chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Disorientation, Injection site erythema, Injection site pruritus, Injection site swelling, Throat tightness
Clinical narrative: Felt disoriented; Little thickening in the throat; The site started with red; The site started with swelling; The site started with itch; This spontaneous case was received on 23-Nov-2022 from other non-healthcare professional (consumer) via Regulatory Communications (reference number: SEQW22-06036) and concerned 60-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included Levoxol (levofloxacin hemihydrate) for unreported indication.   On 06-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular (IM) and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same date, five minutes after receiving Flucelvax Quadrivalent, the patient's site started with a severe itch, red and swelling. Patient felt disoriented and had a little thickening in the throat. Patient reported that he was looking to find ingredients in the vaccine because he will have surgery and needed to run the ingredients to his allergist.   On unspecified date in Nov-2022, the patient used treatment medication Benadryl (diphenhydramine hydrochloride).   On unspecified date in Nov-2022, the patient recovered from all events.  The reporter assessed the events as related to Flucelvax Quadrivalent. As reported, the patient believed it was a reaction to vaccine.  Company comment: A 60-year-old female patient experienced vaccination site swelling, erythema and pruritus, felt disoriented and had throat tightness on the same date, five minutes after vaccination with the suspect Flucelvax Quadrivalent vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Causality is assessed as possibly related for all events based on plausible temporal relationship. The case does not meet Brighton Colaboration criteria for cellulitis at injection site.; Sender's Comments: A 60-year-old female patient experienced vaccination site swelling, erythema and pruritus, felt disoriented and had throat tightness on the same date, five minutes after vaccination with the suspect Flucelvax Quadrivalent vaccine. Information regarding the underlying medical history and concomitant medications has not been provided. Causality is assessed as possibly related for all events based on plausible temporal relationship. The case does not meet Brighton Colaboration criteria for cellulitis at injection site.
Age: 62.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Malaise, Pain, Product administration error
Clinical narrative: Sore; Not feeling well; Flucelvax Quadrivalent and Shingrix vaccine were administered on the same day in the same arm; This spontaneous case was retrieved on 24-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2504348-1) reported by other healthcare professional and concerned a 62-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included albuterol, used for shortness of breath. The patient had no known drug allergy.  On 09-Nov-2022, the patient was vaccinated with non-company, co-suspect Shingrix (varicella zoster vaccine rge (cho); route of administration: intramuscular, anatomical location: right arm, dose, and indication: not reported). The batch number reported was 2LC3P.  On 09-Nov-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: right arm, dose, and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 351711. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Shingrix, the patient experienced just sore and not feeling well.  The outcome of the events of 'feeling unwell' and 'pain' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 62-year-old female patient was vaccinated with Fluad Quadrivalent and with non-company, co-suspect Shingrix, on the same arm and in the same day (explicitly coded as 'Product administration error'). On the same day following vaccination, patient experienced pain and malaise. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to suggestive temporal relationship. Product administration error is assessed as not related as per company specific guidelines.; Sender's Comments: A 62-year-old female patient was vaccinated with Fluad Quadrivalent and with non-company, co-suspect Shingrix, on the same arm and in the same day (explicitly coded as 'Product administration error'). On the same day following vaccination, patient experienced pain and malaise. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to suggestive temporal relationship. Product administration error is assessed as not related as per company specific guidelines.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: the refrigerator that held the shingrix vaccine for the second dose was open for less than an hour and that her second shingrix dose's efficacy may be affected; This case was reported by a consumer via call center representative and described the occurrence of wrong technique in drug usage process in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK receipt date: 28-NOV-2022 Reporters comment: The reporter was the patient and she reported that she received both the doses of shingrix vaccine . The patient stated that last friday(three day before the day of reporting)that means 25th Nov 2022 the pharmacist called and stated that the refrigerator that held the shingrix vaccine for the second dose was opened for less than an hour and that her second shingrix dose's efficacy might be affected. No further information was able to be collected from patient The reporter did not consent to follow-up. Additional Supportive information: The refrigerator that held the shingrix vaccine for the second dose was opened for less than an hour and that her second shingrix dose which led to wrong technique in drug usage process .
Age: 86.0
Sex: U
Vaccine: COVID19-2
Symptoms: Bedridden, Chills, Headache, Tinnitus
Clinical narrative: buzzing on her ears; headache; chills; vaccine put her in bed; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing on her ears), HEADACHE (headache), CHILLS (chills) and BEDRIDDEN (vaccine put her in bed) in an 86-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS716AB) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) and Pfizer (Received other vaccines in the 4 weeks prior to COVID-19 vaccine. All previous 4 doses were Pfizer.). Past adverse reactions to the above products included No adverse event with Flu shot and Pfizer.  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 01-Dec-2022, the patient experienced TINNITUS (buzzing on her ears), HEADACHE (headache), CHILLS (chills) and BEDRIDDEN (vaccine put her in bed). At the time of the report, TINNITUS (buzzing on her ears), HEADACHE (headache) and CHILLS (chills) had not resolved and BEDRIDDEN (vaccine put her in bed) had resolved.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient stated that she received the vaccine on 01-Dec-2022. She stated the vaccine put her in bed. 3 hours after receiving the vaccine she had buzzing in her ears, she also started with headache and chills. All symptoms except buzzing in her ears had stopped.  Treatment information was not provided.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; An expired dose of Moderna Covid-19 vaccine was administered to a 10 yr old patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna Covid-19 vaccine was administered to a 10 yr old patient.) and NO ADVERSE EVENT (No adverse event) in a 10-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna Covid-19 vaccine was administered to a 10 yr old patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna Covid-19 vaccine was administered to a 10 yr old patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (An expired dose of Moderna Covid-19 vaccine was administered to a 10 yr old patient.).    No concomitant information was reported. The 2.5 ml of 1 dose vial was initially stored in the refrigerator on 01-Dec-2022 from freezer to room temperature and did not underwent any temperature excursions. No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had the Moderna vaccine, came down with COVID/felt like had cold; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had the Moderna vaccine, came down with COVID/felt like had cold) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth 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 COVID-19 (Had the Moderna vaccine, came down with COVID/felt like had cold). At the time of the report, COVID-19 (Had the Moderna vaccine, came down with COVID/felt like had cold) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant products reported.  The patient had Covid Friday night, woke up Saturday (as reported) and just felt like had a cold and a week later still felt like just had a cold, never got sick. The patient clarified that she had the Moderna vaccine, had the 2 shots and 2 boosters, total of 4 doses. The patient was going to get the 3rd booster but become positive before getting 3rd booster.  No treatment products reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; HCP calling in to report that an expired dose of PNEUMOVAX 23 was administered on 11/10/2022.; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot# U00306 has been verified to be not valid lot number, expiration date reported as 15-OCT-2022 (Expired product administered ) for prophylaxis (dose, route of administration and anatomical location were not provided). No additional adverse events was reported.
Age: 31.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional AE's were reported.; missed his second dose and still has not received it; This spontaneous report was received from a pharmacist and referred to a 31-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 26-JUL-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date and route of administration were not provided). The patient missed his second dose in September 2022 (reported as would be 2 months from 26-JUL-2022)a nd still had not received it (product dose omission issue). No additional adverse events (AEs) were reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Had both doses, continues to have outbreaks /suspected Vaccination failure; Shingles outbreak on the outside corner of her left eye; Continues to have outbreaks; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and shingles (Family History) (had a family history of family members with shingles outbreak including her mom, sister and brother who even had outbreaks when they were young, before they were elderly).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2021252868, US2022AMR180119   Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The patient had a history of shingles outbreaks. The patient had shingles outbreak before taking dose 1 of Shingrix. The patient had taken both doses of Shingrix and yet continues to have shingles outbreaks. The patient did not remember how many years ago she had the doses of Shingrix. The shots were given at an unspecified pharmacy. The patient did not have the records of Shingrix shots or the lot numbers. The patient currently had a shingles outbreak on the outside corner of her left eye. The patient was currently taking Valtrex to treat this outbreak. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252868:Same reporter US-GSK-US2022AMR180119:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: swelling at injection site/ silver dollar size; redness at injection site; Arm was sore; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and pain in arm to be related to Shingrix.     Additional Information: GSK receipt date: 28-NOV-2022 Reporter's comment: The reporter stated that patient had swelling it was silver dollar size ((1/4 cm in height) and redness at injection site which lasted 2 to 3 days. The patient's arm was sore No other side effects was reported and no medical attendance needed.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: case of shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-Dec-2022 Reporter's Comments:  The healthcare professionals reported that the patient received first dose of Shingrix. The patient experienced shingles approximately one month later. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Scratch, Urticaria
Clinical narrative: Very itchy; Began scratching hives; Hives on wrists, elbows, knees, more on right side, grew larger, hives were very itchy, looked like bug bites; This case was reported by a consumer via call center representative and described the occurrence of hives in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date unknown) for prophylaxis.   On 20th August 2022, the patient received the 1st dose of Shingrix. In September 2022, 1 month after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced pruritus and scratch. The patient was treated with betamethasone dipropionate. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the pruritus was recovered/resolved and the outcome of the scratch was unknown.   It was unknown if the reporter considered the hives, pruritus and scratch to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comment: The reporter was a patient. The patient reporter that he received Shingrix vaccine in the right arm at the pharmacy. The patient stated that approximately one month after received Shingrix vaccine he experienced hives. The patient experienced hives which began on interior and exterior of their wrist and couple of weeks later hives spread to interior and exterior of elbows and outside of both knees. The patient stated that the hives began more on the right side of their body, before spreading to the left side. The patient stated that the hives started out as two or three that looked like bug bites, which then spread after they began scratching them.  The hives also grew larger, to about the size of a pencil point and hives was very itchy.  The patient received betamethasone diproprionate topical ointment as a treatment which was resolved the itching. The patient reported that they continued to develop two or three new hives every other day. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: administration with 5/8 needle instead of  1inch; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect needle gauge used in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29th November 2024) for prophylaxis.   On 27th November 2022, the patient received Boostrix. On 27th November 2022, unknown after receiving Boostrix, the patient experienced incorrect needle gauge used. On an unknown date, the outcome of the incorrect needle gauge used was unknown.   Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comment: The reporter reported that the patient received a dose of Boostrix and administered with a 5/8 needle instead of a 1 inch needle.  The reporter consented to follow up. Additional Supportive Information: The patient received Boostrix with 5/8 needle instead of a 1 inch needle, which led to incorrect needle gauge used.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Rash pustular, Vaccination failure
Clinical narrative: 2 shingrix doses, then shingles; Shingles under right and left  breasts; rash began as little pustules; itchy pustules, ruptured pustules leaving  itchy area; ruptured pustules leaving red area; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression and crohn's disease. Concomitant products included infliximab (Remicade).   On 29th March 2022, the patient received the 2nd dose of Shingrix. On 18th January 2022, the patient received the 1st dose of Shingrix. In November 2022, between 6 and 7 months after receiving Shingrix and between 10 and 11 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pustular rash, pruritus and erythema. On an unknown date, the outcome of the vaccination failure, pustular rash, pruritus and erythema were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pustular rash, pruritus and erythema to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 01-Dec-2022 Reporter's Comments:  This case was self-reported by the patient.  The patient received first dose and the second dose of Shingrix.  The patient reported being unaware of which arm they received doses in, but stated they typically received vaccinations in the left arm.  The patient experienced Shingles outbreak, which began approximately a week and half ago.  The patient reported Shingles outbreak began on the right side, under the right breast along the bra line before spreading the left side, under the left breast two days later. The patient reported rash began as little pustules, which were itchy.  The patient reported pustules have now ruptured, leaving the area red and itchy.  The patient reported being immunosuppressed, due to taking Remicade for treatment of Crohn's disease.  The reporter did not consent to follow up. Additional supportive information: This case considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: SEPSIS; This spontaneous report received from a health care professional (nurse) via social media via a company representative concerned a male of an unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after vaccination the patient experienced sepsis 2 times. The reporter stated "After taking J and J my husband was septic 2 times. The second time he sided. I never took it I m a nurse didn't trust it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sepsis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221209844-Sepsis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had the Moderna vaccine, came down with COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had the Moderna vaccine, came down with COVID) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth 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 COVID-19 (Had the Moderna vaccine, came down with COVID). At the time of the report, COVID-19 (Had the Moderna vaccine, came down with COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant product was reported.  The patient had the 2 shots and 2 boosters, total of 4 doses. The patient was going to get the 3rd booster but become positive before getting 3rd booster.  No treatment product reported
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick for 2 weeks; Initial information was received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who stated sick for 2 weeks after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event sick for 2 weeks (illness) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: have the flu now and it's horrible; Initial information received on 02-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced have the flu now and it's horrible after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious have the flu now and it's horrible (influenza) (unknown latency) following the administration of influenza vaccine. Nothing like the flu we used to get.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Death, Dizziness, Pulmonary embolism
Clinical narrative: dizziness, increased anxiety pulmonary embolism  DEATH
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hypotonia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt. received her flu shot. She appeared to be fine when she left the pharmacy area. A few minutes later she came back asking for help-she felt lightheaded. She sat down and slumped over. A nurse was in line and she assited me to get the patient on the floor and put her legs up on a chair. We called EMS in the meantime. She attemped to sit up once but she was lightheaded still so she laid back down on the floor. EMT arrived and took her by stretcher out to the ambulance.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt came in for 10am appointment for moderna bivalent dose no.5. Vaccine administred as per procedure. Pt was instructed to sit in waiting area for the recommended 15 minutes. Pharmacist administered vaccine to next patient who happened to be pts husband. Pharmacist left vaccination area to come go to the pharmacists to update covid vaccine cards and retrieve immunization coupons. While in the pharmacy pharmacist heard pts husband calling her name. Pharmacy to find pt staring straight and
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: rash on arm, extremities and torso-Medium
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Dizziness, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: redness and mild swelling with warmth to left lateral aspect of arm about 6cm area of erythema. does not affect movement of arm. no other symptoms.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: patient fainted and father said patient hit head on floor. so ambulance was called and paramedics took patient to hospital
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Knot below injection site as well as redness-Medium, Additional Details: Patient came into the pharmacy and reported Shingrix Vaccine caused knot on left arm as well as redness below injection site. Days 2 and 3 were the worst but reports left arm very sore and unable to move without pain. He is recovering but will be contacting primary care provider on monday to report reaction.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Knot below injection site as well as redness-Medium, Additional Details: Patient came into the pharmacy and reported Shingrix Vaccine caused knot on left arm as well as redness below injection site. Days 2 and 3 were the worst but reports left arm very sore and unable to move without pain. He is recovering but will be contacting primary care provider on monday to report reaction.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 3/5/21 Janssen 1802068
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear infection, Exposure during pregnancy, Facial paralysis, Immunisation reaction
Clinical narrative: 33 weeks gestation presents to the emergency department referred from urgent care and her OB/GYN for evaluation of left-sided facial tingling and left-sided facial droop. Bells palsy secondary to left ear infection vs COVID vaccine. Recommended to follow up with neurologist
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 33 weeks gestation presents to the emergency department referred from urgent care and her OB/GYN for evaluation of left-sided facial tingling and left-sided facial droop. Bells palsy secondary to left ear infection vs COVID vaccine. Recommended to follow up with neurologist
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hot flush
Clinical narrative: Narrative:  Patient received first Pfizer COVID-19 vaccination in late October 2021 and PCP reported "He reports receiving covid 19 vaccine on 10/14/2021 w/diarrhea, fatigue, abdominal pain, symptoms improving since receiving the vaccine. He reports he previously had Covid one year ago with same symptoms. Is resting and drinking fluids/PediaLyte. Patient received second Pfizer COVID-19 vaccination middle November 2021 and a message to PCP was sent saying, "I got the second COVID vaccination on Tuesday. I haven't been to work since. I'm very tired, have bad diarrhea, headache, and chills / hot flashes. I'm going to try to find an urgent care this morning. I will send you a copy of the record of treatment. I saw you after the first injection with the same complaints. I wish you would enter into my record that I have these negative effects so that I may avoid both flu and COVID vaccinations in the future. They are not consistent with my crohn's disease and my reduce immune system from years of taking high dose corticoids."
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: Narrative:  Patient received first Pfizer COVID-19 vaccination in late October 2021 and PCP reported "He reports receiving covid 19 vaccine on 10/14/2021 w/diarrhea, fatigue, abdominal pain, symptoms improving since receiving the vaccine. He reports he previously had Covid one year ago with same symptoms. Is resting and drinking fluids/PediaLyte. Patient received second Pfizer COVID-19 vaccination middle November 2021 and a message to PCP was sent saying, "I got the second COVID vaccination on Tuesday. I haven't been to work since. I'm very tired, have bad diarrhea, headache, and chills / hot flashes. I'm going to try to find an urgent care this morning. I will send you a copy of the record of treatment. I saw you after the first injection with the same complaints. I wish you would enter into my record that I have these negative effects so that I may avoid both flu and COVID vaccinations in the future. They are not consistent with my crohn's disease and my reduce immune system from years of taking high dose corticoids."
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Narrative:  Unsure of narrative or history. Patient presented to clinic to establish care and simply noted "anaphylaxis" with Pfizer COVID-19 vaccine. Her physician recommended against the second vaccine.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Drooling, Hyperhidrosis, Mobility decreased, Speech disorder, Unresponsive to stimuli
Clinical narrative: Narrative:  2 minutes after the administration of the vaccine patient became unresponsive, diaphoretic, couldn't hold his arm up on the walker, drooling and could not speak. per notes patient came to in an ambulance was seen in emergency room. EKG ordered and stat labs, patient discharged home
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Narrative: Itchiness after getting the Covid vaccine at about 3 PM today without any associated hives, swelling, chest pain or shortness of breath. Patient sent to  ED from vaccine clinic. Patient had previous allergic reaction to typhoid and  influenza vaccine, Prior to this she has been well. After administration of  medications, patient felt significantly better and discharged from ED.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block first degree, Atrioventricular block second degree, Dyspnoea, Electrocardiogram abnormal, Extrasystoles
Clinical narrative: Narrative:  Patient received second dose of Pfizer COVID-19 vaccine on 9/9/21. Reportedly she developed palpitations 2-3 days after the immunization. Palpitations lasted 1 to 1.5 weeks and occurred every 5 minutes for several hours. The patient felt that her breath was taken away for a few moments. Of note, she appears to have a history of arrhythmias and was on a Zio Patch even prior to initiating the vaccine series. She reports compliance with her metoprolol. She denies drinking energy drinks or caffeine at the time. The palpitations self resolved.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Narrative:  Patient received second dose of Pfizer COVID-19 vaccine on 9/9/21. Reportedly she developed palpitations 2-3 days after the immunization. Palpitations lasted 1 to 1.5 weeks and occurred every 5 minutes for several hours. The patient felt that her breath was taken away for a few moments. Of note, she appears to have a history of arrhythmias and was on a Zio Patch even prior to initiating the vaccine series. She reports compliance with her metoprolol. She denies drinking energy drinks or caffeine at the time. The palpitations self resolved.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Resident was to receive Pfizer Bivalent Vaccine and was inadvertantly given Pfizer Monovalent.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Oedema peripheral, Paraesthesia, Pruritus
Clinical narrative: Narrative:  tingling to arm, itching of arm and swelling feeling to axilla of the same side the injection was given
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: Narrative: Dry mouth reported with covid19 vaccine.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain, Rhinorrhoea
Clinical narrative: Narrative: One day after receiving the booster, patient reported body aches but resolved one day after onset. Appears nasal drainage and cough also started after booster was given.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Infection, Nasopharyngitis
Clinical narrative: Patient reports she held her Humira due to infection, Patient reports she has a cold after taking the flu shot. Patient reports her primary provider prescribed Ibuprofen, Prednisone and antibiotics. No additional information provided. patient does not consent to be contacted.
Age: 66.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Prevnar 13 given vs the ordered Prevnar 20.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the pediatric dose of Hep A (Havrix). Patient was informed and was given the adult dose.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: Redness from shoulder to elbow, warmth, too painful to move Previous cellulitis with a flu vaccine
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills
Clinical narrative: Severe chills
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: I received the vaccine on 12/01/2022. By the next day around midnight I noticed a buzzing (ringing) noise in both ears that has progressed to constant ringing.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I tested positive for COVID-19 on 12/6/22. I had a sore throat and it continued to get worse. I have a slight fever, congestion, cough, and chills. It felt like I had a horrible cold. I was prescribed 5 days' worth of PAXLOVID. I have taken 2 days' worth so far. I am feeling better, but still have congestion.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 12/6/22. I had a sore throat and it continued to get worse. I have a slight fever, congestion, cough, and chills. It felt like I had a horrible cold. I was prescribed 5 days' worth of PAXLOVID. I have taken 2 days' worth so far. I am feeling better, but still have congestion.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Blood creatine phosphokinase normal, Fatigue, Full blood count normal, Gait inability, Influenza
Clinical narrative: Significant fatigue and leg pain noted the night after vaccines, patient unable to walk, constantly fussy/sleepy Seen in office the next day, exquisitely tender, unable to bear weight on legs. Family had been underdosing Tylenol/Ibuprofen. Given high rates of flu, we treated for flu despite testing flu negative (thought it may be myalgias). Patient had negative tests for rhabdomyolysis Seen 2 days later - No Tamiflu given, complete recovery to normal self with increaseing Tylenol/Ibuprofen dose.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Influenza virus test negative, Irritability, Metabolic function test normal, Pain in extremity, Somnolence
Clinical narrative: Significant fatigue and leg pain noted the night after vaccines, patient unable to walk, constantly fussy/sleepy Seen in office the next day, exquisitely tender, unable to bear weight on legs. Family had been underdosing Tylenol/Ibuprofen. Given high rates of flu, we treated for flu despite testing flu negative (thought it may be myalgias). Patient had negative tests for rhabdomyolysis Seen 2 days later - No Tamiflu given, complete recovery to normal self with increaseing Tylenol/Ibuprofen dose.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: Significant fatigue and leg pain noted the night after vaccines, patient unable to walk, constantly fussy/sleepy Seen in office the next day, exquisitely tender, unable to bear weight on legs. Family had been underdosing Tylenol/Ibuprofen. Given high rates of flu, we treated for flu despite testing flu negative (thought it may be myalgias). Patient had negative tests for rhabdomyolysis Seen 2 days later - No Tamiflu given, complete recovery to normal self with increaseing Tylenol/Ibuprofen dose.
Age: 0.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, IPV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given a flulaval flu vaccine to earlier the client is month's old the requirement is 6 months
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Migraine, Nausea, Vomiting
Clinical narrative: migraine, dizziness, nausea/vomiting
Age: 42.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Ear discomfort, Ear infection, Hypersomnia
Clinical narrative: On 12/04/2022, I flew back from traveling out of town and I was unable to equalize pressure in my right ear. When I woke up on 12/05/2022, I had nasal congestion, sore throat, coughing, sneezing, and I still couldn't clear my right ear. I took an at home COVID-19 test and the results were positive. I slept most of that day. Tuesday, I was still under the weather. I felt a little bit better but was still having symptoms. I went to a local walk-in clinic, and they diagnosed an ear infection. I let them know at the clinic, that I had tested positive for COVID-19 with an at home test. They prescribed antibiotics for the ear infection and advised that I call them back if things get worse. Things seem to be getting slowly but steadily better.
Age: 42.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive, Sneezing
Clinical narrative: On 12/04/2022, I flew back from traveling out of town and I was unable to equalize pressure in my right ear. When I woke up on 12/05/2022, I had nasal congestion, sore throat, coughing, sneezing, and I still couldn't clear my right ear. I took an at home COVID-19 test and the results were positive. I slept most of that day. Tuesday, I was still under the weather. I felt a little bit better but was still having symptoms. I went to a local walk-in clinic, and they diagnosed an ear infection. I let them know at the clinic, that I had tested positive for COVID-19 with an at home test. They prescribed antibiotics for the ear infection and advised that I call them back if things get worse. Things seem to be getting slowly but steadily better.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Nodule, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: She got her vaccine, after she went to sleep that night around 11:00 PM her arm started hurting ,she could not lay on the arm and when she felt of it it was warm and swollen.  The next morning when it looked at it in the mirror it was red and swollen from her shoulder to her elbow almost completely around the arm.  Later in the day it developed a hard knot larger than her fist from top to bottom.  You could tell by looking at the arm that it was swollen and warm, which lasted about a week.  She did not call her doctor, but did call the pharmacy to see if there was anything recommended to do for it, and she was advised to put cool compresses on it, which she did not do.  She then called us and left a VM.  She did take some Tylenol a couple of times, and gradually started going down about Wednesday and by Friday it was gone.  it also had a sort of rashy look to it, but nothing really raised, but felt like rough, dry skin.