNORMAL (Spidey senses). At the time of the report, TINNITUS (Chronic tinnitus), CARDIAC DISORDER (debilitating heart issues) and FEELING ABNORMAL (Spidey senses) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       This case contains information about 3 out of 4 patients reported by reporter.  No concomitant medications were reported.  The patient got vaccinated in 2021 to support his healthcare worker wife. Shortly after having the second shot, the patient experienced the events. The patient was dismissed by the doctors until 2023. The patient lived in constant fear, never knew what was going to happen, and just resigned himself to the fact that his days were numbered.  No treatment medications were reported.   This case was linked to AU-MODERNATX, INC.-MOD-2025-784512 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2025: Live significant follow-up received. RA was updated to 07-Apr-2025. On 08-Apr-2025: Live significant follow-up received. country of incidence updated.; Sender's Comments:  AU-MODERNATX, INC.-MOD-2025-784512:Same Report, patient (patient 3)
Vaccine: COVID19
Symptoms: Angina pectoris, Pain assessment
Clinical narrative: Occasional not lasting longer sensations around my heart; Tightness with some pain; Does not persist; Intense itching on the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Apr2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Lot: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 05Apr2025, outcome "unknown", described as "Intense itching on the injection site"; ANGINA PECTORIS (medically significant) with onset 05Apr2025, outcome "recovering", described as "Occasional not lasting longer sensations around my heart; Tightness with some pain; Does not persist". The patient underwent the following laboratory tests and procedures: Pain assessment (0-10): (05Apr2025) 4 or 5. On 03Apr2025 (reported 72 hours before 06Apr2025) the patient had Comirnaty vaccine and this was the 2nd time the patient had it. The patient's concern was patient had been having intermittent. The patient took the vaccine on Thursday (03Apr2025). For 24 hours the patient had no symptoms, not even a sensation or feeling on arm but after since 05Apr2025 (reported as yesterday) so after 48 hours the patient had intense itching on the injection site and occasional not lasting longer sensations around the patient's heart, tightness with some pain but the pain like severe like on 1 to 10 patient had say it about 4 or 5. It is like a construction and then the patient did not know. It goes away within 30 seconds. So it does not persist. so, patient's concern was maybe patient should be evaluating for steroids or something like that or should this resolve it. The patient saw a package insert said that it was a conservative management. In response to further probing: Consumer stated, this might resolve on itself. It did not seem to be getting any worse. So, the patient thought the patient will little longer and by this evening another couple of hours, if it was still bothering patient or being worse patient will go ahead and call back.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Balance disorder, Behcet's syndrome, Diplopia, Dizziness, Fall
Clinical narrative: bishop; Dizziness; Vertical double vision; I fell down twice. It is like balance; I fell down twice. It is like balance; something in my brain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: BEHCET'S SYNDROME (medically significant), outcome "unknown", described as "bishop"; DIZZINESS (non-serious), outcome "unknown"; DIPLOPIA (non-serious), outcome "unknown", described as "Vertical double vision"; FALL (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "I fell down twice. It is like balance"; CEREBRAL DISORDER (non-serious), outcome "unknown", described as "something in my brain".  Clinical course: The patient got the Pfizer COVID-19 Vaccine almost three years and half ago. The patient experienced dizziness, vertical double vision and last year on15Feb2024, the patient fell down twice, and it was like balance. The patient stated that two years and half ago in (redacted), they found something in the patient's brain, but they did not know exactly. The first time they said that it could be 'bishop'. The second time they said it was maybe tumor-like concept, and they sent the patient to (withheld) and said that it was not. After that, they told the patient that it could be inflammation. The patient needed help to get the right medicine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid after Vaccines; Covid after Vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 after Vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: During an inbound call for Reimbursement assistance, the patient stated that on Saturday, he was getting his Paxlovid and working with his pharmacist. They tried several times to get the card and a couple of places said his birthday was wrong. He also said that he got COVID for his Birthday. The patient and his wife don't take many pills and they get vaccines usually on time.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Chronic kidney disease
Clinical narrative: chronic kidney disease; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "fine"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "fine". The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown". The event "chronic kidney disease" required physician office visit. Therapeutic measures were taken as a result of chronic kidney disease. The booster shot gave to the patient chronic kidney disease and it was confirmed by a physician at this point. The patient was required to get kidney infusions twice a year.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 38.0
Vaccine: RAB
Symptoms: No adverse event, Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Imovax is prescribed with off label diagnosis code W54.0XXA OKA Bitten by dog with no adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 38 years old and unknown gender patient who had intentional off label prescription by hcp (healthcare professional): IPV (Vero) [Imovax] is prescribed with off label diagnosis code W54.0XXA oka bitten by dog with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received dose of 1mL (frequency once) suspect IPV (Vero), Suspension for injection (lot number, expiry date and strength not reported) via intramuscular route for bitten by dog (prophylactic vaccination). (Immunisation).   Information on the batch number could not be  requested corresponding to the one at time of event occurrence.  On an unknown date, the patient had intentional off label prescription by hcp (healthecare professional): imovax is prescribed with off label diagnosis code W54.0XXA oka bitten by dog with no adverse event (off label use).  Action taken was not applicable.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion for IPOL as max/low temperature reached: 53 F 45 mins with no reported adverse event; Initial information received on 08-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that had temperature excursion as max/low temperature reached: 53 F 45 mins with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (lot W1C751M and expiry date: 18-Nov-2025) (strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and that had temperature excursion as max/low temperature reached: 53 F 45 mins with no reported adverse event (poor quality product administered).  Reportedly, Reason: Broken refrigerator. Human error was No. Extended stability data did not cover the excursion. Product was administered post excursion. The caller states that this was such a short excursion what if the dose was valid, would it hurt them to get another dose.  Action taken was not applicable.  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.