chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased, Hypertension
Clinical narrative: Shortness of breath; elevated pulse rate of 90 to 120 for over 4 hours; elevated blood pressure as high as 152/83; Initial information was received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer via Pfizer.  This case involves an unknown age and gender patient who experienced shortness of breath, elevated pulse rate of 90 to 120 for over 4 hours and elevated blood pressure as high as 152/83 after receiving influenza usp trival A-B subvirion no preservative vaccine [Fluzone]and tozinameran [Comirnaty].  The patient's past vaccination(s) included Covid-19 vaccine (Dose 5, 4. 3 , 2, 1). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Blood cholesterol increased.  Concomitant medications included atorvastatin.  On 23-Oct-2023 at 13:45 hours, the patient received an unknown dose (dose 1) of suspect influenza usp trival A-B subvirion no preservative vaccine (Suspension for injection) (Lot number not reported) for Immunisation and an unknown dose (dose 1) of suspect Comirnaty not produced by Sanofi Pasteur (Solution for injection) (lot HD9876) for Covid-19 Vaccination (Covid-19 Immunisation) (Expiry date, strength: unknown) via unknown route in the left arm. The information on the batch number will not be available.  On 24-Oct-2023 at 01:30 hours, the patient had shortness of breath (dyspnoea), elevated pulse rate of 90 to 120 for over 4 hours (heart rate increased) and elevated blood pressure as high as 152/83 (hypertension) (latency: 11 hours 45 min) following the administration of influenza usp trival A-B subvirion no preservative vaccine and Comirnaty.   Relevant laboratory test results included: Blood pressure measurement - On 24-Oct-2023: 152/83 [elevated] Heart rate - On 24-Oct-2023:  [elevated- 90 to 120 for over 4 hours] SARS-CoV-2 antibody test - On 24-Oct-2023:  [Negative (Nasal swab)]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events.
Sex: U
Vaccine: COVID19, FLU3
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Shortness of breath; elevated pulse rate of 90 to 120 for over 4 hours; elevated blood pressure as high as 152/83; Initial information was received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer via Pfizer.  This case involves an unknown age and gender patient who experienced shortness of breath, elevated pulse rate of 90 to 120 for over 4 hours and elevated blood pressure as high as 152/83 after receiving influenza usp trival A-B subvirion no preservative vaccine [Fluzone]and tozinameran [Comirnaty].  The patient's past vaccination(s) included Covid-19 vaccine (Dose 5, 4. 3 , 2, 1). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Blood cholesterol increased.  Concomitant medications included atorvastatin.  On 23-Oct-2023 at 13:45 hours, the patient received an unknown dose (dose 1) of suspect influenza usp trival A-B subvirion no preservative vaccine (Suspension for injection) (Lot number not reported) for Immunisation and an unknown dose (dose 1) of suspect Comirnaty not produced by Sanofi Pasteur (Solution for injection) (lot HD9876) for Covid-19 Vaccination (Covid-19 Immunisation) (Expiry date, strength: unknown) via unknown route in the left arm. The information on the batch number will not be available.  On 24-Oct-2023 at 01:30 hours, the patient had shortness of breath (dyspnoea), elevated pulse rate of 90 to 120 for over 4 hours (heart rate increased) and elevated blood pressure as high as 152/83 (hypertension) (latency: 11 hours 45 min) following the administration of influenza usp trival A-B subvirion no preservative vaccine and Comirnaty.   Relevant laboratory test results included: Blood pressure measurement - On 24-Oct-2023: 152/83 [elevated] Heart rate - On 24-Oct-2023:  [elevated- 90 to 120 for over 4 hours] SARS-CoV-2 antibody test - On 24-Oct-2023:  [Negative (Nasal swab)]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 31-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got the flu while receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient got the flu (influenza) (unknown latency). Reportedly Don't believe in the flu shot I've had one in the 60 years I've been alive and it's the only time I got the flu.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu).  At time of reporting, the outcome was Unknown for the event got the flu.
Age: 82.0
Sex: M
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: accidental administration of FLUBLOK Quadrivalent instead of FLUZONE HIGH DOSE Quadrivalent with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from patient.  This case involves a 82 years old male patient who experienced accidental administration of Influenza Quadrivalent Recombinant vaccine [FLUBLOK QIV] instead of Fluzone High Dose quadrivalent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Oct-2023, the patient accidentally received 0.5 ml dose of suspect Influenza Quadrivalent Recombinant vaccine (formulation, lot number and expiry: not reported) via unknown route in the left arm for immunization; instead of Fluzone High Dose Quadrivalent with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested.  No lab data was reported.  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: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: received the FLUZONE HD QUADRIVALENT today. When the patient got home, she realized that she had already gotten the flu-shot a month ago with no reported adverse event.; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 85 years old female patient who received the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] today. when the patient got home, she realized that she had already gotten the flu-shot a month ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   n an unknown date in September 2023, the patient received a unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization. On 30-Oct-2023, the patient received a 0.7 ml (total) dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, formulation: unknown and expiry date: 30-Jun-2024; lot UT8094AA) via unknown route in the left arm as immunization and received the fluzone hd quadrivalent today. when the patient got home, she realized that she had already gotten the flu-shot a month ago with no reported adverse event. (extra dose administered). Information on the batch number was requested.  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: Expanded disability status scale, No adverse event
Clinical narrative: expired TENIVAC was given with no reported adverse event; Initial information received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional (Pharmacy intern).  This case involves a patient of unknown age and gender to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given 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 expired dose 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (strength not reported) (lot U7183AA; Expiration Date: 24-Sep-23) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (unknown latency).  Action taken: not applicable.  Outcome 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: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received 2 FLUZONE HD QIV vaccinations in a relatively short period of time with no reported adverse event; Initial information received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case involves a 66 years old female patient where patient inadvertently received 2 influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] vaccinations in a relatively short period of time with no reported adverse event directly linked with extra dose administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included elasomeran (moderna covid-19 vaccine) for Prophylactic vaccination.  On 31-Oct-2023, the patient received 0.7 ml (TOTAL) dose of suspect influenza quadrival a-b high dose hv vaccine (lot- U8084BA and expiration date- 30-Jun-2024) via intramuscular route in the left deltoid (formulation, strength: not provided) for Immunisation (extra dose administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose with no reported adverse event; Initial information received on 02-Nov-2023 regarding an unsolicited valid non-serious case received from via other health professional.  This case involves a 15-month-old female patient who had administered an expired dose of vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 01-Nov-2023, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UJ786AA, expiry date: 12-Oct-2023) via unknown route in the left thigh for immunization and administered an expired dose with no reported adverse event (expired product administered) (latency: same day).  Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (pentacel (VERO)) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: QUADRACEL was administered instead of PENTACEL with no reported adverse event; QUADRACEL was administered to an 18 month old patient with no reported adverse event; Initial information received on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 17 months old male patient who was administered Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] instead of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Nov-2023, the patient received 0.5 ml dose (dose 4) of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection of lot U7931AB and expiry: 09-Nov-2025 via intramuscular route in the left deltoid for immunization; instead of Diphtheria/Tetanus/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine (Pentacel) at an age of 17 months with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  No lab data was reported.  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: 21.0
Sex: M
Vaccine: FLUC3
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Bump at the site of injection; Pain at injection site that went down through his arm; Trouble to move the arm; Feeling bad; Nausea; This spontaneous case was received on 02-Nov-2023 from a pharmacist (reference number: SEQW23-03980) and concerned a 21-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 24-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease. The batch number reported was 374409 and the expiry date was 30-Jun-2024.  On 30-Oct-2023, at six am, six days after receiving Flucelvax Quadrivalent, the patient started feeling bad and then remembered he had a flu shot. The patient felt like there was a bump on the injection arm and was having trouble moving it. The patient also felt nausea and pain at the injection site that went down through his arm. The patient was treated with Tylenol (paracetamol) and Advil (ibuprofen).   At the time of the initial reporting, the patient had not recovered from the events. As reported, there was less pain than when it started.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 21-year-old patient developed vaccination site mass, pain in arm, decreased mobility of injected arm, abnormal feeling (reported as "feeling bad"), and nausea six days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship and the absence of confounders, causality for vaccination site mass, pain in arm, decreased mobility of injected arm is assessed as probably related. Causality for the remaining events (abnormal feeling and nausea) is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 21-year-old patient developed vaccination site mass, pain in arm, decreased mobility of injected arm, abnormal feeling (reported as "feeling bad"), and nausea six days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship and the absence of confounders, causality for vaccination site mass, pain in arm, decreased mobility of injected arm is assessed as probably related. Causality for the remaining events (abnormal feeling and nausea) is assessed as possibly related, due to plausible temporal relationship.
Age: 21.0
Sex: M
Vaccine: FLUC3
Symptoms: Peripheral swelling, Vaccination site mass
Clinical narrative: Bump at the site of injection; Pain at injection site that went down through his arm; Trouble to move the arm; Feeling bad; Nausea; This spontaneous case was received on 02-Nov-2023 from a pharmacist (reference number: SEQW23-03980) and concerned a 21-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 24-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease. The batch number reported was 374409 and the expiry date was 30-Jun-2024.  On 30-Oct-2023, at six am, six days after receiving Flucelvax Quadrivalent, the patient started feeling bad and then remembered he had a flu shot. The patient felt like there was a bump on the injection arm and was having trouble moving it. The patient also felt nausea and pain at the injection site that went down through his arm. The patient was treated with Tylenol (paracetamol) and Advil (ibuprofen).   At the time of the initial reporting, the patient had not recovered from the events. As reported, there was less pain than when it started.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 21-year-old patient developed vaccination site mass, pain in arm, decreased mobility of injected arm, abnormal feeling (reported as "feeling bad"), and nausea six days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship and the absence of confounders, causality for vaccination site mass, pain in arm, decreased mobility of injected arm is assessed as probably related. Causality for the remaining events (abnormal feeling and nausea) is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 21-year-old patient developed vaccination site mass, pain in arm, decreased mobility of injected arm, abnormal feeling (reported as "feeling bad"), and nausea six days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship and the absence of confounders, causality for vaccination site mass, pain in arm, decreased mobility of injected arm is assessed as probably related. Causality for the remaining events (abnormal feeling and nausea) is assessed as possibly related, due to plausible temporal relationship.
Age: 36.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: This patient was supposed to receive Abrysvo due to its indication for pregnancy, however, Arexvy was given. Patient has not notified clinic with any side effects/complications.
Age: 36.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: This patient was supposed to receive Abrysvo due to its indication for pregnancy, however, Arexvy was given. Patient has not notified clinic with any side effects/complications.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received Prevnar 20 twice within a 5 month period. Patient reports no adverse reactions.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Adverse Event- Flublok vaccine administered to 15 yo female patient.  Treatment: none Outcome: No serious adverse outcome.  Guardian notified of medication error on 10/5/23 when provider notified of medication error.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient came to the pharmacy today to show us her arm after she had called her doctor to let him know about the reaction to the flu shot.  Her doctor told her to come to the pharmacy to let us know and he told her to take Benadryl.  Her arm was red, itchy, swollen, and she stated that it had a burning sensation.
Age: 44.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Shortly after receiving vaccination, patient turned pale and lost consciousness in his chair for about 1 minute. Patient regained consciousness and started sweating. Orange juice was provided per patient request as he reported having symptoms similar to having low blood sugar. Patient was advised to remain in the pharmacy until he feels better and routinely checked by a pharmacist and pharmacy intern. After sitting down for about 45 minutes, patient reported feeling better and left pharmacy.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient asked for the RSV vaccine and already received a dosage on 09/08/2023 and we didn't catch that he shouldn't be getting a second dosage.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient showed picture of big red swollen site with blisters to pharmacy staff on 11/10/23.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: my right eye has begun twitching about 24 hours after my vaccine and is continuing today (about 56 hours post vaccination)
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Ageusia
Clinical narrative: Patient reports taste buds disappeared 2 weeks after administration. Patient evaluated for Sjogen's by ENT - negative.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Swelling, Tenderness
Clinical narrative: Swelling, itching, tenderness
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 2 doses were accidentally given instead of 1 flu and 1 comirnaty
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Inflammation, Mobility decreased, Nausea, Neck pain
Clinical narrative: Injection was given very low in the shoulder, and at the time of injection a nerve type pain was felt all the way up my arm and into my neck. The next two days I had an exaggerated immune response with fever, chills, nausea and a very sore arm. The third day I woke up that morning and was totally unable to move the arm that I received the vaccine in. The whole arm felt like it had a severe muscle cramp and sharp pain. I used my other arm to move this arm and stretch it out a little and was able to regain limited range of motion.  18 days later I am still experiencing severe pain and very limited range of motion in the vaccine shoulder.  I went to my PCP on Nov 2nd and she confirmed that the pain  was inflammation and  injury from the flu shot. She gave me a steroid shot and told me to follow up if it didn?t get better in a week or two.  The steroid shot provided no relief and the pain and limited range of motion has worsened, not improved since then.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain in extremity, Product administered at inappropriate site, Pyrexia, Vaccination site injury
Clinical narrative: Injection was given very low in the shoulder, and at the time of injection a nerve type pain was felt all the way up my arm and into my neck. The next two days I had an exaggerated immune response with fever, chills, nausea and a very sore arm. The third day I woke up that morning and was totally unable to move the arm that I received the vaccine in. The whole arm felt like it had a severe muscle cramp and sharp pain. I used my other arm to move this arm and stretch it out a little and was able to regain limited range of motion.  18 days later I am still experiencing severe pain and very limited range of motion in the vaccine shoulder.  I went to my PCP on Nov 2nd and she confirmed that the pain  was inflammation and  injury from the flu shot. She gave me a steroid shot and told me to follow up if it didn?t get better in a week or two.  The steroid shot provided no relief and the pain and limited range of motion has worsened, not improved since then.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Redness, swelling, and induration over the left deltoid area where the vaccine was administered.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok given to a patient under 18 years old.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Magnetic resonance imaging, Vision blurred
Clinical narrative: Patient reported experiencing dizziness and blurry vision to both eyes the day after receiving the vaccine.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Palpitations
Clinical narrative: Heart palpitations over 3 nights
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt reported dizziness, light-headedness and sweatiness upon injection, which improved over the course of 10-minutes while pt sat and drank water. Pt declined any additional medical attention when RPh offered to call 911. Pt reported similar experience with previous vaccines received at drive-thru COVID-19 vaccination clinic.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Feeling cold, Heart rate increased, Hypertension, Injection site erythema
Clinical narrative: Pain, redness, swelling at injection site. Fever over 102. High blood pressure and high pulse. Rigors, freezing and shaking uncontrollably
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Tremor
Clinical narrative: Pain, redness, swelling at injection site. Fever over 102. High blood pressure and high pulse. Rigors, freezing and shaking uncontrollably
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Arthritis reactive, Hypoaesthesia, Lymphocyte count increased, Polyarthritis
Clinical narrative: 72 hrs post immunization onset of reactive arthritis in all joints, especially those in both arms - shoulders, elbows, wrists, fingers. Right hand numbness. Lesser joint pain in lower joints - ankles and hips primarily.   Pain was intense enough to seek treatment at ER. Prednisone prescribed. Outcome pending.
Age: 5.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Auscultation, Erythema, Immunisation reaction, Swelling
Clinical narrative: 5 year old male present with mother for a swollen red reaction to Proquad vaccine on 11/08/2023. Mother states yesterday (11/09/2023)  it was a small red ring  and today it increased in size. Denies pain or irritation to the area, issues  breathing, or fevers.  Child is well nourished, well developed, and well hydrated, in no apparent distress. Skin: 6cm x 5cm circular red reaction.  Chest/Lungs: Normal respirations; clear to auscultation, good and equal breath sounds. Heart: Regular rate and rhythm, no extra sounds or murmur.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: this was given to a pregnant person by mistake. she did not have any adverse reactions. just reporting that it was given in pregnancy.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient came in for a Influenza vaccine and I was told by another CMA was ok to use private stock. Vaccine was a Fluarix for 6months and older. Patient had no reaction did well with vaccine.
Age: 9.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abnormal behaviour, Blood glucose normal, Crying, Feeling abnormal, Somnolence
Clinical narrative: Mild temperature elevation within couple hours up to 100.3F (tympanic). Patient was seen by her PCP in the other office for this practice and was well and healthy.  Had a WCV this morning.  Received COVID-19 and influenza vaccines today.  Was fine before appointment and at appointment and then after appt, went for smoothies and then was cleaning her room before all this started.  She has had both of the covid and flu vaccines before.  Had pfizer vaccine this time but has had covid vaccines in past. Afterward, she started acting very strange--felt weird. Was really sleepy.  Seemed like she was going to take a nap.  Was hanging out on the couch--started crying and repeating 'I wanna go home,' but was on the couch in h
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Bradykinesia, Dysstasia, Gait disturbance, Gait inability, Walking aid user
Clinical narrative: Unable to stand without assistance. Shot was Friday morning, slept normally, arose normally, normal morning routine. Resumed normal sedentary activities. After about two hours, I was unable to stand and walk. Eventually rose without falling back in my chair. Tried walking around. Did not fall but moved unstably and slowly. Also was unable to recall how to perform some of the daily activities. Returned to chair for another hour. Again, unable to stand and walk normally. Eventually got a cane for safety. This lasted through Saturday. Sunday morning was walking with about 80% of normal stability. By the end of Sunday I was largely normal..
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Blood test normal, Electromyogram normal, Fatigue, Headache
Clinical narrative: (Previous 3 COVID19 Vaccine doses were Pfizer)  Since vaccine, chronic myalgias, chronic peripheral neuropathy, chronic fatigue, post exertional malaise, chronic headaches, insomnia, tinnitus. First was low back pain and right thigh pain, then pins and needles in right foot, then in both hands, then left foot. Sleeping became very difficult. Still taking Gabapentin to deal with nerves. Headaches and fatigue and PEM are now constant. Tinnitus comes and goes.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Malaise, Myalgia
Clinical narrative: (Previous 3 COVID19 Vaccine doses were Pfizer)  Since vaccine, chronic myalgias, chronic peripheral neuropathy, chronic fatigue, post exertional malaise, chronic headaches, insomnia, tinnitus. First was low back pain and right thigh pain, then pins and needles in right foot, then in both hands, then left foot. Sleeping became very difficult. Still taking Gabapentin to deal with nerves. Headaches and fatigue and PEM are now constant. Tinnitus comes and goes.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: (Previous 3 COVID19 Vaccine doses were Pfizer)  Since vaccine, chronic myalgias, chronic peripheral neuropathy, chronic fatigue, post exertional malaise, chronic headaches, insomnia, tinnitus. First was low back pain and right thigh pain, then pins and needles in right foot, then in both hands, then left foot. Sleeping became very difficult. Still taking Gabapentin to deal with nerves. Headaches and fatigue and PEM are now constant. Tinnitus comes and goes.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Patient reported fever of 102.8, diarrhea and nausea for up to 6 days after the vaccination
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Pain in extremity, X-ray
Clinical narrative: Within 2 weeks of the first shot, patient developed acute joint pain in both hands and feet (digits - both). The pain was a 6-7 of 10 for the month of August every day, slowly abating to 5-6 in September, to 3-4 currently in November with fewer days of symptoms (every other day). Pain was most acute in finger knuckles with occasional manifestation in toe joints. No medication or pain relief used during this stretch of observation.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antinuclear antibody, Arteriogram carotid, C-reactive protein, Chest X-ray, Computerised tomogram head
Clinical narrative: Diplopia, double vision Trochlear Nerve 4 palsy
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diplopia, Full blood count, IVth nerve paralysis, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Diplopia, double vision Trochlear Nerve 4 palsy
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Optical coherence tomography, Red blood cell sedimentation rate, Ultrasound scan
Clinical narrative: Diplopia, double vision Trochlear Nerve 4 palsy
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Eye pain, Headache, Nausea
Clinical narrative: Nausea,  headache,  weakness, eye pain, nasal discharge, cough
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Nausea,  headache,  weakness, eye pain, nasal discharge, cough
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was given the fluzone hd instead of fluzone quad
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Dermatitis allergic, Skin reaction, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Patient developed an oval, red, raised skin rash near vaccination site consistent with an delayed allergic skin reaction.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Type IV hypersensitivity reaction
Clinical narrative: Delayed hypersensitivity reaction: COVID arm
Age: 0.17
Sex: F
Vaccine: PNC20
Symptoms: Decreased interest, Developmental regression, Lethargy, Personality change, Staring
Clinical narrative: Change of personality, regression in development acting the way she did at 1 week old instead of normal current behavior, not recognizing familiar objects, lack of interest in things that normally interest her, extreme lethargy non responsive to stimulus, blank stares, loss of desire to track favorite objects and people.
Age: 0.17
Sex: F
Vaccine: PNC20
Symptoms: Unresponsive to stimuli
Clinical narrative: Change of personality, regression in development acting the way she did at 1 week old instead of normal current behavior, not recognizing familiar objects, lack of interest in things that normally interest her, extreme lethargy non responsive to stimulus, blank stares, loss of desire to track favorite objects and people.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Pain, Paraesthesia, Swollen tongue
Clinical narrative: /swollen tongue  /tingling sensation in leg and calf /throbbing in eye
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Pt reported rash on face on wednesday 11-08-2023 and will report to doctor on friday 11-11-2023 if rash doesn't resolve ....Patient had Covid 19 in early October 2023 with symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Dry eye, Dry mouth, Sjogren's syndrome
Clinical narrative: according to the patient her Sjorgens syndrome has reoccur like dryness of mouth and eyes
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Inflammation, Irritability, Malaise, Pruritus
Clinical narrative: 11/7 bad headache and very thirsty. Wednesday morning noticed a rash on some areas of body. Some itching and feeling some what out of sorts. Thursday morning rash had moved to more areas of body. Thursday saw NP. NP gave me prescription for Triamconolone and suggested I take Allegra. Woke up this morning and rash is now on 85 percent or more of my body. Rash is inflamed, itchy, and very elevated hot and I look like I have a sunburn. Not running fever, but not feeling great.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Skin warm
Clinical narrative: 11/7 bad headache and very thirsty. Wednesday morning noticed a rash on some areas of body. Some itching and feeling some what out of sorts. Thursday morning rash had moved to more areas of body. Thursday saw NP. NP gave me prescription for Triamconolone and suggested I take Allegra. Woke up this morning and rash is now on 85 percent or more of my body. Rash is inflamed, itchy, and very elevated hot and I look like I have a sunburn. Not running fever, but not feeling great.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Thirst
Clinical narrative: 11/7 bad headache and very thirsty. Wednesday morning noticed a rash on some areas of body. Some itching and feeling some what out of sorts. Thursday morning rash had moved to more areas of body. Thursday saw NP. NP gave me prescription for Triamconolone and suggested I take Allegra. Woke up this morning and rash is now on 85 percent or more of my body. Rash is inflamed, itchy, and very elevated hot and I look like I have a sunburn. Not running fever, but not feeling great.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Feeling hot, Pain, Pain in extremity, Small fibre neuropathy
Clinical narrative: Warm sensations in body, pain in foot when walking, small fiber neuropathy
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given flu shot last month, but also given flu shot today. Patient and caregiver informed, but did not report any side effects.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Infection, Injection site erythema, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Vaccine was administered to patient on 11/1 patient then came to the pharmacy on 11/9 with her arm black, swollen, red, hot, and infected. Patient first spoke with Pharmacist and then myslef. Patient stated that her arm was hot and red and inflamed in the days following the shot. It spread to the point that she went to the doctor. The doctor informed her that the shot likely caused an infection in her arm that spread to her blood stream and moved down her arm. She was placed on a sling and antibiotics. She wanted me to understand that this was caused by the shot. She stated that if she had known a technician was giving the shot she would not have decided to get it. I informed her that this is a risk of a vaccination because bacteria can get under the skin whenever we break it. I also informed her that technicians receive the same training that pharmacists do and that we swab the injection site with alcohol for this reason. I told patient I would report this event and she agreed that was alright.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Apnoea, Hypersomnia, Hypotonia, Hypoxia, Mechanical ventilation
Clinical narrative: Sedation. Much more than her usual. Floppy unarousable sleeping hours at a time with multiple apneas and hypoxia with desaturations many times to 76%, 68%, 66%, 58% requiring vigorous stimulation, large amounts of oxygen and Noninvasive Ventilator. This went on for days. Never reacted to any of the other vaccines. This was her sixth since she is immune compromised. Could this vaccine somehow have increased the absorption of her other meds which includes many sedating meds used for seizure control?????
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Sedation, Unresponsive to stimuli
Clinical narrative: Sedation. Much more than her usual. Floppy unarousable sleeping hours at a time with multiple apneas and hypoxia with desaturations many times to 76%, 68%, 66%, 58% requiring vigorous stimulation, large amounts of oxygen and Noninvasive Ventilator. This went on for days. Never reacted to any of the other vaccines. This was her sixth since she is immune compromised. Could this vaccine somehow have increased the absorption of her other meds which includes many sedating meds used for seizure control?????
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Cough, Dysphonia, Dyspnoea, Paraesthesia
Clinical narrative: Onset of difficult breathing, itchy tongue, confusion, generalized paresthesias, voice changes, and coughing within 1 hour of receiving vaccine for influenza   Treated with epinephrine with improvement Also received dexamethasone and diphenhydramine   Take famotidine and loratadine at home
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Tongue pruritus
Clinical narrative: Onset of difficult breathing, itchy tongue, confusion, generalized paresthesias, voice changes, and coughing within 1 hour of receiving vaccine for influenza   Treated with epinephrine with improvement Also received dexamethasone and diphenhydramine   Take famotidine and loratadine at home
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache and nausea still ongoing and in waves throughout the day
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for patient who received improperly stored VARIVAX on 02OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; HCP calling to report AE for patient who received improperly stored VARIVAX on 02OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; This spontaneous report was received from Other Health Professional and refers to a unspecified patient.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X007372, expiration date: 12-MAR-2025 (strength, route of administration, and indication were not provided).   On 02-OCT-2023, the patient received improperly stored VARIVAX.  The action taken with VARIVAX regarding the event was reported as Not Applicable.; Sender's Comments:  US-009507513-2310USA007934:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: life tested positive for HPV; then received GARDASIL 9; This spontaneous report was received from a physician and refers to a female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, expiry date, lot #, expiration date and route of administration were not provided). And then later in life (unspecified date), she tested positive for human papilloma virus (HPV) (Human papilloma virus test positive) so she received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (strength, expiry date, and route of administration were not provided) (Interchange of vaccine products). It was unknown how many hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccines she received.   The causal relationship Human papilloma virus test positive and suspect vaccine was not reported.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis contact, Erythema, Macule, Rash, Varicella
Clinical narrative: HCP calling to report AE for patient that received VARIVAX and then developed a rash/rash on both shoulders and arms and it was diagnosed as contact dermatitis/rash, contact dermatitis versus chicken pox; erythematous macules, likely varicella/rash, contact dermatitis versus chicken pox; This spontaneous report was received from a nurse and refers to an approximately 18-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. No known allergies reported.  On 06-OCT-2023, the patient was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, valid lot #W034708, expiration date: 01-NOV-2024, administered in left thigh for prevention of varicella (strength, and route of administration were not provided).  On an unknown date in October 2023, the patient developed a rash. His mother, a 6-month pregnant female was exposed to the "varicella-like" rash (she had not received any company product). On 19-OCT-2023, the patient was seen in doctor's office for a rash on both shoulders and arms and it was diagnosed as contact dermatitis. On the same date, the patient then saw another provider in the same healthcare system, who noted it was "erythematous macules, likely varicella". The patient was seen again in the first office on 20-OCT-2023 and the provider's note stated "rash, contact dermatitis versus chicken pox". The patient was placed in varicella isolation and was prescribed diphenhydramine (BENADRYL) and a cream of unknown name. On 23-OCT-2023, a physician from the first office ordered a varicella antibody test for the patient which had yet to result. No other medical information was known. At the reporting time, the rash was still present. No side effects were reported for the mother.  The causal relationship between the events and varicella virus vaccine live (OKA/MERCK) (VARIVAX) was unknown.