chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Injection given 12:45pm 11-30-20, patient woke at midnight with sore arm and took Tylenol, it did not help. Tuesday 12-1-20 she had chills, fever, joint pain, and nausea.  She took ibuprofen three times that day and it helped. Wednesday 12-2-20 the fever, chills, aches and nausea were gone, but now she has hives, itching and swelling at injection site.  She took Benadryl 12-2-20 in the evening and it helped the itching. Patient called the pharmacy 3pm 12-3-20 about the reaction. She was advised to continue the Benadryl and call her primary care provider.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Injection given 12:45pm 11-30-20, patient woke at midnight with sore arm and took Tylenol, it did not help. Tuesday 12-1-20 she had chills, fever, joint pain, and nausea.  She took ibuprofen three times that day and it helped. Wednesday 12-2-20 the fever, chills, aches and nausea were gone, but now she has hives, itching and swelling at injection site.  She took Benadryl 12-2-20 in the evening and it helped the itching. Patient called the pharmacy 3pm 12-3-20 about the reaction. She was advised to continue the Benadryl and call her primary care provider.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling  of upper R arm; pain, warmth, itchiness
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: PATIENT WOKE UP ON SUNDAY MORNING WITH RASH ALL OVER HER STOMACH AND BETWEEN HER BREAST.  AS THE DAY PROGRESSED, THE RASH SPREAD TO HER LEFT ARM .  ON MONDAY, SHE REACHED OUT TO HER DOCTOR AND HE PRESCRIBED HER ANTIHISTAMINE AND STEROID CREAM.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling
Clinical narrative: patient presented with redness, swelling near injection site. site was marked and patient counseled to apply cold compresses and check in with physician if not resolving in a few days
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort, Pain in extremity
Clinical narrative: No pain after getting the shot. Within a couple of hours, upper arm started to get red and painful, felt like lightning bolts from upper arm down to elbow. Applied ice and waited it out. Called pharmacy about it. The pharmacist said he would send her something but she never received anything.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Caller reports an adverse event happening. She experienced a rash, itching & pain. Patient uses a caption phone.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT HAD 102 DEGREE FEVER AND PAIN AT INJECTION SITE DAY ONE. PT REST AND FEVER WENT AWAY HOWEVER HIS RIGHT ARM IS SWOLLEN FROM HIS SHOULDER DOWN TO HIS HAND. HE ALSO MENTIONED HE WAS DOING YARD AND SCHRUB WORK SO I MENTIONES POSSIBLT GETTING BIT. HE SAIS HE FELT FINE I RECOMMENDED BENADRYL AND TO WATCH FOR FEVER. IF SWELLING DID NOT START GOING AWAY BY TOMORROW CONTACT MD.
Age: 19.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cellulitis, Pain, Peripheral swelling, Pyrexia, Tachycardia
Clinical narrative: Cellulitis, swelling of the left arm and whole left side of legs. Pain, Fever, tachycardia. body ache reported by Mom.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Shoulder has continued to be sore after the immunization
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Shingrix 2 of 2: sore arm, tired, achy, headache, slight fever (99.8 deg F)
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Mobility decreased, Pain in extremity
Clinical narrative: Patient called to ask if they should still being having arm pain. She says she does a lot of physical labor at work and has been having difficulties with her left arm. She said she is unable to lift it at all and still has a bit of pain. She wanted to know how long this pain could last and when she had her flu shot.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Discomfort, Hypoaesthesia, Nausea, Pain in extremity
Clinical narrative: Patient has egg allergy and asked for non-egg based Flublok vaccine, and had daughter 13 y.o. who does not have egg allergy at same time to get Fluarix injected.  Patient claims pharmacist must have switched the vaccines and injected her with Fluarix instead of Flublok. Patient claims, itching and nausea developed within 20 minutes, followed by appearance of hives on her trunk and diarrhea, along with heart palpitations and swelling, pain and numbness on left arm (site of injection).  Patient notified myself today (19 days later) and patient still claims residual hives on body, and continuing discomfort and numbness on left arm.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Pruritus, Swelling, Urticaria, Wrong product administered
Clinical narrative: Patient has egg allergy and asked for non-egg based Flublok vaccine, and had daughter 13 y.o. who does not have egg allergy at same time to get Fluarix injected.  Patient claims pharmacist must have switched the vaccines and injected her with Fluarix instead of Flublok. Patient claims, itching and nausea developed within 20 minutes, followed by appearance of hives on her trunk and diarrhea, along with heart palpitations and swelling, pain and numbness on left arm (site of injection).  Patient notified myself today (19 days later) and patient still claims residual hives on body, and continuing discomfort and numbness on left arm.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Pain
Clinical narrative: Pepsid 40mg, 2 times per day Azelastine HCl nasal spray - .1% 2 times per day 2 puffs each nostril Aspirin 81mg every other day Lovastatin - 40mg tab 1 time per day Singulair - 10mgs per day Aller-fex - 180mgs per day Mixed Vespids Event lasted about 1 day. Did not go to ER/Dr's office. Aches, headache, extremely cold, wore gloves in the house and winter hat. No fever 96.4.
Age: 36.0
Sex: M
Vaccine: FLUR4
Symptoms: Feeling hot, Nausea, Pallor
Clinical narrative: within minutes the patient said that his feet and hands felt hot and he was nauseated. I had him sit down, he asked for a glass of water which I provided. (He did not feel short of breath or weak) the nausea continued and he looked more pale, I had him lay down, and observed him as we chatted . After laying down for 15 minutes he felt better and requested another glass of water. I had him sit down in the chair again for a few minutes. He felt well again , reached for his shopping cart and left the pharmacy to continue shopping.
Age: 3.0
Sex: M
Vaccine: FLUA3
Symptoms: Aphasia, Autism spectrum disorder, Hyperaesthesia, Intentional self-injury, Photophobia
Clinical narrative: Extreme sensitivity to touch and light. Complete loss of speech. Self harming behavior. Child is now autistic.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site mass, Pain, Pyrexia
Clinical narrative: Body chills and aches, Fever, Hard lump with bruising near injection site
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Anxiety, Headache, Muscle spasms
Clinical narrative: Patient states that within 2 hours of vaccination she felt terrible cramps in thighs and shoulders. She also reported a headache, but no fever.  Within 4 hours of vaccination the patient states she was feeling very anxious.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Abnormal behaviour, Slow speech
Clinical narrative: not diaphoretic, BP unknown. Was answering open-ended and close ended questions. Patient did not have anything to eat of drink since yesterday. Denied any pain. Was not shaking. Wife said he wasn't acting normal. Talking in a slow, but not slurred speech.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dry throat, Dysphagia, Headache
Clinical narrative: She said she had severe headache, severe dry/sore throat and could not swallow, chills and profuse sweating, nausea, diarrhea, red/raised warm skin, streaked below injection site
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Inflammation, Injection site reaction, Nausea, Oropharyngeal pain
Clinical narrative: She said she had severe headache, severe dry/sore throat and could not swallow, chills and profuse sweating, nausea, diarrhea, red/raised warm skin, streaked below injection site
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: She said she had severe headache, severe dry/sore throat and could not swallow, chills and profuse sweating, nausea, diarrhea, red/raised warm skin, streaked below injection site
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Very sore arm couldn't raise past shoulder, muscle aches - legs, arms, neck, and headache for 3 days beginning on 11/30/2020 until 12/2/2020 10pm.  Fever of 99.7 until 12/1/2020 8:00 am.  Shivering for 6 hours on 11/30/2020 at 5 pm until 11pm on 11/30/2020.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Very sore arm couldn't raise past shoulder, muscle aches - legs, arms, neck, and headache for 3 days beginning on 11/30/2020 until 12/2/2020 10pm.  Fever of 99.7 until 12/1/2020 8:00 am.  Shivering for 6 hours on 11/30/2020 at 5 pm until 11pm on 11/30/2020.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Day one-very painful arm Day two-chills, headache, nausea, fatigue, sore arm
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swollen area hot, treatment start Keflex and ibuprofen.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site
Clinical narrative: PATIENT CLAIMS FLU SHOT GIVEN IN OCTOBER WAS TOO HIGH ON SHOULDER CAUSING IT TO LOCK UP. SHE ONLY WANTED DEMONSTRATE HOW TO GIVE SHOT CORRECTLY
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain of skin
Clinical narrative: On August 6, 2020 at around 2p.m. I was getting up off my living room couch and both the bottoms of my feet as barefoot hurt terribly when walking across the living room floor. This included the skin hurting up in my arch which is higher somewhat than the floor when I press down. This condition lasted the same until about 3 weeks before my second Shingrix shot on October 6, 2020. The arch hurting in each foot when walking barefoot, lasted and was the last symptom to leave just 4 days before the second Shingrix shot.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: SYNCOPE - Passed out 5 minutes after the vaccination. Recovered right away after less than a minute. No intervention or treatments done.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Erythema, Pruritus, Swelling, Swelling face, Urticaria
Clinical narrative: generalized swelling, itching, and redness; generalized swelling, itching, and redness; generalized swelling, itching, and redness; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient) via Call Center and transmitted to Sanofi on 04-Nov-2020.  This case involves a 36 year old female patient who experienced generalized swelling, itching, and redness (erythema, swelling and pruritus), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date in September 2009, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot number AFLUA456AA Expiration date: Unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced a non-serious generalized swelling, itching, and redness (erythema, swelling and pruritus) (Latency unknown) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was erythema, swelling and pruritus.  No relevant laboratory tests were reported.   The patient was treated with PREDNISONE (PREDNISONE) for the reactions.  At the time of this report, all the events were reported as resolved after five days.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: generalized swelling, itching, and redness; generalized swelling, itching, and redness; generalized swelling, itching, and redness; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient) via Call Center and transmitted to Sanofi on 04-Nov-2020.  This case involves a 36 year old female patient who experienced generalized swelling, itching, and redness (erythema, swelling and pruritus), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date in September 2009, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot number AFLUA456AA Expiration date: Unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced a non-serious generalized swelling, itching, and redness (erythema, swelling and pruritus) (Latency unknown) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was erythema, swelling and pruritus.  No relevant laboratory tests were reported.   The patient was treated with PREDNISONE (PREDNISONE) for the reactions.  At the time of this report, all the events were reported as resolved after five days.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral sensory neuropathy
Clinical narrative: Neurological symptoms - onset 2 days after vaccination.  Developed burning sensations in limbs and back.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Burning sensation, Neurological symptom, Physical examination normal
Clinical narrative: Neurological symptoms - onset 2 days after vaccination.  Developed burning sensations in limbs and back.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: Bleeding; Soreness / for 2 weeks; Bruising for 2 weeks; This case was reported by a pharmacist via call center representative and described the occurrence of hemorrhage in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number LB2K7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th November 2020, the patient received the 1st dose of Fluarix Tetra 2020-2021 season. On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. In November 2020, less than a week after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced hemorrhage (serious criteria GSK medically significant), pain and contusion. In November 2020, the outcome of the hemorrhage was recovered/resolved. On an unknown date, the outcome of the pain and contusion were not recovered/not resolved.   It was unknown if the reporter considered the hemorrhage, pain and contusion to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter mentioned that the patient had a bleeding after the administration of the Fluarix vaccine, presumably at site of injection though reporter was not specific. The patient only had that one bleeding and then presented soreness and bruising for 2 weeks. Brusing and soreness were getting better but still ongoing at the time of reporting. The reporter consented to followup.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Contusion, Haemorrhage, Pain
Clinical narrative: Bleeding; Soreness / for 2 weeks; Bruising for 2 weeks; This case was reported by a pharmacist via call center representative and described the occurrence of hemorrhage in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number LB2K7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th November 2020, the patient received the 1st dose of Fluarix Tetra 2020-2021 season. On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. In November 2020, less than a week after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced hemorrhage (serious criteria GSK medically significant), pain and contusion. In November 2020, the outcome of the hemorrhage was recovered/resolved. On an unknown date, the outcome of the pain and contusion were not recovered/not resolved.   It was unknown if the reporter considered the hemorrhage, pain and contusion to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter mentioned that the patient had a bleeding after the administration of the Fluarix vaccine, presumably at site of injection though reporter was not specific. The patient only had that one bleeding and then presented soreness and bruising for 2 weeks. Brusing and soreness were getting better but still ongoing at the time of reporting. The reporter consented to followup.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician's office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Patient with Immunocompromised sibling received Rotateq despite recommendations; This spontaneous report was received from a physician via company representative and refers to an infant patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitnat therapies were not reported.   On an unknown date, the patient was vaccineted with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (dose, lot # and expiration date were not reported) for prophylaxis.         The patient's family was counseled prior to the infant receiving the vaccination that it was not advisable due to the risk of the immunocompromised sibiling developing rotavirus (Case # 2011USA016850 ). The family went ahead with vaccination of the patient despite recommendations.  .; Sender's Comments:  US-009507513-2011USA016850:
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: She is having problems with her arm, she can't raise her arm fully and can't raise her elbow out; The symptoms mimic bursitis; This initial spontaneous report was received from a female patient of unknown age concerning to herself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided.  On 26-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S006778, expiration date not provided but upon internal review stablished as 28-NOV-2020 (strength, dose, route of administration not provided), in the left arm as prophylaxis. On the same date, after vaccination, the patient was having problems with her arm, as she could not raise it fully, as well as she could not raise her elbow out (movement disorder). She reported that the symptoms mimicked bursitis, and she sought for medical attention, but she had not been diagnosed with this as per her physician.  At the reporting time, the patient had not recovered from the events. Additionally, she would like to know what kind of "filler" was in the vaccine, and if there was any recommendation for the management or treatment of symptoms.   The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. . combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S006778; expirationdate: 28-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature 7.4 F / Time frame 2 hours / the HCP does not know which lot number was administered to the patient.; This spontaneous report was received from a physician, referring to an unspecified number of patients, of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 30-NOV-2020, the patients were vaccinated with virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulations, strengths, doses, vaccination schemes, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not provided), as concomitant therapy a sterile diluent (MERCK STERILE DILUENT) was used, that did not undergo temperature excursion. The vaccines administered experienced a temperature excursion of 7.4 degrees Fahrenheit, for a time frame of 2 hours as recorded by a data logger. There was no previous temperature excursion reported.   This case has been considered non-valid due to the lack of patients' identifiers.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE; PEDVAXHIB was administered post temperatme excursion.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 24-NOV-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T001207, which has been verified to be valid, expiration date reported and validated as 09-JUN-2022). The vaccine administered experienced a temperature excursion of 9.2 degrees Celsius (C), for a time frame of 9 minutes. There was no previous temperature excursion reported and no data logger was involved. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA000913: US-009507513-2012USA000976: US-009507513-2012USA000997:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient had a reaction to Pneumonia shot and had a golf ball sized red swell; The patient had a reaction to Pneumonia shot and had a golf ball sized red swell; This initial spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date, route of administration and anatomical location not provided) as prophylaxis. After the use of the product, the reported advised that the patient had an unspecified reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) as she had a golf ball sized red swell (injection site swelling, injection site erythema). At the reporting time, the outcome of injection site swelling, and injection site erythema was unknown.    The reporter considered injection site swelling and injection site erythema to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PEDVAXHIB was administered post temperature excursion; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 23-NOV-2020, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number T001207, which have been verified to be valid, expiration date reported and validated as 09-JUN-2022) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 9.2 degrees Celsius (C) for 9 minutes. There was no previous temperature excursion reported and no digital data logger was not involved. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA000913: US-009507513-2012USA000834: US-009507513-2012USA001255: US-009507513-2012USA000997: US-009507513-2012USA001384:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received second dose early for 2 dose GARDASIL 9 regimen; This spontaneous report was received from a medical assistant referring to a 14 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 16-SEP-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown). Then, early, on 30-NOV-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown).
Sex: M
Vaccine: VARZOS
Symptoms: Pancreatitis
Clinical narrative: Developed pancreatitis; This case was reported by a other health professional via interactive digital media and described the occurrence of pancreatitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced pancreatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the pancreatitis was unknown.   It was unknown if the reporter considered the pancreatitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient developed pancreatitis. The patient was wondering if he should receive his 2nd dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Chronic obstructive pulmonary disease, Incomplete course of vaccination
Clinical narrative: COPD / was hospitalized five times; Wasnt able to get 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of chronic obstructive pulmonary disease in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chronic obstructive pulmonary disease (serious criteria hospitalization) and incomplete course of vaccination. On an unknown date, the outcome of the chronic obstructive pulmonary disease and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the chronic obstructive pulmonary disease to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but it was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose in March and was not able to get 2nd dose within the 2-6 month time period.  The patient had COPD and was hospitalized five times after March plus the patient was worried about Covid 19 issues. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter asked if he or she should get 2nd dose now or had to start over The patient was extremely worried about the possibility of getting shingles and needed an advice.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: flu like reaction; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involves a female patient of unknown age who experienced flu like reaction (influenza like illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu like reaction (influenza like illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypoaesthesia, Influenza
Clinical narrative: mild numbness; ended up getting the flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who experienced mild numbness (hypoaesthesia) and flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's vaccination(s) included INFLUENZA VACCINE as prophylactic vaccination and patient had reaction to it.  The patient's medical history, concomitant therapy, medical treatment(s) 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious mild numbness (hypoaesthesia) and flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 (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 non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a male patient (age unspecified) who had flu (influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The only time he gets the flu is when he gets the flu shot.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 (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 non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: they were all home sick with the flu; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer and transmitted to Sanofi on 14-Oct-2020.  This case is linked to cases 2020SA291094, 2020SA291095, 2020SA291093, 2020SA291096, 2020SA291097, 2020SA291098, 2020SA291099 and 2020SA291100.  This case involved 5 patients who were all home sick with the flu (influenza), after they received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details and concomitant medication 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 unknown route in unknown administration site for prophylactic vaccination. On an unknown date, it was reported that the patient always developed a non-serious flu, within 2 days following the administration of INFLUENZA VACCINE. It was reported that the reporter never had a flu shot and never had the flu, 28 years and 25 were kindergarten. The reporter had to help out with 5 subordinates. The reporter told a friend not to get it but the others talked her into it. When she got back she told the reporter that she was sorry she did not listen. She said never again. Relevant laboratory test was not reported. Final diagnosis was they were all home sick with the flu. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the reported event. There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 (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 non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient get a flu shot every yea, also the child of patient getting one. He also gets his vaccines. Science has come to far, for us to neglect it, still get the flu, patient would rather feel and be contagious for two days than two weeks. Allergies lead to sinus infections that can create weak immune systems to leave us, others open for what builds up and can spread by a simple sneeze. Get a shot! It hurts alot less (FOR YOU IN THE BACK) than getting the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu after a shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient's child via social media.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294166, 2020SA294167, 2020SA294173, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294144 , 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves2  patients of unknown demographic for whom it was reported that patients had got the flu for a shot (influenza) while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, it was reported that the patients had got the flu for a shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu one time; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient) via social media.  This case involves a patient of an unknown demographic who experienced flu one time (influenza), when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu one time (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case is linked to cases 2020SA296404 and 2020SA296404 (same reporter).  This case involves patient (age and gender unspecified) who experienced flu (influenza), while patient received 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 not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  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 lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves patient (unknown demography) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 (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 non-serious got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 (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 non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.