chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Tremor, Uterine infection, Weight decreased
Clinical narrative: One week after receiving her annual influenza vaccination November 2017, patient experienced an acute onset of nausea and lightheadedness while standing, not associated with her usual groin/pelvic pain, eating, or sudden position change. Within 24-48 hrs she experienced lower extremity tremulousness "like a chill" affecting her from the waist down. Others were able to observe the shaking of her legs.  Over the next 8-10 hours, the tremors would last about 5-10 minutes, abate for 1-2 hrs, and then return without apparent stimulus.  She also noticed an icy-hot' sensation over various parts of her body at various times.  [Continued]  The distribution did not seem to follow a dermatomal pattern.  While the icy-hot' symptoms and pain seemed to slowly diminish in frequency, duration, and intensity over the 4-6 months, the bouts of nausea seemed to persist, with the additional onset of bowel and bladder symptoms.  Her stooling become irregular starting with explosive diarrhea then several days of constipation followed by several months of irregularity. She also experienced bouts of urinary urgency. During this time she lost over 15 lbs from anorexia due to her nausea.  Between Feb and Apr 2018, she experienced several bouts of "low blood pressure".  Her groin/pelvic pain seemed to diminish after a uterine infection was found and she was treated with Flagyl.  Her symptoms have been extensively evaluated by urology, rheumatology, neurology, urogynecology, and gastroenterology with no definitive diagnosis forthcoming. She began to experience an intense sandpapery', lightening-like sensation that radiated under her right ribs to her pelvic area, again not precipitated by movement or other identified activities.  This pain, and later lower back pain, decreased significantly with physical therapy.  She has been treated with magnesium and Vit D with some improvement. Bladder infusions with heparin, antibiotics, and lidocaine had only partial relief.  She underwent pelvic floor PT for several months, although does not complain of dyspareunia or other sexual dysfunction.  She has not experienced vaginal, ocular, or oral dryness.  Over the past two years, her symptoms have slowly improved, such that today, she experiences only an unusual transient (5-10 seconds) deep buzzing' sensation in her right abdomen if she lays on her right side or stomach and sharp pain in both her feet.  Working diagnosis: resolving small fiber neuropathy
Age: 47.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: ITCHING ON THE PALM OF HANDS, BACK , STOMACH, SCALP AND LEGS. HE VISIT A DOCTOR OFFICE WHERE THEY PRESCRIBED HIM CTIRIZINE 10MG DAILY FOR 30 DAYS. HE IS ON THE SECOND ROUND OF PRESCIBED MEDICATION AND STILL EXPERIENCING ITCHING.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Nausea, Pain in extremity, Pallor, Skin discolouration
Clinical narrative: She got the immunizations around 2:30pm.  Her leg was immediately sore and remained sore throughout the day, night, and next day. She fell asleep at 5:45pm, a little over three hours after vaccine, and slept until 8:30am the next morning. Through the night, she complained about her leg hurting. I gave her 5ml children's ibuprofen around 3am, as well as an ice pack for her thigh. She woke up at 8:30am, complaining of a sick stomach. Her face was pale and green. She ran to the toilet and vomited, mostly all yellow bile. She has been on the couch for a few hours since vomiting, and her body feels warm like the beginning of a fever, now at 11:00am, the day after the shots were administered.   She really is not much of a vomiter (maybe once a year) and I have rarely ever seen her face so pale and green, so it seems to me, as the parent, that the symptoms she is exhibiting are related to one or both of the vaccines she received yesterday.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm, Vomiting
Clinical narrative: She got the immunizations around 2:30pm.  Her leg was immediately sore and remained sore throughout the day, night, and next day. She fell asleep at 5:45pm, a little over three hours after vaccine, and slept until 8:30am the next morning. Through the night, she complained about her leg hurting. I gave her 5ml children's ibuprofen around 3am, as well as an ice pack for her thigh. She woke up at 8:30am, complaining of a sick stomach. Her face was pale and green. She ran to the toilet and vomited, mostly all yellow bile. She has been on the couch for a few hours since vomiting, and her body feels warm like the beginning of a fever, now at 11:00am, the day after the shots were administered.   She really is not much of a vomiter (maybe once a year) and I have rarely ever seen her face so pale and green, so it seems to me, as the parent, that the symptoms she is exhibiting are related to one or both of the vaccines she received yesterday.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot
Clinical narrative: Systemic chills/warmth intermittently
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Pain at injection site, weakness of R arm,  loss of ROM
Age: 83.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Dyspnoea exertional, Interstitial lung disease
Clinical narrative: SEVERE EVENT: SIGNIFICANT SHORNESS OF BREATH AFTER FLU SHOT. PATIENT RECEIVED FLU SHOT MID OCTOBER 2019, WITHIN A FEW WEEKS AFTER FLU SHOT HE DEVELOPED NEW SEVERE DYSPNEA ON EXERTION, AND HAS SEEN PULMONARY AND BEEN DIAGNOSED WITH INTERSTITIAL LUNG DISEASE.
Sex: F
Vaccine: DTAPIPV, HEPA, TYP
Symptoms: Burning sensation, Feeling cold, Feeling hot, Paraesthesia
Clinical narrative: Cutaneous sensory symptoms (tingling, burning sensation on the skin, also alternating superficial sensation of hotness and coldness); Spontaneous report received on 11FEB2020 via health authority, Regulatory Authority.  A physician reported that a 33-year-old female consumer had cutaneous sensory symptoms (tingling, burning sensation on the skin, also alternating superficial sensation of hotness and coldness) (PT: Paraesthesia), while being on oral Vivotif (lot number: 3003308), intramuscular Boostrix polio (diphtheria vaccine toxoid/pertussis vaccine acellular 3-component/polio vaccine inactive 3v (Vero)/ tetanus vaccine toxoid) (injection solution; lot number: AC39B131BF) and intramuscular Havrix (hepatitis a vaccine inactive; suspension for injection; lot number: AHAVB995AB;) for immunisation. The consumer received Vivotif, Havrix and Boostrix polio on 22JAN2020. On 23FEB2020, she had cutaneous sensory symptoms. She had a tingling, burning sensation on the skin. Also, alternating sensation of heat and cold superficially. This was distributed bilaterally on the arms, hands, legs, feet and face. She had no clear skin rash. Action taken with Vivotif with respect to the reported event was unknown while that of Havrix and Boostrix polio was not applicable. The symptoms were not resolved at the time of report.  Company Comment: A consumer received Vivotif dose and on the next day she had cutaneous sensory symptoms including tingling, burning sensation on the skin, and also alternating superficial sensation of hotness and coldness (Paraesthesia). This patient received Havrix and Boostrix polio vaccination along with Vivotif on the same day. Paraesthesia was distributed bilaterally on arms, hands, legs, feet and the face. The event was not resolved at the time of the report. Considering the event occurred one day after taking Vivotif, the causality of the event is assessed as possible (confounded by Havrix and Boostrix polio vaccine). The case is considered serious due to the medical significance of the event. Paraesthesia is unlisted as per USPI.; Sender's Comments: Company Comment: A consumer received Vivotif dose and on the next day she had cutaneous sensory symptoms including tingling, burning sensation on the skin, and also alternating superficial sensation of hotness and coldness (Paraesthesia). This patient received Havrix and Boostrix polio vaccination along with Vivotif on the same day. Paraesthesia was distributed bilaterally on arms, hands, legs, feet and the face. The event was not resolved at the time of the report. Considering the event occurred one day after taking Vivotif, the causality of the event is assessed as possible (confounded by Havrix and Boostrix polio vaccine). The case is considered serious due to the medical significance of the event. Paraesthesia is unlisted as per USPI.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received injections of Quadracel and a separate extra dose of Ipol on the same day, no AE; Initial information received on 19-Feb-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This was reported that a four year old patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5656AA, Exp. Date 31-Aug-2021) and IPV (VERO) [IPOL] (lot P1A25, Exp. Date 02-May-2020) via intramuscular route in the right arm for prophylactic vaccination on 18-Feb-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination on 18-Feb-2020.  It was an actual medication error case due to extra dose administered.  It was reported that patient received injections of Quadracel and a separate extra dose of Ipol on the same day.  At the 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.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient receivied an expired dose of Daptacel, No AE; Initial information was received on 19-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 15 month old female patient who was vaccinated with 0.5 ml expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366AA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 18-Feb-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for immunisation.  It was actual medication error due to expired vaccine used.  At the time of report 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 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.
Age: 5.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adacel was given to 5 year old, no AE; child received Adacel instead of Daptacel, no AE; Initial information received on 19-Feb-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a five year old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6273AA, Exp. Date 24-Apr-2021) via intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report, no adverse effects had been observed.  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.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: administered Pentacel incorrectly described as the DTap-IPV portion was not given/no AE; ActHib portion was reconstituted with sterile water/no AE; Initial information received on 21-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] incorrectly described as the Dtap-IPV portion was not given/no AE(product preparation issue) and ACT-HIB portion was reconstituted with sterile water/no AE(product preparation error).  Medical history, medical treatment, vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A).  On 20-Feb-2020, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ226AAA via intramuscular route at the right thigh for prophylactic vaccination. Lot number and expiry date of DTAP-IPV was reported as UJ315AA and 04-Apr-2021 and ACT-HIB as UJ226AA and 04-Apr-2021 respectively.  It was of actual medication error case due to inappropriate reconstitution technique and wrong solution used in drug reconstitution.  At the 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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Act-HIB injection with an expired diluent/no AE; Initial information received on 21-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received 0.5 ml HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] injection with an expired diluent/no AE(expired product administered) on 21-FEB-2020 via unknown route at the right thigh for prophylactic vaccination[lot UI951AA and expiry date 13-JUN-2020]. It was also reported that the expired portion, in particular, was the diluent(lot U6111AA and expiry date 24-JAN-2020).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was of actual medication error case due to expired vaccine used.  At the 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.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Fall, Syncope
Clinical narrative: syncopal spell & he fell from sitting position on exam table onto the floor
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: redness & swelling over 5 inch square area of upper right arm, warm, no fever or itching.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever nausea achy
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Extra dose administered, Infantile spitting up, No adverse event, Oral administration complication
Clinical narrative: Patient was given two Rota Teq due to the fact the patient spit up the entire first dose attempted. Patient also spit up entire second attempt given.   No adverse events occurred since the date vaccine was given.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Pt had vaccines placed in right arm,  Menveo and Influenza.  Patient presents with rash at injection site. Declines pain and fever    Rash is decreasing, not as red as yesterday, patient has been applying ice to site.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAD A DUPLICATE MCIR AND WAS INOCULATED BEFORE THIS WAS DISCOVERED.  PATIENT MOTHER WAS NOTIFIED, STATED UNDERSTANDING AND PATIENT HAS HAD NO ADVERSE REACTION.
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: Presented in office with rash. Rash characterized as red, blister like lesions on face, neck, chest, abd., (L) lower extremitiy.
Sex: F
Vaccine: PNC13
Symptoms: Adverse reaction, Laboratory test normal, Nerve injury, Paraesthesia, Peroneal nerve palsy
Clinical narrative: Lost her right foot from foot drop; Tingling in her leg; Nerve damage in her right leg; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13 [also reported as Prevnar 23]; Lot number: N010106, Expiry Date: 15Nov2018), intramuscular on the left arm in Aug2017 at a single dose for immunization. The patient had no relevant medical history and no concomitant medications. The patient stated that the doctor that gave her the vaccine was her family doctor. She started to have an adverse reaction two weeks after she received the vaccine on an unspecified date in 2017. She received the vaccine in late Aug2017. She received all the doctors reports after he passed away. Her reaction had not improved, but it hasn't gotten worse either. She has not had a vaccine since. She received it at the doctor's office in her left arm. When they gave the vaccine, they took the wrapper from around the vaccine and put it on her chart.  The patient stated that she will never get it again. Within two weeks of the vaccine, on an unspecified date in 2017, she had tingling in her leg. Within 3 months of the vaccine, she lost her right foot from foot drop. She had nerve damage in her right leg. That vaccine was all she had gotten. She had been tested for everything, and nothing showed up on anything. There had been no progression in two years. She went to a physical with her doctor, who had been her doctor for 30 years. She had always refused the flu shot and the shingles shot, but he sprung the pneumococcal 13-valent conjugate vaccine on her. If she had time to think about it , she would have said no. They have done tests and tried to figure out what was going on. Her daughter in law asked if she had gotten any shots around that time, and that was when they realized she had had pneumococcal 13-valent conjugate vaccine two weeks before. Otherwise, she was a healthy woman. Outcome of the event tingling in her leg was not recovered, while for the events lost her right foot from foot drop and nerve damage in her right leg was unknown.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal pain upper, Axillary mass, Axillary pain, Communication disorder, Fatigue
Clinical narrative: December 19th = neck pain and then shoulder pain  same day as vaccination. It was in the same arm as the polio shot.  December 20th = Woke up next day with fever of 103 and armpit pain. Same side. It hurt to lift her arms. She was exhausted all day. Not herself.  Cried hysterically from stomach pain and her shoulder and armpit hurting all day. December 21st= couldnt communicate or speak. just sat there. have a video of it.  fever still on board. December 22nd= fever finally broke with tylenol on board. started to talk briefly. lump still present in her arm pit. December 23rd= able to communicate a bit more and finally ate. by christmas she was back to herself. i am terrified.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pyrexia
Clinical narrative: December 19th = neck pain and then shoulder pain  same day as vaccination. It was in the same arm as the polio shot.  December 20th = Woke up next day with fever of 103 and armpit pain. Same side. It hurt to lift her arms. She was exhausted all day. Not herself.  Cried hysterically from stomach pain and her shoulder and armpit hurting all day. December 21st= couldnt communicate or speak. just sat there. have a video of it.  fever still on board. December 22nd= fever finally broke with tylenol on board. started to talk briefly. lump still present in her arm pit. December 23rd= able to communicate a bit more and finally ate. by christmas she was back to herself. i am terrified.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Diarrhoea, Headache, Pyrexia
Clinical narrative: Patient reports that on 2-22-2020 she developed a rash on her lip. She does report a history of cold sores. On 2-23-2020 she developed a headache, diarrhea, and fever. She contact our clinic on 2-26-2020 and RN advised patient to be seen for evaluation. Dr saw patient and prescribed valacyclovir 500 mg PO TID for one week.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAD A DUPLICATE MCIR WAS NOT DISCOVERED UNTIL VACCINES WERE GIVEN.  PATIENT'S MOTHER WAS CALLED ON 2/26/20--STATED UNDERSTANDING CHILD HAD NO ADVERSE REACTION.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was only administered the liquid C-W-Y component of the vaccine.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Shoulder pain, itching at site.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Bowel movement irregularity, Constipation, Diarrhoea, Dyschezia, Irritability
Clinical narrative: Within 24 hours of the vaccine she became very irritable and her bowel movements stopped. Her belly became distended over time. It took 6 days for her to have a bowel movement after the vaccine. Her first bowel movement was extreme diarrhea, Since February 10th her bowel movements have been irregular and only diarrhea with her struggling to pass the movements, sometimes displaying signs of pain. She now needs assistance to pass gas and have bowel movements by supplements to her diet and exercising/massaging her abdominal area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Sore arm, redness and itchiness
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Arthropathy, Dizziness, Injection site erythema, Injection site swelling, Muscle disorder
Clinical narrative: Muscle and Joint. Dizziness this morning and redness and swelling at injection site.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Atrial fibrillation, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Urgent visit to Emergency Room,  treated by PA .  On arrival had tachycardia to 160 bpm and hypotension.  Reported aches, headache had progressed over several hours to profuse diaphoresis, severe weakness,  nausea.  ER noted tachycardia, Atrial Fibrillation with rapid ventricular response and hypotension. These improved with supportive treatment including 3 liters of IV fluid, metoprolol and a few hours time.  Offered admission to hospital but patient requested transfer for insurance cost reasons and then recovered at home.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypotension, Myocardial necrosis marker normal, Nausea, Pain, Tachycardia
Clinical narrative: Urgent visit to Emergency Room,  treated by PA .  On arrival had tachycardia to 160 bpm and hypotension.  Reported aches, headache had progressed over several hours to profuse diaphoresis, severe weakness,  nausea.  ER noted tachycardia, Atrial Fibrillation with rapid ventricular response and hypotension. These improved with supportive treatment including 3 liters of IV fluid, metoprolol and a few hours time.  Offered admission to hospital but patient requested transfer for insurance cost reasons and then recovered at home.
Age: 59.0
Sex: U
Vaccine: UNK
Symptoms: Balance disorder, Dark circles under eyes, Diarrhoea, Injection site pain, Nausea
Clinical narrative: Box 17 - Shingrix   Pain at injection site, severe body aches, fever (101), sore throat, diarrhea, nausea, black circles under eyes (may be due to lack of sleep), unsteady (also could be due to lack of sleep). No medical attention sought.   Box 22- HepA/B
Age: 59.0
Sex: U
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Box 17 - Shingrix   Pain at injection site, severe body aches, fever (101), sore throat, diarrhea, nausea, black circles under eyes (may be due to lack of sleep), unsteady (also could be due to lack of sleep). No medical attention sought.   Box 22- HepA/B
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that her hands have been hurting since she got the flu vaccination. She stated that she couldn't move her arms for 2 weeks after receiving flu vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: WARM TO TOUCH, 11X9 CM LIGHT ERYTHEMA LEFT UPPER THIGH
Age: 69.0
Sex: U
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Middle insomnia, Mobility decreased, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Box 17- Pneumo23  Unable to use/lift left arm for 5 days. Called family doctor the following day, prescribed Doxycycline. Currently experiencing left shoulder pain to the point that it wakes me up an night.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Injections listed above given. Dates and Lots checked before they were given. I did not catch that the Tdap had expired on 1/17/20. I was thinking that it was good until next January. I gave all injections without problems. When documenting is when I realized that it was in fact past it's expiration date.  Notified my NP that I work under along with the Office Manager.  I have contacted the mom of patient and she reports no side effects noted other then patients arms were sore for a couple of days due to receiving 2 shots in each.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Lt shoulder pain that is not resolving since seasonal flu vaccine administration
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: Flu like symptoms: aches, nausea, fever, chills, fatigue .  Lasted about 24 hours.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms: aches, nausea, fever, chills, fatigue .  Lasted about 24 hours.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red patchs with itchy Welts . My Doctors prescribe steroids pill for one week. it helped some but took about 4 weeks to clear  completely up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Tiredness, headache, shivering, fever.
Age: 21.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Extra dose administered, Pain in extremity, Peripheral swelling
Clinical narrative: The patient received Pneumovax and the influenza vaccine today due to provider error.  She had previously received them both on 12/19/2020. The provider immediately disclosed error to patient.  The provider called the CDC---risk is pain and swelling at injection site.   The patient indeed developed redness, swelling, and pain in R arm.  She was advised to use prn acetaminophen as needed for pain and to place an ice pack wrapped in a light towel on her arm and to follow up in the clinic tomorrow as needed.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles 1 day after receiving vaccination.
Age: 2.08
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT THIGH: redness, swelling and warmth. swelling diameter: 5-6cm.  LEFT THIGH: redness.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Activated partial thromboplastin time shortened, Contusion, Full blood count, Immune thrombocytopenia, Petechiae
Clinical narrative: New onset of multiple bruises and petechiae on Friday 2/21/20 without fever, joint pain, abdominal pain or any other symptoms. Patient came to clinic on Tuesday 2/25/20 for evaluation. Immune thrombocytopenia suspectedand labs ordered. Thrombocytopenia confirmed on CBC, also slightly low PTT but all other findings within normal limits. Patient doing well, has been advised no collision/contact sports until thrombocytopenia resolves to avoid significant internal hemorrhage. Referred to hematologist for further evaluation.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: New onset of multiple bruises and petechiae on Friday 2/21/20 without fever, joint pain, abdominal pain or any other symptoms. Patient came to clinic on Tuesday 2/25/20 for evaluation. Immune thrombocytopenia suspectedand labs ordered. Thrombocytopenia confirmed on CBC, also slightly low PTT but all other findings within normal limits. Patient doing well, has been advised no collision/contact sports until thrombocytopenia resolves to avoid significant internal hemorrhage. Referred to hematologist for further evaluation.
Age: 1.58
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, VARCEL
Symptoms: Exfoliative rash, Inflammation, Rash erythematous, Rash papular
Clinical narrative: Presented with a rash as erythematous, inflamed, papular, and scaly.  Location is abdomen, head, face, back, and whole body.
Age: 1.58
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, VARCEL
Symptoms: Cough, Exfoliative rash, Inflammation, Pyrexia, Rash erythematous
Clinical narrative: Presented with a rash as erythematous, inflamed, papular, and scaly.  Location is abdomen, head, face, back, and whole body.
Age: 1.58
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL, HEPA, HIBV, MMR, VARCEL
Symptoms: Rash macular, Rash papular, Rhinorrhoea
Clinical narrative: Presented with a rash as erythematous, inflamed, papular, and scaly.  Location is abdomen, head, face, back, and whole body.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site paraesthesia, Injection site warmth
Clinical narrative: The patient experienced chills the evening of the vaccine which resolved by morning time.  She also experienced injection site reactions which included redness, warm to the touch at site of injection, and a tingling at injection site.  The tingling at the injection site continues to today,  4 days later, all other symptoms resolved.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Nausea, Pain
Clinical narrative: 2/22/2020 6:30 p.m. arm pain, chills evening 2/23/2020 3:00 a.m. fever, little nausea, chills all night chills all night, poor sleep 2/23/2020  5:00 a.m. aches and fever, took aspirin, felt more comfortable within an hour. 2/23/2020  felt weak and tired until 4:00 p.m.  Arm very sore and red. 2/24/202 until 2/25/2020 arm sore
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Skin reaction
Clinical narrative: 2/22/2020 6:30 p.m. arm pain, chills evening 2/23/2020 3:00 a.m. fever, little nausea, chills all night chills all night, poor sleep 2/23/2020  5:00 a.m. aches and fever, took aspirin, felt more comfortable within an hour. 2/23/2020  felt weak and tired until 4:00 p.m.  Arm very sore and red. 2/24/202 until 2/25/2020 arm sore
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: at time of shot felt like shooting pain down arm, over time  it felt like pain throughout upper arm, difficult to lift past shoulder without pain
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: 2/22/2020 6:30 pm arm  pain, chills Chills all night 2/23/2020 headache, chills, achy in evening, arm pain moved front of arm Bedtime felt better, slept well 2/24/2020 arm pain 2/25/2020 arm pain 2/26/2020 arm pain receded in afternoon
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: On February 25, the day after receiving the 2nd dose she developed a red mark at the injection site, arm soreness, and swelling of shoulder ( above injection site, near collarbone). Patient also reported flu like symptoms and states she felt like she got hit by a truck. Patient has been taking Tylenol to reduce the pain and noted slight improvement today (02/26/2020). Patient denies hx of stomach/intestinal bleeding or kidney issues, and was recommended to try ibuprofen or naproxen if Tylenol is not adequately relieving pain. Patient to follow-up in a few days to let us know if there has been improvement or resolution of adverse reactions and to contact primary care provider if not improving.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no adverse event, he was given an expired vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: pt came to another pharmacy store spoke with staff - regarding her swollen injection site.  Per staff, it looks like a reaction to the vaccine.  It is swollen and red.  Staff said it looks like it is improving.  She recommended pt to take Benadryl to help with the reaction.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling at injection site starting about 48 hours after immunization.  It progressed for about 24 hours and at that time he sought treatment from his PCP.  He was treated with a 5 days course of Cephalexin 500mg TID.  Reaction resolved in about 48 hours and has had no lasting effect.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Bronchiolitis, Cough, Dermatitis, Dyspnoea, Ear pain
Clinical narrative: Bronchialitis coughing fit or episode lasting for minutes straight at a time, causing patient to be out of breath and wheezing. Otitis media or an ear ache that lasted over 3 weeks and was resistant to 2 different antibiotics and resolved itself with a third antibiotic. The cough lasted over 2 months and 3 weeks, would keep him up at night as well. Then a dermatitis or exzema rash developed on his right eye lid.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Eczema, Eyelid rash, Otitis media, Wheezing
Clinical narrative: Bronchialitis coughing fit or episode lasting for minutes straight at a time, causing patient to be out of breath and wheezing. Otitis media or an ear ache that lasted over 3 weeks and was resistant to 2 different antibiotics and resolved itself with a third antibiotic. The cough lasted over 2 months and 3 weeks, would keep him up at night as well. Then a dermatitis or exzema rash developed on his right eye lid.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Swelling
Clinical narrative: Extreme swelling and pain. Body pain. Severe headache
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Joint swelling, Muscle twitching, Pyrexia, Tremor, Urticaria
Clinical narrative: Generalized urticaria, twitching/shaking, fever, swelling of bilateral knee joints; treated w/ PO benadryl, topical hydrocortisone, SQ epi, PO prednisolone, and PO ibuprofen
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: CSF test, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Vaccination complication
Clinical narrative: Leg weakness after 3rd day of administration given IVIG
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Angiopathy, Full blood count normal, Metabolic function test normal, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: serum sickness - like illness: urticarial  rash, vascular, fever = 103 F 2/24/2020  7 days following above vaccines
Age: 1.17
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Serum sickness-like reaction, Urine analysis normal, Urticaria
Clinical narrative: serum sickness - like illness: urticarial  rash, vascular, fever = 103 F 2/24/2020  7 days following above vaccines
Sex: M
Vaccine: HPV4
Symptoms: Drug effective for unapproved indication
Clinical narrative: Disseminated: hands, head, legs warts resolved; HPV vaccine for disseminated: hands, head, legs warts; This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 36 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, candida albicans and curertage. The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for disseminated hands, head and legs warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unspecified date, the patient's disseminated hands, head and legs warts resolved (drug effective for unapproved indication).  The outcome of drug effective for unapproved indication was unknown.  The causal relationship between the vaccination with quadrivalent human papillomavirs (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomarivus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Age: 13.0
Sex: F
Vaccine: HEPAB, MMR, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the Twinrix which is the adult version 18 and older. She should have received the pediatric dose.
Sex: M
Vaccine: HPVX
Symptoms: Complications of transplanted kidney, Death, Product use in unapproved indication, Skin papilloma
Clinical narrative: HPV vaccine for chest, back and extremities warts (flat warts); This literature marketed report has been received from the authors of the published article, concerning a 51 year old male patient. The patient's pertinent medical history included a renal transplant and therapy with liquid nitrogen, tazarotene (TAZORAC) and imiquimod. The patient's current conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) chest, back and extremities warts (flat warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient died due to complications related to the renal transplant. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same literature.
Sex: M
Vaccine: HPV4
Symptoms: Drug effective for unapproved indication
Clinical narrative: Left foot (plantar) warts resolved; HPV vaccine used for left foot (plantar) warts; This literature report has been received from the authors of the published article, titled as stated above, concerning a 45 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, candida albicans, duct tape and zinc (unspecified). The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for left foot (plantar) warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unspecified date, the patient's left foot (plantar warts) resolved (drug effective for unapproved indication).  The outcome of drug effective for unapproved indication was unknown.  The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature;  Sender's Comments: US-009507513-1912USA012734: US-009507513-1912USA012735: US-009507513-1912USA012721: US-009507513-1912USA012722: US-009507513-1912USA012723:  US-009507513-1912USA012724:  US-009507513-1912USA012725: US-009507513-1912USA012726:  US-009507513-1912USA012727: US-009507513-1912USA012728: US-009507513-1912USA012729: US-009507513-1912USA012730:  US-009507513-1912USA012731: US-009507513-1912USA012732: US-009507513-1912USA012733:
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts, Skin papilloma
Clinical narrative: Left thumb warts (unspecified type of warts) resolved; Hpv vaccine used fro left thumb warts (unspecified type of warts); This literature marketed report has been received from the authors of the published article, concerning a 37 year old male patient. The patient's pertinent medical history including therapy with liquid nitrogen, candida albicans, duct tape and curettage. The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for left thumb warts (unspecified type of warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, left thumb warts (unspecified type of warts) resolved (drug effective for unapproved indication).   The outcome of drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication, Skin papilloma
Clinical narrative: Bilateral hand and feet warts (peringual warts); HPV vaccine for bilateral hand and feet warts (peringual warts); This literature marketed report has been received from the authors of the published article, concerning a 52 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, cimetidine and imiquimod. The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) bilateral hand and feet warts (peringual warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the bilateral hands and feet warts resolved (drug effective for unapproved indication).   The outcome of drug effective for unapproved indication was unknown.  The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: HPV vaccine used for disseminated warts (flat warts); This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 45 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, imiquimod (ALDARA) and cimetidine. The patient's current conditions included T-cell immunodeficiency. His concomitant medications were not reported.    On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for disseminated warts (flat warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   A copy of the published article is attached as further documentation of the patient's experience.   This is one of several reports received from the same literature.   Sender's Comments: US-009507513-1912USA001729: