chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Painful, warm, itchy and swollen upper left arm, started the day after receiving the vaccine. Patient treated with ice and MOTRIN, symptoms resolved 3 days later.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Cough, Decreased activity, Decreased appetite, Erythema
Clinical narrative: On 10/11/2017 (5 days after receiving immunizations), pt began to have loose occasional cough, decreased appetite and activity. She vomited once on 10/15. Mother hasn't checked temperature though felt warm to touch. She gave her tylenol which helped at first though eventually didn't. Mother denied recent exposure to animals or recent foreign travel. Pt has been having adequate fluid intake and urine output. Mother denies diarrhea, dyspnea, erythema of hands/feet, lip irritation/cracking, nasal drainage and rash. On 10/16/2017, baby had a temperature of 102.9 F rectally. She looked irritated, tired, had dry lips, and R ear erythema. I placed her on Amoxicillin and will be following up with her closely.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Fatigue, Irritability, Lip dry, Skin warm, Vomiting
Clinical narrative: On 10/11/2017 (5 days after receiving immunizations), pt began to have loose occasional cough, decreased appetite and activity. She vomited once on 10/15. Mother hasn't checked temperature though felt warm to touch. She gave her tylenol which helped at first though eventually didn't. Mother denied recent exposure to animals or recent foreign travel. Pt has been having adequate fluid intake and urine output. Mother denies diarrhea, dyspnea, erythema of hands/feet, lip irritation/cracking, nasal drainage and rash. On 10/16/2017, baby had a temperature of 102.9 F rectally. She looked irritated, tired, had dry lips, and R ear erythema. I placed her on Amoxicillin and will be following up with her closely.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Entire left arm became swollen, warm and tender. Arm was at least 50% bigger than right arm. He had so much swelling that he could not lift his arm due to pain and swelling. Developed a low grade temp but did not develop a fever.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Entire left arm became swollen, warm and tender. Arm was at least 50% bigger than right arm. He had so much swelling that he could not lift his arm due to pain and swelling. Developed a low grade temp but did not develop a fever.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of pain in deltoid, redness and swelling in left arm. Adverse reactions started the next day after administration.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia, Serum sickness-like reaction
Clinical narrative: Serum sickness like reaction. Low grade fever and joint pain.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Progressive redness and swelling of left thigh over 2 days to 18x22cm then resolved. Treatment was Zyrtec and Ibuprofen.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness and soreness on the injection site.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: Muscle soreness and swelling of the glands.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Progressive redness and swelling to 10-12cm at site of injection over 3 days. Resolved after 2 days of treatment with Zyrtec or Ibuprofen. It may have been a dermal injection.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Patient stated that his left arm was swollen extending down to elbow. He said it was red and a little streaky. It was not sore just swollen. I was unable to see the patients arm. I recommended that he seek medical treatment as soon as possible. He said that the day after the vaccination it was more swollen than the day he contacted me (10/19/2017). It was getting better but I still recommended he call his PCP or go see him before the weekend.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Pain, Pyrexia, Skin warm
Clinical narrative: Patient developed fever of 101, red area with swelling and induration that is warm to touch and painful.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling
Clinical narrative: Patient developed fever of 101, red area with swelling and induration that is warm to touch and painful.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on abdomen and site area, no fever noted.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Bacterial infection, Bacterial test, Blood test, Cellulitis, Chills
Clinical narrative: On 10/10/17 patient started with chills around 10:30am and realized she had a low grade fever that afternoon around 1pm. She had pain in her arm but figured all these were normal since she received multiple vaccines. She worked all day on Tuesday, but after that day she got worse. Her temperature got up to 103.5F and she started with a headache. She was taking Tylenol and Ibuprofen around the clock and her temperature was not subsiding. She went to urgent care on Thursday and they sent her to ER because "they were worried [she] was septic." In the ER they diagnosed her with cellulitis and told her she "had a bacterial infection because the vaccine injection site was not cleaned well."  The cellulitis was in her left arm. She said they gave her two IV antibiotics and they sent her home with antibiotics to take by mouth and pain medication. They did blood work and sent a culture of the bacteria that she will get back when she follows up with her doctor next week. She was out of work Wednesday, Thursday, and Friday and was back to work on Monday October 16, 2017.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: On 10/10/17 patient started with chills around 10:30am and realized she had a low grade fever that afternoon around 1pm. She had pain in her arm but figured all these were normal since she received multiple vaccines. She worked all day on Tuesday, but after that day she got worse. Her temperature got up to 103.5F and she started with a headache. She was taking Tylenol and Ibuprofen around the clock and her temperature was not subsiding. She went to urgent care on Thursday and they sent her to ER because "they were worried [she] was septic." In the ER they diagnosed her with cellulitis and told her she "had a bacterial infection because the vaccine injection site was not cleaned well."  The cellulitis was in her left arm. She said they gave her two IV antibiotics and they sent her home with antibiotics to take by mouth and pain medication. They did blood work and sent a culture of the bacteria that she will get back when she follows up with her doctor next week. She was out of work Wednesday, Thursday, and Friday and was back to work on Monday October 16, 2017.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: I called her at 7:45 pm after being notified by another store that she had called and said she had developed a fever. She developed body aches and a "burning forehead". Her temperature was reported normal when her neighbor took it. I told her to go to the ER which she agreed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong immunization was ordered and given to patient. The correct immunization should have been PCV 13, Prevnar. Patient did not have any signs or symptoms of an adverse reaction.
Age: 43.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Persistent increased level of pain and soreness to Left arm/shoulder, not relieved by over the counter Tylenol.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Hives, swollen throat, itching within one hour. Took Claritin, and has continued with Claritin since then.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness of the skin, beginning just below the site of injection and spreading outwards down and around the arm, and now almost reaching the wrist joint. Initially, the affected area was very warm, but, according to the patient, it is now less warm.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Injection site pain, Pain in extremity
Clinical narrative: Nurse gave vaccine at approximately 9:00 AM in right arm. Patient left vaccination area, then returned at approximately 11:20 AM. Patient with complaint of Right arm pain, radiating down from injection site into right forearm, and across right shoulder into chest and into right upper back. Patient noted to have full range of motion of right arm, right shoulder, right hand, and fingers of right hand. Denies numbness and tingling. The injection site checked and noted to be clean, warm, pink, dry, with no bruising or discoloration. Injection site noted approximately 1 inch below acromion (shoulder joint).  Ice pack applied to area, encouraged patient to see PCP or Health Clinic if pain does not improve.  Phone call made on 9-28-17; patient relates pain is improved. She took Aleve for discomfort on 9-27-17. On 10-13-17, spoke to patient, she relates she went to the doctor on 10-09-17 and that she is doing fine, denies pain, numbness or tingling.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, referring to a 23 year old female patient. The patient's medical history or concurrent conditions were not reported. On 23-SEP-2017, the patient was inadvertently vaccinated with PROQUAD (rHA) lot # M017335, expiration date 05-OCT-2017, for prophylaxis (dosage information and route were not reported), which was reconstituted with sterile diluent (MERCK) (lot number and expiration date were unknown). Information regarding concomitant medication was not provided. No adverse effects reported. Product quality complaint was not involved.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on 12Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. In Oct2017 about a day or two later vaccination it started to itch and now it is red and warm. The outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Starting getting hives at 7:00 am this morning; itchy lasting until the time of this VAERS (10:45am).  Called MD who didn't think it was the flu shot, but instructed patient to contact pharmacy.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the pharmacy on 10/19/17 with redness, swelling and warmth on left deltoid. Patient went to the ER for treatment.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain, Tendon calcification
Clinical narrative: Throbbing pain in left upper arm with eventual loss of range of motion and strength to the left arm.   Began Aleve BID on 10/7/17 with no relief of pain, Tylenol helped with the pain. Over the next 7-10 days the ROM and strength returned to the arm.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: Throbbing pain in left upper arm with eventual loss of range of motion and strength to the left arm.   Began Aleve BID on 10/7/17 with no relief of pain, Tylenol helped with the pain. Over the next 7-10 days the ROM and strength returned to the arm.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: APPROXIMATELY 5 MINS POST VACCINATION (HPV, MEN, TDAP) CLIENT APPEARED TO HAVE A SYNCOPAL EPISODE, AS PER WITNESS CLIENT HIT THE BACK OF HEAD, NO S/S LOC, CLIENT ALERT AND VERBAL, REPORTED FEELING DIZZY, DENIED ANY C/O PAIN/DISCOMFORT, PLACED IN TRENDENLENBUR POSITION, COOL COMPRESS APPLIED, SKIN W/D, BP 108/62, CLIENT EVALUATED BY MEDICAL PROVIDER, NO NEW ORDERS NOTED.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Erythema, Induration
Clinical narrative: 7x5 CM oval area of erythema with a 5cm central red indurated area with small clear vesicles.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: At approximately 1:00am the patient woke up with severe deep radiating pain in her left shoulder radiating to the entire arm and neck. The severity lasted approximately 5 days. She was unable to lift or move her left arm without severe pain. On date of this report 10/20/2017, recovery is at approximately 70% according to the patient.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient reported redness and swelling around her whole upper right arm at 10:30 pm on 10/18/2017. The patient was told to take Tylenol (patient can not take Advil) and apply a cold compress. The patient came in this morning at 9:30 am 10/20/2017 and observed the swelling and redness has gone down the arm and near the elbow. She said the swelling has gone down though.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Muscle spasms, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Thirty minutes after receiving vaccine began having spasms and discomfort in area of left scapula. Later in the day spasm and discomfort radiated to left neck. By the following day she began having difficulty moving head side to side. She reported this to Employee Health Monday morning 10/16/17 when she returned to work and was immediately referred to be evaluated by our Physician. She was diagnosed with cervicalgia and decreased neck range of motion secondary to muscle spasms. Today she states improved ROM. Has follow up scheduled for 10/23/17.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: Thirty minutes after receiving vaccine began having spasms and discomfort in area of left scapula. Later in the day spasm and discomfort radiated to left neck. By the following day she began having difficulty moving head side to side. She reported this to Employee Health Monday morning 10/16/17 when she returned to work and was immediately referred to be evaluated by our Physician. She was diagnosed with cervicalgia and decreased neck range of motion secondary to muscle spasms. Today she states improved ROM. Has follow up scheduled for 10/23/17.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Thursday 10.5 ? fairly normal day with a moderate site pain/ some throbbing ? took Iburpofen before bed that evening. Friday 10.6 ? didn't notice anything until afternoon when the site and my upper arm began to ache ? took ibuprofen before bed. Saturday 10.7 ? woke up with a circular swelling which started about 2 fingers below the injection site and was 12.2 centimeters across ? heat and redness present ? feeling of paresthesia in the fingers of that hand ? aching in lower arm. Went to my physician to have it looked at. She suggested light icing and Ibuprofen which I did that day. Sunday 10.8 ? swelling/ heat  mostly gone by end of day ? did not take Ibuprofen that day. Monday 10/9 ? still some general swelling in that arm but no pain/ no paresthesia in my hand.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Thursday 10.5 ? fairly normal day with a moderate site pain/ some throbbing ? took Iburpofen before bed that evening. Friday 10.6 ? didn't notice anything until afternoon when the site and my upper arm began to ache ? took ibuprofen before bed. Saturday 10.7 ? woke up with a circular swelling which started about 2 fingers below the injection site and was 12.2 centimeters across ? heat and redness present ? feeling of paresthesia in the fingers of that hand ? aching in lower arm. Went to my physician to have it looked at. She suggested light icing and Ibuprofen which I did that day. Sunday 10.8 ? swelling/ heat  mostly gone by end of day ? did not take Ibuprofen that day. Monday 10/9 ? still some general swelling in that arm but no pain/ no paresthesia in my hand.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased activity, Fatigue, Glossodynia, Lip blister
Clinical narrative: Morning after receiving vaccine has huge white blister on lower lip, inside cheek and very sore spot on tongue. Also, very very tired, little movement, no energy. Tuesday, patient called MD office, and was told to go to emergency room. Patient went to Hospital and was there 5-6 hours. The MD who saw her said it looked like she had bitter herself. She had not recollection of doing that and said so. They gave her a prescription, but at her pharmacy they told her she should use something else. She went back to the MD office that originally administered the vaccine on that Friday and saw an NP. The NP verified that the blisters were still in her mouth, and have her an antihistamine. The NP also documented this reaction in her medical record. Notes: Patient states she had similar results 2 years ago after receiving this vaccine. Her memory has been affected by numerous brain surgeries, so she did not remember this type of reaction until she had already gotten the vaccine and the reaction started again. Patient felt bullied into receiving the vaccine and is upset that her previous reaction was not listed in her medical record.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Memory impairment, Oral mucosal blistering
Clinical narrative: Morning after receiving vaccine has huge white blister on lower lip, inside cheek and very sore spot on tongue. Also, very very tired, little movement, no energy. Tuesday, patient called MD office, and was told to go to emergency room. Patient went to Hospital and was there 5-6 hours. The MD who saw her said it looked like she had bitter herself. She had not recollection of doing that and said so. They gave her a prescription, but at her pharmacy they told her she should use something else. She went back to the MD office that originally administered the vaccine on that Friday and saw an NP. The NP verified that the blisters were still in her mouth, and have her an antihistamine. The NP also documented this reaction in her medical record. Notes: Patient states she had similar results 2 years ago after receiving this vaccine. Her memory has been affected by numerous brain surgeries, so she did not remember this type of reaction until she had already gotten the vaccine and the reaction started again. Patient felt bullied into receiving the vaccine and is upset that her previous reaction was not listed in her medical record.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Confusional state, Injection site joint pain, Memory impairment
Clinical narrative: Patient felt severe pains in the joints of her hips, knee, and shoulders. Also, she was in a state of confusion where she couldn't remember simple things, people, or numbers.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pain, Neuralgia
Clinical narrative: Initially felt a pain at the injection site and a "nerve pain" radiating to the stomach. 20 minutes later reported redness to injection site and applied ice. Also had dizziness, throat tightening, palpations that last 10 minutes. Generalized body ache and fatigue was then experienced that day.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Palpitations, Throat tightness
Clinical narrative: Initially felt a pain at the injection site and a "nerve pain" radiating to the stomach. 20 minutes later reported redness to injection site and applied ice. Also had dizziness, throat tightening, palpations that last 10 minutes. Generalized body ache and fatigue was then experienced that day.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Nausea, Pain, Peripheral swelling, Pruritus
Clinical narrative: Event: Itchy, swollen feeling in arm 6 hours after immunization. Noticed rash on from shoulder to elbow the following morning. Area is itchy and painful. Patient tried ibuprofen 400mg every four hours at home. Had some nausea, stomach pain, and subjective fever. Treatment: Zyrtec 10mg BID, Zantac 150mg BID x 5 days, Keflex 500mg QID x 5 days, Prednisone 40mg qday x 5 days. Outcome: At last follow up (10 days after initial encounter) patient still complained of itchy area on arm. Patient was instructed to continue Zyrtec and follow up in one week, but did not return for follow up.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Event: Itchy, swollen feeling in arm 6 hours after immunization. Noticed rash on from shoulder to elbow the following morning. Area is itchy and painful. Patient tried ibuprofen 400mg every four hours at home. Had some nausea, stomach pain, and subjective fever. Treatment: Zyrtec 10mg BID, Zantac 150mg BID x 5 days, Keflex 500mg QID x 5 days, Prednisone 40mg qday x 5 days. Outcome: At last follow up (10 days after initial encounter) patient still complained of itchy area on arm. Patient was instructed to continue Zyrtec and follow up in one week, but did not return for follow up.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling
Clinical narrative: Patient experienced swelling in arm down to elbow. Pt told to take BENADRYL and TYLENOL for pt. Pt received antibiotics and steroid for swelling and infection prevention.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram, Haemoglobin decreased, Headache
Clinical narrative: 10/17-10/19-headache, dizziness; 10/19-nausea.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: 10/17-10/19-headache, dizziness; 10/19-nausea.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Aphasia, Developmental delay, Ear infection, Electroencephalogram normal, Febrile convulsion
Clinical narrative: Started with redness and swelling around injection site, and fever around 3:30-4pm, gave her Tylenol and Benadryl. She started having febrile seizures 2:30am 08/01/2015, contacted 911 they sent paramedics we were able to break her fever while paramedics were at our home. 08/01/2015 returned to the dr she had another seizure in the exam room. The Dr said that she had an ear infection starting so that it was a combination from the shots and the ear infection. He examined her ears before she got the vaccines the day before and they were clear. She had 2-3 more seizures after leaving the office and returning home. She was taken to Hospital where they did an EEG kept her overnight and they next day said that she had strep throat and again prescribed amoxicillin. 09/2015 my daughter started having partial complex seizures she had 4-5 in one day was again taken to Hospital another EEG was done they gave her Keppra before the EEG was done, they found nothing. She was discharged and the Dr informed us to call back and they would write a prescription for Keppra. She had many seizures from 09/2015-12/2015 each time she was taken to Medical Center, she continued to test positive for strep but no high fevers. 12/25/2015 she had 2 partial complex seizures that morning I called Dr. who informed me to give her Tylenol as she may be starting to develop a fever. She had a 40 minute grand mal, transported to hospital nothing found given keppra as a prescription and diastat for emergency use.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Focal dyscognitive seizures, Generalised tonic-clonic seizure, Injection site erythema, Injection site swelling, Laboratory test normal
Clinical narrative: Started with redness and swelling around injection site, and fever around 3:30-4pm, gave her Tylenol and Benadryl. She started having febrile seizures 2:30am 08/01/2015, contacted 911 they sent paramedics we were able to break her fever while paramedics were at our home. 08/01/2015 returned to the dr she had another seizure in the exam room. The Dr said that she had an ear infection starting so that it was a combination from the shots and the ear infection. He examined her ears before she got the vaccines the day before and they were clear. She had 2-3 more seizures after leaving the office and returning home. She was taken to Hospital where they did an EEG kept her overnight and they next day said that she had strep throat and again prescribed amoxicillin. 09/2015 my daughter started having partial complex seizures she had 4-5 in one day was again taken to Hospital another EEG was done they gave her Keppra before the EEG was done, they found nothing. She was discharged and the Dr informed us to call back and they would write a prescription for Keppra. She had many seizures from 09/2015-12/2015 each time she was taken to Medical Center, she continued to test positive for strep but no high fevers. 12/25/2015 she had 2 partial complex seizures that morning I called Dr. who informed me to give her Tylenol as she may be starting to develop a fever. She had a 40 minute grand mal, transported to hospital nothing found given keppra as a prescription and diastat for emergency use.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Language disorder, Nuclear magnetic resonance imaging abnormal, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: Started with redness and swelling around injection site, and fever around 3:30-4pm, gave her Tylenol and Benadryl. She started having febrile seizures 2:30am 08/01/2015, contacted 911 they sent paramedics we were able to break her fever while paramedics were at our home. 08/01/2015 returned to the dr she had another seizure in the exam room. The Dr said that she had an ear infection starting so that it was a combination from the shots and the ear infection. He examined her ears before she got the vaccines the day before and they were clear. She had 2-3 more seizures after leaving the office and returning home. She was taken to Hospital where they did an EEG kept her overnight and they next day said that she had strep throat and again prescribed amoxicillin. 09/2015 my daughter started having partial complex seizures she had 4-5 in one day was again taken to Hospital another EEG was done they gave her Keppra before the EEG was done, they found nothing. She was discharged and the Dr informed us to call back and they would write a prescription for Keppra. She had many seizures from 09/2015-12/2015 each time she was taken to Medical Center, she continued to test positive for strep but no high fevers. 12/25/2015 she had 2 partial complex seizures that morning I called Dr. who informed me to give her Tylenol as she may be starting to develop a fever. She had a 40 minute grand mal, transported to hospital nothing found given keppra as a prescription and diastat for emergency use.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: The flu shot was given on October 13, 2017, patient's left arm, in which flu was given still hurts and her left hip hurts as well. We are a week out, as of today. I will continue to monitor over the weekend. I do not know the name of the seasonal flu shot/vaccine. Also, at this point, we have not been back to the doctor's office, I called and spoke to the nurse on Wednesday, 10.18.17, whom advised to give her Ibuprofen.
Sex: F
Vaccine: HPVX
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a currently 26-year-old female patient who was reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies and was not taking any concomitant medications. On an unknown date (reported as "maybe when she was 13 years old"), the patient was vaccinated with the first dose of either GARDASIL 9 or GARDASIL (could not be confirmed which one) in the right arm (dose, route of administration, lot number and expiration date not provided). On an unknown date, after receiving the first dose of the vaccine, the patient developed an allergic reaction, she experienced itchiness on her arm and then developed hives hours later. The patient recovered on an unknown date after the first dose. Then after receiving the second dose of the vaccine, on an unspecified date, the patient developed the same side effects but "only way worse". Her symptoms were so bad that she had to take "a ton of BENDARYL to recover". Her physician stated that it was not recommended to take the third dose of the vaccine. The outcome of the events was reported as recovered. The reporter considered the events to be related to suspect therapy. This is one of two reports referring to the same patient. Sender's Comments: US-009507513-1709USA011119.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified 12 month old patient. The patient had no known drug allergies. His medical history, concurrent conditions and concomitant therapy were not provided. On 21-SEP-2017 the patient was inadvertently vaccinated with the first dose of PROQUAD subcutaneously, in the left thigh, lot # M033216, (dose and expiration date were not provided) for prophylaxis. At the same visit, the patient was also vaccinated with the first dose of VARIVAX subcutaneously, in the right thigh, lot # M038857, (dose and expiration date were not provided) both for prophylaxis, which were reconstituted with sterile diluent (MERCK). Nurse saw M-M-R II component on PROQUAD box thinking it was M-M-R II. The patient had no illness at the time of vaccination. No adverse effects were reported.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76-year-old female patient. The patient drug reactions/allergies included statin drugs. The patient had no medical history. On 18-SEP-2017, the patient was vaccinated in the arm with PNEUMOVAX23 (dose and route of administration were not provided, lot # N010105, expiration date on 15-NOV-2018) as routine vaccination. On the same day, in the same arm the patient was vaccinated with an influenza virus vaccine (dose and route of administration were not provided, manufacturer Sanofi, lot# UI832AD, expiration date on 20-MAR-2018). Concomitant therapies included irbesartan, liothyronine sodium, amlodipine and ranitidine. On unspecified day in September 2017 (reported as either on the 18th or the 19th), the patient experienced swelling, redness and warmth in the upper arm, radiating from the injection site. The patient sought medical attention therefore he spoke to physician and pharmacist. No laboratory diagnostics/studies were performed. It was unknown if the patient received treatment for the adverse events. At the reporting time, the patient was recovering form the events. The causality between the events and PNEUMOVAX23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified patients of unknown age and gender. In approximately 2017, reported as between 05-SEP-2017 and 26-SEP-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (doses and anatomical locations were not reported, lot # N009801 expiration date: 10-NOV-2020, intramuscularly) for an unknown indication. Data logger involved (28.5F for 5 minutes). There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA013890.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a female patient of unknown age who was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On approximately 05-OCT-2017, (also reported as "05 October" and "Thursday"), the patient was vaccinated with expired dose of ZOSTAVAX lot # M003487 with an expiration date 21-APR-2017, 1 injection for prophylaxis (route of administration and anatomical location were not reported).
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 46 year old immunocompromised female patient. The patient's concurrent condition included colitis. The patient's concomitant medications, drug reactions or allergies were not reported. On 30-SEP-2015, the patient was tested for immunity of Hepatits B for unspecified reasons. The results of test were Hepatitis B surface antigen of "0.2" and non-reactive. On 08-OCT-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB for prophylaxis (dosage, route of administration, lot# and expiration date were unknown). On 8-DEC-2015, the patient was vaccinated with the second dose and on 9-MAY-2016 was vaccinated with the third dose of RECOMBIVAX HB. In approximately 2016 for unspecified reasons, the patient was tested for immunity of Hepatitis B and the results were "non-reactive". On 15-SEP-2016, the patient was vaccinated with the fourth dose of RECOMBIVAX HB. On 17-NOV-2016, the patient was vaccinated with the fifth dose and on 16-MAR-2017 was vaccinated with the sixth dose of RECOMBIVAX HB. On 11-JUL-2017, the patient was tested for immunity of Hepatitis B and the result was "0.1" and non-reactive. On 25-JUL-2017, the patient was tested for immunity of Hepatitis B for unspecified reasons and the result was "0.1" and non-reactive. The outcome of negative Hepatitis B surface antibody and non-responder of the therapy with RECOMBIVAX HB were unknown. The relatedness between the events and therapy with RECOMBIVAX HB were not reported.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report has been received from a Nurse practitioner, concerning a 79 year old female patient. The patient concurrent condition included hypertension and concomitant medication included amlodipine besylate, EXFORGE. No allergies or drug reaction were reported. In October 2012 (reported as 5 years ago), the patient was vaccinated with PNEUMOVAX23 intramuscularly in the arm (strength, frequency, lot number and expiration date were not provided) for pneumonia prevention. In October 2012 (reported as on the same day), the patient developed swelling on an unspecified arm. The patient was treated with ibuprofen and ice and one hour later, the patient recovered from the event. No lab diagnostics or studies were performed; the patient did not sought medical attention. The causal relationship between the swelling on the arm and the therapy with PNEUMOVAX23 was not assessed.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Haematology test, Impaired work ability, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist/pharmacy manager refers to a 68-year-old female patient with penicillin allergy. The patient's medical history included anxiety and high blood pressure. On 05-OCT-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N020501, expiry date: 03-MAR-2019), intramuscularly for prevention of pneumonia. Concomitant therapies included amlodipine, lisinopril (manufacturer unknown), hydrochlorothiazide and FLOXACIN. On 06-OCT-2017, the patient developed redness and warmth at the injection site. On 07-OCT-2017, the patient developed fever, chills, and general pain so she went to hospital and was diagnosed with cellulitis. Hematology laboratory test diagnostic, X-Ray and brain scan were performed (result not reported). It was reported that the patient missed a couple days of work. The patient was prescribed a treatment with cefadroxil 1000 mg by mouth twice a day for 5 days. The outcome of cellulitis was reported as recovering. Relatedness between cellulitis and the vaccination with PNEUMOVAX 23 was not reported. Upon internal review, the adverse event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Pyrexia, Scan brain, X-ray
Clinical narrative: This spontaneous report as received from a pharmacist/pharmacy manager refers to a 68-year-old female patient with penicillin allergy. The patient's medical history included anxiety and high blood pressure. On 05-OCT-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N020501, expiry date: 03-MAR-2019), intramuscularly for prevention of pneumonia. Concomitant therapies included amlodipine, lisinopril (manufacturer unknown), hydrochlorothiazide and FLOXACIN. On 06-OCT-2017, the patient developed redness and warmth at the injection site. On 07-OCT-2017, the patient developed fever, chills, and general pain so she went to hospital and was diagnosed with cellulitis. Hematology laboratory test diagnostic, X-Ray and brain scan were performed (result not reported). It was reported that the patient missed a couple days of work. The patient was prescribed a treatment with cefadroxil 1000 mg by mouth twice a day for 5 days. The outcome of cellulitis was reported as recovering. Relatedness between cellulitis and the vaccination with PNEUMOVAX 23 was not reported. Upon internal review, the adverse event of cellulitis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified patients of unknown age and gender. In approximately 2017, reported as between 05-SEP-2017 and 26-SEP-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB (doses and anatomical locations were not reported, lot # M020101 expiration date: 07-MAR-2019, intramuscularly) for an unknown indication. Data logger involved (28.5F for 5 minutes). There was no previous temperature excursion. No adverse events reported. This is one of severel reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1709USA013890.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, with a some swelling, of the left arm, starting from the injection site and spreading down and around the arm (almost 6 inches in diameter). No itching reported. Patient visited her doctor, along with her husband (who also had a similar reaction to same shot received on same day). Both of them were advised to take Diphenhydramine. Symptoms still persists till today 10/20/2017.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Ear discomfort, Laboratory test, Muscle twitching, Muscular weakness
Clinical narrative: I have always gotten the seasonal flu shot/vaccine. Both ears began to pulsate when I went to bed (incline position), sounds like my heartbeat is in my ears. By Saturday, I had facial twitching and right arm weakness. By Sunday, I had right arm weakness. By Monday, my left elbow hurt with any movement.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: I have always gotten the seasonal flu shot/vaccine. Both ears began to pulsate when I went to bed (incline position), sounds like my heartbeat is in my ears. By Saturday, I had facial twitching and right arm weakness. By Sunday, I had right arm weakness. By Monday, my left elbow hurt with any movement.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: Injection sight reaction lasting 48 hours.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm
Clinical narrative: Arm red and warm to the touch extending all the way to the elbow, some itching that was relieved with BENADRYL.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Borrelia test, Chills, Injection site pain, Injection site swelling
Clinical narrative: Began soreness and swelling in the area for roughly 4 days, fever and chills developed on the 8th day for 4 additional days, progressing to rash on both legs, including swelling of ankles and feet, bilaterally. Sores developed inside mouth at which point physician sent patient to ER for consult. Pt admitted to hospital, where patient was successfully treated with TYLENOL and other agents non disclosed for symptomatic treatment. ID is running samples to determine cause.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Parvovirus B19 test, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Began soreness and swelling in the area for roughly 4 days, fever and chills developed on the 8th day for 4 additional days, progressing to rash on both legs, including swelling of ankles and feet, bilaterally. Sores developed inside mouth at which point physician sent patient to ER for consult. Pt admitted to hospital, where patient was successfully treated with TYLENOL and other agents non disclosed for symptomatic treatment. ID is running samples to determine cause.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: Began soreness and swelling in the area for roughly 4 days, fever and chills developed on the 8th day for 4 additional days, progressing to rash on both legs, including swelling of ankles and feet, bilaterally. Sores developed inside mouth at which point physician sent patient to ER for consult. Pt admitted to hospital, where patient was successfully treated with TYLENOL and other agents non disclosed for symptomatic treatment. ID is running samples to determine cause.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Full blood count normal, Metabolic function test normal, Pruritus, Pyrexia, Rash
Clinical narrative: 1 DAYS AFTER VACCINES, DEVELOPED INCREASING RASH CHEST, GROIN, BACK. FEVER PRURITIS TAKE TO ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urine analysis normal
Clinical narrative: 1 DAYS AFTER VACCINES, DEVELOPED INCREASING RASH CHEST, GROIN, BACK. FEVER PRURITIS TAKE TO ER.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test normal, Injection site pain, Malaise, Myalgia
Clinical narrative: Extreme pain at injection site within 24 hours. By the next morning, my whole right arm was screaming in pain (nerve, muscular). Felt physically ill and vomitted a few times. Went back to the same urgent care and they prescribed me with prednisone 5 day treatment at 40mg. I slowly felt better over a couple of days until I felt the pain spread to my left arm, then legs, and now 4 months later, my whole body. The pain turned into joint and muscle and nerve pain, jumping around my body at different times. No pain medicines work, and steroid prednisone does not work anymore. The pain has been slowly subsiding but for these several months I have seen specialists, had a handful of blood panels done, and nothing turned up.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia, Pain, Pain in extremity, Vomiting
Clinical narrative: Extreme pain at injection site within 24 hours. By the next morning, my whole right arm was screaming in pain (nerve, muscular). Felt physically ill and vomitted a few times. Went back to the same urgent care and they prescribed me with prednisone 5 day treatment at 40mg. I slowly felt better over a couple of days until I felt the pain spread to my left arm, then legs, and now 4 months later, my whole body. The pain turned into joint and muscle and nerve pain, jumping around my body at different times. No pain medicines work, and steroid prednisone does not work anymore. The pain has been slowly subsiding but for these several months I have seen specialists, had a handful of blood panels done, and nothing turned up.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Pain, Swelling
Clinical narrative: PATIENT PRESENTED TO PHARMACY AROUND 9:10AM ON 10/20/17 INQUIRING ABOUT POSSIBLE REACTION TO PNEUMOVAX VACCINE IN LEFT ARM. PT REPORTED REDNESS, SWELLING, AND PAIN BEGINNING ON MONDAY EVENING AFTER RECEIVING VACCINE WHICH HAS CONTINUED THROUGH OUT TODAY WITH REDNESS SPREADING FROM UPPER ARM DOWN TO ELBOW AREA. PT REPORTED TO HAVE BEEN CAMPING THIS WEEK SINCE RECEIVING THE VACCINES ON 10/20. WITH THE REDNESS & SWELLING IN THE AREA NOT RELATED TO INJECTION SITE, I ADVISED PT TO SEEK ADVICE OF PHYSICIAN TO DETERMINE WHETHER OR NOT SOMETHING OCCURRED WHILE CAMPING OR AT ANOTHER TIME, UNRELATED TO VACCINE ADMINISTRATION. PT SOUGHT TREATMENT FROM LOCAL URGENT CARE WHERE PHYSICIAN THERE DETERMINED AFTER EXAM THAT REACTION WAS DUE TO VACCINE. PT REPORTED BEING INSTRUCTED TO TAKE OTC NAPROXEN IF NECESSARY & THAT NO OTHER TREATMENT WAS ADMINISTERED OR NECESSARY.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling, tender to touch pt given triamcinolone acetonide cream.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Back pain, Bacterial test, Biopsy tonsil, Blood test, Chills
Clinical narrative: Shortly after receiving the 3rd dose of GARDASIL 4, my son developed allergy like symptoms in the sinuses. Sinusitis developed in September, which was incurable no matter what we tried (CLARITIN, Nasal Wash, BENADRYL). BENADRYL). By October patient experienced his first bout with high fevers and enlarged lymph nodes in the neck (cervical), accompanied by terrible sore throat, neck pain at the base of the head and lower back pain. This lasted for 4 days - 104 days-104 degree fever, chills, exhaustion, loss of sharp thinking. He stated he felt like his head was going to explode and he said he felt as if he wasn't as smart. This pattern of sickness came again - 6 weeks to the day in November, in December, and every 6 week weeks now for a year. We removed his tonsils, biopsied them no cure. We have tried prescription allergy medicine, homeopathic aids- such as arm and hammer wash, but he is still getting symptoms every six weeks to the day.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Epstein-Barr virus test, Fatigue, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: Shortly after receiving the 3rd dose of GARDASIL 4, my son developed allergy like symptoms in the sinuses. Sinusitis developed in September, which was incurable no matter what we tried (CLARITIN, Nasal Wash, BENADRYL). BENADRYL). By October patient experienced his first bout with high fevers and enlarged lymph nodes in the neck (cervical), accompanied by terrible sore throat, neck pain at the base of the head and lower back pain. This lasted for 4 days - 104 days-104 degree fever, chills, exhaustion, loss of sharp thinking. He stated he felt like his head was going to explode and he said he felt as if he wasn't as smart. This pattern of sickness came again - 6 weeks to the day in November, in December, and every 6 week weeks now for a year. We removed his tonsils, biopsied them no cure. We have tried prescription allergy medicine, homeopathic aids- such as arm and hammer wash, but he is still getting symptoms every six weeks to the day.