chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dyspnoea, Immediate post-injection reaction, Peripheral swelling, Swelling face
Clinical narrative: Administered HPV and influenza vaccine at 9:00 AM. Patient had immediate reaction upon administration of influenza and gardasil vaccine. Presented first with difficulty breathing then mild facial swelling and mild right arm swelling occurred shortly after. Patient was instructed to lay flat on the bed, take her mask off,  and use deep breaths. Instructed mom to stay with patient. Went into the hallway and grabbed Dr. immediately to come in and assess patient. Dr. instructed me to then obtain epinephrine. Spoke with staff, another nurse, about dosage needed. Drew up 0.5 mL of epinephrine per instructions on box. Lot # 335174 and Exp # 03/2021. Took epinephrine and a pulse/pulse oximetry meter into the room. Obtained patient's oxygen saturation at 98% and pulse at 72 bpm at 9:15 AM. Administered dose of epinephrine into patient's left deltoid at 9:18 AM per Dr.'s instructions. Patient laid flat again and was monitored for 15 minutes after injection. Patient's oxygen saturation was 99% and pulse was 80 at 9:30 AM. Patient feeling better at that time and showing no signs of distress.  No further doses of epinephrine needed or given per Dr. Patient dismissed and advised to contact us or seek emergency services if symptoms reappear. Patient also given a steroid by Dr. for home use. Spoke with staff, nursing manager, about excess epinephrine. Discarded remainder of epinephrine down the sink.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Starting in the evening on the day of vaccine Friday 9/18 - arm pain that became quite severe, couldn't lift arm. On Saturday evening pain was better, pain was gone on Sunday. On Sunday noticed a rash underneath her arm (area around armpit) was red, gradually spread around right breast and onto back. On Monday spread down arm, to abdomen, and backs of legs. Not itchy, flat red rash. Rash went away on Wednesday. Took ibuprofen to treat pain on Friday which helped a little bit. No treatment given for rash.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swelling, redness, and warmth at the injection site. Counseled patient to take benadryl until it goes away.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Hallucination, Headache, Lethargy, Pain
Clinical narrative: Headache, hallucinations, body aches, lethargic.
Age: 14.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Computerised tomogram head, Confusional state, Differential white blood cell count
Clinical narrative: Patient received flu injection on 9/15/2020 and mom states on 9/19/2020 patient woke up feeling dizzy and light headed, patient explains it as a "dream" and her mind feels "foggy", along with confusion.
Age: 14.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Dreamy state, Feeling abnormal, Full blood count, Metabolic function test
Clinical narrative: Patient received flu injection on 9/15/2020 and mom states on 9/19/2020 patient woke up feeling dizzy and light headed, patient explains it as a "dream" and her mind feels "foggy", along with confusion.
Age: 14.0
Sex: F
Vaccine: FLUA4
Symptoms: Thyroxine free, Urine analysis
Clinical narrative: Patient received flu injection on 9/15/2020 and mom states on 9/19/2020 patient woke up feeling dizzy and light headed, patient explains it as a "dream" and her mind feels "foggy", along with confusion.
Age: 11.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, MNQ, VARCEL
Symptoms: Dizziness, Headache, Nausea, Pallor, Somnolence
Clinical narrative: Pt was brought in by mom to receive vaccines for the first time.  After 1st 2 vaccines pt started feeling light headed. MA had patient lay down on exam table and asked mom if she wanted to proceed with other vaccines. Mom said yes. Patient looked pale and said he wanted to throw up after he received an additional 3 vaccines. At which point MA called for help. LVN came in with emesis bag and wheelchair to assist with pt. Provider came in to assess the pt. Pt stated he wanted to go home and go to sleep. LVN wheeled pt out in the wheelchair to pts car. Mother took pt home and was instructed to call or bring pt back if he's not doing better. LVN called pt @ 2:00pm to check how pt was doing. Pts mother stated pt was doing much better just a slight headache. Pts mother was offered a f/u up appt. Pts mother agreed and rescheduled for 10/02/2020. Pts mother was again instructed to call or bring pt back if she sees any other adverse reactions.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: She has 4-5 red patches on arm
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Patient experienced swelling of the lips, advised to take benadryl. No injection site reaction
Age: 1.0
Sex: M
Vaccine: HEP, PNC13, VARCEL
Symptoms: Cerebellar ataxia, Computerised tomogram head normal, Dysstasia, Electroencephalogram normal, Gait disturbance
Clinical narrative: My child began demonstrating adverse reactions roughly 2.5 weeks following his one year shots. He woke up vomiting on 9/18/2020 and was unable to sit up, stand, or walk. We?ve been to an urgent care center and two hospitals (ER and inpatient stay). He has been diagnosed with acute cerebellar ataxia. He has not been sick in the past month, and all of his extensive medical testing came back normal. His vaccines are entirely responsible for this ataxia. He remains unsteady on his feet and is a fall risk requiring close monitoring.
Age: 1.0
Sex: M
Vaccine: HEP, PNC13, VARCEL
Symptoms: Gait inability, Magnetic resonance imaging brain normal, Respiratory viral panel, SARS-CoV-2 test negative, Scan with contrast normal
Clinical narrative: My child began demonstrating adverse reactions roughly 2.5 weeks following his one year shots. He woke up vomiting on 9/18/2020 and was unable to sit up, stand, or walk. We?ve been to an urgent care center and two hospitals (ER and inpatient stay). He has been diagnosed with acute cerebellar ataxia. He has not been sick in the past month, and all of his extensive medical testing came back normal. His vaccines are entirely responsible for this ataxia. He remains unsteady on his feet and is a fall risk requiring close monitoring.
Age: 1.0
Sex: M
Vaccine: HEP, PNC13, VARCEL
Symptoms: Sitting disability, Streptococcus test negative, Urine analysis normal, Viral test negative, Vomiting
Clinical narrative: My child began demonstrating adverse reactions roughly 2.5 weeks following his one year shots. He woke up vomiting on 9/18/2020 and was unable to sit up, stand, or walk. We?ve been to an urgent care center and two hospitals (ER and inpatient stay). He has been diagnosed with acute cerebellar ataxia. He has not been sick in the past month, and all of his extensive medical testing came back normal. His vaccines are entirely responsible for this ataxia. He remains unsteady on his feet and is a fall risk requiring close monitoring.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Greater than 50mm area of eryrthema, warm to touch.  Cold pack and tylenol.  Advised benadryl for itching.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Autoimmune disorder, Computerised tomogram head, Full blood count, Liver function test
Clinical narrative: Had Prevnar-13 on 7/23/20 and Shingrex #1 on 8/3/20; By 8/11/20 developed petechiae over face, body & inside mouth.  Went to ER on 8/13/20 and platelets were at 6000.  It is unclear whether one or both of the vaccines so close together caused a severe autoimmune reaction.  No other conditions or issues surrounding this & was tested for many things in the ER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth haemorrhage, Petechiae, Platelet count decreased, Red blood cell sedimentation rate, Ultrasound scan
Clinical narrative: Had Prevnar-13 on 7/23/20 and Shingrex #1 on 8/3/20; By 8/11/20 developed petechiae over face, body & inside mouth.  Went to ER on 8/13/20 and platelets were at 6000.  It is unclear whether one or both of the vaccines so close together caused a severe autoimmune reaction.  No other conditions or issues surrounding this & was tested for many things in the ER.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Severe muscle aches throughout body, severe headache, fever, sweating, severe fatigue.  Duration was about two days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Headache, Nausea
Clinical narrative: Extreme nausea, Headache, lightheaded,  loss of appetite that lasted for over a week.
Age: 48.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Lethargy
Clinical narrative: Approximately 6-7 hours after receiving the flu shot, patient developed flu-like symptoms: chills, arthralgia, low grade fever, headache, lethargy.  Patient has received annual flu shot every year for 20+ years and not experienced any adverse events.  Adverse events persist  and are ongoing as of  the time of this report (approximately 24 hours from receiving shot).
Age: 48.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: Approximately 6-7 hours after receiving the flu shot, patient developed flu-like symptoms: chills, arthralgia, low grade fever, headache, lethargy.  Patient has received annual flu shot every year for 20+ years and not experienced any adverse events.  Adverse events persist  and are ongoing as of  the time of this report (approximately 24 hours from receiving shot).
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Pt had a sore arm, fever and his arm was swollen from top of his shoulder to his elbow. Pt's arm felt warm and hard to the touch. This happened a few hours after the vaccine was given on 9/21. Parents called our office on 9/22 to inform us. Parent was told to use Tylenol/ Motrin/ Benadryl and a cold compress to help.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Chills, fever, headache, sore muscles, sore left arm, nausea. 10 hours so far.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, headache, sore muscles, sore left arm, nausea. 10 hours so far.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bruising at injection site.  3 inches below the Injection site was a red, swollen and hot to touch oval area 3 inches long and 2 inches wide
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Right underarm/axilla tenderness and swelling on a pain scale of 5
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Inflammation, Injection site pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Right underarm/axilla tenderness and swelling on a pain scale of 5
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Tenderness
Clinical narrative: Right underarm/axilla tenderness and swelling on a pain scale of 5
Age: 5.0
Sex: F
Vaccine: FLU4, HEPA, IPV, MMRV
Symptoms: Crying, Erythema, Gait inability, Joint swelling, Pain
Clinical narrative: Started running fever (unmeasured by mother) that evening, woke up next morning (9/22) with red and swollen knees and ankles.  Today, 9/24, the child is unable to walk due to excessive pain.  Mother states she cries whenever she is moved.
Age: 5.0
Sex: F
Vaccine: FLU4, HEPA, IPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Started running fever (unmeasured by mother) that evening, woke up next morning (9/22) with red and swollen knees and ankles.  Today, 9/24, the child is unable to walk due to excessive pain.  Mother states she cries whenever she is moved.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Patient called and told pharmacy that she started to taste something weird in her mouth when she got home after receiving vaccine. Communicated to her that we would follow up the next day but to call us if she starts experiencing any worsening symptoms such as rash, inflammation, trouble breathing. Called patient on 9/23/2020 and left a voicemail. Called patient on 9/24/2020 and spoke to patient who told us that the weird taste had resolved the day before and she feels fine.
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event, Poor quality device used
Clinical narrative: met resistance/felt pressure; only "about 1/2 a dose was administered"; Poor quality device used; This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. The patient's concurrent conditions included anxious/tense. There was no information about the patient's drug reactions, allergies, medical history, and concomitant therapies provided.   On an unknown date in August 2020 (reported as on unspecified date "last week"), the patient only received a partial dose of a prefilled pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T009744, expiration date 28-JAN-2020; exact dose and route of administration were not reported) for prophylaxis by a healthcare professional, because the nurse administering it "met resistance/felt pressure" when administering the vaccine (reported as feeling resistance and only about 1/2 a dose was administered) (resistance to movement in device, inappropriate dose of vaccine administered and poor quality device used). The prefilled syringe looked normal prior to the administration and after the partial administration. The plunger appeared to be working normally once withdrawn. The reporter confirmed no additional adverse events as a result of the partial dose. The patient was not anxious/tense after vaccine and no site reactions reported. The reporter had syringe available for retrieval. The sample had been received. No further information provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T009744; expirationdate: 28-JAN-2020; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: Returned to Manufacturer; productreturndate: 11-SEP-2020; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: On 8/31/2020, the patient was administered improperly stored VARIVAX (reconstituted with properly stored Merck STERILE DILUENT); This spontaneous report has been received from a medical assisstant concerning a 13-month-old male patient of unknown ethnicity. The patient's concurrent conditions, known allergies/reactions, and medical history were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 31-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S038701 with expiration date 01-DEC-2021; dosage regimen not reported) (reconstituted with a properly stored sterile diluent), subcutaneously for prophylaxis (indication also reported as ''well check'') , exposed at multiple temperature excursions between -9 degrees centigrades (C) and 8C (average -6.1 C) (no previous temperature excursions). Additionally, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S032355 with expiration date 14-OCT-2021; dosage regimen and route of administration not reported) was also involved in temperature excursion between -14C to 10C for 116 hours; and -9C to 8C (average -6.1C) for 13 hours (time frame also reported as 129 hours) (no previous temperature excursions for this lot #). The call was performed due to a data logger.; Sender's Comments:  US-009507513-2009USA005503:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient Information regarding the patients' drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 31-AUG-2020, the patient received a dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S038701, expiry date 01-DEC-2021, for prophylaxis (reported as "well check")(concentration, dose, dose number, route of administration and frequency were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-9 to 8 Celsius degree) (-6.1 Celsius degree) (multiple excursions). Time frame was unknown by reporter. Data logger was involved. There were no previous excursions reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved.  It was also reported that improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355 has been verified to be a valid lot number, expiration date: 14-OCT-2021 (formulation, strength, exact dose, route of administration and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-14 to -10 Celsius degree) (-6.1 Celsius degree) for 13 hours. Time frame for 129 hours. Data logger was involved. There were no previous excursions reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller states no additional adverse events reported.; Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from a registered nurse, referring to a 5-year-old patient of unknown gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 15-SEP-2020, at the age of 5-year-old, during a temperature excursion, the patient was vaccinated with an improperly store of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis. The vaccine administered experienced a temperature excursion from -14 degrees Celsius (C) to -10C (-13.4C), and from -9C to 8C (-8.2C) for a time of 2 hours. There was none previous temperature excursion reported. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008482:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administration in reference to temperature excursion; This spontaneous report has been received from a reporter concerning a currently 4-year-old patient of unknown ethnicity. The patient's concurrent conditions, allergies/reactions, medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 milliliter (Lot # S031703 with expiration date on 06-APR-2021; route of administration not repoted) for prophylaxis; which had been exposed to temperature excursions (-9.5 celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes) (no previous temperature excursions reported). The call was made through a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administration in reference to temperature excursion; This spontaneous report has been received from a reporter concerning to a currently 1-year-old patient of unknown gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration not reported), lot #S038702, expiration date 01-DEC-2021, administered as prophylaxis. The improperly stored dose experienced a temperature of -9.5 degree Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, without previous temperature excursions. The call was due to digital data logger.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: An unspecified patient received a dose of MMRII via the intramuscular route on 9/16/2020; This spontaneous report has been recieved from a pharmacist concerning an approximately 30-year-old female patient of unknown ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 16-SEP-2020, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II) (dose regimen, batch/lot # and expiration date not reported) by intramuscular route (Incorrect route of product administration).
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine; This spontaneous report was received from an unspecified reporter, referring to a  currently 4 years old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), administered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T005406, expiration date 12-AUG-2021) given as prophylaxis. The vaccine administered experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details were available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008353: US-009507513-2009USA008377: US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008520: US-009507513-2009USA008533: US-009507513-2009USA008553: US-009507513-2009USA008675: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804: US-009507513-2009USA008870:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a physician for long-term prevention of shingles and zoster-related conditions/preventing shingles on a long-term or permanent basis (prophylaxis). Subsequent, after vaccination with zoster vaccine live (ZOSTAVAX) the patient was treated for shingles. As a direct and proximate result of use of the vaccine live (ZOSTAVAX), the patient will continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries, including but not limited to medical losses and cost that included 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 suffers such losses, and damages in the future. The outcome of the event shingles was not recovered.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly stored administered PROQUAD; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 17-SEP-2020, the patient was vaccinated with an imporperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (Lot # T013540 with expiration date on 17-OCT-2021; dosage regimen and route of administration not provided) (temperature excursion from 6 farenheit degree (F) to 14 F (average 11.7 F) for 25 minutes; no previous temperature excursions); for prophylaxis. The call was made by data logger.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, couple of days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that their friend had taken his family to get their flu shots and a few days later, they were all sick. The reporter suspected that maybe they all got the sickness from someone getting their shot.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: still nauseated; achy; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In September 2020, unknown after receiving Shingrix, the patient experienced nausea and pain. On an unknown date, the outcome of the nausea and pain were unknown.   It was unknown if the reporter considered the nausea and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient asked how long side effect last for Shingrix.  It was second shot and the patient had every side effect listed. It was day three still nauseated and achy.
Sex: M
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: side effects Almost killed my father in law; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after receiving Influenza vaccine Quadrivalent unspecified season, the side effects almost killed the patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: fatigue; muscle ache; fever was measured at 101.4; chills; dizziness; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2020, the patient received the 2nd dose of Shingrix. On 16th September 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fatigue, muscle pain, fever, chills, dizziness and headache. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the fatigue, muscle pain, fever, chills, dizziness and headache were recovering/resolving.   It was unknown if the reporter considered the fatigue, muscle pain, fever, chills, dizziness and headache to be related to Shingrix.  Additional details were provided as follows:  The patient received shingrix and on the same day of vaccination at 11:00 pm. the symptoms of fatigue, muscle ache, fever, chills, dizziness and headache presented. The fever was measured at 101.4.  The patient was taking tylenol and ibuprofen to help relieve the symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fatigue; muscle ache; fever was measured at 101.4; chills; dizziness; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2020, the patient received the 2nd dose of Shingrix. On 16th September 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fatigue, muscle pain, fever, chills, dizziness and headache. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the fatigue, muscle pain, fever, chills, dizziness and headache were recovering/resolving.   It was unknown if the reporter considered the fatigue, muscle pain, fever, chills, dizziness and headache to be related to Shingrix.  Additional details were provided as follows:  The patient received shingrix and on the same day of vaccination at 11:00 pm. the symptoms of fatigue, muscle ache, fever, chills, dizziness and headache presented. The fever was measured at 101.4.  The patient was taking tylenol and ibuprofen to help relieve the symptoms.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Anxiety, Condition aggravated
Clinical narrative: since the administration / the anxiety has become worse; This case was reported by a consumer via call center representative and described the occurrence of anxiety aggravated in a 36-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included anxiety (prior to receiving the vaccine).   On 16th September 2020, the patient received RabAvert. On 16th September 2020, less than a day after receiving RabAvert, the patient experienced anxiety aggravated. On an unknown date, the outcome of the anxiety aggravated was not recovered/not resolved.   It was unknown if the reporter considered the anxiety aggravated to be related to RabAvert.  Additional details were reported as follows: The patient received Rabavert for post-exposure prophylaxis. The patient experienced some anxiety prior to receiving the RabAvert vaccine and since the administration of it, the anxiety had become worse, which led to anxiety aggravated. The reporter consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Flushing, Injection site pain, Poor quality sleep, Pyrexia
Clinical narrative: Slight fever (99 degrees); Feeling flushed; Little tired; Did not sleep well; Soreness on upper arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, flushing, tiredness and poor sleep. On 18th September 2020, the patient experienced fever. On an unknown date, the outcome of the injection site pain, fever, flushing, tiredness and poor sleep were unknown.   It was unknown if the reporter considered the injection site pain, fever, flushing, tiredness and poor sleep to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on left deltoid. The patient experienced soreness on upper arm where it was injected, and it was feeling better at the time of reporting. One day after receiving Shingrix, the patient experienced a slight fever of 99 degrees F. The patient also feels flushed, a little tired and did not sleep well last night laid in bed for 2 hours in morning on the day of reporting. At the time of reporting, the patient was up and moving around and feeling a little better. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Severe hearing loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, couple of months after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received shingrix and after couple of months, experienced severe hearing loss. The reporter mentioned that, they were looking into everything that might had caused it and his inoculations and his travelling in an airplane. The reporter did not provided full demographics or any additional information for this AE and also reported that, the man was reliable and was retired urologist. The reporter did not felt comfortable sharing and does not had AE information for this case. The reporter did not consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: large induration / site of injection; (red circle softball look alike) / site of injection; large induration / back of the knee; (red circle softball look alike) / back of the knee; This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 3SM5G, expiry date 10th April 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site induration, injection site erythema, induration and erythema. On an unknown date, the outcome of the injection site induration was not recovered/not resolved and the outcome of the injection site erythema, induration and erythema were unknown.   It was unknown if the reporter considered the injection site induration, injection site erythema, induration and erythema to be related to Shingrix.  Additional details were reported as follows: The patient experienced a large induration (red circle softball looks alike) at the back of the knee and site of injection. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Not been feeling well; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via specialty pharmacy.  This case involves a 75 year old female patient who was not feeling well (malaise), after she received vaccine INFLUENZA VACCINE and was being treated with TREPROSTINIL SODIUM.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Medical history included pulmonary arterial hypertension, which was ongoing at the time of report.  Concomitant medications included MACITENTAN (OPSUMIT) and SILDENAFIL CITRATE (REVATIO).  On 13-Dec-2018, the patient started taking  of TREPROSTINIL SODIUM (lot - 2101813, expiry date: 30-Apr-2021, strength: 0.6 mg/ml) (current dose reported as 60 to 120 micrograms, 10-20 breaths four times a day (QID)), for primary pulmonary arterial hypertension via inhalation (IH) route.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiration date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced non-serious event of not feeling well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE and TREPROSTINIL SODIUM. The patient wondered if her unspecified symptoms were related.  No laboratory data was provided.  Action taken with TREPROSTINIL SODIUM (TREPROSTINIL SODIUM) was not reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The reporter did not provide causality of event malaise with suspects.  There will be no information available for lot number.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discharge, Injection site haemorrhage
Clinical narrative: drop or so of liquid at injection site/ a little bit blood mixed in too; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 77-year-old female patient who experienced drop or so of liquid at injection site and a little bit blood mixed in too (vaccination site haemorrhage), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided. List concomitant or no other vaccines was reported as none.   On 05-Sep-2020 (Saturday), the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [prefilled syringe, lot number and expiry date not reported] via an intramuscular route at the left deltoid for prophylactic vaccination.  On the same day, after vaccination patient observed a drop or 2 or a little liquid an inch below the injection site which was all the way down to her elbow and to her fingertips.  It was reported that, a little bit blood mixed in too with the drop or so of liquid at injection site (vaccination site haemorrhage).   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 vaccination site haemorrhage.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: First shingrix vaccine.  Injection itself was extremely painful.  Within 90 minutes my entire upper arm was achy and I could not touch it.  That evening I took tylenol for pain but still woke at night whenever pressure was applied to my arm and the injection site.  Awoke in the night with severe headache took additional tylenol for headache and arm pain.   In the morning the headache persisted despite tylenol and I was extremely tired and fatugued.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Dysphagia, Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: Employee started having a red swollen very itchy L Deltoid that advanced to difficulty swallowing a couple of hours later. She was sent to the ER for allergic reaction. By the time she went to the ER her throat was red and swollen she was treated for anaphylaxis reaction.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Pharyngeal erythema, Pharyngeal swelling
Clinical narrative: Employee started having a red swollen very itchy L Deltoid that advanced to difficulty swallowing a couple of hours later. She was sent to the ER for allergic reaction. By the time she went to the ER her throat was red and swollen she was treated for anaphylaxis reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: ON 9/24/2020 PATIENT CONTACTED THE PHARMACY AND SPOKE WITH PHARMACIST TO REPORT HER ARM HAS "NO RANGE OF MOTION" AND "FEELS FROZEN." PATIENT STATED THE PHARMACIST "GAVE THE SHOT TOO HIGH" UP IN THE ARM. PATIENT ALSO STATED SHE HAD A CALL INTO HER PHYSICIAN.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Redness, swelling around injection site with hard lump. Pain in armpit. Hot to touch. Diameter about 3 inches. Started to improve 24 Sept 2020 in the afternoon.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Redness, swelling around injection site with hard lump. Pain in armpit. Hot to touch. Diameter about 3 inches. Started to improve 24 Sept 2020 in the afternoon.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: started itching on 9/17- broke out in a rash late in the day on the chest on 9/17- took benadryl without relief. Went to doctor 9/21 and prescribed prednisone
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pyrexia, Stomatitis, Urticaria
Clinical narrative: 9/16/20 Developed a low grade fever 99.5 and sores in mouth that lasted until 9/20/20. 9/17/20 had swollen lymph nodes bilateral clavicle to neck and developed hives  on bilateral ankles. Went to Urgent Care, RX oral Prednisone oral for 10 days and topical  steroid cream. 9/22/20 went to Dermatologist RX to continue Prednisone and topical steroid cream, Zyrtec, Allegra, Hydroxizine, Tagamet
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Respiratory tract congestion
Clinical narrative: Around 6:30 pm on 9/22/2020 I started becoming very congested and it got much worse during the night. By 10:00 pm the itch began all over my body (no rash) and did not begin to subside until early evening on 9/23/2020.  It was the kind of itch where you wish you could have stepped outside of your skin for awhile.  I did take Benadryl tablet form 25 mg.  I contacted my primary physician.
Age: 76.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: After five days, I came drown with the shingles
Age: 76.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster
Clinical narrative: After five days, I came drown with the shingles
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient reported around dinner time she began to have fever, chills and the shakes
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: ARM WHERE INJECTION WAS RECEIVED SORE APPROXIMATELY 3 WEEKS LATER.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left shoulder swelling  and redness
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: 3" weal, warm to the touch, itchy, below injection site noticed 24 hours after injection and persisting at day 3
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Sensitive skin
Clinical narrative: Broke out with shingles on September 17, 2020. Sensitivity, pain, and blisters
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature abnormal, Chills, Eye pain, Headache, Tremor
Clinical narrative: Headache, entire body shaking,chills, to and below normal temp. Eyeball pain
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, mild heat and significant swelling at injection site.  Wheal ~2" in diameter and swelling in the upper arm/deltoid with visible difference from my other arm.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: patient reported swelling of the arm from shoulder to fingertips, pain of the arm and decreased mobility to the point that patient had to use the opposite arm to move it.  Swelling started the morning following the immunization.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site rash, Pyrexia
Clinical narrative: Pt had a fever > 100, rash at site of injection and also a knot on the bicep at site of injection
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Flatulence, Headache, Pruritus
Clinical narrative: Severe itching for 30 minutes and administered 2 Benadryl tablets that took effect after an hour. Very gassy and stomach ache.  Headache
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: asked mom child's name and DOB , she was on the phone and gave me wrong child's info
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented the day after the injection with a slightly raised, red area around the injection site.  We believe it was consistent with an injection site reaction.  When prompted, the patient said she felt slight pain.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced headache and body aches on tuesday. On wednesday, patient reported injection site reaction of arm being red, swollen, warm to the touch, and itchiness.  Recommended patient to take 1 benadryl tablet by mouth to alleviate the symptoms and if they worsen, advised to go to emergency department.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain
Clinical narrative: Patient experienced headache and body aches on tuesday. On wednesday, patient reported injection site reaction of arm being red, swollen, warm to the touch, and itchiness.  Recommended patient to take 1 benadryl tablet by mouth to alleviate the symptoms and if they worsen, advised to go to emergency department.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patients doctor called to inform us that pt had a reaction to a vaccination he received on 9/18/20. We confirmed that is was the Prevnar 13 vaccine. Patients arm was swollen, warm to touch and itchy
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: pt recieved 0.5ml instead of 0.25ml
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Pyrexia, SARS-CoV-2 test, Tremor, Urine analysis
Clinical narrative: Approximately 5 hours after the injection I started having full body shaking with got progressively worse.  I vomited up my dinner twice. I was running a fever of 101.  My wife and I went to the emergency room where I was tested for COVID19. Blood was drawn, urine samples taken. I soon felt better and was sent home the Dr. rulled out food poisoning and said she didn't know what the cause was. We determined by a process of elimination the it was the flu shot.