chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: ingredients in flu vaccine from 2009 / that year she got it and was allergic; gradual swelling; itching; redness; hives; face swelling; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2009-10 season) (batch number AFLUA456AA, expiry date unknown) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season (intramuscular). On an unknown date, less than a month after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced allergic reaction, swelling, pruritus, erythema, hives and facial swelling. On an unknown date, the outcome of the allergic reaction, swelling, pruritus, erythema, hives and facial swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, swelling, pruritus, erythema, hives and facial swelling to be related to Influenza vaccine unspecified 2009-10 season.  Additional details were provided as follows: The age at vaccination was not reported, but could be 35 or 36 years. The reporter called asking for full list of ingredients in flu vaccine from 2009 with lot number AFLUA456AA. She did not knew the name of the flu vaccine, only lot number. The reporter stated that she always used to get a flu vaccine but that year she got it and was allergic. The reporter stated that she was allergic to thimerosal but that did not mean she was not allergic to rest of the ingredients. Upon follow up received on 5th November 2010, it was confirmed that the vaccine received was Fluarix from 2009. The reporter believed the vaccine was given intramuscular. The patient experienced gradual swelling, itching, redness and hives following vaccination that was generalized. The reporter remembered face swelling.  She is unsure how long it lasted but stated a handful of days as she went to see her doctor of medicine and then allergist so at least a week. The reporter gave permission to contact again for further information.
Sex: F
Vaccine: MNQ
Symptoms: Occupational exposure to product, Skin laceration
Clinical narrative: she cut her finger because the vial was broken; 1 vial of MenCYW liquid conjugate that was broken; This case was reported by a other health professional via call center representative and described the occurrence of laceration of finger in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA390A, expiry date 31st August 2021) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, immediately after receiving Menveo, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of finger to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter reported that in a physician's office receive 1 vial of MenCYW liquid conjugate that was broken and was discovered after only 1 dose had been used out of the box. The reporter attempted to remove the vial from the box prior to preparation she cut her finger because the vial was broken. The box did not appear to be damaged from shipping, the product was not administered to a patient, and the HCP attempting to prepare the vaccine was an experienced user. The reporter statet that there was no evidence of leakage in the box, there were pieces of glass still in the carton, and there was no product still present in the vial and the whole circle on the bottom of the vial was broken off and missing. No additional information obtained about the event due to the adverse event  being filed after call. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headaches; pain; This case was reported by a physician via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain. On 25th October 2020, the patient experienced headache. On 29th October 2020, the outcome of the headache and pain were recovered/resolved.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headaches and pain during 3 to 4 days after the adminsitration of Shingrix.  The reporter consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye disorder, Eyelid function disorder, Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles on the left side of her face, in her left nostril and along the gum line in the left side of her mouth; left eye started to flutter she couldn't keep it closed.; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles outbreak in September 2018).   On 27th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles, eye disorder and incomplete course of vaccination. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and eye disorder were recovering/resolving and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and eye disorder to be related to Shingrix.  Additional details were provided as follows: The patient did not have an outbreak after receiving the vaccine until before date of reporting.  Till the time of reporting the patient had not received the 2nd dose which led to incomplete course of vaccination. She had shingles on the left side of her face, in her left nostril and along the gum line in the left side of her mouth and her left eye started to flutter she could not keep it closed.  She had been taking acyclovir and the symptoms were resolving.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Headache, Injection site pruritus, Injection site rash
Clinical narrative: itching at the injection site; rash around the injection site; headache; hurting all over; shivering; swelling at injection site about the size of a baseball; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included multiple myeloma.   On 29th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 4 hrs after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, shivering and general body pain. On 30th October 2020, the patient experienced headache. On 1st November 2020, the patient experienced injection site itching and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash, shivering, headache and general body pain were recovered/resolved and the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site rash, shivering, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was in his 50's, experienced hurting all over, shivering, swelling at injection site about the size of a baseball, rash around the injection site, itching at the injection site, and headache.  Events were resolved.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: itching at the injection site; rash around the injection site; headache; hurting all over; shivering; swelling at injection site about the size of a baseball; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included multiple myeloma.   On 29th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 4 hrs after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, shivering and general body pain. On 30th October 2020, the patient experienced headache. On 1st November 2020, the patient experienced injection site itching and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash, shivering, headache and general body pain were recovered/resolved and the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site rash, shivering, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was in his 50's, experienced hurting all over, shivering, swelling at injection site about the size of a baseball, rash around the injection site, itching at the injection site, and headache.  Events were resolved.  The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Affected area is also tingly / tingle in hand / vaccinating pharmacist hit a nerve; Allegedly pain started out in finger but has now extended to a large majority of hand / Pain and tingle in hand / vaccinating pharmacist hit a nerve; This case was reported by a pharmacist via call center representative and described the occurrence of pain in hand in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 272F3, expiry date 1st October 2022) for prophylaxis.   On 27th October 2020, the patient received Shingrix (intramuscular) .5 ml. On 27th October 2020, immediately after receiving Shingrix, the patient experienced pain in hand. On an unknown date, the patient experienced tingling of extremity. On an unknown date, the outcome of the pain in hand and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the pain in hand and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that during injection the patient said, "Oh My thumb". Allegedly pain started out in finger but had now extended to a large majority of hand. In less than 2 weeks, affected area was also tingly.  When patient went to physician's office, physician said sounds like vaccinating pharmacist hit a nerve. Pain and tingle in hand were not resolved.
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Laboratory test abnormal
Clinical narrative: tested positive for influenza; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 25-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2020, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, 1 week after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Fluarix Quadrivalent 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 provided as follows: The age at vaccination was not reported. Approximately one week after vaccination patient tested positive for influenza via rapid test. The reporter did not consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema
Clinical narrative: Six hours after receiving vaccine, face only turned red, dry, crackly for next 3 to 5 days. Felt as sun/wind burned. No itching, jusr extremely uncomfortable
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye discharge, Eye irritation, Eye pruritus, Ocular hyperaemia
Clinical narrative: Trouble breathing; could not get full breaths lasting 1-1 1/2 hour.  Redness, burning, itching eyes with thick, light yellow discharge lasting 12 hours. Other flu like symptoms for 24 hours. After 36 hours, eyes are somewhat burning, itchy but no more discharge. Did not receive treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Swollen red circles about 2 inches in circumference for one and a little smaller for the other. Rock hard where the injection was. The red circles got bigger and bigger and then as they faded were bruised purple. Extreme fatigue (may be normal but want to document). The circles were on her arm for about 4 days. Starting out small  then gradually getting bigger.
Age: 4.67
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Dermatitis, Urticaria
Clinical narrative: I experienced severe adverse effect associated with  receiving Shingles vaccine (Recombinant zoster vaccine:RZV) which is not currently noted on the list of this vaccine's side effects. I am generally in good health, not having any chronic health conditions other than a history of cold sore.  I am not taking any medications and have no history of chronic skin conditions. However, after receiving Shingles vaccines, per my primary care provider's advice I experienced hives upon consuming sweet foods. The flare up of dermatitis/hives gradually became more severe and reached to its pick in a few months when consuming foods (i.e. bread, sweets, nuts like walnuts, etc.).
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pustule, Rash
Clinical narrative: Rash and Pustules outbreak
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Urticaria
Clinical narrative: Patient states rash and hives occurred later in the evening after receiving an influenza shot.  The rash has continued into the morning.  Patient did take bendaryl and it seemed to help.  The pharmacist instructed the patient to contact their primary care provider.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Listless
Clinical narrative: SEVERE headache, severe nausea, muscle aches, chills, low grade fever, stomach pain with loose stools.  I had to take an Imedrix for my headache and Meclizine for the nausea.   My symptoms were so severe I almost had my husband take me to ER.  Once I got the headache and nausea under control I was able to sleep.  I was in bed all day and all night.  On day two (today) I am without symptoms, just listless.  I know these are all "side effects" and not necessarily "adverse events", but since my symptoms were so severe, I decided to report them anyway.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: SEVERE headache, severe nausea, muscle aches, chills, low grade fever, stomach pain with loose stools.  I had to take an Imedrix for my headache and Meclizine for the nausea.   My symptoms were so severe I almost had my husband take me to ER.  Once I got the headache and nausea under control I was able to sleep.  I was in bed all day and all night.  On day two (today) I am without symptoms, just listless.  I know these are all "side effects" and not necessarily "adverse events", but since my symptoms were so severe, I decided to report them anyway.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache, muscle aches, chills all in first 24 hours
Age: 83.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Ear pain, Fatigue
Clinical narrative: Severe pain in left arm. Muscle pain. Extremely tired and weak. Severe headaches. Shivering. Hot flashes. Upset stomach. Piercing ear pain. 24 hours of severe pain. Then pain subsided.
Age: 83.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Hot flush, Myalgia, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm. Muscle pain. Extremely tired and weak. Severe headaches. Shivering. Hot flashes. Upset stomach. Piercing ear pain. 24 hours of severe pain. Then pain subsided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Shivering, headache, joint pain and fatigue
Age: 63.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Fatigue, Feeling jittery, Injection site pain
Clinical narrative: None  Really tired, jittery, site of injection is a little sore
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Nervous system disorder
Clinical narrative: Pt developed significant neurological deficits ("couldn't walk straight", per her response) on November 10, 2020.  She is currently hospitalized (day one: November 11) for suspected acute onset of Guillain-Barre syndrome and is undergoing treatment with IV immunoglobulin therapy.    Significant prior history: She was diagnosed with pneumonia on October 9, 2020 and treated with PO antibiotics prior to her influenza vaccination.  Her influenza vaccination was delayed until well after her last dose of PO antibiotics and she presented asymptomatic to me on October 27.  She denied prior history of severe allergic reaction to the influenza vaccine and denied a history of Guillain-Barre.  She was vaccinated for influenza last fall with no adverse effects.  She remains hospitalized at the time of this reporting and is expected to undergo physical therapy to address lower extremity weakness.  I don't have information on other signs/symptoms at this time.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Pain in extremity
Clinical narrative: 36 HOURS AFTER VACCINE - DIFFUSE ERYTHEMA ABDOMEN & CHEST LASTED 4 DAYS - HEADACHE 1 WEEK FLARE UP OF RA - INTENSE PAIN HANDS, WRISTS, R ELBOW, HIPS - SWELLING, STIFFNESS AND FATIQUE MD O/C MTX WITH RASH - RENEWED MTX WITH FLAREUP
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 36 HOURS AFTER VACCINE - DIFFUSE ERYTHEMA ABDOMEN & CHEST LASTED 4 DAYS - HEADACHE 1 WEEK FLARE UP OF RA - INTENSE PAIN HANDS, WRISTS, R ELBOW, HIPS - SWELLING, STIFFNESS AND FATIQUE MD O/C MTX WITH RASH - RENEWED MTX WITH FLAREUP
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Varicella
Clinical narrative: Varicella illness developed
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Myalgia
Clinical narrative: 2 MONTHS OF MUSCLE PAIN AND RED AREAS ON BOTH ANKLES AND SOULS OF FEET    .  NO PAIN OR ITCH ON RED AREAS BUT VERY RED
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash like and itching on right side by ribs
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient was given the Shingrix diluent and not the reconstituted vaccine together. No symptoms.
Age: 59.0
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt called office on 11/12 (3 days after receiving vaccine) and stated that her right upper arm was swollen, red, painful, warm to the touch, had a rash and itched. Measured approximately 3 inches by 4-5 inches. The area was wrapping around to the back of her arm. Pt states she thought it would get better after it started, but it had been getting worse. Patient received Haemophilus Influenzae Type B (R upper) and TD/Tdap (R lower) in that arm.  Scheduled pt for clinic appt on 11/13 afternoon. Pt called 11/13 to cancel appt, stating that her right arm where she got the injections had improved and does not feel needs to be seen today. Pt states the site is not hot and not nearly as red.  Pt was not seen by physician. Was instructed to call office if arm worsens or with any concerns.
Age: 59.0
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Injection site warmth
Clinical narrative: Pt called office on 11/12 (3 days after receiving vaccine) and stated that her right upper arm was swollen, red, painful, warm to the touch, had a rash and itched. Measured approximately 3 inches by 4-5 inches. The area was wrapping around to the back of her arm. Pt states she thought it would get better after it started, but it had been getting worse. Patient received Haemophilus Influenzae Type B (R upper) and TD/Tdap (R lower) in that arm.  Scheduled pt for clinic appt on 11/13 afternoon. Pt called 11/13 to cancel appt, stating that her right arm where she got the injections had improved and does not feel needs to be seen today. Pt states the site is not hot and not nearly as red.  Pt was not seen by physician. Was instructed to call office if arm worsens or with any concerns.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt anterior thigh slightly red and warm to touch swollen area. Measuring 10.5cm x 7.5cm wide. Patient carried into office, medicated during meeting with Ibuprofen 100mg/5ml, 7.4ml given in office. After 30 mins patient was encouraged to stand and walked short distance without facial grimace. Nurse practitioner observed pt walking with normal gait outside of the office.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient states she got her flu shot about 2 weeks ago but her arm is still in a lot of pain. Her arm is not red or swollen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: 11/11/20 5:30pm right upper arm difficulty moving arm and painful.   6:15pm took 3 advil over the coarse of an hour. Over the next few hours area of pain and extreme discomfort spread to shoulder area .  Needed the assistance of my left arm to move the right arm.  Ice applied to site Around 8:30 pm chills and body shakes started and continued for about 3 hrs.  Temp was 101.8   Around 10:00 took 2 tylenol extra strength 500mg each. Very restless night with little sleep and lots of pain and discomfort in right arm area noted above. 11/12/20 6:30a, took 3 advil for pain and discomfort 2:15 had o.v. with my PMD Dr. Prescribed advil and ice compress Advil 3 tablets 3 times a day  11/13/20 Continuing with advil as prescribed by PMD and ice.  Less pain in right shoulder/upper arm , more mobility
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Restlessness, Sleep disorder, Tremor
Clinical narrative: 11/11/20 5:30pm right upper arm difficulty moving arm and painful.   6:15pm took 3 advil over the coarse of an hour. Over the next few hours area of pain and extreme discomfort spread to shoulder area .  Needed the assistance of my left arm to move the right arm.  Ice applied to site Around 8:30 pm chills and body shakes started and continued for about 3 hrs.  Temp was 101.8   Around 10:00 took 2 tylenol extra strength 500mg each. Very restless night with little sleep and lots of pain and discomfort in right arm area noted above. 11/12/20 6:30a, took 3 advil for pain and discomfort 2:15 had o.v. with my PMD Dr. Prescribed advil and ice compress Advil 3 tablets 3 times a day  11/13/20 Continuing with advil as prescribed by PMD and ice.  Less pain in right shoulder/upper arm , more mobility
Age: 89.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Injection site pain, Urticaria
Clinical narrative: Developed pain on injection site. Hives. Fatigue.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's left arm was red, warm and swollen
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Called patient on 11/13/20, she has some redness at the site of the injection. She was glad we called her + inquired of the situation. She might go and see the MD today just to make sure it is not an infection. Overall she is fine
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: Given to a patient IM instead of SQ; This spontaneous report has been received from a nurse referring to a 4 years old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were unknown.  On 16-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T015598, expiration date: 02-NOV-2021, strength was unknown, therapy type: recombinant Human albumin (rHA)) 1 dose intramuscularly, rather than subcutaneously for prophylaxis (Incorrect route of product administration). No other adverse events noted.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: an Expired MMRII administered to patient; This spontaneous report has  been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) formulation not reported but defaulted to subcutaneous injection for prophylaxis (dosage regimen, Lot # and expiration date were not reported).  Follow up information was received on 27-OCT-2020. On 26-OCT-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number was R030813, expiration date reported and validated as 24-OCT-2020). There was no experience  temperature excursion.
Sex: F
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: the plunger was not going in the patient's arm; the spraying out came from the dispensing point due to the hard push and there was no defect noticed on the syringe; no additional AE was reported; This spontaneous report was received from a pharmacy intern and refers to a 77-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications and drug allergies/reactions were unknown by the reporter.  On 27-OCT-2020, the reporter tried to administer pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), in the left arm, (lot # T021485 and expiry date 15-MAR-2022; strength, dose, route of administration were unknown) to the patient for prophylaxis.   During the administration, the plunger was not going in the patient's arm. The pharmacy intern then took the syringe out of the patient's arm and pushed it harder this time. The medication then sprayed out. When asked if the spraying medication came from dispensing point due to hard push or was there any other defect noticed on syringe, she stated the spraying out came from the dispensing point due to the hard push and there was no defect noticed on the syringe. She disposed this syringe and used a new syringe from the box. The new syringe worked fine and the patient got her dose. No additional adverse event was 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: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; operatorofdevice: Other; operatorofdeviceother: Pharmacy Intern; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: HCP reported inadvertent administration of expired VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.      On 06-NOV-2020, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, frequency and strength were not reported; lot # was R031626 and expiration date was 01-NOV-2020) (Expired product administered) for prophylaxis. The reporter stated that the varicella virus vaccine live (oka/merck) (VARIVAX) has had no prior temperature excursions.  The outcome of the event was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose of GARDASIL9 later than recommended in the current prescribing information; Information has been received from a pharmacist referring a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown day in October 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) (route of administration, lot number and expiration date were not reported) for prophylaxis. It was reported the patient received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) outside of the recommended prescription (Inappropriate schedule of vaccine administered).
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: limited mobility in injection site arm/ she can't lift shoulder and arm pass her head; This spontaneous report was received from a 56 years old female consumer referring to herself. Information about medical history, concurrent conditions and concomitant therapies were not provided.     On 19-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) single dose shot (route, lot number and expiration date were not reported) for prophylaxis (reported as prevention of pneumonia).   On the same day, the patient experienced limited mobility in injection site arm. She stated she could not lift shoulder and arm pass her head. The patient received medical attention for the issues she was having by her physician. The patient was given antibiotics and pain medication, but did not know the name of the medications given. She stated that she had a follow up appointment on 12-NOV-2020. The outcome of injected limb mobility decreased was recovering. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Some little bit nausea; shivering; night sweats; fever; flu-like symptoms; Pain at the injection site; Redness at the injection site; Swelling at the injection site; Muscle pain(whole side of body was really in pain); tiredness; bad headache; unable to sleep; Could not raise her arm; Upset stomach; Sore arm of injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tablet does not break into pre-defined pieces, unwell and penicillin allergy.   On 3rd November 2020, the patient received Shingrix. On 3rd November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, fever, influenza-like symptoms, sleeplessness and mobility decreased. On 4th November 2020, the patient experienced shivering and night sweat. In November 2020, the patient experienced pain in arm and upset stomach. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness and upset stomach were unknown and the outcome of the mobility decreased was recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness, mobility decreased and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient got her 1st Shingrix shot yesterday (03th November 2020) less than 24 hours ago.  The patient reported sore arm of injection, could not raise her arm yesterday from the day of reporting but it was much better and less sore today.  The patient reported pain, redness (no rash), and swelling at the injection site, muscle pain(whole side of body was really in pain), tiredness, bad headache, shivering, fever, flu-like symptoms, night sweats and some nausea /upset stomach,was unable to sleep last night. The patient did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia, Mobility decreased
Clinical narrative: Some little bit nausea; shivering; night sweats; fever; flu-like symptoms; Pain at the injection site; Redness at the injection site; Swelling at the injection site; Muscle pain(whole side of body was really in pain); tiredness; bad headache; unable to sleep; Could not raise her arm; Upset stomach; Sore arm of injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tablet does not break into pre-defined pieces, unwell and penicillin allergy.   On 3rd November 2020, the patient received Shingrix. On 3rd November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, fever, influenza-like symptoms, sleeplessness and mobility decreased. On 4th November 2020, the patient experienced shivering and night sweat. In November 2020, the patient experienced pain in arm and upset stomach. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness and upset stomach were unknown and the outcome of the mobility decreased was recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness, mobility decreased and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient got her 1st Shingrix shot yesterday (03th November 2020) less than 24 hours ago.  The patient reported sore arm of injection, could not raise her arm yesterday from the day of reporting but it was much better and less sore today.  The patient reported pain, redness (no rash), and swelling at the injection site, muscle pain(whole side of body was really in pain), tiredness, bad headache, shivering, fever, flu-like symptoms, night sweats and some nausea /upset stomach,was unable to sleep last night. The patient did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Some little bit nausea; shivering; night sweats; fever; flu-like symptoms; Pain at the injection site; Redness at the injection site; Swelling at the injection site; Muscle pain(whole side of body was really in pain); tiredness; bad headache; unable to sleep; Could not raise her arm; Upset stomach; Sore arm of injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tablet does not break into pre-defined pieces, unwell and penicillin allergy.   On 3rd November 2020, the patient received Shingrix. On 3rd November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, fever, influenza-like symptoms, sleeplessness and mobility decreased. On 4th November 2020, the patient experienced shivering and night sweat. In November 2020, the patient experienced pain in arm and upset stomach. On an unknown date, the patient experienced nausea. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness and upset stomach were unknown and the outcome of the mobility decreased was recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, influenza-like symptoms, night sweat, nausea, sleeplessness, mobility decreased and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient got her 1st Shingrix shot yesterday (03th November 2020) less than 24 hours ago.  The patient reported sore arm of injection, could not raise her arm yesterday from the day of reporting but it was much better and less sore today.  The patient reported pain, redness (no rash), and swelling at the injection site, muscle pain(whole side of body was really in pain), tiredness, bad headache, shivering, fever, flu-like symptoms, night sweats and some nausea /upset stomach,was unable to sleep last night. The patient did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Pain in extremity, Urticaria
Clinical narrative: rash at the injection site; red welts; The arm was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site rash, erythema urticarial and pain in arm. On an unknown date, the outcome of the injection site rash, erythema urticarial and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site rash, erythema urticarial and pain in arm to be related to Shingrix.  Additional details were provided as follows: A rash at the injection site waspresented a few days after administration of Shingrix that lasted 3-4 days.  It was described as red welts. The patient's arm was sore for a few days also. The reporter did not consent to follow up. This case has been linked with US2020219732 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219732:same reporter (husband´s case)
Sex: M
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID-19; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Influenza vaccine Quadrivalent 2020-2021 season and experienced covid 19 which was recovered . The patient was not sure about the name of the the vaccine if it was Fluarix or Flulaval, but his HCP told him it was manufactured by GSK. The patient stated that he had the flu vaccine 3 weeks back and about 2 weeks back he was diagnosed with COVID 19. The reporter consented to follow up. No further information was available. This case was linked with case US2020221384.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221384:same reporter
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling at site of injection no redness or itching. Swelling went down completely within 01 hour.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain, Pyrexia, Somnolence
Clinical narrative: Body aches, fever up to 102.1, loss of appetite, extreme sleepiness. Fever was the worst the day following the injection. Although it was over 100.5 for the three days following the shot.
Age: 56.0
Sex: F
Vaccine: FLUA3
Symptoms: Balance disorder, Dizziness, Retching
Clinical narrative: patient doesn't remember vaccine name unsteadiness and dizziness with any head movement, pulse 110, could not sit up without feeling like falling over, dry heaving, called PCP on Tuesday and PA suggested no ER visit necessary. Symptoms lasted 5 days
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: I could not lift my arm that entire night. It hurt so badly that I was fighting back tears when I tried to lift my arm. I have gotten a flu shot yearly for probably about 20 years, and though  I have had soreness and bruising a day or few after receiving the shot, I have never had such pain (not soreness) immediately.   I continue to have upper arm pain when I lift my arm up high or fully out to the side. It is the worst when I first wake up, after it hasn't been used all night, but slowly loosens up throughout the day.  However, it always hurts when lifting it, as mentioned.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, HEPA, PNC13
Symptoms: Eye swelling, Rash, Rash erythematous, Swelling
Clinical narrative: On 11/13/20 at 1330, mother called in to the clinic reporting her son who received vaccinations 11/12/20 awoke in the morning with raised red rash across his back and his right eye was swollen. Denied anaphylaxis and any respiratory distress. Mother stated child was eating and acting normally. Nurse recommended children's Benadryl and for further concerns to notify PCP.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Feeling abnormal, Injection site nodule, Muscle tightness, Pain, Pyrexia
Clinical narrative: I had the shot Saturday afternoon. Mid Sunday morning , I started feeling bad, I thought it was allergies. Started to get worse as the morning went on. My masseter muscle in my right jaw started tensing and spasming. That continued all day. I was running a fever between 101.4 to 102.5. My face in my lower jaw was swollen. -I thought I might have the mumps or tray us but I e been vaccinated for those. I generally felt awful. I had a knot at the Injection site snd soreness that lasted a week. In the past I never had discomfort during injection, until this time, this one hurt.  This all lasted for about 24 hours.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Swelling face, Trismus
Clinical narrative: I had the shot Saturday afternoon. Mid Sunday morning , I started feeling bad, I thought it was allergies. Started to get worse as the morning went on. My masseter muscle in my right jaw started tensing and spasming. That continued all day. I was running a fever between 101.4 to 102.5. My face in my lower jaw was swollen. -I thought I might have the mumps or tray us but I e been vaccinated for those. I generally felt awful. I had a knot at the Injection site snd soreness that lasted a week. In the past I never had discomfort during injection, until this time, this one hurt.  This all lasted for about 24 hours.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Immediately left arm got sore, couldn't move arm all day into the next day. Had dizziness, headache for 24 hours, neck pain, and vomited once. Still has soreness, aches all over and feeling tired.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Neck pain, Pain, Pain in extremity, Vomiting
Clinical narrative: Immediately left arm got sore, couldn't move arm all day into the next day. Had dizziness, headache for 24 hours, neck pain, and vomited once. Still has soreness, aches all over and feeling tired.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Erythema, Fall, Syncope
Clinical narrative: Patient seen for a nurse visit for vaccines for school. Ok to give HPV, Menveo, and flu vaccines to patient. Confirmed name and DOB with patient and father. Informed patient and father of vaccines due.   Patient and father agreed to give all vaccines. Administered HPV to LD, the flu and Menveo to RD.   After administering the vaccines, patient was Instructed to sit from the bed to the chair next to his father. After leaving the exam room, the patient had stood up to rotate his arms, fallen and possibly hit his face per the patient's father.   Entering the room, the patient had fainted and does not recall fainting and falling. Patient had a red mark on his nose from the fall.   Patient's vitals recorded:   Time: 4:18pm BP: 147/80 HR: 74 BS: 94 RR: 16 O2 Sat:  98%   At 4:21 p.m. BP: 121/69 HR: 98 RR: 16 O2 Sat: 98%   At 4:26 p.m. BP: 107/66 HR: 92   Paramedics was called and Patient will be transported to the ER.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Agitation, Blood glucose increased, Lethargy, Type 1 diabetes mellitus
Clinical narrative: Child was lethargic, not acting right, very agitated. Overflowing her diapers for several days. Taken to the hospital and diagnosed with type one diabetes.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urine output increased
Clinical narrative: Child was lethargic, not acting right, very agitated. Overflowing her diapers for several days. Taken to the hospital and diagnosed with type one diabetes.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Swollen tongue
Clinical narrative: Patient Reports "tongue swelling but no breathing difficulty". Patient states she went to the Emergency Room the evening of her Flu shot and they gave her Benadryl.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Pyrexia, Tremor
Clinical narrative: Headache, then chills violent tremors, vomiting & fever. After sleeping at night, fever went down, chills too. However, very week for the next 2 days. First time ever took the Sr. Vaccine flu shot. Very terrible reaction!