chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Temperature regulation disorder
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified numbers of patients of unknown age. Healthcare worker reported an unspecified number of patients that may have been vaccinated with live ZOSTAVAX that experienced a temperature excursion however she was unsure of any lots or expiration dates and as to how many patients were vaccinated or when this world have occurred. The office was storing the ZOSTAVAX in refrigerator conditions for a greater length of time that would have been supported by stability information. The outcome of a temperature excursion was unknown. The relatedness for temperature excursion is unknown for live ZOSTAVAX. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN3, MMR
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Horrible rash that continued to worsen. Finally took to ER and they said he was having an allergic reaction to something in the MMR vaccine. It continues to worsen even after Prednisone. No itch cream helps and he is bleeding from constant scratching.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Cheilitis
Clinical narrative: Developed a sore on my lip that kept increasing in size and discomfort.  I've never had this before.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Heart rate irregular, Hyperacusis, Pallor
Clinical narrative: Pale, dizzy, rapid and irregular heart beat, sensitivity to light and sound, disoriented.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia
Clinical narrative: Pale, dizzy, rapid and irregular heart beat, sensitivity to light and sound, disoriented.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Vertigo
Clinical narrative: While sleeping, rolling over in bed, severe dizzy spell, probably vertigo, lasted about 15 seconds. Since then, light dizziness throughout the day. But still today, in bed, laying down or rolling over creates that vertigo like dizziness.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Heart rate increased
Clinical narrative: DIFFUCULTY BREATHING, CHILL, RAPID HEART BEAT.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: BODY ACHES AND FEVER WITH EXTREME WEAKNESS BEGAN.  SWELLING AND REDNESS AT INJECTION SITE. TREATED WITH IBUPROFEN 800 MG EVERY 4 HOURS. BY 3:00 PM HIGH FEVER WITH SEVERE CHILLS AND SHIVERING, NAUSEA, INCREASED REDNESS AND SWELLING IN INJECTION SITE. CONTINUED TREATMENT WITH IBUPROFEN THROUGHOUT 1/10/13. CONTINUED 102 FEVER, NAUSEA, EXTREME WEAKNESS, BODY ACHES. WENT TO URGENT CARE AT 6:00 PM.  RECEIVED TYLENOL, RX FOR PHENERGAN WITH CODEINE AND PREDNISONE. BY 1/11/13, DECREASED FEVER, CONTINUED WEAKNESS, LESSENED BODY ACHES. BY 1/13/13 MOST SYMPTOMS CLEARED, SLIGHT BODY ACHES.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES AND FEVER WITH EXTREME WEAKNESS BEGAN.  SWELLING AND REDNESS AT INJECTION SITE. TREATED WITH IBUPROFEN 800 MG EVERY 4 HOURS. BY 3:00 PM HIGH FEVER WITH SEVERE CHILLS AND SHIVERING, NAUSEA, INCREASED REDNESS AND SWELLING IN INJECTION SITE. CONTINUED TREATMENT WITH IBUPROFEN THROUGHOUT 1/10/13. CONTINUED 102 FEVER, NAUSEA, EXTREME WEAKNESS, BODY ACHES. WENT TO URGENT CARE AT 6:00 PM.  RECEIVED TYLENOL, RX FOR PHENERGAN WITH CODEINE AND PREDNISONE. BY 1/11/13, DECREASED FEVER, CONTINUED WEAKNESS, LESSENED BODY ACHES. BY 1/13/13 MOST SYMPTOMS CLEARED, SLIGHT BODY ACHES.
Age: 1.29
Sex: F
Vaccine: PNC13
Symptoms: Crying, Faeces pale, Influenza virus test negative, Irritability, Pyrexia
Clinical narrative: Throwing up, fever 104 for a day, crying, has to be held all the time, very light color stools.
Age: 1.29
Sex: F
Vaccine: PNC13
Symptoms: Stool analysis normal, Streptococcus test negative, Urine analysis normal, Vomiting
Clinical narrative: Throwing up, fever 104 for a day, crying, has to be held all the time, very light color stools.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Rash starting...pain in region of rash.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash starting...pain in region of rash.
Age: 21.0
Sex: F
Vaccine: HEPA, IPV, YF
Symptoms: Burning sensation, Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: Began with an itchy neck then turned red and warm.  Spread from neck to chest (put anti-itch on which removed the redness). About an hour later spread to left side, then right side with large red area that was itchy and warm to the touch.  Took Benadryl and applied anti-itch cream. Woke up at 1AM that morning to extreme desire to itch my burning arms.   Went to the bathroom and found that both arms from shoulders to wrists were red and inflamed, along with both legs from hips to knees and splotches all over chest and ribs.  Took more Benadryl. Next morning no spots but desire to itch different areas.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Red swollen welt approximately the size of a silver dollar around injection site.  Hot and sore to touch.  Advised patient to take Ibuprofen and Diphenhydramine OTC, and add ice to the injection site to reduce pain and swelling.  Also told patient to see her physician if no improvement within 2-3 days.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site warmth
Clinical narrative: Bruised, red hot circle around injection site.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Aphagia, Arthralgia, Asthenia, Influenza like illness, Insomnia
Clinical narrative: Five hours after vaccination I began to feel very weak. During the same evening I could not eat, my muscle and bone joints became extremely sore and I could not sleep that evening. It felt like I had the Flu but without symptoms like sore throat, diarrhrea, or barfing.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Five hours after vaccination I began to feel very weak. During the same evening I could not eat, my muscle and bone joints became extremely sore and I could not sleep that evening. It felt like I had the Flu but without symptoms like sore throat, diarrhrea, or barfing.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dysphonia, Rash generalised, Rash pruritic, Swollen tongue
Clinical narrative: Itchy body rash, hoarse voice, vomiting, swollen tongue, hives, dizziness; Treatment was to take Benadryl, calling nurses station and visiting urgent care doctor. Body rash had partially subsided with Benadryl and doctor didn't prescribe any meds.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urticaria, Vomiting
Clinical narrative: Itchy body rash, hoarse voice, vomiting, swollen tongue, hives, dizziness; Treatment was to take Benadryl, calling nurses station and visiting urgent care doctor. Body rash had partially subsided with Benadryl and doctor didn't prescribe any meds.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dizziness, Ear infection, Fatigue, Myalgia
Clinical narrative: Fatigue and dizziness. Next morning had high fever, cough, sore throat, and muscle aches. On third morning I woke up with a severe ear infection in both ears that eventually ruptured my eardrum. Still have fever, sore throat, ear infection, and cough 5 days after shot was given.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pyrexia, Tympanic membrane perforation
Clinical narrative: Fatigue and dizziness. Next morning had high fever, cough, sore throat, and muscle aches. On third morning I woke up with a severe ear infection in both ears that eventually ruptured my eardrum. Still have fever, sore throat, ear infection, and cough 5 days after shot was given.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Patient developed cellulitis in the injection arm. Swelling, redness & pain that required an office visit to see MD. Patient diagnosed with cellulitis & prescribed cephalexin 500mg twice daily for 20 days.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received a flu shot with intradermal route that is only approved for ages 18-64.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mass
Clinical narrative: Pt. developed lump on left shoulder / trapezius 1 day after intradermal shot.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Oedema peripheral, Pruritus
Clinical narrative: Pt received the flu shot on 1/11/13 next day she was complaining of swelling of arm, chest pain and itchy. Pt took BENADRYL followed up with pt 1/13/13 she said she was feeling better her arm does not hurt and swelling is going down slowly.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site pain, Malaise, Pain in extremity, Rash
Clinical narrative: Pt. stated: pain, soreness at inj. site & entire arm, rash turning into raised, malaise, fatigue over last 24 hours, told patient to see MD at clinic, MD saw patient and treated for infection ?.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Injection site erythema, Neck mass
Clinical narrative: Patient states that when she got home in the evening she developed a big lump in the neck she took some CLARITIN & in the morning following the vaccine, her eyelids were swollen. The injection site is red.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Malaise, Pyrexia, Throat tightness
Clinical narrative: Patient reports 16 hours post immunization strong headache, fever, malaise, & concern of difficulty breathing d/t throat constriction. She did not self medicate or seek medical help & symptoms were relieved 12 hours post.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Rash, Vomiting
Clinical narrative: Pt's husband reported she experienced chest rash, nausea, vomiting & diarrhea within 2 hrs of vaccine administration.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Neck pain, Pain in extremity
Clinical narrative: Ache down (L) arm and up neck. Redness at inj site. Warmness at inj site.
Age: 1.03
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient. Medical assistant called regarding an expired dose of PNEUMOVAX23 administered to a 12 month old child, (Lot #918242 expiry date 20-NOV-2012) PNEUMOVAX23 was administered on 20-DEC-2012. No adverse effect reported. Follow-up information has been received from a licensed practical nurse. Additional information had been added: product was not PNEUMOVAX23, it was M-M-R II. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Injection site discolouration, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 71 years old male patient with no permanent medical history or drug allergy. On 17-DEC-2012 the patient was vaccinated subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (lot # H013399; Exp Date 07-MAR-2014). No other co-suspects were reported. Concomitant medications included DIOVAX, ANTARA, vitamin D (unspecified), calcium (unspecified), Vitamin C, glucosamine, fish oil and PROTONIX. On 19-DEC-2012 the patient developed redness, pain, itchiness, and irritation at the injection site after receiving a dose of PNEUMOVAX 23. The patient also complained of having "streaks" on the arm and changing of the "color" on the skin at the injection site. The patient sought medical attention and the physician saw the patient. KEFLEX was given to patient as treatment. There was blood test performed without results. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site streaking
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 71 years old male patient with no permanent medical history or drug allergy. On 17-DEC-2012 the patient was vaccinated subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (lot # H013399; Exp Date 07-MAR-2014). No other co-suspects were reported. Concomitant medications included DIOVAX, ANTARA, vitamin D (unspecified), calcium (unspecified), Vitamin C, glucosamine, fish oil and PROTONIX. On 19-DEC-2012 the patient developed redness, pain, itchiness, and irritation at the injection site after receiving a dose of PNEUMOVAX 23. The patient also complained of having "streaks" on the arm and changing of the "color" on the skin at the injection site. The patient sought medical attention and the physician saw the patient. KEFLEX was given to patient as treatment. There was blood test performed without results. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of RECOMBIVAX HB (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were MMR II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. Follow up information as received from the medical assistant refers to a 6 months old patient. The patient was vaccinated IM with improperly stored RECOMBIVAX HB (lot # 666600/0319Z, Exp. Date: 08-OCT-2012) at left thigh on 17-SEP-2012. Concomitant medications administered on the same day included PENTACEL (lot # C2869AA, Exp. Date: 08-OCT-2012, intramuscularly at right thigh), PREVNAR 13 (lot # F62923, Exp. Date: August 2013, intramuscularly at left thigh) and ROTATEQ (lot # 0277AE, Exp. Date: 20-SEP-2013, PO). This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old male patient. The patient was vaccinated subcutaneously right upper tricep with a dose of 0.65 ml live ZOSTAVAX (lot# reported as H019036, expired date: 17-JAN-2014) once on 27-DEC-2012. On 28-DEC-2012 the patient experienced redness, swelling and pain at his injection site over 24 hours following receipt of the dose of live ZOSTAVAX. At the time of this report, the patient stated that his injection site was still red, swollen and painful, but it had improved since he first noticed the reaction. The patient had been taking ibuprofen, which he reported had been helpful with the swelling and pain. The patient denied a rash at the injection site. At the time of reporting, the patient was recovering. The pharmacist did not know if the patient had consulted his healthcare provider. The patient sought medical attention by consulting pharmacist. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated IM with a 0.5 ml dose of RECOMBIVAX HB 5 mcg/0.5 ml (lot # 666804/0658Z) on 17-DEC-2012 that expired on 08-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Headache, Nausea
Clinical narrative: This study case was received from the investigator in a trial on 04 January 2013. A 20-year-old male subject had received the following vaccinations on 19 January 2012: ACAM2000 (lot number, route and site not reported), hepatitis B vaccine (manufacturer, lot number, route and site not reported) and anthrax (manufacturer, lot number, route and site not reported). Five days post-vaccination on 24 January 2012, the subject experienced shortness of breath and palpitations. The subject palpitations on 24 January 2012 and none after. The shortness of breath resolved on 26 January 2012 "after dinner" and the subject experienced none since. After the vaccines, the subject also felt dizzy, which resolved on the say of the vaccine, and nauseated. The subject drank water and felt better. The subject also reported having a light fever the day of the vaccines, as well as a headache. Troponin I was <0.10 ng/ml. Patient had normal electrocardiogram (ECG). The subject was instructed to seek medical treatment. No further information was available at the time of the report. The subject's outcome was recovered on 26 January 2012. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Palpitations, Pyrexia, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 04 January 2013. A 20-year-old male subject had received the following vaccinations on 19 January 2012: ACAM2000 (lot number, route and site not reported), hepatitis B vaccine (manufacturer, lot number, route and site not reported) and anthrax (manufacturer, lot number, route and site not reported). Five days post-vaccination on 24 January 2012, the subject experienced shortness of breath and palpitations. The subject palpitations on 24 January 2012 and none after. The shortness of breath resolved on 26 January 2012 "after dinner" and the subject experienced none since. After the vaccines, the subject also felt dizzy, which resolved on the say of the vaccine, and nauseated. The subject drank water and felt better. The subject also reported having a light fever the day of the vaccines, as well as a headache. Troponin I was <0.10 ng/ml. Patient had normal electrocardiogram (ECG). The subject was instructed to seek medical treatment. No further information was available at the time of the report. The subject's outcome was recovered on 26 January 2012. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: L arm sore, no redness or rash.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: 2" x 3" swelling, very hot, red area 2" x 3" 1/13/2013 swelling down, redness now 2" x 5" and only dark red, hot, and swelling a 1" x 1 1/2" right where the Shingles shot was given.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 2" x 3" swelling, very hot, red area 2" x 3" 1/13/2013 swelling down, redness now 2" x 5" and only dark red, hot, and swelling a 1" x 1 1/2" right where the Shingles shot was given.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyskinesia, Hyperhidrosis, Seizure like phenomena, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (route and lot # not reported) on an unspecified date, and second 0.5 ml dose of GARDASIL (Lot # 670048/0963AA expiration date 09-NOV-2013) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The physician stated that on an unspecified date, the patient felt faint after the first dose of GARDASIL. The outcome of felt faint was unknown. The physician reported that on an unspecified date, the patient was getting her second dose of GARDASIL and she started to feel light headed and dizzy and she became sweaty. The doctor had her lay down for a few minutes, and when she stood back up she experienced seizure like movements and her limbs were jerking. This lasted about 6 seconds and then the patient woke up. The doctor asked her questions to be sure she was not disoriented and then let her leave. The patient did not receive treatment for the adverse events. The patient recovered on the same day the adverse events occurred. Upon internal review seizure like movements were considered medically significant. The relatedness for seizure like movements, became sweaty, dizzy, limbs were jerking and felt faint was unknown for GARDASIL. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Blood test, Computerised tomogram, Diplopia, Hypoaesthesia
Clinical narrative: Double vision, numbness, tingling, shooting pains, started with double vision 5 days after flu shot then numbness ran in back, hands, feet, lips, then shooting pains. Then slowly began to correct it's self one day at a time.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain, Paraesthesia, X-ray
Clinical narrative: Double vision, numbness, tingling, shooting pains, started with double vision 5 days after flu shot then numbness ran in back, hands, feet, lips, then shooting pains. Then slowly began to correct it's self one day at a time.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Started with chills then fever (treated with Tylenol highest was over 103F); aches, headache.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain
Clinical narrative: Severe R upper arm pain where vaccine was administered.  No numbness/tingling/weakness.  Able to move arm but painful in upper arm.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Gait disturbance, Pain, Pain in extremity
Clinical narrative: All over body aches that put me in bed for rest of day. Following day worse..in bed all day. Day 3, pain ended in me extremities, but worsened in lower back to point of barely able to walk or bend. Took 800 mg ibuprofen for minimal relief.
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Chest pain
Clinical narrative: This study case was received from the investigator in a trial on 04 January 2013. A female subject (age and date of birth not reported) had received the following vaccinations on 18 July 2012: ACAM2000 (lot number, site and route not reported) and anthrax vaccine (manufacturer, lot number, route and site not reported). Two days post-vaccination on 20 July 2012, the subject experienced chest pain. The subject had no reported medical history. The subject's outcome was unknown. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Blood pressure decreased, Convulsion, Dizziness, Dyspnoea
Clinical narrative: Anxiety, decreased BP, dizziness, shock, seizing, shortness of breath. Loss consciousness ~30 sec. Regained after EPIPEN administration.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Shock
Clinical narrative: Anxiety, decreased BP, dizziness, shock, seizing, shortness of breath. Loss consciousness ~30 sec. Regained after EPIPEN administration.
Age: 1.7
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 02 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 19 month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3772AA received on 19 July 2011, lot number C3895AA received on 20 September 2011 and lot number C3923AA received on 17 January 2012 (routes and sites of administration not reported). Approximately 10 months after the last dose, on 11 December 2012 the subject developed a cough and paroxysmal cough on 18 December 2012 without a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 21 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 21 December 2012 for five days. The subject was not hospitalized. At the time of final contact on 27 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.7
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 02 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 19 month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3772AA received on 19 July 2011, lot number C3895AA received on 20 September 2011 and lot number C3923AA received on 17 January 2012 (routes and sites of administration not reported). Approximately 10 months after the last dose, on 11 December 2012 the subject developed a cough and paroxysmal cough on 18 December 2012 without a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 21 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 21 December 2012 for five days. The subject was not hospitalized. At the time of final contact on 27 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 02 January 2013 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL on 12 February 2008, 28 March 2008, 30 May 2008, and 10 March 2009 (lot numbers, routes, and sites of administration not reported). The subject developed a cough on 22 March 2012, approximately 3 years after the last dose, and a paroxysmal cough with a whoop on 24 March 2012. The subject also developed cold like symptoms on 22 March 2012, and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 27 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 02 January 2013 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL on 12 February 2008, 28 March 2008, 30 May 2008, and 10 March 2009 (lot numbers, routes, and sites of administration not reported). The subject developed a cough on 22 March 2012, approximately 3 years after the last dose, and a paroxysmal cough with a whoop on 24 March 2012. The subject also developed cold like symptoms on 22 March 2012, and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 27 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.39
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 02 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3432AB received on 02 November 2009, lot number C3432AB received on 04 January 2010, lot number C3471AA received on 02 March 2010 and lot number C3664AA received on 24 January 2011 (routes and sites of administration not reported). Approximately 17months after the last dose, on 23 July 2012, the subject developed a cough with a whoop. The subject also experienced posttussive vomiting, and sleep disturbance. Laboratory testing included positive PCR on 30 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 31 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 09 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.39
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 02 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3432AB received on 02 November 2009, lot number C3432AB received on 04 January 2010, lot number C3471AA received on 02 March 2010 and lot number C3664AA received on 24 January 2011 (routes and sites of administration not reported). Approximately 17months after the last dose, on 23 July 2012, the subject developed a cough with a whoop. The subject also experienced posttussive vomiting, and sleep disturbance. Laboratory testing included positive PCR on 30 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 31 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 09 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from an intern pharmacist refers to a 57 years old male patient with no known allergies and with no relevant past drug history. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number reported as JH012519) on 25-OCT-2012. No other co-suspects were reported. Concomitant medications included FLUVIRIN, nystatin, cough syrup and cefuroxime. In October 2012 the patient experienced 1 inch area of redness at the injection site. The arm side that it was given in was unknown. No treatment information was reported. As of 31-DEC-2012, the patient did not receive any further ZOSTAVAX. At the time of the report the patient continued to have the 1 inch area of redness at the injection site. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large red swelling (average handprint size), itchiness, sore to touch, warm to touch. All around injection site.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Itchy fine, red, raised rash.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: Weak, fever, fatigue.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Axillary pain, Chest pain, Pain in extremity
Clinical narrative: Pain that radiated down arm and under right axilla and into chest. Now only has pain in axilla.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Electromyogram abnormal, Impaired work ability, Monoplegia, Musculoskeletal pain, Neck pain
Clinical narrative: I woke up in excrutiating neck, shoulder, and scapula pain. I iced, heated and massaged the area all day to no avail. I finally had to go to the ER on 11/5/2012 about 1:00 AM. They gave me 2 different shots in both arms and oral medication which did not help. Then slowly throughout the day I lost function of my arm. I haven't been able to work since.  I am still in pain and the paralysis is still there.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Nerve conduction studies abnormal, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: I woke up in excrutiating neck, shoulder, and scapula pain. I iced, heated and massaged the area all day to no avail. I finally had to go to the ER on 11/5/2012 about 1:00 AM. They gave me 2 different shots in both arms and oral medication which did not help. Then slowly throughout the day I lost function of my arm. I haven't been able to work since.  I am still in pain and the paralysis is still there.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth to site of infection 3x4cm in size.
Age: 66.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Developed severe hives all over patients back.  Itching.  Rash started to develop on chest.  Took Benadryl and by morning the rash was subsiding.  No other allergic symptoms.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in jaw
Clinical narrative: Patient called the day following the intradermal vaccine administration and reported a constant mild "jaw pain."
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase decreased, Body temperature increased, C-reactive protein
Clinical narrative: Visit ED with c/o chest discomfort, nausea, shortness of breath and diaphoresis lasting 2-3 hours.  Temp 100.8, P-71, RR 16 and BP 130/68, SaO2 99%. EKG showed acute anterior T-wave flattening. 10/10 Temp 98, P 64, BP 115/71, SaO2 93% on room air. Due to EKG changes, treadmill nuclear stress test performed.  Within 3 minutes of walking, developed sx of chest tightness, 6/110 with dizziness and SOB.  After 5th minute chest discomfort returned, tightness 6-7/10 with SOB, lightheadedness and marked ST depression on lead V3-V6 with up to 6 mm depression noted on V4 and V5.  Stress test stopped at 6 minutes. Nuclear scan revealed left ventricular size and wall motion WNL.  Coronoary angiography performed which was normal.  Provider determined sx due to "reaction to flu vaccine".
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram T wave amplitude decreased
Clinical narrative: Visit ED with c/o chest discomfort, nausea, shortness of breath and diaphoresis lasting 2-3 hours.  Temp 100.8, P-71, RR 16 and BP 130/68, SaO2 99%. EKG showed acute anterior T-wave flattening. 10/10 Temp 98, P 64, BP 115/71, SaO2 93% on room air. Due to EKG changes, treadmill nuclear stress test performed.  Within 3 minutes of walking, developed sx of chest tightness, 6/110 with dizziness and SOB.  After 5th minute chest discomfort returned, tightness 6-7/10 with SOB, lightheadedness and marked ST depression on lead V3-V6 with up to 6 mm depression noted on V4 and V5.  Stress test stopped at 6 minutes. Nuclear scan revealed left ventricular size and wall motion WNL.  Coronoary angiography performed which was normal.  Provider determined sx due to "reaction to flu vaccine".
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Exercise electrocardiogram, Haematocrit normal, Haemoglobin normal, Hyperhidrosis, Nausea
Clinical narrative: Visit ED with c/o chest discomfort, nausea, shortness of breath and diaphoresis lasting 2-3 hours.  Temp 100.8, P-71, RR 16 and BP 130/68, SaO2 99%. EKG showed acute anterior T-wave flattening. 10/10 Temp 98, P 64, BP 115/71, SaO2 93% on room air. Due to EKG changes, treadmill nuclear stress test performed.  Within 3 minutes of walking, developed sx of chest tightness, 6/110 with dizziness and SOB.  After 5th minute chest discomfort returned, tightness 6-7/10 with SOB, lightheadedness and marked ST depression on lead V3-V6 with up to 6 mm depression noted on V4 and V5.  Stress test stopped at 6 minutes. Nuclear scan revealed left ventricular size and wall motion WNL.  Coronoary angiography performed which was normal.  Provider determined sx due to "reaction to flu vaccine".
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Scan myocardial perfusion normal, Troponin normal, Vaccination complication, White blood cell count normal
Clinical narrative: Visit ED with c/o chest discomfort, nausea, shortness of breath and diaphoresis lasting 2-3 hours.  Temp 100.8, P-71, RR 16 and BP 130/68, SaO2 99%. EKG showed acute anterior T-wave flattening. 10/10 Temp 98, P 64, BP 115/71, SaO2 93% on room air. Due to EKG changes, treadmill nuclear stress test performed.  Within 3 minutes of walking, developed sx of chest tightness, 6/110 with dizziness and SOB.  After 5th minute chest discomfort returned, tightness 6-7/10 with SOB, lightheadedness and marked ST depression on lead V3-V6 with up to 6 mm depression noted on V4 and V5.  Stress test stopped at 6 minutes. Nuclear scan revealed left ventricular size and wall motion WNL.  Coronoary angiography performed which was normal.  Provider determined sx due to "reaction to flu vaccine".
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Loss of consciousness, Pallor
Clinical narrative: The vaccination was given and before the pharmacist could return to the pharmacy the patient passed out. The patient appeared very pale and disoriented.  While the patient was sitting in the chair being assessed by the pharmacist, he passed out a second time, and 911 was called.  EMT's evaluated the patient and the patient's mother requested no further service from the pharamcy or EMT and walked out of the pharmacy with the patient.
Age: 25.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Arthralgia, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: Phoned wilth c/o general malaise, h/a, joint aches fever, up to 102 F.  States s&s initiated approx 2 hours after injections. Diarrhea, nausea; no vomiting.
Age: 25.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Phoned wilth c/o general malaise, h/a, joint aches fever, up to 102 F.  States s&s initiated approx 2 hours after injections. Diarrhea, nausea; no vomiting.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Tachycardia
Clinical narrative: Tired, tachycardia.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling on (L) arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: She received intradermal Influenza vaccine in right arm at hospital "Flu Clinic" on 10/12/12. Ever since, she has experienced aching in upper right arm when raises elbow to shoulder height or higher. No medical treatment sought.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Blood glucose normal, Haemoglobin normal, Pallor, Syncope
Clinical narrative: Pre - V/S WNL T. 98.3 P. 69 R. 16 BP. 110/73. Approx. 2-3 mins after receiving 5 immunizations, student became faint, weak & pale, for approx 25-30 mins. Oral glucose given stabilized within 30 mins. Transport to ER.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Infantile spitting up
Clinical narrative: WCC with vaccines 12/21/12 - pt. woke over night w/temp 103. Given ibuprofen, slept ok. 12/22 in the morning, temp 102. Spit up ibuprofen. Seen in office by dr. Pt evaluated. Dad reassured - not forwarded to dt w/dads concerns. Dr rec that pt still receive vaccines as benefit outweighs risk of fever. Hep B was only new vaccine component received.
Age: 48.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Urticaria
Clinical narrative: Hives on 2nd day after receiving vaccine; lasted 2 days; took BENADRYL.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Flushing, Heart rate abnormal, Hyperhidrosis
Clinical narrative: Shortness of breath; fluttering heart rate; left neck pain; facial numbness in tingling on left side of face, dizzy, flushed, sweaty.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Laboratory test, Neck pain, Paraesthesia
Clinical narrative: Shortness of breath; fluttering heart rate; left neck pain; facial numbness in tingling on left side of face, dizzy, flushed, sweaty.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt was c/o redness and swelling from (L) arm. Recommended to ice to arm 4x/day.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Child developed red rash over Varicella injection site - measuring 6 in. long x 6 in. wide - 1 day after receiving vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Eczema, Irritability, Pyrexia, Rash
Clinical narrative: Fever began the evening of immunizations. Baby was seen and examined the following day since he had URI sxs preceding immunizations. There was no evidence OM. He continued to be extremely fussy & irritable & febrile. Seen again 10/17 - no bacterial infection, no meds. Baby did develop facial eczematous rash on 10/15 - resolved with tx for eczema & BENADRYL. Took 2 weeks before happy baby again. MARKED BEHAVIORAL DIFFERENCE.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Pain at injection site, shoulder and neck area.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling cold, Headache, Hyperhidrosis, Middle insomnia
Clinical narrative: Vaccine 3pm 1/11/13 given; bed at 10pm and had headache woke at midnight - felt very cold & shaking uncontrollably & lead to difficulty breathing; shaking continued to be about 30min - then after drinking warm liquid - had to lay down with head of bed up because continued having trouble breathing - woke up at 4am - sweating, soaking wet.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Vaccine 3pm 1/11/13 given; bed at 10pm and had headache woke at midnight - felt very cold & shaking uncontrollably & lead to difficulty breathing; shaking continued to be about 30min - then after drinking warm liquid - had to lay down with head of bed up because continued having trouble breathing - woke up at 4am - sweating, soaking wet.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash to face, chest and arms started between 1 & 2 PM.  NO fever.  Given Benadryl over the weekend.  Rash continues. Referred to family physician.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Chest discomfort, Consciousness fluctuating, Dizziness
Clinical narrative: Patient started with weakness, dizziness. Progressed to inability to move, in and out of consciousness. Hard time breathing with heavy weight on chest. Throat swelling & closing so couldn't swallow and breath. Husband took patient to ER. IV Benadryl and fluids. Does not believe had epinephrine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Influenza virus test negative, Mobility decreased, Pharyngeal oedema
Clinical narrative: Patient started with weakness, dizziness. Progressed to inability to move, in and out of consciousness. Hard time breathing with heavy weight on chest. Throat swelling & closing so couldn't swallow and breath. Husband took patient to ER. IV Benadryl and fluids. Does not believe had epinephrine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Patient started with weakness, dizziness. Progressed to inability to move, in and out of consciousness. Hard time breathing with heavy weight on chest. Throat swelling & closing so couldn't swallow and breath. Husband took patient to ER. IV Benadryl and fluids. Does not believe had epinephrine.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Gave patient flu dose of 0.5 ml instead of 0.25 ml.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Rash erythematous, Skin warm
Clinical narrative: Significant raised, warm erythematous rash chest.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Electrocardiogram ST segment elevation, Flushing, Full blood count normal, Heart rate increased
Clinical narrative: Pt states approx 10:30 AM, 15-30 min after vaccine given, pt noticed "pounding heartbeats, fast HR, flushed face, SOB. Got better then worsened. Called 911 - ER visit EKG - ST 150-170 ? SVT. LOPRESSOR recently d/c'd. 2 doses Adenosine without effect. HR decreased to 80s by 1 PM.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Palpitations
Clinical narrative: Pt states approx 10:30 AM, 15-30 min after vaccine given, pt noticed "pounding heartbeats, fast HR, flushed face, SOB. Got better then worsened. Called 911 - ER visit EKG - ST 150-170 ? SVT. LOPRESSOR recently d/c'd. 2 doses Adenosine without effect. HR decreased to 80s by 1 PM.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Rash pustular
Clinical narrative: Pt felt dizzy, numb, pustule on face.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: 10 PM on 1-9-13 first started to itch in thighs, crotch & then lower abd, inside arms, armpits & after itching welts/hives appeared. At 3 AM took BENADRYL 25 mgm. 6 P still some itching took another BENADRYL & today 1/11/13 is OK. Contacted her Dr. & he agreed with her tx.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pruritus, Skin warm
Clinical narrative: Warm, hard, itchy area 2 inch in diameter.
Age: 13.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary adenopathy 3 days following immunization with GARDASIL into left deltoid.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Large red, warm, firm swelling on right arm at site of vaccine. Lesion 60 cm x 55 cm.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Pain at site of injection, and arm; unable to put on jacket and unable to sleep.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Contusion, Erythema nodosum, Nodule
Clinical narrative: Diagnosed with Erthyema Nodosum - appearance of widespread large nodules of lower extremities followed by bruising & joint pain.