chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lethargy, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Her syptoms started at dinnertime with a feeling of lethargy and pain in arm, which progressed to severe pain,especially in arm, back and legs, a stif neck and arm, and headache. The pain was so severe that she was sobbing and needed to take some oxycodone. The severe pain lasted most of the night, and started to diminish in the morning. However when she called me at 4pm today she was still uncomfortable, lethargic and her arm is swollen and bright pink. She feels like she is definitely improving.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pruritus
Clinical narrative: Red arm, redness was growing and it hurts at the injection site, redness has gone down but is also itchy. Advised her to contact her healthcare provider for further evaluation.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warm at injection site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Injection site erythema
Clinical narrative: 9/20: diarrhea, sore joints, sore muscles, full body weakness (but still able to walk around house), chills. Injection site mildly swollen with 2.5 inch diameter pink area surrounding site. 9/21: symptoms resolving, still some swelling and pain in arm at injection site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: 9/20: diarrhea, sore joints, sore muscles, full body weakness (but still able to walk around house), chills. Injection site mildly swollen with 2.5 inch diameter pink area surrounding site. 9/21: symptoms resolving, still some swelling and pain in arm at injection site.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Injection site pruritus, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Patient received his Anthrax dose (6th) on 18 September and the following day complained of malaise, subjective fever ("feeling hot"), and noted pain/swelling at the vaccination site. He denies rhinoconjunctival, generalized cutaneous, lip/tongue/oral/laryngeal, pulmonary, neurologic, and CV symptoms. He notes a single loose stool. Today he feels the vaccinate site is improving and currently only complains of mild itching at the site. He denies prior adverse vaccine reactions.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site swelling
Clinical narrative: Patient received his Anthrax dose (6th) on 18 September and the following day complained of malaise, subjective fever ("feeling hot"), and noted pain/swelling at the vaccination site. He denies rhinoconjunctival, generalized cutaneous, lip/tongue/oral/laryngeal, pulmonary, neurologic, and CV symptoms. He notes a single loose stool. Today he feels the vaccinate site is improving and currently only complains of mild itching at the site. He denies prior adverse vaccine reactions.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eye swelling, Pyrexia, Rash generalised
Clinical narrative: Patient presented day after injected at pediatricians office. Head to toe rash with swelling in eyes and fever of 100.2 temporal.
Age: 2.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Body temperature increased, Hypersensitivity, Rash, Swelling face, Urticaria
Clinical narrative: Patient presented day after injected at pediatricians office. Head to toe rash with swelling in eyes and fever of 100.2 temporal.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Wrong drug administered
Clinical narrative: 3 yr old should have received FLULAVAL, but received FLUVIRIN. Ran fever of 103 dgrees that night.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Arm got very sore, red and very hot to the touch  about 2 inches below the injection site. Her husband called the doctor office and left a message and then to the pharmacy. The RPh on duty advised the patient to take Benadryl and two Ibuprofen 200mg on Monday evening. The patient went to the doctor Tuesday morning and got a prescription for Keflex 500mg ( four times daily for 5 days).
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Back pain, Chest pain, Chills, Emotional distress
Clinical narrative: Right deltoid arm sore on 09/06/2017 after Influenza vaccine. 09/07/2017 had fever/chills, night sweats, temperature 100F, severe lower/upper back pain radiating to the front of chest, abdominal pain, 10/10. Took 500mg Tylenol, for HA frontal area, wisdom teeth pain, sniffles, applied ice packs to body. Took Epsom salt bath. No nausea, vomiting, diarrhea. Will take today off work , emotionally distraught in tears, has I/A packet.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Night sweats, Pyrexia, Rhinorrhoea
Clinical narrative: Right deltoid arm sore on 09/06/2017 after Influenza vaccine. 09/07/2017 had fever/chills, night sweats, temperature 100F, severe lower/upper back pain radiating to the front of chest, abdominal pain, 10/10. Took 500mg Tylenol, for HA frontal area, wisdom teeth pain, sniffles, applied ice packs to body. Took Epsom salt bath. No nausea, vomiting, diarrhea. Will take today off work , emotionally distraught in tears, has I/A packet.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Toothache
Clinical narrative: Right deltoid arm sore on 09/06/2017 after Influenza vaccine. 09/07/2017 had fever/chills, night sweats, temperature 100F, severe lower/upper back pain radiating to the front of chest, abdominal pain, 10/10. Took 500mg Tylenol, for HA frontal area, wisdom teeth pain, sniffles, applied ice packs to body. Took Epsom salt bath. No nausea, vomiting, diarrhea. Will take today off work , emotionally distraught in tears, has I/A packet.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came in today 9/21/7 at 9:10 am complained of itching and swelling at the injection site, no pain, no symptoms of difficulty breathing. I advised patient to apply ice pack to the site to help reduce swelling, take benadryl for the itching, and advil for the inflammation. Also, advised patient to see the doctor if the swelling increases.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Cough, Throat tightness
Clinical narrative: Shortly after receiving the vaccine, he was coughing and said he felt a little tightness, I quickly gave him 2 Benadryl 25mg tablets and water, had him sit down. I checked on him every few minutes and he said the symptoms were improving. After about 25 minutes, he said he felt fine and was ready to go home. He was instructed to follow up at an emergency room.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Arthralgia, Full blood count abnormal, Lymphadenopathy, Swelling
Clinical narrative: 2nd day post vaccine, left sided neck swelling and tenderness. Supraclavicular lymphadenopathy. 3rd day post vaccine left elbow joint pain. No fever, no signs of cellulitis at injection site. CBC normal. Symptoms resolving by day 7 post vaccine no specific treatment.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: 2nd day post vaccine, left sided neck swelling and tenderness. Supraclavicular lymphadenopathy. 3rd day post vaccine left elbow joint pain. No fever, no signs of cellulitis at injection site. CBC normal. Symptoms resolving by day 7 post vaccine no specific treatment.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Eye swelling, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Over two weeks later after 2nd vaccine, the back of my arm hurt significantly and there are several red bumps and swelling at the injection site. I had a fever 9/20 of 100.1. I e had trouble breathing, and I also experienced swelling of my eyes and hives on my face.  It looks like shingles and the injection site. Also itching.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Pyrexia, Rash vesicular, Urticaria
Clinical narrative: Over two weeks later after 2nd vaccine, the back of my arm hurt significantly and there are several red bumps and swelling at the injection site. I had a fever 9/20 of 100.1. I e had trouble breathing, and I also experienced swelling of my eyes and hives on my face.  It looks like shingles and the injection site. Also itching.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood lactic acid increased, Dizziness, Hyperhidrosis, Injection site erythema
Clinical narrative: Vaccines given on 9/19/17 at approximately 4pm. Patient developed sore throat, profuse sweating with weakness/dizziness within 6-12 hours after receiving both vaccines. Had elevated WBC 20.7 and lactic acid 2.64 on admission to hospital. There is some redness at injection site of pneumococcal vaccine that patient says is getting worse (this is first encounter with patient- 9/21).
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oropharyngeal pain, White blood cell count increased
Clinical narrative: Vaccines given on 9/19/17 at approximately 4pm. Patient developed sore throat, profuse sweating with weakness/dizziness within 6-12 hours after receiving both vaccines. Had elevated WBC 20.7 and lactic acid 2.64 on admission to hospital. There is some redness at injection site of pneumococcal vaccine that patient says is getting worse (this is first encounter with patient- 9/21).
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Myalgia, Pain, Pyrexia
Clinical narrative: Patient returned on 9/21/17 at 830am, to pharmacy to report fever, aches and muscle pain, area to the left of injection site was red. Patient reported she had taken ibuprofen and used ICY HOT on the painful area of left arm. RPh recommended to continue to treat fever/aches and pains with ibuprofen to take oral BENADRYL and to use topical BENADRYL and ice on the painful area. She was told to not use ICY HOT rub which would aggravate the area. She was advised to seek medical treatment if condition worsened.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial infection, Blood test normal, Ear infection, Full blood count normal, Lymph node pain
Clinical narrative: On a Friday, two weeks to the day following vaccination, patient began complaining that her neck hurt (left side, below jaw). The next day (Saturday), her lymph node was swollen to approximately, the size of a golf ball. We took her to the clinic and they saliva tested for Mono (negative). They did a CBC and the results were inconclusive. She was sent home with no medications. On Monday afternoon, we took her back to the clinic because her neck had swollen to the size of an orange. She could not open her mouth or move her head. She had been running a low-grade fever all weekend but once they took a look at her, she began vomiting and they sent us straight to the emergency room. There, they did another CBC and another blood test. The results were again inconclusive. They performed no imaging and said it was either an ear infection or a tooth infection (bacterial). She was given intravenous antibiotics and a 10 day prescription for oral antibiotics and released. Patient took all of her pills as prescribed. It has now been a month since the initial symptoms and she still gets small fevers and although the lump in her lymph node has gone down substantially, it is still the size of a grape, very hard and very tender.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Mononucleosis heterophile test negative, Neck pain, Swelling, Tooth infection
Clinical narrative: On a Friday, two weeks to the day following vaccination, patient began complaining that her neck hurt (left side, below jaw). The next day (Saturday), her lymph node was swollen to approximately, the size of a golf ball. We took her to the clinic and they saliva tested for Mono (negative). They did a CBC and the results were inconclusive. She was sent home with no medications. On Monday afternoon, we took her back to the clinic because her neck had swollen to the size of an orange. She could not open her mouth or move her head. She had been running a low-grade fever all weekend but once they took a look at her, she began vomiting and they sent us straight to the emergency room. There, they did another CBC and another blood test. The results were again inconclusive. They performed no imaging and said it was either an ear infection or a tooth infection (bacterial). She was given intravenous antibiotics and a 10 day prescription for oral antibiotics and released. Patient took all of her pills as prescribed. It has now been a month since the initial symptoms and she still gets small fevers and although the lump in her lymph node has gone down substantially, it is still the size of a grape, very hard and very tender.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: On a Friday, two weeks to the day following vaccination, patient began complaining that her neck hurt (left side, below jaw). The next day (Saturday), her lymph node was swollen to approximately, the size of a golf ball. We took her to the clinic and they saliva tested for Mono (negative). They did a CBC and the results were inconclusive. She was sent home with no medications. On Monday afternoon, we took her back to the clinic because her neck had swollen to the size of an orange. She could not open her mouth or move her head. She had been running a low-grade fever all weekend but once they took a look at her, she began vomiting and they sent us straight to the emergency room. There, they did another CBC and another blood test. The results were again inconclusive. They performed no imaging and said it was either an ear infection or a tooth infection (bacterial). She was given intravenous antibiotics and a 10 day prescription for oral antibiotics and released. Patient took all of her pills as prescribed. It has now been a month since the initial symptoms and she still gets small fevers and although the lump in her lymph node has gone down substantially, it is still the size of a grape, very hard and very tender.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT CALLED INTO THE PHARMACY ON 9/21/17. SHE COMPLAINED THAT SHE WAS SLIGHTLY ITCHY ON THE INJECTION SITE AND RED. I TOLD HER THAT SHE MAY WANT TO CHECK IT WITH A DOCTOR JUST TO MAKE SURE. IT IS A POSSIBLE SIDE EFFECT OF ZOSTAVAX. THE ITCHING AND REDNESS STARTED YESTERDAY ON 9/20/17.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large area of redness, swelling, pain and warmth at site.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Heart rate decreased, Hypotension, Syncope
Clinical narrative: I fainted about 20 minutes after receiving the vaccination.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Limb discomfort, Muscular weakness
Clinical narrative: Swelling and hardness at the injection site, redness at and around injection site, arm weakness and heaviness, itchiness.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Swelling and hardness at the injection site, redness at and around injection site, arm weakness and heaviness, itchiness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site vesicles
Clinical narrative: Pt called this afternoon and reported hot, red, inflammation, blistering around injection site.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports swollen red area at injection site. After assessment of medical history, I recommended ibuprofen and asked patient to consult primary care.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPORTS REDNESS, SWELLING, ITCHING AT INJECTION SITE BY THE LATE AFTERNOON ON DAY OF INJECTION, SITE WARM TO TOUCH, REDNESS SPREADING WHEN SHE PRESENTED 2 DAYS AFTER THE VACCINE ADMINISTRATION. SHE SOUGHT MEDICAL TREATMENT AT HER PCP THAT DAY AND WAS DIAGNOSED WITH SUSPECTED CELLULITIS AND GIVEN KEFLEX.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Patient reports the inside side of her left arm having a large red sore area. The same arm as the injection but on the opposite side to the deltoid. It was painful and patient was having trouble even raising her arm up. By 9-15-17 the swelling and pain had subsided and the area appeared a tanner color than the rest of her arm. She reported having no signs of the reaction on 9-17-17. I told the patient to put ice on the reaction and instructed her to take ibuprofen the day she reported the reaction to me (9-13-17).
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose normal, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: Patient stated that she had syncope, sweating, nausea, weakness, and tingle in her hands. We monitored her blood pressure, elevated her feet, applied cold compress to injection site. Her supervisor called 911. 911 crew monitored her blood pressure and check her blood glucose. All results were normal. Patient decline to be hospitalized for further treatment.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient stated that she had syncope, sweating, nausea, weakness, and tingle in her hands. We monitored her blood pressure, elevated her feet, applied cold compress to injection site. Her supervisor called 911. 911 crew monitored her blood pressure and check her blood glucose. All results were normal. Patient decline to be hospitalized for further treatment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The sight felt a little itchy the evening that it was given. When I woke up I had a tennis ball size raised, red, warm spot on the back of my arm where injection was given. It was still itchy. The next day I woke up to the same spot on my arm only it was the size of a softball and more itchy. I went to the pharmacist after I got off work. He told me to report it and put ice on it.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Approximately 2 hours after vaccine, teen began to complain of rash on legs; legs felt warm to touch and were painful to palpation by self or family member; rash was red and barely palpable; no other new exposures per family.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein increased, CSF test abnormal, Guillain-Barre syndrome
Clinical narrative: Rapidly progressive ascending paralysis.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm pain and swelling at injection site. BENADRYL and ibuprofen given. No medical visit yet.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Patient states she expieranced stomach pain and headache the morning after she recieved her flu shot.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Syncope
Clinical narrative: About 1 minute following the administration of the two vaccines, the patient had an episode of syncope and recovered quickly and symptoms resolved. The patient fainted for a few seconds while seated in a chair and then her symptoms resolved quickly.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray, Chills, Echocardiogram, Laboratory test, Pneumonia
Clinical narrative: Fever, chills, pneumonia admitted to hospital.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever, chills, pneumonia admitted to hospital.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Malaise, Musculoskeletal chest pain, Oedema peripheral, Swelling
Clinical narrative: Pain/swelling under right axilla, chest wall. Started on Wed. 9/20/17. Malaise 9/19/17. Treatment: ADVIL 400 mg TID x 5 days, low heat to area.
Age: 48.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. walked into clinic C/O redness, itching, and swollen, triaged by RN. Pt. scheduled appointment, left before she could be seen. Appointment rescheduled and patient did not come in to scheduled appointment. When calling to reschedule patient stated site is no longer swollen or red. Just itching. Declined to make appointment at that time, would call back if needed. Follow up calls made with no response, along with letter sent to home.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Sore shoulder/pain. ADVIL helps. Has been a bother for a month after vaccination.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None will give ZOSTAVAX in 4 weeks.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Deafness, Injection site swelling, Syncope
Clinical narrative: Pt. had a bump at injection site that was growing over time slowly. Pt. lost vision and hearing. Pt. began to faint. Adrenaline generic was administered. Pt. hearing and vision came back. Pt. bump on injection site went down.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out but quickly regained consciousness.
Sex: U
Vaccine: DTP
Symptoms: Injection site injury
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of injection site injury in a patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced injection site injury. On an unknown date, the outcome of the injection site injury was unknown. The reporter considered the injection site injury to be possibly related to DTPa vaccine. Additional details were reported as follows: This case was reported by a consumer via Interactive Digital Media. The age at vaccination was not reported. The reporter stated that, the vaccine was mutated and didn't give lifetime protection. The reporter had two family members that were injured from the DTaP vaccine. This case has been linked with US2017GSK139613 as reported by the same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Injection site injury
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of injection site injury in a patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced injection site injury. On an unknown date, the outcome of the injection site injury was unknown. The reporter considered the injection site injury to be possibly related to DTPa vaccine. Additional details were reported as follows: This case was reported by a consumer via Interactive Digital Media. The age at vaccination was not reported. The reporter stated that, the vaccine was mutated and didn't give lifetime protection. The reporter had two family members that were injured from the DTaP vaccine. This case has been linked with US2017GSK139600 as reported by same reporter.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapeutic response decreased in a 20-year-old female patient who received ENGERIX B. Co-suspect products included ENGERIX B, ENGERIX B, ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B .5 ml, the 2nd dose of ENGERIX B .5 ml, the 3rd dose of ENGERIX B .5 ml, the 4th dose of ENGERIX B .5 ml and the 5th dose of ENGERIX B .5 ml. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B, ENGERIX B, and ENGERIX B and 61 days after receiving ENGERIX B, the patient experienced therapeutic response decreased, extra dose administered and extra dose administered. On an unknown date, the outcome of the therapeutic response decreased, extra dose administered and extra dose administered were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B, ENGERIX B, ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The patient received a complete ENGERIX B vaccine in 1998. The patient later received a 4th dose in 2015 and a 5th dose in 2016, which led to extra dose administered. The patient was now presenting to the healthcare professional for 6th dose subsequent to a low titer which inappropriately drawn later than 2 months after last dose. Lot number and expiration date for 4th, 5th, and 6th doses were unknown.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: (R) Leg swollen, redness, itching.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Pallor, Seizure, Syncope
Clinical narrative: Patient fainted once then recovered then fainted again and turned pale and body appeared to seize (seizure) for less than 30 seconds and patient return to normal and talking. Ambulance arrived but recovered and did not go to ER as suggested. Patient recovered and said mom had a similar reaction to vaccine after the fact.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Eye irritation, Insomnia, Muscle spasms, Nausea, Vomiting
Clinical narrative: Nausea/vomiting- sleepless nite. Muscle cramps. Eye burning. Pt said took Hydroxyzine and felt better.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: Clammy; sweating; Pt reports feeling hot; challenged breathing. No rash reported: all after about 10-15mins after vaccine.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Pallor, Seizure, Syncope
Clinical narrative: No anaphylaxis/swelling/SOB. Patient fainted once then recovered then fainted again and turned pale and body appeared to seize (seizure) for less than 30 seconds and patient return to normal and talking. Ambulance arrived but recovered and did not go to ER as suggested. Patient recovered and said mom had a similar reaction to vaccine after the fact.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Culture wound negative, Incisional drainage, Injection site abscess, Injection site reaction, Purulent discharge
Clinical narrative: Pt. has had recurrent purulent abscess develop in location of injection. Wound culture collected was sterile. I and D produce expressed yellow/green thick cloudy d/c and parents report reaccumulation even after antibiotic treatment. Pt. being referred to dermatology as well.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pain, Pruritus
Clinical narrative: Large red local reaction 7 cm with itching and pain.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Pt present to clinic c/o bilateral swelling of the hands right more than the left pt had received 2 shots to left arm 1 to right arm no other symptoms likely localized swelling that pooled to her hands while asleep in bed getting a little better by time seen in office today. Pt to monitor area elevate hands pump fists/hands and follow up with PCP in the next 1-2 days or sooner if any worsening or any concerns.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on neck/chest, 09/18/17 11:30am.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Migraine, Pain, Pyrexia
Clinical narrative: Red, raised skin patch where vaccine was administered on left deltoid. 9/12/17 AM. Painful. Fever 2 days after vaccine administration. Migraine PM on 9/11/2017.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Erythema, Injection site pain, Musculoskeletal pain
Clinical narrative: Sore at site - arm became red - warm to touch - edematous - shoulder, wrist and back ache. On 2nd day - arm itching and red from shoulder to wrist - lower arm became deep red progressing to purple for next 3 days - lasted 1 week.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pruritus, Skin discolouration, Skin warm
Clinical narrative: Sore at site - arm became red - warm to touch - edematous - shoulder, wrist and back ache. On 2nd day - arm itching and red from shoulder to wrist - lower arm became deep red progressing to purple for next 3 days - lasted 1 week.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Lip swelling, Rash generalised
Clinical narrative: PM on 9/11/2017 "Rash all over and lips were swollen" per mom. Mom gave BENADRYL and shortly after the reaction had stopped." Mom believes the reaction was from the vaccine. Called the office 9/12/17 to report it. Sx gone at that time. Mom refused to come in for office visit.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin infection
Clinical narrative: Skin infection, swelling and warm at the site, redness. Is taking antibiotic.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Left parotid (face) swelling 2.5 hours after high dose flu was given in Rt. arm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin irritation
Clinical narrative: The patient came to the pharmacy with local irritation, redness and swelling on her left arm.
Age: 7.0
Sex: M
Vaccine: FLU4, HEPA, TD
Symptoms: Rash macular
Clinical narrative: Pt vaccinated on 9/19/17. Woke with generalized macular rash on 9/20/17. Pt seen 9/20/17 4:47 pm. Dad stated rash no worse, no better. Advised BENADRYL. Pt is with limit vaccine record. Has had Tdap and flu, but this was first Hep A.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Injection site pain, Muscle spasms
Clinical narrative: Donor report after 30 minutes of immunization administration, she felt shooting pain across right arm spreading to neck, head, across shoulder. Donor had trouble lifting her right arm and experience cramping in arm as well as dizziness and light headedness. She hydrated herself and ate a snack and after resting/sleeping the next day she felt better with soreness in R. arm. Today she states feeling back to normal.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Donor report after 30 minutes of immunization administration, she felt shooting pain across right arm spreading to neck, head, across shoulder. Donor had trouble lifting her right arm and experience cramping in arm as well as dizziness and light headedness. She hydrated herself and ate a snack and after resting/sleeping the next day she felt better with soreness in R. arm. Today she states feeling back to normal.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt stated she had swelling, redness, and itching at injection site for the last 2-3 days. She put ice on the area and hydrocortisone cream. Pt is going to f/u w/her primary care physician.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Patient received both shot in her left deltoid around 12:46pm on 9/20/17. All procedures were properly followed. She called back the following afternoon and said that when she woke up, she had swelling from her elbow to her shoulder. She went to clinic and saw Dr. who said it looked like cellulitis and prescribed Cefdinir and administered a DECADRON injection.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Rash pruritic
Clinical narrative: At 330 PM she had a itchy rash on her left arm - site of injection, entire back and neck. Her face and cheeks were burning. At 430 PM her doctor told her to take 1 CLARITIN, OTC with minimal improvement. At 7 PM patient took 1 ZYRTEC OTC with some improvement. Patient states that on 9/24 all symptoms subsided. She is taking ZYRTEC 1 tab BID for 1 week as advised by her physician.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Shot was given on 9-11-17 by end of the day area where shot was given and above was swollen/hard/and hot. By the end of the day band-aid made an indent there was bruising delow a 4 x 3 inch patch. Pt. also had a sore arm on 9-14-17 (Thu) pt went to MD office on 9-15-17 less bruising but came into pharmacy.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient having difficulty lifting her arm, after the flu shot administration.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Cartilage injury, Drug administered at inappropriate site, Injection site pain, Insomnia
Clinical narrative: Patient complains of pain and loss of function of left shoulder/arm following Tdap.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: Patient complains of pain and loss of function of left shoulder/arm following Tdap.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient complains of pain and loss of function of left shoulder/arm following Tdap.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tendon disorder, Tendon rupture
Clinical narrative: Patient complains of pain and loss of function of left shoulder/arm following Tdap.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood test, Chest pain, Headache, Swelling face, Visual impairment
Clinical narrative: Swelling of face, vomiting, chest pain, and complaining couldn't see, headache.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Swelling of face, vomiting, chest pain, and complaining couldn't see, headache.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Full blood count normal, Laboratory test normal, Malaise, Sleep study normal
Clinical narrative: In November, 2012, I experienced malaise and fatigue. In December, 2012 I discovered the manufacturer of my Levothyroxine was changed without my knowledge. I originally attributed my fatigue to that change. All subsequent tests related to my thyroid were in the normal range. In the months that followed, my fatigue persisted and became more severe. I informed my doctor that my symptoms appeared to match Chronic Fatigue Syndrome. Over the next 2 years, my doctor ordered tests for increasingly improbable causes of my fatigue, often under protest that I had no symptoms of the disease being tested. My doctor insisted that he must follow protocol to conclude a diagnosis of Chronic Fatigue. After exhausting all recommended tests, my doctor informed me that he does not make diagnoses of Chronic Fatigue. I recently learned that research is currently examining Chronic Fatigue symptoms following the Hepatitis B vaccine. I recalled and confirmed that I had received the Hep B vaccine on 04/12 and 07/12. My Chronic Fatigue symptoms developed months after I received the Hepatitis B vaccine.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Thyroid function test normal
Clinical narrative: In November, 2012, I experienced malaise and fatigue. In December, 2012 I discovered the manufacturer of my Levothyroxine was changed without my knowledge. I originally attributed my fatigue to that change. All subsequent tests related to my thyroid were in the normal range. In the months that followed, my fatigue persisted and became more severe. I informed my doctor that my symptoms appeared to match Chronic Fatigue Syndrome. Over the next 2 years, my doctor ordered tests for increasingly improbable causes of my fatigue, often under protest that I had no symptoms of the disease being tested. My doctor insisted that he must follow protocol to conclude a diagnosis of Chronic Fatigue. After exhausting all recommended tests, my doctor informed me that he does not make diagnoses of Chronic Fatigue. I recently learned that research is currently examining Chronic Fatigue symptoms following the Hepatitis B vaccine. I recalled and confirmed that I had received the Hep B vaccine on 04/12 and 07/12. My Chronic Fatigue symptoms developed months after I received the Hepatitis B vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Chills, Dehydration, Dizziness
Clinical narrative: Tightness of chest, lungs burning, tingling of lips, sensation of throat closing up. Difficulty breathing. Dizziness, weakness, hives near injection site. Swollen itchy eyes, face numbing. Chills, mild fever, reduced oxygen saturation. Wheezing & hoarseness. Pale in face. Took two BENADRYL, drank a ton of water, and monitored vital signs at home. Severe chills in the middle of the night, extreme dizziness, and dehydration. Probably should have gone to the hospital, but husband is a nurse so had him monitor vital signs instead of going to the hospital.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Dyspnoea, Eye pruritus, Eye swelling, Hypoaesthesia
Clinical narrative: Tightness of chest, lungs burning, tingling of lips, sensation of throat closing up. Difficulty breathing. Dizziness, weakness, hives near injection site. Swollen itchy eyes, face numbing. Chills, mild fever, reduced oxygen saturation. Wheezing & hoarseness. Pale in face. Took two BENADRYL, drank a ton of water, and monitored vital signs at home. Severe chills in the middle of the night, extreme dizziness, and dehydration. Probably should have gone to the hospital, but husband is a nurse so had him monitor vital signs instead of going to the hospital.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Oxygen saturation decreased, Pallor, Paraesthesia oral, Pulmonary pain
Clinical narrative: Tightness of chest, lungs burning, tingling of lips, sensation of throat closing up. Difficulty breathing. Dizziness, weakness, hives near injection site. Swollen itchy eyes, face numbing. Chills, mild fever, reduced oxygen saturation. Wheezing & hoarseness. Pale in face. Took two BENADRYL, drank a ton of water, and monitored vital signs at home. Severe chills in the middle of the night, extreme dizziness, and dehydration. Probably should have gone to the hospital, but husband is a nurse so had him monitor vital signs instead of going to the hospital.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Throat tightness, Wheezing
Clinical narrative: Tightness of chest, lungs burning, tingling of lips, sensation of throat closing up. Difficulty breathing. Dizziness, weakness, hives near injection site. Swollen itchy eyes, face numbing. Chills, mild fever, reduced oxygen saturation. Wheezing & hoarseness. Pale in face. Took two BENADRYL, drank a ton of water, and monitored vital signs at home. Severe chills in the middle of the night, extreme dizziness, and dehydration. Probably should have gone to the hospital, but husband is a nurse so had him monitor vital signs instead of going to the hospital.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Pt had severe nausea for one day and chills and was not able to keep food down. The following day, pt was able to keep some food down and be more active.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra Hepatitis A vaccination, he should have received a HPV vaccination. Patient did not have any adverse reaction. Provider and patient's parent were contacted in regard to the extra vaccination that was given.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients (age and gender unknown). The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates the patients might have been vaccinated with an improperly stored dose of M-M-R II rHA (lot # M039913, expiration date 26-SEP-2018, M045401, expiration date 14-NOV-2018; dose and route were unknown) for prophylaxis.    The lot numbers and expiration dates of the sterile diluent used for reconstitution of the M-M-R II were unknown. No adverse effects were reported. The vaccines were stored under 47 Fahrenheit to 77 Fahrenheit (52 Fahrenheit) for 52 hours. There was no previous temperature excursion. Data logger was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified group of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with VARIVAX for prophylaxis (dose, route of administration and anatomical location were not reported). The physician recalled reading that, among the vaccinated patients an increase of diseases they were vaccinated against was noted (varicella) (onset dates were not provided). The outcome of the event was unknown. The relatedness between the event and VARIVAX was not reported. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1709USA007573: US-009507513-1709USA007574.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician, refers to 4 year-old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications includes sterile diluent. On 14-JUL-2017, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa) (Incorrect product storage) (dosing regimen and frequency unknown) for prophylaxis. It was reported that the vaccine was reconstituted with properly a stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. A Digital data logger was involved. The outcome of events was unknown. This is one of 11 reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001467: US-009507513-1708USA001338:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, refers to 4 year old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 25-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M047660, exp. date: 02-DEC-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe of 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. The outcome of events was unknown. On 05-SEP-2017, a return call was received from reporting medical assistant who stated that she would check the chart and fax the patient identifiers and dates of vaccination if any patient were vaccinated with the above products during or after the temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1708USA001467.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a 53 years old female patient, who was reporting on herself. The patient's concurrent conditions included leukemia, migraines and anxiety. The patient's concomitant medications were not reported. The patient was allergic to certain antibiotics (unspecified). On 31-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported), for prevention of pneumococcal disease. On approximately 31-AUG-2017, reported as "since she was administered the PNEUMOVAX 23", she was not feeling well. She spoke with an unspecified healthcare provider at an unspecified cancer hospital where she was being treated for leukemia. The healthcare provider told the patient that what she was experiencing were common side effects of PNEUMOVAX 23. The patient declined to provide the specific reactions she was experiencing. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not assessed by the reporter (she did not want to say they were from PNEUMOVAX 23 if they were not).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to six unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates from 01-SEP-2017 to 13-SEP-2017, the patients was vaccinated with improperly stored doses of PROQUAD (dose, frequency and route of administration were not reported) lot # N014949 and expiration date: 11-NOV-2017. The PROQUAD was reconstituted with properly stored sterile diluent. No adverse event was reported. The PROQUAD was stored between 15 Fahrenheit degrees (F) and 46 Fahrenheit degrees (F) for 240 hours. There was no previous temperature excursion. The digital data logger was not involved in recording the temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Mumps, Rubella
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified group of children of unknown age and gender. There was no information about the children's concurrent conditions, concomitant therapies or medical history provided. On unknown dates,  the children were vaccinated with M-M-R II for prophylaxis (dose, route of administration and anatomical location were not reported). The physician recalled reading that, among the vaccinated children an increase of diseases they were vaccinated against was noted (mumps, rubella and measles) (onset dates were not provided). The outcome of the events was unknown. The relatedness between the events and M-M-R II was not reported. Upon internal review the event of measles was determined to be medically significant. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007574: US-009507513-1709USA006164:
Sex: U
Vaccine: MMRV
Symptoms: Measles post vaccine, Mumps, Rubella, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified group of children of unknown age and gender. There was no information about the children's concurrent conditions, concomitant therapies or medical history provided. On unknown dates,  the children were vaccinated with PROQUAD for prophylaxis (dose, route of administration and anatomical location were not reported). The physician recalled reading that, among the vaccinated children an increase of diseases they were vaccinated against was noted (mumps, rubella, measles and varicella) (onset dates were not provided). The outcome of the events was unknown. The relatedness between the events and PROQUAD was not reported. Upon internal review the event of measles was determined to be medically significant. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1709USA006164: US-009507513-1709USA007573: