chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II, lot number L041457 with expiration date 22-OCT-2017, and lot number M004305 with expiration date 25-JAN-2018 (dose, route and anatomical location were not reported) for prophylaxis. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours in the first cycle; Also on these dates from 04-JAN-2017 to 06-JAN-2017; from 09-JAN-2017 to 11-JAN-2017, on 13-JAN-2017, from 16-JAN-2017 to 20-JAN-2017, from 23-JAN-2017 to 27-JAN-2017 and from 30-JAN-2017 to 31-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10 hours each day; all of them in the first cycle. In addition on 12-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10.5 hours in the first cycle. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002864: US-009507513-1702USA007377: US-009507513-1702USA007375:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Oral herpes
Clinical narrative: This spontaneous report was received from a 59 year old male patient referring to himself.  Concomitant medications included an unspecified high blood pressure medication.  He had no history of drug/reactions/allergies.  He stated he has been a carrier for herpes simplex I for an unspecified amount of time.  On 29-NOV-2016, the patient received ZOSTAVAX subcutaneously for herpes simplex virus prevention (lot number not provided).  An unspecified time later, he experienced lip swelling and fever blisters in his mouth.  He also reported he subsequently transmitted the herpes simplex I virus to his girlfriend.  He went to Urgent Care on an unspecified date and was given a steroid.  The patient receovered from the events.  The patient requested reimbursement for the ZOSTAVAX or he would contact his lawyer. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Local reaction, Mass
Clinical narrative: Local reaction: 5 x 4 cm raised erythematous mass with central puncta.
Age: 4.0
Sex: M
Vaccine: DTAPH, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling and redness to entire R thigh (thigh flu shot given in).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Contusion, Haemorrhage, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient called us 2/16/17, and issues started 12/20/16. Bled more than normal immediately after receiving per patient. Patient did ice on and off after as told to do so by RPH. Had a bruise there for about 2 weeks or more. Still had bruising and swelling when went to urgent care on 1/10/17. As of 2/16/17 no bruising but still some swelling per patient. Constant, dull, throbbing pain radiating from shot site to elbow. Every now and then will have sharp pains. Dr refuses to treat her because he did not administer the vaccine but she plans to go back to the urgent care for additional treatment, she states she just wants pain relief. Advised patient that all we can recommend is to ice on and off for 20 minutes. But advised her to go back to her doctor for treatment.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient called us 2/16/17, and issues started 12/20/16. Bled more than normal immediately after receiving per patient. Patient did ice on and off after as told to do so by RPH. Had a bruise there for about 2 weeks or more. Still had bruising and swelling when went to urgent care on 1/10/17. As of 2/16/17 no bruising but still some swelling per patient. Constant, dull, throbbing pain radiating from shot site to elbow. Every now and then will have sharp pains. Dr refuses to treat her because he did not administer the vaccine but she plans to go back to the urgent care for additional treatment, she states she just wants pain relief. Advised patient that all we can recommend is to ice on and off for 20 minutes. But advised her to go back to her doctor for treatment.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Vaccination site pain
Clinical narrative: Pt came to pharmacy 2 days after being vaccinated. His arm was red and warm around the area he got the shot and he also complained of soreness at vaccination site and extending to his back. I advised him to go the hospital to rule out an infection and to keep us updated. The pt did not go to the hospital until 2/19/2017. The pt's sister called us on 2/20/17 to let us know that they were told the pt had an allergic reaction to one of the components of the PREVNAR 13 vaccine.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 year old patient. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 06-FEB-2017, the patient was vaccinated with an expired dose of PROQUAD (which had the lot # L023113, expiration date 24-DEC-2016) for prophylaxis (dosage information and anatomical site of vaccination were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a Pfizer via nurse via consumer on 08 Feb 2017. Manufacturer report number: 2016547894. This case involves a female patient (age not reported), who was vaccinated with dose of TETANUS TOXOID (Unspecified) (batch number, expiry date, dose, route and site was not reported) on an unspecified date. The patient's ongoing illness, medical history, risk factors and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient was allergic to tetanus. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a health care professional via Pfizer under reference number 2016538292 on 07 February 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus vaccine) (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unpecified date, following the vaccination the patient experienced vomiting. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX, TTOX
Symptoms: Allergy to vaccine, Vomiting
Clinical narrative: Initial unsolicited report received from a health care professional via Pfizer under reference number 2016538292 on 07 February 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus vaccine) (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unpecified date, following the vaccination the patient experienced vomiting. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Rash on front of neck.  One straight horizontal line about an inch in size.  Slightly itchy and hot.  Took Advil.  By day 2 rash was much less noticeable and not bothering patient.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Localized swelling/warmth/redness at site of injection. Nausea/fatigue/low grade fever.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Localized swelling/warmth/redness at site of injection. Nausea/fatigue/low grade fever.
Age: 0.0
Sex: F
Vaccine: UNK
Symptoms: Blood bilirubin, Blood glucose decreased, Constipation, Eczema, Jaundice neonatal
Clinical narrative: Couldn't keep blood sugar up, even though was being fed every half hour. Terrible jaundice we had to get extra testing for. Couldn't have a bowel movement. Still struggles with eczema.
Age: 41.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Confusional state, Crying, Dizziness, Fear, Loss of consciousness
Clinical narrative: Pt was to receive Hep A #1, Yellow fever and Typhoid VI. Pt stated she was nervous about vaccines. Vaccines given in a recliner. She was drinking water and distracting herself with a video game after receiving Typhoid and YFV in right arm, pt asked for a break. After 5 minutes she stated that she was ready to receive Hep A. Gave the vaccine and about 1 minute later she stated she felt dizzy. Gave her apple juice to drink. Reclined her chair more. She was pale but coherent. About another minute later her head turned to the left, she lost consciousness, eyes opened. Broke a smelling salt under her nose. She suddenly woke and was pale and confused. She stated she thought she might have died and was frightened and began to cry. She remained reclined for about 10 minutes, then sat for 10 minutes. Her color had returned to normal. When she stood she stated she felt steady and was ready to leave the office.
Age: 41.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Pallor
Clinical narrative: Pt was to receive Hep A #1, Yellow fever and Typhoid VI. Pt stated she was nervous about vaccines. Vaccines given in a recliner. She was drinking water and distracting herself with a video game after receiving Typhoid and YFV in right arm, pt asked for a break. After 5 minutes she stated that she was ready to receive Hep A. Gave the vaccine and about 1 minute later she stated she felt dizzy. Gave her apple juice to drink. Reclined her chair more. She was pale but coherent. About another minute later her head turned to the left, she lost consciousness, eyes opened. Broke a smelling salt under her nose. She suddenly woke and was pale and confused. She stated she thought she might have died and was frightened and began to cry. She remained reclined for about 10 minutes, then sat for 10 minutes. Her color had returned to normal. When she stood she stated she felt steady and was ready to leave the office.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from nurse referring to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. Since 26-DEC-2016, the patients had been vaccinated with improperly stored doses (incorrect product storage) of PROQUAD (lot # M022401 with an expiration date in 01-NOV-2018), for prophylaxis (dose, dose number, route and frequency were not provided). The doses underwent a temperature excursion > -15 degrees Celsius but < -10 degrees Celsius with a time frame of 2 hours and 19 minutes. The digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008630: US-009507513-1702USA008629.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a student nurse practitioner concerning a 65 years old female patient. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL (strength, lot# and expiration date were unknown) for prophylaxis and completed the 3 vaccination series. It was unknown when the first and second doses were administered to the patient. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 14-APR-2008, 12-MAY-2008 and 08-DEC-2008, the patient was vaccinated with the first, second and third dose, respectively, of GARDASIL (lot# and expirations date were unknown) for prophylaxis. The nurse reported that on 01-FEB-2017, the patient was vaccinated with GARDASIL 9 lot# M034780, expiration date: 15-APR-2019) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a currently 64 year old male patient, reporting on himself. The patient did no have pertinent medical history. The patient's concurrent conditions included a drug reaction or allergy to amoxicillin, also reported as "immoxicilin". On 08-JAN-2016, the patient was vaccinated with ZOSTAVAX (dosage information and anatomical site of vaccination were not informed) (which had the lot # L006392, expiration date 25-MAY-2016) for prevention of shingles. There was no concomitant medication. On several unknown dates, the patient experienced "aches at the injection site". The patient contacted his physician, but did not receive treatment for the adverse event. The patient continued experiencing aches at the injection site. It was also reported that no laboratory tests were performed. There was no product quality complaint involved. At the time of reporting, the outcome of vaccination site pain was not recovered. The causality assessment between aches at the injection site and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9, lot number M018810 with expiration date 28-MAY-2018, and lot number M031557 with expiration date 01-APR-2019 (dose, route and anatomical location were not reported) for prophylaxis. On 03-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 9.5 hours in the first cycle; Also on these dates from 04-JAN-2017 to 06-JAN-2017; from 09-JAN-2017 to 11-JAN-2017, on 13-JAN-2017, from 16-JAN-2017 to 20-JAN-2017, from 23-JAN-2017 to 27-JAN-2017 and from 30-JAN-2017 to 31-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10 hours each day; all of them in the first cycle. In addition on 12-JAN-2017, the vaccines were exposed to temperature between 32 Fahrenheit (F) (0 Celsius (C)) to 36 F (2C) during 10.5 hours in the first cycle. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from nurse referring to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. Since 26-DEC-2016, the patients had been vaccinated with improperly stored doses (incorrect product storage) of VARIVAX (lot # M006157 with an expiration date in 05-FEB-2018), for prophylaxis (dose, dose number, route and frequency were not provided). The doses underwent a temperature excursion > -15 degrees Celsius but < -10 degrees Celsius with a time frame of 2 hours and 19 minutes. The digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA008630: US-009507513-1702USA001653:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. Since 26-DEC-2016, the patients had been vaccinated with improperly stored doses (incorrect product storage) of ZOSTAVAX (lot # M034766 with an expiration date in 26-OCT-2017), for prophylaxis (dose, dose number, route and frequency were not provided). The doses underwent a temperature excursion > -15 degrees Celsius but < -10 degrees Celsius with a time frame of 2 hours and 19 minutes. The digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA001653:  US-009507513-1702USA008629.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT REPORTED, VACCINE WAS EXPIRED ON 02/09/2017, WAS ADMINISTRED TO PT.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Fungal skin infection, Haematochezia, Oral fungal infection
Clinical narrative: He had a fever of 101.7 (on and off) for the next two days (from the 7th to the 8th). He had diarrhea and still has diarrhea now. He had a bloody stool from straining on 02/11/2017. He now has yeast (diaper rash) and in his mouth that we feel was perpetuated from possible the ROTO vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: He had a fever of 101.7 (on and off) for the next two days (from the 7th to the 8th). He had diarrhea and still has diarrhea now. He had a bloody stool from straining on 02/11/2017. He now has yeast (diaper rash) and in his mouth that we feel was perpetuated from possible the ROTO vaccine.
Age: 53.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: ARM PAIN WITH REDNESS.
Age: 54.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Incorrect immunization was given. Patient was given Tdap and was given KINRIX (DTaP and Polio combo).
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Balance disorder, Muscular weakness, Myalgia
Clinical narrative: Diffuse myalgias and muscle weakness. Pt had difficulty climbing stairs and felt like he might fall backwards. Towards end of his work day, his hands became too weak to manipulate instrument controls. Upon climbing into a van his legs felt weak and he had difficulty, and felt he might fall backwards. He did not receive any specific therapy. His symptoms gradually improved and had resolved (or nearly so) by 2/2/2017.
Age: 0.33
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site rash, Rash
Clinical narrative: Mom called stating rash started on abdomen and went down right leg.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Autism, Blood heavy metal test, Blood immunoglobulin G, Cytogenetic analysis, Cytomegalovirus test
Clinical narrative: High Fever, for following 3 days. Treated with MOTRIN, TYLENOL and baths.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Epstein-Barr virus antibody, Full blood count, Herpes simplex test, Human herpes virus 6 serology, Immunoglobulins
Clinical narrative: High Fever, for following 3 days. Treated with MOTRIN, TYLENOL and baths.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immunology test, Laboratory test, Measles antibody, Metabolic function test, Metal poisoning
Clinical narrative: High Fever, for following 3 days. Treated with MOTRIN, TYLENOL and baths.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Mumps antibody test, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Porphyrins urine, Pyrexia, Rubella antibody test
Clinical narrative: High Fever, for following 3 days. Treated with MOTRIN, TYLENOL and baths.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Streptococcus test, Viral test
Clinical narrative: High Fever, for following 3 days. Treated with MOTRIN, TYLENOL and baths.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure abnormal, Inflammation
Clinical narrative: Said arm was severely inflamed and continued for over 3 weeks (almost went to ER); says blood pressure is still now out of whack due to reaction.
Age: 99.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Peripheral swelling, Rash, Urticaria
Clinical narrative: Rash & welts over back, arms, legs, chest. Very swollen right hand and arm. .25 mg. BENADRYL shot, 3 days of prednisone 2/12. 5 days of 10mg. Prednisone prescribed 2/19.
Age: 99.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Rash & welts over back, arms, legs, chest. Very swollen right hand and arm. .25 mg. BENADRYL shot, 3 days of prednisone 2/12. 5 days of 10mg. Prednisone prescribed 2/19.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Erythema, hot, swollen
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Headache, swelling and pain at the injection site. Itching on back, under breast, chest and pox breakout on arm near armpits, face and neck.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypersensitivity, Rash, Swelling face, Urticaria
Clinical narrative: Severe allergic reaction - hives, rash, swelling of the face and dizziness. Started 10:30 AM on 02/10/2017 and is currently ongoing.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in arm at injection site. Pain persisted until 2/20/17. Pharmacy was informed of this reaction on 2/20/17. Pharmacy was unaware of this reaction until 2/20/17.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site pain, Pain in extremity
Clinical narrative: Patient reported pain at injection site which extended to whole arm. Developed chills, temperature up to 102.4 on the day after the injection. Symptom resolved by day #2 except for slight arm soreness.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: 02-03-17 Nausea - vomited early AM of 2-04-17. Severe pain below injection site on 2-4-17 with swelling and redness. Swelling and redness worsened over next 2 days - then slowly receded. Involved my whole upper arm down to elbow.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis, Injection site infection, Local reaction
Clinical narrative: Large local reaction vs secondary infection (cellulitis) at (L) thigh injection site (DTaP and IPV) 3 days prior. Patient treated with BENADRYL and cephalexin.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Sensory loss
Clinical narrative: Dead arm, numb, tingly, unable to raise/lift, push up, carry, etc. Treatment - MRI showed shot went into bone. Cortisone shot and physical therapy. Follow up to be determined.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Skeletal injury
Clinical narrative: Dead arm, numb, tingly, unable to raise/lift, push up, carry, etc. Treatment - MRI showed shot went into bone. Cortisone shot and physical therapy. Follow up to be determined.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Ligament rupture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema peripheral
Clinical narrative: Arm edema, erythema extending from injection site in deltoid distally beyond elbow.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever morning after vaccines received.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Nerve conduction studies
Clinical narrative: No feeling in feet and ankles in May 2016, referred to Dr. in December 2016. Diagnosed with CIDP and started treatment with GAMUNEX-C.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site discharge, Peripheral swelling
Clinical narrative: Patient had an allergic reaction to vaccine. Redness on arm and swelling. Also secretion from injection site.
Age: 7.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: none
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Abnormal sensation in eye, Burning sensation, Hypoaesthesia, Male sexual dysfunction, Pain in extremity
Clinical narrative: None stated.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Paraesthesia
Clinical narrative: None stated.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury, Nuclear magnetic resonance imaging
Clinical narrative: SIRVA. MRI, CSI, PT.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5 cm diameter erythematous, warm, raised area over Left deltoid where DTaP was given.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not provided. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lots # K026532 exp date 06-MAY-2017, L042257 exp date 17-AUG-2018, M001811 exp date 04-NOV-2018 and M020101 exp date 07-MAR-2019) (dose and route not reported) for prophylaxis. The vaccines were exposed to 33.8 Fahrenheit degrees for 1 hour 25 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. As of 06-FEB-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001950: US-009507513-1612USA001951: US-009507513-1612USA001952: US-009507513-1611USA009104.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not provided. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lots # L011846 exp date 16-JUN-2017, L026602 exp date 19-OCT-2017 and L036301 exp date 20-DEC-2017 (dose and route not reported) for prophylaxis. The vaccines were exposed to 33.8 Fahrenheit degrees for 1 hour 25 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. As of 06-FEB-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001949: US-009507513-1612USA001951: US-009507513-1612USA001952: US-009507513-1611USA009104.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not provided. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lots # L045117 exp date 06-OCT-2018 and M010212 exp date 21-JAN-2019) (dose and route not reported) for prophylaxis. The vaccines were exposed to 33.8 Fahrenheit degrees for 1 hour 25 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. As of 06-FEB-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001949: US-009507513-1612USA001950: US-009507513-1612USA001952: US-009507513-1611USA009104.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not provided. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of VAQTA injection (lots # K018181 exp date 04-JUN-2017, M009377 exp date 17-JUN-2017 and L015460 exp date 20-JUL-2017) (dose and route not reported) for prophylaxis. The vaccines were exposed to 33.8 Fahrenheit degrees for 1 hour 25 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. No adverse experiences were reported. As of 06-FEB-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001949: US-009507513-1612USA001950: US-009507513-1612USA001951: US-009507513-1611USA009104.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Anxiety, Crying, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17-year-old non-pregnant female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-OCT-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided), for prevention of cervical cancer, and with a dose of an unspecified influenza virus vaccine. On approximately 04-OCT-2014 (reported as "3 or 4 days after administration"), the patient experienced diarrhoea, that lasted for 1 day. On an unknown date, a few months after the vaccination, the patient was feeling anxious, tired and was crying more often. The symptoms lasted for 1 year. Additionally, on an unknown date, the patient experienced flu-like symptoms and she did not feel very well for a few months. Since an unknown date, she had also personality changes. The patient recovered from diarrhoea (on approximately 05-OCT-2014), personality changes, tiredness, not feeling very well, anxiety and crying on unknown dates. The outcome of flu-like symptoms was not reported. The relatedness between all adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Malaise, Personality change
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17-year-old non-pregnant female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-OCT-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided), for prevention of cervical cancer, and with a dose of an unspecified influenza virus vaccine. On approximately 04-OCT-2014 (reported as "3 or 4 days after administration"), the patient experienced diarrhoea, that lasted for 1 day. On an unknown date, a few months after the vaccination, the patient was feeling anxious, tired and was crying more often. The symptoms lasted for 1 year. Additionally, on an unknown date, the patient experienced flu-like symptoms and she did not feel very well for a few months. Since an unknown date, she had also personality changes. The patient recovered from diarrhoea (on approximately 05-OCT-2014), personality changes, tiredness, not feeling very well, anxiety and crying on unknown dates. The outcome of flu-like symptoms was not reported. The relatedness between all adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Anxiety, Crying, Diarrhoea, Dizziness, Fatigue
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17-year-old non-pregnant female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-OCT-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided), for prevention of cervical cancer, and with a dose of an unspecified influenza virus vaccine. On approximately 04-OCT-2014 (reported as "3 or 4 days after administration"), the patient experienced diarrhoea, that lasted for 1 day. On an unknown date, a few months after the vaccination, the patient was feeling anxious, tired and was crying more often. The symptoms lasted for 1 year. Additionally, on an unknown date, the patient experienced flu-like symptoms and she did not feel very well for a few months. Since an unknown date, she had also personality changes. The patient recovered from diarrhoea (on approximately 05-OCT-2014), personality changes, tiredness, not feeling very well, anxiety and crying on unknown dates. The outcome of flu-like symptoms was not reported. The relatedness between all adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Influenza like illness, Personality change
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17-year-old non-pregnant female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 01-OCT-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided), for prevention of cervical cancer, and with a dose of an unspecified influenza virus vaccine. On approximately 04-OCT-2014 (reported as "3 or 4 days after administration"), the patient experienced diarrhoea, that lasted for 1 day. On an unknown date, a few months after the vaccination, the patient was feeling anxious, tired and was crying more often. The symptoms lasted for 1 year. Additionally, on an unknown date, the patient experienced flu-like symptoms and she did not feel very well for a few months. Since an unknown date, she had also personality changes. The patient recovered from diarrhoea (on approximately 05-OCT-2014), personality changes, tiredness, not feeling very well, anxiety and crying on unknown dates. The outcome of flu-like symptoms was not reported. The relatedness between all adverse events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to unspecified patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medications. On unknown dates, the patients were vaccinated with improperly storage doses of RECOMBIVAX HB lot # L048848 with expiration date of 09-AUG-2018,or lot number reported as L01642 with expiration date of 13-APR-2017 (route of administration and anatomical location were not reported) for prophylaxis, which was stored at a lowest recorded temperature of 32 Fahrenheit (0 Celsius) and a highest temperature of temperature of 36  Fahrenheit (2.2 Celsius) for 34 days, the entire 24 hours each day, and a lowest recorded temperature of 46 Fahrenheit (7.7 Celsius) and a highest of 77 Fahrenheit (25 Celsius) for 24 hours. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002769: US--009507513-1701USA012928: US--009507513-1702USA002768.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M007960, expiration date 05-AUG-2017) for prophylaxis (dose and route of administration were not reported). The vaccine was stored at >5°Fahrenheit, but <14°Fahrenheit for 10 minutes. There were no previous temperature excursions. No adverse effects were reported. Temperature excursion information was obtained from a digital data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008690: US-009507513-1702USA008691.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient might have been vaccinated with a dose of improperly stored ROTATEQ lot # M038728, expiration date 25-APR-2018 oral for prophylaxis, VAQTA lot # reported as M038572, expiration date 11-MAR-2018, GARDASIL 9 lot # M0347890, expiration date 15-APR-2019 or PNEUMOVAX 23 lot # M022086, expiration date 09-OCT-2017. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 2 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray normal, Dyspnoea, Malaise, Myalgia, Pain
Clinical narrative: Information has been received from a 71 year old male patient reporting on himself. The patient had no medical history, his drug reactions/allergies included allergy to gabapentin and his concomitant medications included unspecified "blood thinner", unspecified inhaler and ZOCOR. On 16-JAN-2017, the patient was vaccinated with PNEUMOVAX23 (dose, strength, lot# and expiration date were not provided), subcutaneously, for prevention of pneumococcal disease.  The vaccine was administered by a pharmacist through the band aid (product use issue). On the same day, about three hours after receiving the vaccine, the patient experienced soreness and extreme pain and swelling of the arm. The patient stated that he started having trouble breathing therefore, he went to a hospital and was treated by a physician. He was treated with unspecified intravenous steroid and also received unspecified "breathing treatment". The patient was put on prednisone twice since receiving the vaccine. He had also been diagnosed with a respiratory infection. An X-ray was done to determine if the patient had pneumonia however the results were negative. At the time of reporting the patient was still sick and had not recovered.  The causality assessment between PNEUMOVAX23 and the adverse events was not provided. The reporter considered the event of trouble breathing to be life threatening and the event of respiratory infection to be medically significant. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Product use issue, Respiratory tract infection, Wrong technique in product usage process
Clinical narrative: Information has been received from a 71 year old male patient reporting on himself. The patient had no medical history, his drug reactions/allergies included allergy to gabapentin and his concomitant medications included unspecified "blood thinner", unspecified inhaler and ZOCOR. On 16-JAN-2017, the patient was vaccinated with PNEUMOVAX23 (dose, strength, lot# and expiration date were not provided), subcutaneously, for prevention of pneumococcal disease.  The vaccine was administered by a pharmacist through the band aid (product use issue). On the same day, about three hours after receiving the vaccine, the patient experienced soreness and extreme pain and swelling of the arm. The patient stated that he started having trouble breathing therefore, he went to a hospital and was treated by a physician. He was treated with unspecified intravenous steroid and also received unspecified "breathing treatment". The patient was put on prednisone twice since receiving the vaccine. He had also been diagnosed with a respiratory infection. An X-ray was done to determine if the patient had pneumonia however the results were negative. At the time of reporting the patient was still sick and had not recovered.  The causality assessment between PNEUMOVAX23 and the adverse events was not provided. The reporter considered the event of trouble breathing to be life threatening and the event of respiratory infection to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 16-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # reported as M000768 expiration date: 05-JAN-2018 or lot # reported as L033589, expiration date: 02-SEP-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 12.6 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M000997, expiration date 07-JAN-2018) for prophylaxis (dose and route of administration were not reported). The vaccine was stored at >5°Fahrenheit, but <14°Fahrenheit for 10 minutes. There were no previous temperature excursions. No adverse effects were reported. Temperature excursion information was obtained from a digital data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008691: US-009507513-1702USA002833.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with five improperly stored doses of ROTATEQ (lot # M031650, expiration date 16-MAR-2018) for prophylaxis (dose and route of administration were not reported). The vaccine was stored between 32°Fahrenheit and 36°Fahrenheit for 40 minutes. There were no previous temperature excursions. No adverse effects were reported. Temperature excursion information was obtained from a digital data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002833: US-009507513-1702USA008690.
Age: 71.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, Swelling, Soreness, Warmth to touch.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Neck pain, Pain in extremity, X-ray
Clinical narrative: Within 15 minutes of injection developed severe pain in area of injection. Next day (11/4/16) arm from neck to fingers was in pain. Two different courses of oral cortisone followed by injection of cortisone over the next month. No relief.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. The administered doses of GARDASIL 9 underwent a temperature excursion at 30 degrees Fahrenheit for 14 days. There were no previous temperature excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Follow-up information has been received on 27-JAN-2017. A call was placed to the certified medical assistant. The call went directly to voicemail. A message was left requesting a return call. Additionally, a request was made for the patients' identifiers, lot number, expiration dates, and dates of vaccination. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1611USA010344: US-009507513-1611USA003050: MERCK 1611USA010343:Mfr number.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic, Varicella
Clinical narrative: This spontaneous report has been received from a physician via a company representative, referring to a male patient on his 50's. Information regarding medical history drug reactions, allergies and concomitant therapies was unknown by the reporter.  On an unknown date, the patient was vaccinated with ZOSTAVAX  (strength, dose, frequency, route of administration, (reported as injection), lot# and expiration date were not provided) to prevent shingles. On an unknown date, "reported as 2 weeks later", the patient developed a bad case of chickenpox, which was confirmed by the physician  because the itchy rash was "everywhere on his body, including hands, feet, head, face and neck". It was unknown by the physician if the patient received treatment or if laboratory diagnostics studies were performed. At the time of reporting, the outcome of chickenpox was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.