chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of anaphylactic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 27 September 2011 the subject received a dose of FLULAVAL. On 27 September 2011, less than one day after vaccination with FLULAVAL, the subject experienced anaphylactic reaction. The subject was hospitalised and the pharmacist considered the event was disabling, life threatening and clinically significant (or requiring intervention). On 28 September 2011, the event was resolved. The pharmacist considered the event was probably related to vaccination with FLULAVAL. This event occurred in a total of three subjects. Linked cases include: A0946500A and A0946501A. Follow-up information was received on 15 November 2011. It was reported that the subject was a 28 year old female. She received a dose of FLULAVAL on 27 September 2011, intramuscularly in the left deltoid. The same day, on 27 September 2011, the subject experienced an anaphylactic reaction. She was treated with BENADRYL, epinephrine and SOLUMEDROL, intravenously with normal saline. The event resolved the same day. In the reporter's opinion, the event was probably related to vaccination with FLULAVAL.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of anaphylactic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 27 September 2011 the subject received a dose of FLULAVAL. On 27 September 2011, less than one day after vaccination with FLULAVAL, the subject experienced anaphylactic reaction. The subject was hospitalised and the pharmacist considered the event was disabling, life threatening and clinically significant (or requiring intervention). On 28 September 2011, the event was resolved. The pharmacist considered the event was probably related to vaccination with FLULAVAL. This event occurred in a total of three subjects. Linked cases include: A0946492A and A0946501A. Follow-up information was received on 15 November 2011. It was reported that the subject was a 33 year old female. Medical history was significant for Heparin, Gluten and Bee Sting (Bee Venom) allergies. The subject received a dose of FLULAVAL on 27 September 2011, intramuscularly in the left deltoid. The same day, on 27 September 2011, the subject experienced an anaphylactic reaction. She was treated with BENADRYL, Epinephrine and SOLUMEDROL, intravenously with normal saline. The event resolved the same day. In the reporter's opinion, the event was probably related to vaccination with FLULAVAL.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 37-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 September 2011 at 14:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left deltoid). On 21 September 2011, 1 day after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and rash on chest and back. At the time of reporting the events were unresolved. Follow-up information was received on 02 December 2011. It was reported that the events of injection site redness, swelling injection site and rash began on the day of vaccination, 20 September 2011. They resolved 8 days later on 27 September 2011.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of anaphylactic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 27 September 2011 the subject received a dose of FLULAVAL. On 27 September 2011, less than one day after vaccination with FLULAVAL, the subject experienced anaphylactic reaction. The subject was hospitalised and the pharmacist considered the event was disabling, life threatening and clinically significant (or requiring intervention). On 28 September 2011, the event was resolved. The pharmacist considered the event was probably related to vaccination with FLULAVAL. This event occurred in a total of three subjects. Linked cases include: A0946492A and A0946500A. Follow-up information was received on 15 November 2011. It was reported that the subject was a 29 year old female. Anaphylactic reaction occurred the day after vaccination with FLULAVAL (intramuscularly in the left deltoid) on 28 September 2011. BENADRYL was given as treatment. The event resolved the same day, 28 September 2011. In the reporter's opinion, the event was probably related to FLULAVAL administration.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer (who was also the subject) and described the occurrence of fever in a 71-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included resection of adrenal gland. Concurrent medical conditions included Cushing's syndrome. Concurrent medications included Clonidine, LOSARTAN, LOPRESSOR, NORVASC, Hydrocortisone, FLORINEF, ZETIA, Simvastatin and Aspirin. On 10 November 2011 at 16:00 the subject received a dose of FLULAVAL (.25 ml, unknown route, right arm) and experienced vaccine underdose. The subject was administered 0.25 ml instead of the indicated dose of 0.5 ml for FLULAVAL. On 10 November 2011, less than one day after vaccination with FLULAVAL, the subject experienced fever, tremor of whole body and chills. The subject had "similar reactions" starting 10 years ago when she first began to get the flu shot. On 11 November 2011, the events were resolved.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Pyrexia, Tremor, Underdose
Clinical narrative: This case was reported by a consumer (who was also the subject) and described the occurrence of fever in a 71-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included resection of adrenal gland. Concurrent medical conditions included Cushing's syndrome. Concurrent medications included Clonidine, LOSARTAN, LOPRESSOR, NORVASC, Hydrocortisone, FLORINEF, ZETIA, Simvastatin and Aspirin. On 10 November 2011 at 16:00 the subject received a dose of FLULAVAL (.25 ml, unknown route, right arm) and experienced vaccine underdose. The subject was administered 0.25 ml instead of the indicated dose of 0.5 ml for FLULAVAL. On 10 November 2011, less than one day after vaccination with FLULAVAL, the subject experienced fever, tremor of whole body and chills. The subject had "similar reactions" starting 10 years ago when she first began to get the flu shot. On 11 November 2011, the events were resolved.
Age: 1.35
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Child has chickenpox. Has vesicles in face, ears, arms, hands, abdomen, back, etc.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture negative, Blood electrolytes normal, Body temperature increased, Chest X-ray normal, Culture urine negative
Clinical narrative: At 5:30am on 2/03/12 awoke fussy, with temp 101.3, began shaking in Dad's arms, generalized seizure activity lasted over 20 minutes (as long as 30 min) given IM VERSED by ambulance personnel and brought to ER. CBC, electrolytes, blood culture, urine culture, CXR normal no further seizures/seizure activity.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Irritability, Seizure like phenomena, Tremor
Clinical narrative: At 5:30am on 2/03/12 awoke fussy, with temp 101.3, began shaking in Dad's arms, generalized seizure activity lasted over 20 minutes (as long as 30 min) given IM VERSED by ambulance personnel and brought to ER. CBC, electrolytes, blood culture, urine culture, CXR normal no further seizures/seizure activity.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Musculoskeletal pain, Neck mass, Pyrexia
Clinical narrative: Severe pain in the left shoulder along with fevers up to 102 x 1-2 days. Noticed lump on her neck 2 days later. Also c/o tiredness tiredness and fevers lasted for 3 days. Given LEVAQUIN 500 mg for possible infection.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pyrexia
Clinical narrative: 2 mm x 2 mm area of redness with mild fever.
Age: 28.0
Sex: M
Vaccine: TTOX
Symptoms: Diarrhoea, Fatigue, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Dnr woke up at 630 am on 2-12-12 c/o fever, nausea, fatigue & diarrhea and was sweating. Degree of temp unknown - Donor did not take temp. This lasted for three days.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local reaction, Urticaria
Clinical narrative: Vaccine administered on 2/17/12 patient came in on 2/19/12 and showed me a local reaction (wheal & flare) of about 2" x 3".
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray normal, Cough, Erythema, Headache, Injection site pain
Clinical narrative: Vaccine administered on 2/17/12 patient came in on 2/19/12 and showed me a local reaction (wheal & flare) of about 2" x 3".
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Oedema peripheral, Pain, Pain in extremity, Pleurisy
Clinical narrative: Vaccine administered on 2/17/12 patient came in on 2/19/12 and showed me a local reaction (wheal & flare) of about 2" x 3".
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Vaccine administered on 2/17/12 patient came in on 2/19/12 and showed me a local reaction (wheal & flare) of about 2" x 3".
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Sore arm, just like when I got the flu shot. It never got any better. It hurts when I raise my arm over my head, and I sleep on my left side. I had the shot in my left arm. The pain wakes me up at night.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Administered IM instead of SC.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Blood thyroid stimulating hormone normal, Burning sensation, Cardiomyopathy, Chest pain
Clinical narrative: Tachycardia and diaphoresis within 1/2 hour of vaccine administration, required ER eval where received IV beta blocker, IV fluids and started on oral beta blocker for persistent sinus tachycardia. Also had migrating burning sensation in chest, intermittent chest pain, mild paresthesia and intermittent diaphoresis. Aware of sensation of hypercontractility of heart. Remain on beta blocker with planned follow-up with cardiologist in April.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram abnormal, Feeling abnormal, Haematocrit normal, Hyperhidrosis, Paraesthesia
Clinical narrative: Tachycardia and diaphoresis within 1/2 hour of vaccine administration, required ER eval where received IV beta blocker, IV fluids and started on oral beta blocker for persistent sinus tachycardia. Also had migrating burning sensation in chest, intermittent chest pain, mild paresthesia and intermittent diaphoresis. Aware of sensation of hypercontractility of heart. Remain on beta blocker with planned follow-up with cardiologist in April.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus tachycardia, Stress echocardiogram abnormal, Troponin normal
Clinical narrative: Tachycardia and diaphoresis within 1/2 hour of vaccine administration, required ER eval where received IV beta blocker, IV fluids and started on oral beta blocker for persistent sinus tachycardia. Also had migrating burning sensation in chest, intermittent chest pain, mild paresthesia and intermittent diaphoresis. Aware of sensation of hypercontractility of heart. Remain on beta blocker with planned follow-up with cardiologist in April.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: C-reactive protein increased, Oedema peripheral, Red blood cell sedimentation rate increased
Clinical narrative: Patient had swelling of hands & feet x 2 months.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Expired drug administered, Malaise
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sick in a 59-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 15 September 2011 at 16:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm) and experience expired vaccine used (expired May 2011). On 15 September 2011, less than one month after vaccination with FLULAVAL, the subject experienced sick. The subject who received the vaccine called out sick afterwards. At the time of reporting the outcome of the sick was unspecified.
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash on trunk in a male subject aged between 50 and 59 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 9 September 2011 at 15:00 the subject received a single dose of FLULAVAL at 0.5 ml in the left arm. On an unspecified date in September 2011, less than one week after vaccination with FLULAVAL, the subject experienced rash on trunk. At the time of reporting the event was unresolved.
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of influenza symptoms in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2011 the subject received a dose of FLULAVAL. In 2011, less than one year after vaccination with FLULAVAL, the subject experienced severe influenza symptoms. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with FLULAVAL. On 2 November 2007 the subject received unspecified dose of FLULAVAL in an unknown arm. Immediately after vaccination with FLULAVAL, the subject experienced an injection site reaction. On 4 November 2007, the event was resolved.
Age: 25.0
Sex: F
Vaccine: HPV2
Symptoms: Chills, Fatigue, Influenza like illness, Nausea
Clinical narrative: This case was reported by a physician via a GSK sales representative and described the occurrence of chills in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 21 November 2011 the subject received 1st dose of CERVARIX (.5 ml, unknown route). On 21 November 2011, 2 hours after vaccination with CERVARIX, the subject experienced chills, nausea, flu-like symptoms and tiredness. Duration of symptoms was provided as 36 hours with an end date of 23 November 2011. The physician indicated the outcome of the events as unknown. The physician considered the events were possibly related to vaccination with CERVARIX. Follow-up information was received on 17 January 2012 from a healthcare professional. Concurrent medications included NUVARING. On 23 November 2011, the events resolved. It was reported that the subject had no further symptoms after 36 hours. The subject declined further CERVARIX vaccines.
Age: 25.0
Sex: F
Vaccine: HPV2
Symptoms: Injection site mass, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site lump in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline; unknown; left arm) given on 22 September 2011 at 13:00. On 21 October 2011 at 12:30 the subject received 2nd dose of CERVARIX (.5 ml, unknown route, left arm). On an unspecified date in October 2011, less than one month after vaccination with CERVARIX, the subject experienced injection site lump. At the time of reporting the event was unresolved. Follow up information received from the healthcare professional on 13 January 2012. The healthcare professional contacted the subject in mid November 2011 and the subject reported to the healthcare professional the she was doing "well" and had just a little tenderness in her arm. At the time of the follow up report, the events were resolved.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: This case was reported by a physician, via a GSK sales representative, and described the occurrence of swelling injection site in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 October 2011 the subject received 2nd dose of CERVARIX (details unknown). On 27 October 2011, 3 days after vaccination with CERVARIX, the subject experienced swelling injection site, injection site redness, injection site pruritus and injection site inflammation. The itching was described as "more than normal". At the time of reporting the outcome of the events was unspecified.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Local swelling
Clinical narrative: Immunization was given in Left arm SQ. Next day area swollen, per staff, approximately 4" x 3". Youth c/o itching at site along with pain. Youth was given an ice pack along with Ibuprofen and staff monitored.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient's upper arm swelling. No rash. No SOB. No chills/fever.
Age: 55.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Severe pain in shoulder, constantly for the months following and now with moving certain positions of arm and while laying on left side. Unable to use arm normally.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Death neonatal, Maternal exposure during pregnancy, Premature delivery
Clinical narrative: Case number PHHY2012US013581 is an initial literature report received on 14 Feb 2012. The authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to a neonate whose mother was vaccinated with H1N1 (manufacturer and batch number: unknown) at an unknown gestational period between 01 Oct 2009 to 28 Feb 2010. She had a preterm delivery (see linked case: PHHY2012US013562) on unspecified date and gave birth to this child. The neonate died approximately one month after delivery (reason unspecified). The causality of the case was not reported. The authors stated that the VAERS database search did not reveal any clustering of spontaneous abortions, still births or congenital anomalies. Authors concluded that the pregnant women who were vaccinated with 2009 H1N1 vaccination with inactivated and live vaccines did not show unusual pattern of maternal or fetal outcome.
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose, Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included diabetes. Concurrent medications included insulin. On 19 December 2010 the subject received a dose of FLULAVAL (.8 ml, subcutaneous, unknown) accidentally through his insulin pump and experienced inappropriate route of vaccination and unintentional  overdose. On 19 December 2010, less than one week after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the unintentional overdose and injection site redness were unspecified.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site haemorrhage, Injection site scab, Injection site ulcer
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sore developed at injection site in a 68-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 26 August 2011 at 11:30 the subject received unspecified dose of FLULAVAL (unknown, left arm) and experienced inappropriate route of vaccination. On 19 September 2011, 24 days after vaccination with FLULAVAL, the subject experienced a dime sized opened sore on arm to the injection site [sore developed at injection site], a scab had formed over the sore, fell off and she has been unable to stop the bleeding. The physician felt like the vaccine was injected between skin and muscle instead of directly into the muscle. At the time of reporting the sore developed at injection site, injection site scab and injection site bleeding were unresolved.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Dry eye, Eye swelling, Lip dry, Ocular hyperaemia
Clinical narrative: This case was reported by a consumer and described the occurrence of redness of eyes in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 26 October 2010 at 10:00 the subject received a dose of FLULAVAL (unknown). In October 2010 (dates not specified), less than one month after vaccination with FLULAVAL, the subject experienced redness of eyes, swollen eyes, dry eyes and dry lips. The subject was seen by an allergist on 06 January 2011 and had a skin allergy test that showed she was allergic to thimerosal. The subject was never allergic to thimerosal before. At the time of reporting the events were unresolved.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Reaction to preservatives
Clinical narrative: This case was reported by a consumer and described the occurrence of redness of eyes in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 26 October 2010 at 10:00 the subject received a dose of FLULAVAL (unknown). In October 2010 (dates not specified), less than one month after vaccination with FLULAVAL, the subject experienced redness of eyes, swollen eyes, dry eyes and dry lips. The subject was seen by an allergist on 06 January 2011 and had a skin allergy test that showed she was allergic to thimerosal. The subject was never allergic to thimerosal before. At the time of reporting the events were unresolved.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema of eyelid, Eyelid oedema, Eyelids pruritus, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of hive in a 49-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) . A physician or other health care professional has not verified this report. The consumer reported that she had previously received flu vaccine (unspecified manufacturer) in 2008 and had experienced a "slight reaction" of breaking out in hives which resolved with BENADRYL. She received flu vaccines (unspecified manufacturer) in 2009 and 2010 and experienced no adverse events. Concurrent medications included unknown (unspecified medication). On 1 September 2011 at 9:00 the subject received 1st dose of FLULAVAL (.5 cc, unknown route, right arm). The lot number was reported as AFLLA6838A from the reporter; however, based on safety lot number review, the lot number was updated to AFLLA683BA. On 1 September 2011, 2 hours after vaccination with FLULAVAL, the subject experienced hives, swollen eye lid, erythema of eyelid, itchy eyelids and itching. The subject developed hives on inside of both elbows 2 hours after vaccination with FLULAVAL. Her eyelids then became swollen, red and itchy. At the time of reporting, the hives were on her chest, upper arms and legs, and the subject was itching "like crazy" and stated that "it looks terrible". The subject consulted a physician and reported that the physician told her that because she was not allergic to eggs, it is probably the preservative in the shot. The subject was treated with BENADRYL. At the time of reporting the events were worse.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional  and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that 5 subjects had received FLULAVAL and had experienced injection site pain. This is case 1 of 5 (see case IDs A0949593A-A0949596A for details of the other reports).
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of cold in a 8-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma. Concurrent medications included inhaler. On 17 September 2011 the subject received a dose of FLULAVAL (unknown route, left arm), and experienced wrong vaccine administered. The subject was younger than the indicated age for administration of FLULAVAL. On 07 October 2011, 20 days after vaccination with FLULAVAL, the subject experienced cold, cough and runny nose. At the time of reporting the outcome of the events was unspecified. The consumer reported that her two children had experienced adverse events after vaccination with FLULAVAL. See case ID A0949172A for details of the other report. Follow-up received from a healthcare professional on 07 October 2011: The healthcare professional  reported that the subject received FLULAVAL vaccination at the father's work clinic. The healthcare professional reported the maladministration only and did not provide any adverse event information.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Extensive swelling of vaccinated limb, Influenza like illness, Pruritus
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of extensive swelling of vaccinated limb in a 84-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included flu like symptoms following previous flu shots. The subject reported that she had received flu shots for several years, but had never experienced such a reaction. Concurrent medical conditions included hypertension. On 3 October 2011 at 13:30 the subject received a dose of FLULAVAL (unknown route, right arm). The lot number was reported as AFFLLA669AA from the reporter; however, based on a safety lot number review, the lot number was updated to AFLLA669AA. On 3 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced extensive swelling of vaccinated limb, arm burning upon injection, itching near injection site and erythema near injection site. The subject reported that the extensive swelling, burning and redness occurred at the inner aspect of her right arm (arm of vaccination), but not at the site of the injection. The size of her arm had doubled. She also experienced flu-like symptoms. At the time of reporting the outcome of the events was unspecified.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of stomach cramps in a 9-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 17 September 2011 the subject received a dose of FLULAVAL (unknown route, left arm), and experienced wrong vaccine administered. The subject was younger than the indicated age for administration of FLULAVAL. On 3 October 2011, 16 days after vaccination with FLULAVAL, the subject experienced stomach cramps. On 4 October 2011, the event was resolved. The consumer reported that her two children had experienced adverse events after vaccination with FLULAVAL. See case ID A0949171A for details of the other report. Follow-up received from a healthcare professional on 07 October 2011: Concomitant medications included salbutamol sulphate. The healthcare professional reported that the subject received FLULAVAL vaccination at his father's work clinic. The healthcare professional reported the maladministration only and did not provide any adverse event information.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Maternal exposure during pregnancy, Nasopharyngitis, Pyrexia
Clinical narrative: This prospective pregnancy case was reported by a consumer (also the subject) and described the occurrence of injection site soreness in a 20-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medications included TYLENOL and prenatal vitamins. On 5 October 2011 at 12:30 the subject received a dose of FLULAVAL (unknown route, left arm), and experienced vaccine exposure during the first trimester of her pregnancy. Date of last menstrual period was not provided. Estimated deliver date was 01 June 2012. On 5 October 2011, 30 minutes after vaccination with FLULAVAL, the subject experienced injection site soreness. On 6 October 2011, she experienced sensation of fever. On 7 October 2011, she experienced headache. On 8 October 2011, the subject began "feeling stuffy" (stuffiness [nos]) and thought that she was getting a cold. The injection site soreness resolved on 6 October 2011. The sensation of fever and headache resolved on 7 October 2011. At the time of reporting the events of stuffiness and cold were worse. The consumer considered that the stuffiness and cold were not related to vaccination with FLUARIX, but that the other events were possibly related.
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: This prospective pregnancy case was reported by a consumer (also the subject) and described the occurrence of injection site soreness in a 20-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medications included TYLENOL and prenatal vitamins. On 5 October 2011 at 12:30 the subject received a dose of FLULAVAL (unknown route, left arm), and experienced vaccine exposure during the first trimester of her pregnancy. Date of last menstrual period was not provided. Estimated deliver date was 01 June 2012. On 5 October 2011, 30 minutes after vaccination with FLULAVAL, the subject experienced injection site soreness. On 6 October 2011, she experienced sensation of fever. On 7 October 2011, she experienced headache. On 8 October 2011, the subject began "feeling stuffy" (stuffiness [nos]) and thought that she was getting a cold. The injection site soreness resolved on 6 October 2011. The sensation of fever and headache resolved on 7 October 2011. At the time of reporting the events of stuffiness and cold were worse. The consumer considered that the stuffiness and cold were not related to vaccination with FLUARIX, but that the other events were possibly related.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 October 2011 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination, the subject experienced fever, headache, muscle pain and joint pain. At the time of reporting the events were improved. Follow up received from the nurse practitioner on 08 November 2011. On 6 October 2011 the subject received a dose of FLULAVAL (0.5 ml, unknown route, left deltoid). On 08 October 2011, approximately two days after the vaccination with FLULAVAL, the patient experienced fever, headache, muscle pain and joint pain. The lot number was provided by the nurse practitioner. At the time of the follow up report, the events were improved.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Eye swelling, Fatigue, Headache, Influenza like illness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lip swelling in a 56-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included arteriovenous malformation requiring brain surgery. Concurrent medical conditions included diabetes, high blood pressure, migraine, seizure and skin cancer (recent diagnosis). The migraine and seizure were a result of the brain surgery and were under care of a neurologist. Concurrent medications included verapamil, pravastatin, LEXAPRO, topiramate, metformin, vitamin D, fish oil, vitamin B12 and PRILOSEC. On an unspecified date "last year" (2010), the subject received a dose of INFLUENZA (unknown manufacturer). Two days after vaccination with influenza vaccine, the subject experienced flu-like symptoms of fever and pain ("achiness"). The events resolved after approximately 24 hours. The subject reported that last year was the first year she had experienced adverse events after receiving the flu vaccine. On 28 September 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 10 October 2011, 12 days after vaccination with FLULAVAL, the subject experienced lip swelling which got worse. She also experienced hives from head to toe. She was seen in her local emergency room because her eyes were almost swollen shut. The subject reported that she couldn't speak well because of her lips (speaking problem), but did think that the swelling had decreased. The subject also experienced headache, nocturnal awakening, nausea, upset stomach and flu like symptoms of sore throat and tiredness. The subject was treated with prednisone, ALLEGRA, PREVACID and famotidine. At the time of reporting the events of lip swelling, eyes almost swollen shut and speaking problem were improved. The event of hives was worse, and the outcome of the other events was unspecified.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Middle insomnia, Nausea, Oropharyngeal pain, Speech disorder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lip swelling in a 56-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included arteriovenous malformation requiring brain surgery. Concurrent medical conditions included diabetes, high blood pressure, migraine, seizure and skin cancer (recent diagnosis). The migraine and seizure were a result of the brain surgery and were under care of a neurologist. Concurrent medications included verapamil, pravastatin, LEXAPRO, topiramate, metformin, vitamin D, fish oil, vitamin B12 and PRILOSEC. On an unspecified date "last year" (2010), the subject received a dose of INFLUENZA (unknown manufacturer). Two days after vaccination with influenza vaccine, the subject experienced flu-like symptoms of fever and pain ("achiness"). The events resolved after approximately 24 hours. The subject reported that last year was the first year she had experienced adverse events after receiving the flu vaccine. On 28 September 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 10 October 2011, 12 days after vaccination with FLULAVAL, the subject experienced lip swelling which got worse. She also experienced hives from head to toe. She was seen in her local emergency room because her eyes were almost swollen shut. The subject reported that she couldn't speak well because of her lips (speaking problem), but did think that the swelling had decreased. The subject also experienced headache, nocturnal awakening, nausea, upset stomach and flu like symptoms of sore throat and tiredness. The subject was treated with prednisone, ALLEGRA, PREVACID and famotidine. At the time of reporting the events of lip swelling, eyes almost swollen shut and speaking problem were improved. The event of hives was worse, and the outcome of the other events was unspecified.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lip swelling in a 56-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included arteriovenous malformation requiring brain surgery. Concurrent medical conditions included diabetes, high blood pressure, migraine, seizure and skin cancer (recent diagnosis). The migraine and seizure were a result of the brain surgery and were under care of a neurologist. Concurrent medications included verapamil, pravastatin, LEXAPRO, topiramate, metformin, vitamin D, fish oil, vitamin B12 and PRILOSEC. On an unspecified date "last year" (2010), the subject received a dose of INFLUENZA (unknown manufacturer). Two days after vaccination with influenza vaccine, the subject experienced flu-like symptoms of fever and pain ("achiness"). The events resolved after approximately 24 hours. The subject reported that last year was the first year she had experienced adverse events after receiving the flu vaccine. On 28 September 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 10 October 2011, 12 days after vaccination with FLULAVAL, the subject experienced lip swelling which got worse. She also experienced hives from head to toe. She was seen in her local emergency room because her eyes were almost swollen shut. The subject reported that she couldn't speak well because of her lips (speaking problem), but did think that the swelling had decreased. The subject also experienced headache, nocturnal awakening, nausea, upset stomach and flu like symptoms of sore throat and tiredness. The subject was treated with prednisone, ALLEGRA, PREVACID and famotidine. At the time of reporting the events of lip swelling, eyes almost swollen shut and speaking problem were improved. The event of hives was worse, and the outcome of the other events was unspecified.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at shot site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Little sore, Friday night (started working Sat/had fever). It blew up to size of the orange. It is going down. Went to MD 2/20/13. Prescribed antibiotic & warm compresses.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site, 3" long inside and lighter red 5" oval. Redness subsiding so no treatment used.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Caesarean section, Death, Live birth, Maternal exposure during pregnancy, Post procedural complication
Clinical narrative: Case number PHHY2012US012947 is an initial literature report received on 14 Feb 2012. The authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System (VAERS). This case refers to a female patient (age not specified). She was vaccinated with H1N1 (manufacturer and batch number: unknown) between 01 Oct 2009 to 28 Feb 2010. She was pregnant at the time of vaccination. On an unspecified date she had a cesarean section and she gave birth to a live neonate. Following caesarean the patient experienced uterine atony which led to hemorrhagic shock. The patient died due to hemorrhagic shock. The causality of the case was not reported. The authors stated that the VAERS database search did not reveal any clustering of spontaneous abortions, still births or congenital anomalies. Authors concluded that the pregnant women who were vaccinated with H1N1 inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Shock haemorrhagic, Uterine atony
Clinical narrative: Case number PHHY2012US012947 is an initial literature report received on 14 Feb 2012. The authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System (VAERS). This case refers to a female patient (age not specified). She was vaccinated with H1N1 (manufacturer and batch number: unknown) between 01 Oct 2009 to 28 Feb 2010. She was pregnant at the time of vaccination. On an unspecified date she had a cesarean section and she gave birth to a live neonate. Following caesarean the patient experienced uterine atony which led to hemorrhagic shock. The patient died due to hemorrhagic shock. The causality of the case was not reported. The authors stated that the VAERS database search did not reveal any clustering of spontaneous abortions, still births or congenital anomalies. Authors concluded that the pregnant women who were vaccinated with H1N1 inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Red swollen.
Age: 53.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia oral, VIIth nerve paralysis
Clinical narrative: About 2 hours after receiving injection he started having tingling of his upper lip and side of his mouth. On 12-13-11 had paralysis on the right side of his face without any slurred speech or other motor s/s or other weakness or neuro s/s.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dysmorphism, Eye pain, Eyelid oedema, Joint dislocation, Pachymeningitis
Clinical narrative: Dolor de cabeza fuerte detras del ojo, se cerro el ojo y desplazamiento de mandibula. Se me viro la cara del lado derecho.
Age: 60.0
Sex: F
Vaccine: TTOX
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient complains of pain and tenderness near injection site @ left deltoid, she also has decreased ROM in abduction of left arm.  MD gave diagnosis of questionable bursitis and ordered patient to start Ibuprofen 400-800 mg every 8 hours and advises use of heat or ice.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dyskinesia, Grunting
Clinical narrative: BABY STARTED TO HAVE JERKING OF THE LEGS AND ARMS, TURNING HEAD, GRUNTING WITH EACH JERK, REPEATED 4 TIMES IN 4 HOURS.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Papule, Skin warm, Urticaria
Clinical narrative: Red papules and few hives on back of arm, warmth.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Upper respiratory tract infection
Clinical narrative: Developed headache Tuesday 2/14/12. Wed. 2/13/12 went to her PCP and was diagnosed with an upper URI (antibiotics begun). PCP felt headache from Gardasil. Told by our office staff to call if headache persists.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Spinal disorder
Clinical narrative: Pt complained of numbness and went to the doctor on 11/14/2011. Later the doctor found a lesion on the spine after many MRI's.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash spreading over 45 hours around arm to elbow, then fading over 24 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mass, Staphylococcal infection
Clinical narrative: I felt a pea-size lump on my left groin (mons pubis) and by February 2nd it grew to the size of a walnut; feeling dense and thick. I went to the doctors who felt it was a staph infection. I took anitbiotics for 10days 4x/day. I had one severe like this in 1987 after gall bladder surgery on my inner knee. Nothing so extreme before.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin lesion
Clinical narrative: 1.5 inch red, raised circular, painful lesion.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that 5 had received FLULAVAL and had experienced injection site pain. This is case 2 of 5 (see case IDs A0949586A, A0949594A-A0949596A for details of the other reports).
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, swelling at injection site notified to use BENADRYL, TYLENOL & ice.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh appeared red, swollen, hot to touch and painful on 2/16/12. Mother took pt to ER 2/16/12 and pt was diagnosed with (R) thigh cellulitis.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fatigue, Feeling hot, Pain
Clinical narrative: About 40 min after vaccine patient became hot, weak, light-headed. Pain started from shoulders to feet, feeling "like someone was beating her up." Pain left after 3 hrs. Patient left worn out.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Cognitive disorder, Insomnia, Musculoskeletal chest pain
Clinical narrative: Arm, shoulder sore, impaired perception, joint muscle pain which kept her awake. Pain in her upper back & ribs (approx 3 days).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Arm, shoulder sore, impaired perception, joint muscle pain which kept her awake. Pain in her upper back & ribs (approx 3 days).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 4 cm region of erythema with swelling.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that 5 subjects had received FLULAVAL and had experienced injection site pain. This is case 3 of 5 (see case IDs A0949586A, A0949593A, A0949595A, A0949596A for details of the other reports).
Age: 9.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Warm to the touch & red.