chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity, Swelling
Clinical narrative: She has swelling; She is very sore in the arm and down her right shoulder and in her back.; She is very sore in the arm and down her right shoulder and in her back; She is very sore in the arm and down her right shoulder; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (She has swelling), PAIN IN EXTREMITY (She is very sore in the arm and down her right shoulder and in her back.), BACK PAIN (She is very sore in the arm and down her right shoulder and in her back) and ARTHRALGIA (She is very sore in the arm and down her right shoulder) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 2 or 710F2371A) for COVID-19 prophylaxis.     Patient did not have any medical history or condition.     On 29-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced SWELLING (She has swelling), PAIN IN EXTREMITY (She is very sore in the arm and down her right shoulder and in her back.), BACK PAIN (She is very sore in the arm and down her right shoulder and in her back) and ARTHRALGIA (She is very sore in the arm and down her right shoulder). At the time of the report, SWELLING (She has swelling) and PAIN IN EXTREMITY (She is very sore in the arm and down her right shoulder and in her back.) had not resolved and BACK PAIN (She is very sore in the arm and down her right shoulder and in her back) and ARTHRALGIA (She is very sore in the arm and down her right shoulder) outcome was unknown.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   1st dose received on 16 Feb 2021 and the lot number 030M20A. 2nd dose received on 17 Mar 2021 and the lot number was 031A21A. 3rd dose received on 29 Nov 2021 and the lot number was 058H21A. 4th dose received on 27 Aug 2022 and the lot number was unknown. Patient wanted to know if she could take Advil.  Treatment medication not reported.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: body aches; Chills; injection site pain; fever; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever) and VOMITING (vomiting) in a 15-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine (Patient also had the current flu vaccine.). Past adverse reactions to the above products included No adverse reaction with Flu vaccine.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever), VOMITING (vomiting) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had the body aches, chills and injection site pain and then seemed fine but by the 27th around the 28th patient running a fever had vomiting headache and body aches as if patient had COVID.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2023: Live follow-up received contains significant information: Reporter information, suspect product details were updated.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: body aches; Chills; injection site pain; fever; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever) and VOMITING (vomiting) in a 15-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine (Patient also had the current flu vaccine.). Past adverse reactions to the above products included No adverse reaction with Flu vaccine.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever), VOMITING (vomiting) and HEADACHE (headache). At the time of the report, MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (injection site pain), PYREXIA (fever), VOMITING (vomiting) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had the body aches, chills and injection site pain and then seemed fine but by the 27th around the 28th patient running a fever had vomiting headache and body aches as if patient had COVID.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2023: Live follow-up received contains significant information: Reporter information, suspect product details were updated.
Age: 74.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: patient stated she got a new vaccine 3 weeks ago and has shoulder pain that has gone to her neck. She stated that her arm was sore after getting the vaccine and now the pain has moved from her shoulder to her neck. She stated she has been taking tylenol for the pain and has put ice on the area. She just wanted to let us know about the issue and plans to go to the dr.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Infection
Clinical narrative: Serious infection within 24 hours appeared. Worsened over 72 hours. Requiring emergency care and antibiotics
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received 12+ Moderna instead of 6mo-11yr vaccine due to a misunderstanding
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RSV, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: ABRYSVO (Adult dose RSV) administered instead of BEYFORTUS for PEDS
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Fatigue, Hyperhidrosis, Laboratory test, Musculoskeletal discomfort
Clinical narrative: I had side effects from every shot.  However, the 4th shot Bivalent, I felt this rushing in my chest and my back.  Extreme fatigue.  Also broke out in a sweat two times, experience and SVT two times after shot. Hospitalized mulitple times
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Postural orthostatic tachycardia syndrome, Supraventricular tachycardia, Tilt table test positive, Troponin increased
Clinical narrative: I had side effects from every shot.  However, the 4th shot Bivalent, I felt this rushing in my chest and my back.  Extreme fatigue.  Also broke out in a sweat two times, experience and SVT two times after shot. Hospitalized mulitple times
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Hyperhidrosis, Oropharyngeal pain, Pallor, Syncope, Throat tightness
Clinical narrative: Patient was seen in office for wellness visit. Patient received FLUMIST intranasally at 4:14 pm. Patient was leaving office with mother around 4:25pm when he suddenly stated that he was feeling throat pain right before a syncope event. Medical assistant alerted MD. Patient was found on the floor in the hallway. R/O injury. Patient was pale and diaphoretic. Patient stated that he felt like there was a ball in his throat.
Age: 74.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fatigue, chills, and site soreness on day two that ended by day four, followed by bright redness and swelling first noticed on day four.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Chest pain, Chills, Cough, Diarrhoea, Hyperhidrosis
Clinical narrative: Patient had no adverse reaction until he was sleeping that evening and got up with swollen right arm all the way down to his wrist, with chest pain, sweating and chills.  In addition, he got up and had lots of stomach issues including diarrhea, and vomiting.  He drank some water went back to sleep and the next morning the swelling was much improved, no chest pain and no more stomach issues.  The soreness lingered for about a week and patient had prolonged cough.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Pain, Peripheral swelling, Vomiting
Clinical narrative: Patient had no adverse reaction until he was sleeping that evening and got up with swollen right arm all the way down to his wrist, with chest pain, sweating and chills.  In addition, he got up and had lots of stomach issues including diarrhea, and vomiting.  He drank some water went back to sleep and the next morning the swelling was much improved, no chest pain and no more stomach issues.  The soreness lingered for about a week and patient had prolonged cough.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports swelling, redness, and itching around injection site only. Patient received vaccine on 11/29/2023 and reported to pharmacy today with mild swelling/puffiness, redness, and itching around injection site.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: I have had bilateral arm and bilateral leg itching since receiving the shot last week.  I have tried to take Benadryl along w/ using hydrocortisone itch cream.  It has not gotten better.
Age: 68.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Angiogram cerebral, Aphasia, Arteriogram carotid, Cerebral artery thrombosis, Cerebrovascular accident
Clinical narrative: Acute stroke, M2 segment left middle cerebral artery thrombus Arrived at hospital with right side paralyzed, could not speak Thrombectomy performed Speech returned immediately after procedure Movement on right side returned within the next 2 days Still have some weakness in right arm but good range of motion
Age: 68.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Chest X-ray, Computerised tomogram head, Computerised tomogram spine, Hemiplegia, Laboratory test
Clinical narrative: Acute stroke, M2 segment left middle cerebral artery thrombus Arrived at hospital with right side paralyzed, could not speak Thrombectomy performed Speech returned immediately after procedure Movement on right side returned within the next 2 days Still have some weakness in right arm but good range of motion
Age: 68.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Magnetic resonance imaging head, Muscular weakness, Thrombectomy, X-ray of pelvis and hip
Clinical narrative: Acute stroke, M2 segment left middle cerebral artery thrombus Arrived at hospital with right side paralyzed, could not speak Thrombectomy performed Speech returned immediately after procedure Movement on right side returned within the next 2 days Still have some weakness in right arm but good range of motion
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was given wrong vaccine. Requested Shingles vaccine, was given Flu vaccine. Error was made by Pharmacy employee; Pharmacist on duty was X. Correct vaccine (Shingles) was subsequently administered. Patient already had Flu vaccine approximately 1 month prior. Since 2 vaccines were given simultaneously there is no way to know if there were any side effects that were due solely to the superfluous Flu vaccine.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: MOM AND PATIENT CAME TO THE PHARMACY FOR A VACCINATION AND MOM WANTED TO GET THE FLU SHOT FOR HER AND HER SON. SHE SAID THEY DIDN'T RECEIVE THE FLU SHOT IN THE LAST 6 MONTHS. PATIENT WAS GIVEN THE FLU SHOT. AFTER ADMINISTERING THE FLU SHOT, WENT TO INPUT SHOT IN SYSTEM AND NOTICED A FLU SHOT WAS DOCUMENTED ON 10/2/23. CALLED MOM AND SHE SAID HER SON WAS FINE AND HAD NO SIDE EFFECTS. CALLED MD TO CONFIRM THEY GAVE THE FLU SHOT ON 10/2/23 AND LET THEM KNOW THAT WE ALSO GAVE A FLU SHOT BC MOM AND PATIENT NOT AWARE OF GETTING IT AT THE MD OFFICE.
Age: 0.58
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Erythema, Fatigue, Hypophagia, Malaise, Pyrexia
Clinical narrative: Fever >102 for 2 days, redness (sunburn looking) and hot to the touch, rash on arms, legs, and back. Malaise, tiredness, eating less
Age: 0.58
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Rash, Skin warm
Clinical narrative: Fever >102 for 2 days, redness (sunburn looking) and hot to the touch, rash on arms, legs, and back. Malaise, tiredness, eating less
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Abdominal X-ray, Barium swallow, Chest X-ray, Culture urine, Differential white blood cell count
Clinical narrative: Patient received her 3rd Rotateq vaccine on 11/29 and around 9pm she began having episodes of projectile vomiting. She had 13 episodes of vomiting. Parents took her to the ER on 11/30 at 10:00pm. She was dxed w/ a small bowel intussusception. She was given IV fluids. Intussusception resolved w/o treatment in the ER.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Full blood count, Influenza virus test, Intussusception, Metabolic function test, Respiratory syncytial virus test
Clinical narrative: Patient received her 3rd Rotateq vaccine on 11/29 and around 9pm she began having episodes of projectile vomiting. She had 13 episodes of vomiting. Parents took her to the ER on 11/30 at 10:00pm. She was dxed w/ a small bowel intussusception. She was given IV fluids. Intussusception resolved w/o treatment in the ER.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: SARS-CoV-2 test, Ultrasound abdomen, Urine analysis, Vomiting projectile
Clinical narrative: Patient received her 3rd Rotateq vaccine on 11/29 and around 9pm she began having episodes of projectile vomiting. She had 13 episodes of vomiting. Parents took her to the ER on 11/30 at 10:00pm. She was dxed w/ a small bowel intussusception. She was given IV fluids. Intussusception resolved w/o treatment in the ER.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: As a result of a county mandate for healthcare providers including dentists the victim was forced to be involuntarily inoculated with a Booster (Dose3) In January 2022. The exact date isn't known. The victim told me about a shingles outbreak after Dose3. The victim stated she was given a prescription drug for shingles. To my knowledge she may have been breastfeeding. Her most recent child was 2-3 years old yet she was denied an exemption for being a breastfeeding mother by the county health officer. The info for Dose2/3 is unknown. I am not aware if the victim of her health care providers filed a VAERS report. I believe she can be contacted at her dental practice office. She told me about the adverse event.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis reactive, C-reactive protein increased, Myalgia, Polymyalgia rheumatica
Clinical narrative: Severe arthralgia and myalgia, polymyalgia & rheumatica and reactive arthritis highly elevated sed rate and ESR, Hospitalized and received IV steroids followed by oral prednison for 10 days, tapering dose
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Severe arthralgia and myalgia, polymyalgia & rheumatica and reactive arthritis highly elevated sed rate and ESR, Hospitalized and received IV steroids followed by oral prednison for 10 days, tapering dose
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain, Injection site swelling, X-ray limb abnormal
Clinical narrative: Pain and swelling of Left upper arm where injection administered. Symptoms continued for more than couple months. Affected the mobility of L shoulder
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Cardiac function test normal, Chest discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWELLING AND ERYTHEMA ABOUT 6" AROUND SITE WITH TENDERNESS. CHEST DISCOMFORT SEEN IN ER CARDIAC WORK UP NORMAL
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Received Rotateq #1 on 09--2023. Had persistent vomiting 8 hrs later and resolved after 12 hours Received Rotateq #2 11-21-23. Had projectile vomiting and diarrhea 24 hrs after which resolved after 24hours  On both occasions, vomiting and diarrhea were NOT accompanied by fever exposure to other ill persons spread of disease to family members  persistent symptoms  Child does not attend day care and had no other outside contacts prior to these 2 vaccine dates
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: After giving injection redness & warmth developed at injection site. Right leg.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus, Rash
Clinical narrative: She got her vaccine, it started with her arm soreness, and a little bit of swelling at the site of the vaccine and it got red.  She was tired and felt like she had the flu.  This was all the first day.  Then she began getting rashes, and they would appear on her legs, arms, chest, neck and back.  The rashes were very very itchy.  She started putting over the counter hydrocortisone cream.  She went to a dermatologist and she gave her a large prescription with refills of a steroid cream, and has had to use it every day (triamsinolone cream .1%).  In addition, she have an allergist as she takes shots for her other allergies, and saw a doctor there who finally recommended that she try taking Allegra, which she takes in morning and afternoon, and at night it was suggested by her endocrinologist to try another medicine montelukast sodium.  These have helped a little bit with the reaction.  The itching still continues and has to take another Allegra as the itching has started on her knees.  It will start off as a red rash, or streaks of redness most frequently on her legs, especially around the knees.  She also has them show up on her arms, and even on the palms of her hands.  She also gets them on her chest and neck as well.  It has not gone to her face as yet, but does get it on her back and her waistline.   The doctors cannot up with any other explaination of the where she got it.  The allergist did testing, and she is not allergic to any foods.  The rashes did not start until she got the vaccine.  Sometimes the rashes are so bad, and from the scratching she would get scabs that would bleed.    She went to two different dermatologist to get their opinions, and there wasn't anything specific that she got from that.  She finally talked with her regular allergist and she is the one who suggested that she take the antihistamines more frequently.    She has had a complete round of COVID vaccines, and the flu vaccine every year and has not had anything other than the tiredness, redness and soreness in the arm.  She feels that she is going to spend the rest of her life itching due to the Shingrix vaccine, and it is very disturbing to her.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: She got her vaccine, it started with her arm soreness, and a little bit of swelling at the site of the vaccine and it got red.  She was tired and felt like she had the flu.  This was all the first day.  Then she began getting rashes, and they would appear on her legs, arms, chest, neck and back.  The rashes were very very itchy.  She started putting over the counter hydrocortisone cream.  She went to a dermatologist and she gave her a large prescription with refills of a steroid cream, and has had to use it every day (triamsinolone cream .1%).  In addition, she have an allergist as she takes shots for her other allergies, and saw a doctor there who finally recommended that she try taking Allegra, which she takes in morning and afternoon, and at night it was suggested by her endocrinologist to try another medicine montelukast sodium.  These have helped a little bit with the reaction.  The itching still continues and has to take another Allegra as the itching has started on her knees.  It will start off as a red rash, or streaks of redness most frequently on her legs, especially around the knees.  She also has them show up on her arms, and even on the palms of her hands.  She also gets them on her chest and neck as well.  It has not gone to her face as yet, but does get it on her back and her waistline.   The doctors cannot up with any other explaination of the where she got it.  The allergist did testing, and she is not allergic to any foods.  The rashes did not start until she got the vaccine.  Sometimes the rashes are so bad, and from the scratching she would get scabs that would bleed.    She went to two different dermatologist to get their opinions, and there wasn't anything specific that she got from that.  She finally talked with her regular allergist and she is the one who suggested that she take the antihistamines more frequently.    She has had a complete round of COVID vaccines, and the flu vaccine every year and has not had anything other than the tiredness, redness and soreness in the arm.  She feels that she is going to spend the rest of her life itching due to the Shingrix vaccine, and it is very disturbing to her.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: She got her vaccine, it started with her arm soreness, and a little bit of swelling at the site of the vaccine and it got red.  She was tired and felt like she had the flu.  This was all the first day.  Then she began getting rashes, and they would appear on her legs, arms, chest, neck and back.  The rashes were very very itchy.  She started putting over the counter hydrocortisone cream.  She went to a dermatologist and she gave her a large prescription with refills of a steroid cream, and has had to use it every day (triamsinolone cream .1%).  In addition, she have an allergist as she takes shots for her other allergies, and saw a doctor there who finally recommended that she try taking Allegra, which she takes in morning and afternoon, and at night it was suggested by her endocrinologist to try another medicine montelukast sodium.  These have helped a little bit with the reaction.  The itching still continues and has to take another Allegra as the itching has started on her knees.  It will start off as a red rash, or streaks of redness most frequently on her legs, especially around the knees.  She also has them show up on her arms, and even on the palms of her hands.  She also gets them on her chest and neck as well.  It has not gone to her face as yet, but does get it on her back and her waistline.   The doctors cannot up with any other explaination of the where she got it.  The allergist did testing, and she is not allergic to any foods.  The rashes did not start until she got the vaccine.  Sometimes the rashes are so bad, and from the scratching she would get scabs that would bleed.    She went to two different dermatologist to get their opinions, and there wasn't anything specific that she got from that.  She finally talked with her regular allergist and she is the one who suggested that she take the antihistamines more frequently.    She has had a complete round of COVID vaccines, and the flu vaccine every year and has not had anything other than the tiredness, redness and soreness in the arm.  She feels that she is going to spend the rest of her life itching due to the Shingrix vaccine, and it is very disturbing to her.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Incorrect route of product administration, Pain in extremity, Rash, Rash pruritic
Clinical narrative: She got her vaccine, it started with her arm soreness, and a little bit of swelling at the site of the vaccine and it got red.  She was tired and felt like she had the flu.  This was all the first day.  Then she began getting rashes, and they would appear on her legs, arms, chest, neck and back.  The rashes were very very itchy.  She started putting over the counter hydrocortisone cream.  She went to a dermatologist and she gave her a large prescription with refills of a steroid cream, and has had to use it every day (triamsinolone cream .1%).  In addition, she have an allergist as she takes shots for her other allergies, and saw a doctor there who finally recommended that she try taking Allegra, which she takes in morning and afternoon, and at night it was suggested by her endocrinologist to try another medicine montelukast sodium.  These have helped a little bit with the reaction.  The itching still continues and has to take another Allegra as the itching has started on her knees.  It will start off as a red rash, or streaks of redness most frequently on her legs, especially around the knees.  She also has them show up on her arms, and even on the palms of her hands.  She also gets them on her chest and neck as well.  It has not gone to her face as yet, but does get it on her back and her waistline.   The doctors cannot up with any other explaination of the where she got it.  The allergist did testing, and she is not allergic to any foods.  The rashes did not start until she got the vaccine.  Sometimes the rashes are so bad, and from the scratching she would get scabs that would bleed.    She went to two different dermatologist to get their opinions, and there wasn't anything specific that she got from that.  She finally talked with her regular allergist and she is the one who suggested that she take the antihistamines more frequently.    She has had a complete round of COVID vaccines, and the flu vaccine every year and has not had anything other than the tiredness, redness and soreness in the arm.  She feels that she is going to spend the rest of her life itching due to the Shingrix vaccine, and it is very disturbing to her.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: alopecia detected 1 week after first shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Dec2021 as dose 1, single (Lot number: FK5618) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "alopecia detected 1 week after first shot". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300430519 Same reporter, patient, drug, event; different dose;
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: alopecia detected 1 week after first shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Dec2021 as dose 1, single (Lot number: FK5618) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "alopecia detected 1 week after first shot". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300430519 Same reporter, patient, drug, event; different dose;
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin, sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: FLUZONE HIGH DOSE QUADRIVALENT taken for influenza immunisation, on 08Nov2023 as dose number unknown, single. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, life threatening) with onset 08Nov2023 at 10:00, outcome "recovering", described as "Heart attack". The patient was hospitalized for myocardial infarction (hospitalization duration: 1 day(s)). The event "heart attack" required emergency room visit. Therapeutic measures were taken as a result of myocardial infarction. Clinical course: Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Adverse event treatment reported as Cardiac catherization.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Blood test, Catheterisation cardiac, Electrocardiogram, Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin, sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: FLUZONE HIGH DOSE QUADRIVALENT taken for influenza immunisation, on 08Nov2023 as dose number unknown, single. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, life threatening) with onset 08Nov2023 at 10:00, outcome "recovering", described as "Heart attack". The patient was hospitalized for myocardial infarction (hospitalization duration: 1 day(s)). The event "heart attack" required emergency room visit. Therapeutic measures were taken as a result of myocardial infarction. Clinical course: Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Adverse event treatment reported as Cardiac catherization.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU4, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin, sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: FLUZONE HIGH DOSE QUADRIVALENT taken for influenza immunisation, on 08Nov2023 as dose number unknown, single. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, life threatening) with onset 08Nov2023 at 10:00, outcome "recovering", described as "Heart attack". The patient was hospitalized for myocardial infarction (hospitalization duration: 1 day(s)). The event "heart attack" required emergency room visit. Therapeutic measures were taken as a result of myocardial infarction. Clinical course: Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Adverse event treatment reported as Cardiac catherization.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too; tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too; tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; influenza vaccine inact split 4v (AFLURIA QUADRIVALENT), on 21Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Polymyalgia rheumatica", start date: 2018 (unspecified if ongoing), notes: had Polymyalgia rheumatica for 4 years, been off since Aug2022. Not taking Prednisone. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster), lot number unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious), NECK PAIN (non-serious) all with onset 21Nov2023, outcome "not recovered" and all described as "tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, joint range of motion decreased, neck pain.  Additional information: NDC number of COVID-19 shot: 00069-2392-10. Has been taking Ibuprofen which seems to help but wears off in the morning and really hurts to lift arm, pain runs from shoulder, not the joint but the padding, down the arm. Just had bloodwork done and everything was good.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Blood test, Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too; tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too; tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; influenza vaccine inact split 4v (AFLURIA QUADRIVALENT), on 21Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Polymyalgia rheumatica", start date: 2018 (unspecified if ongoing), notes: had Polymyalgia rheumatica for 4 years, been off since Aug2022. Not taking Prednisone. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster), lot number unknown), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious), NECK PAIN (non-serious) all with onset 21Nov2023, outcome "not recovered" and all described as "tender on arm, which has slowly gotten worse, and now in morning can hardly lift arm, seems to have gone into neck too". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, joint range of motion decreased, neck pain.  Additional information: NDC number of COVID-19 shot: 00069-2392-10. Has been taking Ibuprofen which seems to help but wears off in the morning and really hurts to lift arm, pain runs from shoulder, not the joint but the padding, down the arm. Just had bloodwork done and everything was good.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE/no PQC.; HCP reported a patient was given PROQUAD and VARIVAX concomitantly in error; This spontaneous report was received from Other Health Professional and refers to a patient of unkown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #X018730, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #W025274, expiration date: 10-AUG-2024, administered for prophylaxis by error (accidental overdose) (strength, and route of administration were not provided).  No additional adverse event was reported.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient's response: N/A; Improperly stored vaccine administered; This spontaneous report was received from an office manager referring to a 1-year-old female patient as a part of a report of several patients (unknown number) involved.   Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.  On 24-OCT-2023, the suspect product varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot #x017485, expiration date 25-JUN-2025; also reported as lot #X01748536, expiration date 05-JAN-2025; conflicting information) experienced a temperature excursion (of -11.8 degrees Celsius (C) for 18 minutes) (Product storage error). Temperature was noted to be out of range. Excursion was reported to manufacturer and was deemed viable. Excursion was reported to the staff as well. Then, on 03-NOV-2023 (also reported as stop date) the patient was vaccinated with improperly stored vaccine administered subcutaneously in the left thigh. The patient did not show a response (No adverse event). No treatment was required.  Lot # X01748536 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX).  This is one of several reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient's response: N/A; Improperly stored vaccine administered; This spontaneous report was received from an office manager referring to a 1-year-old male patient as a part of a report of several patients (unknown number) involved.   Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.  On 24-OCT-2023, the suspect product varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot #x017485, expiration date 25-JUN-2025; also reported as lot #X01748536, expiration date 05-JAN-2025; conflicting information) experienced a temperature excursion (of -11.8 degrees Celsius (C) for 18 minutes) (Product storage error). Temperature was noted to be out of range. Excursion was reported to manufacturer and was deemed viable. Excursion was reported to the staff as well. Then, on 03-NOV-2023 (also reported as stop date) the patient was vaccinated with improperly stored vaccine administered subcutaneously in the right thigh. The patient did not show a response (No adverse event). No treatment was required.  Lot # X01748536 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX).  This is one of several reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient's response: N/A; Improperly stored vaccine administered; This spontaneous report was received from an office manager referring to a 1-year-old female patient as a part of a report of several patients (unknown number) involved.   Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.  On 24-OCT-2023, the suspect product varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot #x017485, expiration date 25-JUN-2025; also reported as lot #X01748536, expiration date 05-JAN-2025; conflicting information) experienced a temperature excursion (of -11.8 degrees Celsius (C) for 18 minutes) (Product storage error). Temperature was noted to be out of range. Excursion was reported to manufacturer and was deemed viable. Excursion was reported to the staff as well. Then, on 03-NOV-2023 (also reported as stop date) the patient was vaccinated with improperly stored vaccine administered subcutaneously in the right thigh. The patient did not show a response (No adverse event). No treatment was required.  Lot # X01748536 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: PNC20
Symptoms: Product container issue
Clinical narrative: Had a broken vial; got the shipment and when we open the box, it was broken; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HE6172, Expiration Date: 28Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAINER ISSUE (non-serious), outcome "unknown", described as "Had a broken vial; got the shipment and when we open the box, it was broken".  Causality for "had a broken vial; got the shipment and when we open the box, it was broken" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  Product Quality Group provided investigational results on 24Nov2023: Conclusion: The complaint for "She had a broken vial in her Prevnar 20 order." of "prevnar 20v injectable" was investigated. The investigation included reviewing the involved batch records, deviation investigation, pictures of complaint sample, complaint sample, evaluation of retain sample, an analysis of the complaint history for the reported lot and product type and Annual Product Review. The final scope was determined to be the associated lot(s) of the reported lot "HE6172". The reported defect was present on the returned complaint sample and pictures. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS  withheld concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could be confirmed on the returned complaint sample and pictures. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: RSV
Symptoms: Cough, Dyspnoea, Pain, Pyrexia
Clinical narrative: Cough; fever; body aches; SOB; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient (unknown if pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (life threatening), outcome "unknown"; PYREXIA (life threatening), outcome "unknown", described as "fever"; PAIN (life threatening), outcome "unknown", described as "body aches"; DYSPNOEA (life threatening), outcome "unknown", described as "SOB". It was unknown if therapeutic measures were taken as a result of cough, pyrexia, pain. Therapeutic measures were taken as a result of dyspnea. The reporter said had not seen this severe of side effects with vaccines before.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.