chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: High fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date - 21-NOV-2023  The case was received from the patient via (social media) interactive digital media. The patient stated that she had high fever too but did not want to get shingles. This case was linked with US2023AMR162898 reported by the same reporter for her husband.; Sender's Comments:  US-GSK-US2023AMR162898:HUSBAND CASE ID
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old patient inadvertently received a dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis.   On 21-NOV-2023, the patient received Infanrix. On 21-NOV-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 year old patient inadvertently received a dose of Infanrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 21-NOV-2023 A Nurse practitioner reported that a 11 year old patient inadvertently received a dose of Infanrix which led to inappropriate age at vaccine administration. The reporter consent to follow-up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Developed a fever and soreness afterwards.; Developed a fever and soreness afterwards.; 12 hours after injection, uncontrollably shaking violently that lasted an hour, specifically the jaw.; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (12 hours after injection, uncontrollably shaking violently that lasted an hour, specifically the jaw.), PAIN (Developed a fever and soreness afterwards.) and PYREXIA (Developed a fever and soreness afterwards.) in a 30-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031914) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 25-Nov-2023, the patient experienced TREMOR (12 hours after injection, uncontrollably shaking violently that lasted an hour, specifically the jaw.). 25-Nov-2023, the patient experienced PYREXIA (Developed a fever and soreness afterwards.). On an unknown date, the patient experienced PAIN (Developed a fever and soreness afterwards.). On 25-Nov-2023, TREMOR (12 hours after injection, uncontrollably shaking violently that lasted an hour, specifically the jaw.) and PYREXIA (Developed a fever and soreness afterwards.) had resolved. At the time of the report, PAIN (Developed a fever and soreness afterwards.) outcome was unknown.            No concomitant and treatment medications were reported.  The reporter stated that 12 hours after injection, the patient had uncontrollably shaking violently that lasted an hour, specifically the jaw. Developed a fever and soreness afterwards. It was unknown if the patient experienced any additional symptoms or events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: dizziness; headache; fatigue; weak; chills; swelling at the injection site; 100.6 temperature; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weak), VACCINATION SITE PAIN (pain at the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (swelling at the injection site) in a 43-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030373) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 19-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 20-Nov-2023, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (swelling at the injection site) and PYREXIA (100.6 temperature). On 22-Nov-2023, the patient experienced ASTHENIA (weak) and FATIGUE (fatigue). On 27-Nov-2023, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weak), VACCINATION SITE PAIN (pain at the injection site), CHILLS (chills), VACCINATION SITE SWELLING (swelling at the injection site), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and PYREXIA (100.6 temperature) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Day one patient started with pain at the injection site. On day two and three she had a 100.6 temperature with chills, pain and swelling at the injection site. On day and four she felt weak and tired with pain and swelling at the injection site. On day 5 until the day 9, she had severe dizziness, headache and fatigue. The patient did not experience any additional symptoms/events.  Treatment information was not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: dizziness; headache; fatigue; weak; chills; swelling at the injection site; 100.6 temperature; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weak), VACCINATION SITE PAIN (pain at the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (swelling at the injection site) in a 43-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030373) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 19-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 20-Nov-2023, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (swelling at the injection site) and PYREXIA (100.6 temperature). On 22-Nov-2023, the patient experienced ASTHENIA (weak) and FATIGUE (fatigue). On 27-Nov-2023, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weak), VACCINATION SITE PAIN (pain at the injection site), CHILLS (chills), VACCINATION SITE SWELLING (swelling at the injection site), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and PYREXIA (100.6 temperature) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Day one patient started with pain at the injection site. On day two and three she had a 100.6 temperature with chills, pain and swelling at the injection site. On day and four she felt weak and tired with pain and swelling at the injection site. On day 5 until the day 9, she had severe dizziness, headache and fatigue. The patient did not experience any additional symptoms/events.  Treatment information was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache
Clinical narrative: Terrible headache, stomach ache and watery diarrhea for almost 24
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Chills that were like in waves. I'd have a rush of chills and it would subside for a minute and then come again. Little bit of Headache, Muscle Pain, I ached all over, Tired. A little bit of Nausea. This all started about 8:30 pm with tiredness and muscle aches. About an hour or so later the chills started.  At 10:00 pm, I took 2 Tylenol and went to bed. I continued to have the chills and muscle pain, but did fall asleep. Got up at 6:00 am. No chills, just some muscle pain, tired and little bit of headache. Had breakfast at about 8:00 and took 2 more Tylenol. Slept a couple more hours mid-morning, rested most of the day and by about 4:00 pm, I felt fine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder
Clinical narrative: Chills that were like in waves. I'd have a rush of chills and it would subside for a minute and then come again. Little bit of Headache, Muscle Pain, I ached all over, Tired. A little bit of Nausea. This all started about 8:30 pm with tiredness and muscle aches. About an hour or so later the chills started.  At 10:00 pm, I took 2 Tylenol and went to bed. I continued to have the chills and muscle pain, but did fall asleep. Got up at 6:00 am. No chills, just some muscle pain, tired and little bit of headache. Had breakfast at about 8:00 and took 2 more Tylenol. Slept a couple more hours mid-morning, rested most of the day and by about 4:00 pm, I felt fine.
Age: 12.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: covid vaccine expired on 11/25/23, vaccine was given on 11/27/23-expired dose given to patient. no affects at this time, notified provider who will opt to re-give dose if deemed necessary
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported she received flu vaccine one 11/27/23 and that evening noted some redness, itching and mild swelling to site. Seen in employee health started on keflex, hydrocortisone otc with follow up appointment 11/29/2023
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: One inch nodule formed at injection site 30 minutes post injection - proceeded to swell throughout the evening to three inch area.  Area around injection red, warm to touch, painful.   Arm was very itchy and small hive to upper lip.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: One inch nodule formed at injection site 30 minutes post injection - proceeded to swell throughout the evening to three inch area.  Area around injection red, warm to touch, painful.   Arm was very itchy and small hive to upper lip.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination site pain
Clinical narrative: PERSISTENT PAIN AT VACCINATION SITE ONE WEEK AFTER THE VACCINE WAS ADMINISTERED
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Coordination abnormal, Dysstasia, Gait disturbance, Pyrexia
Clinical narrative: WITHIN 12 HOURS PT REPORTS FEVER OF 101.8 F AND DISCOORDINATION WITH WALKING AND ATTEMPTING TO GET UP--THIS IS A NEW DEVELOP
Age: 73.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Pain, Pollakiuria, Pyrexia
Clinical narrative: Patient stated that they experience body aches, fever, and increased urination for their adverse effects. I recommended that they take tylenol to help with body aches and fever and to increase liquids so they don't get dehydrated, will be seeing doctor within a week for steroid injections and will let them know
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Child was given TDAP instead of DTAP.
Age: 53.0
Sex: F
Vaccine: PNC15, VARZOS
Symptoms: Bone pain, Fatigue, Fear, Gait disturbance, Head discomfort
Clinical narrative: Fatigue extreme Bone pains Foot, hands, extreme headache like pressure. 102 fevers x 24 hours. Sweating, thirsty. Shaking. Unable to walk on my own.
Age: 53.0
Sex: F
Vaccine: PNC15, VARZOS
Symptoms: Hyperhidrosis, Pain in extremity, Thirst, Tremor
Clinical narrative: Fatigue extreme Bone pains Foot, hands, extreme headache like pressure. 102 fevers x 24 hours. Sweating, thirsty. Shaking. Unable to walk on my own.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity, Rash
Clinical narrative: PT COMPLAINED THAT HIS ARM WAS VERY SORE FOR 4 WEEKS AFTER VACCINATION, THEN HE BROKE OUT IN A RASH ON HIS ENTIRE BACK.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Arm is swollen, discolored, and sore
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This happened during a Flu vaccine clinic. Patient is 64 yo. Fluzone HD Quad is indicated for 65 yo and older patients. Patient was administed Fluzone HD Quad on 10/11/2023. I discovered upon resolving a rejection "product not covered" by patient's insurance.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Somnolence, Vertigo, Vomiting
Clinical narrative: Dizzy, vertigo, vomiting for about an hour. Sleep
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Rash on arm, sourness of arm at injection site,  warmness and swelling around injection site, Nausea / Vomitting, Headache and fatigue
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Rash on arm, sourness of arm at injection site,  warmness and swelling around injection site, Nausea / Vomitting, Headache and fatigue
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient given Novavax 0.5ml, left deltoid tolerated without any complications, no s/s of adverse reactions noted at that time. Monitored for 15 minutes. No compliants noted
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Condition aggravated
Clinical narrative: After the first booster, I developed aching legs in my upper thighs, and I went to the doctor and they did blood work. It showed inflammation. Then it got worse. I got the second booster on 10/22/22 at same location, then my shoulder started hurting after that one as well. Soon after that I developed colitis, and I dont think it had anything to do with it, but I developed it in 12/2022. They started me on a regular dose of prednisone
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Periarthritis
Clinical narrative: Received flu vaccine at clinic. Had Right arm injection site pain immediately after. Since then, has had pain to right arm. Since 11/26/23, has not been able to lift right arm. Saw provider yesterday and was diagnosed with frozen shoulder. On steroids and referred to PT
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No known symptoms, was given the 12+ dose of covid Comirnaty Pfizer0.3ml given by mistake due to patients age  There was no adverse  reaction
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known symptoms, was given the 12+ dose of covid Comirnaty Pfizer0.3ml given by mistake due to patients age  There was no adverse  reaction
Age: 16.0
Sex: M
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Patient came in for Well Child and Sports Physical. Patient was due for Men-B and Meningococcal Conjugate immunizations. I cannot explain why or even remember grabbing the Hib immunizations, but that is what was given instead of the Meningococcal Conjugate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A few days after the first Covid booster on 09/29/2021, I had a very mild tinnitis. On 06/03/2022, I had a second Covid Pfizer booster. A few days later my tinnitis level increased - still at a low level. On 10/25.2022, I had a third Covid Pfizer booster. A few days after this, my tinnitis level increased markedly, where it remains today. It was only after the third booster that I read anything about a possible connection between Covid boosters and tinnitis. The two Covid vaccinations that I received in early 2021 had no affect regarding tinnitis.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Caesarean section, Exposure during pregnancy, Foetal heart rate abnormal, Foetal hypokinesia
Clinical narrative: Patient presented to hospital at 35 weeks 1 day with decreased fetal movement, non reassuring heart rate, underwent emergency cesarean, infant born with APGAR or zero, prolonged resuscitation, anoxic brain injury and neonatal death.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Dysarthria, Electrocardiogram, Laboratory test, Loss of consciousness
Clinical narrative: Within 4 minutes of receiving the influenza vaccine, the patient became pale, began slurring her words and speaking very quietly, and then was unable to sit up. I laid the patient back on the exam bed and called for help.  A physician, physician assistant, NP, and MA were immediately available to help.  After a brief assessment by the physician and vital signs were collected, the patient became unconscious. Patient was unresponsive to sternal rub and peripheral pulse was undetected. She received CPR and regained consciousness, was not able to speak for ~3 minutes before beginning to mumble and open eyes. Blood pressure remained in the 90's over 40's, patient continued speaking in mumbles and peripheral pulses were weak but palpable. An EKG was performed and EMS was called. She was transported to the hospital via EMS where she was hospitalized for 2 days.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pallor, Pulse abnormal, Pulse absent, Resuscitation
Clinical narrative: Within 4 minutes of receiving the influenza vaccine, the patient became pale, began slurring her words and speaking very quietly, and then was unable to sit up. I laid the patient back on the exam bed and called for help.  A physician, physician assistant, NP, and MA were immediately available to help.  After a brief assessment by the physician and vital signs were collected, the patient became unconscious. Patient was unresponsive to sternal rub and peripheral pulse was undetected. She received CPR and regained consciousness, was not able to speak for ~3 minutes before beginning to mumble and open eyes. Blood pressure remained in the 90's over 40's, patient continued speaking in mumbles and peripheral pulses were weak but palpable. An EKG was performed and EMS was called. She was transported to the hospital via EMS where she was hospitalized for 2 days.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder, Unresponsive to stimuli
Clinical narrative: Within 4 minutes of receiving the influenza vaccine, the patient became pale, began slurring her words and speaking very quietly, and then was unable to sit up. I laid the patient back on the exam bed and called for help.  A physician, physician assistant, NP, and MA were immediately available to help.  After a brief assessment by the physician and vital signs were collected, the patient became unconscious. Patient was unresponsive to sternal rub and peripheral pulse was undetected. She received CPR and regained consciousness, was not able to speak for ~3 minutes before beginning to mumble and open eyes. Blood pressure remained in the 90's over 40's, patient continued speaking in mumbles and peripheral pulses were weak but palpable. An EKG was performed and EMS was called. She was transported to the hospital via EMS where she was hospitalized for 2 days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Patient was only given the diluent for the vaccine as medical assistant did not remember there was another component needed to reconstitute.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain in extremity, Swelling, Tenderness
Clinical narrative: Swollen, large red cirlce, hot to touch, painful
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: none noted
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: no adverse reactions noted
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Drooling, Eye pain, Facial paralysis, Headache, Lymph node pain
Clinical narrative: 1. cold sore 2. pain in upper right jaw like hammering toothache 3. pain moves around right side of head: behind ear, eye sockets, temples 4. Glands in front of throat swollen and painful 5. Mild paralysis of lips and eye on right side  6. Drooling
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Ophthalmoplegia, Oral herpes, Pain in jaw
Clinical narrative: 1. cold sore 2. pain in upper right jaw like hammering toothache 3. pain moves around right side of head: behind ear, eye sockets, temples 4. Glands in front of throat swollen and painful 5. Mild paralysis of lips and eye on right side  6. Drooling
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Impaired driving ability, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe pain in left arm/shoulder starting one hour after vaccination progressing to the point that the patient was unable to lift her arm. She considered going to the emergency department, but could not drive herself due to the pain. The pain improved by the next day but range of motion (abduction) of the left shoulder was severely restricted. Range of motion has improved since the vaccination but has not returned to pre-vaccination state. Patient plans to consult with an orthopedic surgeon in December.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was given an extra Hepatitis A (3rd dose) No known adverse advents
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Bone pain, Decreased appetite, Ear pain, Erythema
Clinical narrative: The following day after the vaccination, I woke up and could barely walk. My whole body felt like I?ve been in a car wreck. Every joint was an agonizing pain. My neck and shoulder bones hurt. I had a bad earache on my right side. There was a huge red mark about 5 inches round on my right arm where the injection was given. There was a large hard lump underneath the red spot on my right arm. It did not itch. There was a big red spot on my stomach for some reason. It did not itch either. I couldn?t eat during the day I had to just sit, or lay down. It hurts so bad to even get up and walk. It was just a throbbing throughout my whole body from my neck to my legs. Today, Wednesday the 29th, I can walk much better. The red spot is still there. The lump is still there underneath the red spot. But my ear and my neck is not aching. I did not go into my doctor yesterday when this all started because as you may know you cannot get into doctors on spur of the moment anymore. And I wasn?t thinking clearly because I was in such pain that I did not message the office yesterday. However, I did message them today about what happened. But again I did not see him during this because no appointments were available. I was not going to go to the ER because that is a 10 hour ordeal. I took Tylenol,  ibuprofen., aspirin to try to get rid of the aches and pains, but nothing worked. I have never had a reaction to vaccinations before. I get the flu shot every year. I?ve had the Covid shot three times. This is the first one that I?ve had such a bad reaction to. and obviously I never want to get this SV vaccine again!
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site mass, Neck pain
Clinical narrative: The following day after the vaccination, I woke up and could barely walk. My whole body felt like I?ve been in a car wreck. Every joint was an agonizing pain. My neck and shoulder bones hurt. I had a bad earache on my right side. There was a huge red mark about 5 inches round on my right arm where the injection was given. There was a large hard lump underneath the red spot on my right arm. It did not itch. There was a big red spot on my stomach for some reason. It did not itch either. I couldn?t eat during the day I had to just sit, or lay down. It hurts so bad to even get up and walk. It was just a throbbing throughout my whole body from my neck to my legs. Today, Wednesday the 29th, I can walk much better. The red spot is still there. The lump is still there underneath the red spot. But my ear and my neck is not aching. I did not go into my doctor yesterday when this all started because as you may know you cannot get into doctors on spur of the moment anymore. And I wasn?t thinking clearly because I was in such pain that I did not message the office yesterday. However, I did message them today about what happened. But again I did not see him during this because no appointments were available. I was not going to go to the ER because that is a 10 hour ordeal. I took Tylenol,  ibuprofen., aspirin to try to get rid of the aches and pains, but nothing worked. I have never had a reaction to vaccinations before. I get the flu shot every year. I?ve had the Covid shot three times. This is the first one that I?ve had such a bad reaction to. and obviously I never want to get this SV vaccine again!
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: The following day after the vaccination, I woke up and could barely walk. My whole body felt like I?ve been in a car wreck. Every joint was an agonizing pain. My neck and shoulder bones hurt. I had a bad earache on my right side. There was a huge red mark about 5 inches round on my right arm where the injection was given. There was a large hard lump underneath the red spot on my right arm. It did not itch. There was a big red spot on my stomach for some reason. It did not itch either. I couldn?t eat during the day I had to just sit, or lay down. It hurts so bad to even get up and walk. It was just a throbbing throughout my whole body from my neck to my legs. Today, Wednesday the 29th, I can walk much better. The red spot is still there. The lump is still there underneath the red spot. But my ear and my neck is not aching. I did not go into my doctor yesterday when this all started because as you may know you cannot get into doctors on spur of the moment anymore. And I wasn?t thinking clearly because I was in such pain that I did not message the office yesterday. However, I did message them today about what happened. But again I did not see him during this because no appointments were available. I was not going to go to the ER because that is a 10 hour ordeal. I took Tylenol,  ibuprofen., aspirin to try to get rid of the aches and pains, but nothing worked. I have never had a reaction to vaccinations before. I get the flu shot every year. I?ve had the Covid shot three times. This is the first one that I?ve had such a bad reaction to. and obviously I never want to get this SV vaccine again!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient wanted the flu vaccine and the rph administered shingles (shingrix).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Hypertension, Pain
Clinical narrative: Ten minutes after receiving the injection I became dizzy and required help from my wife.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Nausea, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: swollen arm began almost immediately,   SEVERE headache with nausea and vomiting, low grade fever,  began 2am (14 hours after administration) and continued for 16 hours then  Symptoms  began to ease.   36 hours after onset headache is minimal. Treated with 800 mg ibuprophen every 4 hours and ice packs rotated as needed.
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: History of Present Illness (11/7/2023 4:36 PM) The patient is a 72 year old male who presents with a complaint of Skin changes. Note for "Skin changes": Patient has RSV vaccination on 10/23/2023, he then had his high dose influenza vaccination November 2, 2023.  The following morning his wife noticed he had a rash on his legs, then further investigated and found that was on his chest his arms and his abdomen.  Patient does not remember if he had on his face or not.  It does not itch.  He has had no fever no chills no headache no sore throat no urinary symptoms no joint pain he feels perfectly fine.  He has not taken anything for this.  He has never had a skin reaction or reaction to vaccinations in the past.  He is taken influenza vaccinations in the past for several years.  With no prior incident
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: After Influenza Vaccine given, patient complain of feeling itching on the left arm   and on the back.  After inspection, notice mild redness .  Dr. notified.     Doctor assessed patient and order  Diphenhydramine 50 mg/ml injection and given at 10:06.   At 10:15 patient report relief.
Age: 80.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Platelet count decreased
Clinical narrative: Low Platelets
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure before pregnancy, SARS-CoV-2 test positive
Clinical narrative: hospitalized, but wasn't hospitalized for Covid, was hospitalized to give birth.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Exfoliative rash, Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Diffuse, pruritic, painful, erythematous, coalescent maculopapular, scaly rash on head, trunk, arms, and legs.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Haemorrhage
Clinical narrative: pt had bleeding (contained in bandaid) and bruising
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Atrial fibrillation, COVID-19, Cardiac failure, SARS-CoV-2 test positive
Clinical narrative: Patient had a hospital stay for hip pain and subsequently found to have a-fib and new heart failure. In plans to transition to rehab for physical therapy the patient required a Covid-19 test and it came back positive.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away on 11/27/2023.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Hypertension/High Blood Pressure
Age: 5.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: FATHER OF CHILD REQUESTED SECOND DOSE OF FLU VACCINE.  CHILD WAS VACCINATED WITH ADDITIONAL PFIZER COVID VACCINE  AROUND 9AM ON 11/28/23 IN ERROR.  PATIENT HAD RECEIVED THE COVID VACCINE PREVIOUSLY ON 10/25/23.  FOC RETURNED TO PHARMACY AFTER BEING NOTIFIED OF ERROR.  CHILD WAS  THEN ADMINISTERED FLULAVAL.  THERE WERE NO SIGNS OF ADVERSE REACTION.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Exercise tolerance decreased, Headache, Medial tibial stress syndrome
Clinical narrative: Seen after his vaccine series for Headaches, chest pain, shortness of breath, exercise intolerance for 6 months.  First visit for these issues occurred on 7/21/21.    Several visits for these problems over that time period  that have since resolved.  Mom worried this was related to Covid 19 vaccine that he received in 6/14/21 and 5/20/21.   Mom also notes shin splints after and more viral infections after.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: Seen after his vaccine series for Headaches, chest pain, shortness of breath, exercise intolerance for 6 months.  First visit for these issues occurred on 7/21/21.    Several visits for these problems over that time period  that have since resolved.  Mom worried this was related to Covid 19 vaccine that he received in 6/14/21 and 5/20/21.   Mom also notes shin splints after and more viral infections after.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: FATHER OF CHILD REQUESTED SECOND DOSE OF FLU VACCINE. CHILD WAS VACCINATED WITH ADDITIONAL PFIZER COVID VACCINE AROUND 9AM ON 11/28/23 IN ERROR. PATIENT HAD RECEIVED THE COVID VACCINE PREVIOUSLY ON 10/25/23. FOC RETURNED TO PHARMACY AFTER BEING NOTIFIED OF ERROR. CHILD WAS THEN ADMINISTERED FLULAVAL. THERE WERE NO SIGNS OF ADVERSE REACTION.
Age: 3.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Rash, Serum sickness-like reaction
Clinical narrative: Serum sickness-like reaction developed on 11/25/23 with rash, arthralgia and improved after 3 days. Treated with topical hydrocortisone ointment and oral cetirizine.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 6 month old female was given Energix-B instead of Recombivax HB. Mother has not called to report any adverse effects of the vaccine
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: child was accidentally given a 3rd flu shot- received   dose 1- 10/10/23 and dose 2 11/10/23. received extra dose 11/29/23. no adverse reactions noted as of yet but mom has been informed of symptoms of possible site reaction and has been advised of treatment options if site reaction occurs.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Blood test, Chest X-ray normal, Cough, Flank pain
Clinical narrative: 4 days after vaccine..16th started with dry cough, next day deep cough bringing up phlegm at times, cough continued  making sides sore, no control of cough day & night, some mucus from nose but not a regular type cold, tried sleeping in lounge chair since being in bed made cough even worse, 24 went to emergency care thought lungs were congested, X-ray proved not the case, Covid & flu test done?neg., give Benzonatate 100mg & VentolinHFA inhaler for use as needed, cough slowed down day later  & continued to get better but took all the pills except 2, still feel weak & like still in recovery with cough ever so often. Don?t know but think this may have! Been the vaccine. Also arm swelled a lot around site
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Influenza virus test negative, Injection site swelling, Productive cough, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: 4 days after vaccine..16th started with dry cough, next day deep cough bringing up phlegm at times, cough continued  making sides sore, no control of cough day & night, some mucus from nose but not a regular type cold, tried sleeping in lounge chair since being in bed made cough even worse, 24 went to emergency care thought lungs were congested, X-ray proved not the case, Covid & flu test done?neg., give Benzonatate 100mg & VentolinHFA inhaler for use as needed, cough slowed down day later  & continued to get better but took all the pills except 2, still feel weak & like still in recovery with cough ever so often. Don?t know but think this may have! Been the vaccine. Also arm swelled a lot around site
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Erythema, Feeling hot, Lip erythema, Lip swelling
Clinical narrative: Face started to turn bright red and felt on fire, the outline around lips swelled and turned bright red around 4 hours after vaccine, within 5 hours, a rash formed down neck and across chest. started to develop a scratchy throat and slight tightness in chest. Took 50 mgs of Benadryl and 10 mgs of Zyrtec. An hour after taking the meds the scratchy throat and tightness in chest calmed but the rash on my face, around lips, neck and chest until the next morning.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Throat irritation
Clinical narrative: Face started to turn bright red and felt on fire, the outline around lips swelled and turned bright red around 4 hours after vaccine, within 5 hours, a rash formed down neck and across chest. started to develop a scratchy throat and slight tightness in chest. Took 50 mgs of Benadryl and 10 mgs of Zyrtec. An hour after taking the meds the scratchy throat and tightness in chest calmed but the rash on my face, around lips, neck and chest until the next morning.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Blood glucose normal, Loss of consciousness
Clinical narrative: Mom called 11/28/2023, the day after child received vaccine to report that he had "passed out" that night after getting vaccine. Received vaccine in the morning on 11/27/2023. Reported that he passed out and came to right away and seemed little "out of it" but was OK. She checked his blood sugar and it was 141.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Asthma, Condition aggravated, Dyspnoea, Gait disturbance, Muscular weakness
Clinical narrative: She got her vaccine, had shortness of breath and muscle weakness in her legs starting the next day at 10:00 AM.  She lives in a two-story house and had difficulty going up and down the stairs.  She went back to the pharmacy 3 times, talked to the pharmacist and 3 weeks later went to the ER and spent 5 1/2 hours there.  The next day after that she went to see her allergist.  She was told that her heart and lungs were clear.  Her allergist told her that there was not enough research on the vaccine and not enough practical things that he can say about it.   She made an appointment on her to see a cardiologist and is scheduled to see him and to have an echocardiogram on 12/4/23.   The pharmacist did not give her a shot but did tell her that they boost it for 65 and up.  She is wondering because she have asthma and stuff like that and is a small person that the slight boost may have put her over the stop.  Feels that it was way too strong for her.     She has had all of her COVID vaccines and has never had a reaction before.  She also had the flu shot last year, all boosters, and never had a reaction.    She has good days and bad days.  She used to walk 3 1/2 miles a day and she is not able to do this at this time due to the shortness of breath.  She can only walk about a few steps and has to stop and rest.  She is getting better and not like she was before the vaccine.  She did not have some moderate problems with her asthma, goes to the ER about 2 times a year, but has been put on the new medicine and has not had any problems since taking that medicine until the vaccine.
Age: 1.08
Sex: M
Vaccine: FLU4, MMR
Symptoms: Injection site urticaria, Lip swelling, Urticaria, Vomiting
Clinical narrative: Started vomiting about 10 minutes after vaccine injections. Then started to develop a wheal around the site of the MMR injection on his left thigh and a wheal on his face with some mild lip swelling. No cough or difficulty breathing. Rapid response team responded to clinic and transported patient to the ED. Epinephrine, diphenhydramine and famotidine was given. Patient was observed in the ED for a few hours and discharged home without progression of a reaction.
Age: 1.33
Sex: M
Vaccine: DTAPIPV, HIBV, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse effect documented
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was ordered 10/11/23 and was received 10/16/23. Upon receiving vaccine it was stored in medication fridge ( not in freezer ). Vaccine was given to patient on 11/15/23 after the 30 day Beyond Use Date of thawed medication.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle disorder
Clinical narrative: muscle issues
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Muscular weakness, Myalgia
Clinical narrative: Shingrix vaccination was administered by pharmacist at Pharmacy on 8/15/2023 using aseptic technique and proper reconstitution procedures. Vaccination was administered in the left arm. Patient reported feeling generalized weakness directly following vaccine administration during a workout she was doing at the time. She reported being able to "bench press 145lbs, but after the shot I could not get to that weight anymore," trying to lift the weight directly after the vaccine. Since that day, she reported ongoing muscle weakness and soreness, unilateral shoulder on the left side (side of administration). Patient reported to continue weight-lifting during this time period of 3 months since the administration. Patient reported not being assessed by a medical professional yet.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was ordered 10/11/2023 and was received 10/16/2023. Upon receiving vaccine it was stored in medication fridge ( not in freezer ). Vaccine was given to patient on 11/17/23 after the 30 day Beyond Use Date of thawed medication
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin reaction
Clinical narrative: localized reaction to right arm. improving on day 3
Age: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Immunization expired 10/30/2023 and was given by RMA today, 11/29/2023.  Patient is not having any reaction per the mother.  Mother was informed by RMA that the immunization given was expired and that a new dose can be given at anytime. Mother gave verbal understanding and plans to schedule an appointment to repeat the dose.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Second flu shot administered after patient already had one given 09/21/2023 (Afluria, Quadrivalent, Lot: AU1037A. Rt Deltoid)
Age: 10.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The child was given MedQuadfi at age 10 yrs 1 month ? Guidelines (and protocol) recommends at age 11-12. No risk factors identified for  the vaccination to be given early.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Pain
Clinical narrative: General pronounced soreness in upper left body quadrant; acute dull-to-piercing pain under left arm; overall ache and fatigue.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt was given an influenza vaccine on 11-29-2023, but had already had one on 10-17-2023.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Erythema, Pemphigoid, Pruritus, Skin lesion
Clinical narrative: 1. Adverse effect of vaccine, initial encounter / Pemphigoid -Patient received RSV vaccine on 11/10/2023 -Started to develop skin lesions on 11/11/2023, lesions marked by central prominence that opened, leaving erythematous circular patches  -Although patient did not tell a very large bullae or blisters, resultant lesions do appear to be consistent with pemphigoid -There are prior reports of pemphigoid occurring after COVID-19 vaccine, did not find case reports with the RSV vaccine -Empirically treating with prednisone - predniSONE (DELTASONE) 20 mg tablet; 2 po qD x 7 days, then 1 po qD x 7 days then stop.  Dispense: 21 tablet; Refill: 0   2. Cellulitis of back -Patient has been scratching the lesions, concern over developing small cellulitic changes -Short course of doxycycline - doxycycline hyclate (VIBRAMYCIN) 100 mg tablet; Take 1 tablet by mouth 2 times daily.  Dispense: 10 tablet; Refill: 0
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy endometrium abnormal, Body temperature increased, Cervix cancer metastatic, Endometrial cancer, Heavy menstrual bleeding
Clinical narrative: She got her vaccine, feeling malaise, little elevated temeprature, soreness in her arm.  This went away.  She then had her 2nd vaccine.  She had symptoms in January of this year, had heavy, heavy bleeding with menstruation.  The pattern changed, and on 10/8/23 she started hemorrhaging intermittently, and then it would stop, and then it happened for 3 days.  She called her gynecologist and she got her in on 10/11/2023.  The doctor did a PAP smear and a biopsy on an area that looked questionable.  All of her PAP smears have been normal up until this point, never had a history of an abnormality.  Her PAP smear came back as abnormal.  Her biopsy came back as clear cell carcinoma in her endometrium, which is uterine cancer.  She had a radical hysterectomy on 10/25/23.  It had metastatasis already to her cervix and her left ovary.  From what they can tell they got all of her cancer, and she has tumor markers that they are watching.  She is getting chemotherapy for 6 cycles, and being monitored for 2 years.  Every 3 weeks she gets infusions, which she started on 11/28/2023.    She is now on immunotherapy along with the chemotherapy.  The infusions are given the same day.  She will have anti-nausea medicine in case she has nausea from the chemotherapy.  She takes more supplements since she has cancer.  The only symptoms that she had at the time was the bloating feeling and the hemorrhaging.  Now she has fatigue due to the chemotherapy.  Prior to this her symptoms were not severe, but they caught it early enough.    She did get her 2nd COVID vaccine on 4/2/21, and then decided not to get any after that.    She did have yeast infections intermittently since 2020, and does not know if she had a yeast infection at the time of the vaccine.  They did eventually clear up and did not have an active yeast infection at the time of diagnosis or testing with the biopsy.    She did look up her reactions from her vaccine and did see that other people did have 5 different types of cancer following their vaccines from Moderna.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunochemotherapy, Infusion, Malaise, Menstrual disorder, Metastases to ovary
Clinical narrative: She got her vaccine, feeling malaise, little elevated temeprature, soreness in her arm.  This went away.  She then had her 2nd vaccine.  She had symptoms in January of this year, had heavy, heavy bleeding with menstruation.  The pattern changed, and on 10/8/23 she started hemorrhaging intermittently, and then it would stop, and then it happened for 3 days.  She called her gynecologist and she got her in on 10/11/2023.  The doctor did a PAP smear and a biopsy on an area that looked questionable.  All of her PAP smears have been normal up until this point, never had a history of an abnormality.  Her PAP smear came back as abnormal.  Her biopsy came back as clear cell carcinoma in her endometrium, which is uterine cancer.  She had a radical hysterectomy on 10/25/23.  It had metastatasis already to her cervix and her left ovary.  From what they can tell they got all of her cancer, and she has tumor markers that they are watching.  She is getting chemotherapy for 6 cycles, and being monitored for 2 years.  Every 3 weeks she gets infusions, which she started on 11/28/2023.    She is now on immunotherapy along with the chemotherapy.  The infusions are given the same day.  She will have anti-nausea medicine in case she has nausea from the chemotherapy.  She takes more supplements since she has cancer.  The only symptoms that she had at the time was the bloating feeling and the hemorrhaging.  Now she has fatigue due to the chemotherapy.  Prior to this her symptoms were not severe, but they caught it early enough.    She did get her 2nd COVID vaccine on 4/2/21, and then decided not to get any after that.    She did have yeast infections intermittently since 2020, and does not know if she had a yeast infection at the time of the vaccine.  They did eventually clear up and did not have an active yeast infection at the time of diagnosis or testing with the biopsy.    She did look up her reactions from her vaccine and did see that other people did have 5 different types of cancer following their vaccines from Moderna.