chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electric shock sensation, Pain, Pain in extremity
Clinical narrative: patient requested to have fluarix in right arm and pfizer bivalent in left arm. patient reported "electric pain" shooting down in left lower calf when his foot touches the floor while walking 30 minutes after administration.
Age: 16.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: After I gave patient a shot, pt's father told my technician she was fainting. I came out to check on patient, She was conscious and talking normally, no sign of anaphylaxis thus we did not perform CPR, no EpiPen needed. Pt vomited and she got a lot better. We called 911 and paramedics came, and they decided she did not need to go to hospital. Father later on told me she may have been nervous from getting the vaccines.  I called father 4 hours later and he said patient already recovered.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Blood test, Computerised tomogram, Confusional state, Delirium
Clinical narrative: Pt was hospitalized the evening after the vaccination. Pt has suffered from encephalopathy with no other known source. Pt has suffered from delirium, weakness, confusion, tremors. Pt has not improved and continues to undergo assessment and require hospital level care. Pt was independent in all of his activities of daily living, able to self cath, does have mild dementia for which wife does the driving and sets up meds. Pt now requires total A to self feed, complete grooming and hygiene, max assist of 2 for transfers and is not able to walk at this time.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Encephalopathy, Gait inability, Loss of personal independence in daily activities, Magnetic resonance imaging, Tremor
Clinical narrative: Pt was hospitalized the evening after the vaccination. Pt has suffered from encephalopathy with no other known source. Pt has suffered from delirium, weakness, confusion, tremors. Pt has not improved and continues to undergo assessment and require hospital level care. Pt was independent in all of his activities of daily living, able to self cath, does have mild dementia for which wife does the driving and sets up meds. Pt now requires total A to self feed, complete grooming and hygiene, max assist of 2 for transfers and is not able to walk at this time.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: X-ray
Clinical narrative: Pt was hospitalized the evening after the vaccination. Pt has suffered from encephalopathy with no other known source. Pt has suffered from delirium, weakness, confusion, tremors. Pt has not improved and continues to undergo assessment and require hospital level care. Pt was independent in all of his activities of daily living, able to self cath, does have mild dementia for which wife does the driving and sets up meds. Pt now requires total A to self feed, complete grooming and hygiene, max assist of 2 for transfers and is not able to walk at this time.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Balance disorder, Blood test normal, Cardiac stress test normal, Dizziness
Clinical narrative: Several hours after the booster I had a severe headache, sweats, the symptoms disappeared but several days later I had episodes of similar headache pain  with lightheadedness and high blood pressure. Saw cardiologist who did blood work, stress test, evaluation and said everything was normal except for the HBP for which he prescribed a low dose HBP medication. Symptoms did not improve but progressed to pressure in the ears, disequilibrium and migraine-like headache. Had ENT visit and was diagnosed with vestibulopathy.  Symptoms did not change for several months. I then saw a Neuro Otolaryngology at local Eye and Ear. I had an MRI, hearing exam, and vestibular lab exam. Tests were normal. MRI normal.  Blood pressure is still high, vestibular symptoms persist, migraine headaches. I have no history of headaches. No history of high blood pressure
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Hyperhidrosis, Hypertension, Laboratory test normal
Clinical narrative: Several hours after the booster I had a severe headache, sweats, the symptoms disappeared but several days later I had episodes of similar headache pain  with lightheadedness and high blood pressure. Saw cardiologist who did blood work, stress test, evaluation and said everything was normal except for the HBP for which he prescribed a low dose HBP medication. Symptoms did not improve but progressed to pressure in the ears, disequilibrium and migraine-like headache. Had ENT visit and was diagnosed with vestibulopathy.  Symptoms did not change for several months. I then saw a Neuro Otolaryngology at local Eye and Ear. I had an MRI, hearing exam, and vestibular lab exam. Tests were normal. MRI normal.  Blood pressure is still high, vestibular symptoms persist, migraine headaches. I have no history of headaches. No history of high blood pressure
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Migraine, Vestibular disorder
Clinical narrative: Several hours after the booster I had a severe headache, sweats, the symptoms disappeared but several days later I had episodes of similar headache pain  with lightheadedness and high blood pressure. Saw cardiologist who did blood work, stress test, evaluation and said everything was normal except for the HBP for which he prescribed a low dose HBP medication. Symptoms did not improve but progressed to pressure in the ears, disequilibrium and migraine-like headache. Had ENT visit and was diagnosed with vestibulopathy.  Symptoms did not change for several months. I then saw a Neuro Otolaryngology at local Eye and Ear. I had an MRI, hearing exam, and vestibular lab exam. Tests were normal. MRI normal.  Blood pressure is still high, vestibular symptoms persist, migraine headaches. I have no history of headaches. No history of high blood pressure
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: ADULT DOSE GIVEN INSTEAD OF PEDIATRIC
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was withdrawn from a vial that was punctured 12 hours before then administered to the patient.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Dizziness, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient developed lymphadenopathy of the left axillary region  after receiving the vaccine. The lymph node  underneath his left arm pit is swollen, tender, and warm to touch. He is also experiencing headache, dizziness, nausea, cough, and general malaise.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise, Nausea, Skin warm
Clinical narrative: Patient developed lymphadenopathy of the left axillary region  after receiving the vaccine. The lymph node  underneath his left arm pit is swollen, tender, and warm to touch. He is also experiencing headache, dizziness, nausea, cough, and general malaise.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: 11/10 Inflammation of left shoulder, redness, heat, pain.  11/11 Mom observed three small blisters with clear fluid. Continues to have swelling, pain, redness and heat.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: 11/10 Inflammation of left shoulder, redness, heat, pain.  11/11 Mom observed three small blisters with clear fluid. Continues to have swelling, pain, redness and heat.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine was withdrawn from a vial that was punctured 12 hours before then administered to the patient.
Age: 23.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Fall, Syncope
Clinical narrative: patient  fainted right after I finished giving both vaccine.  She fell off from the chair to the floor, she passed out.  We called 911, within few minutes, she recovered, told us she's fine, stop  calling  911.  She rested on the floor for a little while, once  she was fine, she left the store.    Next day, we called her, she said she's fine.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: A Covid vaccine initial series  was scheduled with the first dose to be given on October 15th, 2022.  Instead of the initial Pediatric Pfizer Covid vaccine, a bivalent pediatric Pfizer vaccine was administered.  The error was discovered on November 5th when the patient returned for the second dose 3 weeks later.  The parent was notified.  No further vaccines were given until the patient's physician approves.  No negative outcome was reported at the time of discovery.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: The COVID-19 Moderna Bivalent adult dose (0.5 ml) was administered to an 8 year old patient instead of the reduced dose (0.25 ml)
Age: 78.0
Sex: F
Vaccine: COVID19-2, PNC20, VARZOS
Symptoms: Neurological symptom
Clinical narrative: Patient demonstrated stroke-like symptoms and was taken to the hospital by ambulance.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Syringe issue, Underdose
Clinical narrative: During administration, shot leaked out of hub of syringe.  Administering pharmacy technician decided hardly any was actually injected. A repeat vaccination of flucelvax was given.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: The adult dose (0.5 ml) of the COVID-19 Moderna Bivalent booster was given to an 11 years and 8 month old child instead of the reduced dose (0.25 ml).
Age: 21.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Patient called 11/11/2022 complaining of arm pain and shortness of breath. Advised patient to go to the ER since she did not have a primary care physician to call.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Myalgia, Paranasal sinus discomfort, Pyrexia
Clinical narrative: I had a fever, chills and muscle aches with sinus pressure.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Vaccine drawn up by Covid vaccine clinic nurse for Pediatric patient coming in for monthly injection at request of parent. Patient is 7 years old and Covid 19 mRNA bivalent 12 year-adult booster administered in error.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Urticaria
Clinical narrative: Influenza IIV4 (Quadrivalent) 0.5mL (90686) 2 inch diameter red hard welt, tender and warm to the touch. No other symptoms have developed. Treating with ibuprofen or Tylenol as needed for pain. Ice as tolerated but doesn't prevent normal activities.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest pain, Hypoaesthesia, Neurological symptom, Vision blurred
Clinical narrative: Patient is unsure of the exact day and time of covid shot. She threw away the card. She believes it was July 8th at 1pm, 20 minutes later she started to get symptoms. Went to ED around 6pm that same day. Blood pressure was 200/120, blurred vision,chest pain, numbness in arms and legs. Thought she was having a stroke. The next day she felt like she had a mini stroke-left side numbness.  Was treated with anti-hypertensive medications that were raised 2 days later, but subsequently weaned off with no residual numbness.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer short-dated this lot number and we were unaware of this and administed an expired vaccine. No reaction reported from pt.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Bivalent vaccine was given for initial COVID dose instead of monovalent vaccine.  No adverse effects were noted, pt was called later in day and was doing well.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Bivalent vaccine was given for initial COVID dose instead of monovalent vaccine.  No adverse effects were noted, pt was called later in day and was doing well.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspepsia, Dyspnoea, Oesophagitis, Oropharyngeal pain
Clinical narrative: Got a bad sore throat  Got bad throat and Esophagus ? soreness ?and indigestion Shortness of breath  chest area soreness  I am not sure of the name but am sure that the lot# 131335P3D4H8RW and the other number I wrote down was- UJ899AB and exp- 30June23
Age: 5.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event
Clinical narrative: No adverse events reported.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient experienced swelling, redness and itching from elbow to injection site starting shortly after immunization was administered
Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient came in for a Moderna Covid-19 Bivalent booster and received a Fluad flu shot. No adverse events reported by patient.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer short-dated this lot number and we were unaware of this and administered an expired vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: tachycardia 150 beats per minute, 40 times in 24 hours
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer lot number was short-dated and we were unaware of this and administered an expired vaccine.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer IMZ was short-dated and we were unaware of this and administered an expired vaccine.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Coeliac disease, Feeling abnormal, Hypersomnia, Injection site pain, Lethargy
Clinical narrative: Lethargy, crying, fussiness, fever (100), pain at injection site, sleeping more than usual
Age: 29.0
Sex: F
Vaccine: FLUA4
Symptoms: Wrong patient received product
Clinical narrative: This vaccine was given in error to the patient.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse events, administered expired vaccine
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: try to call patient but line is busy. patient is 76 years and adacel is for patient up to 64 years old.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Product storage error
Clinical narrative: Covid-19 mRNA primary vaccine tris (Pfizer) injection was ordered for this patient at 11/2/22 at 1445. When I was reporting the vaccines punctured for the day to my pharmacy director I saw that there was no primary vaccine for Pfizer that was opened for today. Turns out Covid-19 mRNA updated bivalent booster vaccine Pfizer was dispensed to the patient instead. This dose reached the patient in which on the database primary Pfizer order was charted on but the Lot# recorded on the immunization matches the that of the bivalent booster vaccine Pfizer.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Full blood count normal, Heart rate increased, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: Development of seriously swollen lymph nodes under both arms and across the base of the neck - acute swelling and pain, slight fever, pain under left rib, fast heart rate for days, slight pleural infusion in left lung. Swollen lymph nodes lasted for 6days despite use of acetaminophen and ibuprofen. Rapid heart rate continues to persist 7 days after injection. Pain beneath rib became acute - saw doctor today - chest x-ray reveals slight pleural infusion in lower left lung.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pleural effusion, Pyrexia, Red blood cell sedimentation rate normal, Swelling
Clinical narrative: Development of seriously swollen lymph nodes under both arms and across the base of the neck - acute swelling and pain, slight fever, pain under left rib, fast heart rate for days, slight pleural infusion in left lung. Swollen lymph nodes lasted for 6days despite use of acetaminophen and ibuprofen. Rapid heart rate continues to persist 7 days after injection. Pain beneath rib became acute - saw doctor today - chest x-ray reveals slight pleural infusion in lower left lung.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT REPORTED; BOTH DOSES WERE ADMINISTERED OUTSIDE OF MANUFACTURER EXPIRATION DATE 8/31/22. VACCINE WAS RECEIVED IN SHIPMENT ON 7/22/22 AND PLACED IN FRIDGE WITH BEYOND USE DATE 9/30/22 AND WAS NOT LABELED CORRECTLY TO EXPIRE 8/31/22 ACCORDING TO MANUFACTURE EXPIRATION. VERIFIED WITH MOTHER, NO ADVERSE EFFECTS REPORTED
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient who is 10 years old received Pfizer Bivalent Booster (12 and up). Nurse verified the correct patient, D.O.B, and primary series was completed but did not realize patient was 10 years old by D.O.B. Spoke with parents notifying them about the incorrect vaccine being administered to the child. Parents stated child was experiencing no symptoms.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient didn't experience any adverse event.   We administered the Bivalent Booster by accident instead of the first dose that patient was supposed to received.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient presented to the pharmacy requesting a Covid-19 vaccine and requested the booster dose.  He claimed to have left his previous Covid-19 vaccination card at home.  Upon administering the Moderna Bivalent vaccine and presenting him with his "second" vaccination card, he admitted that he had not received any previous Covid-19 vaccines, and should have been given the original Moderna vaccine.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: BIVALENT BOOSTER GIVEN AS PRIMARY DOSE
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with LOT FL8095 on 09/13/2022  that has expired on 08/31/22
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer pediatric vaccine LOT FL8095 (Expired 08/31/2022) was administered on 09/13/2022.
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Bivalent instead of Moderna 2nd dose
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was expired prior to administering.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer pediatric vaccine LOT FL8095 (Expired 08/31/2022) was administered on 09/13/2022.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer pediatric vaccine LOT FL8095 (Expired 08/31/2022) was administered on 09/13/2022.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was expired prior to administration.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site induration, Injection site mass
Clinical narrative: Patient called approximately 6 hours after receiving Shingrix vaccine.  When removing the bandage, she noticed active bleeding along with a hard lump under the injection site.  She denied any rashing or expanding redness or fever.  She states that shortly after receiving the vaccination, she bumped the injection site on the wall.  She did not notice significant bleeding at the time, but also did not remove the bandage.  During our phone call, she applied ice to the site and the bleeding slowed significantly.  I advised to continue with ice and add antiinflammatories if needed.  Seek out medical intervention if bleeding does not stop within the next 15 minutes.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: seven days after given shot on the left arm I developed itching and swelling at injection site..  treated two days with benadryl but had adverse effects with prostate.  Switched to zyrtex and pepsid twice a day for two days then once a day,.  stoped progression and started to get better. still a little itching and discoloration at injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle ache, shivering, fever, feeling tired.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 10yo patient was given a 3rd Pfizer COVID primary vaccine dose for 5-11yo on 10/19/22 (lot # FT1551). Patient is not immunocompromised and does not fall under the guidelines to receive 3 primary doses. First 2 doses of Pfizer COVID primary vaccines for 5-11yo given on 12/1/21 (lot # FK5127) and 12/24/21 (lot # FL0007). Patient received 3rd dose on 10/19/22 using the primary Pfizer COVID vaccine. Patient should've received the peds (5-11yo) Pfizer COVID bivalent booster vaccine. There is no adverse event, this is reported as a COVID vaccine administration error.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No symptoms or physical signs. Patient was administer the 30mcg/0.3ml dose instead of the 10mcg/0.3ml.  Patient turns 12 in less than 2 months
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was given bivalent instead of primary
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Arthralgia, Dyspepsia, Eye discharge
Clinical narrative: Started with itching of the scalp, neck, upper back, chest, and private area, then hives developed all over my body with severe itching with any kind of pressure, worse at night time; then dermatographia; swollen joints, stiffness and severe joint pain; stomach/digestion issues, bloating; eye infections, with white discharge, puffiness and itching.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Eye pruritus, Joint swelling, Mechanical urticaria, Musculoskeletal stiffness
Clinical narrative: Started with itching of the scalp, neck, upper back, chest, and private area, then hives developed all over my body with severe itching with any kind of pressure, worse at night time; then dermatographia; swollen joints, stiffness and severe joint pain; stomach/digestion issues, bloating; eye infections, with white discharge, puffiness and itching.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pruritus, Urticaria
Clinical narrative: Started with itching of the scalp, neck, upper back, chest, and private area, then hives developed all over my body with severe itching with any kind of pressure, worse at night time; then dermatographia; swollen joints, stiffness and severe joint pain; stomach/digestion issues, bloating; eye infections, with white discharge, puffiness and itching.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine give no adverse event
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given no adverse event.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given no adverse event
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given no adverse event
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: EW0173), in arm, on 18May2021 as dose 2, single (Lot number: EW0168), in arm and on 28Dec2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 43 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing); "surgery" (unspecified if ongoing), notes: If I hadn't had medication left over from a past surgery I would have gone to the ER. Concomitant medication(s) included: BUPROPION oral taken for attention deficit hyperactivity disorder (ongoing); GUANFACINE oral taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "It also wasn't particularly effective, since I caught COVID 3 times."
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: EW0173), in arm, on 18May2021 as dose 2, single (Lot number: EW0168), in arm and on 28Dec2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 43 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing); "surgery" (unspecified if ongoing), notes: If I hadn't had medication left over from a past surgery I would have gone to the ER. Concomitant medication(s) included: BUPROPION oral taken for attention deficit hyperactivity disorder (ongoing); GUANFACINE oral taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "It also wasn't particularly effective, since I caught COVID 3 times."
Age: 43.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: my lips swelled up; red; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0170) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos", start date: 2019 (ongoing); "MS", start date: 2008 (ongoing); "GERD" (ongoing); "IBS" (ongoing); "IVF" (unspecified if ongoing), notes: I was doing IVF and was concerned how the vaccine might effect me. Concomitant medication(s) included: AVONEX taken for multiple sclerosis, start date: 2008 (ongoing); FAMOTIDINE oral taken for gastrooesophageal reflux disease, start date: 2010 (ongoing); ASPIRINE oral, start date: 2021 (ongoing); LEVOTHYROXINE SODIUM oral taken for autoimmune thyroiditis, start date: 2019 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Time: Morning, Anatomical Site of injection: Right arm, Batch/Lot number: EW0150), administration date: 06Apr2021, for COVID-19 immunization, reaction(s): "my chest got bright red", "Very itchy". The following information was reported: LIP SWELLING (non-serious), outcome "unknown", described as "my lips swelled up"; ERYTHEMA (non-serious), outcome "unknown", described as "red"; PRURITUS (non-serious), outcome "unknown", described as "itchy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lip swelling, erythema, pruritus.  Additional information: Patient was prescribed Paxlovid after testing positive. Patient had to stop it do to side effects. Very bad dry mouth. Bad taste (Like I chewed the pills) tasted all day. Diarrhea. Muscle Aches. All went away after patient stopped the Paxlovid. Patient did have an allergic reaction after receiving both vaccine doses. The first dose around 4-5 hours later patient chest got bright red and very itchy. Patient had to take Benadryl. With the second dose around the 4-5 hour mark patient lips swelled up and were red and itchy. Patient had to take Benadryl. Patient did not go for any boosters. Patient was doing IVF and was concerned how the vaccine might effect me. Patient went to an outdoor farm without a mask an got covid 23Oct2022.
Age: 43.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lip swelling, Polymerase chain reaction, Pruritus
Clinical narrative: my lips swelled up; red; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0170) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos", start date: 2019 (ongoing); "MS", start date: 2008 (ongoing); "GERD" (ongoing); "IBS" (ongoing); "IVF" (unspecified if ongoing), notes: I was doing IVF and was concerned how the vaccine might effect me. Concomitant medication(s) included: AVONEX taken for multiple sclerosis, start date: 2008 (ongoing); FAMOTIDINE oral taken for gastrooesophageal reflux disease, start date: 2010 (ongoing); ASPIRINE oral, start date: 2021 (ongoing); LEVOTHYROXINE SODIUM oral taken for autoimmune thyroiditis, start date: 2019 (ongoing). Vaccination history included: BNT162b2 (Dose: 1, Time: Morning, Anatomical Site of injection: Right arm, Batch/Lot number: EW0150), administration date: 06Apr2021, for COVID-19 immunization, reaction(s): "my chest got bright red", "Very itchy". The following information was reported: LIP SWELLING (non-serious), outcome "unknown", described as "my lips swelled up"; ERYTHEMA (non-serious), outcome "unknown", described as "red"; PRURITUS (non-serious), outcome "unknown", described as "itchy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lip swelling, erythema, pruritus.  Additional information: Patient was prescribed Paxlovid after testing positive. Patient had to stop it do to side effects. Very bad dry mouth. Bad taste (Like I chewed the pills) tasted all day. Diarrhea. Muscle Aches. All went away after patient stopped the Paxlovid. Patient did have an allergic reaction after receiving both vaccine doses. The first dose around 4-5 hours later patient chest got bright red and very itchy. Patient had to take Benadryl. With the second dose around the 4-5 hour mark patient lips swelled up and were red and itchy. Patient had to take Benadryl. Patient did not go for any boosters. Patient was doing IVF and was concerned how the vaccine might effect me. Patient went to an outdoor farm without a mask an got covid 23Oct2022.
Age: 43.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 43.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Echocardiogram, Physiotherapy, SARS-CoV-2 antibody test
Clinical narrative: Some flushing. No dizziness or vertigo; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 17Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF8839) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia", start date: 2019 (ongoing); "GERD", start date: 2012 (unspecified if ongoing); "Diverticulitis", start date: 2017 (unspecified if ongoing); "CAD", start date: 2012 (ongoing); "Prediabetic", start date: 2012 (unspecified if ongoing); "BPPV", start date: 2005 (unspecified if ongoing); "Anxiety", start date: 1988 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Time (24 hr): 03:30 pm, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot Number: E49264), administration date: 29Jan2021, for COVID-19 immunisation, reaction(s): "Flushing of ears/chest", "Awkward in the night", "severe vertigo"; BNT162b2 (Dose: 2, Time (24 hr): 02:30 pm, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot Number: EN6198, Some flushing. No dizziness or vertigo. Felt good/normal), administration date: 24Feb2021, for COVID-19 immunisation, reaction(s): "Some flushing". The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "Some flushing. No dizziness or vertigo"; FATIGUE (non-serious), outcome "unknown", described as "Tired".
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal X-ray, Ultrasound scan, Vaccination failure
Clinical narrative: Some flushing. No dizziness or vertigo; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 17Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF8839) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia", start date: 2019 (ongoing); "GERD", start date: 2012 (unspecified if ongoing); "Diverticulitis", start date: 2017 (unspecified if ongoing); "CAD", start date: 2012 (ongoing); "Prediabetic", start date: 2012 (unspecified if ongoing); "BPPV", start date: 2005 (unspecified if ongoing); "Anxiety", start date: 1988 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Time (24 hr): 03:30 pm, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot Number: E49264), administration date: 29Jan2021, for COVID-19 immunisation, reaction(s): "Flushing of ears/chest", "Awkward in the night", "severe vertigo"; BNT162b2 (Dose: 2, Time (24 hr): 02:30 pm, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot Number: EN6198, Some flushing. No dizziness or vertigo. Felt good/normal), administration date: 24Feb2021, for COVID-19 immunisation, reaction(s): "Some flushing". The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "Some flushing. No dizziness or vertigo"; FATIGUE (non-serious), outcome "unknown", described as "Tired".
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing
Clinical narrative: Some flushing. No dizziness or vertigo; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 17Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF8839) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia", start date: 2019 (ongoing); "GERD", start date: 2012 (unspecified if ongoing); "Diverticulitis", start date: 2017 (unspecified if ongoing); "CAD", start date: 2012 (ongoing); "Prediabetic", start date: 2012 (unspecified if ongoing); "BPPV", start date: 2005 (unspecified if ongoing); "Anxiety", start date: 1988 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Time (24 hr): 03:30 pm, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot Number: E49264), administration date: 29Jan2021, for COVID-19 immunisation, reaction(s): "Flushing of ears/chest", "Awkward in the night", "severe vertigo"; BNT162b2 (Dose: 2, Time (24 hr): 02:30 pm, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot Number: EN6198, Some flushing. No dizziness or vertigo. Felt good/normal), administration date: 24Feb2021, for COVID-19 immunisation, reaction(s): "Some flushing". The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "Some flushing. No dizziness or vertigo"; FATIGUE (non-serious), outcome "unknown", described as "Tired".
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE; LPN calling to report administration of expired lot of VARIVAX. Per caller, lot had short-dated expiration from 6/28/2023 to 10/12/2022 due to past temperature excursion; vaccine was administered on 10/25/2022. No additional AEs, no PQCs.; LPN calling to report administration of expired lot of VARIVAX. Per caller, lot had short-dated expiration from 6/28/2023 to 10/12/2022 due to past temperature excursion; vaccine was administered on 10/25/2022. No additional AEs, no PQCs.; This spontaneous report was received from licensed practical nurse (LPN) and refers to an 18-month-old male patient. Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and past drug allergies or drug reactions were not provided.  On an unspecified date, the varicella virus vaccine live (oka/merck) (VARIVAX) lot# U027326 experienced an unreported temperature excursion and due to this the expiration date was short-dated expiration from 28-JUN-2022 to 12-OCT-2022 (product storage error). However on 25-OCT-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml) once administered for prophylaxis (lot #U027326 confirmed to be valid, expiration date reported as 12-OCT-2022, but upon internal validation the expiration date was assessed as 02-SEP-2023, conflicting information) (expired product administered and product storage error) (strength, and route of administration were not provided). No additional adverse event (AEs).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received the Shingrix vaccine and got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingrix vaccine and got shingles as a result.  The reporter wanted to know what compensation was available for his/her follow up care and inconvenience. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Increased risk of GBS; Severe muscle weakness; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and muscle weakness. On an unknown date, the outcome of the guillain barre syndrome and muscle weakness were unknown.   It was unknown if the reporter considered the guillain barre syndrome and muscle weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Nov-2022 Reporter's comment: This case was reported by the patient via interactive digital media. There was an increased risk of Guillain Barre syndrome, severe muscle weakness was observed after vaccination with Shingrix. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and then got shingles/ Suspected vaccination failure; Got the vaccine and then got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-NOV-2022 Reporter's comment: This case was reported by the patient's child via interactive digital media. The reporter stated that the patient had got the vaccine and then had got the shingles. The reporter thought that the event might had been related to the drug. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles vaccine, got shingles/Suspected vaccination failure; Got a bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-NOV-2022 Reporter's Comment: The reporter reported this case via interactive digital media. The reporter stated that one of his/her friend got Shingles vaccine, it didn't work well and she got a bad case of Shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR131302, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR131302:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Immobile
Clinical narrative: practically crippled me, suffering ever since; This case was reported by a consumer via interactive digital media and described the occurrence of immobile in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included decreased immune responsiveness.   In August 2021, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant). On an unknown date, the outcome of the immobile was not recovered/not resolved.   It was unknown if the reporter considered the immobile to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingrix vaccine last year. The patient had been suffering ever since and had practically crippled. The patients doctor did not know what it was and neither patient do. The patient wish he/she had never taken that shot. The patient think it was MS (Multiple sclerosis) but doctor says no.  The patient do had a very weak immune system. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness around injection site, expanding; swelling around injection site, expanding; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received Shingrix. In 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022158153   Additional Information: GSK receipt date: 01-NOV-2022 Reporters comment: The reporter herself reported that she received the  shingrix vaccine and the redness and swelling around the injection site was expanding. The patient asked if this was a concern No other information known . Additional Supportive information:The case US2022AMR158124 is identified as duplicate of case US2022158153  All future correspondence would be added in case US2022AMR158124  which stands as case of record for this patient and the case US2022158153 would be deleted.; Sender's Comments:  US-GSK-US2022158153:same reporter
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 62YO was administered Pediarix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 62-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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.   Linked case(s) involving the same patient:US2022159153   Additional Information: GSK receipt date: 01-Nov-2022 and 02-Nov-2022 Reporter's comment:  The field representative from agency reported that the patient was behind on childhood immunizations received Pediarix. There were no further details shared by field representative. The reporter consent to follow-up. .Additional supportive information: The 62 years old patient received the Pediarix, which led to inappropriate age at vaccine administration.