chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Vaccine's Max/low Temperature: 34.3 F and 49.1 F TOTAL Time of excursion: 24 hours and 19 minutes with no reported adverse event; 1 vaccine was administered after 5th excursion with no reported adverse event; Initial information received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 64 years old male patient where reporter reported diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] max/low temperature: 34.3 f and 49.1 f total time of excursion: 24 hours and 19 minutes with no reported adverse event and 1vaccine was administered after 5th excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot- C5965AA and expiration date- 02-Mar-2024) via intramuscular route in the right deltoid (left arm) (dose, formulation, strength: not provided) for Immunisation (product storage error) (latency- same day).  On an unknown date in 2023, 1 vaccine was administered after 5th excursion with no reported adverse event (poor quality product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  there were 5 temperature excursions: On 11Sep2023 for 8 hours and 38 minutes and temperature was 49.1 F (9.5 C). On 12Sep2023 for 7 hours and 43 minutes and temperature was 48.4 F. On 20Sep2023 for 1 hour and temperature was 48.9 F. On 21Sep2023 for 1 hour and 59 minutes and temperature was 34.9 F. On 22Sep2023 for 4 hours and 15 minutes and temperature was 34.3 F (1.3 C). Unopen Products: TENIVAC Reason: unknown to the reporter, doctor is not sure about what happened, doctor thinks it might be power outage or the refrigerator had malfunction Max/low Temperature: 34.3 F and 49.1 F TOTAL Time of excursion: 24 hours and 19 minutes Human error? Unknown   Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: pentacel was given to a consumer 4 days after the expiration date with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 15 months old female patient received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was given to a consumer 4 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (lot UJ808AB, Expiry date : 23-Oct-2023, strength was unknown) via intramuscular route in the thigh not otherwise specified and pentacel was given to a consumer 4 days after the expiration date with no reported adverse event (expired product administered) (latency : same day) .  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was given to a consumer 4 days after the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: states that a staff administered a patient with expired fluzone qiv with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 62 years old male patient who states that a staff administered a patient with expired influenza quadrival a-b vaccine [Fluzone QIV] with no reported adverse  event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot UT7751JA, Expiry date : 30-Jun-2023, strength was unknown) via intramuscular route in the left arm for Immunization and states that a staff administered a patient with expired fluzone qiv with no reported adverse event (expired product administered) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event states that a staff administered a patient with expired fluzone qiv with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: some of the medication leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event; Initial information received on 29-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old female patient and pharmacist reported that Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Oct-2023, the patient received a 0.7 ml of dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength: high dose, frequency: once, expiry date: unknown and lot U8135AE) via unknown route in unknown administration site as immunization and some of the medication leaked out, not sure if the needle is appropriately put on or not, am not sure the full dose the patient got with no reported adverse event (incorrect dose administered) (same day latency).   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: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Part of the dose was administered intramuscularly and part of the dose was administered subcutaneously with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient where part of the dose of vaccine influenza quadrival a-b vaccine [Fluzone QIV] was administered intramuscularly and part of the dose was administered subcutaneously 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 a dose of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (incorrect route of product administration). There will be no information available on the batch number for this case.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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: FLUA4
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: Vaccine was administered to a patient following a temperature excursion; Excursion, max temp 47.14 F; This spontaneous case was received on 31-Oct-2023 from other healthcare professional via Communications (reference number: SEQW23-03894) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.     On an unspecified date, Fluad Quadrivalent (influenza vaccine inact sag 4v) vaccines were exposed to a temperature excursion peaking at 47,14 degrees Fahrenheit (F) for 45 minutes (explicitly coded as 'Product storage error temperature too high'). The batch numbers reported were 371622 with the expiry date 30-Jun-2024, 374243 and 374228.  On 30-Oct-2023, after the temperature excursion, the patient was vaccinated with Fluad Quadrivalent (dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease (explicitly coded as 'Product administration error').   At the time of initial reporting, it was not reported whether the patient experienced any adverse events after the Fluad Quadrivalent administration.  Company comment: A patient of unreported age and gender was vaccinated with Fluad Quadrivalent an unknown amount of time after it suffered a temperature excursion peaking at 47.14 degrees of Fahrenheit (F) that lasted for 45 minutes (explicitly coded as: 'Product storage error' and 'Product administration error'). It was not reported if the patient experienced any side effects following vaccination. Product storage error and product administration error were assessed as not related as per company's specific guidelines.; Sender's Comments: A patient of unreported age and gender was vaccinated with Fluad Quadrivalent an unknown amount of time after it suffered a temperature excursion peaking at 47.14 degrees of Fahrenheit (F) that lasted for 45 minutes (explicitly coded as: 'Product storage error' and 'Product administration error'). It was not reported if the patient experienced any side effects following vaccination. Product storage error and product administration error were assessed as not related as per company's specific guidelines.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cutaneous vasculitis, Laboratory test, Petechiae, Rash
Clinical narrative: Small vessel vasculitis evident by petechial rash of the legs and lower abdomen. Non painful but distressing to patient.
Age: 1.58
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Irritability, Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: 10/31: Vaccines administered  (Hep A and flu) Fevers started that evening Rash developed on 11/3 - right arm and then progressed to other extremities/face - spared trunk. Hand and foot swelling and pain. Irritability and itching.  Evaluated on 11/4 - rash consistent with hives along with swelling of hands/feet. Started on oral prednisolone once daily x 5 days for SSLR. No recent antibiotic use or illness. Strep exposure 1 week prior - Rapid strep negative. (2 days later Group A strep culture negative)
Age: 1.58
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Streptococcus test negative
Clinical narrative: 10/31: Vaccines administered  (Hep A and flu) Fevers started that evening Rash developed on 11/3 - right arm and then progressed to other extremities/face - spared trunk. Hand and foot swelling and pain. Irritability and itching.  Evaluated on 11/4 - rash consistent with hives along with swelling of hands/feet. Started on oral prednisolone once daily x 5 days for SSLR. No recent antibiotic use or illness. Strep exposure 1 week prior - Rapid strep negative. (2 days later Group A strep culture negative)
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4, PNC20
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction, patient was age 63 when vaccinated with Fluzone High-Dose indicated for age 65+
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Injection site pain, Myalgia
Clinical narrative: Myalgia Chills Prostration Injection site tenderness  Took Tylenol as advised but not much help Could not go to work location this morning, having difficulty doing much
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary mass, Axillary pain, Hypoaesthesia, Nodule, Paraesthesia
Clinical narrative: I received my flu shot on 10/4/2023 in my left arm and noticed the next day I developed a knot/lump in my left armpit with soreness. also,  my left hand now have numbness and tingling sensation that have lasted over three weeks and this is very concerning to me.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Hypersensitivity, Rash, Rash pruritic
Clinical narrative: Patient is currently pregnant received Influenza (Flulaval) vaccine on 10/31/23, at 10 weeks 3 days gestation, due date is on 5/25/24, post administration she started having itch & generalized rash on body. Denies airway issues & facial swelling. Patient called our clinic on 11/3/23 stating her allergic reaction, & continues with a rash with itch, she was triage one of our nurse and recommend to take Zyrtec & to follow label instructions & ED precautions were reviewed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm pain for over 1 month
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Fever, Central abdominal pain,
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity
Clinical narrative: Back and abdomen seizing up, resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient passed out and fell to the floor shortly after receiving the immunzation. She received a cold compress and quickly felt better.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 74.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fatigue the night of the vaccinations. Fever and diarrhea the following day.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Wrong vaccine formulation administered
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Immediate post-injection reaction
Clinical narrative: Patient reported cellulitis due flu vaccine received on 11/2/2; she was calling to about the status of her antibiotic and triamcinolone 0.1% cream written on 11/7/23.  The rph asked the patient if she had if she had reported this matter to the pharmacy before, but she said that she hadn't and didn't blame the pharmacy/immunizing RPH for the adverse event because she said that "cellulitis can happen". She said she felt the issue start "immediately, right away after getting the vaccine" but did not say anything to the pharmacy staff at the time.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: The vaccination hit the nerve.  Which I knew at the time, because it was immediately painful and I started saying, "Nerve, nerve, nerve!"  Now 4 hours on, I have pain and some weakness along my lower arm and into my pinky finger.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site rash, Rash macular, Rash pruritic
Clinical narrative: Patient received Spikevax vaccine and had adverse reaction at the injection site involving a red blotchy rash and itching that lasted approximately 1 week.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine formulation administered
Age: 53.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pain, Pain in extremity
Clinical narrative: patient had pain on first dose and has been experiencing pain in the left arm and increased after getting second dose of hepatitis B, patient has taking  Tylenol  as needed
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Peripheral swelling, Urticaria, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Swelling/bruising at vaccine site day of vaccine; Hives on hand 1-2 days after vaccine. Swelling of Left knee joint, ankle joint and left foot at day 3. Symptoms resolved by day 5
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Pt reported on set of itching 15-30 minutes after injections with subsequent development of raised, erythematous rash.  No current facial swelling, SOB, fevers, syncope.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: on 11/08, pt reported HR of 115 , BP of 150/80 and not able to sleep. advised pt to seek immediate medical attention. pt does not know her baseline. pt did confirm no problem on previous moderna vaccine before this adminstration. spikevax 50mcg/0.5ml Left deltoid, IM,
Age: 70.0
Sex: M
Vaccine: COVID19, FLUA4, RSV
Symptoms: Chest X-ray normal, Productive cough, Respiratory tract congestion
Clinical narrative: Patient reported chest congestion, lungs producing phlegm constantly every evening and morning starting about three to four days after immunization date. Does not feel sick otherwise. Saw his primary care provider who ordered a chest x-ray. Patient reports his physician saw no concerns on x-ray or physical examination.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Date of vaccine 11/5 - Pain at injection site, redness, swelling. Unable to lift arm or sleep on arm . Lethargic - overall not feeling well for 3 days post injection (today 11/8)
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Malaise, Sleep disorder
Clinical narrative: Date of vaccine 11/5 - Pain at injection site, redness, swelling. Unable to lift arm or sleep on arm . Lethargic - overall not feeling well for 3 days post injection (today 11/8)
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site nodule, Skin reaction
Clinical narrative: PATIENT STATED THAT HE HAD A DELAYED ADVERSE REACTION LOOKS LIKE A RED CIRCLE BELOW WHERE THE SHOT WAS GIVEN IN HIS ARM, HE ALSO STATED THAT HE STARTED TO FEEL A NODE AFTER HE GOT THE VACCINE SAME DAY AND THEN IT FEELS BETTER WITH TIME, WAS ADVISED BY ME TO CHECK WITH HIS DR TO MAKE SURE HE IS OK AND IF THE DR MAYBE WOULD CONSIDER SOME MEDS TO HELP HIM HEAL BETTER
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling abnormal, Immediate post-injection reaction, Pain in extremity, Paraesthesia
Clinical narrative: Patient received arexvy and prevnar 20. Immediately after getting the prevnar, she stated that her arm felt strange. She had a hard time describing it. We had her sit at the bench to observe. She stated it got better than she felt tingling all over her body. She doesn't think it was bad, but it was concerning to her. Daughter came in from the car to walk her out.  Called pt a few hours later and she stated all the tingling went away and she feels much better. Just some arm soreness from the shots. She mentioned that she had very little to eat in the morning and could contribute to it.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received Abrysvo on 10/7/23 Lot # HF5024 intramuscularly into the left arm. She again received a 2nd RSV shot Arexvy lot # LL942 intramuscularly into the left arm on 11/7/23. Pt discovered the mistake today while at her doctor's appointment and called the pharmacy. She reports having experienced no adverse side effects.
Age: 62.0
Sex: F
Vaccine: FLUC4, UNK
Symptoms: Soft tissue injury
Clinical narrative: patient claims i  administered vaccination without checking for landmark. she claims i left syringe hanging out of her arm while I reached for a sterile bandage. she told me she experience soft tissue injury
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experience redness, swelling and warmth  about 3 to 4 inches below injection site. I advice patient to see her PCP, she received antibiotics from her doctor due to an infection from the shot.
Age: 84.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: Patient presented to pharmacy informing pharmacist that her arm has been itching for approximately 2 weeks and after injection it bruised some and was red.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: shooting pain in arm, swelling
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Today on November 8th at 1:30 pm my two-month-old son had an appointment at the Dept of Health. My child's father took our son to get vaccines. He was supposed to receive four immunizations. At 6:09 p.m. I received a call from the Assistant Director informing me that my child did not receive his first dose of the HIB but instead received the INCORRECT immunization, Hepatitis B that is supposed to be received at nine months of age. My child is only two months old. Staff administered the wrong immunization to my child. She also printed the certification of immunization that listed all the supposed vaccines even though he did receive the HIB 1.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Crying
Clinical narrative: Patient received 2 vaccinations from intern while being supervised by pharmacist. Two vaccinations were given around 5:15pm (will complete two VAERS): Moderna pediatric (6mo-11yr) and Flucelvax (LOT#944495). The order of the vaccinations are unknown. A moment later, pharmacist ran over and told the other pharmacist to call 911 at 5:17 pm. The fire department/paramedics who were on the phone with pharmacist told her to ensure patient lay on her left side and not be given food or water, and be monitored the entire time. which was done. Patient was conscious, had no shortness of breath, was responsive to all questions, no pain, but crying. Paramedics took her blood pressure and it was within normal range. Her dad was with her and pharmacist monitored her the entire time. Paramedics from the fire department came within 5 - 7 minutes. The paramedics offered to take her to the hospital but the patient's dad declined. Patient was able to walk away from the incident, thanked the pharmacist, and appeared to be fine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse event
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram, Decreased appetite, Headache
Clinical narrative: Fever over 103, severe headache, Blurred vision, nausea, vomitting, stomach pains, loss of appetite, Fainted and was sent to the ER after being released from hospital. Still having mild to severe headaches.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nausea, Pyrexia, Syncope, Vision blurred
Clinical narrative: Fever over 103, severe headache, Blurred vision, nausea, vomitting, stomach pains, loss of appetite, Fainted and was sent to the ER after being released from hospital. Still having mild to severe headaches.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever over 103, severe headache, Blurred vision, nausea, vomitting, stomach pains, loss of appetite, Fainted and was sent to the ER after being released from hospital. Still having mild to severe headaches.
Age: 80.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Atrial flutter, Cardiac failure congestive, Chronic obstructive pulmonary disease, Condition aggravated, Pneumonia
Clinical narrative: Rapid Rate 120-125 Atrial Flutter, for 2 1/2 weeks. October 12, ER. Amiodarone started. went home. October 19 admitted to hospital. Pneumonia COPD exaserbation, congestive heart failure, October 23,23. DCed with O2 at home. October 24, 23 does not require O2 & is doing well.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: hives the following day and had a Recheck appointment on 11/8/23 with Dr. - dx Allergic urticaria
Age: 1.33
Sex: F
Vaccine: COVID19, DTAP, FLU4, VARCEL
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: 11.6.23 Rec'd Pfizer 2023-2024 formulation of Covid Vaccine for 6m-4yr. Inadvertently received full vial after dilution ( Instead of recommended dose of 0.3 mL/3 ug). Administered by MA. Attending MD notified, ID consulted and notified regarding questions about expected adverse reactions, if any. Practice and office managers notified. Parent notified by telephone by office RN. Mother's questions answered, in detail, regarding the actual vaccine administration error, measures being taken to address the administration error, and procedures that will be put into place to avoid this error again in the future. RN will call parent daily for the next three office days to check on status of child.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUA4, VARZOS
Symptoms: Diarrhoea, Dysstasia, Incontinence, Mobility decreased, Pyrexia
Clinical narrative: Fever Vomiting diarrhea unable to sit/stand up incontinence Wife called an ambulance and patient ended up in ER and spent 3 days in hospital.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUA4, VARZOS
Symptoms: Vomiting
Clinical narrative: Fever Vomiting diarrhea unable to sit/stand up incontinence Wife called an ambulance and patient ended up in ER and spent 3 days in hospital.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Chest pain, Hypoaesthesia
Clinical narrative: PATIENT CALLED PHARMACY AND SAID SHE HAS HAD SEVERAL WEEKS OF NUMBNESS IN HER VACCINATED ARM DOWN TO THE FINGERS. SHE ALSO COMPLAINS OF PAIN IN UPPER SHOULDER/CHEST AREA NEAR ARM
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Syncope
Clinical narrative: Injection occurred around 2:20pm on 9/30/2023. Symptoms of lower body numbness started later that day around 5pm. Pt went to emergency room and according to pt., he had blood work, blood pressure done and waited until 9:30 at which time he was discharged because they could not diagnose causation and told pt. to go to primary care provider as soon as possible. Pt contacted Dr and she referred him to another doctor. 3 days later pt saw Dr
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: C-reactive protein, Differential white blood cell count, Dysstasia, Fall, Full blood count
Clinical narrative: Injection occurred around 2:20pm on 9/30/2023. Symptoms of lower body numbness started later that day around 5pm. Pt went to emergency room and according to pt., he had blood work, blood pressure done and waited until 9:30 at which time he was discharged because they could not diagnose causation and told pt. to go to primary care provider as soon as possible. Pt contacted Dr and she referred him to another doctor. 3 days later pt saw Dr
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Gait inability, Hypoaesthesia, Immunisation reaction, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Injection occurred around 2:20pm on 9/30/2023. Symptoms of lower body numbness started later that day around 5pm. Pt went to emergency room and according to pt., he had blood work, blood pressure done and waited until 9:30 at which time he was discharged because they could not diagnose causation and told pt. to go to primary care provider as soon as possible. Pt contacted Dr and she referred him to another doctor. 3 days later pt saw Dr
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Respiratory pathogen panel, Urine analysis
Clinical narrative: Injection occurred around 2:20pm on 9/30/2023. Symptoms of lower body numbness started later that day around 5pm. Pt went to emergency room and according to pt., he had blood work, blood pressure done and waited until 9:30 at which time he was discharged because they could not diagnose causation and told pt. to go to primary care provider as soon as possible. Pt contacted Dr and she referred him to another doctor. 3 days later pt saw Dr
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Blood test, Hypoaesthesia
Clinical narrative: Injection occurred around 2:20pm on 9/30/2023. Symptoms of lower body numbness started later that day around 5pm. Pt went to emergency room and according to pt., he had blood work, blood pressure done and waited until 9:30 at which time he was discharged because they could not diagnose causation and told pt. to go to primary care provider as soon as possible. Pt contacted Dr and she referred him to another doctor. 3 days later pt saw Dr
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Throat tightness
Clinical narrative: Strange sensation in my throat; throat tightening; Started coughing within about 3 minutes of the injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 as dose 1, single (Lot number: HG3663, Expiration Date: 31Dec2023) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Reflux" (unspecified if ongoing), notes: Reflux; "Salt sensitivity/Blood pressure abnormal" (unspecified if ongoing), notes: Salt sensitivity. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE oral taken for blood pressure abnormal, start date: 2013; FAMOTIDINE oral taken for gastrooesophageal reflux disease, start date: 2017. The following information was reported: COUGH (non-serious) with onset 26Oct2023, outcome "unknown", described as "Started coughing within about 3 minutes of the injection"; THROAT TIGHTNESS (non-serious) with onset 26Oct2023, outcome "unknown", described as "Strange sensation in my throat; throat tightening". Therapeutic measures were not taken as a result of throat tightness, cough.  Additional information: Patient received the COVID vaccine on Thursday and had a reaction. She started having a strange sensation in throat and started coughing within about 3 minutes of the injection. When paraphrased, consumer stated, not a throat infection, a throat tightening. No lab test performed. Reporter stated that temporally, it is hard to say no, because temporally it is the direct relationship between the incident and the effect and never having had that before. In her opinion, it was directly related or it could be causally related to the, that was why, she was reporting it, she did think it was the vaccine.
Age: 53.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient scheduled a flu vaccine appointment for 11/06/23 but was checked in by pharmacy clerk for a COVID vaccine instead. A pharmacist administered COVID vaccine to patient without conducting proper screening or verification right before administration. Error was discovered at the end of the night when verifying appointment log with vaccine paperwork. Patient was then contacted that same evening to be notified of the error. Patient was concerned due to already receiving a COVID vaccine one month prior on 10/2/23. He requested to speak to supervisor or another staff pharmacist the next day. On the following day of 11/07/23, I called patient to follow up and apologize on other pharmacist's mistake. Patient reported vomiting and severe headache. He called the CDC and was anxious due to the CDC telling him they are unsure of long-term side effects and possible myocarditis may occur. Patient is not immunocompromised. He will continue to monitor and communicate with corporate.
Age: 53.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Anxiety, Headache, Inappropriate schedule of product administration, Vomiting, Wrong product administered
Clinical narrative: Patient scheduled a flu vaccine appointment for 11/06/23 but was checked in by pharmacy clerk for a COVID vaccine instead. A pharmacist administered COVID vaccine to patient without conducting proper screening or verification right before administration. Error was discovered at the end of the night when verifying appointment log with vaccine paperwork. Patient was then contacted that same evening to be notified of the error. Patient was concerned due to already receiving a COVID vaccine one month prior on 10/2/23. He requested to speak to supervisor or another staff pharmacist the next day. On the following day of 11/07/23, I called patient to follow up and apologize on other pharmacist's mistake. Patient reported vomiting and severe headache. He called the CDC and was anxious due to the CDC telling him they are unsure of long-term side effects and possible myocarditis may occur. Patient is not immunocompromised. He will continue to monitor and communicate with corporate.
Age: 40.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: patient is approximately 34 weeks gestation; she inadvertently administered a dose of Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 40-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FK54C, expiry date 13-MAR-2025) and (batch number 3C7P4, expiry date 05-MAY-2026) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy. On 01-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: she inadvertently administered a dose of Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: patient is approximately 34 weeks gestation). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 01-NOV-2023 The pharmacist reported she inadvertently administered a dose of Arexvy instead of Abrysvo to a pregnant patient, which led to vaccine exposure during pregnancy and wrong vaccine administered. The pharmacist provided lot numbers FK54C and 3C7P4, though she was unsure which was the adjuvant and which was the antigen. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Coordination abnormal, Illness, Lip swelling, Mouth swelling
Clinical narrative: Day after the vaccine, the patient stated that she woke up with swollen lips stating that the doctor advised her to go to the emergency room and attributed the reaction to the vaccine from the previous day.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness
Clinical narrative: Day after the vaccine, the patient stated that she woke up with swollen lips stating that the doctor advised her to go to the emergency room and attributed the reaction to the vaccine from the previous day.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling
Clinical narrative: Day after the vaccine, the patient stated that she woke up with swollen lips stating that the doctor advised her to go to the emergency room and attributed the reaction to the vaccine from the previous day.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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.The following information was reported: BREAST CANCER (medically significant), outcome "unknown". Therapeutic measures were taken as a result of breast cancer. Additional information:The Covid vaccine Before Covid your product gave my mother breast cancer. Luckily it was caught early but she had to have a mastectomy. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported VARIVAX which had a temperature excursion on 06/01/2023 and was short-dated with the outcome "Supported-Within 3 months" was administered on 09/18/2023 after the three-month time period. See information below per attached ar; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-JUN-2023, the varicella virus vaccine live (oka/merck) (VARIVAX) had a temperature excursion of 47 to 77 Fahrenheit degrees for 2 minutes. And the vaccine was short-dated with the outcome "Supported-Within 3 months". On 18-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #W031812, expiration date: 05-OCT-2024; strength, dose and route of administration were not provided) for prophylaxis (Product storage error). No additional adverse event or product quality complaints (PQC).
Age: 49.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects were reported; HCP calling to report that expired MMRII was inadvertently administered to a patient today, 11/1/2023. HCP reports the vaccine had not experienced any temperature excursions. No side effects were reported. No additional information/clarification prov; This spontaneous report was received by a pharmacist reporting a patient with 49 years old of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  Health Care professional (HCP) was calling to report that expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)albumin status rHA (route was not reported) (0.5 ml, lot# U022174, expiration date: 14-JUL-2023 for prophylaxis) was inadvertently administered to this patient today, (01-NOV-2023). Additionally patient received sterile diluent (MERCK STERILE DILUENT) 0.5 ml.      HCP reported the vaccine had not experienced any temperature excursions. No side effects were reported. No additional information/clarification provided. No additional Adverse Event (AE)/no Product Quality Check (PQC).
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: patient had a serious GBS reaction to their 4th Moderna mRNA vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of GUILLAIN-BARRE SYNDROME (patient had a serious GBS reaction to their 4th Moderna mRNA vaccine) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (patient had a serious GBS reaction to their 4th Moderna mRNA vaccine) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (patient had a serious GBS reaction to their 4th Moderna mRNA vaccine) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient had a serious GBS reaction to their 4th Moderna mRNA vaccine.  No treatment information was provided.  Company comment- This is a spontaneous case concerning a patient of unknown gender and age with no medical history reported, who experienced the unexpected serious (medically significant) AESI Guillain-Barre syndrome. A dose of SPIKEVAX COVID-19 VACCINE NOS, given as a fourth dose of COVID vaccine schedule, was administered. Onset date of the event was not provided, hence latency cannot be assessed.  It was reported patient had a serious GBS reaction to 4th Moderna mRNA vaccine. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid within the last 2 years; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (had covid within the last 2 years) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had covid within the last 2 years). At the time of the report, COVID-19 (had covid within the last 2 years) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that unlike the 8 people who were vaccinated and had covid within the last 2 years. Out of the 8 people 3 people received Moderna vaccine(S) and the others Pfizer. Patient nor product details were available for the 3 patients who received the Moderna vaccine. No treatment information was provided. This case is reported for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748522 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748522:Patient 2 out of 3 US-MODERNATX, INC.-MOD-2023-748525:Patient 3 out of 3
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Back pain, Chest pain, Fatigue, Injection site erythema
Clinical narrative: serious fatigue; pain; the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen; the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen; The left side of her chest, stomach and back are paining; The left side of her chest, stomach and back are paining; The left side of her chest, stomach and back are paining; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "serious fatigue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain"; VACCINATION SITE ERYTHEMA (non-serious), outcome "not recovered", VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen"; CHEST PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "The left side of her chest, stomach and back are paining". The events "serious fatigue", "pain", "the injection site is still with 2 or 3 inches of pink/ pinkness around the injection site 2 or 3 inches of pink skin still lingering though before was really red and swollen" and "the left side of her chest, stomach and back are paining" required physician office visit. Therapeutic measures were taken as a result of fatigue, vaccination site pain, vaccination site erythema, vaccination site swelling, chest pain, abdominal pain upper, back pain.  Additional information: patient reported that after vaccination she had a lot of severe fatigue for a few weeks but the beginning ahead pain, redness around the injection site and site was swollen but then she had pain in left side of chest, stomach and in left side of her back and she stated that the injection site is still pink after over a month. The doctor advised her to take ibuprofen and also cortisone (Advil). She used ibuprofen and cortisone cream for over a week .  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.