chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5 C for 102 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5 C for 78 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5 C for 137.5 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Growth retardation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (non-gsk); Sanofi; unknown; unknown given on 13 June 2012; PREVNAR 13 (non-gsk); Wyeth Labs; unknown; unknown given on 13 June 2012. On 13 June 2012 at 12:00 the subject received a dose of KINRIX (.5 ml, unknown route, right thigh) and experienced inappropriate age at vaccine administration and vaccine administered at inappropriate site. The subject was younger than the indicated age for KINRIX and the preferred site for administration is in the deltoid. KINRIX is indicated to be used for the fifth dose in the DTaP series and the fourth dose in the IPV series. The healthcare professional reported a second case with KINRIX. See case A0982926A for details. Follow-up information was received on 16 August 2012 via consumer. Concurrent medical history included low weight and length, the subject is in the 3rd percentile. The consumer reported, his son, the subject, received the KINRIX vaccine on 13 June 2012 at 10:00 (previously reported 12:00). The subject "should not have received it until he was 4-years-old (at time of vaccination he was 4-months-old). The reporter "felt his son's growth had slowed after receiving the vaccine according to the growth chart" [decreased growth rate]. The outcome of decreased growth rate was unspecified. Follow-up information was received on 05 October 2012 via physician. The physician attributed the events to the subject's height and weight percentile prior to receipt of KINRIX was at 77 percent at four days, 2.68 percent at 15 days, 3.79 percent at 2 months, 8.14 percent at 4 months, 3.83 percent at 6 months. The subject has been on the lower side of growth chart since birth. The physician reported the immunization series with KINRIX was discontinued and they have continued with PENTACEL.
Sex: U
Vaccine: DTAPIPV, FLUX
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site infection, Wrong technique in drug usage process
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline), Influenza vaccine unspecified. In November or December 2011 the subject received a dose of KINRIX (unknown arm) and unspecified dose of Influenza vaccine unspecified (unknown arm) on the same day. Less than a year after vaccination with Influenza vaccine unspecified and KINRIX, the subject experienced injection site redness, allergic reaction at injection site, injection site infection and wrong injection technique. The subject was administered KINRIX and flu vaccine at the same time in the same arm a "few months ago" ("November or December 2011"). The subject developed a "big red area around the injection sites". The ID [Infectious Disease] physician was trying to determine whether the subject experienced an allergic reaction or infection and whether related to two injections given too close together. The physician stated the "incident had been reported". At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 07 September 2012 via healthcare professional who reported "This case was previously reported by another provider-no sequelae". At the time of the report no other information was provided.
Age: 0.3
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Injection site swelling, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of swelling injection site in a 4-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On the morning of 27 August 2012, the subject received a dose of KINRIX (.5 ml, unknown route, left thigh) as the 2nd dose in series and experienced wrong vaccine administered and vaccine administered at inappropriate site. The subject was younger than the indicated age for KINRIX. KINRIX is indicated to be used as the fifth dose in the DTaP series and the fourth dose in the IPV series. The preferred site for injection is the deltoid. On 29 August 2012, 2 days after vaccination with KINRIX, the subject experienced swelling injection site. The swelling was less than a centimeter 3 days post vaccination. The subject was "mistakenly given KINRIX on 27 August 2012 for the second dose in the primary series. The subject went to an alternate physician (reporter) 3 days later with swelling less than or approximately a centimeter at injection site. The subject had no fever or other discomfort. The physician refused to provide contact information for follow-up. At the time of reporting the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV, FLU3
Symptoms: Immediate post-injection reaction, Product quality issue, Rash
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; GlaxoSmithKline; unknown; unknown given in 2012. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). In 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of the bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out into a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX with KINRIX and that subject still broke out with a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product"; there were six doses remaining to be returned to GSK for investigation. This is 1 of 4 subjects reported by the physician, for the other cases please see A1004135A - A1004137A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA(and similar batches:AC20B235). There is as of today, no report linked to that batch other than the ones linked to this complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information, it is unlikely that the reported events are related to a manufacturing problem.
Sex: U
Vaccine: DTAPIPV, FLU3
Symptoms: Immediate post-injection reaction, Product quality issue, Rash
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; GlaxoSmithKline; unknown; unknown given in 2012. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). In 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out into a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX and KINRIX and that subject still broke out with a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product"; there were six doses remaining to be returned to GSK for investigation. This is 2 of 4 subjects reported by the physician, for the other cases please see A1004132A, A1004136A and A1004137A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA (and similar batches: AC20B235). There is as of today, no report linked to that batch other than the ones linked to this complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information, it is unlikely that the reported events are related to manufacturing problem.
Sex: U
Vaccine: DTAPIPV, FLU3
Symptoms: Immediate post-injection reaction, Product quality issue, Rash
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; GlaxoSmithKline; unknown; unknown given in 2012. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). On 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of the bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out into a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX with KINRIX and that subject still broke out with a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product"; there were six doses remaining to be returned to GSK for investigation. This is 3 of 4 subjects reported by the physician, for the other cases please see A1004132A, A1004135A and A1004137A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA(and similar batches:AC20B235). There is as of today, no report linked to that batch other than the ones linked to this complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information, it is unlikely that the reported events are related to a manufacturing problem.
Sex: U
Vaccine: DTAPIPV
Symptoms: Immediate post-injection reaction, Product quality issue, Rash
Clinical narrative: This case reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). In 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of the bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out in  a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX with KINRIX that subject still broke out in a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product", there were six does remaining to be returned to GSK for investigation. This is 4 of 4 subjects reported by the physician, for the other cases please see A1004132A, A1004135A and A1004136A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA (and similar batches: AC20B235). There is as of today, no report linked to that batch other than the ones linked to the complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information , it is unlikely that the reported events are related to a manufacturing problem.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered at inappropriate site, Injection site oedema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (certified medical assistant) and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 21 January 2013 the subject received 1st dose of KINRIX (.5 ml, unknown route, right thigh) and experienced vaccine administered at inappropriate site. The dose of KINRIX was administered in the right thigh when the preferred site of administration for KINRIX is the deltoid of the upper arm. In January 2013, within days of vaccination with KINRIX (up to and including 23 January 2013), the subject experienced swelling injection site. The certified medical assistant reported that the subject "swelled up at the injection site to mid knee cap." The subject was treated with prednisone. At the time of reporting the events were improved. Per the certified medical assistant, "the swelling is better but not resolved." The healthcare professional considered the events were probably related to vaccination with KINRIX. Follow up was received from the healthcare professional (certified medical assistant - CMA) on 21 May 2013. The CMA documented that on 22 January 2013, 1 day after vaccination with KINRIX, the subject experienced swelling injection site and injection edema (described as "edema, localized NOS"). The CMA reported these events resolved on 23 January 2013 and identified KINRIX as the suspect product. The CMA did not consider these events to be serious. The CMA also considered that the site of administration of KINRIX, right thigh, was appropriate for a 5 year old subject. The CMA documented that the vaccination series was not delayed or discontinued and that symptoms did not recur following subsequent administration. It was unknown if the subject experienced adverse events following previous vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hot feeling at injection site in a 4-year-old male subject who was vaccinated with KINRIX. On 25 February 2013 at 10:45 the subject received 4th dose of KINRIX (.5 unknown, unknown, right deltoid). On 25 February 2013, less than one day after vaccination with KINRIX, the subject received a KINRIX dose and experienced redness at injection site. The redness was confined to the upper arm area, and did not go below the elbow. The injection site also felt hot. No other events were reported. The subject was being monitored and told that if condition worsens, to come to the physician's office. At the time of reporting the outcome of the hot feeling at injection site redness were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPIPV, HIBV, PNC, RVX
Symptoms: Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (non-gsk); non-GSK manufacturer; unknown; unknown given on 2 April 2013; live attenuated human rotavirus vaccine; manufacturer unspecified; unknown given on 2 April 2013; PREVNAR (non-gsk); non-GSK manufacturer; unknown; unknown given on 2 April 2013. On 2 April 2013 the subject received 2nd dose of DTaP series as KINRIX (.5 ml, unknown, left thigh) and experienced inappropriate age at vaccine administration and vaccine administered at inappropriate site. On 2 April 2013, within hours after vaccination with KINRIX, the subject experienced fever. The healthcare professional reported that a 4-month old subject received KINRIX instead of PENTACEL (due to shortage) on 02 April 2013. The mother reported that the subject had a fever of 101 Fahrenheit rectally. At the time of the report no additional information was available. At the time of reporting the outcome of the fever was unspecified.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of extensive swelling of vaccinated limb in a child of subject of unknown gender (kindergarten age) who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (unknown route, unknown arm). At an unspecified time after vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb, welt injection site, injection site pain and injection site hot to touch. The nurse reported another case with adverse events after receiving KINRIX (A1022685A) and stated that this subject had "the exact same injection site reaction." The subject received the "kindergarten shot" of KINRIX and the subject's "arm swelled up where they got the injection." The subject had a "large welt around the size of 3 by 5 inch wide" (76.5 by 127 millimeters). The welts were swollen and painful to the subject. The nurse also stated that the "welt was hot to touch." At the time of reporting the outcome of the events were unspecified. The nurse reported another case with KINRIX. See case A1022685A for details on the other case. The nurse stated that the subjects in both cases were unrelated and the events happened about 1 week apart. No specific dates were provided. Follow-up information was received on 04 June 2013 via healthcare professional, who is also the subject's mother. She clarified that only one subject was involved and not two as previously reported. The subject received 0.5ml of KINRIX intramuscularly, vaccination date was not provided. The extensive swelling of vaccinated limb, welt injection site, injection site pain and injection site hot to touch started on 19 April 2013 and resolved on 25 April 2013. The subject has previously received PEDIARIX; this is the subject's first time receiving KINRIX. The reporting healthcare professional considered the events probably related to vaccination with KINRIX. The events were not considered serious.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Local reaction
Clinical narrative: This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of bruise injection site in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). varicella virus vaccine (non-gsk). On an unspecified date the subject received a dose of KINRIX (unknown details, unknown arm), and a dose of Varicella virus vaccine (Non-GSK) (unknown details, unknown arm). At an unspecified time after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced bruise injection site. The medical assistant stated the subject experienced "a local reaction to a KINRIX vaccination. Varicella was also received on the same arm, so it could be a reaction to both." The medical assistant described the local reaction as looking "like a bruise." The mother of the subject provided pictures to the physician's office. No additional information was provided. At the time of reporting the outcome of the event was unspecified. Follow up was received from the physician on 18 June 2013. The physician documented that the subject was a 4-year-old female and on 15 May 2013, at an unknown time after vaccination with KINRIX and Varicella virus vaccine (non-GSK), the subject experienced bruise at injection site (described as "medication side effect"). Per the physician, the KINRIX was administered to the left arm intramuscularly and the Varicella Virus Vaccine was administered to the left arm subcutaneously. The physician documented that the outcome of the event as resolved. The physician documented that the event was probably related to KINRIX. The physician documented that KINRIX was the suspect product; however, the physician did not alter or remove Varicella Vaccine as a suspect product for the event. The physician documented that the subject did not die, was not hospitalized, the event was not life threatening, involve severe or permanent disability or jeopardize the patient or require intervention, and did not involve a congenital anomaly or birth defect. The physician did not consider the event to be serious. The physician documented that he did not feel that the event was associated with medical history or concurrent illness, a lack of efficacy, erroneous administration and was not suspected transmission of an infectious agent via a medicinal product. The suspect drug was not reintroduced and the subject had not received the suspect product before.
Sex: U
Vaccine: DTAPIPV
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (unknown details). At an unspecified time after vaccination with KINRIX, the subject experienced nonspecific reaction. Per the reporter, a subject was referred to them who had a reaction to KINRIX. No additional details were reported. At the time of reporting the outcome of the event was unspecified.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Redness, swelling and warmth of L mid arm posteriorly, peaking the next day and a little better at time of exam 10/4/13, mid morning.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Swelling of the face, and throat, difficulty breathing, fast heartbeat, dizziness, weakness, lethargic, coughing, wheezing.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Lethargy, Pharyngeal oedema, Swelling face, Wheezing
Clinical narrative: Swelling of the face, and throat, difficulty breathing, fast heartbeat, dizziness, weakness, lethargic, coughing, wheezing.
Age: 38.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Axillary pain, Chills, Pain
Clinical narrative: Chills and achiness and intense pain in armpit (armpit on the same side as the vaccinations). Chills and achiness lasted a few hours, went to sleep, when I awoke, they were gone. Pain in armpit less intense in morning, but still painful.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Insomnia
Clinical narrative: Headache, sleeplessness.  Took 2 Advil.  Did not help headache, slept fitfully - not enough.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red rash and itch at injection site.  Within 3-1/2 hours rash and itch gone.  First morning after injection rash and itch at injection site had returned and expanded to area approximately 4" X 1-1/2".  2nd morning after injection rash and itch still present, no chage in area size.  At this time, just waiting for change.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Eye discharge, Eyelid margin crusting, Fatigue
Clinical narrative: DIARRHEA THAT NIGHT, THEN SHE WOKE WITH OOZING MATTED EYES, WHICH FELT HOT, CLOUDY VISION AND FEELING WEAK TRIED OVER THE COUNTER BENADRYL AND EYE DROPS. THEN WENT TO URGENT CARE FACILITY IN THE AFTERNOON AND WAS PRESCRIBED IODINE (ETODOLAC) AND METOPROLOL FOR ANXIETY. GIVEN A STEROID SHOT AND ALLERGY SHOT.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Vision blurred
Clinical narrative: DIARRHEA THAT NIGHT, THEN SHE WOKE WITH OOZING MATTED EYES, WHICH FELT HOT, CLOUDY VISION AND FEELING WEAK TRIED OVER THE COUNTER BENADRYL AND EYE DROPS. THEN WENT TO URGENT CARE FACILITY IN THE AFTERNOON AND WAS PRESCRIBED IODINE (ETODOLAC) AND METOPROLOL FOR ANXIETY. GIVEN A STEROID SHOT AND ALLERGY SHOT.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Injection site pain, Muscle tightness, Myalgia, Nausea
Clinical narrative: Pain at injection site, helped by ibuprofen.  Delayed onset of dizziness, muscle pain, nausea on or around 9-26-13 continuing through 10-5-13.  Muscle tension, nausea, dizziness ongoing and hoping it gets better!!!
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling/tenderness/warmth/itching at site and extending around circumference of arm and to axillary region--continuing to spread at 48 hrs post injection.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Redness/swelling/tenderness/warmth/itching at site and extending around circumference of arm and to axillary region--continuing to spread at 48 hrs post injection.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Local swelling, Skin warm
Clinical narrative: Arm is swollen and hot to touch, red circle around area where shot was given and feels hard to the touch.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Local swelling
Clinical narrative: Swelling in the neck and shoulder area--gained 2 pounds from the swelling---took about three days to go away although soreness at the site of shot continued for more than 1 week.
Age: 0.16
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Electroencephalogram normal, Fatigue, Injection site erythema, Injection site mass
Clinical narrative: Redness and swelling at injection site, nickle-sized lump under the skin at injection site (upper thigh), fussiness/tiredness, poor appetite, seizure-like episodes - usually multiple episodes in sequence, several times/day, for months following vaccine.
Age: 0.16
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Irritability, Seizure like phenomena
Clinical narrative: Redness and swelling at injection site, nickle-sized lump under the skin at injection site (upper thigh), fussiness/tiredness, poor appetite, seizure-like episodes - usually multiple episodes in sequence, several times/day, for months following vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Lethargy, Oropharyngeal pain, Pallor, Pyrexia, Streptococcus test negative
Clinical narrative: Fever 103.9 for at least 5 days, severe sore throat to the point she was drooling. Lethargic, pale.  Treated with Tylenol, Motrin, Hydrocodone (prescription), 2 doctors visits.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Head injury, Tension, Vomiting
Clinical narrative: Per patient father, patient tensed up and fell to the floor while standing.  When I first observed the patient, he was beginning to come to and was speaking.  EMTs arrived shortly after and they did not observe any other abnormalities.  Patient did vomit when first sitting up.  EMTs gave patient an IV and took to ER for observation of head injury.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein normal, Erythema, Full blood count normal
Clinical narrative: Skin felt like it was sunburned to the touch.  Ringing in ears that never resolved.  Pain, redness and warmth in both hips that has not resolved.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Skin burning sensation, Skin warm
Clinical narrative: Skin felt like it was sunburned to the touch.  Ringing in ears that never resolved.  Pain, redness and warmth in both hips that has not resolved.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Skin felt like it was sunburned to the touch.  Ringing in ears that never resolved.  Pain, redness and warmth in both hips that has not resolved.
Age: 13.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Paralysis of left side of face.  Seen at ED and diagnosed with Bell's palsy and placed on steroids.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Coordination abnormal, Fall, Pallor, Pyrexia, Screaming
Clinical narrative: Screaming for three hours; falling down; uncoordinated; fever spike to 103.5; pale.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Pruritus, Rash
Clinical narrative: Vaccine was administered via subcutaneous route in back of upper left arm.  Patient complained of left arm itching and was noticably red with rash.  Patient also complained of stomach being upset.  Patient was given 25mg of diphenhydramine at 1:05pm and a second dose at 2:20pm as the itching had returned.  On 10/5/13, patient (an employee) came by the pharmacy to let me know that the redness and itching was completely gone.  She did note that she had felt chills overnight but felt well again on 10/5/13 with no lingering effects.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Erythema, Induration, Local swelling, Pruritus
Clinical narrative: Swelling, itching, blisters, redness, hardness in arm, hot arm. Prescribed antibiotics for 10 days and did not heal, received additional 5 days of antibiotics. Skin still blistered, healing.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Skin warm
Clinical narrative: Swelling, itching, blisters, redness, hardness in arm, hot arm. Prescribed antibiotics for 10 days and did not heal, received additional 5 days of antibiotics. Skin still blistered, healing.
Age: 23.0
Sex: F
Vaccine: HEP, FLU3, HEP
Symptoms: Dysgraphia, Local swelling, Pain in extremity
Clinical narrative: Pain in my right hand and I could not write while I was studying also had a swollen arm.
Age: 23.0
Sex: F
Vaccine: HEP, FLU3, HEP
Symptoms: Hypoaesthesia, Mobility decreased, Sensory loss
Clinical narrative: Pain in my right hand and I could not write while I was studying also had a swollen arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Pyrexia
Clinical narrative: Low grade fever for 2 days following injection, red raised itchy area approximately 1" x 2 & 1/2" with a total red area of 3" x 8".
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness, fatigue - went to bed.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: His left upper arm where he received the flu shot is very swollen.  It is red and itchy and is hot to the touch, even three days later.  It seems to be moving down his arm toward his elbow.  We are treating with ibuprofen and Benadryl.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site joint movement impairment
Clinical narrative: Limited range of motion of left shoulder. Pain with lifting arm overhead.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Site of vaccination very painful to touch. Then pain progressed down entire arm. Started feeling hot, took oral temperature - 100.4 degrees. Second day arm still hurt and still had slight fever of 99.8.
Age: 0.37
Sex: M
Vaccine: DTAPH, HEP, OPV, PNC13
Symptoms: Fatigue, Lethargy, Pyrexia, Vomiting
Clinical narrative: Very tired, became lethargic when woken up, the started running fevers of 102 and vomiting.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Injection site discolouration, Injection site induration, Injection site mass, Injection site urticaria, Urticaria
Clinical narrative: Facial welts coming and going all day. One hive appeared on injection site which was a long lasting hard, purple lump for the last two weeks. Benadryl given.
Age: 0.52
Sex: F
Vaccine: DTAP
Symptoms: Cough, Crying, Decreased appetite, Dreamy state, Electroencephalogram
Clinical narrative: She started to get sick immediately following the shot. I noticed she was drowsy and crying and rubbing her face all over. She then got congestion, cough, and fever. She didn't sleep that night, and wanted me to hold her all night long, she was very restless and loss of appetite. The very next morning she started to look in a dream state and didn't seem to see or respond to me. She then started to lose control of her head to the right side. Her head would drop to her right shoulder and her eyes would roll back in her head. She would also then sometimes drop her head back and roll her eyes. She also took her right hand and rubbed her right ear continually. I thought she was possibly so tired that she was doing these things from sleepiness. But they continued on and off for two weeks and then I knew it was serious and I was scared. I called the pediatrician and brought her immediately in. They saw her, sent me to see a Pediatric Neuroligist, and he sent us to another hospital for an EEG test to see if she was having seizures. All of the staff and doctors saw patient's seizure looking responses and they all saw her loss of muscel control to the right side.
Age: 0.52
Sex: F
Vaccine: DTAP
Symptoms: Gaze palsy, Immediate post-injection reaction, Insomnia, Laboratory test, Posture abnormal
Clinical narrative: She started to get sick immediately following the shot. I noticed she was drowsy and crying and rubbing her face all over. She then got congestion, cough, and fever. She didn't sleep that night, and wanted me to hold her all night long, she was very restless and loss of appetite. The very next morning she started to look in a dream state and didn't seem to see or respond to me. She then started to lose control of her head to the right side. Her head would drop to her right shoulder and her eyes would roll back in her head. She would also then sometimes drop her head back and roll her eyes. She also took her right hand and rubbed her right ear continually. I thought she was possibly so tired that she was doing these things from sleepiness. But they continued on and off for two weeks and then I knew it was serious and I was scared. I called the pediatrician and brought her immediately in. They saw her, sent me to see a Pediatric Neuroligist, and he sent us to another hospital for an EEG test to see if she was having seizures. All of the staff and doctors saw patient's seizure looking responses and they all saw her loss of muscel control to the right side.
Age: 0.52
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Respiratory tract congestion, Restlessness, Seizure like phenomena, Somnolence
Clinical narrative: She started to get sick immediately following the shot. I noticed she was drowsy and crying and rubbing her face all over. She then got congestion, cough, and fever. She didn't sleep that night, and wanted me to hold her all night long, she was very restless and loss of appetite. The very next morning she started to look in a dream state and didn't seem to see or respond to me. She then started to lose control of her head to the right side. Her head would drop to her right shoulder and her eyes would roll back in her head. She would also then sometimes drop her head back and roll her eyes. She also took her right hand and rubbed her right ear continually. I thought she was possibly so tired that she was doing these things from sleepiness. But they continued on and off for two weeks and then I knew it was serious and I was scared. I called the pediatrician and brought her immediately in. They saw her, sent me to see a Pediatric Neuroligist, and he sent us to another hospital for an EEG test to see if she was having seizures. All of the staff and doctors saw patient's seizure looking responses and they all saw her loss of muscel control to the right side.
Age: 0.52
Sex: F
Vaccine: DTAP
Symptoms: Unresponsive to stimuli
Clinical narrative: She started to get sick immediately following the shot. I noticed she was drowsy and crying and rubbing her face all over. She then got congestion, cough, and fever. She didn't sleep that night, and wanted me to hold her all night long, she was very restless and loss of appetite. The very next morning she started to look in a dream state and didn't seem to see or respond to me. She then started to lose control of her head to the right side. Her head would drop to her right shoulder and her eyes would roll back in her head. She would also then sometimes drop her head back and roll her eyes. She also took her right hand and rubbed her right ear continually. I thought she was possibly so tired that she was doing these things from sleepiness. But they continued on and off for two weeks and then I knew it was serious and I was scared. I called the pediatrician and brought her immediately in. They saw her, sent me to see a Pediatric Neuroligist, and he sent us to another hospital for an EEG test to see if she was having seizures. All of the staff and doctors saw patient's seizure looking responses and they all saw her loss of muscel control to the right side.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pain, Swelling, Tenderness
Clinical narrative: Allergic reaction, initial redness, soreness, swelling dime size. Progressively getting worse and spreading to surrounding area now half dollar size and tender and growing.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Skin discolouration
Clinical narrative: Severe swelling of the arm - height of swelling localized about 1/2 cm diameter of dime. Appeared bluish/purple.
Age: 83.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Disorientation, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: High fever, chills, shakes, redness soreness at sight of injection 6-8 hrs after, not getting better. Slightly disorientated.
Age: 83.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Tremor
Clinical narrative: High fever, chills, shakes, redness soreness at sight of injection 6-8 hrs after, not getting better. Slightly disorientated.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Pt. is unable to move her left arm because its been sore since the day after vaccination. Pt could not sleep well because of the throbbing pain. Pain level is 7-8 (10 being the highest from scale 1-10). ALEVE, hot/cold compress temporarily relieve soreness.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Pt. returned to pharmacy on 10/1/13. (L) arm swollen, red, warm to touch. Pt. instructed to seek medical attention from walk-in clinic.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Skin warm
Clinical narrative: Burning sensation at site of injection has been having this sensation since the shot given (9-15-13) hot feeling on arm, no rash, has not tried icing it.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Local swelling
Clinical narrative: Pt. reported arm swelling. Neighbor was a doctor; recommended treatment. Pt. subsequently saw Dr. who prescribed Doxycycline 100mg for cellulitis.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9/27/13: raised, warm and red at site; 9/28/13: pt saw doctor prior to travel to foreign country, did not feel it was infected; cold compress and Benadryl. Advised to have next yr flu shot at doctor office.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At site on injection, raised area (redness).
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fear of injection, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: About 1 minute after the flu shot was administered, patient stated that he felt dizzy. He sat down on a chair with a glass of fluid in his hand. After a few minutes, he became unresponsive. 911 was called. Within a minute, he awoke with no knowledge of his blackout. We laid him down on the floor with his feet elevated on a chair, and he stated that he felt much better. He remained on the floor until the ambulance arrived. He was then seated in a chair and he starting sweating profusely and his BP was low. He was carted and taken to the ER where he was diagnosed with a vagal response possibly due to being afraid of needles. He was fine the next day around 10 AM when I talked to him.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope, Unresponsive to stimuli
Clinical narrative: About 1 minute after the flu shot was administered, patient stated that he felt dizzy. He sat down on a chair with a glass of fluid in his hand. After a few minutes, he became unresponsive. 911 was called. Within a minute, he awoke with no knowledge of his blackout. We laid him down on the floor with his feet elevated on a chair, and he stated that he felt much better. He remained on the floor until the ambulance arrived. He was then seated in a chair and he starting sweating profusely and his BP was low. He was carted and taken to the ER where he was diagnosed with a vagal response possibly due to being afraid of needles. He was fine the next day around 10 AM when I talked to him.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: -Redness and swelling  (entire upper arm swollen and red) and pain (stated evening of vaccination) - Pt advised to use Benadryl and ice and to follow up with MD if no change in sx's. - Rxn reported on Right arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Patient experienced a painful bruise approx 3 x 3 inches. Noticed 48 -72 hours post immunization. She has treated w/ice.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a treating physician's nurse via field representative refers to a 22 year old female patient. On 16-JUL-2013 the patient was vaccinated with her first dose of GARDASIL (injection, intramuscular, standard dose, strength, lot# were unspecified). On 17-SEP-2013 the patient was vaccinated with her second dose of GARDASIL (injection, intramuscular, standard dose, strength, lot# were unspecified). Concomitant medication included unspecified birth control pill that had been taken for the last couple of months. Patient complained of nausea and vomiting that began 24 hours after the injection. Patient had sought medical attention via office visit. Treatment of "Dramomil" was given for the events. The outcome of nausea and vomiting was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age. Nurse reported that the patient was administered the first two doses in RECOMBIVAX HB (strength, formulation, lot#, dose, route and duration were unspecified) series on unspecified dates as recommended in the prescribing information. Patient, who was "a two year old", was in the provider's office more than six months after the first dose in series was administered to receive the third dose of RECOMBIVAX HB (strength, formulation, lot#, dose, route and duration were unspecified) on 26-SEP-2013. No adverse events were reported. The outcome was unknown. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Stomach pains, nausea.
Age: 84.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Pneumonia
Clinical narrative: One hour after vaccine was given patient stated having severe coughing and had to come to ER.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Heart rate increased, Pain, Pharyngeal oedema
Clinical narrative: Throat swelling, coughing, rapid heartbeat of 130/bpm.  Took max dose of liquid Benadryl with about 50% improvement.  About 9pm that same night fever of 100, chills, body ache lasting 1 day.