chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular, Red blood cell count decreased, Red blood cell nucleated morphology
Clinical narrative: Pt states the afternoon after her Flu shot,  she noticed an area on her left thigh that looked like an insect/mosquito bite that began to itch. She states the next morning she had a rash over her left side and after a few more days it progressed to the right side. She states she went to the ER on 12/3/23 and was told that it was a "rare reaction to the Flu shot." She states she was given a prescription for Calamine lotion, Cephalexin 500 mg 3 times per day for 7 days and  Hydroxyzine for itching. She then went home and had a follow up appointment with clinic on 12/7/23. She states she was again told that it was a rare reaction to the Flu Shot and she was to keep taking the medication and follow-up again on 12/14/23. Pt came into the Health Department to report this on 12/13/2023 and she is noted to have lesions starting on the right side of her neck and extending down over her entire trunk and limbs. The lesions range from small eraser size red areas that are slightly raised to large fifty cent size areas that have a halo  effect of redness very similar to a ring worm. Other lesions are full blown blistered areas the size of  golf balls. She reports intense itching and pain. The lesions are under her breast area and she is unable to wear a bra. Pt was sent back to the ER as the doctor's office was closed and nurse felt that this was an emergency situation. Rash is very similar in character to Steven-Johnson Syndrome.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Red cell distribution width normal, Serum sickness, Urticaria, White blood cell count normal
Clinical narrative: Pt states the afternoon after her Flu shot,  she noticed an area on her left thigh that looked like an insect/mosquito bite that began to itch. She states the next morning she had a rash over her left side and after a few more days it progressed to the right side. She states she went to the ER on 12/3/23 and was told that it was a "rare reaction to the Flu shot." She states she was given a prescription for Calamine lotion, Cephalexin 500 mg 3 times per day for 7 days and  Hydroxyzine for itching. She then went home and had a follow up appointment with clinic on 12/7/23. She states she was again told that it was a rare reaction to the Flu Shot and she was to keep taking the medication and follow-up again on 12/14/23. Pt came into the Health Department to report this on 12/13/2023 and she is noted to have lesions starting on the right side of her neck and extending down over her entire trunk and limbs. The lesions range from small eraser size red areas that are slightly raised to large fifty cent size areas that have a halo  effect of redness very similar to a ring worm. Other lesions are full blown blistered areas the size of  golf balls. She reports intense itching and pain. The lesions are under her breast area and she is unable to wear a bra. Pt was sent back to the ER as the doctor's office was closed and nurse felt that this was an emergency situation. Rash is very similar in character to Steven-Johnson Syndrome.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: pt given Moderna covid spikevax vaccine.  lot # 8057456 exp 03/31/24 vaccine was removed from the freezer on 10/10/23  should have been discarded 11/09/23 patient given expired vaccine, no reaction to vaccine
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: ARM SORENESS, THEN SHOULDER JOINT PAIN IN BOTH SHOULDERS THAT IS STILL ONGOING SINCE 10/3/23
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: I had flu-like symptoms starting a few hours after the vaccine, which I know is normal. The symptoms included a headache. I took tylenol for a couple of days. After a couple of days all other symptoms were gone, however, I still had a headache. I have had a headache now ever since getting the vaccine (one month ago today). The headache is on both sides of my head, on the temples, above my eyes to above my ears.  I have it all of the time. It is hard to cope with it.
Age: 1.67
Sex: M
Vaccine: COVID19, DTAP, FLU4, VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient was in office for Well Visit on 12/5/23.  Patient received Pfizer Covid Vaccine 2023-2024 formulation for 6m-4yr.  At the time of reconciliation of vaccine stock at the end of the week by the office RN (12/8/23), it was noted that we had an extra vial of this Covid vaccine.  After extensive investigation as to why we had an extra vial in our inventory, it was determined that the following series of events occurred.  On 12/4/23 a different patient was in the office and received the same formulation of Covid vaccine.  The patient received the correct dilution and dosing.  (Please note that the vials, when diluted, contain three doses available for patient use and it is viable for 12 hours at room temp < 77 F )  The opened, diluted vial from 12/4/23 ws placed back into the refrigerator by one Medical Assistant and it was never discarded at the end of the business day, with the remaining unused unviable doses remaining in the vial.  On 12/5/23, when an order was received by a different Medical Assistant to administer this formulation of Covid vaccine to patient, she went into the refrigerator and pulled out the already opened, uncapped, diluted, unviable doses and re-diluted the vial and used this double-diluted vial of remaining vaccine for this patient.  Therefore, the dose that the patient receied was inadequate and also administered from a non-viable vial.  When vaccine counts were done the morning of 12/8/23, it was noted by the RN that there was an additional vial of Covid vaccine of this formulation available which should have been used.  Once the error was identified, the attending PCP for the patient, Dr. was notified.  Also notified were Dr., Medical Director; Practice Manager; and Office Supervisor, as well as the two Medical Assistants who were involved in the sequence of error.    Appropriate education, extensive counseling and remedialization was provided to the two Medical Assistants involved in the error.  All policies related to Covid Vaccine administration were reviewed with all Medical Assistant staff once again.  The Medical Assistants also have had a binder available to them with resources regarding vaccines as well.  The parent was notified by the attending PCP and the parent plans to come to the office for another, repeat Covid vaccine as the dose that her child received was inadequate.  There have been no untoward or ill effects to this child as a result of this error.  An internal report has been prepared and submitted as well as preparation of this VAERS document.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia oral
Clinical narrative: Patient describes about one hour after receiving the vaccine numbness in lips and around the mouth. Patient was going to try ibuprofen and monitoring for change.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, Premature baby, Umbilical cord abnormality
Clinical narrative: complications with her umbilical cord; she was not getting any nourishment; mother was vaccinated with Gardasil before pregnancy; This spontaneous report has been received from a lawyer from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (# 2310USA011696), concerning a female patient of unknown age (age group: foetus). There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On unknown dates in 2006, the patient's mother was vaccinated with the first and the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact doses, route of administration, anatomical location, lot numbers and expiration dates were not reported), and on an unspecified date in 2007, she was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot number and expiration date were not reported), all for prophylaxis (all doses administered before pregnancy) (foetal exposure before pregnancy).  On an unknown date in 2020, the patient experienced umbilical cord complications and she was not getting any nourishment. Due to the events, an emergency cesarean section (c-section) was done at 36 week of pregnancy. The outcome of the events was not provided. The pregnancy outcome was live birth - preterm. The fetal outcome was assessed as perinatal complication.  The reporter considered the events to be related to the suspect vaccine.; Sender's Comments:  US-009507513-2312USA004380: US-009507513-2312USA004346: US-009507513-2312USA004386: US-009507513-2310USA011696: US-009507513-2312USA004386:
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient's mother brought in vaccination card from another country. It was clear he had receive two polio vaccines in 10/27/2017 and 2/20/2018. RN and I reviewed dosing for IPV and given he had only 2, told mom he needed a 3rd dose (only 3 given 3rd dose was given after he was 4yrs old).  On review of IZ the day after being entered into our EMR I see he received four combination dtap-hib-IPV 9/27/2018, 9/26/2017, 7/5/2017, 5/2/2017. This means the IPV given yesterday was an extra dose that was not needed, and in fact he had already had 6 total doses of polio vaccines given 4 included in combination vaccine and 2 isolated polio vaccines given on separate dates in another country. I called mother today and notified her of the extra dose that he received and why this happened. He has not had any adverse reaction
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site swelling, Oedema peripheral, Swelling
Clinical narrative: Patient called and reported symptoms on swelling at injection site in Left Arm and also around the back and armpit. Patient feels extremely weak.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Nasopharyngitis, Rash, Urticaria
Clinical narrative: pt developed rash and hive for 4 days
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Rash
Clinical narrative: Patient developed pimple like rash on her face, neck, upper chest, No Shortness of breath, not on distress, calm,  was prescribed Motrin for pain at injection site but only has mild pain, did not take it. VS at 1200: 152/83 pulse 90 Respiration 18 )2sat 95%RA Temp 97.5. Md was on location and examined the patient. Dr. ordered to include Moderna covid vaccine to Pharmacy to Allergy profile of the patient.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vision blurred, Visual field tests abnormal
Clinical narrative: Right eye has blurriness, and using field vision test, has 68% vision versus left eye, where it is 97%. I have no family history, high blood pressure or diabetes. This Dr. and a Retina Specialist Doctor cannot explain cause.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: ARM AND SHOULDER PAIN
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac flutter, Chest discomfort, Diarrhoea
Clinical narrative: Heart fluttering, rapid pulse, chest heaviness, difficulty ambulating, diarrhea, migraine, lack of energy, low grade fever, body aches, scratchy throat.  Adverse effects worsened within 24 hours post vaccination,  duration of symptoms was 5 days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Heart rate increased, Migraine, Mobility decreased, Pain
Clinical narrative: Heart fluttering, rapid pulse, chest heaviness, difficulty ambulating, diarrhea, migraine, lack of energy, low grade fever, body aches, scratchy throat.  Adverse effects worsened within 24 hours post vaccination,  duration of symptoms was 5 days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Heart fluttering, rapid pulse, chest heaviness, difficulty ambulating, diarrhea, migraine, lack of energy, low grade fever, body aches, scratchy throat.  Adverse effects worsened within 24 hours post vaccination,  duration of symptoms was 5 days.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Caesarean section, Exposure during pregnancy, Premature labour
Clinical narrative: I was 36 weeks pregnant and went into pre-term labor then ended in giving birth via emergency c section
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Erythema
Clinical narrative: patient had redness on arm 4 days afer injection. pt advised to monitor for improvement and to notify provider
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Asthma, Chills, Condition aggravated, Decreased appetite, Dyspnoea
Clinical narrative: About 11 hours after vaccine (9pm) felt tired and a bit queasy; about 11pm started having severe chill which lasted a few hours.  Chills were accompanied by nausea.  About 3 AM, I woke up to find my breathing labored.  I used my rescue inhaler (Albuterol) which helped.  I also had a severe headache from about 11 PM.  Headache lasted through the next morning but breathing problems and chills had stopped.  I have not been able to eat since about 6PM on Tuesday.  Now, about 2 days later, all symptoms except fatigue have ended.  I feel like I may be able to try a little bland food later today.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Influenza virus test negative, Nausea, SARS-CoV-2 test negative
Clinical narrative: About 11 hours after vaccine (9pm) felt tired and a bit queasy; about 11pm started having severe chill which lasted a few hours.  Chills were accompanied by nausea.  About 3 AM, I woke up to find my breathing labored.  I used my rescue inhaler (Albuterol) which helped.  I also had a severe headache from about 11 PM.  Headache lasted through the next morning but breathing problems and chills had stopped.  I have not been able to eat since about 6PM on Tuesday.  Now, about 2 days later, all symptoms except fatigue have ended.  I feel like I may be able to try a little bland food later today.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Viral test
Clinical narrative: About 11 hours after vaccine (9pm) felt tired and a bit queasy; about 11pm started having severe chill which lasted a few hours.  Chills were accompanied by nausea.  About 3 AM, I woke up to find my breathing labored.  I used my rescue inhaler (Albuterol) which helped.  I also had a severe headache from about 11 PM.  Headache lasted through the next morning but breathing problems and chills had stopped.  I have not been able to eat since about 6PM on Tuesday.  Now, about 2 days later, all symptoms except fatigue have ended.  I feel like I may be able to try a little bland food later today.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Cerumen impaction, Ear infection, Gait disturbance, Laboratory test normal, Vertigo
Clinical narrative: I don't think this was related. Woke up with vertigo and throwing up. Unable to walk unaided. Went to ER. Neurological tests were all good. Probable ear infection. Came home on antibiotics with ear drops for wax impaction.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: I don't think this was related. Woke up with vertigo and throwing up. Unable to walk unaided. Went to ER. Neurological tests were all good. Probable ear infection. Came home on antibiotics with ear drops for wax impaction.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Dysstasia, Nausea, Renal pain
Clinical narrative: Patient reports Nausea, Kidney/Back pain, hard to stand. Symptoms started the following morning after vaccine administration.  Patient had also received a prevnar 20 from her doctor the same morning prior to arrival at the pharmacy.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Malaise, Rales
Clinical narrative: Resident  did not sleep well the night of the day the vaccine was given,  no appetite, general malaise, weakness and tachycardia (HR 135).  Resident attempted to transfer self to w/c and legs came out from under him, nurse present and lowered him to the floor. Dr. notified, ordered bed rest and PO fluids for the day. On 2nd following vaccination resident woke up with woke up early with temp of 99.1, SOB and audible crackles in lungs, weakness,  and respirations 30. Tylenol was given for temp and malaise.  Resident did get up and went to dining room for breakfast a little late, but did feel somewhat better after getting up and adventitious lung sounds cleared once he was up and moving in his w/c. Resident is still experiencing weakness, HR down to 104 at last check, respirations still hovering just below 30. Resident did come up to community room this afternoon as well to have a Christmas "snowball" fight with the Grinch and other residents. Clinical staff are still continuing to monitor and update Dr as needed.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tachycardia, Wheelchair user
Clinical narrative: Resident  did not sleep well the night of the day the vaccine was given,  no appetite, general malaise, weakness and tachycardia (HR 135).  Resident attempted to transfer self to w/c and legs came out from under him, nurse present and lowered him to the floor. Dr. notified, ordered bed rest and PO fluids for the day. On 2nd following vaccination resident woke up with woke up early with temp of 99.1, SOB and audible crackles in lungs, weakness,  and respirations 30. Tylenol was given for temp and malaise.  Resident did get up and went to dining room for breakfast a little late, but did feel somewhat better after getting up and adventitious lung sounds cleared once he was up and moving in his w/c. Resident is still experiencing weakness, HR down to 104 at last check, respirations still hovering just below 30. Resident did come up to community room this afternoon as well to have a Christmas "snowball" fight with the Grinch and other residents. Clinical staff are still continuing to monitor and update Dr as needed.
Age: 16.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: Exposure during pregnancy, Pregnancy test positive, Product use issue
Clinical narrative: List of vaccines given to minor on 11/29/23 Gardasil 9 0.5 mL  11/29/2023   RA X014788       Hep A 0.5 mL  11/29/2023   LA 2YS34  HEP B  0.5 mL  11/29/2023   LA  92DJ3       Inf Quad 6m+ Preserve free 0.5 mL  11/29/2023   RA U8200AA       MenQuadfi 0.5 mL  11/29/2023    LA U7852AA       MMR 0.5 mL  11/29/2023   LA W039698       Polio 0.5 mL  11/29/2023   RA W1A191M       Tdap 0.5 mL  11/29/2023    RA   M7YY5 Varicella 0.5 mL  11/29/2023   RA X017485   Minor is 16 y/o.  Denied sexual activity on initial exam.  Initial pregnancy test negative.  Was given required vaccines for age.  Minor returned on 12/13/23 for follow admitting she was sexually active (5 months before arrival) repeat pregnancy test was positive.  Due to pregnancy MMR/VAR/HPV and Polio would have been held.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt. reports entire arm aching but there has been no soreness, heat or signs of infection.  Pt. reports this soreness gets better with Advil or Tylenol.  Pt. reports she has been taking the OTC meds every 6-8 hours as needed.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: Pharmacist reports that the patient called and told him that she has every single reaction that she had in the literature.  She has general body aches, redness at injection site, and kept going on and on.  She said that she was going to her doctor for her reaction, and had an appointment for the next day.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash, Injection site warmth, Nasal congestion, Oropharyngeal pain, Rash pruritic
Clinical narrative: the patient reports the day following vaccine and had nasal congestion and some slight sore throat.  This gradually improved.  On 12/14/23 she awoke with itchy warm rash over the left deltoid where the injection was given..
Age: 23.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: Immediately after administration of the flu vaccine, the client developed a dime sized nodule beneath the surface of the skin. The nurse applied pressure to the injection site and massaged the site for a few seconds, and the nodule did not dissipate. The client stated that the site was painful from the injection but that he was not experiencing any other symptoms. The RN reassessed the injection site a few minutes later, and found that the client had developed a small red rash around the injection site. The client stated that he felt fine and was not experiencing any itchiness at the site or shortness of breath. Dr., was contacted and assessed the client. The client was instructed to seek medical assistance if he developed any severe symptoms of an allergic reaction, and he said that he would do so.
Age: 67.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Chills, Erythema, Pyrexia, Tenderness
Clinical narrative: patient states she has a very red and tender arm for a week. she had a fever/chills the day of the vaccine. her doctor told her to report it to us.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient reported sharp shooting pain in her arm beginning minutes after vaccine administration and continuing to the present. Reports tenderness at vaccine site and intermittent pain that still disrupts sleep
Age: 59.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: Upon administration of the Shingles vaccine, the syringe leaked which caused the client to not receive a complete dose of the vaccine. Dr gave a verbal to administer a second dose of the Shingles vaccine to the client to ensure that she was sufficiently vaccinated. The client was informed of this and agreed to administration of additional dose today. The client tolerated the administration well and did not have any questions or concerns before leaving the clinic today.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: The patient consented to a flu vaccine today. The patient already received a flu vaccine on 10/12/23 which was unknown by the pharmacist at the time. Discovered upon billing the vaccine to insurance.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration, Type III immune complex mediated reaction
Clinical narrative: Pt appears to have an Arthus reation of anterior right thisgh due to the vaccine being injected too superficially.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Oxygen saturation decreased, Syncope
Clinical narrative: At 1415 mother stated that the patient fainted.  Vital signs at 1420 B/P 118/75, HR 67, O2 93 %, At 1423 patient was placed on oxygen at 2LPM due to oxygen dropped to 83 %.  at this time Ice was placed on chest per provider.  At 1423 B/P was at 144/74 and HR 82, a blood sugar was performed, blood sugar was at 93.  At 1424 02 was at 100% at this time O2 was lowered per provider to 1 LPM.  At 1425 patient started to respond to O2 at this time was at 100% room air, HR 79.  Patient remained in room at 1502 patient vitals were at 99% O2, HR 74 and B/P 103/67 at this time patient was in sitting position and was responding to questions asked by PA.  At 1509 patient was asked to walk in the hallway to see if she was ok and she was not feeling dizzy at this time patient denied feeling dizzy and was released to go home with mother.  Mother and patient had no further questions at this time. Patient was in today for Immunization shots
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Fatigue, Hypertension
Clinical narrative: Muscle aches, dizziness, seeing stars, cognitive confusion, lassitude, severe tinnitus.  The severe tinnitus remains now, two years later, as does the seeing of stars when I move my head.  MOST IMPORTANTLY: I now have serious cardiovascular issues.  I'm being medicated for extremely high blood pressure for the first time in my life, and have periodic racing heartbeat that impedes activity and makes breathing difficult.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Palpitations, Photopsia, Tinnitus
Clinical narrative: Muscle aches, dizziness, seeing stars, cognitive confusion, lassitude, severe tinnitus.  The severe tinnitus remains now, two years later, as does the seeing of stars when I move my head.  MOST IMPORTANTLY: I now have serious cardiovascular issues.  I'm being medicated for extremely high blood pressure for the first time in my life, and have periodic racing heartbeat that impedes activity and makes breathing difficult.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Myositis, Pain in extremity
Clinical narrative: On 11/18/23 Pt sitting in bleachers outside in cold when trying to get up had bilateral pain over thighs for few days. Pt called her doctor listed above and told to hydrate then pt followed up with doctor on  11/21/23, diagnosed with myositis.
Age: 10.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Patient's school nurse called her father who reported to the clinic that the patient developed a rash on her chest, neck, face. When informed that she received an immunization in the left arm this morning, the school nurse checked her arm and stated that rash starts on the arm and moves toward her chest.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Rash, Rash erythematous
Clinical narrative: Local reaction to site, Redness then resident developed a red rash to trunk, abdomen, groin, thighs, and legs
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Rash macular, Urticaria
Clinical narrative: Almost, immediately after vaccine administered. Pt had blotchy erythema of both arms and after scattered hives, worse on Rt. arm, had no swelling, no scab, no wheezing, no emesis.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient came in for a Covid vaccine and was administered a Fluzone Quadrivalent. This was patients 2nd fluzone of the season, his first one being on 10/4/2023. CDC was called and I did obtain information that this will not be harmful to the patient. Pt. will be notified.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Heart rate increased, Malaise, Tremor
Clinical narrative: Patient's wife stated he started to have significant chills, fast heartbeat, tremor, shaking that occurred about 15 minutes after receiving the vaccine.  She described that he is better but still feels unwell after 10 days.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient has not had an adverse reaction .
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Tremor
Clinical narrative: Patient reports that she had several chills and shakes.  Patient reports that she felt like her whole body was shaking. Patient cannot remember the exact time the symptoms started but later in the evening and lasted until after midnight the next day.  Once the symptoms resolved,  she did not have them again.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Moderna Spikevax was administered instead of Moderna 6-11 years injection
Age: 74.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Herpes Zoster followed by post herpetic neuralgia, continuing. Treated first with antiviral. Now ongoing treatment with Gabapentin.  First sx ?s began 36 hours after vaccinations.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Headache, Malaise, Myalgia
Clinical narrative: After receiving vaccinations, patient has had long-term, persistent malaise, muscle ache, fatigue, and mild headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 1.08
Sex: F
Vaccine: HEP, HEPA, MMR, PNC15, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: engerix was given in error, extra dose, no adverse reactions.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Body temperature increased, Fatigue, Full blood count, Heart rate increased, Respiratory rate increased
Clinical narrative: vertigo exhaustion elevated T° elevated rHR increased respirs
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Vertigo
Clinical narrative: vertigo exhaustion elevated T° elevated rHR increased respirs
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Fatigue, Vertigo
Clinical narrative: vertigo exhaustion elevated T° elevated rHR increased respirs
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF RERIGERATED
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Approximately 10 days after vaccination, I started to have urticaria/hives on my body, especially the scalp, face (including around my eyes), neck, check, upper back, hip and groin area, and limited urticaria on my lower legs and feet.  Urticaria were very itchy, but not painful.  I have never had an urticarial reaction like this for any reason, and have no known allergies except occasional seasonal hay-fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Malaise, Syncope
Clinical narrative: Patient fainted in bathroom after getting out of bed the morning after the vaccination. She lost consciousness for 30 seconds. When she regained consciousness, she was extremely tired and felt sick. She went back to bed to sleep. She did not want to eat or drink, but she did with assistance. This continued for 48 hours. Primary care physician's office was notified. They advised that patient be monitored and to update them if condition worsened.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: LARGE AREA OF SWELLING, ERYTHEMA, ITCHING OVER LATERAL UPPER RIGHT ARM BETWEEN INJECTION SITE AND ELBOW
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: The patient came in yesterday, 12/13/2023, and stated that after her vaccination, she couldn't do anything with her hand. She couldn't even hold a cup of coffee. When I was initally giving her the vaccine on 11/25/23, she told me this happened to her a few years ago with another immunizer and flu shot. She stated she went to the doctor then and the doctor stated the immunizer must have hit the radial nerve. She did not go to the physician this time. She told me yesterday that her feeling had came back in her hand. She also stated it came back much sooner this time and that it took 3 months to come back last time this happened. I'm unsure how many years have passed since this happened to her the first time.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Computerised tomogram, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: I started out with slowly having numbness in my legs and then I ended with drop foot in the right foot. Now both feet are having issues with neuropathy.  It seems to be getting a little better. I also had pains through my ribs/chest and back.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Neuropathy peripheral, Peroneal nerve palsy, X-ray
Clinical narrative: I started out with slowly having numbness in my legs and then I ended with drop foot in the right foot. Now both feet are having issues with neuropathy.  It seems to be getting a little better. I also had pains through my ribs/chest and back.
Sex: F
Vaccine: VARZOS
Symptoms: Anti-thyroid antibody increased
Clinical narrative: Thyroid peroxidase antibodies elevated; This non-serious case was reported by a nurse via call center representative and described the occurrence of thyroid peroxidase antibody increased in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced thyroid peroxidase antibody increased (Verbatim: Thyroid peroxidase antibodies elevated). The outcome of the thyroid peroxidase antibody increased was unknown.   It was unknown if the reporter considered the thyroid peroxidase antibody increased to be related to Shingrix.     It was unknown if the company considered the thyroid peroxidase antibody increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-Dec-2023 The reporter reported that she received Shingrix vaccine in last week and few days later she done with laboratory test and the thyroid peroxidase antibodies came back elevated.  The reporter wanted to know if it could had been elevated because of the vaccine.  The reporter stated that she gave her information to the other lady and was upset that she was asking her questions. The reporter did not consent to follow up.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient is under 12 but given this vaccine which she is not of age for. no adverse reaction. mother is aware and has no concerns
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Feeling abnormal
Clinical narrative: blah feeling; was five foot five inches and now is five foot three inches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (blah feeling) and BODY HEIGHT DECREASED (was five foot five inches and now is five foot three inches) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Defibrillator/pacemaker insertion. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Atrial fibrillation and Anxiety. Concomitant products included ALPRAZOLAM for Anxiety.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (blah feeling) and BODY HEIGHT DECREASED (was five foot five inches and now is five foot three inches). At the time of the report, FEELING ABNORMAL (blah feeling) and BODY HEIGHT DECREASED (was five foot five inches and now is five foot three inches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body height: decreased.         The Alprazolam was taking it every day when was anxious. usually cuts in half. They do help sleep so takes a whole one to sleep. It was 1mg.  The patient had the booster shot three weeks ago. It was fine no pain in arm. The next day lost her appetite for three days. was really scared. thought was dying. It was mainly got paranoid because did not have an appetite. After the third day, started eating again. She realized every time, usually gets Moderna, the next day would get blah feeling. She started out with Moderna shot and got reaction from that too, but it was not like this one, was thin and eats healthy, was skeptical, The booster shot as Pfizer Covid booster shot. The loss of appetite started the day after getting the booster shot and then continued on. It was 3 days that did not have her appetite.   The outcome of event was recovered completely. After 3 days started to have the feeling wanted to start eating. would have been very scared if it did not come back.   Treatment medication not reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lethargy, Malaise
Clinical narrative: lethargy; feeling spaced out/felt lousy/just feeling  crummy in general; general malaise; fatigue; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargy), FEELING ABNORMAL (feeling spaced out/felt lousy/just feeling  crummy in general), MALAISE (general malaise) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargy), FEELING ABNORMAL (feeling spaced out/felt lousy/just feeling  crummy in general), MALAISE (general malaise) and FATIGUE (fatigue). At the time of the report, LETHARGY (lethargy), FEELING ABNORMAL (feeling spaced out/felt lousy/just feeling  crummy in general), MALAISE (general malaise) and FATIGUE (fatigue) had resolved.            Concomitant medication was not reported.  Patient started treatment on unreported dates with 5 doses of Moderna COVID-19 vaccine. It was reported the patient experienced the same symptoms each time for 2 days following each dose. The patient felt lousy, with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise.   Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lethargy, Malaise
Clinical narrative: Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), MALAISE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), LETHARGY (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) and FATIGUE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), MALAISE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), LETHARGY (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) and FATIGUE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise). At the time of the report, FEELING ABNORMAL (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), MALAISE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), LETHARGY (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) and FATIGUE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) had resolved.            No concomitant medications were reported.  It was reported that the patient started treatment with 5 doses of Moderna COVID-19 vaccine. It was reported that the patient experienced the same symptoms for 2 days following each dose.  No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaccination site erythema
Clinical narrative: Injection site redness and hardness Urinary Tract Infection; Injection site redness and hardness Urinary Tract Infection; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (Injection site redness and hardness Urinary Tract Infection) and VACCINATION SITE ERYTHEMA (Injection site redness and hardness Urinary Tract Infection) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 10-Dec-2023, the patient experienced URINARY TRACT INFECTION (Injection site redness and hardness Urinary Tract Infection) and VACCINATION SITE ERYTHEMA (Injection site redness and hardness Urinary Tract Infection). At the time of the report, URINARY TRACT INFECTION (Injection site redness and hardness Urinary Tract Infection) and VACCINATION SITE ERYTHEMA (Injection site redness and hardness Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   It was unknown if the patient experienced any additional symptoms/events.  No concomitant and treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Ear pain, Fall, Fatigue, Influenza like illness
Clinical narrative: bed ridden; feel like flu; Body fatigue; weakness in muscles; body aches; neck ache; ear sore; Jaw ache; throat sore; Fell from this shot could not get up for 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in muscles), FALL (Fell from this shot could not get up for 20 minutes), PAIN (body aches), NECK PAIN (neck ache) and EAR PAIN (ear sore) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In 2023, the patient experienced FALL (Fell from this shot could not get up for 20 minutes). On 07-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced MUSCULAR WEAKNESS (weakness in muscles), PAIN (body aches), NECK PAIN (neck ache), EAR PAIN (ear sore), PAIN IN JAW (Jaw ache), OROPHARYNGEAL PAIN (throat sore) and FATIGUE (Body fatigue). On 11-Dec-2023, the patient experienced BEDRIDDEN (bed ridden) and INFLUENZA LIKE ILLNESS (feel like flu). At the time of the report, MUSCULAR WEAKNESS (weakness in muscles), PAIN (body aches), NECK PAIN (neck ache), EAR PAIN (ear sore), PAIN IN JAW (Jaw ache), OROPHARYNGEAL PAIN (throat sore) and FATIGUE (Body fatigue) had not resolved, FALL (Fell from this shot could not get up for 20 minutes) had resolved and BEDRIDDEN (bed ridden) and INFLUENZA LIKE ILLNESS (feel like flu) outcome was unknown.            Concomitant medication was not reported.  It was reported that, patient felt better on 10th for Body fatigue, weakness in muscles, body aches, neck ache, Jaw ache ear sore and throat sore.  It is unknown if the patient experienced any additional symptoms/events  Treatment information was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neck pain, Oropharyngeal pain, Pain, Pain in jaw
Clinical narrative: bed ridden; feel like flu; Body fatigue; weakness in muscles; body aches; neck ache; ear sore; Jaw ache; throat sore; Fell from this shot could not get up for 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in muscles), FALL (Fell from this shot could not get up for 20 minutes), PAIN (body aches), NECK PAIN (neck ache) and EAR PAIN (ear sore) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. In 2023, the patient experienced FALL (Fell from this shot could not get up for 20 minutes). On 07-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced MUSCULAR WEAKNESS (weakness in muscles), PAIN (body aches), NECK PAIN (neck ache), EAR PAIN (ear sore), PAIN IN JAW (Jaw ache), OROPHARYNGEAL PAIN (throat sore) and FATIGUE (Body fatigue). On 11-Dec-2023, the patient experienced BEDRIDDEN (bed ridden) and INFLUENZA LIKE ILLNESS (feel like flu). At the time of the report, MUSCULAR WEAKNESS (weakness in muscles), PAIN (body aches), NECK PAIN (neck ache), EAR PAIN (ear sore), PAIN IN JAW (Jaw ache), OROPHARYNGEAL PAIN (throat sore) and FATIGUE (Body fatigue) had not resolved, FALL (Fell from this shot could not get up for 20 minutes) had resolved and BEDRIDDEN (bed ridden) and INFLUENZA LIKE ILLNESS (feel like flu) outcome was unknown.            Concomitant medication was not reported.  It was reported that, patient felt better on 10th for Body fatigue, weakness in muscles, body aches, neck ache, Jaw ache ear sore and throat sore.  It is unknown if the patient experienced any additional symptoms/events  Treatment information was not reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid 19) in an 88-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031894) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (EM9810) on 05-Feb-2021, Pfizer (EN6200) on 26-Feb-2021, Pfizer (FK9893) on 01-Apr-2021, Pfizer (EW64) in September 2021 and Pfizer (GH9703) on 14-Oct-2021. Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, Pfizer, Pfizer and Pfizer.    On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 07-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. A Call was received from patient, and she stated that her prior doses were Pfizer, and had no problems with them. On 24-Oct-2023 she received Spikevax, referred it as her "yearly shot" and on 07-Dec-2023 she came down with COVID, a bad case of covid. Patient stated, she blames Moderna. She coughed until she thought she was going to cough her head off. Cough was severe. Patient informed that she did inform her HCP, nor received any treatment and did not take any medication. Patient reported she started to get better, that day. She felt like she could live again. She also reported that on Sunday, 10Dec2023, she could not maneuver, and on 11Dec2023, she doesn't feel like she can go out the door. Patient was not hospitalized, but mentioned, that maybe she should have. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Dec-2023: Live follow-up received and updated references.