chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: consumer's mother denied any adverse reactions or side effects. No additional AE reported. No PQC reported.; PROQUAD was administered to a 7-month-old on 4/4/2024.; This spontaneous report was received from a nurse regarding to a 7-month-old patient of unknown gender. The patient's medical history, concomitant therapies, dug reactions or allergies were not reported.  On 04-APR-2024, the patient was inadvertent vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, lot number X023400 (lot number X023400 had been verified to be valid lot number for measles, mumps, rubella and varicella [Oka-Merck] virus vaccine live), expiration date 20-MAR-2025, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical injection site were not provided) (product administered to patient of inappropriate age).  Upon follow up visit, the consumer's mother denied any adverse reactions or side effects. No additional adverse event (AE) reported. No product quality complaint (PQC) reported. No additional information provided.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: Patient gave birth after 35 weeks and 1 day; This is a spontaneous report received from a Physician from medical information team, Program ID:.  A 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 was 34 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE DELIVERY (non-serious), outcome "unknown", described as "Patient gave birth after 35 weeks and 1 day". The baby was delivered premature.  Additional Information: The reporting physician had a patient who received the Abrysvo vaccine 34 weeks in her pregnancy but gave birth after 35 weeks and 1 day (the baby was born about 5 to 6 days later after getting the vaccine). The doctor would like to know if that is enough time to be protected or if they should give another shot to the baby with the antibodies against the RSV. The physician explained that if they had to give the baby a shot it would be nirsevimab (BEYFORTUS) which would give the baby antibodies. She was not sure if there would be enough antibody response or if the baby would have enough protection being born 5 to 6 days after the patient was vaccinated with Abrysvo or if they would now need to give the nirsevimab shot. The patient is curently breastfeeding.   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: Linked Report(s) : US-PFIZER INC-202400283473 Baby case;
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: reaction got stronger every time; hypersensitive reaction; My arm got swollen and was really painful; My arm got swollen and was really painful; This is a spontaneous report received from an Other HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 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 NOS (DOSE 1), for Covid-19 Immunization, reaction(s): "hypersensitive reaction", "My arm got swollen and was really painful"; BNT162B2 NOS (DOSE 2), for Covid-19 Immunization, reaction(s): "reaction got stronger every time", "hypersensitive reaction", "My arm got swollen and was really painful". The following information was reported: CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "reaction got stronger every time"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "hypersensitive reaction"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "My arm got swollen and was really painful". Clinical course: the patient's first 3 doses of Covid-19 vaccine were Pfizer and stated "the reaction got stronger every time". The patient stated "like two days where they would stay in bed almost like and hypersensitive reaction". Also mentioned their arm got swollen and was really painful. The patient fourth Covid-19 vaccine was Moderna and mentioned "the reaction was not that bad".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided and known drug safety profile, the causal association between the event hypersensitivity and condition aggravated; and the suspect drug BNT162B2 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-202400282152 same reporter/patient/event, different vaccine dose;US-PFIZER INC-202400282441 same reporter/patient/event, different vaccine dose;
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Low grade fever; headache; nauseous; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Oct2024 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 21Oct2024, outcome "recovering", described as "Low grade fever"; HEADACHE (non-serious) with onset 21Oct2024, outcome "recovering"; NAUSEA (non-serious) with onset 21Oct2024, outcome "recovering", described as "nauseous". Therapeutic measures were not taken as a result of pyrexia, headache.  Additional Information: The patient was nauseous last night on 21Oct2024 and was feeling better on the morning of 22Oct2024. The patient did not receive any other vaccines on the same date and within 4 weeks prior to the suspect vaccine. The patient was not taking any other medications within 2 weeks of the event starting. The patient had no known allergies.   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: Malaise, Vaccination site pain
Clinical narrative: Malaise; injection site pain; This is a spontaneous report received from an Other HCP from a sales representative.  An adult female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 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: MALAISE (non-serious) with onset Oct2024, outcome "recovered" (Oct2024); VACCINATION SITE PAIN (non-serious) with onset Oct2024, outcome "recovered" (Oct2024), described as "injection site pain". Therapeutic measures were not taken as a result of malaise, vaccination site pain.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Generalised oedema
Clinical narrative: it got significantly worse in the third time swelling; it got significantly worse in the third time swelling; This is a spontaneous report received from a Nurse.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 31 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: YASMIN taken for contraception. Vaccination history included: BNT162b2 (DOSE 1, SINGLE (Lot number: EL0140)), administration date: 28Dec2020, when the patient was 30-year-old, for COVID-19 immunisation, reaction(s): "It didn't feel unwell"; BNT162b2 (DOSE 2, SINGLE (Lot number: EL3247)), administration date: 16Jan2021, when the patient was 30-year-old, for COVID-19 immunisation, reaction(s): "my whole left side of my body swelled from my neck", "All of the lymph nodes became inflamed". The following information was reported: GENERALISED OEDEMA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "it got significantly worse in the third time swelling". Therapeutic measures were not taken as a result of generalised oedema, condition aggravated.  Additional information: The patient felt progressively worse with every shot. It got significantly worse in the third time swelling.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400284106 same patient and suspect drug, different dose;US-PFIZER INC-202400284284 same patient and suspect drug, different dose;
Age: 56.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Laboratory test, Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN taken for diabetes mellitus (the patient stated that everyday something was wrong with him and thought that valsartan had something to do with diabetes); ROSUVASTATIN taken for blood cholesterol abnormal, hypertension. The following information was reported: PERICARDITIS (hospitalization), outcome "unknown". The patient was hospitalized for pericarditis (start date: 20Oct2024, discharge date: 21Oct2024, hospitalization duration: 2 day(s)). The patient thought that he was having a heart attack, but they ended up finding out it was pericarditis. The patient stated that it could be a possible side effect of the new Pfizer vaccine (COVID-19 vaccine); he thought it's very small chances, but he did think it should be reported. The patient underwent the following laboratory tests and procedures: Lab test: (21Oct2024) Unknown Results. Therapeutic measures were taken as a result of pericarditis as the patient was given three new drugs, colchicine, indomethacin and levothyroxine;  one of them, the patient was not sure which one, was for something else that they found while the patient was in the hospital. 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: Vaccination site pain, Vaccination site pruritus
Clinical narrative: had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots; had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots; This is a spontaneous report received from a Nurse.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "had some itchiness and soreness the evening before but no more than I've exp with prev COVID shots".  Additional information: Patient reported that morning after vaccination area where received was itchy and I felt a small lump (had some itchiness and soreness the evening before but no more than I've experienced with prev COVID shots). As day went on the itching got worse. and the lump became wider and harder. Area of arm was sore and when I checked in mirror saw a large welt-looked like a bad bug bite. By Sun evening had trouble sleeping due to the itchiness and tenderness at the site.  PA prescribed 3 days of Prednisone and Zyrtec. The patient did not receive other vaccine in four weeks and received other medication in two weeks.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (hospitalization) with onset Aug2024, outcome "unknown". The patient was hospitalized for bell's palsy (start date: 2024, discharge date: 2024). The event "bell's palsy" required emergency room visit. The patient was in the ICU for 6 days.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: I gave pt 6 months to 4 year vaccine vile which was already diluted from two days ago so it should have been thrown after 12 hours. I did not know that and it was drawn up and administered.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given adult dose (12 years and older) of Spikevax.
Age: 3.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given adult dose of Moderna Spikevax 0.5 mL, no known adverse reactions.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site nodule, Pruritus, Skin warm, Tenderness
Clinical narrative: My left shoulder became red, warm, tender and mild itching.  no fever or chills. it resolved spontaneous but after I am left with a nodule in my left deltoid region.
Age: 28.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dyspnoea, Feeling abnormal, Posture abnormal, Unresponsive to stimuli
Clinical narrative: After giving the flu shot to the patient in the right deltoid muscle, the patient became unresponsive, slouched over in the chair and began breathing heavily as if they were snoring. They remained in this position for an estimated 10 seconds with me holding them upright to avoid having them fall off the chair, once I called out for the other pharmacist the patient became responsive once again and was not aware of the events during the 10 seconds. They reported feeling "out of it" for a few minutes after the event, we did monitor the patient for roughly 15 minutes until the patient felt fine to leave the pharmacy.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: PT EXPERIENCED ICTHING, LARGE SURFACE AREA THAT IS RED AND IS HOT TO THE TOUCH. SHE IS  TAKING BENADRYL AND IBUPROFEN FOR THE LAST 4 DAYS
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pt was given covid vaccine for 6 months to 4 years of age already diluted from Tuesday. But after 12 hours it was supposed to thrown out already. I did not know that. I still administered.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy, Cutaneous vasculitis, Electrophoresis, Full blood count, Haematocrit
Clinical narrative: B/L rash appeared on both feet 12 hours after vaccination was given. Rash then spread up both legs and onto hands and arms paired with significant GI upset. Rash was later diagnosed as Cutaneous small vessel vasculitis. Patient was seen in the ER twice, by primary care 3 times and Dermatology. Rash began to subside 2 weeks after onset with treatment of Prednisone.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Haemoglobin, Metabolic function test, Rash, Urine analysis
Clinical narrative: B/L rash appeared on both feet 12 hours after vaccination was given. Rash then spread up both legs and onto hands and arms paired with significant GI upset. Rash was later diagnosed as Cutaneous small vessel vasculitis. Patient was seen in the ER twice, by primary care 3 times and Dermatology. Rash began to subside 2 weeks after onset with treatment of Prednisone.
Age: 0.17
Sex: M
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: Pt was given the wrong rsv vaccine. He was given the Ob teen vaccine and not the infant one.
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Due to misreading of the labels on a busy clinic day, the patient was accidentally given the pedvaxHIB which has "meningococcal" on the label versus given the meningococcal immunization for a 16 year old.  The patient's mother was contacted today once this error was identified and notified of the incorrect immunization being administered. Management also informed of this incident. The mother states that Patient is doing well. Patient has an appointment with us tomorrow for blood work (will check to ensure that she is still doing well) and a f/u appointment w/ me in 4-6 weeks for medication follow-up at which time we will administered the meningococcal immunization if patient and parents still want to proceed.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Musculoskeletal discomfort, Paraesthesia
Clinical narrative: Started with shoulder blade discomfort. The shoulder blade discomfort went away. Then she started having tingling in elbow, extending down to her index finger.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Brain fog, Chronic fatigue syndrome, Dizziness, Electric shock sensation
Clinical narrative: Experienced major Gastrointestinal Issues, only weeks after vaccination, including vomiting, stomach cramps, dizziness, Brian Fog, Exercise Intolerance,  Chronic Fatigue, Heart Palpitations, Muscle Aches, Numbness and Tingling all over body, Electric shock sensations. I was subsequently Diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, and Small Fiber Neuropathy. I was an athlete before taking these vaccines, now I am bedridden and housebound much of the time and can no longer work. My entire life is ruined.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Exercise tolerance decreased, Fatigue, Hypoaesthesia, Impaired work ability, Mobility decreased
Clinical narrative: Experienced major Gastrointestinal Issues, only weeks after vaccination, including vomiting, stomach cramps, dizziness, Brian Fog, Exercise Intolerance,  Chronic Fatigue, Heart Palpitations, Muscle Aches, Numbness and Tingling all over body, Electric shock sensations. I was subsequently Diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, and Small Fiber Neuropathy. I was an athlete before taking these vaccines, now I am bedridden and housebound much of the time and can no longer work. My entire life is ruined.
Age: 32.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Myalgia, Palpitations, Paraesthesia, Small fibre neuropathy, Vomiting
Clinical narrative: Experienced major Gastrointestinal Issues, only weeks after vaccination, including vomiting, stomach cramps, dizziness, Brian Fog, Exercise Intolerance,  Chronic Fatigue, Heart Palpitations, Muscle Aches, Numbness and Tingling all over body, Electric shock sensations. I was subsequently Diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, and Small Fiber Neuropathy. I was an athlete before taking these vaccines, now I am bedridden and housebound much of the time and can no longer work. My entire life is ruined.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: patient started with red spotty rash on the body  on tuesday 10/22/24) that developed into hives and then circular rashes that looks like bulls eyes on 10/24/24.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Dizziness, Electrocardiogram
Clinical narrative: I was losing my balance starting on the 17th of October and continuing.  On October 21st  I began feeling light-headed and dizzy. And, I am still experiencing dizziness now on October 24th.  I went to urgent care at 9:00 pm on October 22nd.  Informed them that I had taken a Covid shot.  They didn't make the connection with the vaccine. Took my vitals and blood pressure multiple times and did an EKG. I didn't make the connection that it could have been the vaccine until today.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Disclosure to patient regarding receiving 2nd dose of RSV vaccine. Current guideline states only 1 RSV Vaccine is needed. At the time of the outreach, there was No adverse effect or any symptom that patient has reported. Patient stated feeling fine after the administration except for a little soreness on the site. Other than this, everything went back to normal after a day or so. This report is only for awareness...there was no untoward or adverse reaction reported by the patient.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Pain, Pain in jaw
Clinical narrative: Patient called this morning stating that she received her second dose of the Shingles vaccines yesterday and is reporting a reaction to it. Patient states she received the vaccine around 2:30 pm and states she felt symptoms right after (patient did not report any symptoms to the staff yesterday). She states she could not sleep d/t pain located in the right side of the body. She reports that the pain begins from her head (back and top) to her feet, describes it as "really uncomfortable" and rates it an 8/10. She also reports pain in her "teeth and jaw" on her right side. She reports shivering and feeling cold, states her forehead was warm yesterday but did not check her temperature. She is also reporting feeling "really weak." She denies any SOB, chest pain, hives, trouble breathing, or swelling in her face/throat at this moment. I advised pt to be taken to ER today for evaluation of her symptoms. She verbalizes understanding. Patient was at work at the time of our call, but states she is trying to find someone to take her. Informed pt to call ambulance if she cannot find someone to take her. She verbalizes understanding of message. Provider was informed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Toothache
Clinical narrative: Patient called this morning stating that she received her second dose of the Shingles vaccines yesterday and is reporting a reaction to it. Patient states she received the vaccine around 2:30 pm and states she felt symptoms right after (patient did not report any symptoms to the staff yesterday). She states she could not sleep d/t pain located in the right side of the body. She reports that the pain begins from her head (back and top) to her feet, describes it as "really uncomfortable" and rates it an 8/10. She also reports pain in her "teeth and jaw" on her right side. She reports shivering and feeling cold, states her forehead was warm yesterday but did not check her temperature. She is also reporting feeling "really weak." She denies any SOB, chest pain, hives, trouble breathing, or swelling in her face/throat at this moment. I advised pt to be taken to ER today for evaluation of her symptoms. She verbalizes understanding. Patient was at work at the time of our call, but states she is trying to find someone to take her. Informed pt to call ambulance if she cannot find someone to take her. She verbalizes understanding of message. Provider was informed.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Significant arm swelling, erythema, hot to touch, painful. Onset 1 day after vaccination. Time of presentation to pharmacy 2 days post vaccination.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site pain, Pyrexia
Clinical narrative: The patient received the incorrect dosage of the COVID vaccine at our Influenza Vaccination Campaign on 21 October, 2024.  The child is 11 years old and received a 2024 Pfizer COVID vaccination intended for patients 12 years and older (Lot #: LM2219, Exp: 03/29/2025, Site: right deltoid).   I have contacted the patient?s father & mother, and the child is doing well with no serious adverse effects. The father reported the child had mild soreness at the injection site, and a mild fever that went away with ibuprofen. I told the family I will follow up with them on Saturday as well. We went over the manufacturer?s information and dosage information for the 2024 Pfizer COVID-19 vaccination. The father reported he had no further questions.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was mistakenly given 2 doses of Fluad within 1 season.  No adverse reaction reported from patient
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Heat and swelling starting at site of administration and radiating down arm.  Is improving
Age: 52.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Joint swelling
Clinical narrative: mild swelling on ankles
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: patient received 2 flu shots by error, shot in September and another shot in October
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 2 doses of Fluad within the same season. patient had no adverse reactions
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given at age 68 without any underlying conditions to qualify for prior to age 75
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 6 hours after the vaccine she got hives (undearms, groin, abdomen, and sporadically elsewhere). She did a televisit to get steroids, benadryl, and pepcid to treat issue
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 2 days post vaccination patients injection site is erythematous, painful, warm to the touch, and may be purulent
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: pt had red splotchy injection site, pt stated it was hot and itchy
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently administered an adult high-dose trivalent influenza vaccine instead of appropriate vaccine for pt age of 12 yrs.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tinnitus
Clinical narrative: Tinnitus - ringing in right ear
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Hospital annual flu vaccine. I don?t know the name. Last year I felt like my throat was closing up. I took Benadryl and felt better. This year I had another shot, but it was a lot worse. Throat closing up tightness itchy. Immediately took a Benadryl and some allergy nose spray. Hives on my right eye and face got red. I do not know which flu shot it is, but it would not let me go on until I added some thing in. So I just picked the first one
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cognitive disorder, Dizziness, Feeding disorder, Injection site erythema
Clinical narrative: Day of injection (Friday): Nauseous around 8:00 p.m. 9:00 pm: Drousy. Dizzy. Went to be very early.  Next morning (Saturday): Very drousy, unable to function. Felt drugged; brain-dead. Every muscle/joint felt like the worst case of flu I ever had. Unable to eat. Following day (Sunday),  still very achy. Able to eat, and moderately functional.  Fairly functioning. Monday: Fairly normal, although the injection site was quite red and quite raised -- size of a silver dollar -- and extremely tender. Now, two weeks later, the site is still slightly red, clothing can still slightly irritate it.         **FYI:  Sept 27, 2022 I had a Pfizer-Bival booster.  Sept 28: Chills & photoflashes. 9/30: Abdominal pain. 10/5: Emergency Gallbladder surgery
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Day of injection (Friday): Nauseous around 8:00 p.m. 9:00 pm: Drousy. Dizzy. Went to be very early.  Next morning (Saturday): Very drousy, unable to function. Felt drugged; brain-dead. Every muscle/joint felt like the worst case of flu I ever had. Unable to eat. Following day (Sunday),  still very achy. Able to eat, and moderately functional.  Fairly functioning. Monday: Fairly normal, although the injection site was quite red and quite raised -- size of a silver dollar -- and extremely tender. Now, two weeks later, the site is still slightly red, clothing can still slightly irritate it.         **FYI:  Sept 27, 2022 I had a Pfizer-Bival booster.  Sept 28: Chills & photoflashes. 9/30: Abdominal pain. 10/5: Emergency Gallbladder surgery
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: Day of injection (Friday): Nauseous around 8:00 p.m. 9:00 pm: Drousy. Dizzy. Went to be very early.  Next morning (Saturday): Very drousy, unable to function. Felt drugged; brain-dead. Every muscle/joint felt like the worst case of flu I ever had. Unable to eat. Following day (Sunday),  still very achy. Able to eat, and moderately functional.  Fairly functioning. Monday: Fairly normal, although the injection site was quite red and quite raised -- size of a silver dollar -- and extremely tender. Now, two weeks later, the site is still slightly red, clothing can still slightly irritate it.         **FYI:  Sept 27, 2022 I had a Pfizer-Bival booster.  Sept 28: Chills & photoflashes. 9/30: Abdominal pain. 10/5: Emergency Gallbladder surgery
Age: 0.25
Sex: F
Vaccine: PNC15, RV5
Symptoms: Diarrhoea, Haematochezia, Rotavirus test positive, Ultrasound abdomen normal, Vomiting
Clinical narrative: Vomitting and diarrhea started on 19th of October. Blood in stool on 24 of October
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Received a second dose of the 2024 - 2025 FLUAD Vaccine
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Palpitations
Clinical narrative: Severe headache, chills, continuous racing heart for 8-plus hours (80-120 bpm), unable to sleep.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Flushing, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Immediately following vaccination, patient stated that her tongue felt numb.  After 5 minutes, patient complained of dizziness, "tingling" in fingers and lips, chest heaviness, flushing, and nausea.  EMS was called at approximately 1:05pm.  While EMS was on the phone line, the pharmacist administered one dose of epinephrine 0.3mg IM in left thigh.  Patient reported a decrease in nausea, but increase in other symptoms listed above.  911 operator advised against second dose as EMS was arriving to site imminently.  EMS evaluated patient, gave medications on site and transported patient to local hospital.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: Immediately following vaccination, patient stated that her tongue felt numb.  After 5 minutes, patient complained of dizziness, "tingling" in fingers and lips, chest heaviness, flushing, and nausea.  EMS was called at approximately 1:05pm.  While EMS was on the phone line, the pharmacist administered one dose of epinephrine 0.3mg IM in left thigh.  Patient reported a decrease in nausea, but increase in other symptoms listed above.  911 operator advised against second dose as EMS was arriving to site imminently.  EMS evaluated patient, gave medications on site and transported patient to local hospital.
Age: 20.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Breath sounds abnormal, Erythema, Feeling abnormal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient came in to receive flu and covid shots. The patient sat down, and we gave the first dose of the pfizer covid immunization first. I then gave the second immunization which was the fluarix influenza shot. Right after I gave this shot, he slumped down in his chair and turned red and sounded like he was gargling. He was passed out for a second. I rant to get the epi-pen, and as soon as I was back, he was awake and dazed in the chair. He was passed out for about ten seconds. When he came to, he then was very pale. I got him a water, and called 911. After a few minutes and some fluids, the patient was able to walk out on his own, and went to the ambulance to get his vitals checked. I then called the patient's father who was with him to check in on him, and he said that the patient was doing fine, with no other issues.
Age: 20.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pallor, Posture abnormal
Clinical narrative: Patient came in to receive flu and covid shots. The patient sat down, and we gave the first dose of the pfizer covid immunization first. I then gave the second immunization which was the fluarix influenza shot. Right after I gave this shot, he slumped down in his chair and turned red and sounded like he was gargling. He was passed out for a second. I rant to get the epi-pen, and as soon as I was back, he was awake and dazed in the chair. He was passed out for about ten seconds. When he came to, he then was very pale. I got him a water, and called 911. After a few minutes and some fluids, the patient was able to walk out on his own, and went to the ambulance to get his vitals checked. I then called the patient's father who was with him to check in on him, and he said that the patient was doing fine, with no other issues.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Scab
Clinical narrative: Patient reports to pharmacy with 2 scabs on his arm, asking if he got poked twice for the same vaccine. The vaccine administrator only administered vaccine once. The extra scab, or both scabs, may be a result of muscle injury. Often times, there is no scab where the vaccine is administered.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Mouth ulceration, Skin ulcer
Clinical narrative: ulcer on mouth and left ear
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received high dose flu shot instead of flublok   flu shot. Patient had no ill effects from flu shot, when asked how old she was she said 66 which she thought we were asking the year she was born . very busy at in window and she was in a  hurry.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red patch on skin surrounding injection site, very warm to the touch
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Pt had a history of fainting  and when asked she said that was more than 10 years ago and she has had vaccines with no issues since then for years. I asked repeatedly if she is sure that she has had no issues and she confirmed. I asked pt to wait and sat with her in the waiting area. within minutes she said she has to lay down and within seconds of that she started seizing. it lasted around 1-2 min then as soon as she was aware of her environment she denied having any issues. We had called 911 and tried to presuaded her to stay until they come in and check her out. Pt left with paramedic and didnt want to go to er. I strongly suggested her to go and paramedics told her they cant force her but she should go with them to get checked out in the ambulance at least.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient had pain and redness around lower injection site.  Patient had to put both shots in same arm due to lymph note removal.  After growing worst patient came and saw me.  I recommended she go to doctor office and get checked out.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia, Oropharyngeal pain, Pain, Peripheral swelling
Clinical narrative: Patient received the vaccine at approximately 2:53PM on 10/23/2024. Daughter called today, 10/24/24, to report that patient began to experience side effects the same night. Symptoms include: fever of 100.3, sore throat/lost of voice, body aches/pain especially in her shoulder, and slight swelling of her legs/arms.
Age: 85.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: no information regarding outcome or adverse event. Clinic 10/14 took place at nursing home, Immunizer pharmacist screened pt and pt filled out consent form requesting for vaccine, vaccine was administered. Later found out when billing insurance that patient got vaccine month of September 2024
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Migraine, Pyrexia
Clinical narrative: Severe migraines lasting hours, fever on & off , diarrhea on and off, fatigue, shortness of breath on & off
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Loss of consciousness
Clinical narrative: pt passed out, there was a sudden drop in blood pressure .was about 2 to 3 minutes i called paramedic and his wife i kept him
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Blood test, Cognitive disorder, Confusional state
Clinical narrative: Cognitive issues, confusion, memory loss, joint pain, muscle pain,  was diagnosed with auto immune encephalitis
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Encephalitis autoimmune, Lumbar puncture, Magnetic resonance imaging head, Mini mental status examination abnormal
Clinical narrative: Cognitive issues, confusion, memory loss, joint pain, muscle pain,  was diagnosed with auto immune encephalitis
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Positron emission tomogram
Clinical narrative: Cognitive issues, confusion, memory loss, joint pain, muscle pain,  was diagnosed with auto immune encephalitis
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Pain in extremity, Peripheral swelling
Clinical narrative: Very sore arm and swelling. Large, hard lump at injection site. All of my four previous Covid vaccinations were Pfizer, and with those I had no adverse effect.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram abnormal, Laboratory test, Ventricular extrasystoles
Clinical narrative: Employee received flu vaccine and woke up in the middle of the night post vaccine cardiac arrhythmia and has continued constantly for the last 5-6 days and has seen primary MD and is now referred to cardio. Has had EKG confirming PVCs
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid Pfizer Vaccine was stored in the freezer upon arrival instead of the refrigerator. patient called to offer re-vaccination after discovery.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: right arm swelling from top of shoulder down to elbow, redness, and hot to touch. Mother stated it began day after vaccines given and lasted a couple of days. Mother states she would apply ice to area.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Upset stomach, throwing up -- Rph advised patient to go to ER or see MD if condition does no improve.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Peripheral swelling, Ultrasound Doppler normal
Clinical narrative: within 1 hour of vaccine pt. had (L) calf and lower leg swelling, pain. Flu like symptoms for 5 days. Seen by me 10/15/24 - U/S done NO DVT - seen again 10/21/24 due to (L) arm pain/(L) leg pain now including thigh.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Mild erythema of skin, no pruritus No SOB, no wheezing, no swelling. Benadryl 25mg IM injection. Rash improved.
Age: 5.0
Sex: M
Vaccine: COVID19, FLUN3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Incorrect covid vaccine was administered by medical assistant. Patient who is <12 yr old was given Covid vaccine for 12 yr and up.  No adverse effects noted since incorrect administration.
Age: 4.0
Sex: U
Vaccine: IPV, MMR, VARCEL, MMR
Symptoms: Expired product administered
Clinical narrative: No adverse effects noted. No other information provided. No additional AE. No PQC.; HCP states 4 year old patient received expired dose of MMR II; This spontaneous report was received from a nurse regarding to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 04-MAR-2024, the patient was vaccinated with a single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot number W007180 (lot number W007180 had been verified to be valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live), expiration date 01-MAR-2024, (strength, dose, frequency, route of administration and anatomical injection site were not provided) administered for prophylaxis (expired product administered).   No adverse effects noted. No other information provided. No additional adverse event (AE). No product quality complaint (PQC).
Age: 4.0
Sex: U
Vaccine: IPV, MMR, VARCEL, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects noted. No other information provided. No additional AE. No PQC.; HCP states 4 year old patient received expired dose of MMR II; This spontaneous report was received from a nurse regarding to a 4-year-old patient of an unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 04-MAR-2024, the patient was vaccinated with a single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot number W007180 (lot number W007180 had been verified to be valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live), expiration date 01-MAR-2024, (strength, dose, frequency, route of administration and anatomical injection site were not provided) administered for prophylaxis (expired product administered).   No adverse effects noted. No other information provided. No additional adverse event (AE). No product quality complaint (PQC).