chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: It almost killed her; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (hospitalization, life threatening), outcome "unknown", described as "It almost killed her". The patient was hospitalized for near death experience (hospitalization duration: 90 day(s)). Clinical course: Reporter stated that his fiance was in the hospital for 3 months, she had the Pfizer vaccine and it almost killed her, she's 27.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: HPV9
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: No symptoms reported. No injuries reported; Patient who was administered their first dose of GARDASIL 9 on 9/3/2024 but did not receive the full dose due to syringe leakage; Patient who was administered their first dose of GARDASIL 9 on 9/3/2024 but did not receive the full dose due to syringe leakage; Patient who was administered their first dose of GARDASIL 9 on 9/3/2024 but did not receive the full dose due to syringe leakage; This spontaneous report was received from a registered nurse concerning to a patient of unspecified age and gender. Their pertinent medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.    On 03-SEP-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection 1DS X 10 syringes, lot #Y003462, expiration date: 23-APR-2026, 0.5 milliliter/dose, administered for prophylaxis (route of administration and anatomical location were not provided) by a health care professional. However, they did not received the full dose due to syringe leakage around the needle hub  (also reported as while giving the injection, the caller noticed the vaccine leaking from the syringe) (syringe needle was affected at the syringe hub and syringe tip where needles attach), but the nurse stated that they could not visually see a defect, they reported that the needle just leaked during administration; both physician and nurse checked the needle to ensure that it was attached properly and could not determine cause of leakage (Accidental underdose) (Poor quality device used) (Syringe issue). Nevertheless, no symptoms or injuries were reported. Moreover, the nurse stated that the suspect vaccine had not been dropped, the tray was intact at receival, it had been received with the cellophane cover intact and completely sealed, the syringes carton was not damaged prior to use, and was not available for retrieval as it had been discard after administration.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Iron binding capacity total, Lipids, Serum ferritin, Serum ferritin increased
Clinical narrative: the Ferritin/ the highest normal is 150 and hers is 250/ferritin level increased; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Aug2024 as dose 1, single (Lot number: LM2222) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6201, Expiry date: 30Jun2021, Anatomical Location: Arm left.), administration date: 09Feb2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "sores in my mouth code", "fast heart beat", "Dizziness", "Weakness", "severe joint pain", "Headache", "Fever", "Feeling unwell/felt lousy".  The following information was reported: SERUM FERRITIN INCREASED (non-serious) with onset 30Aug2024, outcome "unknown", described as "the Ferritin/ the highest normal is 150 and hers is 250/ferritin level increased". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she took the 24/25 Covid vaccination on Thursday, 29Aug2024 and on Friday 30Aug2024 she had Ferritin, Iron, a TIBC and lipid panel test done. Everything came back normal except the Ferritin. Stated the highest normal was 150 and hers was 250. Her physician called her yesterday (03sep2024) very concerned and doesn't know where that was coming from. Patient thinks it was possible that it may had been the Covid 19 vaccination. Stated she had side effects from every covid vaccination anyways and that was the first time she didn't have a reaction, but her ferritin was 250. She also stated she would like to have a decent informative conversation with her primary doctor if Covid vaccine can affect Ferritin levels. Stated she had no thyroid. She stated at this time declined to report. Patient stated she got the Pfizer 24/25 Covid vaccine 12 year plus injectable. She wanted to know what was going on and have a conversation with her physician. She felt that could possibly be that and would ask for a repeat test because she doesn't want a liver biopsy if she doesn't have to. Stated she researches everything.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263920 Same reporter/product, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, Post-acute COVID-19 syndrome
Clinical narrative: she had long COVID; she got COVID; she got COVID; feel 'flu-like' for a day; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), for Covid-19 immunisation, reaction(s): "she received the first two Pfizer COVID vaccines it made her feel 'flu-like' for a day". The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Dec2023, outcome "not recovered" and all described as "she got COVID"; POST-ACUTE COVID-19 SYNDROME (hospitalization, medically significant) with onset Jan2024, outcome "not recovered", described as "she had long COVID"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "feel 'flu-like' for a day". Clinical course: Caller was a 73-year-old female. Caller states that she had two COVID vaccinations. Vaccinations before she can get the third one past December, she had long COVID and she had long COVID ever since. Caller stated, "she have had the fatigue part of long COVID and a number of other issues that are pretty debilitating, she was kind of- house-bound." Caller was aware that a new vaccine has come out and she wants to know if people with long COVID was getting the new Pfizer COVID vaccine. Caller added that when she received the first two Pfizer COVID vaccines it made her feel 'flu-like' for a day. Caller clarified that when she got the first two vaccinations, she had a little reaction to them and before she can get the third one last December, she got COVID and turned into long COVID, she was in the hospital for a few days, and she was still experiencing long COVID since January. Caller wants to know if she can get the new Pfizer COVID vaccine.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400253009 same patient/product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "got COVID". Therapeutic measures taken as a result of vaccination failure, covid-19 includes Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: received a dose of pfizer at 22 weeks pregnant; COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-773337.  A female patient (pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 22 weeks pregnant at the time of exposure to BNT162b2 omicron (kp.2). The patient was 22 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Aug2024, outcome "not recovered" and all described as "COVID 19"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "received a dose of pfizer at 22 weeks pregnant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Aug2024) Positive. Clinical course: The reporter stated that (withheld) ears were all clogged since just had COVID-19. Received a dose of Pfizer at 22 weeks pregnant. Patient tested positive for Covid on 30Aug2024 and had received Pfizer vaccines.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Throat tightness
Clinical narrative: throat closed up; could not breathe/problems with breathing; extreme reactions/allergic reaction to mRNA vaccines; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00176.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2023 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Novavax (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: THROAT TIGHTNESS (medically significant), outcome "unknown", described as "throat closed up"; DYSPNOEA (medically significant), outcome "unknown", described as "could not breathe/problems with breathing"; ALLERGY TO VACCINE (medically significant), outcome "unknown", described as "extreme reactions/allergic reaction to mRNA vaccines".  Clinical course: The patient reported that she was one of the successful cases with the Novamax vaccine of not having side effects. She had really bad side effects from Moderna and the Pfizer. She was trying to make sure that this season was going to be the same type of vaccine that she had for last year. She stated that her last Novavax vaccine was last 30Oct2023 at (Withheld). She added that it was the best thing that ever happened to her. She wanted to know if there was anything different about it or if it was the same make up in comparison to last year vaccine. She was also querying for the difference between Novamax from the Pfizer and Moderna that she had, because those made her throat closed up that she could not breathe. She had extreme reactions but not from Novamax. It was between not taking the vaccine at all, or if Novamax was in any way different, that can cause her problem again. The patient confirmed that she did not have any side effects from Novavax 2023-2024 formula. She further stated that her Health Care provider does not believe in any of this and he ended up getting COVID four different times, and he was vaccinated. She does not know what he was vaccinated with. Consumer stated that she was concerned with presenting problems with breathing. She also reported that she had allergic reaction to mRNA vaccines.   Batch/lot number is not provided, and it cannot be obtained.
Age: 11.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of Flublok to a patient less than 18 years old (with no reported adverse event); Initial information received on 04-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 11 years old male patient who received Influenza Trivalent Recombinant Vaccine [Flublok Tiv] who was less than 18 years old (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Sep-2024, the 11 year old patient received dose 0.5 ml once Influenza Trivalent Recombinant Vaccine Solution for injection (lot-U8447AA, expiry date: 01-MAY-2025) (with no reported adverse event) (product administered to patient of inappropriate age) via intramuscular route in the deltoid nos (not otherwise specified) (latency-same day) for Immunization.  Reportedly, Pharmacist reported that the patient received no concomitant vaccines.   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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: medical assistant used sterile water to dilute the acthib powder and administered it to a child, with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves unknown age and gender patient and reporter reported that medical assistant used sterile water to dilute the HIB (PRP/T) vaccine [ACT-HIB] powder and administered it to a child, with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 30-Aug-2024, the patient received a standard dose of 0.5 ml suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot UJ978AA and expiry date 08-Nov-2024) once via unknown route in unknown administration site for immunization and medical assistant used sterile water to dilute the HIB (PRP/T) vaccine [ACT-HIB] powder and administered it to a child, with no reported adverse event (product preparation error) (latency same day).  Reportedly, Clinic manager said there's no reaction with the child and everything's okay but she knows that for the efficacy of the vaccine, it may need to be repeated  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: IPV
Symptoms: No adverse event, Poor quality product administered, Product administration error, Product storage error
Clinical narrative: open ipol exposed to 8.8C for 10 minutes and 8.3C upto 9 minutes with no reported adverse event; inappropriate use due to administration post-excursion with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves 2 patients of unknown age and unknown gender and reporter reported vaccine IPV (VERO) [IPOL] was exposed to 8.8c for 10 minutes and 8.3c up to 9 minutes with no reported adverse event and inappropriate use due to administration post-excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller reported that opened IPV (VERO) Suspension for injection (lot- W1C741M, expiry date:17-Nov-2025) (unknown dosage, route and strength) was exposed to 8.8c for 10 minutes and 8.3c up to 9 minutes with no reported adverse event (product storage error) and inappropriate use due to administration post-excursion with no reported adverse event (poor quality product administered)  (latency-same day) in unknown administration site for immunization.  Reportedly, there was a Previous Excursion and human error was unknown.   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: 29.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: got 2 boosters of the IPOL vaccine/ she got another dose of booster one month later, with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 29 years old female patient who got 2 boosters of the IPV (VERO) [IPOL]/ she got another dose of booster one month later, 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 Typhoid vaccine polysacch Vi (Typhim vi) for Immunisation.  On 05-Aug-2024, the patient received a standard Booster dose of 0.5 ml of suspect IPV (VERO) Suspension of injection of standard indication, and she got another dose of standard booster one month later on 04-Sep-2024 (lot number- W1A101M and expiry date- 10-Feb-2025) via intramuscular route in the left deltoid for Immunization with no reported adverse event (extra dose administered) (latency- 1 day).  Reportedly, Pharmacist said that patient came and got the booster of IPOL because patient was travelling and patient got another dose of booster one month later. Pharmacist said that  the patient was vaccinated maybe 30 years ago in the 90s and just needing for one booster for travel purpose. Pharmacist said that the patient cannot confirm what polio was given to her in the 90s but it was maybe a series.  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 and Regulatory Authority 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: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Muscular weakness, Syncope
Clinical narrative: Arm weakness and fainting
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Product administration error, Vaccination error
Clinical narrative: Patient in clinic for Well Child Visit. Received Kinrix, Proquad and Varicella vaccines. Error in administration identified.  Consulted with Dr as to administration of Proquad instead of MMR vaccine.  Provider notified that patient received two doses of varicella vaccine; provider advised that this will likely not be an issue.  Informed parent of patient that child received two doses of varicella vaccine.  Parent of patient verbalized understanding of vaccines error.  Parent of patient was provided record that reflected vaccines given in clinic.  Advised parent of patient to provide child with Tylenol or Ibuprofen for any arm soreness or low grade fever.  Advised to seek emergency care if any severe allergic reactions such as hives, severe rash, trouble breating or swelling of the face, tongue, or throat occurs.  Contact Pediatrician or go to ED if fever over 102 degrees develops. Nurse Supervisor attempted to contact representative for guidance; no response on 9/11/2024.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Arthralgia, Blood test normal, Chest pain, Cough, Fatigue
Clinical narrative: All over muscle and Joint pain, early on cough and some chest pain, extreme tiredness and weary. unable to sleep
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Myalgia, Sleep disorder
Clinical narrative: All over muscle and Joint pain, early on cough and some chest pain, extreme tiredness and weary. unable to sleep
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Choking, Cough, Gaze palsy, Infant irritability, Nausea
Clinical narrative: Infant was at baseline day prior and morning of 4-month well visit. She  received her 4-month vaccines at 10 AM at her PCP office.  Around 5 PM, she became fussy and parents attempted to give her Tylenol for temperature of 102.4F.  She vomited the Tylenol dose.  The second attempt with oral Tylenol  around 10-11PM the infant coughed, choked and her whole body shook briefly with eye deviated. She appeared to stop breathing for 3-5 seconds.  Parents took her to the ER for high fever and the body shaking.  At the ER, the medical team attempted a urine sample due to unable to cath and the bagged urine was not a sufficient sample.  There was concern for UTI given fever, nausea and vomiting. She was discharged home with a prescription for Zofran and Cefdinir (to treat unconfirmed UTI).  She was then seen back her PCP office the next morning. She was able to tolerate Tylenol and breastmilk at subsequent feedings. Family didn't start Cefdinir. Her fever resolved within 24 hours from onset and  no new systems developed nor repeat episodes of choking or body shaking.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Pyrexia, Tremor, Urine analysis, Vomiting
Clinical narrative: Infant was at baseline day prior and morning of 4-month well visit. She  received her 4-month vaccines at 10 AM at her PCP office.  Around 5 PM, she became fussy and parents attempted to give her Tylenol for temperature of 102.4F.  She vomited the Tylenol dose.  The second attempt with oral Tylenol  around 10-11PM the infant coughed, choked and her whole body shook briefly with eye deviated. She appeared to stop breathing for 3-5 seconds.  Parents took her to the ER for high fever and the body shaking.  At the ER, the medical team attempted a urine sample due to unable to cath and the bagged urine was not a sufficient sample.  There was concern for UTI given fever, nausea and vomiting. She was discharged home with a prescription for Zofran and Cefdinir (to treat unconfirmed UTI).  She was then seen back her PCP office the next morning. She was able to tolerate Tylenol and breastmilk at subsequent feedings. Family didn't start Cefdinir. Her fever resolved within 24 hours from onset and  no new systems developed nor repeat episodes of choking or body shaking.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: The day after my most recent Covid booster shot for 2024, I experienced a growing red spot around the injection site. My arm was sore as it was during previous doses, but the swelling and red spot have been expanding over the last day or so. It is also sensitive and warm to the touch.  I have not been to my dr or the emergency room yet as I am hoping for it to decrease in size by tomorrow.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient called pharmacy on 09/11 to report an adverse event following a shot. The patient received two vaccines on 09/9/24. Patient received spikevax and the High Dose influenza vaccine. They were both given in the left arm. The patient reports severe joint pain in his legs, arm, and across his shoulders.  The patient tried ibuprofen and tylenol but found minimal relief. Pharmacist told patient to continue to try tylenol and ibuprofen and to contact doctor. Pharmacist called patient later in the day on 09/11 and patient symptoms had improved. The pharmacist will follow-up with patient on 09/12.  Patient has received prior doses of Moderna before without issue.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm swelling
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Immune thrombocytopenia, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient began onset of unexplained bruising around 8/23/24.  Bruising continued worsening and petechiae started forming the following week.  Patient went to ER on 9/7/24 and was diagnosed with Acute ITP/Thrombocytopenia.  Bloodwork revealed her platelet level was extremely low at 5.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Pyrexia, Respiration abnormal, Wrong product administered
Clinical narrative: I went to Clinic to get Kindergarten shot, my child who is 5 years of age. He was treated by nurse and she injected my child with a vaccine that was not to be administered until the age of 11-12 or if directed by a doctor could be at the age of 7 if major injury or health concern (CDC). My child had effects after the injection consisting of high fever, sore injection site and had random periods where he would take deep breaths like he couldn't breathe. I was contacted by the school nurse September 4th in regard to him not having his kindergarten shots in which this all came to my attention he was given the wrong vaccination and 6-7 years to early. When I requested the paperwork from the clinic it showed that the nurse that did the injection had my child's name, date of birth and age at the top but below showed Tdap age 7.  I will be taking my child into a pediatrician to be examined for potential injury to my child. I will file a formal complaint with the clinic with my concerns and will look into legal action for medical malpractice and negligence towards my child.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Neck pain, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient called pharmacy to report adverse event on 09/11. Patient received the Comirnaty Pfizer vaccine on 09/9/24. Patient reported arm soreness and severe pain that radiated into the neck. She also reported a bump under the skin at the injection site and the arm was hot to touch.  Pharmacist told patient to try tylenol and ibuprofen to relieve pain and to contact her physician. Pharmacist attempted to reach patient later on 09/11 to check in but no answer by the patient.  Pharmacist will try and follow-up with patient on 09/12.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE REPORTED - MOTHER CONTACTED AND NOTIFIED VIA PHONE CALL AT 5:54PM
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pfizer Covid-19 vaccine for ages 5-11 given to a 16 year old.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Body aches, severe nausea, and throwing up several times
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE REPORTED - MOTHER CONTACTED VIA PHONE CALL AT 5:54PM AT 9/11/24
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Covid 19 Pfizer ages 5-11 vaccine given to 13 year old.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 Comirnaty Pfizer COVID 19 vaccines in same day.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Fatigue, Pain in extremity
Clinical narrative: Patient requested & received Arexvy (RSV) vaccine after it was discovered that she had already received first dose in October 2023.  Followed up with patient 30 hours later and patient reported no adverse effects, besides the usual soreness in the injection arm and fatigue associated with vaccinations.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Delusion, Pyrexia
Clinical narrative: pt reported having a very high fever of over 104 degrees the day after receiving this and her flu shot.  her son took her to the ER because she was acting delusional, which she does not remember.  She was at the ER for 4-5 hours and they gave her IV fluids, some tylenol or ibuprofen, and something else that she was not sure what it was.  Her fever resolved after that 4-5 hour timeframe and they released her to home.  She has a follow up with her PCP office this week. She has had no residual effects since besides being a bit more tired.  The ER did not send her home with any additional meds.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Migraine
Clinical narrative: Redness on arm for 2 days and migraine.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Syncope
Clinical narrative: The client had a syncopal episode approximately 10 mins after vaccination. No injuries were seen. The client did not have anything to eat before vaccination. Emergency medical services was called, and the client was sent to Hospital for further evaluation. He was sent home in good condition.
Age: 54.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Urticaria
Clinical narrative: 1 inch hive on right cheek
Age: 16.0
Sex: F
Vaccine: COVID19, MENB, MNQ
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Vaccine administered on 8/14/24 at 1530. Pt reports symptom onset 8/15/24 at 1400 of headache and fever. At 1600, onset of sharp leg pain, fever of 102F, chills, sweats, body aches. Pt reports fever and body aches were relieved by Tylenol. Symptoms lasted roughly 24 hours; on 8/16/24 in the evening, pt reports feeling "okay." Pt denies nausea, vomiting, hives, swelling, urticaria, difficulty breathing. Pt denies any adverse symptoms with 1st dose of MCV4 which was received in 2023. Pt reports this was her first COVID dose. Pt presented to clinic today for MenB dose #2; that was how the adverse event was discovered.
Age: 24.0
Sex: F
Vaccine: FLUR4, PNC20, RSV, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: 36 weeks 6 days gestation. Inadvertently administered Prevnar 20
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient received dose at her MD office and received 2nd vaccine from retail pharmacy on the same day. Wrongly communicated to the staff of what vaccine she needed
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site discharge, Injection site pain, Sleep disorder
Clinical narrative: Localized R arm pain developed at site of HPV injection 9d after received (9-7-24). Hurt to lie/sleep on that side. Guardian and pt squeezed muscle and reportedly expressed scant amount clear yellow liquid. Pt was examined 9-10-24-no erythema, lesion. Small (<1cm) poorly defined area of muscle thickening palpated mid lateral deltoid, mildly tender to palpation. Instructed to take ibuprofen at bedtime for up to a week, until symptoms resolve. Call if sxs worsen or no resolution within 2 weeks. (Has f/u appt for other issues end September)
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient complained of numbness from top of arm to tip of fingers after receiving Fluzone HD triv. She stayed in the pharmacy area until 4:19pm. She did state as she was leaving that she had worked out at the gym on her arms - it was "arm  day." Called her later in the day to check on her. She had taken Tylenol and said her arm was still a little numb but she felt better.
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Wrong product administered
Clinical narrative: Patient received two does of the fuad on the same day, one from MD office and another from retail pharmacy. miscommunication asked for flue vs wanted covid
Age: 78.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site cellulitis
Clinical narrative: PATIENT SUFFERED FROM CELLULITIS AT THE INJECTION SITE HAD TO BE HOSPITALIZED AND IV ANTIBIOTICS WERE GIVEN TO THE PATIENT. THEY ARE DOING BETTER NOW. THE SITE IS SHOWING IMPROVEMENT. THIS WAS REPORTED VIA PHONE BY THE PATIENT
Age: 46.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea without nausea or vomiting x 5 days, with onset 2 days after vaccination of SPIKEVAX 2024-25; spontaneously resolved.
Age: 1.25
Sex: F
Vaccine: PNC15
Symptoms: Fatigue, Irritability, Wrong product administered
Clinical narrative: Vaxneuvance was accidentally given instead of Vaqta. So far no unusual symptoms. Tired, fussy. MOP will watch for further symptoms and let us know.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Local red warm tender elevated lump about 1.5-2 inches in diameter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Low-grade fever (99-100.1), muscle aches
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Red, blistering rash/bumps on both butt cheeks, not near anus. Approximately 20, raised up from skin, appearing like many ant bites. No painful, child was seemingly unaware of them.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest pain, Palpitations
Clinical narrative: Chest pain and heart pounding. Did not have this side effect during prior Covid or Flu vaccines, but in March 2024, I got sick with Covid for the first time and had similar symptoms. Now it seems the vaccine might be triggering it again. Took Advil (NSAID), hoping it resolves. Haven't contacted a doctor but will if symptoms persist or worsen.
Age: 4.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Nurse called to report a patient was inadvertently administered ROQUAD and MMRII concomitantly on 8/27/2024, however the patient was due for MMRII only, and VARIVAX. Confirmed no side effects reported. Patient was due for their second dose of MMRII,; Nurse called to report a patient was inadvertently administered ROQUAD and MMRII concomitantly on 8/27/2024, however the patient was due for MMRII only, and VARIVAX. Confirmed no side effects reported. Patient was due for their second dose of MMRII,; Nurse called to report a patient was inadvertently administered ROQUAD and MMRII concomitantly on 8/27/2024, however the patient was due for MMRII only, and VARIVAX. Confirmed no side effects reported. Patient was due for their second dose of MMRII,; Information has been received from a nurse, referring to 4 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 27-AUG-2024, the patient was inadvertently administered with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin) injection, lot #y010247, expiration date: 30-NOV-2025 administered for prophylaxis (strength, and route of administration were not provided) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #x022986, expiration date: 11-JUN-2025 (strength, route of administration, and indication were not provided).  it was reported that the patient was at the facility for their second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX), only. Instead, the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No adverse effects were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: only had swelling at injection site; Inflammation at injection site; hardness at injection site; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (only had swelling at injection site), VACCINATION SITE INFLAMMATION (Inflammation at injection site), VACCINATION SITE PAIN (hardness at injection site) and FATIGUE (Fatigue) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy, Asthma and Visual discomfort.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (only had swelling at injection site), VACCINATION SITE INFLAMMATION (Inflammation at injection site), VACCINATION SITE PAIN (hardness at injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE SWELLING (only had swelling at injection site), VACCINATION SITE INFLAMMATION (Inflammation at injection site), VACCINATION SITE PAIN (hardness at injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773521 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773521:Same patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pain in extremity, Somnolence
Clinical narrative: Almost achy like a virus; Just sleepy; General bad feeling; Left arm pain; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Aug2024 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Post solid organ transplant", start date: 2001 (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: TACROLIMUS, start date: 21May2001. Past drug history included: Bactrim, reaction(s): "Allergy"; Flagyl, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "General bad feeling", "Achy like a virus", "Left arm pain", "Just sleepy". The following information was reported: PAIN (non-serious) with onset 28Aug2024 at 19:00, outcome "recovering", described as "Almost achy like a virus"; FEELING ABNORMAL (non-serious) with onset 28Aug2024 at 19:00, outcome "recovering", described as "General bad feeling"; SOMNOLENCE (non-serious) with onset 28Aug2024 at 19:00, outcome "recovering", described as "Just sleepy"; PAIN IN EXTREMITY (non-serious) with onset 28Aug2024 at 19:00, outcome "recovering", described as "Left arm pain". Therapeutic measures were taken as a result of pain, somnolence, feeling abnormal, pain in extremity.  Additional information: Patient had left arm pain and general bad feeling. Did not know how to describe it, just sleepy, almost achy like a virus. Similar to the first ever Covid vaccine she got. Patient took Advil as treatment for the adverse events. The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). The patient was taking other medication (Tacrolimus) within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site was just a little sore , which is typical from previous Covid shots; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: ER8727) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 1999 (unspecified if ongoing), notes: 25 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot number: EN6203, right arm), administration date: 01Mar2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site was just a little sore , which is typical from previous Covid shots".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400252152 Same patient and drug, similar event, different dose;
Sex: F
Vaccine: COVID19, FLUX, PPV, TTOX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Caller has never had an adverse reaction to any COVID, flu, pneumonia, shingles, or tetanus. Caller's arm would get a little sore; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE) for immunisation; influenza vaccine (INFLUENZA VACCINE) for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE) for immunisation; tetanus vaccine (TETANUS VACCINE) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller has never had an adverse reaction to any COVID, flu, pneumonia, shingles, or tetanus. Caller's arm would get a little sore".
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; only received the diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: only received the diluent). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK receipt date: 04-SEP-2024 The reporter was calling to get a little bit more information in regards to a specific situation in the office, patient was given the medication, a patient was scheduled to receive a Shingrix vaccine and it appeared that they only received the diluent, not the full Shingrix reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They were not sure which patient it was, they were able to find that one medication in the fridge had an extra antigen vial and a diluent was missing.  Their have a possibility of eleven patients that it could be and we were trying to find out what would be the recommendations for these eleven patients if we could not isolate who got the placebo if it was okay for them to receive a 3rd dose what would be the dosing time recommendation.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Malaise, Pyrexia
Clinical narrative: intestinal upset; general malaise; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (intestinal upset), MALAISE (general malaise), CHILLS (chills) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE, JANSSEN COVID-19 VACCINE (Johnsonn) and CORONAVAC. Past adverse reactions to the above products included No adverse effect with CORONAVAC, JANSSEN COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 06-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 07-Sep-2024, the patient experienced ABDOMINAL DISCOMFORT (intestinal upset), MALAISE (general malaise), CHILLS (chills) and PYREXIA (fever). At the time of the report, ABDOMINAL DISCOMFORT (intestinal upset), MALAISE (general malaise), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient had very bad symptoms the next day until Sunday. It was reported that the patient claimed not having diabetes and always had a great health. Patient was informed to return for a new dose of Moderna vaccine in Mar-2025, however she said she would not take it. No treatment medication was reported.
Age: 3.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: "A three year old received Bexsero instead of regular meningococcal vaccine"; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: "A three year old received Bexsero instead of regular meningococcal vaccine"). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-SEP-2024 Healthcare Professional reported that a three year old received Bexsero instead of regular meningococcal vaccine, which led to inappropriate age at vaccine administration. Consented to follow up.