chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: patient did have a little flu like symptoms; Initial information regarding an unsolicited valid non-serious case was received from  a healthcare professional via the agency (Reference number- 00360277) via the call center and transmitted to Sanofi on 16-Nov-2020.  This case involves a 52 year old female patient who had little flu like symptoms (Influenza), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 13-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot number UJ211AA Expiration date: 30-Jun-2020, standard Strength) at a dose of 0.5 mL via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient mentioned that she had a little flu like symptoms (Influenza) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for Influenza.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site pain, Mobility decreased, Pain in extremity, Syncope
Clinical narrative: patient stated the vaccine administration itself was extremelly painful.  She felt faint.  Patient stated that her arm was more sore than normal the next day and rested the use of her left arm.  Two days post-administration, she noticed that the mobility in her left arm was limited.  When the limited mobility did not resolve on its own, she consulted with her physician.  The patient was sent to physical therapy and has been for the last several weeks.  Her strength has not been affected.  However, physical therapy has helped but not fully resolved her limited mobility.  She was recently referred to an orthopedic physican.  The patient was given a prescription for naproxen.  She was offered a steroid shot, but will see if the naprosen helps before proceeding with the steroid.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Oropharyngeal pain, Swelling face
Clinical narrative: Patients eyes and half of her face swelled up along with a sore throat. She went to doctor and received prednisone (steroid).
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Headache, Injection site nodule, Injection site urticaria, Vomiting
Clinical narrative: Patients reaction occurred at the left arm injection site. This was where the DTaP was administered. His adverse reactions included: hives,  headache and vomiting.  Also, a large, hard lump formed at the injection site (golfball size.) His vomiting lasted for over a week
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site pain, Paraesthesia, Sleep disorder
Clinical narrative: Pt had flu vaccine on 11/6, reports "it burned and stung more than normal." That evening felt very sore, thought it was her normal. low grade temp of 99. Since then has had daily burning pain, "like it shocks me." goes from clavicle downward and pulses where she got the vaccine. Has noticed a knot there. No redness. Now feels more pulsing in her nexplanon. No numbness in her finger tips but  has felt tingling down her arm. No chest pain or SOB. No breast pain beyond her normal with her cycles.   Has tried icy hot, rest, heat/cold. Works as a phlebotomist, does notice it while working but worse when waking up and when going to bed. Has made it more difficult to sleep
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient said was sore and a little swollen on Sunday evening after shower.  She put alcohol on it. She said today it had a rash, swollen to elbow, hot and painful. I recommended she contact her doctor.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Headache, Heart rate increased, Injection site pain, Throat tightness
Clinical narrative: Right side of throat tight, chest very heavy, rapid heartbeat, headache, soreness at site.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Influenza virus test negative, Injection site nodule
Clinical narrative: Tenderness, swelling, with hardened lump in middle area at injection site. Day after injection, these symptoms became more severe with addition of fever (max 101 F), chills, body aches, headache, mild nausea, fatigue.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Tenderness, swelling, with hardened lump in middle area at injection site. Day after injection, these symptoms became more severe with addition of fever (max 101 F), chills, body aches, headache, mild nausea, fatigue.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Tenderness, swelling, with hardened lump in middle area at injection site. Day after injection, these symptoms became more severe with addition of fever (max 101 F), chills, body aches, headache, mild nausea, fatigue.
Age: 12.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Received vaccines 11/24/2020.  Evening of 12/11 child started having raised vesicular style rash, started on his chest and then they also discovered lesions in his groin area, back of his head, and on his back.  Mom reports they do crust over when they pop.  No fever.    As of today (12/14) child has had 13 lesions, with about a quarter of them crusted over.  He is still getting new ones.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Swelling
Clinical narrative: No problem the first day. Next morning patient had tenderness or pain at needle site. Changed to pain if touched. Pain was from shoulder to about 2 inches above elbow. Swelling began to go down after taking ibuprofen and cold pack. I t was still tender.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: Severe flu-like symptoms; fever; headache; chills; fatigue
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Amnesia, Fatigue, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: After his flu shot on 11/13, he was being driven home by his brother and he started seizing. He was shaking and unresponsive and urinated in the car seat. Brother pulled the car over and shook patient who came around. He was very tired afterward, and did not remember the event. He also had a seizure after a series of immunizations as a young child, but not sure which shot caused it that time. Mom thinks flu vaccine was one of the shots given that day. We will no longer give him flu shots.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: After his flu shot on 11/13, he was being driven home by his brother and he started seizing. He was shaking and unresponsive and urinated in the car seat. Brother pulled the car over and shook patient who came around. He was very tired afterward, and did not remember the event. He also had a seizure after a series of immunizations as a young child, but not sure which shot caused it that time. Mom thinks flu vaccine was one of the shots given that day. We will no longer give him flu shots.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Hyperhidrosis, Pain
Clinical narrative: I had chills, diarrhea, vomiting, racing heart, sweats, weakness, body aches and a fever of 100.8.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia, Vomiting
Clinical narrative: I had chills, diarrhea, vomiting, racing heart, sweats, weakness, body aches and a fever of 100.8.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site swelling
Clinical narrative: Patient reports bump at site of flu vaccine injection done on 9/15/20. Pharmacist noticed bump is well below deltoid muscle. Patient denies pain associated with "bump".
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Central venous catheterisation, Chest X-ray, Eye swelling, Intensive care, Laboratory test
Clinical narrative: Started as a runny nose then progressed to swelling of the nose and eyes. A rash started on the face and then by morning had progressed to a full body itchy rash. We went to the hospital er and they sent us to the pediatric ICU for the night. They ran many test and by the time we were released they told us it was something "viral". There was a slight rash left over. We were referred to an allergist and he said it looked viral from the pictures i showed him. We scheduled for allergy testing but then the pandemic hit.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Rash, Rash pruritic, Rhinorrhoea, Swelling face
Clinical narrative: Started as a runny nose then progressed to swelling of the nose and eyes. A rash started on the face and then by morning had progressed to a full body itchy rash. We went to the hospital er and they sent us to the pediatric ICU for the night. They ran many test and by the time we were released they told us it was something "viral". There was a slight rash left over. We were referred to an allergist and he said it looked viral from the pictures i showed him. We scheduled for allergy testing but then the pandemic hit.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Viral rash, White blood cell count increased
Clinical narrative: Started as a runny nose then progressed to swelling of the nose and eyes. A rash started on the face and then by morning had progressed to a full body itchy rash. We went to the hospital er and they sent us to the pediatric ICU for the night. They ran many test and by the time we were released they told us it was something "viral". There was a slight rash left over. We were referred to an allergist and he said it looked viral from the pictures i showed him. We scheduled for allergy testing but then the pandemic hit.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Diarrhoea, Hypersensitivity, Nasopharyngitis, Rash
Clinical narrative: (I completed a form before this one with a previous reaction to the flu shot in 2019) The reaction this time around was allergy like symptoms, swelling and red rash around the face that spread within a few hours to the whole body. The rash was very hot and itchy and her temperature got to 101 at home. This is a head to bottom of feet rash that covers her whole body. (we have pictures from both occasions). The reaction started 10 days after the vaccine and we took her in to the er on the 24th of October. We tried to control it with the medications we were sent home with from the last visit but it was not working. She was tested for Covid and other viral infections. IV. She was sent to the hospital for the night. Neither time was anaphylactic. The first time they used an epi pen (I forgot to mention) that worked in making her comfortable for 45 min but then it came back worse. She had diarrhea and vomiting both times.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic, SARS-CoV-2 test, Skin warm, Swelling
Clinical narrative: (I completed a form before this one with a previous reaction to the flu shot in 2019) The reaction this time around was allergy like symptoms, swelling and red rash around the face that spread within a few hours to the whole body. The rash was very hot and itchy and her temperature got to 101 at home. This is a head to bottom of feet rash that covers her whole body. (we have pictures from both occasions). The reaction started 10 days after the vaccine and we took her in to the er on the 24th of October. We tried to control it with the medications we were sent home with from the last visit but it was not working. She was tested for Covid and other viral infections. IV. She was sent to the hospital for the night. Neither time was anaphylactic. The first time they used an epi pen (I forgot to mention) that worked in making her comfortable for 45 min but then it came back worse. She had diarrhea and vomiting both times.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Viral test positive, Vomiting, White blood cell count increased
Clinical narrative: (I completed a form before this one with a previous reaction to the flu shot in 2019) The reaction this time around was allergy like symptoms, swelling and red rash around the face that spread within a few hours to the whole body. The rash was very hot and itchy and her temperature got to 101 at home. This is a head to bottom of feet rash that covers her whole body. (we have pictures from both occasions). The reaction started 10 days after the vaccine and we took her in to the er on the 24th of October. We tried to control it with the medications we were sent home with from the last visit but it was not working. She was tested for Covid and other viral infections. IV. She was sent to the hospital for the night. Neither time was anaphylactic. The first time they used an epi pen (I forgot to mention) that worked in making her comfortable for 45 min but then it came back worse. She had diarrhea and vomiting both times.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Hypersensitivity, Pityriasis rosea, Pruritus, Rash macular
Clinical narrative: red itchy patches on torso and in body creases originally diagnosed as pityriasis rosea by Internal Medicine on October 2, 2020.  Use of Benedryl and triamcinolone topical 0.5% cream did not improve condition  On November 30, 2020 saw Staff who diagnosed eczema, allergic reaction and prescribed a decreasing prescription of Prednisone along with skin moisturizers and changing  soap used on body and laundry detergent.
Age: 10.0
Sex: M
Vaccine: FLUA4, HPV9
Symptoms: Urticaria
Clinical narrative: Hives on the face No other symptoms including shortness of breath or facial/lip swelling  Hives resolved after 1 dose of Benadryl
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site swelling, Injection site urticaria, Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: The day after vaccines were given, she had swelling at injection site of Trumenba, hives on that arm, swelling of the face, hives  on arm/head/face, and throat swelling. She was given a dose pack of methylprednisolone and was feeling better the next day.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Injection site bruising
Clinical narrative: Employee reports diarrhea and bruising to site where she received her flu shot.  Per agency have the employee follow-up with panel provider.  vaccination was received approx 2 weeks prior to report.  Now reports all symptoms resolved.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Employee received a flu shot there on 10/22, she went to her doctor on 11/11 with increasing left shoulder pain since the shot. I'm on weight lifting restriction and I'm now being sent for an ultrasound and to an orthopedic surgeon for a possible shoulder injury.  This was copied directly from an email from the employee.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient reported on 11/20/20 that she has been having pain following flu vaccine (received on 10/23). She stated that the "pain got so bad I had to give in and go to my doctor". Patient was put on a 20lb lifting restriction, though this does not affect her duties. She stated that her doctor stated he thinks this is a shoulder injury due to the flu vaccine but that it should heal on it's own with rest.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH SPINE TO BELLYBUTTON LEFT SIDE
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient given Kinrix in error.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered
Clinical narrative: No adverse effects reported.; the patient was inadvertently administered a fourth dose of GARDASIL 9; the third dose of the GARDASIL 9 series on 19-FEB-2020. Nurse reported that on 01-DEC-2020, the patiens was inadvertently administered a fourth dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-FEB-2020, the patient received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 01-DEC-2020, the patient was inadvertently administered a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S023476, expiration date 26-MAR-2022 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023476; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No adverse events; Temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T008697 with expiration date on 04-JUN-2021 (strength, route and dose were not provided) for prophylaxis.         On 16-NOV-2020, it was found that hepatitis a vaccine, inactivated (VAQTA), experienced a temperature excursion of 3.0F, on a time frame of 3 hours and 30 minutes. Information regrading previous excursions was not provided. Call was made due to a data logger. The reported stated that the patient had no adverse reactions.   This is one of several reports received by the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T008697; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA010999: US-009507513-2012USA006031:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-DEC-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # 1637648, expiration date 19-JUN-2022 (anatomical location and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 14.7 degrees Celsius for 19 hours and 14 minutes.  Data logger was involved. There were no previous excursions reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2012USA004766:
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No adverse events; Temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, route, dose, lot # and expiration date were not provided) for prophylaxis.         On 16-NOV-2020, it was found that hepatitis b vaccine (recombinant)(RECOMBIVAX HB), experienced a temperature excursion. The reported stated that the patient had no adverse reactions. Information regrading the temperature excursion in which the vaccine was involved was not provided.  This is one of several reports received by the same source.; Sender's Comments:  US-009507513-2011USA010999: US-009507513-2012USA002966:
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased
Clinical narrative: couldn't raise arm above a certain height; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose in arm for immunization. The patient's medical history and concomitant medications were not reported. The patient had a reaction to pneumonia vaccine in the past and couldn't raise arm above a certain height. She took diphenhydramine hydrochloride (BENADRYL) after the pneumonia shot and the symptoms then resolved.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Contusion, Decreased appetite, Insomnia, Mobility decreased, Pain
Clinical narrative: was sore/still hurts when lifting to a high elevation; couldn't eat; couldn't sleep; couldn't get her shirt off; The arm was bruised and at present; This is a spontaneous report from a contactable other health professional.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration in arm in Oct2020 at single dose for immunization, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via an unspecified route of administration in arm in Oct2020 at unknown dose for immunization.  The patient's medical history and concomitant medications were not reported. It was reported in Oct2020, she received "3 vaccinations in one day." Per caller she received "Tdap in one arm and in the other arm the 65 Plus flu shot and the pneumonia vaccines."  Per the caller, 3 hours after getting the vaccinations she "was sore, couldn't eat, couldn't sleep, couldn't sit, couldn't get her shirt off." The arm was bruised and at present, the caller stated her arm "still hurts when lifting to a high elevation." The outcome of the events was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pain in extremity
Clinical narrative: was sore/still hurts when lifting to a high elevation; couldn't eat; couldn't sleep; couldn't get her shirt off; The arm was bruised and at present; This is a spontaneous report from a contactable other health professional.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration in arm in Oct2020 at single dose for immunization, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via an unspecified route of administration in arm in Oct2020 at unknown dose for immunization.  The patient's medical history and concomitant medications were not reported. It was reported in Oct2020, she received "3 vaccinations in one day." Per caller she received "Tdap in one arm and in the other arm the 65 Plus flu shot and the pneumonia vaccines."  Per the caller, 3 hours after getting the vaccinations she "was sore, couldn't eat, couldn't sleep, couldn't sit, couldn't get her shirt off." The arm was bruised and at present, the caller stated her arm "still hurts when lifting to a high elevation." The outcome of the events was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flue; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves patient (gender and age unspecified) who got the flue (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flue (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reporter that, patient had never taken shot since.   Details of laboratory data not reported.     It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: Never felt better; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics)who experienced never felt better (feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date (January), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious never felt better (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: had a reaction; Initial information regarding this unsolicited valid non-serious case received from a consumer (patient) via social media Facebook on 13-Nov-2020.  This case involves an unknown demographic patient who had a reaction (Adverse reaction), after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient had a reaction (Adverse reaction), following the administration of INFLUENZA VACCINE.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on batch number for this case.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A Pharmacist was supposed to give a 14 years old patient Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; A Pharmacist was supposed to give a 14 years old patient Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; A Pharmacist was supposed to give a 14 years old patient Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from the other health care professional via Pharmacy manager via phone via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA323872, 2020SA324116 and 2020SA323616.  This case involves a 14 years old male patient who's pharmacist was supposed to give FLUARIX, however pharmacist accidentally grabbed and administered a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Prefilled Syringe lot number: UJ552AA via intramuscular route in the left arm on 05-Nov-2020 for prophylactic vaccination (wrong product administered, product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No other vaccines given.  It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and it was also a case of overdose (latency: same day).  No Adverse Events were noted and no treatments were administered to the patient.  Product used : Used.  Still using product : Yes.  Was Device Used : Yes.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: SWELLING/HIVES, ITCHING, PAIN, BRUISING
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Headache, Injection site pain, Pain
Clinical narrative: on 11/30/2020 around 2:00pm, I started having chills and a headache. At 3 am, on 12/01/2020, my breathing was not good. I took my inhaler to assist with my breathing. Stayed in bed all day, felt like the flu. Aching and chills still. On 12/02/2020, arm was sore at the site, still had a headache as well.  12/03/2020 I had a sore arm still, but felt better. Doctor I saw virtually told me to take Claritin for 7 days, and I did that.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: on 11/30/2020 around 2:00pm, I started having chills and a headache. At 3 am, on 12/01/2020, my breathing was not good. I took my inhaler to assist with my breathing. Stayed in bed all day, felt like the flu. Aching and chills still. On 12/02/2020, arm was sore at the site, still had a headache as well.  12/03/2020 I had a sore arm still, but felt better. Doctor I saw virtually told me to take Claritin for 7 days, and I did that.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt developed hives on arms, face, neck, torso, legs about 3 hours following the vaccine administration. She reported to Urgent Care in the community for evaluation/treatment
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Illness, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Client came in to show us her arm.  Stated she woke up with reaction.  Left deltoid area where shot was given was noticibly red, raised, firm and very warm- about 3inch x3inch circumference. Client states it is bothersome and itchy. Client also states she has mild systemic type illness.  Discussed relief options and to let us know if site did not improve.   Dec. 14, 2020- follow up call with client- she reports vast improvement of local symptoms- no swelling, slightly pink , some itching at times.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Client came in to show us her arm.  Stated she woke up with reaction.  Left deltoid area where shot was given was noticibly red, raised, firm and very warm- about 3inch x3inch circumference. Client states it is bothersome and itchy. Client also states she has mild systemic type illness.  Discussed relief options and to let us know if site did not improve.   Dec. 14, 2020- follow up call with client- she reports vast improvement of local symptoms- no swelling, slightly pink , some itching at times.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dysuria, Influenza virus test negative, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient reports that she received influenza and pneumococcal vaccine around 9 am on 12/1/2020 and approximately one hour later, started developing pain in the left arm where the 2 vaccines had been given.  She presented to urgent care on 12/2/2020 with pain 10/10 , "patchy erythematous plaque-like rash over the lateral mid to distal deltoid area of the left arm. . No central clearing or central pallor. No papules, vesicles, or other skin lesion changes. Allodynia tenderness palpation." per provider  She was to continue to take acetaminophen and ibuprofen and start cetirizine.  Later on 12/2/2020, she presented to the emergency room with a fever Temperature maximum of 102, dysuria, tachycardia and leukocytosis. COVID-19 and influenza tests were negative. Per provider, the urinalysis was negative for infection and she was negative for sepsis and meningitis. At that time, the provider reported that there was some firmness and erythema on her left upper arm consistent with cellulitis. She was given fluids, pain medications and cephalexin. On 12/7/2020, she presented with increased edema since 12/2/2020.  She had taken 5 days of cephalexin and she chose to continue to take the cephalexin versus changing to another antibiotic at that time. On 12/10/2020, significant improvement noted by provider, with only tenderness to the area. Patient to continue to take cephalexin.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site rash, Leukocytosis, Neutrophil count decreased, Oedema, Pyrexia
Clinical narrative: Patient reports that she received influenza and pneumococcal vaccine around 9 am on 12/1/2020 and approximately one hour later, started developing pain in the left arm where the 2 vaccines had been given.  She presented to urgent care on 12/2/2020 with pain 10/10 , "patchy erythematous plaque-like rash over the lateral mid to distal deltoid area of the left arm. . No central clearing or central pallor. No papules, vesicles, or other skin lesion changes. Allodynia tenderness palpation." per provider  She was to continue to take acetaminophen and ibuprofen and start cetirizine.  Later on 12/2/2020, she presented to the emergency room with a fever Temperature maximum of 102, dysuria, tachycardia and leukocytosis. COVID-19 and influenza tests were negative. Per provider, the urinalysis was negative for infection and she was negative for sepsis and meningitis. At that time, the provider reported that there was some firmness and erythema on her left upper arm consistent with cellulitis. She was given fluids, pain medications and cephalexin. On 12/7/2020, she presented with increased edema since 12/2/2020.  She had taken 5 days of cephalexin and she chose to continue to take the cephalexin versus changing to another antibiotic at that time. On 12/10/2020, significant improvement noted by provider, with only tenderness to the area. Patient to continue to take cephalexin.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: SARS-CoV-2 test negative, Tachycardia, Urine analysis, White blood cell count increased
Clinical narrative: Patient reports that she received influenza and pneumococcal vaccine around 9 am on 12/1/2020 and approximately one hour later, started developing pain in the left arm where the 2 vaccines had been given.  She presented to urgent care on 12/2/2020 with pain 10/10 , "patchy erythematous plaque-like rash over the lateral mid to distal deltoid area of the left arm. . No central clearing or central pallor. No papules, vesicles, or other skin lesion changes. Allodynia tenderness palpation." per provider  She was to continue to take acetaminophen and ibuprofen and start cetirizine.  Later on 12/2/2020, she presented to the emergency room with a fever Temperature maximum of 102, dysuria, tachycardia and leukocytosis. COVID-19 and influenza tests were negative. Per provider, the urinalysis was negative for infection and she was negative for sepsis and meningitis. At that time, the provider reported that there was some firmness and erythema on her left upper arm consistent with cellulitis. She was given fluids, pain medications and cephalexin. On 12/7/2020, she presented with increased edema since 12/2/2020.  She had taken 5 days of cephalexin and she chose to continue to take the cephalexin versus changing to another antibiotic at that time. On 12/10/2020, significant improvement noted by provider, with only tenderness to the area. Patient to continue to take cephalexin.
Age: 68.0
Sex: M
Vaccine: FLUA3, PPV, TD
Symptoms: Body temperature increased, Fatigue, Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: Malaise, myalgias, mild elevation of temperature, fatigue. Unable to do regular activities. Tylenol helped. Spent the following day on the couch. Mild soreness right arm, moderate to severe pain left upper arm (could not raise my arm beyond 20 degrees without increased pain; could not abduct my upper arm to 90 degrees). Still cannot sleep on left side for at least 3 nights.
Age: 68.0
Sex: M
Vaccine: FLUA3, PPV, TD
Symptoms: Myalgia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Malaise, myalgias, mild elevation of temperature, fatigue. Unable to do regular activities. Tylenol helped. Spent the following day on the couch. Mild soreness right arm, moderate to severe pain left upper arm (could not raise my arm beyond 20 degrees without increased pain; could not abduct my upper arm to 90 degrees). Still cannot sleep on left side for at least 3 nights.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Erythema, Fatigue, Hypoacusis
Clinical narrative: Day after the shot tenderness, redness, hard lump, tiredness muscle aches, chicken pox like, dizziness,  ears feel full and won't pop, hard to hear.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Mass, Myalgia, Tenderness
Clinical narrative: Day after the shot tenderness, redness, hard lump, tiredness muscle aches, chicken pox like, dizziness,  ears feel full and won't pop, hard to hear.
Age: 50.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Swelling
Clinical narrative: Patients husband reports a half dollar size raised red mark.  Patients husband called on Monday, vaccine was given on friday. Said that they have iced it 3 times a day since then.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: SEVERE SHARP PAIN IN SHOULDER AND ARM. LASTED 3 WEEKS. UNABLE TO USE ARM OR TO DRESS ALONE. SAT UP IN A CHAIR TO SLEEP. STLL HAVE WEAKNESS IN ARM.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Pain
Clinical narrative: After receiving the vaccine, patient called an a few hours later and said he was experiencing 10/10 pain. On 12/12/2020, patient comes into the pharmacy to say that his pain was horrible and he had to take some codeine tablets and the pain was radiating to his shoulder.
Age: 77.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: -Patient received Fluarix Flu shot 9/5/2020. -Then came in 10/28/2020 for his second Shingrix and was given Shingrix (2nd) dose and Fluad H.D. Flushot
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain
Clinical narrative: (L) neck/shoulder pain onset 11/14/2020 @ 0800
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: RASH AND FEVER
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: REC'D PNEUMOVAX 23 IM IN RIGHT DELTOID AND WITHIN ONE HOUR BEGAN HAVING PAIN, REDNESS, SWELLING AND BRUISING AT INJECTION SITE. PAIN RADIATING TO RIGHT SHOULDER AND NECK. PATIENT ALSO REPORTS ITCHING AT SITE.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Neck pain
Clinical narrative: REC'D PNEUMOVAX 23 IM IN RIGHT DELTOID AND WITHIN ONE HOUR BEGAN HAVING PAIN, REDNESS, SWELLING AND BRUISING AT INJECTION SITE. PAIN RADIATING TO RIGHT SHOULDER AND NECK. PATIENT ALSO REPORTS ITCHING AT SITE.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: My arm swelled substantially, first all around the injection site, and then gradually all the way down my arm to my wrist.  My arm seemed to get larger every day as the swelling crept down my arm.  After a week, it began to subside and did so gradually over the course of several days.  I used ice packs wrapped around my arm to attempt to reduce the swelling and took a couple of Benedryl.  I told the pharmacist the next time I was at the store.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: inflamed lymph node under arm of vaccination
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity, Periarthritis
Clinical narrative: patient stated that he had arm/shoulder pain that did not resolve and was later diagnosed with adhesive capsulitis
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Blood urea increased, Chills, Computerised tomogram head normal, Decreased appetite
Clinical narrative: Developed fever, chills, severe frontal headache, expressive aphasia and unsteady gait with loss of appetite on 1/30/2020 that  lasted 5 days. Resolved completely by 7 days
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Echocardiogram normal, Electrocardiogram normal, Full blood count normal, Gait disturbance, Headache
Clinical narrative: Developed fever, chills, severe frontal headache, expressive aphasia and unsteady gait with loss of appetite on 1/30/2020 that  lasted 5 days. Resolved completely by 7 days
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Laboratory test normal, Lipids normal
Clinical narrative: Developed fever, chills, severe frontal headache, expressive aphasia and unsteady gait with loss of appetite on 1/30/2020 that  lasted 5 days. Resolved completely by 7 days
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging brain normal, Pyrexia, Scan with contrast, Ultrasound Doppler normal
Clinical narrative: Developed fever, chills, severe frontal headache, expressive aphasia and unsteady gait with loss of appetite on 1/30/2020 that  lasted 5 days. Resolved completely by 7 days
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Seizure, Syncope
Clinical narrative: seizure or fainting - memory loss prior to event
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient experiencing swelling and pain below injection site that is slowly moving down the arm
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient reported pain and numbness in arm night of vaccination. reported going to the ER was discharged same night
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient's arm swelled at the site and swelling continued down upper arm and became itchy. Patient was still at the Dr.'s office when symptoms began. Dr. prescribed Benadryl and an ice pack
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness at injection within one day of vaccine.  Woke in the night with fever and shivering.  When  I got up to use the bathroom and shower at 6;30 am, felt very light headed with slight headache and nauseous.  Had to exit the shower due to increasing extreme dizziness/feeling faint.  Fever at the time was 100.3.  Took acetaminophen 1000mg and laid down with cool cloth on head , but was able to return to normal daily routine about three hours later.  Continued to feel tired with slight headache continued much of the work day. Arm tenderness at injection site continued for two days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Sleep disorder
Clinical narrative: Redness and soreness at injection within one day of vaccine.  Woke in the night with fever and shivering.  When  I got up to use the bathroom and shower at 6;30 am, felt very light headed with slight headache and nauseous.  Had to exit the shower due to increasing extreme dizziness/feeling faint.  Fever at the time was 100.3.  Took acetaminophen 1000mg and laid down with cool cloth on head , but was able to return to normal daily routine about three hours later.  Continued to feel tired with slight headache continued much of the work day. Arm tenderness at injection site continued for two days.
Age: 0.25
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: On 12/10/2020 at 9pm patient went to bed with a fever 99.5, pain and chills. Caller took aleve and on Friday patient  called Primary care physician and alerted Nurse of  symptoms. Nurse returned call after speaking with Primary doctor and patient was told to take Tylenol and  stay hydrated.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Bladder catheterisation, Blood test, Constipation, Decreased appetite, Diarrhoea
Clinical narrative: Diarrhea, stopped pooping, excessive vomitting, fatigue, not eating.  We had to take her to the ER to recieve fluids, she got an xray that showed bowel obstruction. We got transfered to hospital where she got an NG tube put in. They did more stays and found it was bad enough for surgery.  She had surgery done and they found intussusception along with meckels divertickulum. We had to stay almost a week in the hospital.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Fatigue, Gastrointestinal tube insertion, Intestinal obstruction, Intussusception, Surgery
Clinical narrative: Diarrhea, stopped pooping, excessive vomitting, fatigue, not eating.  We had to take her to the ER to recieve fluids, she got an xray that showed bowel obstruction. We got transfered to hospital where she got an NG tube put in. They did more stays and found it was bad enough for surgery.  She had surgery done and they found intussusception along with meckels divertickulum. We had to stay almost a week in the hospital.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Urine analysis, Vitello-intestinal duct remnant, Vomiting, X-ray abnormal, X-ray with contrast
Clinical narrative: Diarrhea, stopped pooping, excessive vomitting, fatigue, not eating.  We had to take her to the ER to recieve fluids, she got an xray that showed bowel obstruction. We got transfered to hospital where she got an NG tube put in. They did more stays and found it was bad enough for surgery.  She had surgery done and they found intussusception along with meckels divertickulum. We had to stay almost a week in the hospital.