chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea
Clinical narrative: Client received immunization in the morning and states she started feeling systemic symptoms by that evening. She mentioned her symptoms were headaches, elevated temperature of about 100F, muscle aches, malaise, loss of appetite, nausea. States all symptoms "hit all at once." Symptoms continued for 2 days and today she feels better. States symptoms felt worse in the evenings. States symptoms were not those that she usually has felt after vaccinations in the past where she "could go about [her] day," but were intense systemic symptoms. Describes as feeling "significantly sick." Client used anti-inflammatory medications for symptoms. Did not visit a provider.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Pt. reported hive type rash/reaction about 2 days after getting her vaccines. She reports the reaction being specific to where she got her flu shot (lower in her left upper arm muscle). She used Benadryl 50mg PO q4h PRN as recommended. She called her PCP and pharmacy for this recommendation and was also told to follow up with urgent care if the reaction gets worse or does not get better. Pt states as of 9/15/17 about 11am that the rash is better/going away and the Benadryl is helping.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Injection given and area puffed out quickly per MA report. Cold pack placed on area and patient asked to wait. A few minutes later triage RN checked w/ patient, visualized area, discussed home care instruction and released patient to home. Mild swelling, slight discoloration, mild pain. No redness, no SOB. Symptoms improving per patient report. Following day patient reported arm fine and symptoms resolved.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: On 9/13/17 patient presented with slightly raised red area that is about 2 in. below the vaccination site. The vaccination site itself has no bruise, no soreness or any markings. The site that is red is hot to the touch and measures about 2.5 in. by 5 in.  The area affected is not itchy. The patient also reported that several years ago when she received a ZOSTAVAX vaccination 4 years ago, her arm swelled up significantly but did return to normal after several days.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Mother stated the induration appeared about 24-hrs after receiving VZV vaccination and now is approximately the size of a quarter, red and warm to the touch, cold packs placed over site and given Tylenol for discomfort. Advised mother to continue watching site and continue home treatment plan. If condition worsens or she has more concerns she can contact their PCP or if site get larger or she has more concerns she can take her daughter to ER for additional Treatment during the weekend.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT STATED RIGHT ARM WAS RED AND SWOLLEN AFTER INJECTION.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient developed a lump at the site of injection. The lump is firm and tender. No sign of bruising.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling/redness/warmth 4 inch circumference. Starting approx 2 inches BELOW injection site and extending downward toward elbow. Look like increased immune response and not infection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patients left arm was very read at the injection site. Very red and warm and hard it was the size of a quarter or larger. The surronding area was red and warm completely around about 3 to 4 inches all the way around. I asked if he had done anything and he said not. I suggested cold compresses and benadryl. We call the on call md and he said warm compresses and benadryl and if not better by morning go to er.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports following symptoms that started around 2 weeks after immunization with zostavax. She received PREVNAR 13 on 5/19/17 but she does not attribute the symptoms to the PREVNAR 13. She described pins and needles feelings or electric shocks from wrist to elbow. She describes pain as if she were bruised (but not actually bruised) from elbow to shoulder. Muscle at shoulder "catches" and knots up. The right arm has been weak. Recently she started similar symptoms in the left arm but saw Dr.  who says that he sees symptoms like this frequently from ZOSTAVAX immunizations. He treated her with steroids and the left arm is much better. This summer she spent time in a rehab for the wound on her hip that wasn't healing well. I do not believe that she thinks this is related to the immunization at all.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Peripheral swelling
Clinical narrative: PT EXPERIENCED EXTREME BRUISING AND SWELLING IN ARM. SHE ICED IT.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Throat tightness, Tremor, Urticaria
Clinical narrative: Patients states that he broke out with hives on his face, uncontrollable shaking, fever 101.9, throat closing up. Went to ER right away.
Age: 5.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Pyrexia
Clinical narrative: High grade fever.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports red, swollen painful area around injection site. Area was also warm to the touch. Patient is icing the area at home and I recommended she use BENADRYL tonight as she states each day the reaction gets worse. She is going to call me tomorrow to report how her arm is.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Insomnia, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: Night of vaccination, patient's arm was sore and she had trouble sleeping because of it. In the morning, on 9/14/17, she went back to bed for 3 hours. She took TYLENOL throughout the day for the soreness. A fever had developed the morning of 9/14/17 also, but the fever was gone by 9/15/17. The morning of 9/15, she noticed and felt an itchy rash starting on her upper left arm that spread down to her elbow. As of 7pm on 9/15/17 when she reported the event to the pharmacy, the rash was still present.
Age: 68.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: A FEW HOURS AFTER VACCINES PATIENT'S ARM BECAME VERY SWOLLEN AND PAINFUL. HE DESCRIBED IT AS BEING THE "SIZE OF A SOFTBALL"
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Laryngitis
Clinical narrative: Laryngitis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Anion gap, Asthenia, Band neutrophil count increased, Basophil count normal, Basophil percentage
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity decreased
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea increased, Blood urea nitrogen/creatinine ratio, Carbon dioxide normal
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Differential white blood cell count abnormal, Dizziness, Eosinophil count normal, Eosinophil percentage decreased, Full blood count abnormal
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Glomerular filtration rate, Haematocrit normal, Haemoglobin normal, Hypersensitivity
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell volume normal, Mean platelet volume normal, Metabolic function test abnormal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth swelling, Nausea, Neutrophil count normal, Neutrophil percentage, Platelet count normal
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell count normal, Red cell distribution width increased, White blood cell count normal
Clinical narrative: Patient is a 69 y.o. female presenting to the ED for allergic reaction. Pt has flu vaccine at 10:30 this morning. She reports a possible allergic reaction with sx's of feeling nausea, dizziness, mouth swelling, hand numbness around 10:55 this morning after the vaccine. Pt denies any chills, fever, sore throat, SOB, CP, abdominal pain, diarrhea, vomiting, dysuria, back pain, pallor, rash, HA. The pt states she felt "weak" and had "trouble ambulating" to the ED room this afternoon. She denies any new laundry detergents or foods recently before arrival. The pt states she is on "some new medications" including Entresto. Pt denies taking any benadryl PTA. Hx of pulmonary clinic appointment this morning PTA. Hx of defibrillator.
Age: 14.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Loss of consciousness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a male patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), blackout (serious criteria GSK medically significant), difficulty breathing and dizziness. On an unknown date, the outcome of the anaphylactic reaction, blackout, difficulty breathing and dizziness were unknown. The reporter considered the anaphylactic reaction, blackout, difficulty breathing and dizziness to be almost certainly related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient previously had a dose of MENACTRA with no adverse reaction. A GlaxoSmithKline (GSK) sales representative called in to report an adverse event. The patient received a dose of BEXSERO and experienced an anaphylactic reaction, described as trouble breathing, felt dizzy, and blacked out. The patient was seen in the emergency room the same day. The sales representative was unsure if the patient was admitted. The GSK notified date was documented as 8th September 2017, but it was unclear when this adverse event was initially reported to the sales representative. The patient was not being seen by reporting health care professional. This adverse event was reported to the doctor by a friend and then relayed to the sales representative.
Sex: F
Vaccine: DTP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via Interactive Digital Media and described the occurrence of vaccination failure in a 4-year-old female patient who received DTP vaccine (A or W not known). Co-suspect products included DTP vaccine (A or W not known) and DTP vaccine (A or W not known). On an unknown date, the patient received the 1st dose of DTP vaccine, the 2nd dose of DTP vaccine and the 3rd dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, DTP vaccine and DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine, DTP vaccine and DTP vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient had 3 DTP (A or W unknown) shots by the time she was 4 years old. She contracted whooping cough at 4 years old anyway. The reporter stated that she highly that the patient has got the whooping cough from her grandparents. Also stated that the patient might have spread whooping cough to other people. This case was considered as suspected vaccination failure because the primary vaccination schedule and laboratory confirmation was unknown. The reporter had not given consent to contact them further. The case had been linked with the case US2017GSK139598, reported by the same reporter.
Sex: M
Vaccine: DTP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via Interactive Digital Media and described the occurrence of vaccination failure in a male patient who received DTP vaccine (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient was fully vaccinated and had whooping cough but it was milder than his sister. This case was considered as suspected vaccination failure because the primary vaccination schedule and laboratory confirmation was unknown. The case had been linked with the case US2017GSK139597, reported by the same reporter.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient is having pain at site of inject.
Age: 46.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dermatitis acneiform, Product storage error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash acneiform in a 46-year-old male patient who received BOOSTRIX (batch number 594SR, expiry date 8th July 2019). Co-suspect products included FLUARIX QUADRIVALENT (batch number 9M3F7, expiry date 30th May 2018). Concomitant products included ARIMIDEX. On 23rd August 2017, the patient received BOOSTRIX (intramuscular) .5 ml and FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a month after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced rash acneiform and incorrect storage of drug. On an unknown date, the outcome of the rash acneiform was not recovered/not resolved and the outcome of the incorrect storage of drug was unknown. The reporter considered the rash acneiform to be unrelated to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were reported as follows: At the time of reporting, the patient returned to the pharmacy and reported an acne-like rash from his hips down on both sides of legs. In August 2017, the BOOSTRIX given to the patient was part of lot that was left outside of the refrigerator for 4 hours, which led to an incorrect storage of vaccine. The healthcare professional contacted GlaxoSmithKline Medical Information at that time to confirm whether the vaccine was acceptable to use. The healthcare professional was not concerned about the temperature excursion and felt it had nothing to do with patient's adverse event.
Age: 1.25
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given in error at 15 months of age.
Age: 69.0
Sex: U
Vaccine: PNC13
Symptoms: Back pain, Blood culture, Blood lactic acid, Borrelia test, Differential white blood cell count
Clinical narrative: C/o nausea, LBP (but hx of), HA, arm sore at site. Temp 101. Took extra strength TYLENOL. Also dizzy. The arm was not swollen, but was little warm. Felt too dizzy to leave house to come in. 8/9/10 went to ED - CBC with diff, CMP, Lyme titer + U/A, blood culture + lactic acid done. Use antipyretic med PRN and return if worse.
Age: 69.0
Sex: U
Vaccine: PNC13
Symptoms: Dizziness, Full blood count, Headache, Injection site pain, Metabolic function test
Clinical narrative: C/o nausea, LBP (but hx of), HA, arm sore at site. Temp 101. Took extra strength TYLENOL. Also dizzy. The arm was not swollen, but was little warm. Felt too dizzy to leave house to come in. 8/9/10 went to ED - CBC with diff, CMP, Lyme titer + U/A, blood culture + lactic acid done. Use antipyretic med PRN and return if worse.
Age: 69.0
Sex: U
Vaccine: PNC13
Symptoms: Nausea, Skin warm, Urine analysis
Clinical narrative: C/o nausea, LBP (but hx of), HA, arm sore at site. Temp 101. Took extra strength TYLENOL. Also dizzy. The arm was not swollen, but was little warm. Felt too dizzy to leave house to come in. 8/9/10 went to ED - CBC with diff, CMP, Lyme titer + U/A, blood culture + lactic acid done. Use antipyretic med PRN and return if worse.
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injection site swelling in a female patient who received BOOSTRIX (batch number EY273, expiry date 18th March 2019). On 6th September 2017, the patient received BOOSTRIX. In September 2017, less than a week after receiving BOOSTRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that the patient came back and injection site was swollen. The spots on which where the reporter grabbed the muscle to administer had prints because it was swollen from the reaction site. The injection site and the area below that was also reddened and warm. It was about 5:20pm the site was warm also. The patient's arm was extremely sore. It was really hard for the patient to lift her arm and it was very painful to her.
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injection site swelling in a female patient who received BOOSTRIX (batch number EY273, expiry date 18th March 2019). On 6th September 2017, the patient received BOOSTRIX. In September 2017, less than a week after receiving BOOSTRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injected limb mobility decreased, pain in arm and muscle soreness to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that the patient came back and injection site was swollen. The spots on which where the reporter grabbed the muscle to administer had prints because it was swollen from the reaction site. The injection site and the area below that was also reddened and warm. It was about 5:20pm the site was warm also. The patient's arm was extremely sore. It was really hard for the patient to lift her arm and it was very painful to her.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hepatitis B antibody negative in a male patient who received TWINRIX. Co-suspect products included TWINRIX and TWINRIX. On an unknown date, the patient received the 1st dose of TWINRIX, the 2nd dose of TWINRIX and the 3rd dose of TWINRIX. In August 2017, unknown after receiving TWINRIX, TWINRIX and TWINRIX, the patient experienced hepatitis B antibody negative. On an unknown date, the outcome of the hepatitis B antibody negative was unknown. It was unknown if the reporter considered the hepatitis B antibody negative to be related to TWINRIX, TWINRIX and TWINRIX. Additional details were reported as follows: The age at vaccination was not reported and provided only month and date for the patient's birthdate information. In August 2017, two weeks ago from the time of reporting, the patient's routine blood test was performed, which showed no antibodies against Hepatitis B so now needed to be re-inoculated. The patient was treated with pain medicines. The patient could not recall the exact name of the vaccine product but thought that he received GlaxoSmithKline's Hepatitis B vaccine back in 2007. Then he said that he received hepatitis A vaccine of unknown manufacturer the same day on which he received his hepatitis B vaccine but was not sure if he was given a combination product or not. The patient found some paperwork which indicated that he was billed by his health care provider for TWINRIX on 30th October 2007, 13th November 2007 and 18th April 2008. The patient said those date were the dates he was billed but suspected those were also the dates in which he most probably received TWINRIX. The reporter had denied permission to contact their physician.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Arm pain, swelling, welt from elbow to shoulder x 3 days. Pain persisted x1 wk. Pain did not limit activity. General malaise. No measured fever.
Sex: U
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to BEXSERO. Additional details were reported as follows: This case was reported via email. The age at vaccination was not reported. The patient experienced a very large erythema.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen, rosy in color on arm/vaccine site. Painful.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Injection site swelling, Rash generalised, Swelling
Clinical narrative: Patient reported with complaint of body swelling and rash all over the body. Per patient, experienced a slight shortness of breath as well. Still swollen for 4 days from injection with trembling and body chills.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Patient reported with complaint of body swelling and rash all over the body. Per patient, experienced a slight shortness of breath as well. Still swollen for 4 days from injection with trembling and body chills.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Patient came to the pharmacy and complained that she experienced a rash and pain 4 days after getting PREVNAR 13 shot. The pharmacist on duty suggested to see her doctor, but she did not want to go to her doctor. She wants to take something over the counter. Therefore, the pharmacist suggested taking BENADRYL. She experienced some relief from the itching, but believes the medication is still causing a reaction and pain.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Patient took a nap after returning from the pharmacy. Upon waking the patient was covered in painful muscle aches. She was unable to move for a few hours and contributes the effects to the vaccine. The day after the vaccination the patient came to the pharmacy and said the pain was only in her legs at that time.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Varicella post vaccine, Varicella virus test positive
Clinical narrative: 9 days after vaccine patient developed varicella, (Fever 104) 1 gm for varicella (positive) on 9/12/17, IgG negative.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mass, Pain, Pruritus, Swelling
Clinical narrative: < 24 hrs after injection woke next day with red, slightly swollen area size of quarter and sore to touch. Temp 98.5. Instructed by Dr. to apply cold compresses to arm intermittently and Ibuprofen with meal for a couple of days. Report expanding redness or fever.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site inflammation, Injection site pain, Pain
Clinical narrative: Patient received PPSV23 vaccine in right deltoid 9/6/17. Patient reported soreness after injection. Soreness continued into the following day, 9/7/17. Patient given prescription of ibuprofen 800 mg tablets (30 tablets) to take for pain. Injection muscle was inflamed and tender.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Emotional disorder, Tremor
Clinical narrative: Unilateral arm shaking. Mom reports after an episode of being upset, mom noticed left arm shaking which lasted about 30 seconds at 07:00 on 09/08/17. Later that afternoon Grandmother noted Right arm shaking, which lasted longer. Pt. remained afebrile, otherwise well. Mom contacted by our office 09/11/17 pt. had not had any further episodes of arm shaking.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Mother reports pt. felt warm last night (same evening as vaccine administration). Temperature of 99.8 at 8:00am today and 101.5 degrees F at 10:00am today. Pt. lethargic with no appetite but did sleep well last night. Right lower leg began redness, warmth and swelling sometime between 8:00-10:00am.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Skin warm
Clinical narrative: Mother reports pt. felt warm last night (same evening as vaccine administration). Temperature of 99.8 at 8:00am today and 101.5 degrees F at 10:00am today. Pt. lethargic with no appetite but did sleep well last night. Right lower leg began redness, warmth and swelling sometime between 8:00-10:00am.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt states that when he got home from the clinic after his appt. he noticed the redness at the injection site. Pt states that the next morning the redness had grown in size. Today the size of the redness is doubled. Skin warm to the touch and tender to the touch.
Age: 12.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm, redness, swelling, warmth at site, headache.
Age: 12.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm, redness, swelling, warmth at site, headache.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus
Clinical narrative: Pt noticed local redness and itchiness on right upper arm on Tuesday (9/12/17). By Weds and Thurs, she noticed the redness has spread to most of her right upper arm. She also felt burning sensation. I asked her to go get it checked out by a doctor.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Patient reported soreness, redness that's spreading, swollen at the injection sites and pumps on the arm. Pharmacist advised patient to use BENADRYL and seek medical help if condition is not improved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash reported. Some redness and "very itchy".
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Nausea, Oral herpes, Pain
Clinical narrative: Came in for shot, then went grocery shopping. While bagging Pt felt weak and had to sit down. Pt was with friend who drove. Pt managed to put groceries away at home. Pt had a meal, got very nauseous about an hour later. Went to sleep. Was not feeling good when she awoke. Ate, then throw up again. Woke up next night, arm was red, warm and puffy. Call MD, MD said bad reaction to shot. Next day arm not sore and throbbing like previous night. MD urged Pt to eat. MD wanted pt to go to emergency room. Pt could not go. Does not have a car. Pt got fever blister on 9/15/17. Arm not hurting on 9/15/17, like before improved.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Skin warm, Swelling, Vaccination complication, Vomiting
Clinical narrative: Came in for shot, then went grocery shopping. While bagging Pt felt weak and had to sit down. Pt was with friend who drove. Pt managed to put groceries away at home. Pt had a meal, got very nauseous about an hour later. Went to sleep. Was not feeling good when she awoke. Ate, then throw up again. Woke up next night, arm was red, warm and puffy. Call MD, MD said bad reaction to shot. Next day arm not sore and throbbing like previous night. MD urged Pt to eat. MD wanted pt to go to emergency room. Pt could not go. Does not have a car. Pt got fever blister on 9/15/17. Arm not hurting on 9/15/17, like before improved.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at site of injection.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Positive cellulitis around injection site.
Age: 27.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Syncope, Tremor, Vision blurred
Clinical narrative: Patient complained about vision not being clear; extremities shakiness and fainted for about 1 minute.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Pain, Vomiting
Clinical narrative: First oral dose taken before lunch. Second oral dose taken 2nd day after first before lunch on empty stomach-same as first day. After second dose in the later afternoon-felt a bit off. After dinner stomach ache started. It got progressively worse-burning pain. Vomited several times. Went to bed exhausted and finally slept. Woke up feeling better with a slight stomach ache. Felt better in the morning- no more symptoms.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Measles antibody negative, Pain, Rash macular
Clinical narrative: Vaccine 1-23-15 - In evening felt lethargic - slept 11 hours / achy for 24 hours 6 days later 1-28-15 blotchy rash on stomach, legs, arms, neck, and back of hands.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Vaccination site erythema
Clinical narrative: Black and blue bruise. Red spot 2 inches away from vac. site.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: Severe all body joint pain.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Severe all body joint pain.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Arthralgia, Blood test normal, Impaired driving ability, Musculoskeletal pain, Neck pain
Clinical narrative: Severe all body joint pain.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe all body joint pain.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Discomfort, Pain
Clinical narrative: Patient stated she felt fine and had no sx's after receiving injection on 9/7/17. On 9/14/17 in the evening she noticed bruising on arm. She woke up on the morning of 9/15/17 and was in discomfort and felt pain when trying to put on her pants. She called pharmacy to report, she was told by pharmacist to take some TYLENOL, which she did. Called back in a few hours and, patient said she was feeling much better and pain had decreased significantly.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Erythema, Injection site swelling, Swelling
Clinical narrative: Seen on 9/12 for swelling around injection site and given 3 days of Prednisolone 15 mg/5ml. Seen on 9/13 for swelling, redness and temp of 99.1. Continue steroids and add in MOTRIN.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Dyspnoea, Vomiting
Clinical narrative: Patient started to have SOB and vomiting on 9-12-17 at 7:00pm. She had received Varicella around 11:00am on 9-12-17 and Hepatitis A vaccine on 9-11-17.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injected limb mobility decreased
Clinical narrative: Patient claiming of not being able to lift arms. She is taking Ibuprofen to help reduce discomfort. Husband got the same vaccinations and experiencing no issues. Primary physician notified.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia
Clinical narrative: Patient experienced pain for several weeks in her right shoulder joint several day following the second administration of her RABAVERT series.
Sex: U
Vaccine: MMRV
Symptoms: Blister, Erythema, Swelling
Clinical narrative: (L) arm: skin reaction with red raised area 12 cm, with central bullae. (R) arm: raised area.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Patient received the BOOSTRIX vaccine about 4:30 pm on 9/7/17. She said she started having stomach pains shortly after and started vomiting. She went to hospital and had.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Skin irritation
Clinical narrative: Shortly after injection given the patient experienced localized redness and irritation. Within 30 minutes had localized swelling greater than 50 mm at the injection site. Patient denies itchy, SOB, eye irritation or throat swelling. ZYRTEC 10 mg tablet given in the office per o/o Doctor. Continue ice or heat tx and ZYRTEC for next 2 days.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis L thigh surrounding injection site.
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: Epistaxis, Haemoglobin decreased, Immunoglobulin therapy, Neutrophil count decreased, Platelet count decreased
Clinical narrative: Previously unvaccinated child received Tdap 8/31/17 and MMRV 9/4/17 developed thrombocytopenia and epistaxis 9/14/17. No recent illness. Currently being treated for presumed ITP.
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: Thrombocytopenia, White blood cell count decreased
Clinical narrative: Previously unvaccinated child received Tdap 8/31/17 and MMRV 9/4/17 developed thrombocytopenia and epistaxis 9/14/17. No recent illness. Currently being treated for presumed ITP.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 12 hours: painful injection site left arm. 24 hours: severe myalgias, arthralgias, fatigue, redness and severe pain inferior to injection site left side. 48 hours: severe myalgias, arthralgias, fatigue, redness and severe pain inferior to injection site left side 7 x 4 cm, fever 101.9 F. 72 hours: residual myalgias, arthralgias, fatigue; worsening redness and severe pain inferior to injection site left side 10 x 7 cm with 4 x 4 cm induration in the middle of the erythema. 96 hours: myalgias, arthralgias gone; mild fatigue; improving redness and induration left side.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: 12 hours: painful injection site left arm. 24 hours: severe myalgias, arthralgias, fatigue, redness and severe pain inferior to injection site left side. 48 hours: severe myalgias, arthralgias, fatigue, redness and severe pain inferior to injection site left side 7 x 4 cm, fever 101.9 F. 72 hours: residual myalgias, arthralgias, fatigue; worsening redness and severe pain inferior to injection site left side 10 x 7 cm with 4 x 4 cm induration in the middle of the erythema. 96 hours: myalgias, arthralgias gone; mild fatigue; improving redness and induration left side.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Flu shot given 2 days ago. Red and warm to the touch, localized to her shoulder. No fever. Doesn't seem to be bothering her.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: Autism.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Rash
Clinical narrative: Patient was administered PNEUMOVAX 23 with AFLURIA on her Left arm 09/12. A rash spread on her left arm the next day. She went to the urgent care 09/14, and MD put her on KEFLEX 500mg, 1 capsule 3 times a day for 7 days. She started to feel better on 09/15.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Pain, Pain in extremity
Clinical narrative: Tenderness, firmness over injection site. No redness. Hurts when she moves extremity.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Chills, Diarrhoea, Peripheral swelling, Pyrexia
Clinical narrative: Patient called and stated RA arm swelled to softball size. She complained of fever, chills and diarrhea. She stated swelling has improved over 2 days but still present. Pharmacy will follow up Monday to confirm s/sx continue to improve.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin reaction
Clinical narrative: Skin reaction to top of shoulder to elbow.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient has developed a raised red area about 3 inches in length and 1 inch wide around injection site.  Patient has never had a reaction in the past.  Patient also states feeling sick to stomach and feeling a little unbalance, but is unsure if this is related to the vaccine.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site reaction, Rash macular
Clinical narrative: Patient presented 4 days post vaccination with red splotch marks down her arm from the injection site to the elbow. She also reported that they were painful, but did not appear to be a rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS PAIN SWELLING AT INJECTION SITE TREATMENT:  BENADRYL, ICE
Age: 72.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient presented with a circular red, itchy patch at the injection site of LA about the size of a half dollar. Patient symptoms are approved as of 09/16/17 12:50PM.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Rash
Clinical narrative: 5 hours after administration: rash/hives on left elbow and upper left quandrant on back with chills. PCP contacted. The next day 9/14 she said that the rash and chills had resolved.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: PATIENT CAME BACK UP TO THE COUNTER WITHIN 20 MINUTES AND HE HAD A LUMP ON HIS ARM JUST TO THE RIGHT AND BELOW WHERE SHOT WAS GIVEN. THE LUMP WAS HARD BUT NOT RED OR WARM TO THE TOUCH. PATIENT STATED THE AREA DID NOT HURT BUT WAS A LITTLE ITCHY.  ADVISED PATIENT IF NOT HURTING TO MASSAGE AREA. PATIENT WIFE ASKED IF HE COULD ICE THE AREA AND TAKE A BENADRYL, I LET HER KNOW ICE AND BENADRYL WOULD BE FINE.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bedridden, Inflammation, Pain in extremity
Clinical narrative: Patient stated during the night of immunization her left arm became very inflamed and hurt. She had to take TYLENOL and mentioned using a heating pad. She states she was bedridden for multiple days.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Contusion, Myalgia, Pruritus, Pyrexia
Clinical narrative: Patient had swelling, bruising, fever, blisters, itching and severe muscle aches.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient had swelling, bruising, fever, blisters, itching and severe muscle aches.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia
Clinical narrative: PAIN IN HIP AND KNEE JOINTS FOR ABOUT 3 DAYS.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: SWELLING AND REDNESS OF THE INTERIOR UPPER AND LOWER LEFT ARM.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue, General symptom, Headache, Injection site erythema
Clinical narrative: Redness and swelling at injection site on left arm spreading distally from shoulder towards elbow over 24-72 hours with extreme sensitivity to touch and severe pain - within 24-48 hours fairly severe body (mostly back) ache, mild headache, malaise, fatigue, dizziness, and lightheadedness - low grade fever (100.1) at 48 hours - general body symptoms resolved between 48-72 hours - injection site remains mildly sensitive and red, but significantly improved at 120 hours.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Laboratory test, Malaise, Pain
Clinical narrative: Redness and swelling at injection site on left arm spreading distally from shoulder towards elbow over 24-72 hours with extreme sensitivity to touch and severe pain - within 24-48 hours fairly severe body (mostly back) ache, mild headache, malaise, fatigue, dizziness, and lightheadedness - low grade fever (100.1) at 48 hours - general body symptoms resolved between 48-72 hours - injection site remains mildly sensitive and red, but significantly improved at 120 hours.