chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity, Palpitations, Paraesthesia, Pharyngeal oedema
Clinical narrative: Several minutes after vaccine, I began to feel warmth and swelling in the back of my throat and tongue, and heat down the from of my chest, as well as tenderness. I had a little heart racing, and some minor trouble breathing. I emailed my doctor at 12:30 PM. Some pressure in chest. Took a nap, and woke at 3:30 PM with tingling in hands and fingers. Called doctor. Left a message. Call was returned around 4 PM. Was having tingling in face, stiff neck. Sore arm, left shoulder but not red. She told me my doctor had left and to file this report and that I would probably feel better but would never get this "acella"? dosage again.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Swollen tongue, Tenderness
Clinical narrative: Several minutes after vaccine, I began to feel warmth and swelling in the back of my throat and tongue, and heat down the from of my chest, as well as tenderness. I had a little heart racing, and some minor trouble breathing. I emailed my doctor at 12:30 PM. Some pressure in chest. Took a nap, and woke at 3:30 PM with tingling in hands and fingers. Called doctor. Left a message. Call was returned around 4 PM. Was having tingling in face, stiff neck. Sore arm, left shoulder but not red. She told me my doctor had left and to file this report and that I would probably feel better but would never get this "acella"? dosage again.
Age: 0.46
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Agitation, Dyspnoea, Hypercapnia, Mechanical ventilation, Oxygen consumption increased
Clinical narrative: Hypercarbia, increased work of breathing, retractions, increased oxygen needs, and ventilatory needs, agitation.
Age: 0.46
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Use of accessory respiratory muscles
Clinical narrative: Hypercarbia, increased work of breathing, retractions, increased oxygen needs, and ventilatory needs, agitation.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cochlea implant, Deafness, Hypoacusis
Clinical narrative: Sounds started sounding muffled and then the next day I was completely deaf.  I went to Hearing Specialist that Monday and they sent me to facility that next week and I received cortisone shot in ear drum and it did not help. I now have a cochlear implant.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Deafness, Hypoacusis
Clinical narrative: Sounds started sounding muffled and then the next day I was completely deaf.  I went to Hearing Specialist that Monday and they sent me to facility that next week and I received cortisone shot in ear drum and it did not help. I now have a cochlear implant.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Redness, heat at site, body aches, fever, fatigue.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 12.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of red welt at injection site in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 11 January 2013 at 15:30 the subject received unspecified dose of INFANRIX (.5 ml, unknown, left deltoid). On 25 January 2013, 14 days after vaccination with INFANRIX, the subject experienced red welt at injection site, injection site hives and injection site pruritus. The subject developed red welts, hive and itching at local injection site. The father of the subject stated he panned to follow-up with the subject's physician and have an evaluation with an allergist on 30 May 2013. At the time of reporting the red welt at injection site, injection site hives and injection site pruritus were improved.
Age: 0.85
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.55
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.49
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.21
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listen in item 13.
Age: 0.54
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. Per the medical assistant, the subject was evaluated by the doctor. At the time of reporting the outcome of the events were unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060686A, A1060686A, A1060686A and A1060686A for details on the other cases.
Age: 0.32
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 7.0
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of fever in a 2-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 1 November 2013 the subject received 1st dose of INFANRIX (unknown). The lot number was reported as "21534", base on lot number review the lot number was updated to 2J534. On 1 November 2013, within hours of vaccination with INFANRIX, the subject experienced fever greater than 100 degrees. On 2 November 2013, the fever was received. It was reported that the physician intends to complete the INFANRIX vaccination series. The sales representative reported another case on behalf of the physician with PEDIARIX, please see A1049742A.
Age: 0.36
Sex: F
Vaccine: DTP, IPV
Symptoms: Crying, Discomfort, Hypersensitivity
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of unusual crying in a 4-month-old female subject who was vaccinated with DTP vaccine (A or W not known) (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included umbilical cord infection. Relevant medical history included an infection of the umbilical cord when the subject was 10 days old. The infection was treated with an antibiotic; however, the subject's mother does not know the name of the antibiotic. Concurrent vaccination included poliomyelitis vaccine (described as "OPVIPV1"), unspecified; manufacturer unspecified; unknown given on 3 March 1989. Per the subject's mother, there were no concomitant medications at the time of vaccination. There were no adverse events to previous vaccinations. On 3 March 1989 the subject received 1st dose of DTP vaccine (unknown details). The DTP vaccine was described as "DTP1 vaccine." The mother was unsure of the manufacturer of the DTP1 vaccine but the other siblings received "DTP1 vaccine" from Conna. On 3 March 1989, less than one day after vaccination with DTP vaccine (described as "after the shot"), the subject experienced unusual crying (described as a "high pitch whine") and discomfort (described as "uncomfortable"). The mother described the events as "an allergic reaction." The subject was treated with TYLENOL and, per the mother, the "symptoms resolved shortly after that." At the time of reporting the events were resolved. Per the mother of the subject, the DTP vaccine series was discontinued. Follow up was received from the consumer (subject's mother) on 25 October 2013. Per the mother, the subject decided to receive a Tdap vaccine and "had no side effect or complication."
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Severe swelling of left upper extremity.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Muscle twitching, Musculoskeletal stiffness, Pyrexia, Seizure like phenomena
Clinical narrative: About 4 hours following DTAP administration patient developed 103 fever with "seizure-like" movements for 3 nights (per mom). Pt never evaluated by medical provider for episode. Arms and legs would "stiffen and twitch" at nighttime when fever was highest. Fever persisted for 3 days, but "seizure-like movements" only at nighttime.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain of left upper arm. Seen in office. Resolved on its own.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Vaccination site induration
Clinical narrative: Red, hard area noted to vaccination site, measures 4 x 3 cm. Seen in office 5/21/14.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The certified medical assistant (CMA) reported that the following improperly stored doses of vaccines administered to 3 patients on unspecified date: 3 doses of LIQUID PEDVAXHIB (dose, route, lot# not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discolouration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came back 5/20/14 with swollen, warm, tender injection site accompanied by pain and headache, site was a light purple about 3 inches long. No fever or chills.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: 4.2 by 6.4cm cellulitis and redness to Rt upper arm after a few hours of getting the vaccine. Pt was given a script for DURICEF caps 500mg 1 cap PO BID x 10 days.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.27
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.83
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 13.
Age: 0.16
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.62
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.51
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine (s) listed in item 3.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.36
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.03
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.22
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The certified medical assistant (CMA) reported that the following improperly stored doses of vaccines were administered to 5 patients on unspecified dates: 5 doses of GARDASIL (dose, route, lot# not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The certified medical assistant (CMA) reported that the following improperly stored doses of vaccines were administered to 4 patients on unspecified dates: 4 doses of RECOMBIVAX HB (dose, route, lot# not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to  22 year old female patient who was 34 weeks pregnant at reporting time. There were no pertinent medical history or drug reactions/allergies. The last menstrual period (LMP) was approximately on 11-SEP-2013. On approximately 05-MAR-2014 the patient was inadvertently vaccinated with her first dose GARDASIL lot # J011272, expire date 21-APR-2016, (dose, route not provided) for immunization at 25 week gestation. Concomitant therapy included prenatal vitamins. The patient did not seek medical attention. The pregnancy outcome was unknown. Action taken with GARDASIL was not reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's medical history and drug reactions were not reported. On 09-APR-2013 the 11 year old patient was vaccinated with a dose of ZOSTAVAX (lot# H010447 as reported is an invalid lot number for zoster vaccine live) (expiration date, dose, route were unknown). Other concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two healthcare workers refers to unspecified patients of unknown age. On 05-MAY-2014 between 8:50 a.m and 9:10 a.m, unspecified patients were vaccinated with VAQTA (strength, dose, route unknown, lot# J01135, expiration date 10-MAR-2016). It was reported that the patients received improperly stored VAQTA, it was exposed to 26.2F for 5.5 hours. One reporter reported that they believed the VAQTA was in recommended storage temperature when removed from refrigerator and administered, but they were not 100% certain so they included the products in the excursion information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two healthcare workers refers to unspecified patients of unknown age. On 05-MAY-2014 between 8:50 a.m and 9:10 a.m, unspecified patients were vaccinated with ROTATEQ (strength, dose, lot#, expiration date were unknown) oral. It was reported that the patients received improperly stored ROTATEQ, it was exposed to 26.2F for 5.5 hours. One reporter reported that they believed the ROTATEQ was in recommended storage temperature when removed from refrigerator and administered, but they were not 100% certain so they included the products in the excursion information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.51
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.47
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.4
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.09
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.85
Sex: F
Vaccine: IPV
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.19
Sex: M
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions or allergies. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011828, expiry date 26-DEC-2014, 0.65 ml, subcutaneous (anatomical location not specified). Concomitant therapies included CYMBALTA and HEATHER. On approximately 01-APR-2014, reported as 24 hours after injection, the patient called the pharmacy to report that she experienced itching, redness and pain at the injection site. The patient reported that the itching, redness and pain had spread to her elbow and she was seen in the ER of an unspecified hospital, but was not admitted. An unspecified ER physician diagnosed her with an allergic reaction and possible cellulitis. The patient was given BENADRYL OTC, prednisone and an unspecified steroid injection and was prescribed KEFLEX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Follow up information has been received from the pharmacist via questionnaire concerning the patient who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # K000726, expiration date 09-JAN-2015) (previously reported as lot # J011828) SQ. The pharmacist reported that on 31-MAR-2014, several hours after vaccination, the patient experienced rash on injection site. The patient was advised to take BENADRYL. The next day on 01-APR-2014, rash continued to spread along length of arm, with current swelling. The patient worked at a hospital, her colleagues told her to have an ER doctor examine. The patient was diagnosed with cellulitis. The patient was prescribed antibiotics and steroids. Took over a week for cellulitis to clear. Rash soon disappeared as well. At the time of the report, the patient was well with no injuring side effects. Cellulitis was considered to be medically significant by the pharmacist. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions or allergies. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011828, expiry date 26-DEC-2014, 0.65 ml, subcutaneous (anatomical location not specified). Concomitant therapies included CYMBALTA and HEATHER. On approximately 01-APR-2014, reported as 24 hours after injection, the patient called the pharmacy to report that she experienced itching, redness and pain at the injection site. The patient reported that the itching, redness and pain had spread to her elbow and she was seen in the ER of an unspecified hospital, but was not admitted. An unspecified ER physician diagnosed her with an allergic reaction and possible cellulitis. The patient was given BENADRYL OTC, prednisone and an unspecified steroid injection and was prescribed KEFLEX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Follow up information has been received from the pharmacist via questionnaire concerning the patient who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # K000726, expiration date 09-JAN-2015) (previously reported as lot # J011828) SQ. The pharmacist reported that on 31-MAR-2014, several hours after vaccination, the patient experienced rash on injection site. The patient was advised to take BENADRYL. The next day on 01-APR-2014, rash continued to spread along length of arm, with current swelling. The patient worked at a hospital, her colleagues told her to have an ER doctor examine. The patient was diagnosed with cellulitis. The patient was prescribed antibiotics and steroids. Took over a week for cellulitis to clear. Rash soon disappeared as well. At the time of the report, the patient was well with no injuring side effects. Cellulitis was considered to be medically significant by the pharmacist. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions or allergies. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011828, expiry date 26-DEC-2014, 0.65 ml, subcutaneous (anatomical location not specified). Concomitant therapies included CYMBALTA and HEATHER. On approximately 01-APR-2014, reported as 24 hours after injection, the patient called the pharmacy to report that she experienced itching, redness and pain at the injection site. The patient reported that the itching, redness and pain had spread to her elbow and she was seen in the ER of an unspecified hospital, but was not admitted. An unspecified ER physician diagnosed her with an allergic reaction and possible cellulitis. The patient was given BENADRYL OTC, prednisone and an unspecified steroid injection and was prescribed KEFLEX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Follow up information has been received from the pharmacist via questionnaire concerning the patient who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # K000726, expiration date 09-JAN-2015) (previously reported as lot # J011828) SQ. The pharmacist reported that on 31-MAR-2014, several hours after vaccination, the patient experienced rash on injection site. The patient was advised to take BENADRYL. The next day on 01-APR-2014, rash continued to spread along length of arm, with current swelling. The patient worked at a hospital, her colleagues told her to have an ER doctor examine. The patient was diagnosed with cellulitis. The patient was prescribed antibiotics and steroids. Took over a week for cellulitis to clear. Rash soon disappeared as well. At the time of the report, the patient was well with no injuring side effects. Cellulitis was considered to be medically significant by the pharmacist. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Atrial septal defect, Attention deficit/hyperactivity disorder, Intermittent explosive disorder, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: Patient developed tics that never went away.  His behavior dramatically declined shortly after receiving his flu shot.  He's currently living in a residential setting.  His dx include ASD, ADHD, intermittent explosive disorder, Tourette's, pANDAS.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Tic, Tourette's disorder
Clinical narrative: Patient developed tics that never went away.  His behavior dramatically declined shortly after receiving his flu shot.  He's currently living in a residential setting.  His dx include ASD, ADHD, intermittent explosive disorder, Tourette's, pANDAS.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Swelling, Tenderness
Clinical narrative: Day #1&2: severe pain & swelling, unable to use affected arm. Day #3&4: continued severe pain, swelling, tenderness PLUS hives & redness of entire upper arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Day #1&2: severe pain & swelling, unable to use affected arm. Day #3&4: continued severe pain, swelling, tenderness PLUS hives & redness of entire upper arm.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Balance disorder, Coordination abnormal, Nuclear magnetic resonance imaging abnormal, Speech disorder, Spinocerebellar ataxia
Clinical narrative: Started to feel unbalanced, trouble with coordination and speaking.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Nausea, Pyrexia, Vertigo, Vomiting
Clinical narrative: After receiving vaccine at 4 PM, arrived home at 6:00 PM and developed nausea and mild vertigo. Ate a small dinner and went to bed. Slept well. In the morning around 8:30 AM had 2 episodes of vomiting and 1 bout of loose stools. Low grade fever 100. I spoke with patient at 11:00 AM and she is improving. I recommended to increase fluids and seek medical treatment if symptoms do not resolve over the course of today or worsen.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: She developed Guillain-Barre Syndrome. Numbness and tingling in arms and legs followed by loss of reflexes.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Pain in extremity
Clinical narrative: Employee states two days after Hepatitis B shot, she had a headache and her blood pressure was 140/108. She states that is better, but her arm remains sore. Sent to facility to be seen by MD.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Blood test normal, Diarrhoea, Dysuria, Gastroenteritis
Clinical narrative: The morning after receiving his MMR vaccine, my son started having diarrhea. The following day he had a lot of diarrhea and stomach pain with the diarrhea and said it hurt when he urinated. I took him back to the dr and dr said the diarrhea was likely a stomach bug. Dr did a urine test because of the pain with urination and a slight amount of red blood cells showed up in his urine. After about 4 days, thankfully, the diarrhea and stomach cramps stopped. Several days after that, my son got strep throat which was treated with antibiotics. We went back to dr 2 weeks after the first urine test to have my son's urine retested, and it still had some red blood cells in it. Also, his strep throat infection came back and he is now on a different antibiotic. (I'm aware that the strep throat has nothing to do with the MMR, other than that the vaccine may have temporarily lowered his immunity). The dr ordered a standard blood test because of the continued red blood cells in urine, and I just got a call back from the dr that his blood tests all came back normal! I'm so relieved!! Now we just have to go in for a follow up urine test in 2 weeks to see to check again for red blood cells in his urine. This may all be a coincidence but I am reporting it to you in case it is related to the vaccine.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Pharyngitis streptococcal, Red blood cells urine positive
Clinical narrative: The morning after receiving his MMR vaccine, my son started having diarrhea. The following day he had a lot of diarrhea and stomach pain with the diarrhea and said it hurt when he urinated. I took him back to the dr and dr said the diarrhea was likely a stomach bug. Dr did a urine test because of the pain with urination and a slight amount of red blood cells showed up in his urine. After about 4 days, thankfully, the diarrhea and stomach cramps stopped. Several days after that, my son got strep throat which was treated with antibiotics. We went back to dr 2 weeks after the first urine test to have my son's urine retested, and it still had some red blood cells in it. Also, his strep throat infection came back and he is now on a different antibiotic. (I'm aware that the strep throat has nothing to do with the MMR, other than that the vaccine may have temporarily lowered his immunity). The dr ordered a standard blood test because of the continued red blood cells in urine, and I just got a call back from the dr that his blood tests all came back normal! I'm so relieved!! Now we just have to go in for a follow up urine test in 2 weeks to see to check again for red blood cells in his urine. This may all be a coincidence but I am reporting it to you in case it is related to the vaccine.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Headache, Insomnia, Miliaria, Vomiting
Clinical narrative: A report from a consumer via MHRA concerns a male patient of unknown age. Concomitant medications included dihydrocodeine, paracetamol, and sertraline. The patient received an unspecified influenza virus vaccine (without reported manufacturer, brand name, route of administration, or batch identifier) and Pneumococcal polysaccharide vaccine during 2013. On the same day that he received these vaccinations he experienced headache and vomiting. Patient went to doctors the following day and was sent to hospital and spent 4 days there. All symptoms occur every 2 weeks. The day after the vaccinations, he developed diarrhea, difficulty sleeping, and sweat rash. Felt like an infection. At the time of reporting, diarrhoea, difficulty sleeping, sweat rash, vomiting, and headache were ongoing. Reporter considered the events to be serious based on hospitalization and as important medical events.
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Fear of injection, Injection site movement impairment, Injection site nerve damage, Injection site pain
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 13 February 2014 the subject received a dose of BOOSTRIX (unknown). Within months of vaccination with BOOSTRIX, the subject experienced adverse event. At the time of reporting the outcome of the event was unspecified. No other information was provided. The lot number was reported as "YJ4575" from the reporter; however, based on a safety lot number review, the lot number was updated to YJ475. Follow up was received from consumer (patient) on 16 May 2014. The patient reported that in February 2014, within a month after vaccination with BOOSTRIX, she experienced injection site nerve damage and injection site reaction (described as "hurt my nerves or bone"), arm pain at injection site (described as "terrible pain in the arm where administered"), injection site movement impairment (described as "range of motion in the arm is still affected" and "cannot move it as freely as the unaffected arm"), fear of injection, vaccine administered at inappropriate site (described as "administered the vaccine incorrectly in wrong place"), and wrong injection technique (described as "technician did something wrong"). At the time of reporting, injection site nerve damage, injection site reaction, arm pain at injection site, and fear of injection were unresolved. At the time of reporting, injection site movement impairment was improved. The patient reported "that she is not certain whether her doctor wants to get involved. She did see her doctor for what she thought was a reaction to the vaccine (terrible pain in the arm where administered, could not move the arm after the shot) and the doctor told her this was not a reaction, the doctor and the patient believe the technician at (the pharmacy) administered the vaccine incorrectly 'in wrong place, hurt my nerves or bone or something.' She still has arm pain since February 2014. She believes the manager of the (pharmacy) reported this to GSK as a problem with the vaccine but the patient reports she is 90 percent certain the pharmacy technician did something wrong. The patient also reports that her range of motion in the arm is still affected, she cannot move it as freely as the unaffected arm. The patient will not use BOOSTRIX in the future because she states she now has a fear of the administration" (fear of injection). The follow up was faxed to legal.
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Wrong technique in drug usage process
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 13 February 2014 the subject received a dose of BOOSTRIX (unknown). Within months of vaccination with BOOSTRIX, the subject experienced adverse event. At the time of reporting the outcome of the event was unspecified. No other information was provided. The lot number was reported as "YJ4575" from the reporter; however, based on a safety lot number review, the lot number was updated to YJ475. Follow up was received from consumer (patient) on 16 May 2014. The patient reported that in February 2014, within a month after vaccination with BOOSTRIX, she experienced injection site nerve damage and injection site reaction (described as "hurt my nerves or bone"), arm pain at injection site (described as "terrible pain in the arm where administered"), injection site movement impairment (described as "range of motion in the arm is still affected" and "cannot move it as freely as the unaffected arm"), fear of injection, vaccine administered at inappropriate site (described as "administered the vaccine incorrectly in wrong place"), and wrong injection technique (described as "technician did something wrong"). At the time of reporting, injection site nerve damage, injection site reaction, arm pain at injection site, and fear of injection were unresolved. At the time of reporting, injection site movement impairment was improved. The patient reported "that she is not certain whether her doctor wants to get involved. She did see her doctor for what she thought was a reaction to the vaccine (terrible pain in the arm where administered, could not move the arm after the shot) and the doctor told her this was not a reaction, the doctor and the patient believe the technician at (the pharmacy) administered the vaccine incorrectly 'in wrong place, hurt my nerves or bone or something.' She still has arm pain since February 2014. She believes the manager of the (pharmacy) reported this to GSK as a problem with the vaccine but the patient reports she is 90 percent certain the pharmacy technician did something wrong. The patient also reports that her range of motion in the arm is still affected, she cannot move it as freely as the unaffected arm. The patient will not use BOOSTRIX in the future because she states she now has a fear of the administration" (fear of injection). The follow up was faxed to legal.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Arthralgia, Arthritis, Bursitis, Dysstasia
Clinical narrative: FEVER 104 SUSTAINED. BODY ACHE, FATIGUE, INVOLUNTARY LEG MUSCLE CONTRACTIONS, JOINT PAIN, HEADACHE, INABILITY TO WALK AND REMAIN STANDING.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Headache, Inflammation, Muscle contractions involuntary, Orchitis noninfective
Clinical narrative: FEVER 104 SUSTAINED. BODY ACHE, FATIGUE, INVOLUNTARY LEG MUSCLE CONTRACTIONS, JOINT PAIN, HEADACHE, INABILITY TO WALK AND REMAIN STANDING.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Rash generalised
Clinical narrative: FEVER 104 SUSTAINED. BODY ACHE, FATIGUE, INVOLUNTARY LEG MUSCLE CONTRACTIONS, JOINT PAIN, HEADACHE, INABILITY TO WALK AND REMAIN STANDING.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: From office note 11/14/2011: "complaining of a rash on his left arm and pain extending from his neck down his left arm down into the base of his thumb" "Left upper arm shows vesicles grouped on an erythematous base consistent with C6 dermatome." Treated with acyclovir 800 mg 5 times a day for 5 days.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Rash
Clinical narrative: From office note 11/14/2011: "complaining of a rash on his left arm and pain extending from his neck down his left arm down into the base of his thumb" "Left upper arm shows vesicles grouped on an erythematous base consistent with C6 dermatome." Treated with acyclovir 800 mg 5 times a day for 5 days.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist via filed representative refers to a male patient of unknown age who was also a physician. on unspecified date in April 2014, "about one month ago", the patient was vaccinated with a dose of ZOSTAVAX (injection, strength, lot#, dose, route and duration were unspecified. On an unspecified date in 2014 the patient developed cellulitis at injection site. Patient had sought unspecified medical attention. He was treated with unspecified antibiotic therapy. Unknown of event resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse via a field employee refers to two patients of unknown ages and genders. On unknown dates the patients were vaccinated with the second or third dose of GARDASIL (lot#, dose and route not reported). The nurse reported that 2 patients experienced arm pain at the injection site for 2 weeks duration, after receiving the second or third dose of GARDASIL. These patients received the same lot number of GARDASIL, but the actual lot number was unspecified. The outcome of arm pain at the injection site was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 17 unspecified patients of unknown demography. On an unknown date, the 17 unspecified patients received improperly stored (Oka/Merck) VARIVAX (dose, route and frequency were not reported) exposed up to 6F for a total of 5 day period which started on 13-MAR-2014. No adverse effect reported. No further information was provided. Additional information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from physician via field representative refers to a 60 years old female patient. On 11-NOV-2013, the patient was vaccinated with ZOSTAVAX 19400 plaque units (PFU) (strength, dose, frequency and route of administration were not provided) for age. No concomitant medications were reported. On 12-NOV-2013, the patient developed a shingles like rash around the injection site where ZOSTAVAX was administered and a red welt around the injection site. Physician reported the patient had streaking and associated redness. Patient sought medical attention due to office visit. Unspecified antihistamine, doxycycline was given for adverse events. No product quality complaint (PQC) was involved. On 19-NOV-2013, the outcome of events was resolved. Causality was not reported. VZV (Varicella zoster virus) packet was mailed. No further information provided. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 51 years old male patient. Pertinent medical history included chronic obstructive pulmonary disease (COPD), smoker and asthma. On 15-NOV-2011, the patient was vaccinated with PNEUMOVAX23 (strength, dose, frequency and route of administration were not provided) for high risk patient. No concomitant medications were reported. On 17-NOV-2011, the patient developed an area around the injection site where PNEUMOVAX23 was administered that was red, tender and hot to touch. Physician mentioned the patient had streaking down the arm. Patient sought medical attention due to office visit. Unspecified antihistamine, KEFLEX was given for adverse events. No product quality complaint (PQC) was involved. On 21-NOV-2011, the outcome of events was resolved. Causality was not reported. NO further information provided. Additional information has been requested.
Age: 0.23
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. This case is linked to case 1404USA014115 (sibling). On 21-JAN-1999, the patient was vaccinated with their first dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided). On 24-FEB-1999, the patients were vaccinated with their second dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided) in another facility. The registered nurse had no access to those lot numbers. No co-suspect or concomitant therapies were reported. The nurse reported that, on an unknown date in 2005, the patient had negative (not immune) hepatitis B titers, and on 10-MAY-2013, the patient received their third dose of RECOMBIVAX HB 5 MCG/0.5ML, lot # H017304, expiration date 11-JUL-2015 (route not provided). At the time of the report, the outcome and relatedness for the event "had negative (not immune) hepatitis B titers" were unknown. The registered nurse stated that the patient and his sibling were coming in for a well visit (date unavailable). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer unknown age. No information provided regarding concurrent condition and medical history. On November-2012, reported as about one and half year ago the patient was vaccinated with ZOSTAVAX (route, lot#, dose not reported). No concomitant medications reported. On an unknown date he patient experienced shingles. The reporter wanted to know if he should get the vaccination again. It was unspecified whether the patient sought medical attention. The outcome of shingles was unknown. Product quality complaint was not involved. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: TYP, YF
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash generalised
Clinical narrative: No treatment from Safeway. Patient had red rash bumps all over his body. His arms, legs, forehead and neck were covered with red rash bumps, and big red rash at injection site.
Age: 0.71
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.59
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 1.06
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.38
Sex: M
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 0.34
Sex: F
Vaccine: IPV, PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Temperature excursions of vaccine(s) listed in item 13.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Injection site swelling, Pyrexia
Clinical narrative: Patient stated her left arm where she was vaccinated swelled up to the size of a golf ball and her eyes became swollen. Patient reported this 1 day after vaccine administration. Patient states on 5/22/2014 She became dizzy and has a fever.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Amenorrhoea, Arthralgia, Computerised tomogram, Cyanosis, Dizziness
Clinical narrative: Extreme chronic fatigue, dizziness, muscle weakness, joint pain, headaches, diaphoresis, nausea, skin rashes, hot flashes, primary amenorrhea (failure to start period before age 16), and cyanosis. Symptoms increasing over the last 4 years. Year Round all star athlete prior to vaccination.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Headache, Hot flush
Clinical narrative: Extreme chronic fatigue, dizziness, muscle weakness, joint pain, headaches, diaphoresis, nausea, skin rashes, hot flashes, primary amenorrhea (failure to start period before age 16), and cyanosis. Symptoms increasing over the last 4 years. Year Round all star athlete prior to vaccination.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Hyperhidrosis, Laboratory test, Muscular weakness, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Extreme chronic fatigue, dizziness, muscle weakness, joint pain, headaches, diaphoresis, nausea, skin rashes, hot flashes, primary amenorrhea (failure to start period before age 16), and cyanosis. Symptoms increasing over the last 4 years. Year Round all star athlete prior to vaccination.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Rash, X-ray
Clinical narrative: Extreme chronic fatigue, dizziness, muscle weakness, joint pain, headaches, diaphoresis, nausea, skin rashes, hot flashes, primary amenorrhea (failure to start period before age 16), and cyanosis. Symptoms increasing over the last 4 years. Year Round all star athlete prior to vaccination.
Age: 19.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Rash of red dots on L arm from bicep to the top of his hand.