chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient states that 1 week after vaccination, shingrix vaccine is swollen, red/inflamed, and painful with reaction radiating down to elbow
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Skin warm, Swelling, X-ray
Clinical narrative: Swelling, red, heat in arm 5-6 days after injection. 3-4 weeks after injection,  severe joint pain in feet, knees,  some fingers, and left elbow.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Sleep disorder
Clinical narrative: Sore shoulder for over 10 days - waking up in middle of the night, can't comfortably raise left arm more than shoulder height. Pain started after vaccine administration, slowly getting better.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal distension, Arthralgia, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Joint pain, fever, scratchy throat, swelling of joints, fingers and feet and face., nausea
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling face, Throat irritation
Clinical narrative: Joint pain, fever, scratchy throat, swelling of joints, fingers and feet and face., nausea
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Oral mucosal eruption, Oral pain, Rash
Clinical narrative: Patient was in to receive her 2nd shingles dose on 6/4/25. Called pharmacy on 6/7/25 to report an itchy rash on certain parts of her body that started the day after the vaccine. She is reporting allergic type, itchy rash on back of right neck, lower back and left side of mouth. She is also reporting that the roof of her mouth is sore and has to consume soft, non-spicy, non-acidic type foods. She also is reporting 2 bumps a few inches below the injection site that are not painful. she has not had any difficulty breathing, has been using ice and taking benadryl.  Patient did not have any reactions to dose 1 of the series
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient was in to receive her 2nd shingles dose on 6/4/25. Called pharmacy on 6/7/25 to report an itchy rash on certain parts of her body that started the day after the vaccine. She is reporting allergic type, itchy rash on back of right neck, lower back and left side of mouth. She is also reporting that the roof of her mouth is sore and has to consume soft, non-spicy, non-acidic type foods. She also is reporting 2 bumps a few inches below the injection site that are not painful. she has not had any difficulty breathing, has been using ice and taking benadryl.  Patient did not have any reactions to dose 1 of the series
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: fever of 103 9 days after shot. for over 24 hours, Motrin didn't take it down so we had to give Tylenol too
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac disorder
Clinical narrative: paracardia-micardia
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: DUPLICATE VACCINE. PATIENT RECEIVED BOOSTRIX 07/25/2024
Age: 50.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Confusional state, Euphoric mood, Hand-eye coordination impaired, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: After receiving PCV21 and Shingrix at the same time, starting later that day or next day - felt 'loopy' and confused for 3 days - panicky, disassociating, dropping things, poor hand-eye coordination - needed help being fed.
Age: 50.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Panic reaction
Clinical narrative: After receiving PCV21 and Shingrix at the same time, starting later that day or next day - felt 'loopy' and confused for 3 days - panicky, disassociating, dropping things, poor hand-eye coordination - needed help being fed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Patient reported redness, swelling, and bruising at the injection site. Symptoms started the day after receiving the injection. Injection site was still swollen and red 4 days later.  Injection site was not warm to the touch or looked very irritated when seen today.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: slight swelling, redness on the injection site. But patient has blistering rash on both arms. She said the day she got the shot, she started having fever and chills from about 8pm that day
Age: 70.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient reported severe arm/shoulder pain that prompted a visit to the emergency room.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Localized erythema, induration, increased warmth, and pruritus. No medical intervention.
Age: 43.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Syncope
Clinical narrative: Patient had a syncope episode after receiving the vaccines. Patient 911 was contacted and the patient was transported to the hospital.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Neck pain, Pain, Paralysis, Peripheral coldness
Clinical narrative: Paralysis in neck, sharp shooting pains in neck, aches all over body. Saw chiropractor, didn't help, couldn't get into doctors. Couldn't get in hospital for treatment be. Eventually regained movement. Severe pain lasted 48 hrs. Slowly reduced in severity over a period of several months. A month or so later, developed Reynauds disease, causing severe cold feelings in toes and fingers when room temperature dropped below about 72 degrees, also developed severed arthritis like pain in knees, hips, ankles. It's hard to know if this is from the TDAP/Shingles Vaccine combination, or the COVID vaccines I had the previous month.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Raynaud's phenomenon
Clinical narrative: Paralysis in neck, sharp shooting pains in neck, aches all over body. Saw chiropractor, didn't help, couldn't get into doctors. Couldn't get in hospital for treatment be. Eventually regained movement. Severe pain lasted 48 hrs. Slowly reduced in severity over a period of several months. A month or so later, developed Reynauds disease, causing severe cold feelings in toes and fingers when room temperature dropped below about 72 degrees, also developed severed arthritis like pain in knees, hips, ankles. It's hard to know if this is from the TDAP/Shingles Vaccine combination, or the COVID vaccines I had the previous month.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness vertigo
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle injury, Neck pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Shortly after vaccine administration, patient began experiencing severe upper arm, neck and back pain on a scale of 8 out of 10. Pharmacist (redacted name) confirmed administration was too high up on arm and probably adversely impacted either deltoid muscle or bone. Patient saw PCP on 05/23/2025 and again on 06/12/2025 to discuss ongoing severe pain. PCP also confirmed injury was either to deltoid muscle or bone due to improper vaccine administration too high up on arm. Vaccine site was 2 fingers below top of shoulder. Pain continues at level 8 out of 10.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Skeletal injury
Clinical narrative: Shortly after vaccine administration, patient began experiencing severe upper arm, neck and back pain on a scale of 8 out of 10. Pharmacist (redacted name) confirmed administration was too high up on arm and probably adversely impacted either deltoid muscle or bone. Patient saw PCP on 05/23/2025 and again on 06/12/2025 to discuss ongoing severe pain. PCP also confirmed injury was either to deltoid muscle or bone due to improper vaccine administration too high up on arm. Vaccine site was 2 fingers below top of shoulder. Pain continues at level 8 out of 10.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: progressively worsening/intensifying skin sensitivity to visible light
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: none reported
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain at site of injection following administeration, erythyma at injection site 24 hours post administration with continued growth in circumference 4 days post administeration -- site of erythma without reduction in size to date
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Balance disorder, Condition aggravated, Eye infection, Facial pain, Fall
Clinical narrative: Sick; Got fluid in both ears; I cannot even hardly stand up and my equilibrium is gone; I cannot even hardly stand up and my equilibrium is gone; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GW7965) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; EAR DISORDER (non-serious), outcome "unknown", described as "Got fluid in both ears"; DYSSTASIA (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "I cannot even hardly stand up and my equilibrium is gone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, ear disorder, dysstasia, balance disorder.   Additional information: The patient was so sick, cannot even hardly stand up and her equilibrium was gone and  have got fluid in both ears. The patient was given Azithromycin and Meclizine.
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Fatigue, Headache, Laboratory test, Pain, Sinusitis
Clinical narrative: Sick; Got fluid in both ears; I cannot even hardly stand up and my equilibrium is gone; I cannot even hardly stand up and my equilibrium is gone; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GW7965) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; EAR DISORDER (non-serious), outcome "unknown", described as "Got fluid in both ears"; DYSSTASIA (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "I cannot even hardly stand up and my equilibrium is gone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, ear disorder, dysstasia, balance disorder.   Additional information: The patient was so sick, cannot even hardly stand up and her equilibrium was gone and  have got fluid in both ears. The patient was given Azithromycin and Meclizine.
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Balance disorder, Dysstasia, Laboratory test, Malaise, Middle ear effusion
Clinical narrative: Sick; Got fluid in both ears; I cannot even hardly stand up and my equilibrium is gone; I cannot even hardly stand up and my equilibrium is gone; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GW7965) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; EAR DISORDER (non-serious), outcome "unknown", described as "Got fluid in both ears"; DYSSTASIA (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "I cannot even hardly stand up and my equilibrium is gone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, ear disorder, dysstasia, balance disorder.   Additional information: The patient was so sick, cannot even hardly stand up and her equilibrium was gone and  have got fluid in both ears. The patient was given Azithromycin and Meclizine.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: Patient visited MD diagnosed cellulitis, received abx prescription and pain medication.  Patient states flu like symptoms also.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: Patient visited MD diagnosed cellulitis, received abx prescription and pain medication.  Patient states flu like symptoms also.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Influenza like illness, Injection site erythema, Pain
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: Patient visited MD diagnosed cellulitis, received abx prescription and pain medication.  Patient states flu like symptoms also.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: Patient visited MD diagnosed cellulitis, received abx prescription and pain medication.  Patient states flu like symptoms also.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported.; HCP reported a lot of PROQUAD was administered on 23MAY2025 after the product experienced a temperature excursion on 19MAY2025.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-MAY-2025, a temperature excursion occurred at a temperature of 10.5 Fahrenheit during a time frame of 1 hour. On 23-May-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL, lot #Y010930; which has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported and upon internal validation establish as 14-DEC-2025 and with the sterile diluent (BAXTER STERILE DILUENT) 0.5 mL, lot #1950636; which has been verified to be valid, expiration date reported and upon internal validation establish as 22-JAN-2026, 0.5 mL, both administered for prophylaxis (dose number, vaccination site scheme, route and anatomical site of administration were not provided) (Product storage error). No previous temperature excursion. No symptoms reported (No adverse event).
Vaccine: MEN
Symptoms: Extra dose administered
Clinical narrative: Patient given a 3rd dose of meningococcal by mistake last week, with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non healthcare professional).  This case involves a patient with unknown age and gender patient who was given a 3rd dose of Meningococcal Vaccine by mistake last week, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (dose 3) of suspect Meningococcal Vaccine produced by unknown manufacturer (lot number, expiry date and formulation not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and received 3rd dose by mistake last week, with no reported adverse event (inappropriate schedule of product administration) (latency same day).   Reportedly, they did speak with the dad a few days ago and did report it and as per him. patient was feeling fine. Was there anything I need to do.  Action taken was not applicable.  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.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMRV, VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Extreme swelling and redness of arm. Started Saturday. Increasingly got worse.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Craniofacial fracture, Fracture reduction, Syncope
Clinical narrative: The patient was sitting on the patient table/bed for the vaccine, as per protocol for pediatric patients for the nurse to get a good landmark of the upper arm to administer the vaccine. Vasovagal syncope occurred  seconds (within the minute) after the vaccine was administered. The exact time reported under patient information may not be accurate, but it was definitely within the minute after the vaccine was administered. The patient fell off the patient table/bed after the vasovagal syncope and broke his nose. He quickly regained conscious after the fall. He had visits with the ENT doctor and required "closed reduction of nasal fracture" on 6/18/24. The patient did not return to our clinic after the vaccine, so I am not aware of any longterm outcomes.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Genital herpes, Stomatitis
Clinical narrative: Extreme fatigue and malaise began 05/10/25 and is ongoing.  Mouth sores from 06/01/25 to 06/07/25.  Multiple outbreaks of genital herpes continuously without a day's break from 05/25 to 06/08/25 and ongoing.  Outbreaks were in 5 different locations.  I have had herpes for 50 years and this is the worst continuous outbreak since my very first one 50 years ago.
Age: 27.0
Vaccine: RAB
Symptoms: Malocclusion, Off label use
Clinical narrative: intentional off label prescription by hcp: imovax is prescribed with off label diagnosis open bite of unspecified upper arm, initial encounter with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 27 years old and unknown gender patient was prescribed IPV (Vero) [movax] with off label diagnosis open bite of unspecified upper arm, initial encounter with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was prescribed 1ML dose of suspect IPV (Vero) (once) Powder for Solution for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for open bite of unspecified upper arm, initial encounter [bite] (off label use).  Information regarding batch number corresponding to the one at time of event occurrence was requested.  Reportedly, Imovax was prescribed with off label diagnosis code S41.159A Open bite of unspecified upper arm.  Action taken was not applicable.  No follow-up is possible as Reporter cannot be contacted by Sanofi
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Heart rate decreased, Pallor, Vertigo
Clinical narrative: Low HR-42 O2-100% BP 86/52 - 5 min post vaccine admin. Pallor Vertigo
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Customer called and reported that a dose of VAXTA expired on 5/11/2025 and was administered on 5/15/2025. No temperature excursions through date of administration. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from an Other health professional and refers to a male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (lot #X026485, expiration date: 11-May-2025) 1 mL for prophylaxis (Expired product administered). There were no temperature excursions through date of administration. No additional AE was reported (No adverse event).
Sex: F
Vaccine: PNC21
Symptoms: Headache, Mobility decreased
Clinical narrative: immobility; Merk Employee calling on behalf of HCP to report an AE for CAPVAXIVE.  HCP reported that the their pharmacy administered a dose of CAPVAXIVE, and following the administration, the patient developed a "severe headache and immobility." HCP also reporte; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered intramuscularly (IM) (lot # and expiration date were not reported) for Streptococcus pneumoniae prophylaxis.  On an unknown date in May 2025 (reported as sometime last weekend), following the administration, the patient developed a severe headache and immobility. HCP also reported that the patient had to be taken to the emergency room following the administration. No other symptoms or side effects were reported. The outcome of the events was not reported.  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.    Upon internal review, the event of immobility was determined to be medically significant.  Lot# is being requested and will be submitted if received.
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE; administration of expired VARIVAX to a patient; Information has been received from Business Partner/CRO on 06-Jun-2025.  This spontaneous report was received from a/an Physician Assistant and refers to a(n) patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 06-Jun-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #X011424, expiration date: 19-Apr-2025). On 06-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of prophylaxis.  On 06-Jun-2025, the patient experienced administration of expired VARIVAX to a patient. On an unknown date, the patient experienced No additional AE.   At the reporting time, the outcome of administration of expired VARIVAX to a patient and No additional AE was unknown.   The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  Patient had a problem with the vaccine. Patient never had the Pfizer vaccine but had Moderna. Patient was asking about Paxlovid, medication taken after COVID.  No treatment medication was reported.   Reporter did not allow further contact
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: PER DOCUMENTATION OF REPORTER, THE INCORRECT VACCINE  WAS O RDERED AND WAS ADMINISTERED TO PATIENT. WERE NOTIFIED OF MISTAKE.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect vaccine given. No immediate adverse reaction or symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Paraesthesia, Urticaria
Clinical narrative: About an hour or so after vaccination, I felt burning stings on my left shoulder, down my trunk left side and then across my back.  It was an experience similar to being bitten by fire ants.  Large welts came up like insect bites across all those referenced sites.  I removed clothing and showered in case it was insects.  Needle prick sensation and welts continued for about 90 minutes.  I took 2 antihistamine tablets and some tylenol which helped.  2 days later, those welts are still visible and remain a little itchy.  Antihistamines continue to help.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Blood test, Pneumonia
Clinical narrative: Vaccinated on 4/24/2025 - diagnosis with pneumonia on 5/26/2025 - hospital stay from 5/25/25 until 6/6/25.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: right arm redness, warmth, swelling on 6/8/25, mild intermittent pain right upper arm, tender and stiff,   treatment: ice back on/off, can take ibuprofen or tylenol, follow up in 4-5 days is needed
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine- patient reports no issues
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Blood glucose, Brief resolved unexplained event, Electrocardiogram, Febrile convulsion, Laboratory test
Clinical narrative: Patient seen in the ER after presumed febrile seizure and BRUE on 6/5/25.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Abdominal distension, Injection site erythema, Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: Large swelling at injection site. Redness and hot to touch. Day 2 swelling was size of golf ball and very tender. Day three swelling was the size of an orange and redness had spread around the shoulder to midway to elbow. Today 6/9/25 swelling down to size of a quarter and still red. Also sight of injection has scabs around injection sight.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth
Clinical narrative: Large swelling at injection site. Redness and hot to touch. Day 2 swelling was size of golf ball and very tender. Day three swelling was the size of an orange and redness had spread around the shoulder to midway to elbow. Today 6/9/25 swelling down to size of a quarter and still red. Also sight of injection has scabs around injection sight.
Age: 51.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: BEGAN HAVING REDNESS AND SWELLING AT SHOT SITE THAT BEGAN TO GET VERY HOT AND SWELL TO PAST HER ELBOW DESPITE ICE PACKS, BENADRYL AND OTHER COMFORT MEASURES.  NOW CLAIMS TO HAVE SWELLING AND TIGHTNESS TO HER RIGHT JAW.  CALLED HER PCP TODAY AND AM AWAITING A CALL BACK FOR FURTHER TREATMENT DECISIONS
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Night sweats
Clinical narrative: Patient started to notice her skin felt hot, and also was sore. She kept a long sleeve shirt on and didnt think much about it. She stated on sunday am she put a short sleeve shirt on. That is when she discovered a red, raised, hot to the touch rash on the same arm the vaccine was given. It was under the injection site. it went down 4 inches and was 2.5 inches wide, located medial to inner arm. When she woke up the night after the vaccine she did experience night sweats, and felt fatigue with a sore arm.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Given the diluent without the actual medication mixed, no adverse reaction
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Confusional state, Dizziness, Headache, Lethargy, Myalgia
Clinical narrative: Headache, dizziness, muscle aches, confusion, lethargic
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Fall, Flushing, Head injury, Headache
Clinical narrative: Patient had possible seizure activity after vaccine administration. The incident happened after patient exited the room. She fell and hit the floor.  Medic was called right away. Patient believed to have hit her head, but unwitnessed fall. Immediately patient began moving arms and legs in a rhythmic motion with nystamus. Patient positioned onto her side and patient placed on heart rate and spo2 monitor. SP02 at 100, but heart rate decreased to low 50-60s. Patient had convulsion like movements lasting approximately 2 minutes. During this time, patient SP02 remained 100 but heart rate decreased to 50-60s bpm. At end of two minutes, patient stopped making repetitive movements and patient began trying to get up and saying her head hurt. Patient was diaphoretic with flushed cheeks. We kept patient on floor and continued watching her movements and VS. Blood glucose taken during event and it was 104mg/DL. During this time patient was able to answer where she was, her name, she stuck out her tongue, pupils were equal, round,and reactive, patient wiggled fingers and toes. Upon arrival of medic, report given then when they attempted to place cervical collar on patient, she projectile vomited. Once collar was secured, patient placed on stretcher and given versed by medic. Last VS taken in office SP02 99% and HR 62. Mom left with medic for Transporation to Hospital
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Heart rate decreased, Hyperhidrosis, Nystagmus, Seizure, Subdural haematoma
Clinical narrative: Patient had possible seizure activity after vaccine administration. The incident happened after patient exited the room. She fell and hit the floor.  Medic was called right away. Patient believed to have hit her head, but unwitnessed fall. Immediately patient began moving arms and legs in a rhythmic motion with nystamus. Patient positioned onto her side and patient placed on heart rate and spo2 monitor. SP02 at 100, but heart rate decreased to low 50-60s. Patient had convulsion like movements lasting approximately 2 minutes. During this time, patient SP02 remained 100 but heart rate decreased to 50-60s bpm. At end of two minutes, patient stopped making repetitive movements and patient began trying to get up and saying her head hurt. Patient was diaphoretic with flushed cheeks. We kept patient on floor and continued watching her movements and VS. Blood glucose taken during event and it was 104mg/DL. During this time patient was able to answer where she was, her name, she stuck out her tongue, pupils were equal, round,and reactive, patient wiggled fingers and toes. Upon arrival of medic, report given then when they attempted to place cervical collar on patient, she projectile vomited. Once collar was secured, patient placed on stretcher and given versed by medic. Last VS taken in office SP02 99% and HR 62. Mom left with medic for Transporation to Hospital
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Subdural haematoma evacuation, Vomiting projectile
Clinical narrative: Patient had possible seizure activity after vaccine administration. The incident happened after patient exited the room. She fell and hit the floor.  Medic was called right away. Patient believed to have hit her head, but unwitnessed fall. Immediately patient began moving arms and legs in a rhythmic motion with nystamus. Patient positioned onto her side and patient placed on heart rate and spo2 monitor. SP02 at 100, but heart rate decreased to low 50-60s. Patient had convulsion like movements lasting approximately 2 minutes. During this time, patient SP02 remained 100 but heart rate decreased to 50-60s bpm. At end of two minutes, patient stopped making repetitive movements and patient began trying to get up and saying her head hurt. Patient was diaphoretic with flushed cheeks. We kept patient on floor and continued watching her movements and VS. Blood glucose taken during event and it was 104mg/DL. During this time patient was able to answer where she was, her name, she stuck out her tongue, pupils were equal, round,and reactive, patient wiggled fingers and toes. Upon arrival of medic, report given then when they attempted to place cervical collar on patient, she projectile vomited. Once collar was secured, patient placed on stretcher and given versed by medic. Last VS taken in office SP02 99% and HR 62. Mom left with medic for Transporation to Hospital
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Ultrasound scan, Vomiting
Clinical narrative: Pt started vomiting 05/30/2025. Diagnosed with intussusception on 05/31/2025 at ER
Age: 5.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: PATIENT WAS SUPPOSED TO  RECEIVE THEIR DTAP AND IPV VACCINE. PATIENT WAS ACCIDENTALLY GIVE TDAP AND MCV4 VACCINE INSTEAD.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Dyspnoea, Feeling cold, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Body cold, fever in head, pale skin, injection area was swollen, temperature 103 at hospital, blood pressure 240BPM, panting, redness and swelling at the injection site, screaming in pain at times and moaning and lethargic at other times, vomiting.  At hospital his vitals were checked, they administered a tylenol suppository then motrin to reduce the fever, fever broke shortly after being breast fed
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Moaning, Pain, Pallor, Pyrexia, Screaming
Clinical narrative: Body cold, fever in head, pale skin, injection area was swollen, temperature 103 at hospital, blood pressure 240BPM, panting, redness and swelling at the injection site, screaming in pain at times and moaning and lethargic at other times, vomiting.  At hospital his vitals were checked, they administered a tylenol suppository then motrin to reduce the fever, fever broke shortly after being breast fed
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: Body cold, fever in head, pale skin, injection area was swollen, temperature 103 at hospital, blood pressure 240BPM, panting, redness and swelling at the injection site, screaming in pain at times and moaning and lethargic at other times, vomiting.  At hospital his vitals were checked, they administered a tylenol suppository then motrin to reduce the fever, fever broke shortly after being breast fed
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke august 2021 and december 2021
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient arm was red on sunday and went to urgent care. They thought it was possibly cellulitis and gave her an antibiotic.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Burning sensation, Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Significant left arm pain and numbness. S/P Meningitis B vaccine 5 days ago.  Exquisite pain to palpation. Radial distribution neuropathy with burning, numbness, and tingling. Cold compress and tylenol without improvement -  r/o post vaccine rhabdo
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Significant left arm pain and numbness. S/P Meningitis B vaccine 5 days ago.  Exquisite pain to palpation. Radial distribution neuropathy with burning, numbness, and tingling. Cold compress and tylenol without improvement -  r/o post vaccine rhabdo
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient came in for Hep B vaccine was signed out and review by other medical staff, under dosage error was not capture until it was being documented, proper medical staff was made aware on the incident, patient was notified, patient verbalized understanding the error that had accrued and understood that she was not in any harm base on her labs results.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, TDAP
Symptoms: Syncope
Clinical narrative: Pt waited 15 minutes, pt experienced a syncope episode while giving the vaccines, pt was given a juice. Pt monitored for 15 minutes,  Pt had no reaction after that. Pt and guardians informed to hold off remaining vaccines for another day in-clinic. Pt guardians stated that pt has a hx of syncope with blood draws after syncope episode occurred and  after consent was given. Vaccine verified by LPN.
Age: 1.25
Sex: M
Vaccine: EBZR
Symptoms: Feeling hot, Hypophagia, Influenza A virus test negative, Influenza B virus test negative, Injection site erythema
Clinical narrative: Parents noted fussiness a few hours after the vaccine was given on 6/4/2025. Patient was fussy. He felt warm and had a temp 102-104  by temporal thermometer. Patient got a bath and Motrin. His right thigh was red and swollen and tender the evening of 6/4/25. On 6/5/2025 Patient was seen in our office at approximately 3:30pm and patient was walking, had decreased po intake that day, no rash and seemed to be improving.  Site coloration was bluish-red; minimally tender over of 2cmx1cm on right lateral thigh with central 1-mm diameter scab. This overlies firm muscle of about 4x3cm. He has FROM and walked well. No bleeding, no other rash. Parent did take patient to the ER on 6/5/2025 approximately 9pm for complaint of a fever. ER gave Acetaminophen  and patient responded and was discharged.
Age: 1.25
Sex: M
Vaccine: EBZR
Symptoms: Injection site pain, Injection site scab, Irritability, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Parents noted fussiness a few hours after the vaccine was given on 6/4/2025. Patient was fussy. He felt warm and had a temp 102-104  by temporal thermometer. Patient got a bath and Motrin. His right thigh was red and swollen and tender the evening of 6/4/25. On 6/5/2025 Patient was seen in our office at approximately 3:30pm and patient was walking, had decreased po intake that day, no rash and seemed to be improving.  Site coloration was bluish-red; minimally tender over of 2cmx1cm on right lateral thigh with central 1-mm diameter scab. This overlies firm muscle of about 4x3cm. He has FROM and walked well. No bleeding, no other rash. Parent did take patient to the ER on 6/5/2025 approximately 9pm for complaint of a fever. ER gave Acetaminophen  and patient responded and was discharged.
Age: 1.25
Sex: M
Vaccine: EBZR
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Parents noted fussiness a few hours after the vaccine was given on 6/4/2025. Patient was fussy. He felt warm and had a temp 102-104  by temporal thermometer. Patient got a bath and Motrin. His right thigh was red and swollen and tender the evening of 6/4/25. On 6/5/2025 Patient was seen in our office at approximately 3:30pm and patient was walking, had decreased po intake that day, no rash and seemed to be improving.  Site coloration was bluish-red; minimally tender over of 2cmx1cm on right lateral thigh with central 1-mm diameter scab. This overlies firm muscle of about 4x3cm. He has FROM and walked well. No bleeding, no other rash. Parent did take patient to the ER on 6/5/2025 approximately 9pm for complaint of a fever. ER gave Acetaminophen  and patient responded and was discharged.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Limb injury
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Additional Details: Patient stated she gets tired after receiving vaccines at times bit was not specific as to which
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Condition aggravated, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: COVID-19/Asthma Flare-Severe, Additional Details: Patient had COVID-19 and an Asthma Flare which required steroids and antibiotics
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Systemic: Patient says she always gets sick every time she gets a COVID vaccine. Patient did not elaborate on symptoms.-Medium, Additional Details: Patient says she always gets sick every time she gets a COVID vaccine. Patient did not elaborate on symptoms.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient stated that every time he has gotten a covid vaccination he has experienced soreness at the site of injection that has resolved in a few days. He indicated that the intensity and duration has decreased with every vaccine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Systemic: Fever-Mild, Additional Details: Patient stated that after his 1st dose of the shingrix, he felt like he had the flu for 1 day
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: AE reported by wife. Reported fever, feeling miserable, achiness, and flu-like feeling for 24 hours after vaccine and then resolved
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Systemic: Headache-Severe, Additional Details: Patient says she has a prior history of headaches from a couple of years ago, but the headaches have gotten worse. Patient is unsure if the COVID vaccine is the cause, but says it is getting worse.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Patient says she had COVID in 2020 and continues to experience breathing issues and has remained on oxygen 24/7.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Vomiting-Medium, Additional Details: The vomiting lasted the same day that the vaccine was administered, however, the patient stated that he didn't feel well for at least a week following the injection.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Systemic: Headache-Medium
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Head injury, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient accompanied to MC  by Mom to get a Meningococcal vaccine required for college admission. After patient received vaccine while sitting in bed, noted to have a Syncopal episode. She hit her head on the wall while leaned backwards with eyes closed. Assisted to lay in bed, checked for pulse, called 911 and checked vital signs. Pulse was present and vital signs stable. Became AAO x 4 after about 2 minutes. EMT responded and assessed patient. Bp 91/54. Transferred to ED by EMT and Mom.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Other Flu-Like Symptoms-Medium, Systemic: Headache-Medium
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis bullous, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient saw her doctor today 6/4/25. Dr. stated it is a local reaction on the left arm.  Doctor described it as a bullous.  Patient was advised to ice, take zyrtec, and benadryl and use hydrocortisone cream.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient had pain after two injections in one arm. The pain has lasted several months and is now causing her to not sleep.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated that she is experiencing pain and swelling at the injection site. It has impacted her ability to sleep on arm
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient reported that she experienced a big red circle at the injection side that was associated with a hot and achy feeling that lasted for a week. She also mentioned that this happened the last two times you received the COVID vaccine., Other Vaccines:  VaccineTypeBrand: FLUAD TRIVALENT 2024-2025; Manufacturer: ; LotNumber: 388461; Route: intramuscular; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Patient was administered five vaccines (Shingrix, Boostrix, Moderna, Capvaxive and Arexvy) at pharmacy on  06/04/2025. Pharmacy was made aware that patient was being seen in the ER on 06/05/2025 by ER staff. , Other Vaccines:  VaccineTypeBrand: Boostrix; Manufacturer: ; LotNumber: 793PT; Route: unknown; BodySite: unknown; Dose: unknown; VaxDate: 06/04/2025, VaccineTypeBrand: Moderna; Manufacturer: ; LotNumber: 3046732; Route: unknown; BodySite: unknown; Dose: unknown; VaxDate: 06/04/2025, VaccineTypeBrand: Capvaxive/ and arexvy; Manufacturer: ; LotNumber: Z002626/ and 4B22T; Route: unknown; BodySite: unknown; Dose: unknown; VaxDate: 06/04/2025
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild, Additional Details: Potential Resurgence of skin inflammation processes on abdominal area from previous shingles infection
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Systemic: Patient got COVID in October 2024 (a month after COVID vaccine)-Mild, Additional Details: Patient got COVID in October 2024 (a month after COVID vaccine)
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Influenza like illness, Injection site pain, Pain, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reports later in day after Capvaxive immunization, felt flu like body/joint aches as well as develpoed splotchy rash down arm of vaccine. Day after vaccine was the worst then started to improve somewwhat day after that. Still achy and splotch rash although improved.