chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: ANTH, JEVX, ANTH, JEV1
Symptoms: Allodynia, Feeling hot, Injection site pain, Myalgia, Pain of skin
Clinical narrative: He received vaccines on 29 Apr '16. He was fine until the next morning when he awoke to find his left arm (JEV arm) injection site painful as was his scalp, even to light touch. Over the next 24 hours, the tactile allodynia, first noticed in his scalp, descended to affect his chest and extremities. There was no rash, redness, or other skin changes. Later in the day he felt as though he had a fever (didn't take temperature) and developed generalized myalgia, without arthralgia. States no one in the family was ill at the time. He went in to ER on 2 May (no entry found). Took ibuprofen, 1-2 doses/day. He states that the allodynia and myalgia peaked on day 2, lasted about 24-36 hrs, then slowly resolved such that he was symptom-free about 5 days following immunization. He has no hx of medical problems, takes no chronic meds, other than an OTC supplement, which he stopped about the time he received his shots. No previous reactions to any vaccines. No allergies. He has been symptom-free for over 30 days. Received 2nd JEV vaccine singly one month later with no reaction. Will receive 2nd AVA singly also in 1 week.
Age: 32.0
Sex: M
Vaccine: ANTH, JEVX, ANTH, JEV1
Symptoms: Tenderness
Clinical narrative: He received vaccines on 29 Apr '16. He was fine until the next morning when he awoke to find his left arm (JEV arm) injection site painful as was his scalp, even to light touch. Over the next 24 hours, the tactile allodynia, first noticed in his scalp, descended to affect his chest and extremities. There was no rash, redness, or other skin changes. Later in the day he felt as though he had a fever (didn't take temperature) and developed generalized myalgia, without arthralgia. States no one in the family was ill at the time. He went in to ER on 2 May (no entry found). Took ibuprofen, 1-2 doses/day. He states that the allodynia and myalgia peaked on day 2, lasted about 24-36 hrs, then slowly resolved such that he was symptom-free about 5 days following immunization. He has no hx of medical problems, takes no chronic meds, other than an OTC supplement, which he stopped about the time he received his shots. No previous reactions to any vaccines. No allergies. He has been symptom-free for over 30 days. Received 2nd JEV vaccine singly one month later with no reaction. Will receive 2nd AVA singly also in 1 week.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Activities of daily living impaired, Blood test abnormal, Dysmenorrhoea, Dyspnoea, Fatigue
Clinical narrative: Information has been received from a licensed vocational nurse concerning her 16 year old daughter. The patient was allergic to macrolides. She had no pertinent medical history. On unspecified dates, the patient received 2 doses of unidentified Merck human papillomavirus (HPV) vaccine (name and lot number not provided) (dose and route not provided). There was no concomitant therapy. The nurse stated she picked up her daughter from school and noticed her neck was swollen and she was having difficulty breathing. On 13-AUG-2015, the nurse took her daughter to the emergency room where blood work was performed and the patient was diagnosed with hyperthyroidism. It was also reported that the patient also had irregular periods with extreme cramps, headaches, numbness in her legs and extreme fatigue (onset dates unknown). The patient was a competitive cheerleader and she had to stop cheering since starting treatment with levothyroxine sodium (manufacturer unknown). Because she had extreme fatigue and difficulty breathing, she could not do anything upside down anymore. The outcome of all the events was reported as not recovered. The relationship between the events and the vaccination was not reported. The reporter considered the events of extreme fatigue and hyperthyroidism to be disabling. The reporter considered all the events to be life threatening. Upon internal review, the event hyperthyroidism was considered to be medical significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Hyperthyroidism, Hypoaesthesia, Local swelling, Menstruation irregular
Clinical narrative: Information has been received from a licensed vocational nurse concerning her 16 year old daughter. The patient was allergic to macrolides. She had no pertinent medical history. On unspecified dates, the patient received 2 doses of unidentified Merck human papillomavirus (HPV) vaccine (name and lot number not provided) (dose and route not provided). There was no concomitant therapy. The nurse stated she picked up her daughter from school and noticed her neck was swollen and she was having difficulty breathing. On 13-AUG-2015, the nurse took her daughter to the emergency room where blood work was performed and the patient was diagnosed with hyperthyroidism. It was also reported that the patient also had irregular periods with extreme cramps, headaches, numbness in her legs and extreme fatigue (onset dates unknown). The patient was a competitive cheerleader and she had to stop cheering since starting treatment with levothyroxine sodium (manufacturer unknown). Because she had extreme fatigue and difficulty breathing, she could not do anything upside down anymore. The outcome of all the events was reported as not recovered. The relationship between the events and the vaccination was not reported. The reporter considered the events of extreme fatigue and hyperthyroidism to be disabling. The reporter considered all the events to be life threatening. Upon internal review, the event hyperthyroidism was considered to be medical significant. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Injection site inflammation, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 26 May 2016. Manufacturer control number: 2016268325. This case involves a female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. Patient's previous medication included TETANUS TOXOID which she took probably 3-4 years ago. On unspecified date following the vaccination, the patient experienced fever and the injection site was very inflamed. Laboratory data and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose decreased, Fatigue, Headache, Pyrexia, Thinking abnormal
Clinical narrative: Patient called pharmacy day after shot and was driving home complaining of fatigue,"loss of thought", fever, headache. RPH told her to go directly to ER or MD for evaluation. At the ER she was told her Blood Sugar was very low(26).  RPH followed up with phone call on 6/15/2016 and patient was doing much better,
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever, Sore arm, Feeling sick.
Age: 13.0
Sex: F
Vaccine: HPV9, TYP
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Vomiting after vaccine administration, Felt achy, Nausea.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Feeling abnormal, Nausea, Pain, Pyrexia
Clinical narrative: Patient states that the afternoon that she received the injection she started feeling really bad. When she woke up the next am she had a fever of 102, severe body aches, diarrhea and nausea. This lasted for 2 days.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse, refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a dose of PROQUAD (lot # L040415, expiration date 13-APR-2017) or VARIVAX (lot# L031068, expiration date 18-AUG-2017). On an unspecified date, the vaccines were exposed to temperature 17 Fahrenheit (F) during 55 hours. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with an unidentified "rubella vaccine" (manufacturer unknown) (name, lot #, dose and route were unspecified). On an unknown date the patient had an unspecified allergic reaction to the "rubella vaccine". The outcome of the event was not provided. The reporter considered the event to be related to the unidentified "rubella vaccine" (manufacturer unknown). Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: HEP, HEPA, PPV, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Given ZOSTAVAX vaccine. Patient had received previous ZOSTAVAX vaccine on 12/18/2015.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Swelling
Clinical narrative: Site redness, Slightly swollen. Spoke with mom at 08:15 AM today. PCP notified. No SOB, no rash/hives, no facial swelling. Advised to observe, check with PCP for Meds, ER if conditions worsens.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: Non pruritic rash surrounding injection site, no swelling, no pain, stable and not progressing.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported a similar event for two patients. This is the first of two reports. A 16 year-old female patient of an unspecified ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on 01Jun2016. The patient medical history and concomitant medications were not reported. The patient fainted 15 minutes after the vaccination on 01Jun2016. Outcome was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported the same event for two patients. This is second of two reports. A 17-year-old male patient of an unspecified ethnicity received the first single dose of TRUMENBA, on 19May2016. 15 minutes later the patient fainted. The outcome of the event was unknown.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Malaise, Muscular weakness, Walking aid user
Clinical narrative: No fever. Extreme weakness - especially legs. Overall very sick feeling. Absolute dependence on walker - before could walk without help.
Age: 1.26
Sex: M
Vaccine: VARCEL
Symptoms: Condition aggravated, Pyrexia, Seizure
Clinical narrative: Fever causing seizure (day 1). Seizure (day 7).
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Diarrhoea, Enterovirus test positive, Haematochezia, Human rhinovirus test positive, Intensive care
Clinical narrative: Acute febrile illness, following vaccination, acute diarrhoea and vomiting requiring admission for rehydration (4/7/16-4/10/16). Hematochezia on 4/15.16. Admitted to PICU (4/7/16-4/9/16), Discharged home on 4/10/16.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: Acute febrile illness, following vaccination, acute diarrhoea and vomiting requiring admission for rehydration (4/7/16-4/10/16). Hematochezia on 4/15.16. Admitted to PICU (4/7/16-4/9/16), Discharged home on 4/10/16.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Paraplegia, Walking aid user, Wheelchair user
Clinical narrative: 10 day wchair. 10 day walker. In nursing home 1 month. Paralyzed, waist down for 1 month.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: 11/4/15 pt admitted to hosp w/(B) lower extremity weakness and numbness and paresthesias of (B) hands.
Sex: U
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2012US021091 is an initial spontaneous report received from a medical assistant on 24 Oct 2012. This case refers to three patients (age and gender not reported). These patients were vaccinated with MENVEO (batch number: not reported) intramuscularly on unspecified dates. Two patients were vaccinated two weeks before and other patient vaccinated about one month before the time of this report. All the three patients fainted following vaccination. No other information was available.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2012US007401 is a spontaneous report initially received from a health care professional on 30 Mar 2012 with a follow-up received on 16 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that he was vaccinated intramuscularly only with the MenA lyophilized conjugate of MENVEO (batch number: A10058) reconstituted with a sterile diluent and that he did not receive the MenCYW-135 liquid conjugate vaccine component on an unspecified date. No adverse event was reported following this drug administration error. The Marketing Authorization Holder (MAH) attempted further follow-up but no response received so far from the reporter. Hence the case was closed due to lack of response. Follow up report was received on 16 Apr 2012: Updated information about lost to follow-up. Following an internal review on 18 May 2012 of the data received on 16 Apr 2012 it was observed that the event verbatim "received only Men A lyophilized conjugate component of MENVEO vaccine' was erroneously coded to drug administration error and hence the event was now recoded to inappropriate preparation of medication.
Sex: U
Vaccine: MNQ
Symptoms: Seizure like phenomena
Clinical narrative: Case number PHEH2012US013317 is an initial spontaneous report received from a nurse on 27 Jun 2012. This case refers to multiple patients (four to five). These patients were vaccinated with MENVEO (batch number: unknown) intramuscularly on an unspecified date. After vaccination, they experienced seizure like activity. The outcome and causality of the events was not reported.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site atrophy, Injection site discolouration, Injection site dryness, Injection site nodule, Injection site pain
Clinical narrative: initial: pPin at injection site on left arm. Current: nodual under skin at injection site and indented on the surface; skin appeared dry and purple.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site atrophy, Injection site discolouration, Injection site dryness, Injection site induration
Clinical narrative: initial: pPin at injection site on left arm. Current: nodual under skin at injection site and indented on the surface; skin appeared dry and purple.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: initial: pPin at injection site on left arm. Current: nodual under skin at injection site and indented on the surface; skin appeared dry and purple.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised
Clinical narrative: Pt presented to the Immunizations clinic with a noticeable rash.  Pt states he woke up with the rash all over his body. Denies using or trying anything new. Did not have any other symptoms at the time he presented to the clinic.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site reaction, Swelling
Clinical narrative: MOM OBSERVED SITE TO BE RED AND PUFFY.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: SITE SWOLLEN, RED HARD PER MOTHER. TEMP 101.5.  SHE STATES SHE TOOK HIM TO ER ON SATURDAY AND NOTHING WAS DONE FOR CHILD. SHE BROUGHT HIM IN HERE 06/13/2016 FOR EVAL.  SITE OF BOTH KINRIX AND MMRV WERE RED.  KINRIX SITE HOT, SWOLLEN AND HARD, ALSO. REFERRED TO ANOTHER FACILITY.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure like phenomena, Skin discolouration
Clinical narrative: Client passed out and had seizure like activity when getting into the car. No fall or injury. Mother walked to client back to the Health Department at 1420. His color was greenish but client was alert and oriented. Given water and crackers and laid on the exam table for 15 minutes without further incident.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Started with soreness at injection site.  Then fatigue set in.  Fatigue became severe and muscle and joint aches began at around 4:00 PM.  Fever and chills set in by 8:00 PM.  All these symptoms remained for 24-36 hours after this.  Symptoms resolved by 6:00 PM or so on 05/16/2016.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Started with soreness at injection site.  Then fatigue set in.  Fatigue became severe and muscle and joint aches began at around 4:00 PM.  Fever and chills set in by 8:00 PM.  All these symptoms remained for 24-36 hours after this.  Symptoms resolved by 6:00 PM or so on 05/16/2016.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Pain
Clinical narrative: Unsure of when exactly event happened - child reports feeling weak/dizzy, body aches for about 1month after each vaccination.
Age: 1.88
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Arm is warm to touch and swollen from shoulder to elbow.
Age: 10.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Stuffy nose, soar throat, low fever.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Influenza like illness, Malaise, Pain, Pericarditis
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of pericarditis in a 44-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced pericarditis (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the pericarditis was unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the pericarditis and sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: This case was received from consumer via the vaccine patient assistance program. The age at vaccination was not reported. The patient experienced allergic reaction in the form of pericarditis and sick for about 6 weeks. The patient experienced swollen arm, severe pain and flu like symptoms after vaccination with tetanus vaccine. This case has been linked to case US2016GSK079166, reported for pharma drugs.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of pericarditis in a 44-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced pericarditis (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the pericarditis was unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the pericarditis and sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: This case was received from consumer via the vaccine patient assistance program. The age at vaccination was not reported. The patient experienced allergic reaction in the form of pericarditis and sick for about 6 weeks. The patient experienced swollen arm, severe pain and flu like symptoms after vaccination with tetanus vaccine. This case has been linked to case US2016GSK079166, reported for pharma drugs.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Ear congestion, Tinnitus
Clinical narrative: Hearing loss, extreme feeling of ears filling with fluid, and loud ringing in ears that lasted three to four months. The loud ringing persists.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal distension, Back pain, Dizziness, Dyspnoea, Eye swelling
Clinical narrative: Has seasonal allergies. Mom says she tends to have Fall allergies not Spring allergies. Mom also stated that patient had some pain on the side of her neck prior to taking any oral typhoid vaccine. Came in and received Tdap, Flu, and oral typhoid pills. Did not begin taking oral typhoid until 5/20/16. Timeline: 5/20/16-Took first oral typhoid pill at bedtime. 5/21/16-Woke at 8:30 am with allergy-like symptoms. Patient complained of scratchy throat, not feeling well. She took ALLER TEC in the morning and BENADRYL at night. 5/22/16-Woke up with same symptoms as on the 21st. Still taking ALLER TEC and BENADRYL. Took 2nd oral typhoid pill at bedtime. 5/23/16-Woke up with same symptoms as on the 21st but now has a sore throat and dizziness. Still taking ALLER TEC and BENADRYL. 5/24/16-Same symptoms and took 3rd oral typhoid pill at bedtime. 5/25/16-Woke up at 8:30 am patient stated that she couldn't breathe well, her face, eyes, and tongue were swollen. Her mother gave her 2 BENADRYLS and went to the urgent care. The physician there told her to stop taking the oral typhoid and continue with allergy treatments. 5/26/16-Woke up with similar symptoms but not as severe; achy neck. Travel. Dr. called in a prescription for 5-day course of prednisone. Over the weekend patient stated that her eyes were not so puffy but complained of neck and back ache. 5/28/16-Patient still has neck and back ache but states that stomach feels swollen. 5/29/16-Patient returned home and texted Dr. He told her if not feeling well in the morning to go to the doctor. 5/30/16-Patient awoke feeling bad again, face and eyes swollen and returned to urgent care. She was sent to the ER. The ER tested for strep which came back negative. They then tested for mononucleosis which came back positive. She was given a shot of prednisone and patient stated that symptoms subsided within 3 hrs. Still taking ALLER TEC and BENADRYL. 5/31/16-Woke up and throat is feeling better but by night throat was sore again. 6/1/16-Mom states that she is still not feeling good today. This is the last time I visited with the mother.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Feeling abnormal, Hypersensitivity, Malaise, Mononucleosis heterophile test positive, Neck pain
Clinical narrative: Has seasonal allergies. Mom says she tends to have Fall allergies not Spring allergies. Mom also stated that patient had some pain on the side of her neck prior to taking any oral typhoid vaccine. Came in and received Tdap, Flu, and oral typhoid pills. Did not begin taking oral typhoid until 5/20/16. Timeline: 5/20/16-Took first oral typhoid pill at bedtime. 5/21/16-Woke at 8:30 am with allergy-like symptoms. Patient complained of scratchy throat, not feeling well. She took ALLER TEC in the morning and BENADRYL at night. 5/22/16-Woke up with same symptoms as on the 21st. Still taking ALLER TEC and BENADRYL. Took 2nd oral typhoid pill at bedtime. 5/23/16-Woke up with same symptoms as on the 21st but now has a sore throat and dizziness. Still taking ALLER TEC and BENADRYL. 5/24/16-Same symptoms and took 3rd oral typhoid pill at bedtime. 5/25/16-Woke up at 8:30 am patient stated that she couldn't breathe well, her face, eyes, and tongue were swollen. Her mother gave her 2 BENADRYLS and went to the urgent care. The physician there told her to stop taking the oral typhoid and continue with allergy treatments. 5/26/16-Woke up with similar symptoms but not as severe; achy neck. Travel. Dr. called in a prescription for 5-day course of prednisone. Over the weekend patient stated that her eyes were not so puffy but complained of neck and back ache. 5/28/16-Patient still has neck and back ache but states that stomach feels swollen. 5/29/16-Patient returned home and texted Dr. He told her if not feeling well in the morning to go to the doctor. 5/30/16-Patient awoke feeling bad again, face and eyes swollen and returned to urgent care. She was sent to the ER. The ER tested for strep which came back negative. They then tested for mononucleosis which came back positive. She was given a shot of prednisone and patient stated that symptoms subsided within 3 hrs. Still taking ALLER TEC and BENADRYL. 5/31/16-Woke up and throat is feeling better but by night throat was sore again. 6/1/16-Mom states that she is still not feeling good today. This is the last time I visited with the mother.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Streptococcus test negative, Swelling face, Swollen tongue, Throat irritation
Clinical narrative: Has seasonal allergies. Mom says she tends to have Fall allergies not Spring allergies. Mom also stated that patient had some pain on the side of her neck prior to taking any oral typhoid vaccine. Came in and received Tdap, Flu, and oral typhoid pills. Did not begin taking oral typhoid until 5/20/16. Timeline: 5/20/16-Took first oral typhoid pill at bedtime. 5/21/16-Woke at 8:30 am with allergy-like symptoms. Patient complained of scratchy throat, not feeling well. She took ALLER TEC in the morning and BENADRYL at night. 5/22/16-Woke up with same symptoms as on the 21st. Still taking ALLER TEC and BENADRYL. Took 2nd oral typhoid pill at bedtime. 5/23/16-Woke up with same symptoms as on the 21st but now has a sore throat and dizziness. Still taking ALLER TEC and BENADRYL. 5/24/16-Same symptoms and took 3rd oral typhoid pill at bedtime. 5/25/16-Woke up at 8:30 am patient stated that she couldn't breathe well, her face, eyes, and tongue were swollen. Her mother gave her 2 BENADRYLS and went to the urgent care. The physician there told her to stop taking the oral typhoid and continue with allergy treatments. 5/26/16-Woke up with similar symptoms but not as severe; achy neck. Travel. Dr. called in a prescription for 5-day course of prednisone. Over the weekend patient stated that her eyes were not so puffy but complained of neck and back ache. 5/28/16-Patient still has neck and back ache but states that stomach feels swollen. 5/29/16-Patient returned home and texted Dr. He told her if not feeling well in the morning to go to the doctor. 5/30/16-Patient awoke feeling bad again, face and eyes swollen and returned to urgent care. She was sent to the ER. The ER tested for strep which came back negative. They then tested for mononucleosis which came back positive. She was given a shot of prednisone and patient stated that symptoms subsided within 3 hrs. Still taking ALLER TEC and BENADRYL. 5/31/16-Woke up and throat is feeling better but by night throat was sore again. 6/1/16-Mom states that she is still not feeling good today. This is the last time I visited with the mother.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site hypoaesthesia, Injection site oedema, Injection site paraesthesia
Clinical narrative: Received FLUZONE vaccine to left deltoid had immediate reaction of edema, redness and complains of numbness/tingling from site to elbow.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: 2 days after receiving shot on 10/14/15 lost the ability to grip right hand still undergoing treatment.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Acute pain at injection site in upper right shoulder at bed time, the day I received vaccine. Next morning pain in both forearms both hands were stiff and swollen. After a week of no improvement took prednisone "6 pack", relieved symptoms but they returned 2 days after stopping prednisone. 2 months later symptoms mostly gone - still some swelling in hands pain in shoulder took a full month and a half for swelling to completely go away.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, fever and body aches. Vancomycin 1000 mg once, methylprednisolone 125 mg once, ketorolac tromethamine 30 mg once.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient called on 2/15/2016 and said she was having difficulty with arm movement had injection on 2/1/16 and I referred her to primary care physician.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Back pain, Fibromyalgia, Herpes zoster, In vitro fertilisation
Clinical narrative: This spontaneous report was received from a registered nurse, referring to her daughter, an 18 year old no-pregnant female patient. The patient presented drug allergy/reaction to DENEROL, however, no information about the patient's pertinent medical history was reported. On an unknown date (when the patient was 12 year old), the patient was vaccinated with VARIVAX (strength, dose, lot number, route and anatomical location were not reported). Concomitant medications were not reported. On an unknown date, the patient had been coming down with singles episodes, she was currently 29 years old and she had 5 shingles episodes since age 18 (date unspecified) and currently was having sensation on her back around S3 vertebrae area, similar to what she experienced with each episode of shingles. The patient was suspecting that she might becoming down with possibly 6th shingles. Nurse reported that the patient's very first episode of singles was presented with right hip pain and two days later, the patient noticed legions on her back, L3 and L4 vertebrae area, along with pain. Nurse reported that the patient's all 5 episodes of shingles manifested exactly the same way, each time, with hip pain and legions on her back. The current pre-shingles sensation the patient was experiencing was around S3 area on vertebrae but patient was yet to have external symptoms of rash but patient described to the reporter that sensation was very similar to what she felt with previous cases of shingles. Nurse also reported that the patient was diagnosed with fibromyalgia in the year following first case of shingles. Nurse reported that her daughter also had polycystic ovarian syndrome and currently going through in vitro fertilization (IVF) treatment. The patient sought medical attention via an office visit and received Acyclovir for the shingles. No lab diagnostic studies were performed. At the time of reporting, the outcome of fibromyalgia, herpes zoster, polycystic ovaries and sensory disturbance was reported as not recovered/not resolved. The relatedness between the events and the vaccination with VARIVAX was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Polycystic ovaries, Sensory disturbance
Clinical narrative: This spontaneous report was received from a registered nurse, referring to her daughter, an 18 year old no-pregnant female patient. The patient presented drug allergy/reaction to DENEROL, however, no information about the patient's pertinent medical history was reported. On an unknown date (when the patient was 12 year old), the patient was vaccinated with VARIVAX (strength, dose, lot number, route and anatomical location were not reported). Concomitant medications were not reported. On an unknown date, the patient had been coming down with singles episodes, she was currently 29 years old and she had 5 shingles episodes since age 18 (date unspecified) and currently was having sensation on her back around S3 vertebrae area, similar to what she experienced with each episode of shingles. The patient was suspecting that she might becoming down with possibly 6th shingles. Nurse reported that the patient's very first episode of singles was presented with right hip pain and two days later, the patient noticed legions on her back, L3 and L4 vertebrae area, along with pain. Nurse reported that the patient's all 5 episodes of shingles manifested exactly the same way, each time, with hip pain and legions on her back. The current pre-shingles sensation the patient was experiencing was around S3 area on vertebrae but patient was yet to have external symptoms of rash but patient described to the reporter that sensation was very similar to what she felt with previous cases of shingles. Nurse also reported that the patient was diagnosed with fibromyalgia in the year following first case of shingles. Nurse reported that her daughter also had polycystic ovarian syndrome and currently going through in vitro fertilization (IVF) treatment. The patient sought medical attention via an office visit and received Acyclovir for the shingles. No lab diagnostic studies were performed. At the time of reporting, the outcome of fibromyalgia, herpes zoster, polycystic ovaries and sensory disturbance was reported as not recovered/not resolved. The relatedness between the events and the vaccination with VARIVAX was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Product preparation error
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a 15 year old male patient. The patient had no concurrent conditions, medical history and no drug reaction or allergies to be reported. On 02-JUN-2016 (also reported as 06-JUN-2016) the patient was vaccinated with the third dose of GARDASIL 0.5 ml, lot # L040460, expiration date 27-MAY-2017, intramuscularly. Other suspect therapies include sterile diluent (manufacturer unknown) (dose unknown) lot # reported as L045726, expiration date: 26-MAY-2018 (not valid for sterile diluent but valid for GARDASIL), administered on 02-JUN-2016. Concomitant medications were not reported. The pharmacy technician reported that when the medical assistant administered the vaccine, she added an unspecified amount of sterile water diluent (manufacturer unknown) to the 0.5ml dose of GARDASIL. It was also reported that the patient experienced pain at the injection site immediately after the vaccination that lasted for an unspecified duration and resolved on an unspecified date in June 2016. No laboratories were performed. The causality between pain and GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to possibly 3 patients of unknown age and gender. On an unknown date in 2016 the patients were vaccinated with a dose of GARDASIL (reported lot# M004116, expiration date 12-OCT-2017, was invalid for GARDASIL and dose of RECOMBIVAX HB (lot# L004754, expiration date 10-NOV-2016; lot# L040458, expiration date 04-FEB-2018) (doses and routes were not reported). The vaccines were exposed to temperature between 32 Fahrenheit (F) and 34F, 10 days in May 2016. Medical assistant did not even known which vaccines were administered. No symptoms were reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Blood culture, Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother of infant reported temp. of 101.4 at 7pm Thursday 6/2/16. Her right leg felt warm, was red and swollen. She was given TYLENOL every 4h through Friday 6/3/16. Mom was instructed to take to ER.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: Received flu vaccine on 10/20/15. Initially post flu shot my arm was tender as it had been for previous flu shots. However, pain began to increase steadily and did not subside. Severe and throbbing pain in left arm with diminished range of motion. Heated, iced and took ibuprofen. Treated with physical therapy and shoulder injection.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Full blood count, Injection site induration, Injection site mass
Clinical narrative: Vaccine administered 6/9/16, mom noticed lump on (R) thigh the following day when bathing child. Denies fever. Lump was hard. Pt seen by doctor on 6/14/16. Treatment plan: Apply ice x 10 minutes 3x a day, acetaminophen as needed for pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Local induration, erythema. Fever, swelling at (L) upper arm.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: Arm where vaccinated swollen to the elbow.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Arm where vaccinated swollen to the elbow.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Within minutes of giving last vaccine, patient fainted. Skin pale and diaphoretic. Patient aroused with use of ammonia inhalant. Mother present. Pt reports she did not eat prior to appointment. Food given to patient, along with sweet tea provided by mother. Transferred to w/c to private room to lie down. Observed x 15 min. with no further issues. Pt with history of seizures and will notify neurologist. Denies further issues.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Presented 6/1/16 to nurse with 2 1/2 inch raised red patch on upper right arm. Outlined circumference with marker. Advised patient to seek medical attention if fever or difficulty breathing occur. Provided with instructions to ice 10 minutes hourly. To discuss with physician at appt on 6/3/16.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Child started running a fever up to 102.3 after vaccines were administered. The next day Mom noticed hives develop on child's face, back and extremities. The hives resolve within 15 minutes and have randomly reappeared since initial onset. TYLENOL has been used twice for treatment.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Cold sweat, Nasopharyngitis, Pallor, Syncope
Clinical narrative: After third vaccine (HPV) administered client got cool, clammy and pale. Client fainted for approx. 20-30 seconds. Oxygen was administered - BP was 100/60. Client was alert and oriented to person, place and time. Blood pressure rechecked 15 min later 110/60. Client stayed at office for an hour and felt fine.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Myalgia, Pain in extremity
Clinical narrative: (L) arm pain; muscle aches over entire body; diarrhea; fatigue.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Pain
Clinical narrative: Localized pain, redness, body aches, fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Mass
Clinical narrative: Two days after receiving ZOSTER vaccine, pt reports pain, redness, swelling, tenderness and extreme warmth/heat at the injection site. Also reports a lump under the skin approx. 3 inches in diameter. Nausea but no vomiting. No fever, SOB, dizziness or chest pain. Treated with doxycycline, calamine, cool compresses.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Two days after receiving ZOSTER vaccine, pt reports pain, redness, swelling, tenderness and extreme warmth/heat at the injection site. Also reports a lump under the skin approx. 3 inches in diameter. Nausea but no vomiting. No fever, SOB, dizziness or chest pain. Treated with doxycycline, calamine, cool compresses.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered improperly stored doses of PEDAXHIB (lot #, dose and route unknown). The vaccines were exposed at 63 Fahrenheit for 156 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical assistant referring to two patients of unknown age and unknown gender. Information about the concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, two doses of improperly stored VARIVAX (lot # L008272, expired date 03-NOV-2016) (dose, frequency and route was not provided) were administered to two unknown patients. The vaccines were store between min 13.0 F to max 18.1 F for 4 hours. There were no previous temperature excursions. No digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ (lot # and dose unknown) orally. The vaccines were exposed at 63 Fahrenheit for 156 hours. There was no previous temperature excursion. No adverse effect was reported. This is one two reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's concurrent or historical condition was not provided. On 09-JUN-2016 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K008198 with expired date of 05-JUN-2016, once and strength unknown) subcutaneously. Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or drug reactions/allergies were not provided. They were vaccinated with improperly stored GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017, dose and route not provided) or ROTATEQ (lot # L038534, expiration date 19-AUG-2017, dose and route not provided) on multiple unknown dates (Incorrect product storage). Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. Temperature: 47F. Time frame: 120 hours. Was it administered (AE): Yes. Previous temperature excursion: No. Was call because of a "data logger": No. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: 6/6/16 Appt at 2:30 - shot given approx. 3:00 pm - 4 hours later started with 102 degree, severe headache, and vomiting. - Given MOTRIN by patient for headache and temp. - Prescribed "ondansetron 4 mg tabs" for nausea and vomiting.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Body temperature increased, Headache, Nausea, Vomiting
Clinical narrative: 6/6/16 Appt at 2:30 - shot given approx. 3:00 pm - 4 hours later started with 102 degree, severe headache, and vomiting. - Given MOTRIN by patient for headache and temp. - Prescribed "ondansetron 4 mg tabs" for nausea and vomiting.
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unknown demography. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (dose, strength, route, lot # and expiration date unknown), that was mixed with sterile water diluent. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. In June 2016 (reported as "starting on or after 01-JUN-2016" until the reporting time of 13-JUN-2016), the patients were vaccinated with improperly stored VARIVAX (lot # L041207, expiration date 20-OCT-2017, dose and route not reported). It was reported that the vaccines were stored at -10.4 centigrade degree for 45 minutes. There was no previous excursion. No adverse effect reported. This case was reported because of a digital data logger issue. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site rash
Clinical narrative: Cellulitis of upper limb, rash - lt arm deltoid - 4.5 cm x 7.5 cm in diameter, irregular borders. Tx: Cefdinir 250 mg/5ml oral susp. Take 8 ml qd PO with meals x 10 days.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site redness - redness in quarter size diameter from injection point-warm skin in area of injection.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea, Frequent bowel movements, Haematochezia, Occult blood positive
Clinical narrative: 1 day after rotavirus vaccine had loose, frequent stools, some bloody, ongoing for several days.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with doses of improperly stored PEDVAXHIB (the lot #, expiration date, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 0.3C for 26 days and -11C for 5 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling to (R) and (L) leg. Right thigh 10 cm across. Left thigh 6 cm across. Warm to touch. MOTRIN, BENADRYL, TYLENOL, Ice pack.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unknown age and gender patient. The patient's medical history and concurrent conditions were not reported. On 09-JUN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX vial, subcutaneous, lot # L006381 and expiration date 25-MAY-2016 (Dosage, dose number, anatomical location were not reported). No other suspect therapies or concomitants were reported. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.