chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLUX, HEP, IPV, TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: The Ipol product that was administered was expired(with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 12 years old female patient who received vaccine IPV (VERO) [IPOL] and the ipol product that was administered was expired(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 INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 11-Oct-2022, the patient received an dose of 0.5 ml of suspect IPV (VERO) (formulation, strength, route: unknown) lot T1E872M, expiration date: 10-Oct-2022 in the left arm as Immunization  On 11-OCT-2022 the ipol product that was administered was expired(with no reported adverse event (expired product administered) same day following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (The Ipol product that was administered was expired(with no reported adverse event).  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Seasonal symptoms such as hives; Seasonal symptoms such as hives; This spontaneous case was received on 03-Oct-2022 from other non-healthcare professional via Agency (reference number: SEQW22-03965) and concerned an adult female patient in late 20's to early 30's.  The patient's medical history and concomitant medications were not reported.  On unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose: 0.5 ml, route of administration: intramuscular (IM) and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported. As reported, the specific batches of vaccine previously received was unknown, but it was suspected that the product was Flucelvax.  On unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced seasonal symptoms such as hives.  The outcome of the events was not reported.  The reporter did not provide a causality assessment. As reported, it was unclear exactly what the was the cause. The employee's doctor may suspect that seasonal influenza vaccination may be one possible cause.  The case was assessed as non-serious.  Company comment: An adult female patient in late 20's to early 30'swas vaccinated with the suspect product influenza vaccine. An unspecified amount of time after vaccination the patient developed seasonal symptoms such as hives. Information regarding the underlying medical history and related diagnostic findings has not been provided. Due to limited information provided, causality is unassessable.; Sender's Comments: An adult female patient in late 20's to early 30'swas vaccinated with the suspect product influenza vaccine. An unspecified amount of time after vaccination the patient developed seasonal symptoms such as hives. Information regarding the underlying medical history and related diagnostic findings has not been provided. Due to limited information provided, causality is unassessable.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Sleep disorder, Urticaria
Clinical narrative: Horrible hives again/hives on his legs and side/ribcage, on his back and the tops of thighs/the hives have been constant but are worse at night when he was not as distracted; Up all night; This spontaneous case was received on 05-Oct-2022 from other non-healthcare professional (consumer) via Novartis (reference number: NUS2022US152520_NC) and concerned a 65-year-old, male patient.  The patient's past medical history included hives. The patient's concomitant medications were not reported.  On 23-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On 26-Sep-2022, three days after receiving Fluad Quadrivalent, the patient experienced horrible hives again. The patient was up all night with hives on his legs and side, ribcage area. The hives had been constant but worse at night when the patient was not as distracted. Later, the patient experienced hives on his back and the tops of his thighs.  The outcome of both events was not reported.  The reporter assessed the events of 'hives' and 'sleep disturbed' as related to Fluad Quadrivalent. As reported, the patient was fairly sure that the Fluad thing did something to kick up his immune system.  Company comment: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. Three days after vaccination the patient developed hives. As reported patients could not sleep all night due to the event. Based on plausible time relationship, causality for the event urticaria is assessed as possibly related. Based on provided information causality for the event sleep disorder is assessed as not related to suspect product.; Reporter's Comments: As reported, the patient was fairly sure that the Fluad thing did something to kick up his immune system.; Sender's Comments: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. Three days after vaccination the patient developed hives. As reported patients could not sleep all night due to the event. Based on plausible time relationship, causality for the event urticaria is assessed as possibly related. Based on provided information causality for the event sleep disorder is assessed as not related to suspect product.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Palmar rash - both hands
Age: 4.0
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: Rotarix was administered IM; 4YO was administered Rotarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 4-year-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K33EZ, expiry date 15th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 10th October 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 10th October 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate route of vaccination and inappropriate age at vaccine administration were 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: 10-OCT-2022 Reporter's comment: The reporter reported that Rotarix lyophilized administered intramuscularly to a patient. The Vaccine Administration Facility was the same as primary reporter. Outside phone number for GlaxoSmithKline medical information given for future reference and transfer provided. The reporter consented to follow up. Additional Supportive Information: The four years old patient received dose of Rotarix lyophilized intramuscularly, which led to inappropriate route of vaccination and inappropriate age at vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Nausea
Clinical narrative: Side effects are different after taking this vaccine; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects are different after taking this vaccine) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects are different after taking this vaccine) and NAUSEA (Nauseous). At the time of the report, IMMUNISATION REACTION (Side effects are different after taking this vaccine) and NAUSEA (Nauseous) outcome was unknown.            Concomitant medications were not reported. Patient stated that her side effects were different after taking this vaccine. Patient also didn't get some side effects that she got after previous doses. No treatment information was provided by the reporter.   This case was linked to MOD-2022-659179 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021); This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021)) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0048A21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 (19-Mar-2021) and Dose-2 (06-Apr-2021)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurses gave an expired Tenivac Vaccine with no adverse event; Initial information was received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient with unknown demographics and nurse gave an expired Diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, a nurse gave an expired total dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult suspension for injection 0.5 ml (expiration date: Oct-2018) (with unknown strength, lot number and administration site) via intramuscular route for immunization with no adverse event (expired product administered) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: 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.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number abxb59aa, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-Oct-2022 Reporter's comment: The medical assistance reported that the patient was administered with an expired dose of Bexsero. The adverse event was not reported. The patient's identifiers was not provided. Additional Supportive Information: The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 6 year old, administered full adult dose; 6 year old, administered full adult dose; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 6-year-old female patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 7th October 2022, the patient received the 2nd dose of Havrix adult. On 7th October 2022, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the 6 years old patient inadvertently received full dose of Havrix vaccine. The reporter stated that this was the 2nd dose of the patient series. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional Supportive Information: The child patient was administered a full dose of Havrix, which led to overdose and adult product administered to child.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This case was reported by a other health professional via sales rep and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's comment: The reporter stated that the patient had an incident of GBS(Guillain Barre syndrome) in the past from potentially a Flu vaccine. No Flu vaccine brand name was specified in form. The reporter consented to follow-up.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; Bumps at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 11-year-old male patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number KH3N5, expiry date 16th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th October 2022, 1 days after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling and injection site mass. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site mass were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site mass to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   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: 11-Oct-2022 Reporter's comment: The healthcare professionals reported that the patient received the Flulalval Quadrivalent on left deltoid. The patient experience local redness, swelling, and bumps at the injection site.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo administered without reconstitution; Menveo administered without reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA733A, expiry date 31st October 2023) for prophylaxis.   On 5th October 2022, the patient received Menveo. On 5th October 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: The medical assistant reported that the patient received a dose of the liquid vial of Menveo without reconstitution with the powder.  The reporter consented to follow up. Additional Supportive Information: The patient received a dose of the liquid vial of Menveo without reconstitution with the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: FLU4
Symptoms: Back pain
Clinical narrative: chronic lower back pain; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.   This case involves an unknown age and gender patient who experienced chronic lower back pain , after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported at an unknown dose via unknown route in unknown administration site for prophylactic vaccination.  On 05-Oct-2022 (latency: 1 day) ,the patient developed a non-serious event of chronic lower back pain (back pain) following the administration.   It was reported "On October 05 2022 I was given bilateral SI Joint injections by my pain management doctor for my chronic lower back pain. Those injections were a combination of triamcinolone and lidocaine. What are the drug interactions of the flu vaccine and injections? Have I compromised the effectiveness of the flu vaccine and injections? Has my health been seriously compromised? What steps do I need to take? Information from web/email communication."  Action taken: not applicable  Corrective treatment: bilateral SI Joint injections  for the event   Outcome: Unknown
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired doses of fluzone high dose quadrivalent were administered with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient to whom expired doses of Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] were administered 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 suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route: unknown) (lot number: UJ742AC and expiry date: 30-Jun-2022) in unknown administration site for Immunization, reportedly expired doses were administered with no reported adverse event (expired product administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: have administered expired PENTACEL to a patient with no reported AE; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who received vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] and it was reported that have administered expired pentacel to a patient with no reported ae (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the patient received an unknown dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (formulation, strength: unknown) lot UJ569AAA, expiration date: 02-Oct-2022 in unknown administration site as Immunization.  On 10-OCT-2022 the patient was administered expired pentacel with no reported ae (expired product administered) same day following the administration of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (have administered expired PENTACEL to a patient with no reported AE).  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: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The day after injection, a large red, raised bump appeared at the injection site. It was approximately  2 inches in diameter and the height of a quarter. It was very itchy, but not warm to touch. 4 days after injection the swelling went down and it faded into a bruise. No other noticeable symptoms were present.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Injection site pain, Resuscitation
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient got both shots and complaint of dizziness i told him to keeping seating while a call 911. The paramentics came in started cpr and took the patient away to the hospital
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphonia, Influenza virus test negative, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: Sore Throat along with wheezing  Coughing with mucus Hoarseness in voice
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Secretion discharge, Streptococcus test negative, Wheezing
Clinical narrative: Sore Throat along with wheezing  Coughing with mucus Hoarseness in voice
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Eye swelling, Headache, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild, Systemic: Headache-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: patient experienced swelling mild swelling under right eye and more severe swelling on left side under eye, and left arm and left axillae felt like many hard marbles according to patient.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild, Systemic: Headache-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: patient experienced swelling mild swelling under right eye and more severe swelling on left side under eye, and left arm and left axillae felt like many hard marbles according to patient.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: she experience mild tongue swelling that went away within 10 minutes. she declined to wait for ems
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Discomfort, Headache, Injection site pain, Nausea
Clinical narrative: Severe headache, severe body aches, chills, nausea 3 hours post vaccine. Took ibuprofen. Symptoms resumed 6 hours later. Took more ibuprofen. Symptoms persist 5 hours later. Persistent pain in arm at rest at injection site. Persistent severe body aches and headache. Extremely uncomfortable. OTC ibufrofen ineffective.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Severe headache, severe body aches, chills, nausea 3 hours post vaccine. Took ibuprofen. Symptoms resumed 6 hours later. Took more ibuprofen. Symptoms persist 5 hours later. Persistent pain in arm at rest at injection site. Persistent severe body aches and headache. Extremely uncomfortable. OTC ibufrofen ineffective.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cold sweat, Dizziness, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: PATIENT PASESED OUT AFTER VACCINATIONS ADMINISTERED. MOVED TO THE FLOOR, PATIENT PULSE AND BREATHING STEADY. PATIENT BEGANT TO SEIZE. CALLED 911. SEIZING STOPPED, PATIENT CAME TO, VERY CLAMMY AND SWEATY. WIFE AND PHARMACIST REMAINED WITH THE PATIENT UNTIL HE CAME TO AND EMERGENCY TEAM ARRIVED AT PHARMACY.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: PATIENT PASESED OUT AFTER VACCINATIONS ADMINISTERED. MOVED TO THE FLOOR, PATIENT PULSE AND BREATHING STEADY. PATIENT BEGANT TO SEIZE. CALLED 911. SEIZING STOPPED, PATIENT CAME TO, VERY CLAMMY AND SWEATY. WIFE AND PHARMACIST REMAINED WITH THE PATIENT UNTIL HE CAME TO AND EMERGENCY TEAM ARRIVED AT PHARMACY.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out about 3 minutes afte receiving both vaccines. Informed us he didn't eat in the morning. Once passed out when giving blood.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Additional Details: patient came in for flu vaccine and notified rph that upon receiving new covid booster patient experienced no pain but an extremely large bruise. bruise is still very noticeable after 24 days from injection date. patient wanted rph to report to vaers
Age: 54.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer vaccine instead of intended 0.3 mL bivalent Pfizer booster.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Bell's palsy, Ear pain, Eyelid function disorder, Hypoaesthesia oral, Laboratory test
Clinical narrative: Bell's Palsy, left side; Painful.  Started with pain behind ear and left side of neck around 9/30/22 or 10/1/22.  On 10/5 lip was partly numb.  10/6 eye would not close.  Went to emergency room and hospital visit.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain
Clinical narrative: Bell's Palsy, left side; Painful.  Started with pain behind ear and left side of neck around 9/30/22 or 10/1/22.  On 10/5 lip was partly numb.  10/6 eye would not close.  Went to emergency room and hospital visit.
Age: 54.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster. No adverse reaction occurred; medication administration error due to Pfizer monovalent/bivalent vials looking similar.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Severe, Additional Details: convulsions, she had to go to the emergency room that night she received the immunization.
Age: 61.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer vaccine instead of intended 0.3 mL bivalent Pfizer booster. Medication administration error due to Pfizer monovalent/bivalent vials looking similar with same-colored caps.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: patient reportedly presented with massively swollen arm around injection site, was concerned it might be an infection, as patient claims to have not been swabbed with alcohol at time of vaccination. reporter did not interact with patient during injection or when patient returned to different pharmacy to report
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Flushing, Hyperhidrosis, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: gave patient hepatitis a shot and afterward pt felt dizzy. He sat on chair and mom call nurse. After few minutes, he said felt better
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal distension, Abdominal pain upper, Nausea
Clinical narrative: Stomachache, bloating and a sense of fullness, nausea
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling
Clinical narrative: Systemic: swelling in hands and feet-Medium, Additional Details: pt complained of swelling in hands and feet in the evening after getting her flu shot
Age: 28.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone, Burning sensation, Cardiac discomfort, Chest X-ray
Clinical narrative: The morning after (10/10/22) I had the shot I had a mild burning or irritation sensation around in the area of my heart.  A sensation I have never had before.  That sensation lasted most of the day.  By that evening that sensation stopped.  The following day (tuesday) i appeared to be fine.  I completed a very physical day of work outside, however that evening I felt more tired than usual.  Wednesday, I had a stressful experience at work, and I started to have heart palpitations, and occasional a-fib symptoms.  Thursday the palpitations where strong and continued through the night.  I went to the emergency room on friday morning to make sure it was not something more serious.  I have had a-fib symptoms a few times every year since I was 21 years old.  They gave me an iv at the hospital and the palpitations reduced quite a bit.  I was not in a-fib,  but was having a irregular heart beat.   I don't know that the issues are related, but I have never experienced the burning/irritation feeling in my chest before, and it seems possibly too coincidental for them to be separate issues.  That is why I am reporting the situation.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Differential white blood cell count, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: The morning after (10/10/22) I had the shot I had a mild burning or irritation sensation around in the area of my heart.  A sensation I have never had before.  That sensation lasted most of the day.  By that evening that sensation stopped.  The following day (tuesday) i appeared to be fine.  I completed a very physical day of work outside, however that evening I felt more tired than usual.  Wednesday, I had a stressful experience at work, and I started to have heart palpitations, and occasional a-fib symptoms.  Thursday the palpitations where strong and continued through the night.  I went to the emergency room on friday morning to make sure it was not something more serious.  I have had a-fib symptoms a few times every year since I was 21 years old.  They gave me an iv at the hospital and the palpitations reduced quite a bit.  I was not in a-fib,  but was having a irregular heart beat.   I don't know that the issues are related, but I have never experienced the burning/irritation feeling in my chest before, and it seems possibly too coincidental for them to be separate issues.  That is why I am reporting the situation.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate irregular, Metabolic function test, Palpitations, Stress, Thyroxine free
Clinical narrative: The morning after (10/10/22) I had the shot I had a mild burning or irritation sensation around in the area of my heart.  A sensation I have never had before.  That sensation lasted most of the day.  By that evening that sensation stopped.  The following day (tuesday) i appeared to be fine.  I completed a very physical day of work outside, however that evening I felt more tired than usual.  Wednesday, I had a stressful experience at work, and I started to have heart palpitations, and occasional a-fib symptoms.  Thursday the palpitations where strong and continued through the night.  I went to the emergency room on friday morning to make sure it was not something more serious.  I have had a-fib symptoms a few times every year since I was 21 years old.  They gave me an iv at the hospital and the palpitations reduced quite a bit.  I was not in a-fib,  but was having a irregular heart beat.   I don't know that the issues are related, but I have never experienced the burning/irritation feeling in my chest before, and it seems possibly too coincidental for them to be separate issues.  That is why I am reporting the situation.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin I
Clinical narrative: The morning after (10/10/22) I had the shot I had a mild burning or irritation sensation around in the area of my heart.  A sensation I have never had before.  That sensation lasted most of the day.  By that evening that sensation stopped.  The following day (tuesday) i appeared to be fine.  I completed a very physical day of work outside, however that evening I felt more tired than usual.  Wednesday, I had a stressful experience at work, and I started to have heart palpitations, and occasional a-fib symptoms.  Thursday the palpitations where strong and continued through the night.  I went to the emergency room on friday morning to make sure it was not something more serious.  I have had a-fib symptoms a few times every year since I was 21 years old.  They gave me an iv at the hospital and the palpitations reduced quite a bit.  I was not in a-fib,  but was having a irregular heart beat.   I don't know that the issues are related, but I have never experienced the burning/irritation feeling in my chest before, and it seems possibly too coincidental for them to be separate issues.  That is why I am reporting the situation.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: EMS came to store and took patient to hospital
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension, Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: EMS came to store and took patient to hospital
Age: 42.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect dose administered, No adverse event, Product administration error, Wrong product administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium
Age: 36.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect dose administered, Product administration error, Wrong product administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot
Clinical narrative: Face and ears are hot
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid breakthrough case
Age: 65.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 44.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect dose administered, Product administration error, Wrong product administered
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 37.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid breakthrough case
Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient requested a different vaccine, received this vaccine in error
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 5/30/21, 6/28/21. Pfizer 9/9/21. Positive on 10/17/22
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid breakthrough case
Age: 39.0
Sex: M
Vaccine: COVID19, SMALLMNK
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer due to medication administration error. Pfizer monovalent/bivalent vials look similar and have the same-colored caps which led to the pharmacist drawing up the wrong dose. Patient was informed of the error within a few days and provided medical advice. No adverse reactions reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood In Urine
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive pt, hospitalized, vaccinated X4
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: nothing
Age: 77.0
Sex: F
Vaccine: COVID19-2, PPV
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Headache, Menstrual disorder
Clinical narrative: 10 day menstural cycle (September 14-  10 days long - not when I was supposed to have it).  COVID positive 10/15/22 (cough, sore throat, fever, runny nose, headache, muscle aches, chills)
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: 10 day menstural cycle (September 14-  10 days long - not when I was supposed to have it).  COVID positive 10/15/22 (cough, sore throat, fever, runny nose, headache, muscle aches, chills)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I started with a sore throat and then I got a headache and a cough. I tested positive for COVID-19 on July 27, 2022, with an at home test. I contacted my doctor on the same day and describe my symptoms. He offered me Paxlovid and I decided not to take it at the time and the next day I was feeling much better. The fever kept coming and going for two weeks straight.