chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 years old patient received Flublok in the left deltoid; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by mistake (lot QFAA1912, expiry date 28-Jun-2020) via unknown route in the left deltoid on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  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 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.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose administered to a 6 month old patient / no AE; Fluzone High Dose administered to a 6 month old patient / no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ284AA (Expiry date 25-May-2020) via intramuscular route in the right thigh on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting no adverse event was reported.  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 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.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was admistered to patient, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves an unknown age male patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number not reported, expiry date: 22-Mar-2019) via unknown route and unknown site of administration, 02-Oct-2019  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 expired vaccine used.  At the time of reporting the patient had no adverse event.  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 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.
Age: 9.0
Sex: U
Vaccine: DTAPIPV, IPV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: medical assistant administered Quadracel to a 9 year old child instead of Tdap and IPV, no AE; 9 year old patient administered Quadracel, no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 9 years old patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5656AA (Expiry date unknown) via unknown route in the right deltoid on 03-Oct-2019, instead of POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. This would have been a fifth dose of IPV. This was also a fifth dose of DTaP.  The patient's past vaccination(s) included fourth dose of IPV (POLIOMYELITIS VACCINE (INACTIVATED)) on 22-MAR-2011. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).   It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  It was reported that it was intended to vaccinate a 9 year old child for Tdap and IPV Quadracel was given in the right deltoid. Later it was realized that Quadracel is not indicated for use in a 9 year old.  At the time of reporting no adverse reaction was reported.  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 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.
Sex: F
Vaccine: IPV, UNK
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: IPOL as Tubersol skin test in error/no AE; IPOL as Tubersol skin test in error via intradermal route/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old female patient received vaccine IPV (VERO) [IPOL] instead of TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  . On 07-OCT-2019, the patient received a 0.5 ml dose of suspect IPV (VERO) lot P1A242M via intradermal route in the left arm.  It was of actual medication error case due to Inappropriate route of vaccination and Wrong vaccine administered.  It was unknown whether adverse event was noticed or not.  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 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.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: gave an expired Menactra/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a female patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX).  On 14-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA (expiry date: 06-Oct-2019).  It was of actual medication error due to expired vaccine used..  It was unknown whether adverse event was noticed or not..  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 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. .
Sex: U
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: whole arm was swollen; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who experienced whole arm was swollen (peripheral swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Food allergy. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced whole arm was swollen (peripheral swelling).  (Other relevant tests included no lab data.)  Final diagnosis was swelling arm.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a Flublok vaccine to an 11 year-old child/no AE; gave a Flublok vaccine to an 11 year-old child/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 years old patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant therapy was received.  On 15-Oct-2019, the patient received a single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1933 via intramuscular route in the left deltoid.  It was of actual medication error due to Inappropriate age at vaccine administration and overdose.  It was unknown whether adverse event was occurred or not.  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 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Overdose
Clinical narrative: given a patient 1ml of Fluzone Quadrivalent instead of .5ml dose/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who received 1ml dose instead of 0.5ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to overdose NOS..  It was reported that no adverse event was noted.  Information on the batch number was requested.  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 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: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Allergy to vaccine, Anaphylactic reaction, Hypersensitivity, Rhinorrhoea, Throat tightness
Clinical narrative: anaphylactic reaction; nose started running; throat started closing up; allergic reaction to Daptacel; Seriousness criteria: medically significant.   Initial information received on 18-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 4 years old male patient who experienced anaphylactic reaction (anaphylactic reaction), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  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 Food allergy.  On 18-Oct-2019, the patient received fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious anaphylactic reaction, nose started running (rhinorrhoea), throat started closing up (throat tightness) and allergic reaction to daptacel (allergy to vaccine) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was anaphylactic reaction.  It was not reported if the patient received a corrective treatment.  The patient was recovering from all the events.; Sender's Comments: This case concerns 4 years old male patient who experienced anaphylactic reaction after vaccination with DAPTACEL. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: seizure; Initial information received on 17-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a patient who experienced (seizure), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number, expiry date, route and site of administration were not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  On an unknown date, the patient had seizure (seizure) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  This event was assessed as medically significant as per IME list.  Lab data was not reported.  Final diagnosis was seizure.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for seizure.  Batch number requested.; Sender's Comments: This case concerns patient who had seizure following the vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. The patient's past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling of arm that spread down to left leg causing leg swelling,  pain and unable to bend leg. Occurred next day following flu shot
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Bed rest, Headache
Clinical narrative: Headaches started at 5pm on 10/17/19, went to the ER on the evening of 10/18. Patient reports "worst headache in entire life", in bed for 5 days afterward, 10/22 is first day without headaches.
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Catheter placement, Computerised tomogram spine, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging brain
Clinical narrative: Influenza vaccine information is not available.  10/14/19 Patient presented to the hospital with rapidly progressive bilateral lower extremity weakness s/p flu shot one week prior.  Received IVIG, changed to plasma exchange.  10/23 slightly more movement of fingers
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Muscular weakness, Plasmapheresis
Clinical narrative: Influenza vaccine information is not available.  10/14/19 Patient presented to the hospital with rapidly progressive bilateral lower extremity weakness s/p flu shot one week prior.  Received IVIG, changed to plasma exchange.  10/23 slightly more movement of fingers
Age: 41.0
Sex: U
Vaccine: FLU4
Symptoms: Discomfort, Hyperhidrosis, Immediate post-injection reaction, Injection site irritation, Injection site pain
Clinical narrative: This is a report for about 20 individuals who all reported very similar outcomes.  Immediately within an hour of vaccination, patients experienced nausea (90%), vomiting (10%), severe pain or site irritation (90%), overnight sweats and other discomforts (80%).  However, those who received vaccines from a different manufacturer/product did NOT have the same reactions.
Age: 41.0
Sex: U
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: This is a report for about 20 individuals who all reported very similar outcomes.  Immediately within an hour of vaccination, patients experienced nausea (90%), vomiting (10%), severe pain or site irritation (90%), overnight sweats and other discomforts (80%).  However, those who received vaccines from a different manufacturer/product did NOT have the same reactions.
Age: 86.0
Sex: M
Vaccine: FLUA3
Symptoms: Dry skin, Injection site discolouration, Injection site pruritus, Injection site reaction, Limb discomfort
Clinical narrative: Darkening of the skin (circular around site around 2 inches in diameter), roughening or drying or skin, itching, "heaviness" feeling.  These symptoms have lasted (and are still there) for 2 weeks so far.
Age: 90.0
Sex: M
Vaccine: UNK
Symptoms: CSF glucose normal, CSF lymphocyte count increased, CSF protein increased, Demyelination, Electromyogram abnormal
Clinical narrative: Patient received flu shot and two days later developed Guillain-Barré syndrome that confirmed by CSF analysis and EMG/NCS .
Age: 90.0
Sex: M
Vaccine: UNK
Symptoms: Guillain-Barre syndrome, Nerve conduction studies abnormal
Clinical narrative: Patient received flu shot and two days later developed Guillain-Barré syndrome that confirmed by CSF analysis and EMG/NCS .
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Right arm is swollen, red, and warm from elbow to shoulder. Pt has high temperature: 102.5 when measured on 10/23/2019
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Incorrect route of product administration
Clinical narrative: THIS PATIENT WAS INADVERTENTLY GIVEN ROTARIX VIA PARENTERAL ROUTE ( IM ) INSTEAD OF ORAL ROUTE
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Injection site reaction, Pain in extremity, Tendonitis
Clinical narrative: In the initial 24 hour post vaccination period pt experienced unusual severe pain and tendinitis that caused significant limitation to her left arm. So much so, that she only had about 50% ROM for the first 48 hours post influenza/T-dap vaccine administered on 10/12.  The tendinitis slowly improved and ROM was probably about 75-80% on day 5 put there  still was persistent upper left arm tendinitis causing pain localized at rotator cuff of around a 4 during motion.  Pt was 29 weeks GA. EDA 1/03/2020
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: As reported by his mother today,  on the way home after leaving clinic yesterday where he received is influenza vaccine, he started coughing.  by suppertime increased work of breathing and wheezing.  Mom gave him Albuterol at 1800 and he improved.  No issues or recurrences and no other symptoms at the time.
Age: 40.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: Patient became diaphoretic, felt faint, felt nauseaous, felt hot, left arm tingling.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Peripheral swelling, Tremor, Vomiting
Clinical narrative: Patient had arm swelling, chills, shaking and vomiting approximately 7 hours after vaccine administration.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Swelling, Wrong technique in product usage process
Clinical narrative: Pt relates that she received the vaccine at a Flu clinic and the person was rough and now she has pain, swelling, and pain going to her left side of her neck and left shoulder
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Incorrect route of product administration
Clinical narrative: PATIENT was inadvertently given rotarix Intra muscular  , instead of orally
Age: 86.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Next morning, stomach cramps started and lasted a couple of hours.   On 10/12 had diarrhea; it lasted about 9 hours on and off.   Patient took some Tylenol and it helped.   Called store to get item for diarrhea (Kelp acidopholis Saccharomyces Boulardii probiotic) and started taking them 10/13. Medicine helped and also took some water with electrolytes.   Patient has not called administering facility yet.    Has received Flu vaccine before with no problems.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Immune system disorder, Influenza like illness, Myalgia
Clinical narrative: I don't know if this a side effect of the vaccine, but I feel like I am suffering a long viral syndrome, like a flu.  Anergic, weak, myalgias, occasional arthralgias, that have become severe for over two weeks. I do not see anywhere if the vaccine was tested on patients with cancer.  I have ovarian cancer with metastasis, currently at a standstill (according to my oncologist) most likely due to the activity of my immune system.  If this makes me immunosupressed, should it have been so indicated?
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: I don't know if this a side effect of the vaccine, but I feel like I am suffering a long viral syndrome, like a flu.  Anergic, weak, myalgias, occasional arthralgias, that have become severe for over two weeks. I do not see anywhere if the vaccine was tested on patients with cancer.  I have ovarian cancer with metastasis, currently at a standstill (according to my oncologist) most likely due to the activity of my immune system.  If this makes me immunosupressed, should it have been so indicated?
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Heart rate increased, Pharyngeal swelling, Urticaria
Clinical narrative: Employee stated that she felt symptoms of increased heart rate, swollen throat, difficulty breathing while she was still at work approximately 2000. Employee went home and developed hives around 2100. Employee took some Benadryl and went to sleep. She awoke the following day and all her symptoms had resolved. Employee did not seek medical attention. Employee did not report symptoms to medical staff until 10/23/2019.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: Itchy rash started at injection site after vaccine over next two days spread over body
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Headache, Myalgia, Pyrexia
Clinical narrative: Fever  101 degrees for eight hours. Currently have Muscle aches, no energy, headache,  loss of appetite
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: The patient came in on 10/23 and reported that following her vaccination on 10/02/19, she began to have swelling on her arm from shoulder to elbow with a clear white line separating the swollen skin from non-swollen, which she reports being significant and painful. Patient reports that she didn't have any problem breathing. The swelling resolved on its own prior to the time the patient reported the incident to pharmacy staff on 10/23/19.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pain in my arm lasting about 4 days.  Itching, swelling, and redness covering about 1/2 of my upper arm, which continues.  I had the vaccine almost one week ago.
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: LEFT DELTOID PAIN TO TOUCH AND CANNOT LIFT ARM SINCE THE TIME SHE WAS INJECTED. THE PATIENT WAS INSTRUCTED TO SEE HER PHYSICIAN
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: After receiving a flu vaccine, patient reported significant pain at the injection site. This persisted over the next 24 hours and was accompanied by a bruise at the injection site.  The pain subsided, two weeks after injection the patient started experiencing additional pain in her shoulder which has increased over time.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Diplopia, Headache, Magnetic resonance imaging normal, Strabismus, VIth nerve paralysis
Clinical narrative: Patient came to the student health center at University on 10/2/19 with complaints of sudden onset stabismus, sixth abducent nerve palsy to the R eye, headaches, and diplopia. Patient stated the symptoms had began approximately 2 weeks prior to her coming in. Pt had received MCV Vaccine on 08/26/2019 at 1:49pm. PA-C referred patient to see Dr. the next day for an acute appointment 10/3/19 at 5:40pm. Eye exam revealed R eye was clear, no tears, no detachments. Isolated 6th nerve palsy, not involving pupil or other cranial nerves. No APD, no optic disc edema, full EOMs besides limited abduction OD, normal lid function, no trauma. PA-C also consulted with Dr. and Dr. Dr. consulted with PA-C about his findings and requested PA-C to order MRI for patient. If MRI is negative, Dr. requested blood sugar, ESR, CRP, platelet count, RPR, FTA-ABS, and lyme titer be drawn with a lumbar puncture taken into consideration as well. Pt was also referred to Radiology for an MRI with and without contrast. MRI was conducted on 10/18/2019 at 3:53pm. MRI was negative for any abnormalities referable to he globes, optic pathways, or visualized cranial nerves. No signs of acute infarct or hemorrhage per Dr. PA-C determined this was an adverse reaction to the MCV vaccine. Labs were not drawn. Lumbar puncture not completed.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: Patient came to the student health center at University on 10/2/19 with complaints of sudden onset stabismus, sixth abducent nerve palsy to the R eye, headaches, and diplopia. Patient stated the symptoms had began approximately 2 weeks prior to her coming in. Pt had received MCV Vaccine on 08/26/2019 at 1:49pm. PA-C referred patient to see Dr. the next day for an acute appointment 10/3/19 at 5:40pm. Eye exam revealed R eye was clear, no tears, no detachments. Isolated 6th nerve palsy, not involving pupil or other cranial nerves. No APD, no optic disc edema, full EOMs besides limited abduction OD, normal lid function, no trauma. PA-C also consulted with Dr. and Dr. Dr. consulted with PA-C about his findings and requested PA-C to order MRI for patient. If MRI is negative, Dr. requested blood sugar, ESR, CRP, platelet count, RPR, FTA-ABS, and lyme titer be drawn with a lumbar puncture taken into consideration as well. Pt was also referred to Radiology for an MRI with and without contrast. MRI was conducted on 10/18/2019 at 3:53pm. MRI was negative for any abnormalities referable to he globes, optic pathways, or visualized cranial nerves. No signs of acute infarct or hemorrhage per Dr. PA-C determined this was an adverse reaction to the MCV vaccine. Labs were not drawn. Lumbar puncture not completed.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Patient called pharmacy on 10/13/2019 to report extreme pain in her right leg that she associated with receiving the Fluad vaccine. She stated her leg was numb, painful and she could hardly get out of bed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Patient took Aspirin the morning of the vaccine.   Next day, by night, patient was achy and cramping on upper abdomen.   At around 2am patient woke up and was nauseous.   By 2:15am to 2:30am started throwing up.  Patient had cramps in abdomen and since then a headache.  Diarrhea started on Tuesday. Yesterday had cramps again.  Last night, by evening woke up and vomited again in the morning.  Patient contacted vaccine administrator today and was recommended to follow-up with doctor; appointment scheduled for tomorrow at 1:30pm.   Today patient ate lunch today with no problem, has a little cramping and no diarrhea.  Diarrhea usually starts at nigh when in bed. Patient is at 80% recovery.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient took Aspirin the morning of the vaccine.   Next day, by night, patient was achy and cramping on upper abdomen.   At around 2am patient woke up and was nauseous.   By 2:15am to 2:30am started throwing up.  Patient had cramps in abdomen and since then a headache.  Diarrhea started on Tuesday. Yesterday had cramps again.  Last night, by evening woke up and vomited again in the morning.  Patient contacted vaccine administrator today and was recommended to follow-up with doctor; appointment scheduled for tomorrow at 1:30pm.   Today patient ate lunch today with no problem, has a little cramping and no diarrhea.  Diarrhea usually starts at nigh when in bed. Patient is at 80% recovery.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Pallor, Rash, Rash macular
Clinical narrative: Diffuse blanching macular rash on extremities and torso
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Peripheral swelling, Urticaria
Clinical narrative: PT CALLED AT 630 PM COMPLAINING OF HIVES SWOLLEN LIPS AND BOTTOMS OF FEET
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood sodium decreased, Chills, Decreased appetite, Flank pain
Clinical narrative: Patient  presented to urgent care with overall full body weakness, poor appetite, and nausea/vomiting. Patient had intermittent fevers, chills, and unable to walk due to weakness since two days after shingles vaccine.  Patient's with 7-9/10 pain in left flank near kidney level.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Glomerular filtration rate decreased, Nausea, Pyrexia, Renal failure
Clinical narrative: Patient  presented to urgent care with overall full body weakness, poor appetite, and nausea/vomiting. Patient had intermittent fevers, chills, and unable to walk due to weakness since two days after shingles vaccine.  Patient's with 7-9/10 pain in left flank near kidney level.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Patient  presented to urgent care with overall full body weakness, poor appetite, and nausea/vomiting. Patient had intermittent fevers, chills, and unable to walk due to weakness since two days after shingles vaccine.  Patient's with 7-9/10 pain in left flank near kidney level.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: The patient called the next day and said her arm had a large red swollen spot and it was hot to the touch. I told her to take benadryl and to put ice on her arm. She came in the next day (10/23/2019) and showed me her arm and said she had used ice and benadryl and it got worse the second day. The red spot was in the same area of the injection and was also moving down her arm. I told her to take ibuprofen for the inflammation, continue benadryl and ice and to probably not get the second shot of the series.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: numbness tingling left hand, lip and tongue
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: CSF test, Electromyogram, Guillain-Barre syndrome, Nerve conduction studies
Clinical narrative: Guillain-Barré syndrome
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Feeling hot, Flushing
Clinical narrative: Patient  came in  to flu clinic and stated she has had a reaction before 2 years ago but not in  2018. She had  similar symptoms this time which are, flushing, feeling hot, tightness in chest, cough.  BP 144/108 HR 82 RR:30  No temp taken
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Pyrexia, Urticaria
Clinical narrative: By the time patient got home there was a red spot vaccination site raised like a giant welt.  Contacted doctor and vaccine administrator and was told that reaction was somewhat expected.  On Friday, contacted both facilities since it got worse.   Patient did not have fever and used cold compress but did not take any medication; treatment did not help welt doubled in size by next day.  By afternoon, welt was over 3 inches in diameter.  Contacted both facilities and told to keep watching it for changes, to treat fever with Motrin and give Benadryl if itching.  On Saturday, fever was 101.8, welt spread to size of palm.  Contacted Pediatrician and took patient to Urgent Care since fever kept rising; diagnosis was cellulitis.    Patient prescribed Bactrim. Affected area had expanded to 3 inches up from elbow.  Patient told to keep area clean and dry.  By next day, redness decreased to a milder pink color. Redness resolved within 48 hours.   Fever resolved since Sunday.   Notified Pediatrician that patient was on medication. Today patient is feeling much better; almost back to normal except for a little bruise at vaccination site. Area a little itchy but is not horrible.  Patient took Benadryl on Saturday night and last night.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site bruising, Vaccination site reaction
Clinical narrative: By the time patient got home there was a red spot vaccination site raised like a giant welt.  Contacted doctor and vaccine administrator and was told that reaction was somewhat expected.  On Friday, contacted both facilities since it got worse.   Patient did not have fever and used cold compress but did not take any medication; treatment did not help welt doubled in size by next day.  By afternoon, welt was over 3 inches in diameter.  Contacted both facilities and told to keep watching it for changes, to treat fever with Motrin and give Benadryl if itching.  On Saturday, fever was 101.8, welt spread to size of palm.  Contacted Pediatrician and took patient to Urgent Care since fever kept rising; diagnosis was cellulitis.    Patient prescribed Bactrim. Affected area had expanded to 3 inches up from elbow.  Patient told to keep area clean and dry.  By next day, redness decreased to a milder pink color. Redness resolved within 48 hours.   Fever resolved since Sunday.   Notified Pediatrician that patient was on medication. Today patient is feeling much better; almost back to normal except for a little bruise at vaccination site. Area a little itchy but is not horrible.  Patient took Benadryl on Saturday night and last night.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Blister, Dizziness, Headache, Lethargy, Urticaria
Clinical narrative: MMR instant after injection- blister 3in x 2 in, welt, and later on in day felt dizzy, lethargic, and headache. No fever.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient says patient developed rash in left arm. unknown time and date on development on rash. Patient couldn't remember.  initially reported on 10/22/2019 to pharmacy. Per patient, it was quarter size rash on left arm. Patient has been putting neosporin on but wasn't able to resolve rash for few weeks. We notified patient to contact the doctor. According to patient on 10/23/2019, doctor prescribed antibiotic ointment.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Patient went got home, by 6pm, heart started pounding, felt dizzy and weak--could hardly make it to another room.  Nose was running thick with mucus; mucus getting thicker so couldn't breathe.   Patient was also sweating and had chills.  Could hardly go to the restroom and felt like if was going to throw up. Patient had pounding heart and a bursting headache; felt like if eyeballs were going to pop.  Patient called the ambulance.  Patient went to Hospital and kept overnight for observation; they specified flu-like symptoms for diagnosis.   On 10/11, patient feeling better upon discharge except for headache. Recovered completely and has not gone to doctor.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Influenza like illness, Nausea, Ocular discomfort, Palpitations
Clinical narrative: Patient went got home, by 6pm, heart started pounding, felt dizzy and weak--could hardly make it to another room.  Nose was running thick with mucus; mucus getting thicker so couldn't breathe.   Patient was also sweating and had chills.  Could hardly go to the restroom and felt like if was going to throw up. Patient had pounding heart and a bursting headache; felt like if eyeballs were going to pop.  Patient called the ambulance.  Patient went to Hospital and kept overnight for observation; they specified flu-like symptoms for diagnosis.   On 10/11, patient feeling better upon discharge except for headache. Recovered completely and has not gone to doctor.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Secretion discharge
Clinical narrative: Patient went got home, by 6pm, heart started pounding, felt dizzy and weak--could hardly make it to another room.  Nose was running thick with mucus; mucus getting thicker so couldn't breathe.   Patient was also sweating and had chills.  Could hardly go to the restroom and felt like if was going to throw up. Patient had pounding heart and a bursting headache; felt like if eyeballs were going to pop.  Patient called the ambulance.  Patient went to Hospital and kept overnight for observation; they specified flu-like symptoms for diagnosis.   On 10/11, patient feeling better upon discharge except for headache. Recovered completely and has not gone to doctor.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Blood thyroid stimulating hormone normal, Diarrhoea, Dizziness, Full blood count normal, Headache
Clinical narrative: Thus far, I feel like I have the actual flu with moderate levels of nausea, muscular-skeletal pain throughout my entire body (seemingly generating from inside my bones & spreading outward to my muscles), sudden & stabbing pains that come and go in different areas of my body (including neck, spine, arms and legs), dizziness, diarrhea, swollen lymph nodes and headache.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Lymphadenopathy, Metabolic function test normal, Musculoskeletal pain, Nausea
Clinical narrative: Thus far, I feel like I have the actual flu with moderate levels of nausea, muscular-skeletal pain throughout my entire body (seemingly generating from inside my bones & spreading outward to my muscles), sudden & stabbing pains that come and go in different areas of my body (including neck, spine, arms and legs), dizziness, diarrhea, swollen lymph nodes and headache.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Thus far, I feel like I have the actual flu with moderate levels of nausea, muscular-skeletal pain throughout my entire body (seemingly generating from inside my bones & spreading outward to my muscles), sudden & stabbing pains that come and go in different areas of my body (including neck, spine, arms and legs), dizziness, diarrhea, swollen lymph nodes and headache.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: About 3 minutes after patient received vaccines  patient stated he felt dizzy. He immediately closed his eyes and passed out. Patient stated he was just closing his eyes but was non responsive for about one minute. About 5 minutes later patient vomited and stated he felt much better. Patient was sweating. He was given apple juice, water and offered cookies. Patients vitals were taken as well as blood sugar levels. Vitals and Blood glucose were within normal limits.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Malaise, Muscle discomfort, Myalgia
Clinical narrative: 27.5 hours of significant malaise and muscle discomfort, containing 11 hours of extreme malaise and muscle aches
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose increased, Dyspnoea, Erythema, Flushing, Productive cough
Clinical narrative: Next day, started getting hives and body flushing--turning red.   Hives started on face and chest then moved to rest of body including palms arms and legs.   Patient did not take any medication.  Wednesday called company, went to compensation office.  They administered cortisone shot on buttocks and told to take Benadryl.  Medicine helped for 1 day.   On Thursday felt ok but on Friday the symptoms worsened.  Eyes closed shut, barely breathing, and had hives all over including on ear canal-- looked like cabbage patch doll dipped in red.  On Saturday, patient thought he was going to die. Patient called doctor and was given steroid pill (Methylprednisolone 4mg)--took 6 pills on first day.  Took medicine. Sunday symptoms started to subside.   Patient has received the Flu before with no problem.    Recovery at 80% back to normal.  Patient is extremely itchy and wearing gloves.    Coughing yellow discharge so not sure if developing flu.  In addition, his sugar readings have been higher because of steroids so patient is being careful what he eats.    Currently has about 30 hives on each hand.  Patient has received all different types of flu vaccines in the past10-12 times beforeincluding nasal and jet injector.  Usually area was only itchy and hurt a bit.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: Next day, started getting hives and body flushing--turning red.   Hives started on face and chest then moved to rest of body including palms arms and legs.   Patient did not take any medication.  Wednesday called company, went to compensation office.  They administered cortisone shot on buttocks and told to take Benadryl.  Medicine helped for 1 day.   On Thursday felt ok but on Friday the symptoms worsened.  Eyes closed shut, barely breathing, and had hives all over including on ear canal-- looked like cabbage patch doll dipped in red.  On Saturday, patient thought he was going to die. Patient called doctor and was given steroid pill (Methylprednisolone 4mg)--took 6 pills on first day.  Took medicine. Sunday symptoms started to subside.   Patient has received the Flu before with no problem.    Recovery at 80% back to normal.  Patient is extremely itchy and wearing gloves.    Coughing yellow discharge so not sure if developing flu.  In addition, his sugar readings have been higher because of steroids so patient is being careful what he eats.    Currently has about 30 hives on each hand.  Patient has received all different types of flu vaccines in the past10-12 times beforeincluding nasal and jet injector.  Usually area was only itchy and hurt a bit.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Arthralgia, Asthenia, Diarrhoea, Headache
Clinical narrative: nothing yet taking ibuprofen / Tylenol and bed rest .  I described the symptoms in earlier fields. I got the shot on the 15th of october and am still sick today ... 8 days
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Lethargy, Malaise, Myalgia, Pain
Clinical narrative: nothing yet taking ibuprofen / Tylenol and bed rest .  I described the symptoms in earlier fields. I got the shot on the 15th of october and am still sick today ... 8 days
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: nothing yet taking ibuprofen / Tylenol and bed rest .  I described the symptoms in earlier fields. I got the shot on the 15th of october and am still sick today ... 8 days
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported shoulder pain and trouble moving her arm. She did not seek medical attention and said she will follow up with me in a few days. The condition has improved slightly over the last 10 days. The photo she provided showed that the injection may have been high on the shoulder.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Headache, Hypoaesthesia oral, Paraesthesia oral, Pyrexia
Clinical narrative: Fever of 104, chills, numbness and tingling of lips, severe headache
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Swelling
Clinical narrative: 102 FEVER, CHILLS, SWELLING, SEVERE HEADACHE TREATED WITH TYLENOL ALTERNATING WITH IBUPROPHEN SYMPTOMS REDUCING AT 24 HRS SWELLING STILL PRESENT
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Erythema, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: About 1 hr after injection, she experienced pain in the total upper portion of Right arm, redness, swelling & hot to the touch.  Felt tired, and sleepy for 2 days along with arm pain, etc. This reaction appeared as a tall red band starting about 4 inches above the elbow and continued to about 1 inch below the elbow.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: About 1 hr after injection, she experienced pain in the total upper portion of Right arm, redness, swelling & hot to the touch.  Felt tired, and sleepy for 2 days along with arm pain, etc. This reaction appeared as a tall red band starting about 4 inches above the elbow and continued to about 1 inch below the elbow.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Sore arm,fever, shivering, tired/sleepyness
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Somnolence
Clinical narrative: Headache after injection.  Later sore arm, sleepiness.