chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Prothrombin time, Pulmonary embolism
Clinical narrative: On November 10, 2023, I called pharmacy, asking if they had Pfizer COVID-19 vaccine, and they said they did. Then I took my daughter and filled out the intake form. Also, they offered the flu vaccine, and I accepted. As I was leaving the technician did not give me the vaccine information sheet, so I asked for it. I noticed she had administered my daughter the Moderna COVID-19 vaccine, instead. Then, I asked her why they had not administered my daughter Pfizer because I asked for it specifically, and she told me they did not have it. Within the a week following the inoculation, my daughter started complaining about pain in her legs, she also started experiencing difficulty to walk, until one morning her legs were swollen and she not able to get up. Then, I took my daughter to the emergency room, and she was diagnosed with DVT (deep vein thrombosis) and PE (Pulmonary Embolism). She has ever since had several medical procedures, she has been Will provide additional information upon request.
Age: 87.0
Sex: F
Vaccine: FLUA4, PNC20, VARZOS, FLUX, PNC20, VARZOS
Symptoms: Alopecia, Muscle spasms, Muscular weakness, Pruritus
Clinical narrative: hives fatigue loss of appetite urticaria weakness
Age: 87.0
Sex: F
Vaccine: FLUA4, PNC20, VARZOS, FLUX, PNC20, VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Urticaria
Clinical narrative: hives fatigue loss of appetite urticaria weakness
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Acute kidney injury, Aspiration pleural cavity, Blood creatinine increased, Blood lactic acid
Clinical narrative: According to the ER he did have the flu vaccination today but later on according to son he started having fevers and tremors and shakes.  He presented to the emergency room found to be hypotensive and meeting sepsis criteria he was pancultured given IV fluid resuscitation.  He was also found to have an elevated lactate level and increase AKI.  He was then subsequently started on Levophed and referred to the hospitalist service for admission to the ICU.  He did have a CT which did show some bilateral renal fat stranding potential for infection although the UA was not remarkable.  Septic shock, unclear etiology.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Chest X-ray abnormal, Chills, Computerised tomogram abdomen, Hypotension
Clinical narrative: According to the ER he did have the flu vaccination today but later on according to son he started having fevers and tremors and shakes.  He presented to the emergency room found to be hypotensive and meeting sepsis criteria he was pancultured given IV fluid resuscitation.  He was also found to have an elevated lactate level and increase AKI.  He was then subsequently started on Levophed and referred to the hospitalist service for admission to the ICU.  He did have a CT which did show some bilateral renal fat stranding potential for infection although the UA was not remarkable.  Septic shock, unclear etiology.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Leukocytosis, Pleural effusion, Renal disorder, Staphylococcus test negative, Tremor
Clinical narrative: According to the ER he did have the flu vaccination today but later on according to son he started having fevers and tremors and shakes.  He presented to the emergency room found to be hypotensive and meeting sepsis criteria he was pancultured given IV fluid resuscitation.  He was also found to have an elevated lactate level and increase AKI.  He was then subsequently started on Levophed and referred to the hospitalist service for admission to the ICU.  He did have a CT which did show some bilateral renal fat stranding potential for infection although the UA was not remarkable.  Septic shock, unclear etiology.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: According to the ER he did have the flu vaccination today but later on according to son he started having fevers and tremors and shakes.  He presented to the emergency room found to be hypotensive and meeting sepsis criteria he was pancultured given IV fluid resuscitation.  He was also found to have an elevated lactate level and increase AKI.  He was then subsequently started on Levophed and referred to the hospitalist service for admission to the ICU.  He did have a CT which did show some bilateral renal fat stranding potential for infection although the UA was not remarkable.  Septic shock, unclear etiology.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Acute kidney injury, Blood culture negative, Blood lactic acid increased, Blood pressure decreased, Chills
Clinical narrative: According to the ER he did have the flu vaccination today but later on according to son he started having fevers and tremors and shakes.  He presented to the emergency room found to be hypotensive and meeting sepsis criteria he was pancultured given IV fluid resuscitation.  He was also found to have an elevated lactate level and increase AKI.  He was then subsequently started on Levophed and referred to the hospitalist service for admission to the ICU.  He did have a CT which did show some bilateral renal fat stranding potential for infection although the UA was not remarkable.  Septic shock, unclear etiology.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram kidney abnormal, Hypotension, Intensive care, Pyrexia, Renal disorder
Clinical narrative: According to the ER he did have the flu vaccination today but later on according to son he started having fevers and tremors and shakes.  He presented to the emergency room found to be hypotensive and meeting sepsis criteria he was pancultured given IV fluid resuscitation.  He was also found to have an elevated lactate level and increase AKI.  He was then subsequently started on Levophed and referred to the hospitalist service for admission to the ICU.  He did have a CT which did show some bilateral renal fat stranding potential for infection although the UA was not remarkable.  Septic shock, unclear etiology.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Septic shock, Tremor, Urine analysis normal
Clinical narrative: According to the ER he did have the flu vaccination today but later on according to son he started having fevers and tremors and shakes.  He presented to the emergency room found to be hypotensive and meeting sepsis criteria he was pancultured given IV fluid resuscitation.  He was also found to have an elevated lactate level and increase AKI.  He was then subsequently started on Levophed and referred to the hospitalist service for admission to the ICU.  He did have a CT which did show some bilateral renal fat stranding potential for infection although the UA was not remarkable.  Septic shock, unclear etiology.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: The next day after my shot it was red and going toward my elbow. I had marked it where it was red and it went outside the line. I went to the hospital and they said it was cellulitus and released me.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Injection site cellulitis, Injection site erythema, Ultrasound scan
Clinical narrative: The next day after my shot it was red and going toward my elbow. I had marked it where it was red and it went outside the line. I went to the hospital and they said it was cellulitus and released me.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: Pt came to outreach site for vaccination. Pt tolerated vaccines well, and left in  no acute distress.  (principal) of the school came into the room and stated that the pt  vomited, and was looking pale with some dizziness.   Vitals taken --   O2 @ 98  P @ 87  Pt did not eat breakfast. Pt drank water and ate crackers and was feeling much  better. Per staff, pt was in good spirits before we left the outreach site  and was engaging with other students.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Woke up after two days to extreme muscle stiffness as if I pulled my deltoid. 2-3 weeks since it began and I still cannot lift my arm outward from the side of my hip to being level with my neck (direction of movement is similar to flapping arms like wings). Condition is improving but wanted to report in case the issue persists or gets worse.
Age: 46.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Night sweats
Clinical narrative: Night sweats every night since the vaccination (1 week ago). Large (6" x 2") itchy/burning red mark around the injection site which developed within 1 day and lasted for 5 days before starting to dissipate.
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Sinusitis
Clinical narrative: sinusitis again; original Pneumococcal vaccine 16 years ago and it cleared up his sinusitis; This spontaneous report was received from a consumer and referred to himself, a male patient of unknown age.  The patient's medical history included sinusitis. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2008 (reported as 16 years ago), the patient started therapy with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (anatomical location, strength, dose, route, lot number, and expiration date were not reported) for prophylaxis.  On an unknown date in 2008 (reported as 16 years ago), the patient got the original pneumococcal vaccine 16 years ago and it cleared up his sinusitis(Therapeutic response unexpected). On an unknown date in 2024 (reported as now), the patient experienced sinusitis again(Sinusitis). No treatment was given for the event. At the time of reporting, the patient had not recovered from the event of sinusitis again.  The causal relationship between the event of sinusitis again and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired MMR II product administered. MMR II with labeled expiration date of 9/15/2024 was administered to a single patient today 10/8/2024.; This spontaneous report was received from a Medical Assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On 08-OCT-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, 0.5 milliliter, lot # W029541 and expiration date: 15-SEP-2024 (Expired product administered), as prophylaxis (strength, and route of administration were not provided) which was reconstituted with a sterile diluent (strength, lot #, expiry date, route of administration were not provided). The vaccine did not experience any temperature excursions through the date of administration. Diluent was not expired and did not experience any temperature excursions. No additional adverse event (AE) reported. No PQC involved.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE/PQC reported at this time; Caller reported VAXNEUVANCE PFS broke during administration.; Caller reported VAXNEUVANCE PFS broke during administration.; This spontaneous report was received from a nurse regarding to a patient of not reported age and gender.  The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 14-OCT-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, at a dose of 0.5 milliliter, lot #X027947, expiration date: 12-JAN-2026, administered intramuscularly for prophylaxis (strength and anatomical site of injection was not provided).  On that same date, during the administration of the vaccine, the pre-filled syringe (PFS) broke (syringe issue) (Poor quality device used); however, the patient was not injured due to the PFS breakage.  No additional adverse event was reported (No adverse event).   This case is non-valid due to no patients' identifiers. This is one from 2 reports received from the same reporter. ; Sender's Comments:  US-009507513-2410USA005905:
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Sensory loss
Clinical narrative: Loss of feeling in arm; numbness in arm; This non-serious case was reported by a physician via sales rep and described the occurrence of loss of sensation in a adult female 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 loss of sensation (Verbatim: Loss of feeling in arm) and numbness of upper extremities (Verbatim: numbness in arm). The outcome of the loss of sensation was not resolved and the outcome of the numbness of upper extremities was not reported.   The reporter considered the loss of sensation to be related to Shingrix. It was unknown if the reporter considered the numbness of upper extremities to be related to Shingrix.     The company considered the loss of sensation to be related to Shingrix. It was unknown if the company considered the numbness of upper extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-OCT-2024 The patient had Shingrix vaccine previously and had numbness in arm and loss of feeling in arm in vaccine was given.  She was now afraid to get the second vaccine.  The reporting doctor wanted more information.
Sex: F
Vaccine: RSV
Symptoms: Syringe issue, Underdose
Clinical narrative: Incomplete dose administered/Under dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-SEP-2024, the patient received Arexvy. On 28-SEP-2024, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: Incomplete dose administered/Under dose). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 The reporter explained that a patient only received half of a dose of Arexvy (unknown if it was the first dose), because vaccine leaked out, which led to accidental underdose. The patient was concern that they did not get adequate coverage.  Lot number and expiration date were unknown by nurse.  After a call back, agent confirmed that Nurse gave consent to follow up with Safety Team. The reporter consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: she was allergic to the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a elderly female patient who received Herpes zoster (Shingrix) (batch number E3XT9, expiry date 19-JUN-2026) for prophylaxis.   On 09-SEP-2024, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergy to vaccine (Verbatim: she was allergic to the vaccine). The outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingrix.     It was unknown if the company considered the allergy to vaccine to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter was a patient that reported she received the Shingrix, she thought in her right arm, on 9-SEP-2024, and had a bad reaction for about a week. The patient stated that she was allergic to the vaccine. The patient reported that the bad reaction started either the evening of the vaccine (9-SEP-2024) or the next morning (10-SEP-2024) and lasted for about a week (no specific dates provided).  The patient reported that that she did have a different shingles vaccine 14-15 years ago (No product Information Provided).  No further information was provided about this adverse event.  The reporter did not consent to follow-up.
Age: 9.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: reports that a 9-year old patient with no record of vaccination was given Adacel instead of DTaP with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9 years old male patient with no record of vaccination was given diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) and hpv vaccine vlp rl1 4v (yeast) (Gardasil) both for Immunisation.  On 01-Aug-2024, the 9 years old male patient with no record of vaccination was received suspect diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] (Suspension for injection), (strength: standard), (frequency: once) (lot U8015AA and expiry date: 01-Mar-2026) via intramuscular route in the right arm  instead of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] (Suspension for injection) for Immunization with no reported adverse event (wrong product administered).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menquadfi was given to a patient 2 weeks earlier from the recommended minimum age with no adverse event; Initial information received on 04-Oct-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Adolescent and unknown gender patient who received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] 2 weeks earlier from the recommended minimum age with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Dose 2 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (dose, strength, route, lot and expiry:unknnown) 2 weeks earlier from the recommended minimum age with no adverse event (product administered to patient of inappropriate age) for Prophylactic Vaccination.  Information on batch number corresponding to the one at time of event occurrence was requested   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Heart rate increased, Hyperhidrosis, Night sweats, Pyrexia
Clinical narrative: he got severe shivering and chills; temperature was 101.4; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 70 years old male patient who experienced severe shivering, chills and temperature was 101.4 after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s) and family history were not provided. He had COVID vaccine 4 weeks prior receiving Fluzone HD. He had pneumonia vaccine early the beginning of the year.  The concomitants included RSV vaccine and shingles vaccines for immunization.   On 07-Oct-2024 at 10:00 AM, the patient received 0.5 mL dose of suspect influenza usp trival a-b high dose subvirion vaccine (Suspension for injection in pre-filled syringe) (strength: Fluzone High Dose Trivalent) (frequency: once) (lot U8527AA) (expiry date not reported) via intramuscular route in the left arm for Influenza.  On 07-Oct-2024, the patient developed severe shivering and chills (chills) (latency: 8 hours) and temperature was 101.4 (pyrexia) (latency: same day) following the administration of influenza usp trival a-b high dose subvirion vaccine.  Reportedly, the shivering lasted for about 15 minutes. The fever maintained for hours and he took 2 Tylenols. When he slept he had profuse night sweats, like really soaking sweats. His heart rate was elevated to 104. His normal heart rate is about 84. The next morning, everything was normal. The sweating stopped, his fever and heart rate went down. At the time of the call he is feeling fine.He did contact his primary care doctor and cardiologist, who told him these were not normal reactions to the flu shot. He is concerned if he should take the flu shot again next year, as he does not want to experience a more severe reaction. Caller stated all night long he had profuse sweating. It was really bad to the point that it was soaking his pajamas, the sheet and things like this. He also has one of the cardiac devices, like an EKG (electrocardiogram). He did that and his heart rate was 104 all night long.  Relevant laboratory test results included: Body temperature - On 07-Oct-2024: 101.4 UNK [101.4]  Action taken was not applicable.  Corrective treatment: The patient took 2 PARACETAMOL (TYLENOL) for Pyrexia.  At time of reporting, the outcome was Recovered / Resolved on 07-Oct-2024 for both the events.
Sex: F
Vaccine: UNK
Symptoms: Nervousness, Product colour issue
Clinical narrative: get nervous about vaccines; it looked a little orange; This spontaneous case, initially received on 07-Oct-2024, was reported by a non-health professional and concerns a female patient.  Administration of company suspect drug(s): On an unknown date in Oct-2024, the patient received Flucelvax (TIV) for Flu immunization, Dose regimen: .5 ml, Lot number: 388523. Route of administration: other (prefill syringe)   No additional suspect drugs.  Adverse reactions/events and outcomes: On Oct-2024, the patient experienced get nervous about vaccines (outcome: Unknown), it looked a little orange (outcome: Not Reported).  Patient had the Flucelvax over the weekend and gets nervous about vaccines, so she was reading the paper that came with it, and saw that the liquid should be clear, and reported that she saw when the pharmacist was giving it to her, that it looked a little orange. So, the patient was wondering was there something on the syringe, or was there like an orange sticker that would have reflected light and wanted to know it was the right thing. The patient discover the defect during the use and the full dose was administered to the patient.   Flucelvax (TIV) action taken: Not Applicable  The reporter considered the events as non-serious, and the causality was not reported to the administration of Flucelvax (TIV).; Reporter's Comments: The event I get nervous at the time we were speaking is considered related to the administration of Flucelvax (TIV). due to close temporal relationship.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram thorax abnormal, Cough, Fatigue, Fibrin D dimer
Clinical narrative: On 10/5/2024 patient had syncopal event, EMTs were called and patient declined Emergency Room Evaluation. 10/7/2024, patient had onset of severe sore throat, ensuring days fatigue and dry cough (unable to work during this time due to symptoms) 10/11/2024 he attempted to return to work but only lasted 1/2 day. 10/12/2024, symptoms worsening and he went to urgent care, told has Pneumonia, but in fact there was no infiltrat on Chest X ray, started on amoxicillin and azithromycin 10/14/2024 woke up in very early morning with acute onset of right flank pain, went to emergency room, diagnosed that morning with bilateral pulmonary emboli and right lower lobe infract, started on heparin, discharged on 10/15/2024 on Eliquis
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Impaired work ability, Oropharyngeal pain, Pneumonia, Pulmonary embolism
Clinical narrative: On 10/5/2024 patient had syncopal event, EMTs were called and patient declined Emergency Room Evaluation. 10/7/2024, patient had onset of severe sore throat, ensuring days fatigue and dry cough (unable to work during this time due to symptoms) 10/11/2024 he attempted to return to work but only lasted 1/2 day. 10/12/2024, symptoms worsening and he went to urgent care, told has Pneumonia, but in fact there was no infiltrat on Chest X ray, started on amoxicillin and azithromycin 10/14/2024 woke up in very early morning with acute onset of right flank pain, went to emergency room, diagnosed that morning with bilateral pulmonary emboli and right lower lobe infract, started on heparin, discharged on 10/15/2024 on Eliquis
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary infarction, Scan with contrast abnormal, Syncope
Clinical narrative: On 10/5/2024 patient had syncopal event, EMTs were called and patient declined Emergency Room Evaluation. 10/7/2024, patient had onset of severe sore throat, ensuring days fatigue and dry cough (unable to work during this time due to symptoms) 10/11/2024 he attempted to return to work but only lasted 1/2 day. 10/12/2024, symptoms worsening and he went to urgent care, told has Pneumonia, but in fact there was no infiltrat on Chest X ray, started on amoxicillin and azithromycin 10/14/2024 woke up in very early morning with acute onset of right flank pain, went to emergency room, diagnosed that morning with bilateral pulmonary emboli and right lower lobe infract, started on heparin, discharged on 10/15/2024 on Eliquis
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Blood test, Borrelia test, Chills, Computerised tomogram
Clinical narrative: Days 1 and 2 after vaccine: Fever, chills, muscle and body aches. Day 3: Nausea, some vomiting, begin inability to eat or drink. Days 4 and 5: Extreme nausea and uncontrolled vomiting even without food or drink.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Magnetic resonance imaging, Myalgia, Nausea, Pain
Clinical narrative: Days 1 and 2 after vaccine: Fever, chills, muscle and body aches. Day 3: Nausea, some vomiting, begin inability to eat or drink. Days 4 and 5: Extreme nausea and uncontrolled vomiting even without food or drink.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis, Vomiting, X-ray
Clinical narrative: Days 1 and 2 after vaccine: Fever, chills, muscle and body aches. Day 3: Nausea, some vomiting, begin inability to eat or drink. Days 4 and 5: Extreme nausea and uncontrolled vomiting even without food or drink.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal disorder, Walking aid user
Clinical narrative: 4 hrs after vaccine loss use of legs. Needs a walker I am a healthcare provider. Canot go to ER. Son got me Liquid IV and pedialite. Called Dr. She said to continue what I was doing and if I was no better in 2days go to ER. Continued to improve but my legs are still weak but not need walker. This was my 6th and last covid shot.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Petit mal epilepsy, Seizure
Clinical narrative: The following day (9/28/24) I had 4 seizures and on 9/29/24 I had 3 absence seizures (prior to this, I had no had a seizure for 15 days). I recovered from all seizures on both days and did not need to seek medical attention. My neurologist explained that vaccines can cause an inflammatory reaction and lower one's seizure threshold.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: (L) upper arm swelling from tip of acromion to elbow on lateral aspect with severe swelling, induration + warmth. No fever. (R) arm with 5 cm wheal around injection site.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I had Novavax Covid vaccine about 9am. About 11am noticed my heart was beating harder. It was regular, No SOB or chest pain. My BP was 150's/80's. HR 92. This persisted for about 11 or 12 hours. I was able to sleep normally. I had maybe one or two very short episodes of this over the next week or two. Nothing since. Reported to my NP and she did not feel it was myocarditis, etc.
Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: The glass surrounding the syringe plunger was broken. The glass pieces were lying next to the syringe in the box. Only one syringe in the box was broke. The other vaccines were unaffected.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: 10/10/2025 Sir/Madam: SPIKEVAX, Moderna prefilled syringe Covid-19 vaccine has problem. It is very difficult to pull the cap out of the syringe. We have to FIGHT with the syringe in order to pull the cap out, connect the syringe with the needle and be ready to vaccinate patients Fighting to pull the cap out of the syringe leads us to touch the tip of the prefilled syringe, contaminate the tip of the syringe and we have to throw away the syringe. We do not have problem with Flucelvax, Fluad 65, Fluzone HD and etc. It is easy to pull the caps out of those syringes and connect with the needles. Sir/Madam, please help ask Moderna to solve the issue. Thank you very much
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash, Rash papular
Clinical narrative: On 10/14/24, he was given the Flucelvax Quadrivalent vaccine, the next morning he woke up with a raised rash on his hands, back of his arms, both feet and his left foot is swollen.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: Flu immunization would not inject into patient, syringe locked up. Patient given two needle sticks, second immunization injected. Patient tolerated situation, no adverse affects occurred. No additional details of the injection or product are available beyond what is mentioned here.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: At an employee health flu vaccination clinic, I attached a 25gx1 inch needle on the vaccine syringe and pushed out the air bubble. I poked the employee and as I went to push the vaccine into the employe, it sprayed out of the plastic. Needle was removed from employee and safety device was opened. I inspected the needle and syringe and could not see any visible cracks or issues. Needle was screwed on firmly and not loose. I had not pushed much of the vaccine through so after removing the needle from the employee I attempted to see where it was leaking from and it was unclear if it was coming out of the plastic at the base of the needle or if it was coming out of the vaccine syringe. I have given hundreds of vaccines this year and had not seen this before. Syringe and needle were disposed of. Employee received a new vaccine at a different injection site with a new vaccine and needle. No issue this time. No further information about the product or injection is available other than when is mentioned here.
Age: 45.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Pain in extremity, Pyrexia
Clinical narrative: The morning after receiving Prevnar 20, patient woke up with a very painful arm and a fever that got as high as 103.8. The arm was warm to the touch and had a large red circle surrounding the injection site.  The area was also hard. Patient visited her PCP and they suspect cellulitis. She was given antibiotics 10/17, Bactrim DS 1 BID for 1 week. She has a follow up with PCP 10/21/2024.
Age: 45.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Skin warm
Clinical narrative: The morning after receiving Prevnar 20, patient woke up with a very painful arm and a fever that got as high as 103.8. The arm was warm to the touch and had a large red circle surrounding the injection site.  The area was also hard. Patient visited her PCP and they suspect cellulitis. She was given antibiotics 10/17, Bactrim DS 1 BID for 1 week. She has a follow up with PCP 10/21/2024.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted with covid on 9/7 and pt died on 10/20. Pt also received covid vaccines on 3/11/21 and 4/8/21. Both Moderna.
Age: 8.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on abdomen, sides, underarms and legs including genital area. Seemed improving 24 hours after starting. Vaccines were administered at pharmacy.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo began day after and continues, only slightly improving by the 2 week mark following the injection.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye pain, Headache, Oropharyngeal discomfort, Paraesthesia oral
Clinical narrative: Pressure in throat, tingling lips, headache, eyes hurt, and cold chills
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Erythema, Nausea, Pain
Clinical narrative: erythema, swelling midsection left upper arm; intense pruritic BUE; epigastric pain radiating to back with nausea and anorexia
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: erythema, swelling midsection left upper arm; intense pruritic BUE; epigastric pain radiating to back with nausea and anorexia
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received a flu shot 2 weeks prior and we gave her another flu shot instead of a covid shot
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash on side of body after vaccinated
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Skin discolouration
Clinical narrative: PT STATES THAT THEIR ARM STARTED TO SWELL THE FOLLOW DAY. IT WAS RED TO THE TOUCH AND IT KEPT SPREADING. PT WAITED A COUPLE OF DAYS THEN STARTED USING OTC NEOSPORIN AND HYDROCORTISONE ON IT. THE REDNESS DECREASED NOW AND THE ARM IS SLIGHTLY BLACK AND BLUE LIKE A BRUISE. PT DID NOT SEEK MEDICAL TREATMENT EVEN THOUGH WE RECOMMENEDED TO PT SEVERALL TIMES TO GO AND FOLLOW UP WITH A DOCTOR.
Age: 66.0
Sex: M
Vaccine: MMR, PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: SWELLING AND REDNESS FOR 2 DAYS WHICH SPREAD DOWN THE ARM TO ELBOW, MILD PAIN. NO FEVER, NO SHORTNESS OF BREATHE PAIN DECREASED
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Gave a second dose of flu vaccine a week after the first dose.
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC20, VARCEL
Symptoms: Wrong product administered
Clinical narrative: PT AND MOTHER WERE IN CLINIC FOR FP AND WCR VISIT. WHEN I ASKED ABOUT VACCINES, MOM STATES PT GETS AT PCP. AT END OF VISIT, MOM STATED THAT HE AS SUPPOSE TO GET HIS VACCINES HERE THAT DAY. I PULLED VACCINES AND ADMINISTERED PRIOR TO SCANNING IN ORDER TO SAVE TIME SINCE PT HAD BEEN THERE FOR A BIT ALREADY. CAUGHT MISTAKE AFTERWARDS WHEN SCANNING THAT I PULLED A MMRV INSTEAD OF PLAIN MMR.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted immediately after injection. Recovered completely within a minute or two. VS stable.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: sore arm, typical for patient
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: ADMINISTERED A SECOND 2024-2025 FLU SHOT IN ERROR, RECEIVED SHOT ONE 8/10/2024, SHOT TWO WAS 10/17/2024.  NO ADVERSE REACTION REPORTED AS OF 10/21/2024.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Rash, Rash macular
Clinical narrative: Patient received vaccine 10/10/24 and a rash started developing on 10/12/24. Rash covered torso, legs, and back. Purple splotches that turned red after several days. Rash was not painful or itchy. Other symptoms included headache, body aches, and fatigue. Patient saw doctor and began taking Zyrtec with mild improvement. Patient reported event to pharmacy 10/18/24. She has seen gradual improvement with rash and symptoms but she is still not 100% recovered.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Hypersensitivity, Nausea, Pharyngeal swelling, Swelling face
Clinical narrative: 1 hour after receiving vaccine, he began to have abdominal pain, nausea, vomiting, feeling of throat swelling, facial swelling, persisted into next day when he came to see me at urgent care and I treated him for allergic reaction to vaccine
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 1 hour after receiving vaccine, he began to have abdominal pain, nausea, vomiting, feeling of throat swelling, facial swelling, persisted into next day when he came to see me at urgent care and I treated him for allergic reaction to vaccine
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased
Clinical narrative: Within 30 minutes of injection increased Heartrate to 160 and BP 155/99
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Pt administered ProQuad and Varivax which is contraindicated, no adverse reactions at this point in time but can occur 2 weeks after administration, pt mother was called and informed of this by overseeing physician.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, PNC13, TDAP
Symptoms: No adverse event
Clinical narrative: Administered prevnar13 vaccine.  Protocol states Prevnar 13 should be administered to immunocompromised patients or increased risk factors for people age 16. Patient did not meet criteria.  No adverse effects of vaccine administration noted.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error - quadracel given at age 2 and not indicated until age 4
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Somnolence
Clinical narrative: i have never been able to fall right a sleep. as soon a i received the shop i could fall a sleep wit out doing anything . heve in my life have i fell a sleep when someone is driving. but right after i could fall a sleep any where is is scary i dont even have to move it can just falll a sleep it is scary. i dont know what to do. it is scarry if i dont keep my hands  moving i can fall a sleep.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood test, Mobility decreased, Muscle spasms, Pain
Clinical narrative: Pt states he always gets the flu vax but after getting this years vaccine he started getting pain in left knee. He couldn't straighten or bend it. The pain moved into his calf where he developed muscle spasms. His right shoulder started hurting. The pain has moved to his arms, hands, and fingers. His has alot of pain in elbows and knees. Has pain all over and it continues to get worse.  He called doctors office and was told to go to the emergency for treatment.  He was given lidocaine patches and cream for pain that helps some but he is going to follow up with PCP through the facility. His pain is so severe that he fears it will cause more heart problems and worried his heart cannot withstand the pain he is having.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Ultrasound Doppler normal, X-ray normal
Clinical narrative: Pt states he always gets the flu vax but after getting this years vaccine he started getting pain in left knee. He couldn't straighten or bend it. The pain moved into his calf where he developed muscle spasms. His right shoulder started hurting. The pain has moved to his arms, hands, and fingers. His has alot of pain in elbows and knees. Has pain all over and it continues to get worse.  He called doctors office and was told to go to the emergency for treatment.  He was given lidocaine patches and cream for pain that helps some but he is going to follow up with PCP through the facility. His pain is so severe that he fears it will cause more heart problems and worried his heart cannot withstand the pain he is having.
Age: 1.0
Sex: M
Vaccine: HEP, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt inadvertently received an additional Hep B vaccine. No adverse side effects noted.
Age: 27.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Tremor, Unresponsive to stimuli
Clinical narrative: Patient received flu shot and COVID shot from the pharmacy.  Patient got both vaccines in the left arm - refused to get 1 in each arm.  Patient passed out and started shaking.  Was unresponsive - pharmacist called 911. Patient came to and said he was okay and stated that it happens sometimes with needles due to extreme anxiety. Ambulance came and checked the patient out. Patient refused treatment and left the pharmacy.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Chills, Gingival swelling, Lip swelling, Urticaria
Clinical narrative: On the evening of my vaccine, I experienced unusual reactions such Hives around my face (forehead) which were treated with Zyrtec. I also had swollen lips, chills, as well as my chest felt heavy. My gums were also swollen. I am a health care employee, and I get yearly flu shot but this is the first time it has happened
Age: 78.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: IM Flu and RSV administered in the am around 1030. By 5 PM that night patient started having  increased swelling and pain to the right hand/wrist then spread to the right. Increased swelling and pain x 2 days.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Patient called office 10/16/24 to state that she got both her Covid and Flu shot 10/10.  She reported that her right arm had a red rash around the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Beginning that night patient reported a large red spot at injection site, growing down the arm towards the elbow.  Warm to touch.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cardiac monitoring, Heart rate increased, Tachycardia
Clinical narrative: tachycardia, heart rate went up to sustained 170 beats/min. I went to hospital ER within an hour of this high beat rate. They gave me metoprolol and heart rate went down.
Age: 3.0
Sex: F
Vaccine: TD
Symptoms: Injection site discolouration, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: DTaP was given to my daughter-I didn't specify the manufacturer due to lack of knowledge of it. The next day after the vaccine, redness appeared around the injection site, then swelling and oedema. The swelling and redness covered the entire thigh around including the groin. The are was hot to the touch. The redness in places turned pale purple. I gave her Motrin 7.5ml on Friday and Saturday (10.18-19) and Zyrtec Saturday and Sunday (10.19-20). It seems to calms down, but still you feel it's warm and red-purple.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Skin exfoliation
Clinical narrative: About 1-2 days after patient got her Gardasil shot, she noticed a rash starting around her eyes. This progressed to swelling in her eyelids. Currently, the swelling had gone down some but she still has a raised, red, itchy rash spreading across her face. The skin is peeling in some areas, like around her mouth and the corners of her eye. Denies any lip or tongue or throat swelling. Treating with OTC allergy meds & ointments
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling of eyelid
Clinical narrative: About 1-2 days after patient got her Gardasil shot, she noticed a rash starting around her eyes. This progressed to swelling in her eyelids. Currently, the swelling had gone down some but she still has a raised, red, itchy rash spreading across her face. The skin is peeling in some areas, like around her mouth and the corners of her eye. Denies any lip or tongue or throat swelling. Treating with OTC allergy meds & ointments
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: She actually did not have any side effect to the vaccine but it has come to my knowledge today that she was given Pentacel, instead of DTaP. She got Hib on 8/19/24. Mom only wants 1 vaccine at a time. I informed her of the error today and naturally she was upset. I also informed her that the Hib component of the Pentacel would not count for her series because it was given early.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Syncope
Clinical narrative: Syncope 10 minutes after vaccination with anaphylactic symptoms following
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: pt states her legs starting hurting and she became very tired and fatigued. She had severe headache, became sick to her stomach and had diarrhea. Her nose became very runny. As of today  her nose is still runny, she is still very weak and tired feeling with some upset stomach.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: pt states her legs starting hurting and she became very tired and fatigued. She had severe headache, became sick to her stomach and had diarrhea. Her nose became very runny. As of today  her nose is still runny, she is still very weak and tired feeling with some upset stomach.
Age: 5.0
Sex: M
Vaccine: DTPPVHBHPB, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event reported, vaccines given outside of recommended use
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given a pediatric dose of the COVID vaccine. No adverse reaction.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Polymenorrhoea
Clinical narrative: Before the vaccine, I had my period for approximately 5 days and my cycle was 29-30 days apart. Starting July 12th, I have had my period twice a month for a week long. That is a 14 day cycle with 7 days actively bleeding. The only thing that has changed is me getting this vaccine.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient reported to pharmacy 10-17 with rash on right arm extending down from injection site about 6-8 inches in diameter. She said it started "a few nights ago" - but didn't begin itching until 10-16. Presentation could have been delayed hypersensitivity reaction or possible injection. Patient was contacted on 10-20 and rash was improving and itching less. She had no further questions/concerns. Patient was going to call if case started to worsen.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient had redness, heat, hardness in injection site, has slowly decreased on all over last 2 days
Age: 28.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Influenza vaccine intended but HPV vaccine administered. Patient has previous HPV 4 (Gardasil) on 8/3/2007, 12/3/2009, 1/14/2010, and 10/14/2010.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received children's vaccine dose
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Gave children's covid vaccine dose