chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number 9349T, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 7th July 2018 (please refer the case US2018GSK194710). On 19th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness. In September 2018, the outcome of the pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, influenza-like symptoms, fatigue and weakness to be related to SHINGRIX. Additional details were reported as follows: The patient experienced the same arm pain bad as she had after 1st dose, same symptoms as before but this time the pain radiated throughout the shoulder blade. She also had flulike symptoms feelings of fatigue, weakness but the symptoms subsided by the second day post administration. She did not seek any medical attention. The nurse did not agree to be followed up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 19th April 2018, for tolerance refer case US2018187700). On 15th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 15th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, shoulder pain and injected limb mobility decreased. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, shoulder pain and injected limb mobility decreased were unchanged. It was unknown if the reporter considered the injection site pain, shoulder pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: At 12:00, the patient received SHINGRIX on the left arm. The patient experienced severe pain at the injection site and shoulder. She could not even lift her arm. The patient had denied permission to contact their physician. The patient was referred to her physician. No further details were provided.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site swelling, Interchange of vaccine products
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO (batch number 169821, expiry date 31st January 2019) for prophylaxis. Co-suspect products included TRUMENBA for prophylaxis. On 3rd August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of TRUMENBA. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling and interchange of vaccine products. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the interchange of vaccine products was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient developed swelling and redness at injection site. No treatment provided to the patient. The patient received 1st dose of TRUMENBA, which led to interchange of vaccine products. This case is 1 of the 4 linked cases reported by the same reporter.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 19-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. Previously administered products included BEXSERO (1st dose received on 18th September 2017). On 2nd August 2018, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient never received TRUMENBA. This is 1 of the 4 linked cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a 66-year-old female patient who received SHINGRIX (batch number 27K24, expiry date unknown) for prophylaxis. On 7th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and injection site pain. On an unknown date, the outcome of the swelling arm and injection site pain were recovered/resolved. It was unknown if the reporter considered the swelling arm and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient experienced after vaccination arm swelling and pain at the injection site. Her arm stayed sore for 3 to 4 days. She did not seek medical attention. The nurse did not agree to followed up. For tolerance to next dose, refer case US2018GSK190783.
Age: 40.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Had vaccine on Tuesday. Wednesday around 11 am, deltoid area had a small palm size pink area, no warmth, no edema noted. Thursday around 11 am, larger area to deltoid was noted to be red in color, slight edema noted and slightly warmer that rest of arm. Friday 7am area is much larger, spreads from shoulder to almost elbow, very red in color, swollen and hot to touch. Treatment to include: BENADRYL 25mg tid prn, ibuprofen 400mg tid prn and ice to area 20min on and 20 min off.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: 10/18/18 red area left arm. 10/19/18 Localized cellulitis left arm, hot and red. KEFLEX ordered. Area larger than previous day. Continued to monitor. On 10/20/18 less inflamed. Continue to monitor. 10/22/18 no erythema at site of pneumonia vaccine. Continue KEFLEX. 10/25/18 cellulitis of left arm resolved.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: 12 hours after receiving the vaccine the patient developed a very large hive at about 1 inch below the injection site. Mother took him to the closest clinic and was told to use BENADRYL or ZYRTEC for what was diagnosed as a Urticaria.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Anaemia, Diarrhoea haemorrhagic, Full blood count abnormal, Irritability, Occult blood positive
Clinical narrative: According to mom pretty immediately baby started getting bloody diarrhea. On 8/14 went to APR Hospital. Testing was completed; positive stool test, no X-rays, CBC shows some anemia. Patient was released; clinically looked good all the time. Follow-up the next day attributed incident to diaper rash.  Mother reports patient was also fussy and vomiting but not sure if related to reflux. Mother reports 2 days of bloody stools. Regular doctor visit on 10/25 but no vax were administered due to the reported incident. Patient recovered completely.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: According to mom pretty immediately baby started getting bloody diarrhea. On 8/14 went to APR Hospital. Testing was completed; positive stool test, no X-rays, CBC shows some anemia. Patient was released; clinically looked good all the time. Follow-up the next day attributed incident to diaper rash.  Mother reports patient was also fussy and vomiting but not sure if related to reflux. Mother reports 2 days of bloody stools. Regular doctor visit on 10/25 but no vax were administered due to the reported incident. Patient recovered completely.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Pt. Originally came in for an Influenza Vaccine but was mistakenly given a Hep A Vaccine instead.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Joint swelling, Pruritus, Rash, Rhinorrhoea
Clinical narrative: At 4 p.m. patient started to have a runny nose and back pain. These resolved by the next morning. While the patient was asleep (midnight to 8 a.m.), she developed itchy, puffy bumps on arms. Patient called the doctor's office on 10/19/18 to see if they could prescribe something to help with symptoms. No one from the office called patient back. Three days after bumps appeared, patient started using Cortisone cream. She used about two rounds of cream, which gave her relief from itching for 1 hour. As of 10/26, bumps have gotten better, but she can still see faint marks of where the bumps were. She still has a bump on her elbow that's about the size of half a marble.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Burning sensation
Clinical narrative: Patient reported ongoing burning sensation down her right arm.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Blood bilirubin increased, Blood sodium decreased, Carbon dioxide decreased, Differential white blood cell count normal, Full blood count normal
Clinical narrative: After immunization, rash developed within 5-10 minutes. Hives developed within 10-15 minutes after injection. 30 minutes after vaccine, felt throat closing, wheezing, and stridor. Immediately went to ER. Received BENADRYL, SOLU-MEDROL, PEPCID, and epinephrine. Admitted for observation overnight.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Stridor, Throat tightness, Urticaria, Wheezing
Clinical narrative: After immunization, rash developed within 5-10 minutes. Hives developed within 10-15 minutes after injection. 30 minutes after vaccine, felt throat closing, wheezing, and stridor. Immediately went to ER. Received BENADRYL, SOLU-MEDROL, PEPCID, and epinephrine. Admitted for observation overnight.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dyspnoea, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Chills after an 1 hour after vaccination. Red and swollen arm to elbows fever shortness of breath. Pt took BENADRYL.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid red, raised and painful. Could not do blood pressure on arm due to pain.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pruritus, Rash, Urticaria
Clinical narrative: Rash started 24 hrs after flu shot. Areas affected with bilateral forearms, sides of abdomen, center of back and lower back at beltline. Chills but no fever. Patient still had hive rash 9 days later. Not painful, itchy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Musculoskeletal pain, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling on arm, neck, side, and shoulder, along with pain, soreness, and patient feeling sick. Patient went to hospital on 10/14/18 and they prescribed steroids.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling on arm, neck, side, and shoulder, along with pain, soreness, and patient feeling sick. Patient went to hospital on 10/14/18 and they prescribed steroids.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient's mother noticed hives only on RD area. Pt had no other symptoms on 10-20-18 or around 10:00 am. Gave pt CLARITIN 10 minutes after she noticed the hives. Hives went away. Had nothing the following day.
Age: 74.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Gait inability
Clinical narrative: After leaving the pharmacy, the patient drove across the street to go to the grocery store. When he got out of his car, he experienced severe pain in both hips, reporting that the pain was more severe in his left hip. He had to sit back down in his car and felt unable to walk due to the pain and he immediately called the pharmacy, which happened about 20 minutes after his vaccine was administered. He denied any difficulty breathing, dizziness, or heart pounding. The pain started to subside and after about 10 minutes the patient said he felt safe to drive home. I called him about 30 minutes later and the pain was gone. He said it lasted 15 to 20 minutes in total. At that point he was not experiencing any symptoms.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Child received vaccine while in care of mother this morning around 8am at Family Practice clinic. Father picked up from daycare brought to clinic for flu vaccine not knowing of the previous dose this am. Flu vaccine 0.5ml dose administered at 10:05am in pediatric clinic per father's consent.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Malaise, Pruritus, Pyrexia
Clinical narrative: Family stated that patient was tired and laid down instead of playing Friday night after getting the shot that morning (9/28/18). By Saturday (9/29/18) morning she started running a temperature of up to 100 and had a headache. Continued to run a fever on Sunday 9/30/18) and wasn't feeling well enough to go to school on Monday (10/1/18) morning and was taken into the local clinic with a fine red rash on her face and by the time she left the clinic had the rash from "head-to-toe". She was put on a MEDROL dose pack at the clinic which she started on Monday morning and instructed to take BENADRYL for the rash and itching. Ran a low-grade temperature on Monday in the 99 degree F area. By Monday evening after two doses of BENADRYL the rash was gone and she has been feeling fine since. Never had any respiratory issues.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Family stated that patient was tired and laid down instead of playing Friday night after getting the shot that morning (9/28/18). By Saturday (9/29/18) morning she started running a temperature of up to 100 and had a headache. Continued to run a fever on Sunday 9/30/18) and wasn't feeling well enough to go to school on Monday (10/1/18) morning and was taken into the local clinic with a fine red rash on her face and by the time she left the clinic had the rash from "head-to-toe". She was put on a MEDROL dose pack at the clinic which she started on Monday morning and instructed to take BENADRYL for the rash and itching. Ran a low-grade temperature on Monday in the 99 degree F area. By Monday evening after two doses of BENADRYL the rash was gone and she has been feeling fine since. Never had any respiratory issues.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal chest pain
Clinical narrative: Employee received vaccination and approx. 1 hour later started to complain of right sided chest wall pain.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Patient had a rash all over the upper arm, doctor treated her with prednisone, cephalexin and loratadine.
Age: 1.67
Sex: M
Vaccine: DTAPIPV, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Temporal therometer to right thigh injection site was 101.2 and forehead temporal was 102.6 at 1300. Mom circles the red spots around his right thigh injection site at 1230 and the redness has spread significantly since then. Mom called advice nurse who reassured them the fever was normal but asked that his leg get checked. The pt is slightly fussy, not as happy as he usually is. Pt presents with concern for vaccine reaction/fever. I believe that this redness on his thigh is a normal vaccine reaction and i believe his fever (although tested temporally which can be inaccurate) is also a normal vaccine reaction.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Nausea, Tremor
Clinical narrative: No problems with prior vaccines. Shortly after vaccination became dizzy, with nausea, tremors. Sx came on suddenly. No chest pain, SOB, cough, rash, hives, or angioedema. Stated she felt unsteady on her feet. Symptoms lessoned the following day. Symptoms fully resolved in 2 days.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: ARM GOT SWOLLEN FROM DELTOID DOWN TO ELBOW. THE PATIENT ALSO EXPERIENCED A FEVER. THIS ALL LASTED FOR A COUPLE DAYS
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: Pain at the time of injection, no symptoms until 5 hours later, beginning with sore arm and then developing malaise, nausea, chills, body aches and headache. Continuing into and throughout day after injection, minimal relief with acetaminophen.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain at the time of injection, no symptoms until 5 hours later, beginning with sore arm and then developing malaise, nausea, chills, body aches and headache. Continuing into and throughout day after injection, minimal relief with acetaminophen.
Age: 51.0
Sex: F
Vaccine: FLU4, HEP, HEPA, PPV, TDAP
Symptoms: Blood pressure increased, Chills, Dysphagia, Dyspnoea, Heart rate increased
Clinical narrative: Complaints of fever of 102, right arm pain and shaking 2 hours after left the clinic. Went to the ER in and received treatment and medications (she did not indicate which medications given).  Discharged that evening. Next morning had chills and "did not feel well". Went to work that morning but left early and went to the ER. She stated her HR and BP were elevated, her right hand fingertips were numb. She stated she was having difficulties breathing and swallowing. She was given BENADRYL and steroids and other medications. She was discharged that evening.
Age: 51.0
Sex: F
Vaccine: FLU4, HEP, HEPA, PPV, TDAP
Symptoms: Hypoaesthesia, Malaise, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Complaints of fever of 102, right arm pain and shaking 2 hours after left the clinic. Went to the ER in and received treatment and medications (she did not indicate which medications given).  Discharged that evening. Next morning had chills and "did not feel well". Went to work that morning but left early and went to the ER. She stated her HR and BP were elevated, her right hand fingertips were numb. She stated she was having difficulties breathing and swallowing. She was given BENADRYL and steroids and other medications. She was discharged that evening.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not have any adverse effects or symptoms.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dysstasia, Nausea
Clinical narrative: Dizzy. Weakened and could not stand- dropped to floor, nauseated. Cold compress to back of neck applied by spouse and anti- nausea pill. Ten minutes feeling better.
Age: 90.0
Sex: M
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient claims he had very severe left arm pain after flu shot given. He claims that it is very hard to move arm. I recommended that he call his MD.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chest pain, Dizziness, Dyspepsia, Gastric disorder
Clinical narrative: About 1 AM experienced extreme indigestion and reflux with pain in chest and shoulders. About 4 AM I had become so weak and dizzy that it was hard to get out of bed. At this time my blood pressure was 117/75 and my pulse was weak and 175 beat per min. I took a nitro pill and some milk by 5Am my pulse rate had come down and my stomach disorder seemed to have gone away.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Gastrooesophageal reflux disease, Mobility decreased, Musculoskeletal pain, Pulse abnormal
Clinical narrative: About 1 AM experienced extreme indigestion and reflux with pain in chest and shoulders. About 4 AM I had become so weak and dizzy that it was hard to get out of bed. At this time my blood pressure was 117/75 and my pulse was weak and 175 beat per min. I took a nitro pill and some milk by 5Am my pulse rate had come down and my stomach disorder seemed to have gone away.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Pain in extremity, Paraesthesia
Clinical narrative: Arm started out sore immediately after the administration was completed. The arm has become more sore each day with ROM now limited with increased pain when lifted away from the body or up in the air. Opening the car door and applying a seatbelt is painful. Tingling and slight numbness began 10/25/18. Hot pack provided little relief. Ibuprofen helps with pain but not ROM. Point of admin remains tender but is not red or ecchymotic.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Injection site warmth, Pruritus, Skin warm
Clinical narrative: Around 9pm, patient reported swelling at the injection site. Throughout the evening, swelling spread down to elbow, up to should and across the upper chest; became red and warm to the touch and tender. Patient consulted PCP who prescribed an antibiotic and steroid course (unknown specifics as filled at other pharmacy); patient took full dose yesterday and reports decreased swelling, tenderness, but still some heat at the site. Itching is now predominating - recommended to take BENADRYL tonight.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Around 9pm, patient reported swelling at the injection site. Throughout the evening, swelling spread down to elbow, up to should and across the upper chest; became red and warm to the touch and tender. Patient consulted PCP who prescribed an antibiotic and steroid course (unknown specifics as filled at other pharmacy); patient took full dose yesterday and reports decreased swelling, tenderness, but still some heat at the site. Itching is now predominating - recommended to take BENADRYL tonight.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: The patient called on 10/25 and said that he got redness around the injection site for a few days but his redness got better as following up with him on 10/26.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Hyperhidrosis, Vomiting
Clinical narrative: Vaccine was given at approximately 6:00pm. My son was 'normal' and in bed and asleep before 8:30pm. Within 10-15mins, he forcefully and in large amounts, woke to vomiting. Was back to sleep before 9:30pm and slept through the night, however, had three episodes of extreme sweating during the night. Woke the next morning feeling exhausted but with no other symptoms. Event reported to County Public Health.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm became red, warm, and slightly swollen which was noticed the morning after the vaccine was administered. It encompassed most of the upper arm about 75% around. By the next morning 100% of upper arm was involved. The patient applied an ice pack, and had also taken 2 doses of acetaminophen during the day after vaccine was administered. About 96 hours after the vaccination, complete resolution of all signs and symptoms had resolved.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: The patient developed shoulder pain shortly after the vaccine administration. He was prescribed indomethacin on 10/20/18 and then naproxen on 10/25/18. He stated his prescriber thinks the vaccine was administered too high and caused some tendonitis. He is being treated with NSAIDS.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Significant swelling in left arm down to elbow and slightly into chest. At vaccination site pt described as the size of a lemon. Also experienced chills and fever last night. No report of hives or difficulty breathing.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient has had limited range of motion in left arm and pain since the vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Speech disorder, Syncope
Clinical narrative: Syncope vasovagal; difficulty speaking for minutes. Treatment was given by medical doctor at the office and then went home after full recovery.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient had red circle the size of golf ball and pain on inside upper arm near armpit.
Age: 1.33
Sex: F
Vaccine: FLU4, HIBV
Symptoms: Irritability, Rash erythematous, Rash macular, Vomiting projectile
Clinical narrative: Patient went home after the vaccine and called our office and spoke with the NP reporting the symptoms. Initial call was made at 12:50 PM where symptoms were reported: patient woke up projectile vomiting, she was more fussy than usual, parents were not sure if she had a fever but they denied that she had difficulty breathing, they reported 3 episodes of emesis. Per the physicians orders we advised the Parents were advised to come into the office to be examined, and also to give a dose of BENADRYL before coming in (Parents were unable to give dose as they were en route to office- dose to be given at the office). The parents where the doctor examined a pinpoint rash on her trunk. NO swelling of lips, tongue, difficulty breathing, drooling, diarrhea or further emesis once at the office. She was given a dose of BENADRYL 12.5 mg/5 ml) (3.75 ml) and transported to the hospital via parents despite doctor's recommendation to go via ambulance and administer EPIPEN before travelling there. In the ED, patient appeared well with no distress, no respiratory distress and negative for any abnormalities on physical exam. The rash mildly erythematous macular rash mainly distributed over the trunk. Because there were 2 systems involved (GI and SKIN, the child was given epinephrine 0.1 mg injection and ZANTAC in the ER Epinephrine injection given at 3:49 PM no 10/26/18. They observed her for two hours and then discharged her home with BENADRYL, ZANTAC and ORAPRED. Dr. talked to the parents today and received an update that she is better today, no fever, no vomiting, almost seems to be back at baseline. Reinforced the continuation of medication that was given from the ED, and a follow-up made for Monday to be seen at Pediatrics. Told to call 911 or our answering service over the weekend if any symptoms occur. Parents verbalized understanding and had no further questions or concerns at that time. (Patient does have a known suspected egg allergy and per recommendations did receive the Flu Vaccine on this day).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Pyrexia
Clinical narrative: Chills began approx. 7 PM night of vaccination, followed by fever two hours later. Mild headache followed and continued into the following day, along with some lethargy.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Lymphadenopathy, Pain
Clinical narrative: Cervical Lymphadenopathy, pain.
Sex: M
Vaccine: FLUN4
Symptoms: Crying, Dermatitis allergic, Fatigue, Headache, Pyrexia
Clinical narrative: A spontaneous report has been received from consumer via the regulatory authority. The report concerns a male patient of unknown ethnic origin (age 10 years, height 135 cm). No medical history was reported. No concomitant products were reported. The patient received FLUENZ TETRA, via nasal route, for influenza immunisation on 04-Oct-2018. On 05-Oct-2018, the patient experienced fever, crying, allergic rash, headache and tired all the time. At the time of reporting, the fever, crying, allergic rash, headache and tired all the time were ongoing. The events fever, crying, allergic rash, headache and tired all the time to be serious with seriousness criteria important medical event. Sender's Comments: Pyrexia, crying and dermatitis allergic are not listed in the company core data sheet of Live attenuated influenza vaccine (Q/LAIV). The events occurred 1 day after the administration of drug. Rash is expected with Q/LAIV. However, due to limited information on details of events (treatment given, outcome), medical history, concurrent diseases, concomitant medications, etiological and diagnostic work up (complete blood count, allergy test), it is not possible to make a conclusive assessment of the causal relationship of events with suspect drug.
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves an adult female patient (age was not reported) who experienced cellulitis, while she received vaccine INFLUENZA VACCINE (unknown manufacturer). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a serious cellulitis, 1 day following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No lab data reported. Final diagnosis was cellulitis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for cellulitis. Sender's Comments: This is a poorly documented case which involves an adult female patient who experienced cellulitis after vaccination. Time to onset is not properly known to decide the compatibility with the role of vaccine. More details regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reported no significant pain during injection, but within a few minutes had pain at injection site, by the next day felt as though he had significant pain at injection site, enough to diminish ROM and strength of his LUE. Care sought in our clinic 10/24. No abnormalities of LUE found on exam.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Loss of consciousness, Vomiting
Clinical narrative: 34 year old scheduled and arrived in flu clinic with husband and 3 children for routine annual flu vaccine. Screening questions were asked and patient was sitting on exam table and vaccine was given. Shortly after flu vaccine was given patient stated that she needed to sit down and then that she felt like she was going to pass out. Myself and the other MA that were working together in the flu clinic immediately layed the patient down on the exam table and put her feet up, got her a wet cold towel to place on forehead.  patient then passed out. I left the room to go and call for help while the other MA stayed with the patient. I proceeded to call the cisco number for on-site emergencies and asked another MA that was not involved to place the page for me for on-site emergency. A pediatric physician happened to be sitting close as well and stepped into the room with the patient to check on her. Patient came back around and alert before I could get ahold of anyone to come evaluate and assist. Patient was given juice and crackers and kept in the clinic for about a half an hour. Patient had a small amount of vomit after drinking the juice and was given water. Patient recovered and felt much better and left clinic with husband and 3 children. LPN and RN arrived after patient was gone - LPN did not start in clinic until 8:30 and RN stated that pager was malfunctioning. I called to follow up with patient the following Tuesday and she said that that day she had a headache and went home and took a nap but she was doing fine and stated that we were great and that she appreciated the follow up call. Patient was notified to always mention that she has the tendency to pass out so that precautions can be taken ahead of time. Patient mentioned after the fact that she had passed out with all 3 of her children but she had the flu shot sitting up the last couple years and did not have a problem and that is why she did not mention it.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Pt/mother was asked to stay 15 mins to monitor, mother said pt was "fine" and left after 5 mins of receiving vaccine, when family reached front of clinic pt was pale and fainted as reported by parents, did not injure self, parent was able to catch pt before falling, medical staff called to front of clinic, pt awake on arrival of medical staff. Pt was then brought back to exam room where she was observed and evaluated by NP. Pt d/c'd home once stable. Pt w/hx of vasovagal - near syncope w/fingersticks.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Loss of consciousness, Syncope, Vomiting
Clinical narrative: Pt received 2nd dose of this season's influenza immunization. Minutes later while walking to check out pt had episode of syncope. Pt quickly regained consciousness. Pt then had episode of emesis.  BP quickly improved to baseline. Glucose was also checked and was normal. No previous history  of adverse reaction to immunizations. Pt is a previously healthy 3year old. Dr.
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: PT DEVELOPED RASH, MILD SANDPAPER, PAPULAR ERYTHEMATOUS RASH TO B CHEEKS, LOWER NECK, UPPER CHEST, NO RESPIRATORY INVOLVEMENT. PT REMAINED IN CLINIC X1.5 HOURS TO MONITOR, GIVEN BENADRYL, RASH RESOLVED 1.5 HOURS POST FLU VACCINE.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pt developed left shoulder pain with limitation in ROM 2d following flu vaccine administration in same arm.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient reports fever and headache. Pt also reports redness and swelling that was warm to the touch on entire upper arm (shoulder to elbow).
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling from injection site in shoulder down to elbow. Pt did not report fever or other symptoms.
Age: 80.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Blood pressure increased, Erythema, Flushing
Clinical narrative: Patient started having elevated blood pressure right after influenza (FLUAD) and pneumococcal conjugate (PREVNAR-13) vaccinations. Patient doubled-up on blood pressure medications about every other day for 5 to 6 days while pressure was high. Patient now feels well with minor complaints (elevated blood pressure, flushing, face getting red --- although blood pressure has been normal past few days).
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: Crying, Wrong product administered
Clinical narrative: Patient came to our office for his one month health check. Post check up Provider ordered the second dose of Hep B. Medical Assistant administered the flu vaccine by error thinking that it was the Hep B. Medical Assistant as soon as she recognized her error she informed the provider of the incident. Provider spoke to patient's mom and explained to her what happened. She advised patient's mom to please keep a close eye on patient and if she saw any changes in his behavior to please bring him back to the facility or call 911 and go to the nearest ER if nothing occurred then to please come back in 48 hours for recheck. Patient's mother stated that she understood the instructions given to her.   10/19/2018: Samuel and his mother returned to the clinic Provider examined Samuel and stated that Samuel was cryful but comfortable, no redness or induration noted to the site of vaccine. Mom was asked to return in 10 days for follow up.
Age: 56.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site rash, Injection site reaction, Urticaria
Clinical narrative: Patient showed up at the pharmacy on 10/26/2018 in the afternoon and stated her arm has been sore however when she woke up this morning she noticed the welts/rash on her upper left arm.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Local reaction, Pruritus generalised
Clinical narrative: Large local reaction left upper arm, with redness and itching, then few days later systemic allergic reaction with whole body rash, itching. Unfortunately he was given both immunizations AFLURIA flu shot and SHINGRIX at the same location in the left upper arm at the pharmacy.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash generalised
Clinical narrative: Large local reaction left upper arm, with redness and itching, then few days later systemic allergic reaction with whole body rash, itching. Unfortunately he was given both immunizations AFLURIA flu shot and SHINGRIX at the same location in the left upper arm at the pharmacy.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient stated that she had hives and a rash on her right arm. Patient took benadryl and tylenol and it went away a little bit and is getting better.
Age: 1.92
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Malaise
Clinical narrative: Patient came in for a sick visit follow up. Provider ordered the Flu vaccine for Patient. Our new  Medical Assistant grabbed the PEDIARIX vaccine by accident and administered it. Provider, FNP was notified immediately and entered the room and spoke to mom of what occurred. Signs and symptoms were discussed by provider and myself to mom. Mom was also assured that this will not occurred again in the future. Mom verbalized understanding.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injection site pain, Pain in extremity
Clinical narrative: Pt stated that the next day after receiving vaccine she had headaches and a pain that radiated down from the head to left side of arm to injection site. Headaches were lasting until reporting date.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Erythema
Clinical narrative: Stated red face, tight feeling in chest within 30 minutes of vaccination. Gave self EPIPEN since he carries for life threatening bee allergy.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Culture throat, Headache, Influenza virus test negative, Oropharyngeal pain
Clinical narrative: PATIENT WOKE UP AT 2:45 A.M. ON 10/26/18 WITH A 101.8 DEGREE FEVER, CHILLS, SORE THROAT ON THE RIGHT SIDE ONLY, HEADACHE, ACHINESS. I TOOK HER TO A MED CARE FACILITY. THEY DID A STREP TEST AND FLU TEST, BOTH OF WHICH WERE NEGATIVE. THEY DID A THROAT CULTURE TO BE SENT OFF TO A LAB TO CONFIRM THAT IT IS NOT STREP. THEY PRESCRIBED A CHILDRENS' Z PACK (AZITHROMYCIN). THEY PRESCRIBED A BROMPHEN PRODUCT AND A LIDOCAINE MOUTH WASH. AT 5:30 P.M. HER FEVER WAS 102.3 DEGREES. WE ARE GIVING HER CHILDRENS' MOTRIN FOR THE FEVER.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Streptococcus test negative
Clinical narrative: PATIENT WOKE UP AT 2:45 A.M. ON 10/26/18 WITH A 101.8 DEGREE FEVER, CHILLS, SORE THROAT ON THE RIGHT SIDE ONLY, HEADACHE, ACHINESS. I TOOK HER TO A MED CARE FACILITY. THEY DID A STREP TEST AND FLU TEST, BOTH OF WHICH WERE NEGATIVE. THEY DID A THROAT CULTURE TO BE SENT OFF TO A LAB TO CONFIRM THAT IT IS NOT STREP. THEY PRESCRIBED A CHILDRENS' Z PACK (AZITHROMYCIN). THEY PRESCRIBED A BROMPHEN PRODUCT AND A LIDOCAINE MOUTH WASH. AT 5:30 P.M. HER FEVER WAS 102.3 DEGREES. WE ARE GIVING HER CHILDRENS' MOTRIN FOR THE FEVER.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: Pt reported on 10/26/18 at 9;20am a hard itchy spot where the shot was given. She did not report it was painful.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Patient was brought to urgent care at 1545 on 10/26/18 with swelling around his eyes. While the patient was in the check in process, he also developed swelling of the upper lip. After treatment, patient began to show signs of resolution of edema within 25 minutes of Benadryl administration.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Myalgia, Pain
Clinical narrative: Significant pain, no swelling, bruising, or redness. Pain goes up to the neck muscle and down to the elbow. Pain woke her up at night. Aching, sick feeling. Followed up with Provider, and Provider felt it was a reaction to the vaccine. Recommended to not have another flu shot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Carpal tunnel syndrome, Electromyogram abnormal, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Patient received vaccine in left deltoid. The next day had fairly sizeable local swelling that resolved. On 20 July started to get pain in left shoulder; it was minor and not concerning but on 22 July (Sunday) awoke and had markedly limited ROM. This was initially investigated with ER visit where there was a normal X-Ray. Subsequent exam in my office showed inability to activate rotator cuff; and initial diagnosis of frozen shoulder made but then was found to have full passive ROM. MRI of shoulder showed normal structures and tendons; EMG was then ordered but there was a delay in getting study done; this was completed on 13 October and showed only mild Carpal tunnel but by then all her symptoms had resolved and exam in my office 26 October confirmed that there was no further residual shoulder weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Rotator cuff syndrome, X-ray limb normal
Clinical narrative: Patient received vaccine in left deltoid. The next day had fairly sizeable local swelling that resolved. On 20 July started to get pain in left shoulder; it was minor and not concerning but on 22 July (Sunday) awoke and had markedly limited ROM. This was initially investigated with ER visit where there was a normal X-Ray. Subsequent exam in my office showed inability to activate rotator cuff; and initial diagnosis of frozen shoulder made but then was found to have full passive ROM. MRI of shoulder showed normal structures and tendons; EMG was then ordered but there was a delay in getting study done; this was completed on 13 October and showed only mild Carpal tunnel but by then all her symptoms had resolved and exam in my office 26 October confirmed that there was no further residual shoulder weakness.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Insomnia, Joint stiffness, Pyrexia
Clinical narrative: Patient complains of hand and finger joint stiffness and fever after receiving flu vaccine Monday Oct 15th at pharmacy. Fever of 102F that 1st appeared on Friday Oct 19th, relieved by APAP. 2nd fever Wed Oct 24th, with chills, awake most of night with fever up to 105F, treated with cold compress on forehead with relief of fever w/ APAP. Since then pt is experiencing stiffness and pain in joints, alleviated with tiger balm patches. Fever 99.2 - 100.1 over last 24 hours. Assessment questions were asked per triage protocol and the patient answered "no" to all questions except for the following: Pt has been exercising regularly and is losing approx 1 lb per week, no other significant health status changes. Pertinent negatives include never had a vaccine rxn in past. Fingers and hands are not cold or blue; normal daily movements are possible with accompanying pain. Pt describes thick red blotch on knuckles with shiny skin. Vaccine reaction review: Pt denies cough, itching, hoarseness, rash or reaction at injection site, breathing difficulties. Recommendation Disposition: Instructed patient to seek medical care within 2-4 hours at Care Clinic for assessment by provider for possible vaccine reaction vs exposure to a different virus. RN conferred with triage MD to and decided to report moderate vaccine reaction to VAERS reporting system. RN completed. Advice Agreement: Patient verbalizes understanding and agrees to follow through with the recommended disposition and advice given. Pt advised to give the clinic a call early next week to make f/u appt with her PCP. Denies additional questions and concerns.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: Patient complains of hand and finger joint stiffness and fever after receiving flu vaccine Monday Oct 15th at pharmacy. Fever of 102F that 1st appeared on Friday Oct 19th, relieved by APAP. 2nd fever Wed Oct 24th, with chills, awake most of night with fever up to 105F, treated with cold compress on forehead with relief of fever w/ APAP. Since then pt is experiencing stiffness and pain in joints, alleviated with tiger balm patches. Fever 99.2 - 100.1 over last 24 hours. Assessment questions were asked per triage protocol and the patient answered "no" to all questions except for the following: Pt has been exercising regularly and is losing approx 1 lb per week, no other significant health status changes. Pertinent negatives include never had a vaccine rxn in past. Fingers and hands are not cold or blue; normal daily movements are possible with accompanying pain. Pt describes thick red blotch on knuckles with shiny skin. Vaccine reaction review: Pt denies cough, itching, hoarseness, rash or reaction at injection site, breathing difficulties. Recommendation Disposition: Instructed patient to seek medical care within 2-4 hours at Care Clinic for assessment by provider for possible vaccine reaction vs exposure to a different virus. RN conferred with triage MD to and decided to report moderate vaccine reaction to VAERS reporting system. RN completed. Advice Agreement: Patient verbalizes understanding and agrees to follow through with the recommended disposition and advice given. Pt advised to give the clinic a call early next week to make f/u appt with her PCP. Denies additional questions and concerns.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Injection site pain, Pain
Clinical narrative: Soreness in right shoulder, increasing pain with motion moving arm above shoulder height. 18.5 weeks pregnant when shoulder pain increased. Expected due date is 03-20-2019.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Influenza virus test negative, Pain in extremity, Pyrexia
Clinical narrative: Patient said started running a fever and chills and arm got red so she went to ER... they tested her for flu but it was negative. Patient says today arms is still red and sore and she is supposed to go see primary care in 3-4 days.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient has muscle pain in her shoulder and she is not able to lift up her arm. She is currently seeing an orthopedic doctor for her pain.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Joint range of motion decreased, Pain
Clinical narrative: Within 24 hours of vaccination, patient started to develop pain and limited range of motion. She also had a bruise that lasted for 2 weeks. Her initial symptoms have improved, but she still says that she is experiencing a deep throbbing pain. She has been using massage, ibuprofen, and hot tub to relieve symptoms.