chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Therapy non-responder
Clinical narrative: did not respond to pneumococcal polysacharide vaccination; This literature marketed report has been received from the authors of a published literature article, and refers to a  female patient of unknown age.   She had a history of recurrent strep throat in young childhood, but no other significant infections. At age 16 years, she was diagnosed with hypothyroidism with goiter and underwent total thyroidectomy with pathology noting significant lymphocytic infiltrate. She developed joint pains and fevers at age 32 years and was diagnosed with having seronegative rheumatoid arthritis. Trialed treatments included multiple immunemodulators including hydroxychloroquine, methotrexate, tumor necrosis factor inhibitors, andsteroids. She transitioned to abatacept with dramatic improvement in her joint pain and was tapered off steroids. During this time, she had moderate hypogammaglobulinemia in the setting of frequent upper respiratory infections.   She had heterozygous CTLA-4 mutation. Her son was diagnosed with inflammatory bowel disease. On an unknown date, the patient was vaccinated with an unspecified pneumococcal vaccine (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. She did not respond to the suspect vaccine. The outcome of the event was not provided. The authors of the article considered lack of response to the suspect therapy as related to pneumococcal vaccine. Lot # is being requested and will be submitted if received. This is one of 3 reports derived from the same literature article (linked GSD #2266119 and 2263700).
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Therapeutic response decreased
Clinical narrative: poor response to pneumococcal vaccination.; This literature marketed report has been received from the authors of a published literature article, and refers to a  female of unknown age with history of autoimmune thyroid disease presented with recurrent mucocutaneous candidiasis. She was diagnosed with having autoimmune thyroid disease at age 7 years and on thyroid replacement. She had 6 lifetime pneumonias that responded to antibiotics and was recently found to have bronchiectasis on computed tomography scan. Since age 5 years, she had recurrent mucocutaneous candidiasis treated with numerous courses of fluconazole. Her sister was diagnosed with having type 1 diabetes at age 12 years and had less severe mucocutaneous candidiasis. IgG, IgA, and IgM levels were normal. IgG2 level was low. She had STAT1 GOF mutation.  On an unknown date, the patient was vaccinated with an unspecified pneumococcal vaccine (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. She had a poor response to the suspect vaccine. The outcome of the event was not provided. The authors of the article considered poor response to the suspect therapy as related to pneumococcal vaccine. Lot # is being requested and will be submitted if received. This is one of 3 reports derived from the same literature article (linked GSD #2266118 and 2263700).
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report an TE in VAXNEUVANCE in which the vaccine was administered.; No other AE; This spontaneous invalid report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with a dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE )((lot #Y010032, expiration date: 17-FEB-2027, for prophylaxis) (exact dose, route of administration, and anatomical location were not reported)) that on an unknown date underwent temperature excursion (TE). Vaccine was stored in the temperature of 27.1 F for 1 hour and 21 minutes. No adverse event was reported.  This case is invalid due to unidentifiable patient.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site mass, Injection site swelling
Clinical narrative: Injection site lump; swollen at injection site; he felt light-headed and dizzy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 33fd3) for prophylaxis.   On 08-MAR-2025, the patient received Shingrix (intramuscular) .5 ml. On 08-MAR-2025, less than a day after receiving Shingrix, the patient experienced injection site lump (Verbatim: Injection site lump), injection site swelling (Verbatim: swollen at injection site) and light headedness (Verbatim: he felt light-headed and dizzy). The outcome of the injection site lump, injection site swelling and light headedness were unknown.   The reporter considered the injection site lump, injection site swelling and light headedness to be related to Shingrix.     The company considered the injection site lump, injection site swelling and light headedness to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2025 The healthcare professional was the reporter. The reporter stated she administered the first dose of Shingrix to a patient on 08th March 2025. The healthcare professional reported the consumer had a lump and swelling immediately at the injection site. Approximately 5 minutes post injection the patient stated he felt light-headed and dizzy. No further information was provided/obtained.; Sender's Comments:  US-GSK-US2025AMR029594:Same reporter/ different patient
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Somnolence
Clinical narrative: rash the size of a dime on her left arm; her first dose of SHINGRIX she was sleepy and her left arm was sore.; her first dose of SHINGRIX she was sleepy and her left arm was sore.; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-MAR-2025 16:56, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 07-MAR-2025, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: her first dose of SHINGRIX she was sleepy and her left arm was sore.) and pain in arm (Verbatim: her first dose of SHINGRIX she was sleepy and her left arm was sore.). On 08-MAR-2025, the patient experienced rash (Verbatim: rash the size of a dime on her left arm). The outcome of the rash was not resolved and the outcome of the sleepiness and pain in arm were unknown.   It was unknown if the reporter considered the rash, sleepiness and pain in arm to be related to Shingrix.     It was unknown if the company considered the rash, sleepiness and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2025 The consumer was the reporter. The patient had her first dose of Shingrix vaccine administered on 07th March 2025 at 4:56 pm in her left arm. The reporter stated the evening of 08th March 2025 she noticed a rash the size of a dime on her left arm. The reporter stated the rash was not located at the site of injection. Consumer states on the evening of 09th March 2025 the rash was the size of a lemon. The consumer stated on 10th March 2025, the rash remains the same size. The reporter stated the rash was not itchy, bothersome, or painful. The consumer stated after receiving her first dose of Shingrix she was sleepy and her left arm was sore. No other information was provided/obtained. This case has been linked to the US2025AMR029990 case reported by the same reporter.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I get firts dose april of 2024, and my second dose just now; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (recived 1st dose on April 2024).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I get firts dose april of 2024, and my second dose just now). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 11-MAR-2025 This case was reported by a patient via (Chat bot) interactive digital media. The patient recived  first dose April of 2024, and his/her second dose just now which led to, drug dose administration interval too long. The reporter had a question he/she need restart and get other shot.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the booster; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 5-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 2 doses on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: missed the booster). The outcome of the incomplete course of vaccination was not applicable.   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: 12-MAR-2025 This case was reported by a patient via (Bexsero GSK Cht bot) interactive digital media. The reporter reported that the patient had bexero vaccine when he was 19 months and 21months old, so two doses in total.  The reporter was ask did he need 3rd booster dose. Till the time of reporting, the patient did not receive 3rd dose of Bexsero, which led to incomplete course of vaccination.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 15-month-old patient received a dose of Kinrix on 28/Feb/2025.; Kinrix was the 3rd dose for each (DTap and IPV); 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 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Vaxelis (received 1st dose of Vaxelis in May 2024) and Vaxelis (received 2nd dose of Vaxelis in August 2024).   On 28-FEB-2025, the patient received the 3rd dose of Kinrix. On 28-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 15-month-old patient received a dose of Kinrix on 28/Feb/2025.) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was the 3rd dose for each (DTap and IPV)). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable.   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: 10-MAR-2025 On 10-Mar-2025 a reporter reported that vaccine was given prior to the recommended age.  Reporter mentioned that a 15-month-old patient received a dose of Kinrix on 28/Feb/2025.  Reporter also mentioned that patient received 2 prior doses of Vaxelis for their first 2 doses of DTaP and IPV, one in May and the other in August of 2024, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. Kinrix was the 3rd dose for each DTap and IPV.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Overdose; 2 year old female given Havrix 1440 adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 2-year-old female patient who received HAV (Havrix 1440 adult) for prophylaxis.   On 11-MAR-2025, the patient received the 1st dose of Havrix 1440 adult. On 11-MAR-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: 2 year old female given Havrix 1440 adult). The outcome of the overdose and adult product administered to child were not applicable.   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: 12-MAR-2025 The reporter reported that 2 year old female given Havrix 1440 EL.U/ml dose for 1st in Hepatitis A series on 11 MAR 2025 which led to Adult product administered to child and Overdose. They request to advise as pediatric patient received adult Havrix formulation. The vaccine administration facility was the same as primary reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face) in a 54-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced BELL'S PALSY (Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 4.0
Sex: F
Vaccine: YF
Symptoms: Inflammation, Pruritus
Clinical narrative: Inflammation and itchyness
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: pain and erythema at injection site. 100.3 F oral temperature 3/20/2025 fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Swollen arm red and tender to the touch, heat in arm
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Swollen and hot to touch, Tender
Age: 83.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not report any adverse reaction. Spikevax requires a beyond use date of 2 months when moving from  freezer to refrigerator. Expiration date was 06/16/2025 and beyond use date was 03/10/25. Patient received vaccination on 03/14/2025.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Menveo vaccine ordered by provider in error on a 10 year old child, the MA did not question the order and administered the vaccine. No medical reason for the child to receive the dose early.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not report any adverse reaction. Spikevax requires a beyond use date of 2 months when moving from  freezer to refrigerator. Expiration date was 06/16/2025 and beyond use date was 03/10/25. Patient received vaccination on 03/14/2025.
Age: 63.0
Sex: M
Vaccine: CHIK
Symptoms: Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever, Loss of Appetite, Fatigue
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB, PNC20, UNK
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Possible febrile seizures x2 in less than 24 hours
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Pain
Clinical narrative: Pt received vaccine and ~ 1 hr post, pt started to develop lightheadedness, aches, weakness, loss of appetite and dizziness. Over course of next 3 days to current time of this report, pt still has those symptoms now w/ developed diarrhea. Pt is non-ill appearing and in no distress at time of visit. Treated w/ Tylenol and Zofran w/ diet modification w/ f/u planned in 1 day.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC20
Symptoms: Rash
Clinical narrative: Presented to ER for evaluation on 3/20/2025 at 7:18 AM with report of "rash." Child was evaluated by the ER physician and received oral cetirizine and acetaminophen. Child was discharged in stable condition. Family presented to the office with child to report potential reaction to vaccinations. Reported the child had facial swelling upon awakening that morning, greater than 12 hours following vaccination administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed within 48hrs of administration. 5-6 inch diameter on RT.
Age: 11.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MMR was given instead of required Meningococcal vaccine. MMR was a third dose. Medical Director  was notified. No adverse reaction noted and no follow-up required.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given wrong vaccine, parent called to verify what was given, child has no adverse reaction from vaccine given
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pts mother describes red, hot to touch and hard area at site of vaccine injection.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site raised area of redness to left thigh noticed on 3/19/2025.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Has continued to feel weak and poor through the course of the week.  No nausea vomiting urinary symptoms cough.  It sounds like a week ago had a T-max of a 101° but nothing over the last several days.  She has right posterior arm pain at the injection site. Baseball size area of erythema posterior right proximal upper arm with tenderness and central firm area.  Appears consistent with mild cellulitis. Patient continues to be extremely tired, dizzy and doesn?t have an appetite. In addition, since last Thursday (03/13), she has had very painful spasms in her fingers on both hands. She describes it as having a Charlie horse in her fingers. At first it was at night, alternating hands. She has applied heat and uses a stress ball to try to stretch her fingers . Now it is happening during the day too. I have given her water w electrolytes and regular water. The spasms seem to last about a half hour- sometimes longer and lingers in the thumb for even longer.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Full blood count, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Has continued to feel weak and poor through the course of the week.  No nausea vomiting urinary symptoms cough.  It sounds like a week ago had a T-max of a 101° but nothing over the last several days.  She has right posterior arm pain at the injection site. Baseball size area of erythema posterior right proximal upper arm with tenderness and central firm area.  Appears consistent with mild cellulitis. Patient continues to be extremely tired, dizzy and doesn?t have an appetite. In addition, since last Thursday (03/13), she has had very painful spasms in her fingers on both hands. She describes it as having a Charlie horse in her fingers. At first it was at night, alternating hands. She has applied heat and uses a stress ball to try to stretch her fingers . Now it is happening during the day too. I have given her water w electrolytes and regular water. The spasms seem to last about a half hour- sometimes longer and lingers in the thumb for even longer.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Metabolic function test, Muscle spasms, Pain in extremity, Respiratory pathogen panel, SARS-CoV-2 test
Clinical narrative: Has continued to feel weak and poor through the course of the week.  No nausea vomiting urinary symptoms cough.  It sounds like a week ago had a T-max of a 101° but nothing over the last several days.  She has right posterior arm pain at the injection site. Baseball size area of erythema posterior right proximal upper arm with tenderness and central firm area.  Appears consistent with mild cellulitis. Patient continues to be extremely tired, dizzy and doesn?t have an appetite. In addition, since last Thursday (03/13), she has had very painful spasms in her fingers on both hands. She describes it as having a Charlie horse in her fingers. At first it was at night, alternating hands. She has applied heat and uses a stress ball to try to stretch her fingers . Now it is happening during the day too. I have given her water w electrolytes and regular water. The spasms seem to last about a half hour- sometimes longer and lingers in the thumb for even longer.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong vaccine given. Not age appropriate.  No adverse reactions.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies positive, Arthritis, Arthritis reactive, COVID-19, Dry eye
Clinical narrative: Following the J&J COVID vaccine, I developed arthritis in my hands and wrists. I saw several rheumatologists. It subsided after 7-8 months, but came back after a COVID infection in 2022, and again in 2023, and again in 2024. I have now had it since September 2024. I again saw rheumatologists in 2022, who confirmed that I have reactive arthritis. I also have strange new allergies including to the sun and raw fruits/vegetables/nuts, regular UTIs (7 in 2024), gastrointestinal issues, and other problems. I saw a dermatologist in February 2025 about two strange marks on my back, and after a few more questions, she tested me for Lupus, which I received a borderline positive result on. The Lupus symptoms started a few weeks after the J&J vaccine, and have continued.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Food allergy, Gastrointestinal disorder, Hypersensitivity, Photosensitivity reaction
Clinical narrative: Following the J&J COVID vaccine, I developed arthritis in my hands and wrists. I saw several rheumatologists. It subsided after 7-8 months, but came back after a COVID infection in 2022, and again in 2023, and again in 2024. I have now had it since September 2024. I again saw rheumatologists in 2022, who confirmed that I have reactive arthritis. I also have strange new allergies including to the sun and raw fruits/vegetables/nuts, regular UTIs (7 in 2024), gastrointestinal issues, and other problems. I saw a dermatologist in February 2025 about two strange marks on my back, and after a few more questions, she tested me for Lupus, which I received a borderline positive result on. The Lupus symptoms started a few weeks after the J&J vaccine, and have continued.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Sneezing, Urinary tract infection
Clinical narrative: Following the J&J COVID vaccine, I developed arthritis in my hands and wrists. I saw several rheumatologists. It subsided after 7-8 months, but came back after a COVID infection in 2022, and again in 2023, and again in 2024. I have now had it since September 2024. I again saw rheumatologists in 2022, who confirmed that I have reactive arthritis. I also have strange new allergies including to the sun and raw fruits/vegetables/nuts, regular UTIs (7 in 2024), gastrointestinal issues, and other problems. I saw a dermatologist in February 2025 about two strange marks on my back, and after a few more questions, she tested me for Lupus, which I received a borderline positive result on. The Lupus symptoms started a few weeks after the J&J vaccine, and have continued.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Our system showed the patient due for pneumonia shot so the pharmacist gave the shot Prevnar 20. Then we got an email from our corporate to review file for duplicate claim that's when we realized Patient already got Prevnar 20 last year in a span of less than a year. Patient experienced no side effects so far.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Hospice care, passed away
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received adult dose instead of peds dose of Vaqta Hep A vaccine. No reaction noted from incorrect dose.
Age: 70.0
Sex: M
Vaccine: HEPAB, PNC20, RSV
Symptoms: Asthenia, Fatigue, Impaired work ability, Mobility decreased, Somnolence
Clinical narrative: patient described severe fatique and weakness, not able to climb stairs or work in the yard for more than an hour and has to take frequent naps during the day.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change
Clinical narrative: One or two AM I was freezing, an hour later on my body got very hot. I took 2 tylenol which helped
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant gave Adult Hepatitis A  Vaccine (Vaqta) to patient instead of pediatric dose.
Age: 2.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Injection site mass
Clinical narrative: Patient's mother called to report a knot on her daughter's thigh after receiving vaccines. Mother noted it the morning of 3/20/25. She reported it to be the size of a quarter. Area did not seem tender based on her report. This provider counseled her over the phone about reasons to come into clinic.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cyanosis, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: Patient turn blue and unresponsive immediately after given the vaccines, vitals were taken and patient O2sats was 100% so no oxygen was administered. ,patient was observed here in the office for about 45 mins and checked multiple times by the Doctor.
Age: 0.75
Sex: F
Vaccine: RV5, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Rotavirus oral vaccine after the recommended age. At this time no symptoms.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event didn't realized she had already had arevxy 9/2023 so this was outside CDC recommendation
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given the contents of the Pfizer Covid vaccine for ages 6 mos through < 5 years.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: skin reaction - erythema, warmth, itching
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Periorbital swelling
Clinical narrative: Patient with periorbital swelling, upper lip swelling within 1 hour of taking Influenza Vaccine and Zofran
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Neck pain
Clinical narrative: 3-4 hours after administration bruising appeared at the site of administration that worsened over the next 72 hours. Patient experienced shoulder pain that spread into the neck and caused extreme discomfort. Patient did not seek evaluation as she thought the symptoms were normal following vaccine administration.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ, TDAP, TDAP
Symptoms: Feeling jittery, Headache, Loss of consciousness
Clinical narrative: Patient experienced unconscicousness after TDAP and MCV4 immunization vaccination. Around 10-15 seconds. Patient awaken and able to walk to nurses office to recover. C/O headache and feeling jittery. Pupils PERRLA. No injury to patient noted from losing consciousness.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Left Arm Pain that developed following day, aching pain with tingling and burning that radiated into the neck. Patient still having aching pain as of 3/20/25 when he presented to my medical office for evaluation.
Age: 15.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse event described. Given too Soon. Vaccine Error.
Age: 28.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: I gave an expired vaccine. exp 03/04/25 todays date 03/20/25
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: erythema, intermittent localized rash for 8 weeks
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: severe right shoulder and arm pain.  Due to the severity of the pain and shoulder movement limitations patient was sent to the emergency room for further evaluation and treatment
Age: 1.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Provider had ordered for patient to receive the MMR vaccine and was given the meningococcal vaccine
Age: 86.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Joint contracture, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: pain in right arm and hand started end of Oct 2024.  Was seen by doctor in December 2024 after trying to self treat with warm packs, cold, etc.  Hand curls up at night and difficult to open up the next morning.  Lost use of right hand, can't even open soda pop cans anymore like she use to. Doctor told her likely caused by covid vaccine. Had doctor visit March 18 and has another appt in April.
Age: 13.0
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events/side events reported. This was given off schedule and was already given full series of PCV13.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Condition aggravated, Haematoma, Joint effusion, Limb injury
Clinical narrative: Patient was seen in office on 10/21/2024. He received an influenza vaccine in right deltoid. Patient's pharmacy also administered Shingrix and RSV vaccine the same day. Patient followed up in office on 12/17/2024 with complaints of right upper extremity pain and swelling. Diagnosed with hematoma. Patient suffered with pain of right upper extremity due to hematoma X many months resulting in multiple Drs office trips, and ED visit, and MRI of right shoulder. MRI of right shoulder revealed advanced arthritic changes of the AC joint and glenohumeral joint with large joint effusion. There is complete tear of the supraspinatus and infraspinatus tendon compatible with superior rotator cuff tear. Tendonitis of the subscapularis and coracohumeral narrowing. Patient seen ortho on 3/4/25. Patient states that he was told that the hematoma caused from the vaccine has aggravated an old injury in his right shoulder and now he may suffer with chronic LROM and pain in right shoulder.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Pain in extremity, Peripheral swelling, Rotator cuff syndrome
Clinical narrative: Patient was seen in office on 10/21/2024. He received an influenza vaccine in right deltoid. Patient's pharmacy also administered Shingrix and RSV vaccine the same day. Patient followed up in office on 12/17/2024 with complaints of right upper extremity pain and swelling. Diagnosed with hematoma. Patient suffered with pain of right upper extremity due to hematoma X many months resulting in multiple Drs office trips, and ED visit, and MRI of right shoulder. MRI of right shoulder revealed advanced arthritic changes of the AC joint and glenohumeral joint with large joint effusion. There is complete tear of the supraspinatus and infraspinatus tendon compatible with superior rotator cuff tear. Tendonitis of the subscapularis and coracohumeral narrowing. Patient seen ortho on 3/4/25. Patient states that he was told that the hematoma caused from the vaccine has aggravated an old injury in his right shoulder and now he may suffer with chronic LROM and pain in right shoulder.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Tendon rupture, Tendonitis
Clinical narrative: Patient was seen in office on 10/21/2024. He received an influenza vaccine in right deltoid. Patient's pharmacy also administered Shingrix and RSV vaccine the same day. Patient followed up in office on 12/17/2024 with complaints of right upper extremity pain and swelling. Diagnosed with hematoma. Patient suffered with pain of right upper extremity due to hematoma X many months resulting in multiple Drs office trips, and ED visit, and MRI of right shoulder. MRI of right shoulder revealed advanced arthritic changes of the AC joint and glenohumeral joint with large joint effusion. There is complete tear of the supraspinatus and infraspinatus tendon compatible with superior rotator cuff tear. Tendonitis of the subscapularis and coracohumeral narrowing. Patient seen ortho on 3/4/25. Patient states that he was told that the hematoma caused from the vaccine has aggravated an old injury in his right shoulder and now he may suffer with chronic LROM and pain in right shoulder.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration
Clinical narrative: The vaccine was inadvertently given subcutaneously instead of intramuscularly, as labeled by the manufacturer, by a pharmacy intern. The patient was quickly notified (within 5 minutes of vaccination) and administration site looked over by myself, as the pharmacist on staff. I confirmed the vaccine was not given in the deltoid and went over potential adverse effects with the patient (injection site reaction, pain at injection site), how to manage effects, and when to follow up with a physician. I contacted the manufacturer to clarify if a repeat dose needs to be administered and am awaiting reply.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension
Clinical narrative: The day after pt received her vaccination she had an appointment with her Primary Care Provider and at her appointment her blood pressure was very low for her.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Patient had mucousy, bloody stool later that day
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 83-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2024, outcome "unknown" and all described as "Tested positive for COVID-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2024) Positive; (Jul2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  This case is for the child's (reporter) father. The patient's child tested positive for COVID-19 and was staying at the parents' and all three of them have tested positive. They did two tests each. So, the patient's child tested the patient that morning (14Jul2024), and his child and his wife all three of them have it. Now the patient and his wife, they're 82 and 85 and the child doesn't want to have to take them to get re-tested, but all three of them were positive. The child guessed the reason why they haven't gotten it like extremely bad (they were pretty sick), but the service was like a week ago, and guessed it's probably been hanging on to it. But just recently, the patient started feeling really out of sorts on 11Jul2024 and luckily, they all have been taking Pfizer vaccine even up until the last available one. And they've all taken them and so the child was wondering. The patient and his wife have doctors, and the child will call them and asked if they could call in a prescription for the patient and his wife. Both the patient and his wife take quite a few medications. With the patient's age, the child was concerned too and guessed that it's best that they got it now because they've been vaccinated. They've been taking the Pfizer Vaccination from day one, and then they were all up to date. The child thinks the last time they got vaccinated was maybe 3 or 4 months ago (2024), they got the final most recent one. They were all vaccinated up, child guessed on the third or the fourth kind, the new when Pfizer kept coming out with the next one for the next strain, they would go and get it so that's obviously what's helped them to be functioning. The child was told that an aunt and her husband went into nirmatrelvir/ritonavir (PAXLOVID) and so the child trying to figure out what to do for him/herself, the patient, and patient's husband to get them on it as quickly as possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500058182 Same Vaccine/AE, Diff Pt;US-PFIZER INC-PV202500031906 Same Vaccine/AE, Diff Pt;
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site cellulitis, Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before; rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before; diagnosed with cellulitis; Significant pain started in left arm <5 hours after shot; rash was red/on arm approximately 2cm below the injection site; Initial information received on 15-Mar-2025 regarding an unsolicited valid  non-serious case received from a consumer/ Non-Healthcare Professional.  This case involves a 16 years old female patient who was diagnosed with cellulitis after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history included Pharyngitis streptococcal on 14-FEB-2025. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 13-Mar-2025, the patient received an unknown dose of Bexsero not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported) via unknown route in the left arm and received a  dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date- unknown and lot U8369AA) via intramuscular route in the left arm for Routine vaccination (Immunization).   On 13-Mar-2025 the patient developed a significant pain started in left arm <5 hours after shot (pain) (latency- approximately few hours) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On 14-Mar-2025 the patient was diagnosed with cellulitis (cellulitis) (latency- 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On 15-Mar-2025 the patient developed rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before (rash) (condition aggravated) (latency- 2 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On an unknown date in MAR-2025 the patient developed rash was red/on arm approximately 2cm below the injection site (rash erythematous) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero.  Reportedly, Pain continued on 16-MAR-2025. Touching/bumping arm caused significantly more pain. Rash, that was swollen, pink, and hot to the touch noted on arm around 8pm approximately 2cm below the injection site.  Circle drawn around the rash. Oral cephalexin prescribed  Action taken was not applicable.  The patient was treated with IBUPROFEN (ADVIL 12 HOUR), NAPROXEN and PARACETAMOL (TYLENOL) for Symptomatic treatment.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive, Pyrexia, Vaccination failure
Clinical narrative: flu; patient went to the emergency room last night around midnight with a 106F fever,; Patient received a Sanofi flu shot, and it did not work; Initial information received on 17-Mar-2025 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's mother).  This case involves an unknown age male patient who received influenza vaccine flu shot, and it did not work and experienced flu.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date In September 2024, the patient received an unknown  dose of suspect  influenza vaccine, produced by unknown manufacturer, unknown formulation, Strength: standard, frequency: once, lot number not reported via unknown route in unknown administration site for Influenza (vaccination failure) (latency:same day).  On 17-Mar-2025 the patient developed flu (influenza) and went to the emergency room last night around midnight with a 106f fever, (pyrexia) (latency: 6 months approximately) following the administration of influenza vaccine .  Relevant laboratory test results included: Body temperature - On 17-March-2025: 106 F Influenza virus test - On 17-March-2025:  [tested positive for flu]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (influenza) (pyrexia)  At time of reporting, the outcome was Unknown for the events (influenza) (pyrexia)  Seriousness criteria: Medically significant for the event (vaccination failure); Sender's Comments: Sanofi company comment dated 19-Mar-2025:: This case involves an unknown age male patient who received influenza vaccine flu shot, and it did not work and experienced flu. Further information regarding allergic history, medical history, concomitant medication, any history of exposure to flu;  are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ACT-HIB was administrated with a different diluent (sterile water), with no adverse event; Initial information received on 17-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to:- US-SA-2025SA079793.   This case involves a 1 years old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] with a different diluent (sterile water), with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 14-Mar-2025, the patient received a 0.5ml dose 3 of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK093AB and expiry 30-Sep-2025) standard strength, frequency-once via intramuscular route in the left vastus lateralis for immunization with a different diluent (sterile water), with no adverse event (product preparation error) (latency-same day).  Reportedly-Nurse called to get information about reconstituting ACTHIB with a different diluent (sterile water), which was administered to 2 patients.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA079793:02451344
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inbound call from HCP asking about continuing GARDASIL 9 series after the 3rd dose is late. 1st dose 11/14/2019, 2nd dose 7/8/2020 (see request case 02761318). No adverse effects were reported. Unknown Lots and Expiration dates. Caller did not provid; No adverse effects were reported; This spontaneous report was received from a pharmacist and refers to a current 18-year-old female patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 14-NOV-2019, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (strength, exact dose, route of administration, anatomical location, lot #, and expiration date were not reported). Then on 08-JUL-2020, the patient received the second dose of the suspect vaccine (as described above). Both administered as prophylaxis. Therefore, the third dose was late (inappropriate schedule of vaccine administered).  No adverse effects were reported (no adverse event).
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: VFC immunization coordinator calling to report T/E for VAQTA that was administered.; This spontaneous report has been received from a nurse concerns a unspecified age and gender patient. There was no information about medical history, current conditions and concomitant medications.   On 03-MAR-2025, the patient was vaccinated with an improper storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) suspension for injection, 2nd dose, lot number Y008483 (who had been verified to be a valid number, expiration date reported and validated as 26-NOV-2025) (exact dose, and anatomical route of administration were not provided). It was reported that the excursion occurred with a temperature of 32.0F with a time frame of 2 hours 12 minutes 0 seconds and there was no information about previous temperature excursion (product storage error).