chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients over 7 years received Infanrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Infanrix) (batch number 73SX2) for prophylaxis.   Previously administered products included Daptacel (previously vaccinated with 2 Daptacel vaccines on an unknown date).   On 17-MAY-2024, the patient received Infanrix. On 17-MAY-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patients over 7 years received Infanrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAY-2024 The pediatric nurse practitioner reported that a patient who was over 7 years old received a dose of Infanrix vaccine above than the recommended age limit, which led to an inappropriate age at vaccine administration. This case was linked with US2024063034, reported by same reporter.; Sender's Comments:  US-GSK-US2024063034:Same reporter, Different patient
Age: 0.75
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error, Underdose
Clinical narrative: RECEIVED HIBERIX DILUENT ALONE; RECEIVED HIBERIX DILUENT ALONE; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 9-month-old patient who received Hib (Hiberix) (batch number 2A95F, expiry date 20-JAN-2026) for prophylaxis.   On 30-APR-2024, the patient received Hiberix. On 30-APR-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: RECEIVED HIBERIX DILUENT ALONE) and inappropriate dose of vaccine administered (Verbatim: RECEIVED HIBERIX DILUENT ALONE). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024 The reporter stated that a baby (patient) received a dose of Hiberix vaccine diluent alone which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This was 1 of  5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024061908:INTIAL CASE US-GSK-US2024AMR063489:Same reporter / different patient US-GSK-US2024AMR063485:Same reporter / different patient US-GSK-US2024AMR063487:Same reporter / different patient US-GSK-US2024AMR063479:Same reporter
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Cervical dysplasia, Loop electrosurgical excision procedure
Clinical narrative: high-grade CIN requiring LEEP.; This spontaneous report was received from a physician concerning to a female patient of unspecified age. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies 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) injection or with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, either of them administered as prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided). The number of doses received of either of the suspect vaccines was not specified, but it was stated that she had been fully vaccinated as confirmed by the physician in her vaccination records.   On an unspecified date, the patient developed a high-grade cervical intraepithelial neoplasia (CIN) (cervical dysplasia) that required loop electrosurgical excision procedure (LEEP). At the time of reporting, the outcome of cervical dysplasia had not been reported.   The causal relationship between cervical dysplasia and either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided. Moreover, the physician stated that she had been seeing ''a lot'' of cervical dysplasia in recipients of either of the suspect vaccines and was wondering if new strains were driving this.   This is one of two reports received by the same patient.   Lot number was being requested and would be updated if submitted.; Sender's Comments:  US-009507513-2405USA007222:MSD
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report that patient received inappropriately stored VARIVAX.  No adverse effects reported.  No PQC. Please see case 02607099 note section for 34 associated AE cases.  VARIVAX  LOT X026789   11/14/2025 Temp: 19.8 F Time: 20 Hours 15 Min; HCP calling to report that patient received inappropriately stored VARIVAX.  No adverse effects reported.  No PQC. Please see case 02607099 note section for 34 associated AE cases.  VARIVAX  LOT X026789   11/14/2025 Temp: 19.8 F Time: 20 Hours 15 Min; This spontaneous report was received from a medical assistant concerning to an 1-year-old patient of unspecified gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 21-MAY-2024, the patient was vaccinated with a single dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X026789, expiration date: 14-NOV-2025, administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided) that had been improperly stored as it went through a temperature excursion (TE) of 19.8 degree Fahrenheit (F) during 20 hours and 15 minutes (Product storage error). However, there were no adverse effects reported and there had not been any previous TE.  This was one of multiple reports received from the same medical assistant.; Sender's Comments:  US-009507513-2405USA007924:2405USA007771
Age: 61.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Acupuncture, Arthralgia, Dysstasia, Gait disturbance, Injection site pain
Clinical narrative: pain during injection, "this one is a bugger" the tech told me when I complained. the week after I started with horrible pain on (R) side of body, unable to stand up straight, walking was horrific, pain unbearable (R) hip, (R) muscle upper leg. (L) ankle pain continues ttD! I have a calender I use for s/s & I can provide. I am going to acupunture 6X now, will continue 1X mos. I feel 81 not 61!
Age: 61.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: pain during injection, "this one is a bugger" the tech told me when I complained. the week after I started with horrible pain on (R) side of body, unable to stand up straight, walking was horrific, pain unbearable (R) hip, (R) muscle upper leg. (L) ankle pain continues ttD! I have a calender I use for s/s & I can provide. I am going to acupunture 6X now, will continue 1X mos. I feel 81 not 61!
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: noted some difficulty breathing, fatigue and leg weakness a few hours after injection.  Next morning noted redness, swelling and warmth of the left arm at the site of the Men B injection
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Muscular weakness
Clinical narrative: noted some difficulty breathing, fatigue and leg weakness a few hours after injection.  Next morning noted redness, swelling and warmth of the left arm at the site of the Men B injection
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Skin ulcer
Clinical narrative: Open sores surrounding neck and cheeks. 3 months and counting. No response to topical ointments.
Age: 1.17
Sex: F
Vaccine: HIBV, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PPSV23 given instead of PCV20. Unable to read warning about not giving to those under two year of age on vial due to extremely small print. Recommend manufacturer have this highlighted if it can't be bold/larger.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Pediarix administered as dose 4 for Dtap and IPV
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Hep B 3 dose series. Doses administered at wrong intervals and extra dose administered on 5/13/24. Doses administered on 10/2/23, 2/19/24, 3/18/24, 5/13/24.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Product preparation error
Clinical narrative: NS vs. correct diluent was administered
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Erythema, Fall, Skin abrasion, Syncope
Clinical narrative: Patient presented to immunization room with mother and two siblings. She was apprehensive and appeared scared but wanted to go first. She sat in the chair to receive her 2nd Hepatitis B vaccine and tolerated it well. Following the vaccine administration she got up and stood by her mom while her older brother received his vaccine. While her brother was getting his vaccine, pt. had a syncopal episode and fell forward. RN immediately went down to the floor to assess her. She aroused as RN gently turned her over. She appeared frightened, tearful, and confused as to why she was on the floor. She received a quarter sized abrasion to her chin (skin was red- no bleeding noted), otherwise no other apparent injuries. Mom consoled and reassured patient. Mom states that she had her first syncopal episode following a finger prick at age 4 so she was not surprised by her daughter?s fainting after receiving her vaccine. Mom sat in chair with daughter for approximately 10 minutes. Patient remained alert and responsive. Offered patient water and a snack but patient refused. Mom wanted to take patient home to ?relax and rest for the day.? Mom left office at around 10:35 AM.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Tearfulness
Clinical narrative: Patient presented to immunization room with mother and two siblings. She was apprehensive and appeared scared but wanted to go first. She sat in the chair to receive her 2nd Hepatitis B vaccine and tolerated it well. Following the vaccine administration she got up and stood by her mom while her older brother received his vaccine. While her brother was getting his vaccine, pt. had a syncopal episode and fell forward. RN immediately went down to the floor to assess her. She aroused as RN gently turned her over. She appeared frightened, tearful, and confused as to why she was on the floor. She received a quarter sized abrasion to her chin (skin was red- no bleeding noted), otherwise no other apparent injuries. Mom consoled and reassured patient. Mom states that she had her first syncopal episode following a finger prick at age 4 so she was not surprised by her daughter?s fainting after receiving her vaccine. Mom sat in chair with daughter for approximately 10 minutes. Patient remained alert and responsive. Offered patient water and a snack but patient refused. Mom wanted to take patient home to ?relax and rest for the day.? Mom left office at around 10:35 AM.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Pediarix administered as dose 4 of Dtap and IPV.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: REDNESS AND PRURITUS TO BOTH ARMS, LEFT ARM WARM AND ITCHIER THAN RIGHT.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Throat irritation
Clinical narrative: Patient reports itching at injection site starting about 1 hour after injection. Then reported she had a scratchy throat later , so she took her allergy medication as well as her inhaler for good measure. She reports that this all resolved later in the day.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Nausea, Vision blurred
Clinical narrative: Patient reported chills, blurry vision and nausea approximately 15 minutes after injection
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Influenza virus test negative, Pyrexia, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: per mom, at around 5pm child had fevers over 102 F, has been giving child tylenol as needed , temperature has not gone down,returned to the office this morning and was seen by the provider.gave a dose of tylenol in our office around 1058am.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a DTaP vaccine instead of the intended Tdap vaccine.  No adverse reactions occcured
Age: 47.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Blood pressure decreased, Cyanosis, Fall, Immediate post-injection reaction
Clinical narrative: The patient received the Twinrix vaccine first on her left deltoid followed by the MMR on right deltoid. The patient had never received either of these vaccines before and had answered no to all screening questions including adverse reactions to vaccines. After the MMR vaccine was administered the patient said ?ahhhh? and fell onto the chair adjacent to her and slowly rolled to the floor headfirst. The pharmacist was able to quickly get to the patient before she fully hit the floor and rolled her on her side and held her head while another employee grabbed a pillow and ice pack for the back her neck. The patient?s lips appeared blue/purple and the pharmacist asked the front staff to call EMS to assess the patient. While waiting the pharmacist checked her blood pressure which was low (92/62 mmHg). The patient slowly sat up about 5 minutes after laying down and drank some Gatorade and the color in her face and lips appeared normal again. The patient never loss consciousness. The patient was moved to the cot with support from staff and EMS came shortly after. They walked her to the EMS vehicle outside and patients blood pressure had returned. She self-walked back and asked to receive her final vaccine (rabies - Rabavert IM in the right deltoid) she she tolerated well.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: Joint aches, aches at past injury sites, general tiredness and weakness, slight fever (plus 1.3 degrees) later cold and chills, later cold chills and body uncontrollably shaking from chills, then night sweats (soaked pajamas and pillow cover).  TREATMENT:  Thin soup,  light meals, lots of fluids, took Aleve to relieve joint pain, and bed rest under heavy covers.   OUTCOME: 5/31 no chills and no fever, still weak and some joint pain.  PLAN, (5/31)  Lots of fluids, light meals Aleve and rest.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Tremor
Clinical narrative: Joint aches, aches at past injury sites, general tiredness and weakness, slight fever (plus 1.3 degrees) later cold and chills, later cold chills and body uncontrollably shaking from chills, then night sweats (soaked pajamas and pillow cover).  TREATMENT:  Thin soup,  light meals, lots of fluids, took Aleve to relieve joint pain, and bed rest under heavy covers.   OUTCOME: 5/31 no chills and no fever, still weak and some joint pain.  PLAN, (5/31)  Lots of fluids, light meals Aleve and rest.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Immediate post-injection reaction, Mobility decreased, Pain, Periarthritis
Clinical narrative: Immediate swelling and pain. The swelling lasted roughly 2 weeks. The swelling went down but the pain remained. Eventually I started to lose mobility. I have seen my General Practitioner and was sent for Physical Therapy. I am now waiting for an ultrasound guided steroid injections in hopes of alleviating pain per Orthopedic Physician.. I had an ultrasound of my shoulder and it showed bursitis and tendonitis.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, Swelling, Ultrasound joint abnormal, X-ray limb abnormal
Clinical narrative: Immediate swelling and pain. The swelling lasted roughly 2 weeks. The swelling went down but the pain remained. Eventually I started to lose mobility. I have seen my General Practitioner and was sent for Physical Therapy. I am now waiting for an ultrasound guided steroid injections in hopes of alleviating pain per Orthopedic Physician.. I had an ultrasound of my shoulder and it showed bursitis and tendonitis.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Pancreatic carcinoma, Weight decreased
Clinical narrative: Pt has weight loss and epigastric pain.  Dx with pancreatic CA, these shots are causing Cancer
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Pyrexia, Rash, Swelling face
Clinical narrative: Patient experienced fever, body rash , swelling of lips, face , forehead . She took  Tylenol , Benadryl to help with the symptoms. She went to the ER later in the day and was prescribed Prednisone  for the symptoms .
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site discolouration, Injection site induration, Injection site mass, Injection site reaction, Injection site swelling
Clinical narrative: PT was given vaccine that was administered in the left thigh about 10 min or less, MOC caught MA attention to state that pt had a welt about 1in away from the injection site. MOC also mentioned possible rash but was also previously there.  Later this evening MOC updated us Shot reaction site update: Swelling continued to about 2? around hard lump and began to discolor like bruising. Went ahead and administered benedryl dose.  Currently applying ice at 10 min on 30 min off.
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Urticaria
Clinical narrative: PT was given vaccine that was administered in the left thigh about 10 min or less, MOC caught MA attention to state that pt had a welt about 1in away from the injection site. MOC also mentioned possible rash but was also previously there.  Later this evening MOC updated us Shot reaction site update: Swelling continued to about 2? around hard lump and began to discolor like bruising. Went ahead and administered benedryl dose.  Currently applying ice at 10 min on 30 min off.
Age: 0.58
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event noted.  Vaccines given too early.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: shivering, pain in the shoulder, low appetite, vomiting, low energy and frequent bowel movement with loose stool
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Frequent bowel movements, Vomiting
Clinical narrative: shivering, pain in the shoulder, low appetite, vomiting, low energy and frequent bowel movement with loose stool
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pt received only the saline diluent for the ActHIB. The vaccine had not been reconstituted. No symptoms at this time.  They are in similar vials and have different colored lids, but the diluent never used to have the same lot# as the actual HIB.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient received vaccine on 5/24/24 in left arm came in on 5/31/24 for office visit and unable to lift left arm and area to left arm where got injection is red and approximately 4cm in size and warm to touch and radiating down left arm. Provider prescribed patient antibiotic at this time and was dx with cellulitis.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Havrix 19y+ was administered to an 18 year old patient. No adverse reactions within observation time frame.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Havrix 19+ given to 18 yr old client. No adverse affects during observation period.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Unevaluable event
Clinical narrative: ER doctor accessed patient, gave motrin and ice. patient followed up with pediatrician and was okay
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Mass, Pain of skin, Pruritus, Skin warm
Clinical narrative: SHOT GIVEN ON 5/24/24; REACTION BEGAN ON 5/30/24 RED, LUMP, WARM TO TOUCH, TENDER TO TOUCH, VERY ITCHY
Age: 56.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered vaccine, which was outside of the age guidelines.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blindness, Stent placement, Visual impairment
Clinical narrative: This form not adequate.  What is described here is the first Covid shot , had 2 more. First on 3/28/2021 and others  on 4/25/21 and one on 12/17/21. I had a blockage of eye sight  on Aug 5 2021 and diagnosed with afib in October 2021.  Recently have seen info on increase on afib, caused by Covid shot. Have impairment to vision in right eye now and taking blood thinners, also 2 stents placed.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adrenal insufficiency, Angina pectoris, Blood glucose increased, Brain neoplasm, Brain operation
Clinical narrative: Stabbing headaches on the left side of my head started within a few hours of receiving the 1st vaccination and caused a rare brain tumor to grow
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Craniopharyngioma, Diabetes insipidus, Fatigue, Headache, Impaired gastric emptying
Clinical narrative: Stabbing headaches on the left side of my head started within a few hours of receiving the 1st vaccination and caused a rare brain tumor to grow
Age: 53.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: MA gave dose IM and not SQ
Age: 38.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Pain in extremity
Clinical narrative: left arm pain, left sided chest pain, shortness of breath, present to ER 05/19/24 diagnosed with Idiopathic Pericarditis.
Age: 38.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Pericarditis, Troponin
Clinical narrative: left arm pain, left sided chest pain, shortness of breath, present to ER 05/19/24 diagnosed with Idiopathic Pericarditis.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Groin pain, Loss of personal independence in daily activities, Magnetic resonance imaging, Muscular weakness, Myalgia
Clinical narrative: PATIENT REPORTED "NORMAL" SIDE EFFECTS THE FIRST 3 DAYS AFTER THE VACCINE: SORE MUSCLE.  HE STATED THAT ON DAY 3 AFTER THE VACCINE HE HAD SEVERE MUSCLE WEAKNESS FROM GROIN ALL THE WAY DOWN HIS LEGS THAT PREVENTED HIM FROM HIS NORMAL WALKS, PAINFUL RASH ALL OVER, PAINFUL RASH ON SCALP THAT IS STILL BOTHERING HIM TWO MONTHS LATER.  HE ALSO REPORTED THAT AFTER HIS FIRST DOSE OF SHINGRIX, HE RATHER SUDDENLY EXPERIENCED NERVE PAIN AND HIS DOCTOR REFERRED HIM TO A NEUROLOGIST WHO STARTED HIM ON LYRICA WHICH HE IS STILL TAKING TODAY.  LOOKING BACK HE WONDERS IF THAT NERVE PAIN WAS AN ADVERSE REACTION TO HIS FIRST SHINGRIX DOSE.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Rash
Clinical narrative: PATIENT REPORTED "NORMAL" SIDE EFFECTS THE FIRST 3 DAYS AFTER THE VACCINE: SORE MUSCLE.  HE STATED THAT ON DAY 3 AFTER THE VACCINE HE HAD SEVERE MUSCLE WEAKNESS FROM GROIN ALL THE WAY DOWN HIS LEGS THAT PREVENTED HIM FROM HIS NORMAL WALKS, PAINFUL RASH ALL OVER, PAINFUL RASH ON SCALP THAT IS STILL BOTHERING HIM TWO MONTHS LATER.  HE ALSO REPORTED THAT AFTER HIS FIRST DOSE OF SHINGRIX, HE RATHER SUDDENLY EXPERIENCED NERVE PAIN AND HIS DOCTOR REFERRED HIM TO A NEUROLOGIST WHO STARTED HIM ON LYRICA WHICH HE IS STILL TAKING TODAY.  LOOKING BACK HE WONDERS IF THAT NERVE PAIN WAS AN ADVERSE REACTION TO HIS FIRST SHINGRIX DOSE.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Henoch-Schonlein purpura, Hypersensitivity, Injection site rash, Peripheral swelling, Rash
Clinical narrative: 6 days post vaccine developed a rash , initially just on legs and torso, but worsened over the next 4 days. Rash was raised, not pruritic, and accompanied by very mild puffiness of the hands and feet. Once elements of the rash appeared, mom felt it stayed in one place for several days.   No fever and clinically well without GI sxs, URI sxs loss of appetite or energy.  Playful. On Day 10 after vaccination, rash was head to toe, and parents brought him to an urgent care.  The provider there was sufficiently concerned to send him on to the ER thinking he had a severe allergic reaction or Henoch Schonlein Purpura. .  No tests were performed, but the pt was given steroids, antihistamine and H2 blocker.     The pt followed up with me 2 days later in clinic, and the rash had resolved.  The photos shown to me in clinic looked much more like erythema multiforme, although I did not have the opportunity to see the rash in my office. He continues to feel well, so I took him off of the steroids and antihistamines.  He is scheduled for an evaluation by allergy immunology in a month.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash papular, Swelling face
Clinical narrative: 6 days post vaccine developed a rash , initially just on legs and torso, but worsened over the next 4 days. Rash was raised, not pruritic, and accompanied by very mild puffiness of the hands and feet. Once elements of the rash appeared, mom felt it stayed in one place for several days.   No fever and clinically well without GI sxs, URI sxs loss of appetite or energy.  Playful. On Day 10 after vaccination, rash was head to toe, and parents brought him to an urgent care.  The provider there was sufficiently concerned to send him on to the ER thinking he had a severe allergic reaction or Henoch Schonlein Purpura. .  No tests were performed, but the pt was given steroids, antihistamine and H2 blocker.     The pt followed up with me 2 days later in clinic, and the rash had resolved.  The photos shown to me in clinic looked much more like erythema multiforme, although I did not have the opportunity to see the rash in my office. He continues to feel well, so I took him off of the steroids and antihistamines.  He is scheduled for an evaluation by allergy immunology in a month.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: gave patient extra  HIb instead of the Menveo. no adverse reaction.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Breast swelling, Eye swelling, Injection site induration, Injection site mass, Ocular hyperaemia
Clinical narrative: FIRM MASS ON LEFT          1-she got 6 month vaccines ( left upper  thigh  was Pediarix ) 2-the other concern is about bump on her  R breast developed this morning  no discharge or fluid comes out from the nipple ,  3 -she had mildly red swollen left eye this morning per dad  which resolved now
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This vaccine should have been given I.m.   It was given subcutaneous in error
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Skin: firm bump on the upper L arm which feels warm to touch, erythema and mild swelling down to mid arm on the L arm
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Immunisation reaction, Muscle atrophy, Rash, Skin indentation, X-ray
Clinical narrative: I have muscle atrophy. It looks like a rash on the outside but theres an indentation on the inside of my arm in the muscle.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Fatigue, Muscle atrophy
Clinical narrative: I have muscle atrophy. It looks like a rash on the outside but theres an indentation on the inside of my arm in the muscle.
Age: 70.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Chills, Dyspnoea, Dysstasia, Ear congestion, Erythema
Clinical narrative: Chills, fatigue, weird yawning tremor that would happen for a few seconds and then go away. This would continue over a few hours, approximately 4-5 hours. These side effects happened while the patient was asleep, happened the night after the shot. Tried to walk and legs buckling, couldn?t walk or stand, gasping of air, rush through body seeing red and veins (could be attributed to Bp med), cotton in ear (hard to hear),
Age: 70.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Fatigue, Gait disturbance, Hypoacusis, Yawning
Clinical narrative: Chills, fatigue, weird yawning tremor that would happen for a few seconds and then go away. This would continue over a few hours, approximately 4-5 hours. These side effects happened while the patient was asleep, happened the night after the shot. Tried to walk and legs buckling, couldn?t walk or stand, gasping of air, rush through body seeing red and veins (could be attributed to Bp med), cotton in ear (hard to hear),
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, General physical health deterioration, Pulse absent, Respiratory arrest
Clinical narrative: Resident received the Covid vaccine on 5/23/24, he was monitored with no advese effects. On 5/27/24 resident became short of breath, drowsy, with some confusion noted. Resident was sent hospital to eval and treat.  Resident returned to the facility talking to staff and vocied no concerns, hospital stated they could not find the source as to why resident was declining. Nurse enterd room to complete accu check and resident appeared to have no respirations, resident was assessed no apical pulsepresent, code status was DNR.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Resident received the Covid vaccine on 5/23/24, he was monitored with no advese effects. On 5/27/24 resident became short of breath, drowsy, with some confusion noted. Resident was sent hospital to eval and treat.  Resident returned to the facility talking to staff and vocied no concerns, hospital stated they could not find the source as to why resident was declining. Nurse enterd room to complete accu check and resident appeared to have no respirations, resident was assessed no apical pulsepresent, code status was DNR.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Dtap #5 was given at incorrect interval date due to prior vaccination history of Dtap #4 not being put into system by clerical staff until Dtap was already given to the child. Child tolerated immunization well.  Child had no side effects to my knowledge.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm got really swelled and red and fevered at site of injection;  This happened the morning after the shot was given; It is very painful and still extremly red;  Patient works for a drs office and they actually gave her a steroid shot just in case of allergic rxn;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac tamponade, Chemotherapy, Computerised tomogram abdomen, Computerised tomogram thorax, Diabetes mellitus
Clinical narrative: Non-Hodkin's Lymphoma in Pericardia Sac, Diabetes, Bilateral Pulmonary Embolisms, Cardiac Tamponade
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Non-Hodgkin's lymphoma, Pericardial drainage, Pulmonary embolism, Type 1 diabetes mellitus
Clinical narrative: Non-Hodkin's Lymphoma in Pericardia Sac, Diabetes, Bilateral Pulmonary Embolisms, Cardiac Tamponade
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Hand numbness, numbness traveling down arm, feeling pins and needles
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: HIVES TO BODY AFTER RECEIVING 4 YEAR OLD SHOTS 1 DAY BEFORE ALSO COMPLAINS OF PAIN TO LEGS AND ITCHINESS ALL OVER HIS BODY AND RASH IS REDNESS ALL OVER HIS BODY NO DIFFICULTY BREATHING. ADVIL 170MG GIVEN ORAL, SOLU-MEDROL 17.2MG GIVEN IM, ALSO PRELONE ORDERED 15MG/5 ML TAKE 5MLS BY MOUTH DAILY FOR 5-7 DAYS ORAL
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Swelling AT INJECTION SITE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema of right thigh
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Pt visited PCP on 11/17/2023 for skin issue, has chronic Eczema. Referred to dermatologist.  Received Covid vaccine-- Spikevax on same day.  As per PCP, mother reported that "had severe worsening of his eczema since getting the Covid vaccines".
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch.
Sex: F
Vaccine: HPV9
Symptoms: Menstruation delayed
Clinical narrative: a patient experienced a delay in their menstrual cycle directly following administration of GARDASIL 9; This spontaneous report was received from a nurse prescriber via an employee, referring to an 11-year-old female patient. The patient's pertinent medical history, drug reactions/allergies and, concomitant therapies were unknown.     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) injection (strength, dose, dose number, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis.         On an unknown date in 2022, following administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced a delay in her menstrual cycle directly. No other symptoms reported. It was unknown if the patient sought medical attention. It was unknown if the patient received treatment for the event. It was unknown if the lab diagnostic/study was performed. The outcome of menstruation delayed was unknown.      The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event was not provided.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: After 3 doses of pneumococcal polysaccharide vaccine (23 serotypes), he had only 5/23 titers greater than 1.3 mcg/mL / He was not immune to varicella and diphtheria after primary series; After 3 doses of pneumococcal polysaccharide vaccine (23 serotypes), he had only 5/23 titers greater than 1.3 mcg/mL; After 3 doses of pneumococcal polysaccharide vaccine (23 serotypes), he had only 5/23 titers greater than 1.3 mcg/mL; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 2 years old patient.  The patient's medical history included recurrent infections. Since birth, the patient suffered from over 8 episodes of otitis media, 2 episodes of pneumonia, 2 episodes of gastroenteritis and many viral upper respiratory infections. He underwent adenoidectomy and myringotomy tube placement. The patient's concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with 3 doses of pneumococcal 23v polysaccharide vaccine (manufacturer unknown) (inappropriate schedule of product administration; extra dose administered) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  After 3 doses of pneumococcal 23v polysaccharide vaccine (manufacturer unknown), the patient had only 5/23 titers greater than 1.3 mcg/mL (antibody test negative).  The authors considered only 5/23 titers greater than 1.3 mcg/mL to be related to pneumococcal 23v polysaccharide vaccine (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of 2 reports derived from the same literature article (cross referenced with # 2405USA009931).  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2405USA009931:
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Nurse reporting that one of 2 unrelated children were given VARIVAX on 5/13/2024 and 10 days later they both returned to the office and were diagnosed with Varicella virus. No additional symptoms or side effects were reported. Many fields marked "unk; This spontaneous report was received from a nurse refers to a child patient of unknown exact age and gender.    The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 13-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # x026320, expiration date: 07-NOV-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.         On 23-MAY-2024 (reported as: 10 days later), experienced varicella virus test positive. It was reported that the patient returned to the office and was diagnosed with Varicella virus. The outcome of varicella virus test positive was unknown.        The causality assessment was not provided.  This is one of two reports from the same reporter.
Age: 2.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects; HCP called to report T/E case for VAXNEUVANCE (PFS). VAXNEUVANCE was administered to 4 patients.; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-FEB-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X022475 which had been confirmed to be a valid lot number, expiration date reported and confirmed as 23-JAN-2026, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided) (Product storage error). The temperature excursion was reported as 53.0 degree Fahrenheit (F) for 4 hours, 30 minutes, 0 seconds. No side effects or any other information was known by the reporter (no adverse event). No data logger was involved and no previous temperature excursion occurred.    Operator of device was reported as health professional.  This is one of the 4 cases received from same reporter. ; Sender's Comments:  US-009507513-2405USA009246: US-009507513-2405USA009564:
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: He was not immune to varicella after primary series; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 2 years old patient.  The patient's medical history included recurrent infections. Since birth, the patient suffered from over 8 episodes of otitis media, 2 episodes of pneumonia, 2 episodes of gastroenteritis and many viral upper respiratory infections. He underwent adenoidectomy and myringotomy tube placement. The patient's concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first dose (primary series) of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection, primary series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient was not immune to varicella (antibody test negative).  The authors considered no immunity to varicella to be related to varicella virus vaccine live (oka/merck) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of 2 reports derived from the same literature article (cross referenced with # 2405USA001291).  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2405USA001291:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; with a horrible case of shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAY-2024, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: with a horrible case of shingles now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAY-2024 The case was received from the patient interactive digital media.  The patient received both shingles shots less than a year prior to the reporting date. The patient was dealing with a horrible case of shingles at the time of reporting which had it about a week. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult vaccine administered outside of indication to a pediatric patient; Adult vaccine administered outside of indication to a pediatric patient; This non-serious case was reported by a nurse via sales rep and described the occurrence of overdose in a infant female patient who received HAV (Havrix 1440 adult) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Adult vaccine administered outside of indication to a pediatric patient) and adult product administered to child (Verbatim: Adult vaccine administered outside of indication to a pediatric patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 22-MAY-2024 The reporter reported that a havrix adult vaccine administered outside of indication to a pediatric patient, which led to overdose and adult product administered to a child.
Sex: U
Vaccine: RSV
Symptoms: Dry throat, Dysphagia, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Headache; hurt all over my arm; dry throat; Hrad to swallow; arm was swollen hot and very tender to the touch; arm was swollen hot and very tender to the touch; arm was swollen hot and very tender to the touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Headache), pain in arm (Verbatim: hurt all over my arm), dry throat (Verbatim: dry throat), swallowing difficult (Verbatim: Hrad to swallow), swelling arm (Verbatim: arm was swollen hot and very tender to the touch), extremities hot feeling of (Verbatim: arm was swollen hot and very tender to the touch) and tenderness (Verbatim: arm was swollen hot and very tender to the touch). The outcome of the headache, pain in arm, dry throat, swallowing difficult, swelling arm, extremities hot feeling of and tenderness were not reported.   It was unknown if the reporter considered the headache, pain in arm, dry throat, swallowing difficult, swelling arm, extremities hot feeling of and tenderness to be related to Arexvy.     It was unknown if the company considered the headache, pain in arm, dry throat, swallowing difficult, swelling arm, extremities hot feeling of and tenderness to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-MAY-2024 The case was received from the patient via interactive digital media. The pharmacist suggested to patient to take third shingles shot along with the RVS. The patient self reported that his/her arm was swollen hot and very tender to the touch 10 minutes before he/she left the pharmacy.  The patient stated now it was been 15 hours and he/she especially hurt all over arm. The patient kept ice on it on and off since injection. The patient definitely had headache dry throat hard to swallow etc but no coughing though. The pharmacist forgot to give the side effects papers, he/she would go back today and get it to be sure any side effects that should not be.
Sex: U
Vaccine: RSV
Symptoms: Skin warm, Tenderness
Clinical narrative: Headache; hurt all over my arm; dry throat; Hrad to swallow; arm was swollen hot and very tender to the touch; arm was swollen hot and very tender to the touch; arm was swollen hot and very tender to the touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Headache), pain in arm (Verbatim: hurt all over my arm), dry throat (Verbatim: dry throat), swallowing difficult (Verbatim: Hrad to swallow), swelling arm (Verbatim: arm was swollen hot and very tender to the touch), extremities hot feeling of (Verbatim: arm was swollen hot and very tender to the touch) and tenderness (Verbatim: arm was swollen hot and very tender to the touch). The outcome of the headache, pain in arm, dry throat, swallowing difficult, swelling arm, extremities hot feeling of and tenderness were not reported.   It was unknown if the reporter considered the headache, pain in arm, dry throat, swallowing difficult, swelling arm, extremities hot feeling of and tenderness to be related to Arexvy.     It was unknown if the company considered the headache, pain in arm, dry throat, swallowing difficult, swelling arm, extremities hot feeling of and tenderness to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-MAY-2024 The case was received from the patient via interactive digital media. The pharmacist suggested to patient to take third shingles shot along with the RVS. The patient self reported that his/her arm was swollen hot and very tender to the touch 10 minutes before he/she left the pharmacy.  The patient stated now it was been 15 hours and he/she especially hurt all over arm. The patient kept ice on it on and off since injection. The patient definitely had headache dry throat hard to swallow etc but no coughing though. The pharmacist forgot to give the side effects papers, he/she would go back today and get it to be sure any side effects that should not be.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tenderness
Clinical narrative: Nausea; Tender arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nausea (Verbatim: Nausea) and pain in arm (Verbatim: Tender arm). The outcome of the nausea and pain in arm were not reported.   It was unknown if the reporter considered the nausea and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the nausea and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2024 The patient had nausea and a tender arm after receiving a dose of Shingles vaccine. The physician did not consent to follow-up.