chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test normal, Colonoscopy normal, Cutaneous T-cell lymphoma, Rash macular
Clinical narrative: Right after getting the Janssen vaccine, my first, in June 2021 I had blotches appear on my legs and inner arms within days.  I figured that my body did not like the vaccine and was slightly concerned by the light pink/purple areas which started to fade within a few days, not noticeable after 1-2 weeks except for my left knee where it continued to be agitated. I did not dare take another vaccine for concern of what a second dose could cause. After many months I realized that my knee was not going to get better, I thought that it was a reoccurrence of a spot in the same place that had been diagnosed as dermatitis about 5 years earlier, which went away within weeks of using a basic topical, but it was changing and was different so I went to my PCP who tried a few local and systemic treatments to no avail.  Over time the condition continued to worsen and spread to a second spot above my left knee.  My doctor referred me to a dermatologist, and I went to the dermatology and began a series of treatments that included Cyclosporine, Clobetasol, Opzulera, Rinvoq, Dupizent, and other topic and oral drugs.  I had many biopsies and dozens of vials of blood drawn, a colonoscopy, body scans, all negative.  By now it was late 2022 and the condition was spreading to both legs, feet, bottom of feet, on arms and was worsening.  The areas were in the same location and shape of the blotches that I had right after getting the COVID vaccine.  I continued seeing specialists in city and city Medical Centers to no avail all were amazed at how bad it looked (like 3rd degree burns) but no labs or biopsies showed results. My first dermatologist then did different lab and sent another biopsy off but this time to a very experienced pathologist.  The pathologist called when he saw the biopsy as he was sure that it was cancer. My doc sent me straight to Facility where they did more labs and pathology and determined in January 2024 that I have Cutaneous T-Cell Non-Hodgkin?s Lymphoma (Mycosis Fungoides).  Don?t know if there is a connection, or if the vaccine triggered a cancer that already existed.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Scan normal
Clinical narrative: Right after getting the Janssen vaccine, my first, in June 2021 I had blotches appear on my legs and inner arms within days.  I figured that my body did not like the vaccine and was slightly concerned by the light pink/purple areas which started to fade within a few days, not noticeable after 1-2 weeks except for my left knee where it continued to be agitated. I did not dare take another vaccine for concern of what a second dose could cause. After many months I realized that my knee was not going to get better, I thought that it was a reoccurrence of a spot in the same place that had been diagnosed as dermatitis about 5 years earlier, which went away within weeks of using a basic topical, but it was changing and was different so I went to my PCP who tried a few local and systemic treatments to no avail.  Over time the condition continued to worsen and spread to a second spot above my left knee.  My doctor referred me to a dermatologist, and I went to the dermatology and began a series of treatments that included Cyclosporine, Clobetasol, Opzulera, Rinvoq, Dupizent, and other topic and oral drugs.  I had many biopsies and dozens of vials of blood drawn, a colonoscopy, body scans, all negative.  By now it was late 2022 and the condition was spreading to both legs, feet, bottom of feet, on arms and was worsening.  The areas were in the same location and shape of the blotches that I had right after getting the COVID vaccine.  I continued seeing specialists in city and city Medical Centers to no avail all were amazed at how bad it looked (like 3rd degree burns) but no labs or biopsies showed results. My first dermatologist then did different lab and sent another biopsy off but this time to a very experienced pathologist.  The pathologist called when he saw the biopsy as he was sure that it was cancer. My doc sent me straight to Facility where they did more labs and pathology and determined in January 2024 that I have Cutaneous T-Cell Non-Hodgkin?s Lymphoma (Mycosis Fungoides).  Don?t know if there is a connection, or if the vaccine triggered a cancer that already existed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No signs or symptoms were reported by the patient. Patient was notified.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Dizziness, Ear pain, Feeling of body temperature change
Clinical narrative: Mon eve- scratchy throat, congestion- unsure if getting sick.  Tues: runny nose, sneezing, sore throat, def sick. By Wed: dizzy, nauseous, terrible headache that tylenol didnt help, constant sneezing, ear ache,  hot & cold, breathing poorly, coughing. Thurs: tested pos for covid -19.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Headache, Malaise, Nausea, Oropharyngeal pain, Respiratory syncytial virus test
Clinical narrative: Mon eve- scratchy throat, congestion- unsure if getting sick.  Tues: runny nose, sneezing, sore throat, def sick. By Wed: dizzy, nauseous, terrible headache that tylenol didnt help, constant sneezing, ear ache,  hot & cold, breathing poorly, coughing. Thurs: tested pos for covid -19.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Streptococcus test
Clinical narrative: Mon eve- scratchy throat, congestion- unsure if getting sick.  Tues: runny nose, sneezing, sore throat, def sick. By Wed: dizzy, nauseous, terrible headache that tylenol didnt help, constant sneezing, ear ache,  hot & cold, breathing poorly, coughing. Thurs: tested pos for covid -19.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Throat irritation
Clinical narrative: Mon eve- scratchy throat, congestion- unsure if getting sick.  Tues: runny nose, sneezing, sore throat, def sick. By Wed: dizzy, nauseous, terrible headache that tylenol didnt help, constant sneezing, ear ache,  hot & cold, breathing poorly, coughing. Thurs: tested pos for covid -19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Ventricular extrasystoles
Clinical narrative: PVC?s began 2days following vaccination,  occurring throughout the day. These continued to occur and were noted at my pre-op EKG for my second total knee, ordered holter monitor, treadmill by Dr in December as precaution before surgery in early January.  The PVC?s abated after about 2 weeks before scheduled  tests, followed through with testing which was within normal limits.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was to recieve Gardisil (HPV) #2 but the Medical Assistant administered Boostrix (Tdap) instead. No Adverse effects occured.
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Headache, Influenza like illness, Malaise, Respiratory tract congestion
Clinical narrative: She got her vaccine, had no initial reaction.  Then on Thursday morning she had taken a Tylenol as she has neuropathy and felt terrible.  She knew she had taken a Tylenol, and woke up with congestion, runny nose, like coming down with the flu.  She was not nauseous but she has not felt like eating, but she is trying to drink a lot of water.  Her doctor is out of the country until the 2nd week in February so she is not able to contact the office.  She called pharmacy and mentioned to them if it was ago to take Mucinex, and asked if she could take Tylenol for the headache, and she was told that was OK too.
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Rhinorrhoea
Clinical narrative: She got her vaccine, had no initial reaction.  Then on Thursday morning she had taken a Tylenol as she has neuropathy and felt terrible.  She knew she had taken a Tylenol, and woke up with congestion, runny nose, like coming down with the flu.  She was not nauseous but she has not felt like eating, but she is trying to drink a lot of water.  Her doctor is out of the country until the 2nd week in February so she is not able to contact the office.  She called pharmacy and mentioned to them if it was ago to take Mucinex, and asked if she could take Tylenol for the headache, and she was told that was OK too.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Patient is 29 year old female, week 33 of pregnancy. Estimated delivery date is 3/15/24.  Two days after receiving the vaccine she presented to the pharmacist displaying a bright red spot about 2 inches in diameter. This coincided with the vaccine administration site. When gently pressed upon, a solid mass was felt under the skin, and the patient complained of moderate pain. One day after reporting the event, the patient reports the arm is feeling better after icing the area and using acetaminophen as needed for pain. The redness had not yet dissipated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Very bad stomach cramping that lasted 3-4 days. She thought she had diverticulitis.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: pt was given HPV and FLU vaccines and had a syncope response and recovered less than a minute after episode .
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 5 hours my left arm was red, swollen, and hot to the touch down to the elbow and it has continued through today (1/29).
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given two doses of Moderna Spikevax within 3.5 weeks of each other, no adverse effects reported at the time of this report. Patient tolerating injection at this time
Age: 44.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient did not experience any side effect
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: High dose Fluad given to patient by mistake, contacted manufacture, advised that it was tested in adults 18-64 and in that study it was deemed safe. Patient was notified, this dose was tolerated well with no side effects noted.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Hyporesponsive to stimuli, Pallor
Clinical narrative: After the 1st shot was administered, there was a  delay in crying (Dtap-HepB-IPv), then as the others was  administered baby continued to cry mom proceeded to comfort the baby as she passed the baby to dad, About 2 minutes pass ..as I am administering Rotavirus to baby #2 I look over at the baby and noticed she was pale, I proceed to arouse the infant and she was having a hard time responding , so I got help from the Medical Assistant who went and got the doctor who aroused the baby and stated it was a Hypotonic Hyporesponsive Episode
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received an additional dose of varicella vaccine on 01/27/2024  which was too soon from the initial dose was given on 01/16/2024 .No harm /injury reported for patient .MD  was made aware
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Nausea, Headache, body ache, fever 100F for 2 days, chill, migraine symptom/light flash - all for about 2 days and now better, also inj site rxn on RA - red/rash/hot/large area and tender
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain, Photopsia
Clinical narrative: Nausea, Headache, body ache, fever 100F for 2 days, chill, migraine symptom/light flash - all for about 2 days and now better, also inj site rxn on RA - red/rash/hot/large area and tender
Age: 51.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: headache, severe fatigue, pain in right arm
Age: 71.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Anorectal discomfort, Diarrhoea, Dysarthria, Dysphonia, Pruritus
Clinical narrative: She got her vaccines, and was OK.  The next day she had a few hives, and then go more and more.  By 12/28/23 she had to go on Prednisone because they moved to her organs and ears, throat.  When she finished the Prednisone she took Benadryl for 42 hours and then went back to her doctor and he put her back on Prednisone.  The Prednisone works while she is on it, but when she stops it is just like when she started taking the Prednisone.  She has a FU appointment with her doctor on Wednesday.   The pharmacist is the one who recommended that she get the RSV vaccine when she went to get the pneumonia vaccine and informed him that she was afraid to get vaccines, and told her that since she could not take antibiotics that he should get the vaccine.  She questioned whether to take it with the other vaccine, and was informed that it was OK.  She said they should be educated not to push the vaccine and not to give at the same time as another one.    The hives were inside her intestines and she would have diarrhea and when she would have to go to the bathroom it would burn.  This has subsided and is now only on her skin.  She has hives all over her body and has difficulty speading and it has affected her voices.   The itching is very intense.
Age: 71.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Urticaria
Clinical narrative: She got her vaccines, and was OK.  The next day she had a few hives, and then go more and more.  By 12/28/23 she had to go on Prednisone because they moved to her organs and ears, throat.  When she finished the Prednisone she took Benadryl for 42 hours and then went back to her doctor and he put her back on Prednisone.  The Prednisone works while she is on it, but when she stops it is just like when she started taking the Prednisone.  She has a FU appointment with her doctor on Wednesday.   The pharmacist is the one who recommended that she get the RSV vaccine when she went to get the pneumonia vaccine and informed him that she was afraid to get vaccines, and told her that since she could not take antibiotics that he should get the vaccine.  She questioned whether to take it with the other vaccine, and was informed that it was OK.  She said they should be educated not to push the vaccine and not to give at the same time as another one.    The hives were inside her intestines and she would have diarrhea and when she would have to go to the bathroom it would burn.  This has subsided and is now only on her skin.  She has hives all over her body and has difficulty speading and it has affected her voices.   The itching is very intense.
Age: 56.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: THERE IS NO ADVERSE EVENT WE RECIEVED THE PRESCRIPTION FORM APN ON 10/10/2023 AND BASE ON THE STORY THAT THE PATIENT TOLD US HE HAD LUNG DISEASES AND HE WAS WORRIED TO NOT GETTING THE RSV SO HIS APN SENT US THE PRESCRIPTION AND WE GAVE IT TO HIM.
Age: 1.17
Sex: M
Vaccine: DTAP, FLU4, IPV
Symptoms: Decreased appetite, Diarrhoea, Injection site reaction, Injection site warmth, Lethargy
Clinical narrative: Grandma (guardian) called our clinic (where patient received his shots) and stated that on the evening of 1/26/24 patient started having diarrhea and was projectile vomiting, she said she notices a 3 by 4 inch rash on his left leg and that it was a little red and warm to touch. She stated that this continued on and he later developed a 101.7 F fever and stated he was also lethargic. She stated that she did give medication to help with fever. She did not go to urgent care, hospital, or providers office. Grandma stated that everything has been improving he no longer has fever, rash is getting better, appetite is getting better.
Age: 1.17
Sex: M
Vaccine: DTAP, FLU4, IPV
Symptoms: Pyrexia, Rash erythematous, Vomiting projectile
Clinical narrative: Grandma (guardian) called our clinic (where patient received his shots) and stated that on the evening of 1/26/24 patient started having diarrhea and was projectile vomiting, she said she notices a 3 by 4 inch rash on his left leg and that it was a little red and warm to touch. She stated that this continued on and he later developed a 101.7 F fever and stated he was also lethargic. She stated that she did give medication to help with fever. She did not go to urgent care, hospital, or providers office. Grandma stated that everything has been improving he no longer has fever, rash is getting better, appetite is getting better.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Pt. received a dose of Flu on 12/08/2023 and then a second dose on 1/5/2024 Pt. today is 31w5days pregnant .
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Sleep disorder, X-ray
Clinical narrative: Arm was really sore. Can't sleep on it. a lot of pain.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Accelerated hypertension, Anaemia, Atrial fibrillation, COVID-19, Hyperglycaemia
Clinical narrative: Hospitalization for COVID-19 infection, hypomagnesemia, accelerate hypertension, hyperglycemia, thrombocytopenia, atrial fibrillation, physical deconditioning, anemia on dates 1/9/2024-1/27/2024 . Treated with Remdesivir, vitamin C 500 mg PO daily.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Hypomagnesaemia, Physical deconditioning, Thrombocytopenia
Clinical narrative: Hospitalization for COVID-19 infection, hypomagnesemia, accelerate hypertension, hyperglycemia, thrombocytopenia, atrial fibrillation, physical deconditioning, anemia on dates 1/9/2024-1/27/2024 . Treated with Remdesivir, vitamin C 500 mg PO daily.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, COVID-19, Chest pain
Clinical narrative: Hospitalization for chest pain- suspected ACS NSTEMI, possible AKI, COVID-19 on dates 1/19/2024- 1/26/2024. Treated with vitamin C 500 mg PO daily, zinc 50 mg PO daily.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over whole body, not raised, prickly mostly. After 4 days, does not seem to be going away.,
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Hypotension, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: felt very weak, looked pale, slumped in chair- we were able to get her to floor before she passed out. Never lost consciousness. arms initially stiffened but no other seizure like activity. blood pressure low which is her normal. oral  hydration and time, improved.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Posture abnormal
Clinical narrative: felt very weak, looked pale, slumped in chair- we were able to get her to floor before she passed out. Never lost consciousness. arms initially stiffened but no other seizure like activity. blood pressure low which is her normal. oral  hydration and time, improved.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Pt. was given a flu vaccine on 12/08/2023 and then received a second dose on 1/5/2024 .Pt. is 27w6d pregnant.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Patient said she is experiencing pain in her left arm. Patient said pain is radiating  from her arm to neck area. patient was referred to her primary care dr for further evaluation and follow up
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Chronic obstructive pulmonary disease, Condition aggravated, Pneumonia
Clinical narrative: She got her vaccine and started having  hair loss on 10/25/23 for pneumonia, and was out on 10/30/23 and also had COPD exacerbation after being on antibiotics at home.  The hair falling out got worse and when she rushed it and brushed it it kept falling out.  The pharmacist asked if she brushed her hair and her hair just keeps coming out continuously.   This hair falling out started when she had her first vaccine, and did not pay attention to it, but it always happens after getting her COVID vaccine.  She did have some of her vaccines at the same time with the flu vaccine, but every time she got a vaccine it fell out.   She then went to her doctor for the hair loss, and spoke to her gastroenterologist as she sees her every 3 months and she said what did it have to do to anything.  She felt it had to do with malabsorption, but she felt it was not related to that.  She spoke with her pulmonologist and do not feel that it's related to her lungs.  She has not seen her primary since being in the hospital in October as she has not recovered from her pneumonia.   Her initial COVID vaccine was on 3/26/21, and lot#:  ER8727, 2nd one on 4/15/21, lot#:  EW2150, 3rd one on 10/16/21, lot #:  30125BA; 7/6/22, lot#:  FM7553; bivalent on 10/21/22, lot# GH9707.   She has not been any treatment for her hair loss.  She is going to see her PCP in March and see what he has to say about this.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: She got her vaccine and started having  hair loss on 10/25/23 for pneumonia, and was out on 10/30/23 and also had COPD exacerbation after being on antibiotics at home.  The hair falling out got worse and when she rushed it and brushed it it kept falling out.  The pharmacist asked if she brushed her hair and her hair just keeps coming out continuously.   This hair falling out started when she had her first vaccine, and did not pay attention to it, but it always happens after getting her COVID vaccine.  She did have some of her vaccines at the same time with the flu vaccine, but every time she got a vaccine it fell out.   She then went to her doctor for the hair loss, and spoke to her gastroenterologist as she sees her every 3 months and she said what did it have to do to anything.  She felt it had to do with malabsorption, but she felt it was not related to that.  She spoke with her pulmonologist and do not feel that it's related to her lungs.  She has not seen her primary since being in the hospital in October as she has not recovered from her pneumonia.   Her initial COVID vaccine was on 3/26/21, and lot#:  ER8727, 2nd one on 4/15/21, lot#:  EW2150, 3rd one on 10/16/21, lot #:  30125BA; 7/6/22, lot#:  FM7553; bivalent on 10/21/22, lot# GH9707.   She has not been any treatment for her hair loss.  She is going to see her PCP in March and see what he has to say about this.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: arm pain goes into shoulder on the right arm
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Back pain
Clinical narrative: I have had pretty consistent lower back pain since the day after the shot. Its a sharp pain and it kind of feels like my muscles are torn.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncope
Age: 10.0
Sex: M
Vaccine: COVID19, FLUN4, HEPA, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client given Comirnaty 12 plus, but he was only 10 years and 11 months of age, and should have received Pfizer 5-11 years.  Upon review of vaccine records prior to appointment today 01/29/24 for 2nd varicella and other vaccines  noted that received COVID vaccine for 12+ age group. Client did not have any adverse reactions.  Guardian who was present with client today informed.
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported itching and redness at injection site and approximately 2 inches around injection site.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Heart rate increased, Hypertension
Clinical narrative: Diarrhea and nausea, high blood pressure, headaches consistently. Stomach cramps that felt like a wave over my body and it made my heart rate go up high.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Diarrhea and nausea, high blood pressure, headaches consistently. Stomach cramps that felt like a wave over my body and it made my heart rate go up high.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, Echocardiogram, Laboratory test, Scleroderma
Clinical narrative: NEW ONSET RAPIDLY PROGRESSIVE SCLERODERMA JAN 1 2023 INVOLVING HANDS, CHEST FACE, LEGS.  EARLY PULMONARY INVOLVEMENT.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient received a high-dose flu shot intramuscularly into the left deltoid from one of the pharmacists at our location. The patient stated that the injection hurt, but continues to hurt. She states that over the next couple weeks, the pain began to radiate down her arm. Currently, the fingers of her left hand tingle, and she is unable to lift any objects or raise her left arm. She talked to one of the pharmacists at our location who advised her to discuss the issue with her pain management provider. Per the patient, the provider stated that there was nothing she could do until she talked to the pharmacy again. No medical or laboratory tests have been done. The patient returned to the pharmacy on 1/28/24 and discussed the adverse event with another pharmacist, who discussed the issue with the pharmacy manager and pain clinic on 1/29/24. We called the patient and told her that we would address the adverse event by reporting it using VAERS. We will also notify the pain clinic that this action has been taken.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acupuncture, Anxiety, Biofeedback therapy, Computerised tomogram, Hearing aid therapy
Clinical narrative: Tinnitus starting light buzzing from Jan. 2022 until Aug 2022. From Sept 2022 until present it is at a level 10. noise level is around 70 decibles.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Panic attack, Therapeutic procedure, Tinnitus
Clinical narrative: Tinnitus starting light buzzing from Jan. 2022 until Aug 2022. From Sept 2022 until present it is at a level 10. noise level is around 70 decibles.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Genital rash, Injection site rash, Rash, Rash erythematous
Clinical narrative: On  Saturday 01/27/2024 the baby started getting a red unraised rash on the stomach and privates. Then by approximately 8:00 PM in the evening the rash had spread to his chest, back, legs, arms, and tops of his hands. He was seen by a provider. The parent was instructed to give Benadryl and the child improved.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Eye swelling
Clinical narrative: Donor states at the first sign of Right eye swelling he took a Zyrtec that stopped the swelling and eye resumed back to normal size. Donor denies any loss of vision, spots, pressure in right eye or any reoccurring swelling of eye. Donor denies any other reaction symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV, UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: Pentacel was mixed incorrectly. Only received the DTap and IPV did not receive the Hib component. Guardian notified on 1/29/2024, no adverse effects reported. Will call back to reschedule to receive proper vaccination.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Haematochezia, Intussusception, Vomiting projectile
Clinical narrative: Patient was taken to ER 1/27/24 due to projectile vomiting and blood/jelly stool. Diagnosed with intussusception
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Computerised tomogram thorax abnormal, Cough, Echocardiogram abnormal
Clinical narrative: Jan 1st 2024 - fever, chills, light cough. Jan 2nd 2024 - cough worsens, fever stays, mild chest pain. Jan 3rd 2024 - fever gone, chest pain continues, urgent care visited. No sign of pneumonia but some crackling in lungs. Chest pain worsens throughout day. Evening, visited ER and was admitted to severe wing. Symptoms pointed to heart attack. Docs performed ECG (abnormal), blood work (very high troponin levels), and an echo on the heart. Jan 4th 2024 - still in hospital. Troponin levels lower somewhat overnight. Docs perform CT scan and identified, along with echo, that heart was in good condition, but that I had pneumonia and Myopericarditis. Relased that afternoon with antibiotics for pneumonia and colchicine for heart inflammation. Doc speculated that the Covid vaccine may have caused the issue due to fine health in young adult male otherwise. From that point I have been on medical leave (still am) on very light duty. Pneumonia almost gone and heart is limiting physical activity currently.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Impaired work ability, Loss of personal independence in daily activities, Myopericarditis, Pneumonia
Clinical narrative: Jan 1st 2024 - fever, chills, light cough. Jan 2nd 2024 - cough worsens, fever stays, mild chest pain. Jan 3rd 2024 - fever gone, chest pain continues, urgent care visited. No sign of pneumonia but some crackling in lungs. Chest pain worsens throughout day. Evening, visited ER and was admitted to severe wing. Symptoms pointed to heart attack. Docs performed ECG (abnormal), blood work (very high troponin levels), and an echo on the heart. Jan 4th 2024 - still in hospital. Troponin levels lower somewhat overnight. Docs perform CT scan and identified, along with echo, that heart was in good condition, but that I had pneumonia and Myopericarditis. Relased that afternoon with antibiotics for pneumonia and colchicine for heart inflammation. Doc speculated that the Covid vaccine may have caused the issue due to fine health in young adult male otherwise. From that point I have been on medical leave (still am) on very light duty. Pneumonia almost gone and heart is limiting physical activity currently.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rales, Troponin increased
Clinical narrative: Jan 1st 2024 - fever, chills, light cough. Jan 2nd 2024 - cough worsens, fever stays, mild chest pain. Jan 3rd 2024 - fever gone, chest pain continues, urgent care visited. No sign of pneumonia but some crackling in lungs. Chest pain worsens throughout day. Evening, visited ER and was admitted to severe wing. Symptoms pointed to heart attack. Docs performed ECG (abnormal), blood work (very high troponin levels), and an echo on the heart. Jan 4th 2024 - still in hospital. Troponin levels lower somewhat overnight. Docs perform CT scan and identified, along with echo, that heart was in good condition, but that I had pneumonia and Myopericarditis. Relased that afternoon with antibiotics for pneumonia and colchicine for heart inflammation. Doc speculated that the Covid vaccine may have caused the issue due to fine health in young adult male otherwise. From that point I have been on medical leave (still am) on very light duty. Pneumonia almost gone and heart is limiting physical activity currently.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report was received from a nurse refers to a 1-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 29-DEC-2023, the patient was vaccinated with an improperly stored doses haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X008998, expiration date: 14-NOV-2025, intramuscular in the left thigh (exact dose was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX)(GSK), lot # was reported as: 7HM5J, expiration date: 13-SEP-2024, intramuscular in the right thigh (formulation and exact dose were not provided) for prophylaxis.   It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 29-DEC-2023. Administered doses of vaccines were exposed to the temperature excursion on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes; and on 29-DEC-2023 of 1.7 (units not provided) for 1 hour and 44 minutes (product storage error). No additional adverse event reported (no adverse event).
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Occupational exposure to product
Clinical narrative: No additional AE/PQC; her eye may have been exposed to fluid; This spontaneous report was received from a  48 year old non pregnant female patient reporting on herself who also is an health care professional (HCP). The patient's concurrent conditions included iodine allergy.No information regarding the patient's pertinent medical history and concomitant therapy were provided.  On 23-JAN-2024, a patient was vaccinated with the second vial of Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) (2 ml, lot # 1965567, expiration date: 30-AUG-2024) for prophylaxis and coughed immediately after (captured in MARRS: 2401USA015014). The reporter's (HCP) eye may have been exposed to fluid (occupational exposure to product); the HCP states she was not sure if the fluid got into her eye or if she is "imagining things". The HCP notes that she was experiencing no irritation or reaction, she was not sure if it was a true exposure. No adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA015014:
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Consumer stated she saw blood in feces of her child right after her child received the ROTATEQ vaccine.; This spontaneous report was received from the patient's mother concerning to her 5-month-old, a patient of unspecified gender.  The patient's medical history, historical drugs, known drug allergies and concomitant therapies were not reported. The patient's concurrent conditions included soy and or dairy allergy, and they were also currently being breastfeed.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, administered for prophylaxis (strength, exact dosage, lot #, expiry date, and route of administration were not provided). On 19-JAN-2024, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, administered for prophylaxis (strength, exact dosage, lot #, expiry date, and route of administration were not provided).   On the same day (19-JAN-2024) (also reported as ''right after the patient received the suspect vaccine), the patient's mother saw blood in their feces (Haematochezia). At the time of reporting, the outcome and further information regarding this event had not been provided.   The causal relationship between haematochezia and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown, as the reporter was not sure if it had been due to this vaccine or if it was something that she ate containing dairy or soy as her child was breastfeed. Upon internal review, the event of haematochezia was considered to be medically significant.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of product administration
Clinical narrative: received 3 doses of the unspecified hepatitis B vaccine at 0 months, 2 months, and 9 months old; received 3 doses of the unspecified hepatitis B vaccine at 0 months, 2 months, and 9 months old; his titers came back negative; This spontaneous report was received from a patient as a 2-month-old male patient, who was currently 21 years old. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with three doses of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection (dose, strength, lot # and expiration date were not provided) intramuscularly for routine vaccination, at 0 months, 2 months (Inappropriate schedule of product administration), and 9 months old (Inappropriate schedule of product administration).  On an unknown date in August 2023, the patient's titers came back negative (Hepatitis B surface antibody negative). No treatment was given for the event. The patient did not seek medical attention. At the time of reporting, the outcome of the event Hepatitis B surface antibody negative was not known. The causal relationship between Hepatitis B surface antibody negative and the vaccine was unknown.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: revaccination/booster with VARIVAX since "[her] levels were low" after receiving a titer through her work; This spontaneous report was received from pharmacist and refers to a female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced levels were low after receiving a titer through her work. At the time of reporting, the outcome of the event was not known.   The causal relationship between adverse event and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 4-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 26-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 5-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 28-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 4-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 28-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 4-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 26-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X0108584, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.  The lot number #X0108584 was estimated to be estimated as not valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 5-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 04-OCT-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 5-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 26-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 9-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 04-OCT-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported. .
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 4-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 02-OCT-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.