chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE. UPPER ARM ON SIDE OF INJECTION HAD REDNESS STREAKING DOWN TO ELBOW, SWELLING UPPER ARM TO ELBOW, AND "FEVER". INJECTION WAS ON SATURDAY 9/21, REACTION WAS TUESDAY 9/24. WAS BETTER IN APPEARANCE ON WEDNESDAY 9/24 (LOOKED NORMAL TO ME ON INSPECTION). PATIENT SAID THIS DID NOT HAPPEN WITH FIRST INJECTION. DID NOT HAVE ANY OTHER REACTION ELSEWHERE ON BODY.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Peripheral swelling, Pyrexia
Clinical narrative: PT  HAD FEVER AND INJECTION SITE REACTION; SWELLING ON LEFT ARM. RECOMMENDED TO USE TYLENOL AND IBUPROFEN OTC; BENADRYL,25 AT BEDTIME AND CORTISONE CREAM.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient got red over entire body for 10 to 15 hours
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: PATIENT FAINTED AFTER VACCINATION AND MOTHER STATED HE CONVULSED FOR A COUPLE OF SECONDS. PATIENT DID NOT SUSTAIN A HEAD INJURY AND REGAINED CONSCIOUSNESS ALMOST IMMEDIATELY.  PATIENT WAS TREATED AND TRIED TO GET UP ON FEET AFTER ABOUT 10 MINUTES BUT FAINTED AGAIN. MOTHER OPTED TO CALL AMBULANCE AND CHILD WAS TAKEN TO HOSPITAL.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: After getting both the tdap and not sure which one and the flu vaccine I began to have extreme entire leg swelling daily.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is under the age of 65 and was given a dose of Fluzone HD
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cough, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient got the Pneumovax23 in her right arm. Per patient, her arm swelled up from her elbow to her shoulder and turned bright red and was warm to the touch. She also experienced headache, fatigue, and coughing. As of 9/25/19, symptoms are improving.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site warmth
Clinical narrative: Patient got the Pneumovax23 in her right arm. Per patient, her arm swelled up from her elbow to her shoulder and turned bright red and was warm to the touch. She also experienced headache, fatigue, and coughing. As of 9/25/19, symptoms are improving.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient's left arm became red, swollen, warm to the touch, and had a rash form.
Age: 76.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's arm was red and swollen almost to the the elbow
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal swelling, Swollen tongue
Clinical narrative: patient reported that a couple hours after the immunization, she started to eat a salad.  she then began to feel that her throat was swelling, tongue swelling and it was hard to breathe.  patient took a Benadryl capsule.   she didn't report to the pharmacy or the dr office until another day she called the pharmacy on 09/23 and I called the dr on 09/25
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave HD dose to 63 year old patient inadvertedly
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Eye movement disorder, Feeling jittery, Pyrexia, Somnolence
Clinical narrative: Pt reports eyes shifting really fast, eyes jumping, sleepy, fever, dizziness, jitters with flu shot.  He also recieved Boostrix and Pneumovax but attributes these side effects to the flu shot as they are similar to what he experienced years ago.   He is better today and expects to be fully recovered by tomorrow.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Hyporesponsive to stimuli, Nervousness, Urinary incontinence
Clinical narrative: Patient was nervous about getting her flu shot but did calm down to receive it while holding her moms hand.  I administered the shot and asked if she was ok and she said she was then I walked away.  Another patient in line told me that we had a problem and I walked over to her and she was laying on the floor and had urinated herself.  She was breathing but in and out of responsiveness.  She never stopped breathing nor did she show signs of anaphylaxis so I did not administer epinephrine.  I called 911 and they arrived and she alert and oriented and able to talk to them and they took her to the ER.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome, Mobility decreased, Nervous system disorder
Clinical narrative: Approximately 10 days following vaccination patient began to have nerve and mobility issues. Per the patient she was eventually diagnosis with Guillian-Barre syndrome.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Computerised tomogram, Dysstasia, Electrocardiogram, Gait inability
Clinical narrative: Approximately 10 days following vaccination patient began to have nerve and mobility issues. Per the patient she was eventually diagnosis with Guillian-Barre syndrome.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Immunology test, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Approximately 10 days following vaccination patient began to have nerve and mobility issues. Per the patient she was eventually diagnosis with Guillian-Barre syndrome.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Walking aid user, X-ray
Clinical narrative: Approximately 10 days following vaccination patient began to have nerve and mobility issues. Per the patient she was eventually diagnosis with Guillian-Barre syndrome.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain and redness at injection site on day of injection followed by significant swelling  and redness of elbow on same arm as injection site one day later. Patient reported no pain at elbow but only redness and swelling.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Palpitations, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Mouth/throat tingling, chills/rigors, heart palpitations
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling abnormal, Hypoaesthesia, Skin tightness
Clinical narrative: Patient states that the following day he noticed redness, numbness, and tightness in the arm but it has been improving. Patient still experiences some tightness and an "unusual" feeling.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever of 100-101F and rash with irritability that lasted for three days.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccination on Sunday and called the pharmacy Wednesday morning reporting severe pain and difficulty lifting arm. Site was red/swollen and hot. Patient had to have assistance getting dressed as the pain was too severe to do on her own. She stated the pain began Tuesday evening and woke her from sleep due to severity.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Middle insomnia
Clinical narrative: Patient received vaccination on Sunday and called the pharmacy Wednesday morning reporting severe pain and difficulty lifting arm. Site was red/swollen and hot. Patient had to have assistance getting dressed as the pain was too severe to do on her own. She stated the pain began Tuesday evening and woke her from sleep due to severity.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint and muscle pain in the arm of the vaccine for 1 day
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Feeling hot, Nausea, Pharyngeal swelling, Respiratory tract congestion
Clinical narrative: lightheaded, nauseous, dizziness, rush of heat, throat swelling, congestion
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Influenza like illness, Injection site reaction
Clinical narrative: PATIENT RECEIVED VACCINE ON 09/20/2019. PATIENT STATES FLU-LIKE SYMPTOMS AND AN ENLARGED INJECTION SITE REACTION THAT WORSENED UNTIL SHE VISITED HER PHYSICIAN ON 09/25/2019. PATIENT STATES THAT SHE RECEIVED PREDNISONE AND WAS ADVISED TO TAKE BENADRYL. SHE ALSO HAS A PRESCRIPTION FOR HYDROXYZINE IF NEEDED. PATIENT CONTACTED PHARMACY TO INFORM THEM OF ADVERSE REACTION. PHARMACIST HAS OFFERED ASSISTANCE TO PATIENT IF NEEDED. ALLERGY TO SHINGRIX HAS BEEN ADDED TO PATIENT PROFILE. PATIENT HAS BEEN ADVISED NOT TO RECEIVE THE SECOND DOSE OF SHINGRIX UNLESS DIRECTED BY PHYSICIAN.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness, Urticaria
Clinical narrative: Patient had severe tenderness, swelling, hand 'shingle' looking hives come out on her body the same day as the injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Chills, Fatigue, Headache
Clinical narrative: Severe joint pain where I currently have arthritis, severe headache, flu-like muscle aches, chills, fatigue for approximately 24 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Severe joint pain where I currently have arthritis, severe headache, flu-like muscle aches, chills, fatigue for approximately 24 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: Nausea, terrible headache, feverish and very congested
Age: 43.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Headache, Influenza, Injection site pain, Muscle spasms, Pain
Clinical narrative: At time of injection patient reports not feeling sick. Patient reports feeling pain and aches the next day after immunization at site of injection and around body. Patient reports symptoms of fever, headaches, and cramps. Patient later went to care clinic and was told she had symptoms of the flu and given a prescription for Tamiflu. Time course: 9/24/2019 immunization given at 11:47am. Patient reports symptoms started on 9/25/2019 at 6:00am and did not resolve. Patient went to prompt care around 6pm and given tamiflu prescription.
Age: 43.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Pyrexia
Clinical narrative: At time of injection patient reports not feeling sick. Patient reports feeling pain and aches the next day after immunization at site of injection and around body. Patient reports symptoms of fever, headaches, and cramps. Patient later went to care clinic and was told she had symptoms of the flu and given a prescription for Tamiflu. Time course: 9/24/2019 immunization given at 11:47am. Patient reports symptoms started on 9/25/2019 at 6:00am and did not resolve. Patient went to prompt care around 6pm and given tamiflu prescription.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: Very sore upper left arm, nausea, very tired
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Patient called the pharmacy on 9/25/19 and said she has been sick since the day she received her flu shot(9/19/19). She reported  nausea, vomiting, fever, chills, severe soreness at injection site, headache, and fatigue. She said shortly after she arrived home, the headache began (~1 hr after vaccination) then the others followed and lasted for days. She said she is feeling better now and "on the mend." She didn't reach out to her primary doctor, the pharmacist recommended for her to contact her doctor.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient called the pharmacy on 9/25/19 and said she has been sick since the day she received her flu shot(9/19/19). She reported  nausea, vomiting, fever, chills, severe soreness at injection site, headache, and fatigue. She said shortly after she arrived home, the headache began (~1 hr after vaccination) then the others followed and lasted for days. She said she is feeling better now and "on the mend." She didn't reach out to her primary doctor, the pharmacist recommended for her to contact her doctor.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient Called reporting an "itchy raised tangerine sized welp"  with itching radiating down to her left elbow.  She tried to apply an ice pack which helped a little with the swelling but not the itching.  She stated that she gets a pneumo shot every year and has never had a reaction before.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Gait disturbance, Myalgia
Clinical narrative: At about 11 pm I started shivering uncontrollably, couldn't get warm, took a hot bath, turned on my heater in bed and just kept shivering. In the morning I woke up with muscle aches, fatigue, wobbly legs and just overall exhaustion continuing throughout the day. Got shivery again mid-day and it's subsided for a while. Took OTC Tylenol and Advil.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There hasn't been any adverse event reported.  This is to report to VAERS that the patient was given a High Dose vaccine at the age of 59.  Upon completion of the Flu Clinic it was discovered that a High Dose flu shot was given to a patient under the age of 65.  A patient aged 59 was given the High Dose.  We tried reaching out to the patient multiple times  but kept going to a voice mailbox that was not set up. Called patient around 12:20pm 9/25/19, 12:45pm  9/25/19, 1:20pm 9/25/19 and then again at 4:35pm on 09/25/2019.  We reached out to his MD and informed them of the situation. They said they would call if any questions.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: There hasn't been any adverse event reported.  This is to report to VAERS that the patient was given a High Dose vaccine at the age of 59.  Upon completion of the Flu Clinic it was discovered that a High Dose flu shot was given to a patient under the age of 65.  A patient aged 59 was given the High Dose.  We tried reaching out to the patient multiple times  but kept going to a voice mailbox that was not set up. Called patient around 12:20pm 9/25/19, 12:45pm  9/25/19, 1:20pm 9/25/19 and then again at 4:35pm on 09/25/2019.  We reached out to his MD and informed them of the situation. They said they would call if any questions.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Ear pain, Epstein-Barr virus test positive, Fatigue
Clinical narrative: I have been experiencing headache, ear pain, swollen glands, extreme fatigue, eye nerve pain, weakness, and dizziness for nearly 6 months beginning the day following the Shingrix booster.  I had Pleurisy for about a month about two weeks after the booster.  I had several months of not being able to control my body temperature.  I had several weeks of thyroid gland pain, even though an ultrasound was normal.   I have had numerous labs, imaging, doctor and specialist appointments plus the one ER visit for pleurisy.  I tested positive for the Epstein Barr Virus (negative Mono) and even though I've been on Prednisone for the past 5 weeks, my inflammation markers are still high and it only seems to be suppressing my symptoms for a bit until they increase the dose again.  There seems to be no hope in sight.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Imaging procedure, Inflammatory marker increased, Laboratory test, Lymphadenopathy
Clinical narrative: I have been experiencing headache, ear pain, swollen glands, extreme fatigue, eye nerve pain, weakness, and dizziness for nearly 6 months beginning the day following the Shingrix booster.  I had Pleurisy for about a month about two weeks after the booster.  I had several months of not being able to control my body temperature.  I had several weeks of thyroid gland pain, even though an ultrasound was normal.   I have had numerous labs, imaging, doctor and specialist appointments plus the one ER visit for pleurisy.  I tested positive for the Epstein Barr Virus (negative Mono) and even though I've been on Prednisone for the past 5 weeks, my inflammation markers are still high and it only seems to be suppressing my symptoms for a bit until they increase the dose again.  There seems to be no hope in sight.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Mononucleosis heterophile test negative, Neuralgia, Pleurisy, Temperature regulation disorder, Thyroid pain
Clinical narrative: I have been experiencing headache, ear pain, swollen glands, extreme fatigue, eye nerve pain, weakness, and dizziness for nearly 6 months beginning the day following the Shingrix booster.  I had Pleurisy for about a month about two weeks after the booster.  I had several months of not being able to control my body temperature.  I had several weeks of thyroid gland pain, even though an ultrasound was normal.   I have had numerous labs, imaging, doctor and specialist appointments plus the one ER visit for pleurisy.  I tested positive for the Epstein Barr Virus (negative Mono) and even though I've been on Prednisone for the past 5 weeks, my inflammation markers are still high and it only seems to be suppressing my symptoms for a bit until they increase the dose again.  There seems to be no hope in sight.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound thyroid normal
Clinical narrative: I have been experiencing headache, ear pain, swollen glands, extreme fatigue, eye nerve pain, weakness, and dizziness for nearly 6 months beginning the day following the Shingrix booster.  I had Pleurisy for about a month about two weeks after the booster.  I had several months of not being able to control my body temperature.  I had several weeks of thyroid gland pain, even though an ultrasound was normal.   I have had numerous labs, imaging, doctor and specialist appointments plus the one ER visit for pleurisy.  I tested positive for the Epstein Barr Virus (negative Mono) and even though I've been on Prednisone for the past 5 weeks, my inflammation markers are still high and it only seems to be suppressing my symptoms for a bit until they increase the dose again.  There seems to be no hope in sight.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Mobility decreased, Pain in extremity
Clinical narrative: Patients arm became sore on the evening of the vaccination 9/23. Her arm was very sore on 9/24 and she could hardly move it. On 9/25/19, she noticed it started bruising; however, the soreness started to subside
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: Patient complained of dizziness and feeling warm after immunization was administered. Patient passed out in chair.
Age: 87.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal discomfort, Dizziness, Eye disorder, Headache, Injection site discolouration
Clinical narrative: upset stomach                           dizzy                                        right arm hurt                            eye problem  HEADACHE today is 9/23/19 & my right arm is still black and blue where injected!
Age: 87.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: upset stomach                           dizzy                                        right arm hurt                            eye problem  HEADACHE today is 9/23/19 & my right arm is still black and blue where injected!
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Balance disorder, Fall, Feeling drunk, Gait disturbance
Clinical narrative: Received vaccinations 9/10/19. On ~9/12/19 started losing her balance "walking like a drunkard" as per mother. falling, staggering. resolved slowly over the next 2 weeks. was only seen at PCP's office 9/25/19 when history was told. at that point she's almost totally resolved, so monitoring was recommended.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: About 45 min after vaccine was given, patient felt dizzy, lightheaded & states "not ok".  an hour later feels more lightheaded & almost fainted,  was pale & diaphoretic.  Given Benadryl 50mg P.O. & to be followed on the next shift. Benadryl order 3x daily for 3 days  patient was called to medical but refused to be seen
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Mom stated child had a rash all over x 48 hrs after vaccine was administered.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot
Clinical narrative: pt was sitting and given the injection.  She then complained that she had a hot sensation in her body which moved up to her head.   I laid her down and the sensation passed  vital signs remained normal  Unable to enter Manufacture GSK
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Vaccination complication
Clinical narrative: Cellulitis on Right Arm. Redness Around site. Reaction occurred on 9/22/19 (Adverse Reaction to Pneumovax 23)
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large area of Redness on Entire (L) thigh spreading to entire thigh - hot to touch and swelling
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, redness and swelling on right arm. Rt eye swelling. Rt leg pain, rt cald and rt thigh aches.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient present to office on 9/25/19 with Redness, swelling and pain to Left upper arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red Swollen area on Left Deltoid Warm to touch size of a Small orange. Use cool compresses. Take antihistamine etc Benadryl. Ibuprofen or Tylenol as needed.
Age: 9.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Systemic rash, hives Started about 12 hrs after injections treated with Benadryl otc
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck mass, Pain
Clinical narrative: 3 DAYS AFTER iMMUNiZATiON, PT SAiD SiTE DEVELOPED A GOLF BALL SiZED LUMP ON THE RiGHT SiDE OF HER NECK AND A SMALLER LUMP ON THE LEFT SiDE. BUMPS ARE 3" UNDER EACH EAR AND PAiNFUL. PT SOUGHT MEDiCAL ATTENTiON AND REPORTED THAT MD WAS UNSURE OF CAUSE BUT THOUGHT LYMPH NODES MiGHT BE iNVOLVED. NO TREATMENT GiVEN AT THAT TIME.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear pruritus, Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Redness/Swelling & Itchy on site area where vaccine was given. Also Right ear was itchy starting 09/25/2019 @ 10:00 AM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of pain after shot (immunization) could not lift her arm the night and had a
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient reported arm and shoulder pain that night of vaccine. Patient went to her doctor's clinic 9/25/19 and was told pain was probably from vaccine and should take OTC pain medication. Doctor says vaccine was probably given too close to shoulder. She came to the pharmacy today and told us about the visit.
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Chest pain, Dyspnoea, Pruritus, Rash, Wheezing
Clinical narrative: Shortness of breath; Tightness in chest; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An adolescent male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath and tightness in chest following a dose of meningococcal group b rlp2086 vaccine. The patient was treated in the office and sent to hospital for further evaluation. Office did not hear back from patient or parent. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath; Tightness in chest; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An adolescent male patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath and tightness in chest following a dose of meningococcal group b rlp2086 vaccine. The patient was treated in the office and sent to hospital for further evaluation. Office did not hear back from patient or parent. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: body sore; experiencing rigors; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) (batch number 3RN95, expiry date unknown) for prophylaxis.   On 4th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced general body pain and rigors. On an unknown date, the outcome of the general body pain and rigors were unknown.   It was unknown if the reporter considered the general body pain and rigors to be related to Shingrix.  Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. 2 days after vaccination with Shingrix, the patient notified to pharmacy about whole body was sore. The patient went to hospital and experincined rigors.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain
Clinical narrative: body sore; experiencing rigors; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) (batch number 3RN95, expiry date unknown) for prophylaxis.   On 4th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced general body pain and rigors. On an unknown date, the outcome of the general body pain and rigors were unknown.   It was unknown if the reporter considered the general body pain and rigors to be related to Shingrix.  Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. 2 days after vaccination with Shingrix, the patient notified to pharmacy about whole body was sore. The patient went to hospital and experincined rigors.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headache; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 54-year-old female patient who received HBV (Engerix B) (batch number N754X, expiry date 11th November 2021) for prophylaxis.   On 11th September 2019, the patient received Engerix B (intramuscular) .5 ml. In September 2019, less than a week after receiving Engerix B, the patient experienced dizziness and headache. Engerix B was continued with no change. In September 2019, the outcome of the dizziness and headache were recovered/resolved.   It was unknown if the reporter considered the dizziness and headache to be related to Engerix B.  Additional case details were reported as follows: The registered nurse reported an adverse event on behalf of the patient. The patient received vaccine in left deltoid. The patient experienced headache and dizziness that lasted for approximately 3 to 4 days. The reporter not provide any additional information. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Site also itched / itching on arm; Site was swollen; Site was warm to touch; Site was hard; Rash down further the arm from the injection site and nearer to the elbow; redness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, 3 days after receiving Shingrix, the patient experienced pruritus, swelling, skin warm, induration, rash and erythema of extremities. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus, swelling, skin warm, induration, rash and erythema of extremities were recovering/resolving.   It was unknown if the reporter considered the pruritus, swelling, skin warm, induration, rash and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. About 3 days after the injection of Shingrix, patient developed a rash down further the arm from the injection site and nearer to the elbow. It was described as 2 inches by 4 inches in size.  The site also itched, was warm to the touch, and swollen. The patient took Benadryl. The event at time of report was almost gone. The patient sent a picture of the redness to reporter. Upon callback to healthcare professional, patient reported that in addition to swelling and warm to touch, and the site was also hard. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Site also itched / itching on arm; Site was swollen; Site was warm to touch; Site was hard; Rash down further the arm from the injection site and nearer to the elbow; redness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, 3 days after receiving Shingrix, the patient experienced pruritus, swelling, skin warm, induration, rash and erythema of extremities. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus, swelling, skin warm, induration, rash and erythema of extremities were recovering/resolving.   It was unknown if the reporter considered the pruritus, swelling, skin warm, induration, rash and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. About 3 days after the injection of Shingrix, patient developed a rash down further the arm from the injection site and nearer to the elbow. It was described as 2 inches by 4 inches in size.  The site also itched, was warm to the touch, and swollen. The patient took Benadryl. The event at time of report was almost gone. The patient sent a picture of the redness to reporter. Upon callback to healthcare professional, patient reported that in addition to swelling and warm to touch, and the site was also hard. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Rash, Skin warm
Clinical narrative: Site also itched / itching on arm; Site was swollen; Site was warm to touch; Site was hard; Rash down further the arm from the injection site and nearer to the elbow; redness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, 3 days after receiving Shingrix, the patient experienced pruritus, swelling, skin warm, induration, rash and erythema of extremities. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus, swelling, skin warm, induration, rash and erythema of extremities were recovering/resolving.   It was unknown if the reporter considered the pruritus, swelling, skin warm, induration, rash and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. About 3 days after the injection of Shingrix, patient developed a rash down further the arm from the injection site and nearer to the elbow. It was described as 2 inches by 4 inches in size.  The site also itched, was warm to the touch, and swollen. The patient took Benadryl. The event at time of report was almost gone. The patient sent a picture of the redness to reporter. Upon callback to healthcare professional, patient reported that in addition to swelling and warm to touch, and the site was also hard. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Site also itched / itching on arm; Site was swollen; Site was warm to touch; Site was hard; Rash down further the arm from the injection site and nearer to the elbow; redness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, 3 days after receiving Shingrix, the patient experienced pruritus, swelling, skin warm, induration, rash and erythema of extremities. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus, swelling, skin warm, induration, rash and erythema of extremities were recovering/resolving.   It was unknown if the reporter considered the pruritus, swelling, skin warm, induration, rash and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. About 3 days after the injection of Shingrix, patient developed a rash down further the arm from the injection site and nearer to the elbow. It was described as 2 inches by 4 inches in size.  The site also itched, was warm to the touch, and swollen. The patient took Benadryl. The event at time of report was almost gone. The patient sent a picture of the redness to reporter. Upon callback to healthcare professional, patient reported that in addition to swelling and warm to touch, and the site was also hard. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states that he has had ongoing pain and difficulty raising his arm following vaccination
Age: 0.42
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Influenza vaccine administered to patient under 6 months of age.
Age: 0.42
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Influenza vaccine administered to patient under 6 months of age.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain
Clinical narrative: Previously documented redness and pain at injection site, but had additional symptoms of pain upon raising arm above head, and neck pain as same side as injection.  Three days out, symptoms still exist, although I am able to raise arm above head without pain.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; patient was administered two live vaccines outside of the minimum interval; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The concomitant medications included sterile diluent. Information about the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 15-JUN-2017, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were unknown by the reporter).   On 06-JUL-2017, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were unknown by the reporter).  It was reported that the patient was vaccinated with two live vaccines outside of the minimum interval (inappropriate schedule of product administration).  No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Deafness, Herpes zoster
Clinical narrative: Shortly after receiving Zostavax vaccine, suffered a stroke, hearing loss, and shingles.; Shortly after receiving Zostavax vaccine, suffered a stroke, hearing loss, and shingles.; Shortly after receiving Zostavax vaccine, suffered a stroke, hearing loss, and shingles.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around 2012, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     On an unknown date, reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)", the pt suffered a stroke (cerebrovascular accident), hearing loss (deafness), and shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt 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.    The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).  The reporter considered the events to be disabling. Upon internal review, stroke, hearing loss were determined to be medically significant events.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, No adverse event
Clinical narrative: On 11-SEP-2019, the patient was administered the second dose of MMR II after first dose of MMR II was administered on 20-AUG-2019; No adverse effect; On 11-SEP-2019, the patient was administered the second dose of MMR II after first dose of MMR II was administered on 20-AUG-2019; This spontaneous report has been received from nurse referring to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's current condition, pertinent medical history, drug reactions/allergies were not reported. On 20-AUG-2019, the patient was administered with first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot number, expiry date, frequency, route of administration were not reported) for prophylaxis. On 11-SEP-2019, the patient was administered with second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot number R030806, expiry date 24-OCT-2020, therapy type rHA (dose, strength, frequency, route of administration were not reported) for prophylaxis (inappropriate schedule of product administration) (circumstance or information capable of leading to medication error). No adverse effects were reported. There was no product quality complaint present.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse effects; Received a dose of GARDASIL 9 on 8/26/2019 and discovered she was pregnant on 9/7/2019; This spontaneous prospective pregnancy report was received from a medical assistant concerning to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On 26-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency and route of administration were not reported) (lot # R009614 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and establish as 30-NOV-2020) , the patient discovered that she was pregnant on 07-SEP-2019 (exposure during pregnancy); the last menstrual period, date of conception and estimated date of delivery were not known. The pregnancy outcome was outcome pending.    No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; that patient received first dose of Hepatitis A vaccine (unspecified name and manufacturer) in 2011 and second dose of Hepatitis A vaccine in 2017; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.          On an unspecified date in 2011, the patient received the first dose of hepatitis a vaccine, inactivated (manufacture unknown) (dosage schedule, route, anatomical location, lot number and expiration date were not reported).   On an unknown date in 2017, the patient received the second dose of hepatitis a vaccine, inactivated (manufacture unknown) (inappropriate schedule of product administration) (dosage schedule, route, anatomical location, lot number and expiration date were not reported). No adverse effects reported.    The outcome of inappropriate schedule of product administration was unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of PEDVAX was administered to the patient on an unknown date; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # N024570 and expiration date on 01-MAY-2020 (strength, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed to a temperature below 36 degree fahrenheit (32.1F) during 8 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Improperly stored dose of GARDASIL 9 was administered to the patient on an unknown date; No adverse effects; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date: 14-JUN-2020 (strength, dose, schedule and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; Nurse reports the administration of one dose of an improperly stored vaccine, ROTATEQ, to one patient; This spontaneous report was received from a Registered Nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 16-SEP-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route with lot # R030924 and expiration date 10-JUL-2020  for prophylaxis.   The administered dose of vaccine experienced the temperature excursion of (0.24 °C) (multiple) degrees Celsius for 5 hours and 30 min. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient was administered VAQTA post expiration; This spontaneous report was received from a Nurse Practitioner refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-SEP-2019, the patient was vaccinated with 0.5 milliliter one dose of hepatitis a vaccine, inactivated(VAQTA) (lot # R027431, expiration date was reported as 09-SEP-2019, but upon internal validation established as 08-SEP-2019, 25/0.5 (units unspecified), anatomical location and route were not reported) post expiration for prophylaxis (expired product administered). No adverse effects reported. No product quality complaint involved. No additional information provided.