chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Pyrexia, Tonsillar hypertrophy
Clinical narrative: DX: Vaccine induced measles - moderate fever > 101 starting, 4/11/14 and lasting 3 days. Multiple purple/violet macules noted ranging in size from 1-3 mm on face, trunk,  and upper/lower extremities bilaterally . Examination of the oropharynx showed petechial hemorrhages on the soft and hard palate. 1+ enlargement and erythema of both tonsils. Exudate also noted on both tonsils.
Sex: F
Vaccine: VARZOS
Symptoms: Lip dry, Lip exfoliation, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a female pharmacist via a company representative refers to herself. In April 2013, the patient was vaccinated with ZOSTAVAX, lot #, expiration date, dose and route not reported. The pharmacist reported that since receiving ZOSTAVAX in April 2013, she experiences monthly episodes of lips tingling, drying and peeling. The outcome of the events was reported as not recovered. The patient had not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 3 or 4 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with VARIVAX 1350 U. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The healthcare worker reported that 3 or 4 patients received VARIVAX that had been stored improperly at 14 degrees F. to 17 degrees F. for an extended unspecified amount of time (on an unknown date). No adverse effect reported. The healthcare worker also mentioned that they had PPD (manufacturer unspecified) in an open vial that had been in use longer than indicated in the prescribing information for the product. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On an unspecified date in 2011, the patient received her first dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). The second dose of GARDASIL was given 13 months after the first dose on an unspecified date. The third dose of GARDASIL was administered 25 months after the first dose on unspecified date. No adverse effect was reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood creatine phosphokinase increased, Fall, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient received vaccine on 10/2/13 and presented to hospital on 11/16/13 with weakness and a fall. Patient noticed weakness in his hips and tingling in his toes and fingertips. Neurology evaluated patient and diagnosed him with Guillain-Barre. Patient was treated with 5 doses of IVIG.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient received vaccine on 10/2/13 and presented to hospital on 11/16/13 with weakness and a fall. Patient noticed weakness in his hips and tingling in his toes and fingertips. Neurology evaluated patient and diagnosed him with Guillain-Barre. Patient was treated with 5 doses of IVIG.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received on 11 April 2014 from a non health care professional. A 61 year-old female patient with a history of diabetes, hypertension, an allergy to Cymbalta and was not acutely ill at time of vaccination had received on 08 April 2014 a left deltoid dose of ADACEL, lot number C4543AA (route of administration not reported) and two days later on 10 April 2014, experienced redness, swelling and warmth at injection site. Redness measured 4 x 3 inches. Doctor felt it was cellulitis. Treatment included Doxycycline. The vaccine was administered using a 5/8 inch needle. The patient's last tetanus shot was over 10 years ago. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (frequency, route, indication, dose strength was not reported) and the patient developed red area at the injection site that was warm to touch and persistent the next day. The reporter stated that patient informed that she did not have rash and believe that reaction is still present. The outcome of red area at the injection site and warm to touch was reported as not recovered/not resolved. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 17 year old patient. The patient's pertinent medical history and concurrent conditions were not reported. On 09-APR-2014 the patient was vaccinated with 2 doses of GARDASIL (Dose and route of administration were not reported) in the same office visit at an unspecified physician's office. No adverse effects were reported. The outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Vaccination failure
Clinical narrative: This spontaneous report as received from a nurse via a field representative refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date the patient was vaccinated with GARDASIL injection. No concomitant medication was reported. On an unknown date the patient experienced vaccine failure. The result of a Papanicolaou (PAP) smear (date not specified) was positive. No outcome was reported. No causality assessment was provided. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Petechiae, Rash
Clinical narrative: Immediately after administration of immunizations, patient developed a petechial rash on chest and back. Given BENADRYL 7.5 ml of 12.5 mg/5ml. Rash became less pronounced. Patient discharged.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Abdominal X-ray, Barium enema, Enema administration, Haematochezia, Intussusception
Clinical narrative: Blood in stool. Vomiting. Ileocolic Intussusception. Admitted to hospital reduced by Ba enema.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Ultrasound abdomen, Vomiting, X-ray gastrointestinal tract
Clinical narrative: Blood in stool. Vomiting. Ileocolic Intussusception. Admitted to hospital reduced by Ba enema.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Blood in stool. Vomiting. Ileocolic Intussusception. Admitted to hospital reduced by Ba enema.
Age: 1.49
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Miliaria, Rash
Clinical narrative: Mother states that "rashes, described as heat bumps" appeared on the back of the arms, stomach and thighs. Mother applied hydrocortisone that brought temporarily relief and rashes still visible up to this date.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thyroiditis, Convulsion, Coordination abnormal, Drooling, Dysgeusia
Clinical narrative: Unsure of exact dates, felt sick after the vaccine, didn't continue series.  Numerous ER visits for years after vaccine for reasons listed below. Facial paralysis, debilitating headaches, right side palsy. Shaking, tremors, numbness right side of body, difficulty walking and coordinating, Hashimotos thyroiditis, excessive swelling.  Current symptoms: Frequent Urination (becomes thick and smelly at the end); Fullness/Pressure in head; Sporadic headache behind ear/eyeball; Stiff/Heavy Neck; Hear noise in head, leaks down throat, odd taste; Tremors; Seizures; Difficulty breathing, becomes heavy for a few minutes; High heart rate; Right Side Paralysis with Drooling; No feeling in right eye, right cheek, and wrists; Numbness of Face, Arms and Legs; Swollen Face, Arms, and Legs.; Difficulty Speaking, swallowing, walking; Poor coordination. Lost feeling to the right side of my body on April 14, 2014.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Dyspnoea, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: Unsure of exact dates, felt sick after the vaccine, didn't continue series.  Numerous ER visits for years after vaccine for reasons listed below. Facial paralysis, debilitating headaches, right side palsy. Shaking, tremors, numbness right side of body, difficulty walking and coordinating, Hashimotos thyroiditis, excessive swelling.  Current symptoms: Frequent Urination (becomes thick and smelly at the end); Fullness/Pressure in head; Sporadic headache behind ear/eyeball; Stiff/Heavy Neck; Hear noise in head, leaks down throat, odd taste; Tremors; Seizures; Difficulty breathing, becomes heavy for a few minutes; High heart rate; Right Side Paralysis with Drooling; No feeling in right eye, right cheek, and wrists; Numbness of Face, Arms and Legs; Swollen Face, Arms, and Legs.; Difficulty Speaking, swallowing, walking; Poor coordination. Lost feeling to the right side of my body on April 14, 2014.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia eye, Local swelling, Malaise, Musculoskeletal stiffness, Paralysis
Clinical narrative: Unsure of exact dates, felt sick after the vaccine, didn't continue series.  Numerous ER visits for years after vaccine for reasons listed below. Facial paralysis, debilitating headaches, right side palsy. Shaking, tremors, numbness right side of body, difficulty walking and coordinating, Hashimotos thyroiditis, excessive swelling.  Current symptoms: Frequent Urination (becomes thick and smelly at the end); Fullness/Pressure in head; Sporadic headache behind ear/eyeball; Stiff/Heavy Neck; Hear noise in head, leaks down throat, odd taste; Tremors; Seizures; Difficulty breathing, becomes heavy for a few minutes; High heart rate; Right Side Paralysis with Drooling; No feeling in right eye, right cheek, and wrists; Numbness of Face, Arms and Legs; Swollen Face, Arms, and Legs.; Difficulty Speaking, swallowing, walking; Poor coordination. Lost feeling to the right side of my body on April 14, 2014.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pollakiuria, Speech disorder, Swelling, Swelling face, Tinnitus
Clinical narrative: Unsure of exact dates, felt sick after the vaccine, didn't continue series.  Numerous ER visits for years after vaccine for reasons listed below. Facial paralysis, debilitating headaches, right side palsy. Shaking, tremors, numbness right side of body, difficulty walking and coordinating, Hashimotos thyroiditis, excessive swelling.  Current symptoms: Frequent Urination (becomes thick and smelly at the end); Fullness/Pressure in head; Sporadic headache behind ear/eyeball; Stiff/Heavy Neck; Hear noise in head, leaks down throat, odd taste; Tremors; Seizures; Difficulty breathing, becomes heavy for a few minutes; High heart rate; Right Side Paralysis with Drooling; No feeling in right eye, right cheek, and wrists; Numbness of Face, Arms and Legs; Swollen Face, Arms, and Legs.; Difficulty Speaking, swallowing, walking; Poor coordination. Lost feeling to the right side of my body on April 14, 2014.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Urine odour abnormal, VIIth nerve paralysis
Clinical narrative: Unsure of exact dates, felt sick after the vaccine, didn't continue series.  Numerous ER visits for years after vaccine for reasons listed below. Facial paralysis, debilitating headaches, right side palsy. Shaking, tremors, numbness right side of body, difficulty walking and coordinating, Hashimotos thyroiditis, excessive swelling.  Current symptoms: Frequent Urination (becomes thick and smelly at the end); Fullness/Pressure in head; Sporadic headache behind ear/eyeball; Stiff/Heavy Neck; Hear noise in head, leaks down throat, odd taste; Tremors; Seizures; Difficulty breathing, becomes heavy for a few minutes; High heart rate; Right Side Paralysis with Drooling; No feeling in right eye, right cheek, and wrists; Numbness of Face, Arms and Legs; Swollen Face, Arms, and Legs.; Difficulty Speaking, swallowing, walking; Poor coordination. Lost feeling to the right side of my body on April 14, 2014.
Age: 0.69
Sex: M
Vaccine: DTAPHEPBIP, FLU3, MNQHIB, PNC13
Symptoms: Ecchymosis, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: 2 days prior to 01/06/2014 office visit, developed rash at earlobe.  At office, child was afebrile.  He had petechiae at right earlobe, left wrist, neck and chest as well as ecchymoses on abdomen.  CBC that day showed a platelet level of 4.  He was admitted to the hospital for Hem/Onc consultation.  He has received several IVIG infusions for ITP.  Most recent platelet count on 4/1/14 was 25.  Of note RE: illnesses prior to onset of ITP: on 12/02/2013 had LOM treated with Omnicef.  12/19/2013 OM was resolved, prescribed Zithromax for sinus infection.
Age: 0.69
Sex: M
Vaccine: DTAPHEPBIP, FLU3, MNQHIB, PNC13
Symptoms: Rash, Sinusitis
Clinical narrative: 2 days prior to 01/06/2014 office visit, developed rash at earlobe.  At office, child was afebrile.  He had petechiae at right earlobe, left wrist, neck and chest as well as ecchymoses on abdomen.  CBC that day showed a platelet level of 4.  He was admitted to the hospital for Hem/Onc consultation.  He has received several IVIG infusions for ITP.  Most recent platelet count on 4/1/14 was 25.  Of note RE: illnesses prior to onset of ITP: on 12/02/2013 had LOM treated with Omnicef.  12/19/2013 OM was resolved, prescribed Zithromax for sinus infection.
Age: 0.76
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Influenza vaccine 6-35 month ordered, influenza vaccine 3+ given to patient. Dr. notified parent unaware attempted to contact parent after inceident. Will continue to try to contact parent.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, fatigue.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 2 days after injection patient reported to urgent care with worsening and spreading pain and redness at the site of injection.  She also had warmth and tenderness at the injection site.  She was diagnosed with cellulitis and treated with Cephalexin.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Local swelling
Clinical narrative: Left shoulder pain developed 4/14/14. Swelling to left hand and left fingers developed 4/15/14. Skin to entire left arm was slightly more pink that the right arm. Treatment included ice, Naproxen, Hydrocodone, rest, and gentle stretching exercises.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: RED RING AROUND THE SITE; WARM, PAIN ON SITE; ICTCHINESS; NO TROUBLE BREATHING OR ITCHY THROAT.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Injection site rash, Rash
Clinical narrative: Raised bumps on right leg and cheek, diarrhea 24 hours later, bumps lasted 4 days.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Ultrasound scan normal
Clinical narrative: Patient presented to the ED for evaluation. Diagnosed with cellulitis of the upper right arm. Treatment in the ED consisted of oral antibiotics (Keflex and Bactrim) for infection, and opiods (Norco) for pain control.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash, Irritability, Rash generalised, Rash macular, Urticaria
Clinical narrative: A few minutes after vaccines given developed red splotches on face, lip, abdomen and became very fussy. After several min. some rash faded while new ones appeared on (L) cheek, arms and legs. Rash flat not raised. After 30 min 2 small urticarial rash appeared in occipital area. Gave BENADRYL 12.5 mg/5 1/2 tsp. After 10 min rash totally disappeared.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A spontaneous report was received on 10-APR-2014 from a registered nurse concerning a male patient (age unknown). The patient received the GARDASIL vaccine serious intramuscularly on the following dates: first dose on 08-OCT-2013, second dose on 13-FEB-2014 and the third dose on 09-APR-2014. No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Local swelling, Skin warm, Tenderness
Clinical narrative: Swelling and redness to left arm 5x4 cm and induration, warm and tender to touch. 4/14/14 ff-up vaccine site much better greater size redness. 4/16/14 completely healed.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Local swelling, Skin warm, Tenderness
Clinical narrative: Redness and swelling to left arm with 2 1/2x2cm induration and 7x8cm erythema, warm and tender to touch. 4/14/14 vaccine site clear
Age: 44.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Third Hep B administered in left deltoid muscle. Soreness never fully subsided. Since March, mobility is limited and muscle is sore and moderately painful when lifting left arm equal to or above shoulder laterally, especially when bearing weight or flexed. Pain can be felt through forearm.
Age: 7.0
Sex: F
Vaccine: HEP, HEPA, MMRV
Symptoms: Unevaluable event
Clinical narrative: 04/17/2014 moderate other.
Age: 0.01
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Six hours of crying. Not eating.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. He reported that the patient received a dose of GARDASIL (lot #, expiry date, dose and indication unknown) today (15-APR-2014) which was inadvertently injected into the "AC (acromioclavicular) joint" or shoulder joint "just below the clavicle". He reported that no adverse events had been reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's current conditions or medical history were not reported. On 09-APR-2014, the patient was vaccinated with the first dose of expired PROQUAD (Merck) 0.5 ml subcutaneous injection on the right thigh (lot number H015781 expiration date 24-FEB-2014). No adverse effects reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 6 month old female patient with reflux and with none drug reactions/allergies. On 09-APR-2014 the patient was vaccinated with a dose of VARIVAX (Lot reported as J003711; expiration date: 27-MAR-2015) 0.5 ml, subcutaneous in the right thigh. There was none concomitant medication. The nurse stated that at the time of the report, on 09-APR-2014, the 6 month old child was vaccinated with (Oka/Merck) VARIVAX and was a staff error only. On the same day, the child had a rash on her back. Treatment was ATARAX syrup. None lab diagnostic studies were performed. At the time of the report, the outcome of rash on her back was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Herpes simplex serology negative, Labia enlarged, Tenderness, Vulval ulceration
Clinical narrative: Information has been received from a physician concerning a 13 year old patient. On an unspecified date the patient was vaccinated with GARDASIL, dose number 2. Two days after the administration of GARDASIL she complained of an extremely painful vulvar ulcerations with swelling of the labia minora. The onset was rapid. The patient did not have any sexual contact of any kind, including sexual abuse. There was no personal or family history of autoimmune, rheumatologic, GI disease (including IBD), or HSV. There were no recent viral illnesses. The patient did have a history of canker sores since early childhood but no prior GU. A "Woman's Health Panel" was sent (date not provided) and was negative for all STIs including HSV. Upon examination she had a somewhat swollen labia minora and several well-demarcated, shallow, ovoid 1-3 cm ulcers with fibrinous bases and erythematous borders, tender to palpation, on the mucosal surfaces of vulva, primarily at the posterior fourchette. The physician stated that she was certain that is was vulvar aphthosis. The physician stated that she "doubts this patient's presentation has anything to do with GARDASIL". Additional information is not expected.
Sex: U
Vaccine: HEPA, HPV4, MENHIB, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a physician who reported that an unspecified number of patients may have received improperly stored GARDASIL, PEDVAXHIB, ROTATEQ and VAQTA. No symptoms were reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US027651, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518543) website on 06 Mar 2014 and a follow-up received from Quality Assurance Department (reference number: 286547) on 10 Apr 2014: This report refers to a 51-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1310101) intramuscularly in the left arm on 01 Jan 2014. On 03 Jan 2014, she was taken to the emergency room and diagnosed with Bell's palsy. The outcome of the event reported as not recovered. The seriousness and causality of the event were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1310101) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 286547) on 12 Mar 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 286547) on 10 Apr 2014: Updated batch review report.
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Case number PHHY2014US027724 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 519095) on 06 Mar 2014 and a follow-up received from Quality Assurance Department (reference number: 286558) on 10 Apr 2014:: This report refers to a 19-year-old female patient. Medical history included non-functional ovaries. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13421P) intramuscularly in to the right arm on 07 Jan 2014. On the same day after vaccination, she passed out at front of store, she felt lightheaded and passed out, she immediately regained consciousness and was sitting on the floor. She felt fine and had no injury. She continued to sit for 15 minutes and drank sprite. She felt fine and had not eaten since previous day. Outcome of the events was reported as complete recovery as on 07 Jan 2014. No further information about seriousness and causality was reported. Based on the investigation performed, QA department stated that, the  FLUVIRIN (batch number: 13421P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 286558) on 10 Apr 2014: Updated batch review report.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US043172 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 519259) website on 08 Apr 2014 with a follow-up received on 14 Apr 2014. This report refers to a 68-year-old female patient. Her historical drugs included morphine, nickel, zinc and ROBITUSSIN. This polymedicated patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in the left arm on 28 Dec 2013. On 29 Dec 2013, 24 hours after vaccination she experienced Bell's palsy. The patient visited the emergency room. She had a MRI of brain to rule out stroke and result was negative (normal). The final outcome of the event reported as not recovered. The event was reported as non-serious; however the case was internally upgraded to medically significant by the agency. The causality of the event was not reported. The quality assurance (QA) department stated that 0874924A was not a valid batch number for FLUVIRIN; therefore, as per procedures, no batch review would be initiated. Follow-up received from the quality assurance (QA) department on 14 Apr 2014: Updated comment from the QA department. Batch number for FLUVIRIN was earlier captured as 0874924A, which was later on changed to unknown, after QA department confirmed that it was a non-valid batch number for FLUVIRIN.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US046598, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520217) website on 14 Apr 2014. This report refers to a 56-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309201) in the right arm and PNEUMOVAX (batch number: H022280) in the left arm, both intramuscularly on 23 Oct 2013. On 24 Oct 2013, she experienced injection site swelling, redness and feverish. The patient went to the doctor and was diagnosed with cellulitis. She received antibiotic treatment and now better. The final outcome of the events reported as recovered. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2014US046598, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520217) website on 14 Apr 2014. This report refers to a 56-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309201) in the right arm and PNEUMOVAX (batch number: H022280) in the left arm, both intramuscularly on 23 Oct 2013. On 24 Oct 2013, she experienced injection site swelling, redness and feverish. The patient went to the doctor and was diagnosed with cellulitis. She received antibiotic treatment and now better. The final outcome of the events reported as recovered. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Periarthritis
Clinical narrative: Case number PHHY2014US043220 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 520911) website on 08 Apr 2014 with a follow-up received on 14 Apr 2014. This report refers to a 64-year-old female patient. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 12 Sep 2013. On the same day, post vaccination she experienced pain (severe) at injection site and had a visit to primary care physician who had referred her to orthopedist. Pain and numbness in (L) fingers continued. She saw orthopedist specialist in shoulders who diagnosed adhesive capsulitis on 24 Jan 2014. The physician stated that it was most likely secondary to flu vaccine. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Outcome and causality of the events were not reported. The quality assurance (QA) department stated that 1207901 was not a valid batch number for FLUVIRIN, therefore, as per procedures, no batch review would be initiated. Follow-up received from the quality assurance (QA) department on 14 Apr 2014: Updated comment from the QA department. Batch number for FLUVIRIN was earlier captured as 1207901, which was later on changed to unknown, after QA department confirmed that it was a non-valid batch number for FLUVIRIN.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Culture, Injection site reaction, Rash, Rash pustular, Rash vesicular
Clinical narrative: Vesicular rash that started on lower extremities and forearms.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Excoriation, Macule, Papule, Pruritus, Rash generalised
Clinical narrative: Onset of a rash on his hands, and tops of feet 10 days post vaccination with SPV and AVA on 21 Mar 14. Rash initially started on wrists, spread to fingers and feet and now has a lesion on his left elbow. Stated lesions are itchy, denies pain but notes a "tight feeling" along his fingers. He denies lesions in his mouth/lips, and other parts of his body. He denies headache, fever, N/V, chest pain, or shortness of breath. He denied problems with his vaccination site. Other than rash reports he is doing well. Multiple macules and papules noted on palmar and dorsal surfaces of hands, between fingers and one lesion on elbows for total of 10-15 lesions. No pustules or vesicles. Slight excoriation of wrist lesion.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Skin lesion, Skin tightness
Clinical narrative: Onset of a rash on his hands, and tops of feet 10 days post vaccination with SPV and AVA on 21 Mar 14. Rash initially started on wrists, spread to fingers and feet and now has a lesion on his left elbow. Stated lesions are itchy, denies pain but notes a "tight feeling" along his fingers. He denies lesions in his mouth/lips, and other parts of his body. He denies headache, fever, N/V, chest pain, or shortness of breath. He denied problems with his vaccination site. Other than rash reports he is doing well. Multiple macules and papules noted on palmar and dorsal surfaces of hands, between fingers and one lesion on elbows for total of 10-15 lesions. No pustules or vesicles. Slight excoriation of wrist lesion.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Clumsiness, Headache, Systemic lupus erythematosus
Clinical narrative: This spontaneous report was received from a registered nurse who read a life story of a 17 year old patient on a website. On an unknown date the patient was vaccinated with GARDASIL dose 2 (dose, lot no and route not reported).    On an unknown date after the 2nd dose, the patient experienced clumsiness, headache and lupus.    The outcome of lupus, headache and clumsiness was unknown. Upon internal review, lupus was determined to be medically significant. This is one of the several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a registered nurse who read about the life story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL, (dose, lot no. route not reported). On an unknown date the patient died from an unspecified cause. This is one of reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a registered nurse who read a story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL (dose, lot no and route not reported). On an unknown date the patient experienced seizures after vaccination. The outcome of seizures was unknown. Upon internal review, seizures was determined to be medically significant. This is one of several reports received from the same source. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Arthritis, Asthenia, Blood test, Bone pain
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Convulsion, Injection site pain, Loss of consciousness, Mobility decreased, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Negative thoughts, Pain, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Suicidal ideation
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Convulsion, Dermatitis contact, Injection site pain, Loss of consciousness, Middle insomnia
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Negative thoughts, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Suicidal ideation
Clinical narrative: This spontaneous report as received from a consumer in his 60's refers to himself. His concurrent conditions included diabetes and allergy to codeine. In February 2014 (reported as "this past February") the patient was revaccinated with second dose of PNEUMOVAX 23 0.5 ml one dose, intramuscularly (injection site, lot# and expiration date not reported). Indication for the vaccination was reported as "diabetic, indicated age for vaccination and scheduled time for revaccination". Time of the first vaccine administration was reported as "about two years ago". Metformin was reported as a concomitant medication. On an unknown date in February 2014, within minutes from injection, the patient experienced fever and shooting pains that went halfway across his collar bone and arm. He also noted that when he slept on that particular arm it would wake him up because of the pain. The patient stated that he had an injection site pain that "felt like the needle was still stuck in his arm"; the pain lasted for a month and he recovered from it on an unspecified date in March 2014. On an unknown dates in 2014 the patient experienced four separate incidents of a high fever (greater that 102F) which caused him to have a seizure and a black out. On an unspecified dates in 2014 the patient also had negative thoughts and suicidal thoughts, felt weaker and had developed bilateral arthritis which caused increased pain in his shoulders, arms, wrist, hands and knuckles. He also complained about decrease limb mobility such as not being able to close his hand fully. The patient sought medical attention via contacting a physician. Unspecified "blood tests" were performed (results unknown). The patient was treated with unspecified arthritic medication and oral prednisone (exact indication not reported). The patient reported that he recovered from "some of the noted adverse events" but did not recover from arthritic pain and decreased limb mobility. Relatedness between use of PNEUMOVAX 23 and reported adverse events was unknown. Additional information has been requested.