chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle contractions involuntary, Muscle twitching, Muscular weakness, Neuropathy peripheral, Pain in extremity
Clinical narrative: (Please note, I am a medical doctor reporting this for the first time) A couple days after the first vaccine I awoke at midnight with extreme lower extremity contractors. Much more intense than any "Charlie Horse" in my life. It felt like I was going to fracture my tibia and fibula. This continued for weeks, multiple times during the night. During the day I was experiencing muscle fasciculations in my thighs and calf muscles. Not painful but extremely disconcerting. I was also experiencing tinnitus which I didn't have before. I shouldn't have gotten the second dose but my work required it (I'm an anesthesiologist). After the second injection the symptoms worsened with more intense tinnitus and muscle fasciculations. Over 1.5 years the muscle twitching subsided until I contracted Covid in 10/22 and then again in 6/23. At which point I went into full blown "Post Covid peripheral neuropathy" in my legs. I am currently under the care of a neurologist. Dr and have been seen at the Clinic. I am now on anti seizure medications (Lyrica) and unable to work because of the pain and weakness in my legs.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: (Please note, I am a medical doctor reporting this for the first time) A couple days after the first vaccine I awoke at midnight with extreme lower extremity contractors. Much more intense than any "Charlie Horse" in my life. It felt like I was going to fracture my tibia and fibula. This continued for weeks, multiple times during the night. During the day I was experiencing muscle fasciculations in my thighs and calf muscles. Not painful but extremely disconcerting. I was also experiencing tinnitus which I didn't have before. I shouldn't have gotten the second dose but my work required it (I'm an anesthesiologist). After the second injection the symptoms worsened with more intense tinnitus and muscle fasciculations. Over 1.5 years the muscle twitching subsided until I contracted Covid in 10/22 and then again in 6/23. At which point I went into full blown "Post Covid peripheral neuropathy" in my legs. I am currently under the care of a neurologist. Dr and have been seen at the Clinic. I am now on anti seizure medications (Lyrica) and unable to work because of the pain and weakness in my legs.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Back pain
Clinical narrative: She got her vaccine, and had no problems initially.  On Monday 2/19/24 had pain in her back, felt it would go away.  It did not go away and Tuesday and Wednesday she was on a heating pad all day long it hurt so bad.  It was like a baseball was in the middle of her back in the bra line area.  It hurt so bad, it was terrible.  She took some Aleve and Gabapentin to alleviate the pain which did help some.  She is still having some of the pain today, it's a little bit lower and not as severe.  Tuesday or Wednesday it was so sever it was awful.  She did contact her doctor and she was told that it was possibly from the shot.  She did not tell her to take anything other than what she was doing.  She was told that the symptoms would last about 5 days, and that is up and feels that it would quit.
Age: 28.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Tunnel vision
Clinical narrative: Dizziness, lightheadedness, tunnel vision, increased sweating, feeling the need to pass out. Patient had their vitals monitored while being seated. Placed ice packs on the back of the patient's neck and fanned the patient, and elevated patient's feet. Patient was more coherent by the time EMTs arrived and looked over the patient. Patient made it home safely and refused to go to the Emergency Room after.
Age: 64.0
Sex: M
Vaccine: COVID19, RSV, VARZOS
Symptoms: Blister, Myalgia, Rash
Clinical narrative: The patient reports feeling sore in his ab muscles on Saturday.  He describes it as doing 1000 sit ups.  A few days later the patient has a rash with blisters  going down his legs
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, HEPA, HIBV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate vaccine for the patient's age. Hepatitis A given with patient being under 12 months old.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC15, VARCEL
Symptoms: Rash
Clinical narrative: RASH ON HER BODY
Age: 25.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: Itchy, redness, and splotching localized to left deltoid.
Age: 1.25
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: erythema and swelling to left thigh, tender to touch, sz 8 cm. No warmth, no induration, no fever. started 2/21, approx 48 hrs after administration. picture in chart.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Carditis, Exercise tolerance decreased, Fatigue, Head discomfort
Clinical narrative: Insomnia, extreme skull pressure, neurological damage, vision damage, floaters everywhere, extreme body wide inflammation, muscle weakness, Inability to excercise, myocarditis, heart inflammation, numbness and tingling in limbs, weakness, extreme fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Inflammation, Insomnia, Muscular weakness, Myocarditis
Clinical narrative: Insomnia, extreme skull pressure, neurological damage, vision damage, floaters everywhere, extreme body wide inflammation, muscle weakness, Inability to excercise, myocarditis, heart inflammation, numbness and tingling in limbs, weakness, extreme fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nervous system disorder, Paraesthesia, Visual impairment, Vitreous floaters
Clinical narrative: Insomnia, extreme skull pressure, neurological damage, vision damage, floaters everywhere, extreme body wide inflammation, muscle weakness, Inability to excercise, myocarditis, heart inflammation, numbness and tingling in limbs, weakness, extreme fatigue
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Adenomyosis, Dysmenorrhoea, Menstrual disorder, Ultrasound pelvis abnormal
Clinical narrative: Within months, my periods went from being approximately 4-5 days to all happening in about 24-48 hours.  The entire period all at once.  It is extremely painful with cramps associated with the volume at which I lose blood.  Recently I went for a pelvic ultrasound and have what appears to be adenomyosis.
Age: 43.0
Sex: F
Vaccine: HPV9, PNC20
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Patient started itching and got red blotches on face about a half hour after shots were given.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC20, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Parent sent photo afternoon of 2/14 of left leg. Tender, half dollar sized circular red area that parents state felt like hard lump and hot to touch, fever.  Told parents to administer motrin or tylenol, warm compress, gentle massage, circle the area. Follow up picture sent 2/15. Redness and size decreased, not as tender, fever gone. By 2/16 mom reports nearly resolved.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC20, RV5
Symptoms: Pyrexia
Clinical narrative: Parent sent photo afternoon of 2/14 of left leg. Tender, half dollar sized circular red area that parents state felt like hard lump and hot to touch, fever.  Told parents to administer motrin or tylenol, warm compress, gentle massage, circle the area. Follow up picture sent 2/15. Redness and size decreased, not as tender, fever gone. By 2/16 mom reports nearly resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbing and pins/needles in both feet and hands.  Progressively worse
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: PATIENT STATES THAT SHE HAS HAD ARM PAIN STARTING 2 DAYS AFTER THE VACCINE AND SHE TOOK A WHILE TO GO TO THE DOCTOR AND THEY SAID IT WAS HER ROTATOR CUFF.  SHE SAID THE PAIN HAS CONTINUED THIS WHOLE TIME SINCE THE VACCINE
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: The patient was due for a MMR and received a MMRV. she was contacted by the provider, she was instructed to come in so the provider can do a full examination, she had no complications during her visit. Mom explained to the provider that she didn't exhibit any strange behavior at home. she is scheduled to be seen in a week or before if she starts to have any symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood testosterone decreased, Brain fog, Irritability, Menopause
Clinical narrative: My estradiol level went from 458.0 to <5.0 and my testosterone levels went down as well within days of having the booster shot. I had blood drawn and tested on 11/2/2023 and again on 11/17/2023. My levels went down significantly within 8 days of getting the booster shot and I have experienced many many side affects (extreme brain fog, significant loss of strength, increase in irritability etc.). The booster shot put me in a perimenopausal state with extreme side affects.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oestradiol decreased
Clinical narrative: My estradiol level went from 458.0 to <5.0 and my testosterone levels went down as well within days of having the booster shot. I had blood drawn and tested on 11/2/2023 and again on 11/17/2023. My levels went down significantly within 8 days of getting the booster shot and I have experienced many many side affects (extreme brain fog, significant loss of strength, increase in irritability etc.). The booster shot put me in a perimenopausal state with extreme side affects.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Was given MMRV when was over the CDC recommended age group.  No adverse effects noted.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE AFFECT
Age: 23.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Peripheral swelling, Rash
Clinical narrative: Rash on arm & large bump. 32 weeks pregnant and due date April 12th
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Rash, Rash erythematous, Skin warm
Clinical narrative: patient got vaccine  and noticed a red and warm rash on her arm a few days later, she got diagnosed with cellulitis by a provider
Age: 15.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NOne
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Rash
Clinical narrative: rash after vaccine administration
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Irritability, Rash, Rash erythematous
Clinical narrative: rash on  abdomen and belly that started after she received her MMR and varicella vaccines. Patient received her vaccines on January 5, 2024. The injection site was red and remained red for two weeks. Rash started one - two days after her vaccines. Patient also was fussy and had rhinorrhea starting the day after her vaccines . The rash started on her legs and then moved to her tummy and chest. Denies any scratching or itching. Denies any vesicles or pustules. States that the rash is flat, and faint pink in color. Denies any blood red spots. She has not had any fever. Mother has tried using Aquaphor after bathing patient to help with rash but it has not done anything. Patient was given Tylenol when she was fussy which helped and she slept better. No new detergents, no new bath or body lotions, no new baby shampoos. Recently switched to Toddler formula from infant formula, but it's the same company and product.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: rash on  abdomen and belly that started after she received her MMR and varicella vaccines. Patient received her vaccines on January 5, 2024. The injection site was red and remained red for two weeks. Rash started one - two days after her vaccines. Patient also was fussy and had rhinorrhea starting the day after her vaccines . The rash started on her legs and then moved to her tummy and chest. Denies any scratching or itching. Denies any vesicles or pustules. States that the rash is flat, and faint pink in color. Denies any blood red spots. She has not had any fever. Mother has tried using Aquaphor after bathing patient to help with rash but it has not done anything. Patient was given Tylenol when she was fussy which helped and she slept better. No new detergents, no new bath or body lotions, no new baby shampoos. Recently switched to Toddler formula from infant formula, but it's the same company and product.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Within just a couple of hours, she spiked a very high fever that lasted a couple of days. Her mother knew instinctively the vaccine was the cause of this dangerously high fever.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: did not report any adverse issues or side effects from the administration. No other AE information; Improperly stored vaccine was administered to the patient; This spontaneous report was received from a certified medical assistant (CMA) and referred to a 12-month-old patient of unknow gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 04-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 54.3 degree Fahrenheit (F) for 9 hours 32 minutes 0 seconds; on 05-DEC-2023, temperature excursion with 57.7F for 15 hours 30 minutes 0 seconds; on 06-DEC-2023, temperature excursion with 50.2F for 5 hours 43 minutes 0 seconds; on 07-DEC-2023, temperature excursion with 30.6F for 1 hour 55 minutes 0 seconds, 52.7F for 11 hours 3 minutes 0 seconds; on 11-DEC-2023, temperature excursion with 48.4F for 1 hour 47 minutes 0 seconds.  On 18-JAN-2024, the patient was vaccinated with improper stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5ml / once, lot #X003664, expiration date: 10-NOV-2025, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (product storage error). The patient did not report any adverse issues or side effects from the administration (no adverse event).; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015463: US-009507513-2401USA015454:
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Dysmenorrhoea
Clinical narrative: Patient has been experiencing cramping but no menstruation; Pt called to report information she garnered while in conversations with a Medical Assistant at an HCP office. Medical Assistant reported her daughter received two doses of GARDASIL 9, and after each dose the daughter's period would be "stalled" fo; Pt called to report information she garnered while in conversations with a Medical Assistant at an HCP office. Medical Assistant reported her daughter received two doses of GARDASIL 9, and after each dose the daughter's period would be "stalled" fo; This spontaneous report was received from a medical assistant and refers to a 13 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.    On an unspecified dated in December 2022,  the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); and on 26-DEC-2023, she received the second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot #, expiration date, route of administration, anatomical location not provided for any dose) as prophylaxis.  On unspecified date in December 2022, after first vaccination, the patient's period would be "stalled" for approximately 2 months after (amenorrhea); and on an unspecified date in December 2023, after second vaccination, happened again the event of amenorrhea. Since unspecified date, she was also experiencing period cramping (dysmenorrhea) but with no menstruation. Medical attention was sought. At the reporting time, the outcome of amenorrhea (onset date: December 2022) and dysmenorrhea was unknown; and the outcome of amenorrhea (onset  date: December 2023) was considered as not recovered, as it was reported that as of 14-FEB-2024, the patient's period had still not  returned.   Causality assessment between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Papilloma viral infection
Clinical narrative: she was diagnosed with high risk HPV; This spontaneous report has been received from an office receptionist referring to herself, a female patient of unknown age. Information about the patient's current condition, medical history and concomitant medication was unknown.   On unknown dates, between the years of 2000 and 2005, when she was between the age of 12 and 14 years, the patient was vaccinated with 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, route, batch/lot# and expiration date were unknown) for prophylaxis.         On an unknown date in 2008, the patient was diagnosed with high risk human papillomavirus (HPV). The patient had sought medical attention. In the same year, after she was diagnosed, she had a colposcopy and had been fine since. The patient reported that she would have a follow up appointment with her doctor soon. The outcome of the event of high risk HPV was reported as recovered on an unknown date. The causality between the event and the suspect vaccine was unknown.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Cyst rupture, Feeling abnormal, Immunodeficiency, Influenza virus test negative
Clinical narrative: Bad acne; Immune system compromised; He has had 2 instances where he was sick for 2 weeks or more; He has had 2 instances where he was sick for 2 weeks or more; He had a cyst on his ear/but it recently burst; He has had many other health issues; welt or swelling on shoulder; welt or swelling on shoulder; This spontaneous report has been received from a consumer referring to himself, a 58 years old male patient. The patient's historical condition included a cyst on his ear since birth, which was dormant. Information regarding the patient's current condition and concomitant medications was unknown.  On 20-APR-2017, the patient was vaccinated with dose of zoster vaccine live (ZOSTAVAX) (dose number, strength, batch/lot# and expiration date were unknown) subcutaneously for prophylaxis (the indication was reported as vaccine).         The patient stated that zoster vaccine live (ZOSTAVAX) had given him major issues. On 20-APR-2017, the patient's initial symptoms were a welt or swelling on shoulder. On unknown dates, the patient experienced bad acne and immune system compromised. He felt he had not been right since. On unknown dates, he had had 2 instances where he was sick for 2 weeks or more, which was determined it was not corona virus disease (COVID) or the flu. On an unknown date (reported as recently), the patient's dormant cyst on his ear bursted. He had had many other health issues since having the vaccine as well. When he got labs and tests done, they all came back negative. He did not specify the labs and tests, he said there had been many. The patient had sought medical attention and was hospitalized on unknown dates due to the events. The patient received unspecified treatments for the events. The outcome of the events was reported as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered as related.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Malaise, SARS-CoV-2 test negative, Swelling, Urticaria
Clinical narrative: Bad acne; Immune system compromised; He has had 2 instances where he was sick for 2 weeks or more; He has had 2 instances where he was sick for 2 weeks or more; He had a cyst on his ear/but it recently burst; He has had many other health issues; welt or swelling on shoulder; welt or swelling on shoulder; This spontaneous report has been received from a consumer referring to himself, a 58 years old male patient. The patient's historical condition included a cyst on his ear since birth, which was dormant. Information regarding the patient's current condition and concomitant medications was unknown.  On 20-APR-2017, the patient was vaccinated with dose of zoster vaccine live (ZOSTAVAX) (dose number, strength, batch/lot# and expiration date were unknown) subcutaneously for prophylaxis (the indication was reported as vaccine).         The patient stated that zoster vaccine live (ZOSTAVAX) had given him major issues. On 20-APR-2017, the patient's initial symptoms were a welt or swelling on shoulder. On unknown dates, the patient experienced bad acne and immune system compromised. He felt he had not been right since. On unknown dates, he had had 2 instances where he was sick for 2 weeks or more, which was determined it was not corona virus disease (COVID) or the flu. On an unknown date (reported as recently), the patient's dormant cyst on his ear bursted. He had had many other health issues since having the vaccine as well. When he got labs and tests done, they all came back negative. He did not specify the labs and tests, he said there had been many. The patient had sought medical attention and was hospitalized on unknown dates due to the events. The patient received unspecified treatments for the events. The outcome of the events was reported as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was considered as related.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient involved has not reported any medical concerns regarding the administration; Medical Assistant calling to report an adverse event regarding an improperly stored and administered GARDASIL 9.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 15-SEP-2023, a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was exposed to a temperature excursion. On 18-SEP-2023, the patient was vaccinated with two or three dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, with lot number reported as 195740 and expiration date 05-OCT-2025, administered for prophylaxis (strength, route of administration and anatomical location were not provided) (incorrect product storage).  The patient did not have any medical concern regarding the administration of the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (no adverse event).
Sex: M
Vaccine: RVX
Symptoms: Malaise, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; contracted RSV (2nd time) after having the shot; ill for over 8 weeks now; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 87-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: contracted RSV (2nd time) after having the shot) and unwell (Verbatim: ill for over 8 weeks now). The patient was treated with guaifenesin;pseudoephedrine hydrochloride (Mucinex D). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection and unwell were not resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and unwell to be related to RSV vaccine.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection and unwell to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 17-FEB-2024 It was reported that patient had contracted Respiratory syncytial virus infection twice. The patient stated that he had taken all the shots available and had been ill for over 8 weeks now.  The patient stated that he was taking all the medication his primary physician had given him. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for RSV and laboratory confirmation regarding RSV were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Auricular swelling, Joint swelling, Peripheral swelling, Swelling
Clinical narrative: Swelling of the hands; Swelling of the joints; Swelling of the ear lobe; Swelling of the Neck; This non-serious case was reported by a other health professional via sales rep and described the occurrence of hand swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hand swelling (Verbatim: Swelling of the hands), swollen joints (Verbatim: Swelling of the joints), auricular swelling (Verbatim: Swelling of the ear lobe) and neck swelling (Verbatim: Swelling of the Neck). The outcome of the hand swelling, swollen joints, auricular swelling and neck swelling were not reported.   It was unknown if the reporter considered the hand swelling, swollen joints, auricular swelling and neck swelling to be related to Shingrix.     It was unknown if the company considered the hand swelling, swollen joints, auricular swelling and neck swelling to be related to Shingrix.   Additional Information: GSK receipt date: 14-FEB-2024 The reporter reported that the patient had received Shingrix vaccine and experienced swelling of the hands, joints, ear lobes and neck. The reporter did not consent to follow up.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, Immediate post-injection reaction, Regurgitation, Vaccine positive rechallenge
Clinical narrative: A second dose was given and the baby spit that dose out as well; A second dose was given and the baby spit that dose out as well; baby spit the dose out; baby spit the dose out; This non-serious case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number LN425, expiry date 13-OCT-2025) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number LN425, expiry date 13-OCT-2025) for prophylaxis.   On 13-FEB-2024, the patient received Rotarix lyophilized formulation. On 08-FEB-2024, the patient received the 1st dose of Rotarix lyophilized formulation. On 08-FEB-2024, not applicable after receiving Rotarix lyophilized formulation and immediately after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: baby spit the dose out) and accidental underdose (Verbatim: baby spit the dose out). On 13-FEB-2024, the patient experienced regurgitation of medication (Verbatim: A second dose was given and the baby spit that dose out as well) and accidental underdose (Verbatim: A second dose was given and the baby spit that dose out as well). Rechallenge with Rotarix lyophilized formulation was positive. The outcome of the regurgitation of medication and regurgitation of medication were not reported and the outcome of the accidental underdose and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device.   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: 14-FEB-2024  The nurse reported 2-month-old patient was administered a dose of Rotarix and the baby (patient) spit the dose out. A 2nd dose was given and the baby spit that dose out as well which led to accidental underdose and regurgitation of medication. This was the patients first of the Rotarix series. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: likely gave just the diluent for Priorix/there is one vial of powder with no diluent; likely gave just the diluent for Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: likely gave just the diluent for Priorix/there is one vial of powder with no diluent) and inappropriate dose of vaccine administered (Verbatim: likely gave just the diluent for Priorix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 14-FEB-2024 A nurse practitioner (NP) stated they had a vaccine clinic and had a woman working there who likely gave just the diluent for Priorix but they could not confirm/deny since no one knows for sure but could only assume.  They just know there was one vial of powder with no diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix was administered to a patient who is under the age of 10; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M7YY5, expiry date 08-DEC-2025) for prophylaxis.   On 12-FEB-2024, the patient received Boostrix. On 12-FEB-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix was administered to a patient who is under the age of 10). 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: 15-FEB-2024 Clinical coordinator reported that Boostrix was administered to a patient who was under the age of 10 year. The patient had not experienced any side effects. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The reporter reported that the below recommended age patient received the Boostrix vaccine, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: Vaccination failure/suspected vaccination failure; Breakthrough shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's disease.   On 25-FEB-2022, the patient received the 2nd dose of Shingrix. On 02-NOV-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Vaccination failure/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Breakthrough shingles). The patient was treated with acyclovir. 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-FEB-2024: The patient reported she received two doses of Shingrix vaccine and had had several breakthrough shingles cases. The patient was currently having shingles and she was taking acyclovir. The patient also had the history of crohns disease with infusions and she cannot get her infusions while she currently has shingles. This case was considered as suspected vaccination failure since the details regarding time to onset for shingles and laboratory confirmation of shingles disease were unknown at the time of reporting. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vision blurred
Clinical narrative: Report of blurred vision in one eye after 3rd dose; Report of progressively higher fevers after each dose of Moderna's COVID-19 vaccine (doses 1, 2 and 3); This spontaneous case was reported by an other health care professional and describes the occurrence of VISION BLURRED (Report of blurred vision in one eye after 3rd dose) and PYREXIA (Report of progressively higher fevers after each dose of Moderna's COVID-19 vaccine (doses 1, 2 and 3)) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Report of blurred vision in one eye after 3rd dose) and PYREXIA (Report of progressively higher fevers after each dose of Moderna's COVID-19 vaccine (doses 1, 2 and 3)). At the time of the report, VISION BLURRED (Report of blurred vision in one eye after 3rd dose) and PYREXIA (Report of progressively higher fevers after each dose of Moderna's COVID-19 vaccine (doses 1, 2 and 3)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 degree Fahrenheit.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  The patient's fever reached about 104-degree Fahrenheit after last dose (third dose).  Treatment information was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath; On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of COUGH (On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath) and DYSPNOEA (On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath) in a 69-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Non-smoker.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced COUGH (On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath) and DYSPNOEA (On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath). At the time of the report, COUGH (On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath) and DYSPNOEA (On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  On Oct-2023 patient developed a cough that turned into a big cough (2-minute cough) and then shortness of breath. Patient physician was trying to find out what was wrong with him. Since October patient had been having difficulty breathing and at one point at the very beginning it turned into a, a cough, a persistent cough, and they had been running all kinds of tests. He just got through going to a pulmonary doctor yesterday and right now nobody knows what was wrong with him. Patient had always been a healthy person. He was not a smoker but he had a difficulty breathing problem right now. He was trying to find a cure. Nobody knows what it is.  Treatment information was not provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lichen planus, Nasal congestion
Clinical narrative: Patient started experiencing hard bumps on his legs, torso, back and feet on 10-Oct-2021 and was diagnosed with Lichen planus in 2022; Patient also reported nasal congestion starting in 2021; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (Patient started experiencing hard bumps on his legs, torso, back and feet on 10-Oct-2021 and was diagnosed with Lichen planus in 2022) and NASAL CONGESTION (Patient also reported nasal congestion starting in 2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 030B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASAL CONGESTION (Patient also reported nasal congestion starting in 2021). In 2022, the patient experienced LICHEN PLANUS (Patient started experiencing hard bumps on his legs, torso, back and feet on 10-Oct-2021 and was diagnosed with Lichen planus in 2022). At the time of the report, LICHEN PLANUS (Patient started experiencing hard bumps on his legs, torso, back and feet on 10-Oct-2021 and was diagnosed with Lichen planus in 2022) and NASAL CONGESTION (Patient also reported nasal congestion starting in 2021) had not resolved.            No concomitant medication was reported.  No treatment information was reported.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Little transfer device on the medication is malfunctioned and it failed; Spilled out when they were about to mix it; Liquid in it just squirted all over the counter top like as if the little syringe was defective; This is a spontaneous report received from a Pharmacist, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9855, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "Little transfer device on the medication is malfunctioned and it failed; Spilled out when they were about to mix it"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown", described as "Liquid in it just squirted all over the counter top like as if the little syringe was defective".  Additional information: A pharmacist was calling regarding to the Abrysvo vial. The little transfer device on the medication was malfunctioned and it failed. It was reported that the pharmacist followed the standard process for Abrysvo and put that little connector cap on the top and then transfer the liquid in. When they went to transfer the liquid in, it just squirted all over the countertop as if the little syringe was defective. The little transfer device on the medication was malfunctioned and it failed. It was the only one in the box. Lot number and expiration date provided for tracking purposes. The pharmacist did not have the actual product because it was discarded into a sharp container as it was useless. Another functional vial was used to administered to patient.
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: chronic cough; This is a spontaneous report received from a Pharmacist.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary series, manufacturer unknown), for covid-19 immunisation. The following information was reported: COUGH (non-serious) with onset Dec2023, outcome "not recovered", described as "chronic cough". The event "chronic cough" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough. Additional information: Patient who is the son of the pharmacist who reported this, was a subject in one of the original vaccine trials. He received the 2023 booster and then has developed a chronic cough which has evaded diagnosis despite evaluation by urgent care, his PCP and Pulmonary medicine. Patient received treatment which were Antibiotics (albeit inappropriately).  Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Relevant past drug history Name of Drug as Reported:moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 at 10:00 as dose 1, single), in left arm, on 19Feb2021 at 10:00 as dose 2, single), in left arm, on 23Oct2021 at 10:00 as dose 3 (booster), single), in left arm, on 02Apr2022 at 10:00 as dose 4 (booster), single), in left arm, on 26Apr2023 at 09:00 as dose 6 (booster), single), in left arm and on 30Sep2023 at 11:00 as dose 7 (booster), single (Lot number: 30330368), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022 at 10:00, outcome "recovered", described as "Relevant past drug history Name of Drug as Reported:moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (Feb2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Negative, notes: testing negative for 4 days after finishing 5 days of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Feb2024 to 13Feb2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 at 13:00 as dose 1, single (Lot number: 3030536) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Known allergies: artificial sweeteners, protein whey powder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 12Oct2022, when the patient was 68-year-old, for COVID-19 Immunization; comirnaty (Batch/Lot No: FU49989, Location of injection: Arm Left), administration date: 26Apr2022, when the patient was 68-year-old, for COVID-19 Immunization; BNT162b2 (Batch/Lot No: FC3183, Location of injection: Arm Left), administration date: 12Oct2021, when the patient was 67-year-old, for COVID-19 Immunization; comirnaty (Batch/Lot No: ENU204, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 67-year-old, for COVID-19 Immunization; BNT162b2 (Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 26Feb2021, when the patient was 67-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment from 06Feb2024 to 08Feb2024).