chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called the pharmacy 5/3 to report that the area around where he got Shingrix on 5/1 had become red, swollen, sore, and slightly raised-- an area about the diameter of a baseball-- which started sometime the previous night.  Counseled him to monitor this and to use a cold compress/ice pack and possibly OTC benadryl to treat this reaction.
Age: 43.0
Sex: F
Vaccine: COVID19-2, HEP, TDAP
Symptoms: Bell's palsy, Dizziness, Drooling, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Pt. presents to clinic reporting that she received at total of 3 shot in both of her arms on Friday of last week. That evening her tongue began to feel numb. Sat- R side of lipSun- whole lip and R side of face starting below her eye. Also in Sunday she experienced a shooting pain in her neck and radiated down her R arm. She couldn't feel her R arm. Immediately her head started tingling in the back of her head.  She called a friend whom told her that she did not have enough symptoms to be  seen at the hospital and they probably wouldn?t do anything for her anyways. So  she turned round and went home. Pt. came into the clinic today because she feels like ? there is definitely  something wrong? Pt. is unable to control spit from R corner mouth. Cannot close eyes with arms straight without veering to the R and becoming dizzy. Pt. was directed to go to the ER for eval. Pt. drove herself in today and refuses ambulance ride.  Patient came back to clinic May 3rd to report to vaccine clinic that the ER diagnosed her with bells palsy.
Age: 43.0
Sex: F
Vaccine: COVID19-2, HEP, TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt. presents to clinic reporting that she received at total of 3 shot in both of her arms on Friday of last week. That evening her tongue began to feel numb. Sat- R side of lipSun- whole lip and R side of face starting below her eye. Also in Sunday she experienced a shooting pain in her neck and radiated down her R arm. She couldn't feel her R arm. Immediately her head started tingling in the back of her head.  She called a friend whom told her that she did not have enough symptoms to be  seen at the hospital and they probably wouldn?t do anything for her anyways. So  she turned round and went home. Pt. came into the clinic today because she feels like ? there is definitely  something wrong? Pt. is unable to control spit from R corner mouth. Cannot close eyes with arms straight without veering to the R and becoming dizzy. Pt. was directed to go to the ER for eval. Pt. drove herself in today and refuses ambulance ride.  Patient came back to clinic May 3rd to report to vaccine clinic that the ER diagnosed her with bells palsy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: 3/7 tiredness, muscle pain, headache, shivering, nausea, skin sensitivity;  3/8 -3/10 increasing redness/swelling from injection site to mid-bicep;  3/11 increased redness/swelling from injection site to elbow (including bicep and interior or arm), tingling at tip of tongue, tingling lips -at 12:00pm used anti-itch cream - effect lasted only 20-30 minutes each time, at 9:30pm took diphenhydramine hcl 25ml tab; 3/12 took 1 diphenhydramine hcl 25mg tab - arm still itchy and red - swelling to elbow and inside of arm.  3/13took 1 diphenhydramine hcl 25mg tab arm itchy, swollen to elbow and inside of arm
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Paraesthesia oral, Peripheral swelling
Clinical narrative: 3/7 tiredness, muscle pain, headache, shivering, nausea, skin sensitivity;  3/8 -3/10 increasing redness/swelling from injection site to mid-bicep;  3/11 increased redness/swelling from injection site to elbow (including bicep and interior or arm), tingling at tip of tongue, tingling lips -at 12:00pm used anti-itch cream - effect lasted only 20-30 minutes each time, at 9:30pm took diphenhydramine hcl 25ml tab; 3/12 took 1 diphenhydramine hcl 25mg tab - arm still itchy and red - swelling to elbow and inside of arm.  3/13took 1 diphenhydramine hcl 25mg tab arm itchy, swollen to elbow and inside of arm
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Sensitive skin
Clinical narrative: 3/7 tiredness, muscle pain, headache, shivering, nausea, skin sensitivity;  3/8 -3/10 increasing redness/swelling from injection site to mid-bicep;  3/11 increased redness/swelling from injection site to elbow (including bicep and interior or arm), tingling at tip of tongue, tingling lips -at 12:00pm used anti-itch cream - effect lasted only 20-30 minutes each time, at 9:30pm took diphenhydramine hcl 25ml tab; 3/12 took 1 diphenhydramine hcl 25mg tab - arm still itchy and red - swelling to elbow and inside of arm.  3/13took 1 diphenhydramine hcl 25mg tab arm itchy, swollen to elbow and inside of arm
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3rd dose and did not need it...vaccine series was started at the age where only 2 doses were necessary.....no adverse effects to report
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysstasia, Hypotension, Incoherent, Loss of consciousness, Speech disorder
Clinical narrative: The patient came into pharmacy to get their Covid vaccine booster. She had a caregiver with them and had to help them into the vaccine room. After the shot the patient had difficulty standing.  After 10-15 minutes they still had difficulty standing and was helped into the wheelchair. They left the pharmacy area. In the front of the store the patient became incoherent having difficulty speaking and was coming close to passing out. The patient's daughter was came in and the 911 was called. They patient was believed to have low blood pressure at this point and left the store via ambulance.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a 4th dose when she already had completed the series with 3 doses when she was under 18....no adverse effects to report
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose when he did not need one....series started at age where only 2 doses are needed
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Autoimmune thyroiditis, Hypersensitivity
Clinical narrative: Developed yeast allergy, developed autoimmune disease
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Brain fog, Chills, Lethargy, Nausea, Pain
Clinical narrative: Night after shot was administered I woke up feeling really nauseous and starting projectile vomiting all night. The next day I had a fever, chills and body pain all over, in addition to nausea and extreme lethargy/sleepiness. The puking has stopped and chills went away after two days, but the nausea, extreme lethargy and mind fog has continued on for several more days and hasn't gotten better.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Somnolence, Vomiting projectile
Clinical narrative: Night after shot was administered I woke up feeling really nauseous and starting projectile vomiting all night. The next day I had a fever, chills and body pain all over, in addition to nausea and extreme lethargy/sleepiness. The puking has stopped and chills went away after two days, but the nausea, extreme lethargy and mind fog has continued on for several more days and hasn't gotten better.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptom shown.
Age: 3.0
Sex: F
Vaccine: RAB
Symptoms: Cough, Urticaria
Clinical narrative: Mom called reporting patient w/cough and hives. Denied wheezing or vomiting. Mom took to an urgent care facility near by. Per mom given Benadryl and prescription for prednisone. Spoke to mom frequently after episode reports sx have resolved.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Moderna Covid vaccine on 10/21/22 which had expired on 10/19/2022. Vaccines removed from refrigerator and discarded. State notified. Patient notified and made aware that would need dose repeated. VAERS form Completed and Faxed.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Brief resolved unexplained event, Dyskinesia, Electrocardiogram normal, Electroencephalogram normal, Erythema
Clinical narrative: A FEW HOURS AFTER VACCINES HE TENSED UP, TURNED RED, ARMS AND LEGS EXTENDED. LASTED 5-10 SECONDS. HE THEN WENT LIMP, PALE, UNRESPONSIVE, THEN STOPPED BREATHING ABOUT 20 SECONDS. BACK BLOWS GIVEN BUT NO CPR. BREATHING WAS THEN SHALLOW. WAS SEEN IN ER AND ADMITTED. LABS NORMAL. NO EKG CHANGES. CARDIOLOGY FELT IT WAS NOT HEART RELATED. VIDEO EEG WAS NORMAL. WAS DIAGNOSED WITH ALTERED MENTAL STATUS + B.R.U.E.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypopnoea, Hypotonia, Laboratory test normal, Mental status changes, Pallor
Clinical narrative: A FEW HOURS AFTER VACCINES HE TENSED UP, TURNED RED, ARMS AND LEGS EXTENDED. LASTED 5-10 SECONDS. HE THEN WENT LIMP, PALE, UNRESPONSIVE, THEN STOPPED BREATHING ABOUT 20 SECONDS. BACK BLOWS GIVEN BUT NO CPR. BREATHING WAS THEN SHALLOW. WAS SEEN IN ER AND ADMITTED. LABS NORMAL. NO EKG CHANGES. CARDIOLOGY FELT IT WAS NOT HEART RELATED. VIDEO EEG WAS NORMAL. WAS DIAGNOSED WITH ALTERED MENTAL STATUS + B.R.U.E.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Respiratory arrest, Tension, Unresponsive to stimuli
Clinical narrative: A FEW HOURS AFTER VACCINES HE TENSED UP, TURNED RED, ARMS AND LEGS EXTENDED. LASTED 5-10 SECONDS. HE THEN WENT LIMP, PALE, UNRESPONSIVE, THEN STOPPED BREATHING ABOUT 20 SECONDS. BACK BLOWS GIVEN BUT NO CPR. BREATHING WAS THEN SHALLOW. WAS SEEN IN ER AND ADMITTED. LABS NORMAL. NO EKG CHANGES. CARDIOLOGY FELT IT WAS NOT HEART RELATED. VIDEO EEG WAS NORMAL. WAS DIAGNOSED WITH ALTERED MENTAL STATUS + B.R.U.E.
Sex: U
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Legal problem
Clinical narrative: On 09/22/2022 at about 01:15 pm, the Chief Nursing Officer (CNO) at Hospital illegally scanned her badge at the pharmacy door and gained access to the pharmacy to retrieve COVID-19 (Moderna Bivalent) vaccines. When the CNO was informed by the pharmacist that she (CNO) had illegally gained access to the pharmacy, then CNO replied that since she (CNO) was the boss of the pharmacist and supervised the pharmacist, she (CNO) could scan her badge to the pharmacy door to gain access to the pharmacy. The pharmacist then reported the matter to the State Board of Pharmacy. The CNO retrieved on e2.5 mL vial of COVID19 Moderna Bivalent vaccine and administered to patients. The following week, pharmacist requested for and reviewed the vaccine administration record. It shows that the CNO used the one 2.5 mL vial to administer to 8 patients. Since on 2.5 mL vial fo COVID-19 (Moderna Bivalent) vaccine can not be safely administered to 8 patients, the pharmacist then submitted a SQSS Risk Report, utilized by the hospital, and also sent an email to the CEO, and copied the Risk Assessment Nurse and the CNO. The pharmacist no longer works for Hospital and is concerned that the hospital administration and the CNO would not take appropriate steps to address the vaccine administration event, since the person in question is the CNO who is aldo a top administration member.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling and cellulitis and pain at the injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Moderna Covid Vaccine on 10/20/2022 which  had expired on 10/19/2022, vaccines removed from refrigerator and discarded. State notified, patient notified and made aware that would need dose repeated.   Vaers form completed and faxed.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity, Periarthritis
Clinical narrative: 2d of soreness at injection site. Then gradual increase in pain around arm which progressed to adhesive capsulitis 2 wks after vaccine. rx for ibuprofen TID w/ food. PT referral & ortho for possible steroid injection.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Blood fibrinogen increased, C-reactive protein, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: Pt with history of pulmonary fibrosis and a stable pulmonary nodule that had not changed much in years, but then took four RNA shots from January 2021-9/2021 and it is now clear that the lung mass is lung CA and now with mets., having worsening dyspnea with exertion of walking few feet. Last June/23/2022 had the second booster Pfitzer vaccine worsening the respiratory symptoms and 2 months later she was admitted at hospital for elevated D-Dimer and worsening dyspnea and was found to have elevated troponins , and severe tricuspid regurg and pulmonary hypertension.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea exertional, Fibrin D dimer increased, Interleukin level, Lung cancer metastatic, Pulmonary hypertension
Clinical narrative: Pt with history of pulmonary fibrosis and a stable pulmonary nodule that had not changed much in years, but then took four RNA shots from January 2021-9/2021 and it is now clear that the lung mass is lung CA and now with mets., having worsening dyspnea with exertion of walking few feet. Last June/23/2022 had the second booster Pfitzer vaccine worsening the respiratory symptoms and 2 months later she was admitted at hospital for elevated D-Dimer and worsening dyspnea and was found to have elevated troponins , and severe tricuspid regurg and pulmonary hypertension.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary mass, Respiratory symptom, Tricuspid valve incompetence, Troponin increased
Clinical narrative: Pt with history of pulmonary fibrosis and a stable pulmonary nodule that had not changed much in years, but then took four RNA shots from January 2021-9/2021 and it is now clear that the lung mass is lung CA and now with mets., having worsening dyspnea with exertion of walking few feet. Last June/23/2022 had the second booster Pfitzer vaccine worsening the respiratory symptoms and 2 months later she was admitted at hospital for elevated D-Dimer and worsening dyspnea and was found to have elevated troponins , and severe tricuspid regurg and pulmonary hypertension.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram, Erythema, Fatigue, Magnetic resonance imaging heart
Clinical narrative: 1) Profound fatigue - onset 6 hours -> Resolved in 5 days. 2) Left chest base, area of apex of heart - onset 3 days -> resolved in 3 months. 3) Dyspnea with exertion - onset 3 days -> improved after 3 1/2 months but still with symptoms 4) Left index finger redness, swelling and pain at MCP jt. - onset 1 week -> resolved in 2 months.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Stress echocardiogram, X-ray limb
Clinical narrative: 1) Profound fatigue - onset 6 hours -> Resolved in 5 days. 2) Left chest base, area of apex of heart - onset 3 days -> resolved in 3 months. 3) Dyspnea with exertion - onset 3 days -> improved after 3 1/2 months but still with symptoms 4) Left index finger redness, swelling and pain at MCP jt. - onset 1 week -> resolved in 2 months.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Moderna Covid vaccine on 10/21/22 which had expired on 10/19/2022. Vaccines removed from refrigerator and discarded, state notified. Patient notified and made aware that would need dose repeated. Vaers form completed and faxed
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Influenza vaccine given too early. No known adverse event at this time.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Brain fog, Dyspnoea, Electrocardiogram, Electromyogram
Clinical narrative: Symptoms very similar to Guillain-Barre syndrome. Weakness in arms & legs. Muscle atrophy in same places. Occassional paralysis. Pins & Needles head to toe. Trouble breathing. Fatigue easily. Limited Mobility. Severe Mental Fog. Gastrointestinal issues. Erectile Dysfunction
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epidural injection, Erectile dysfunction, Fatigue, Gastrointestinal disorder, Magnetic resonance imaging head
Clinical narrative: Symptoms very similar to Guillain-Barre syndrome. Weakness in arms & legs. Muscle atrophy in same places. Occassional paralysis. Pins & Needles head to toe. Trouble breathing. Fatigue easily. Limited Mobility. Severe Mental Fog. Gastrointestinal issues. Erectile Dysfunction
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Mobility decreased, Muscle atrophy, Muscular weakness, Paraesthesia
Clinical narrative: Symptoms very similar to Guillain-Barre syndrome. Weakness in arms & legs. Muscle atrophy in same places. Occassional paralysis. Pins & Needles head to toe. Trouble breathing. Fatigue easily. Limited Mobility. Severe Mental Fog. Gastrointestinal issues. Erectile Dysfunction
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: Symptoms very similar to Guillain-Barre syndrome. Weakness in arms & legs. Muscle atrophy in same places. Occassional paralysis. Pins & Needles head to toe. Trouble breathing. Fatigue easily. Limited Mobility. Severe Mental Fog. Gastrointestinal issues. Erectile Dysfunction
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Painful feeling at injecting site, and now cannot move her arm
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Rash with redness & swelling extending from armpit to elbow.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Coronary artery disease, Hypotension, Pulmonary oedema, Sepsis
Clinical narrative: Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------- I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 2/9/2021 PULMONARY EDEMA I95.9 HYPOTENSION 8/22/2021 PULMONARY EDEMA I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 2/9/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 8/22/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 2/9/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 8/22/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 2/9/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 8/22/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Laboratory test abnormal, Metastases to peritoneum, Surgery
Clinical narrative: Pt developed abdominal pain and bloating. Work up and surgery revealed peritoneal carcinomatosis requires major surgery and chemo
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sinus infection; Pfizer/BioNTech COVID-19 vaccine details Date: 10Sep2022/Flu vaccine Date: 10Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 10Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date/Time:, Time (24hr): 08:00, Site and Route of Injection:, Anatomical site of Injection: Left arm), administration date: 14Jan2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2nd, Date/Time:, Time (24hr): 12:00, Site and Route of Injection:, Anatomical site of Injection: Left arm), administration date: 01Feb2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 3rd, Date/Time:, Time (24hr): 14:00, Site and Route of Injection:, Anatomical site of Injection: Right arm), administration date: 02Oct2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 10Sep2022, outcome "unknown", described as "Pfizer/BioNTech COVID-19 vaccine details Date: 10Sep2022/Flu vaccine Date: 10Sep2022"; SINUSITIS (non-serious) with onset 26Dec2022, outcome "unknown", described as "sinus infection". Therapeutic measures were taken as a result of sinusitis.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccine was not Administered at Facility. Vaccination Facility Type: Public Health Clinic/Administration Facility. Doxycycline Reason for taking: Sinus Infection Route: Oral Start date: 26Dec2022 Stop date: 30Dec2022. Had these symptoms before COVID infection. The patient took the Bivalent booster on 10Sep2022 and caught COVID-19 On 29Dec2022, took Paxlovid for the full course, was 100% better and tested negative by antigen test for four days, became symptomatic and suffered second course of COVID on Day10 after initial diagnosis. My second round was a little worse but not serious at all.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product use issue, Sinusitis
Clinical narrative: sinus infection; Pfizer/BioNTech COVID-19 vaccine details Date: 10Sep2022/Flu vaccine Date: 10Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 10Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date/Time:, Time (24hr): 08:00, Site and Route of Injection:, Anatomical site of Injection: Left arm), administration date: 14Jan2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2nd, Date/Time:, Time (24hr): 12:00, Site and Route of Injection:, Anatomical site of Injection: Left arm), administration date: 01Feb2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 3rd, Date/Time:, Time (24hr): 14:00, Site and Route of Injection:, Anatomical site of Injection: Right arm), administration date: 02Oct2021, when the patient was 47-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 10Sep2022, outcome "unknown", described as "Pfizer/BioNTech COVID-19 vaccine details Date: 10Sep2022/Flu vaccine Date: 10Sep2022"; SINUSITIS (non-serious) with onset 26Dec2022, outcome "unknown", described as "sinus infection". Therapeutic measures were taken as a result of sinusitis.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Vaccine was not Administered at Facility. Vaccination Facility Type: Public Health Clinic/Administration Facility. Doxycycline Reason for taking: Sinus Infection Route: Oral Start date: 26Dec2022 Stop date: 30Dec2022. Had these symptoms before COVID infection. The patient took the Bivalent booster on 10Sep2022 and caught COVID-19 On 29Dec2022, took Paxlovid for the full course, was 100% better and tested negative by antigen test for four days, became symptomatic and suffered second course of COVID on Day10 after initial diagnosis. My second round was a little worse but not serious at all.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: TDAP, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Swelling
Clinical narrative: Worst case of Shingles, getting worse, been at Dr,; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received Shingrix (unknown arm). In APR-2023, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: Worst case of Shingles, getting worse, been at Dr,). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The case was self reported by the patient. The patient received the Shingrix vaccine three weeks ago and a week later he/she got the worse case of shingles. The patient had been to the doctor twice and things were getting worse. The pharmacist gave him/her another vaccine at the same arm at the same time, at pharmacy and the patient understanding now what he did was wrong.
Sex: U
Vaccine: TDAP, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Worst case of Shingles, getting worse, been at Dr,; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received Shingrix (unknown arm). In APR-2023, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: Worst case of Shingles, getting worse, been at Dr,). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The case was self reported by the patient. The patient received the Shingrix vaccine three weeks ago and a week later he/she got the worse case of shingles. The patient had been to the doctor twice and things were getting worse. The pharmacist gave him/her another vaccine at the same arm at the same time, at pharmacy and the patient understanding now what he did was wrong.
Sex: U
Vaccine: TDAP, VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain in extremity, Rash
Clinical narrative: Worst case of Shingles, getting worse, been at Dr,; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received Shingrix (unknown arm). In APR-2023, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: Worst case of Shingles, getting worse, been at Dr,). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-APR-2023 The case was self reported by the patient. The patient received the Shingrix vaccine three weeks ago and a week later he/she got the worse case of shingles. The patient had been to the doctor twice and things were getting worse. The pharmacist gave him/her another vaccine at the same arm at the same time, at pharmacy and the patient understanding now what he did was wrong.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; HCP called to report patient was given a dose of PROQUAD that was stored outside of prescribing information temperatures. Product TE outcome was supported( case 02370482); This spontaneous report has been received from a nurse, regarding a unknown number of patients of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 12-APR-2023, the patien was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number: W036931, which was determined to be valid as syringe formulation, with an expiration date on 19-MAY-2024).  The administered dose underwent a temperature excursion of 9.8 degrees Fahrenheit (F) for 1 hour and 42 minutes as it was stored outside of prescribing information temperatures. There was not any previous temperature excursion reported. (Product storage error)  No additional adverse event was reported, and no further information provided.   This case was determined to be non-valid, due to the lack of the patient's identifiers.  Follow-up information has been received from a health care professional on 01-MAY-2023. The patient's demographic information was updated. This case was regarding a 1-years-old male patient. The reported administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection was performed subcutaneously in the left thigh on a private doctor's office/hospital with public funds. It was reported that the temperature excursion occurred as a result of a reading from a data logger, because the power blipped, and the temperature went up to 9.8 degrees Fahrenheit (F) for 1 hour and 43 minutes.  This case is one of two reports from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of MMR II was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concurrent condition and drug reactions/allergies was not reported. Concomitant therapy included sterile diluent (manufacturer unknown).  On 20-APR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (therapy type: rHA, 0.5 milliliter, lot #U011149, expiration date: 08-APR-2023, strength was not reported) subcutaneously for prophylaxis (expired product administered). No additional AEs or PQC reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; HBP with responsibility for vaccine storage calling to report a temperature excursion. Product administered. No additional AEs. No PQCs.     ?    Names of vaccines involved (including lot/exp) VARIVAX W025273 08/10/2024        ?    Temperature: -; This spontaneous report was received from a healthcare business professional (HBP), referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccinations and route of administration were not reported; lot number W025273, expiration date reported and validated as 10-AUG-2024) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse events.  The vaccine experienced a temperature excursion of minus (-) 10 degrees Celsius (C) for 59 minutes. There was no previous temperature excursion.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: They also stated that they got Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (They also stated that they got Covid) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1), Moderna covid-19 vaccine (Dose 4, booster), Moderna covid-19 vaccine (Dose 3, booster) and Moderna covid-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (They also stated that they got Covid). At the time of the report, COVID-19 (They also stated that they got Covid) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. They did not have their vaccination card with them at the time of the call but they stated that they had 2 initial and 2 boosters, the last recorded was on 21-Apr-2022 but the latest one was not recorded as they did not bring the vaccination card with them. No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "green pepper allergy" (unspecified if ongoing); "melons allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid on 19Apr2023 to 24Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 to the events COVID-19 and drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300175757 same reporter/patient, different drug/event;
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jan2022, outcome "not recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Apr2023 to 24Apr2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202300175660 same  patient/reporter, different drug/AE;
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: Gh9703) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications within 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 21Apr2023 to 25Apr2023.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: we had two of the Pfizer vaccines. After she passed away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 2022, outcome "fatal", described as "we had two of the Pfizer vaccines. After she passed away". The patient date of death was 2022. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: The reporter stated patient had two of the Pfizer vaccines. Patient was passed away in last summer (2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: we had two of the Pfizer vaccines. After she passed away
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: inflammation of her left arm; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 67-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammation of her left arm". The action taken for tofacitinib citrate was dosage permanently withdrawn. Additional information: Patient states that she is no longer on Xeljanz (5 mg) because she had inflammation of her left arm during the time when she took Xeljanz and her doctor changed Xeljanz to Rinvoq to see how it works. She did not know if it was caused by Xeljanz or her COVID vaccines. She has been on Rinvoq for two months now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient got the Pfizer covid-19 vaccine bivalent in October and they acquired covid-19 virus in April this year; Patient got the Pfizer covid-19 vaccine bivalent in October and they acquired covid-19 virus in April this year; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Patient got the Pfizer covid-19 vaccine bivalent in October and they acquired covid-19 virus in April this year". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023SA104066 (Sanofi).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Hives".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: is not good at walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "is not good at walking".  Additional information : A caller was calling on behalf of her husband and herself. She said that her husband was a senior who was not good at walking around and he was homebound too. Her husband managed to get himself a shot to a supermarket where they did covid shots and she had a home visit for her shot. The second time they had shots was a home visit and that was in Aug. She wants to know if they can arrange another home visit for the bivalent vaccine. Also the caller mentioned that when she had those two vaccines she said it's like not feeling so great but she's fine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300177504 same reporter/drug, different patient/AE;US-PFIZER INC-202300177505 same reporter/drug, different patient/AE;
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost of taste; lost of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "lost of taste"; ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "lost of taste and smell".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; body aches; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.