chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dizziness
Clinical narrative: Patient received FLUZONE at one store then BOOSTRIX and MMR at another store. After receiving the shot, the patient felt faint and dizzy. The following actions were completed: 1) patient was seated in safe area with supervision by pharmacist, 2) emergency protocol followed; EPIPEN at station; supervision at all times, 3) assessment was performed; no shortness of breath; patient felt slightly dizzy and faint but did not fall; patient was given orange juice and high sugar content snacks, 4) reassessed every 5 minutes, showed significant improvement after 10 minutes; patient stayed for approximately 20 min total, 5) patient went back to MD office to let them know of the situation, patient is okay and being monitored, 7) VAERS submitted.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Urticaria
Clinical narrative: Hive rash on face, neck, upper limbs, hands, below the knees, lower back, scalp, noticed rash at 730am on 1/10/2019 and estimate it started around 5am judging by speed of growth.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness, cellulitis, mom took pt to MD.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness, cellulitis.
Age: 29.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Dizziness, Incontinence, Loss of consciousness, Pallor
Clinical narrative: Patient had verbalized he was afraid of needles as the pharmacist was administeringt the vaccinations. He had also mentioned that he has never had a flu shot prior to this. He was getting both vaccines because his wife is currently pregnant with their second child. After the vaccinations the patient stood up but the pharmacist recommended he sat down for a while just in case he "felt woozy". Patient agreed as he was already starting to feel woozy. Patient became pale, unconsious, and soiled his pants. He arose after about a minute and unsure of what happened. He remained seated on the chair throughout.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness, cellulitis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Very sore and aching muscles, kind of flu like symptoms the first 2 days, better the third and fine the fourth day.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Administration site swelling, Pain, Pyrexia
Clinical narrative: Patient reports swelling at location of administration, intense pain, and fever.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever up to 102.5, loose stools x 2 d. Some congestion. Pertinent negs no abd pain, chest pain, coughing, ear pain, headaches, nausea, muscle aches, rash, sleepiness, vomiting, wheezing.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Crying, Discomfort, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Leg pain, red raised lump, crying excessively, uncomfortable, low grade fever.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Leg pain, red raised lump, crying excessively, uncomfortable, low grade fever.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Seizure
Clinical narrative: Approximately 10 minutes after receiving her vaccine, the patient fell to the floor and appeared to have a seizure that lasted approximately 30-60 seconds. She hit her head on the floor as she fell to the ground. She had a clear pulse and clear respirations in the duration of the event. 911 was immediately called and an ambulance dispatched. The patient's father was with her and refused to be transported to a medical facility. The patient insisted that she was fine and she left with her father after further assessment. She had an appointment on Monday, January 14th with her PCP for follow-up.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Lacrimation increased, Ocular hyperaemia
Clinical narrative: 5 min. after vaccine, while patient was lying down, he developed red, watery eyes. No rash, no SOB, no itch, he was given BENADRYL 25 mg PO and S/S resolved in 10 minutes.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Neuralgia, Pain in extremity
Clinical narrative: Arm started hurting 2 days after shot, got so bad couldn't lift arm. Still hurting feels like nerve pain.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: The patient received her immunization after her older sister. She witnessed her older sister pass out and have a seizure after receiving her flu sot. After watching her sister she became weak and felt as if she was going to faint. She did appear to faint after her sister's incident occurred, but was conscious the entire time and was speaking with the healthcare professionals in the room and her father. The father declined a ride in an ambulance and she was to follow-up with her PCP.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injected limb mobility decreased, Pain, Swelling
Clinical narrative: Pt had redness for about 3 weeks, swollen for about 1 month and pain till now. Did not report before, has taken ibuprofen 600mg 2 to 3 times daily depends on the severity of the pain. As of 1/11/2019, the pain is better but still there, cannot raise the left arm in full range.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Induration, Pruritus, Swelling
Clinical narrative: Swelling, discomfort, expanding red circle on arm approx 12" in diameter. Went back to dr. 1/10/19 for exam received steroid shot and told to take ADVIL and PEPCID. Continues to itch and hard red circle approx 3" in diameter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching, and soreness, at injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Muscle pain, went to dr and he gave prednisone 5mg dosepak.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Insomnia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Extreme pain in arm, unable to lift or sleep. Ringing in ears. Tingling/stabbing pain in left hand (fingertips) and left foot (toes and foot pain), pain in hip joints. Pain in left wrist joint.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Tinnitus
Clinical narrative: Extreme pain in arm, unable to lift or sleep. Ringing in ears. Tingling/stabbing pain in left hand (fingertips) and left foot (toes and foot pain), pain in hip joints. Pain in left wrist joint.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: PATIENT HAS EXPERIENCED A FEVER UP TO 102 DEGREES F. SHE HAS HAD SOME MILD REDNESS AND A LUMP AT THE INJECTION SITE.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Severe arm swelling, warmth and and erythema improved without antibiotics over several days (still resolving but much better).
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: Running nose and post nasal drip for 12 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction, Pain
Clinical narrative: ERYTHEMA AT INJECTION SITE. MODERATE TO SEVERE LOCAL REACTION WITH 1 WEEK SORENESS.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Patient experienced fever, chills, and diarrhea after receiving the first SHINGRIX vaccine in her series. It lasted for a day or two.
Age: 52.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Headache, Injection site pruritus, Injection site swelling, Malaise, Myalgia
Clinical narrative: Severe malaise, muscle pain, headache, nausea and local pain, swelling and itching at injection site lasting 7 days.
Age: 52.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Severe malaise, muscle pain, headache, nausea and local pain, swelling and itching at injection site lasting 7 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Infection, Pain, Pyrexia
Clinical narrative: Fatigue-January 10-12. Low fever (99-100)-January 10-11. Injection site soreness--ongoing.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Migraine
Clinical narrative: 1-10-19 5:30 p.m. I felt exhausted, 10:00 severe stomach cramps, diarrhea, body chills. 1-11-19 9:00 a.m. exhausted, body pain, nausea, vomiting, migraine all day and night. 1-12-19 9:00 a.m. body ache, severe migraine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: 1-10-19 5:30 p.m. I felt exhausted, 10:00 severe stomach cramps, diarrhea, body chills. 1-11-19 9:00 a.m. exhausted, body pain, nausea, vomiting, migraine all day and night. 1-12-19 9:00 a.m. body ache, severe migraine.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU4, HEPAB, MNQ, PPV, TDAP
Symptoms: Feeling hot, Headache, Hyperhidrosis, Lymphadenopathy, Myalgia
Clinical narrative: Overheated and diaphoretic, syncopal episode, swollen neck lymph nodes, nausea, post-occipital headache, and muscular pain.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU4, HEPAB, MNQ, PPV, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Overheated and diaphoretic, syncopal episode, swollen neck lymph nodes, nausea, post-occipital headache, and muscular pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Ear infection, Electroencephalogram, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging, Partial seizures
Clinical narrative: Right ear infections, multiple focal seizures, multiple grand mal seizures.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: Got the shot in the morning (at grocery store pharmacy) and at night in bed back seemed stiff.  Awoke next morning to a lot of soreness and some pain in lower back; wasn't present before. Hadn't done any heavy lifting, etc. to bring that on.
Age: 15.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Approximately 2 or 3 minutes after receiving vaccines, pt stated that he felt weird and started to sway. Then he passed out. After several minutes, he regained consciousness. He has never had a syncopal event before. He had not eaten breakfast on that day.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Aggression, Attention deficit/hyperactivity disorder, Decreased appetite, Insomnia, Middle insomnia
Clinical narrative: He had a seizure. Weeks afterwards he wasn't himself, he was throwing extremely rambunctious tantrums. He had very little appetite, and wasn't sleeping very good and kept waking up screaming in the middle of the night. In general wasn't as happy. Now he has ADHD.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Screaming, Seizure, Sleep disorder
Clinical narrative: He had a seizure. Weeks afterwards he wasn't himself, he was throwing extremely rambunctious tantrums. He had very little appetite, and wasn't sleeping very good and kept waking up screaming in the middle of the night. In general wasn't as happy. Now he has ADHD.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pain, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea and body aches.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Musculoskeletal stiffness, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: On the day following immunization, patient came to the pharmacy reporting a reaction only in her right arm (PNEUMOVAX 23). Symptoms included redness, swelling, and stiffness of the arm. She felt feverish and experienced nausea and vomiting. Pharmacist on duty counseled the patient to go to a clinic if symptoms worsened but BENADRYL and ice could be utilized now for symptom reduction. Pharmacist called to check on patient later that evening, and she reported she was already improving. She decided not to go to a doctor. The administering pharmacist called to check on the patient on 1/3/19, and patient reported about 80% of the redness, swelling, and stiffness was already gone. She was still experiencing nausea (no vomiting), but had been taking some ZOFRAN she had on hand at home from a previous fill. When the pharmacist was discussing this with the patient, the patient profile was being viewed. Pharmacist noted patient had a ZOFRAN allergy listed on her profile. When pt was asked about this, she said she now does remember reporting an allergy to it, but cannot remember what the allergy was as she had had a stroke in  the past that interfered with her memory. Patient decided to stop taking ZOFRAN and take Meclizine OTC at recommendation of the pharmacist. Patient was appreciative of the call. Pharmacist listed 'Pneumococcal vaccine' as allergy under patient profile.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: On the day following immunization, patient came to the pharmacy reporting a reaction only in her right arm (PNEUMOVAX 23). Symptoms included redness, swelling, and stiffness of the arm. She felt feverish and experienced nausea and vomiting. Pharmacist on duty counseled the patient to go to a clinic if symptoms worsened but BENADRYL and ice could be utilized now for symptom reduction. Pharmacist called to check on patient later that evening, and she reported she was already improving. She decided not to go to a doctor. The administering pharmacist called to check on the patient on 1/3/19, and patient reported about 80% of the redness, swelling, and stiffness was already gone. She was still experiencing nausea (no vomiting), but had been taking some ZOFRAN she had on hand at home from a previous fill. When the pharmacist was discussing this with the patient, the patient profile was being viewed. Pharmacist noted patient had a ZOFRAN allergy listed on her profile. When pt was asked about this, she said she now does remember reporting an allergy to it, but cannot remember what the allergy was as she had had a stroke in  the past that interfered with her memory. Patient decided to stop taking ZOFRAN and take Meclizine OTC at recommendation of the pharmacist. Patient was appreciative of the call. Pharmacist listed 'Pneumococcal vaccine' as allergy under patient profile.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Approximately 8 hours following the injection I began experiencing body aches and a headache. Then during the night I developed a fever along with chills and shivering. TYLENOL 500mg was taken. By 9am the fever was gone. Fatigue, headache and body aches continued.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: Headache, Body aches, joint aches, Fever 101.5F.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Dyspnoea, Muscular weakness, Throat irritation
Clinical narrative: Pt reported cough and scratchy throat 30 minutes after vaccination. The day after severe weakness, extreme muscle weakness, blurry vision and difficulty breathing.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Pt reported cough and scratchy throat 30 minutes after vaccination. The day after severe weakness, extreme muscle weakness, blurry vision and difficulty breathing.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Myalgia
Clinical narrative: Patient noticed muscle pain in right arm in December a few months after vaccinations. OTC medications and chiropractic therapies could not alleviate bothersome pain.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Abnormal faeces, Breath holding, Confusional state, Crying
Clinical narrative: A few hours after she was vaccinated these problems began; she was very fussy and didn't want to eat and she always had a great appetite before this. She was holding her head and screaming in pain. She had a loose smelly bowel movement, yellow in color. She didn't sleep well that night due to crying in pain. The next morning I noticed her forehead looked swollen and there was no reason for that because she didn't hit her head or fall on anything. Her cheeks are puffy and eyes look sunken in. She doesn't seem to be interacting with people as much, no interest in playing with her friend, would rather take a toy and sit by herself. Doesn't say words she said very clear, acts as if she doesn't know them anymore. When I tried getting her to say them she looks confused and gets frustrated because she can't say them. She has almost no appetite and won't eat her favorite snacks because of the texture. She rests her head on the floor and other times banging her head on the back of her chair or hits herself. Other times she holds her head and moans in pain. Also pulls her hair and ears. Runny nose, congested sounding in her chest, raspy breathing and at other times holding her breath when she's sleeping. She's continued to have 3-5 yellow loose strong smelling stool a day. Seems to be more sleepy, tired and fussy. Sleeping more hours during the day than before. When she wakes up her eyes are crusty. No interest in reading her books or pointing at things and saying "what's that" and she was always curious what things are, seems zombified. The day after her shots she held her breath in her sleep twice. Sometimes when sleeping she moans in pain but doesn't wake up, stirs in her sleep like she's uncomfortable. I brought her back to the doctors on 01/11/2019 because I am very concerned  about her.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Discomfort, Eating disorder, Eyelid margin crusting, Faeces discoloured
Clinical narrative: A few hours after she was vaccinated these problems began; she was very fussy and didn't want to eat and she always had a great appetite before this. She was holding her head and screaming in pain. She had a loose smelly bowel movement, yellow in color. She didn't sleep well that night due to crying in pain. The next morning I noticed her forehead looked swollen and there was no reason for that because she didn't hit her head or fall on anything. Her cheeks are puffy and eyes look sunken in. She doesn't seem to be interacting with people as much, no interest in playing with her friend, would rather take a toy and sit by herself. Doesn't say words she said very clear, acts as if she doesn't know them anymore. When I tried getting her to say them she looks confused and gets frustrated because she can't say them. She has almost no appetite and won't eat her favorite snacks because of the texture. She rests her head on the floor and other times banging her head on the back of her chair or hits herself. Other times she holds her head and moans in pain. Also pulls her hair and ears. Runny nose, congested sounding in her chest, raspy breathing and at other times holding her breath when she's sleeping. She's continued to have 3-5 yellow loose strong smelling stool a day. Seems to be more sleepy, tired and fussy. Sleeping more hours during the day than before. When she wakes up her eyes are crusty. No interest in reading her books or pointing at things and saying "what's that" and she was always curious what things are, seems zombified. The day after her shots she held her breath in her sleep twice. Sometimes when sleeping she moans in pain but doesn't wake up, stirs in her sleep like she's uncomfortable. I brought her back to the doctors on 01/11/2019 because I am very concerned  about her.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Fatigue, Irritability, Lid sulcus deepened, Moaning, Pain
Clinical narrative: A few hours after she was vaccinated these problems began; she was very fussy and didn't want to eat and she always had a great appetite before this. She was holding her head and screaming in pain. She had a loose smelly bowel movement, yellow in color. She didn't sleep well that night due to crying in pain. The next morning I noticed her forehead looked swollen and there was no reason for that because she didn't hit her head or fall on anything. Her cheeks are puffy and eyes look sunken in. She doesn't seem to be interacting with people as much, no interest in playing with her friend, would rather take a toy and sit by herself. Doesn't say words she said very clear, acts as if she doesn't know them anymore. When I tried getting her to say them she looks confused and gets frustrated because she can't say them. She has almost no appetite and won't eat her favorite snacks because of the texture. She rests her head on the floor and other times banging her head on the back of her chair or hits herself. Other times she holds her head and moans in pain. Also pulls her hair and ears. Runny nose, congested sounding in her chest, raspy breathing and at other times holding her breath when she's sleeping. She's continued to have 3-5 yellow loose strong smelling stool a day. Seems to be more sleepy, tired and fussy. Sleeping more hours during the day than before. When she wakes up her eyes are crusty. No interest in reading her books or pointing at things and saying "what's that" and she was always curious what things are, seems zombified. The day after her shots she held her breath in her sleep twice. Sometimes when sleeping she moans in pain but doesn't wake up, stirs in her sleep like she's uncomfortable. I brought her back to the doctors on 01/11/2019 because I am very concerned  about her.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Poor quality sleep, Respiration abnormal, Respiratory tract congestion, Rhinorrhoea, Screaming
Clinical narrative: A few hours after she was vaccinated these problems began; she was very fussy and didn't want to eat and she always had a great appetite before this. She was holding her head and screaming in pain. She had a loose smelly bowel movement, yellow in color. She didn't sleep well that night due to crying in pain. The next morning I noticed her forehead looked swollen and there was no reason for that because she didn't hit her head or fall on anything. Her cheeks are puffy and eyes look sunken in. She doesn't seem to be interacting with people as much, no interest in playing with her friend, would rather take a toy and sit by herself. Doesn't say words she said very clear, acts as if she doesn't know them anymore. When I tried getting her to say them she looks confused and gets frustrated because she can't say them. She has almost no appetite and won't eat her favorite snacks because of the texture. She rests her head on the floor and other times banging her head on the back of her chair or hits herself. Other times she holds her head and moans in pain. Also pulls her hair and ears. Runny nose, congested sounding in her chest, raspy breathing and at other times holding her breath when she's sleeping. She's continued to have 3-5 yellow loose strong smelling stool a day. Seems to be more sleepy, tired and fussy. Sleeping more hours during the day than before. When she wakes up her eyes are crusty. No interest in reading her books or pointing at things and saying "what's that" and she was always curious what things are, seems zombified. The day after her shots she held her breath in her sleep twice. Sometimes when sleeping she moans in pain but doesn't wake up, stirs in her sleep like she's uncomfortable. I brought her back to the doctors on 01/11/2019 because I am very concerned  about her.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Social avoidant behaviour, Somnolence, Speech disorder, Swelling face
Clinical narrative: A few hours after she was vaccinated these problems began; she was very fussy and didn't want to eat and she always had a great appetite before this. She was holding her head and screaming in pain. She had a loose smelly bowel movement, yellow in color. She didn't sleep well that night due to crying in pain. The next morning I noticed her forehead looked swollen and there was no reason for that because she didn't hit her head or fall on anything. Her cheeks are puffy and eyes look sunken in. She doesn't seem to be interacting with people as much, no interest in playing with her friend, would rather take a toy and sit by herself. Doesn't say words she said very clear, acts as if she doesn't know them anymore. When I tried getting her to say them she looks confused and gets frustrated because she can't say them. She has almost no appetite and won't eat her favorite snacks because of the texture. She rests her head on the floor and other times banging her head on the back of her chair or hits herself. Other times she holds her head and moans in pain. Also pulls her hair and ears. Runny nose, congested sounding in her chest, raspy breathing and at other times holding her breath when she's sleeping. She's continued to have 3-5 yellow loose strong smelling stool a day. Seems to be more sleepy, tired and fussy. Sleeping more hours during the day than before. When she wakes up her eyes are crusty. No interest in reading her books or pointing at things and saying "what's that" and she was always curious what things are, seems zombified. The day after her shots she held her breath in her sleep twice. Sometimes when sleeping she moans in pain but doesn't wake up, stirs in her sleep like she's uncomfortable. I brought her back to the doctors on 01/11/2019 because I am very concerned  about her.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, and redness at injection site and radiating (beginning about 16 hours after injection) Fever reaching 103.2 degrees Fahrenheit (beginning about 25.5 hours after injection and initially unresponsive to acetaminophen). Chills and shivering related to fever noted above. Headache.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain, swelling, and redness at injection site and radiating (beginning about 16 hours after injection) Fever reaching 103.2 degrees Fahrenheit (beginning about 25.5 hours after injection and initially unresponsive to acetaminophen). Chills and shivering related to fever noted above. Headache.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Patient experienced fever (100.3) and extreme flu-like symptoms (pain in joints, nausea, fatigue).  Slept for 18 hours to recover, taking acetaminophen every 6 hours.  Patient felt recovered 1/13/2019 at 6:00 AM. Because of ITP, patient has had splenectomy, which increases the risk of becoming sick or getting serious infections.  It is for that reason that the vaccination was ordered. Patient has experienced similar adverse events after Influenza vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site reaction, Injection site warmth, Nausea
Clinical narrative: The first day, very painful vaccinated arm, felt achey, like flu - took tylenol & diphenhydramine to sleep. Second morning felt nauseated to the point of vomiting, very sore arm & body, like flu. No energy, went to bed for most of the day. Third day arm still pretty sore then a hot, red, rash about 4" long & 3" wide appeared below/around the injection site. Continuing to take tylenol & diphenhydramine as it helps pain & heat of rash. Fourth day better but still have a rash that is hot to the touch. Taking above meds to help. Fifth day, pain is much better but arm still aches & have smaller rash that itches & is warm to the touch, and low energy. Sixth day, arm aches and a small rash is still there and warm to the touch. Tylenol & diphenhydramine help a lot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash erythematous, Rash pruritic, Vomiting
Clinical narrative: The first day, very painful vaccinated arm, felt achey, like flu - took tylenol & diphenhydramine to sleep. Second morning felt nauseated to the point of vomiting, very sore arm & body, like flu. No energy, went to bed for most of the day. Third day arm still pretty sore then a hot, red, rash about 4" long & 3" wide appeared below/around the injection site. Continuing to take tylenol & diphenhydramine as it helps pain & heat of rash. Fourth day better but still have a rash that is hot to the touch. Taking above meds to help. Fifth day, pain is much better but arm still aches & have smaller rash that itches & is warm to the touch, and low energy. Sixth day, arm aches and a small rash is still there and warm to the touch. Tylenol & diphenhydramine help a lot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Sore and painful left arm, numbness in two fingers (fore finger and second finger).
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Patient came in today on 1/13/19 and stated she has had a very severe large bruise since she received the SHINGRIX vaccine on 12/27/18. She showed me the very large bruise - it encompassed almost her entire deltoid region of her arm. It was very black and purple still even after almost over 2 weeks since the vaccination occurred. She said it was painful and swelling.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site swelling
Clinical narrative: Patient came in today on 1/13/19 and stated she has had a very severe large bruise since she received the SHINGRIX vaccine on 12/27/18. She showed me the very large bruise - it encompassed almost her entire deltoid region of her arm. It was very black and purple still even after almost over 2 weeks since the vaccination occurred. She said it was painful and swelling.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site erythema, Muscle atrophy, Muscular weakness, Pain
Clinical narrative: Left arm extremely weak, muscle wasting, red ring around injection site, left arm bruise for 7 weeks, very painful aching sensation from 9/21/2018 to present - aching has subsided but is still present, arm remains weak.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Dysstasia, Feeding disorder, Hypersomnia, Injection site swelling
Clinical narrative: I had extreme swelling on my upper right arm. From the elbow to the shoulder. I could not move my arm without extreme pain from Wednesday to Friday nor could I stand, eat or take care of myself. I slept for 48 hrs straight. The pain was a 10 plus if I moved. Today is Sunday and my arm still has swelling but much better. However I still cannot sleep at night as the pain returns. On Friday, I went to the pharmacy and they gave me this website to report it. I also had fever and chills at night. I have never had a reaction to these shots before. I am allergic to penicillin and its relatives. I told the pharmacy so. So what happened to me?
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain, Pyrexia
Clinical narrative: I had extreme swelling on my upper right arm. From the elbow to the shoulder. I could not move my arm without extreme pain from Wednesday to Friday nor could I stand, eat or take care of myself. I slept for 48 hrs straight. The pain was a 10 plus if I moved. Today is Sunday and my arm still has swelling but much better. However I still cannot sleep at night as the pain returns. On Friday, I went to the pharmacy and they gave me this website to report it. I also had fever and chills at night. I have never had a reaction to these shots before. I am allergic to penicillin and its relatives. I told the pharmacy so. So what happened to me?
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: Patient reported diarrhea, nausea, muscle ache, chills lasted for 2-3 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient called and stated that it was very painful at the injection site and felt like she had a fatty mass in the area and that the skin was hanging down low. She was instructed to seek medical attention.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, headache, upset stomach, fever, chills.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Two days after vaccination, patient reported noticing a rash around injection site that itches, about the size of a post-it note. Called to report on Sunday, four days after vaccination.
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Fall
Clinical narrative: The patient became disoriented and dizzy a few hours after the vaccination. He then fell but was uninjured.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Pt was given the hepatitis B vaccine within 1 week of hire at her new job in my office.  She developed diarrhea shortly after receiving the hepatitis B vaccine. She then had nausea and vomiting. She was sent home from work and prescribed zofran which decreased her nausea and vomiting. She got worse and went to the ER. She was admitted to the hospital.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Elevated Red area 2in x 1in on right thigh. Warm to the touch. No treatment needed at this time.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Nausea
Clinical narrative: I had the first of two SHINGRIX vaccinations around 4:00 PM on Friday January 4, 2019. I felt nauseous at about 7:00 PM. When I went to bed around 10:00 PM my muscle in my upper arm hurt from the vaccination. It hurt for nearly three days. For the first two nights, I could not sleep on my left side where I had the vaccination because of the pain.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Wheezing
Clinical narrative: Aggressive swelling on arm of injection from her shoulder to her elbow. Patient also reported chills and wheezing in the following days of receiving vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAS PUFFY, RED, WARM RASH ABOUT 3X3 INCH AROUND THE SITE OF INJECTION ON THE ARM. PATIENT ALSO HAD FEVER FOR ABOUT 4 HOURS THAT NIGHT. SHE HAD LIMITED MOVEMENT OF HER LEFT ARM.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: PATIENT HAS PUFFY, RED, WARM RASH ABOUT 3X3 INCH AROUND THE SITE OF INJECTION ON THE ARM. PATIENT ALSO HAD FEVER FOR ABOUT 4 HOURS THAT NIGHT. SHE HAD LIMITED MOVEMENT OF HER LEFT ARM.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue blistering
Clinical narrative: 3 weeks after the vaccination I developed painful blisters under tongue on the right side only.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site paraesthesia, Nerve conduction studies normal
Clinical narrative: Patient reports shortly after receiving the vaccines he experienced pain and tingling below the injection site. The pain continued to increase and he was seen by his primary care physician. His physician believed his nerve may have been struck by one of the immunizations. He was told by his primary care to take over the counter medications. The pain continued and he was referred to a neurologist. According to the patient, the neurologist's tests were inconclusive.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bone pain, Diarrhoea, Headache, Influenza like illness
Clinical narrative: Later on the day that I received the SHINGRIX vaccine, I experienced malaise, then flu like symptoms such as muscle/bone aches all over my body, vomiting, multiple episodes (10-12) of diarrhea, and major headache. The following morning I took a ZOMIG 5mg (for the HA), 2 IMODIUM, and over the day finished 2 quarts of Pedialyte (as I am prone to electrolyte imbalance following the diarrhea). I had the flu vaccine through work. Although weak, I was much better by Saturday evening.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Vomiting
Clinical narrative: Later on the day that I received the SHINGRIX vaccine, I experienced malaise, then flu like symptoms such as muscle/bone aches all over my body, vomiting, multiple episodes (10-12) of diarrhea, and major headache. The following morning I took a ZOMIG 5mg (for the HA), 2 IMODIUM, and over the day finished 2 quarts of Pedialyte (as I am prone to electrolyte imbalance following the diarrhea). I had the flu vaccine through work. Although weak, I was much better by Saturday evening.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthropathy, Balance disorder, CSF protein increased, CSF white blood cell count increased, Electromyogram abnormal
Clinical narrative: 10/2018 Malaise setting in, some days worse than others. By the end of the month having trouble with LT knee being weak, walking with slight limp. 11/2018 Both knees are weak, more fatigue. By end of the month difficult to climb stairs, knees buckle at times. Difficulty lifting/raising legs, requires a lot of energy to move and is exhausting to walk. 12/9/18 Fell inside home, LT knee buckled. 12/11/18 LT leg goes numb/tingles from knee down. 12/12/2018 positive MRI thoracic spine, signal in cord and surface cord enhancement of lumbar nerve roots. 12/20/18 spinal tap-elevated proteins and white cells. 12/21/18 EMG-NCV absent peroneal F responses and tibial H reflexes. 12/21-12/23/2018 admitted to hospital for IV steroids-no help. 12/21/2018 MRI lumbar spine finding consistent with Guillain-Barre syndrome. 12/24/2018-1-10-19 oral steroid taper down. 12/24/2018 tingling is now waist down to toes, numbness in vagina and rectum-difficult to move bowels, cold feet, horrible balance, unsteady gait. 1/1/2019 RT calf tightness. 1/2/2019 bilateral calf tightness when walking, tingling sensation feels like light vibrations from waist down to toes. Declining balance. 1/8-1/12/2019 IV immunoglobulin therapy. Current day 1/13/19 waiting to see how I respond to IVIG therapy. I will begin aqua physical therapy 1/14/2019 to help with abdominal/lower leg weakness. Balance is slightly improved, tingling sensation is slightly less at rest but very much present when walking. Bowel movements have improved. Feet are still cold.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Fatigue, Functional gastrointestinal disorder, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 10/2018 Malaise setting in, some days worse than others. By the end of the month having trouble with LT knee being weak, walking with slight limp. 11/2018 Both knees are weak, more fatigue. By end of the month difficult to climb stairs, knees buckle at times. Difficulty lifting/raising legs, requires a lot of energy to move and is exhausting to walk. 12/9/18 Fell inside home, LT knee buckled. 12/11/18 LT leg goes numb/tingles from knee down. 12/12/2018 positive MRI thoracic spine, signal in cord and surface cord enhancement of lumbar nerve roots. 12/20/18 spinal tap-elevated proteins and white cells. 12/21/18 EMG-NCV absent peroneal F responses and tibial H reflexes. 12/21-12/23/2018 admitted to hospital for IV steroids-no help. 12/21/2018 MRI lumbar spine finding consistent with Guillain-Barre syndrome. 12/24/2018-1-10-19 oral steroid taper down. 12/24/2018 tingling is now waist down to toes, numbness in vagina and rectum-difficult to move bowels, cold feet, horrible balance, unsteady gait. 1/1/2019 RT calf tightness. 1/2/2019 bilateral calf tightness when walking, tingling sensation feels like light vibrations from waist down to toes. Declining balance. 1/8-1/12/2019 IV immunoglobulin therapy. Current day 1/13/19 waiting to see how I respond to IVIG therapy. I will begin aqua physical therapy 1/14/2019 to help with abdominal/lower leg weakness. Balance is slightly improved, tingling sensation is slightly less at rest but very much present when walking. Bowel movements have improved. Feet are still cold.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Malaise, Mobility decreased, Muscle tightness
Clinical narrative: 10/2018 Malaise setting in, some days worse than others. By the end of the month having trouble with LT knee being weak, walking with slight limp. 11/2018 Both knees are weak, more fatigue. By end of the month difficult to climb stairs, knees buckle at times. Difficulty lifting/raising legs, requires a lot of energy to move and is exhausting to walk. 12/9/18 Fell inside home, LT knee buckled. 12/11/18 LT leg goes numb/tingles from knee down. 12/12/2018 positive MRI thoracic spine, signal in cord and surface cord enhancement of lumbar nerve roots. 12/20/18 spinal tap-elevated proteins and white cells. 12/21/18 EMG-NCV absent peroneal F responses and tibial H reflexes. 12/21-12/23/2018 admitted to hospital for IV steroids-no help. 12/21/2018 MRI lumbar spine finding consistent with Guillain-Barre syndrome. 12/24/2018-1-10-19 oral steroid taper down. 12/24/2018 tingling is now waist down to toes, numbness in vagina and rectum-difficult to move bowels, cold feet, horrible balance, unsteady gait. 1/1/2019 RT calf tightness. 1/2/2019 bilateral calf tightness when walking, tingling sensation feels like light vibrations from waist down to toes. Declining balance. 1/8-1/12/2019 IV immunoglobulin therapy. Current day 1/13/19 waiting to see how I respond to IVIG therapy. I will begin aqua physical therapy 1/14/2019 to help with abdominal/lower leg weakness. Balance is slightly improved, tingling sensation is slightly less at rest but very much present when walking. Bowel movements have improved. Feet are still cold.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Peripheral coldness
Clinical narrative: 10/2018 Malaise setting in, some days worse than others. By the end of the month having trouble with LT knee being weak, walking with slight limp. 11/2018 Both knees are weak, more fatigue. By end of the month difficult to climb stairs, knees buckle at times. Difficulty lifting/raising legs, requires a lot of energy to move and is exhausting to walk. 12/9/18 Fell inside home, LT knee buckled. 12/11/18 LT leg goes numb/tingles from knee down. 12/12/2018 positive MRI thoracic spine, signal in cord and surface cord enhancement of lumbar nerve roots. 12/20/18 spinal tap-elevated proteins and white cells. 12/21/18 EMG-NCV absent peroneal F responses and tibial H reflexes. 12/21-12/23/2018 admitted to hospital for IV steroids-no help. 12/21/2018 MRI lumbar spine finding consistent with Guillain-Barre syndrome. 12/24/2018-1-10-19 oral steroid taper down. 12/24/2018 tingling is now waist down to toes, numbness in vagina and rectum-difficult to move bowels, cold feet, horrible balance, unsteady gait. 1/1/2019 RT calf tightness. 1/2/2019 bilateral calf tightness when walking, tingling sensation feels like light vibrations from waist down to toes. Declining balance. 1/8-1/12/2019 IV immunoglobulin therapy. Current day 1/13/19 waiting to see how I respond to IVIG therapy. I will begin aqua physical therapy 1/14/2019 to help with abdominal/lower leg weakness. Balance is slightly improved, tingling sensation is slightly less at rest but very much present when walking. Bowel movements have improved. Feet are still cold.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Vaccination complication
Clinical narrative: Pt complained about numbness at the site of injection. 12-31-18-Pt's son comes to the pharmacy to let us know pt had a reaction to vaccine given on 9/28/18. 1-2-19-We speak to PCP. They inform us that they saw pt on 11/2 and 11/19. 11/19 pt complained about numbness he felt from vaccine give on 11/2. (?) later on it was confirmed that vaccine was administer on 11/2. 1/3/19 pt was seen again. Given CELEBREX (anti-inflammatory) by MD. Per pt (1/13) he is feeling somewhat better.
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Antinuclear antibody increased, Arthritis reactive, Peripheral swelling, Pyrexia, Seizure
Clinical narrative: She had very high fever. Arm extremly swollen and and appears to have minor seizures within the next few weeks. Holistics approach was used she recovered but we stopped giving her the last DTP dose. Only few months later she developed reactive arthritis. Ended up in hospital and since then has had high ANA results on and off. On May/14 we tried TD only. This time her arm was swollen even more.
Age: 19.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A 19-year-old female patient received TRUMENBA, (lot number: W09937, expiry date: Jan2020, NDC number: 00005010005), via an unspecified route of administration on 05Jan2019 at 0.5 ml, single for vaccination against meningitis B. Medical history was none. The patient's concomitant medications were not reported. The patient passed out on 05Jan2019. It appeared that about one to 2 hours after getting the shot, the patient passed out. The pharmacist on duty called her every hour after and she was getting better. The pharmacist stated that there is an outbreak of Meningitis B at patient's school so the patient wanted to be protected. The outcome of the event was recovering. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event passed out.
Age: 3.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to case 2019SA010202, same reporter. This case involves a 3 years old male patient who experienced reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm, while he received vaccine FLUZONE QUADRIVALENT. The patients past medical history included Sinusitis in DEC-2018 and patient was treated with Cefdinir 250mg/5 ml dose history of allergy to Amoxicillin but no allergy to eggs. The patient's past vaccination(s) included 3 flu shots in the past. The patient did not receive any concomitant medication. On 07-Jan-2019, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B Vaccine, lot UJ087AA, expiry date 30-Jun-2019 via intramuscular route in the right thigh. On 07-Jan-2019, the patient developed a non-serious reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm (inflammation) (vaccination site reaction) 2 days following the administration of Influenza Quadrival A-B Vaccine. Lab data was not provided. Final diagnosis was reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm. As a corrective treatment physician ordered Prednisolone 2.5 ml BID for 5 days. The patient outcome is reported as Unknown for reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm. List of documents held by sender- none.