chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: 0.1ml of IPOL was injected intradermal instead of Tubersol with no reported adverse event; 0.1ml of IPOL was injected intradermal instead of Tubersol with no reported adverse event; 0.1ml of IPOL was injected intradermal instead of Tubersol with no reported adverse event; Initial information received on 06-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult male patient who was injected 0.1ml of Poliomyelitis Vaccine (Inactivated) (IPOL) IPV (VERO) intradermal instead of Tuberculin Test [Tubersol] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-May-2024, the patient received 0.1 ml of suspect IPV (VERO) Suspension for injection (lot number: V1B902M) (with an unknown strength, expiry date) via intradermal route in unknown administration site for immunization.  On 06-May-2024,  the patient was injected 0.1ml of Poliomyelitis Vaccine (Inactivated) (IPOL) IPV (VERO) intradermal instead of Tuberculin Test [Tubersol] with no reported adverse event (wrong product administered) (incorrect route of product administration) (incorrect dose administered) (n latency: same day).  Patient did not experience any additional symptoms/events.  It was reported, No signs or symptoms.  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: 24.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: patient received the first vaccine and then three days later, was given the second vaccine instead of seven days later (with no reported adverse event); Initial information received on 26-Apr-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 25 years old female patient who had received the first Rabies (Hdc) Vaccine [Imovax Rabies] and then three days later, was given the RABAVERT vaccine instead of seven days later (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2024, the patient received a (dose 1) dose of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as pre-exposure prophylaxis (immunization).  On 21-Apr-2024, the patient received a unknown (dose 2) of suspect RABAVERT not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site as Prophylactic vaccination and received the first vaccine and then three days later, was given the second vaccine instead of seven days later (with no reported adverse event) (inappropriate schedule of product administration) (latency: same day). Information on the batch number was requested.  It was reported "Pharmacist reports that a 25 year-old woman: presented for a pre-exposure IMOVAX administration on 4/18/2024. She received that immunization as day 0 dose. Then on 4/21/2024, she went to a different pharmacy and received Rabevert vaccine, 3 days after her initial IMOVAX dose. Her Day 7 IMOVAX dose was due yesterday, but when she came in to Walgreens for it, the pharmacist realized that she had received another rabies vaccine on the 21st, so he did not give a dose on 4/25".  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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administering PENTACEL to a patient and only administered the liquid portion, the DTap-IPV portion, to the patient, that the patient did not get the HIB part, with no reported adverse event; Initial information received on 26-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of unknown age and gender to whom new medical assistant was administering diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and only administered the liquid portion, the dtap-ipv portion, to the patient, that the patient did not get the hib part, 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 unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK003AA; Expiration Date :15-Mar-2025) via unknown route in unknown administration site for Prophylactic vaccination and only administered the liquid portion, the dtap-ipv portion, to the patient, that the patient did not get the hib part, with no reported adverse event (single component of a two-component product administered) (unknown 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.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only the diluent/DTAP/IPV was given. The dose was not reconstituted with the ACTHIB portion with no reported adverse event; Initial information received on 29-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 months old male patient to whom only the diluent/dtap/ipv was given. the dose was not reconstituted with the acthib portion with no reported adverse event for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 24-Apr-2024, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection lot UJP74AC, expiry date- 24-NOV-2025 via intramuscular route in the right outer thigh for immunization (strength unknown) only the diluent/dtap/ipv was given. the dose was not reconstituted with the acthib portion with no reported adverse event (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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered ACT-HIB to an infant post temperature excursion with no reported adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 12 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2024, the patient was administered a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength, dose, expiry date- not reported) via unknown route in unknown administration site for Immunization; post temperature excursion with no reported adverse event (poor quality product administered) (latency- same day). Batch/lot number requested, not available at the time of call.  Reportedly, Human Error: NO, Reason: Wire was not completely attached to the data logger Max/Lowest Temp reached: 10.76F -13hrs 50minutes 10.69F - 8hrs 21 mins    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: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: products have been administered post excursion, Max/Lowest Temp reached: 10.76F -13hrs 50minutes, 10.69F - 8hrs 21 mins with no reported adverse event; Initial information received on 30-Apr-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 meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] and diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] administered post excursion, max/lowest temp reached: 10.76f -13hrs 50minutes, 10.69f - 8hrs 21 mins with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Apr-2024, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection and meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number, strength, expiry and dose not reported) via unknown route in unknown administration site both as immunization which were administered post excursion, max/lowest temp reached: 10.76f -13hrs 50minutes, 10.69f - 8hrs 21 mins with no reported adverse event (poor quality product administered) (Latency: same day).  Reportedly, Reason: Wire was not completely attached to the data logger, Human Error: 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: 12.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered ADACEL and MENQUADFI to a patient post temperature excursion with no reported adverse event.; Initial information received on 30-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old female patient who had received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] and Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] post temperature 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-Apr-2024, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection and Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength, expiry date and lot number not reported via unknown route in unknown administration site as immunization and administered after post temperature excursion with no reported adverse event (poor quality product administered) (latency: same day). Information on the batch number was requested.   Reportedly:   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: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen and given to a patient by accident, with no reported adverse event; Initial information received on 03-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age/ gender patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] frozen by accident, 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 dose of frozen suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, suspension for injection by accident (poor quality product administered) (latency same day) (dose, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  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: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dizziness postural, Impaired work ability
Clinical narrative: PATIENT RECEIVED VACCINE ON 5/9/24 AROUND 5:20PM. CALLED THE PHARMACY ON 5/10/24 AROUND 9:00AM TO REPORT THAT SHE WAS FEELING DIZZY AND HAD BEEN FEELING DIZZY SINCE ABOUT 3:00AM THAT MORNING. WHEN  LYING DOWN IT HELPED TO EASE THE DIZZINESS BUT IF SHE WOULD TRY TO SIT OR STAND IT WOULD BECOME MORE NOTICEABLE. SHE TOOK THE DAY OFF WORK TO STAY HOME.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: There is erythema and swelling that is very warm to touch at injection site. It measures 5 cm x 6 cm. There is a raised little red bump at the center of the erythema measuring 0.3 cm in diameter.  Mom has been giving her Tylenol and Ibuprofen for discomfort/pain. Mom reported low grade fever. Treatment is to continue to monitor, and if symptoms continue to worsen, to contact the clinic for further treatment and evaluation.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: There is erythema and swelling that is very warm to touch at injection site. It measures 5 cm x 6 cm. There is a raised little red bump at the center of the erythema measuring 0.3 cm in diameter.  Mom has been giving her Tylenol and Ibuprofen for discomfort/pain. Mom reported low grade fever. Treatment is to continue to monitor, and if symptoms continue to worsen, to contact the clinic for further treatment and evaluation.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall
Clinical narrative: Resident had COVID vaccine the morning of 5/7/2024. Resident had an unwitnessed fall on 5/8 at approximately 6:00 AM. Resident was found sitting next to bed and had no obvious injury. No other adverse events or side effects noted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Full blood count normal, Neuralgia, Pain in jaw, Paraesthesia
Clinical narrative: Patient reported pins and needles starting in her feet and moving up beginning ~April (~40 days after her second shingrix vaccine).  Patient stated she is experiencing chills.  She is now having severe jaw pain and the nerve pain moves all over.  Labwork has returned normal.  Upon further questioning concern over delayed GBS due to post marketing reports of delayed GBS in patients >65 up to 42 days later.  Patient denies any problems breathing.  I counseled her to seek care if respiratory distress occurs. Denies bilateral weakness.  Advised patient to follow up with provider to rule out GBS.  Patient also has an appt with Neuro.  Currently taking low dose Gabapentin,  likely will need to be increased after evaluation.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Dysstasia, Fatigue, Gait disturbance, Malaise, Myalgia
Clinical narrative: Patient states she was given three vaccines at the time of administration, however records show that only two were administered. Patient called to report the incident on 5/10/2024, two days after administration. Patient states they are feeling incredibly ill and nearly went to the hospital last evening. Patient complains of fever, difficulty standing and walking, and overall muscle aches and fatigue.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states she was given three vaccines at the time of administration, however records show that only two were administered. Patient called to report the incident on 5/10/2024, two days after administration. Patient states they are feeling incredibly ill and nearly went to the hospital last evening. Patient complains of fever, difficulty standing and walking, and overall muscle aches and fatigue.
Age: 1.25
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pt's mother only speaks language and had brought only the sister for vaccinations today..  Pt's mother came into vaccination room where there were two separate volunteer rns  vaccinating at separate stations. Mother proceeded to sit with sister at separate vaccination station with sister and other rn vaccinator to be vaccinated and she handed pt off to other volunteer RN vaccinator. When pt's sister was vaccinated mother then transferred to other station and took pt from rn volunteer vaccinator and  that volunteer proceeded to give a different  pt's 3mos old vaccines. An Rn who pre-conferenced the sister saw what happened and stopped the vaccinator but pt received a rotateq oral vaccination.  Mother and pt and sister were taken to separate room to be counseled with interpreter  who relayed what mother should watch for  abdominal pain, intussception, nausea, vomiting and to seek medical care if child experiences any symptoms as a 1and3mos old child should not receive a rototeq. Mother then relayed to the interpreter that she would like her little boy vaccinated too. Pt was added on to our clinic scheduled and received the appropriate vaccinations for his age. Clinic manager and Vaccine Nurse manager notified.
Age: 17.0
Sex: M
Vaccine: YF
Symptoms: Altered state of consciousness, Blood glucose normal, Dizziness, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: Five minutes after vaccine administration - Diaphoresis, Pale, Dizziness, Nausea, ALOC - Administered 0.3mg Epi-Pen and activated EMS.
Age: 17.0
Sex: M
Vaccine: YF
Symptoms: Nausea, Pallor
Clinical narrative: Five minutes after vaccine administration - Diaphoresis, Pale, Dizziness, Nausea, ALOC - Administered 0.3mg Epi-Pen and activated EMS.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: computer error, selected wrong drop down.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Product confusion
Clinical narrative: vaccinator got confused. Had previously discussed vaccines given subq and then the vaccine that needed to be given was IM,  vaccinator ended up giving subq instead of IM by mistake
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash papular, Swelling
Clinical narrative: Patient has a red dark circle the size of an adult palm,  with a light red ring around the rash. Raised and swollen.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in face, lips and mouth and trouble swallowing.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Hypotension, Pallor, Syncope
Clinical narrative: Pt was administered the vaccine, after placing the band-aid pt stated they were feeling woozy and began to faint. Pt. did not fully lose consciousness breathing was maintained. Pt looked very pale and clammy, after fainting he was able to sit up and breathing was steady, pt was given water and Ems was contacted, pt did depart the scene with Ems, reporting low blood pressure.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary embolism, Resuscitation
Clinical narrative: Developed double embolism in lungs and had to be revived back .
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Gingival bleeding, Gingival disorder, Raynaud's phenomenon, X-ray
Clinical narrative: Localized autoimmune reaction- gum ulcerations, gum bleeding, delaminated gum from tooth (took 6 months to recover). Treatment: Mixture of antibiotic courses and root planing. Gentle dental hygiene regimen.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Comirnaty Covid-19 vaccine given past its expiration date. Called Pfizer to confirm next steps, they verified that in research there was no effect to stability of vaccine up to 7 days post-expiration date as long as it was kept at recommended temperatures. Called patient to make aware of issue and to ask if they were okay, left voicemail.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Comirnaty Covid-19 vaccine given past its expiration date. Called Pfizer to confirm next steps, they verified that in research there was no effect to stability of vaccine up to 7 days post-expiration date as long as it was kept at recommended temperatures. Called patient to make aware of issue and to ask if they were okay. Patient confirmed no side effects.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Comirnaty Covid-19 vaccine given past its expiration date. Called Pfizer to confirm next steps, they verified that in research there was no effect to stability of vaccine up to 7 days post-expiration date as long as it was kept at recommended temperatures. Called patient to make aware of issue and to ask if they were okay. Patient confirmed no side effects.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain/redness - left deltoid antibiotic given for 7 days
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no reports or symptoms from the patient related to the expired administration of MMR-II; expired dose of MMR-II that was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 08-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) third dose, 0.5 milliliter, subcutaneous, lot # x005836, expiration date: 03-MAY-2024, Albumin status: rHA (anatomical location and strength were not provided) for prophylaxis (expired product administered).        Confirmed no reports or symptoms from the patient related to the expired administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: Measles, Rubella and Varicella titers were measured and are low/Varicella 135; Measles, Rubella and Varicella titers were measured and are low/Measles <13.5; Measles, Rubella and Varicella titers were measured and are low/Rubella 0.97; This spontaneous report was received from Pharmacist and refers to a 21-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (either 2004 or 2005), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose number, dose, lot #, expiry date, anatomical location and route of administration were not provided); and  with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose number, dose, lot #, expiry date, anatomical location and route of administration were not provided) both as prophylaxis (reported as full course of both vaccines).  On unknown date in 2024, Measles, Rubella and Varicella titers were measured and were low: Measles was less than 13.5 (measles antibody negative), Rubella 0.97 (rubella antibody negative) and Varicella 135 (Antibody test negative). Mump titers were within normal range. The outcome of the events was not reported. No additional doses were administered to patient, but the reporter was inquiring about need for revaccination.   The causal relationship between the vaccines and the events was not reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: endlessly draggy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of laziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date and felt great).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced laziness (Verbatim: endlessly draggy). The outcome of the laziness was not reported.   It was unknown if the reporter considered the laziness to be related to Shingles vaccine.     It was unknown if the company considered the laziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2024 This case was reported by the consumer via interactive digital media. The patient felt endlessly draggy after the 2nd dose.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: his antibodies is minus 4 times higher than hers even they received the exact same shot even neither of the got COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), on 15May2021 as dose number unknown, single (Lot number: EW0180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "his antibodies is minus 4 times higher than hers even they received the exact same shot even neither of the got COVID". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller reported that he and his wife took the Pfizer COVID vaccine three years ago with lot numbers EW0180 and EW0182. Caller stated that they had their antibodies checked for the spike protein and the results came out as his antibodies is minus 4 times higher than hers even they received the exact same shot even neither of the got COVID. Caller also would like to know the normal antibody count after 3 years. Caller clarified that his wife is 4 times lower than his antibody count. Caller stated that even why after three years, his antibody levels are still high.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: his antibodies is minus 4 times higher than hers even they received the exact same shot even neither of the got COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), on 15May2021 as dose number unknown, single (Lot number: EW0180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "his antibodies is minus 4 times higher than hers even they received the exact same shot even neither of the got COVID". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller reported that he and his wife took the Pfizer COVID vaccine three years ago with lot numbers EW0180 and EW0182. Caller stated that they had their antibodies checked for the spike protein and the results came out as his antibodies is minus 4 times higher than hers even they received the exact same shot even neither of the got COVID. Caller also would like to know the normal antibody count after 3 years. Caller clarified that his wife is 4 times lower than his antibody count. Caller stated that even why after three years, his antibody levels are still high.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Laboratory test
Clinical narrative: Guillian-Barre syndrome
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Hives started 9 hours after the event and were treated with Benadryl. There was no vomiting, mouth swelling, or respiratory distress.
Age: 59.0
Sex: M
Vaccine: HEP, MENB
Symptoms: Wrong product administered
Clinical narrative: Patient received bexsero instead of heplisav
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy bone, Malaise, Pain in extremity, White blood cell count increased
Clinical narrative: Patient said he had pain in his arm and did not feel good. Ended up going to clinic and his white blood cell count was elevated. Has been elevated since the vaccine per patient. They though that he had leukemia, but that war ruled out. They are unsure of what is the cause of the elevated white blood cell count.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Tremor
Clinical narrative: My arms and hands developed a severe shakiness and inability to hold objects within 2 weeks of the first shot.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Neck pain, Pain in extremity, Peripheral swelling, Spinal pain
Clinical narrative: inflamation and pain in spine , neck and feet
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: inflamation and pain in spine , neck and feet
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Blood electrolytes normal, Cardiac stress test, Chest X-ray normal, Cough
Clinical narrative: Jaw swelling, numbing of lips, abdominal cramps, cough
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Echocardiogram normal, Electrocardiogram normal, Full blood count normal, Hypoaesthesia oral, Metabolic function test
Clinical narrative: Jaw swelling, numbing of lips, abdominal cramps, cough
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling face, Troponin normal
Clinical narrative: Jaw swelling, numbing of lips, abdominal cramps, cough
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site erythema, Myalgia, Peripheral swelling
Clinical narrative: Pt received the Shingrix vaccine on 5/7/24. She called the pharmacy in the morning on 5/11/24 to report a reaction. Her symptoms started the evening of her vaccine. Her arm swelled and she developed a 4 inch red circle below where she received the injection. She started feeling bad including muscle aches, fever, and chills. Symptoms resolve with tylenol. The local site reaction is resolving at this time but she is still experiencing the fever, chills, and muscle aches at this time, 5 days after the vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt received the Shingrix vaccine on 5/7/24. She called the pharmacy in the morning on 5/11/24 to report a reaction. Her symptoms started the evening of her vaccine. Her arm swelled and she developed a 4 inch red circle below where she received the injection. She started feeling bad including muscle aches, fever, and chills. Symptoms resolve with tylenol. The local site reaction is resolving at this time but she is still experiencing the fever, chills, and muscle aches at this time, 5 days after the vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye irritation, Headache, Insomnia, Lethargy
Clinical narrative: Left arm pain, significant headache, lethargy, insomnia, all over muscle ache, 100.5 fever and chills, burning eyes (fever like symptoms)
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Left arm pain, significant headache, lethargy, insomnia, all over muscle ache, 100.5 fever and chills, burning eyes (fever like symptoms)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Inflammation
Clinical narrative: Patient said that she developed an arthritis reaction in her knees about 5 weeks after injections. The prescriber said that the only thing she got recently was the shot and they prescribed prednisone to help with the inflammation.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pain in extremity, Sleep disorder, Swelling
Clinical narrative: Patient had adverse reaction last for almost 4 weeks.  Patient has sore arm, swelling, feel tired and can't sleep due to soreness.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Lymphoedema, Lymphoma, Peripheral swelling
Clinical narrative: Lymphedema swollen arm. Cancer.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Full blood count normal, Haematochezia, Metabolic function test normal, Polymerase chain reaction positive
Clinical narrative: Bloody stools and diarrhea began within 24 hours of oral administration of rotateq and patient had 2 emergency room visits to rule out other causes including infections or obstruction or intususception. All studies NEGATIVE except PCR positive for rotavirus at Hospital.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Rotavirus test positive, Ultrasound abdomen normal
Clinical narrative: Bloody stools and diarrhea began within 24 hours of oral administration of rotateq and patient had 2 emergency room visits to rule out other causes including infections or obstruction or intususception. All studies NEGATIVE except PCR positive for rotavirus at Hospital.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: mother consented to flu vaccine stating that child had not had a flu shot this year, however, when record was checked in system, it was noted that child just had a flu shot in march and shot had been given
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient has a large red circle at the site of injection and had antibiotic prescribed for it. The circle is warm to the touch and felt hard
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: LOCALIZED REACTION AT INJECTION SITE WITH SWELLING, IRRITATION, TENDERNESS AND ITCHING.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Somnolence, Transient ischaemic attack
Clinical narrative: The patient states she experience a seizure followed by mini-strokes 3 days following shingrix administration.  She did have flu-like symptoms (drowsiness, soreness) one day after administration.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Shingles outbreak 2 weeks post vaccine, moderate outbreak even know I had shingrix vaccine 4 yrs ago. Still with post herpetic neuralgia 3 months later.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Decreased range of motion, pain at humeral head, pain running down arm to middle finger
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Biopsy, Blood test, Colitis ulcerative, Colonoscopy, Computerised tomogram
Clinical narrative: Developed ulcerative colitis.  An autoimmune disease
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Heart rate irregular, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediately after first shot, I my heart rate went up and it felt like my heart was pounding very fast. I also had a whooshing, dizzy feeling in my head like my blood pressure had gone up. This went on for the next 24 hours. I had no insurance and was afraid I would be turned away at an emergency clinic. The next day, along with with the racing heart, I had tingling and  numbness in my face for another 12 hours or so. After this, I was afraid to get the second round. But I felt pressure from my employer and peers. Because I had no insurance or doctor, I had no one to consult about it. I decided that I would go to my 2nd round appointment and ask advice from the professionals there. This was a Govt facilitated vaccine clinic. The person who was going to administer the shot seemed surprised and had not heard of such side effects. They therefore called in an Nurse. I explained my situation and asked if it was advisable to get the 2nd shot. He was reluctant to give me information but eventually admitted that my symptoms were known side effects and callously asked "well do YOU think you should get the second shot?". I felt embarrassed and went along and got the second shot. This time in my right arm as the nurse suggested that as a solution l. They made me sit for an extra 15 minutes past the normal wait time at the medic table in the back of the room. I started to feel the numbness in my face again but was too embarrassed to speak up. When I stood up and  walked out of the building,  again my head was filled with whooshing and dizziness, much like high blood pressure events. Since then I have had a work physical where the doctor pointed out an irregular heartbeat. I have always been healthy. I recently found a primary care doctor and my heart beat seemed fine at my last visit. Never the less, I'm still concerned and will be following up with my new PC.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Immediately after first shot, I my heart rate went up and it felt like my heart was pounding very fast. I also had a whooshing, dizzy feeling in my head like my blood pressure had gone up. This went on for the next 24 hours. I had no insurance and was afraid I would be turned away at an emergency clinic. The next day, along with with the racing heart, I had tingling and  numbness in my face for another 12 hours or so. After this, I was afraid to get the second round. But I felt pressure from my employer and peers. Because I had no insurance or doctor, I had no one to consult about it. I decided that I would go to my 2nd round appointment and ask advice from the professionals there. This was a Govt facilitated vaccine clinic. The person who was going to administer the shot seemed surprised and had not heard of such side effects. They therefore called in an Nurse. I explained my situation and asked if it was advisable to get the 2nd shot. He was reluctant to give me information but eventually admitted that my symptoms were known side effects and callously asked "well do YOU think you should get the second shot?". I felt embarrassed and went along and got the second shot. This time in my right arm as the nurse suggested that as a solution l. They made me sit for an extra 15 minutes past the normal wait time at the medic table in the back of the room. I started to feel the numbness in my face again but was too embarrassed to speak up. When I stood up and  walked out of the building,  again my head was filled with whooshing and dizziness, much like high blood pressure events. Since then I have had a work physical where the doctor pointed out an irregular heartbeat. I have always been healthy. I recently found a primary care doctor and my heart beat seemed fine at my last visit. Never the less, I'm still concerned and will be following up with my new PC.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis
Clinical narrative: Arthritis,
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dairy intolerance, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Approximately 6 hours after I began with fever and chills like many others. This evolved into migraine, nausea, headaches, vomiting, extreme fatigue, numbness in feet. Still not resolved though the migraines are managed by a combination of medication daily and Botox every 3 months. Also developed dairy intolerance.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia, Vomiting
Clinical narrative: Approximately 6 hours after I began with fever and chills like many others. This evolved into migraine, nausea, headaches, vomiting, extreme fatigue, numbness in feet. Still not resolved though the migraines are managed by a combination of medication daily and Botox every 3 months. Also developed dairy intolerance.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Heart rate increased, Hot flush
Clinical narrative: 4 days post-vaccination, I began to feel pain/pressure in the left middle side of my chest. I also began to experience pain and pressure in my left carotid artery. This began out of nowhere while I was driving. When I arrived to my destination, I also began to feel hot flashes and bouts of nausea. I felt a sense of doom and anxiety as if I needed to make someone aware of my symptoms in case I passed out or experienced a heart attack. My resting HR was elevated and I couldn't relax or calm down. I made people around me aware and ended up going to my school's student health center because a nurse from my nursing department felt my HR was elevated after taking my radial pulse. At the student health center, I was monitored for 20ish minutes and they decided to call the paramedics because my RHR was elevated and was not going down. The paramedics recommended I should go to the local hospital because they observed an elevated HR that wasn't going down. Paramedics clocked a 156/(?) BP as well. My normal BP is around 113/80 and my normal RHR is between the 60s-70s. At the hospital, they detected an elevated HR and BP. My symptoms lasted 2-3 weeks from initial onset. I went to the ER 4 times after that because I couldn't get my HR down. I was feeling really anxious, my adrenaline was high, and I couldn't relax. When I would try to sleep, my eyes would shoot wide open immediately because the adrenal was just up there. It took me 4-6 weeks to feel like myself again. The HR symptoms lasted 2-3ish weeks. I stopped by my PCP's office w/out an appointment because I just couldn't take it anymore
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Sleep disorder
Clinical narrative: 4 days post-vaccination, I began to feel pain/pressure in the left middle side of my chest. I also began to experience pain and pressure in my left carotid artery. This began out of nowhere while I was driving. When I arrived to my destination, I also began to feel hot flashes and bouts of nausea. I felt a sense of doom and anxiety as if I needed to make someone aware of my symptoms in case I passed out or experienced a heart attack. My resting HR was elevated and I couldn't relax or calm down. I made people around me aware and ended up going to my school's student health center because a nurse from my nursing department felt my HR was elevated after taking my radial pulse. At the student health center, I was monitored for 20ish minutes and they decided to call the paramedics because my RHR was elevated and was not going down. The paramedics recommended I should go to the local hospital because they observed an elevated HR that wasn't going down. Paramedics clocked a 156/(?) BP as well. My normal BP is around 113/80 and my normal RHR is between the 60s-70s. At the hospital, they detected an elevated HR and BP. My symptoms lasted 2-3 weeks from initial onset. I went to the ER 4 times after that because I couldn't get my HR down. I was feeling really anxious, my adrenaline was high, and I couldn't relax. When I would try to sleep, my eyes would shoot wide open immediately because the adrenal was just up there. It took me 4-6 weeks to feel like myself again. The HR symptoms lasted 2-3ish weeks. I stopped by my PCP's office w/out an appointment because I just couldn't take it anymore
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site induration, Injection site mass, Tenderness
Clinical narrative: Painful/tender shoulder at injection site, small and hard lump at injection site
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Biopsy skin, Rash, Rash pruritic
Clinical narrative: ithcy rash over torso and legs
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Endotracheal intubation, Epiglottitis, Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Lengthy  hospitalization  severe Guillain Barre
Age: 59.0
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Fall, Mouth haemorrhage, Syncope
Clinical narrative: Patient fainted a couple of minutes after IMZ administration and fell down. There was some bleeding in her mouth. EMS was called and arrived at the scene. Patient's vitals were stable - patient elected to go home w/ family members. No hospitalization required.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Dizziness, Erythema, Lymph node pain
Clinical narrative: Thursday: PM Sorness, puffy and swollen: Friday: painful joints and stiffness all over, muscle pain, weakness in hands and accompanied with dizziness. Friday PM: muscle pain spread to shoulder places and other areas in the thorax and no longer localized. Saturday: patient began to note improvement, motrin that was started Thursday is continued. redness and swelling are also improved. Saturday night: noticeable pain in left lymph node, still experiencing discomfort and soreness on the left side.