chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Vomiting
Clinical narrative: Typical as listed until night time. I woke up five tomes to pee and poo. Then the nausea kept me up for several hours vomiting (dry heaves and bile.) Lost my appetite. Drumming headache. I almost forgot, I also took 12-hour guafenosin at 11:28 am on 12/09 as directed for the sinusitis. Today I have a headache but it isn?t a sinus type.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events; patient received VAQTA pediatric dose instead of adult dose; This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown gender and age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-OCT-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) pediatric dose instead of adult dose (incorrect dose administered) (lot number S021092, expiration date: 18-MAY-2020) (dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: TD, TYP
Symptoms: Rash
Clinical narrative: rash has become worse and is covering her body; Initial information received on 24-May-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse.  This case involves a 66 years old female patient who experienced rash has become worse and is covering her body, while she received vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 22-May-2018, the patient received a dose  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA via intramuscular route in unknown administration site. On 22-May-2018, the patient received a dose  dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot N1C154M via intramuscular route.  The patient developed a non-serious rash has become worse and is covering her body (vaccination site rash) <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and <<Unknown latency>> following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Final diagnosis was rash has become worse and is covering her body.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for rash has become worse and is covering her body.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patent had Menactra at ages 11 and 14, less than 4 years between injections; Based on information previously received with Agency: 22-AUG-2018, the following information have been amended.   Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old patient who vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's concomitant medications, medical history was not reported.  It was a case of actual medication error due to inappropriate schedule of drug administration.  It is not known whether the patient had any untoward experiences after administration.  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 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.  Additional information was received from pharmacist on 02-Oct-2018.  No new information received.  Addendum: Based on information previously received with Agency: 22-AUG-2018, the following information have been amended.
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: improper storage; Based on information previously received with CSD: 22-AUG-2018, the following information [Reporter's State was updated to ASKU] have been amended.   Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 14 years old male patient who received vaccine which was improperly stored (improper storage), while he received vaccine Influenza Quadrival A-B Multidose Vaccine Preserved (Fluzone).  This is actual medication error case due to patient received vaccine which was stored improperly (product storage error).  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2018, the patient received a dose of 0.5 ml of suspect Influenza Quadrival A-B Multidose Vaccine Preserved lot UI982AC, exp date: 30-June-2019, in the left arm.   It was not reported if the patient experienced any adverse event.  Lab test and corrective treatment: not applicable  Outcome: not applicable.  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.  Documents held by sender: none.  Addendum: Based on information previously received with CSD: 22-AUG-2018, the following information [Reporter's State was updated to ASKU] have been amended.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired Ipol vaccine/ No adverse event; Based on information previously received with Agency: 18-DEC-2018, the following information have been amended.   Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old male patient (weight: 225.4, height: 67.5) who was inadvertently administered with a 0.5 ml (fourth dose) expired vaccine of IPV (VERO) [IPOL] (lot M1453 and Exp. Date not reported) via intramuscular route in the left deltoid.  The patient had a visit to the doctor on 18-Sep-2018.  The patients past medical history, medical treatment(s), vaccination(s) and family history were none.  Concomitant medication was not reported.  It was a case of actual medication error due to expired vaccine used.  No adverse event was experienced. reported as No signs or symptoms from expired vaccine.  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 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 sender: none.  Follow up information was received from a nurse on 14-NOV-2018.  No new information added.  Follow up information was received from a nurse on 18-Dec-2018.  Information regarding medical history and family history updated.  Information regarding adverse event was updated. changes was made in the narrative accordingly.  List of documents held by sender: none.  Addendum: Based on information previously received with Agency: 18-DEC-2018, the following information have been amended.
Sex: F
Vaccine: YF
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Painful underarm; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Other company (Mylan).  This case involves a 56 years old female patient who experienced swollen lymph nodes (lymphadenopathy) and painful underarm (axillary pain), while she received vaccine YELLOW FEVER VACCINE - FR [STAMARIL].  The patient medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - FR lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious swollen lymph nodes (lymphadenopathy) and painful underarm (axillary pain) (Unknown latency) following the administration of YELLOW FEVER VACCINE - FR.  Other relevant tests were not reported.  Final diagnosis was painful underarm and swollen lymph nodes underarm.  It was not reported if the patient received a corrective treatment.  The outcome was not reported for both the events.  There will be no information available on the batch number for this case.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 32 week pregnant patient inadvertently received two doses of Adacel, no advesre event; 32 week pregnant patient inadvertently received two doses of Adacel, no advesre event; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 27 years old female patient who was 32 weeks pregnant and  was vaccinated with two doses (0.5 ml) of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6272AA and expiration date 26-Apr-2021) inadvertently on 08-Oct-2019 and on 21-Oct-2019 via an intramuscular route in the right deltoid.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was unknown.  The gestation period was 32 weeks. The date of last menstrual period was 15-Mar-2019. The estimated due date is 14-Dec-2019. Information on previous pregnancy not reported. Medical history and concomitant medications were not reported.  It was a case of actual medication error due to extra dose administered.  Also this was a case of vaccine exposure during pregnancy.  At the time of reporting, no adverse reaction reported.  Additionally, at time of reporting, the pregnancy was still ongoing.  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: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: itchiness on the left leg; swelling on the left leg; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves eight years old female patient who experienced itchiness on the left leg (vaccination site pruritus) and swelling on the left leg (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ237AB, Exp. Date 30-Jun-2020 via unknown route in the left vastus lateralis.  On 27-Nov-2019, the patient developed a non-serious itchiness on the left leg (vaccination site pruritus) and swelling on the left leg (vaccination site swelling) at night following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Final diagnosis was vaccination site pruritus and vaccination site swelling.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for vaccination site pruritus and vaccination site swelling.
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was 9 years old and the Quadracel was given, no adverse event; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a nine years old female patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA and expiration date  09-Oct-2020) via an intramuscular route in the right arm on 04-Oct-2019.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) received on 04-Oct-2019 and she did not experience any side effects.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Erythema, Musculoskeletal pain, Musculoskeletal stiffness, Swelling
Clinical narrative: 1600; Swollen and red like a rectangular 4in flag patch. 1800; Stiff and sore shoulder. Saturday 7 december, more of the same. sunday, red reduced to 1" circular bruise.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: EMPLOYEE FELT NAUSEA'S, VOMITING, LIGHTHEADED AND WEAKNESS, SYMPTOMS ARE CURRENTLY ACTIVE.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness left shoulder, aching, slight fever
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Swelling of eyelid
Clinical narrative: Redness at the site, swollen eyelids, was also on a new prescription for Macrobid.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Severe chills with teeth chattering for about six hours.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Bilateral lower extremity weakness, diagnosed with Guillain Barre Syndrome treated with IVIG
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Dyspepsia, Headache, Pain
Clinical narrative: Received the flu shot on Wed, 11/27. Started to feel achy on Sun, 12/1. Felt progressively worse (achy) on Mon, 12/2. Mon night threw up and from Mon thru Wed evening, 12/4 had chills, fever, dizziness. Started to feel better on Thur, 12/5, but had a headache from Thur - Sat, 12/8. Took Tylenol (capsules) during this entire time and drank 16 oz of water on avg. every few hours to hydrate. Started taking probiotics on Sat, 12/8 because food (toast) wouldn't digest well.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Received the flu shot on Wed, 11/27. Started to feel achy on Sun, 12/1. Felt progressively worse (achy) on Mon, 12/2. Mon night threw up and from Mon thru Wed evening, 12/4 had chills, fever, dizziness. Started to feel better on Thur, 12/5, but had a headache from Thur - Sat, 12/8. Took Tylenol (capsules) during this entire time and drank 16 oz of water on avg. every few hours to hydrate. Started taking probiotics on Sat, 12/8 because food (toast) wouldn't digest well.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Skin irritation, Urticaria
Clinical narrative: Patient experienced rash, hive and irritation on the body, and he said that he is not using anything
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Influenza like illness, Pain in extremity, Pustule, Spinal pain
Clinical narrative: Patient described pain in spine, pain and pustule on calf, pain in the side, and flu like symptoms.  Lasting more than 3 weeks.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Acoustic stimulation tests abnormal, Computerised tomogram, Deafness bilateral, Dizziness, Ear congestion
Clinical narrative: I was feeling sick, with mild flu like symptoms/stuffy head and ears/ within a week of the flu shot, and I had a minor nose bleed a couple times over the course of a couple weeks, with some dizziness.  I then seemed to improve and then within three weeks had some episodes of virtigo that last less than a minute.  Over the weeks following the flue shot my family members noticed that I was missing high frequency sounds and turning up tv louder to hear programming.  On Nov 30 ringing started in my ears and became progressively worse, on Sunday, it took till Fri Dec 6th to ENT, I had significant hearing  hearing loss confirmed with audio test, bilateral which the ENT says was probable viral induced. I have severe high pitch disabling tinnitus ringing in my left ear and some in right ear
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Ear, nose and throat examination, Epistaxis, Hypoacusis, Influenza like illness, Malaise
Clinical narrative: I was feeling sick, with mild flu like symptoms/stuffy head and ears/ within a week of the flu shot, and I had a minor nose bleed a couple times over the course of a couple weeks, with some dizziness.  I then seemed to improve and then within three weeks had some episodes of virtigo that last less than a minute.  Over the weeks following the flue shot my family members noticed that I was missing high frequency sounds and turning up tv louder to hear programming.  On Nov 30 ringing started in my ears and became progressively worse, on Sunday, it took till Fri Dec 6th to ENT, I had significant hearing  hearing loss confirmed with audio test, bilateral which the ENT says was probable viral induced. I have severe high pitch disabling tinnitus ringing in my left ear and some in right ear
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Sinus congestion, Tinnitus, Vertigo, Viral infection
Clinical narrative: I was feeling sick, with mild flu like symptoms/stuffy head and ears/ within a week of the flu shot, and I had a minor nose bleed a couple times over the course of a couple weeks, with some dizziness.  I then seemed to improve and then within three weeks had some episodes of virtigo that last less than a minute.  Over the weeks following the flue shot my family members noticed that I was missing high frequency sounds and turning up tv louder to hear programming.  On Nov 30 ringing started in my ears and became progressively worse, on Sunday, it took till Fri Dec 6th to ENT, I had significant hearing  hearing loss confirmed with audio test, bilateral which the ENT says was probable viral induced. I have severe high pitch disabling tinnitus ringing in my left ear and some in right ear
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Pt experienced rash on chest and arms. At first treated with benaryl tabs and aquaphor. She did not have relief and was prescribed triamcinolone cr and hydroxyzine tabs
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Deafness neurosensory, Malaise, Pyrexia, Tinnitus
Clinical narrative: Flu vaccine administered elsewhere. Pt developed high fever and felt ill a couple of hours after vaccination. She then developed high pitched loud tinnitus in L ear and also lost hearing. Dx elsewhere (urgent care) with acute sensorineural hearing loss and given prednisone. She was seen by ENT who thought possibly related to flu vaccine given temporal proximity.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash vesicular
Clinical narrative: Redness and swelling at injection site, also painful blistery rash on face.
Age: 31.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Lip disorder, Oropharyngeal discomfort, Pruritus, Urticaria
Clinical narrative: s/p hep a and typhoid vaccine earlier today, after about 1.5-2 hours later noted generalized pruritis, hives, abnormal feeling of lips, tickle in throat.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Pt called the same day after receiving the vaccine in the morning complaining of symptoms of swelling in left arm above and below the place the vaccine was administered.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: Receive shot at approximately 3:30pm on November 29, 2019.  About 7:00 pm I couldn't lift my right arm.  Pain, numbness and tingling feeling up and down entire right arm.  Shot given in very upper portion of right shoulder.  As of today, December 10, 2019 I still have pain in right shoulder, some pain in right arm and tingling and some numbness in right hand.  From November 29, 2019 to half day on Sunday, December 1, 2019 couldn't lift my right arm at all without help with the use of my left hand.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Receive shot at approximately 3:30pm on November 29, 2019.  About 7:00 pm I couldn't lift my right arm.  Pain, numbness and tingling feeling up and down entire right arm.  Shot given in very upper portion of right shoulder.  As of today, December 10, 2019 I still have pain in right shoulder, some pain in right arm and tingling and some numbness in right hand.  From November 29, 2019 to half day on Sunday, December 1, 2019 couldn't lift my right arm at all without help with the use of my left hand.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Atypical pneumonia, Chest X-ray normal, Chills, Computerised tomogram thorax, Cough
Clinical narrative: 10/03/2019  He developed severe chills & fever. with flu-like symptoms, a non-productive cough With pain on deep inspiration,  We were on vacation; with a normal temp the next am, he wanted to keep going; but he continued to have a low grade fever & flu-like SX.  Finally on 10/21/2019 he saw a nurse practitioner who diagnosed him with walking pneumonia.  His chest x-ray & CBC were unremarkable.  On 10/23 he was admitted to the hospital for 6 days; his DX was RLL pneumonia & 3 pulmonary emboli.  His recovery has been very slow, & he continues to have a temp of 99 to 100.4 every evening.  He has not been afebrile for 24 hrs since 10/02/2019.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fibrin D dimer, Full blood count normal, Influenza like illness, Painful respiration, Pneumonia
Clinical narrative: 10/03/2019  He developed severe chills & fever. with flu-like symptoms, a non-productive cough With pain on deep inspiration,  We were on vacation; with a normal temp the next am, he wanted to keep going; but he continued to have a low grade fever & flu-like SX.  Finally on 10/21/2019 he saw a nurse practitioner who diagnosed him with walking pneumonia.  His chest x-ray & CBC were unremarkable.  On 10/23 he was admitted to the hospital for 6 days; his DX was RLL pneumonia & 3 pulmonary emboli.  His recovery has been very slow, & he continues to have a temp of 99 to 100.4 every evening.  He has not been afebrile for 24 hrs since 10/02/2019.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pulmonary embolism, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: 10/03/2019  He developed severe chills & fever. with flu-like symptoms, a non-productive cough With pain on deep inspiration,  We were on vacation; with a normal temp the next am, he wanted to keep going; but he continued to have a low grade fever & flu-like SX.  Finally on 10/21/2019 he saw a nurse practitioner who diagnosed him with walking pneumonia.  His chest x-ray & CBC were unremarkable.  On 10/23 he was admitted to the hospital for 6 days; his DX was RLL pneumonia & 3 pulmonary emboli.  His recovery has been very slow, & he continues to have a temp of 99 to 100.4 every evening.  He has not been afebrile for 24 hrs since 10/02/2019.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: patient states a few days after immunization she had joint pain and arm weakness that lasted a couple to a few months. it is currently in pretty good shape with only occasional joint ache in her arm when she exercises. she has not had any issues in about 3 weeks.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: PATIENT COMPLAINT WAS HAVING A SEVERE EFT LEG PAIN (THIGH AREA) COUPLE DAYS AFTER GETTING THE VACCINATION.
Age: 41.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling starting one day (11/26/19) after administration of vaccine in the back left arm (where MMR was likely administered). Swelling continued up until now with little to no improvement and no resolution after ice and ibuprofen. Redness is also occurring.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient called on 12/10/19 to report persistent pain at the site of injection.  She stated she felt pain upon vaccine administration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bed rest, Pain in extremity
Clinical narrative: My legs felt like I had shingles (I had shingles before).  I was in much pain.  Next day I was unable to do anything, I stayed in bed all day.  The next 2 days after that I was weak.  The pain in my legs slowly ease up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: PATIENT REPORTED HAVING SORENESS, REDNESS AND PAIN AT INJECTION SITE. SHE WAS ALSON UNABLE TO USE THE AFFECTED ARM FOR MORE THAN A WEAK. PATIENT WAS DIAGNOSED WITH SHINGLES OUTBREAK WITHIN DAYS FOLLOWING VACCINATION.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lymphadenitis, Pyrexia
Clinical narrative: pt stated flu like symptoms fever chills, then swelling in neck near lymph nodes, referred to MD, nurse stated normal for the swelling.  Not to worry (3:30 pm 12.10.19)
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: On 12-8-19, pt started with fever, rash, fussiness.  Fever subsided on 12/9/18 with improvement of rash, PO intake. Mom reported possible  pain in shoulder area due to fussiness taking  shirt off.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Areflexia, Arthralgia, Balance disorder, Borrelia test, C-reactive protein
Clinical narrative: (R) Knee/Leg pain and difficulty going up stairs (intermittant). parents waited 1 wk then went to emergency dept. Then she started to have abnormal gait and seemed off balance. Nerology admitted for GBS, had no DTR in lower Legs. - admitted to hospital given IVIG & started PT. as of 11/30/19 she was walking well.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test
Clinical narrative: (R) Knee/Leg pain and difficulty going up stairs (intermittant). parents waited 1 wk then went to emergency dept. Then she started to have abnormal gait and seemed off balance. Nerology admitted for GBS, had no DTR in lower Legs. - admitted to hospital given IVIG & started PT. as of 11/30/19 she was walking well.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: (R) Knee/Leg pain and difficulty going up stairs (intermittant). parents waited 1 wk then went to emergency dept. Then she started to have abnormal gait and seemed off balance. Nerology admitted for GBS, had no DTR in lower Legs. - admitted to hospital given IVIG & started PT. as of 11/30/19 she was walking well.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MENB
Symptoms: Injection site pain, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Patient came into office 24 hours after immunization w/complaints of muscle soreness and weakness, plan was to observe and return iF symptoms continued. Patient came back into office 11-27-19 with continued muscle weakness and soreness at injection site. PAIN WAS IN THE ARM THAT BEXSERO WAS ADMINISTERED
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyskinesia, Pallor, Tremor
Clinical narrative: dizziness, paleness, tremors, jerky movements for few seconds, temperature normal
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Patient's right deltoid became red, inflamed, and hot about an hour after getting Pneumovax 23. Rash went from deltoid to Bicep & was hot.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Headache, Impaired work ability, Insomnia
Clinical narrative: had fever afterwards; This case was reported by a consumer and described the occurrence of fever an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated, she read that some people got fever after vaccination with Shingrix. This case has been linked to US2019AMR202683, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: had fever afterwards; This case was reported by a consumer and described the occurrence of fever an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated, she read that some people got fever after vaccination with Shingrix. This case has been linked to US2019AMR202683, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Bedridden, Pyrexia
Clinical narrative: had fever afterwards; This case was reported by a consumer and described the occurrence of fever an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated, she read that some people got fever after vaccination with Shingrix. This case has been linked to US2019AMR202683, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: had fever afterwards; This case was reported by a consumer and described the occurrence of fever an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated, she read that some people got fever after vaccination with Shingrix. This case has been linked to US2019AMR202683, reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster
Clinical narrative: Pt came down with painful rash 2 days after receiving her first Shingrix injection. Rash was extensive, thoughout the right side of scalp, Mastoid bone, occipital bone,  C2 dermatome. Rash and blisters were cultured and positive for Varicella Zoster.  Pt treated with Valtrex. Rash also became super infected, treated with topical mupiricin.  Pt has continued neurological pain. Is planned for nerve ablation due to post herpetic neuralgia and itch. It is affecting her mental health and anxiety.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Blister, Neuralgia, Post herpetic neuralgia, Pruritus
Clinical narrative: Pt came down with painful rash 2 days after receiving her first Shingrix injection. Rash was extensive, thoughout the right side of scalp, Mastoid bone, occipital bone,  C2 dermatome. Rash and blisters were cultured and positive for Varicella Zoster.  Pt treated with Valtrex. Rash also became super infected, treated with topical mupiricin.  Pt has continued neurological pain. Is planned for nerve ablation due to post herpetic neuralgia and itch. It is affecting her mental health and anxiety.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella zoster virus infection, Viral test positive
Clinical narrative: Pt came down with painful rash 2 days after receiving her first Shingrix injection. Rash was extensive, thoughout the right side of scalp, Mastoid bone, occipital bone,  C2 dermatome. Rash and blisters were cultured and positive for Varicella Zoster.  Pt treated with Valtrex. Rash also became super infected, treated with topical mupiricin.  Pt has continued neurological pain. Is planned for nerve ablation due to post herpetic neuralgia and itch. It is affecting her mental health and anxiety.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blood test, Chills, Hypoaesthesia, Magnetic resonance imaging, Muscle spasms
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Neuralgia, Pyrexia
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Blood test normal, CSF protein increased, Cardiac function test normal, Chest X-ray normal, Chest pain
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Chills, Demyelination, Electrocardiogram normal, Fatigue, Feeling cold
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Gait inability, Headache, Hyperhidrosis, Hypertension, Hypoaesthesia
Clinical narrative: After second dose, problems started on 10/11 at about 9pm. Patient had fever, chills, uncontrollable shakinghad to put on 3 blankets--and symptoms lasted for 4 hours.   On 10/12, feeling like coming down with a bug; also had fever, chills, body aches, and chest pain.  On 10/16 went to Urgent care.  They ran tests for heart (EKG, x-ray lungs, blood test) and left arm hurting; specified it was a viral infection.    Went back to Urgent care because both arms-- from top of shoulder to fingertipswere having spasms; spasms lasted from 1.30pm-6:15pm.   It felt like electricity running through nerves and nerve pain was like if arms were on fire.  The pain was 10+ on a 1-10 scale. The pain was worse on the spots they put the EKG sensors as if they flared up the nervous system. Blood pressure was at 187/110.  The Urgent Care ran heart test again and sent patient home after test cleared up.    After 5 days, problems also started to affect legs.  Problems in arm continued; patient had to take Advil (2 every 4 hours) and hot showers for temporary relief. Patient could not sleep with so much pain so went back to Urgent Care on 10/19. There were 2 neurologist, they ran a lot of tests provided no treatment or diagnosis.   On 10/24 patient went to Dr. (neurologist) who ordered a lumbar puncture test. On 11/10 post-nasal drip and cough started. On 11/14, there was pain on neck, top of neck and shooting pain to skullstarted on right side and then affected both sides.   On 11/18, patient went to new PCP Dr.,  she provided referral to another neurologists. On 11/19 top of head went numb.   On 11/21, patient went to neurologist Dr. who specified patient was fighting a viral infection.  Provider offered patient Gabapentin but patient has not taken it because of the possible side effects.  On 12/7 went back to same Urgent care and given antibiotics for sinus infection (Amoxicillin/Clavulanic Acid 875 MG for 10 days).  This is day 55 and nerves/muscles on arm continue to have pain and numbness including the back of the skull.   Patient also reports fever at night.   The doctors unsure of next steps in terms of diagnosis/testing  After first dose, patient only reports soreness after first day.