chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 3 of 6 (see case IDs A0952647A, A0952653A, A0952655A-A0952657A for details of the other reports).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 4 of 6 (see case IDs A0952647A, A0952653A, A0952654A, A0952656A, A0952657A for details of the other reports).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer (the company owner) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the outcome of the event was unspecified. The consumer reported that 5 employees at one company and one employee at another company all reported extreme redness at the injection site after receiving FLULAVAL. This is case 5 of 6 (see case IDs A0952647A, A0952653A-A0952655A, A0952657A for details of the other reports).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). In 2011 in the same year after vaccination with FLULAVAL, the subject experienced left arm pain and arm rash. The pharmacist stated there was nothing present around the injection site. The exact location of the rash on the arm was unknown. The patient stated to the pharmacist that "I still have pain in my arm and now have a rash". At the time of reporting the events were unresolved. Follow up information received from the pharmacist on 13 December 2011. At the time of the follow up report the events were resolved. The pharmacist considered the events as unrelated to the vaccination with FLULAVAL. The rash was on the opposite arm of the vaccination and the subject was seen by her provider who felt that the rash was due to a bug bite and unrelated to the vaccine. The pharmacist selected that the events were not serious.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Immediate post-injection reaction, Incorrect route of drug administration, Injection site cellulitis, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 21-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to sulfa drugs. On 31 October 2011 the subject received a dose of FLULAVAL (intradermal, left arm), and experienced inappropriate route of vaccination. The vaccine was administered intradermally instead of the indicated intramuscular route. On 31 October 2011, immediately after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritus and raised area injection site, followed by cellulitis type appearance at the injection site. At the time of reporting, the subject had a 3-inch raised area that was unresolved. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up was received 28 November 2011 from the nurse practitioner. The diagnosis provided was "cellulitis as vaccine given intradermally". The outcome of the events was unknown. A complete blood count was performed on 2 November 2011 and was normal. No biopsy was performed. The nurse practitioner assessed the event as non-serious and associated the events "most likely" to erroneous administration.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 21-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to sulfa drugs. On 31 October 2011 the subject received a dose of FLULAVAL (intradermal, left arm), and experienced inappropriate route of vaccination. The vaccine was administered intradermally instead of the indicated intramuscular route. On 31 October 2011, immediately after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritus and raised area injection site, followed by cellulitis type appearance at the injection site. At the time of reporting, the subject had a 3-inch raised area that was unresolved. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up was received 28 November 2011 from the nurse practitioner. The diagnosis provided was "cellulitis as vaccine given intradermally". The outcome of the events was unknown. A complete blood count was performed on 2 November 2011 and was normal. No biopsy was performed. The nurse practitioner assessed the event as non-serious and associated the events "most likely" to erroneous administration.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950781A, A0950782A and A0950781A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950780A, A0950781A and A0950783A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950780A, A0950782A and A0959783A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified injection site reaction. At the time of reporting the outcome of the event was unspecified. It was reported that 3 additional subjects experienced unspecified injection site reactions following administration of FLULAVAL. Another subject, A0949617A, experienced an entire arm reaction and chest reaction in addition to injection site reactions. This case was considered to be serious. Linked cases include A0949617A, A0950781A, A0950782A and A0959783A.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arms redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline), PNEUMOVAX. On an unspecified date the subject received a dose of FLULAVAL (unknown route, left arm) and unspecified dose of PNEUMOVAX (unknown route, left arm). It was not clear whether the vaccinations were mixed together or whether they were just administered in the same arm. At an unspecified time after vaccination with FLULAVAL and PNEUMOVAX, the subject experienced "redness in arm", injection site pain and fever. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4, 7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown route, unknown). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspecting a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the event was unspecified. This is two of five cases. See cases A0952517A, A0952521A, A0952522A and A0952523A for information regarding the other cases.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of muscle weakness in a 78-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included the subject's normal regimen of medications (unspecified). The subject had experienced some ongoing similar events which he considered to be related to statin use. On 27 September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, right deltoid). On an unspecified date in 2011, less than one month after vaccination with FLULAVAL, the subject experienced muscle weakness and difficulty walking up stairs. The pharmacist considered the events were disabling. At the time of reporting the events were unresolved. The pharmacist considered the events were unrelated to vaccination with FLULAVAL. Follow-up information indicated that events of muscle weakness and difficulty walking up the stairs were unresolved and considered to be unrelated to FLULAVAL vaccine. It was additionally reported that the subject has had problems with muscle weakness in the past.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Maternal exposure during pregnancy, Nasopharyngitis
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (also the subject) and described the occurrence of a cold in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. Concurrent medications included Prenatal vitamins. The subject had previously received flu shots and had a cold within a few days of getting the previous flu shots (details unknown). On 18 October 2011 the subject received a dose of FLULAVAL (1 ml, unknown, left arm), and experienced overdose and vaccine exposure during her first trimester of pregnancy. The subject received a 1 ml dose of FLULAVAL instead of the indicated dose of 0.5 ml. On 21 October 2011, 3 days after vaccination with FLULAVAL, the subject experienced a cold. The cold lasted 7 days. The gestational age at the time of vaccination was not specified. Date of last menstrual period was not provided. The estimated date of delivery was 12 May 2012. On 28 October 2011, the cold was resolved. At the time of the report, the pregnancy was ongoing. Follow-up information was received via the consumer on 19 December 2011. It was reported that the subject's date of last menstrual period was 06 August 2011. Conception was reported to be normal and the pregnancy involved a single fetus. FLULAVAL was administered intramuscularly to the pregnant subject on 18 October 2011, at 10 weeks gestation. The dose of FLULAVAL administered was actually 0.5 ml as opposed to 1.0 ml reported initially. The subject did not receive an overdose of FLULAVAL. Concurrently and starting prior to conception, the subject received pre-natal vitamins and acetaminophen. The cold experienced by the pregnant subject resolved on 28 October 2011 as previously reported. No additional details were provided. Follow-up information was received via a nurse (office manager) on 22 December 2011 and 03 January 2012. It was reported that the conception was normal. The nurse noted that the subject had not been seen in their clinic regarding the FLULAVAL vaccination. She stated that they do not administer this type of flu vaccine. The facility did not have any further information to provide regarding this issue.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Dizziness, Erythema, Muscle tightness, Rash
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of lightheadedness 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. On 23 September 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 23 September 2011, approximately 1 hour after vaccination with FLULAVAL, the subject experienced lightheadedness and tightening in the throat and base of the neck. The next morning, she discovered both sides of her face were red and pimply, as well as her neck, chest and back. She applied BENADRYL cream and the rash resolved after 2 days. On 25 September 2011, the events were resolved.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of lightheadedness 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. On 23 September 2011 the subject received a dose of FLULAVAL (unknown route, right arm). On 23 September 2011, approximately 1 hour after vaccination with FLULAVAL, the subject experienced lightheadedness and tightening in the throat and base of the neck. The next morning, she discovered both sides of her face were red and pimply, as well as her neck, chest and back. She applied BENADRYL cream and the rash resolved after 2 days. On 25 September 2011, the events were resolved.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer (the subject's daughter) and described the occurrence of arm pain in a 92-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 breast cancer, dementia and hypertension. Concurrent medications included Lisinopril, HCTZ, ZETIA, KCl, Atenolol and Anastrozole. On an unspecified date in October 2011 the subject received a dose of FLULAVAL (unknown route, right arm). In October 2011, less than one month after vaccination with FLULAVAL, the subject experienced right arm pain, injection arm pain, right shoulder pain and difficulty lifting right arm. The subject's physician was contacted and at the time of reporting the subject planned to follow-up with her physician. At the time of reporting the events were unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema of arm at injection site in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown arm). In November 2011, less than one week after vaccination with FLULAVAL, the subject experienced erythema of arm at injection site, arm swelled at injection site, arm pain at injection site and arm warm at site of injection. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported events for this female, another female and herself with FLULAVAL. See cases A0953236A and A0953274A for details regarding the other cases.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was described by a healthcare professional (nurse who was the also the subject) and described the occurrence of hard lump at injection site in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 4 November 2011, less than one day after vaccination with FLULAVAL, the subject experienced hard lump at injection site ("hard bump" and "arm firm" at injection site) and in November 2011, less than a week after vaccination with FLULAVAL, the subject experienced erythema of arm at injection site, arm swelled at injection site, arm pain at injection site and arm warm at site of injection. At the time of reporting the hard lump at injection site and erythema of arm at injection site were unresolved; the arm swelled at injection site and arm pain at injection site were resolved; and the outcome for arm warm at site of injection was unknown. The subject had received Tetanus in the past, but it was unclear if any reaction occurred. The healthcare professional reported events for herself and two other females with FLULAVAL. See cases A0953257A and A0953274A for details regarding the other two cases.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: This case was described by a healthcare professional (nurse who was the also the subject) and described the occurrence of hard lump at injection site in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 4 November 2011, less than one day after vaccination with FLULAVAL, the subject experienced hard lump at injection site ("hard bump" and "arm firm" at injection site) and in November 2011, less than a week after vaccination with FLULAVAL, the subject experienced erythema of arm at injection site, arm swelled at injection site, arm pain at injection site and arm warm at site of injection. At the time of reporting the hard lump at injection site and erythema of arm at injection site were unresolved; the arm swelled at injection site and arm pain at injection site were resolved; and the outcome for arm warm at site of injection was unknown. The subject had received Tetanus in the past, but it was unclear if any reaction occurred. The healthcare professional reported events for herself and two other females with FLULAVAL. See cases A0953257A and A0953274A for details regarding the other two cases.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium enema abnormal, Blood bicarbonate normal, Blood creatinine increased, Diarrhoea, Enema administration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 20 weeks old male patient with no pertinent medical history and no known previous illness who on 07-NOV-2011 was vaccinated orally with the third dose of ROTATEQ (lot number: 669529/0548AA). Concomitant vaccines given on the same day included a third IM dose of ENGERIX-B (lot number: AHBVC070AA) into the right leg, the third dose of PREVNAR 13 (lot number: F13780) (route of administration was not reported) and the third IM dose of PENTACEL (lot number: C390AA) into the right leg. On 24-NOV-2011, the patient experienced vomiting, diarrhea and bloody stool. The patient was diagnosed with intussusception. The patient presented with 11-12 episodes of vomiting for 2 days. The patient developed bloody stool, mild tachycardia, lethargy. On an unspecified date the patient's intussusception was reduced by barium enema. On an unspecified date, the patient was admitted to surgical intervention unit. It was reported that the patient did not develop signs or symptoms of intussusception during observation period. On an unspecified date, the intussusception resolved. On 19-DEC-2011, KUB X-ray was abnormal. Barium enema was abnormal. Abdominal ultrasound was abnormal. Plasma bicarbonate test was 17 low (L). Diarrhoea, enema administration, haematochezia, intussusception, lethargy, tachycardia and vomiting were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID# is 444902. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669529/0548AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669529/0548AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Lethargy, Tachycardia, Ultrasound abdomen abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 20 weeks old male patient with no pertinent medical history and no known previous illness who on 07-NOV-2011 was vaccinated orally with the third dose of ROTATEQ (lot number: 669529/0548AA). Concomitant vaccines given on the same day included a third IM dose of ENGERIX-B (lot number: AHBVC070AA) into the right leg, the third dose of PREVNAR 13 (lot number: F13780) (route of administration was not reported) and the third IM dose of PENTACEL (lot number: C390AA) into the right leg. On 24-NOV-2011, the patient experienced vomiting, diarrhea and bloody stool. The patient was diagnosed with intussusception. The patient presented with 11-12 episodes of vomiting for 2 days. The patient developed bloody stool, mild tachycardia, lethargy. On an unspecified date the patient's intussusception was reduced by barium enema. On an unspecified date, the patient was admitted to surgical intervention unit. It was reported that the patient did not develop signs or symptoms of intussusception during observation period. On an unspecified date, the intussusception resolved. On 19-DEC-2011, KUB X-ray was abnormal. Barium enema was abnormal. Abdominal ultrasound was abnormal. Plasma bicarbonate test was 17 low (L). Diarrhoea, enema administration, haematochezia, intussusception, lethargy, tachycardia and vomiting were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID# is 444902. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669529/0548AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669529/0548AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urinary system X-ray, Vomiting, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 20 weeks old male patient with no pertinent medical history and no known previous illness who on 07-NOV-2011 was vaccinated orally with the third dose of ROTATEQ (lot number: 669529/0548AA). Concomitant vaccines given on the same day included a third IM dose of ENGERIX-B (lot number: AHBVC070AA) into the right leg, the third dose of PREVNAR 13 (lot number: F13780) (route of administration was not reported) and the third IM dose of PENTACEL (lot number: C390AA) into the right leg. On 24-NOV-2011, the patient experienced vomiting, diarrhea and bloody stool. The patient was diagnosed with intussusception. The patient presented with 11-12 episodes of vomiting for 2 days. The patient developed bloody stool, mild tachycardia, lethargy. On an unspecified date the patient's intussusception was reduced by barium enema. On an unspecified date, the patient was admitted to surgical intervention unit. It was reported that the patient did not develop signs or symptoms of intussusception during observation period. On an unspecified date, the intussusception resolved. On 19-DEC-2011, KUB X-ray was abnormal. Barium enema was abnormal. Abdominal ultrasound was abnormal. Plasma bicarbonate test was 17 low (L). Diarrhoea, enema administration, haematochezia, intussusception, lethargy, tachycardia and vomiting were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID# is 444902. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669529/0548AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 669529/0548AA met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Dizziness, Fatigue
Clinical narrative: Muscle pain, joint pain, dizziness, severe migraines, fatigue, insomnia, stomach pain, itchy, rashy, acid reflux, ear pain, twitches.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Gastrooesophageal reflux disease, Headache, Influenza like illness, Insomnia, Migraine
Clinical narrative: Muscle pain, joint pain, dizziness, severe migraines, fatigue, insomnia, stomach pain, itchy, rashy, acid reflux, ear pain, twitches.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Myalgia, Night sweats, Pruritus generalised
Clinical narrative: Muscle pain, joint pain, dizziness, severe migraines, fatigue, insomnia, stomach pain, itchy, rashy, acid reflux, ear pain, twitches.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Ear pain, Fatigue
Clinical narrative: Muscle pain, joint pain, dizziness, severe migraines, fatigue, insomnia, stomach pain, itchy, rashy, acid reflux, ear pain, twitches.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Gastrooesophageal reflux disease, Insomnia, Migraine, Muscle twitching, Myalgia
Clinical narrative: Muscle pain, joint pain, dizziness, severe migraines, fatigue, insomnia, stomach pain, itchy, rashy, acid reflux, ear pain, twitches.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Pruritus
Clinical narrative: Muscle pain, joint pain, dizziness, severe migraines, fatigue, insomnia, stomach pain, itchy, rashy, acid reflux, ear pain, twitches.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Muscle pain and weakness continues.  Unable to lift arm or lift objects.  The pain has gotten worse instead of better.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever for the entire day and the next morning.
Age: 0.8
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV
Symptoms: Pyrexia
Clinical narrative: Fever 101 degrees.  Treating with Tylenol.
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth, Needle issue, Wrong technique in drug usage process
Clinical narrative: This case was reported by a pharmacist (also the subject) and described the occurrence of injection site inflammation in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in November 2011 the subject received a dose of FLULAVAL (unknown route, unknown arm). The pharmacist reported that the needle used during administration of FLULAVAL was 0.5 inches, instead of the recommended 1 inch. She was concerned that the vaccine may not have been administered intramuscularly. She also noticed that the vaccine was given at a 90 degree angle, but was not sure about the technique used to vaccinate other employees. The pharmacist also noted that the nurse who administered the vaccine "bunched up the tissue". In November 2011, less than one day after vaccination with FLULAVAL, the subject experienced injection site inflammation, hotness at injection site and injection site soreness. At the time of reporting the events were resolved after 2 days.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Aortic valve incompetence, Dizziness, Gastrointestinal disorder, Postural orthostatic tachycardia syndrome, Salmonella test positive
Clinical narrative: Information has been received from a physician concerning her 18 year old son with family history of HLAB7 with cross reactive autoimmune phenomena to Salmonella and Shidella infection and history of migraine who in June 2010 (also reported as June 2011), was vaccinated intramuscularly (IM) with the first 0.5 ml dose of GARDASIL (lot number and dose not reported) and was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number, dose and route not reported) in August 2010 along with a second dose of meningococcal vaccine (unspecified). The physician reported that in July 2010, after receiving his first dose of GARDASIL her son traveled to another country during which time he had some gastrointestinal (GI) symptoms. After he received his second dose of GARDASIL he started college and went on a camping trip (during which time water filter broke) in September 2010. The GI symptoms worsened over the summer and early fall. On 17-SEP-2010, her son was admitted to an unspecified hospital for dizziness. The patient underwent "a bunch of tests" and it was determined he had a "salmonella issue" a diagnosis of salmonellosis was made. At that time he was also diagnosed with aortic insufficiency - on an autoimmune basis due to salmonella. After he was discharged from the hospital it was determined that the patient had an autoimmune condition called POTS (Postural orthostatic tachycardia syndrome) that caused him to have syncope while standing up. Since POTS can be an autoimmune phenomenon, the physician thought that her son case could be related to his Salmonella infection and subsequent autoimmune sequelae. It was reported that over a year ago the patient had recovered from the events. The third dose of the vaccine had not been administered because the patient's mother (physician) did not wish to, although she believed the patient's condition was not vaccine related. However, because of the temporal relationship to vaccination with the second dose of GARDASIL she wanted to inquire about any known relationship between POTS and vaccination. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Salmonellosis, Syncope
Clinical narrative: Information has been received from a physician concerning her 18 year old son with family history of HLAB7 with cross reactive autoimmune phenomena to Salmonella and Shidella infection and history of migraine who in June 2010 (also reported as June 2011), was vaccinated intramuscularly (IM) with the first 0.5 ml dose of GARDASIL (lot number and dose not reported) and was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number, dose and route not reported) in August 2010 along with a second dose of meningococcal vaccine (unspecified). The physician reported that in July 2010, after receiving his first dose of GARDASIL her son traveled to another country during which time he had some gastrointestinal (GI) symptoms. After he received his second dose of GARDASIL he started college and went on a camping trip (during which time water filter broke) in September 2010. The GI symptoms worsened over the summer and early fall. On 17-SEP-2010, her son was admitted to an unspecified hospital for dizziness. The patient underwent "a bunch of tests" and it was determined he had a "salmonella issue" a diagnosis of salmonellosis was made. At that time he was also diagnosed with aortic insufficiency - on an autoimmune basis due to salmonella. After he was discharged from the hospital it was determined that the patient had an autoimmune condition called POTS (Postural orthostatic tachycardia syndrome) that caused him to have syncope while standing up. Since POTS can be an autoimmune phenomenon, the physician thought that her son case could be related to his Salmonella infection and subsequent autoimmune sequelae. It was reported that over a year ago the patient had recovered from the events. The third dose of the vaccine had not been administered because the patient's mother (physician) did not wish to, although she believed the patient's condition was not vaccine related. However, because of the temporal relationship to vaccination with the second dose of GARDASIL she wanted to inquire about any known relationship between POTS and vaccination. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus
Clinical narrative: Received on Fri at 2/17 a 2:30. No problem. Sat evening started itching & redness at injection site some hardness with irritation. Gave patient Diphenhydramine 25 mg for itching.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Chills, Injected limb mobility decreased, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 45 year old female patient with gastrointestinal discomfort and allergic reaction to losartan potassium (WAES# 1202USA02194), who on 16-SEP-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 669579/0595AA, expiration date 30-AUG-2012) in the left arm (dose and route were not reported). Concomitant therapy included FLUZONE (Sanofi Pasteur) in the right arm. It was reported that on 17-SEP-2011 the patient experienced the injection site reaction following vaccination with PNEUMOVAX 23. The injection site was described as swollen (Half dollar size), painful, tender and fever, body aches, chills and loss of movement in the arm. On 18-SEP-2011 the patient went to emergency room but was not admitted. On 20 and 21-SEP-2011 the patient missed work. On 28-SEP-2011 the patient was examined and the injection site reaction was then described as "indurated and tender". The nurse asked for a lot check for PNEUMOVAX 23 (lot # 669579/0595AA, expiration date 30-AUG-2012). No lab diagnostics studies were performed. On unknown date, the patient recovered from the adverse experiences. Injection site reaction described as swollen, painful, tender with fever, body aches and chills and loss of movement in the arm, induration and the patient could not work on 2 days were consider to be disabling, the patient missed work on two days. Lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 45 year old female patient with gastrointestinal discomfort and allergic reaction to losartan potassium (WAES# 1202USA02194), who on 16-SEP-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 669579/0595AA, expiration date 30-AUG-2012) in the left arm (dose and route were not reported). Concomitant therapy included FLUZONE (Sanofi Pasteur) in the right arm. It was reported that on 17-SEP-2011 the patient experienced the injection site reaction following vaccination with PNEUMOVAX 23. The injection site was described as swollen (Half dollar size), painful, tender and fever, body aches, chills and loss of movement in the arm. On 18-SEP-2011 the patient went to emergency room but was not admitted. On 20 and 21-SEP-2011 the patient missed work. On 28-SEP-2011 the patient was examined and the injection site reaction was then described as "indurated and tender". The nurse asked for a lot check for PNEUMOVAX 23 (lot # 669579/0595AA, expiration date 30-AUG-2012). No lab diagnostics studies were performed. On unknown date, the patient recovered from the adverse experiences. Injection site reaction described as swollen, painful, tender with fever, body aches and chills and loss of movement in the arm, induration and the patient could not work on 2 days were consider to be disabling, the patient missed work on two days. Lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiovascular disorder, Delivery, Live birth, Maternal distress during labour, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with a history of chlamydial infection and no known drug reactions or allergies who received first, second and third doses of GARDASIL (lot number unknown) on 23-NOV-2007, 30-APR-2008 and 15-OCT-2010 respectively. Concomitant therapy included SPRINTEC. The physician reported that on 01-NOV-2010 the patient had a positive home pregnancy test. Her last menstrual period and her estimated date of delivery were not reported. Follow up information was received via telephone from a registered nurse who also was the mother of the patient and stated when she was asked about complications that the patient had experienced a placental abruption with the vaginal delivery and circulatory distress during delivery. She elaborated that cardiac medications were given in delivery to the patient (not specified reason why or medications used) and the distress was controlled within the delivery room. On 02-JUL-2011, the patient gave birth to a healthy baby boy. The baby weighed 9 lbs. The baby suffered no distress and did fine post delivery. The nurse was asked if the patient's hospital stay was prolonged due to the difficulty in delivery; she reported that her stay was a normal 48 hours. The nurse stated that she did not know the patient's exact LMP or EDD but stated that the patient was a "couple days overdue" for delivery. Upon internal review, circulatory distress during delivery treated with cardiac medications was determined to be an other important medical event. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Premature separation of placenta
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with a history of chlamydial infection and no known drug reactions or allergies who received first, second and third doses of GARDASIL (lot number unknown) on 23-NOV-2007, 30-APR-2008 and 15-OCT-2010 respectively. Concomitant therapy included SPRINTEC. The physician reported that on 01-NOV-2010 the patient had a positive home pregnancy test. Her last menstrual period and her estimated date of delivery were not reported. Follow up information was received via telephone from a registered nurse who also was the mother of the patient and stated when she was asked about complications that the patient had experienced a placental abruption with the vaginal delivery and circulatory distress during delivery. She elaborated that cardiac medications were given in delivery to the patient (not specified reason why or medications used) and the distress was controlled within the delivery room. On 02-JUL-2011, the patient gave birth to a healthy baby boy. The baby weighed 9 lbs. The baby suffered no distress and did fine post delivery. The nurse was asked if the patient's hospital stay was prolonged due to the difficulty in delivery; she reported that her stay was a normal 48 hours. The nurse stated that she did not know the patient's exact LMP or EDD but stated that the patient was a "couple days overdue" for delivery. Upon internal review, circulatory distress during delivery treated with cardiac medications was determined to be an other important medical event. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Malaise, Nasal congestion, Nasopharyngitis
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 58 year old male patient with no drug reactions/allergies, who on 31-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23 (lot number 672041/1477AA, expiration date 14-MAY-2013) (dose and route not reported). On 20-JAN-2012, the patient also received a second dose of PNEUMOVAX 23 (lot number 672041/1477AA, expiration date 14-MAY-2013) (dose and route not reported). There was no concomitant medication. It was reported that on 20-JAN-2012, the patient developed injection site reaction following vaccination with PNEUMOVAX 23. The injection site reaction was described as swollen and painful with the patient complaining of "not feeling well". The patient caught a "cold" following the second vaccination with PNEUMOVAX 23 and experienced mild nasal congestion on 23-JAN-2012. Treatment given for adverse experience included TYLENOL and ADVIL. The nurse asked for a lot check for PNEUMOVAX 23 (lot number 672041/1477AA, expiration date 14-MAY-2013). The patient sought unspecified medical attention, he contacted office. No lab diagnostics studies were performed. On an unknown date, the patient recovered from the adverse experience. Injection site reactions swollen and painful, not feeling well, a cold and mild nasal congestion were consider to be disabling, the patient could not work 4 days. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Hypoaesthesia oral, Hypoglycaemia, Paraesthesia oral, Tremor
Clinical narrative: Vaccine given at approx 1pm, at approx 1:05 pt complains of numbness and tingling in lips. Denies difficulty breathing, no itching, no rash, BP 138/92 Dr. notified - Monitor and complete forms. While monitoring pt complains of feeling "sugar drop" and hands shaking. Wife gives food and drink, after eating pt states he feels much better - adds it was not vaccine, but his sugar dropping.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Disorientation, Headache, Malaise, Pyrexia
Clinical narrative: Pt. states he was here on 12-19-11 & got the flu shot & felt fine when he was here & about 6 pm that afternoon he started getting chills, elevated fever, HA & slightly disoriented. Appt for dr visit when flu shot was given at 1:00 pm. Pt states "that flu shot made me sick & I will never take another one."
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Nasopharyngitis, Rash maculo-papular, Viral infection
Clinical narrative: Symptoms occurred during viral cold. Pt has papular rash on abdomen, back 7 days after vaccines given. Lesions do not itch and are not hives.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Decreased appetite, Exposure to communicable disease, Eye pruritus, Fatigue, Multiple sclerosis
Clinical narrative: Information has been received from a 49 year old female patient with glaucoma, elevated cholesterol, triglyceride, sulfa and iodine allergy and a medical history of laser surgery for glaucoma, who on 08-FEB-2012, was exposed to VARIVAX (Merck) (dose and lot numbers not reported) through her daughter who was vaccinated on 27-JAN-2011. Concomitant therapy included NEURONTIN, KLONOPIN, baclofen, levothyroxine sodium (manufacturers unspecified) and unnamed eye drops. It was reported that on 08-FEB-2012, the patient developed red itchy spots on her chest, then upper back, scalp, face, legs and arms and stated her "unspecified" eye was red and itchy. She reported that on some areas the scabbing was falling off but new lesions were appearing. The patient believed she had contracted chickenpox from her daughter because she had touched one of the daughter's lesions. It was also reported that the patient was very tired, nauseated and was not hungry. The patient stated she probably had multiple sclerosis. The consumer took BENADRYL Liquid and calamine and CALADRYL topically for the lesions as treatment. The consumer reported that her cholesterol and triglyceride medication were held. It was noted that the consumer had not notified the doctor. At the time of the report, the patient outcome was unknown. Upon internal review multiple sclerosis was considered as another important medical event. This is one of the several reports coming from the same source. Additional information has been requested.