chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Cough, Diarrhoea, Loss of personal independence in daily activities
Clinical narrative: Pt received the vaccine approximately 1:30pm on 10/05/17. He states about 2 hours after receiving the Flu shot, he started with sneezing and coughing. Later in the day, he started having Nausea, Vomiting and diarrhea. By Monday, 10/09/17, he went to the ER and was given IV fluids. He was not admitted as inpatient. On Wed 10/11/17, pt complaining of continued weakness with nausea and diarrhea (vomiting had subsided). He was still having coughing, sneezing and increased phlegm in his lungs. Pt started taking Probiotic, ZOFRAN RX, IMODIUM AD, PEPTO BISMOL, TUMS and CORIDIDAN HBP. Patient states he is holding down rice, applesauce, banana, toast and cream of wheat. He is still having nausea in between the ZOFRAN every 6 hour dosing. He states he has always had a "nervous stomach" and last upper and lower GI was given 3 years prior. He was not diagnosed with any chronic GI illness at that time. Wed 10/11/17 8pm. Patient states he is showing slight improvement with his coughing, sneezing and runny nose. He has had no fever. His chief complaint is stomach pain and the pharmacist recommended Omeprazole 20mg OTC and pharmacy delivered out medication to patient around 8:30pm. Pt normally had an active lifestyle. He had just come from a swim prior to the vaccine and rides a bicycle on a regular basis. He has not been able to resume normal activity since the vaccine. Pharmacist recommended he follow up with his primary care physician if his symptoms do not improve or worsen. Pharmacist will follow up with patient on Friday 10/13/17.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: Pt received the vaccine approximately 1:30pm on 10/05/17. He states about 2 hours after receiving the Flu shot, he started with sneezing and coughing. Later in the day, he started having Nausea, Vomiting and diarrhea. By Monday, 10/09/17, he went to the ER and was given IV fluids. He was not admitted as inpatient. On Wed 10/11/17, pt complaining of continued weakness with nausea and diarrhea (vomiting had subsided). He was still having coughing, sneezing and increased phlegm in his lungs. Pt started taking Probiotic, ZOFRAN RX, IMODIUM AD, PEPTO BISMOL, TUMS and CORIDIDAN HBP. Patient states he is holding down rice, applesauce, banana, toast and cream of wheat. He is still having nausea in between the ZOFRAN every 6 hour dosing. He states he has always had a "nervous stomach" and last upper and lower GI was given 3 years prior. He was not diagnosed with any chronic GI illness at that time. Wed 10/11/17 8pm. Patient states he is showing slight improvement with his coughing, sneezing and runny nose. He has had no fever. His chief complaint is stomach pain and the pharmacist recommended Omeprazole 20mg OTC and pharmacy delivered out medication to patient around 8:30pm. Pt normally had an active lifestyle. He had just come from a swim prior to the vaccine and rides a bicycle on a regular basis. He has not been able to resume normal activity since the vaccine. Pharmacist recommended he follow up with his primary care physician if his symptoms do not improve or worsen. Pharmacist will follow up with patient on Friday 10/13/17.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient presented 2 days after the vaccines were given with a red arm that was swollen. The patient was advised to ice the arm, take TYLENOL and BENADRYL. The patient will follow up with her primary care provider if the symptoms do not resolve by the 3 day post vaccination.
Age: 32.0
Sex: F
Vaccine: FLUA3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test, Lumbar puncture, Neuropathy peripheral
Clinical narrative: Oct 14- both legs and feet started tingling. Oct 17th-went to PCP B/C they wouldn't stop tingling. He did back X-ray which was negative to rule out back problems. Sent me to physical therapy because my insurance wouldn't cover MRI without it. PT didn't help. Oct 30-both arms started tingling too. Neurology consult ordered. Nov 17-got into neurologist who sent me directly to emergency room for lumbar puncture and was admitted for 5 days. Received IVIG. Still have neuropathy of arms and legs and feet to this day.
Age: 32.0
Sex: F
Vaccine: FLUA3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Spinal X-ray normal
Clinical narrative: Oct 14- both legs and feet started tingling. Oct 17th-went to PCP B/C they wouldn't stop tingling. He did back X-ray which was negative to rule out back problems. Sent me to physical therapy because my insurance wouldn't cover MRI without it. PT didn't help. Oct 30-both arms started tingling too. Neurology consult ordered. Nov 17-got into neurologist who sent me directly to emergency room for lumbar puncture and was admitted for 5 days. Received IVIG. Still have neuropathy of arms and legs and feet to this day.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came into pharmacy with painful and itchy red, swollen right arm, on the outside of the arm starting under the deltoid and extending to the elbow. Recommended ibuprofen and cold compresses for the pain and swelling and diphenhydramine for itching. Referred to primary doctor if symptoms did not improve and resolve within a few days or if she had worsening or systemic symptoms.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Photophobia, Vision blurred
Clinical narrative: The patient complained the next day of blurry vision, light sensitivity, and dizziness.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site mass, Injection site pain
Clinical narrative: Pt requested both vaccines in same arm. Pt stated that day after injection she felt discomfort, tenderness, and sometimes a lump near site. Pt claims her affected arm is limited in usage and mobility. Pt self treated with ibuprofen otc. Pt states that the only time she feels relief is when she sleeps on her right side with her left arm not bearing weight. Pt was referred to PCP. PCP gave order for mobic 7.5mg once daily. Pt claims that PCP is having requesting imaging and sonargraphy of area.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Erythema, Induration, Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: Patient said both arms were red and swollen the size of a baseball. Both arms were sore. The Left arm was the worst and of the longest duration. It also had a hard lump. She had fever for a day. She called her doctor who advised BENADRYL. She took BENADRYL until the symptoms went away. She showed it to a doctor when she went along to her daughter's doctor visit, but was not treated.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Patient said both arms were red and swollen the size of a baseball. Both arms were sore. The Left arm was the worst and of the longest duration. It also had a hard lump. She had fever for a day. She called her doctor who advised BENADRYL. She took BENADRYL until the symptoms went away. She showed it to a doctor when she went along to her daughter's doctor visit, but was not treated.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Patient said both arms were red and swollen the size of a baseball. Both arms were sore. The Left arm was the worst and of the longest duration. It also had a hard lump. She had fever for a day. She called her doctor who advised BENADRYL. She took BENADRYL until the symptoms went away. She showed it to a doctor when she went along to her daughter's doctor visit, but was not treated.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Gaze palsy, Laboratory test normal
Clinical narrative: On 9/16/17 pt states at 2:20pm left eye froze and then she had double vision, 5 episodes that day went to ER has had numerous tests with no conclusive results all normal. On day 9/17-9/20/17 had at least one episode per day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Patient stated that the symptoms started the night of her vaccination and worsened on Saturday. She stated that the area became red, inflamed, hot to the touch, and itchy. The area is about a 3 inch by 1 inch area. She stated that it is starting to improve now.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dry eye, Eye swelling, Pruritus, Rash
Clinical narrative: Patient woke up the following day on 10/08/2017 with rash, swollen eyes and itchiness. She took some BENADRYL and by the time she called the Pharmacy claimed to have been getting better with the itching and swelling. She then went to see her Primary Doctor today 10/11/2017 and all the rash was cleared and her eyes were still a bit dry but Doctor told her that they should clear off in a few days. No more rash and no longer swollen. Patient claims to be doing well.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nasal congestion, Nausea, Pyrexia
Clinical narrative: Chills, fever of 104, nausea, nasal congestion.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash generalised
Clinical narrative: PT HUSBAND STATES THAT SHE BROKE OUT IN A SYSTEMIC RASH ON HER STOMACH AND ARMS. HE IS AN RPH AND STATES THEY REPORTED IT TO VAERS AS WELL.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient reported redness and swelling of right arm from elbow to shoulder. Patient reported that it made her feel sick all day. This resolved after 1 day to only minor swelling and resolved completely after 2 more days.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on arms and hands.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Neuralgia
Clinical narrative: Patient explained that 2 days after his ZOSTAVAX vaccination he developed two red rings that formed above his left ankle which had a sensation of nerve pain. He explained that the rings and pain disappeared after approximately 2 weeks. He did not report the adverse event to anyone before today.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Asthenia, Hyperhidrosis, Malaise, Seizure
Clinical narrative: Patient's husband returned 10/11/2017 stating that patient returned home "not looking well", she was sweating and weak. Then she had a seizure. He did not seek medical attention or call the pharmacy. He states she is okay now but very weak.
Age: 54.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chest discomfort
Clinical narrative: Patient reported chest tightness (at 8:00 pm) shortly after receiving the above immunizations (at 7:45 and 7:50 pm). Her blood pressures were 134/77, 128/76, and 117/77. Her skin did not change color. She was able to speak to us as usual. When calling paramedic, it was advised that we give her 2 tablets of aspirin 325 mg and we did. Paramedic arrived very quick. They checked her blood pressure, heart rate and oxygen level. All came back normal per paramedic. Upon questioning, she stated that she experienced similar chest tightness before and was diagnosed with depression. However, she just picked her bupropion XL 150 mg and had not take it yet. She refused to go to the hospital with the paramedic. At 8:40 pm, she decided to front end to purchase Q-tip and will go home with her daughter.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Irritability, Pyrexia, Rash
Clinical narrative: Fever lasting until the next day, fussiness (wanting held constantly and crying). Small bumps on forehead, under eyes and across nose the next evening.
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Pyrexia, Rash, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema in a child patient who received MENVEO (batch number M16172, expiry date 31st October 2018). On 2nd October 2017, the patient received MENVEO. On an unknown date, less than a week after receiving MENVEO, the patient experienced erythema, swelling, fever and rash. On an unknown date, the outcome of the erythema, swelling, fever and rash were unknown. The reporter considered the erythema, swelling, fever and rash to be possibly related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by office manager. This patient along with another 11 year old was given the vaccine on the same date from the same lot. Both developed redness, a rash and the area was raised of swollen. One of the patients developed a low grade fever but the sales rep did not know which, so this event included it on both records. Very little information was provided by this sales rep. She was uncertain if it has been previously reported. The office was told to discontinue use of the product and to contact GSK. This case has been linked with case US2017GSK154155, as reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLUARIX Quadrivalent (batch 5GC54, expiry date 21st May 2018. Previously administered products included influenza vaccine (add received on an unknown date and had no reaction with flu vaccines). On an unknown date, the patient received FLUARIX Quadrivalent. On an unknown date, less than a year after receiving FLUARIX Quadrivalent, the patient experienced injection site erythema, injection site induration, injection site itching and injection site swelling. On an unknown date. the outcome of the injection site erythema, injection site induration, injection site itching and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site itching and injection site swelling to be related to FLUARIX Quadrivalent. Additional details were reported as follows: This case was reported by a Registered Pharmacist. The age at vaccination was not reported. The patient experienced red, hard, swollen and very itchy area, about 3 inches in diameter around the injection site. The patient had not yet seen her physician, but would be going. This case was linked to case US2017GSK152337, as reported by same reporter.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Patient states at he woke and felt feverish, joints aching, cold/chills, sweaty, S/B told him he felt like skin was burning - did not assess temp. He took ibuprofen at that time and went back to bed. He got up at 8 AM and no longer felt feverish and had no body aches, he rested until 10 AM at which time he felt achy again, he then took 800 mg ibuprofen and rested most of day and night, he continued resting. Sunday AM 10-8-17 he stated he woke and felt "normal", he started doing household chores, at midday, he began feeling achy and fatigued again. He states by evening Sunday, he was feeling "normal" again but yesterday Tuesday 10-10-17 he had a "stiff neck" and "my trapezius muscles felt tight he states it "cleared up" as the day went on. He denies further complaints after yesterday.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Muscle tightness, Musculoskeletal stiffness, Pyrexia, Skin burning sensation
Clinical narrative: Patient states at he woke and felt feverish, joints aching, cold/chills, sweaty, S/B told him he felt like skin was burning - did not assess temp. He took ibuprofen at that time and went back to bed. He got up at 8 AM and no longer felt feverish and had no body aches, he rested until 10 AM at which time he felt achy again, he then took 800 mg ibuprofen and rested most of day and night, he continued resting. Sunday AM 10-8-17 he stated he woke and felt "normal", he started doing household chores, at midday, he began feeling achy and fatigued again. He states by evening Sunday, he was feeling "normal" again but yesterday Tuesday 10-10-17 he had a "stiff neck" and "my trapezius muscles felt tight he states it "cleared up" as the day went on. He denies further complaints after yesterday.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Burning sensation, Chills, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Patient states at he woke and felt feverish, joints aching, cold/chills, sweaty, S/B told him he felt like skin was burning - did not assess temp. He took ibuprofen at that time and went back to bed. He got up at 8 AM and no longer felt feverish and had no body aches, he rested until 10 AM at which time he felt achy again, he then took 800 mg ibuprofen and rested most of day and night, he continued resting. Sunday AM 10-8-17 he stated he woke and felt "normal", he started doing household chores, at midday, he began feeling achy and fatigued again. He states by evening Sunday, he was feeling "normal" again but yesterday Tuesday 10-10-17 he had a "stiff neck" and "my trapezius muscles felt tight he states it "cleared up" as the day went on. He denies further complaints after yesterday.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Muscle tightness, Musculoskeletal stiffness, Pain, Pyrexia, Vomiting
Clinical narrative: Patient states at he woke and felt feverish, joints aching, cold/chills, sweaty, S/B told him he felt like skin was burning - did not assess temp. He took ibuprofen at that time and went back to bed. He got up at 8 AM and no longer felt feverish and had no body aches, he rested until 10 AM at which time he felt achy again, he then took 800 mg ibuprofen and rested most of day and night, he continued resting. Sunday AM 10-8-17 he stated he woke and felt "normal", he started doing household chores, at midday, he began feeling achy and fatigued again. He states by evening Sunday, he was feeling "normal" again but yesterday Tuesday 10-10-17 he had a "stiff neck" and "my trapezius muscles felt tight he states it "cleared up" as the day went on. He denies further complaints after yesterday.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Pyrexia, Rash, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema in a 11-year-old patient who received MENVEO (batch number M16172, expiry date 31st October 2018). On 2nd October 2017, the patient received MENVEO. In October 2017, less than a week after receiving MENVEO, the patient experienced erythema, swelling, fever and rash. On an unknown date, the outcome of the erythema, swelling, fever and rash were unknown. The reporter considered the erythema, swelling, fever and rash to be possibly related to MENVEO. Additional details were provided as follows: This case was reported by Office Manager. This patient along with another patient was given the vaccine on the same date from the same lot. Both developed redness, a rash and the area was raised or swollen. One of the patients developed a low grade fever but the sales rep did not know which, so this event included it on both records. Very little information was provided by this sales rep. She was uncertain if it has been previously reported. The office was told to discontinue use of the product and to contact GSK. This case has been linked with case US2017GSK154154, as reported by same reporter.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Hyperaesthesia, Myalgia, Pyrexia
Clinical narrative: Muscle aches in waist, legs, arms. Burning skin all over body painful by touching. Fever and headache, chills. Very sensitive skin. Pains even washing hands. 36 hrs.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Skin burning sensation, Tenderness
Clinical narrative: Muscle aches in waist, legs, arms. Burning skin all over body painful by touching. Fever and headache, chills. Very sensitive skin. Pains even washing hands. 36 hrs.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO. Concomitant products included FLUARIX TETRA. On 29th September 2017, the patient received BEXSERO. On 29th September 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient was the daughter of the reporting pharmacist. The patient received BEXSERO and FLUARIX TETRA in an unknown arm. The patient experienced injection site pain that had not resolved. FLUARIX TETRA was administered in opposite arm but the patient had not complained about pain in that arm. The healthcare professional did not had lot number or expiry information for either vaccine administered.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration
Clinical narrative: Had redness on side of back, had red spots - on wrist still visible 10/11/17, she said nothing near injection site. She applied HC cream. She went to MD for son and MD asked if she got the ZOSTAVAX instead - I said no you got flu shot. Pt. is fine.
Age: 62.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Vaccine received 9/25/17. She called the office 9/27/17 stating she was not responding to NSAIDS for pain after the vaccine. On 8/3/17 she returned for an office visit and had mild pain distal to injection site but decreased ROM with arm especially lateral abduction.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Eye swelling, Vomiting
Clinical narrative: Eye swelling - 10:30 AM - took BENADRYL. Vomiting/diarrhea 12:30 PM.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Formication, Oedema peripheral, Pruritus
Clinical narrative: Patient came back to pharmacy to show me swelling under his left arm. He stated that he felt like ants were on his body an had intense itching across chest area.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Fall, Malaise, Peripheral swelling
Clinical narrative: Patient states she fell to the floor and was feeling generally sick and had to call paramedics. Also claims her arms are red and swollen.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Eye swelling, Peripheral swelling
Clinical narrative: Patient states she fell to the floor and was feeling generally sick and had to call paramedics. Also claims her arms are red and swollen.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Infection, Injection site erythema
Clinical narrative: Patient was given a flu shot on 9/18/17. She developed redness at injection site. She went to a clinic who then sent her to emergency department. She was treated for cellulitis and was given an antibiotic for the infection.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Mother called day after vaccine to report "palm sized" red, hot, firm reaction at vaccine site.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: No known adverse reactions-Patient received adult Hepatitis A dose instead of pediatric dose of Hepatitis A.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site reaction, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, tingling, soreness of (L) arm that began one day after hepatitis B vaccination (1/3 of series). Seen in ED on 8/22/17 and diagnosed with (L) sided deltoid localized post injection site reaction.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt's. arm is red, warm and slightly swollen over whole upper arm. Pt. states had reaction like this before but never so big/last so long.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood pressure decreased, Head injury, Syncope
Clinical narrative: Patient fainted 5-7 minutes after vaccination. Hit head called 911-paramedics said everything ok. Waiting to follow up with MD. MD stated BP decreased from flu shot taken him have to lay down.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt. came in 10/10/17 after getting flu shot 10/5/17 with complaints of shoulder pain and pain going down arm. Taking TYLENOL OTC but not helping.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Erythema, Immediate post-injection reaction, Pyrexia, Rash
Clinical narrative: Rash, Onset: 2 days ago. The problem is worse. Location is left leg. The patient describes the rash as itchy. Associated symptoms include diarrhea, fever and painful rash. Pertinent negatives include cough, nausea and vomiting. Additional information: Child had flu shot at left anterior thigh 2 d ago. Immediate redness, now red spot is larger and hot. Tried BENADRYL cream without any help. Spot is itchy. Diarrhea yesterday. IZ, Pt is UTD, Assessment/Plan.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Rash, Onset: 2 days ago. The problem is worse. Location is left leg. The patient describes the rash as itchy. Associated symptoms include diarrhea, fever and painful rash. Pertinent negatives include cough, nausea and vomiting. Additional information: Child had flu shot at left anterior thigh 2 d ago. Immediate redness, now red spot is larger and hot. Tried BENADRYL cream without any help. Spot is itchy. Diarrhea yesterday. IZ, Pt is UTD, Assessment/Plan.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Breast pain, Injection site erythema, Skin reaction
Clinical narrative: Red arm on vaccination area and spreading to underarm - tried BENADRYL/and ibuprofen. Breast hurting.
Age: 39.0
Sex: U
Vaccine: FLU4
Symptoms: Throat irritation, Urticaria
Clinical narrative: Patient presented today 10/6/17 to report S/S after flu vaccine on 9/29/17 during employee flu clinic. Verbalized feeling itchy and scratchy throat about 1hr after vaccination. Verbalized hives started in abdomen, then (R) side of body and quickly spread all over. Pt didn't report or go to MD. Took antihistamine and applied lotion. Some hives still visible today on abdomen today 10/6/17. Reported today and instructed to notify MD regarding next year flu vaccination if concerned. Pt. aware will be reporting.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site urticaria, Rash, Urticaria
Clinical narrative: Extensive hives noted 2 days after vaccine admin. to trunk and legs. On day 3, she also had hives to R arm around injection site. None to L arm. Rash resolved over next few days with antihistamine.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Two days later came back with redness and soreness about 4 inches behind on flu shot site.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient got PNEUMOVAX 23 shot on her Right arm and she got localized redness on her upper arm and little on her back of shoulder.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Pt reported fever of approximately 100.00 F, chills, and general malaise roughly one hour after vaccination.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Could not lift arm, severe pain in shoulder down arm, collar bone, up left neck. Kept me from sleeping with the pain and if I slept, would wake me up. Taking aspirins and rubbing BIOFREEZE. After almost 3 plus weeks still pain when trying to lift arm.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Could not lift arm, severe pain in shoulder down arm, collar bone, up left neck. Kept me from sleeping with the pain and if I slept, would wake me up. Taking aspirins and rubbing BIOFREEZE. After almost 3 plus weeks still pain when trying to lift arm.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bone pain, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Could not lift arm, severe pain in shoulder down arm, collar bone, up left neck. Kept me from sleeping with the pain and if I slept, would wake me up. Taking aspirins and rubbing BIOFREEZE. After almost 3 plus weeks still pain when trying to lift arm.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness, induration at site. 6 x 4 inches.
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Headache
Clinical narrative: Headache and joints pain occur the day following vaccine administration.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
Clinical narrative: Pt. had dizziness, light headed and rapid heart beat. Pt. blood pressure was elevated and pt. had to pick her up. She was given rest and water. Ambulance offered but pt. refused - pt. did not have any known indications from.
Age: 50.0
Sex: M
Vaccine: MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Client was given MMR-V - too old for this vaccine.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient had pain in entire arm in the evening of 10/02/2017 she went to the emergency room.
Age: 77.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness on upper deltoid of Rt. arm.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: When the patient stood up after administration of the flu vaccine, he fainted.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Red arm swollen.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Approximate 4x4 inch rash around sight of injection lasting for about a week.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Pt has a large bruise on arm where he received flu shot. Arm is sore as well.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Local reaction, Reaction to preservatives
Clinical narrative: Localized reaction to either HPV or Meningococcal. Suspect reaction to the preservatives in the vaccine.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Cough, Dyspnoea, Pulmonary function test decreased, Respiratory tract congestion, Wheezing
Clinical narrative: States in the middle of the night he woke up gasping for air, wheezing, cough - non productive, lasted 1-2 hours then improved, propping self up with pillows. This AM better but still feels congested, no more SOB or wheezing.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Headache, Injection site paraesthesia, Paraesthesia
Clinical narrative: C/O tingling (L) arm shoulder to hand. (L) neck and face. Headache and chest pain.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Wrong flu dose given. .5mL given instead of .25mL.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: 24 hours later large (4in square) red, raised, warm firm to the touch.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Local swelling to right thigh.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 6 inches x 10 inches area of redness and pain, severe swelling of right upper arm, systemic itching. Only affected on right arm where PNEUMOVAX was given. No reaction to FLUZONE HD given in left deltoid.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Large red rash localized to injection site on left arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Oral mucosal eruption, Paraesthesia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Face tingling, small red, painful itchy "dots". Around mouth, forehead. Went to walk in clinic, prescribed Mupirocin oint and top. cortisone cr. Peeling and flaky skin.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Skin exfoliation
Clinical narrative: Face tingling, small red, painful itchy "dots". Around mouth, forehead. Went to walk in clinic, prescribed Mupirocin oint and top. cortisone cr. Peeling and flaky skin.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Pain at injection site after administration - 4 hrs later had pain down arm, elbow and (L) pinkie and ring fingers. Next day pain was less but still had mild weakness in little finger and ring finger - ice applied to injection site next day.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Discomfort, Erythema, Malaise, Myalgia
Clinical narrative: 9-26-17 6:00pm Redness, swelling, discomfort-worsening by next day 9-27-17. 9-27-17 AM-Fever, chills, malaise, myalgia (very ill) worsening through the night - and continuing- 9-29-17 - called me to Report feeling much better.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: 9-26-17 6:00pm Redness, swelling, discomfort-worsening by next day 9-27-17. 9-27-17 AM-Fever, chills, malaise, myalgia (very ill) worsening through the night - and continuing- 9-29-17 - called me to Report feeling much better.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Dysphagia, Rash
Clinical narrative: Pt. had trouble swallowing about 20 minutes after ZOSTAVAX. Contacted Dr, gave epinephrine pen injection one time in outer thigh. Pt. relieved and could swallow easily after one minute. No redness at inj. site - maybe developed - bumps felt.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Haemorrhage, Immediate post-injection reaction, Nodule
Clinical narrative: Instant nodule appeared - small amount of blood - used cotton to wipe. Area turned red and swelled up. Rechecked in 15 minutes. Still swollen. Some soreness in arm. Printed inj. site rxn paper to tell to use ice and NSAID. Rechecked following Monday - she took ADVIL and had a half dollar bruise.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Swelling
Clinical narrative: Instant nodule appeared - small amount of blood - used cotton to wipe. Area turned red and swelled up. Rechecked in 15 minutes. Still swollen. Some soreness in arm. Printed inj. site rxn paper to tell to use ice and NSAID. Rechecked following Monday - she took ADVIL and had a half dollar bruise.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Feeling cold, Hot flush, Hyperhidrosis, Tremor
Clinical narrative: Vaccines administered approx. 12:30 pm 10/5/17 - at 4:30 pm pt experiencing shakiness, hot flashes, excessive sweating. At 6 pm pt reports feeling better, but cold.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Vaccination site discolouration
Clinical narrative: Vaccines given at 1600. At approx 1610 dad came and said pt had a white spot at vaccine site. Pt had 2 hives at site of injections (L thigh) between MMR and varicella. BENADRYL 2.5 ml given.
Age: 8.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Wrong drug administered
Clinical narrative: Pt. was given DTaP when needed TDaP.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; an unspecified number of unspecified patients were administered doses of VARIVAX which were improperly stored.; This spontaneous report as received from a other health professional refers to a patient of unknown age. The patients' medical history and concurrent conditions were not reported. On 01-SEP-2017, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # M049127 reconstituted with STERILE DILUENT (unknown lot, unknown expiration) for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). Administered vaccine experienced the temperature excursion of -14°C to -10°C (-14.2°C) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. The outcome of incorrect product storage and no adverse event were unknown. No product quality complaint(PQC) was involved.    This is one of everal reports from the same reporter.  Lot number N010107 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck)(VARIVAX).  As of 10-OCT-2017, all telephone attempts to obtain follow up information have been unsuccessful.; Sender's Comments:  US-009507513-1709USA002098:
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Swelling face, Throat irritation
Clinical narrative: Itchy throat within 20 minutes of administration--red, swollen face and trouble breathing and driven back to our office by mom within 40 min of visit. At office, observed, mom had given benedryl.  Pt calm and comfortable after benedryl. Observed in office, then sent home stable with f/u to allergist.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: I went to pharmacy to get my vaccines, and I had gotten the flu and PREVNAR 13 two years ago with no reactions just a soar arm. The day of the flu and pneumonia 23 shots I had a welt on my bicep the size of a 50 cent coin, raised, red, and hot to touch. I actually went back to Rite Aid to show the pharmacist the welt, and Sunil Sonawane, pharmacist, was very concerned with the reaction.  He told me to keep in touch if it does not get better, the next day the welt was still there and was still hot to touch. Then on 09/11/2017 I was suppose to go out of town, however, the infection was getting worse.  So I went to Urgent Care and MD said I had an infection and cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Cough, Erythema, Fatigue, Infection
Clinical narrative: I went to pharmacy to get my vaccines, and I had gotten the flu and PREVNAR 13 two years ago with no reactions just a soar arm. The day of the flu and pneumonia 23 shots I had a welt on my bicep the size of a 50 cent coin, raised, red, and hot to touch. I actually went back to Rite Aid to show the pharmacist the welt, and Sunil Sonawane, pharmacist, was very concerned with the reaction.  He told me to keep in touch if it does not get better, the next day the welt was still there and was still hot to touch. Then on 09/11/2017 I was suppose to go out of town, however, the infection was getting worse.  So I went to Urgent Care and MD said I had an infection and cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Skin warm, Urticaria
Clinical narrative: I went to pharmacy to get my vaccines, and I had gotten the flu and PREVNAR 13 two years ago with no reactions just a soar arm. The day of the flu and pneumonia 23 shots I had a welt on my bicep the size of a 50 cent coin, raised, red, and hot to touch. I actually went back to Rite Aid to show the pharmacist the welt, and Sunil Sonawane, pharmacist, was very concerned with the reaction.  He told me to keep in touch if it does not get better, the next day the welt was still there and was still hot to touch. Then on 09/11/2017 I was suppose to go out of town, however, the infection was getting worse.  So I went to Urgent Care and MD said I had an infection and cellulitis.
Age: 17.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Eye pain, Headache, Lumbar puncture, Musculoskeletal pain, Neck pain
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 17-year-old patient of an unspecified gender and ethnicity received, on 12Sep2017, TRUMENBA, (Lot. S56024, Expiration date: Feb2019) at single dose, for immunization. Relevant medical history included eye pain (from an unspecified date, in Sep2017, about 3 days before the vaccination and ongoing). Concomitant medications were unknown. On an unspecified date, in Sep2017, about 2 days after the vaccination, the patient complained of shoulder pain, mild swelling of deltoid, fever. On an unspecified date, in Sep2017, about 14 days after the vaccination, the patient complained also, at the ER visit, neck pain and headache. Spinal tap at ER was performed. Clinical outcome of the events was unknown at time of this report.
Age: 17.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 17-year-old patient of an unspecified gender and ethnicity received, on 12Sep2017, TRUMENBA, (Lot. S56024, Expiration date: Feb2019) at single dose, for immunization. Relevant medical history included eye pain (from an unspecified date, in Sep2017, about 3 days before the vaccination and ongoing). Concomitant medications were unknown. On an unspecified date, in Sep2017, about 2 days after the vaccination, the patient complained of shoulder pain, mild swelling of deltoid, fever. On an unspecified date, in Sep2017, about 14 days after the vaccination, the patient complained also, at the ER visit, neck pain and headache. Spinal tap at ER was performed. Clinical outcome of the events was unknown at time of this report.
Age: 17.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Headache, Lumbar puncture, Musculoskeletal pain, Neck pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 17-year-old patient of an unspecified gender and ethnicity received, on 12Sep2017, TRUMENBA, (Lot. S56024, Expiration date: Feb2019) at single dose, for immunization. Relevant medical history included eye pain (from an unspecified date, in Sep2017, about 3 days before the vaccination and ongoing). Concomitant medications were unknown. On an unspecified date, in Sep2017, about 2 days after the vaccination, the patient complained of shoulder pain, mild swelling of deltoid, fever. On an unspecified date, in Sep2017, about 14 days after the vaccination, the patient complained also, at the ER visit, neck pain and headache. Spinal tap at ER was performed. Clinical outcome of the events was unknown at time of this report.
Age: 17.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 17-year-old patient of an unspecified gender and ethnicity received, on 12Sep2017, TRUMENBA, (Lot. S56024, Expiration date: Feb2019) at single dose, for immunization. Relevant medical history included eye pain (from an unspecified date, in Sep2017, about 3 days before the vaccination and ongoing). Concomitant medications were unknown. On an unspecified date, in Sep2017, about 2 days after the vaccination, the patient complained of shoulder pain, mild swelling of deltoid, fever. On an unspecified date, in Sep2017, about 14 days after the vaccination, the patient complained also, at the ER visit, neck pain and headache. Spinal tap at ER was performed. Clinical outcome of the events was unknown at time of this report.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: After flu shot, start on Tuesday pt. started throwing up and severe diarrhea (poop out while throwing up) until today, living in a small town, has not seeing a doctor. She is getting PEPTO BISMOL, TUMS.  per her daughter 5:24pm.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chest discomfort, Cold sweat, Diarrhoea, Dizziness
Clinical narrative: Unsure of type of influenza shot. About 10 hours go by and I feel very achy and weak (11:00 PM Tuesday October 10th). Had trouble sleeping all night and constant movement. Upon waking up (7:30 AM Wednesday, October 11th) I still had aches all over my body and was very lightheaded. Went to work and remained lightheaded when moving and slight nausea every half hour or so along with diarrhea two times during the day. Fast forward (11:00 PM Wednesday, October 11th) I am having very difficulty sleeping and extreme tightness in my chest that is made worse when laying down. Left side arm pain all throughout arm. Took over the counter ibuprofen (four 200mg circular tablets at approximately 2:17 AM Thursday, October 12th. The pain in both my arms and chest has since subsided. Nausea exists but it is easier to breathe. Burping every so often. I do still have the body aches and hot and cold sweats. Weakness with opening doors and sore muscles.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Eructation, Feeling hot, Insomnia, Myalgia, Nausea
Clinical narrative: Unsure of type of influenza shot. About 10 hours go by and I feel very achy and weak (11:00 PM Tuesday October 10th). Had trouble sleeping all night and constant movement. Upon waking up (7:30 AM Wednesday, October 11th) I still had aches all over my body and was very lightheaded. Went to work and remained lightheaded when moving and slight nausea every half hour or so along with diarrhea two times during the day. Fast forward (11:00 PM Wednesday, October 11th) I am having very difficulty sleeping and extreme tightness in my chest that is made worse when laying down. Left side arm pain all throughout arm. Took over the counter ibuprofen (four 200mg circular tablets at approximately 2:17 AM Thursday, October 12th. The pain in both my arms and chest has since subsided. Nausea exists but it is easier to breathe. Burping every so often. I do still have the body aches and hot and cold sweats. Weakness with opening doors and sore muscles.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Unsure of type of influenza shot. About 10 hours go by and I feel very achy and weak (11:00 PM Tuesday October 10th). Had trouble sleeping all night and constant movement. Upon waking up (7:30 AM Wednesday, October 11th) I still had aches all over my body and was very lightheaded. Went to work and remained lightheaded when moving and slight nausea every half hour or so along with diarrhea two times during the day. Fast forward (11:00 PM Wednesday, October 11th) I am having very difficulty sleeping and extreme tightness in my chest that is made worse when laying down. Left side arm pain all throughout arm. Took over the counter ibuprofen (four 200mg circular tablets at approximately 2:17 AM Thursday, October 12th. The pain in both my arms and chest has since subsided. Nausea exists but it is easier to breathe. Burping every so often. I do still have the body aches and hot and cold sweats. Weakness with opening doors and sore muscles.
Age: 0.0
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abdominal pain upper, Dyspnoea, Vomiting projectile
Clinical narrative: Stomach ache around 11pm and projectile vomiting multiple times around 3am. Heavy breathing.