chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blepharitis, Dermatitis contact, Eye pain, Eye pruritus
Clinical narrative: It was around May or June of 2022 I had symptoms related to my eyes. My eyes would get itchy, and I would rub them and rub them and by the next morning they would be very swollen. I was initially diagnosed with blepharitis but this continued on and off for months so the more research I did, I eventually recognized my symptoms to be dermatitis. I went to a dermatologist who diagnosed me with  contact dermatitis. She said it was due to an allergen I was coming in contact with.  She advised I could do allergy testing but it was costly and they do not do it. She reported that allergy testing also doesn't test for everything so I could do all the testing and riving back and forth and could still end up not knowing the cause of my symptoms. Therefore, I just had to change my make-up, personal care items, laundry detergent, cleaning products, not wear jewlery, and not use any air fresheners. My dermatologist said it could be a metal allergy, fragrance allergy, or from preservatives in make-up and personal care products. This has NEVER been an issue for me, and it turned my entire life upside down having to change everything. Not to mention the absolute pain and discomfort from my eyes swelling up.  I have also recently started losing my hair as of 1/2024.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling
Clinical narrative: It was around May or June of 2022 I had symptoms related to my eyes. My eyes would get itchy, and I would rub them and rub them and by the next morning they would be very swollen. I was initially diagnosed with blepharitis but this continued on and off for months so the more research I did, I eventually recognized my symptoms to be dermatitis. I went to a dermatologist who diagnosed me with  contact dermatitis. She said it was due to an allergen I was coming in contact with.  She advised I could do allergy testing but it was costly and they do not do it. She reported that allergy testing also doesn't test for everything so I could do all the testing and riving back and forth and could still end up not knowing the cause of my symptoms. Therefore, I just had to change my make-up, personal care items, laundry detergent, cleaning products, not wear jewlery, and not use any air fresheners. My dermatologist said it could be a metal allergy, fragrance allergy, or from preservatives in make-up and personal care products. This has NEVER been an issue for me, and it turned my entire life upside down having to change everything. Not to mention the absolute pain and discomfort from my eyes swelling up.  I have also recently started losing my hair as of 1/2024.
Age: 89.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC20
Symptoms: Seizure, Wrong product administered
Clinical narrative: Patient came in  for A flu and a Prevnar 20 vaccine. Both were entered for the patient.  The patient was accidently administered the COVID-19 vaccine. Patient continue to receive the flu and covid vaccine but had had a seizure about 5 minutes after receiving the vaccine.  According to patient the receive the Civid-vaccine in 2021 and had a seizure. EMS was contacted and patient was rushed to the hospital.
Age: 63.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient has scheduled for Monkey pox # 2 on 09/11/24. The nurse has counted the wrong days and given vaccine to patient a week too early. Patient has no reaction, signs, or symptoms.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Dyskinesia, Feeling hot, Limb discomfort, Paraesthesia
Clinical narrative: Involuntary moment in left hand, pain in left shoulder, left leg was heavy, pain was described as warm pen needles.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Dyskinesia, General physical condition abnormal, Head titubation
Clinical narrative: Patient received Daptacel, PedVax, and IPOL at 2 months without any complications. This was his first time receiving them together via Pentacel. He was sleeping in his car seat and woke up when I brought him inside. He looked dazed and his head started jerking. The head shaking passed within a few minutes but he continued to seem out of it for the next thirty minutes or so.
Age: 37.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Headache, body aches, fever, chills, general unwell feeling began roughly 12 hours after vaccinations.  Increased fluid intake, took ibuprofen, and went to bed early. Symptoms persisted on day 2 but were not as severe. By day 3 symptoms had mostly resolved.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: PATIENT BECAME LIGHTHEADED A FEW MINUTES AFTER THE VACCINES WERE ADMINISTERED AND SHE BECAME PALE. PATIENT DID NOT LOSE CONSCIOUSNESS.  AFTER IMMEDIATELY BEING PLACED IN A SUPINE POSITION, PATIENT STATED LIGHTHEADED SYMPTOMS WERE BETTER AND RESOLVED WITIHIN LESSS THAN 5 MINUTES.  BP STABILIZED AT 90'S/60'S AND PULSE IN LOW 80'S. PATIENT WAS DISCHARGED HOME TO MOTHER AT 8:50 A.M. WITH POST VACCINATION PRECAUTIONS AND INSTRUCTIONS.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient had high fever, along with vomiting. I followed up with the patient about 24 hours later and he said he was feeling much better and had no fever. He took tylenol and slept most of the day.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Paraesthesia oral
Clinical narrative: I had slight dizziness and tingling around lips for about 10 minutes and shortness of breath for about 30 seconds. I did take benadryl with complete relief
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cellulitis
Clinical narrative: patient reported celluitis
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient stated heat to injection site, redness and swelling down arm.  rash to elbow.   Patient applied ice to site and took tylenol.   Pharmacist suggested taking benadryl and calling doctor.  doctor sent out triamcinolone 0.5% cream to be applied twice daily to affected area.
Age: 1.25
Sex: M
Vaccine: PNC20
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: During administration of vaccine, patient moved, needle came out and approximately half of the vaccine went onto the table
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash, Pruritus
Clinical narrative: PT PRESENTS ON 9/11/24 WITH A RASH ON HIS LEFT DELTOID. RASH PRESENTED ITSELF ON SUNDAY 9/8/24, MOC GAVE BENDRYL AND ON 9/10/24 RASH ENLARGED IN SIZE. SIDE EFFECTS INCULDE ITCHINESS.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4, PNC13
Symptoms: Feeling abnormal, Injection site erythema, Injection site haemorrhage, Lethargy, Peripheral swelling
Clinical narrative: First, I felt a little funny. Went to work the next day I wear sleeves so I didn?t think about it until I took the bandages off like a few hours later so I wasn?t bleeding anymore. And throughout the night, my arm has a redness at the injection site and it has swollen up considerably. I mean, obviously there?s an adverse reaction my arm is swollen, and I have a fever and lethargy
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4, PNC13
Symptoms: Pyrexia
Clinical narrative: First, I felt a little funny. Went to work the next day I wear sleeves so I didn?t think about it until I took the bandages off like a few hours later so I wasn?t bleeding anymore. And throughout the night, my arm has a redness at the injection site and it has swollen up considerably. I mean, obviously there?s an adverse reaction my arm is swollen, and I have a fever and lethargy
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Loss of consciousness, Malaise, Presyncope
Clinical narrative: patient had a vasovagal reaction and passed out. We evaluated the patient for 20 minutes before she started feeling better
Age: 60.0
Sex: F
Vaccine: COVID19, DTAP, FLUR4
Symptoms: Eye discharge, Eye swelling, Eyelid disorder, Induration, Vision blurred
Clinical narrative: Left eye swollen and bottom eyelid is hard and stiff.  Blurry vision during the dY, discharge from my eye occurs when I sleep
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Penile erythema
Clinical narrative: Penile redness and swelling few hours after vaccine administration. Resolved after 2 days with hydrocortisone application
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Pain, Pain in extremity, Pruritus, Rash macular
Clinical narrative: It was almost immediately following the 2nd dose of this covid 19 vaccine, I received a horrible pain radiating in my hip all the way down my leg on the side of the shot.  My skin was BURNING - very hot to the touch, it felt as if I was on fire - and it turned a grayish blue color with a lot of hyperpigmentation, almost black.  It was painful and itchy.  The healthcare professionals at work with me in the nursing home all agreed it seemed to be a result of the vaccination - and assumed it would fade or go away over time.  I used over the counter products such as lotions, blemish removers, vitamins, hyaluronic acid, anti itch ointments, etc.  The hyperpigmentation was also present on my face, my hairline, my neck, and up and down both of my arms and hands.  I was itchy all over my body.  I had never had any concerns or issues with my skin previously so this was all new.  I used sunscreens, and lotions.  It was very dark, splotchy and awfully itchy.   The pain in my hip took a few weeks to reside, and eventually that did.  This was not a pain I have ever previously experienced.  The itchy splotchy skin was horrible and consistent, It remains today.   My scalp itches constantly also.  I have even tried antihistamine's such as Benedryl to alleviate the itching and hydrocortisone, but they do not touch the itch or offer any relief.  Nothing I have used on my own has eliminated these symptoms at all.  I made an appointment 8/30 with a dermatologist because I am not able to get relief or to deal with the ugly skin that is splotchy and leper like.    I was prescribed a powerful product to place on the affected area to treat that I am currently trying.  A short few days since that prescription was given, it has not appeared to accomplish anything.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin burning sensation, Skin hyperpigmentation, Skin warm
Clinical narrative: It was almost immediately following the 2nd dose of this covid 19 vaccine, I received a horrible pain radiating in my hip all the way down my leg on the side of the shot.  My skin was BURNING - very hot to the touch, it felt as if I was on fire - and it turned a grayish blue color with a lot of hyperpigmentation, almost black.  It was painful and itchy.  The healthcare professionals at work with me in the nursing home all agreed it seemed to be a result of the vaccination - and assumed it would fade or go away over time.  I used over the counter products such as lotions, blemish removers, vitamins, hyaluronic acid, anti itch ointments, etc.  The hyperpigmentation was also present on my face, my hairline, my neck, and up and down both of my arms and hands.  I was itchy all over my body.  I had never had any concerns or issues with my skin previously so this was all new.  I used sunscreens, and lotions.  It was very dark, splotchy and awfully itchy.   The pain in my hip took a few weeks to reside, and eventually that did.  This was not a pain I have ever previously experienced.  The itchy splotchy skin was horrible and consistent, It remains today.   My scalp itches constantly also.  I have even tried antihistamine's such as Benedryl to alleviate the itching and hydrocortisone, but they do not touch the itch or offer any relief.  Nothing I have used on my own has eliminated these symptoms at all.  I made an appointment 8/30 with a dermatologist because I am not able to get relief or to deal with the ugly skin that is splotchy and leper like.    I was prescribed a powerful product to place on the affected area to treat that I am currently trying.  A short few days since that prescription was given, it has not appeared to accomplish anything.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional AE; nurse gave patient a dose of PROQUAD & VARIVAX on the same day; This spontaneous report was received from a registered nurse and refers to a 17-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 13-JUN-2004, the patient was vaccinated by another nurse with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, and with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, for prophylaxis (strength, exact dose, lot #, expiry date, route of administration and anatomical site of vaccination  were not provided for both vaccines) (Overdose). No additional adverse event (AE) (no adverse event) was reported.
Age: 37.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; received their first GARDASIL 9 shot one year ago and received a second one today; This spontaneous report was received from a pharmacist and refers to a 38-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On an unknown date in August 2023 (reported as one year ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis.   On 30-AUG-2024 (also reported as today), the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration), because the patient did not realize it was a series. There was no adverse event reported.  Lot # is being requested and will be submitted if received.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received her 1st dose on Oct 12 2018 at age 14. She received her 2nd dose on 8/31/24.; This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant mediations was provided.  On 12-OCT-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 31-AUG-2024, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). The patient asked if she needed the third dose of vaccine (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of MMR-II after a temperature excursion. Vaccine was administered on 03SEP2024 to a patient. Limited patient demographics provided. No additional AE/PQC.    ?    Names of vaccines involved (including; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 03-SEP-2024, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # X026222 and expiration date 06-NOV-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lasted for 7 hours in temperature of 64 Fahrenheit degrees. No previous excursion were noted (product storage error). No additional adverse event reported (no adverse event).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; but still got the disease that lasted for months; was in misery; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: but still got the disease that lasted for months) and feeling miserable (Verbatim: was in misery). The outcome of the vaccination failure and feeling miserable were not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and feeling miserable to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2024 The case was received from the patient's wife via interactive digital media. The patient had the two Shingrix shots but still got the disease that lasted for months. The patient was in misery. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(1 and 2 dose).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: dose one of Shingrix series (LOT Y77XY Exp: August 21,, 2024) was given to a female patient today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number Y77XY, expiry date 21-AUG-2024) for prophylaxis.   On 03-SEP-2024, the patient received the 1st dose of Shingrix. On 03-SEP-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: dose one of Shingrix series (LOT Y77XY Exp: August 21,, 2024) was given to a female patient today). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-SEP-2024 The other health professional reported that expired dose one of Shingrix series was given to a female patient on the day of reporting which led to expired vaccine used. The other health professional reported there were no reactions, everything went fine, the patient had been notified, and there were no concerns. No further details available.
Sex: M
Vaccine: RVX
Symptoms: Fatigue, Headache, Illness, Nausea, Tinnitus
Clinical narrative: sick; fatigue; headaches; ear pounding; nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a elderly 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 sickness (Verbatim: sick), fatigue (Verbatim: fatigue), headache (Verbatim: headaches), ear noises (Verbatim: ear pounding) and nausea (Verbatim: nausea). The outcome of the sickness, fatigue, headache, ear noises and nausea were not reported.   It was unknown if the reporter considered the sickness, fatigue, headache, ear noises and nausea to be related to RSV vaccine.     It was unknown if the company considered the sickness, fatigue, headache, ear noises and nausea to be related to RSV vaccine.   Additional Information: GSK receipt date: 01-SEP-2024 This case was reported by a patient via (social media) interactive digital media. The patient wife reported that the her husband and she had received RSV vaccine and experienced sick, intense fatigue, headaches ear pounding and nausea. The reporter mentioned that they was 76 and 80s. The reporter mentioned it was terrible more responsible research must be initiated. This case had been link with US2024AMR110356, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR110347:Original Case : US2024AMR110347 US-GSK-US2024AMR110356:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient doesn't want the second dose; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient doesn't want the second dose). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK Receipt Date: 01-SEP-2024 The pharmacist reported that the provider requested data on efficacy of Shingrix after only one dose, the patient did not want the second dose. Also ask what was the guidance regarding second dose of Shingrix if patient develops shingles after first dose. No further information was provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Overdose; Maladministration of booster adult dose to a pediatric patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 3-year-old male patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 31-AUG-2024, the patient received Havrix adult. On 31-AUG-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: Maladministration of booster adult dose to a pediatric patient). The outcome of the overdose was not reported and the outcome of the adult product administered to child 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: 03-SEP-2024 The pharmacist called to report a pediatric patient received a booster adult dose of Havrix, which led to overdose and child use of adult product. Pharmacist wanted to know if there was any Safety Information of advise that the pharmacist could mention to the patient´s parents.  Vaccination date and detail, as well as patient demographics obtained and registered in sections above.  No further information was provided from the pharmacist in this call. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration to a 4 month old patient; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 03-SEP-2024, the patient received Kinrix. On 03-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to a 4 month old patient). 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: 03-SEP-2024 The other health professional reported that, they had a medication error with the Kinrix vaccine, it was given to a patient that was to young for it which led to inappropriate age at vaccine administration.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient was administered the Engerix pediatric vaccine; adult patient was administered the Engerix pediatric vaccine instead of the adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 31-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient was administered the Engerix pediatric vaccine) and adult use of a child product (Verbatim: adult patient was administered the Engerix pediatric vaccine instead of the adult). The outcome of the underdose and adult use of a child product were not reported.   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: 05-SEP-2024 The healthcare professional (HCP) reported that an adult patient was administered the Engerix B pediatric vaccine instead of the adult version, which led to underdose and adult use of a child product.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: aches, chills and fever for 18-24 hours; aches, chills and fever for 18-24 hours; aches, chills and fever for 18-24 hours; experienced a sore arm for 3 days with both vaccines; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches, chills and fever for 18-24 hours), PAIN IN EXTREMITY (experienced a sore arm for 3 days with both vaccines), CHILLS (aches, chills and fever for 18-24 hours) and PYREXIA (aches, chills and fever for 18-24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]), ATORVASTATIN, OMEGA-3 [OMEGA-3 NOS], CALCIUM CITRATE, ASCORBIC ACID, THIAMINE HYDROCHLORIDE (VITAMIN B AND C COMPLEX), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), UBIDECARENONE (CO Q10) and VITAMIN D3 for an unknown indication.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches, chills and fever for 18-24 hours), PAIN IN EXTREMITY (experienced a sore arm for 3 days with both vaccines), CHILLS (aches, chills and fever for 18-24 hours) and PYREXIA (aches, chills and fever for 18-24 hours). At the time of the report, PAIN (aches, chills and fever for 18-24 hours), PAIN IN EXTREMITY (experienced a sore arm for 3 days with both vaccines), CHILLS (aches, chills and fever for 18-24 hours) and PYREXIA (aches, chills and fever for 18-24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included Dophilus EPS. Patient had no drug allergy. Patient received steroid injections in her Sacroiliac (SI) joints. Patient took Pfizer vaccine for the first time on 01-Sep-2024 at 10 P.M with batch number Lm2215 to left arm. On the same day, the patient received flu vaccine with batch number UT8437AA to left arm. On 03-Sep-2024, patient had fatigue, aches, chills, fever, vomiting and headache which had lasted 3 days so far.  No treatment medication was reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle fatigue, Nausea, Pyrexia
Clinical narrative: Low Grade Fever; Mild Nausea; Muscle fatigue; Overall fatigue; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low Grade Fever), NAUSEA (Mild Nausea), MUSCLE FATIGUE (Muscle fatigue) and FATIGUE (Overall fatigue) in a 25-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 01-Sep-2024, the patient experienced PYREXIA (Low Grade Fever), NAUSEA (Mild Nausea), MUSCLE FATIGUE (Muscle fatigue) and FATIGUE (Overall fatigue). At the time of the report, PYREXIA (Low Grade Fever), NAUSEA (Mild Nausea), MUSCLE FATIGUE (Muscle fatigue) and FATIGUE (Overall fatigue) was resolving.            Concomitant medication was not provided. Treatment information was not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Musculoskeletal stiffness, Oral herpes, Pruritus
Clinical narrative: cold sore yesterday (3rd day after administration) on her left upper lip; systemic itching; erythema/redness; slowness and hardness of the fist; fatigued; rash; pain at injection site; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (erythema/redness), PRURITUS (systemic itching), ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip), MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist) and FATIGUE (fatigued) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042646) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Visual discomfort. Concurrent medical conditions included Asthma and Allergy.    On 05-Sep-2024 at 5:10 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 05-Sep-2024, the patient experienced ERYTHEMA (erythema/redness), MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist), FATIGUE (fatigued), RASH (rash) and VACCINATION SITE PAIN (pain at injection site). On 06-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PRURITUS (systemic itching). On 08-Sep-2024, the patient experienced ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 07-Sep-2024, PRURITUS (systemic itching) had resolved. At the time of the report, ERYTHEMA (erythema/redness), ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip) and FATIGUE (fatigued) had not resolved, MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist) outcome was unknown, RASH (rash) was resolving and VACCINATION SITE PAIN (pain at injection site) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter considered ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip) to be related. No further causality assessments were provided for ERYTHEMA (erythema/redness), PRURITUS (systemic itching), MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist), FATIGUE (fatigued), RASH (rash) and VACCINATION SITE PAIN (pain at injection site).    No concomitant medication was reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that on 09-Sept was the first day she did not take any Benadryl every 4 hours. She stated that what was different for her this time, is that she never had any rash or anything systemic (except fatigue) in the past (with previous vaccines).   This case was linked to US-MODERNATX, INC.-MOD-2024-773524 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: cold sore yesterday (3rd day after administration) on her left upper lip; systemic itching; erythema/redness; slowness and hardness of the fist; fatigued; rash; pain at injection site; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (erythema/redness), PRURITUS (systemic itching), ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip), MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist) and FATIGUE (fatigued) in a 62-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042646) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Visual discomfort. Concurrent medical conditions included Asthma and Allergy.    On 05-Sep-2024 at 5:10 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 05-Sep-2024, the patient experienced ERYTHEMA (erythema/redness), MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist), FATIGUE (fatigued), RASH (rash) and VACCINATION SITE PAIN (pain at injection site). On 06-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PRURITUS (systemic itching). On 08-Sep-2024, the patient experienced ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 07-Sep-2024, PRURITUS (systemic itching) had resolved. At the time of the report, ERYTHEMA (erythema/redness), ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip) and FATIGUE (fatigued) had not resolved, MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist) outcome was unknown, RASH (rash) was resolving and VACCINATION SITE PAIN (pain at injection site) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter considered ORAL HERPES (cold sore yesterday (3rd day after administration) on her left upper lip) to be related. No further causality assessments were provided for ERYTHEMA (erythema/redness), PRURITUS (systemic itching), MUSCULOSKELETAL STIFFNESS (slowness and hardness of the fist), FATIGUE (fatigued), RASH (rash) and VACCINATION SITE PAIN (pain at injection site).    No concomitant medication was reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that on 09-Sept was the first day she did not take any Benadryl every 4 hours. She stated that what was different for her this time, is that she never had any rash or anything systemic (except fatigue) in the past (with previous vaccines).   This case was linked to US-MODERNATX, INC.-MOD-2024-773524 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: right arm swell down to her elbow; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (right arm swell down to her elbow) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced PERIPHERAL SWELLING (right arm swell down to her elbow). At the time of the report, PERIPHERAL SWELLING (right arm swell down to her elbow) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect vaccine dosage text was reported as unknown. Patient asked if she could still get covid vaccine shot even if there was an incident happened last year around September-October 2023. The right arm swelled down to her elbow for couple of weeks after taking the covid vaccine. Also asked if she was protected against covid since she got couple of shots from Moderna. Reporter causality was not reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: One vial was cracked; reporter received the product broken; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 28Aug2024, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician from product quality group. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Apr2024 as dose 1, single (Lot number: HM7010) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "One vial was cracked; reporter received the product broken". Additional information: The reporter reported of a damaged COVID-19 vial (later clarified as Comirnaty; as reported). It was cracked and they want to, I don't know that you will do a replacement. Like the nurse didn't tell the office that there was one that was cracked. The reporter was wanting to know how to return it for credit. The reporter then clarified that they received a broken product. The sample was available for return.   The reporter considered "one vial was cracked; reporter received the product broken" not related to BNT162b2 omi xbb.1.5. Causality for "one vial was cracked; reporter received the product broken" was determined associated to device constituent of BNT162b2 omi xbb.1.5 (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Nausea
Clinical narrative: Redness; Nausea; Diarrhea; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic to polysorbate" (unspecified if ongoing); "GI system problems" (unspecified if ongoing), notes: polysorbate gives patient GI system problems. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster), Single), for COVID-19 Immunization; Bnt162b2 (Dose 4 (Booster), Single), for COVID-19 Immunization; Bnt162b2 (Dose 5 (Booster), Single), for COVID-19 Immunization; Bnt162b2 (Dose 6 (Booster), Single), for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; NAUSEA (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  Additional information: Patient reported that she had reactions to the Pfizer COVID vaccine previously. Patient called about an adverse reaction for the Pfizer COVID vaccine which caller already reported as redness, nausea, and diarrhea. She was allergic to polysorbate and experienced reactions such as redness, nausea and diarrhea. Patient had a total of seven Pfizer COVID vaccines, has all of those on the card. Patient had initially called in because was allergic to polysorbate, so patient wanted to validate if polysorbate was in the vaccine as a filler. When patient called in about the polysorbate, the answer she got was petty, if one person says the information was unknown, and then next person says no, patient was kind of weary to believe. Patient initially had really called to find out about polysorbate, polysorbate gives her GI system problems, so wanted to know if polysorbate was in vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Area at injection site (on left arm) is swollen; Area at injection site (on left arm) is red; Area at injection site (on left arm) is sore if touched firmly; Covid arm/1st time to have rash; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Aug2024 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy (unknown drug)" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunization; Comirnaty nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Comirnaty nos (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Comirnaty nos (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Comirnaty nos (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 29Aug2024 at 08:00, outcome "recovering", described as "Area at injection site (on left arm) is red"; VACCINATION SITE PAIN (non-serious) with onset 29Aug2024 at 08:00, outcome "recovering", described as "Area at injection site (on left arm) is sore if touched firmly"; VACCINATION SITE SWELLING (non-serious) with onset 29Aug2024 at 08:00, outcome "recovering", described as "Area at injection site (on left arm) is swollen"; VACCINATION SITE RASH (non-serious) with onset 29Aug2024 at 08:00, outcome "recovering", described as "Covid arm/1st time to have rash". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site rash.  Additional information: Location of suspect vaccine was left upper arm. Reported Event: "Covid arm". Had received 6 prior doses Pfizer Covid vaccine/boosters. This was the 1st time to have rash or swelling. Noticed today, 30Aug2024, area at injection site (on left arm) was swollen, red and sore if touched firmly. The area was not itchy. There was no loss of arm function and no need for antihistamine or pain med. No known allergies. Facility where vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines on the same date as the suspect vaccine(s), the patient did not receive any other vaccines within 4 weeks prior to the suspect vaccine(s) and the patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site joint movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: limited mobility near injection site; Extreme injection site soreness; swelling near injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 26-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 26 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Drug Allergy" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Nov2023. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Aug2024 at 18:00, outcome "recovering", described as "Extreme injection site soreness"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) with onset 30Aug2024 at 18:00, outcome "recovering", described as "limited mobility near injection site"; VACCINATION SITE SWELLING (non-serious) with onset 30Aug2024 at 18:00, outcome "recovering", described as "swelling near injection site". Therapeutic measures were not taken as a result of vaccination site joint movement impairment, vaccination site pain, vaccination site swelling.  Additional Information: The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine. Yes, the patient taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: limited mobility near injection site; Extreme injection site soreness; swelling near injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 26-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 26 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Drug Allergy" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Nov2023. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Aug2024 at 18:00, outcome "recovering", described as "Extreme injection site soreness"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) with onset 30Aug2024 at 18:00, outcome "recovering", described as "limited mobility near injection site"; VACCINATION SITE SWELLING (non-serious) with onset 30Aug2024 at 18:00, outcome "recovering", described as "swelling near injection site". Therapeutic measures were not taken as a result of vaccination site joint movement impairment, vaccination site pain, vaccination site swelling.  Additional Information: The patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine. Yes, the patient taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.