chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: 9/6/20197 AM body aches, including neck, hips, low back. Fatigue. 1,000 mg Tylenol taken at 8 AM . Within 45 mins, symptoms abated. 6 hours later, symptoms reappeared. Another dose of Tylenol 1,000 mg taken at 2:30 PM. 6:00 PM fever 100.5 (normal temp 97.4).  Slept through the night  6/7/19 Awoke 7 AM, fatigued, less achyness, but some,  sore arm, large hot red area at injection site. Tylenol every 6 hours through the day.   9/8/19 symptoms gone, except for redness and heat at injection site. Still sore to the touch 1000 mg tylenol taken at 1 PM  9/9/19 all symptoms except redness and heat at injection site gone
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: 9/6/20197 AM body aches, including neck, hips, low back. Fatigue. 1,000 mg Tylenol taken at 8 AM . Within 45 mins, symptoms abated. 6 hours later, symptoms reappeared. Another dose of Tylenol 1,000 mg taken at 2:30 PM. 6:00 PM fever 100.5 (normal temp 97.4).  Slept through the night  6/7/19 Awoke 7 AM, fatigued, less achyness, but some,  sore arm, large hot red area at injection site. Tylenol every 6 hours through the day.   9/8/19 symptoms gone, except for redness and heat at injection site. Still sore to the touch 1000 mg tylenol taken at 1 PM  9/9/19 all symptoms except redness and heat at injection site gone
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle swelling, Myalgia
Clinical narrative: swelling and tenderness to the muscle
Age: 55.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Cough, Fluid intake reduced, Hypophagia, Influenza like illness, Influenza virus test negative
Clinical narrative: Extreme drainage from nose, then developed into severe cough and flu-like symptoms. Ended up flat in bed without being able to drink or eat for 3 days, missed a week of work. Tested and did not have flu, but determined had flu-like virus..With help from my holistic doctor treating adverse reaction to the shingrix vaccine, I began drinking and eating and am recovering.
Age: 55.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Loss of personal independence in daily activities, Rhinorrhoea, Viral infection
Clinical narrative: Extreme drainage from nose, then developed into severe cough and flu-like symptoms. Ended up flat in bed without being able to drink or eat for 3 days, missed a week of work. Tested and did not have flu, but determined had flu-like virus..With help from my holistic doctor treating adverse reaction to the shingrix vaccine, I began drinking and eating and am recovering.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: I have no idea which Tdap vaccine was used, ask hospital. Next day I had sharp stomach aches in the lever area all day. Also, I had pain in my arm at the shot area. Then, I had slight fever couple of times over the night and sharp stomach aches continued. During night severe diarrhea began.  All next day my stomach aches got heavier and longer, diarrhea continued until next morning. I had no appetite, felt very tired, had mild fever few times during the day. All problems began to subside in the morning on 09/08/2019, three days after shot was given. I did not seek any medical help, as it was during weekend.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: I have no idea which Tdap vaccine was used, ask hospital. Next day I had sharp stomach aches in the lever area all day. Also, I had pain in my arm at the shot area. Then, I had slight fever couple of times over the night and sharp stomach aches continued. During night severe diarrhea began.  All next day my stomach aches got heavier and longer, diarrhea continued until next morning. I had no appetite, felt very tired, had mild fever few times during the day. All problems began to subside in the morning on 09/08/2019, three days after shot was given. I did not seek any medical help, as it was during weekend.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness and swelling the size of a tennis ball, and it was itchy.  Resolved with cool and warm compresses.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: three patients received a dose of high dose fluzone which shipment was delayed for 48 hours, Three patients received the dose/No AE; Initial information received on 30-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (pharmacy other).  This case involves three patients of unknown demographics who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] which shipment was delayed for 48 hours lot number and expiry date not reported (route and site of administration not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Epistaxis
Clinical narrative: He has had a bloody nose for three days; Initial information received on 30-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 6 years old male patient who experienced bloody nose for three days (epistaxis), while he received vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing cerebral cyst.   On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient had a bloody nose for three days (epistaxis) (Unknown latency) following the administration of IPV (VERO).  Final diagnosis was epistaxis.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for epistaxis.  List of document held by sender: none.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: Patient reported to the clinic because her PCP is here. states she got a second dose of the varicella  Vaccine at pharmacy last night between 4 & 5. This morning she noticed the approximately 3" chickpox like rash at the injections site. the rash itches, red , mild discomfort, no fevers.
Sex: M
Vaccine: HEP, RV5
Symptoms: Peripheral swelling, Rash
Clinical narrative: PER PATIENT MOTHER HAD REACTIONS TO HEP B WHICH INCLUDED SWELLING/RASH TO BILATER LOWER EXTREMITIES AND LOWER ABDOMEN GIVEN AT ANOTHER FACILITY.  ROTATEQ GIVEN PO  ON 01/17/2014 1ST DOSE SERIES PER PATIENT MOTHER STATES CAUSED BOWEL ISSUES AND PATIENT HAD TO BE SEEN IN THE ER
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT HAD RED, ITCHY SITE REACTION
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Hypoaesthesia, Nausea, Pharyngeal swelling
Clinical narrative: Patient reported numbness in hand, headache, nausea, and swelling in throat
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia, Vomiting
Clinical narrative: Fever of 101.3. For 4 days of fever, chills, vomiting, fatigue.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Rash, Rash erythematous, Skin discolouration, Swelling
Clinical narrative: VERY BIG RED AND BLACK SPOTS WITH SWELLING AND LITTLE ITCHING FOR LAST 3 DAYS AND STILL NOT GOING AWAY
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Hiccups, Nausea, Vomiting
Clinical narrative: Patient called me on 9/8/19 at 10 am and let me know that around 10 pm on 9/7/19 he started to experience fits of hiccuping followed by vomiting. This continued throughout the night until around 8 am the next morning. When he and I spoke at 10 am he was still feeling nauseous but was no longer hiccuping or throwing up.
Age: 17.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient 17yo  presented to the office that had never had any vaccinations. Wrong vaccinations given per patient age per doctors order.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: ON 09/05/2019 LEFT UPPER ARM RED AND HOT WHICH STARTED AT INJECTION SITEAND WENT HALF WAY DOWN THE ARM AND THE TISSUE HAD WRINKLY WAVY LINES THROUGH IT AND ON 09/06/2019 HE HAD A FEVER ALL DAY AND THE ARM WASNT AS HARD, ON 09/07/2019 REDDNESS AND SWELLING WAS RECEEDING AND FEVER DOWN 09/09/2019 ARM IS MUCH BETTER. TREATMENT CEFDINIR 600MG FOR 10 DAYS AND DIPHENHYDRAMINE 50MG EVERY 6 HOURS FOR 72 HOURS.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: ON 09/05/2019 LEFT UPPER ARM RED AND HOT WHICH STARTED AT INJECTION SITEAND WENT HALF WAY DOWN THE ARM AND THE TISSUE HAD WRINKLY WAVY LINES THROUGH IT AND ON 09/06/2019 HE HAD A FEVER ALL DAY AND THE ARM WASNT AS HARD, ON 09/07/2019 REDDNESS AND SWELLING WAS RECEEDING AND FEVER DOWN 09/09/2019 ARM IS MUCH BETTER. TREATMENT CEFDINIR 600MG FOR 10 DAYS AND DIPHENHYDRAMINE 50MG EVERY 6 HOURS FOR 72 HOURS.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: At about 0330 on 09/07/19  patient began having nausea, vomiting, body aches, chills, extreme sweating, pain and redness around injection site, and fatigue. Patient took Tylenol for pain, but could not hold anything down due to nausea. Signs and symptoms resolved by the evening of 09/08/19.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: At about 0330 on 09/07/19  patient began having nausea, vomiting, body aches, chills, extreme sweating, pain and redness around injection site, and fatigue. Patient took Tylenol for pain, but could not hold anything down due to nausea. Signs and symptoms resolved by the evening of 09/08/19.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site reaction, Nodule, Skin warm
Clinical narrative: Golf ball size knot within 2 hours as well as slight fever in arm. After acetaminophen and an ice pack overnight, fever increased in arm and large red mark. ***TYPE OF INFLUENZA VACCINE NOT KNOWN.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Fatigue, Irritability, Pyrexia, Rash, Viral rash
Clinical narrative: Fever developed 6 hours after immunization--Received ibuprofen/tylenol, rash developed about 15-18 hours after immunization and he was a bit more tired and clingy than normal.  rash looked similar to the post viral exanthum type of rash.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: After gettting the shots, at nighttime, patient complaint of hot/ burning, swollen, very sore, painful and red (but not itchy) left upper arm. In the afternoon of the next day when she came to the pharmacy to share with us, we took some photos to document it and to make sure the redness did not spread some more.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Itchy hives on anterior & posterior trunk & face. Swelling, redness, pain, and warmth at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Itchy hives on anterior & posterior trunk & face. Swelling, redness, pain, and warmth at injection site.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into our clinic on 09/09/19 with significant swelling at sight of injection, site was hot to the touch, and felt knotted at the site. According to patient this was the 3rd day she said that the 24 hours after the injection she felt fine but that she started to  notice that the sight was swelling hot to the touch and felt a bump, she also explained that due to pain she was unable to rest on her right side and that she felt fatigued the past 2 days.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: PATIENT FELT FAINT AND EXPERIENCED SYNCOPE
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient had a rash, soreness, warmth, and swelling on her arm which she received the flu shot
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient had a rash, soreness, warmth, and swelling on her arm which she received the flu shot
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had a rash, soreness, warmth, and swelling on her arm which she received the flu shot
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: she got pneumovax 23 and developed redness on the arm
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Vaccination site bruising
Clinical narrative: Pt began experiencing pain within 24 hours after receiving the vaccine. Pt also had an extremely large bruise around the vaccination site, he said when he received the vaccine he did not experience any pain
Age: 1.75
Sex: M
Vaccine: HEP, PNC13, MMR
Symptoms: Dysstasia, Erythema, Pyrexia, Rash erythematous, Skin warm
Clinical narrative: Fever 101.6 by 5pm as well as large raised deep red hives or spots. Hot to the touch.  He won't stand or let anyone touch his legs Especially tge right one. Hip to ankle in red spots
Age: 1.75
Sex: M
Vaccine: HEP, PNC13, MMR
Symptoms: Urticaria
Clinical narrative: Fever 101.6 by 5pm as well as large raised deep red hives or spots. Hot to the touch.  He won't stand or let anyone touch his legs Especially tge right one. Hip to ankle in red spots
Age: 1.75
Sex: M
Vaccine: HEP, PNC13, MMR
Symptoms: Aphonia, Decreased appetite, Ear infection, Insomnia, Pyrexia
Clinical narrative: Fever 101.6 by 5pm as well as large raised deep red hives or spots. Hot to the touch.  He won't stand or let anyone touch his legs Especially tge right one. Hip to ankle in red spots
Age: 1.75
Sex: M
Vaccine: HEP, PNC13, MMR
Symptoms: Rash, Screaming
Clinical narrative: Fever 101.6 by 5pm as well as large raised deep red hives or spots. Hot to the touch.  He won't stand or let anyone touch his legs Especially tge right one. Hip to ankle in red spots
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Computerised tomogram head abnormal, Congenital central nervous system anomaly, Cytogenetic analysis, Electroencephalogram normal, Magnetic resonance imaging brain abnormal
Clinical narrative: She woke me up at 5 am going through a seizure and she had two more at the hospital!
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Seizure
Clinical narrative: She woke me up at 5 am going through a seizure and she had two more at the hospital!
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Herpes zoster, Rash
Clinical narrative: PT CAME TO THE PHARMACY COMPLAINING ABOUT RASH , REDNESS AND TIREDNESS. PT WAS DIAGNOSED WITH SHINGLE ON 09/09/2019 AS WELL
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: DONOR REPORTED SEVERAL WELTS APPEARED ONLY ON HIS L ARM WHERE SHOT WAS GIVEN THE DAY AFTER RECEIVING THE IMMUNIZATION. DONOR STATES THE WELTS LASTED FOR 2 DAYS AND  RESOLVED  ON THEIR OWN. DONOR DID NOT SEEK MEDICAL TX .
Age: 31.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt experienced increasing pain and redness at the injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: rash on injection site and under breasts/across front torso. started night of vaccine or next day and continued a week. rash would go away and come back on torso/under breasts faintly. notices that rash begins after playing sports in the heat. rash has resolved now and patient doesn't have any ongoing issues. patient is consulting with md to see if can get dose 2.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was administered HIB vaccine by mouth instead of intramuscularly at 9/9/19 @ ~1200.  Pt was observed for 30 minutes post-ingestion and no adverse reactions were observed.  Poison Control was contacted 9/9/2019 @ 1215 and they recommended to vaccinate the child correctly today and that no adverse reactions were anticipated.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Screaming
Clinical narrative: Inconsolable screaming that evening. Spreading rash that evening increasing the following days.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Alopecia, Blood oestrogen, Cough, Dyspnoea, Laboratory test
Clinical narrative: Within the first week of having the vaccination, I noticed handfuls of hair loss.  Within the 4 weeks after the injection so much hair loss, hair breakage and thinning resulted in me having to purchase a full wig.  For 6-8 weeks after the injection I also experienced excessive coughing,  and difficulty breathing that my rescue inhale could not handle so I was using a nebulizer to get relief.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Thyroid function test
Clinical narrative: Within the first week of having the vaccination, I noticed handfuls of hair loss.  Within the 4 weeks after the injection so much hair loss, hair breakage and thinning resulted in me having to purchase a full wig.  For 6-8 weeks after the injection I also experienced excessive coughing,  and difficulty breathing that my rescue inhale could not handle so I was using a nebulizer to get relief.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: pt developed rash from elbows down to fingers within 48 hours of recieving flu vaccine
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: Gave patient wrong vaccine instead of Menactra I gave her Bexsero (which are almost similar) per RN. Bexsero is recommended at age 16 like a booster vaccine and she shouldn't have any reactions to the vaccine, N.P and I
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: on 9/3/19, I had the first dose of the SHINGRIX 50 MCG vaccine. Within hours, the injection site was beginning to swell. Within 24, I had a headache, nausea, fever, and chills. These symptoms lasted about 36 hours. 5 days later, the injection site is still swollen, red, and warm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: on 9/3/19, I had the first dose of the SHINGRIX 50 MCG vaccine. Within hours, the injection site was beginning to swell. Within 24, I had a headache, nausea, fever, and chills. These symptoms lasted about 36 hours. 5 days later, the injection site is still swollen, red, and warm.
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Got second shingles vaccine injection about 6PM. Just as I was about to fall asleep in bed (11:30PM) I began to shiver. It lasted about 2 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Lipoma, Magnetic resonance imaging abnormal, Ultrasound chest, Ultrasound scan abnormal
Clinical narrative: Got shingrix # 2 on left deltoid. Claims huge lipoma left shoulder chest wall after that
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Rash pruritic
Clinical narrative: C/O shivers for 2 days after receiving vaccine on 9/1/19, noticed bumps on wrist of right arm. Bumps have continued to increase & are covering 3/4 of her arm. They itch & states had 10-12 bumps currently. Encouraged client to call her PCP to be seen. 9/9/19 Talk to client Left message to return call re condition of bumps on arm & if saw PCP. Client returned call & left message. States she seen her PCP on Friday 9/6/19 & is being treated for shingles. States is taken an antiviral medication & antibiotic medication.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Magnetic resonance imaging normal, Malaise, Pain in extremity
Clinical narrative: pt came to pharmacy on 9/9/19 around noon time reported that his arm is still sore, had constant vomiting post vaccination and had to call 911- he had his shot on 9/5/2019 and he had to take 3 advils po for pain. as per pt, his side effects were more moderate such as arm soreness ( still painful). he said, he went to hospital and did all reports, check up, MRI- but everything was normal, and they did not find anything wrong as per pt. he has ENT visit coming up next to find out more.  educated pt on common side effects such as soreness, HA, redness, injection site pain. but pt was saying his side effects were not mild and he had to call 911 because constant vomit & not feeling well post vaccine
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: pt came to pharmacy on 9/9/19 around noon time reported that his arm is still sore, had constant vomiting post vaccination and had to call 911- he had his shot on 9/5/2019 and he had to take 3 advils po for pain. as per pt, his side effects were more moderate such as arm soreness ( still painful). he said, he went to hospital and did all reports, check up, MRI- but everything was normal, and they did not find anything wrong as per pt. he has ENT visit coming up next to find out more.  educated pt on common side effects such as soreness, HA, redness, injection site pain. but pt was saying his side effects were not mild and he had to call 911 because constant vomit & not feeling well post vaccine
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Diarrhoea, Infantile spitting up, Lethargy, Pyrexia
Clinical narrative: Pt has had fever every day since vaccine - @ 101.3 & watery diarrhea, spitting up after breast feedings, more lethargic. No rednes or swelling at sites.
Age: 9.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Injection site bruising, Injection site swelling, Pain
Clinical narrative: Swelling and bruising of arm where vaccine was administered. Also caused entire body aches. Treating with Acetaminophen and Benadryl.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt. had pain in left arm, which was intense in 1st week, which diminished. Pt used Tylenol w/pain, with some relief. Patient still has some residual pain 2 months after
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Lt deltoid a size of an egg. Swelling warm on the area. Some pain. Mom gave pt Benadryl, Motrin and hydrocortisone cream was applied. By the day after reaction was mostly cleared.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: 9/6/2019 12:35 pm c/o quarter size bump at (L) deltoid; hot & itchy, sl. redness. (- SOB, - fever) 9/6/2019 4:21 PM - swelling @ (L) lymph node 9/9/2019 9:33 AM - (L) clavicle pain/swelling resolving
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: 9/6/2019 12:35 pm c/o quarter size bump at (L) deltoid; hot & itchy, sl. redness. (- SOB, - fever) 9/6/2019 4:21 PM - swelling @ (L) lymph node 9/9/2019 9:33 AM - (L) clavicle pain/swelling resolving
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Local swelling, warmth & mild erythema at right upper arm & extending into right axilla
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swelling
Clinical narrative: Local swelling, warmth & mild erythema at right upper arm & extending into right axilla
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Heart rate increased, Nausea, Rash macular
Clinical narrative: patient reported to pharmacy with red blotching near injection site. Also complained of nausea, chills, fatigue and increased heart-rate
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever, arm redness & swelling 8/29/19
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Contusion
Clinical narrative: Patient had severe bruising on 9/6 since vaccine administration.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Blood thyroid stimulating hormone, Burning sensation, Chest X-ray, Dizziness, Dyspnoea
Clinical narrative: Called Public Health (where treatment was authorized) 8/21 and c/o numbness, tingling, feeling "on fire" since "earlier" in the day. Advised PCP, who advised ED. Presented c/o light-headedness, SOB, Nausea, tingling and syncope. Responded to IVF and Zofran, discharged later in day. Denied similar Sx w/subsequent doses, and has since complete Rabies PEP series.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Electrocardiogram, Full blood count, Hypoaesthesia, Metabolic function test, Nausea
Clinical narrative: Called Public Health (where treatment was authorized) 8/21 and c/o numbness, tingling, feeling "on fire" since "earlier" in the day. Advised PCP, who advised ED. Presented c/o light-headedness, SOB, Nausea, tingling and syncope. Responded to IVF and Zofran, discharged later in day. Denied similar Sx w/subsequent doses, and has since complete Rabies PEP series.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia, Pregnancy test urine, Syncope, Thyroxine free, Urine analysis
Clinical narrative: Called Public Health (where treatment was authorized) 8/21 and c/o numbness, tingling, feeling "on fire" since "earlier" in the day. Advised PCP, who advised ED. Presented c/o light-headedness, SOB, Nausea, tingling and syncope. Responded to IVF and Zofran, discharged later in day. Denied similar Sx w/subsequent doses, and has since complete Rabies PEP series.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Burning sensation, Pain, Rash erythematous
Clinical narrative: Patient had broken out in a red stinging/burning rash on the inside of her (R) arm all the way down starting on 9/5/19. Patient came into the clinic on 9/6/19 was evaluated and given a kenalog shot and told to go to ER if she got woRse.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Rash
Clinical narrative: Patient presented to clinic to be evaluated. SkinRash & Chills
Age: 68.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Rash
Clinical narrative: Dizziness & Rash
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Myalgia & flu like symptoms
Sex: F
Vaccine: TYP
Symptoms: Hypotonia, Injected limb mobility decreased, Injection site joint pain, Pain, Product administered at inappropriate site
Clinical narrative: 24 hrs after immunization, had rotator cuff type pain, especially when reaching. Arm goes limp and painful upon most but not all movements. Debilitating. Struggling to changes clothes by onseself. Pain/unable to reach to wash hands without good arm assisting. Seems like SIRVA possibly due to bad injection location. Headed to urgent care today. Problem is with medical service injecting too high on the arm (1-2 fingers width down instead of 3 fingers width down). Also provider stood while patient sal.
Sex: F
Vaccine: TYP
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: 24 hrs after immunization, had rotator cuff type pain, especially when reaching. Arm goes limp and painful upon most but not all movements. Debilitating. Struggling to changes clothes by onseself. Pain/unable to reach to wash hands without good arm assisting. Seems like SIRVA possibly due to bad injection location. Headed to urgent care today. Problem is with medical service injecting too high on the arm (1-2 fingers width down instead of 3 fingers width down). Also provider stood while patient sal.
Age: 11.0
Sex: M
Vaccine: UNK, HPV9, MNQ, TDAP
Symptoms: Headache, Hypersomnia, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Developed headache, vomiting, high fevers that evening (102 degrees) that persisted for a few days. Was seen in ER. Was given Ibu, Zofran. Told to follow up with PCP if symptoms continued.
Age: 11.0
Sex: M
Vaccine: UNK, HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Developed headache, vomiting, high fevers that evening (102 degrees) that persisted for a few days. Was seen in ER. Was given Ibu, Zofran. Told to follow up with PCP if symptoms continued.
Age: 11.0
Sex: M
Vaccine: UNK, HPV9, MNQ, TDAP
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Developed headache, vomiting, high fevers that evening (102 degrees) that persisted for a few days. Was seen in ER. Was given Ibu, Zofran. Told to follow up with PCP if symptoms continued.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse affects have been reported.; patient inadvertently received GARDASIL 9 at 2 months and 6 days old; This spontaneous report was received from a medical assistant and refers to a 2 months and 6 days old patient of gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-AUG-2019, the patient inadvertently was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot# and expiry date were not specified) for prophylaxis at 2 months and 6 days old. No adverse affects had been reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse affects have been reported.; patient inadvertently received GARDASIL 9 at 2 months and 6 days old; This spontaneous report was received from a medical assistant and refers to a 2 months and 6 days old patient of gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-AUG-2019, the patient inadvertently was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot# and expiry date were not specified) for prophylaxis at 2 months and 6 days old. No adverse affects had been reported.
Sex: F
Vaccine: UNK, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse effects were reported; a 37 weeks pregnant patient was inadvertently administered one dose of Gardasil 9; This spontaneous prospective pregnancy report was received from a physician and refers to a female pregnant patient of unknown age. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 23-AUG-2019, 37 weeks pregnant patient was inadvertently administered on dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # 1614897, expiration date 20-SEP-2021 (dose and route of administration were not reported). Following dates were estimated: last menstrual period (LMP): 14-DEC-2018 and date of delivery: 20-SEP-2019. The pregnancy outcome was pending. The fetal outcome was unknown at the time of the report. No adverse effects were reported.
Sex: F
Vaccine: UNK, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse effects were reported; a 37 weeks pregnant patient was inadvertently administered one dose of Gardasil 9; This spontaneous prospective pregnancy report was received from a physician and refers to a female pregnant patient of unknown age. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 23-AUG-2019, 37 weeks pregnant patient was inadvertently administered on dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # 1614897, expiration date 20-SEP-2021 (dose and route of administration were not reported). Following dates were estimated: last menstrual period (LMP): 14-DEC-2018 and date of delivery: 20-SEP-2019. The pregnancy outcome was pending. The fetal outcome was unknown at the time of the report. No adverse effects were reported.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site nodule
Clinical narrative: She has a hard knot at the injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose at left arm to prevent pneumonia administered at the pharmacy. Medical history included acid reflux, knee pain, low thyroid, and allergies to pollen. Concomitant medication included levothyroxine sodium for low thyroid started almost 3 months ago, omeprazole for acid reflux started a month and a half ago, and paracetamol (TYLENOL) for knee pain started about a month ago. On the same day in the other arm (right arm), she received the shingles vaccine, specific name unknown to reporter but it was the new one where you had to have 2 shots. A couple years ago she received the old Shingles vaccine. It was reported that she had a hard knot at the injection site on an unspecified date. Pharmacist administered the injection. A doctor did not prescribe it. The patient was not hospitalized. No treatment. The outcome of event was not recovered.    Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: She has a hard knot at the injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose at left arm to prevent pneumonia administered at the pharmacy. Medical history included acid reflux, knee pain, low thyroid, and allergies to pollen. Concomitant medication included levothyroxine sodium for low thyroid started almost 3 months ago, omeprazole for acid reflux started a month and a half ago, and paracetamol (TYLENOL) for knee pain started about a month ago. On the same day in the other arm (right arm), she received the shingles vaccine, specific name unknown to reporter but it was the new one where you had to have 2 shots. A couple years ago she received the old Shingles vaccine. It was reported that she had a hard knot at the injection site on an unspecified date. Pharmacist administered the injection. A doctor did not prescribe it. The patient was not hospitalized. No treatment. The outcome of event was not recovered.    Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: My arm was pretty sore but I expected that.  2 days after the injection the injection site became swollen,  red and warm to the touch and the area that was red started feeling lumpy.  On the 3rd day (Sunday) I developed a red rash on my chest.  On day 4 (Monday) I went to the nurse practitioner at my family practice and she prescribed cephalexin 500mg capsules (1 capsule by mouth three times daily for 7 days).  This is now day 5 (Tuesday) and the redness is diminishing.  I think the cephalexin is doing it's job.  I will have a follow-up appt. with the NP on  day 7 (Thursday)
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: My arm was pretty sore but I expected that.  2 days after the injection the injection site became swollen,  red and warm to the touch and the area that was red started feeling lumpy.  On the 3rd day (Sunday) I developed a red rash on my chest.  On day 4 (Monday) I went to the nurse practitioner at my family practice and she prescribed cephalexin 500mg capsules (1 capsule by mouth three times daily for 7 days).  This is now day 5 (Tuesday) and the redness is diminishing.  I think the cephalexin is doing it's job.  I will have a follow-up appt. with the NP on  day 7 (Thursday)
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: My arm was pretty sore but I expected that.  2 days after the injection the injection site became swollen,  red and warm to the touch and the area that was red started feeling lumpy.  On the 3rd day (Sunday) I developed a red rash on my chest.  On day 4 (Monday) I went to the nurse practitioner at my family practice and she prescribed cephalexin 500mg capsules (1 capsule by mouth three times daily for 7 days).  This is now day 5 (Tuesday) and the redness is diminishing.  I think the cephalexin is doing it's job.  I will have a follow-up appt. with the NP on  day 7 (Thursday)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test, Depression, Fatigue, Fibromyalgia
Clinical narrative: Joint pain, chronic fatigue, depression, headaches, muscular aching, fibromyalgia symptoms
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Myalgia
Clinical narrative: Joint pain, chronic fatigue, depression, headaches, muscular aching, fibromyalgia symptoms
Age: 29.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: patient had redness, swelling, and warm to the touch of injection site and pain that went up into her neck. Patient was prescribed Pepcid, Prednisone, and Clindamycin. Patient should be taking steroids for the next 7 days. Patient was also given Methylprednisolone at time of visit before she left.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Site edema, redness, and pain; Left shoulder swelling and Pain; Left anterior aspect of neck swelling, pain; General malaise, nausea, chills, and headache
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Nausea, Swelling
Clinical narrative: Site edema, redness, and pain; Left shoulder swelling and Pain; Left anterior aspect of neck swelling, pain; General malaise, nausea, chills, and headache
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Impaired driving ability, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Extreme pain in arm,  unable to move arm in any direction.  Lasted 12 hours.  Could not drive. Could not use arm at all.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; a 32 year old patient, received one dose of PROQUAD/Adult patient received PROQUAD; This spontaneous report was received from a medical assistant referring to a 32 years old patient of unknown gender. Information of concomitant medication, concurrent condition, pertinent medical history and drug reaction/allergy was not provided.  On 22-AUG-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S006830 with expiration date 02-SEP-2020; strength and dose detail were not reported) subcutaneously for prophylaxis(adult use of a child product). Other suspect therapy included sterile diluent (lot # S013899 with expiration date 07-MAR-2022; strength, dose, route and indication were not reported). No adverse effects were reported. The outcome of the event was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: The patient was vaccinated with an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 23-APR-2019, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis, lot # S002459 and expiration date on 15-MAY-2020 (dose and frequency was not reported).   The temperature was of 52.5° for 4 hours and 40 minutes and there were no previous temperature excursion. The call was placed because of a digital data logger report.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; the patient, who is 13 years old, was inadvertently administered one dose of the adult VAQTA; This spontaneous report was received from a medical assistant referring to a 13 years old patient of unknown gender. Information of concomitant medication, concurrent condition, pertinent medical history and drug reaction/allergy was not provided.  On 29-AUG-2019, the patient was vaccinated with one dose of the adult hepatitis a vaccine, inactivated(VAQTA) (lot # R025518 with expiration date 15-NOV-2019; strength and dose detail were not reported) intramuscularly for prophylaxis (inappropriate age at vaccine administration). No adverse effects were reported. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Ear disorder, Herpes zoster, Oedema, Pain
Clinical narrative: double pneumonia; Also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment; Also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment; ear problems; swelling of her lower extremities; edema; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 03-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (the dosage regimen information was not reported). In December 2016 (also reported as "shortly thereafter"), the patient was diagnosed with double pneumonia, which was caused by the zoster vaccine live (ZOSTAVAX) vaccine, resulting in her hospitalization (unknown dates). As a result of zoster vaccine live (ZOSTAVAX), the patient also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment. Since zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered swelling of her lower extremities and edema that continued at the time of the report. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX). The adverse events were considered to be disabling as the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and inability to work.  Upon internal review, pneumonia and cellulitis were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pneumonia, Swelling face
Clinical narrative: double pneumonia; Also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment; Also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment; ear problems; swelling of her lower extremities; edema; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 03-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (the dosage regimen information was not reported). In December 2016 (also reported as "shortly thereafter"), the patient was diagnosed with double pneumonia, which was caused by the zoster vaccine live (ZOSTAVAX) vaccine, resulting in her hospitalization (unknown dates). As a result of zoster vaccine live (ZOSTAVAX), the patient also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment. Since zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered swelling of her lower extremities and edema that continued at the time of the report. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX). The adverse events were considered to be disabling as the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and inability to work.  Upon internal review, pneumonia and cellulitis were considered to be medically significant.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; one unspecified "15 month old patient" received both MMR II and VARIVAX via intramuscular route on the same day.; This spontaneous report was received from a pharmacist referring to a 15 months old patient of unknown gender.  Information of concomitant medication, concurrent condition, pertinent medical history and drug reaction/allergy was not provided.  On 03-SEP-2019, the patient was vaccinated with both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, lot # and expiration date were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis(subcutaneous injection formulation administered by other route). Other suspect therapy included sterile diluent (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis. No adverse effects were reported. The outcome of the event was unknown.