chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: heplisav; Manufacturer: dynavax; LotNumber: 946060; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: patient present on 7/10 with rash at injection site and is itchy/warm to the touch. recommended pt to try topical ice and hydrocortisone cream. and to let us know if it gets any worse.
Age: 41.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient waiting to see if symptoms subside prior to doctor visit if symptoms persist patient will proceed with doctor visit within 72 hours. Will followup with patient in 24 hours from vaccine administration.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: arexvy; Manufacturer: ; LotNumber: xa53y; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 07/07/2025
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Skin exfoliation
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient came in on 07/10/2025 at 5:08pm stating the vaccine she had received on 06/20/25 had caused her to have current reddness, injection site pain and peeling of skin around the injection site. Stated when she had the injection on 06/20/25, she had experienced some arm pain and it had continued to worsen. Advised patient to seek medical attention as soon as she can to look at the condition. Patient denied that she is unable to breathe and is able to continue with her daily activities
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Medium, Additional Details: pt stopped by the pharmacy and complained of skin redness that developed a day after receiving shingrix vaccine at the pharmacy. Skin redness described as  ( 4x6 in) area on the left lateral arm, right beneath her deltoid region where she received the injection. Smooth looking skin with no raised lesions or hives observed at the redness area.  Pt said she has been applying ice to the area.  Recommended her to take benadryl to control the allergic rxn sx and advised her to go to urgent care
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Flushing
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: She began coughing within 5 minutes of the vaccine and started grabbing her throat. By the time I got out to her, she was in extreme distress.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: She began coughing within 5 minutes of the vaccine and started grabbing her throat. By the time I got out to her, she was in extreme distress.
Age: 54.0
Sex: M
Vaccine: PNC21
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Severe, Systemic: Headache-Medium, Additional Details: pain, swelling, redness traveled from injection site down to the hand over a week after the vaccine
Age: 54.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Severe, Systemic: Headache-Medium, Additional Details: pain, swelling, redness traveled from injection site down to the hand over a week after the vaccine
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: patient said her arm hurt and she cannot lift it above her shoulder. she does not wantt to go to md  since she has high deductible, Other Vaccines:  VaccineTypeBrand: boostrix; Manufacturer: ; LotNumber: kr75k; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pt came in on 07/14/25 at 9:05 am and displayed her arm with slight redness and swelling from when she got a prevnar 20 and covid 19 (pfizer) vaccine together on the same day. Pt has gotten a covid vaccine before and suspects it to be from prevnar. Advised pt to seek professional help for check up and pt confirmed no limitations to daily activities, Other Vaccines:  VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: me6072; Route: intramuscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 14.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given Men A and Men B too early.  Parents notified that patient will need imms again at later date.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Muscle spasms, Pain in extremity
Clinical narrative: Soreness at the injection site, lower back spasms, and pain on the left side from lower back to leg.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Nervous system disorder, Tinnitus
Clinical narrative: Fatigue, tinnitus, burning sensations, other nervous system events,
Age: 88.0
Sex: F
Vaccine: MMR, PNC20, VARZOS
Symptoms: Dizziness, Dysstasia
Clinical narrative: Patient started feeling very dizzy about 15 minutes post immunizations.  He couldn't stand and had to put his head between his legs.  He eventually felt well enough to drive.  He refused an ambulance.
Age: 11.0
Sex: F
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Covid vaccine was  administered outside the recommended 10 weeks after taken from the ultra cold environment.
Age: 6.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: Covid vaccine was  administered outside the recommended 10 weeks after taken from the ultra cold environment.
Age: 12.0
Sex: F
Vaccine: COVID19, TYP
Symptoms: Laboratory test, Palpitations
Clinical narrative: Per patient's mother, patient had gone to the ER the night of 7/17/25 due to palpitations. Based on the encounter, the medical staff had run tests and sent the patient home with instructions to continue monitoring heartrate.
Age: 78.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Dizziness, Dizziness postural, Headache, Rash erythematous, Rash pruritic
Clinical narrative: Patient came to pharmacy 7/18/25 @ 09:20 reporting a left-arm circumferential pink rash 3 inches below vaccination site (and 1 inch above elbow bend).  States it started the morning after injection of both Prevnar 20 and Comirnaty.  Patient states she felt dizzy spells and tingles in her head at night with some headache. She also reported mild orthostasis/dizziness upon rising from a reclined or lying position. She says the rash it a little itchy. I recommended she speak to her MD immediately (she states she did and has an appointment this Monday, 7/21/25). I recommended some 1% hydrocortisone to help reduce the pinkness and itchiness from the rash and to report to her MD immediately if her dizzy spells continue.  I advised her not to drive (she did drive to the pharmacy today to report her adverse events).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pharyngeal swelling, Swelling face, Throat irritation, Urticaria
Clinical narrative: Two days following immunization she developed facial swelling, hives, throat itching/swelling. No other symptoms of illness and no medications taken in the last month.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Drooling, Lip swelling, Pyrexia
Clinical narrative: The morning after receiving vaccinations, patient presented to the ED for swelling of the lower lip, mild drooling, and fever. Patient was observed at ED without any increase in swelling or evidence of angioedema or anaphylaxis.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: took the Pfizer vaccine and passed away after it; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-788038 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "took the Pfizer vaccine and passed away after it". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller stated knew of a that took the Pfizer vaccine and passed away after it. It is unknown if the patient experienced any additional symptoms/events.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: unknown cause of death
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Musculoskeletal stiffness, Nausea, Pallor, Sensory disturbance
Clinical narrative: Immediately after HPV given child became tense and pushed backward into chair and was unresponsive to verbal stimuli for about 15 seconds. Skin diaphoretic. Lips pale. Gradually became more responsive. Color improved. Said he felt like he was in a "movie trailer". Felt nauseated, but no emesis. Had breakfast before appointment and  given juice drink at time of vaccination. Observed additional 15 minutes after said was feeling better. Walked to car unassisted. Gait steady.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Immediately after HPV given child became tense and pushed backward into chair and was unresponsive to verbal stimuli for about 15 seconds. Skin diaphoretic. Lips pale. Gradually became more responsive. Color improved. Said he felt like he was in a "movie trailer". Felt nauseated, but no emesis. Had breakfast before appointment and  given juice drink at time of vaccination. Observed additional 15 minutes after said was feeling better. Walked to car unassisted. Gait steady.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Infection, Injection site pain
Clinical narrative: pt states after a couple of days of getting the first dose of the vaccine he started having pain in his right arm at the injection site. As time went on the pain continued to move down his arm but the major pain is at the injection site. He contacted his doctor to let them know he was in pain and he was told to come in to have a steroid shot. He did not go in to have the shot.  He had to go to the ER  on 7/17/2025. He was told by Dr that he had an infection. He was given an IV with antibiotics and  pain medication. He was discharged to home and prescribed Amoxicillin, amox-clav 125 mg, naproxen 500 mg, and cyclobenzaprine 10mg. He continues to be in pain and will need to follow up with his primary doctor.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Chills, fever, pain at injection site, fatigue, headaches,
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Body temperature increased
Clinical narrative: Rectal temperature of 103.3 degrees Farenheit within 24 hours of vaccine administration.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Libido decreased
Clinical narrative: I had, up until the injections, a very strong libido and experienced strong penal erections at any time of the day with only a certain mental exertion, but since the injections I have not only experienced the opposite (low libido and only experiencing few soft erections, only able to have semi-flacid erections during intercourse, and when using deer-antler-velvet sprays would only ejaculate without any erection).  Calling it a disorder would be an understatement!
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Infectious mononucleosis, Malaise, SARS-CoV-2 test positive
Clinical narrative: He has been sick every month since getting the shots. He said he received 4 vaccinations in the span of 6 months. He also said that he tested positive for Covid at least 5 times. When I asked if he has a PCP he said he'd talk to her about it but she would just yell at him. Said he's always been in good health prior and is a non-smoker, body builder. He said he keeps getting mono since the vaccine which is surprising at 52.
Age: 60.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient order for Trumenba vaccine but was dispensed/administered Bexsero product.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports swelling and heat on area of arm surrounding injection site. Also some redness at injection site.  I instructed patient to take Benadryl if she had it and contact her doctor for further follow up.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Oropharyngeal discomfort, Peripheral swelling, Rash, Swelling face
Clinical narrative: left arm localized swelling,rash on face with facial swelling, and throat tingling
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Biopsy lymph gland, Biopsy skin, Blood test normal, Computerised tomogram abdomen
Clinical narrative: itchiness at vaccine site, rash at vaccine site within 1 week, rash spread to back, shoulders, hands,face, scalp, nose, ears within 1 month, joint pain in hands and wrists within 1 month, enlarged lymph node in groin within 2 months. June 5: Went to PCP for advice on rash, abdomen CT on June 6, 2025 resulted in ER visit on June 6. General surgeon advised lymph node biopsy on June 10 (negative for lymphoma), PCP recommended visits to infectious disease and dermatologist. 2 punch biopsies performed on June 25 and pathology ultimately reports a finding of multicentric reticulohistiocytosis on July 1.  Infectious disease tests for a variety of potential illnesses, bloodwork has been good from a variety of sources. PCP recommends visit to oncologist who orders more bloodwork which returns good. After MRH diagnosis, patient contacts rheumatology at hospital and consults with Dr who recommends testing to rule out any malignancies and a consult with a dermatologist in order to coordinate a treatment plan for MRH. Visit to Dr on July 18 for diagnosis confirmation and treatment plan
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Lymphadenopathy, Multicentric reticulohistiocytosis, Rash
Clinical narrative: itchiness at vaccine site, rash at vaccine site within 1 week, rash spread to back, shoulders, hands,face, scalp, nose, ears within 1 month, joint pain in hands and wrists within 1 month, enlarged lymph node in groin within 2 months. June 5: Went to PCP for advice on rash, abdomen CT on June 6, 2025 resulted in ER visit on June 6. General surgeon advised lymph node biopsy on June 10 (negative for lymphoma), PCP recommended visits to infectious disease and dermatologist. 2 punch biopsies performed on June 25 and pathology ultimately reports a finding of multicentric reticulohistiocytosis on July 1.  Infectious disease tests for a variety of potential illnesses, bloodwork has been good from a variety of sources. PCP recommends visit to oncologist who orders more bloodwork which returns good. After MRH diagnosis, patient contacts rheumatology at hospital and consults with Dr who recommends testing to rule out any malignancies and a consult with a dermatologist in order to coordinate a treatment plan for MRH. Visit to Dr on July 18 for diagnosis confirmation and treatment plan
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: Rash, swelling, pain at sight of injection about 5" in diameter. Fever, chills, body aches.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Rash, swelling, pain at sight of injection about 5" in diameter. Fever, chills, body aches.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Blister rupture, Erythema, Pruritus
Clinical narrative: Patient presented with a rash to upper arm around 4 inches vertically and wrapping around half her arm. She said it was sore the day after, then it got red, a few days later it turned into a rash with what she described as some blisters that popped open. It appeared to be sensitive raise bumps at the upper right quadrant of the arm. She said it still itched some, recommended hydrocortisone otc since there were no open wounds. No other issues were reported to me. She is still recovering from the rash.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient presented with a rash to upper arm around 4 inches vertically and wrapping around half her arm. She said it was sore the day after, then it got red, a few days later it turned into a rash with what she described as some blisters that popped open. It appeared to be sensitive raise bumps at the upper right quadrant of the arm. She said it still itched some, recommended hydrocortisone otc since there were no open wounds. No other issues were reported to me. She is still recovering from the rash.
Age: 55.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Noted a red rash and swelling around the injection site that spread down about half way down the upper arm (patient had mark the furthest spreading of the rash with pen on the arm). Patient had told this to their neighbor who had a similar reaction that turned out to be an infection and advised patient see a doctor. Patient completed a tele-health visit  who sent in a prescription for Doxycycline Hyclate 100 mg caps, taking 1 capsule twice daily for 5 days. Associated ICD10 code: L089. Rash and swelling reduced significantly at the time that I saw him on 07/18 (3 days of therapy completed).
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: PATIENT AT 35 WEEKS OF PREGNANCY HAD INFLAMMATION, REDNESS AND HEAT SENSATION  LOCALLY AT THE LEFT ARM WERE TDAP VACCINE WAS GIVEN ON 07/15/2025 . PATIENT ADVISED TO CONSULT PRESCRIBER TO SEE IF ANY FURTHER TREATMENT IN ADDITION TO COLD COMPRESS WAS NEEDED SINCE WE NOTICED HER ARM  WHILE ADMINISTERING RSV VACCINE ON 07/18/2025 AT THE ALTERNATE RIGHT ARM
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Anticonvulsant drug level, Blood electrolytes, Full blood count, Injection site swelling, Seizure
Clinical narrative: She got her 4 year vaccines and 4 hours later she had a seizure. Since Monday she?s had 11-12 seizures, injection site swelled beyond 5 inches reaching 8 across and 4 up and down wrapping towards her inner thigh. Contacted pediatrician 24 hours after vaccination for guidance as well as Wednesday 7/16. My daughter Thursday 7/17 was taken by ambulance for prolonged seizures not being controlled even with rescue doses and experienced syncope the entire week.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Syncope
Clinical narrative: She got her 4 year vaccines and 4 hours later she had a seizure. Since Monday she?s had 11-12 seizures, injection site swelled beyond 5 inches reaching 8 across and 4 up and down wrapping towards her inner thigh. Contacted pediatrician 24 hours after vaccination for guidance as well as Wednesday 7/16. My daughter Thursday 7/17 was taken by ambulance for prolonged seizures not being controlled even with rescue doses and experienced syncope the entire week.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: COMPLAINED OF PAIN, SWELLING, AND FEVER
Age: 25.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administered Tdap to adult patient with previous Tdap given on 2/11/2025.  No treatment necessary. Pt is doing well.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dyskinesia, Immediate post-injection reaction, Muscle spasms, Syncope
Clinical narrative: Patient was given 2 vaccines and experienced a fainting episode. Immediately after fainting episode, pt experienced brief involuntary muscle jerks/spasms. Patient regained consciousness and was evaluated by medical staff in office. Vitals signs normal post syncope episode.
Age: 37.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Delayed local site reaction, itching, tender, erythema. Treated with antihistamine and oral abx for possible cellulitis.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received pneumonia vaccine but had severe arm pain and could not lift objects. Did not resolve in 2 days so patient went to urgent care and received a steroid prescription. Patient improving but when presented to pharmacy, pharmacist noted the vaccine was administered higher than recommended.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Computerised tomogram, Limb mass, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Pt reported having pain in arm approximately 3 days after injection.  He had gone to PCP, who did an X-ray and didn't find anything wrong, and so pt went home.  A few days later pt had more severe pain under the armpit down to elbow, and noticed a knot under the arm. He ended up going to the ER to rule out a heart attack since it was his left arm, which concerned him.  They did a CT scan and after some discussion with pt, in regards to type of pain, onset of pain,  and fact that pt had recently had a vaccine, that it was likely a case of Sirva.  Pt has extremely double jointed shoulders that he has been able to pull in and out of socket easily over the years.  He has had surgery on the right should to help correct this, but not the left one.  The ER doctor thinks that when pt relaxed his shoulder prior to injection, it may have shifted his joint down lower than what would be normal and expected, which could have resulted in IMZ going into the joint or bursa.  Even though dose was given correctly in what appeared to be pt's deltoid area, due to his unusual anatomy, (which the doctor indicated he had a longer than normal structure in his shoulder, but the pt couldn't recall exactly  what part), the injection did not end up just in his deltoid muscle.  Pt left the ER after confirming his heart was ok.  The pain subsided over the next 6 weeks or so, and is currently minimal.  Pt did not seek any other treatment other than putting ice on it from home. Pt did not feel like this was due to negligence on the administration of the IMZ, but just a fluke incident due to his non-traditional shoulder anatomy.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: Pt reported having pain in arm approximately 3 days after injection.  He had gone to PCP, who did an X-ray and didn't find anything wrong, and so pt went home.  A few days later pt had more severe pain under the armpit down to elbow, and noticed a knot under the arm. He ended up going to the ER to rule out a heart attack since it was his left arm, which concerned him.  They did a CT scan and after some discussion with pt, in regards to type of pain, onset of pain,  and fact that pt had recently had a vaccine, that it was likely a case of Sirva.  Pt has extremely double jointed shoulders that he has been able to pull in and out of socket easily over the years.  He has had surgery on the right should to help correct this, but not the left one.  The ER doctor thinks that when pt relaxed his shoulder prior to injection, it may have shifted his joint down lower than what would be normal and expected, which could have resulted in IMZ going into the joint or bursa.  Even though dose was given correctly in what appeared to be pt's deltoid area, due to his unusual anatomy, (which the doctor indicated he had a longer than normal structure in his shoulder, but the pt couldn't recall exactly  what part), the injection did not end up just in his deltoid muscle.  Pt left the ER after confirming his heart was ok.  The pain subsided over the next 6 weeks or so, and is currently minimal.  Pt did not seek any other treatment other than putting ice on it from home. Pt did not feel like this was due to negligence on the administration of the IMZ, but just a fluke incident due to his non-traditional shoulder anatomy.
Age: 66.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Metamorphopsia, Nausea, Vision blurred
Clinical narrative: distorted vision, blured vision, headache and nausea
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance
Age: 0.67
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance as to whether or not the patient needs to be revaccinated.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 2 days after the "10-week once received" expiration date. The local health department does not allow us to enter that date into computer, but rather the date on the box, which is much farther out. As a result, we have to manually check a little label handwritten on the vaccine box. If the actual date of expiration (10 week) was allowed to be put in the computer, errors like this could be avoided.
Age: 2.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Vaccine was expired - 10-week expiration date from when box of vaccine was received into clinic, not expiration date on box which is much longer. 10-week Vaccine expiration date was 5/1/2025. According to local health department, the 10-week expiration date cannot be entered into the computer, but rather the expiration date on box, as the state system is unable to record both dates. As such, the clinic needs to manually check the expiration dates. If the 10-week expiration date was to be put into computer, this expired vaccine would have been given. The local health department, VAERS, the CDC, and manufacturer Pfizer, were all contacted and none of the agencies could provide guidance
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; administration of GARDASIL-9 to an 18-year old female patient outside the recommended dosing interval.. Caller states the first dose was administered on 18-APR-2025, the second dose on 30-MAY- 2025, and the third dose on 21-JUN-2025.; This spontaneous report was received from a pharmacist and refers to an 18-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 18-Apr-2025 and 30-May-2025, the patient was vaccinated with the first and second doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), Suspension for injection, 5 mL (lot # and expiration date were not reported) as prophylaxis. On 21-Jun-2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) Suspension for injection (lot #Z005469, expiration date: 27-Feb-2026), 5 mL, as prophylaxis (Inappropriate schedule of product administration). No adverse events were provided.  Lot # is being requested and will be submitted if received
Vaccine: PNC21
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported CAPVAXIVE administered during temperature excursion.  No other information provided.  No additional AE/PQC reported. ?    Names of vaccines involved (including lot/exp) CAPVAXIVE Y019158  5/20/2026        ?    Temperature 18C; This spontaneous report was received from an other health professional and refers to a 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 an unknown date, the patient started was vaccinated with an improperly stored dose of Pneumococcal 21-valent Conjugate Vaccine Injection (CAPVAXIVE) (route of administration and anatomical location of vaccine); lot #Y019158, expiration date reported as 20-MAY-2026 0.5 mL for Prophylaxis. On 25-JUN-2025, the dose experienced a Temperature excursion of 18C for a time fram of 5 hours and 30 minutes. No previous excursion was reported. No additional adverse event were reported.
Age: 41.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Alopecia, Blindness, Blood thyroid stimulating hormone decreased, Brain fog, Fatigue
Clinical narrative: Neurological injury; Emotional disorder; Autoimmune Injuries; hyperactive thyroid/ Hair loss/ hot flashes/ weight loss; Brain fog/fatigue/memory loss; Emotional suffering; Pain; Grave's disease/weight loss/vision loss; Information has been received from a lawyer regarding a case in litigation concerning a 42-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On unknown day (when she was 41 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine  (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot number, and expiry ate were not provided) as prophylaxis . Then on unknown date (when she was 42 years old), she received the second and third dose of the suspect vaccine (as described above).  On unknown day, within days of the second dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine  (GARDASIL), patient began to experience hot flashes, fatigue, hair loss, and weight loss. Moreover, she had to wear protective styles and wigs for her thinning hair. Therefore, patient scheduled an appointment with her gynecologist and primary care provider to evaluate her symptoms. Providers performed blood work and the results showed she had hyperactive thyroid. Then, in June 2023, she was diagnosed with Grave's disease. Hence, the patient was treated with medication (unspecified) and saw an endocrinologist to monitor her disorder. In addition, se continued experienced daily brain fog, vision loss, hot flashes, and her weight continued to fluctuate. Patient had suffered and continues to suffer severe and permanent emotional injuries, including pain and suffering. As a direct and proximate result of her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the patient suffered economic losses, including considerable financial expenses for medical care and treatment.  The outcome of the events was considered as not recovered (as reported has suffered and continues to suffer severe and permanent physical injuries).   The lawyer considered all events to be related to quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine  (GARDASIL). In addition, all the events were considered as disabling.
Age: 41.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Graves' disease, Hot flush, Hyperthyroidism, Weight decreased, Weight fluctuation
Clinical narrative: Neurological injury; Emotional disorder; Autoimmune Injuries; hyperactive thyroid/ Hair loss/ hot flashes/ weight loss; Brain fog/fatigue/memory loss; Emotional suffering; Pain; Grave's disease/weight loss/vision loss; Information has been received from a lawyer regarding a case in litigation concerning a 42-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On unknown day (when she was 41 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine  (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot number, and expiry ate were not provided) as prophylaxis . Then on unknown date (when she was 42 years old), she received the second and third dose of the suspect vaccine (as described above).  On unknown day, within days of the second dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine  (GARDASIL), patient began to experience hot flashes, fatigue, hair loss, and weight loss. Moreover, she had to wear protective styles and wigs for her thinning hair. Therefore, patient scheduled an appointment with her gynecologist and primary care provider to evaluate her symptoms. Providers performed blood work and the results showed she had hyperactive thyroid. Then, in June 2023, she was diagnosed with Grave's disease. Hence, the patient was treated with medication (unspecified) and saw an endocrinologist to monitor her disorder. In addition, se continued experienced daily brain fog, vision loss, hot flashes, and her weight continued to fluctuate. Patient had suffered and continues to suffer severe and permanent emotional injuries, including pain and suffering. As a direct and proximate result of her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the patient suffered economic losses, including considerable financial expenses for medical care and treatment.  The outcome of the events was considered as not recovered (as reported has suffered and continues to suffer severe and permanent physical injuries).   The lawyer considered all events to be related to quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine  (GARDASIL). In addition, all the events were considered as disabling.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Cellulitis on their arms; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Jul2025 as dose number unknown, single (Lot number: LN4929, Expiration Date: 31Jul2026) at the age of 58 years intramuscular for pneumonia. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis on their arms". Therapeutic measures were taken as a result of cellulitis. Additional information: Five days after was given the vaccine, was given antibiotics, a cream and a medication for allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500144941 Same reporter/vaccine/event, different patients;
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: She had a large rash on her back that persisted for approximately one week; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Mar2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Mar2023. The following information was reported: RASH (non-serious) with onset Mar2023, outcome "recovered" (Mar2023), described as "She had a large rash on her back that persisted for approximately one week". Therapeutic measures were not taken as a result of rash. Additional information: Patient received Prevnar 20 from doctor's office on same day as starting Singulair.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: PNC13
Symptoms: Erythema, Impaired work ability, Malaise, Muscle swelling, Myalgia
Clinical narrative: arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red/arm will swell up or turn this angry red; my arm started hurting a lot/arm/deltoids is still painful; fever of 101 to 102; arm will swell up; sick; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 07Jul2025 at 09:30 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), RASH (non-serious) all with onset 07Jul2025 at 16:00, outcome "unknown" and all described as "arm/deltoids is still painful and very red, like a rash"; ERYTHEMA (non-serious) with onset 07Jul2025 at 16:00, outcome "not recovered", described as "arm/deltoids is still painful and very red/arm will swell up or turn this angry red"; VACCINATION SITE PAIN (non-serious) with onset 07Jul2025 at 16:00, outcome "unknown", described as "my arm started hurting a lot/arm/deltoids is still painful"; PERIPHERAL SWELLING (non-serious) with onset Jul2025, outcome "not recovered", described as "arm will swell up"; PYREXIA (non-serious) with onset Jul2025, outcome "recovered" (Jul2025), described as "fever of 101 to 102"; ILLNESS (non-serious) with onset Jul2025, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received Prevnar shot last 07Jul2025 at 9:30 AM. Patient was fine until around 4 pm when arm started hurting a lot. Patient had fever of 101 to 102F for almost two days. Missed work. On 10Jul2025, arm/deltoids was still painful and very red, like a rash. Patient wasn't told that arm will swell up or turn this angry red. On 12Jul2025, it was still the same. The vaccine made the patient sick.
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red, like a rash; arm/deltoids is still painful and very red/arm will swell up or turn this angry red; my arm started hurting a lot/arm/deltoids is still painful; fever of 101 to 102; arm will swell up; sick; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 07Jul2025 at 09:30 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), RASH (non-serious) all with onset 07Jul2025 at 16:00, outcome "unknown" and all described as "arm/deltoids is still painful and very red, like a rash"; ERYTHEMA (non-serious) with onset 07Jul2025 at 16:00, outcome "not recovered", described as "arm/deltoids is still painful and very red/arm will swell up or turn this angry red"; VACCINATION SITE PAIN (non-serious) with onset 07Jul2025 at 16:00, outcome "unknown", described as "my arm started hurting a lot/arm/deltoids is still painful"; PERIPHERAL SWELLING (non-serious) with onset Jul2025, outcome "not recovered", described as "arm will swell up"; PYREXIA (non-serious) with onset Jul2025, outcome "recovered" (Jul2025), described as "fever of 101 to 102"; ILLNESS (non-serious) with onset Jul2025, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received Prevnar shot last 07Jul2025 at 9:30 AM. Patient was fine until around 4 pm when arm started hurting a lot. Patient had fever of 101 to 102F for almost two days. Missed work. On 10Jul2025, arm/deltoids was still painful and very red, like a rash. Patient wasn't told that arm will swell up or turn this angry red. On 12Jul2025, it was still the same. The vaccine made the patient sick.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient got Covid three months ago; Patient got Covid three months ago; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "Patient got Covid three months ago".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Malaise
Clinical narrative: increase frequency of humlra due to frequent flare ups; not feeling well; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020032 (BioNTech).  This case involves elderly female patient who was not feeling well and increase frequency of Humira due to frequent flare ups while being treated with DUPILUMAB [DUPIXENT] delivered via Single dose Pre-Filled Pen and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In Sep2023, the patient started taking DUPIXENT (DUPILUMAB) Solution for Injection at a strength and dose of 300 mg QOW subcutaneously delivered via Single dose Pre-Filled Pen for Asthma. On an unknown date, the patient started taking COVID-19 VACCINE with unknown strength, dose, frequency, route and indication. On an unknown date, the patient developed a non-serious event "not feeling well" (malaise) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. On an unknown date, the patient developed a non-serious event "increase frequency of Humira due to frequent flare ups" (asthma) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. Information regarding batch number and expiration date corresponding to the one at the time of event occurrence was requested. It was reported "The patient (pt) reports had covid vaccines yesterday and not feeling well. Md (medical doctor) Is aware and md Is working to increase frequency of Humira due to frequent flare ups. Unknown If md aware. Action taken with DUPILUMAB: No action taken for both events. Action taken with COVID-19 VACCINE was unknown for both events. The patient was treated with ADALIMUMAB (HUMIRA) for Asthma and was not reported for malaise. At time of reporting, the outcome was Unknown for both events.  BNT162b2 is under agreement with BIONTECH SE.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.