chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: she broke out in horrible hives; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp(health care professional).  This case involves a 76 years old female patient who experienced horrible hives after receiving vaccine influenza vaccine .  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of influenza vaccine  produced by unknown manufacturer (with unknown formulation, frequency, strength, dose, route, lot number and expiration)  in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient developed  horrible hives (urticaria) (latency: same day) following the administration of influenza vaccine   It was reported that "she ended up in the E.R. It took a couple of days for it to go away. I wonder just what is in that Senior Flu shot!."  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (she broke out in horrible hives).  At time of reporting, the outcome was Unknown for the event she broke out in horrible hives.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu, never again will I get a flu shot, that was the first flu I ever had; Initial information was received on 19-Nov-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 unknown gender of patient who got the flu, never again will i get a flu shot, that was the first flu i ever had 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 a dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, dosage, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patient who got the flu, never again will i get a flu shot, that was the first flu i ever had (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu, never again will I get a flu shot, that was the first flu I ever had).  At time of reporting, the outcome was Unknown for the event got the flu, never again will i get a flu shot, that was the first flu i ever had.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: ill; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced ill 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 had developed ill (illness) after receiving an unknown dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (ill).  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm was going to fall off, terrible pain; Initial information received on 19-Nov-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp via Flu Social Media page.  This case involves a patient unspecified demographics who experienced arm was going to fall off, terrible pain while receiving vaccine 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 suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation strength, dose, lot number, route in unknown administration site) for influenza vaccination.  On an unknown date, the patient developed a non-serious arm was going to fall off, terrible pain (pain in extremity) at unknown latency following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE was 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 arm was going to fall off, terrible pain.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired product with no reported adverse event; Initial information received on 17-Nov-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 16-year-old female patient who received an expired product with no reported adverse event after receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine.  On 16-Nov-2022, the patient received 0.5ml (once) dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (batch lot: U7140BB) (expiry date: 07-Nov-2022) via intramuscular route in the left deltoid (form, strength: unknown) for Immunization.  On 16-Nov-2022 the patient developed a non-serious event of received an expired product with no reported adverse event (expired product administered) (latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken with meningococcal vaccine (menactra) was not applicable.  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: F
Vaccine: FLUX
Symptoms: Condition aggravated, Sinusitis
Clinical narrative: Child has a sinus infection/symptoms worsened; Condition aggravated; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp ( non-health care professional ).  This case involves an unknown age female patient who reported that she  has a sinus infection/symptoms worsened after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitnats, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer ( with unknown strength, form, route, batch number and expiration date ) at unknown administration site for prophylactic vaccination.  On an unknown date the patient ha  a non-serious event sinus infection/symptoms worsened (sinusitis) (Condition aggravated) (latency : same day )   No lab data included  Action taken : not applicable.  corrective treatment : antibiotics for both events.  Outcome : Unknown.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: office intentionally administered Fluzone HD QIV to this patient because the patient was so close to being 65 with no reported adverse event; Initial information received from on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old female patient who had experienced office intentionally administered fluzone hd qiv to this patient because the patient was so close to being 65 with no reported adverse event while receiving 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 an unknown date, the patient had received a unknown dose of suspect  influenza quadrival a-b high dose hv vaccine  (strength, frequency,expiration date, route and batch number: unknown) at unknown administration site for Immunization.   On an unknown date the patient developed a non-serious office intentionally administered fluzone hd qiv to this patient because the patient was so close to being 65 with no reported adverse event (off label use) (same day latency) following the administration of influenza quadrival a-b high dose hv 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.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: child patient received ACTHIB vaccine about an hour ago that was expired with no reported adverse event; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 3 years old male child patient who received acthib vaccine about an hour ago that was expired with no reported adverse event while receiving vaccine hib (prp/t) vaccine [Act-Hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Nov-2022, the patient received a dose 4 suspect hib (prp/t) vaccine Powder and solvent for solution for injection at a dose of  0.5 ml units total  ( lot UJ600AAB) (expiry date: unknown) via intramuscular route in the left thigh for Immunization.  On an unknown date the patient was diagnosed with non-serious event of "child patient received acthib vaccine about an hour ago that was expired with no reported adverse event" (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken was not applicable.  Outcome was Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the fluzone qiv np vaccine in the back of her arm subcutaneously,with no reported adverse event; Initial information received on 18-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who was administered the fluzone qiv np vaccine in the back of her arm subcutaneously,with no reported adverse event after receiving quadrivalent influenza vaccine (Fluzone QIV).  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 a dose of suspect quadrivalent influenza vaccine, Suspension for injection (strength, dose, expiry date: unknown) lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient was administered the fluzone qiv np vaccine in the back of her arm subcutaneously,with no reported adverse event (incorrect route of product administration) (unknown latency).  It was reported, patient received the FLUZONE QIV NP vaccine in the back of her arm subcutaneously and is inquiring if its effective or would the patient need to be redosed in the deltoid?   Action taken: not applicable  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.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itching, redness and warmth on the injection site; Itching, redness and warmth on the injection site; Itching, redness and warmth on the injection site; This spontaneous case was received on 10-Nov-2022 from other healthcare professional (consumer/nurse) via Communications (reference number SEQW22-05668) and concerned a 65-years-old, female patient.  The patient had no relevant medical history. The patient's concomitant medication included Zoloft (sertraline hydrochloride), calcium and vitamin e, all used for unreported indication.   On 07-Nov-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0,5 ml, route of administration and anatomical location: not reported), for influenza prophylaxis. The batch number was not reported.  On the same date, after receiving Fluad Quadrivalent, the patient experienced itching, redness and warmth on the injection site.  The outcome of events vaccination site warmth, vaccination site erythema and vaccination site pruritus was unknown.  The reporter assessed case as non-serious.  Company comment: A 65-year-old male patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced itching, redness and warmth on the injection site. Causality is assessed as possibly related, based on anatomical and chronological plausibility.; Sender's Comments: A 65-year-old male patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced itching, redness and warmth on the injection site. Causality is assessed as possibly related, based on anatomical and chronological plausibility.
Age: 42.0
Sex: M
Vaccine: FLUC3
Symptoms: Body temperature increased, Cough, Fatigue, Headache, Malaise
Clinical narrative: Mild cough which got worse over the course of the day; Feeling a little sick; Sore throat; General soreness; Temperature was 102.1; Headache; General fatigue; This spontaneous case was received on 12-Nov-2022, from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-05741) and concerned a 42-year-old male patient.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included two Flucelvax Quadrivalent (influenza vaccine inact sag 4v), both administered on an unspecified date, over the past two years.   On 06-Oct-2022, at approximately 9am, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.   On 11-Nov-2022, one month and five days after receiving Flucelvax Quadrivalent, the patient started feeling a little sick. The patient woke up with very mild cough which got worse over the course of the day. The symptoms persisted overnight.  On an unspecified date in Nov-2022 (between 11-Nov-2022 and 12-Nov-2022), an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced cough, mild sore throat, headache, general fatigue/soreness, and his temperature was 102.1.  On unspecified date in Nov-2022, the patient took two COVID-19 tests, and the results were negative. At the time of the initial reporting, the patient did not have any plans to go to the doctor or be tested for any other respiratory viruses.  At the time of the initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment. It was in the patient's opinion that these were possible adverse events, but he was not 100 percent sure if they were reportable.  The case was assessed as non-serious.  Company comment: A 42-year-old male patient was vaccinated with Flucelvax Quadrivalent. Approximately one month following vaccination, patient reported cough, oropharyngeal pain, pain, body temperature increased, headache, fatigue and malaise. Due to unsuggestive temporal relationship, reported events are assessed as not related to the suspect product.; Sender's Comments: A 42-year-old male patient was vaccinated with Flucelvax Quadrivalent. Approximately one month following vaccination, patient reported cough, oropharyngeal pain, pain, body temperature increased, headache, fatigue and malaise. Due to unsuggestive temporal relationship, reported events are assessed as not related to the suspect product.
Age: 42.0
Sex: M
Vaccine: FLUC3
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test negative
Clinical narrative: Mild cough which got worse over the course of the day; Feeling a little sick; Sore throat; General soreness; Temperature was 102.1; Headache; General fatigue; This spontaneous case was received on 12-Nov-2022, from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-05741) and concerned a 42-year-old male patient.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included two Flucelvax Quadrivalent (influenza vaccine inact sag 4v), both administered on an unspecified date, over the past two years.   On 06-Oct-2022, at approximately 9am, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.   On 11-Nov-2022, one month and five days after receiving Flucelvax Quadrivalent, the patient started feeling a little sick. The patient woke up with very mild cough which got worse over the course of the day. The symptoms persisted overnight.  On an unspecified date in Nov-2022 (between 11-Nov-2022 and 12-Nov-2022), an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced cough, mild sore throat, headache, general fatigue/soreness, and his temperature was 102.1.  On unspecified date in Nov-2022, the patient took two COVID-19 tests, and the results were negative. At the time of the initial reporting, the patient did not have any plans to go to the doctor or be tested for any other respiratory viruses.  At the time of the initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment. It was in the patient's opinion that these were possible adverse events, but he was not 100 percent sure if they were reportable.  The case was assessed as non-serious.  Company comment: A 42-year-old male patient was vaccinated with Flucelvax Quadrivalent. Approximately one month following vaccination, patient reported cough, oropharyngeal pain, pain, body temperature increased, headache, fatigue and malaise. Due to unsuggestive temporal relationship, reported events are assessed as not related to the suspect product.; Sender's Comments: A 42-year-old male patient was vaccinated with Flucelvax Quadrivalent. Approximately one month following vaccination, patient reported cough, oropharyngeal pain, pain, body temperature increased, headache, fatigue and malaise. Due to unsuggestive temporal relationship, reported events are assessed as not related to the suspect product.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Decreased vibratory sense, Immunoglobulin therapy, Loss of proprioception, Lumbar spinal stenosis, Magnetic resonance imaging spinal abnormal
Clinical narrative: Progressive leg weakness beginning on 10/17/22. Patient had to use a cane at time of presentation. Received 5 days of IVIG. strength intact but difficulty with lower extremity control, loss of vibration and proprioception.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscular weakness, Musculoskeletal disorder, Spinal osteoarthritis, Walking aid user
Clinical narrative: Progressive leg weakness beginning on 10/17/22. Patient had to use a cane at time of presentation. Received 5 days of IVIG. strength intact but difficulty with lower extremity control, loss of vibration and proprioception.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypoxia, Mental status changes
Clinical narrative: Altered Mental Status causing Hypoxia, cardiac event
Age: 32.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Abortion spontaneous
Clinical narrative: normal pregnancy with no visible issues untill miscarriage 2 months after taken the vacine estimated date of birth was October 2021
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to plants, Asthma, Condition aggravated, Cough, Increased viscosity of upper respiratory secretion
Clinical narrative: Beginning some time in the two weeks after the vaccine my asthma became uncontrolled. Use of my albuterol rescue inhaler increased from once or twice a week to once or twice per day. This continued through the summer and into the beginning of November, when my breathing became better and rescue inhaler use decreased back to baseline. During the period of uncontrolled asthma I experienced daily wheezing, a cough, and heavy mucus buildup in my throat and trachea. I had no fever, and the symptoms were generally not worse during exercise. The rescue inhaler provided only partial relief. There was smoke from forest fires during part of the summer, but the uncontrolled asthma did not align temporally with the smoke, although the smoke made it worse. When I travelled during the summer and fall, the asthma did not significantly change.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Mite allergy, Pulmonary function test normal, Seasonal allergy, Skin test positive, Wheezing
Clinical narrative: Beginning some time in the two weeks after the vaccine my asthma became uncontrolled. Use of my albuterol rescue inhaler increased from once or twice a week to once or twice per day. This continued through the summer and into the beginning of November, when my breathing became better and rescue inhaler use decreased back to baseline. During the period of uncontrolled asthma I experienced daily wheezing, a cough, and heavy mucus buildup in my throat and trachea. I had no fever, and the symptoms were generally not worse during exercise. The rescue inhaler provided only partial relief. There was smoke from forest fires during part of the summer, but the uncontrolled asthma did not align temporally with the smoke, although the smoke made it worse. When I travelled during the summer and fall, the asthma did not significantly change.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Night sweats
Clinical narrative: Systemic: Flushed / Sweating-Medium, Additional Details: Patient experienced night sweats with each dose of Pfizer Covid vaccine
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Injection site swelling, Paraesthesia, Swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Numbness and swelling-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Numbness and swelling
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain
Clinical narrative: Systemic: Joint Pain-Severe, Additional Details: Pain on left side of body, in hip area. Started following vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Unknown. 2 bivalent covid booster in less than 2 months
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood test, Chest X-ray normal, Decreased appetite, Dehydration, Electrocardiogram normal
Clinical narrative: Flushing across chest area, loss of appetite, lethargic, rapid heart beat, jittery. Would seem to feel better then symptoms started again.  Went to Urgent care test showed  no Covid, no flu. Diagnosed hyponatremia and dehydration Stopped farxiga, hydrochlorathorazide and fossinapril Next day 11/23 went to ER still having flushing across chest.  Tested for more viruses showed none EKG and chest X-ray normal Diagnosed hyponatremia and reaction to influenza immunization Next day still had flushing lack of appetite 11/24 after eating  better increased sodium rich foods Feel much better . No flushing across chest Told to follow up with nephrologist
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Feeling jittery, Flushing, Heart rate increased, Hyponatraemia, Immunisation reaction
Clinical narrative: Flushing across chest area, loss of appetite, lethargic, rapid heart beat, jittery. Would seem to feel better then symptoms started again.  Went to Urgent care test showed  no Covid, no flu. Diagnosed hyponatremia and dehydration Stopped farxiga, hydrochlorathorazide and fossinapril Next day 11/23 went to ER still having flushing across chest.  Tested for more viruses showed none EKG and chest X-ray normal Diagnosed hyponatremia and reaction to influenza immunization Next day still had flushing lack of appetite 11/24 after eating  better increased sodium rich foods Feel much better . No flushing across chest Told to follow up with nephrologist
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Influenza virus test negative, Lethargy, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: Flushing across chest area, loss of appetite, lethargic, rapid heart beat, jittery. Would seem to feel better then symptoms started again.  Went to Urgent care test showed  no Covid, no flu. Diagnosed hyponatremia and dehydration Stopped farxiga, hydrochlorathorazide and fossinapril Next day 11/23 went to ER still having flushing across chest.  Tested for more viruses showed none EKG and chest X-ray normal Diagnosed hyponatremia and reaction to influenza immunization Next day still had flushing lack of appetite 11/24 after eating  better increased sodium rich foods Feel much better . No flushing across chest Told to follow up with nephrologist
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy, onset 11/07/2022
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: tested +for covid - symptoms: headache, mild cough, head congestion started Paxlovid on Day 1
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: There were no adverse reactions. Patient received lower dose than is recommended.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dizziness, Headache, Influenza, Influenza virus test positive
Clinical narrative: I had the Pfizer covid bivalent vaccine on 11/19/2022. Severe headache happened  to me on 11/20/22. Then I started to not feel well on 11/21/22. I had symptoms of cough,  running nose, and issues with my sinuses. On Wednesday, 11/23/22, I  had same symptoms plus I felt lightheaded like I was going to pass out around 3:30pm. I was at work at the time. I  went home feeling sick and later in the evening around 7pm I went to clinic and was tested on 11/23/2022. I  was positive for the flu. I am sharing this as a possible complication with the covid-19 booster. I  had already taken the flu vaccine about a month ago. I still got flu after recently getting the covid-19 bivalent booster on 11/19/2022.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Rhinorrhoea, Sinus disorder
Clinical narrative: I had the Pfizer covid bivalent vaccine on 11/19/2022. Severe headache happened  to me on 11/20/22. Then I started to not feel well on 11/21/22. I had symptoms of cough,  running nose, and issues with my sinuses. On Wednesday, 11/23/22, I  had same symptoms plus I felt lightheaded like I was going to pass out around 3:30pm. I was at work at the time. I  went home feeling sick and later in the evening around 7pm I went to clinic and was tested on 11/23/2022. I  was positive for the flu. I am sharing this as a possible complication with the covid-19 booster. I  had already taken the flu vaccine about a month ago. I still got flu after recently getting the covid-19 bivalent booster on 11/19/2022.
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: after receiving the bivalent pfizer vaccine patient's arm started to itch and he had some redness up and down arm. it was then warm. i advised him to take benadryl and watch it closely. if it gets worse to go to urgent care/ER.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Pain in extremity
Clinical narrative: No adverse event reported but Pfizer monovalent was given by mistake when it should have been Pfizer bivalent. The patient reports no side effects other than a sore arm.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Patient reported no adverse effects.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Patient reported no adverse effects.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Dyspnoea, Full blood count, Gait disturbance
Clinical narrative: Days 1-3 severe headache and weakness.  Starting Day 4 severe muscle weakness, muscle pain, muscle spasms, shortness of breath.   My symptoms seem to correspond to a diagnosis of Rhabdomyolysis and I am now undergoing regular IV infusions to help with my pain and weakness via a local Hematologist.   Symptoms Continue even today which is now 26 days post vaccine.  I still have difficultly walking any distance and have severe muscle pain
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Metabolic function test, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Days 1-3 severe headache and weakness.  Starting Day 4 severe muscle weakness, muscle pain, muscle spasms, shortness of breath.   My symptoms seem to correspond to a diagnosis of Rhabdomyolysis and I am now undergoing regular IV infusions to help with my pain and weakness via a local Hematologist.   Symptoms Continue even today which is now 26 days post vaccine.  I still have difficultly walking any distance and have severe muscle pain
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rhabdomyolysis
Clinical narrative: Days 1-3 severe headache and weakness.  Starting Day 4 severe muscle weakness, muscle pain, muscle spasms, shortness of breath.   My symptoms seem to correspond to a diagnosis of Rhabdomyolysis and I am now undergoing regular IV infusions to help with my pain and weakness via a local Hematologist.   Symptoms Continue even today which is now 26 days post vaccine.  I still have difficultly walking any distance and have severe muscle pain
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: The patient went to the emergency room who diagnosed her to have Cellulitis at the site of injection that spread to both upper extremities.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Central venous catheterisation, Device related thrombosis, Intensive care, Jugular vein thrombosis
Clinical narrative: While I did have a port in my jugular for chemo a few weeks after receiving Moderna shot I presented with a 3"-4" blood clot in my right jugular. Every doctor/surgeon stated they had never seen a clot this big from a port. I was rushed to ER and then spent one week in ICU on IV blood thinners. I was sent home and kept on blood thinners for the next 6 months.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Influenza virus test negative, Malaise
Clinical narrative: High fever, EXTREME body aches, malaise, fatigue, headache, dizziness? for over a week
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: High fever, EXTREME body aches, malaise, fatigue, headache, dizziness? for over a week
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biliary colic, Cholecystectomy
Clinical narrative: Received vaccine on Monday, had sudden Gall bladder attack on Friday. No prior symptoms at all, emergency gallbladder removal surgery done on Saturday Nov 12, 2022
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Visual impairment
Clinical narrative: On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Patient mentioned that they have had some recent vision issues but was informed that there is no incident of the vaccine causing vision issues. Patient was told the vision issue could be due to something else.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Patient reported no adverse effects.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: On 11/23/2022 the patient was given Pfizer Monovalent Vaccine when they should have received Pfizer Bivalent Vaccine. Attempted to reach patient to report error but patient has not responded to our phone calls.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal disorder, Muscle spasms, Muscle twitching, Paraesthesia
Clinical narrative: Patient reports twitching in legs, GI issues including significant diarrhea, tingling and cramping in the feet
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Patient had his shot at 5pmish on the 18th.  We drank lots of water to stay hydrated, etc.  He woke up at 3:15 am on the 19th feeling very nauseous.  He threw up and continued to throw up (no food in stomach so just bile) on and off every 10-15 minutes until 7:30 am when he feel asleep exhausted.  He woke up, threw up one more time then feel back asleep and slept until 12pm om the 19th.  He had a headache and was very tired but otherwise ok.  No more vomiting that day.  He felt much better on Sunday the 20th.  I will have a hard time getting him to have any future updated vaccines after that reaction.  I debating taking him to the emergency room but he finally stopped.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dermatomyositis
Clinical narrative: On Jan. 2022 diagnosed with Dermatomyositis
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 61.0
Sex: M
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Cough, Dyspnoea, Intensive care, Oxygen saturation decreased
Clinical narrative: I recived the following shots in Oct 6th .PFizer 0 500  R FJ2601 ML / Fluceliam Segirus 0.5 ML  942437 / Moderna covb Moderna 0.5 ML K37164B Cough / breathing very low oxygen down to 57 levels
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Premature delivery
Clinical narrative: I was 24 weeks pregnant when I had my baby boy .he was born 1lb and 6 oz . He was born August 1 2022 and my due date was November 20 2022
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Client received a pediatric Monovalent dose, instead of adult bivalent dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Neurological symptom
Clinical narrative: Stroke like symptoms, facial drooping left side, r/o CVA, TIA, r/o Bell?s Palsey, went to ER and was transferred to alternate Hospital for possible stroke.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Sleep disorder, Stress, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out approximately 3 minutes after vaccine adminstration. He denies fainting with vaccines during vaccines questionaires. He reports he has been under lots of stress, sleeping poorly lately and has not been eating well, as well as not having breakfast before he received the vaccine today.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster was administered less than 2 months from previous COVID vaccine.  Last dose was 10/20/2022.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: PATIENT STATES SHOULDER PAIN LASTING ALMOST 2 MONTHS AFTER VACCINATION.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Patient came into the pharmacy friday around 3 pm to pick up prescriptions written by cnp in mdo for hydroxyzine hcl 25 mg and medrol dosepack for injection site reaction of left arm following covid omnicron booster on mon 11-21-22. Arm was swollen, red and  warm to the touch. Pt reported that she started feeling chills, feverish, shaky,achy joints, and sweating into the second night,  swelling started that night as well but gradually got worse to cover a swollen area which included elbow to shoulder.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site warmth, Pyrexia, Tremor
Clinical narrative: Patient came into the pharmacy friday around 3 pm to pick up prescriptions written by cnp in mdo for hydroxyzine hcl 25 mg and medrol dosepack for injection site reaction of left arm following covid omnicron booster on mon 11-21-22. Arm was swollen, red and  warm to the touch. Pt reported that she started feeling chills, feverish, shaky,achy joints, and sweating into the second night,  swelling started that night as well but gradually got worse to cover a swollen area which included elbow to shoulder.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED LOT FL8095 ADMINISTERED. EXPIRED 08/31/2022 AND GIVEN ON 09/20/2022
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: LOT FL8095 WAS EXPIRED ON 08/31/2022 AND ADMINISTERED TO PATIENT ON 09/20/2022
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: widespread body rash
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling and discomfort of lymph node in neck on left side (same side as vaccine administration) starting 2 days after dose. Patient chose to monitor at home and not seek medical attention. Has gradually reduced and as of 11/24/22 was almost back to baseline.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching on hand of arm of vaccine administration
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Head injury, Loss of consciousness, Sudden onset of sleep
Clinical narrative: PATIENT REPORTED TIREDNESS, FELL ASLEEP/OR PASSED OUT AND HIT HEAD AND HOUR AFTER FLU SHOT. PATIENT WENT TO HOSPITAL. IT'S BEEN REPORTED THAT PATIENT MAY HAVE HAD COVID AT TIME OF VACCINE, BUT NO INFORMATION TO CONFIRM.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Cerebellar ataxia, Computerised tomogram normal, Condition aggravated, Dysarthria
Clinical narrative: Equilibrium became worse (already has an existing condition due to Meniere's) , affected gait, slurred speech,  lower body muscle degradation (cannot get up from a sitting position without help), significant brain fog all occurred post- vaccine.  Some PT, no marked response.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Electromyogram normal, Feeling abnormal, Gait disturbance, Muscle atrophy
Clinical narrative: Equilibrium became worse (already has an existing condition due to Meniere's) , affected gait, slurred speech,  lower body muscle degradation (cannot get up from a sitting position without help), significant brain fog all occurred post- vaccine.  Some PT, no marked response.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scan with contrast normal
Clinical narrative: Equilibrium became worse (already has an existing condition due to Meniere's) , affected gait, slurred speech,  lower body muscle degradation (cannot get up from a sitting position without help), significant brain fog all occurred post- vaccine.  Some PT, no marked response.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Dementia, Dementia Alzheimer's type, Disturbance in attention, Intelligence test
Clinical narrative: Patient diagnosed with mild cognitive impairment approximately September 2021 and on October 20, 2022 diagnosed with Alzheimer's disease. Symptoms include dementia, memory impairment, mental impairment, cognitive disorder, disturbance in attention, and loss of personal independence in daily activities.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Memory impairment, Mental impairment
Clinical narrative: Patient diagnosed with mild cognitive impairment approximately September 2021 and on October 20, 2022 diagnosed with Alzheimer's disease. Symptoms include dementia, memory impairment, mental impairment, cognitive disorder, disturbance in attention, and loss of personal independence in daily activities.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Pain, Pyrexia
Clinical narrative: fever, pain in body, esp to injured areas. The 1st booster was worse and issues laste 3 days
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Malaise, Pain in extremity, Palpitations
Clinical narrative: Patient had severe arm pain, chest pain, palpitations, and overall unwell. Patient went to hospital that evening and med team ruled out any heart problem/concerns. Patient went home and was told to rest well. 11/26/22: Patient stated feeling better at this time, but not 100% yet.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Gastroenteritis Escherichia coli, Genital rash, Hypovolaemic shock, Rash
Clinical narrative: Admitted on 10/19/2022 for hypovolemic shock in the setting of small bowel obstruction and watery diarrhea. He was found to have EPEC on stool panel. New onset of rash on 10/29/22 and ID was consulted. The rash initially appeared on his back, then spread to involve all extremities, scalp, face, and genitals. The lesions appeared in different stages of healing, with some scabbed, some appearing vesicular, and some papular/possibly umbilicated on his lower back. his vesicle swab returned positive for varicella zoster, confirmed vaccine strain at clinic.