chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Fungal infection, Fungal test positive, Injection site pain, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Additional Details: As per letter that was provided by the patient's spouse on 4/15/25, the patient at the time, back in December, reported serious pain at the site where the vaccine was given. Patient went to the local emergency department on 12/22/24, according to the letter provided to us, and that the swelling and pain is ongoing. Also according to the letter, recent aspiration and lab test revealed "yeast/fungus infection" and is "under treatment for the fungal infection."
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Visual impairment, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Medium, Additional Details: pt upon feeing ligh headedness was placed to ground with fee elevated. she vomited on the side clear spit/fluid.  paramadics then arrived. , Other Vaccines:  VaccineTypeBrand: Boostrix; Manufacturer: GlaxoSmithKline; LotNumber: KR75D; Route: Im; BodySite: left arm; Dose: 1; VaxDate: 04/15/2025
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Injection site pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: his caregiver called back after a week stating his arm was hurting and he has a fever but it was discovered that he did in fact have covid.  the fever did break.  I have been calling back weekly to check on him or either she would call the pharmacy to speak with me and he would say it still hurts but it was not as bad as initially.  it has been almost a month from the injection and he did get 3 shots on 3-18 but that is why i made sure to put that one specifically in the right arm so he would kn
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: has been suffering from long covid before and after vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lethargy, Pain, Post-acute COVID-19 syndrome, Tremor
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: has been suffering from long covid before and after vaccine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: has been suffering from long covid before and after vaccine
Age: 53.0
Sex: M
Vaccine: PNC21
Symptoms: Asthenia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Weakness-Mild
Age: 53.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site swelling, Lethargy, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Weakness-Mild
Age: 31.0
Vaccine: TDAP
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient began brusing at injection site the evening of getting the vaccine. The next day, bruise was darker and bigger. On the 3rd day, part of her arm under the injection site began to swell, turn pink and felt hot. She put a ice pack to help. One week later (day she came in to report adverse effect), she still has a bruise the size of the bottom of a soda can and it has been a little itchy for a few days. Slight muscle pain when she pushes on area. No reaction to vaccines in the past.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient began brusing at injection site the evening of getting the vaccine. The next day, bruise was darker and bigger. On the 3rd day, part of her arm under the injection site began to swell, turn pink and felt hot. She put a ice pack to help. One week later (day she came in to report adverse effect), she still has a bruise the size of the bottom of a soda can and it has been a little itchy for a few days. Slight muscle pain when she pushes on area. No reaction to vaccines in the past.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction, Extra dose administered, Injection site pain, Wrong product administered
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient requesting 2 vaccines from a list she had from the doctor. Patient needed Hep B vaccine but was given Tdap. Patient had already received Tdap at the doctor's office so this was a second administration of the vaccine. Patient was given refund and did not have any side effects of vaccine while in store. Patient later reported vaccine error and reported going to the ER due to bad reaction.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium
Age: 41.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Spinal pain
Clinical narrative: Received vaccines on 02/21/25. Patient reported left shoulder/arm pain and decreased ROM in left arm to facility staff on 3/5/25. Also pain in left back, hip and thigh.  MD ordered prednisone.  Pt reported steroids help but still has pain in lower spine and shoulder as of 3/25/25.  Prednisone reordered on 4/8/25.
Age: 39.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Loss of consciousness, Pallor, Underdose, Unresponsive to stimuli
Clinical narrative: Heplisav vaccine was administered into left deltoid. A few minutes passed as immunizer prepared second vaccine. Administration of MMR vaccine into left arm (subcutaneous) was initiated and patient became pale and then unresponsive for a few seconds. Needle was withdrawn before entire dose administered. Patient appeared to lose consciousness for a few seconds (<10). When patient was able to respond to immunizer, he was assisted to elevate his feet and remain seated. Pharmacist provided a cool cloth for patient's face and neck. Patient was full coherent and reported that he felt fine and that this had happened before when he was much younger. Pharmacist remained with patient for about 5 minutes before he was allowed to move to waiting area for further observation. Patient remained at pharmacy for about 20 additional minutes with no additional symptoms.
Age: 73.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site oedema, Injection site reaction, Local reaction, Oedema peripheral
Clinical narrative: severe local reaction :approx 8 x 20 cm , noted below injection site and circling upper left arm.   edema of upper and lower left arm
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient given pediatric dose of Hep A
Age: 43.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Contusion, Injection site bruising, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Onset of pain, swelling and bruising 24 hours after Tdap given on L arm. Swelling and bruising still present on 4/9/25, area measured at 3 cm x 2 cm. Slight swelling and discoloration still present on 4/21/25.  Onset of bruising 24 hours after Flu and Hep B given on R arm, no swelling or pain. Bruising still present on 4/9/25, measured at 2 cm x 2 cm. Discoloration still present on 4/21/25.  Bruising at L forearm PPD site with same time line as immunizations.
Age: 43.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Iron deficiency anaemia
Clinical narrative: Onset of pain, swelling and bruising 24 hours after Tdap given on L arm. Swelling and bruising still present on 4/9/25, area measured at 3 cm x 2 cm. Slight swelling and discoloration still present on 4/21/25.  Onset of bruising 24 hours after Flu and Hep B given on R arm, no swelling or pain. Bruising still present on 4/9/25, measured at 2 cm x 2 cm. Discoloration still present on 4/21/25.  Bruising at L forearm PPD site with same time line as immunizations.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Apnoea, Loss of consciousness, Muscle contractions involuntary, Muscle rigidity, Pallor
Clinical narrative: Patient received immunization, all questions were answered. Patient was assisted to a chair by her mom to wait the suggested 15 minutes in the clinic immediately following the shots. She requested water and the nurse stepped out of the room to get the water. Within 5 seconds patients mom yelled for help. Nurse returned to the room immediately and found patient unconscious, pale, entire body rigid, hands clenched into fists and not breathing. Nurse yelled patients name, shook her head and shoulders and lightly tapped cheeks for response. Patient did not respond and nurse yelled for the CSR at the front desk to call "Dr." over the intercom (page for medical emergency). 6-7 personnel responded from within the building to the call and by this time patient was awake and responsive. Patient was unresponsive for approximately a total of 15-20 seconds. Patient was helped to the exam table. Patient was able to confirm, date, place and her name; her color returned, and she was given orange juice. Vital signs were 76/43, pulse 44, respirations 12 at 10:16am. Provider,FNP-BC, APRN, came into the room to assess patient and obtain hx from patient's mom. After the visit, patient and mom were given the following instructions: Do not leave patient unattended, especially in places like the shower, for the next 48 hours and to seek medical attention for headache or another episode and to report this event to her pediatrician. Mom stated she understood. Vital Signs at 10:23 99/64, pulse 56 and respirations 12. Patient left with her mom at 10:42. Nurse left a message on phone number listed on the consent Friday 4/18/25 and Monday 4/21/25 to have mom call back to give update on her daughter. No returned phone call has been received.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received immunization, all questions were answered. Patient was assisted to a chair by her mom to wait the suggested 15 minutes in the clinic immediately following the shots. She requested water and the nurse stepped out of the room to get the water. Within 5 seconds patients mom yelled for help. Nurse returned to the room immediately and found patient unconscious, pale, entire body rigid, hands clenched into fists and not breathing. Nurse yelled patients name, shook her head and shoulders and lightly tapped cheeks for response. Patient did not respond and nurse yelled for the CSR at the front desk to call "Dr." over the intercom (page for medical emergency). 6-7 personnel responded from within the building to the call and by this time patient was awake and responsive. Patient was unresponsive for approximately a total of 15-20 seconds. Patient was helped to the exam table. Patient was able to confirm, date, place and her name; her color returned, and she was given orange juice. Vital signs were 76/43, pulse 44, respirations 12 at 10:16am. Provider,FNP-BC, APRN, came into the room to assess patient and obtain hx from patient's mom. After the visit, patient and mom were given the following instructions: Do not leave patient unattended, especially in places like the shower, for the next 48 hours and to seek medical attention for headache or another episode and to report this event to her pediatrician. Mom stated she understood. Vital Signs at 10:23 99/64, pulse 56 and respirations 12. Patient left with her mom at 10:42. Nurse left a message on phone number listed on the consent Friday 4/18/25 and Monday 4/21/25 to have mom call back to give update on her daughter. No returned phone call has been received.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient reported today at routine doctor's appointment. S/s: right arm localized injection site, red itchy rash
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: After 7 hours from the administered vaccine Patient noticed he has an itchy 4 small dots size of a quarter on his left forearm (forming letter J).He said it must have been an allergic reaction/ rash from the covid shot. Patient said he is applying an OTC diphenhydramine cream and today, 04/21/2025 it's a size of a penny,
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Skin disorder
Clinical narrative: After 7 hours from the administered vaccine Patient noticed he has an itchy 4 small dots size of a quarter on his left forearm (forming letter J).He said it must have been an allergic reaction/ rash from the covid shot. Patient said he is applying an OTC diphenhydramine cream and today, 04/21/2025 it's a size of a penny,
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Rash - pink, raised rash from head to toe, fever
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Hypoaesthesia, Migraine, Nausea
Clinical narrative: 1-2 hours later patient began complaining of an extreme headache and feeling numb. He is nauseous but has not vomited. Has a history of migraines but states this is worse than any migraine he has had. Has not had a migraine in a couple of years per family report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vacine expired 2 days prior 4/19/2025
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: developed small red, raised dot on arm over next couple days, progressed into patchy and itchy rash down entire arm, some swelling of local lymph nodes. Improved with Benadryl but not yet resolved (as of ~6 days post vaccination)
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness around the injection site; pain to the touch
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Paralysis
Clinical narrative: she had like a type of palsy; This is a spontaneous report received from an Other HCP from medical information team.  A 15-month-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in thigh for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), as dose number unknown, single) for immunisation; hib vaccine conj (tet tox) (ACT HIB), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "she had like a type of palsy". The patient underwent the following laboratory tests and procedures: Specialist consultation: allergist think there was an egg or animal, notes: component that could have caused the episode. It was unknown if therapeutic measures were taken as a result of paralysis. Reporter was unable to clarify palsy further to include location on body.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event palsy was related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Stillbirth
Clinical narrative: Delivered a stillborn baby at 37 weeks; This is a spontaneous report received from a Nurse.  A 35-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing). The patient was 37 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: STILLBIRTH (medically significant) with onset Mar2025, outcome "unknown", described as "Delivered a stillborn baby at 37 weeks". The pregnancy resulted in still birth. This was the patient's second pregnancy. The reporter stated that a friend of hers received the RSV vaccine and delivered a stillborn baby about a month ago.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event stillbirth and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500078577 mother/ baby case;
Age: 37.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Myelin oligodendrocyte glycoprotein antibody-associated disease, Visual acuity tests
Clinical narrative: diagnosed with MOGAD; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Feb2025 as dose number unknown, single) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Unknown manufacturer), for Covid-19 immunization. The following information was reported: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (prolonged hospitalization, disability) with onset 07Apr2025, outcome "not recovered", described as "diagnosed with MOGAD". The patient prolonged hospitalization for myelin oligodendrocyte glycoprotein antibody-associated disease (hospitalization duration: 10 day(s)). The patient underwent the following laboratory tests and procedures: Visual acuity tests: (13Apr2025) like 85, notes: His vision was much better. Therapeutic measures were taken as a result of myelin oligodendrocyte glycoprotein antibody-associated disease. The clinical course was reported as follows: The patient was diagnosed with Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The exact cause was not fully understood but the neurologist thought it may have been triggered by the flu vaccine and covid booster. As a symptom of MOGAD, the patient had optic neuritis which was inflammation in the optic nerve and it was causing some vision loss, eye pain, and headache. He lost vision in his left eye (his right eye was not great either) and had headaches and eye pain. He got seven rounds of steroids (last one on 02Apr2025) to help reduce the inflammation and it was really helping. He started having headaches and eye pain again this week and he lost vision in his right eye fully on 09Apr2025. He went to get steroids on 12Apr2025 to help with inflammation. His vision was much better at like 85% on 13Apr2025. Still in hospital and receiving steroids, rounds of plasmapheresis and inebilizumab-cdon.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Fainting; passing out; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: SYNCOPE (medically significant), outcome "unknown", described as "Fainting"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passing out".  Clinical course: Reporter wanted to know if fainting or like passing out, is a long-term effect of the Pfizer vaccination after receiving the vaccine a couple of years ago. Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question. When probed to clarify if reporter is having the side effects after the vaccine, reporter stated, "Well not myself but someone close to me and I was just wondering I am not 'going in or' anything, I do not have the 'fax', but I was just wondering if it could be connected with the Pfizer." was reporting for someone else  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate sinus tachycardia, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Fainting; POTS; inappropriate sinus tachycardia; This is a spontaneous report received from a Consumer or other non HCP.  A 23-year-old female patient (not pregnant) 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. Concomitant vaccines and prior vaccinations within 4 weeks were none. The following information was reported: SYNCOPE (disability), outcome "not recovered", described as "Fainting"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability), outcome "not recovered", described as "POTS"; INAPPROPRIATE SINUS TACHYCARDIA (disability), outcome "not recovered". The clinical course was reported as follows: The patient experienced fainting, and was diagnosed with postural orthostatic tachycardia syndrome (POTS) and inappropriate sinus tachycardia after receiving vaccine. She had been healthy prior to this. The patient took medication to treat the events. Therapeutic measures were taken as a result of syncope, postural orthostatic tachycardia syndrome, inappropriate sinus tachycardia.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Cognitive disorder
Clinical narrative: suffered a stroke; permanent cognitive problems; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "suffered a stroke"; COGNITIVE DISORDER (disability), outcome "not recovered", described as "permanent cognitive problems". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Dissociation, Hallucination, Headache, Tremor
Clinical narrative: mild hallucinations; disassociation/not being fully aware of where she was; an extreme headache has settled that has lasted since 09Apr2025; chills; shakes; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Apr2025 at 15:00 as dose 1, single (Lot number: LP1776), in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 08Apr2025 as dose 1, single (Lot number: UT8485MA), in left arm for immunisation. The patient's relevant medical history included: "Just occasional heartburn" (unspecified if ongoing). Concomitant medication(s) included: HEPLISAV B taken for immunisation, on 01Apr2025 as dose 2, single; TDAP taken for immunisation, on 01Apr2025 as dose 1, single; TYPHOID VACCINE POLYSACCH VI taken for immunisation, on 01Apr2025 as dose 1, single; VITAMIN D NOS, start date: 26Mar2025; SIMPESSE, start date: 27Mar2025; OMEPRAZOLE, start date: 04Apr2024. Vaccination history included: Heplisav b (Dose 1), for Immunization. The following information was reported: CHILLS (non-serious) with onset 09Apr2025, outcome "recovered" (09Apr2025); TREMOR (non-serious) with onset 09Apr2025, outcome "recovered" (09Apr2025), described as "shakes"; HEADACHE (non-serious) with onset 09Apr2025 at 13:00, outcome "not recovered", described as "an extreme headache has settled that has lasted since 09Apr2025"; DISSOCIATION (non-serious) with onset 09Apr2025 at 13:00, outcome "recovered" (Apr2025), described as "disassociation/not being fully aware of where she was"; HALLUCINATION (medically significant) with onset 09Apr2025 at 13:00, outcome "not recovered", described as "mild hallucinations". The events "mild hallucinations", "disassociation/not being fully aware of where she was" and "an extreme headache has settled that has lasted since 09apr2025" required emergency room visit. Therapeutic measures were taken as a result of hallucination, dissociation, headache. Clinical details: The next morning after taking the two vaccines, she had her normal reaction of chills, shakes, etc, but after that stopped an extreme headache has settled that has lasted since 09Apr2025. She was having mild hallucinations the first couple days, not being fully aware of where she was. Went to urgent care, they prescribed Fioricet, which has stopped the disassociation, but has not touched the actual headache. The patient had none known allergies.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got the covid virus around Dec2022; got the covid virus around Dec2022; This is a spontaneous report received from a Consumer or other non HCP.  A 55--old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8736), in left arm, on 06May2021 as dose 2, single (Lot number: ER8736), in left arm and on 12Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 54 years, in left arm 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 Dec2022, outcome "unknown" and all described as "got the covid virus around Dec2022". Clinical course: Got covid virus after her second shoulder surgery, which is probably around Christmas time after her second shoulder surgery, got the COVID virus around Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500081919 Same patient and product; different dose and events;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Meniscus injury, Muscle disorder, Myalgia, Rheumatoid arthritis
Clinical narrative: got the covid virus around Dec2022; got the covid virus around Dec2022; This is a spontaneous report received from a Consumer or other non HCP.  A 55--old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8736), in left arm, on 06May2021 as dose 2, single (Lot number: ER8736), in left arm and on 12Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 54 years, in left arm 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 Dec2022, outcome "unknown" and all described as "got the covid virus around Dec2022". Clinical course: Got covid virus after her second shoulder surgery, which is probably around Christmas time after her second shoulder surgery, got the COVID virus around Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500081919 Same patient and product; different dose and events;
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. 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: died
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID/we were both positive; COVID/we were both positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE) 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 17Feb2024, outcome "unknown" and all described as "COVID/we were both positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). Clinical course: The reporter and her husband got a box (Paxlovid) about a year and a half ago because they were going on vacation and then they didn't use it. Her husband brought COVID home from the gym on Friday (16Feb2024) and on Saturday (17Feb2024), patient started to feel sick. Yesterday (19Feb2024), the they took the test and they were both positive so they shared the beginning of the first box (Paxlovid). The area was supposed to have really high covid at time of report. The patient and her husband had all the vaccines, every single one of them. She didn't have any reaction to Pfizer. The last one was Moderna: it was the only one she had a reaction to. It wasn't terrible, patient woke up feeling like she was hit by a truck, everything aches and that was it (Moderna). The patient added "I mean it's not like the worst reaction I have ever had to anything which was much worse than a little sore arm."  Amendment: This follow up report is being submitted to amend previously reported information: reporter contact information added, suspect vaccine name was updated from BNT162B2 NOS to BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)).; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500039883 Same reporter, product, and event; different patient;
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: a single person with severe asthma experienced worsening symptoms; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 15Apr2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "a single person with severe asthma experienced worsening symptoms". Additional information: In a 2021 case study, a single person with severe asthma experienced worsening symptoms following the second dose of the Pfizer-BioNTech vaccine. However, researchers were not able to definitively establish a cause-and-effect relationship and were unable to draw conclusions based on a single case study. More research is necessary to determine whether any relationship exists.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: health dwindling/ health is worse; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "not recovered", described as "health dwindling/ health is worse". Therapeutic measures were not taken as a result of general physical health deterioration.  Additional information: The patient was calling about the first dose and second dose of the COVID vaccine. He is just curious since he got the first dose in 2020 or 2021. Then he got the second dose right after that from clinic. Confirms both doses were the Pfizer COVID vaccine which he received from clinic. States it is still three years later and he is still trying to decide what was in the vaccine. With his body he was a very healthy individual before the vaccine, and after had a large downslide with his health after the second dose. He did not really have time or economic stability to confront the situation. Basically wanted to know what was in in the vaccine and why his health dwindled after the second dose. He was asking what can be derived about this, he was just looking for information. When querying medical conditions states he was smoking. He was overworked. Treatment: No. He was able to work through it but his body did not like whatever the vaccine was. When querying when his health started dwindling, clarifies that he felt this pretty immediately within two weeks after the first dose. Then he got the second dose thinking it was just the vaccine doing its job. Outcome: health is worse since got the vaccine, he is referring to both doses. He does not know if its coincidental.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500081832 Same patient/product/event; different dose;
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: health dwindling/ health is worse/ had a large downslide with his health; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Sep2021, for COVID-19 immunisation. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "health dwindling/ health is worse/ had a large downslide with his health".   Additional information: Patient was calling about the first dose and second dose of the covid vaccine. He is just curious since he got the first dose in 2020 or 2021. Then he got the second dose right after that from clinic. Confirms both doses were the Pfizer covid vaccine which he received from clinic. States it is still three years later and he is still trying to decide what was in the vaccine. With his body he was a very healthy individual before the vaccine, and after had a large downslide with his health after the second dose. He did not really have time or economic stability to confront the situation. Basically wants to know what it is in the vaccine and why his health dwindled after the second dose. He is asking what can be derived about this, he is just looking for information. Declined to provide address. States he can be followed up with via phone. He has heard two scenarios with his position, clarifies that he heard that the first dose had mu metal in it and then also heard that the second dose may have formaldehyde in it which is an embalming fluid, asking if this is true. He is not sure where his vaccine card is. When querying when his health started dwindling, clarifies that he felt this pretty immediately within two weeks after the first dose. Then he got the second dose thinking it was just the vaccine doing its job.  Outcome: health is worse since got the vaccine, he is referring to both doses. He does not know if its coincidental.    The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: she gave the wrong medication to a 4-month old patient/patient received QUADRACEL and a HIB vaccine, but the patient was supposed to receive PENTACEL, with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 4 months old female patient to whom received Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] and a hib vaccine, instead of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine (Hib) Rotavirus vaccine and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 09-Apr-2025, the patient received a 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 09-Nov-2025 and lot U7931AB) via intramuscular route in the left vastus lateralis as immunization instead of Pentacel  with no reported adverse event (wrong product administered) (same day latency).  Action taken: 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: 8.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 8.5 °C to 8.8 °C Duration: 30 minutes and administered with no adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 8 years old female patient who received IPV (VERO) [IPOL] that exposed to max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for Immunisation.  On 10-Apr-2025, the patient received Dose 3 of 0.5 ml of suspect IPV (VERO) Suspension for injection of standard strength once with lot X1C891M and expiry date 31-Oct-2026 via intramuscular route in the right deltoid for Immunisation.  04-Apr-2025, the suspect IPV (VERO) exposed to max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes and administered with no adverse event (product storage error) (unknown latency)  Reportedly, Human error involved. No previous excursion. Extended stability data did not cover the excursion.   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.; Sender's Comments:  02490903: US-SA-2025SA113179: US-SA-2025SA113172:Master case
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion/temperature reached: 8.5 °C to 8.8 °C for 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to master case US-SA-2025SA112035.  This case involves a 19 years old female patient who was administered Influenza Usp Trival A-B Subvirion Vaccine [Fluzone] after temperature excursion/temperature reached: 8.5 °c (Degree Celsius) to 8.8 °c for 30 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Nurse called to report a temperature excursion that occurred on 04-Apr-2025.    On 14-Apr-2025, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion Vaccine Suspension for injection (lot U8442BA, Expiry: 20-Jun-2025) (Strength: Standard) via intramuscular route in the left deltoid as Influenza immunization that had temperature excursion/temperature reached: 8.5 °c to 8.8 °c for 30 minutes with no reported adverse event (product storage error). Human error: yes  Reportedly, No adverse events were noted. There was no previous excursion and extended stability data does not cover the excursion.  Action taken: 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.; Sender's Comments:  US-SA-2025SA112035:Master case
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: product administered after excursion with no adverse event; Temperature excursion/temperature reached: 8.5 °C to 8.8 °C with 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases- US-SA-2025SA113850, US-SA-2025SA113376, US-SA-2025SA113846, US-SA-2025SA113257, US-SA-2025SA113835, US-SA-2025SA113170, US-SA-2025SA113172, US-SA-2025SA112035  This case involves a 22 years old female patient to whom INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] product administered after excursion with no adverse event and temperature excursion/temperature reached: 8.5 °c to 8.8 °c with 30 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-APR-2025 temperature excursion/temperature reached: 8.5 °c to 8.8 °c with 30 minutes with no reported adverse event (product storage error).  On 15-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE dose 0.5 ml 1x(once) Suspension for injection (strength standard) lot U8442BA Expiry date-20-Jun-2025 via intramuscular route in the left deltoid for Influenza immunization, product administered after excursion with no adverse event (poor quality product administered) (latency same day).  Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking)  Action taken: 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.; Sender's Comments:  US-SA-2025SA112035: US-SA-2025SA113170: US-SA-2025SA113835: US-SA-2025SA113257: US-SA-2025SA113846: US-SA-2025SA113850: US-SA-2025SA114290: