chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Immediate post-injection reaction, Irritability, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: - Pt reports immediate fussinesss, irritable, with no energy (around 10 am after injection)  - After dinner felt fatigued, stomach rumbling/hurting - Felt nauseous with a headache and a low grade fever < 100 F overnight. - The next morning pt reported arm swelling with a large white outline the size of her palm, lower than where injection site was.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pt stated she woke up with a sore arm and it remained sore for 2 weeks
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient experienced hives on her chest and back.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Mobility decreased, X-ray normal
Clinical narrative: arm bothering her, cant lift arm, went to orhto, he ran xrays and all was clear. pt is going to start physical therapy and now taking antiinflammatory
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered an improperly stored dose of  PEDVAXHIB; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-OCT-2019, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S000356, expiration date: 17-OCT-2021 (dose and route of administration were not provided) for prophylaxis. No adverse effects were reported.  Administered dose of vaccine experienced temperature excursion of 46.5 degree Fahrenheit for 15 minutes. No previous temperature excursion was reported. Digital data logger was not involved.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pain
Clinical narrative: patient developed soreness at the injection site; Information has been received from a physician referring to a 5 years old female patient. The patient had no medical history, no concurrent condition, no drug allergies or concomitant medications.  On 16-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, lot#, expiration date were unknown) and sterile diluent(STERILE DILUENT) (dose, strength, lot#, expiration date were unknown) subcutaneously into her inner upper thigh for prevention of measles, mumps, rubella and chicken pox.  On the same date, the patient experienced soreness at the injection site. On 17-OCT-2019, the patient came to physician's office and the patient recovered from the event. No treatment was given for the event. No lab diagnostics/studies were performed. The causality was unknown by reporter.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Culture throat, Febrile convulsion, Influenza virus test, Metabolic function test, Pyrexia
Clinical narrative: Fever- Febrile seizure, seen at ED.  Treated with Tylenol, responded well.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Urine analysis
Clinical narrative: Fever- Febrile seizure, seen at ED.  Treated with Tylenol, responded well.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash, Skin warm, Tenderness
Clinical narrative: Patient experienced a rash on her right arm that was warm to the touch, swollen, and tender that was noticed the following day. Patient went to urgent care on 10/22/2019 and was prescribed triamcinolone and doxycycline but the patient did not take the doxycycline.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Heart rate increased, Pain, Pain in extremity
Clinical narrative: Arm extremely sore, Hot to touch, headache, achy. Next day  10/24/19, I felt like I was hit by a truck!   Fast/rapid heartbeats  Mfr - Glaxosmith Klein
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin abrasion, Vaccine positive rechallenge
Clinical narrative: Arm extremely sore, Hot to touch, headache, achy. Next day  10/24/19, I felt like I was hit by a truck!   Fast/rapid heartbeats  Mfr - Glaxosmith Klein
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Symptoms started same night as injection : nausea, vomited twice during the night with diarrhea, raging headache; report given next morning symptoms gradually getting better.
Age: 20.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Chills, Headache, Influenza virus test, Nausea, Pain
Clinical narrative: PT Describes Body aches, shakes, and chills all over her body that started in the Left arm approximately 2 hours after vaccination. Pt also describes nausea and headaches.
Age: 20.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Tremor
Clinical narrative: PT Describes Body aches, shakes, and chills all over her body that started in the Left arm approximately 2 hours after vaccination. Pt also describes nausea and headaches.
Age: 61.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Eye swelling, Lip swelling, Pain, Peripheral swelling, Pruritus
Clinical narrative: 3 HOURS AFTER VACCINES,  LOTS OF SWELLING IN RIGHT ARM WHICH IS THE ARM THAT GOT THE PNEUMO SHOT.  6 HOURS LATER STILL SWELLING, PAIN, ITCHY, AND FEVER.  FEVER AND SWELLING IN ARM LASTED 3 DAYS. A FEW DAYS AFTER VACCINE SHE DEVELOPED SWELLING ON LIPS AND EYES AND LASTED 15 MIN. PT SAYS NOW HER BODY IS STILL ITCHY AND ITS BEEN 7 DAYS. NO BREATHING PROBLEMS. PT IS STILL TAKING REGULAR MEDICATIONS.
Age: 61.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia
Clinical narrative: 3 HOURS AFTER VACCINES,  LOTS OF SWELLING IN RIGHT ARM WHICH IS THE ARM THAT GOT THE PNEUMO SHOT.  6 HOURS LATER STILL SWELLING, PAIN, ITCHY, AND FEVER.  FEVER AND SWELLING IN ARM LASTED 3 DAYS. A FEW DAYS AFTER VACCINE SHE DEVELOPED SWELLING ON LIPS AND EYES AND LASTED 15 MIN. PT SAYS NOW HER BODY IS STILL ITCHY AND ITS BEEN 7 DAYS. NO BREATHING PROBLEMS. PT IS STILL TAKING REGULAR MEDICATIONS.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling of the entire arm, redness, area was feeling warmer than usual,  pain in the site of injection, and rest of the arm.  Symptoms started on the evening of 10/22/2019.  As of 10/24/2019 10;25am, swelling is almost gone, no redness can be observed, but patient indicates upper arm still hurts.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Fatigue, Injection site joint pain, Injection site pain
Clinical narrative: Generalized myalgia; tenderness of R upper arm; fatigue;  low grade fever; joint pain (R shoulder, base of neck,  bilateral hip joints)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: Generalized myalgia; tenderness of R upper arm; fatigue;  low grade fever; joint pain (R shoulder, base of neck,  bilateral hip joints)
Sex: F
Vaccine: UNK
Symptoms: Dacryostenosis acquired, Jaundice, Phototherapy
Clinical narrative: Development of severe jaundice which led to a reaction requiring bilirubin lights treatment and wearing eye mask which caused clogged tear ducts in 4-6 day old newborn. This is an ongoing condition commonly causing surgical repair and/or vision impairment.
Age: 33.0
Sex: M
Vaccine: FLUR4
Symptoms: Loss of consciousness, Snoring, Syncope
Clinical narrative: Syncope Pt immediately passed out, started snoring with his head down as I supported his weight in the chair.  I revivied him with smelling salts after 15-20 seconds.  He remained pale for a few minutes while I monitored him.  He sat and rested for 10 minutes then felt better and left with his mother.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: MOP states patient had her 15/18 month immunizations on 9/30/2019, no other new exposures reported.   Vaccines received were DTaP #4 (SKB lot numbers CX59C left thigh, hepatitis A #2 lot #9 PE L5M mfx SKB, and HIB- PRP-OMP #3 Merck lot #S008729). She had no immediate reactions. Two days later, MOP noted a red raised area behind neck  in the morning followed by continued development  of urticarial lesions throughout the day to include her face, torso, extremities. The lesions were  extremely pruritic. She denies SOB, cough, wheezes, oral, face, throat, tongue swelling, flushing, watery eyes, conjunctivitis, rhinorrhea, cough emesis or diarrhea. She was seen the next day  and treated with benadryl, Zyrtec and both topical and oral steroid. The duration of symptoms was five days, then fully resolved and have not recurred.  Mom states she did have a mild reaction to 12 mo immunizations (MMR, varicella #1 & Prevnar #4) described as tiny erythematous papules  that lasted only hours .
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Chills, Dizziness, Eye swelling, Pain
Clinical narrative: Within one hour patient began to feel fever, chills, body aches, dizziness. Later that evening developed abdominal pain and swelling in right eye.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Within one hour patient began to feel fever, chills, body aches, dizziness. Later that evening developed abdominal pain and swelling in right eye.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Dr. orderd a Pentacel on 10/23/2019 for this patient but medical assistant administered a Kinrix instead of the Pentacel.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, TDAP
Symptoms: Loss of consciousness, Nausea
Clinical narrative: After receiving HPV vaccine patient lost consciousness.  Patient recovered approximately 10 seconds later to consciousness and reported nausea.  Patient was assisted to lay supine on the floor and provided with a juice drink.  Ten minutes later patient was able to rise unassisted and sit in chair and then stand.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient reported a tingling feeling in his right arm (vaccine administered in left arm).   Tingling described as going from his elbow to his pinkie and ring fingers.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Feeling hot, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: October 21 - I began feeling pain and heat within a few hours of receiving the shot. I iced the area and took an Advil. As the night wore on the pain increased. I could not lay on my left side. I was not able to get any rest. October 22 - By morning, the pain and swelling had increased. I repeated the measures taken the night before.  I re-read the flyer given me by the nurse and saw that although rare, this was probably one of the more rare reactions.  By late morning  my arm, upper back and shoulder were on fire.  There was a distinct line between my upper arm and the area below my elbow.  It almost looked like someone had put a rubberband around my arm the color differences were so vast and the swelling so pronounced. The swelling above the elbow was substantial.  I propped up that side on pillows, took Advil, and hoped to get rest. I had this shot last fall and encountered nothing like this! October 23 - Yesterday the circle around my arm just up from the elbow joint was still present.  The redness was beginning to abate a little. There was still moderate pain and stiffness but nothing like the day before.  I notified my doctor and she told me to report this to you and gave me this website. October 24 - My arm is red and blotchy with little puffiness and swelling here and there. My shoulder is still a little sore but not bad.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Rash macular, Skin discolouration, Swelling
Clinical narrative: October 21 - I began feeling pain and heat within a few hours of receiving the shot. I iced the area and took an Advil. As the night wore on the pain increased. I could not lay on my left side. I was not able to get any rest. October 22 - By morning, the pain and swelling had increased. I repeated the measures taken the night before.  I re-read the flyer given me by the nurse and saw that although rare, this was probably one of the more rare reactions.  By late morning  my arm, upper back and shoulder were on fire.  There was a distinct line between my upper arm and the area below my elbow.  It almost looked like someone had put a rubberband around my arm the color differences were so vast and the swelling so pronounced. The swelling above the elbow was substantial.  I propped up that side on pillows, took Advil, and hoped to get rest. I had this shot last fall and encountered nothing like this! October 23 - Yesterday the circle around my arm just up from the elbow joint was still present.  The redness was beginning to abate a little. There was still moderate pain and stiffness but nothing like the day before.  I notified my doctor and she told me to report this to you and gave me this website. October 24 - My arm is red and blotchy with little puffiness and swelling here and there. My shoulder is still a little sore but not bad.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PT STARTED HAVING REACTION ON WEDNESDAY, SWELLING AT THE INJECTION SITE, REDNESS AND ITCHING UP TO HER ELBOW
Age: 53.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: PATIENT REPORTED FEELING LIGHT HEADED AFTER GIVING BOTH SHOTS, HE WAS SWEATING ABOUT A MINUTE AFTER THE VARIVAX SHOT. PT FAINTED FOR AROUND 30 SECONDS AND WOKE BACK UP. 911 WAS CALLED AND PT WAS TAKEN TO HOSPITAL. PT DID NOT EAT THE MORNING OF SHOTS AND WALKED 6 MILES BEFOREHAND.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient experienced her first shingles outbreak 7-10 days after she was given the vaccine
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site swelling, Pain in extremity
Clinical narrative: Person receiving shot stated that on the day after the vaccination her arm became sore and in the evening her arm was numb and she had swelling to right deltoid area
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Patient reported to clinic she had taken a positive pregnancy test 10/21/2019 at a local Emergency Room. Came to clinic for confirmation and referral to OBGYN. Requested to have this seasons flu vaccine. Provider agreed, verified with our pharmacy if OK to give to patient or if their was a preservative free dose available to give to adult pregnant female. Pharmacist advised we did not have preservative free dose available and to give from multi-dose vial. Multi-dose vial dose given to pregnant patient. Expected due date is 6/2020.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Vomiting
Clinical narrative: Stomach pain, chills, diarrhea and throwing up.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Red bumpy rash that appeared 6 to 8 hours after injection.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reports arm being swollen, red, and hot to the touch the day after vaccination (10/23/2019)
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: low grade temp, itching and rash on neck and upper chest area
Age: 38.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; Patient was inadvertently administered one dose of PROQUAD intramuscularly instead of subcutaneously; This spontaneous report was received from a registered nurse and refers to a 38-year-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, allergies, drug reactions and concomitant medications was provided.  On 25-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), intramuscularly, one dose (lot#, expiration date, albumin status, exact dose were not provided) for prophylaxis. The vaccine was inadvertently administered intramuscularly instead of subcutaneously(incorrect route of product administration). No adverse effects were reported. The outcome of incorrect route of product administration was unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S000356, expiration date 17-OCT-2021 (exact dose and route of administration was not reported) for prophylaxis. The administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion of 46.5 degrees Fahrenheit for 15 minutes. Data logger was not involved. There were no previous excursions reported. There was no adverse effect reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2011, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was unknown. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: 2 patients received unspecified doses of VARIVAX that was improperly stored; No adverse effects reported.; This spontaneous report as received from a registered nurse refers to two unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On unknown dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R009820, expiration date 03-APR-2020 (dose and route of administration were not provided) for prophylaxis, that was reconstituted with properly stored sterile diluent. The vaccines were stored in temperature -9 degree Celsius to 8 degree Celsius for 7 hours 25 minutes. Previous temperature excursion was reported as temperature -9 degree Celsius to 8 degree Celsius for 24.5 hours and -14 (units not provided) to -10 degree Celsius for 1 hour. Digital data logger was involved. No adverse effects were reported.   This case is non-valid due to the lack of the patients' identifiers.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 04-SEP-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles was considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 28-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a bad case of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles was considered to be disabling.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Nephrolithiasis, Pain, Renal impairment
Clinical narrative: kidney stones; kidney function problems; pain; This spontaneous report was received from a a nurse practitioner and refers to a 12 year old female patient. The patient's concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported), to protect against hpv related cancers and diseases.  On an unknown date, the patient experienced kidney stones, kidney function problems, pain and missed a year of school. The patient was hospitalized on an unknown date at the clinic. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided by the reporter (however reporter mentioned that unspecified person at the clinic said "problems were due to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)").   All events were considered to be disabling due to the patient missed a year of school. Upon internal review, the events of kidney stones and kidney function problems were considered to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Death, Injury
Clinical narrative: dies from Gardasil vaccine injuries; 3 years of suffering; This information was obtained from a website and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced unspecified injuries. On an unknown date, the patient experienced an unspecified adverse event, which caused suffering lasting 3 years. On an unknown date, at the age of 19 years, the patient died of the unspecified injuries. It was unknown if the autopsy was performed. The outcome of the unspecified adverse event was unknown.  The reporter considered the event of unspecified injuries to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The relatedness between the unspecified adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.; Sender's Comments:  US-009507513-1910USA012728:
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash vesicular
Clinical narrative: Arm pain; Vesicular rash over the rib along the anterolateral chest and was accompanied by pain; Pain; This case was reported by a physician and described the occurrence of pain in arm in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, vesicular rash and pain. On an unknown date, the outcome of the pain in arm, vesicular rash and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, vesicular rash and pain to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's father in law. The age at vaccination was not reported. The patient had no specific medical history declared. The patient received Shingrix in an unknown arm. The patient experienced arm pain after the dose of Shingrix but what was of concern to them was the vesicular rash which occurred 2 to 3 days after the dose developed over the rib along the anterolateral chest and was accompanied by pain. There was no rash at or near the injection site nor on the arm at all. The rash and the accompanying pain apparently resolved completely within 3 to 4 days. There were no other hypersensitivity reaction symptoms experienced by the patient after his first dose of Shingrix.  Till the time of reporting, the patient not yet received his second dose of Shingrix.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the flu; This is a spontaneous case initially received from other non-health care professional via Merck via Communications on 16-Oct-2019, concerning a female patient of unspecified age.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was administered unspecified flu vaccine [influenza vaccine; dose, route of administration, anatomical location, batch umber, expiry date: not reported] for an unknown indication.   On an unspecified date, an unknown amount of time after vaccination, the patient got the flu.   The outcome of the event flu was not reported.   The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The patient experienced influenza on an unspecified date, an unknown amount of time after vaccination with unspecified flu vaccine. Chronology is unclear but plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Gestational diabetes
Clinical narrative: Gestational diabetes; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 16-Oct-2019, concerning a 32-year-old, pregnant, female subject of body weight: 117.5 lbs, height: 62.3 inches and body mass index (BMI): 21.3, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The subject's medical history included Rhesus (Rh) D negative and insomnia. Concomitant medications included Rhophylactic (anti-D immunoglobulin) for RhD negative, Prenatal gummy (mineral not specified (NOS,) vitamins NOS) for pregnancy and Unisom (doxylamine succinate) for insomnia.  The subject had no previous pregnancies. The subject had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 07-Mar-2019, the estimated delivery date (EDD) was reported as 12-Dec-2019. The type of pregnancy was singleton.   On 03-May-2019, 16-May-2019 and 13-Aug-2019, the subject underwent ultrasound and no MCMs were noted.   On 25-Sep-2019, at approximately 29 weeks of gestation, the subject was administered Afluria QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, batch number: P100118566, dose , route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.   On 07-Oct-2019, the subject developed gestational diabetes.   At the time of initial reporting, the subject was not recovered from the event of gestational diabetes.  The case was assessed as serious. The reporter did not provide causality assessment.  The subject experienced gestational diabetes after vaccination with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnant state may provide alternative aetiology for the event. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. For the event gestational diabetes causal role of the suspect product is assessed as unlikely related.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea
Clinical narrative: Headaches and Nausea
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Sneezing
Clinical narrative: INTENSE SNEEZING THAT LASTED FOR ABOUT 4 HOURS ITCHING
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Injection site pain persisted for about 5 days, with a red raised patch about 5 inches by three inches around site. On Saturday morning (vaccination was Thursday afternoon) I woke with bright red patches on neck, inner arm, under breasts.   Not highly itchy; hot and slightly swollen.  Look just like "Hives" similar to those I got previously with ibuprofen, and after some foods, possibly shrimp and fish.  Improved by topical antihistamine cream and by 25 mg benadryl at bedtime on first day of symptoms; took 25 mg three times on second day of symptoms and repeated application of antihistamine cream.   Fading by Tuesday, no longer visible by Thursday.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Injection site pain persisted for about 5 days, with a red raised patch about 5 inches by three inches around site. On Saturday morning (vaccination was Thursday afternoon) I woke with bright red patches on neck, inner arm, under breasts.   Not highly itchy; hot and slightly swollen.  Look just like "Hives" similar to those I got previously with ibuprofen, and after some foods, possibly shrimp and fish.  Improved by topical antihistamine cream and by 25 mg benadryl at bedtime on first day of symptoms; took 25 mg three times on second day of symptoms and repeated application of antihistamine cream.   Fading by Tuesday, no longer visible by Thursday.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches,  pain at injection site
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient with large local reaction following administration of flu vaccine 2 days ago. No systemic symptoms. Swelling and erythema is spreading distally and not proximally. Advised trial of zyrtec and benadryl at night if needed, but will also start cephalexin for concerns of potential cellulitis. Area of erythema and patchy erythema outlined. Return to clinic if symptoms worsen. Reviewed red flag symptoms indicating need for immediate evaluation. Father and patient voiced understanding.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site discomfort, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Patient's mother reported to us that patient had shoulder discomfort following injection and went to Urgent Care for a cortisone injection. Per mother the urgent care told her the vaccine was "given too high" and caused "bursitis and shoulder impingement".  Our office has not seen the patient for any kind of post vaccine/shoulder pain evaluation or follow up.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chest discomfort, Eye discharge, Eye swelling, Headache
Clinical narrative: The vaccination was a flu shot; it is unknown to me the exact type, lot, manufacturer. Pharmacy staff (pharmacist and tech) came to my work place and injected the flu shot around 11:30AM. By the end of my shift (3PM), I began to feel my chest compress. My eyes began to swell and had a discharge. By the time I got home, around 3:40PM, I had a 100.4 F temperature, body aches, sore throat and headache. I took 50mg of Benadryl and 2 Advil capsules. Before bedtime, 10PM, my temperature was 100.5 F. I decided not to take any more Advil to see if the temperature would lower on its own. At 3AM, I woke up with a temperature of 100.4F and lips swollen. I took two Advil capsules and 50mg of Benadryl. I woke up at 8AM with a headache and took two more Advil capsules.  Due to having Keratoconus on both eyes.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Oropharyngeal pain, Pain
Clinical narrative: The vaccination was a flu shot; it is unknown to me the exact type, lot, manufacturer. Pharmacy staff (pharmacist and tech) came to my work place and injected the flu shot around 11:30AM. By the end of my shift (3PM), I began to feel my chest compress. My eyes began to swell and had a discharge. By the time I got home, around 3:40PM, I had a 100.4 F temperature, body aches, sore throat and headache. I took 50mg of Benadryl and 2 Advil capsules. Before bedtime, 10PM, my temperature was 100.5 F. I decided not to take any more Advil to see if the temperature would lower on its own. At 3AM, I woke up with a temperature of 100.4F and lips swollen. I took two Advil capsules and 50mg of Benadryl. I woke up at 8AM with a headache and took two more Advil capsules.  Due to having Keratoconus on both eyes.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Asthenia, Biopsy brain, Blood test, Burning sensation
Clinical narrative: Her symptoms included burning head pain, brain pain, burning feet pain, dizziness to the point of not being able to stand up, fever, all over low energy, severe nausea without vomiting, overall feeling of malaise, diarrhea, joint pains, muscle pains, stuffy nose, bloody nose, increased bruising easily.  continuous now to have symptoms relating to her vaccine injury to any one of the above listed vaccines administered on the day in June.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Diarrhoea, Dizziness, Dysstasia, Epistaxis, Headache
Clinical narrative: Her symptoms included burning head pain, brain pain, burning feet pain, dizziness to the point of not being able to stand up, fever, all over low energy, severe nausea without vomiting, overall feeling of malaise, diarrhea, joint pains, muscle pains, stuffy nose, bloody nose, increased bruising easily.  continuous now to have symptoms relating to her vaccine injury to any one of the above listed vaccines administered on the day in June.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Increased tendency to bruise, Malaise, Myalgia, Nasal congestion, Nausea
Clinical narrative: Her symptoms included burning head pain, brain pain, burning feet pain, dizziness to the point of not being able to stand up, fever, all over low energy, severe nausea without vomiting, overall feeling of malaise, diarrhea, joint pains, muscle pains, stuffy nose, bloody nose, increased bruising easily.  continuous now to have symptoms relating to her vaccine injury to any one of the above listed vaccines administered on the day in June.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Her symptoms included burning head pain, brain pain, burning feet pain, dizziness to the point of not being able to stand up, fever, all over low energy, severe nausea without vomiting, overall feeling of malaise, diarrhea, joint pains, muscle pains, stuffy nose, bloody nose, increased bruising easily.  continuous now to have symptoms relating to her vaccine injury to any one of the above listed vaccines administered on the day in June.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Ear swelling, Joint stiffness, Lung disorder, Muscle tightness, Muscle twitching
Clinical narrative: Itchy hands feet Swollen throat and ears Twitching muscles Tightening of shoulders lungs and back
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Pharyngeal swelling, Pruritus
Clinical narrative: Itchy hands feet Swollen throat and ears Twitching muscles Tightening of shoulders lungs and back
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Joint swelling, Joint warmth, Lymphadenitis, Pain in extremity
Clinical narrative: Patient described symptoms as follows:  On October 22nd, the morning after receiving the vaccine, her knuckles on her right hand were swollen and hot. On October 23rd, she experienced swelling and throbbing in her right armpit, and pain down her arm. On October 24th, when she came to the pharmacy to report the reaction, the symptoms were still present but diminished from the previous day.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: The patient presented to the pharmacy the day after her vaccination with Pneumovax 23 with a rash surrounding injection site.  The rash was around the injection site and extended around the underside of the arm but did not extend below the elbow.  The patient also stated that her arm was very sore but she was able to move and lift her arm.  I advised the patient to apply cool compresses and acetaminophen for the pain.  I advised her to check with her doctor if the symptoms worsened or if she experienced limited mobility.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Mom reported to this nurse over the phone on the following day that child had spiked a fever of 102.3 degrees Fahrenheit from midnight to 3am.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient has a rash on her upper right arm, sore and painful.  Treatment: use a cold compress and take Tylenol for pain, she was offered a topical steroid but she denied.  Patient is to monitor site for worsening redness, swelling, itching or pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site bruising, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Patient reports that within 10 minutes of relieving  the influenza vaccine her arm started hurting and burning.  For the next week injection site proceeded to become swollen, hot and very discolored bruising in appearance. Patient showed staff photos she took of the injection site.  Patient reports that she had a fever and flu like symptoms for 7 days,
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient reports that within 10 minutes of relieving  the influenza vaccine her arm started hurting and burning.  For the next week injection site proceeded to become swollen, hot and very discolored bruising in appearance. Patient showed staff photos she took of the injection site.  Patient reports that she had a fever and flu like symptoms for 7 days,
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Oxygen saturation normal, Wheezing
Clinical narrative: Patient was given Benadryl (25mg) for wheezing after vaccine administration. Symptoms of wheezing and shortness of breath resolved with administration of home med of albuterol. Oxygenation was 100% and resolution of symptoms at 0940.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient said her arm turned red, became swollen, and warm to the touch. It was also extremely sore. It began the night the vaccine was given. She reported it to her doctor 3 days later that she still had symptoms.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ARM BECAME RED, SWOLLEN, AND PAINFUL TO TOUCH. FROM INJECTION SITE TO ELBOW.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Prostatic specific antigen increased
Clinical narrative: Nine days after adverse effect of headache, body ache, tiredness typical with Shingrix, I went in for a routine blood panel for annual physical.  The PSA test came in abnormal; twice any previous reading.  I will see a Urologist soon to check but have learned that an infection can cause abnormal readings.  Any history of Shingritz  causing an abnormal PSA test?
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: While the pneumonia shot was being administered, it hurt extremely much.  I described exactly how it felt as it was moving down my arm. By the time I got home, about 5 minutes later, I could not move my right arm at all.  It felt like I had been hit with a shotgun blast in the upper part of my arm and beat with a lead pipe on my forearm. I called the pharmacy the next morning and was told that the pain and not being able to use my arm was "normal". I said  "it may be common, but it is certainly not normal."  They told me to put ice or heat (I don't remember which) on it.  I called my doctor on Thursday to see what he recommended as treatment and was told either ice or heat, which ever felt better. I had to use 3 sick days at work because I was unable to get out of bed because of the intense pain.  I went to my doctor's office on March 14th because the pain was still unbearable and I had lost most of the movement in my right arm.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Pt complained of tenderness in the left side of her neck and upper back after receiving the flu shot.
Age: 43.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Dyspnoea, Hyperhidrosis, Loss of consciousness, Posture abnormal, Snoring
Clinical narrative: Vaccine order: Tdap/Boostrix (L deltoid IM), Hep A/Havrix (L deltoid IM), then Typhoid/Typhim Vi (R deltoid IM); Approximately 5 seconds after last immunization, patient slumped over to left side and began breathing heavy/snoring for approximately 5-10 seconds. Patient quickly came to, but was very sweaty & slightly tearful. Ice pack applied to back of neck, juice and a snack offered/accepted. Patient monitored and remained seated in exam room for 20 minutes following episode. Pt returned to baseline and felt safe to depart. Patient was still sweaty upon departure, but stated that she felt fine otherwise.
Age: 43.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Tearfulness
Clinical narrative: Vaccine order: Tdap/Boostrix (L deltoid IM), Hep A/Havrix (L deltoid IM), then Typhoid/Typhim Vi (R deltoid IM); Approximately 5 seconds after last immunization, patient slumped over to left side and began breathing heavy/snoring for approximately 5-10 seconds. Patient quickly came to, but was very sweaty & slightly tearful. Ice pack applied to back of neck, juice and a snack offered/accepted. Patient monitored and remained seated in exam room for 20 minutes following episode. Pt returned to baseline and felt safe to depart. Patient was still sweaty upon departure, but stated that she felt fine otherwise.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Hypersomnia
Clinical narrative: About 6 PM the evening of vaccination, the employee reports developing aches and pain in joints, then chills and fever.  In approximately 2 hours developed diarrhea which continued throughout the night.  The following day felt very tired and slept all day.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: About 6 PM the evening of vaccination, the employee reports developing aches and pain in joints, then chills and fever.  In approximately 2 hours developed diarrhea which continued throughout the night.  The following day felt very tired and slept all day.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: Pt waited the recommended 15 minutes post-injection without incident.  She left the facility and returned shortly thereafter c/o facial swelling and some tingling in her mouth.  Vital signs obtained and wnl. Diphenhydramine 50 mg IM given with good results.  Pt was monitored for 1 hour post injection.  Released when spouse arrived to drive her home.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site reaction, Rash erythematous, Urticaria
Clinical narrative: Welt of tough skin formed at site about half an inch off of skin and and inch wide. He walked with a limo for a week .  About four days after the shot a large circular red rash formed at the injection site  about 8? by 6?. The rash took a week from its emergence to recede away.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient has developed singles after receiving the shingles vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test, Herpes zoster, Rash
Clinical narrative: Patient has developed singles after receiving the shingles vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with Shingles : Rash located upper chest right side/Upper back on right side: Patient being treated for outbreak with Valtrex
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test, Herpes zoster, Rash
Clinical narrative: Broke out with Shingles : Rash located upper chest right side/Upper back on right side: Patient being treated for outbreak with Valtrex
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: patient stated started getting rash 10/23 two days after vaccine. area at rash is sore, rash starting moving down the arm