chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Pain, Paralysis
Clinical narrative: Gillian Beret syndrome: paralyzation and pain; Gillian Beret syndrome: paralyzation and pain; Gillian Beret syndrome: paralyzation and pain; Initial information was received on 10-Nov-2020 regarding an unsolicited valid serious social media case from a consumer/non-health professional). This case involves a patient with unknown demography who experienced guillian beret syndrome: paralyzation and pain (Guillain-Barre syndrome, paralysis and pain), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed gillian beret syndrome: paralyzation and pain. (Guillain-Barre syndrome, paralysis and pain), (unknown latency) following the administration of INFLUENZA VACCINE. The event Guillain-Barre syndrome and paralysis was assessed as medically significant.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of all the events were unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly document case received concerns a patient with unknown demography who experienced Guillain-Barre syndrome, paralysis and pain, after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Sex: M
Vaccine: DTAP
Symptoms: Incorrect route of product administration
Clinical narrative: administered 0.5ml vaccination of Daptacel in the left thigh, SQ instead of IM/no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via Medical Information  (Reference number- 00318955) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 4-year-old male patient who was vaccinated with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (suspension for injection), (batch number: C5706AA and expiry date: 11-Mar-2022) (in the left thigh via subcutaneous route, the vaccine was administered) (incorrect route of product administration) on 15-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient included measles vaccine/mumps vaccine/ rubella vaccine (MMR), INFLUENZA VACCINE and Aracilla (not coded).  It was an actual medication error case due to incorrect route of drug administration (latency: same day) At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pharyngitis, Pyrexia
Clinical narrative: One month after the vaccine, Pt was to come for a follow-up of health concerns. It was then that the "adverse event" was reported to us. She reports fever (100.3), sore throat, fatigue, headache. She went to see primary care where she was diagnosed with tonsillitis and pharyngitis. Tonsils reportedly +4.  She was started on an antibiotic. No GI symptoms.  No localized reaction at the injection site.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tonsillitis
Clinical narrative: One month after the vaccine, Pt was to come for a follow-up of health concerns. It was then that the "adverse event" was reported to us. She reports fever (100.3), sore throat, fatigue, headache. She went to see primary care where she was diagnosed with tonsillitis and pharyngitis. Tonsils reportedly +4.  She was started on an antibiotic. No GI symptoms.  No localized reaction at the injection site.
Age: 76.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient was given Shingrix and Boostrix in the left arm intramuscularly around 12:45 PM on 11/20/2020. Shingrix vaccine was given first.  Patient experience extreme pain upon injection. Boostrix was given after, and patient did not experience pain with that shot. Patient was able to move their arm afterward. Roughly 3 hours later patient called pharmacy from home reporting continued pain and restricted motion of arm.  Patient used hydrocodone and acetaminophen tablets prescribed for another condition and aspirin, which did not seem to help the condition. Patient was advised to seek medical treatment immediately. On 11/21/2020 patient still reported pain that affected their sleep and restricted motion of the arm. As of 11/23/2020 patient has not been seen by a doctor, but they have scheduled an appointment with urgent care today 11/23/2020. They report improved movement but still a significant amount of pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Patient developed a widespread rash within a week of vaccine administration. Rash spread all over back, trunk, and arms, and is described by patient as "very itchy and painful"; is compared by patient to contracting chicken pox. Patient has visited the doctor and received topical steroids, with minimal benefit to the symptoms and rash. Symptoms are still present, almost two months after the vaccine was administered.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Injection site soreness and body aches
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site warmth
Clinical narrative: The day after injection, a sore and reddened area developed about an inch or two from injection site. Hot to touch and very sensitive.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Nausea, Pain, Pyrexia, Tachycardia
Clinical narrative: This patient developed body aches, chills, and nausea an hour and a half after receiving Bexsero. She went to the ED where she was febrile to 103 and tachycardic to the 140s. She was admitted overnight and discharged the next day.
Sex: F
Vaccine: FLUX
Symptoms: Facial pain, Headache, Influenza like illness, Paraesthesia
Clinical narrative: within 36 hours of rec flu shot. I started having a severe headache and started feeling sharp pains in left entire left side of face parasthesia. Lasted about two. I never reached out to PCP because i'm a NP. I monitored my symptoms. No fever. I did have flu like symptoms for about two. I did not take anything for the pain. A year later i spoke with my PCP about symptoms and he stated that the symptoms could not be caused by the shot. I also spoke to my infectious disease colleague and they stated the same thing because i was concerned with taking it again.  * I do not remember which location I received the shot**
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nausea, Neck pain
Clinical narrative: Pt experienced severe dizziness, stabbing head pain/HA, nausea, and neck pain. She stated she almost went to the emergency room but was able to lie down and take OTC pain meds for relief
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Nausea, severe chills and shivering, severe fatigue
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Vulvovaginal rash
Clinical narrative: Pt had bumps on lower back (6). 6 months later pt had 2nd flu vaccine at doctor's office: Dr., no reaction.  Pt had shingrix vaccines: pharmacy, last one 11/15/2020. Pt had painful bump on vagina. Pt used cortisone cream.   No medical attention for any AE.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: passed out in facility 11-21-20 at 12:33pm- was told Monday 11/23-2020 by company
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Pain, Pyrexia, Sleep disorder, Tremor
Clinical narrative: Within about 5 hours of vaccination, I became extremely chilled and started shaking uncontrollably. By then, the pharmacy was closed. My husband helped me put on extra clothing to include 2 pairs of socks and winter gloves. Sometime around midnight, the shaking began to subside, and it was not until the wee hours that I could sleep. As of now, I am typically sore and have mild fever. However I have NEVER had a reaction like this to flu vaccine. The only time I ever had chills and uncontrollable shaking like this was when I had a transfusion reaction during a hospitalization many years ago. I did call the pharmacy when they opened, but there seemed to be no interest in follow-up or reporting.
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Tremor
Clinical narrative: Within about 5 hours of vaccination, I became extremely chilled and started shaking uncontrollably. By then, the pharmacy was closed. My husband helped me put on extra clothing to include 2 pairs of socks and winter gloves. Sometime around midnight, the shaking began to subside, and it was not until the wee hours that I could sleep. As of now, I am typically sore and have mild fever. However I have NEVER had a reaction like this to flu vaccine. The only time I ever had chills and uncontrollable shaking like this was when I had a transfusion reaction during a hospitalization many years ago. I did call the pharmacy when they opened, but there seemed to be no interest in follow-up or reporting.
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Pain, Pyrexia, Sleep disorder, Tremor
Clinical narrative: Patient reported shortly after immunization, she began to uncontrollably and violently shake
Age: 65.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Tremor
Clinical narrative: Patient reported shortly after immunization, she began to uncontrollably and violently shake
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Pruritus, Skin warm, Urticaria, Vomiting
Clinical narrative: After receiving vaccines pt went to the lab for bloodwork but before labs were drawn he vomited and was noted to be itchy, diffusely red, warm to touch and developing hives within approx 20min after receiving vaccines. Attempted to give pt liquid Benadryl but he spit out most of the medication. Epipen Jr was then given and ambulance was called. Pt taken to local ER.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, X-ray
Clinical narrative: Patient reported that his arm has been sore and painful since he received his flu shot in September. Patient mentioned that he initially attributes the pain to his history of a torn rotator cuff in his left arm which he admitted that he failed to mention prior to receiving his flu shot. He stated that he had an X-ray done and he is awaiting an MRI to further investigate why the pain is worsening. He also asked for a copy of his PQCF because he needed it for school records which I provided to him.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Lip swelling
Clinical narrative: Patient called 11/19/20 at 1:00pm and reported swelling above her lip and also partially on her lip. She was concerned it could be an adverse reaction from the vaccines received on 11/18/20.  Patient has a history of cold sores, but states this does not feel like a cold sore. Patient also gets lip injections. Explained to patient that this may be a cold sore or a result of her lip injections.  Also counseled patient regarding anaphylactic reactions and recommended seeking medical attention if swelling continues or patient has any difficulty breathing.  Followed up with patient 11/23/20 when back in the pharmacy and patient stated that all swelling at and above the lip was gone when she woke up on 11/20/20.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Anal incontinence, Diarrhoea, Fatigue, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: I was at home on Sunday November 15, 2020 when sometime in the afternoon I began to experience fatigue and a stiff neck.  My shoulders began feeling stiff as well.  I had tingling in my toes as if I was stepping on branches.  My longer middle toe finger was going numb.  Over the course of the evening my spine was sore and by now my neck and shoulders felt like they were fused together. I was very tired and went to bed early.  Sometime in the early hours of Monday I started to feel my stomach churning.    I had so much excruciating nerve pain in my neck and shoulders.  I could not lift my head or shoulders.  I felt like I needed to use the bathroom however I could not move.  I was stuck.  I felt like I was locked in my position.  Soon after I had an accident in bed.  I was completely distraught that I had a bowel movement in bed. My wife was laying next to me.  In the morning I was able to roll to my side and get to the bathroom.  I had diarrhea.  I was in excruciating pain in and out of bed.  Because I was afraid of contracting Covid19 I did not go to the hospital.    I had nausea and wanted to burp however the feeling of vomiting prevented me from burping.    On Tuesday I felt the same.  My family thought I had Covid19 and so we scheduled a test.   On Wednesday I was able to get out of bed and move around. On Thursday I took the covid test.  While waiting in line I looked on the internet for an answer to my excruciating pain and locked neck and shoulders.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Nausea, Paraesthesia, Physical examination, SARS-CoV-2 test, Spinal pain
Clinical narrative: I was at home on Sunday November 15, 2020 when sometime in the afternoon I began to experience fatigue and a stiff neck.  My shoulders began feeling stiff as well.  I had tingling in my toes as if I was stepping on branches.  My longer middle toe finger was going numb.  Over the course of the evening my spine was sore and by now my neck and shoulders felt like they were fused together. I was very tired and went to bed early.  Sometime in the early hours of Monday I started to feel my stomach churning.    I had so much excruciating nerve pain in my neck and shoulders.  I could not lift my head or shoulders.  I felt like I needed to use the bathroom however I could not move.  I was stuck.  I felt like I was locked in my position.  Soon after I had an accident in bed.  I was completely distraught that I had a bowel movement in bed. My wife was laying next to me.  In the morning I was able to roll to my side and get to the bathroom.  I had diarrhea.  I was in excruciating pain in and out of bed.  Because I was afraid of contracting Covid19 I did not go to the hospital.    I had nausea and wanted to burp however the feeling of vomiting prevented me from burping.    On Tuesday I felt the same.  My family thought I had Covid19 and so we scheduled a test.   On Wednesday I was able to get out of bed and move around. On Thursday I took the covid test.  While waiting in line I looked on the internet for an answer to my excruciating pain and locked neck and shoulders.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling and redness that spanned from elbow to armpit of the vaccinated arm (right arm). She also had fever, chills and fatigue. I advised her to follow up with a physician, as when she called (11/20), she had already been having the reaction for 2-3 days and it didn't seem to be improving at all. She did finally go in today (11/23) and the physician believes that she has cellulitis. However, of note, she also told me that she had a similar reaction to a Shingrix reaction in the past.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Patient had swelling and redness that spanned from elbow to armpit of the vaccinated arm (right arm). She also had fever, chills and fatigue. I advised her to follow up with a physician, as when she called (11/20), she had already been having the reaction for 2-3 days and it didn't seem to be improving at all. She did finally go in today (11/23) and the physician believes that she has cellulitis. However, of note, she also told me that she had a similar reaction to a Shingrix reaction in the past.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Large red raised area around site Warm to touch Itchy at site Painful to touch  No intervention. Lasted for 4-5 days
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt has a history of fainting with blood draws. Small fainting spell. Did not fall out of chair or injure herself. Woke back up within seconds. Mother and daughter left shortly thereafter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Nausea
Clinical narrative: Most of Upper arm very red even on day 3, feels hot to touch Headache Shivering fever nausea feeling of being really tired
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Most of Upper arm very red even on day 3, feels hot to touch Headache Shivering fever nausea feeling of being really tired
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported that she "got shingles from the vaccine" because she had her first shingles outbreak 4 days after the vaccination on her back.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest pain, Electrocardiogram, Pain in extremity
Clinical narrative: On 11.23.2020 around 3:20 pm, 10-15  minutes after administration the patient started complaining of sharp pain in the arm of vaccination, with pain in the chest and back area as well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash at injection site mostly where Kinrix was administered, patient did not have a fever
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bladder pain, Headache, Injection site pain, Micturition urgency
Clinical narrative: Headache, nausea, muscle aches, fever 102, back pain radiating to sides, injection site very painful, bladder pain-urgency on day 3 so far not better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, nausea, muscle aches, fever 102, back pain radiating to sides, injection site very painful, bladder pain-urgency on day 3 so far not better.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient states that the spot on her left arm where she received the vaccination has been sore since 10/6/20. She thought it would be sore for a couple days but she can still feel the "prick" on her arm and her arm feels sore. She went to her doctors office to find out what to do about it and they told her to take pain medication. They told her to report this to the pharmacy where she received the immunization.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye pruritus, Eyelid margin crusting, Fatigue, Headache
Clinical narrative: Extreme coughing about 2 hours after the shot. accompanied with a sore throat. Had watery eyes, itchy and matted. Coughing and sore throat went away in about 2 and a half hours. Rest of evening, extremely tired and had headaches. The next morning, lips were swollen. She is not not imaginer. Everything is fine now.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Lacrimation increased, Lip swelling, Oropharyngeal pain
Clinical narrative: Extreme coughing about 2 hours after the shot. accompanied with a sore throat. Had watery eyes, itchy and matted. Coughing and sore throat went away in about 2 and a half hours. Rest of evening, extremely tired and had headaches. The next morning, lips were swollen. She is not not imaginer. Everything is fine now.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Rash erythematous, Rash pruritic
Clinical narrative: red, itchy rash with blisters around injection site on arm
Age: 0.58
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired on 10-12-2020.  No side effect.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Pt experienced a low grade fever (100.9) and very painful joints after receiving the 2nd dose of the shingrix vaccine.  He started feeling this about 12 hours after the vaccine was given. He received vaccine on 11/20.  He started to feel a lot better today 11/23.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Seizure
Clinical narrative: Pt developed a fever and seizures that same day following vaccination
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Nausea, headache, low grade fever, chills, body aches, tiredness
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Nausea, headache, low grade fever, chills, body aches, tiredness
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient states he was fine when he left pharmacy, he went shopping at different pharmacy and while he was checking out his groceries in line he got really itchy on his arms and chest. He took off his coat and saw he was covered in hives just on his chest and arms. It lasted for 20 minutes and then disappeared. States at this time he is currently fine and no longer has the hives.  States he did not feel need to go to ER when he had them (he worked in emergency medicine for 40 years so he said he didnt feel need at that time).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PT SAID THAT SHE HAD SYMPTOMS ON HER WAISTLINE THAT RESEMBLED A SHINGLES RASH THAT STARTED THE DAY AFTER HER VACCINE. SHE SAID IT WAS NOT SEVERE AND WAS MANAGING WITHOUT TALKING TO HER DOCTOR.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Caller is experiencing hives with itching that continues to get worse.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Musculoskeletal discomfort, Pain
Clinical narrative: Pt complaining of muscle soreness in her left shoulder/upper arm area that started immediately after getting flu shot. Patient describes pain a couple inches below her left shoulder in her arm. When asked to describe the pain, she states is like a "tooth ache", an ache, not a sharp stabbing pain. No redness or swelling is present at the area. Today while at shopping market, she noticed significant discomfort and pain on top of her shoulder, such that to the point she no longer utilized her arm to push her cart. She mentions during my conversation with her that she thought it was odd at how high the pharmacist who gave her the flu shot had gone on her arm and even mentioned it to her friend after getting the shot. Patient called over weekend to make us aware, and to see if anyone else had presented with the same issues. To my knowledge, no one has presented to the pharmacy with any similar complaint. Pt states she is uncomfortable enough such that she has made a doctors appt 11/24/20 for an evaluation.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Pt complaining of muscle soreness in her left shoulder/upper arm area that started immediately after getting flu shot. Patient describes pain a couple inches below her left shoulder in her arm. When asked to describe the pain, she states is like a "tooth ache", an ache, not a sharp stabbing pain. No redness or swelling is present at the area. Today while at shopping market, she noticed significant discomfort and pain on top of her shoulder, such that to the point she no longer utilized her arm to push her cart. She mentions during my conversation with her that she thought it was odd at how high the pharmacist who gave her the flu shot had gone on her arm and even mentioned it to her friend after getting the shot. Patient called over weekend to make us aware, and to see if anyone else had presented with the same issues. To my knowledge, no one has presented to the pharmacy with any similar complaint. Pt states she is uncomfortable enough such that she has made a doctors appt 11/24/20 for an evaluation.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt states woke up around 2am with extreme chills and stiffness having trouble moving and soreness in arms, shoulders, and neck.  She stated she had taken her temperature and was around 101.9.  She called today, 11/23/20, around 2pm and reported these events.  She states that she still has these symptoms and that her hands are swollen.  She had contacted her PCP and spoke to her about it.  She reports taking 1 Tylenol 325mg every 3 to 6 hours around the clock to try and help with fever. She states she can not take NSAIDS d/t CHF.  She states still running a fever and soreness, but has slightly improved since began Saturday night.  She states PCP told her to continue Tylenol and to seek medical attention if symptoms are not getting better or worsen in 1 to 2 days.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt states woke up around 2am with extreme chills and stiffness having trouble moving and soreness in arms, shoulders, and neck.  She stated she had taken her temperature and was around 101.9.  She called today, 11/23/20, around 2pm and reported these events.  She states that she still has these symptoms and that her hands are swollen.  She had contacted her PCP and spoke to her about it.  She reports taking 1 Tylenol 325mg every 3 to 6 hours around the clock to try and help with fever. She states she can not take NSAIDS d/t CHF.  She states still running a fever and soreness, but has slightly improved since began Saturday night.  She states PCP told her to continue Tylenol and to seek medical attention if symptoms are not getting better or worsen in 1 to 2 days.
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Joint injury, Pain
Clinical narrative: Patient wrote a letter to pharmacy stating shoulder joint injury. Patient description states "hurt to move arm," "pain was about 6-7". Patient went to see PCP.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoglycaemia, Malaise, Nervousness
Clinical narrative: On Thursday 11/5 I administered a flu shot to the patient and shortly after administering it I discovered that he was not feeling well. By the time I was made aware of the situation and made it to the patient a member of management was already on scene and EMT's had already been called. I spoke with the patient's mother and the patient to try to determine how he was feeling and what his complaint was when EMT's arrived. They checked his blood pressure and O2 sats and determined that the child was likely hypoglycemic due to not eating much that day and the previous day. The child was likely not feeling well due to his low blood sugar and the nerves he experienced while getting a flu shot. The EMT's determined that he did not need further evaluation at a hospital he just needed to eat lunch and was sent home with his mother. Before he left he was given an ICEE from the cafe to help him get some sugar in his system.
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Dizziness, Loss of consciousness, Road traffic accident
Clinical narrative: Patient reports that he left the pharmacy and on his drive home experienced a wave of faintlike feelings where he said he "couldn't keep his eyes open" and when he got to his neighborhood he said he "all of a sudden was in the ditch" and didn't know how it happened. Appears to be faint-like.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Nausea, Oropharyngeal pain, Skin discolouration, Throat tightness
Clinical narrative: Shortly after vaccine the patient stated that he felt like his throat was closing and that he needed to vomit. I quickly assessed the patient and he didn't seem to be grasping for air or turning purple. I asked his father again about any allergic reactions or past reactions to vaccines and he said no and then he gave me permission to give a diphenhydramine 25mg tablet and a bottle of water. I checked his BP which was 107/92 and continued to monitor him closely. The patient said he was starting to feel better but his throat was sore. I had them stay in the pharmacy for continued observation for 30 minutes and then the family felt they were feeling well enough to leave. I called back later in the evening and his mother said he was feeling fine.
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Eye movement disorder, Seizure, Syncope
Clinical narrative: After first round of vaccines  HEPA, MCV4, MMR were administered pt reported feeling like he was going to faint. Pt fainted, eyes rolled back, experienced convulsions for less than a minute. Pt   was laid down with legs elevated,  BP, HR, O2 stat were taken. Pt was given a Pedialyte popsicle. Pt reported feeling better. After second round of vaccines  TDaP, VZV and Influenza were administered, pt reported feeling like he was going to faint and fainted.  Pt was laid down, vitals were taken again. Pt reported feeling better.  Pt sat down for another 15-20 min, reported feeling well and was able to ambulate safely without assistance.  Nurse escorted pt the building front door, asked pt if he fell well, pt reported he felt well. Nurse advised pts mother to call clinic if she had any question or concerns. Mother of pt agreed with plan. Pt went home with mother.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint injection, Joint range of motion decreased, Orthopaedic examination, Physiotherapy
Clinical narrative: Significant pain within the shoulder joint itself and decreased range of motion that lasted beyond expected for this vaccine
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site joint inflammation, Injection site joint pain
Clinical narrative: Patient experienced gradual onset of increasing pain described as aching in the joint in the right shoulder after injection of flu vaccine.  A physician visit summary on 11/20/2020 showed a diagnosis of localized arthritis of the right shoulder joint, probably as a result of intra-articular injection of flu vaccine into the joint.  Proposed treatment consists of a home exercise program, treatment with NSAID's, and possibly physical therapy as necessary.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt described an up and in technique for the shingles shot. pt complained of a sore arm 2 months post vaccination
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pruritus, Urticaria
Clinical narrative: Patient stated that she ended up with welts that were itchy as well as overall itchiness. Pain at the injection site lasting 13 days after injection.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received the vaccine for shingrix. After a little over a week (10 days later), he got a rash which appeared like shingles. Patient  already had shingles prior and stated it looked the same as his last outbreak.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever, myalgias
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Peripheral swelling, Skin warm
Clinical narrative: Patient came into pharmacy to show me her arm. It was red, hot, swollen from shoulder to her elbow. This was 2 days after her Pneumovax and Fluzone HD in the same left arm, appropriately spaced. Patient has had other vaccines with us, but never had a reaction that looked like this and she wasn't able to lift her arm over her head, it was to painful. I referred her to her PCP for evaluation, and sent her home with ibuprofen and Benadryl if appropriate after speaking with her PCP.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, hardness/swelling, and pain around injection site beginning the evening immediately after the vaccine. As of 11/23/2020 the diameter of red area was approximately 5 inches.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Heart rate increased
Clinical narrative: In the middle of the night patient experienced increased heart rate (>100bpm) and almost went to the ER.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Nausea, Sleep disorder, Vital signs measurement
Clinical narrative: Severe Nausea for the last four days non stop to the point of crying and waking up in the night having to sleep with heating pad just to subside the nausea,
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site urticaria, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: patient experienced severe right arm pain where we injected pneumovax 23. specifically she has red blotches, itching, swelling, pain localized mainly in front of arm, hives on area where we injected and surrounding area. only hives on right arm and shoulder area. Reaction has been going on for 2 days and injection was on 11/20/2020. she is feeling much better today on 11-23-2020. Patient took benadryl.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site pain, Limb discomfort, Mobility decreased
Clinical narrative: About a day later, my right arm, which is where the injection occurred, started feeling heavy and I was unable to lift my arm for about 8 hours. The next morning, the site of the injection was a little tender, but the weird thing was that my armpit hurt for about 24 hours,  and the inside of my armpit was red, as if I had an injury there. It disappeared the next day but for that day, my armpit hurt and was red on the other side of my arm -- the side away from the injection site. I thought that was strange, so I wanted to report it. So I had 1) tenderness at site, 2) inability to lift arm, 3) redness on inner area near armpit and 4) my armpit hurt -- not excruciating, but enough for me to say "ow."
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Laboratory test, Lumbar puncture
Clinical narrative: Guillian-Barre Syndrome.  My mom was in ICU for 2 weeks with compromised respiratory system, fully intubated, blood pressure and full paralysis. Still not able to move her legs,.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Paralysis, Respiratory disorder, X-ray
Clinical narrative: Guillian-Barre Syndrome.  My mom was in ICU for 2 weeks with compromised respiratory system, fully intubated, blood pressure and full paralysis. Still not able to move her legs,.
Age: 14.0
Sex: U
Vaccine: FLU4, HPV4
Symptoms: Injection site pain
Clinical narrative: PROLONGED, MODERATELY SEVERE ARM PAIN IN RIGHT DELTOID WITH NO IMPROVEMENT 8 DAYS AFTER VACCINES - DURATION SEEMED ATYPICAL
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: Swollen throat Breathing difficulties
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: SKIN PAINFUL TO TOUCH ENIRE L ARM, DELTOID AREA VERY SWOLLEN L ARM, AND BRIGHT RED, DELTOID AREA L ARM GREATER THAN 1/2" RAISED IN CIRCULAR PATTERN APPROX 2-3" WIDE; TOOK JUST OVER ONE WK TO RESOLVE; HAS NEVER HAPPEN BEFORE
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy, Mobility decreased
Clinical narrative: Same day of vaccinie at approximately 11:00pm, lymph node in armpit was swollen and patient could not lift arm above head. Mother of child iced and gave ibuprofen. Patient was scheduled to see Doctor on day after vaccine administration. Provider advised to continue with ice and Tylenol and return to clinic if any weakness or unimproved pain in next week or soon if fever or systemic signs of illness appear.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Pt received shingrix and fluzone in left arm 1 inch apart. Pt stated her arm is frozen or stiff with limited mobility. Pt is taking Ibuprofen (OTC) and has contacted PCP
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Shingrix was administered on 11/14/20 on 11/16/20 patient broke out in rash on body. She did see her doctor who prescribed on 11/17/20, prednisone 5mg, (alahist anD benadryl
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram normal, Hypoaesthesia, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: 9/14 at 10:40 I received a pneumovax syringe injection high on my left arm as did my husband. We returned home and in the next two hours my arm grew numb, began to throb and I experienced severe pain. I contacted my primary care physician but he was unable to see me right away. By 2 to 3 o'clock the pain was so intense I asked to be taken to the Hospital. The acute pain in my left arm persisted. I was administered an imaging test and EKG. I was discharged at approximately 8:00 p.m with instructions to take 400 mg. of motrin and 600 mg. of ibuprofen every eight hours and provided with a sling to use for 1 week. The severe pain persisted for 4 days. Since then milder pain persists daily. I am unable to carry heavy objects and soreness when raising my arm continues.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: X-ray normal
Clinical narrative: 9/14 at 10:40 I received a pneumovax syringe injection high on my left arm as did my husband. We returned home and in the next two hours my arm grew numb, began to throb and I experienced severe pain. I contacted my primary care physician but he was unable to see me right away. By 2 to 3 o'clock the pain was so intense I asked to be taken to the Hospital. The acute pain in my left arm persisted. I was administered an imaging test and EKG. I was discharged at approximately 8:00 p.m with instructions to take 400 mg. of motrin and 600 mg. of ibuprofen every eight hours and provided with a sling to use for 1 week. The severe pain persisted for 4 days. Since then milder pain persists daily. I am unable to carry heavy objects and soreness when raising my arm continues.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Ageusia, Anosmia, Asthenia, Decreased appetite, Exposure to SARS-CoV-2
Clinical narrative: Two hours afTer injecTion came down wiTh a fever. The nexT 2 days was in bed. SlepT for 6 hrs aT a Time. Did noT eaT or drink anyThing for 2 days. AfTer ThaT I had To force Myself To eaT. Three day LaTer was expose to Covid 19. No energy, sleep a loT, no appeiTaTe, no sense of smell, no sense of TasTe. After being informed of being exposed to Covid 19 I self QuarTined for 14 days. I am feeling much beTTer; buT sTill have no sense of sMell and no sense of TasTe.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersomnia, Pyrexia
Clinical narrative: Two hours afTer injecTion came down wiTh a fever. The nexT 2 days was in bed. SlepT for 6 hrs aT a Time. Did noT eaT or drink anyThing for 2 days. AfTer ThaT I had To force Myself To eaT. Three day LaTer was expose to Covid 19. No energy, sleep a loT, no appeiTaTe, no sense of smell, no sense of TasTe. After being informed of being exposed to Covid 19 I self QuarTined for 14 days. I am feeling much beTTer; buT sTill have no sense of sMell and no sense of TasTe.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: Started feeling weak around 9AM, tired, ache all over. At 7 AM my husband noticed my (R) arm where I had my shot was red and swallon, and hot. Took 2 Tynols 1-Benadryl. was sick up until 10/26 - still takening Tynol & uped Benadryl to 2 every 6 hrs. Got vacc. in my (R) arm - sick next day felt like a rag doll, weak, achy couldn't think I could walk so tired, Then my husband noticed rash, red, swallen & hot on my arm. Took Tyneol & Benadryl for several days - I took care of myself - most of it was once the weekend. I did call a 24hr nurse# & they suggest to go to a care center. I felt better Sunday after then my arm with rash, hot & red & swallon. So I kept up with Tynole & Benadryle. This was my 2nd vacc. for Shingles - same 1st one I had - 8/21/20 from pharmacy Didn't have a reaction then - Hope this helps - I don't have internet so I had to do it this way.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pain
Clinical narrative: Started feeling weak around 9AM, tired, ache all over. At 7 AM my husband noticed my (R) arm where I had my shot was red and swallon, and hot. Took 2 Tynols 1-Benadryl. was sick up until 10/26 - still takening Tynol & uped Benadryl to 2 every 6 hrs. Got vacc. in my (R) arm - sick next day felt like a rag doll, weak, achy couldn't think I could walk so tired, Then my husband noticed rash, red, swallen & hot on my arm. Took Tyneol & Benadryl for several days - I took care of myself - most of it was once the weekend. I did call a 24hr nurse# & they suggest to go to a care center. I felt better Sunday after then my arm with rash, hot & red & swallon. So I kept up with Tynole & Benadryle. This was my 2nd vacc. for Shingles - same 1st one I had - 8/21/20 from pharmacy Didn't have a reaction then - Hope this helps - I don't have internet so I had to do it this way.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Swelling-tenderness-muscle pain-headache I was shivering-very Lethargic-No appetite For days The Injection area was very red It was the size of a 1/2 Tennis Ball by the end of the week. It was much better a little Black & Blue on Injection area. (The only thing I didn't Get was the Fever.)
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Swelling, Tenderness
Clinical narrative: Swelling-tenderness-muscle pain-headache I was shivering-very Lethargic-No appetite For days The Injection area was very red It was the size of a 1/2 Tennis Ball by the end of the week. It was much better a little Black & Blue on Injection area. (The only thing I didn't Get was the Fever.)
Age: 82.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Dermatitis contact, Drug hypersensitivity, Injection site swelling, Lactose intolerance, Perfume sensitivity
Clinical narrative: *SWELLING UNDER LEFT ARM BETWEEN SHOULDER AND ELBOW - MIGRATED TO ELBOW IN FOLLOWING DAYS - WENT AWAY AFTER A COUPLE OF WEEKS
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Eye discharge, Eye pruritus, Headache, Myalgia
Clinical narrative: Red itchy eyes green goop extracting out of eyes slight headache, sore + aching muscles sinus cavity, back of throat, inside of mouth all very sore and felt lots of pressure. No Treatment after 24 hrs. all ways OK.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Oral pain, Oropharyngeal pain, Sinus pain
Clinical narrative: Red itchy eyes green goop extracting out of eyes slight headache, sore + aching muscles sinus cavity, back of throat, inside of mouth all very sore and felt lots of pressure. No Treatment after 24 hrs. all ways OK.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: entire body started breaking out in bright red rash - spread quickly + itching within 10 minutes of immunization - Refused EMT rash intensified!
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: flu shot administeRed 11/2. On 11/3 woke up with welts on legs + Ribs. Pt called doctoR - told to take benadRyl. A few days lateR when not healed md advised the pt to add ClaRitin. Pt was seen on 11/10 and given hydRxyzine + medRol dose pack. They have also scheduled an appointment on 11/11 to see an allergist.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Severe pain in arm + fever 99 degrees receiving shot (L) for 48hrs -ice + Advil continued pain weeks 2, 3 - especially when lifting arm - Advil Week 4 - notified Pharmacy 11/10, spoke again 11/13 Limited range of motion lifting to front or side pain when lifting greater than 90 degrees using heat and Advil when needed
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Cranial nerve paralysis, Eye movement disorder
Clinical narrative: his eyes was turning inward; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient whose eyes was turning inward (strabismus), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 20-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot HB7L7 and expiration date 31-Aug-2021] via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient eyes was turning inward (strabismus) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Strabismus, Vaccination complication
Clinical narrative: his eyes was turning inward; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient whose eyes was turning inward (strabismus), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 20-Jul-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot HB7L7 and expiration date 31-Aug-2021] via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient eyes was turning inward (strabismus) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.