chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: 12 year old child, new to area, no vaccination records. Parent - non language speaking but Pt is fluent. Pt reports that about 1 hour after receiving vaccines. She broke out in itchy rash all over body. Hives unresolved 3 days after vaccines. Sent to clinic for MD eval.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: 1600 pt passed out, in the lobby on their way out home. Became pale, non responsive, US taken & showed for few minutes as inquiry noted. MD notified. regained consciousness & recovered.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Anorexia, Asthenia, Dizziness, Dry mouth
Clinical narrative: Severe pain and inability to lift arm headache, stomachache, nausea pale, dizzy, weak, dry mouth & throat.  This lasted 3 days, missed (1) day of work.  7-13-09 7PM - Still some weakness/ appetite loss. 1/7/2010 PCP records for wellness visit 7/9/2009.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dry throat, Headache, Injected limb mobility decreased, Nausea, Pain in extremity
Clinical narrative: Severe pain and inability to lift arm headache, stomachache, nausea pale, dizzy, weak, dry mouth & throat.  This lasted 3 days, missed (1) day of work.  7-13-09 7PM - Still some weakness/ appetite loss. 1/7/2010 PCP records for wellness visit 7/9/2009.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor
Clinical narrative: Severe pain and inability to lift arm headache, stomachache, nausea pale, dizzy, weak, dry mouth & throat.  This lasted 3 days, missed (1) day of work.  7-13-09 7PM - Still some weakness/ appetite loss. 1/7/2010 PCP records for wellness visit 7/9/2009.
Age: 42.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Painful, swollen, red right arm.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Ear pain, Facial palsy, Hypoaesthesia, Migraine, Paralysis
Clinical narrative: Started feeling sluggish on 6/27/09, then got a migraine on 6/29/09 pain still on right side. started having right ear pain on 6/30/09 and woke up on 7/2/09 with numbness to lips and tongue which turned into paralysis by 7/3/09. Went to FMD on 7/6/09. Dx with BELL'S palsy. R/T Hep B injection.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Somnolence, Vomiting
Clinical narrative: Received DTAP, HIB and PREVNAR on 6/29/09.  Fever occurred several hours later - sleepy that day & fussy that evening.  3 loose stools & 1 emesis 6/30/09, 7/2/09 diarrhea, vomiting & increased temp.
Age: 0.9
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: High fever up to 104.8 (R) for 3 days till seen.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: 4 cm round reddish area at site of injection - No induration. No pain.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 12 X 13 cm red mildly tender area around the injection site.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, itchy, hot to touch, approx 1 1/2 inch swelling.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, irritated, itchy Injection site. Swelling of entire upper arm, painful.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Induration, Swelling
Clinical narrative: 7 cm swelling with 5cm induration/swelling tx with antibiotic KEFLEX.
Age: 1.8
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, fussiness/irritability began several hours after vaccine, resolved in 48 hrs.
Age: 18.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Blindness transient, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Transient vision loss.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck) on an unspecified date. The reporter did not want to report an adverse event. No adverse event involved. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with ZOSTAVAX vaccine (Merck). The pharmacist reported that the patient developed "a knot" at the injection site. The pharmacist was the one who administered the vaccine. The patient sought unspecified medical attention. Additional information. has been requested
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Local swelling, Muscle spasms, Neck pain
Clinical narrative: A 42-year-old female patient had received a left deltoid intramuscular injection of ADACEL, lot number C2965AA and one day later, she developed a fever of 102 degrees Fahrenheit and right sided neck swelling, with spasm and pain.  She also developed edema which radiated to the left elbow, severe redness and pain.  She was seen by her treating physician and received corrective treatment with KEFLEX.  The patient had no concurrent illnesses and no known allergies.  Her past history included asthma and hypertension.  Concomitant therapies included FLONASE, ATENOL, "ADAVER", and "CINGULAR".  At the time of the report, the patient was recovered from the event.  Follow-up information received from a health care professional on 31 July 2008.  The reporter indicated that the patient's right sided neck pain and right sided neck muscle spasms started in early May, prior to the ADACEL injection.  The injection site reaction started on 16 May 2008 and ended on 20 May 2008.  The patient's temperature was 100.3 degrees Fahrenheit on 16 May 2008 and 98.4 degrees Fahrenheit on 20 May 2008.  Concomitant therapies, previously reported as "ADAVER" and "CINGULAR" were confirmed to be ADVAIR and SINGULAIR, respectively.  Follow-up information received from a health care professional on 08 September 2008.  The reporter stated that there was no additional information at that time.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema, Pyrexia
Clinical narrative: A 42-year-old female patient had received a left deltoid intramuscular injection of ADACEL, lot number C2965AA and one day later, she developed a fever of 102 degrees Fahrenheit and right sided neck swelling, with spasm and pain.  She also developed edema which radiated to the left elbow, severe redness and pain.  She was seen by her treating physician and received corrective treatment with KEFLEX.  The patient had no concurrent illnesses and no known allergies.  Her past history included asthma and hypertension.  Concomitant therapies included FLONASE, ATENOL, "ADAVER", and "CINGULAR".  At the time of the report, the patient was recovered from the event.  Follow-up information received from a health care professional on 31 July 2008.  The reporter indicated that the patient's right sided neck pain and right sided neck muscle spasms started in early May, prior to the ADACEL injection.  The injection site reaction started on 16 May 2008 and ended on 20 May 2008.  The patient's temperature was 100.3 degrees Fahrenheit on 16 May 2008 and 98.4 degrees Fahrenheit on 20 May 2008.  Concomitant therapies, previously reported as "ADAVER" and "CINGULAR" were confirmed to be ADVAIR and SINGULAIR, respectively.  Follow-up information received from a health care professional on 08 September 2008.  The reporter stated that there was no additional information at that time.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inappropriate schedule of drug administration, Injection site induration, Oedema peripheral, Pruritus
Clinical narrative: Initial report was received 29 May 2008 from a health care provider. A 74-year-old female patient with a history of shingles (March 2008) and diverticulosis, had received a left deltoid intramuscular injection of ADACEL, lot number C2766AA on 22 May 2008, and five days later, she developed itching, redness and swelling. She was evaluated by her physician on 29 May 2008 with symptoms which consisted of a red swollen left arm, 11cm by 6cm in size which extended 6-8 cm below the left deltoid injection site. Corrective treatments were not reported. At the time of the report, the symptom of itching had resolved but the symptoms of redness and swelling persisted. The patient had not recovered from the event. Follow-up information was received 01 August 2008 from a health care professional in the United States. The reporter indicated that the event consisted of a local reaction "11 x 6 cm area of erythema, plus induration, the left upper arm". The patient received corrective treatments with t.i.d BENADRYL plus 1cc of CELESTENE. At the time of the report, the patient had not recovered from the event.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain
Clinical narrative: This non-serious case was received from a health professional on 11 June 2008. A 29-year-old female patient, with a history of sulfa drug allergy and bipolar disorder, received an intramuscular left deltoid injection of ADACEL (lot number not known) on 21 April 2008. The same day, she also received an intramuscular right deltoid injection of Hepatitis B (manufacturer and lot number not known). Approximately 24 hours after vaccination, the patient complained of left shoulder pain. Three days later, the pain intensified, and at the time of the report was still ongoing. The patient had undergone unspecified testing, the results of which were not known by the reporter. She had been referred to an occupational medicine clinic for additional evaluation. Follow-up information was received 09 September 2008 from a health care professional. The patient had been vaccinated during a new hire physical and had received ADACEL, lot number C2899AA (expiration 09 May 2010) and a sixth dose of Hepatitis B, lot number AHBVB448AA (expiration 24 January 2010. The patient had not received any other vaccines during the four weeks prior to receipt of ADACEL and Hepatitis B vaccines. No additional information was provided at the time of the report.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial toxaemia, Drug exposure during pregnancy, Serology normal, Ultrasound scan normal, Vaginal haemorrhage
Clinical narrative: Initial report received on 24 June 2008 from a health care professional. A 20-year-old female patient whose past medical history includes the current pregnancy, had received a 0.5 mL intramuscular deltoid injection of ADACEL (Lot # not provided) on 15 April 2008. The patient had no prior obstetrical history. The date of the patient's last menstrual period was on 17 March 2008, and her expected date of delivery is on 22 December 2008. It was not known the patient was pregnant at the time of the vaccination with ADACEL on 15 April 2008. At the time of this report, the patient had not experienced any adverse events. Follow-up information received on 13 February 2009 from a health care professional. Per the reporter, the patient received the "first" dose of ADACEL in the left deltoid on 15 April 2008 prior to knowing that she was pregnant. The patient had two episodes of bleeding while pregnant which were not described. It was not reported whether the patient required any specific activity limitations or treatment for the bleeding. On 09 June 2008 serology testing was completed that was normal. On 22 July 2008 an ultrasound was completed that was normal. On 16 December 2008, the patient delivered via vaginal delivery a single female baby at 39 weeks gestation. The baby weight and length was reported as "7.1". The baby had no congenital anomalies. The baby's Apgar scores were eight at one minute and nine at five minutes. Pregnancy complications were identified as toxemia; however, it was not reported whether the patient suffered any effects from the toxemia, or if she required any treatment. It was reported the patient had an uneventful pregnancy and delivery. Follow-up information was received 04 May 2009 from a health care professional. The patient's bleeding occurred prior to 14 weeks gestation and the patient and fetus suffered no adverse effects. The patient sought care two days after the second episode resolved. For the event of toxemia, the reporter only knew that MgSO4 was administered post-partum and no other data was available. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Initial report received on 07 July 2008 from a health care professional. A 57-year-old female patient, who has a past medical history of "blood clotting disorder" and palpitations, had received an intramuscular left deltoid injection of ADACEL (Lot # C2767AA) on 17 June 2008. Two days after vaccination, the patient experienced redness and swelling the size of an orange at the injection site, and leg pain which lasted for seven days. The patient was treated with antihistamines and ice. No relevant diagnostic tests/laboratory data were performed. The patient subsequently recovered (date of recovery not reported). Follow-up information received on 21 August 2008 from a health care professional. The patient had a history of heterozygous Leiden mutation. She was not taking any concomitant medications. The patient was evaluated by a physician and no diagnosis was made. The patient recovered from her symptoms on 20 July 2008.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Disturbance in attention, Dizziness, Hyperhidrosis, Injection site nodule, Injection site pain
Clinical narrative: Initial non-serious case received from a Healthcare Professional on 21 July 2008. A 58-year-old female patient developed a general feeling of not feeling well, lightheadedness, trouble focusing, right arm axillary tenderness and swelling with a possible lump, right deltoid nodule at the injection site, intermittent episodes of profuse sweating and nausea 24 hours after receiving an intramuscular right deltoid injection of ADACEL (lot number C2766AA) and an intramuscular left deltoid injection of PNEUMOVAX (manufacturer Merck, lot number 1381U). The patient was seen at the doctor's office and received treatment with CLARITIN, BENADRYL and an allergy shot (not specified). Patient outcome was reported as 'not recovered'. The patient was to follow-up with the doctor's office in 24-48 hours. Follow-up received from a Healthcare Professional on 15 August 2008. Date of ADACEL and PNEUMOVAX vaccinations was amended from 17 July 2008 to 16 July 2008 and the adverse event onset date was amended from 18 July 2008 to 17 July 2008. The symptom, "trouble focusing", was clarified to mean trouble focusing mentally, rather than blurred vision; coding was amended accordingly. It was initially reported that the patient had a possible axillary lump. Findings from a physical exam performed on 21 July 2008 stated, "swelling and tenderness in axillary region, diffuse"; coding of this symptom was also amended. Another finding from that exam was firmness in the deltoid region. At the time of the vaccinations, the patient had sinusitis. No additional medically relevant information was provided. Follow-up received from a Healthcare Professional on 29 September 2008. Progress Notes dated 21 July 2008 indicated that, in addition to the previously reported symptoms, the patient reported feeling groggy. Her blood pressure was 139/70, pulse 62, oral temperature 97.7 degrees Fahrenheit. The patient's lungs were clear to auscultation and percussion. The event was reported to be a questionable reaction to the ADACEL. Treatment included alternate cool compresses/warm moist compresses to the axillary region, allergy injection per patient request, CLARITIN, BENADRYL at night, hydration and rest. The patient indicated that she was fine before being vaccinated. Follow up information was received on 23 December 2008 from a health care professional. The patient had sinusitis at the time of vaccination. The patient recovered on 21 July 2008 and did not return for follow up within 24-48 hours. No further information was provided.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Malaise, Nausea
Clinical narrative: Initial non-serious case received from a Healthcare Professional on 21 July 2008. A 58-year-old female patient developed a general feeling of not feeling well, lightheadedness, trouble focusing, right arm axillary tenderness and swelling with a possible lump, right deltoid nodule at the injection site, intermittent episodes of profuse sweating and nausea 24 hours after receiving an intramuscular right deltoid injection of ADACEL (lot number C2766AA) and an intramuscular left deltoid injection of PNEUMOVAX (manufacturer Merck, lot number 1381U). The patient was seen at the doctor's office and received treatment with CLARITIN, BENADRYL and an allergy shot (not specified). Patient outcome was reported as 'not recovered'. The patient was to follow-up with the doctor's office in 24-48 hours. Follow-up received from a Healthcare Professional on 15 August 2008. Date of ADACEL and PNEUMOVAX vaccinations was amended from 17 July 2008 to 16 July 2008 and the adverse event onset date was amended from 18 July 2008 to 17 July 2008. The symptom, "trouble focusing", was clarified to mean trouble focusing mentally, rather than blurred vision; coding was amended accordingly. It was initially reported that the patient had a possible axillary lump. Findings from a physical exam performed on 21 July 2008 stated, "swelling and tenderness in axillary region, diffuse"; coding of this symptom was also amended. Another finding from that exam was firmness in the deltoid region. At the time of the vaccinations, the patient had sinusitis. No additional medically relevant information was provided. Follow-up received from a Healthcare Professional on 29 September 2008. Progress Notes dated 21 July 2008 indicated that, in addition to the previously reported symptoms, the patient reported feeling groggy. Her blood pressure was 139/70, pulse 62, oral temperature 97.7 degrees Fahrenheit. The patient's lungs were clear to auscultation and percussion. The event was reported to be a questionable reaction to the ADACEL. Treatment included alternate cool compresses/warm moist compresses to the axillary region, allergy injection per patient request, CLARITIN, BENADRYL at night, hydration and rest. The patient indicated that she was fine before being vaccinated. Follow up information was received on 23 December 2008 from a health care professional. The patient had sinusitis at the time of vaccination. The patient recovered on 21 July 2008 and did not return for follow up within 24-48 hours. No further information was provided.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 01 December 2008. A 43-year-old female patient who had stepped on a nail and who had a pre-existing cough, was inadvertently given a second dose of ADACEL, administered intramuscularly to the left deltoid on 25 November 2008 (lot number UF455BA; other lot number C3004). The patient had previously received a dose of ADACEL on 10 January 2007. On 27 November 2008, the patient experienced an orange-sized area of redness, swelling, warmth and itching that became worse in 28 November 2008. As of 01 December 2008, the symptoms had resolved. It was also reported that the patient's cough had worsened after the ADACEL vaccination. No fever or additional events were reported. Outcome of cough was not reported. Follow up information was received on 22 December 2008 from a health care professional. The reporter clarified the patient had a staple in her finger at the time of vaccination, previously reported as stepping on a nail. The reporter confirmed that the orange sized redness, swelling, warmth and itching were all symptoms at the injection site, the left deltoid. Treatment included ice and MOTRIN. Concomitant therapy included NORVASC, FLEXERIL and MOTRIN. The cough worsened on 26 November 2008 and then resolved by 28 November 2008. The patient did not seek medical attention. No other information was provided. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Overdose
Clinical narrative: Initial report received from a health care professional on 01 December 2008. A 43-year-old female patient who had stepped on a nail and who had a pre-existing cough, was inadvertently given a second dose of ADACEL, administered intramuscularly to the left deltoid on 25 November 2008 (lot number UF455BA; other lot number C3004). The patient had previously received a dose of ADACEL on 10 January 2007. On 27 November 2008, the patient experienced an orange-sized area of redness, swelling, warmth and itching that became worse in 28 November 2008. As of 01 December 2008, the symptoms had resolved. It was also reported that the patient's cough had worsened after the ADACEL vaccination. No fever or additional events were reported. Outcome of cough was not reported. Follow up information was received on 22 December 2008 from a health care professional. The reporter clarified the patient had a staple in her finger at the time of vaccination, previously reported as stepping on a nail. The reporter confirmed that the orange sized redness, swelling, warmth and itching were all symptoms at the injection site, the left deltoid. Treatment included ice and MOTRIN. Concomitant therapy included NORVASC, FLEXERIL and MOTRIN. The cough worsened on 26 November 2008 and then resolved by 28 November 2008. The patient did not seek medical attention. No other information was provided. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Cough
Clinical narrative: This non-serious case was received from a physician on 08 December 2008. A 60-year-old male patient, with no reported medical history, received an injection of ADACEL (lot number UF456CA / C3005) and FLUZONE SV 2008-2009 (lot number U2810AA) on 04 December 2008. Approximately five hours after vaccination, the patient developed a "dry, hacking cough". The physician was going to prescribe cough medicine (unspecified). Outcome was not reported. Follow-up information was received 22 December 2008 from a health care professional. ADACEL was administered intramuscularly in the right deltoid and FLUZONE SV was administered intramuscularly in the left deltoid. The reporter kept in touch with the patient by telephone and reported that the symptom off cough subsided five to six hours after onset. The reporter spoke with the patient "that evening and following - patient felt fine". The patient recovered from the event. No additional information was provided.
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 08 December 2008. An adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, fever and sore arm. No diagnostic tests or lab data were performed. The patient received treatment symptomatically. The patient recovered. No additional details were reported. Follow-up information received 09 February 2009 from a health care professional. According to the reporter, ADACEL had been administered in the patient's right deltoid and the injection site swelling had been approximately one inch. The patient had no illness at the time of vaccination and the events resolved in five days. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03925, 2008-03926 and 2008-03927, all from the same reporter. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 08 December 2008. an adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, low grade fever and sore arm. No diagnostic tests or lab data were performed. The patient received treatment symptomatically and recovered. No additional details were reported. Follow-up information received 09 February 2009 from a health care professional. ADACEL had been administered in the patient's left deltoid. The injection site swelling was approximately one inch and the low grade fever approximately 100 degrees. the patient had no illness at the tome of vaccination and according to the reporter, the events resolved in five days. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03923, 2008-03926 and 2008-03927, all from the same reporter. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 08 December 2008. An adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, fever and sore arm. No diagnostic tests or lab data were performed. The patient received antibiotics and recovered. The patient had previously received an intramuscular left deltoid injection of FLUZONE (lot number U2761AA) on 15 September 2008. No additional details were reported. Follow-up information received 09 February 2009 from a health care professional. ADACEL had been administered in the patient's left deltoid. The injection site swelling was three to four inches across with a hard core at the center. The patient had no illness at the time of vaccination and according to the reporter, the events resolved in approximately 14 days. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03925, 2008-03923 and 2008-03927, all from the same reporter. Documents held by sender: None.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 08 December 2008. An adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) and a first intramuscular left deltoid injection of FLUZONE (lot number U2761AA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, fever and sore arm. No diagnostic tests or lab data were performed. The patient received treatment symptomatically and recovered. No additional details were reported. Follow-up information received on 09 February 2009 from a health care professional. The injection site swelling was approximately one inch. According to the reporter, the events resolved in five to seven days.  Follow-up information received 16 March 2009 from a health care professional. The reporter verified that the patient's right arm had been sore. ADACEL had been administered in the patient's right deltoid and FLUZONE was administered in the left deltoid and it had been greater than two years since the patient last received a Td booster. Corrective treatment consisted of a compress and exercise. No further information was provided. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03925, 2008-03926 and 2008-03923, all from the same reporter.  Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Initial information was received on 16 December 2008 from a health care professional.  A 38 year old female patient with no known allergies received a first time dose of ADACEL (lot number C2965AA) in the left deltoid intramuscularly on 12 December 2008.  On 13 December 2008 the patient reported pain and swelling at the injection site.  The patient was seen by a physician on 15 December 2008 and the site was inflamed and red 3"x3".  The patient did not have a fever or chills.  The patient's recovery status was unknown at the time of the report.  No further information was reported.  Follow-up information received 09 February 2009 from a health care professional who reported that the patient recovered from the event (previously reported as unknown).  No additional information was provided.  List of Documents held by Sender:  None.
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Initial report received on 05 February 2009 from a health care professional.  A cluster of 10 to 15 patients out of an unspecified number of vaccines had received a deltoid injection of ADACEL, lot number C2865AA (route and date of administration not reported) and an unspecified amount of time later, developed local reactions at the injection site consisting of arm swelling, half dollar size knots, reddened areas and soreness.  One patient was reported to have had cellulitis (location of cellulitis was unknown at the time of the report).  According to the  reporter, they did not have the patient records and did not know the patients that had the reactions.  No additional information was available at the time of the report.  Follow-up information was received 16 March 2009 from a health care professional who reviewed the case and had no additional information to provide at the time of the report.  Follow-up information was received 24 April 2009 from a health care professional who stated that she can not identify specific patients and only the reactions were documented.  No additional information was provided.  Documents held by sender:  none.
Age: 31.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Initial report received 19 February 2009 from a health care professional. A 31-year-old female patient with known allergies to Penicillin and Cephalosporins, had received an intramuscular right deltoid injection of ADACEL, lot number C3032AA, and an intramuscular left deltoid injection of TYPHIM VI, lot number B0424, and an intramuscular right deltoid injection HAVRIX (manufacturer Glaxosmithkline), lot number AHAVB275AA on 06 February 2009 and on the day of vaccination, she experienced pain radiating to her neck and down to her hand resulting in limited mobility. The patient was evaluated at a walk-in clinic (date not reported) and prescribed a sling. The patient was also evaluated by a chiropractor and acupuncturist (dates not reported). At the time of the report, her recovery status was unknown. No additional information was provided. Follow-up information was received 27 April 2009 from a health care professional who reported that they had no additional information to provide. The patient had returned to her home country and no forwarding address was left. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Cough, Eye discharge, Ocular hyperaemia, Throat tightness
Clinical narrative: This non serious case was received on 24 February 2009 from VAERS (reference number 331469) via a search of the agency database. A 58 year old female received an intramuscular injection of ADACEL (lot number not reported, FLUZONE (lot number U2744AA, and PNEUMOVAX (manufacturer Merck, lot number not reported) on 23 October 2008. On that day, the patient complained of a cough, chills, her throat closing up, eye drainage, blood shot eyes, and a possible fever. She took TYLENOL for her symptoms. A local site reaction was not reported. The patient was reported as recovered. List of Documents held By Sender: None.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Erythema, Eye pruritus, Eye swelling, Flushing
Clinical narrative: This case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 332974). A 42-year-old female patient received intramuscular injections of ADACEL (lot number C2774AA) and FLUZONE SV 2008-2009 (lot number U2744AA) on 05 November 2008. Later that day, she began experiencing itchy eyes and a persistent, productive cough. Her eyes became red and puffy, cheeks flushed, face puffy, lips swollen, and chest red, warm and itching. She later complained of a headache, fever, chills, and body aches. She took one Ibuprofen and treated the swelling with ice chips. She did not seek medical treatment. A doctor's appointment was reportedly scheduled for 06 November 2008, however no details were provided regarding this appointment. Outcome was not provided.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Lip swelling, Ocular hyperaemia, Pain, Productive cough
Clinical narrative: This case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 332974). A 42-year-old female patient received intramuscular injections of ADACEL (lot number C2774AA) and FLUZONE SV 2008-2009 (lot number U2744AA) on 05 November 2008. Later that day, she began experiencing itchy eyes and a persistent, productive cough. Her eyes became red and puffy, cheeks flushed, face puffy, lips swollen, and chest red, warm and itching. She later complained of a headache, fever, chills, and body aches. She took one Ibuprofen and treated the swelling with ice chips. She did not seek medical treatment. A doctor's appointment was reportedly scheduled for 06 November 2008, however no details were provided regarding this appointment. Outcome was not provided.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pruritus, Pyrexia, Skin warm, Swelling face
Clinical narrative: This case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference number 332974). A 42-year-old female patient received intramuscular injections of ADACEL (lot number C2774AA) and FLUZONE SV 2008-2009 (lot number U2744AA) on 05 November 2008. Later that day, she began experiencing itchy eyes and a persistent, productive cough. Her eyes became red and puffy, cheeks flushed, face puffy, lips swollen, and chest red, warm and itching. She later complained of a headache, fever, chills, and body aches. She took one Ibuprofen and treated the swelling with ice chips. She did not seek medical treatment. A doctor's appointment was reportedly scheduled for 06 November 2008, however no details were provided regarding this appointment. Outcome was not provided.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cough, Ocular hyperaemia, Respiratory tract congestion
Clinical narrative: This case was extracted from the VAERS database via OSCAN on 24 February 2009 (reference numbers 336106 and 335552). A 26-year-old female patient received intramuscular injections of Fluzone SV 2008-2009 (lot number U2848AA) and Adacel (lot number C3027AA) on 17 December 2008. One hour post-vaccination, she developed red eyes, a cough, and was "stopped up". She was instructed to report to the emergency department for evaluation; no additional information was reported.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site irritation
Clinical narrative: This non serious case was received on 04 March 2009 from a health care professional.  A 74 year old female with a history of rheumatoid arthritis, hypothyroidism, hypertension, and hypercholesterolemia received ADACEL (lot number C3031AA) intramuscularly in the left deltoid on 27 February 2009.  The day prior to vaccination the patient received REMICADE.  At the injection site the patient developed an area the size of a half dollar which was red and slightly indurated.  The patient complained of burning in the area.  The patient did not have any range of motion limitations.  The patient was not recovered at the time of vaccination.  List of Documents held by Sender:  none.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Culture negative, Injection site abscess sterile
Clinical narrative: A cluster of 3 patients who received ADACEL (lot number C3068AA), and developed injection site reactions. Initial report received on 17 March 2009 from a healthcare professional. A patient, whose age, gender, medical history and concomitant medications were not reported, received ADACEL (lot number C3068AA) on an unspecified date and developed a sterile abscess at the injection site. Corrective treatment was not reported. The patient's outcome was unknown. Follow-up information received 19 March 2009 from a health care professional. The patient was a 34-year-old female who received a right deltoid injection of ADACEL on 27 February 2009 at 14:30 pm. On 12 March 2009, 13 days after receiving the vaccine, the patient developed a 3 x 2 cm abscess at the right deltoid which required a doctor's visit. On 16 March 2009, a culture was performed which showed no growth. The patient had no past medical history, no concurrent illnesses and she had not been taking any concomitant medications at the time of vaccination. According to the reporter, the patient recovered from the event (date of recovery not reported). Cases 2009-01136 and 2009-01137 with the same reporter and same ADACEL lot number were created for the other 2 patients. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report received on 20 March 2009 from a health professional. A 42 year old female patient, with no medical history other than seasonal allergies, received the following vaccines on 20 March 2009: a first intramuscular injection of ADACEL (lot number C3098AA) in the left deltoid, an intramuscular injection of HAVRIX (GlaxoSmithKline, lot number AHAVB252AA) in the right deltoid, and an intramuscular injection of RECOMBIVAX HB (Merck, lot number 1040V) in the right deltoid. Immediately after vaccination, the patient developed a swollen, red, indurated area of 3.5 cm in diameter at the injection site (side not reported). Within five minutes, the area had decreased to 2 cm in diameter. The patient had no pain at the site. No other symptoms were reported. At the time of the report, the patient's recovery status was unknown. Follow-up information received 27 April 2009 from a health care professional. It was unknown how many Tdap vaccines the patient had received in the past; however the patient's last Td was likely more than 10 years ago. The reporter confirmed the reaction had occurred in the patient's left deltoid. Corrective treatments included intramuscular BENADRYL 25 mg, ice to the affected area, and Ibuprofen as needed for pain and inflammation. The patient reported that her symptoms fully resolved by the time she left the office and no additional treatment was necessary. The patient fully recovered from the event. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Excoriation, Local swelling, Skin warm
Clinical narrative: This non serious case was received on 01 April 2009 from a health care professional. A 40 year old female patient received ADACEL (lot number UF457DA) intramuscularly in the right deltoid on 24 March 2009 at 10:00 AM. Concomitant therapy included Sudafed. On 28 March 2009 at 4:00 PM the patient  developed swelling, redness, and warmth at the right axilla near the right side of the breast. The patient developed a blister on the right wrist which was 1 cm round. The patient was reported as recovered. List of Documents held by Sender: none.
Age: 28.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This non serious case was received on 06 April 2009 from a health care professional. A 28 year old female patient received ADACEL (lot number C3065, US lot number U2078CA), MENACTRA (lot number U2844AA) and RECOMBIVAX HB (manufacturer Merck, lot number 1648X) on 30 March 2009 at 4:00 PM. On 06 April 2009 at 3:15 PM the patient developed a 5.5 x 4.5 cm red, warm area with 2 cm indurated area to the right deltoid 10 cm below shoulder which was tender to touch. The patient was instructed to return to the office to visit with nurse practitioner, however the patient did not return. The recovery status was not known. List of Documents held by Sender: none.
Age: 47.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Body temperature increased, Chills, Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: A 47 year old female patient with a history of migraines received an initial dose of Adacel (lot number C3097AA) intramuscular in the left Gluteal and HAVRIX (manufacturer GSK, lot number AHAV3251DA) Intramuscularly in the right gluteal on 24 April 2009. Concomitant therapy included Topamax and Maxalt. On 25 April 2009 the patient had vomiting, a temperature of 100, chills, diarrhea, and fatigue. The patient had a large, tender, red lump in the left gluteal area. On 28 May 2009 the patient had a doctor's visit, however details were not provided. On 01 May 2009 the patient called the reporter to state that she was getting better. The recovery status was reported as unknown. On 28 May 2009 the patient is scheduled for a doctor's visit.
Age: 47.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site mass, Injection site pain, Vomiting
Clinical narrative: A 47 year old female patient with a history of migraines received an initial dose of Adacel (lot number C3097AA) intramuscular in the left Gluteal and HAVRIX (manufacturer GSK, lot number AHAV3251DA) Intramuscularly in the right gluteal on 24 April 2009. Concomitant therapy included Topamax and Maxalt. On 25 April 2009 the patient had vomiting, a temperature of 100, chills, diarrhea, and fatigue. The patient had a large, tender, red lump in the left gluteal area. On 28 May 2009 the patient had a doctor's visit, however details were not provided. On 01 May 2009 the patient called the reporter to state that she was getting better. The recovery status was reported as unknown. On 28 May 2009 the patient is scheduled for a doctor's visit.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Dizziness, Lymphadenopathy, Pain
Clinical narrative: This case was received from a consumer on 11 June 2008. A 58-year-old patient, with a history of Lyme Disease, reported that she received in intramuscular right deltoid injection of ADACEL (lot number not reported) on 05 June 2008. The following morning, she awoke with swollen lymph nodes in her neck, body aches, light-headedness, dizziness, joint pain, and diarrhea. She was seen by her physician, who prescribed Avalox. Per the reporter, the symptoms then worsened, and so Avalox was discontinued. The patient was slowly improving.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Initial report received on 22 September 2008 from a consumer, who is the patient. A 54 year old female, with no medical history, received on 16 September 2008 a left deltoid intramuscular injection of ADACEL (lot number C2997AA). The patient had no illness at the time of vaccination. She had received her last Td vaccination 20 years ago and had no adverse events following prior vaccinations. On 17 September 2008, one day post vaccination, the patient had developed a six inch rash around the left deltoid injection site. The area was red, hot, and itchy and there was a lump which measured approximately one inch. Corrective treatment was not reported. At the time of the report, 22 September 2008, the patient's symptoms showed some improvement, but she had not recovered. Follow-up information was received 09 October 2008 from a consumer, who is the patient. Laboratory and diagnostic testing was reported to have been not applicable (N/R). No additional medically significant information was provided at the time of the report. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Blood thyroid stimulating hormone, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This non serious case was received on 03 March 2009 from a consumer. A  49 year old female patient received a first time dose of ADACEL (lot not reported) in the right deltoid on 04 January 2009. On 05 January 2009 the patient developed a red, hard lump at the injection site 4 inches in diameter which lasted for 2 weeks. Currently she has a dime size hard lump under the skin at the injection site. She went to the doctor's office multiple times with no relief. No further information was provided. Follow-up information was provided. Follow-up information received 19 March 2009 from a consumer. The patient received ADACEL due to a cut on her left finger which required sutures at the time of vaccination. She had not received any other vaccines within four weeks of ADACEL. The patient continued to have right upper arm ache/pain everyday and had been taking over the counter pain relief. No laboratory and diagnostic testing had been performed. The patient reported the event to multiple providers including the hospital were ADACEL was administered, when seen for follow-up for a respiratory illness; when sutures were removed; when she had her blood drawn and during an orthopedic appointment for an unrelated knee injury. According to the patient, she received multiple "tetanus only" boosters in the past and "none ever caused this type of reaction". She also reported that she had a past history of Pertussis "whooping cough" approximately one and a half years prior. No further information was provided. The reporter for this is the same as for case numbers 2009-01149 and 2009-01150. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: This report was received from a consumer on 09 March 2009. A 47-year-old female patient received an injection of ADACEL (lot number not reported) on 05 March 2009. She stated that a 5/8 inch needle was used, and that she believes the injection may have been given subcutaneously. Within one day of vaccination, she experienced a red, hard, tender, itchy knot at the injection site, approximately the size of a 50 cent piece. The event was ongoing at the time of the report.