chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases- 2018SA226820, 2018SA226774, 2018SA226819, 2018SA226816, 2018SA226817, same reporter for patients receiving same vaccine. This case involves an unknown age male patient who vaccinated with MENACTRA which had excursion actually for 9 days and ranged from 48-49 f. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date starting in May, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5833AA, expiry date 25 Feb 2019 via intramuscular route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient was received MENACTRA vaccine which had excursion, was actually for 9 days, starting in May, and ranged from 48-49 F. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from Health Care Professional on 14-Aug-2018.  This case was linked to 2018SA226820, 2018SA226818, 2018SA226774, 2018SA226816 and 2018SA226817 (same reporter). This case involves a male patient who was vaccinated with a dose of MENACTRA that were used around the time or after the time of the excursion (excursion for 45 minutes, but caller states the excursion was actually for 9 days, starting in May, and ranged from 48-49 f) (Batch number: U5833AA, expiration date: 25-Feb-2018, dose: 0.5 ml, route : intramuscular and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was a case of potential medication error due to incorrect product storage. It was unknown if patient had adverse event. 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. List of documents held by sender : none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a patient (age and gender not reported), who was vaccinated with an expired dose of MENACTRA (Batch number: U5567CA and expiry date: 28-Jun-2018) (dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by the sender: None.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received expired vaccine RABIES (HDC) VACCINE. The patient's past medical history and family history were not provided.  The patient did not receive any concomitant medication. On 14-Aug-2018, the patient received a second dose of pre-exposure series of suspect RABIES (HDC) VACCINE lot M1296, expiry date 12 Jun 2018 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient was given expired rabies vaccine on 14 Aug 2018 that got expired on 12 Jun 2018. The patient did not experience any symptoms or need for treatment. 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. List of documents held by sender- none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA227515 (same reporter). This case involves a six-months-old patient (gender not reported), who was vaccinated with a once dose of PENTACEL (batch number: C5551AA and expiry date: 10-Oct-2019) in the right thigh (dose, dose in series and route of administration were not reported) on 13-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were unpacked and storage of the vaccine may not have been within recommended temperatures which puts into question the viability of the vaccine. It was reported that the patient was visited to the doctor on 13-Aug-2018. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. Documents held by the sender: None.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Burning sensation, Facial pain, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Patients mother called to report. She stated the patient experienced pain and burning in the rib area the night of the vaccination. The pain and burning spread to the back, buttocks, hands, arms, face and scalp over the next several days. The patient continues to have a burning sensation to date. Has been seen in ER. ER MD consulted neurology via phone consult. Spoke to a Dr who feels this is a rare side effect of the Tdap vaccination.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pain of skin, Vaccination complication
Clinical narrative: Patients mother called to report. She stated the patient experienced pain and burning in the rib area the night of the vaccination. The pain and burning spread to the back, buttocks, hands, arms, face and scalp over the next several days. The patient continues to have a burning sensation to date. Has been seen in ER. ER MD consulted neurology via phone consult. Spoke to a Dr who feels this is a rare side effect of the Tdap vaccination.
Age: 21.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Malaise, Pallor, Syncope
Clinical narrative: Patient experienced syncope. She didn't feel well, turned pale and felt dizzy and faint. She sat in a chair for awhile and also laid on the floor. She was fine after about 20 minutes or so.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: Fatigue, muscle pain all over, slightly headachy, arm soreness, general crappy feeling.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Eructation, Headache, Lethargy, Lymphadenopathy, Nausea
Clinical narrative: Tdap and MMR given at the same time (Manufacturer unknown) This was the 2nd Tdap and 2nd MMR.   He began running a low grade fever just hours later - 99.7. The next day, July 24th, he had a higher fever up to 102.4, headache lethargy, swollen glands, nausea, light sensitivity. sore throat. I took him in to urgent care to be evaluated and because of his red throat a culture was done to rule out strep throat. It was negative. He continued to have a fever for 4 days. On Monday, August 30th he developed a rash on his upper chest and back. The rash was small red dots that lasted for a few days and were no accompanied with a fever. He continues to have a problem with burping/belching that seemingly started right after these shots as well.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Photophobia, Pyrexia, Rash, Rash erythematous
Clinical narrative: Tdap and MMR given at the same time (Manufacturer unknown) This was the 2nd Tdap and 2nd MMR.   He began running a low grade fever just hours later - 99.7. The next day, July 24th, he had a higher fever up to 102.4, headache lethargy, swollen glands, nausea, light sensitivity. sore throat. I took him in to urgent care to be evaluated and because of his red throat a culture was done to rule out strep throat. It was negative. He continued to have a fever for 4 days. On Monday, August 30th he developed a rash on his upper chest and back. The rash was small red dots that lasted for a few days and were no accompanied with a fever. He continues to have a problem with burping/belching that seemingly started right after these shots as well.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Tdap and MMR given at the same time (Manufacturer unknown) This was the 2nd Tdap and 2nd MMR.   He began running a low grade fever just hours later - 99.7. The next day, July 24th, he had a higher fever up to 102.4, headache lethargy, swollen glands, nausea, light sensitivity. sore throat. I took him in to urgent care to be evaluated and because of his red throat a culture was done to rule out strep throat. It was negative. He continued to have a fever for 4 days. On Monday, August 30th he developed a rash on his upper chest and back. The rash was small red dots that lasted for a few days and were no accompanied with a fever. He continues to have a problem with burping/belching that seemingly started right after these shots as well.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Rash, swelling, redness, pain, hives, heat at sight of injection. Mom sent photos to confirm reaction Dr looked at the photos and confirmed it was a reaction advised mom to use supportive care ice/warm compresses, ibuprofen.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Rash, swelling, redness, pain, hives, heat at sight of injection. Mom sent photos to confirm reaction Dr looked at the photos and confirmed it was a reaction advised mom to use supportive care ice/warm compresses, ibuprofen.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Chills, Tremor
Clinical narrative: Patient states he felt like his face was on fire, had the chills, and was shaking.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to the pharmacy on the fourth day 8/18/18 complaining of and visibly noticeable red inflamed painful and itchy patch around injection site as well as swelling that radiated to the whole upper arm. The patient also stated that she had fever. The patient was advised to go to urgent care immediately. During the follow up conversation over the phone, the patient explained that urgent care gave her a prescription for cephalexin 500 mg, 3 times a day for 7 days. She said that she felt better that same evening - her fever, swelling, itchiness resolved and pain substantially subsided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient presented to the pharmacy on the fourth day 8/18/18 complaining of and visibly noticeable red inflamed painful and itchy patch around injection site as well as swelling that radiated to the whole upper arm. The patient also stated that she had fever. The patient was advised to go to urgent care immediately. During the follow up conversation over the phone, the patient explained that urgent care gave her a prescription for cephalexin 500 mg, 3 times a day for 7 days. She said that she felt better that same evening - her fever, swelling, itchiness resolved and pain substantially subsided.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Anti-NMDA antibody negative, Blood thyroid stimulating hormone normal, C-reactive protein normal, CSF culture negative, Depression
Clinical narrative: Depression, memory impairment, slow gait, isolating himself, decrease in grades, speech-lower voice, less interactions, and psych motor retardation. He has had Neurology evaluation, hospitality and psychological evaluation.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Developmental delay, Differential white blood cell count normal, Educational problem, Full blood count normal, Gait disturbance
Clinical narrative: Depression, memory impairment, slow gait, isolating himself, decrease in grades, speech-lower voice, less interactions, and psych motor retardation. He has had Neurology evaluation, hospitality and psychological evaluation.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Laboratory test normal, Memory impairment, Metabolic function test, Metabolic function test normal, Neurological examination
Clinical narrative: Depression, memory impairment, slow gait, isolating himself, decrease in grades, speech-lower voice, less interactions, and psych motor retardation. He has had Neurology evaluation, hospitality and psychological evaluation.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Nuclear magnetic resonance imaging brain normal, Psychiatric evaluation, Psychomotor retardation, Red blood cell sedimentation rate normal, Social avoidant behaviour
Clinical narrative: Depression, memory impairment, slow gait, isolating himself, decrease in grades, speech-lower voice, less interactions, and psych motor retardation. He has had Neurology evaluation, hospitality and psychological evaluation.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Speech disorder
Clinical narrative: Depression, memory impairment, slow gait, isolating himself, decrease in grades, speech-lower voice, less interactions, and psych motor retardation. He has had Neurology evaluation, hospitality and psychological evaluation.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's arm was red and swollen.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received shot Wednesday morning, started getting pain in arm a few hours later. Patient says no rash or swelling, but has bad pain. It gets worse if he moves his arm. Pain hasn't gone away or gotten better (now Monday).
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Fall
Clinical narrative: Patient received two vaccinations with out difficulty. Patient and step father were checking out at front desk, then there was a big bang. Front office staff call for the nurse. When nurse arrived, patient was sitting on the floor with back against wall. Step father was asking pt if he was ok. Step father assisted pt into a standing position. Nurse escorted pt back into a room, had pt lay down on table, and placed a cool paper towel on pt head. Step father and MA came into room and asked pt if he hit his head when he fell. Patient stated he did not hit his head. Patient was offered a popsicle or a cookie and pt refused. Patient stated in room with step father for approx. 10-15 mins. Step father came out and stated pt felt fine. Patient and step father left office with no further concerns present.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Generalized urticaria and pruritis starting about 19 hours after the vaccination. Treated with CLARITIN gel capsule. Adverse event resided about 12 hours post onset.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Bacterial test, Culture wound, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: 1 - 2 days after receiving Varicella and QUADRACEL in (L) arm developed red, painful left upper arm which worsened and followed by well shaped cluster of vesicles around 2 cm by 3 cm (remainder of skin clear). Pt. started on acyclovir at visit. I will follow up clinically. Wound culture and viral culture pending.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Viral test
Clinical narrative: 1 - 2 days after receiving Varicella and QUADRACEL in (L) arm developed red, painful left upper arm which worsened and followed by well shaped cluster of vesicles around 2 cm by 3 cm (remainder of skin clear). Pt. started on acyclovir at visit. I will follow up clinically. Wound culture and viral culture pending.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Biopsy skin abnormal, Rash papular, Rash vesicular, Scab
Clinical narrative: Patient broke out with papular rash on his arms bilaterally. He used hydrocortisone on the rash but did not help so he sought evaluation at local clinic on Monday, 7/16/18. Upon physical examination the patient had papular lesion going up the arms bilaterally and some crusting on his ears bilaterally. On Tuesday (17July2018), papular lesions increasing and looking more vesicular. Dermatology evaluation: Skin biopsy was taken and patient given AQUAPHOR, benzoyl peroxide wash, and triamcinolone to use. Speciments sent to test for vaccinia. Over time, lesions gradually improved and resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient reported having "normal" injection site reactions but with hives covering entire body. Pt saw PCP who gave her prednisone taper dose.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Decreased appetite, Dizziness, Headache, Musculoskeletal stiffness, Otitis externa
Clinical narrative: Had vaccines at 130pm 8-16-18 first symptoms started at 5pm Headache, fever, stiff neck, dizzy, blurred vision, decreased appetite fever 103.0. Diagnosed w/otitis externa (R) ear at office visit.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Had vaccines at 130pm 8-16-18 first symptoms started at 5pm Headache, fever, stiff neck, dizzy, blurred vision, decreased appetite fever 103.0. Diagnosed w/otitis externa (R) ear at office visit.
Age: 50.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: Left arm - redness, swelling, C/O soreness, warm to touch at site; Placed cold compress on site.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 9x5.5cm oval warm red, firm area surrounding injection site of PENTACEL. Was improving in the 10hrs prior to OV. More central clearing at OV.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA006189:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling below injections site; fatigue, fever (100.3), headache, chills.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness and swelling below injections site; fatigue, fever (100.3), headache, chills.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Pain, Pain in extremity, Rash
Clinical narrative: The day after the vaccine her arm was a bit sore and she was tired, then the next day (second day after receiving vaccine) she noticed a huge rash on her arm, was very lethargic and had irritating pain. She saw a physician who prescribed antibiotics for a possible infection.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Fall, Injury, Oral pain, Pain in extremity, Pain in jaw
Clinical narrative: Patient received the three above immunizations and about 15 min later she had a syncope episode that caused her to fall and hit the hard floor.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient received the three above immunizations and about 15 min later she had a syncope episode that caused her to fall and hit the hard floor.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury, Jaw fracture, Tooth fracture
Clinical narrative: Patient received the three above immunizations and about 15 min later she had a syncope episode that caused her to fall and hit the hard floor.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: He developed herpes zoster 2-3 days after receiving first dose of SHINGRIX.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: He developed herpes zoster 2-3 days after receiving first dose of SHINGRIX.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt received injection 8/15/18 and began to notice redness and warmth at injection site, growing larger. Suggested that patient mark red area (presently 5x3 inches) and try some BENADRYL tonight to see if reaction decreased. Pt will call back tomorrow if appointment is needed for MD evaluation.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Pain at the site of injection (left deltoid), tender/sensitive to the touch. Fever with chills. The person that submitted the event completed an outdated form which makes it unclear whether or not the result of the adverse event was a visit to the emergency room or a visit to the doctor's office.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Nausea, Pyrexia
Clinical narrative: The night of vaccine administration, the patient had a high fever and went to the Emergency Room. He also experienced difficulty breathing and nausea. The symptoms resolved in 24 hours and the patient felt better.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: C/O A PAINFUL LUMP @ INJECTION SITE. AREA IS RED. NO FEVER.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain at the site of injection (right deltoid), tender and red, warm to touch. Started around 8:30 pm on 8/7/2018.
Age: 61.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Contusion, Erythema, Feeling hot, Pain
Clinical narrative: PATIENT PRESENTED TO THE CLINIC ON 8/20/2018 C/O LEFT ARM REDNESS AND BRUISING. PATIENT STATED HAVING SOME PAIN AND FEELING WARMTH AFTER SHE GOT THE VACCINES ON 8/16/2018. TODAY 8/20/2018 SHE DENIES ANY PAIN, ITCHING, RASH, FEVER OR CHILLS. PATIENT WAS INSTRUCTED TO TAKE TYLENOL FOR PAIN AND APPLY COLD COMPRESSES.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Headache
Clinical narrative: Pt started getting symptoms within a few hours. The symptoms she reported were: nausea, H/A, dizziness, joint pain, fever, chills, cramping/sore muscles, and her whole deltoid area was red and hot. She finally was feeling a little bit better on Saturday, so she came into the store and reported this to me. Her deltoid was still slightly red, but had faded and was no longer hot - clearly outlined area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Nausea, Pyrexia, Skin warm
Clinical narrative: Pt started getting symptoms within a few hours. The symptoms she reported were: nausea, H/A, dizziness, joint pain, fever, chills, cramping/sore muscles, and her whole deltoid area was red and hot. She finally was feeling a little bit better on Saturday, so she came into the store and reported this to me. Her deltoid was still slightly red, but had faded and was no longer hot - clearly outlined area.
Age: 3.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Lip swelling, Urticaria
Clinical narrative: Mom reported that patient broke out in hives and lip swelling.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was administered the MMRV instead of the MMR which resulted in a double dose of varicella.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HPV9, MMRV, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt is four years old and was given GARDASIL 9, MENACTRA, and BOOSTRIX. Pt reported no issues.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Feeling hot, Headache, Pharyngitis
Clinical narrative: Employee received Hepatitis B Vaccine on 08/14/18. Donor had no reactions post vaccination. On 08/16/18, employee reported to nurse that she experienced shakiness, dizziness, headache and feeling hot on 08/15/18 around 1630 when at home. Nurse encouraged employee to seek PCP evaluation. On 08/17/18, employee reported to another nurse all her previous s/s experienced on 08/15/18 and that on 08/16/18 around 1900, she went to her PCP for evaluation due to chills and headache. She was then diagnosed with throat infection and swollen tonsil. Her PCP mentioned that it could be a reaction from the vaccine. Employee was prescribed Amoxicillin and Motrin. Employee reported that she felt stable and healthy on this date 08/17/18.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Tonsillar hypertrophy, Tremor
Clinical narrative: Employee received Hepatitis B Vaccine on 08/14/18. Donor had no reactions post vaccination. On 08/16/18, employee reported to nurse that she experienced shakiness, dizziness, headache and feeling hot on 08/15/18 around 1630 when at home. Nurse encouraged employee to seek PCP evaluation. On 08/17/18, employee reported to another nurse all her previous s/s experienced on 08/15/18 and that on 08/16/18 around 1900, she went to her PCP for evaluation due to chills and headache. She was then diagnosed with throat infection and swollen tonsil. Her PCP mentioned that it could be a reaction from the vaccine. Employee was prescribed Amoxicillin and Motrin. Employee reported that she felt stable and healthy on this date 08/17/18.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Dry skin, Injection site dryness, Injection site pruritus, Rash generalised, Rash pruritic
Clinical narrative: Rash for 2-3 days Rash on various areas of body. He got dry itchy patches on whole body, more on limbs the day after vaccination.
Age: 20.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient said about 3 hours after receiving the immunization she could not mover her arm. Only able to raise arm above body about 30 degrees without severe pain. Is not able to touch arm around the injection site without severe pain. No redness, no change in temperature at all. No drainage. No fevers. Ice made it worse. Heat helped. Saw a physician the next day. No sign of infection at the injection site. Able to lift arm somewhat higher today. Pain at injection site. Continue with heat. Rx Diclofenac 75 MG BID prn x 5 days ordered.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Erythema, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Patient presented to pharmacy on approximately 2:20pm 8/20/2018 reporting the following symptoms: fever of 101, redness, flu like symptoms, and asthma-like (cough) feelings on 8/17/18 till Sunday 8/19/2018. Patient still feels fatigued and has a cough as of 8/20/2018.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site rash, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient started feeling pain and stiffness in right arm Sunday evening, which turned to excruciating pain all over the body and rash around injection site on upper right arm. There's sharp shoulder pain but patient is also having trouble breathing. Pharmacist called the PCP so that they are aware of the patient's current status from potentially receiving vaccinations and suggested to the patient to seek urgent care visit.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient started feeling pain and stiffness in right arm Sunday evening, which turned to excruciating pain all over the body and rash around injection site on upper right arm. There's sharp shoulder pain but patient is also having trouble breathing. Pharmacist called the PCP so that they are aware of the patient's current status from potentially receiving vaccinations and suggested to the patient to seek urgent care visit.
Age: 10.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed urticaria about 10 minutes after administration, Benadryl and Prednisolone given, stayed under observation for 1 hour and 30 minutes, vitals monitored.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Irritability, Poor quality sleep, Pruritus
Clinical narrative: Per Dr. "15 yo female. Seen 3 days ago for WCC and received MMR and Varicella vaccines. Started y/d with rash. Started with one spot and then put her down for a nap and she woke with more and now spots are spreading all over. She is irritable. Scratching at her head and grabbing at her diaper. She has had diarrhea x 3 today and twice yesterday. Threw up once yesterday. Restless sleep. Major decrease in appetite. Went to urgent care after hours yesterday and they gave her some benadryl and by the time she left the whelps had all but gone away but then by the middle of the night one small whelp had come back. Had benadryl at 6:30 am and again at 12:30pm and tylenol today for fussiness. Also with fever to 102.7 yesterday. No stuffy nose, RN, cough or sneezing. Fevers started a few hours after the vaccines."
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Urticaria, Vomiting
Clinical narrative: Per Dr. "15 yo female. Seen 3 days ago for WCC and received MMR and Varicella vaccines. Started y/d with rash. Started with one spot and then put her down for a nap and she woke with more and now spots are spreading all over. She is irritable. Scratching at her head and grabbing at her diaper. She has had diarrhea x 3 today and twice yesterday. Threw up once yesterday. Restless sleep. Major decrease in appetite. Went to urgent care after hours yesterday and they gave her some benadryl and by the time she left the whelps had all but gone away but then by the middle of the night one small whelp had come back. Had benadryl at 6:30 am and again at 12:30pm and tylenol today for fussiness. Also with fever to 102.7 yesterday. No stuffy nose, RN, cough or sneezing. Fevers started a few hours after the vaccines."
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Half hour after receiving injection, patient experienced hives that went down side of arm. Patient took BENADRYL and hives turned into a bump on bicep that still has not gone away three days after injection. Patient will call doctor one week after injection if still symptomatic.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt had a pneumonia vaccination given by her rheumatologist on Monday Aug 13th. Pt reported to Dr. on August 16th at our walk in clinic, sore arm. Large raised reddened area at injection site that appears to be outside the normal paramaters for vaccine injections into the muscle.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain in extremity
Clinical narrative: Patient received the vaccine on 7/23/2018 and then the next day mom called to report of left arm very painful and headache for 3 days straight.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, slight fever, headache.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient started having chills, pain, redness and warmth at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure abnormal, Computerised tomogram normal, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: Patient came to pharmacy 8/20/18 to ask if she should get second dose of SHINGRIX based on events that occurred 1 month after she received the first dose. She stated that she started experiencing symptoms of high blood pressure the week of 6/4/18-lightheadedness, head pressure, and weakness in arms. Another episode happened on 6/11/18. She went to her primary care physician and saw the nurse practitioner who prescribed HCTZ 12.5 mg qd. On 6/15/18, she had 2 more episodes of high blood pressure for which she called her doctor and was instructed to go to the ER. She had a CT scan and work up and everything was normal except for blood pressure. On 6/19/18, she was started on metoprolol er 25 mg qd. Then on 6/21/18 she had another episode of the same symptoms as before but also with blurred vision. She went to the ER and had a CT with dye which was normal. She had her last episode of high blood pressure symptoms on 7/6/18 and has been controlled on the previously prescribed meds since that time.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Head discomfort, Hypertension, Muscular weakness, Scan with contrast normal, Vision blurred
Clinical narrative: Patient came to pharmacy 8/20/18 to ask if she should get second dose of SHINGRIX based on events that occurred 1 month after she received the first dose. She stated that she started experiencing symptoms of high blood pressure the week of 6/4/18-lightheadedness, head pressure, and weakness in arms. Another episode happened on 6/11/18. She went to her primary care physician and saw the nurse practitioner who prescribed HCTZ 12.5 mg qd. On 6/15/18, she had 2 more episodes of high blood pressure for which she called her doctor and was instructed to go to the ER. She had a CT scan and work up and everything was normal except for blood pressure. On 6/19/18, she was started on metoprolol er 25 mg qd. Then on 6/21/18 she had another episode of the same symptoms as before but also with blurred vision. She went to the ER and had a CT with dye which was normal. She had her last episode of high blood pressure symptoms on 7/6/18 and has been controlled on the previously prescribed meds since that time.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Apparent life threatening event, Blood pressure fluctuation, Blood pressure increased, Computerised tomogram normal, Hypertension
Clinical narrative: Patient came to pharmacy 8/20/18 to ask if she should get second dose of SHINGRIX based on events that occurred 1 month after she received the first dose. She stated that she started experiencing symptoms of high blood pressure the week of 6/4/18-lightheadedness, head pressure, and weakness in arms. Another episode happened on 6/11/18. She went to her primary care physician and saw the nurse practitioner who prescribed HCTZ 12.5 mg qd. On 6/15/18, she had 2 more episodes of high blood pressure for which she called her doctor and was instructed to go to the ER. She had a CT scan and work up and everything was normal except for blood pressure. On 6/19/18, she was started on metoprolol er 25 mg qd. Then on 6/21/18 she had another episode of the same symptoms as before but also with blurred vision. She went to the ER and had a CT with dye which was normal. She had her last episode of high blood pressure symptoms on 7/6/18 and has been controlled on the previously prescribed meds since that time.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scan with contrast normal, Visual impairment
Clinical narrative: Patient came to pharmacy 8/20/18 to ask if she should get second dose of SHINGRIX based on events that occurred 1 month after she received the first dose. She stated that she started experiencing symptoms of high blood pressure the week of 6/4/18-lightheadedness, head pressure, and weakness in arms. Another episode happened on 6/11/18. She went to her primary care physician and saw the nurse practitioner who prescribed HCTZ 12.5 mg qd. On 6/15/18, she had 2 more episodes of high blood pressure for which she called her doctor and was instructed to go to the ER. She had a CT scan and work up and everything was normal except for blood pressure. On 6/19/18, she was started on metoprolol er 25 mg qd. Then on 6/21/18 she had another episode of the same symptoms as before but also with blurred vision. She went to the ER and had a CT with dye which was normal. She had her last episode of high blood pressure symptoms on 7/6/18 and has been controlled on the previously prescribed meds since that time.
Age: 55.0
Sex: U
Vaccine: TD
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever 100.0 F, achy, nausea, headache.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Abnormal behaviour, Dehydration, Diarrhoea, Emotional distress, Erythema
Clinical narrative: On 10/31/18, Patient received his second round of infant vaccines. A few hours after vaccines, he became extremely fuzzy and would not nurse, eat, or take a nap. Around 5 pm, I noticed he was turning red and hot, and realized he had a fever growing. I first recorded his fever at 102.3 degrees. I gave patient a lukewarm bath to try to decreased his fever. That did not help and instead his fever increased to 104.9 degrees, within an hour or so. He was beyond inconsolable and very irritable. There was swelling and redness at the injection site on both of his thighs, and his head and body were extremely hot. I immediately rushed him to Hospital. We stayed overnight in observation and until he was stable and his fever had gone down. He had diarrhea that lasted over a week, which made him very lethargic and dehydrated. He also developed a minor rash on his upper torso area. His babbling decreased, and at age two, he is experiencing a severe speech delay, as well as behavioral problems.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling, Irritability, Lethargy, Pyrexia
Clinical narrative: On 10/31/18, Patient received his second round of infant vaccines. A few hours after vaccines, he became extremely fuzzy and would not nurse, eat, or take a nap. Around 5 pm, I noticed he was turning red and hot, and realized he had a fever growing. I first recorded his fever at 102.3 degrees. I gave patient a lukewarm bath to try to decreased his fever. That did not help and instead his fever increased to 104.9 degrees, within an hour or so. He was beyond inconsolable and very irritable. There was swelling and redness at the injection site on both of his thighs, and his head and body were extremely hot. I immediately rushed him to Hospital. We stayed overnight in observation and until he was stable and his fever had gone down. He had diarrhea that lasted over a week, which made him very lethargic and dehydrated. He also developed a minor rash on his upper torso area. His babbling decreased, and at age two, he is experiencing a severe speech delay, as well as behavioral problems.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Rash, Skin warm, Speech disorder developmental, Urine analysis
Clinical narrative: On 10/31/18, Patient received his second round of infant vaccines. A few hours after vaccines, he became extremely fuzzy and would not nurse, eat, or take a nap. Around 5 pm, I noticed he was turning red and hot, and realized he had a fever growing. I first recorded his fever at 102.3 degrees. I gave patient a lukewarm bath to try to decreased his fever. That did not help and instead his fever increased to 104.9 degrees, within an hour or so. He was beyond inconsolable and very irritable. There was swelling and redness at the injection site on both of his thighs, and his head and body were extremely hot. I immediately rushed him to Hospital. We stayed overnight in observation and until he was stable and his fever had gone down. He had diarrhea that lasted over a week, which made him very lethargic and dehydrated. He also developed a minor rash on his upper torso area. His babbling decreased, and at age two, he is experiencing a severe speech delay, as well as behavioral problems.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Swelling, redness, heat, fatigue stomach upset, nausea and headache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Swelling
Clinical narrative: Swelling, redness, heat, fatigue stomach upset, nausea and headache.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Swelling, redness, heat, fatigue stomach upset, nausea and headache.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Swelling
Clinical narrative: Swelling, redness, heat, fatigue stomach upset, nausea and headache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Two days after injection patient developed cellulitis from shoulder to elbow. MD treated with cephalexin 500mg four times daily for 7 days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Patient states she has chills, fever on and off for 1 week since the injection. Patient also has upset stomach, nausea and loss of appetite.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: PATIENT STATED FEELING ITCHING UNDER THE ARMS AND TINGLING IN THE LIPS APRROX. 10 MINUTES AFTER VACCINATION GIVEN. PATIENT PURCHASED BENADRYL AND DIDN'T WANT TO WAIT LONGER AT PHARMACY.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Feeling abnormal, Vomiting
Clinical narrative: He threw up with force. He was very tired and didn?t feel good.
Age: 64.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Pt got Tdap in right arm and SHINGRIX in upper right arm/FLUZONE lower right deltoid on 8/11. On 8/13, she returned to pharmacy to show pharmacist her arm. The SHINGRIX site had a ring around the injection site, was red and swollen, approximately half dollar-size, (normal, expected side effect). The FLUZONE injection site was more inflamed, and had a softball-sized ring around the injection site (still a more severe, but expected side effect).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash
Clinical narrative: Pt got first SHINGRIX shot 8/15/18 reports that on Friday she developed "U shaped" rash below collar bone and then reports warmth at the injection site and rash on elbows that started 1-2 days later.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Affective disorder, Electrocardiogram abnormal, Fatigue, Immediate post-injection reaction, Loss of personal independence in daily activities
Clinical narrative: Immediate partial paralysis to limb which has resolved. Seizures, fevers, fainting episodes, muscle burning, fatigue, migraines, cramps, speech impairment, mood disorder, school days missed for feeling nauseated or migraines. Some of these symptoms are still happening, mostly muscle problems, fatigue and speech issues, and mood swings.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Migraine, Monoplegia, Muscle spasms, Myalgia, Nausea
Clinical narrative: Immediate partial paralysis to limb which has resolved. Seizures, fevers, fainting episodes, muscle burning, fatigue, migraines, cramps, speech impairment, mood disorder, school days missed for feeling nauseated or migraines. Some of these symptoms are still happening, mostly muscle problems, fatigue and speech issues, and mood swings.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Seizure, Sinus arrhythmia, Speech disorder, Syncope
Clinical narrative: Immediate partial paralysis to limb which has resolved. Seizures, fevers, fainting episodes, muscle burning, fatigue, migraines, cramps, speech impairment, mood disorder, school days missed for feeling nauseated or migraines. Some of these symptoms are still happening, mostly muscle problems, fatigue and speech issues, and mood swings.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Urticaria
Clinical narrative: Large red like hive, applying warm compresses2-3 times daily along with cream to put on 3-4 times daily.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea exertional, Hyperhidrosis, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Fevers, drenching sweats, body aches, arm soreness, hand stiffness, dyspnea on exertion starting one day after vaccine administration. Symptoms improving gradually with supportive care that included ibuprofen and acetaminophen.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fevers, drenching sweats, body aches, arm soreness, hand stiffness, dyspnea on exertion starting one day after vaccine administration. Symptoms improving gradually with supportive care that included ibuprofen and acetaminophen.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports swelling, pain, and "hard" bump in arm. Been like this since Saturday.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Crying, Cyanosis, Decreased eye contact, Disorientation, Eye movement disorder
Clinical narrative: 7pm, fever of 102.5, gave Tylenol and put her to bed. 12:30 am. fever of 105 degrees Fahrenheit. found in her crib with blue lips, pale face, and having a seizure. eyes rolling to the back of the head and unresponsive for a few minutes. then woke and was in a weird state for the next few hours. crying and no sense of where they were, no eye contact.