chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE; HCP called to report TE where PROQUAD was administered.; This spontaneous report was received from a physician referring to a 4-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 11-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (lot # y006782, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 24-SEP-2025; strength and route of administration were not provided). It was reported that the vaccine underwent a temperature excursion and products were not currently back in range, excursion data unknown at this time (product storage error). No previous temperature excursion was reported. No additional information was provided. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inappropriate use due to storing expired vaccines with no adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who had inappropriate use due to storing expired HIB (PRP/T) Vaccine [ACT-HIB] 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 In 2024, the patient received a expired unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength and lot number not reported; expiry date: 25-Mar-2024) via unknown route in unknown administration site as prophylactic vaccination (immunization) and inappropriate use due to storing expired vaccines with no adverse event (expired product administered) (same day latency).   Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  Reportedly: "She complained on why it was written like that since it's confusing. It's a weird way to write the expiration date like that. She added that it was unknown if it was administered to any patients after the expiration date."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Transcription medication error, Underdose
Clinical narrative: lot corresponds to VAQTA SYRINGES 50 U/1ML/the dose was charted as pediatric dose administered to an adult patient due to product confusion; No additional AE; This spontaneous report was received from other health professional and refers to a adult patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 50/1.0 u/ml, lot #x006702, expiration date: 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). It was noted by one of coding systems that the pediatric formulation of vaccine was administered to an adult, but it was coded wrong (Transcription medication error). No additional adverse event was reported.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative
Clinical narrative: a patient who was vaccinated with MMR II on 6/22/1995 and 6/15/1999 had titers drawn on 8/26/2024 and the Titers showed low immunity; a patient who was vaccinated with MMR II on 6/22/1995 and 6/15/1999 had titers drawn on 8/26/2024 and the Titers showed low immunity; a patient who was vaccinated with MMR II on 6/22/1995 and 6/15/1999 had titers drawn on 8/26/2024 and the Titers showed low immunity; This spontaneous report was received from an other health professional (Physician Assistant) and refers to a 30-year-old female patient.  The patient's medical history was not reported. The patient' concurrent conditions included allergy to latex. Concomitant therapies were not reported.  On 22-JUN-1995, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided). On 15-JUN-1999, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided).   On 26-AUG-2024, Measles, Mumps, Rubella (MMR) titers were drawn and it showed low immunity (Measles antibody negative, Mumps antibody test negative, Rubella antibody negative). The reporter could not be sure if the dosing schedule was correct or if the patient missed any doses. No additional adverse event (AE) was reported. At the time of reporting, the outcome of the events was unknown. The action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) regarding the events was not applicable.   The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Aphasia
Clinical narrative: medical assistants niece went from verbal to non verbal; This spontaneous report was received from a medical assistant refers to her niece, female patient of unknown age. The patient's concurrent condition included autism spectrum disorder (reported as: autistic). The patient's medical history, and concomitant therapies were not provided.  On an unknown date (also reported as: at 12 years old),  the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 05-SEP-2024 (after received the first dose of vaccine), the patient experienced aphasia. It was reported that the patient went from verbal to non verbal. The outcome of aphasia was unknown.        The relatedness between the event and the suspect vaccine was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Menstruation delayed
Clinical narrative: has not had a menstrual cycle for 74 days; This spontaneous report was received from a consumer refers to a 15-year-old female patient.  The patient's medical history included eating disorder. The patient's concurrent conditions and concomitant therapies were not provided.  On an unknown exact date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 28-JUN-2024 (estimated date, reported as: for 74 days), the patient experienced menstruation delayed (has not had a menstrual cycle for 74 days). The outcome of menstruation delayed was reported as not recovered/not resolved.   On 29-JUN-2024 (estimated date, reported as: 73 days ago), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs; Caller states HCP ordered for patient to receive VARIVAX but patient received SHINGRIX instead.; Caller states HCP ordered for patient to receive VARIVAX but patient received SHINGRIX instead.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapy, drug Reactions and allergies were not reported.  The reporter stated that HCP ordered on 10-SEP-2024 for patient to receive varicella virus vaccine live (oka/merck) (VARIVAX) but patient received varicella zoster vaccine rge (cho) (SHINGRIX) instead (Wrong product administered, Product confusion). Details of the product confusion are unknown at this time. No other information was provided. No additional adverse event (No adverse event).
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: The second dose of Jynneos vaccine was administered to a patient five days past the expiration date; The expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials; Case reference number US-BN-2024-002436 is a spontaneous case initially received from pharmacist (reference number USBAV24-2262) on 06-Sep-2024 and concerns a patient of unspecified gender or age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient received the first dose of Jynneos (batch number: unknown), at an unknown dose, route or site for administration, for unknown indication.  On an unspecified date, unknown amount of time after the first dose, as reported five days pass the expiration date and the patient received the second dose of Jynneos (batch number: unknown), at an unknown dose, route or site of administration (explicitly coded 'expired vaccine used'). As reported the expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials (explicitly coded 'product expiration date missing').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  No further information was provided.; Reporter's Comments: A patient of unspecified gender or age received the second dose of Jynneos five days pass the expiration date which is considered as expired vaccine used. Reportedly, the expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials which is considered as product expiration date missing. Expired product administered and product expiration date issue are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Expired product administered and product expiration date issue are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified gender or age received the second dose of Jynneos five days pass the expiration date which is considered as expired vaccine used. Reportedly, the expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials which is considered as product expiration date missing. Expired product administered and product expiration date issue are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Expired product administered and product expiration date issue are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2262:
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: pain at injection site following Shingrix vaccination/both doses were very painful; couldn't lift their arm until around a half hour after applying the cream; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site following Shingrix vaccination/both doses were very painful) and injected limb mobility decreased (Verbatim: couldn't lift their arm until around a half hour after applying the cream). The outcome of the injection site pain and injected limb mobility decreased were resolved.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site pain and injected limb mobility decreased to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR115758   Additional Information: GSK Receipt Date: 10-SEP-2024 This case was reported by a patient via (social media) interactive digital media. The patient stated that, a pointer for anyone thinking about the Shingrix vaccine; CBD cream works amazingly well for the painful arm at the injection site. Both doses for patient were extremely painful, and he/she could not lift her arm until about half hour after he/she applied the cream. For tolerance of 2nd dose reference case US2024AMR115758.; Sender's Comments:  US-GSK-US2024AMR115758:Same reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza like illness, Malaise, Musculoskeletal chest pain
Clinical narrative: Explosive diarrhea 4 hours after injection. Flu-like symptoms afterwards, extreme body aches, headache  and general sickly feeling. Five days after the injection I woke up with a bad pain in my left side ribs area. It still hurts and feels worse today. I haven?t otherwise hurt myself in my rib area, and can only attribute the pain to the vaccine. I?m going to go see my doctor. I?ve read that it?s one of the side effects, inflammation and chest or rib pain.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Explosive diarrhea 4 hours after injection. Flu-like symptoms afterwards, extreme body aches, headache  and general sickly feeling. Five days after the injection I woke up with a bad pain in my left side ribs area. It still hurts and feels worse today. I haven?t otherwise hurt myself in my rib area, and can only attribute the pain to the vaccine. I?m going to go see my doctor. I?ve read that it?s one of the side effects, inflammation and chest or rib pain.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complex regional pain syndrome, Gait disturbance, Walking aid user, Wheelchair user
Clinical narrative: I developed Complex regional pain syndrome within a couple weeks of my first dose of the vaccine starting in my right ankle . It has since spread to all of my limbs and my spine since that time. By  the time I went in for my second dose three weeks later I was already on crutches. It proceeded to get worse from there leading to me having to learn to walk again. There was no significant injury that could?ve lead to CRPS at that time.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenitis, Pain, Peripheral swelling, Swelling
Clinical narrative: swollen left arm to shoulder and back, inflamed lymph nodes, pain
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: left arm pain swelling, elevated temp 104, congestion Tylenol taken for pain and fever ice to site
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: left arm pain swelling, elevated temp 104, congestion Tylenol taken for pain and fever ice to site
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: High fever lethargy arm hurt one week diarrhea cold sores
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Rash erythematous, Rash papular
Clinical narrative: 1. Pain and soreness at the injection site lasting almost 1 week.  2. Red, raised bumps formed behind my left ear. It appears to be some form of Eosinophilic Folliculitis.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Lip swelling, Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: Patient received flu vaccine approximately 9:15 am on 9/17/2024.  At 10:40 am on 9/17/2024 patient returned to health clinic and stated her  "lips and tongue feel puffy", and reported feeling "itchy".  Patient stated these symptoms began at 10:15 am.  Patient taken into exam room and discussed event with myself and director of patient services,  RN. Per RN, patient given one 25 mg tablet of Benadryl at 10:48 am. Patient was educated to continue to monitor symptoms and contact health department staff if symptoms worsen. At 1:45 pm writer called to check on patient. Patient stated her tongue no longer felt puffy or tingly, but "lips feel tingly", and a "little tiny bit" on arms. Writer discussed updated information with RN and she advised patient continue to take one 25 mg Benadryl tablet every 8 hours for the next 24 hours. This information given to patient.  Writer called patient 09/17/2024 at 11:10 am to monitor symptoms. Patient stated she still felt "a little strange but much better than yesterday".  Writer advised patient if symptoms worsen to contact her provider.  Attempted to call patient 09/19/2024 for update on symptoms, unable to reach patient.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Patient received flu vaccine approximately 9:15 am on 9/17/2024.  At 10:40 am on 9/17/2024 patient returned to health clinic and stated her  "lips and tongue feel puffy", and reported feeling "itchy".  Patient stated these symptoms began at 10:15 am.  Patient taken into exam room and discussed event with myself and director of patient services,  RN. Per RN, patient given one 25 mg tablet of Benadryl at 10:48 am. Patient was educated to continue to monitor symptoms and contact health department staff if symptoms worsen. At 1:45 pm writer called to check on patient. Patient stated her tongue no longer felt puffy or tingly, but "lips feel tingly", and a "little tiny bit" on arms. Writer discussed updated information with RN and she advised patient continue to take one 25 mg Benadryl tablet every 8 hours for the next 24 hours. This information given to patient.  Writer called patient 09/17/2024 at 11:10 am to monitor symptoms. Patient stated she still felt "a little strange but much better than yesterday".  Writer advised patient if symptoms worsen to contact her provider.  Attempted to call patient 09/19/2024 for update on symptoms, unable to reach patient.
Sex: M
Vaccine: TDAP
Symptoms: Antibody test, Therapeutic response decreased
Clinical narrative: Low titers after vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5E43J) for prophylaxis.   On 26-JAN-2011, the patient received Boostrix. On 30-AUG-2024, 4965 days after receiving Boostrix, the patient experienced therapeutic response decreased (Verbatim: Low titers after vaccination). The outcome of the therapeutic response decreased 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: 09-SEP-2024 The nurse reported that the patient received Boostrix on January 26th 2011 and titers were measured low on August 30th 2024. The reporter asked should administer Tdap or Td vaccine. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 6.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to patient at age 6, currently only recommended to give to patients above age 10.  No symptoms reported from patient. following vaccination.
Age: 0.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: After the vaccines were given the patient developed a fever and a rash the same day.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Redness and swelling arm arm that has gotten progressively worse over 5 days, and still going. Area is hot to the touch. Pain ceased after 3 days. Area is still raised and still itches. Red raised area grows larger each day. Today is day 5.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Hypophagia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness, swelling at injection site, diarrhea; drinking tea but not eating anything, gatoraide to rehydrate,
Age: 80.0
Sex: M
Vaccine: COVID19, FLU3, RSV, COVID19, FLU3, RSV
Symptoms: Erythema, Injection site rash, Rash erythematous
Clinical narrative: ADVERSE EVENT: PATIENT CAME BACK INTO PHARMACY 9/19/24 AND SAID HE NOTICED ON 9/17/24 (DAY AFTER VACCINE ADMINISTRATION) A RASH (RED, NON-ITCHY, NO BUMPS) AREA ON EACH ARM WHERE THE VACCINES WERE ADMINISTERED.   TREATMENT: HE SAID HE DID NOT TAKE OR APPLY ANYTHING TO THE AFFECTED AREAS ON ARM.  HE NOTICES A RED AREA ON HIS CHEST 9/19/24 THINKING IT LOOKED SIMILAR TO THE RED AREAS ON HIS ARMS. STILL NON ITCHY, NO BUMPS AND NOT WARM TO THE TOUCH).
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dysgeusia, Headache, Paraesthesia oral
Clinical narrative: Tingling tongue, metallic taste in mouth. headache. Received treatment of vitals taken, Released to take Benadryl at home. Tongue tingling persists as of 9/19/2024 9:38 AM
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Head titubation, Tremor
Clinical narrative: Tremors in neck and head. They have lessened with time, but I thought it was important to report
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tension headache
Clinical narrative: Dull headache predominantly in back of head but sometimes in temples.  A feeling of tightness in head.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: VAXELIS USED AS THE 5TH DTAP AND IS ONLY TO BE USED IN THE FIRST 3 PRIMARY DOSES OF DTAP
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Annual booster shot administered 16Sep2024. (Last booster received October 2023.) Within three hours of injection felt nauseous. Following morning (17Sep), pain and swelling at the injection site, fever of 101.2, nausea, vomiting and aching of joints. Persisted the entire day, but fever and achiness helped with acetaminophen and ibuprofen. Wednesday (18Sep), pain and swelling at the injection site was worsened with red hardened lump of about a 1.25inch radius from the injection site. Fever and achiness continued and patient (myself) sought medical treatment at the work wellness clinic where the vaccine was administered. Ibuprofen and acetaminophen and regular intervals helped with pain and fever.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Annual booster shot administered 16Sep2024. (Last booster received October 2023.) Within three hours of injection felt nauseous. Following morning (17Sep), pain and swelling at the injection site, fever of 101.2, nausea, vomiting and aching of joints. Persisted the entire day, but fever and achiness helped with acetaminophen and ibuprofen. Wednesday (18Sep), pain and swelling at the injection site was worsened with red hardened lump of about a 1.25inch radius from the injection site. Fever and achiness continued and patient (myself) sought medical treatment at the work wellness clinic where the vaccine was administered. Ibuprofen and acetaminophen and regular intervals helped with pain and fever.
Age: 35.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Exposure during pregnancy, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: I am almost 8 months pregnant and received the pfizer covid and flu vaccinations at the recommendation of my OB on 9/14. After the vaccinations, I experienced some pain in both arms and tiredness, which is normal. The pain in my left arm, where I received my COVID shot, was still prevalent a few days after and on 9/15 I began to notice moderate joint pain in my left arm,  specifically my left wrist and shoulder.  Starting on 9/17  if I use my left hand/wrist I experience discomfort and low levels of pain. If I move my left wrist in some typical ways it can lock, it is very painful when locked or when getting it unlocked. I have wrapped my wrist the last few days to reduce movement. I am having no residual flu vaccination pain in my right arm. However, I am experiencing low-level aches in other joints, my left hip, upper back pain,  and some aches in my right wrist.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Headache, Injection site pain, Pain, Peripheral swelling
Clinical narrative: Left thumb and index finger are itchy, red, warm, and slightly swollen. Right thumb and index finger are itchy but less red and warm than left and not yet swollen. Itching started with left thumb around bed time and seen in other fingers this morning. This is my second Moderna booster (Pfizer was my primary series). First time experiencing this side effect.  Also have expected headache, injection site and increased body aches (as happened with past vaccines), but no fever.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Skin warm
Clinical narrative: Left thumb and index finger are itchy, red, warm, and slightly swollen. Right thumb and index finger are itchy but less red and warm than left and not yet swollen. Itching started with left thumb around bed time and seen in other fingers this morning. This is my second Moderna booster (Pfizer was my primary series). First time experiencing this side effect.  Also have expected headache, injection site and increased body aches (as happened with past vaccines), but no fever.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cold sweat, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient was experiencing numbness in arm, tingliness and having a clamy feeling
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local site reaction with erythema, swelling and pain.  Appears to be improving at day 2 following administration of vaccine
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU3, MMRV
Symptoms: Dyskinesia, Eye movement disorder, Immediate post-injection reaction, Muscle rigidity, Pallor
Clinical narrative: Patient immediately cried .  then within a couple minutes, had a seizure (arms/legs extended, head and eyes rolling back, very rigid),  lasted about 15 seconds.  then became sleepy and pale.  slowly returned to normal and about 30 minutes later was back to normal.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU3, MMRV
Symptoms: Posture abnormal, Seizure, Somnolence
Clinical narrative: Patient immediately cried .  then within a couple minutes, had a seizure (arms/legs extended, head and eyes rolling back, very rigid),  lasted about 15 seconds.  then became sleepy and pale.  slowly returned to normal and about 30 minutes later was back to normal.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Ear infection, Feeling abnormal, Gait disturbance, Respiratory tract congestion
Clinical narrative: Patient reported feeling imbalanced, stuffy head, and trouble walking on September 9th 2024. Patient said he is getting better but his doctor suggested he might have gotten adverse effect from the vaccine. He reports no fever but suspected ear infection.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Arrhythmia, Cardiac monitoring abnormal, Supraventricular extrasystoles
Clinical narrative: Developed PAC's 14 days after immunization.  Many early on but have nearly resolved in last 3 weeks.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Laboratory test
Clinical narrative: Non-productive cough
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immunisation reaction, Injection site erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient's mom said that her arm got red, swollen, and the shot site redness was two to three times larger than it started out. She said the patient also had a low-grade fever.
Sex: U
Vaccine: MENB
Symptoms: Poor quality product administered, Product complaint
Clinical narrative: The HCP administered two doses after having difficulty removing large bubble; Product Complaint; This non-serious case was reported by a physician via sales rep and described the occurrence of poor quality product administered in a patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced poor quality product administered (Verbatim: The HCP administered two doses after having difficulty removing large bubble) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the poor quality product administered and pharmaceutical product complaint were 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: 09-SEP-2024 The physician reported that the health care professional administered two doses after having difficulty removing large bubble from pre-filled Bexsero syringes.  The physician was not comfortable using the remaining eight pre-filled syringes of the Bexsero box of ten doses due to appearance (large bubble in syringe that is difficult to remove, and sticky/oily appearance of resuspended vaccine).  The physician reported large bubble formed after product shaken.  The bubble stuck to the sides of the syringe and didn't dissipate with flicking or tilting syringe.  The physician reported this was different than previous Bexsero boxes.  The physician reported that the defect was discovered during preparation for administration. The physician reported that two doses were administered, the remaining eight doses were not administered.  The physician reported the bubble was about one-third the volume of the Bexsero suspension. The suspension seemed stickier or oilier as it was sticking to the sides of the syringe and a large bubble forms. The large bubble was difficult to expel.  The physician was able to remove the bubble and administered two of the suspect doses.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of Fluad for the same flu season (2024-2025).
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Deep vein thrombosis, Diagnostic aspiration, Haematoma, Magnetic resonance imaging abnormal, Seroma
Clinical narrative: 2/6/24: no complaints of vaccine site, diagnosed with DVT in R posterior tibial vein, referred to Oncology, prescribed Eliquis. 5/24/24: Pt reported small bump initially at site of vaccine, but seemed to resolve 1/2024. Recently bump recurred. U/S ordered. 9/9/24: Pt reported was seen at Orthopedics over the summer, aspiration 2x for R UE mass. Mass persists, now "lemon size"
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound scan abnormal, Vaccination site swelling
Clinical narrative: 2/6/24: no complaints of vaccine site, diagnosed with DVT in R posterior tibial vein, referred to Oncology, prescribed Eliquis. 5/24/24: Pt reported small bump initially at site of vaccine, but seemed to resolve 1/2024. Recently bump recurred. U/S ordered. 9/9/24: Pt reported was seen at Orthopedics over the summer, aspiration 2x for R UE mass. Mass persists, now "lemon size"
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Patient received a Fluad shot on 8/1/24 and then again on 9/18/24
Age: 51.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Swollen tongue
Clinical narrative: Approximately 15 minutes after vaccination his tongue swelled and he had a small spot on his right torso that was itchy, he was given diphenhydramine 50mg and the swelling and itching went away.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Adverse reaction, Chills, Nightmare, Pain in extremity, Platelet count decreased
Clinical narrative: Normal reaction: chills, sore arm, Abnormal reaction: back & tailbone pain all night long, plus conspiracy, psychotic, disturbing nightmares. Second night after vaccine was normal.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Psychotic disorder
Clinical narrative: Normal reaction: chills, sore arm, Abnormal reaction: back & tailbone pain all night long, plus conspiracy, psychotic, disturbing nightmares. Second night after vaccine was normal.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: She got her vaccine, didn't have any issue until 11:00 AM yesterday.  She then had pretty significant pain at the site, and she thought it would get better, but did not get better.  She slept with ice on it last night, and it's very very sore, hard bump in that area that is red.  In the center of it looks like a vaccine site circle, and is a very hard lump.  She has put on ice on it but nothing else.  She took Ibuprofen 600 mg yesterday.  She called her doctor regarding her symptoms, and she is waiting for them to call her back.
Age: 78.0
Sex: M
Vaccine: PNC20
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Patient said he started experiencing a sore arm the same day as vaccination (07/24/24) and over the course of a few days it spread to his chest. He says he still has the pain today (09/19/24), pt says he gets some relief with tylenol and spray on icy hot.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dyspnoea, Fatigue, Injection site urticaria, Nausea
Clinical narrative: Developed hives, shortness of breath, nausea, fatigue, full body pain and discomfort after 24 hours post vaccination. Still currently have a big hive near injection site that is being treated with steroid ointment and antihistamines
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Developed hives, shortness of breath, nausea, fatigue, full body pain and discomfort after 24 hours post vaccination. Still currently have a big hive near injection site that is being treated with steroid ointment and antihistamines
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Pain
Clinical narrative: Same day pain and weakness, developed Guillan-Barre syndrome, hospitalized for one month 5/29/24-6/30/24 and died in the hospital
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose of vaccine is administered to the patient on day 23 of the cycle and the window time begins on day 24 of the cycle.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash - full body
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received the high dose variant of the Fluzone vaccine instead of the vaccine indicated for those 65 and under.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Dr order a dtap and the m/a wasent pat attention and gave a kinrex
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient was ordered a MenQuadFi vaccine but received a HPV Gardisil 9 instead. No known reaction was observed or reported by staff or parent.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Headache
Clinical narrative: severe head ache back of head and front of head started and unusual for patient. took blood pressure and that was elevated referred her to her dr. when she declined offer to call EMS
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: at time of vaccination no adverse events occurred, per provider to advise mom to look out for fever and administer Tylenol as needed. Fever could be the potential adverse event to occur.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Wrong patient received product, Wrong product administered
Clinical narrative: Patient and husband requested covid (Spikevax) and Fluad vaccines. Technician had all 4 vaccines in the same basket and accidentally gave the same patient 2 covid vaccines instead of 1 covid and 1 flu. Pt was informed that instead of 0.5ml she received 1ml of covid vaccine. She was calm.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Arthralgia, Biopsy skin abnormal, Blood test, Depression
Clinical narrative: About 2 weeks after receiving the shot, I started getting an extremely itchy rash, almost hive-like, around my ankles. It spread up my calves and on both knees. The knees were the worst. Very bubbly and red. Over the following 2.5 years, the rash would appears on random parts of my body. On my stomach, elbows, neck, thighs, buttocks, the palms of my hands. The itch was so intense, I had trouble sleeping or engaging in everyday life.  I had went to my family doctor several times, before he eventually referred me to a dermatologist. The dermatologist took a biopsy, and it said a possible bite from a scorpion. That being impossible, he referred me to an allergist.  After several visits to the allergist and trying his "patented creams",  I made the decision to see a rheumatoid doctor.  There was never anything conclusive found.  I found another allergist who could not figure out what it was.  They wanted to start me on Dupixent.  I lost my insurance, so I started going to my local clinic.  The allergist there believes this was an adverse reaction to the vaccine.  I also began seeing the pain doctor there, as I had been having joint stiffness and pain since the rash started.  The pain doctor also believes this to be an adverse reaction from the vaccine.   After several months of appeals with my allergist, he got me approved for Dupixent.  I have now been on the Dupixent for about 6 months. I did start to see improvement after 3 months of the Dupixent. However, I continue to get the rash about once or twice a month. But, it's not as severe as it was.  I am very worried about what will happen once I am no longer on the Dupixent.  I don't believe this is something I can take for life.   This rash has ruined my life over the past 3 years, and caused me depression and reclusiveness.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Immunisation reaction, Insomnia, Joint stiffness, Loss of personal independence in daily activities
Clinical narrative: About 2 weeks after receiving the shot, I started getting an extremely itchy rash, almost hive-like, around my ankles. It spread up my calves and on both knees. The knees were the worst. Very bubbly and red. Over the following 2.5 years, the rash would appears on random parts of my body. On my stomach, elbows, neck, thighs, buttocks, the palms of my hands. The itch was so intense, I had trouble sleeping or engaging in everyday life.  I had went to my family doctor several times, before he eventually referred me to a dermatologist. The dermatologist took a biopsy, and it said a possible bite from a scorpion. That being impossible, he referred me to an allergist.  After several visits to the allergist and trying his "patented creams",  I made the decision to see a rheumatoid doctor.  There was never anything conclusive found.  I found another allergist who could not figure out what it was.  They wanted to start me on Dupixent.  I lost my insurance, so I started going to my local clinic.  The allergist there believes this was an adverse reaction to the vaccine.  I also began seeing the pain doctor there, as I had been having joint stiffness and pain since the rash started.  The pain doctor also believes this to be an adverse reaction from the vaccine.   After several months of appeals with my allergist, he got me approved for Dupixent.  I have now been on the Dupixent for about 6 months. I did start to see improvement after 3 months of the Dupixent. However, I continue to get the rash about once or twice a month. But, it's not as severe as it was.  I am very worried about what will happen once I am no longer on the Dupixent.  I don't believe this is something I can take for life.   This rash has ruined my life over the past 3 years, and caused me depression and reclusiveness.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular, Social problem
Clinical narrative: About 2 weeks after receiving the shot, I started getting an extremely itchy rash, almost hive-like, around my ankles. It spread up my calves and on both knees. The knees were the worst. Very bubbly and red. Over the following 2.5 years, the rash would appears on random parts of my body. On my stomach, elbows, neck, thighs, buttocks, the palms of my hands. The itch was so intense, I had trouble sleeping or engaging in everyday life.  I had went to my family doctor several times, before he eventually referred me to a dermatologist. The dermatologist took a biopsy, and it said a possible bite from a scorpion. That being impossible, he referred me to an allergist.  After several visits to the allergist and trying his "patented creams",  I made the decision to see a rheumatoid doctor.  There was never anything conclusive found.  I found another allergist who could not figure out what it was.  They wanted to start me on Dupixent.  I lost my insurance, so I started going to my local clinic.  The allergist there believes this was an adverse reaction to the vaccine.  I also began seeing the pain doctor there, as I had been having joint stiffness and pain since the rash started.  The pain doctor also believes this to be an adverse reaction from the vaccine.   After several months of appeals with my allergist, he got me approved for Dupixent.  I have now been on the Dupixent for about 6 months. I did start to see improvement after 3 months of the Dupixent. However, I continue to get the rash about once or twice a month. But, it's not as severe as it was.  I am very worried about what will happen once I am no longer on the Dupixent.  I don't believe this is something I can take for life.   This rash has ruined my life over the past 3 years, and caused me depression and reclusiveness.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: About 2 weeks after receiving the shot, I started getting an extremely itchy rash, almost hive-like, around my ankles. It spread up my calves and on both knees. The knees were the worst. Very bubbly and red. Over the following 2.5 years, the rash would appears on random parts of my body. On my stomach, elbows, neck, thighs, buttocks, the palms of my hands. The itch was so intense, I had trouble sleeping or engaging in everyday life.  I had went to my family doctor several times, before he eventually referred me to a dermatologist. The dermatologist took a biopsy, and it said a possible bite from a scorpion. That being impossible, he referred me to an allergist.  After several visits to the allergist and trying his "patented creams",  I made the decision to see a rheumatoid doctor.  There was never anything conclusive found.  I found another allergist who could not figure out what it was.  They wanted to start me on Dupixent.  I lost my insurance, so I started going to my local clinic.  The allergist there believes this was an adverse reaction to the vaccine.  I also began seeing the pain doctor there, as I had been having joint stiffness and pain since the rash started.  The pain doctor also believes this to be an adverse reaction from the vaccine.   After several months of appeals with my allergist, he got me approved for Dupixent.  I have now been on the Dupixent for about 6 months. I did start to see improvement after 3 months of the Dupixent. However, I continue to get the rash about once or twice a month. But, it's not as severe as it was.  I am very worried about what will happen once I am no longer on the Dupixent.  I don't believe this is something I can take for life.   This rash has ruined my life over the past 3 years, and caused me depression and reclusiveness.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: The patient received 0.3ml and moved and 0.2ml remained in the syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 3-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number ZR3ED, expiry date 30-JUN-2025) for prophylaxis.   On 09-SEP-2024, the patient received FluLaval 2024-2025 season (intramuscular) .3 ml. On 09-SEP-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incomplete dose administered (Verbatim: The patient received 0.3ml and moved and 0.2ml remained in the syringe). The outcome of the incomplete 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: 09-SEP-2024 The other health professional reported that administering an underdose of Flulaval TIV to a 3 year 11 month old patient.  The patient received 0.3ml and moved and 0.2ml remained in the syringe which led to incomplete dose administered.
Age: 80.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient's spouse reported that injection site became red and inflammed the day after administration of vaccine.  Patient took acetaminophen and used topical hydrocortisone.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: All Right of Administration were done, right patient, right medication, right route. Patients chart was reviewed, patient had an order placed for RSV.  Patient was called back; name and date of birth were confirmed. Patient was given information about the vaccine. Patient was given the vaccine, with no complications.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Patient called the pharmacy and stated that later in the evening after receiving the vaccine, they broke out in red, "splotchy" bumps all down their arm. The patient took Benadryl but the red bumps are still persisting. The patient has received the Moderna Covid vaccines in the past and has never had a reaction before.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A MenB vaccine was ordered for a patient but a MenQuadFi was drawn up and given to the patient. No known reaction was observed by staff or parent
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Urticaria
Clinical narrative: Hives on buttocks, torso, upper arms and swollen eyes
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site mass, Mobility decreased, Nasal congestion, Pruritus
Clinical narrative: Red lump/bump on left arm at injection site, itching in armpit, difficulty raising arm on both right and left sides, sneezing and stuffy nose.