chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I inadvertently gave a 19 year old healthy patient a Shingrix vaccine. I know it can be given to 18+ with immunocompromised situations; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: I inadvertently gave a 19 year old healthy patient a Shingrix vaccine. I know it can be given to 18+ with immunocompromised situations). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 27-MAY-2025 The pharmacist inadvertently gave a 19 year old healthy patient a Shingrix vaccine, which led to inappropriate age at vaccine administration. The reporter know it could be given to 18 years with immunocompromised situations.  The reporter was ask any information on response in healthy individuals.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles before and after the Shingrix vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles before and after the Shingrix vaccines). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by the patient via interactive digital media. The patient contracted with shingles before and after receiving both doses of Shingrix vaccines. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: I got the first shot on wed and my blood sugar has been really high ever since; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blood sugar increased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blood sugar increased (Verbatim: I got the first shot on wed and my blood sugar has been really high ever since). The outcome of the blood sugar increased was not reported.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.     It was unknown if the company considered the blood sugar increased to be related to Shingrix.   Additional Information: GSK receipt date: 25-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had received the first shot on Wednesday, and his/her blood sugar had been really high ever since. The patient was wondered if it was caused by the shot.
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administration of only adjuvant component of the Shingrix; administration of only adjuvant component of the Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 95-year-old female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis.   On 23-MAY-2025, the patient received Shingrix. On 23-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of only adjuvant component of the Shingrix) and inappropriate dose of vaccine administered (Verbatim: administration of only adjuvant component of the Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 23-MAY-2025 The nurse requested guidance and data regarding how to proceed following the administration of only the adjuvant component of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient was administered only the adjuvant portion of Shingrix; a patient was administered only the adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis.   On 20-MAY-2025, the patient received the 1st dose of Shingrix. On 20-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: a patient was administered only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date :23-MAY-2025 The reporter questioned that how to proceed after a patient was administered only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Intravenously administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 793PT, expiry date 29-AUG-2027) for prophylaxis.   On 27-MAY-2025, the patient received Boostrix. On 27-MAY-2025, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Intravenously administration). The outcome of the intramuscular formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-MAY-2025 The health care professional reported that a nurse upstairs administered the Boostrix vaccine intravenously instead of intramuscularly, which led to intramuscular formulation administered by other route. Then the reporter just concern what the potential ramifications of that. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) (batch number 5y9ca, expiry date 31-JAN-2027) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2023).   In MAR-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix Late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 27-MAY-2025 The pharmacist reported that a female adult received Shingrix first dose back in 2023 (no additional data), but then her second dose was on march 2025 which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: two autoimmune diseases; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "two autoimmune diseases".  Clinical course: Three high school sport athlete and two college sport daughters had to give up their swimming and track career after taking the Covid shot. One now has a bad heart and has POTS and the other has two autoimmune diseases.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He has gotten Covid twice after getting the Pfizer Covid 19 Vaccines; He has gotten Covid twice after getting the Pfizer Covid 19 Vaccines; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), outcome "unknown" and all described as "He has gotten Covid twice after getting the Pfizer Covid 19 Vaccines". The reporter stated that the the vaccine caused nothing but harm, the antibodies were gone after 6 weeks, and it didn't protect him at all, he has gotten Covid twice after getting the Pfizer Covid 19 Vaccines.   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-202300133675 Same patient, same product, different AE;
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus
Clinical narrative: Glucose spike/Diabetic; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: DIABETES MELLITUS (medically significant), outcome "unknown", described as "Glucose spike/Diabetic". The patient underwent the following laboratory tests and procedures: Blood glucose: Spike, notes: went from 100 to 267.  Additional information: Caller states he has gotten so many problems from the Pfizer Covid 19 Vaccine. Caller states he just got his Glucose tested and it went from 100 to 402 and he was passing out. Caller states his doctor said it was from the Covid Vaccine. He states he has talked to 2 other friends and they git a Glucose spike, one went from 100 to 267. Caller states they are Diabetic now, everybody was Diabetic now.   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
Symptoms: Blood glucose, Diabetes mellitus
Clinical narrative: Got a Glucose spike / Diabetic; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: DIABETES MELLITUS (medically significant), outcome "unknown", described as "Got a Glucose spike / Diabetic". The patient underwent the following laboratory tests and procedures: Blood glucose: 367, notes: spike/went up to.  Clinical course: Caller stated that he had experienced many problems following the Pfizer COVID-19 vaccine. He reported that he had recently had his glucose tested and it had increased from 100 to 402, and that he was experiencing episodes of passing out. Caller stated that his doctor told him the spike was related to the COVID-19 vaccine. He mentioned that he had spoken with two friends who also experienced glucose spikes one went from 100 to 267 and another went up to 460 and his sister went up to 367, Caller questioned What is the deal with the Covid Vaccine spiking Glucose that you guys said it was safe and effective. Caller stated that he and others are now diabetic, saying, Everybody was diabetic now. Caller stated his Doctor said he has shortened his life by 5 years, 5-10 years.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "got the same glucose spike". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated 3 other friends got the same glucose spike that he just talked to.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109803 Same reporter/product/event; different patient;US-PFIZER INC-202500109802 Same reporter/product/event; different patient;
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cardiac flutter, Extrasystoles, Palpitations, Ventricular extrasystoles
Clinical narrative: Heart Palpitations which began the next morning.  I was put on a heart monitor and diagnosed with (PVC) Premature Ventricular Contractions.  My heart was fluttering every 3-7 minutes every day until bedtime for 5 days then it started 3 days later.  This went on for  6 months straight.  The skipping, palpitation, & fluttering slowed down tremendously but haven't completely gone away.  From time to time at least weekly my heart goes into palpitations.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Myalgia, Myelitis transverse
Clinical narrative: Autonomic dysfunction, transverse myelitis, muscle pain
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: Right arm is painful, soreness when its touched, redness, body aches, chills, fatigued.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Tenderness
Clinical narrative: Right arm is painful, soreness when its touched, redness, body aches, chills, fatigued.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt in clinic for vaccines, given HepA vaccine too early.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC20
Symptoms: No adverse event
Clinical narrative: No adverse reaction at this time.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain, Pain of skin, Skin warm, Urticaria
Clinical narrative: *COVID Vaccine (a mRNA vaccine) 1/15/21, 2/10/21, &11/18/21): SIGNIFICANT and  PERMANENT increase in Proteinuria & Glomerulonephritis, which was found 6 weeks later during routine labs. CKD decline after first two covid vaccines, AND AGAIN (more damage) after 11/2021 vaccine. Was reported on VAERS. Of note: I got a Tetanus vaccine booster: Tdap (ADACEL) (Tetanus, diphtheria, acellular pertussis)  on 4/21/25 & had no NO PROBLEMS. *RSV Vaccine (a mRNA vaccine, Arexvy) 5/27/25: At 12 hours, welts, red, & painful.  At 24 hours, less ?welty,? still red and painful. At 36 hours, now warm, red, and more painful, still slightly raised (cortisone to site and ice x 1 hour). At 42 hours, still red, warm, and painful to light touch, still slightly raised (took Zyrtec). Will not know if this mRNA vaccine will cause another decline in renal function until next lab draw  in July, unless nephrologist wants to do earlier. Dr informed of allergic reaction. *I do not think [remember] if I had a localized reaction to the Covid vaccines.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Palpitations, Swollen tongue
Clinical narrative: 16 minutes after the vaccine my tongue swelled. The pharmacy said to walk around the store for 15 minutes. I walked out to the car and my tongue swelled, my heart raced. I turned around and went back into the store. I reported it to the pharmacist but the swelling subsided. I don't know if the pharmacist reported this in the system. Since this vaccine, I have not received any more covid vaccines. I have had joint pain since this date also.
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB, MMR, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave Vaxelis  for ages 6 weeks through 4 years, pt is age 5.  Pt had not received any vaccines therefore needed several. RN focused on decreasing number of needle sticks and overlooked age limit. Should have given  Pediarix.  Ct did not experience any adverse SE's. no clinic or ER etc visit required. Upon discovering error  this RN contacted VFC help desk who advised "no vaccines have to be re given but VAERS report should be done".
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Staff made vaccination error on a 2nd dose of a hep B vaccine.  The 2nd vaccine of the Heplisev vaccine was given too early, the patient will need to be re-vaccinated. The first dose was given 5/14/2025. The second vaccine should have been given at least 4 weeks apart according to the CDC.   I was working too fast and did not pay enough attention to the vaccination dates. This was my error. The patient will need to return to the clinic for his 2nd Hep B vaccine. The patient will be contacted. The patient's pcp has already been contacted as well for safety.  CDC was contacted, the vaccine preformed on 5/16/2025 does not count as completing the series. The patient will need to return to the clinic for his 2nd Hep B vaccine.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Swelling face
Clinical narrative: pt stated that her right jaw was swollen for 2 day and she could not eat anything until swelling resolved 2 days later
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Patient experienced Syncope after receiving vaccinations. Vaccines were administered in both arms intramuscular. Tdap and Menveo given first in the left arm, then HPV in the second arm. Patient was sitting on the exam table while the vaccines were being administered. As the vaccines were being disposed of in the sharps container Patient lost consciousness and fell off the exam table to the right. Patient was still sitting on the exam table when she experienced the syncope. Event happened approximately 30 seconds to a minute after the administration of the HPV vaccine which was done last. Patient hit the right side of her head and regained consciousness in 15 to 30 seconds. After regaining consciousness Patient appeared to be fine and was re-examined by the Doctor. Repeat blood pressure was done after the event. Blood pressure was 110/60. Blood sugar was also taken after the event. Blood sugar was 105. Mother stated Patient had not eaten anything before the vaccines were administered.
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "got the same glucose spike". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated 3 other friends got the same glucose spike that he just talked to.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109801 Same reporter/product/event; different patient;US-PFIZER INC-202500109803 Same reporter/product/event; different patient;
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Anxiety, Cognitive disorder, Depressed mood
Clinical narrative: After my son got the vaccine his cognitive ability declined. He was good in math and could no longer do math work anymore. His anxiety went up and he was not as happy as he use to be. He had a very sharp decline in his ability to critical think.  He no longer can pick up on social cues it was like it got autism and we are looking to get him tested for it. The court order at the time for our parenting plan stated that i had joint medical decision making and this was done illegally with out my consent and the doctors did not call to speak with me about the decision. My son has been with his dad a victim of abuse.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Feeling hot, Muscle spasms
Clinical narrative: The patient and I were sitting discussing something and she suddenly got very dizzy about one minute after receiving the second dose of the vaccine. She immediately turned bright red and said she was hot when asked. I checked the site of administration and besides a little blood for which a band-aid was applied, nothing looked abnormal. The patient was given water and fanned for a couple of minutes. Then she developed cramps in her back and then her legs. I stepped out to verify if this sort of reaction had been reported.  Temperature was checked on both arms and they were both warm. She started to regain normal color in her face, so she was given time to sit alone and relax. She was checked on after about 7 minutes and her color was back to normal and the cramps had gone away. She stated before the vaccine that she had had no reaction to the first dose.
Age: 12.0
Sex: M
Vaccine: TD, TD
Symptoms: Cognitive disorder, Depression, Illiteracy, Loss of personal independence in daily activities, Reading disorder
Clinical narrative: I was not there not there and again current court order, Mother did not consent and it was against my will the father and doctor did not call me. I filed a police report. As soon as my son got this shot he became even worse he can barley critically think he can not live on his on. And it was obvious after the first round that he was acting more immature. And then when we got to this last round of vaccine my son was starting to fail school he almost had to stay back. He lost all motivation to really be active and social. He currently has a high level social anxiety and was diagnosed with depression and i think the mild autism that he had is even worse. He has verbal issues and what he wants to say the opposite comes out of his mouth. He is having issues with reading. And when you speak to him at a normal pass he will ask you to slow down. He is not able to  speak with you at a normal pass his congnivate ability has gone down. Now at this time he was living with his dad. But his dad moved back and my son wanted to try to live with his dad full time. Against my better judgement. And i didn't not find out about this vaccine for a year or two after he got it. And i just got this report and looked at it for the first time. When i filed the police report it was the same day that i found out - 03/14/2025. I just moved a month before. My son had said something but didn't know what vaccine it was and the dad did not tell me. He is currently visiting friends for the summer that where he dad lives but he is not in contact with him or have a relationship with him. I have 2 cases. His last Dr, states we need to get him neurologically tested.
Age: 12.0
Sex: M
Vaccine: TD, TD
Symptoms: Social anxiety disorder, Thinking abnormal
Clinical narrative: I was not there not there and again current court order, Mother did not consent and it was against my will the father and doctor did not call me. I filed a police report. As soon as my son got this shot he became even worse he can barley critically think he can not live on his on. And it was obvious after the first round that he was acting more immature. And then when we got to this last round of vaccine my son was starting to fail school he almost had to stay back. He lost all motivation to really be active and social. He currently has a high level social anxiety and was diagnosed with depression and i think the mild autism that he had is even worse. He has verbal issues and what he wants to say the opposite comes out of his mouth. He is having issues with reading. And when you speak to him at a normal pass he will ask you to slow down. He is not able to  speak with you at a normal pass his congnivate ability has gone down. Now at this time he was living with his dad. But his dad moved back and my son wanted to try to live with his dad full time. Against my better judgement. And i didn't not find out about this vaccine for a year or two after he got it. And i just got this report and looked at it for the first time. When i filed the police report it was the same day that i found out - 03/14/2025. I just moved a month before. My son had said something but didn't know what vaccine it was and the dad did not tell me. He is currently visiting friends for the summer that where he dad lives but he is not in contact with him or have a relationship with him. I have 2 cases. His last Dr, states we need to get him neurologically tested.
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Cough, Discomfort, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash on arm  slightly down arm from injection site , patient says painful to touch and beneath skin, slightly swollen,. Patient feels like she has covidlike symptoms of achy all over , feels heaviness all over, with runny nose and cough
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Nasopharyngitis, Pain, Rhinorrhoea
Clinical narrative: Rash on arm  slightly down arm from injection site , patient says painful to touch and beneath skin, slightly swollen,. Patient feels like she has covidlike symptoms of achy all over , feels heaviness all over, with runny nose and cough
Age: 0.25
Sex: F
Vaccine: RV1
Symptoms: Erythema, Irritability
Clinical narrative: Patient's mom stated she has not noticed any redness, irritability, or any other symptoms on patient.
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Balance disorder, Condition aggravated, Eye infection, Facial pain, Fall
Clinical narrative: pt states her severe chronic fatigue was triggered and her sinuses became infected. She had eye infection in her right eye and severe headache. Her equilibrium is not the same. She went to ER due to the pain and she was falling. They were going to admit her but they ended up sending her home because there were a lot of covid patients there.  She is going clinic seeing Dr. He has her antibiotics for the sinus infection but she continues to have a terrible headache and now her entire face hurts. She also has pain from her waist down. She feels like these symptoms were all brought on or made worse by the pneumonia vaccine.
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Fatigue, Headache, Laboratory test, Pain, Sinusitis
Clinical narrative: pt states her severe chronic fatigue was triggered and her sinuses became infected. She had eye infection in her right eye and severe headache. Her equilibrium is not the same. She went to ER due to the pain and she was falling. They were going to admit her but they ended up sending her home because there were a lot of covid patients there.  She is going clinic seeing Dr. He has her antibiotics for the sinus infection but she continues to have a terrible headache and now her entire face hurts. She also has pain from her waist down. She feels like these symptoms were all brought on or made worse by the pneumonia vaccine.
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Balance disorder, Dysstasia, Laboratory test, Malaise, Middle ear effusion
Clinical narrative: pt states her severe chronic fatigue was triggered and her sinuses became infected. She had eye infection in her right eye and severe headache. Her equilibrium is not the same. She went to ER due to the pain and she was falling. They were going to admit her but they ended up sending her home because there were a lot of covid patients there.  She is going clinic seeing Dr. He has her antibiotics for the sinus infection but she continues to have a terrible headache and now her entire face hurts. She also has pain from her waist down. She feels like these symptoms were all brought on or made worse by the pneumonia vaccine.
Age: 19.0
Sex: F
Vaccine: IPV, TDAP, TYP
Symptoms: Dizziness, Erythema, Fall, Head injury, Pallor
Clinical narrative: After vaccines were administered client c/o feeling dizzy while sitting in office chair. Clients color became very pale and as this nurse was walking to client around the desk the client fainted and fell to the floor striking right side of face and head. Client was turned over on back and was awake but confused about where she was at. Client was reoriented and legs elevated. Vital signs were 102/68 BP, 74HR, 16R, 99% O2 sat. Client was clammy and shaky. Client assisted to sitting position on floor and cool ice pack placed to back of neck. Client was able to move all extremities and state her name and todays date. Abrasions to right cheek were noted. Small redness present underneath right lower eyelid. Second larger abrasion to mid cheek approximately 2 inches long and third abrasion to jaw area round and approximately 2 inches. Scant amount of blood coming from jaw abrasion. All areas cleaned with soap and water and ice pack applied to area. Client c/o of mild pain in abrasion area but no other pain elsewhere. Client spoke with parents and declined calling 911. Advised client to have family member pick her up. Grandfather picked client up and client left office in stable condition. Client advised to follow up with PCP and call 911 if experiencing any dizziness, increase pain, or excessive tiredness.
Age: 19.0
Sex: F
Vaccine: IPV, TDAP, TYP
Symptoms: Skin abrasion, Syncope
Clinical narrative: After vaccines were administered client c/o feeling dizzy while sitting in office chair. Clients color became very pale and as this nurse was walking to client around the desk the client fainted and fell to the floor striking right side of face and head. Client was turned over on back and was awake but confused about where she was at. Client was reoriented and legs elevated. Vital signs were 102/68 BP, 74HR, 16R, 99% O2 sat. Client was clammy and shaky. Client assisted to sitting position on floor and cool ice pack placed to back of neck. Client was able to move all extremities and state her name and todays date. Abrasions to right cheek were noted. Small redness present underneath right lower eyelid. Second larger abrasion to mid cheek approximately 2 inches long and third abrasion to jaw area round and approximately 2 inches. Scant amount of blood coming from jaw abrasion. All areas cleaned with soap and water and ice pack applied to area. Client c/o of mild pain in abrasion area but no other pain elsewhere. Client spoke with parents and declined calling 911. Advised client to have family member pick her up. Grandfather picked client up and client left office in stable condition. Client advised to follow up with PCP and call 911 if experiencing any dizziness, increase pain, or excessive tiredness.
Age: 64.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Angioedema
Clinical narrative: Angioedema, has had the Tdap vaccine before
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Multiple sclerosis, Diagnosed a year and a half later, left sided numbness, drop foot
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple sclerosis, Peroneal nerve palsy, X-ray
Clinical narrative: Multiple sclerosis, Diagnosed a year and a half later, left sided numbness, drop foot
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Anaphylactic reaction, Chest pain, Dysphagia, Pharyngeal swelling, Urticaria
Clinical narrative: Pt complained of chest pain, vomiting, started to feel throat swelling, difficulty swallowing, hives on face consistent with anaphylactic reaction. 911 was called. Prior to EMS arrival, patient was given epinephrine 0.3 mg IM R arm and 25 mg liquid benadryl which he vomited up.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Pt complained of chest pain, vomiting, started to feel throat swelling, difficulty swallowing, hives on face consistent with anaphylactic reaction. 911 was called. Prior to EMS arrival, patient was given epinephrine 0.3 mg IM R arm and 25 mg liquid benadryl which he vomited up.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20
Symptoms: Swelling face
Clinical narrative: mom reports swollen face 30 min after leaving the office, patient sent to ER.  At hospital mom reports right side of patient face swelled 20 min after vaccine administration. mom reports giving the patient Motrin after vaccinations. but swelling largely resolved by the time patient seen at ER.  seen at ER f/u on 5/29/2025: no facial swelling noticed by provider and patient overall in good health.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Altered state of consciousness, Listless, Pallor
Clinical narrative: BRUE that afternoon. Became pale and listless, turned blue.  Altered consciousness for up to 2 minutes, then returned to baseline.
Age: 45.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Cellulitis, Erythema, Injection site induration, Peripheral swelling
Clinical narrative: Patient came in to the pharmacy on 05/29/25 to pick up antibiotics and report the adverse event. She received Boostrix on 05/22/25 and approx.  36 hours later her arm was red and puffy with a hard lump around injection site. She was seen by a MD and was diagnosed with cellulitis.  She also reported red streaks on her arm. Patient received antibiotic on 05/29/25.
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "got the same glucose spike". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated 3 other friends got the same glucose spike that he just talked to.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109801 Same reporter/product/event; different patient;US-PFIZER INC-202500109802 Same reporter/product/event; different patient;
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Yellow fever vaccine administered subcutaneously in patient's left arm while she was seated on exam table. About three minutes later, patient lost consciousness, slid off exam table, and hit head on floor. Patient regained consciousness within a few minutes and was alert and oriented x4.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events reported. Kinrix given instead of separate DTaP / Polio.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: ptnt did not come in but called. Arm stated to be red and swollen at site and hurting.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed Red rash on arm after receiving her immunizations.  8 days after receiving the immunization patient still has the rash patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient showed her doctor the injection site which was bigger than normal and she described it as hot.  He asked her to come back to the pharmacy for us to report the potential issue to VAERS. She was advised that it should go down significantly in the next day or two and if it got any bigger or did not go down to go back to her doctors office
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient came in on May 29, 2025, and said within 24 hours her arm was red and hurt for about a week. It resolved on its own and she didn't seek medical help.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Dizziness, Headache, Loss of consciousness, Malaise
Clinical narrative: Before getting the vaccine she warned me that she has issues with needles so I told her to remain seated after the vaccine until she felt like she sure she would not have any issues from the injection. I couple minutes after the injection she said she did not feel well: dizzy and headache. I offered her water but before  I could go get it she starting feeling worse and she started to lean back in the chair and passed out for just a few moments. I was holding her up to make sure she didn't fall then I had a tech  help me lower her to the floor. We called a code white and an ambulance was called. The EMS team checked her out and determined she had an anxiety attack when I gave her the vaccine. She stabilized and refused transport to hospital and left with family member.
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Blood creatinine increased, C-reactive protein increased, Decreased appetite, Hepatic enzyme increased, Rash
Clinical narrative: Client reported rash to face, neck and torso along with loss of appetite and one episode of vomiting.  Denied fever and/or chills.  She was seen by Urgent Care and given Pepcid and Claritin.  She was instructed to follow up with her PCP the following day.  On 5/23/25, she saw NP at Clinic where her CRP, creatinine and liver enzymes were elevated.  She given one liter IV fluids and instructed to hydrate at home and to return to clinic on 5/26/25.  She was seen most recently on 5/26/25, where repeat liver and renal lab results were improved.  Potassium was still elevated.  Client still reported fatigue but rash was improved.  She was instructed to return for labs again on 5/29/25.
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: Client reported rash to face, neck and torso along with loss of appetite and one episode of vomiting.  Denied fever and/or chills.  She was seen by Urgent Care and given Pepcid and Claritin.  She was instructed to follow up with her PCP the following day.  On 5/23/25, she saw NP at Clinic where her CRP, creatinine and liver enzymes were elevated.  She given one liter IV fluids and instructed to hydrate at home and to return to clinic on 5/26/25.  She was seen most recently on 5/26/25, where repeat liver and renal lab results were improved.  Potassium was still elevated.  Client still reported fatigue but rash was improved.  She was instructed to return for labs again on 5/29/25.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: pt has red warm area on right this where vaccines was given. she also has a reported fever from mom of 100.9
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Incessant dry coughing, wheezing, raging headache, diarrhea, nausea, intermittent fever, chills, fatigue.  Most symptoms disappeared after 24 hrs, but coughing, wheezing, headache, and fatigue lasted 2+ days.  I was bed-ridden for 2 full days.  I have NEVER had a reaction remotely like this to any vaccine.  The shot site on my arm may be sensitive and my muscles may ache a bit, but this was significantly more intense.  Something in the 2025 COVID vaccine formulation was problematic for me.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pyrexia, Wheezing
Clinical narrative: Incessant dry coughing, wheezing, raging headache, diarrhea, nausea, intermittent fever, chills, fatigue.  Most symptoms disappeared after 24 hrs, but coughing, wheezing, headache, and fatigue lasted 2+ days.  I was bed-ridden for 2 full days.  I have NEVER had a reaction remotely like this to any vaccine.  The shot site on my arm may be sensitive and my muscles may ache a bit, but this was significantly more intense.  Something in the 2025 COVID vaccine formulation was problematic for me.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash, Rash erythematous
Clinical narrative: Patient stated the day after receiving the vaccine, she developed a red rash at the injection site and also a bruise on her arm below where she received the injection. She still has a rash and bruise 6 days later.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary sarcoidosis, Sarcoidosis
Clinical narrative: Sarcoidosis in her lungs, 1.7cm nodules in her lungs; 1.7cm nodules around her spleen and in her legs; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: PULMONARY SARCOIDOSIS (medically significant), outcome "unknown", described as "Sarcoidosis in her lungs, 1.7cm nodules in her lungs"; SARCOIDOSIS (non-serious), outcome "unknown", described as "1.7cm nodules around her spleen and in her legs". The events "sarcoidosis in her lungs, 1.7cm nodules in her lungs" and "1.7cm nodules around her spleen and in her legs" required physician office visit.  Clinical course: The reporter stated his wife got Sarcoidosis in her lungs, 1.7cm nodules in her lungs, around her spleen and in her legs. Reporter stated about 9 months after the Pfizer Covid Vaccine she went to her doctor and was told she has nodules all in her lungs. His wife was never by chemicals and never by anything. Doctor said initially they didn't know what it was from, but now it is listed as a side effect that it could cause Sarcoidosis. Reporter stated that the vaccine causes nothing but harm.    The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Pain in extremity
Clinical narrative: Patient received vaccination approximately 4:30pm on 5/24. Seemed to be ok at that time. Patient called on 5/26  maybe around noon and stated that her arm hurt and it was difficult to move. At that time (since I personally have had a sore arm for several days) I advised to use cold compresses and take tylenol or ibuprofen.  Patient was still having issues with her arm being sore/red and difficult to move by 5/28 so she made appointment with primary care MD. He stated that it appeared that she had infection and proceeded to prescribe an antibiotic (cephalexin). Patient called pharmacy around 5:35 pm on 5/29 to let us know what had happened.
Age: 68.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Malaise
Clinical narrative: ON 5/26/25- PATIENT STARTED WITH MALAISE & PATIENT TOOK THERAFLU AND FELT BETTER.  THE FOLLOWING DAY THE PATIENT NOTICED THE AREA ON THE RIGHT ARM WAS HARD, HOT TO THE TOUCH AND RED.. THE PATIENT THEN CAME TO THE PHARMACY WHERE SHE WAS INSTRUCTED TO START A PAIN RELIEVER, ANTIHISTAMINE, AND WARM COMPRESS TO THE AFFECTED AREA.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died 6 Days after getting the Pfizer Covid 19 Vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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, medically significant), outcome "fatal", described as "died 6 Days after getting the Pfizer Covid 19 Vaccine". The date and cause of death for the patient were unknown.  Clinical course: Reporter stated his Mother in Law died 6 Days after getting the Pfizer Covid 19 Vaccine and she was perfectly fine and they listed the vaccine as the cause on her death certificate.  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
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 66-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization completed), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID After Pfizer Shots". Patient got the booster then still got COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.