chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Nasal congestion, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: The first day I had a sore shoulder, to be expected, but I also had a runny nose, fever and head ache. By day two I had a sore throat, head ache, runny nose, congested nose, fever, body aches, and was nausea. By day three All of my symptoms were getting worse. By day four I was absolutely miserable with all symptoms continuing. Day five, six were also horrible. Day seven I finally began to feel some relief from the symptoms. The only treatment I used was Tylenol to keep my fever under control. Because I am pregnant I could not use anything else. I am severly disappionted in the CDC, FDA and Goverment for falsely reporting how long these reactions actually last. I have spoken to other family members and friends and found that 9 out of 10 have had the same reaction that I had, to include my husband. We were all vaccinated in different places and some used the Flumist instead of the injectable version but still we all have had a long lasting reaction that severly effected our ability to perform daily functions. I found in all my research that these symptoms are only supposed to last 2 days. What a lie! And how misleading! I have never before gotten a flu vaccine nor has my husband, and we will never again waste our time getting one again. Why get a vaccine that makes you just as ill as the illness its self. I'd rather take my chances getting the real thing instead of getting those same sypmtoms from the vaccine that's supposed to prevent them in the first place.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: The first day I had a sore shoulder, to be expected, but I also had a runny nose, fever and head ache. By day two I had a sore throat, head ache, runny nose, congested nose, fever, body aches, and was nausea. By day three All of my symptoms were getting worse. By day four I was absolutely miserable with all symptoms continuing. Day five, six were also horrible. Day seven I finally began to feel some relief from the symptoms. The only treatment I used was Tylenol to keep my fever under control. Because I am pregnant I could not use anything else. I am severly disappionted in the CDC, FDA and Goverment for falsely reporting how long these reactions actually last. I have spoken to other family members and friends and found that 9 out of 10 have had the same reaction that I had, to include my husband. We were all vaccinated in different places and some used the Flumist instead of the injectable version but still we all have had a long lasting reaction that severly effected our ability to perform daily functions. I found in all my research that these symptoms are only supposed to last 2 days. What a lie! And how misleading! I have never before gotten a flu vaccine nor has my husband, and we will never again waste our time getting one again. Why get a vaccine that makes you just as ill as the illness its self. I'd rather take my chances getting the real thing instead of getting those same sypmtoms from the vaccine that's supposed to prevent them in the first place.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site reaction, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: First noticed red marks after band-aids where taken off.  The following day baby had small raised red dots on legs and arms.  Over the course of the next three days the dots became much worse, and large blotches appeared as well. She had these marks over her whole body except on her back.  Mainly on her arms and legs, though.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Initial report was received on 29 September 2011 from a consumer, who is also a company representative. A 10-year-old female patient who had received several previous doses of influenza vaccine, had received "sometime the week of 12 September 2011" FLUZONE (lot number, route, site and exact date of administration not reported) and 24 to 36 hours later, experienced bumps and hives on the arms which then spread to the legs and trunk. The patient was treated by her physician with Prednisone and two other unspecified medications. The patient was to see an allergist. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 29 September 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a three year old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 4 doses of DAPTACEL; lot number C2749BA received on 21 September 2007, lot number C2797AA received on 26 November 2007, lot number C2800AA received on 22 January 2008, and lot number C2956AA received on 29 October 2008 (routes and sites of administration not reported). The subject developed a cough on 14 July 2011, approximately 33 months after the last dose. On 21 July 2011, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 08 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 August 2011 for four days. The subject was not hospitalized. At the time of final contact on 11 August 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 29 September 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a three year old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 4 doses of DAPTACEL; lot number C2749BA received on 21 September 2007, lot number C2797AA received on 26 November 2007, lot number C2800AA received on 22 January 2008, and lot number C2956AA received on 29 October 2008 (routes and sites of administration not reported). The subject developed a cough on 14 July 2011, approximately 33 months after the last dose. On 21 July 2011, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 08 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 August 2011 for four days. The subject was not hospitalized. At the time of final contact on 11 August 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Initial report was received 29 September 2011 from a health care professional, who heard about the following report. An unidentified patient had received an injection of FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient had a feeling of their throat closing and had to be taken to the hospital for treatment (treatments unspecified). According to the reporter, this patient had received FLUZONE HIGH-DOSE at another facility from another person. Outcome was not reported. No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2011-09435.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Infection, Laboratory test abnormal, Nausea, Vomiting
Clinical narrative: Initial report was received 30 September 2011 from a healthcare professional which involved a cluster of four patients. Four elderly patients above 65 years of age, had received FLUZONE HIGH-DOSE, lot number UH452AA within a two week period. All of the patient had been fine while at the doctors office, but a few hours later after returning home, all developed symptoms of nausea, vomiting and chills. One patient was hospitalized. Unspecified laboratory testing confirmed it was an infection (not specified) and further testing was required. No additional information was provided and outcomes were not reported. Documents held by sender: None.
Sex: M
Vaccine: HIBV
Symptoms: Abasia, Autism, Childhood disintegrative disorder, Eating disorder, Haemophilus infection
Clinical narrative: Initial report was received on 29 September 2011 from an electronic lay press article. A 13 month-old male patient, who "acted like other normal toddlers-he cruised around, talked and used utensil", had received theHib VACCINE(manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, had a severe regression. He could no longer walk, talk, eat or roll over. He was evaluated for muscular dystrophy and other neurological disorders. The patient attended a preschool for the blind. Ten days prior to his fourth birthday he was diagnosed with Haemophilus influenza type b (Hib) and staph. By his fourth birthday, he was non-verbal. He was diagnosed with autism, mental retardation, cortical visual impairment and a non-functioning immune system. According the patient's mother, "he didn't get the antibodies from his vaccine. he got the disease. The doctors weren't looking for it because he was vaccinated." The patient's outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Immune system disorder, Mental retardation, Mobility decreased, Speech disorder developmental, Staphylococcal infection
Clinical narrative: Initial report was received on 29 September 2011 from an electronic lay press article. A 13 month-old male patient, who "acted like other normal toddlers-he cruised around, talked and used utensil", had received theHib VACCINE(manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, had a severe regression. He could no longer walk, talk, eat or roll over. He was evaluated for muscular dystrophy and other neurological disorders. The patient attended a preschool for the blind. Ten days prior to his fourth birthday he was diagnosed with Haemophilus influenza type b (Hib) and staph. By his fourth birthday, he was non-verbal. He was diagnosed with autism, mental retardation, cortical visual impairment and a non-functioning immune system. According the patient's mother, "he didn't get the antibodies from his vaccine. he got the disease. The doctors weren't looking for it because he was vaccinated." The patient's outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Visual impairment
Clinical narrative: Initial report was received on 29 September 2011 from an electronic lay press article. A 13 month-old male patient, who "acted like other normal toddlers-he cruised around, talked and used utensil", had received theHib VACCINE(manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, had a severe regression. He could no longer walk, talk, eat or roll over. He was evaluated for muscular dystrophy and other neurological disorders. The patient attended a preschool for the blind. Ten days prior to his fourth birthday he was diagnosed with Haemophilus influenza type b (Hib) and staph. By his fourth birthday, he was non-verbal. He was diagnosed with autism, mental retardation, cortical visual impairment and a non-functioning immune system. According the patient's mother, "he didn't get the antibodies from his vaccine. he got the disease. The doctors weren't looking for it because he was vaccinated." The patient's outcome was not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Initial report was received on 29 September 2011 from a healthcare professional. A cluster of two unidentified patients had received FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount time after vaccination, complained that they felt their throat was closing. Treatments were not reported. No further information was available at the time of the report. Outcomes were not reported. Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Asphyxia, Completed suicide, Death, Drug screen negative, Toxicologic test normal
Clinical narrative: Information has been received from a physician concerning an 18 year old male patient with acne and no drug allergy or reaction who on 16-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot number 668554/0306AA; Expired date: 10-MAY-2013) and a dose of VAQTA (Lot number: 670377/0126AA; Expired date: 07-DEC-2013, dose in series unknown). On 22-JUL-2011, the patient received the second dose of GARDASIL (Lot number 668262/0841AA; Expired date: 18-APR-2013). Concomitant therapy included SEPTRA. Follow up phone call from the physician was received. The physician reported that the patient had no medical history. The last time he saw the patient was on 22-JUL-2011, when the patient received his second dose of GARDASIL. The physician also reported that there was no indication from the patient that he was troubled. On 27-JUL-2011 the patient committed suicide. The cause of death was asphyxiation by hanging. The death report that the physician received was that the patient had a normal examination. The Toxic screen indicated that there were no medications involved in the patient's death. The patient's mother had asked the physician if GARDASIL could have caused her son to commit suicide. The physician reported to the patient's mother that he did not feel that GARDASIL was the cause of her son's suicide. The physician stated that he was not aware of any reported deaths by suicide that were related to GARDASIL. Lot checks have been initiated for 668554/0306AA, 668262/0841AA for GARDASIL and 670377/0126AA for VAQTA. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Sore (R) arm- approx 5x6 inch red non raised area.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Psychomotor hyperactivity, Pyrexia, Urticaria
Clinical narrative: The afternoon after vaccine, fever, body aches, chills, hives over entire body, felt hyper.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient noticed redness when removing band aid on 10/10/11. Redness gradually got worse. Became raised & side about 3 x 2 inch. Was brought to my attention on 10/12/11. Called physician & they called patient. Was to go in if got worse.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysphagia, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Felt tired & weak for a few days headache, tender throat, discomfort swallowing (L) side of neck has swollen lymph node.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Felt tired & weak for a few days headache, tender throat, discomfort swallowing (L) side of neck has swollen lymph node.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: left arm redness, warmth and edema
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Feeling cold, Headache
Clinical narrative: cold and could not warm up, headache still to the next day, and severe fatigue.
Age: 0.83
Sex: F
Vaccine: IPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Showed almost immediate signs of fever over 101 and very lethargic.  Tylenol took while to help the symptoms.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Eye irritation, Ocular hyperaemia
Clinical narrative: Mild rigor with temperature elevation.  Reddened and irritated eyes.  Rigor moderated in about 1.5 hours.  About 2.5 hours after onset, temperature was 1 degree above normal temp.  Drank fluids.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: hives, itching, short of breath - Benadryl, epi pen, tapering dose of prednisone
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Crying, Screaming
Clinical narrative: persistent high pitched screaming for 3 hours
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, convulsive shivering (3 episodes, 30 minutes each over 12 hour period), aches.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Cyanosis, Full blood count normal, Grand mal convulsion, Influenza virus test negative, Metabolic function test normal
Clinical narrative: grand mal seizure, quit breathing turned blue, seized for about 3 minutes then stopped took to dr office per his request, started seizing again, they gave him a shot of volume and called 911
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Mycoplasma test, Respiratory arrest, Respiratory syncytial virus test negative
Clinical narrative: grand mal seizure, quit breathing turned blue, seized for about 3 minutes then stopped took to dr office per his request, started seizing again, they gave him a shot of volume and called 911
Age: 4.0
Sex: F
Vaccine: DTPIPV
Symptoms: Erythema, Skin warm
Clinical narrative: 5 1/2cm by 8cm red warm to touch spot
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Onset began with numbness and weakness in legs and eventual loss of function of legs- paralysis from waist down.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Onset began with numbness and weakness in legs and eventual loss of function of legs- paralysis from waist down.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Muscle spasms, Pain, Pyrexia
Clinical narrative: Severe Aches all over the body, High Fever (102 F), Violent Chills, Violent Spasms (on legs), Weakness
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness, Urticaria
Clinical narrative: Within 2 hours she had a wheal and flair of several inches. Then it spread from her shoulder to elbow over the next 6 hours. Extreme point tenderness. She took 1000mg of Tylenol and 50mg of Benadryl.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Pyrexia
Clinical narrative: Fever, chills, headache, difficulty breathing.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted immediately after administration of HPV vaccine episode lasted 5 seconds.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Severe allergic reaction, tongue swelling.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Pain, Vomiting
Clinical narrative: Patient has a temperature of 99-100 degrees F, is vomiting and experiencing chills and aches.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received ZOSTAVAX on 12/23/09. Patient developed shingles on 10/07/2011. Had to be treated with acyclovir.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Pt developed several small hives on body approximately 2 hours post influenza vaccine. 1 on foot, 2 on knee, 1 on side of right hip. All approx  cm across with 5-7 cm red rash surrounding.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: 2d after PNEUMOVAX 23 SQ given (10-11-11), pt. developed 2 1/2" circle of redness, warmth at site. Also complained of "not feeling well" w/ fatigue, malaise, Treated w/ TYLENOL, BENADRYL 50mg BID.
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Death, Diabetic coma
Clinical narrative: Case number PHEH2011US06146 is an initial spontaneous report received from a consumer on 05 Oct 2011: This case refers to 27-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 01 Oct 2011. After vaccination his sugar was 1500 because of flu shot. The flu shot raised his blood sugar to a diabetic coma that he did not wake up. The patient received care at hospital. The critical team worked on him for 12-hours and he expired on 03 Oct 2011. No other information was provided.
Age: 27.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Death, Diabetic coma
Clinical narrative: Case number PHEH2011US06146 is an initial spontaneous report received from a consumer on 05 Oct 2011: This case refers to 27-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 01 Oct 2011. After vaccination his sugar was 1500 because of flu shot. The flu shot raised his blood sugar to a diabetic coma that he did not wake up. The patient received care at hospital. The critical team worked on him for 12-hours and he expired on 03 Oct 2011. No other information was provided.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Dry throat, Ocular hyperaemia
Clinical narrative: Both eyes very red, pt c/o dry mouth and throat. Suggested BENADRYL 25 mg PO q4h PRN and f/u with PCP if cont. or worsen.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lymphadenopathy, Muscle spasms, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Swelling of left arm lymph glands, muscle cramp left leg calf, sore throat, running nose and headaches.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: Pt under 19 years old - original DOB stated as 1990 - found to 1994. No side effects or negative sequelae.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Muscle spasms, Pain
Clinical narrative: About 8 hours after injection patient experienced a headache followed by achiness all over body. Also experienced shivers & muscle spasms on left side for 45 minutes. Patient went to sleep & woke up with no more adverse reaction.
Age: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: 0908: (B) fingers itchy & swollen, face itchy. No rash. No resp. complaints. Lungs CTA (B). HR 74 BP 124/86 RR 16 O2 Sats 96%. T 98.1 0910: 50 mg im BENADRYL given. 0925: Symptoms significantly improved (but not resolved) 0940: Released from care.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm very sore to raise it up.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Area approx 12" in length and 6" in width red warm to touch noted (L) upper arm minimal discomfort.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt developed redness, swelling, warm to touch at vaccine site. Also developed a rash on his face.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized reaction red, swollen, warm to touch Rt arm from mid deltoid to shoulder - Lt arm red, warm, swollen area - size of baseball.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: (L) arm redness, pain, increased warmth and swelling. Tx = cephalexin 500mg 1 tab 4 times a day, warm compress, elevate arm.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Rash, hives, swelling of face.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called pharmacy a couple of hours after getting the flu shot and stated she had arm pain. Asked pt. to take some ibuprofen for the arm pain and we would follow up with her. Followed up with her & patient stated she went to urgent care for the pain in arm.
Age: 86.0
Sex: U
Vaccine: UNK
Symptoms: Bed rest, Cough, Malaise, Oropharyngeal pain, Productive cough
Clinical narrative: Within hour: nasal drip, sore throat, developed into coughing, heavy mucus (yellow/green). Very ill for two weeks. Bed rest and fluids. Gradually symptoms tapered off. 10/6/2011 still have some mucus.
Age: 86.0
Sex: U
Vaccine: UNK
Symptoms: Upper-airway cough syndrome
Clinical narrative: Within hour: nasal drip, sore throat, developed into coughing, heavy mucus (yellow/green). Very ill for two weeks. Bed rest and fluids. Gradually symptoms tapered off. 10/6/2011 still have some mucus.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Very large swelling on the arm where the shot was administered; followed by heat around the area. Allergic reaction.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia, Pruritus, Rash
Clinical narrative: Pt received Flu shot and shortly after she had numbness & tingling in the forearm of the same arm. Then it became itchy and a mild rash appeared, Pt also became lightheaded. I monitored pt and within 1/2 hour lightheadedness went away, 50mg BENADRYL took down itch & rash.
Age: 1.2
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site nodule
Clinical narrative: Father of child noticed a bump under the skin in patient's right upper thigh last night when changing his clothing.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Inflammation, Pain, Pyrexia
Clinical narrative: Pt had low-grade (99-100 degrees) fever & cellulitis-like (red, hot to touch, painful & inflamed) spot on arm with bruise. Went to walk in clinic on Saturday morning but wasn't given anything until Sunday when he noticed a new red spot. They gave him antibiotics d/t worry of possible infection.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Pt had low-grade (99-100 degrees) fever & cellulitis-like (red, hot to touch, painful & inflamed) spot on arm with bruise. Went to walk in clinic on Saturday morning but wasn't given anything until Sunday when he noticed a new red spot. They gave him antibiotics d/t worry of possible infection.
Sex: F
Vaccine: FLUX
Symptoms: Autopsy, Cardio-respiratory arrest, Convulsion, Death, Hypoxic-ischaemic encephalopathy
Clinical narrative: Case number PHHY2011US89577 is an initial literature report received on 06 Oct 2011: The authors analyzed clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program. This report refers to a female child. She was one of the triplet and her medical history included recurrent CNS infections by unidentified agents, but which were thought to have been viral. She was developmentally delayed and microcephalic. At the age of 3 years and 9 months, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. Two weeks later, she presented with CNS symptoms similar to those she had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respiratory therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy. The authors concluded that provided evidences were not supportive of direct relationship between a given vaccine and a specific CNS complication. Pathogenesis of majority of the cases was apparent and not a complication of vaccination.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory therapy, Similar reaction on previous exposure to drug, Status epilepticus
Clinical narrative: Case number PHHY2011US89577 is an initial literature report received on 06 Oct 2011: The authors analyzed clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program. This report refers to a female child. She was one of the triplet and her medical history included recurrent CNS infections by unidentified agents, but which were thought to have been viral. She was developmentally delayed and microcephalic. At the age of 3 years and 9 months, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. Two weeks later, she presented with CNS symptoms similar to those she had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respiratory therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy. The authors concluded that provided evidences were not supportive of direct relationship between a given vaccine and a specific CNS complication. Pathogenesis of majority of the cases was apparent and not a complication of vaccination.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site induration
Clinical narrative: Td clinic 10/5/11 (L) arm upper deltoid with 17x22 cm area of erythema, induration onset 8-12 hours after Tdap. T 101. No pain.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen (L) arm 7 3/4" w/ pain. Unswollen (R) arm 6 3/4. No fever. After cold compresses/swollen has gone down.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Pain/soreness of right shoulder/back area - despite injection given in left arm.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Nasopharyngitis, Petechiae, Platelet count decreased
Clinical narrative: 16 days after receiving vaccine - developed petechiae & mild cold symptoms - resolved 22 days after vaccine given (plt - 146).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Paraesthesia
Clinical narrative: Approximately 4 hours after injection, patient's husband called & said patient was light-headed & "tingly" with no fever. I advised them to go to urgent care because they have no doctor here yet. (Pt also had diarrhea).
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site reaction, Urticaria
Clinical narrative: Patient had a painless welt: 3" x 4" from pharmaject injector & back pain the next morning and mom thinks it could be from injector. On 9/20/11, patient's mom reports lingering back pain and welt has gone down to injection site.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm where injected - became red sore, and swollen at site of injection.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Immediate post-injection reaction, Injection site pruritus
Clinical narrative: Patient received influenza vaccine around 0930 in the morning and reported immediate pruritis around injection site along with difficulty breathing. Was given oral BENADRYL which decreased symptoms.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Nausea, Peripheral coldness, Vomiting
Clinical narrative: Pt started feeling lightheaded, dizzy & nauseated 2 mins after vaccine admin. He ran to the bathroom & vomited undigested oatmeal. His hands were cool to touch. RN stayed with pt in bathroom. He sat on the floor for 15 mins after applying cool H2O to face. He was off balance & holding to wall, assisted him back to chair in the room. BP was 128/88, HR 8, w/c was higher than his usual. He sat for another ten minutes and stated he felt better. He walked out of the room with steady gait. RN reminded him to call back or report back if symptoms persisted. No reply after 2 attempts (calls) by person in office.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: Pt started feeling lightheaded, dizzy & nauseated 2 mins after vaccine admin. He ran to the bathroom & vomited undigested oatmeal. His hands were cool to touch. RN stayed with pt in bathroom. He sat on the floor for 15 mins after applying cool H2O to face. He was off balance & holding to wall, assisted him back to chair in the room. BP was 128/88, HR 8, w/c was higher than his usual. He sat for another ten minutes and stated he felt better. He walked out of the room with steady gait. RN reminded him to call back or report back if symptoms persisted. No reply after 2 attempts (calls) by person in office.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: (R) arm has heat & swelling - redness. Second red area under arm on tricep administered 9/24.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 102.6 within 24hrs of receiving vaccine. TYLENOL.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: Second year for reaction to flu vaccine. Less this yr. - Headache, nausea, no appetite, body aches, cold/diaphoresis. Busy week with heavy patient work load to care for.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Injection site rash, Latex allergy, Pharyngeal oedema, Swollen tongue
Clinical narrative: Patient had a latex allergy to FLUVIRIN Multi-dose vials after Pharmacist confirmed with Novartis that it was latex free. Needle/syringe & glove was also latex-free. Patient had injection site rash & throat/tongue swelled up - was given BENADRYL at nurse's office.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Injection site rash, Latex allergy, Swollen tongue, Throat tightness
Clinical narrative: Patient had a latex allergy to FLUVIRIN Multi-dose vials after Pharmacist confirmed with Novartis that it was latex free. Needle/syringe & glove was also latex-free. Patient had injection site rash & throat/tongue swelled up - was given BENADRYL at nurse's office.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Pain, Swelling
Clinical narrative: Pt. returned to pharmacy and presented with redness below injection site, inner part of arm and on her side also had swelling and was very painful. Located on left side.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Hyperhidrosis, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Sore throat, both arms hurt, sweating, body aches, fatigue. Pt states Saturday afternoon felt a little better & by Sunday was OK.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in jaw, Rash
Clinical narrative: Pt. stated he received Flu vax Tues 10/4/11 and noticed rash on forehead with Rt. sided jaw pain later that day, but no reaction at injection site.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Patient died in crib 48-hours after receiving the series of vaccines identified in Box 13 below. Coroner listed the cause of death as SIDS.
Age: 4.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site mass, Pyrexia, Vomiting
Clinical narrative: Red knot in leg (Rt thigh). Pt did experience fever and vomiting after injection at home. Warm compress, ibuprofen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt received shot in left deltoid (IM) & about 3 inches below developed a red, warm, sore spot about 4 inches in diameter one day after shot. No treatment.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site anaesthesia, Injection site discomfort, Injection site induration, Injection site warmth
Clinical narrative: 24 hours after injection - site warm to touch, 2 1/4 inch area of induration with some discomfort & numbness.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Muscular weakness, Myalgia
Clinical narrative: Day of injection: itching & redness at injection site. Following a.m.: severe leg muscle pain and resultant weakness.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Several hours after receiving the pneumonia shot patient complained of soreness in the injection site and redness & swelling on the upper right arm. The area is warm to touch and is sore. PCP has been contacted. Red and swollen area has spread to entire inner upper arm area 48 hours after injection. MD recommended ice packs and BENADRYL.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Local swelling, Neck pain
Clinical narrative: Pt reported swelling & pain (L) upper arm, (L) axilla and up into base of (L) neck.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Aphagia, Chills, Fatigue, Nausea
Clinical narrative: Achy, nauseous, vomiting, chills, arm very sore, intestinal discomfort. Couldn't eat. Started mid afternoon, continued through the night. Very tired next day, stomach still little upset. Third day much better.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Achy, nauseous, vomiting, chills, arm very sore, intestinal discomfort. Couldn't eat. Started mid afternoon, continued through the night. Very tired next day, stomach still little upset. Third day much better.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Development of shingles on buttocks.
Age: 76.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Blood pressure increased, Mobility decreased, Procedural pain
Clinical narrative: Increased weakness and decreased mobility starting day after received H1N1 vaccination - had trouble getting out of bed next 3 mornings. States has had increased weakness ever since. Dental procedures are more painful afterwards. Another example is increase BP after eye exams. Generally more weak since vaccination.
Age: 10.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Blister, Rash
Clinical narrative: Bilat nares developed blistering that progressed to facial rash on nose and around eyes.
Age: 10.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Blister, Rash, Swelling face
Clinical narrative: Bilat nares developed blistering that progressed to facial rash on nose and around eyes.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dyspnoea, Pruritus generalised, Swelling
Clinical narrative: Within 12 hrs of receiving injection, trouble breathing, intense burning and itching over entire body with various body parts swelling. This resulted in 48 hours of symptoms - unrelieved by medication.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Hyperhidrosis
Clinical narrative: - Coughing & shortness of breath 3 hours after shot given; patient alleviated by sitting in car with AC on. - Chills & sweaty about 4-5 hours after shot that went away on its own.
Age: 96.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma
Clinical narrative: Patient stated he saw a bruise at the site of injection after removing bandage. The bruise starts at site of injection to his elbow. Pt stated no pain and no swelling.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haemorrhage
Clinical narrative: Ecchymosis 11.5x10 cm at injection site and 2 1cm areas dorsal forearm LUE.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Influenza, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Case number PHEH2011US05683 is an initial spontaneous report received from a nurse on 30 Sep 2011: This case refers to a 52-years-old male patient. His medical history included headache, decreased appetite, low grade fever, a tender gland, and swelling in the right area of the gland. These symptoms were started about one week before FLUVIRIN vaccination. He was vaccinated with FLUVIRIN (batch number: 1100601) intramuscularly on 27 Sep 2011. Blood test was reported to be "positive for Influenza A and B". A rapid flu test was performed after vaccination with FLUVIRIN and it was found weakly positive and then went to negative. No exact dates were provided for blood test and rapid flu test. The causality and event outcome were not reported.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Feeling hot
Clinical narrative: Red & pink - given subcutaneously 4in by 3in area. Felt very warm and tired.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria (hives) 1 hr after HepA vaccine.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Nerve root lesion, Pain in extremity, Paraesthesia
Clinical narrative: Paresthesia of left arm & nerve root irritation. Left arm pain & tingling.
Age: 24.0
Sex: F
Vaccine: FLUN3, HEPA, YF
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse events at time of vaccination. After vaccination pt discovered she is pregnant LMP 9-10-11.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Pain & decreased ROM (L) shoulder glenohumeral/deltoid since receiving vaccination in (L) deltoid on 9/6/11. Pain was within 1 hour & persists despite use of NSAID's (ibuprofen). Referring to occupational med provider for further eval & Tx.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctival hyperaemia, Dysphagia, Eye discharge, Eye irritation, Eye pruritus
Clinical narrative: 45 min. after vaccination started having trouble swallowing. Progressed to severe throat swelling and inability to swallow. Eyes started burning and itching with erythematous conjunctiva and green discharge. Tx with Solumedrol IM, and BENADRYL.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: 45 min. after vaccination started having trouble swallowing. Progressed to severe throat swelling and inability to swallow. Eyes started burning and itching with erythematous conjunctiva and green discharge. Tx with Solumedrol IM, and BENADRYL.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Back pain, Inflammation, Local reaction, Muscle spasms, Nerve root lesion
Clinical narrative: Severe local pain at vaccine site on arm. Very severe muscle spasms entire right side of back with deep inflammation around lumbar vertebrae #3. 2 months duration of event treated with trigger point injections. Physical therapy & deep tissue massage.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Vaccination site pain
Clinical narrative: Severe local pain at vaccine site on arm. Very severe muscle spasms entire right side of back with deep inflammation around lumbar vertebrae #3. 2 months duration of event treated with trigger point injections. Physical therapy & deep tissue massage.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: 10/13/2011 Mom called and stated child has welts all over and a high fever. Mom called his doctor who told her to call the Health Department.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Colitis ulcerative, Condition aggravated, Frequent bowel movements, Gastrointestinal pain
Clinical narrative: Headache, runny nose, sore throat. Some mild cramping in colon. 2 - 3 more bowel movements than normal.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, Sigmoidoscopy abnormal
Clinical narrative: Headache, runny nose, sore throat. Some mild cramping in colon. 2 - 3 more bowel movements than normal.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray gastrointestinal tract abnormal
Clinical narrative: Headache, runny nose, sore throat. Some mild cramping in colon. 2 - 3 more bowel movements than normal.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chest pain, Chills, Headache
Clinical narrative: 10:30AM Arm pain and body aches, 2:00 PM Body aches and bad headache, 6:00PM Body aches, throbbing headache, sharp pains shooting up left side of neck, chest pains on right side.  Symptoms lasted until layed down to go to bed approximately 9:00PM; was too weak to nurse her baby.  After 9:00PM chills set in and ran fever of 99.9.  Took some type of flu medication at this time. 10:00PM fever 100.4.  10-12-11 at 12 midnight got extremely hot fever was 100.6, started sweating but fever did not go down.  2:00am fever still 100.6, 5:30am fever at 100.8, couldn't hardly move; call in to worked will not be in. 6:00AM fever broke.  Achy all day fever back 99.9 at 2:00PM.  4:00PM fever finally gone felt better.  Returned to work 10/13/11 still a little weak but feeling much better.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: 10:30AM Arm pain and body aches, 2:00 PM Body aches and bad headache, 6:00PM Body aches, throbbing headache, sharp pains shooting up left side of neck, chest pains on right side.  Symptoms lasted until layed down to go to bed approximately 9:00PM; was too weak to nurse her baby.  After 9:00PM chills set in and ran fever of 99.9.  Took some type of flu medication at this time. 10:00PM fever 100.4.  10-12-11 at 12 midnight got extremely hot fever was 100.6, started sweating but fever did not go down.  2:00am fever still 100.6, 5:30am fever at 100.8, couldn't hardly move; call in to worked will not be in. 6:00AM fever broke.  Achy all day fever back 99.9 at 2:00PM.  4:00PM fever finally gone felt better.  Returned to work 10/13/11 still a little weak but feeling much better.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 10:30AM Arm pain and body aches, 2:00 PM Body aches and bad headache, 6:00PM Body aches, throbbing headache, sharp pains shooting up left side of neck, chest pains on right side.  Symptoms lasted until layed down to go to bed approximately 9:00PM; was too weak to nurse her baby.  After 9:00PM chills set in and ran fever of 99.9.  Took some type of flu medication at this time. 10:00PM fever 100.4.  10-12-11 at 12 midnight got extremely hot fever was 100.6, started sweating but fever did not go down.  2:00am fever still 100.6, 5:30am fever at 100.8, couldn't hardly move; call in to worked will not be in. 6:00AM fever broke.  Achy all day fever back 99.9 at 2:00PM.  4:00PM fever finally gone felt better.  Returned to work 10/13/11 still a little weak but feeling much better.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Influenza like illness, Malaise, Myalgia
Clinical narrative: Moderate fever (102F); chills; congestion (sinus/chest); muscle aches; malaise; cough; sore throat - identical to influenza symptoms, lasting 9 days.  NOTE: Not every dose of vaccine can be QC tested for complete inactivation - which is my friggin' concern here.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pulmonary congestion, Pyrexia, Sinus congestion
Clinical narrative: Moderate fever (102F); chills; congestion (sinus/chest); muscle aches; malaise; cough; sore throat - identical to influenza symptoms, lasting 9 days.  NOTE: Not every dose of vaccine can be QC tested for complete inactivation - which is my friggin' concern here.