chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Dysstasia, Infection, Influenza like illness, Malaise
Clinical narrative: This consumer report (initial receipt 24-Feb-2014) concerns an 82 year old female patient who had a medical history of COPD (chronic obstructive pulmonary disease) and emphysema for the past 17 years and allergies to clindamycin, sulfa drugs and pethidine. Concomitant medications included fluticasone/salmeterol, an unspecified nebuliser, oxygen and albuterol/ipratropium. On an unspecified date around the second week of Dec-2013, the patient received an unspecified flu shot (manufacturer and batch number not specified) one shot via injection. The vaccination was a booster flu shot for patients over 65. About one week and a half later, the patient became sick with an unspecified infection which was some kind of bug that felt similar to the flu. The infection made her so weak that she was unable to walk. It was never determined whether the infection was viral or bacterial but when the patient was admitted to hospital on the 27-Dec-2013, a hospital X-ray found that the illness was not pneumonia. While she was hospitalised, she was administered an unspecified dosage and frequency of moxifloxacin via IV (intravenous) which made her so sick she thought she would die. The moxifloxacin caused severe burning in her veins which she reported to a nurse but was told nothing could be done about it. The patient vomited every day whilst receiving the moxifloxacin and was still vomiting on the 30-Dec-2013 when the moxifloxacin IV was stopped and she was discharged. She commenced moxifloxacin 400mg orally daily on discharge but only took one of the three tablets that she was prescribed due to worsening side effects. Around the 07-Jan-2014, the patient was hospitalised for a day and a half and received unspecified treatment. Whilst in hospital, it was found that her electrolytes were completely depleted and she had no potassium or sodium. She had experienced many ongoing and worsening side effects. She had experienced severe dizziness such that she had to be helped to use the bathroom because she was too dizzy to stand. She also developed worsening astronomical pains in her arms and shoulders as well as burning and muscle weakness in her arms and shoulders which has begun spreading into her legs. Her arms were so weak that she could not use them and could not even lift a gallon of milk. Her pulse was generally staying over 120 and sometimes was lower but not lower than 110. She also experienced bruising and severe shortness of breath. She never had the degree of shortness of breath that she had been experiencing since Dec-2013 around the time that she became ill and was given moxifloxacin. She spoke with medical professionals whilst hospitalised and pharmacists. Outcome was not reported.
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity, Vascular pain, Vomiting
Clinical narrative: This consumer report (initial receipt 24-Feb-2014) concerns an 82 year old female patient who had a medical history of COPD (chronic obstructive pulmonary disease) and emphysema for the past 17 years and allergies to clindamycin, sulfa drugs and pethidine. Concomitant medications included fluticasone/salmeterol, an unspecified nebuliser, oxygen and albuterol/ipratropium. On an unspecified date around the second week of Dec-2013, the patient received an unspecified flu shot (manufacturer and batch number not specified) one shot via injection. The vaccination was a booster flu shot for patients over 65. About one week and a half later, the patient became sick with an unspecified infection which was some kind of bug that felt similar to the flu. The infection made her so weak that she was unable to walk. It was never determined whether the infection was viral or bacterial but when the patient was admitted to hospital on the 27-Dec-2013, a hospital X-ray found that the illness was not pneumonia. While she was hospitalised, she was administered an unspecified dosage and frequency of moxifloxacin via IV (intravenous) which made her so sick she thought she would die. The moxifloxacin caused severe burning in her veins which she reported to a nurse but was told nothing could be done about it. The patient vomited every day whilst receiving the moxifloxacin and was still vomiting on the 30-Dec-2013 when the moxifloxacin IV was stopped and she was discharged. She commenced moxifloxacin 400mg orally daily on discharge but only took one of the three tablets that she was prescribed due to worsening side effects. Around the 07-Jan-2014, the patient was hospitalised for a day and a half and received unspecified treatment. Whilst in hospital, it was found that her electrolytes were completely depleted and she had no potassium or sodium. She had experienced many ongoing and worsening side effects. She had experienced severe dizziness such that she had to be helped to use the bathroom because she was too dizzy to stand. She also developed worsening astronomical pains in her arms and shoulders as well as burning and muscle weakness in her arms and shoulders which has begun spreading into her legs. Her arms were so weak that she could not use them and could not even lift a gallon of milk. Her pulse was generally staying over 120 and sometimes was lower but not lower than 110. She also experienced bruising and severe shortness of breath. She never had the degree of shortness of breath that she had been experiencing since Dec-2013 around the time that she became ill and was given moxifloxacin. She spoke with medical professionals whilst hospitalised and pharmacists. Outcome was not reported.
Sex: U
Vaccine: HEPA, HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (strength, dose unit, route, lot # and expiry date unknown). Other suspect therapies included VAQTA and LIQUID PEDVAXHIB, (strength, dose unit, route, lot # and expiry date unknown). On an unknown date with GARDASIL, VAQTA and LIQUID PEDVAXHIB were improperly stored. Registered nurse reported that she was unsure if improperly stored vaccines were administered and no adverse effects reported, but she does not think so. Registered nurse also reported that another nurse at VFC handles the issue. The outcome of unsure if improperly stored vaccines; GARDASIL, VAQTA, PEDVAXHIB, were administered and no adverse effects reported was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with expired MMR II lot # 0184AE, expiry date 18-JAN-2014, 0.5 ml, subcutaneous for an unknown indication. Anatomical location of vaccination and dose number were not reported. No adverse events were reported. Action taken, outcome and causal relationship were not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old female patient. On 28-FEB-2014, the patient was vaccinated with a expired dose of PROQUAD (merck) (lot# reported as H015639, expiry date 23-FEB-2014) injection, 0.5 ml, subcutaneous. No adverse effect was reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 26-FEB-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported) and a dose of PROQUAD (Merck) (lot #, dose and route not reported) during the same visit. No symptoms reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a consumer refers to a 12 month old patient of unknown gender. On unspecified date, the patient was vaccinated with a dose of VARIVAX (Merck) (strength, dose number, dose unit, route, lot # and expiry date not reported) and a dose of PROQUAD (strength, dose number, dose unit, route, lot # and expiry date not reported) at the same time. No further information was provided. It was unspecified if the patient sought medical attention. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown demographics. On 01-MAR-2014, the patient was vaccinated with ZOSTAVAX (lot # J004310 expiry date of 12-JUL-2014), 0.65 ml, subcutaneous. On 03-MAR-2014, the patient experienced 3 inch by 5 inch red welt at the injection site. The patient sought medical attention by contacting pharmacy. The outcome of 3 inch by 5 inch red welt at the injection site was reported as recovered on 04-MAR-2014 without any medical treatment. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD, subcutaneous. On an unknown date, the patient older than 12 years of age was administered PROQUAD. It was inappropriate age for administration of vaccine. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. On 03-MAR-2014, two patients were vaccinated with ZOSTAVAX (dose, unit, route, lot# and expiry date unknown) that has exposed to 38.6 Fahrenheit (F) for 1.5 hours. No adverse events were reported. The outcome of two patients was administered doses of ZOSTAVAX that were exposed to 38.6F for 1.5 hours and no adverse event was unknown. No further information was provided. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Impaired healing, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Injection site not healing, patient feeling pain and tingling sensation upon touch of the injection site - also complain of numbness of left hand occasional.
Sex: U
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacist via an unspecified physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 could not be ruled out at the time of the call (lot #, expiration date and dose/frequency not reported). The pharmacist reported that a physician informed the pharmacist that one of the physician's current patient's (but the physician informed the pharmacist that the patient's anaphylactic reaction did not occur under the current physicians care) experienced on an unknown date (reported as sometime in the past, described as years ago) anaphylactic reaction to pneumococcal vaccine (manufacturer unspecified). The outcome of anaphylactic reaction was reported as recovered/resolved (date unspecified). Relatedness was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient stated it started to get red later the same day. Reaction became more pronounced the next day and included swelling, itching, and warm to the touch. Area affected included triceps to elbow.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth, hard knot at site.  Swelling at 6 in diameter by 06 3/6/14.  Rec'd IV Benadryl 50 mg without much relief or decrease in sx.  Cool compress applied.
Age: 19.0
Sex: M
Vaccine: HEP, TYP, YF
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Patient developed a generalized papular rash, distributed mailnly on his trunk and both arms.  Papules become more sparsely distributed in the legs and head/neck regions.  The rash is very itchy.  Patient self administered Benadryl 25 mg tablets every 6 hours without relief.  Consult initiated with allergist ASAP and F/U with Dr. should symptoms worsen.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: SEVERE ARM PAIN, FEVER, CHILLS, BODY ACHES, HEADACHES, NAUSEA.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: SEVERE ARM PAIN, FEVER, CHILLS, BODY ACHES, HEADACHES, NAUSEA.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever and shaky.
Age: 37.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Rash chest and arms appeared after few days. Pruritus using Benadryl. Rash resolving per patient.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 41 year old female patient. On 03-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J011882 (Expiry: 04-JAN-2015) (dose and frequency were not reported) subcutaneous. On 03-MAR-2014, a small amount of ZOSTAVAX leaked out from the injection site. The pharmacist reported that the patient was less than 50 years of age at the time of vaccination with ZOSTAVAX. No adverse reaction reported. No further information was provided. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, Caesarean section, Exposure during pregnancy, Fall, Guillain-Barre syndrome
Clinical narrative: Admitted to Hospital 2/3/14 for repeat C-section. She has Guillain-Barre syndrome after a flu shot given during this pregnancy at the community clinic. She was admitted prior to delivery for 5 days IVIG treatment.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunoglobulin therapy, Sensory disturbance
Clinical narrative: Admitted to Hospital 2/3/14 for repeat C-section. She has Guillain-Barre syndrome after a flu shot given during this pregnancy at the community clinic. She was admitted prior to delivery for 5 days IVIG treatment.
Age: 1.68
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 20 month old patient of unknown gender. On 20-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot number not reported) in error. No adverse event was reported, no product confusion discovered. The outcome was not reported. Additional information is not expected.
Age: 0.29
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Diarrhoea, Mucous stools
Clinical narrative: 24hrs after vaccines, baby had runny, large stools with mucous. Lasted 3 days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: Enema administration, Intussusception, Rash
Clinical narrative: Intussusception 3/1 - 3/2/ 2014. Enema reduction. ? Rash on the face 24 hours after vaccine. Resolved in 2 days.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Breath holding, Loss of consciousness, Pyrexia
Clinical narrative: Fever - 100.6. Breath holding spell -> lead to a brief unconscious period lasting 3 min. No tremors.
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Later on the day of injection a red ring developed around injection site approximately the size of the pts tricep. Pt states no pain.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of cleft lip and palate in a foetus subject of unspecified gender who was exposed to FLULAVAL (GlaxoSmithKline), Cephalexin, and Amoxicillin in utero when the mother received treatment for urinary tract infection during pregnancy. On 14 October 2013, the 19-year-old mother started amoxicillin orally at an unknown total daily dose and received a dose of FLULAVAL. On 21 October 2013, the mother started cephalexin orally at a total daily dose of 1000mg. The mother's last menstrual period was 10 August 2013 and estimated date of delivery was reported as 23 May 2014. Per the nurse, the fetus was exposed to amoxicillin and FLULAVAL at 9 weeks and 2 days gestation and exposed to cephalexin at 9 weeks 3 days gestation. The exposures were during the first trimester. Examination of results revealed no evidence of defect from prenatal testing at the time of reporting on 11 November 2013. Results of an obstetrics ("OB") ultrasound examination on "30 January 2014 showed right cleft lip and palate." On 30 January 2014, 101 days after exposure to cephalexin and 108 days after vaccination with FLULAVAL and exposure to amoxicillin, the fetus experienced cleft lip and palate. At the time of reporting, the outcome of the event was unknown. The reporting nurse did not document whether she considered the event related to the mother's treatment with amoxicillin, FLULAVAL or cephalexin. The healthcare professional considered the events were a congenital anomaly. GlaxoSmithKline considered the event to be medically serious.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Patient developed itching at time of vaccine that worsened after taking a shower. On 3/5/14 developed full body rash and hives. Was seen in the ED, given Benadryl with good response and discharged home. Was doing well on 3/6/14.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: I noticed a rash affecting my skin. The rash started on my neck and slowly started to cover my torso, arms and thighs. It was a severe rash. The skin was red and it broke out on some areas of my neck.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Constant aching pain in injection site that spreads down to fingers and up through shoulder. Aches like arthritis all the time.  Never lets up.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Redness, itching that has spread throughout the body.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Abasia, Local swelling, Pain in extremity, Rash
Clinical narrative: The patient's mother states that the patient had pain and swelling in leg and was unable to walk. She reports skin rash, but was unable to describe the skin rash because the incident occurred a few weeks ago.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Arthralgia, Joint swelling, Pyrexia, Serum sickness, Urticaria
Clinical narrative: Serum Sickness (urticarial rash and fever and joint pain and swelling). Treatment: Prednisolone and Cetirizine.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Administered SQ. Saturday she had the chills all day. 3" red, raised, warm, tender area at injection site.
Age: 35.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Erythema, Fatigue, Lethargy, Skin warm
Clinical narrative: Administered SQ Friday - AM. Dizzy in the afternoon. Has softball - baseball sized red, raised, hot area. Sunday lethargic and tired.
Age: 35.0
Sex: F
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: Administered SQ Friday - AM. Dizzy in the afternoon. Has softball - baseball sized red, raised, hot area. Sunday lethargic and tired.
Age: 53.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Chills, Erythema, Skin warm, Swelling
Clinical narrative: Administered sub Q. Large, red, raised warm area - approximately 8" x 5". Chills. Seen in ER Sunday 3/2/2014. Last vaccine - flu shot in the fall.
Age: 53.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Chills, Erythema, Incorrect route of drug administration, Local swelling
Clinical narrative: Administered sub Q. Large, red, raised warm area - approximately 8" x 5". Chills. Seen in ER Sunday 3/2/2014. Last vaccine - flu shot in the fall.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Mass, Pain, Tenderness
Clinical narrative: Received Menomune. W/i 30 minutes tender to touch, w/i 24 hours painful, red - "about the size of a soda can". Turned into a lump "about the size of a silver dollar" for 2 weeks.
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pruritus, Rash
Clinical narrative: "hurt right away" administered SQ. Saturday had red welt about the size of a half dollar. Sunday much bigger, very tender, rash. Lasted 3-4 days and continued to be itchy for 6 days.
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Tenderness, Urticaria
Clinical narrative: "hurt right away" administered SQ. Saturday had red welt about the size of a half dollar. Sunday much bigger, very tender, rash. Lasted 3-4 days and continued to be itchy for 6 days.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling cold, Pruritus, Skin warm, Swelling
Clinical narrative: Administered SQ. Itchy, tender, chilly x 3 day. Red, raised, warm area the "size of a petri dish".
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: Administered SQ. Itchy, tender, chilly x 3 day. Red, raised, warm area the "size of a petri dish".
Age: 55.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Tenderness, Urticaria
Clinical narrative: A 'welt' 1.5-2 in in diameter, raised, tender, red, itchy half-way between elbow and shoulder on back of arm. Resolved after 8 days. No VIS given. Did not see vial, syringe was filled.
Age: 0.5
Sex: F
Vaccine: FLU3, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Came to our office 2 days after vaccinations with rash that had started that morning (3/5/14) and had spread throughout the day. Per doctors assessment rash was generalized and located on her face, scalp, trunk, and buttocks. No other symptoms.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in upper right arm to shoulder--more pain when moving arm--occurs nearly every day but is not continuous pain.  Told by pharmacist that pain could last up to a year.  No treatment yet.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Arthralgia, Blood copper, Blood creatine phosphokinase, C-reactive protein
Clinical narrative: Started in the evening with tingling in arms, hands, legs and feet.  Hand and feet were freezing cold and sweaty at same time. As the days progressed, I also experienced joint pain, muscle pain, muscle spasms, muscle weakness.  I was diagnosed by Dr. with damaged sensory nerves due to the flu vaccine.  This is practically 4 months later after the flu shot.  I am still suffering today.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Electrophoresis protein, Hyperhidrosis, Metabolic function test, Muscle spasms, Muscular weakness
Clinical narrative: Started in the evening with tingling in arms, hands, legs and feet.  Hand and feet were freezing cold and sweaty at same time. As the days progressed, I also experienced joint pain, muscle pain, muscle spasms, muscle weakness.  I was diagnosed by Dr. with damaged sensory nerves due to the flu vaccine.  This is practically 4 months later after the flu shot.  I am still suffering today.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nerve conduction studies, Nerve injury, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Started in the evening with tingling in arms, hands, legs and feet.  Hand and feet were freezing cold and sweaty at same time. As the days progressed, I also experienced joint pain, muscle pain, muscle spasms, muscle weakness.  I was diagnosed by Dr. with damaged sensory nerves due to the flu vaccine.  This is practically 4 months later after the flu shot.  I am still suffering today.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Protein total, Red blood cell sedimentation rate, Thyroid function test, Vitamin B12
Clinical narrative: Started in the evening with tingling in arms, hands, legs and feet.  Hand and feet were freezing cold and sweaty at same time. As the days progressed, I also experienced joint pain, muscle pain, muscle spasms, muscle weakness.  I was diagnosed by Dr. with damaged sensory nerves due to the flu vaccine.  This is practically 4 months later after the flu shot.  I am still suffering today.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vitamin D, Vitamin E
Clinical narrative: Started in the evening with tingling in arms, hands, legs and feet.  Hand and feet were freezing cold and sweaty at same time. As the days progressed, I also experienced joint pain, muscle pain, muscle spasms, muscle weakness.  I was diagnosed by Dr. with damaged sensory nerves due to the flu vaccine.  This is practically 4 months later after the flu shot.  I am still suffering today.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eyelid oedema, Swelling face, Vomiting
Clinical narrative: Facial swelling: In the morning following vaccination, patient woke up with puffy and swollen eyes and cheeks. Eyes were really puffy but looked better by doctor's appointment later in the morning.  No difficulty breathing, no difficulty swallowing, no rash.  Vomiting: Vomited 2-3 times at night when the vaccinations were administered in the afternoon.  No vomiting the following day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: ERYTHEMA, SWELLING, WARMTH, TENDER AT INJECTION SITE- ABOUT THE SAME DIAMETER INDURATION AS A BASEBALL- RIGHT POSTERIOR UPPER ARM. PT WAS ADVISED TO TAKE DIPHENHYDRAMINE, AND TO LET US KNOW IF SYMPTOMS DO NOT IMPROVE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT RECEIVED MMRV ON 2/26/2014 GRANDMOTHER PHONED 02/29/2014 STATING THE RIGHT THIGH HAD A ROUND RED SWOLLEN AREA. SEEN BY DR., TREATED WITH BENADRYL LIQUID 25MG TWICE A FOR 5 DAYS.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Fatigue, Somnolence, Vomiting
Clinical narrative: Received telephone call from mother today 03/06/2014 stating that her daughter "vomited 5 hours after vaccine administration" (DTaP/HB/IPV and MMR/VZV) on 03/04/14. She also reported that her daughter is feeling very tired and "wants to sleep all the time" for 2 days after vaccine administration. She states her daughter is still currently feeling this way but no current reports of vomitting. Advised mother to take daughter to see a pediatrician/physician for evaluation and treatment. Mother hung up right after recommendation was given. Unable to determine if mother understood the direction/education given. Physician notified. Attempted to call mother back at 1:30 PM to follow up on daughter's status; no answer, no voicemail set up. Attempted to call alternate number in chart but number is out of state.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash papular
Clinical narrative: Red fine papular lesion on forehead and red around eye.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Erythema, Feeling hot, Headache, Local swelling
Clinical narrative: Headache, stomach ache, low grade fever 99-100, redness/swelling of entire upper arm (from shoulder to elbow, 3/4in increase in diameter), warmth, pain for 3days.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, stomach ache, low grade fever 99-100, redness/swelling of entire upper arm (from shoulder to elbow, 3/4in increase in diameter), warmth, pain for 3days.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old male patient. The patient's current conditions or medical history were not reported. On 27-JAN-2014 at 5:25 pm, the patient was vaccinated with the first dose of VARIVAX (merck) subcutaneous (lot number reported as 1718AA) (dose was not reported) instead of ZOSTAVAX. On 15-FEB-2014, the patient experienced herpetic like rash on right lower back like a band. At the time of the report outcome for herpetic like rash was unknown. The patient was treated with VALTREX 1g every 8 hours. The reporter considered herpetic like rash to be medically significant because it required medical/surgical intervention to prevent serious criteria. This is one from two cases from the same source. MARRS 1401USA013877. Lot number 1718AA is an invalid lot number for VARIVAX (merck). That lot is for sterile diluent. Additional information has been requested.
Age: 0.79
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Faeces discoloured, Gastroenteritis, Gastrooesophageal reflux disease, Vomiting
Clinical narrative: Emesis multiple x Fri and Sat, loose green stool. Emesis 1x daily for 3 days. Seen in office on 2/28/14 Dx Gastroenteritis, GERD (reaction to shot). Script for Ranitidine for 2 wks. Parents and siblings had aches, pains and stomach issues x 1 day.
Age: 1.3
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Autism, Convulsion, Pyrexia
Clinical narrative: This consumer report (initial receipt 26-Feb-2014) concerns a 15 month old male patient. On an unspecified date, the patient received the flu vaccine (manufacturer and batch number not reported), the MMRII vaccine (batch number not reported) and VARIVAX (batch number not reported). On an unspecified date after immunisation, the patient had seizures, a fever for two months and was later diagnosed with autism. Outcome was reported as not recovered.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site vesicles, Rash erythematous
Clinical narrative: 2-26-14 Red and raised rash; prior to date somewhat sensitive. 2-27-14 Blistering rash site of injection, 1 spot on her side. 2-27-14 Prescribed triamcinolone cream 0.1% twice daily. 3-6-14 Rash area is smaller, raised at site blisters did not break open or scab.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Indurate, erythematous, tender and itchy 3-4 cm surrounding injection site.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient noticed swelling of right upper arm on 3/5/14 at 5:30 pm and became worse by 3/6/14 at 7:00am, swelling, redness, itching, and mild pain at injection site stayed the same throughout the day. pt rates pain 2/10. Pt has felt relief with ice and ibuprofen. Induration measures at 6.25 in by 6 in. Pt informed to take BENADRYL 25 mg every 6-8 hrs as need for itching at 3/6/14 5:00pm.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Blood culture, C-reactive protein increased, Human chorionic gonadotropin negative, Metabolic function test normal, Nodule
Clinical narrative: 11 Feb: Patient began to develop painful nodules on bilateral arms. 14 Feb: TX w/ MEDROL pack x 5 days and symptoms resolved. 21 Feb: Completed MEDROL pack and symptoms returned in 1-2 days. 2 Mar: TX w/ prednisone 50mg QD x 5 day symptoms resolved.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Streptococcus test negative, Urine analysis normal
Clinical narrative: 11 Feb: Patient began to develop painful nodules on bilateral arms. 14 Feb: TX w/ MEDROL pack x 5 days and symptoms resolved. 21 Feb: Completed MEDROL pack and symptoms returned in 1-2 days. 2 Mar: TX w/ prednisone 50mg QD x 5 day symptoms resolved.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Dermatitis contact, Injection site cellulitis, Injection site rash, Rash generalised
Clinical narrative: 18FEB: Noticed rash around smallpox vaccine seen in ER and dx as cellulitis tx SEPTRA 800/160 1 tab 2x day 10 days. 24 FEB: Rash had spread to hands seen in ER and dx contact dermatitis tx w/ MYCOLOG TID and ATARAX 1 tab QD. 4 MAR: Rash had spread to bilateral arms, hands, chest, face and neck tx w/prednisone 20 mg 1 tab 3x day 10 days.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Dermatitis contact, Rash, Vaccination site rash
Clinical narrative: 18FEB: Noticed rash around smallpox vaccine seen in ER and dx as cellulitis tx SEPTRA 800/160 1 tab 2x day 10 days. 24 FEB: Rash had spread to hands seen in ER and dx contact dermatitis tx w/ MYCOLOG TID and ATARAX 1 tab QD. 4 MAR: Rash had spread to bilateral arms, hands, chest, face and neck tx w/prednisone 20 mg 1 tab 3x day 10 days.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Rec'd 15 mo imm. on 3-4-14; Developed red, indurated bumps (quarter-size) and 2x2" redness to surrounding area to bilat thighs (LT) thigh with ? pustule (no exudate); S/S began today; Afebrile; No S/S rxn after given. Tx with Keflex 250/5 5ml BID x 10D; Supportive care: RTN PRN.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site rash, Pain, Pruritus
Clinical narrative: Patient received Zostavax on left arm and has a rash close to where Zostavax was administered and is complaining of itching and slight pain. Directed to see MD or urgent care/ER.
Age: 0.56
Sex: U
Vaccine: HIBV, IPV
Symptoms: Injection site erythema, Injection site pain, Irritability
Clinical narrative: Developed red area on (R) thigh with tenderness and fussiness.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: 11:20 AM 3-6-14 I gave the immunizations listed below at approximately 11:20 then wrote down the lot numbers on paper so I could then enter in computer immediately after that (4 min later) mom said both legs red - nurse practitioner immediately examined him then doctor examined him, he also had multiple red blotches arm, legs, chest, back which all faded away.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report was received from a nurse, concerning a 62 year old male patient with hypertension, hyperlipidemia and with no drug reaction/allergies. On 26-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015780, expiration date 11-JUN-2014, 0.5 ml), intramuscular in the left arm. Concomitant therapies included losartan potassium (manufacturer unknown) and atorvastatin. The nurse reported that on 27-FEB-2014, after received PNEMOVAX23, the patient developed pain, redness and swelling of his left upper arm "that extends down past the elbow". The patient was seen in the office on 28-FEB-2014, at which time an unspecified physician prescribed cephalexin and BENADRYL as treatment. At the time of the report the outcome was reported as not recovered. Patient seek medical attention with and unspecified physician that prescribed cephalexin and BENADRYL as treatment. No labs diagnostics studies were performed. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse, concerning a 62 year old male patient with hypertension, hyperlipidemia and with no drug reaction/allergies. On 26-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015780, expiration date 11-JUN-2014, 0.5 ml), intramuscular in the left arm. Concomitant therapies included losartan potassium (manufacturer unknown) and atorvastatin. The nurse reported that on 27-FEB-2014, after received PNEMOVAX23, the patient developed pain, redness and swelling of his left upper arm "that extends down past the elbow". The patient was seen in the office on 28-FEB-2014, at which time an unspecified physician prescribed cephalexin and BENADRYL as treatment. At the time of the report the outcome was reported as not recovered. Patient seek medical attention with and unspecified physician that prescribed cephalexin and BENADRYL as treatment. No labs diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of doses of VAQTA (single dose, route and lot number were not reported) were administered to patients on unspecified dates after a supported excursion of 20C over a period of 15 hours. No adverse  events were reported. This case is linked to cases 1403USA001475, 1403USA002926, 1403USA002928 and 1403USA002929 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unkonwn age and gender. Nurse reported that an unspecified number of doses of RECOMBIVAX HB (single dose) (dose, route and lot number were not reported) were administered to patients on unspecified dates after a supported excursion of 20C over a period of 15 hours. No adverse events were reported. This case is linked to cases 1403USA001475, 1403USA002926, 1403USA002927 and 1403USA002929 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of doses of PNEUMOVAX 23 (single dose) (dose, route and lot number were not reported) were administered to patients on unspecified dates after a supported excursion of 20C over a period of 15 hours. No adverse events were reported. This case is linked to cases 1403USA001475, 1403USA002926, 1403USA002927 and 1403USA002928 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Certified Medical Assistant) refers to a patient of unknown age and gender. On 26-FEB-2014 the patient was vaccinated with an expired dose of PROQUAD (Merck), lot # H015629, expiry date: 24-FEB-2014, (dose, route and indication not reported). No adverse symptoms reported. The healthcare worker stated the product did not have any previous temperature excursions. It was not reported if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of doses of GARDASIL (single dose) (dose, route and lot number were not reported) were administered to patients on unspecified dates after a supported excursion of 20C over a period of 15 hours. No adverse events were reported. This case is linked to cases 1403USA001475, 1403USA002927, 1403USA002928 and 1403USA002929 via same reporter link. 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 a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that an unspecified number of doses of ROTATEQ (single dose) (dose, route and lot number were not reported) were administered to patients on unspecified dates after a supported excursion of 20C over a period of 15 hours. No adverse events were reported. This case is linked to cases 1403USA002926, 1403USA002927, 1403USA002928 and 1403USA002929 via same reporter link. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a nurse refers to a 25 year old female patient without drug reactions or allergies. The patient's current conditions were not reported. The patient's medical history included: took trazodone, tretinoin cream and minocycline in the past and no drug reactions/allergies. On 23-OCT-2013, the patient was vaccinated with the first dose of GARDASIL 120 y (dose, route, lot and expiration date were not reported). On 06-FEB-2014, the patient was vaccinated with the second dose of GARDASIL 120 y (dose, route, lot and expiration date were not reported). On 06-FEB-2014, the reporter mentioned that the patient felt woozy after receiving her second dose of GARDASIL. The reporter stated that the patient remained in the office for a little while before going home and mentioned that the patient was recovered when she left the office. The patient did not received treatment for the event. No lab diagnostics were performed. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner for HPV rL1 6 11 16 18 vaccine, a Pregnancy Registry product, concerning a 23 year old female patient who was pregnant after receiving a second dose of HPV rL1 6 11 16 18 vaccine (route, dosage and lot # not reported) in the last several weeks. The LMP was 19-DEC-2011, estimate delivery date is 24-SEP-2012. No further information is available.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Condition aggravated, Heart rate increased, Mydriasis, Pupillary reflex impaired
Clinical narrative: Case number PHHY2013US000749 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471050) website on 02 Jan 2013 with the follow up information received from the quality assurance department (QA reference number: 209102) on 18 Mar 2013. This report refers to a 23-year-old female patient. Medical history included oral birth control and anxiety. Concomitant drug included oral birth control medication. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in the left arm on 23 Oct 2012. On the same date, after vaccination approximately at noon, patient had blurry vision in right visual field. On examination, patient's right eye did not respond to light stimulus and remained dilated at approximately 4 to 5 mm. She had no redness, discharge, itchiness or other symptoms, but after 10 minutes patient noted increased blurry vision in right visual field and consequently returned for evaluation. Her pulse rate was normal and she self-administered cetirizine 10 mg, orally once daily. After sitting quietly for another 15 minutes, the pulse increased and patient reported anxiety attack. Patient was referred to emergency department for examination of eye and evaluation of anxiety. The outcome of the events was reported as condition unchanged. The causality of the events was not reported. Upon follow up receipt from the quality assurance department, it was stated that the initially reported batch number, 11264P was invalid and hence the QA investigation was canceled for the complaint 209102. Follow up information received from the quality assurance department on 18 Mar 2013: QA comments updated.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Case number PHHY2013US000749 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471050) website on 02 Jan 2013 with the follow up information received from the quality assurance department (QA reference number: 209102) on 18 Mar 2013. This report refers to a 23-year-old female patient. Medical history included oral birth control and anxiety. Concomitant drug included oral birth control medication. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in the left arm on 23 Oct 2012. On the same date, after vaccination approximately at noon, patient had blurry vision in right visual field. On examination, patient's right eye did not respond to light stimulus and remained dilated at approximately 4 to 5 mm. She had no redness, discharge, itchiness or other symptoms, but after 10 minutes patient noted increased blurry vision in right visual field and consequently returned for evaluation. Her pulse rate was normal and she self-administered cetirizine 10 mg, orally once daily. After sitting quietly for another 15 minutes, the pulse increased and patient reported anxiety attack. Patient was referred to emergency department for examination of eye and evaluation of anxiety. The outcome of the events was reported as condition unchanged. The causality of the events was not reported. Upon follow up receipt from the quality assurance department, it was stated that the initially reported batch number, 11264P was invalid and hence the QA investigation was canceled for the complaint 209102. Follow up information received from the quality assurance department on 18 Mar 2013: QA comments updated.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Blood culture negative, CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count
Clinical narrative: Case number PHHY2013US000635 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference no: 473271) website received on 02 Jan 2013 with the follow up received from Quality Assurance Department (reference numbers: 203005) on 05 Feb 2013 and non-significant follow up received on 11 Feb 2014. This report refers to a 63-year-old male patient. His medical history included high blood pressure. Concomitant medications included ALEVE, FLOMAX, fluoxetine and AMBIEN. He was vaccinated with FLUVIRIN (batch number 1206701) in his left arm, PNEUMOVAX (other manufacturer, batch number H009826) in his left arm and ZOSTAVAX (other manufacturer, batch number H013021) in his right arm on 24 Oct 2012. On 25 Oct 2012, he experienced aseptic meningitis with myalgia, headache, chills and fever. On 26 Oct 2012, he was hospitalized. On 28 Oct 2012, he experienced left arm cellulitis. His cerebro spinal fluid analysis revealed white blood cell 15 (9S, 91M), protein 74, glucose 57 and culture was negative. His blood cultures were negative and CT arm revealed cellulitis. The outcome of the events was reported as recovered. The causality assessment of the events was not reported. Based on the QA investigation performed QA department stated the FLUVIRIN (batch number 1206701) was manufactured in accordance with the approved internal procedures and is in compliance with cGMP requirements. QA department canceled QA investigation with reference number 203016 as it was opened in error. Non-significant follow up received from Quality Assurance Department (reference numbers: 203005 and 203016) on 08 Jan 2013: Updated QA reference numbers only. Follow up received on 05 Feb 2013 and 11 Feb 2014 was combined: Updated QA investigation summary. There was no new medically significant information received on 11 Feb 2014.