chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Rash
Clinical narrative: rashes; Initial information received on 17-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced rashes after receiving vaccine TYPHOID VACCINE.  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 TYPHOID VACCINE produced by unknown manufacturer (lot number, strength, dose, form and expiry not reported) via oral route in unknown administration site as Immunization.  On an unknown date the patient developed a rashes (rash) (unknown latency) following the administration of TYPHOID VACCINE.  It was reported "inquire if it will be safe to administer the IM TYPHIM VI to the patient instead of the oral. She also wanted to know the difference between the oral and the IM vaccine based on composition."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Extra dose administered, No adverse event, Wrong patient received product
Clinical narrative: extra menquadfi dose was administered in lieu of the tdap dose with no reported adverse event; inadvertently administered two doses of menquadfi on the same day with no reported adverse event; Initial information received on 17-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had extra Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] dose was administered on same day in lieu of the Diphtheria, Tetanus And Acellular Pertussis Vaccine dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were administered.    On 17-Jul-2024, the patient received 2 doses of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (lot U7996BB, with unknown strength, dose and expiry) via unknown route in the left deltoid and right deltoid as prophylactic vaccination in lieu of the Diphtheria, Tetanus And Acellular Pertussis Vaccine dose (unknown strength, batch, form and expiry) with no reported adverse event (extra dose administered) and (wrong product administered) (Latency: same day).  It was reported "So the extra MenQuadfi dose was administered in lieu of the Tdap dose. However, there was no confusion between the MenQuadfi and the Tdap vaccine. What happened is that the patient's brother was also in the room, and the second dose of MenQuadfi was meant for him, but it was accidentally administered instead to the patient (who had already received one MenQuadfi dose). So, it was not the MenQuadfi and the Tdap vaccines that were confused, it was that the two brothers were confused. Was it due to similarity between the labelling of the products? No Was it due to similarity between syringes? No Is it a problem with the similarity of the names of the products? No"    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: 0.25
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pediarix (dtap-ipv-hepb) was administered to a 3-month-old patient yesterday (16jul2024). however, ipol was administered also today (17jul2024) with no reported adverse event; Initial information received on 17-Jul-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves, diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (Pediarix) was administered to a 3-month-old female patient yesterday (16jul2024). however, IPV (VERO) [IPOL] was administered also today (17jul2024) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 16-Jul-2024, the patient received an unknown dose of suspect PEDIARIX not produced by Sanofi Pasteur (strength, lot number, expiry date: unknown) via unknown route in unknown administration site as prophylactic vaccination (immunistaion).   On 17-Jul-2024, the patient received of 0.5 ml total (dose 2) dose of suspect IPV (VERO), Suspension for injection (strength: unknown) (lot: W1C831M, expiry date:23-Nov-2025) via intramuscular route in the left thigh as immunization and pediarix (dtap-ipv-hepb) was administered to a 3-month-old patient yesterday (16jul2024). however, ipol was administered also today (17jul2024) with no reported adverse event (extra dose administered) (latency: same day).  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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: not getting the correct vaccine using the wrong diluent of sterile water, only the HIB portion was injected, but the HIB portion was mixed with the wrong diluent, with no reported adverse event; not getting the correct vaccine using the wrong diluent of sterile water, only the HIB portion was injected, but the HIB portion was mixed with the wrong diluent, with no reported adverse event; Initial information received on 17-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] that not getting the correct vaccine using the wrong diluent of sterile water, only the hib portion was injected, but the hib portion was mixed with the wrong diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 16-Jul-2024, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine  (Powder and suspension for suspension for injection) (lot UK037AA , Expiry date: 30-Jun-2025, strength was unknown) via unknown route in the right thigh for Prophylactic vaccination (Immunization) and not getting the correct vaccine using the wrong diluent of sterile water, only the hib portion was injected, but the hib portion was mixed with the wrong diluent, with no reported adverse event (product preparation error) and (single component of a two-component product administered) (latency : same day).   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: 31.0
Sex: U
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: accidentally gave IPOL instead of PPD intradermally twice with no reported adverse event; accidentally gave IPOL instead of PPD intradermally twice with no reported adverse event; accidentally gave IPOL instead of PPD intradermally twice with no reported adverse event; Initial information received on 17-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 31 years old patient of an unknown gender who accidentally received Poliomyelitis Vaccine (Inactivated) Ipv (Vero) (Ipol)  instead of ppd intradermally twice with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jul-2024, the patient received 0.1 (unit unknown) total of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (with an unknown expiry date, strength, lot number) via intradermal route in unknown administration site for immunisation. On 15-Jul-2024, patient also received 0.1 (unit unknown) total dose of vaccine Suspension for injection (with an unknown expiry date, strength, lot number) via intradermal route in unknown administration site for immunisation.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  On 03-Jul-2024, the patient accidentally received Poliomyelitis Vaccine (Inactivated) instead of ppd intradermally twice with no reported adverse event (incorrect route of product administration) (latency: same day).  On 15-JUL-2024, the patient accidentally received Poliomyelitis Vaccine (Inactivated) instead of ppd intradermally twice with no reported adverse event (wrong product administered) (extra dose administered) (latency: 12 days).   Reportedly, They wanted to know if there are any harms or adverse events they should watch out for.  They wanted to know if there are any harms or adverse events they should watch out for. No additional information was obtained. Follow up to be defined by PV (Pharmacovigilance).   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: 36.0
Sex: M
Vaccine: FLUC3
Symptoms: Dizziness, Posture abnormal
Clinical narrative: Dizziness / Lightheadness; Patient slumped to floor from chair; This spontaneous case, initially received on 10-Jul-2024, was reported by a health professional and concerns an adult male patient.  The patient had no known drug allergies.   Administration of company suspect drug(s): On 11-Nov-2023, the patient received Flucelvax Quadrivalent (influenza vaccine inact sag 4v) for an unknown indication. Route of administration: Intramuscular, Anatomical location: Left arm. Lot number: 944483.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 11-Nov-2023, after vaccination, the patient experienced Dizziness / lightheadedness (Medically Significant, outcome: Recovered / Resolved, stop date: 11-Nov-2023) and slumped to floor from chair (Medically Significant, outcome: Recovered / Resolved, stop date: 11-Nov-2023). The patient was immediately able to sit back down with help. No injury, breathing an puls was normal, no flushing, rash or swelling. The patient was monitored for about 30 minutes and stated he felt fine after.    Non-drug treatment/Other action taken:  Flucelvax Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide a causality assessment. The case was assessed as non-serious.; Reporter's Comments: Causality: Due to suggestive temporal relationship, causality for the suspect vaccine is assessed as possibly related for the event of dizziness. Fall is assessed as not related since it was a consequence of a dizziness.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Syncope, Tremor
Clinical narrative: Patient fainted for a few seconds and begin to shake after administration of HPV9 vaccine approximately 3 mins after administration. Pt also reported numbness and stiffness throughout body. Pt vs took and monitored. Pt offered juice and fluids after. PCP notified and pt assessed in clinic by medical staff including primary care provider. Pt stable and reported feeling better before discharge.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Salivary hypersecretion, Swollen tongue
Clinical narrative: After the patient received the vaccination  she waited to be observed for adverse reactions. Within 5 minutes of sitting she experienced a metallic taste and excessive saliva production. I decided to wait with her in the immunization room to monitor her. I gave her a dose of oral Benadryl. She said her tongue felt slightly swollen. I readied an EpiPen and told her I would call EMS, but she refused saying she was fine.  I asked if she could breath and swallow, and she said yes. She then left with her family and I instructed them to monitor her and administer the Epipen if her condition worsened.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain
Clinical narrative: Redness and pain at injection site. Pain radiated up to neck. Patient called clinic to report symptoms on 7/19/24. Nurse advised going to urgent care or ER if it is an allergic reaction. Patient used hydrocortisone cream on the area. Patient reports symptoms are improving when I called on 7/23/24. No signs/symptoms of anaphylaxis.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Decreased appetite, Injection site erythema, Lethargy, Pyrexia
Clinical narrative: Per mom, within an hour of receiving vaccine, patient had all these symptoms: vomiting, fever, chills, no appetite, lethargy. This continued for a week with very little ability to hold down food or water, not much respite from the fever, and very interrupted sleep. A week later, the injection site (which had previously looked fine) flared into a huge red bullseye. Also experienced rapid breathing within the 1st hour and for the first week.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Respiratory rate increased, Sleep disorder, Vomiting
Clinical narrative: Per mom, within an hour of receiving vaccine, patient had all these symptoms: vomiting, fever, chills, no appetite, lethargy. This continued for a week with very little ability to hold down food or water, not much respite from the fever, and very interrupted sleep. A week later, the injection site (which had previously looked fine) flared into a huge red bullseye. Also experienced rapid breathing within the 1st hour and for the first week.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect Vaccine was given on 07/23/2024 at around 5:00 pm. No adverse effect noted till now 7/23/2024 6:50 pm
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Incorrect Hepatitia A (adult dose) given. No adverse effect noted so far.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions.  Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions. Vaccine was administered outside of the timeframe recommended by the manufacturer
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event. After administering Varivax, patient said he received MMR a day before at a different facility. Patient was advised to take Tylenol around the clock just to prevent potential symptoms.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness
Clinical narrative: after vaccinations, patient felt faint.  patient never lost consciousness, was always able to respond.  But did lie down and applied ice packs to head and wrists.  was able to then sit up, sit in chair, then stand up.  whole process lasted about 10 minutes.  patient felt confident she could drive herself home
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of thetimeframe recommended by the manufacturer.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted.  Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted.  Vaccine was administered outside of the timeframe recommended by the manufacturer
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted.  Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 67.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Blood pressure increased, Muscular weakness, Musculoskeletal discomfort, Neck pain
Clinical narrative: patient was administered vaccines approximately at 6pm on 07/22/2024. Patient compalined of weakness in the legs and neck pain/discomfort. Patient was asked to remain seated for observation.  A family member was called to come and pick her up due to her weakness of legs compalint.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse reaction. Vaccine was administered outside of the timeframe recommended by the manufacturer .
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reaction noted. vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Seizure
Clinical narrative: Child received vaccine while sitting in shot room.  He got up and walked outside to car with family .  Mother said child seemed did seem preoccupied while walking to care.  Once child was buckled into car, mother said child started sweating and then lowered his head and had a seizure.  This happened minutes after receiving the vaccine.   Mother immediately called 911.  Family went to ER with child.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted.  Vaccine was administered outside of the timeframe recommended by the manufacturer
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine administered outside of the timeframe recommended by the manufacturer.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction noted. vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral normal, Dyspraxia, Echocardiogram, Electrocardiogram, Immunisation reaction
Clinical narrative: PFIZER #1 9/10/2021 PFIZER #2 10/1/2021.  PATIENT DEVELOPED SPEECH APRAXIA.  POST-EXERTIONAL MALAISE.  CT ANGIOGRAM OF HEAD WAS NEGATIVE.  DIAGNOSIS:  COVID-19 VACCINE INDUCED SPEECH APRAXIA.  TREATED WITH IVERMECTIN X 90 DAYS, NICOTINE PATCH, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Malaise
Clinical narrative: PFIZER #1 9/10/2021 PFIZER #2 10/1/2021.  PATIENT DEVELOPED SPEECH APRAXIA.  POST-EXERTIONAL MALAISE.  CT ANGIOGRAM OF HEAD WAS NEGATIVE.  DIAGNOSIS:  COVID-19 VACCINE INDUCED SPEECH APRAXIA.  TREATED WITH IVERMECTIN X 90 DAYS, NICOTINE PATCH, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED . Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions noted. Vaccine was administered outside of the timeframe recommended by the manufacturer.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Gait disturbance, Hyperhidrosis, Pallor
Clinical narrative: pt received vaccine, sat for a few minutes, attempted to walk to get receipt, began stumbling, lightheaded, pale, sweating
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: muscle stiffness in the shoulder area; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle stiffness (Verbatim: muscle stiffness in the shoulder area). The outcome of the muscle stiffness was resolved.   It was unknown if the reporter considered the muscle stiffness to be related to Shingrix.     It was unknown if the company considered the muscle stiffness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR085778   Additional Information: GSK Receipt Date: 09-JUL-2024 The patient reports that he was administered the 1st dose of Shingrix and experienced muscle stiffness in the shoulder area, but it was resolved in one or two days. The reporter consented for follow up was not requested.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Immunisation reaction, Muscle atrophy, Rash, Skin indentation, X-ray
Clinical narrative: pt reports having severe fatigue and muscular atrophy
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Fatigue, Muscle atrophy
Clinical narrative: pt reports having severe fatigue and muscular atrophy
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia, Rash, Skin burning sensation
Clinical narrative: Fever; Chills; Sore throat; burning skin from head to pelvis; This non-serious case was reported by a consumer and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number NDC:58160-0823-11, expiry date 21-APR-2026) for prophylaxis.   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 12-JUN-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), sore throat (Verbatim: Sore throat) and burning skin (Verbatim: burning skin from head to pelvis). The outcome of the fever, chills, sore throat and burning skin were not resolved.   It was unknown if the reporter considered the fever, chills, sore throat and burning skin to be related to Shingrix.     It was unknown if the company considered the fever, chills, sore throat and burning skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2024 The patient was self-reported this case. The patient received Shingrix vaccine and experienced fever, chills, sore throat and burning skin from head to pelvis. The patient needed help/advise for ongoing symptoms as they had persisted for 28 days and now at the time of reporting they are not easing up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Oropharyngeal pain, Pyrexia, Skin burning sensation
Clinical narrative: Fever; Chills; Sore throat; burning skin from head to pelvis; This non-serious case was reported by a consumer and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number NDC:58160-0823-11, expiry date 21-APR-2026) for prophylaxis.   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 12-JUN-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), sore throat (Verbatim: Sore throat) and burning skin (Verbatim: burning skin from head to pelvis). The outcome of the fever, chills, sore throat and burning skin were not resolved.   It was unknown if the reporter considered the fever, chills, sore throat and burning skin to be related to Shingrix.     It was unknown if the company considered the fever, chills, sore throat and burning skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2024 The patient was self-reported this case. The patient received Shingrix vaccine and experienced fever, chills, sore throat and burning skin from head to pelvis. The patient needed help/advise for ongoing symptoms as they had persisted for 28 days and now at the time of reporting they are not easing up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test abnormal, Breast pain, Burning sensation, Chills, Dry skin
Clinical narrative: Fever; Chills; Sore throat; burning skin from head to pelvis; This non-serious case was reported by a consumer and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number NDC:58160-0823-11, expiry date 21-APR-2026) for prophylaxis.   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 12-JUN-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), sore throat (Verbatim: Sore throat) and burning skin (Verbatim: burning skin from head to pelvis). The outcome of the fever, chills, sore throat and burning skin were not resolved.   It was unknown if the reporter considered the fever, chills, sore throat and burning skin to be related to Shingrix.     It was unknown if the company considered the fever, chills, sore throat and burning skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2024 The patient was self-reported this case. The patient received Shingrix vaccine and experienced fever, chills, sore throat and burning skin from head to pelvis. The patient needed help/advise for ongoing symptoms as they had persisted for 28 days and now at the time of reporting they are not easing up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Inflammatory marker increased, Malaise, Post herpetic neuralgia
Clinical narrative: Fever; Chills; Sore throat; burning skin from head to pelvis; This non-serious case was reported by a consumer and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number NDC:58160-0823-11, expiry date 21-APR-2026) for prophylaxis.   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 12-JUN-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), sore throat (Verbatim: Sore throat) and burning skin (Verbatim: burning skin from head to pelvis). The outcome of the fever, chills, sore throat and burning skin were not resolved.   It was unknown if the reporter considered the fever, chills, sore throat and burning skin to be related to Shingrix.     It was unknown if the company considered the fever, chills, sore throat and burning skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2024 The patient was self-reported this case. The patient received Shingrix vaccine and experienced fever, chills, sore throat and burning skin from head to pelvis. The patient needed help/advise for ongoing symptoms as they had persisted for 28 days and now at the time of reporting they are not easing up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Fever; Chills; Sore throat; burning skin from head to pelvis; This non-serious case was reported by a consumer and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number NDC:58160-0823-11, expiry date 21-APR-2026) for prophylaxis.   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On 12-JUN-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), sore throat (Verbatim: Sore throat) and burning skin (Verbatim: burning skin from head to pelvis). The outcome of the fever, chills, sore throat and burning skin were not resolved.   It was unknown if the reporter considered the fever, chills, sore throat and burning skin to be related to Shingrix.     It was unknown if the company considered the fever, chills, sore throat and burning skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2024 The patient was self-reported this case. The patient received Shingrix vaccine and experienced fever, chills, sore throat and burning skin from head to pelvis. The patient needed help/advise for ongoing symptoms as they had persisted for 28 days and now at the time of reporting they are not easing up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergic reaction to excipient, Hypersensitivity
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; LIPITOR taken for hyperlipidaemia, stop date: 17Jul2024. Past drug history included: Polyethylene glycol, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "not recovered" and all described as "COVID-19". The clinical course was reported as follows: The patient reported to have had multiple doses of Comirnaty. The patient was currently suffering from COVID-19 and nirmatrelvir, ritonavir (PAXLOVID) was prescribed on 18Jul2024 for a positive COVID-19 test but had to discontinue it on 19Jul2024 due to a full body allergic rash. The patient underwent the following laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021330189 same patient, different dose and event;US-PFIZER INC-202400220502 same patient, different dose and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; LIPITOR taken for hyperlipidaemia, stop date: 17Jul2024. Past drug history included: Polyethylene glycol, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "not recovered" and all described as "COVID-19". The clinical course was reported as follows: The patient reported to have had multiple doses of Comirnaty. The patient was currently suffering from COVID-19 and nirmatrelvir, ritonavir (PAXLOVID) was prescribed on 18Jul2024 for a positive COVID-19 test but had to discontinue it on 19Jul2024 due to a full body allergic rash. The patient underwent the following laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021330189 same patient, different dose and event;US-PFIZER INC-202400220502 same patient, different dose and event;
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Customer called and reported that a dose of VARIVAX expired on 7/13/2024 and was administered on 7/15/2024. The dose had no temperature excursions. No PQC reported. No additional information provided.; This spontaneous report has been received from other (reported as technician), referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 15-JUL-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection at the dose of one dosage form (reported as a dose) for prophylaxis (strength, exact dose, frequency, route of administration, and anatomical injection site were not reported; lot number W022294, has been verify to be a valid lot number for varicella virus vaccine live (Oka/Merck) with an expiration date reported and established as 13-JUL-2024) (Expired product administered). The dose had no temperature excursions. No additional information provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Poor peripheral circulation, Sensory loss
Clinical narrative: Sudden loss of circulation and sensation in hands and feet
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cytomegalovirus test positive, Dizziness, Epstein-Barr virus test
Clinical narrative: I had fever, weakness, flu-like symptoms for 2 weeks after resulting in me revisiting my doctor on June 11th. I complained of extreme tiredness, fever, chills, dizziness, feeling like I was going to faint. Lab results came back showing elevated liver enzymes. On 6/14/24, I visited the emergency room with persistent symptoms which now included extreme itchiness. I advised every medical professional that my symptoms started after the 2nd dose of the Shindrix vaccine. Originally misdiagnosed with HIV, I insisted on being tested for anything possibly related to nucleosisthe Shingles virus. Results came back positive for Mononucleosis and a week later, on 6/21/24, positive for CMV. I continue to experience symptoms which include sore throat, swollen glands, tiredness and muscle aches.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hepatic enzyme increased, Influenza like illness, Lymphadenopathy, Mononucleosis heterophile test positive
Clinical narrative: I had fever, weakness, flu-like symptoms for 2 weeks after resulting in me revisiting my doctor on June 11th. I complained of extreme tiredness, fever, chills, dizziness, feeling like I was going to faint. Lab results came back showing elevated liver enzymes. On 6/14/24, I visited the emergency room with persistent symptoms which now included extreme itchiness. I advised every medical professional that my symptoms started after the 2nd dose of the Shindrix vaccine. Originally misdiagnosed with HIV, I insisted on being tested for anything possibly related to nucleosisthe Shingles virus. Results came back positive for Mononucleosis and a week later, on 6/21/24, positive for CMV. I continue to experience symptoms which include sore throat, swollen glands, tiredness and muscle aches.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: I had fever, weakness, flu-like symptoms for 2 weeks after resulting in me revisiting my doctor on June 11th. I complained of extreme tiredness, fever, chills, dizziness, feeling like I was going to faint. Lab results came back showing elevated liver enzymes. On 6/14/24, I visited the emergency room with persistent symptoms which now included extreme itchiness. I advised every medical professional that my symptoms started after the 2nd dose of the Shindrix vaccine. Originally misdiagnosed with HIV, I insisted on being tested for anything possibly related to nucleosisthe Shingles virus. Results came back positive for Mononucleosis and a week later, on 6/21/24, positive for CMV. I continue to experience symptoms which include sore throat, swollen glands, tiredness and muscle aches.
Sex: F
Vaccine: RSV
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This non-serious case was reported by a consumer and described the occurrence of swollen lymph nodes in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 58160-0848-11) for prophylaxis.   Concomitant products included umeclidinium bromide (Incruse Ellipta), evolocumab (Repatha), montelukast and levocetirizine.   On 28-JUN-2024, the patient received Arexvy (intramuscular) .5 ml. On 30-JUN-2024, 2 days after receiving Arexvy, the patient experienced swollen lymph nodes (Verbatim: Swollen lymph nodes). The outcome of the swollen lymph nodes was not resolved.   It was unknown if the reporter considered the swollen lymph nodes to be related to Arexvy.     It was unknown if the company considered the swollen lymph nodes to be related to Arexvy.   Additional Information: GSK Receipt date: 15-JUL-2024 A reporter reported that she called her doctor and was told it was a normal side effect (Swollen lymph nodes) and the symptoms were not treated.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second dose was administered in less than 1 month after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 24-APR-2024, the patient received the 2nd dose of Shingrix. On 24-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: the second dose was administered in less than 1 month after the first dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2024 The pharmacist had a question regarding the Shingrix vaccine, the pharmacist wanted to know if the vaccine had been taken, the 2nd dose of Shingrix was administered in less than 1 month after the 1st dose, in exact 20 days earlier than the recommended time interval, which led to shortening of the vaccination schedule. The pharmacist asked was the vaccine considered valid or should the patient be revaccinated. The patient was not immunocompromised and had the recommended age for administration.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to reconstituting ACT-HIB with sterile water with no reported adverse event; Initial information received on 16-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12-month-old female patient and is reported inappropriate use due to reconstituting HIB (PRP/T) vaccine [ACT-HIB] with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); and pneumococcal vaccine conj 20V (CRM197) (Prevnar 20) for Prophylactic vaccination (immunisation).  On 09-Jul-2024, the patient received a 0.5 ml dose (dose 4) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UJ978AA and expiry date: 08-Nov-2024 via intramuscular route in the left thigh as Immunization and is reported inappropriate use due to reconstituting act-hib with sterile water with no reported adverse event (product preparation error) (latency: on same day).   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: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, C-reactive protein normal, Electromyogram abnormal, Impaired quality of life, Neuropathy peripheral
Clinical narrative: a few hours after vaccine,(that night,)awoke with excruciating pain and burning in feet and legs-never had before- persisting to this day and causing sleep disturbances and taking joy out of life
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Sleep disorder
Clinical narrative: a few hours after vaccine,(that night,)awoke with excruciating pain and burning in feet and legs-never had before- persisting to this day and causing sleep disturbances and taking joy out of life
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Migraine, Tremor
Clinical narrative: Migraine headache with aura at 10:30am, uncontrollable body tremors, began at 10:00pm
Age: 45.0
Sex: F
Vaccine: TBE
Symptoms: Facial spasm, Muscle spasms
Clinical narrative: Hemifacial spasms (left side upper lip that spread to left cheek) with increasing frequency, from once daily to multiple times throughout everyday. Then a  sudden drop in occurrence one week following its onset, coinciding with sudden muscle spasm at lower extremities.