chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Nervous system disorder, Neurological symptom, Paraesthesia
Clinical narrative: I have attempted to complete this report 3 times, each time being cut off without warning. It is not possible to explain the entire course of events in the timeframe allotted. However, I will state I have never been so sick in my entire life as I was when I received the vaccine and the following day. I was deathly ill, with multiple symptoms. It progressed to all 4 extremities and tongue becoming weak, numb, and tingly with internal vibrations and tremors. I had difficulty walking, cognitive issues, and extreme generalized weakness along with many other symptoms which timeframe will not allow for listing.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue movement disturbance, Tremor, Vibratory sense increased
Clinical narrative: I have attempted to complete this report 3 times, each time being cut off without warning. It is not possible to explain the entire course of events in the timeframe allotted. However, I will state I have never been so sick in my entire life as I was when I received the vaccine and the following day. I was deathly ill, with multiple symptoms. It progressed to all 4 extremities and tongue becoming weak, numb, and tingly with internal vibrations and tremors. I had difficulty walking, cognitive issues, and extreme generalized weakness along with many other symptoms which timeframe will not allow for listing.
Age: 85.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: On 9/01/2022 patient received expired Moderna with beyond use date of 8/26/2022.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: INCORRECT DILUTION, THE DOSE (0.2 ML) WAS GIVEN BEFORE DILUTING THE ORIGINAL VIAL
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inflammation, Lip swelling, Pain, Pharyngeal swelling
Clinical narrative: Lips, face, tongue, throat swelling and inflammation.  At day 2 my tongue, throat and mouth broke out in lesions.  It took a steroid to lesson the swelling and pain after 4 days.  I had to go to the ED as throat was closing. I had an event in Dec 2020, March 2021 and July of 2022 - following each dose:  dec 2020, jan 2021, nov 2021, July 2022 Pfizer
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Swelling face, Throat tightness
Clinical narrative: Lips, face, tongue, throat swelling and inflammation.  At day 2 my tongue, throat and mouth broke out in lesions.  It took a steroid to lesson the swelling and pain after 4 days.  I had to go to the ED as throat was closing. I had an event in Dec 2020, March 2021 and July of 2022 - following each dose:  dec 2020, jan 2021, nov 2021, July 2022 Pfizer
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, MMRV, PNC13
Symptoms: Wrong product administered
Clinical narrative: MMRV was given at this appt instead of varicella alone.  Also MMR was given as well.  Therefore the child received two doses of mmr today at the appointment which was a mistake.  the MA reported the error, and the mother was made aware.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: no sx. no adverse reaction
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Pfizer monovalent vaccine as a first booster on 9/1/22
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: On 8/31/22 pt received first doses of Tdap, Menactra and HPV. Received call from Pt's mother today 9/2/22 she  called to report yesterday 9/1/22  pt's arm was red and swollen at injection site in muscle area of left arm. She gave pt benadryl and ibuproen, the redness and warmth swelling   was the size of quarter/ golf ball size, now  today 9/2/22 redness and warmth is size of soft ball on left arm. Mom stated pt does not have any fever, and no nausea or vomiting. Instructed mother to take pt to her primary care Dr for eval today. She stated dr.'s office does not have any appts open today. She will take her to urgent care today for evaluation.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: 3rd dose of Pfizer monovalent given
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbing sensation in the left and right feet and toes (10/28/21 to 9/2/22).
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Pfizer -pediatric was not diluted prior to administering.  was not discovered until later on that evening.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dehydration, Fluid intake reduced, Mobility decreased, SARS-CoV-2 test negative
Clinical narrative: On 08/26/2021  in the morning around 10:00AM I wasn't able to get out of my bad. I was completely out. I didn't understand what my wife was telling me. We called EMS to the hospital  because I was dehydrated due to the fact that I couldn't drink anything. They gave me breathing treatments every six hours. They did all kinds of blood test.  I stayed in the hospital for 2-3 days. They didn't prescribed me any thing new. They advised me to continue taking my regular meds. This happened through out all the COVID-19 vaccines. About 1-2 weeks I started feeling better.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Tingling and numbing feeling in the left and right feet and toes (4/9/2022 to 9/2/2022). Pins-and-needles and numbing feeling in the left and right legs (4/9/2022 to 9/2/2022). Pins-and-needles and numbing feeling in the middle section of body [front, sides, and back] (4/9/2022 to 9/2/2022). Joint and muscle pain (dull) in the right knee (4/9/2022-9/2/2022). Occasional muscle pain (dull) in the middle area of the lower back (4/9/2022-9/2/2022).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FDA and CDC rescinded their authorization for booster dossing (12 and over) Pfizer .
Age: 38.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Vaccination error
Clinical narrative: The RN was unable to get a bubble when administering the vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Feeling of body temperature change, Vomiting
Clinical narrative: Patient was feeling really cold and then hot, patient also started vomiting within 2-4 hours of vaccine administration. Recommended to take the patient to ER.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Incorrect product formulation administered
Clinical narrative: 3RD Dose of Pfizer monovalent vaccine given
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered 2nd Moderna Booster dose 0.25ml, no adverse reactions, Health Department requested to be reported due to Monovalent given instead of Bivalent.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: 3RD dose of Pfizer monovalent given
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent Pfizer for 2nd booster.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Oropharyngeal pain, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: I received post nasal drip; light sore throat;  shortness of breath for 3 days and I took Paxlovid and the symptoms  have not resolved.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna 1st booster administered, no adverse reactions. Health Department requested to be reported due to Monovalent given instead of Bivalent
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash erythematous, Urticaria
Clinical narrative: flat red rash on lower jaw and cheeks of face; today spread to back, bil arms, hands, abd, neck, starting on bil legs (new tonight); hives covered
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasopharyngitis, Pain in jaw
Clinical narrative: On June 27, 2022 I tested positive for COVID-19. Four days before I had a really bad cold. I had headaches, my jaw was hurting, runny nose, and a bunch of coughing. I ran a low-grade fever the following days.  I contacted my doctor and they sent me a z pack and that did not help so I started taking my asthma medicine to help with my breathing. I kept testing positive for a week and a half.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On June 27, 2022 I tested positive for COVID-19. Four days before I had a really bad cold. I had headaches, my jaw was hurting, runny nose, and a bunch of coughing. I ran a low-grade fever the following days.  I contacted my doctor and they sent me a z pack and that did not help so I started taking my asthma medicine to help with my breathing. I kept testing positive for a week and a half.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent Pfizer for the first booster.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna 1st booster administered, no adverse reactions. Health Department requested to be reported due to Monovalent given instead of Bivalent
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received Monovalent Moderna 2nd booster
Age: 66.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Patient with erythema, tenderness and a palpable nodule in the site of vaccination for 1 week. Has not changed in size. He did not have any other symptoms after vaccination
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Illness, Immunodeficiency, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient received both Menveo and Bexero in clinic.  Within 2 to 4 hours after receiving both vaccines the patient developed fever and sore throat.  Mom took the patient to the ED and she reports the provider in the ED told her receiving both vaccines at the same time compromised his immune system causing an illness.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent Moderna 1st dose
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Moderna 1st booster administered no adverse reactions. Health Department requested to be reported due to Monovalent given instead of Bivalent
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PT RECEIVED THE PEDIATRIC PFIZER VACCINE. THE VACCINE WAS NOT DILUTED, PT RECEIVED 0.2 ML OF THE UNDILUTED VACCINE.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: The vaccine was ordered to be delivered on 8/31/22 and this was done. However, the vaccine administration was done the next day on 9/1/22. This was an errant administration since the FDA required the use of Bivalent COVID-19 vaccines as of 9/1/2022. There were no adverse physical events associated with this administration.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Pt given 4th booster dose of Pfizer monovalent
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent Moderna booster.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient given Pfizer monovalent for the first booster.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: Incorrect DOB  provided by caregiver during  12/2021 immunization.  During review by vaccine team on 6/27/22 when caregiver requested for correction, pt was not eligible at the time for COVID-19 vaccinations. No reactions reported  by caregiver.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: pt given pfizer  monovalent booster dose
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt given 4th dose of pfizer monovalent  vaccine
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: Patient given Pfizer monovalent vaccine for the 4th dose.
Age: 32.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Epistaxis, Fatigue, Tinnitus, Vertigo
Clinical narrative: Nosebleed 20 minutes after leaving the venue, but went away quickly. Another nosebleed later that night. Next day, tinnitus/ears ringing off and on throughout day.  Fatigued, slight vertigo
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Discomfort, Dizziness, Feeling hot, Syringe issue
Clinical narrative: Patient was to receive JYNNEOS 0.1mL intradermal. However, syringe malfunction caused all of dose to leak out. So, injection was repeated successfully.  A few minutes into observation, patient reported feeling warm, uncomfortable, and "going to pass out". Lead RN and auxiliary RNs immediately began anaphylaxis assessments. Patient was moved from seated position on chair to seated position on floor against wall to mitigate possible physical trauma.  ~11:45 = BP 118/82, HR 88, RR 16, Diaphoretic, Lethargic, Bilateral Lung Sounds Clear ~11:55 = BP 120/78 HR 84, RR 16, Less Diaphoretic, AOX4, Bilateral Lung Sounds Clear  Patient was held in observation station for an additional 30 minutes. Thereafter, patient verbalized feeling OK. RNs noted fully AOX4, normal gait, sans gross neurological deficit, and pleasantly conversational. Patient counselled to watch for further adverse at home and to immediately call 911 if such occurs. Patient discharged.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 9/1/22 - Patient received 50 microgram dose of Moderna vaccine, as opposed to recommended 25 microgram dose for his age group. Provider contacted parents and reported that patient so far has not had any side effects from vaccine. Provider made follow up call today, 9/2/22, and mother reported  that patient had no fever, no redness or swelling at the injection site.
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Injection site reaction, Seizure
Clinical narrative: Patient received JYNNEOS 0.1mL intradermally. While sitting at observation station, auxiliary RN saw patient convulsing mildly while seated on chair. Lead RN & auxiliary RNs immediately gathered around patient to support (but not restrain) body to prevent fall. Convulsions lasted for a few seconds then patient exclaimed "I'm OK everyone! I'm OK. This happens sometimes."  ~12:40 BP 124/78, HR 80, RR 14, AOX4, Lung Sounds Bilateral Clear  ~12:45 BP 124/80, HR 80, RR 12, AOX4, Lung Sounds Bilateral Clear  Patient kept at observation station for another 30 minutes. Given snacks and water. RN assessments prior to discharge = AOX4, no gross neurological deficits, normal gait, pleasantly conversational. Counselled to always disclose history of seizures/convulsions to any future healthcare clinic or organization. Counselled to monitor for further adverse effects and to call 911 if such occurs. Discharged ~1315.  Telephone F/U next day 9/2/22. Patient reported that he felt well today. Felt well night before. Standard side effects at injection site. Counselled to monitor for further adverse effects and to call 911 if such occurs. Left cell # to Ops Deputy for future questions.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy bone marrow, Blood disorder, Blood test abnormal, Laboratory test abnormal, T-cell prolymphocytic leukaemia
Clinical narrative: TPLL leukemia. Rare T cell blood disease
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: T-lymphocyte count increased, White blood cell count increased
Clinical narrative: TPLL leukemia. Rare T cell blood disease
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: New MA inadvertently give MMR and Varicella IM rather than SQ
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient came to pharmacy to get his second dose of MMR. Medication was mixed properly but given IM instead of SQ. Patient had no known adverse event. Patient did not stay in store for 15 minutes after shot but called the store later and told a technician he was fine. Technician told him to stay on the phone because pharmacist wanted to speak with him but he hung up. Could not call patient back because he didn't leave his number.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Intensive care, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 1/14/2 (lot # 024M20A), 2/11/21 (lot # 024M20A), and 12/30/21 (lot # 013H21B). On 8/24/22, patient admitted to our inpatient facility with acute hypoxemic respiratory failure due to COVID-19 pneumonia.  Patient transferred to med/surg unit on 8/26/22 and as of today (9/2/22), patient is still admitted in the med/surg unit.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was provided vaccine on 9/2/22 that was past it's beyond use date of 8/31/22.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test abnormal, T-cell prolymphocytic leukaemia, White blood cell count increased
Clinical narrative: Developed TPLL a rare leukemia. Severely increase in WBC especially T cells. Other abnormal counts.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Gave 4th dose to 7 year old child
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Lethargy, Nausea, Pyrexia, Sinus headache
Clinical narrative: Fever, severe sinus headache, nausea for 18-48 hours after injection.  Continued sinus headeach & pressure & general lethargy for another 2 days following.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Product preparation issue, Pyrexia
Clinical narrative: On 9-1-2022,  We withdrawn the Pfizer vaccine for age 5 to <12 years, 0.2 ml from the vial.  The vial was NOT diluted with 0.9 % Sodium Chloride for Injection.  The quantity was verified from the vial.  Our Pharmacy Technician withdrew and Injected the medication into the patients Left Arm.  The patient stayed at the pharmacy for 15 minutes. The patient showed no symptoms when she was at the pharmacy.   When we were counting available vials in the box of vaccines, we remembered the vial should have been diluted.  We called the doctors office and the parents regarding the incident. Unable to get hold of doctor.  Called to mother, patient had mild fever of 100'F, body aches, diarrhea. Took some medication for fever.  Patient better today.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: no adverse reaction, monovalent booster given end date of monovalent booster doses
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent Pfizer as first booster dose
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Armpit swelling and pain.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Gave 4th dose to 10 year old
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Patient with MS on Tysabri received Moderna COVID-19 vaccine full dose on 01/22/2021 and 02/25/2021; then received Moderna COVID-19 vaccine booster dose on 10/28/2021 and 02/23/2022, instead of a third full dose of primary series.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic myeloid leukaemia, Immunodeficiency
Clinical narrative: Patient received two doses of Pfizer COVID-19 for primary series and one dose of Moderna COVID-19 booster. Patient was diagnosed with CML a few months later and is now immunocompromised.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Condition aggravated, Confusional state, Loss of consciousness, Pain in extremity
Clinical narrative: The patient filled out their paperwork and included a history of seizures but was said they did not have known history of seizures related to vaccines. The patient was advised to wait in our waiting room for 15 minutes after the administration.  As they were standing up to leave after 15 minutes she started seizing.  As I, the pharmacist, ran out to help, her friend and an observer assisted in slowly lowering her to the floor.  She was lowered without injury and turned onto her side.  As this was occurring a pharmacy team member called 911, even though the friend denied service as "she has had seizures for over 20 years". I informed them we had to call 911 but they had the right to deny transport. The seizure lasted maybe less than 1 minute, stopped for about 30 seconds but patient was unresponsive but with pulse and then another seizure occurred lasting maybe less than 1 minute.  The patient then regained consciousness but was confused. I directed her to remain laying down, but she slowly sat into a sitting position. She almost immediately grabbed her chest and complained of severe chest pain.  She then also complained of jaw pain and shook her arm and complained of right sided arm pain when asked. I asked a pharmacy team member to get 4 chewable baby aspirin (81mg x4) as these are signs of a heart attack. The friend stated she has a long history of heart issues but in the adrenaline of the moment I do not remember what issues she stated.  As the staff member was getting the Aspirin EMS arrived and agreed to administer the 325 mg total of chewable aspirin.  The EMS assisted the patient in taking the aspirin and helped her off the floor onto their gurney.  I gave as much detail in my report to EMS as possible and they took the patient out of the store to the hospital. At the time of transport she was alert and still complaining of chest pain.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in jaw, Seizure, Unresponsive to stimuli
Clinical narrative: The patient filled out their paperwork and included a history of seizures but was said they did not have known history of seizures related to vaccines. The patient was advised to wait in our waiting room for 15 minutes after the administration.  As they were standing up to leave after 15 minutes she started seizing.  As I, the pharmacist, ran out to help, her friend and an observer assisted in slowly lowering her to the floor.  She was lowered without injury and turned onto her side.  As this was occurring a pharmacy team member called 911, even though the friend denied service as "she has had seizures for over 20 years". I informed them we had to call 911 but they had the right to deny transport. The seizure lasted maybe less than 1 minute, stopped for about 30 seconds but patient was unresponsive but with pulse and then another seizure occurred lasting maybe less than 1 minute.  The patient then regained consciousness but was confused. I directed her to remain laying down, but she slowly sat into a sitting position. She almost immediately grabbed her chest and complained of severe chest pain.  She then also complained of jaw pain and shook her arm and complained of right sided arm pain when asked. I asked a pharmacy team member to get 4 chewable baby aspirin (81mg x4) as these are signs of a heart attack. The friend stated she has a long history of heart issues but in the adrenaline of the moment I do not remember what issues she stated.  As the staff member was getting the Aspirin EMS arrived and agreed to administer the 325 mg total of chewable aspirin.  The EMS assisted the patient in taking the aspirin and helped her off the floor onto their gurney.  I gave as much detail in my report to EMS as possible and they took the patient out of the store to the hospital. At the time of transport she was alert and still complaining of chest pain.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area has swollen with redness, sore around two inches on next day (after 24 hours). Injection area extra bright red. Nurse report this has been common effect.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Insomnia, Malaise, Nausea
Clinical narrative: Following immunization, during the evening patient reported soreness at injection site, fever, chills, nausea, difficulty sleeping. Patient reported to be feeling better the next morning but was still not well.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Following immunization, during the evening patient reported soreness at injection site, fever, chills, nausea, difficulty sleeping. Patient reported to be feeling better the next morning but was still not well.
Age: 25.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Electrocardiogram normal, Hyperhidrosis, Hypophagia, Laboratory test, Lethargy
Clinical narrative: Patient was given Varivax subcutaneous in left arm tricep area, MMR II right arm tricep area, and Hepatitis B Hepislav-B IM in left deltoid around 11:45 AM in a clinic setting by me. After giving all vaccines patient became lethargic, diaphoretic, pallor, and had a thready pulse of 20-30s after 1 minute. Patient legs were elevated and patient was reclined on exam table. EMS was called and patient remained lethargic, pale, with pulse in 20-30s, with pulse oximeter of 85% on room air (we do not have oxygen in this clinic). Gave patient an ammonia inhalant and patient began to be more conversant after 5 minutes. Pulse now in  40-50s. Paramedics arrived after 5 minutes, patient now alert and oriented, EKG performed and patient was in sinus rhythm. Patient was taken to Hospital for further work up but was discharged around 2:00 PM. Patient came back by clinic to thank clinic staff. Patient did inform staff after the situation that he had not eaten, had worked out and taken pre-workout before vaccination appointment.
Age: 25.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Pallor, Pulse abnormal
Clinical narrative: Patient was given Varivax subcutaneous in left arm tricep area, MMR II right arm tricep area, and Hepatitis B Hepislav-B IM in left deltoid around 11:45 AM in a clinic setting by me. After giving all vaccines patient became lethargic, diaphoretic, pallor, and had a thready pulse of 20-30s after 1 minute. Patient legs were elevated and patient was reclined on exam table. EMS was called and patient remained lethargic, pale, with pulse in 20-30s, with pulse oximeter of 85% on room air (we do not have oxygen in this clinic). Gave patient an ammonia inhalant and patient began to be more conversant after 5 minutes. Pulse now in  40-50s. Paramedics arrived after 5 minutes, patient now alert and oriented, EKG performed and patient was in sinus rhythm. Patient was taken to Hospital for further work up but was discharged around 2:00 PM. Patient came back by clinic to thank clinic staff. Patient did inform staff after the situation that he had not eaten, had worked out and taken pre-workout before vaccination appointment.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Minor received third dose of Pfizer vaccine on 8/29/2022. Then received a fourth dose of Pfizer vaccine on 9/2/2022.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Blood test, Computerised tomogram, Muscle twitching, Oral discomfort
Clinical narrative: Twitching tongue, loss of taste, white coating and burning mouth.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue discolouration, Tongue discomfort
Clinical narrative: Twitching tongue, loss of taste, white coating and burning mouth.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Major hives/rash (large and small) all around the vaccine injection spot on her thigh. Also the area was swollen for 3  weeks around the injection spot too.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Minor received third dose of Pfizer Vaccine on 8/29/2022 Then received a fourth dose of Pfizer Vaccine on 9/2/2022
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac pacemaker insertion, Erythema, Induration, Pruritus
Clinical narrative: The patient woke up this morning with redness on the arm and complains of itchiness. The redness is about 4 inches in length below the site of injection. She states her arm felt sore and hard a day after the vaccination.  She is not running a fever.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was immunized with monovalent Pfizer vaccine booster dose 0.3ml. Vaccine was administered into the right deltoid by our member. Private was informed to no longer administer monovalent vaccines after the vaccine was given by the clinical team. The bivalent vaccine boosters were authorized on this day.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a booster dose of Pfizer COVID-19 vaccine that had expired 5 days prior.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Myalgia, Nausea, Rash, Vaccination site swelling
Clinical narrative: Narrative: Myalgia, Rash, NauseaVomiting, red, raised & warm area at vaccination site 4 1/2 inches wide x 2 inches length
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: Narrative: Myalgia, Rash, NauseaVomiting, red, raised & warm area at vaccination site 4 1/2 inches wide x 2 inches length
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Headache, Myalgia, PAIN AT INJECTION SITE. Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache & NauseaVomiting Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Myalgia
Clinical narrative: Myalgia HEARTBURN. Narrative:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Narrative: Headache, Arthralgia, Fatigue
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Cough, Dyspnoea, Hypoxia
Clinical narrative: Narrative:  Patient had three Pfizer COVID 19 Vaccines (Jul,Aug 2021, and Jan 2022). The patient tested positive for COVID 19 on 28 April 2022. The patient presented to the ED with shortness of breath. The patient was admitted to the hospital with respiratory failure and hypoxia with COVID, but also severe COPD exacerbation. The patient was treated with inhalers and steroids. The patient was discharged on 29 April 2022. The patient presented to the ED on 15 May 2022 with another acute exacerbation of COPD with cough and congestion. The patient was treated with steroids and inhalers. Reported per EUA.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory failure, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient had three Pfizer COVID 19 Vaccines (Jul,Aug 2021, and Jan 2022). The patient tested positive for COVID 19 on 28 April 2022. The patient presented to the ED with shortness of breath. The patient was admitted to the hospital with respiratory failure and hypoxia with COVID, but also severe COPD exacerbation. The patient was treated with inhalers and steroids. The patient was discharged on 29 April 2022. The patient presented to the ED on 15 May 2022 with another acute exacerbation of COPD with cough and congestion. The patient was treated with steroids and inhalers. Reported per EUA.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypertension
Clinical narrative: Headache, Arthralgia, HYPERtension, severe HA hypertensive 173/119 Narrative:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Narrative: Patient received Pfizer COVID 19 Vaccine on 17 February 2021. The patient experienced shortness of breath that required the use of his albuterol inhaler four times and then improved per note on 27 June 2022 originally reported by doctor on 27 June as historical. The patient did not go to the hospital.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site discomfort, Injection site swelling
Clinical narrative: Headache Discomfort and swelling at injection site. Narrative:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Myalgia & Fever Narrative:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache FATIGUE. Narrative:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site discomfort
Clinical narrative: Headache DISCOMFORT AT INJECTION SITE. Narrative:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache & Myalgia  Narrative: NA
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Narrative: Per 05/07/2022 note "Pt has reaction to Shingles Vaccine and her right arm is swollen, red, and itching. Sleeve is very tight on her arm." Provider administered a methylprednisolone shot IM in office and prescribed patient antihistamine and prednisone for short term use.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, COVID-19, Cough, Dyspnoea, Oropharyngeal pain
Clinical narrative: Narrative:  Pt received two doses of Pfizer Covid Vaccine in Dec 2020 and Jan 2021. The patient presented to the ED with cough, sore throat, and shortness of breath on 30 June 2022. The patient tested positive for COVID 19 and was admitted to the hospital with acute kidney injury and covid 19. The patient was treated with guaifenesin and other symptomatic medications. The patient was discharged on 6 July in stable condition to the assisted living facility.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative:  Pt received two doses of Pfizer Covid Vaccine in Dec 2020 and Jan 2021. The patient presented to the ED with cough, sore throat, and shortness of breath on 30 June 2022. The patient tested positive for COVID 19 and was admitted to the hospital with acute kidney injury and covid 19. The patient was treated with guaifenesin and other symptomatic medications. The patient was discharged on 6 July in stable condition to the assisted living facility.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Confusional state, Cough, Encephalopathy, SARS-CoV-2 test positive
Clinical narrative: Narrative: Patient received two doses of Pfizer COVID 19 Vaccine in Mar/Apr 2021. The patient presented to the ED on 4 June 2022 with confusion and cough. The patient tested positive for COVID 19 and was admitted with COVID 19 encephalopathy. The patient was treated with supportive care. The patient was discharged in stable condition on 6 June 2022.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Myocardial infarction, Temperature intolerance
Clinical narrative: Heat/cold intolerance , shivering , SOB Pt was taken away by Ambulance Pt came in on 9/3 to p/u meds and reported that she had a Heart Attack
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow; Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow; Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow; Shooting pain in muscle; I couldn't straighten but elbow it would lock up; The initial case was missing the following minimum criteria: (ICH unspecified AE) Upon receipt of follow up information on (29Aug2022), this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 at 10:30 as dose 1, single (Lot number: FC3180) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "High blood pressure" (ongoing), notes: High blood pressure. Concomitant medication(s) included: ONGLYZA [SAXAGLIPTIN] oral taken for diabetes mellitus, start date: 2018 (ongoing); NOVOLOG taken for diabetes mellitus, start date: 2000 (ongoing); AMLODIPINE oral taken for hypertension, start date: 2000 (ongoing). Other Concomitant medication included atlantus ins through shot in belly for diabetes mellitus. The following information was reported: JOINT RANGE OF MOTION DECREASED (disability) with onset 13Aug2021 at 14:00, outcome "recovering", described as "I couldn't straighten but elbow it would lock up"; MYALGIA (disability) with onset 13Aug2021 at 14:00, outcome "recovering", described as "Shooting pain in muscle"; PAIN (disability), PAIN IN JAW (disability), PAIN IN EXTREMITY (disability) all with onset 13Aug2021 at 14:00, outcome "recovering" and all described as "Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow". Therapeutic measures were not taken as a result of pain, pain in jaw, pain in extremity, myalgia, joint range of motion decreased. Clinical course: It was reported that on 13Aug2021 a few hrs later got 1st shot 10:30. By 14:00, 13Aug2021 whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow. Shooting pain in muscle and when it hit inside elbow it shoot out like electric going down wire. Then hitting elbow would spread all the time plus I couldn't straighten but elbow it would lock up. Couldn't use left arm much. Had an knot where shot was given. It's been over an year but the 2 mos has been better. 22Aug2022. No boosters shots. The patient also received atlantus ins and novolog ins through shot in belly for diabetes mellitus on an unspecified dates. The patient had no Specific relevant test.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint range of motion decreased, Myalgia, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow; Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow; Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow; Shooting pain in muscle; I couldn't straighten but elbow it would lock up; The initial case was missing the following minimum criteria: (ICH unspecified AE) Upon receipt of follow up information on (29Aug2022), this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 at 10:30 as dose 1, single (Lot number: FC3180) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "High blood pressure" (ongoing), notes: High blood pressure. Concomitant medication(s) included: ONGLYZA [SAXAGLIPTIN] oral taken for diabetes mellitus, start date: 2018 (ongoing); NOVOLOG taken for diabetes mellitus, start date: 2000 (ongoing); AMLODIPINE oral taken for hypertension, start date: 2000 (ongoing). Other Concomitant medication included atlantus ins through shot in belly for diabetes mellitus. The following information was reported: JOINT RANGE OF MOTION DECREASED (disability) with onset 13Aug2021 at 14:00, outcome "recovering", described as "I couldn't straighten but elbow it would lock up"; MYALGIA (disability) with onset 13Aug2021 at 14:00, outcome "recovering", described as "Shooting pain in muscle"; PAIN (disability), PAIN IN JAW (disability), PAIN IN EXTREMITY (disability) all with onset 13Aug2021 at 14:00, outcome "recovering" and all described as "Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow". Therapeutic measures were not taken as a result of pain, pain in jaw, pain in extremity, myalgia, joint range of motion decreased. Clinical course: It was reported that on 13Aug2021 a few hrs later got 1st shot 10:30. By 14:00, 13Aug2021 whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow. Shooting pain in muscle and when it hit inside elbow it shoot out like electric going down wire. Then hitting elbow would spread all the time plus I couldn't straighten but elbow it would lock up. Couldn't use left arm much. Had an knot where shot was given. It's been over an year but the 2 mos has been better. 22Aug2022. No boosters shots. The patient also received atlantus ins and novolog ins through shot in belly for diabetes mellitus on an unspecified dates. The patient had no Specific relevant test.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Malaise, Musculoskeletal chest pain, Nasal congestion
Clinical narrative: Vaccination failure; tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) and VACCINATION FAILURE (Vaccination failure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 prophylaxis.     Concomitant products included MONTELUKAST, ALBUTEROL [SALBUTAMOL], PROMETHAZINE HYDROCHLORIDE (PROMETH), CEFUROXIME, METHYLPREDNISOLONE, COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN, IRBESARTAN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and AMLODIPINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (tested positive for Covid-19). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (tested positive for Covid-19) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         Concomitant products included Bausch and Lomb Preservision Areds,  and Prometh-D. It was reported that the patient did not have a history or current diagnosis or pericarditis or myocarditis. No treatment medication was provided.  Company comment: This spontaneous case concerns a 63-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure was considered as an additional event. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-637077 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure was considered as an additional event. The events occurred approximately 6 months after the second dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.