chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Injection site inflammation, Injection site swelling, Tremor
Clinical narrative: Information regarding PREVNAR was received from a patient's mother regarding her 4-month-old son who experienced injection site swelling, body tremors and injection site inflammation. The patient received a dose in Apr-2008. In 2008 the patient was administered PREVNAR and the following day experienced injection site swelling and injection site inflammation. Three days later, he experienced "body tremors" which lasted a few seconds. The mother stated that these were not seizures and there was no fever associated with the reaction. She also stated that the child recovered fully but not has been rechallenged with PREVNAR. No additional information was available at the time of this report.
Age: 0.8
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 9-month-old patient who experienced facial rash.  The patient received a dose on an unspecified date. The patient experienced facial rash and was treated with BENADRYL.  Patient has since recovered.  No further information was provided.
Sex: U
Vaccine: PNC
Symptoms: Induration
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced induration. The patient received the second dose on an unspecified date. The patient experienced induration. Outcome unknown. No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: HEP, PNC
Symptoms: Rash generalised
Clinical narrative: Information regarding PREVNAR was received form a consumer regarding a 4-month-old male patient who experienced broke out all over with a rash. The patient received the second dose on an unspecified date. The reporter noted after her son's second PREVNAR dose, he broke out all over with a rash. The patient's outcome is unknown. No additional information was available at the time of this report.
Age: 0.3
Sex: U
Vaccine: PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Information regarding PREVNAR was received from a pharmacist regarding a 4-month-old patient who experienced rash and fever. At 4 months of age, the patient received the second dose on 06-May-2008. The patient experienced rash and fever on 06-May-2008. Treatments and outcome are unknown and no further information was available at the time of this report.
Age: 1.3
Sex: U
Vaccine: DTAP, PNC
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a pharmacist regarding a 15-month-old patient who experienced fever of 103.9 degrees.  The patient received the fourth dose on 06-May-2008.  The patient experienced fever of 103.9 degrees on 06-May-2008.  The patient's fever "went down" after patient was given an unspecified antipyretic.  The outcome was resolving and no additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Body temperature increased, Erythema, Mass, Pyrexia, Swelling
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced red swollen lump on lateral thigh that went down to her knee and fever of 102 degrees. At 2 months of age, the patient received a dose on an unspecified date. The patient experienced red swollen lump on lateral thigh that went down to her knee and fever of 102 degrees F. Patient was treated with TYLENOL and recovered for the event of fever after 12 hours.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC, RV1
Symptoms: Body temperature increased, Pyrexia, Rash
Clinical narrative: Additional information was received that provided medical confirmation of the events, and also included patient demographics, and recovery status. Information regarding PREVNAR was received from a consumer regarding a 6-month-old male patient who experienced fever up to 104.6 rectal and rash on forehead, shoulders, hands and legs. The patient received a dose of DTaP (manufacturer unknown) and a dose of ROTARIX (Glaxosmithkline) on 09-Jul-2008. Additional suspect medication included Hib. The patient experienced fever up to 104.6 rectal on 09-Jul-2008 and rash on forehead, shoulders, hands and legs on 10-Jul-2008. On an unspecified date, the patient recovered from the events. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site reaction
Clinical narrative: Information regarding PREVNAR was received from a nurse regarding her grandson, a male patient (age unknown), who experienced reaction on the injection site.  The patient received a dose on an unspecified date.  The patient experienced a reaction on the injection site.  The outcome was not reported.  No additional information was available at the time of this report.
Age: 1.06
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR was received from a mother regarding her 12-month-old female daughter who experienced swelling and redness at the injection site. At 12 months of age, the patient received a dose on 02-Sep-2008.The patient experienced injection site swelling and redness on 03-Sep-2008. The events are listed as not recovered. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who experienced urticaria on both legs. At 2 months of age, the patient received the first dose on 08-Sep-2008. The patient also received a dose of DTaP on 08-Sep-2008. Additional suspect medication included ROTATEQ, IPOL, and Hib. The patient experienced urticaria on both legs on 12-Sep-2008. Prednisone was prescribed but the mother did not use the drug. The patient recovered. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Rash generalised
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who experienced rash from head to toe. At 1 month of age, the patient received the first dose on 03-Jul-2008. The patient also received the first dose of DAPTACEL (Aventis-Pasteur), the first dose of ROTATEQ (Merck & Co Inc), the first dose of RECOMBIVAX-HB (Merck Sharp & Dome), the first dose of Polio-Vaccine (Not Specified) and the first dose of Hib (manufacturer unknown) on 03-Jul-2008. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced rash from head to toe on 08-Jul-2008. There was no fever or other symptoms. The rash lasted 2 weeks and the patient recovered. No additional information was available at the time of this report. See related case(s): US-WYE-H06087008 (adverse event, non-expedited).
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 13-month-old male patient who experienced hives,  extensive, located on chest back and extremities.  The patient received fourth dose on 06-Aug-2008.  The patient also received the first dose of MMRII (Merck), the first dose of HAVRIX (Smith Kline Beecham) and the first dose of VARIVAX (Merck) on 06-Aug-2008.  The patient experienced hives, extensive, located on chest back and extremities on 09-Aug-2008.  Treatment included BENADRYL and PRELONE and patient was instructed to avoid heat.  On an unspecified date in 2008, the patient recovered.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Decreased appetite, Rash
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced decreased appetite and widespread rash. The patient received a dose in Oct-2008. The patient experienced decreased appetite and widespread rash in Oct-2008. On 09-Oct-2008, the patient was examined by a physician and prescribed BENADRYL. The patient recovery status was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site pain
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced extreme pain when PREVNAR was administered.  The patient received a dose on an unspecified date.  The patient experienced extreme pain when PREVNAR was administered.  The physician commented that he wondered if the pain has something to do with the PH of the vaccine.  The patient's outcome was unknown. 07/02/2009 Additional information indicated the patient recovered. Manufacturer's Comment: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Age: 0.3
Sex: U
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Information was received from a pediatrician regarding a 4-month-old patient who experienced diarrhea. The patient received a dose on an unspecified date. The patient experienced diarrhea. No additional information was available at the time of this report. See related cases: US-WYE-H07073908 (adverse event, non-expedited); US-WYE-H07074008 (adverse event, non-expedited); and US-WYE-H07074108 (adverse event non-expedited).
Age: 0.5
Sex: U
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 6-month-old patient who experienced diarrhea.  At 6 months of age, the patient received a dose on an unspecified date.  The patient experienced diarrhea.  No additional information was available at the time of this report.
Age: 0.5
Sex: U
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 6-month-old patient who experienced diarrhea. At 6 months of age, the patient received a dose on an unspecified date. The patient experienced diarrhea. No additional information was available at the time of this report. See related cases: US-WYE-H07067108 (adverse event, non-expedited); US-WYE-H07073908 (adverse event, non-expedited); and US-WYE-H07074108 (adverse event, non-expedited)
Age: 1.0
Sex: U
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 12-month-old patient who experienced diarrhea.  At 12 months of age, the patient received a dose on an unspecified date.  The patient experienced diarrhea.  No additional information was available at the time of this report.
Age: 1.1
Sex: M
Vaccine: PNC
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Information was received from a healthcare professional regarding a 13-month-old male patient who experienced injection site swelling and fever of 103. At 13 months of age, the patient received a dose on 03-Feb-2009. The patient also received a dose of Tuberculin PPD (manufacturer unknown) on 03-Feb-2009. The patient experienced injection site swelling and fever of 103 on 04-Feb-2009. Outcome was unknown. No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Injection site swelling, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old male patient who experienced injection site swelling and fever. At 6 months of age, the patient received the third dose on 03-Feb-2009. The patient also received a dose of TRIPACEL (Adventis-Pasteur), a dose of polio vaccine "Pasteur" and a dose of HIBEST (Pasteur vaccines) (haemophilus b conjugate vaccine (tetanus) on 03-Feb-2009. The patient experienced injection site swelling and fever on 04-Feb-2009. The outcome of the events is unknown. No additional information was available at the time of this report. Follow-up information provided event outcomes. The patient experienced injection site swelling and fever on 04-Feb-2009. The patient recovered. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Injection site discolouration
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who experienced injection site hyperpigmentation.  At 2 months of age, the patient received a dose on 09-Dec-2008.  After receiving PREVNAR therapy, the patient experienced a mark at the injection site.  It was noted that within minutes of receiving the injection a "brown area formed over the exact site and continued to grow to the sized of a quarter."  The parents stated that it got "bigger and bigger and there was no itching or any other symptoms occurring at the site".  The mark is demarcated and has hyperpigmentation.  Patient has not yet recovered.  No further information was provided.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Pt developed a sore throat and fever 2 days after receiving the vaccine.  Fever resolved after 1 day, but sore throat persisted for several days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site inflammation, Injection site rash, Injection site reaction
Clinical narrative: Localized injection site reaction.  Softball sized slightly swollen and red injection site area in left arm in subcutaneous upper tricept area.  Received injection on 4-16-09. Reported to pharmacy on 4-21-09 with localized signs and symptoms.  Patient did not complain of shortness of breath or anaphylaxis during complete time span.  Patient had very mild flu-like symptoms lasting about 24 hours after injection during which time she developed the softball sized, slightly inflamed subcutaneous injection site reaction. There was also a smaller area inside the softball area that was raised and bumpy. I had advised her to use a cold pack and use the Claritin once daily that she takes for her hay allergy since she is very sensitive to benadryl.  I contacted the Collaborative Practice Physician and explained adverse event on 4-21-09 and agreed that the adverse event sounded localized, continue treatment as previously described, and have her contact her PCP if condition worsens.  I followed up with her on 4-24-09 and she stated that the area was only the size of a quarter now with a scab.  I told her to keep the scab clean and to use Aquaphor to help healing.  She stated that she did not need to see her PCP and she had no other complications.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab, Injection site swelling
Clinical narrative: Localized injection site reaction.  Softball sized slightly swollen and red injection site area in left arm in subcutaneous upper tricept area.  Received injection on 4-16-09. Reported to pharmacy on 4-21-09 with localized signs and symptoms.  Patient did not complain of shortness of breath or anaphylaxis during complete time span.  Patient had very mild flu-like symptoms lasting about 24 hours after injection during which time she developed the softball sized, slightly inflamed subcutaneous injection site reaction. There was also a smaller area inside the softball area that was raised and bumpy. I had advised her to use a cold pack and use the Claritin once daily that she takes for her hay allergy since she is very sensitive to benadryl.  I contacted the Collaborative Practice Physician and explained adverse event on 4-21-09 and agreed that the adverse event sounded localized, continue treatment as previously described, and have her contact her PCP if condition worsens.  I followed up with her on 4-24-09 and she stated that the area was only the size of a quarter now with a scab.  I told her to keep the scab clean and to use Aquaphor to help healing.  She stated that she did not need to see her PCP and she had no other complications.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash vesicular
Clinical narrative: Parents told me today at a sibling's visit that ~2 weeks after patient received her Varivax she developed a fever and what looked like chicken pox lesions at the site of injection, and ~2 weeks after that multiple contacts (cousins, church nursery) broke out with chicken pox.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Warmth, redness, swelling, induration, & pain at injection site. unable to lift arm. Started taking Tylenol 1000 mg per recommendations.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Warmth, redness, swelling, induration, & pain at injection site. unable to lift arm. Started taking Tylenol 1000 mg per recommendations.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Ear pain, Hyperhidrosis, Syncope
Clinical narrative: Intense sweating, chills, fainting, pain deep in ears
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: Several hours after the vaccine my upper arm began to swell. The injection site had a rash, my entire upper arm looked like a giant hive.  It was very painful.  I called the on call physician.  He advised me to take an antihistimine and apply ice.  At that point the swelling stopped.  Over 24 hours later the arm is still very sore and very swollen.
Age: 1.0
Sex: F
Vaccine: DTPIPV, HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Diarrhoea, Emotional disorder, Hypophagia
Clinical narrative: fever, diarrhea, crying (insolable), stopped eating typical foods she liked, needed to be in constant motion (baby jumper)to be happy, didn't want to be held, no eye contact, how she played changed (stacking objects only play), stopped making any sound at all  6/17/09 PCP records - DOS 11/18/00 to 5/27/02   Assessment: Eczematous dermatitis Records indicate healthy newborn. At about 1 year of age child presented with a rash. Dermatology consult - Eczematous dermatitis.\ksk
Age: 1.0
Sex: F
Vaccine: DTPIPV, HIBV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: fever, diarrhea, crying (insolable), stopped eating typical foods she liked, needed to be in constant motion (baby jumper)to be happy, didn't want to be held, no eye contact, how she played changed (stacking objects only play), stopped making any sound at all  6/17/09 PCP records - DOS 11/18/00 to 5/27/02   Assessment: Eczematous dermatitis Records indicate healthy newborn. At about 1 year of age child presented with a rash. Dermatology consult - Eczematous dermatitis.\ksk
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: After shot(pneumococcal polysaccharide) my husband had swelling at the sight and red and very hot.The redness and swelling went down the inside of his arm. He ran a fever and it was very painful. This lasted 5 days and then disappeared. No treatment was given
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: After shot(pneumococcal polysaccharide) my husband had swelling at the sight and red and very hot.The redness and swelling went down the inside of his arm. He ran a fever and it was very painful. This lasted 5 days and then disappeared. No treatment was given
Age: 38.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Erythema multiforme, Pain in extremity, Rash
Clinical narrative: This serious case was received via a search of the VAERS database on 11 January 2009 (reference number 318230). A 38-year-old patient received the following vaccinations on 20 June 2008: a percutaneous injection of smallpox (trade name and manufacturer unknown, lot number not reported) and an intramuscular injection of TYPHIM VI (lot number not reported). On 03 July 2008, 13 days post-vaccination, the patient developed a disseminated rash which started on the right arm and quickly moved to the left arm, neck, scalp, and forehead. His left arm was described as "very sore". He denied fever, nausea or weakness. He presented to the emergency department on 04 July 2008 where he was diagnosed with erythema multiforme and treated with BENADRYL and non-steroidal anti-inflammatories. Outcome was not reported. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, C-reactive protein increased, Chest X-ray normal, Chest pain
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database (318844).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 19-year-old male patient received the following vaccination on 06 May 2008: a percutaneous injection of SMALLPOX (tradename and manufacturer unknown, lot not reported), an intramuscular injection of TYPHOID (TYPHIM VI, lot not reported), and a subcutaneous injection of ANTHRAX (BIOTHRAX, lot not reported, manufactured by Bioport Corporation).  On 17 May 2008, 11 days after receiving the vaccines (also reported as 13 days post SPV), the patient experienced chest pain and shortness of breath and developed myocarditis.  Laboratory results from 17 May 2008 revealed CK (increased - 909), CKMB (105), CKMB index (11.6), and CRP (increased - 52.6).  On 18 May 2008, Troponin I was elevated (15.32) and a cardiac MRI was performed.  The impression noted "multiple areas of enhancement within the left ventricular lateral wall consistent with history of clinical myocard".  On an unspecified date, a chest x-ray and echocardiogram were performed; both with normal findings.  The patient was diagnosed with acute myocarditis and recovered from the event.  The patient's date of recovery was not reported.  The outcome for the event was reported as "required intervention to prevent impairment/ damage".  No additional information was provided.  Documents held by sender:  None  A corrective version was created to amend the product to ACAM2000.  Although the SMALLPOX vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Echocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging abnormal, Troponin I increased
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database (318844).  It was originally reported to VAERS by another manufacturer (manufacturer unknown).  A 19-year-old male patient received the following vaccination on 06 May 2008: a percutaneous injection of SMALLPOX (tradename and manufacturer unknown, lot not reported), an intramuscular injection of TYPHOID (TYPHIM VI, lot not reported), and a subcutaneous injection of ANTHRAX (BIOTHRAX, lot not reported, manufactured by Bioport Corporation).  On 17 May 2008, 11 days after receiving the vaccines (also reported as 13 days post SPV), the patient experienced chest pain and shortness of breath and developed myocarditis.  Laboratory results from 17 May 2008 revealed CK (increased - 909), CKMB (105), CKMB index (11.6), and CRP (increased - 52.6).  On 18 May 2008, Troponin I was elevated (15.32) and a cardiac MRI was performed.  The impression noted "multiple areas of enhancement within the left ventricular lateral wall consistent with history of clinical myocard".  On an unspecified date, a chest x-ray and echocardiogram were performed; both with normal findings.  The patient was diagnosed with acute myocarditis and recovered from the event.  The patient's date of recovery was not reported.  The outcome for the event was reported as "required intervention to prevent impairment/ damage".  No additional information was provided.  Documents held by sender:  None  A corrective version was created to amend the product to ACAM2000.  Although the SMALLPOX vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed SMALLPOX vaccine at the time of the patient's vaccination.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dizziness, Headache, Hypoaesthesia, Nausea, Oedema peripheral
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database (319910). It was originally reported to VAERS by another manufacturer, Emergent Biosolutions. A 30-year-old male patient received the following vaccinations on 14 July 2008: a percutaneous injection of smallpox (trade name and manufacturer unknown, lot not reported), an intramuscular injection of TYPHIM VI (lot not reported), and a subcutaneous injection of BIOTHRAX (lot not reported, manufacturer Bioport Corporation). On 17 July 2008, three days post-vaccination, the patient developed a rash, intense swelling, numbness of the hand, headaches, fever, nausea and dizziness. The outcome for the event was reported as "required intervention to prevent permanent impairment/damage". The patient's recovery status was not reported. No additional information was provided. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pyrexia, Rash
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database (319910). It was originally reported to VAERS by another manufacturer, Emergent Biosolutions. A 30-year-old male patient received the following vaccinations on 14 July 2008: a percutaneous injection of smallpox (trade name and manufacturer unknown, lot not reported), an intramuscular injection of TYPHIM VI (lot not reported), and a subcutaneous injection of BIOTHRAX (lot not reported, manufacturer Bioport Corporation). On 17 July 2008, three days post-vaccination, the patient developed a rash, intense swelling, numbness of the hand, headaches, fever, nausea and dizziness. The outcome for the event was reported as "required intervention to prevent permanent impairment/damage". The patient's recovery status was not reported. No additional information was provided. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 23.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, Chest X-ray normal, Chest pain, Dyspnoea
Clinical narrative: This serious case was received via a search of the VAERS database on 11 January 2009 (reference number 320782). A 23-year-old male (corrected on 18 March 2009 from 31-year-old) patient received the following vaccinations on 22 July 2008: percutaneous smallpox (trade name and manufacturer unknown, lot number not reported) and TYPHIM VI (lot number not reported). Five days after vaccination, on 27 July 2008, the patient developed substernal chest pain, flu-like symptoms, and dyspnea. A CBC revealed a WBC of 12.7K. CPK was normal, and CPK-MB, troponin, and chest x-ray were negative. Per the reporter, the event required intervention to prevent permanent impairment/damage. Outcome was not reported. Documents held by sender: None. A corrective version was created to amend the product to ACAM 2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. 18 March 2009: A corrective version was created, using the receipt date from the previous version, in order to amend the patient's age in the narrative from 31 to 23. No additional information was added.
Age: 23.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Influenza like illness, Troponin, White blood cell count increased
Clinical narrative: This serious case was received via a search of the VAERS database on 11 January 2009 (reference number 320782). A 23-year-old male (corrected on 18 March 2009 from 31-year-old) patient received the following vaccinations on 22 July 2008: percutaneous smallpox (trade name and manufacturer unknown, lot number not reported) and TYPHIM VI (lot number not reported). Five days after vaccination, on 27 July 2008, the patient developed substernal chest pain, flu-like symptoms, and dyspnea. A CBC revealed a WBC of 12.7K. CPK was normal, and CPK-MB, troponin, and chest x-ray were negative. Per the reporter, the event required intervention to prevent permanent impairment/damage. Outcome was not reported. Documents held by sender: None. A corrective version was created to amend the product to ACAM 2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. 18 March 2009: A corrective version was created, using the receipt date from the previous version, in order to amend the patient's age in the narrative from 31 to 23. No additional information was added.
Age: 21.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Anaemia, Aplastic anaemia, Biopsy bone marrow abnormal, Bone marrow failure, Condition aggravated
Clinical narrative: This serious case was received via a search of the VAERS database on 11 January 2009 (reference number 331142). A 21-year-old male patient received the following vaccinations on 15 April 2008: percutaneous smallpox (trade name and manufacturer unknown, lot number not reported) and intramuscular TYPHIM VI (lot number not reported). The patient, who was participating in a smallpox vaccine protocol, was noted to have a low platelet count prior to receipt of vaccine on 15 April 2008. Subsequent testing indicated thrombocytopenia and anemia, and the patient was noted to have ecchymosis. A bone marrow biopsy showed pancytopenia with marked reduction in platelets. Erythrocytes showed an increase in MCV and MCH. Lymphocyte, monocyte, and neutrophil counts were decreased. Additional diagnoses included aplastic anemia and bone marrow failure. Outcome was not reported. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 21.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Ecchymosis, Lymphocyte count decreased, Mean cell haemoglobin, Mean cell volume increased, Monocyte count decreased
Clinical narrative: This serious case was received via a search of the VAERS database on 11 January 2009 (reference number 331142). A 21-year-old male patient received the following vaccinations on 15 April 2008: percutaneous smallpox (trade name and manufacturer unknown, lot number not reported) and intramuscular TYPHIM VI (lot number not reported). The patient, who was participating in a smallpox vaccine protocol, was noted to have a low platelet count prior to receipt of vaccine on 15 April 2008. Subsequent testing indicated thrombocytopenia and anemia, and the patient was noted to have ecchymosis. A bone marrow biopsy showed pancytopenia with marked reduction in platelets. Erythrocytes showed an increase in MCV and MCH. Lymphocyte, monocyte, and neutrophil counts were decreased. Additional diagnoses included aplastic anemia and bone marrow failure. Outcome was not reported. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 21.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Neutrophil count decreased, Pancytopenia, Platelet count decreased, Red blood cell count increased, Thrombocytopenia
Clinical narrative: This serious case was received via a search of the VAERS database on 11 January 2009 (reference number 331142). A 21-year-old male patient received the following vaccinations on 15 April 2008: percutaneous smallpox (trade name and manufacturer unknown, lot number not reported) and intramuscular TYPHIM VI (lot number not reported). The patient, who was participating in a smallpox vaccine protocol, was noted to have a low platelet count prior to receipt of vaccine on 15 April 2008. Subsequent testing indicated thrombocytopenia and anemia, and the patient was noted to have ecchymosis. A bone marrow biopsy showed pancytopenia with marked reduction in platelets. Erythrocytes showed an increase in MCV and MCH. Lymphocyte, monocyte, and neutrophil counts were decreased. Additional diagnoses included aplastic anemia and bone marrow failure. Outcome was not reported. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: This case was received on 15 December 2008 via a QScan search on the VAERS database, under reference number 323915.  A 31 year-old female patient received the following vaccination on 02 August 2008:  SMALLPOX (ACAM2000, Sanofi Pasteur Biologics Co., lot number not reported).  Eleven days after vaccination, the patient complained of "systemic reaction to SMALLPOX vaccination".  A  fever of 102 degree F was reported.  The patient also experienced cross contamination to the lower arm and neck area.  List of documents held by sender:  None
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Laboratory test, Mass
Clinical narrative: This report was received on 15 December 2008 via a QScan search on the VAERS database, under reference number 323981.  A 26-year-old female patient received the following vaccinations on 09 August 2008:  SMALLPOX (ACAM2000), sanofi Pasteur biologics Co., lot number not reported) and ANTHRAX (manufacturer unknown, lot number not reported).  The patient reported a lump on her right arm, onset 20 August 2008, which was thought to be a possible allergic reaction to the ANTHRAX shot.  Supportive care with non-steroidal anti-inflammatory medication, BENADRYL, heat and cold compresses was administered.  The patient was told to not received further ANTHRAX vaccine in the future and was instructed to initiate a VAERS report.  List of documents held by sender:  none
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Angiogram normal, Blood creatine phosphokinase increased, Blood creatinine decreased, Blood urea normal, Chest pain
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 324136. A 29-year-old male patient, whose medical history was not reported, received on 20 August 2008 a smallpox vaccine (trade name and manufacturer unknown, lot number not reported). On 30 August 2008, ten days post-vaccination, the patient developed chest pain, fever, and shortness of breath. After three days, on 02 September 2008, the symptoms were persisting and the patient went to a medical clinic. At the time of the visit, the patient's temperature was 99.6 F and he was diaphoretic. The chest pain was rated to be 3 out of 10. An ECG was not performed due to equipment failure. The patient was given ASA 162 mg, nitroglycerin sublingual, an intravenous line was started and he received morphine sulphate 2 mg IV push. The patient was transferred to another medical facility. ECG in the emergency room noted normal sinus rhythm, early repolarization, with possible ST segment elevation in lead 1, and possible incomplete right bundle branch block. Laboratory test results included the following: positive troponin and CK-MB and a negative rapid strep test. The patient was started on nitroglycerin drip and heparin. He was transferred to another facility and admitted for heart catheterization. He was discharged on 03 September 2008 with a normal echocardiogram, normal ejection fraction, and was started on a beta blocker and ACE inhibitor for two to four weeks with follow-up with cardiology scheduled four weeks later. On 12 September 2008, hospital records were reviewed for 02 and 03 September 2008 and indicated the following: Final diagnosis: none provided. The patient experienced chest pain, shortness of breath, muscle aches, decreased appetite and dizziness three to four days prior to admission. INR 1.16; Troponin 4.79; CPK-M 23; K+ 4; Creatinine 1; BUN 11; WBC 14900; HGB 14.4; ECG-completed as noted above, angiogram performed, and normal per physician's note. LABS: EKG abnormal. CK 230 (H); ESR 43 (H). NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Electrocardiogram abnormal, Haemoglobin normal
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 324136. A 29-year-old male patient, whose medical history was not reported, received on 20 August 2008 a smallpox vaccine (trade name and manufacturer unknown, lot number not reported). On 30 August 2008, ten days post-vaccination, the patient developed chest pain, fever, and shortness of breath. After three days, on 02 September 2008, the symptoms were persisting and the patient went to a medical clinic. At the time of the visit, the patient's temperature was 99.6 F and he was diaphoretic. The chest pain was rated to be 3 out of 10. An ECG was not performed due to equipment failure. The patient was given ASA 162 mg, nitroglycerin sublingual, an intravenous line was started and he received morphine sulphate 2 mg IV push. The patient was transferred to another medical facility. ECG in the emergency room noted normal sinus rhythm, early repolarization, with possible ST segment elevation in lead 1, and possible incomplete right bundle branch block. Laboratory test results included the following: positive troponin and CK-MB and a negative rapid strep test. The patient was started on nitroglycerin drip and heparin. He was transferred to another facility and admitted for heart catheterization. He was discharged on 03 September 2008 with a normal echocardiogram, normal ejection fraction, and was started on a beta blocker and ACE inhibitor for two to four weeks with follow-up with cardiology scheduled four weeks later. On 12 September 2008, hospital records were reviewed for 02 and 03 September 2008 and indicated the following: Final diagnosis: none provided. The patient experienced chest pain, shortness of breath, muscle aches, decreased appetite and dizziness three to four days prior to admission. INR 1.16; Troponin 4.79; CPK-M 23; K+ 4; Creatinine 1; BUN 11; WBC 14900; HGB 14.4; ECG-completed as noted above, angiogram performed, and normal per physician's note. LABS: EKG abnormal. CK 230 (H); ESR 43 (H). NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Hyperhidrosis, International normalised ratio decreased, Myalgia, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 324136. A 29-year-old male patient, whose medical history was not reported, received on 20 August 2008 a smallpox vaccine (trade name and manufacturer unknown, lot number not reported). On 30 August 2008, ten days post-vaccination, the patient developed chest pain, fever, and shortness of breath. After three days, on 02 September 2008, the symptoms were persisting and the patient went to a medical clinic. At the time of the visit, the patient's temperature was 99.6 F and he was diaphoretic. The chest pain was rated to be 3 out of 10. An ECG was not performed due to equipment failure. The patient was given ASA 162 mg, nitroglycerin sublingual, an intravenous line was started and he received morphine sulphate 2 mg IV push. The patient was transferred to another medical facility. ECG in the emergency room noted normal sinus rhythm, early repolarization, with possible ST segment elevation in lead 1, and possible incomplete right bundle branch block. Laboratory test results included the following: positive troponin and CK-MB and a negative rapid strep test. The patient was started on nitroglycerin drip and heparin. He was transferred to another facility and admitted for heart catheterization. He was discharged on 03 September 2008 with a normal echocardiogram, normal ejection fraction, and was started on a beta blocker and ACE inhibitor for two to four weeks with follow-up with cardiology scheduled four weeks later. On 12 September 2008, hospital records were reviewed for 02 and 03 September 2008 and indicated the following: Final diagnosis: none provided. The patient experienced chest pain, shortness of breath, muscle aches, decreased appetite and dizziness three to four days prior to admission. INR 1.16; Troponin 4.79; CPK-M 23; K+ 4; Creatinine 1; BUN 11; WBC 14900; HGB 14.4; ECG-completed as noted above, angiogram performed, and normal per physician's note. LABS: EKG abnormal. CK 230 (H); ESR 43 (H). NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Streptococcal identification test, Troponin, White blood cell count increased
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 324136. A 29-year-old male patient, whose medical history was not reported, received on 20 August 2008 a smallpox vaccine (trade name and manufacturer unknown, lot number not reported). On 30 August 2008, ten days post-vaccination, the patient developed chest pain, fever, and shortness of breath. After three days, on 02 September 2008, the symptoms were persisting and the patient went to a medical clinic. At the time of the visit, the patient's temperature was 99.6 F and he was diaphoretic. The chest pain was rated to be 3 out of 10. An ECG was not performed due to equipment failure. The patient was given ASA 162 mg, nitroglycerin sublingual, an intravenous line was started and he received morphine sulphate 2 mg IV push. The patient was transferred to another medical facility. ECG in the emergency room noted normal sinus rhythm, early repolarization, with possible ST segment elevation in lead 1, and possible incomplete right bundle branch block. Laboratory test results included the following: positive troponin and CK-MB and a negative rapid strep test. The patient was started on nitroglycerin drip and heparin. He was transferred to another facility and admitted for heart catheterization. He was discharged on 03 September 2008 with a normal echocardiogram, normal ejection fraction, and was started on a beta blocker and ACE inhibitor for two to four weeks with follow-up with cardiology scheduled four weeks later. On 12 September 2008, hospital records were reviewed for 02 and 03 September 2008 and indicated the following: Final diagnosis: none provided. The patient experienced chest pain, shortness of breath, muscle aches, decreased appetite and dizziness three to four days prior to admission. INR 1.16; Troponin 4.79; CPK-M 23; K+ 4; Creatinine 1; BUN 11; WBC 14900; HGB 14.4; ECG-completed as noted above, angiogram performed, and normal per physician's note. LABS: EKG abnormal. CK 230 (H); ESR 43 (H). NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Discomfort, Erythema, Hypoaesthesia, Induration, Paraesthesia
Clinical narrative: This case was received on 15 December 2008 via a search on the VAERS database, under reference number 324153. A 25-year-old male patient, whose medical history was not reported, received ACAM2000 (lot number not reported) on 26 August 2008. On 02 September 2008, 7 days after vaccination, the patient had a 100 mm area of slight erythema and induration that was slightly uncomfortable and he also had numbness and tingling in the area. The patient's recovery status was not reported.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Alopecia, Cough, Injection site pain, Injection site pruritus, Injection site pustule
Clinical narrative: This case was received on 15 December 2008 via a search on the VAERS database, under reference number 324534. A 25-year-old female patient, whose medical history was not reported, received ACAM 2000 (lot number not reported) on 27 August 2008. She had also received the first dose and second doses of Anthrax vaccine (trade name and manufacturer unknown, lot number not reported) on 15 August 2008 and 03 September 2008, respectively. On an unspecified date, the patient developed constant itching, a rash, and small pustules around the injection site. One week later, she was still itching and her arm was swollen around the injection site. Two weeks later, there was extreme tenderness around injection site, it was painful and the patient's lymph nodes on the left side of her body were swollen, mainly under the left arm and groin. Additionally, the patient reported that she had a rather large amount of hair fall out in the shower on 03 September 2008. She also had a constant cough and sore throat since vaccination. On September 2008, a physician put the patient on "quarters", directed her to take MOTRIN for the pain, and apply a warm compress on the injection site. The patient's recovery status was not reported.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Injection site rash, Injection site swelling, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: This case was received on 15 December 2008 via a search on the VAERS database, under reference number 324534. A 25-year-old female patient, whose medical history was not reported, received ACAM 2000 (lot number not reported) on 27 August 2008. She had also received the first dose and second doses of Anthrax vaccine (trade name and manufacturer unknown, lot number not reported) on 15 August 2008 and 03 September 2008, respectively. On an unspecified date, the patient developed constant itching, a rash, and small pustules around the injection site. One week later, she was still itching and her arm was swollen around the injection site. Two weeks later, there was extreme tenderness around injection site, it was painful and the patient's lymph nodes on the left side of her body were swollen, mainly under the left arm and groin. Additionally, the patient reported that she had a rather large amount of hair fall out in the shower on 03 September 2008. She also had a constant cough and sore throat since vaccination. On September 2008, a physician put the patient on "quarters", directed her to take MOTRIN for the pain, and apply a warm compress on the injection site. The patient's recovery status was not reported.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion
Clinical narrative: This case was received on 15 December 2008 via a QScan search on the VAERS database, under reference number 325136.  An 18-year-old male patient received the following vaccination on 08 September 2008:  SMALLPOX (ACAM2000, Sanofi Pasteur Biologics Co, lot number not reported), ANTHRAX (BIOTHRAX, manufacturer and lot number not reported), and influenza (FLUMIST, Wyeth, lot number not reported).  Four days after vaccination, on 12 September 2008, a "satellite lesion on the left shoulder net to primary" was reported.  List of documents held by sender:  None