chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: Swelling, redness, pain, heat at injection site, dizziness, sweating,  chills, fatigue.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, pain, heat at injection site, dizziness, sweating,  chills, fatigue.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: Coughing, wheezing, chest pressure, difficulty breathing, rapid heart rate. Received Albuterol via inhaler, 50mg Benadryl, Medrol 4mg.
Age: 32.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Heart rate increased, Wheezing
Clinical narrative: Coughing, wheezing, chest pressure, difficulty breathing, rapid heart rate. Received Albuterol via inhaler, 50mg Benadryl, Medrol 4mg.
Age: 55.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Immunizations (flu and pneumococcal 13) given on 12/29/2014. Came in to clinic on 1/2/2015. L deltoid region with erythema, swelling and warmth. Area measures 10cm by 8cm. Treated with Prednisone 40mg for 3 days, Benadryl 50mg at bedtime, and tramadol for pain.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Anger, Belligerence, Crying, Depressed mood
Clinical narrative: Within 3 days, and continuing presently:  Angry, belligerent outbursts lasting up to 20 minutes per episode / 3 or 4 times per day (totally out of character--never seen before); fixation on lights; extreme difficulty focusing; repetitive and stimulating behavior; OCD behaviors; inappropriate playing with toys (lining up toys); must hold an item at all times; crying/sad moods (not seen before); often mixing up words in sentence (not seen before).  Within 10 days:  facial rash which lasted 4 weeks.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Disturbance in attention, Eccentric fixation, Obsessive-compulsive disorder, Rash, Speech disorder
Clinical narrative: Within 3 days, and continuing presently:  Angry, belligerent outbursts lasting up to 20 minutes per episode / 3 or 4 times per day (totally out of character--never seen before); fixation on lights; extreme difficulty focusing; repetitive and stimulating behavior; OCD behaviors; inappropriate playing with toys (lining up toys); must hold an item at all times; crying/sad moods (not seen before); often mixing up words in sentence (not seen before).  Within 10 days:  facial rash which lasted 4 weeks.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Stereotypy, Vision blurred
Clinical narrative: Within 3 days, and continuing presently:  Angry, belligerent outbursts lasting up to 20 minutes per episode / 3 or 4 times per day (totally out of character--never seen before); fixation on lights; extreme difficulty focusing; repetitive and stimulating behavior; OCD behaviors; inappropriate playing with toys (lining up toys); must hold an item at all times; crying/sad moods (not seen before); often mixing up words in sentence (not seen before).  Within 10 days:  facial rash which lasted 4 weeks.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site reaction, Pallor, Pruritus generalised
Clinical narrative: When I woke up at 4:00 am., I noticed the blanchiness and severe itching at the left upper arm with few small rashes. I also have itchiness in my body but no rashes.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Culture throat negative, Influenza virus test negative, Rhinorrhoea, Streptococcus test negative
Clinical narrative: 12/30/2014 10:37:32 AM > seen for WCC/shots yesterday - mom states that he woke up with temp of 101 (axillary with degree added); Motrin was given and went back to sleep. Hasn't had any diarrhea so far today - states that stooled 2 good stools and several small traces throughout the day.  Presented to office on 12/31/2014 reporting temp up to 104.5 (axillary with degree added) and runny nose x 2 days - clear in color.  Noted to have Tonsillitis; started on Amoxicillin.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Tonsillitis
Clinical narrative: 12/30/2014 10:37:32 AM > seen for WCC/shots yesterday - mom states that he woke up with temp of 101 (axillary with degree added); Motrin was given and went back to sleep. Hasn't had any diarrhea so far today - states that stooled 2 good stools and several small traces throughout the day.  Presented to office on 12/31/2014 reporting temp up to 104.5 (axillary with degree added) and runny nose x 2 days - clear in color.  Noted to have Tonsillitis; started on Amoxicillin.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Gait disturbance, Limb discomfort
Clinical narrative: Heaviness in right leg; difficulty in brisk walking, jogging or running.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Heaviness in right leg; difficulty in brisk walking, jogging or running.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Hypoaesthesia, Intermittent claudication, Limb discomfort
Clinical narrative: Heaviness in right leg; difficulty in brisk walking, jogging or running.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal, Pain in extremity, Peripheral venous disease
Clinical narrative: Heaviness in right leg; difficulty in brisk walking, jogging or running.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Heaviness in right leg; difficulty in brisk walking, jogging or running.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Body temperature increased, Cough, Diarrhoea, Fatigue
Clinical narrative: Numbness, Tingling, Pain in bilateral fingers/toes, Paresthesia; Debilitating & Excruciating Pain Mid-Thoracic, Lumbar, Sacral Region & bilateral lower extremities, (lower back, pelvic, hips, posteriolateral thighs).  Temperature 101.9, Headache, Nausea, Diarrhea, Bronchial cough, Pharyngitis, Mouth Ulcers, Rhinitis, Fatigue, Malaise, Generalized Muscle & Joint Aches.  TREATED IN THE EMERGENCY ROOM with the FOLLOWING MEDS: MorphineSulfate 5mg, IV Stat 0.9% Normal Saline, 100mL, Infuse a 500 mL Bolus Methocarbamol (Robaxin) 1.5GM Tablet, PO STAT Prednisone 50 MG, PO, STAT Ketorolac (Toradol-NSAID) 15 MG, IV Push STAT
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Malaise, Mouth ulceration, Myalgia
Clinical narrative: Numbness, Tingling, Pain in bilateral fingers/toes, Paresthesia; Debilitating & Excruciating Pain Mid-Thoracic, Lumbar, Sacral Region & bilateral lower extremities, (lower back, pelvic, hips, posteriolateral thighs).  Temperature 101.9, Headache, Nausea, Diarrhea, Bronchial cough, Pharyngitis, Mouth Ulcers, Rhinitis, Fatigue, Malaise, Generalized Muscle & Joint Aches.  TREATED IN THE EMERGENCY ROOM with the FOLLOWING MEDS: MorphineSulfate 5mg, IV Stat 0.9% Normal Saline, 100mL, Infuse a 500 mL Bolus Methocarbamol (Robaxin) 1.5GM Tablet, PO STAT Prednisone 50 MG, PO, STAT Ketorolac (Toradol-NSAID) 15 MG, IV Push STAT
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Paraesthesia, Pharyngitis, Rhinitis
Clinical narrative: Numbness, Tingling, Pain in bilateral fingers/toes, Paresthesia; Debilitating & Excruciating Pain Mid-Thoracic, Lumbar, Sacral Region & bilateral lower extremities, (lower back, pelvic, hips, posteriolateral thighs).  Temperature 101.9, Headache, Nausea, Diarrhea, Bronchial cough, Pharyngitis, Mouth Ulcers, Rhinitis, Fatigue, Malaise, Generalized Muscle & Joint Aches.  TREATED IN THE EMERGENCY ROOM with the FOLLOWING MEDS: MorphineSulfate 5mg, IV Stat 0.9% Normal Saline, 100mL, Infuse a 500 mL Bolus Methocarbamol (Robaxin) 1.5GM Tablet, PO STAT Prednisone 50 MG, PO, STAT Ketorolac (Toradol-NSAID) 15 MG, IV Push STAT
Age: 74.0
Sex: M
Vaccine: TYP
Symptoms: Cellulitis
Clinical narrative: These case reports were previously actioned by Crucell (CRX-2014-000869). The data was taken directly from the database repository and entered verbatim (including labeling and causality assessments) on to the safety database. Where labeling and causality assessments were absent, database took the decision to assign according to company guidelines. This case version was created on 22-OCT-2014 for the purposes of quality improvement. Upon review the following corrections were made: Version date, Received by Case Processing Center, was amended to 04-JUL-2014 for the initial case version (previously it was recorded as 02-JUL-2014). Case version 4 was created using 16-JUL-2014 as the ICH date to action case quality corrections to legacy data. The following fields were updated in the database: reporter information, reported disease, country where vaccine obtained, dosage information, action taken with suspect drug, company unit identification number (2014-CRU259), initiating company narrative. Revision to the information received on 02-Jul-2014. Upon review the following corrections were made: The event of 'cellulitis' was upgraded to serious, other medically important condition (previously it was considered as non-serious).
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Facial pain, Hypoaesthesia, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A 68-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Lot Number: J67645), via an unspecified route of administration on 18Dec2014. No other vaccinations were given at this time. The patient's medical history and concomitant medications were not reported. On an unknown date in Dec2014 within 24 hours after receiving the vaccination, the patient started to experience intense pain, then progressed to arm numbness radiating down the arm and through fingertips, and intense pain radiating up the neck, into the jawbone and cheek. The patient went to the emergency room and it was unknown if the patient was admitted. Lab tests were unknown. Therapeutic measures were taken in response to the events and included treatment with steroids. The events were not recovered.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous case from a contactable physician reporting 3 cases. This is the first of three cases. A 74 years old female patient received the first dose of PREVNAR 13 (lot J49846, Exp date 29Feb2016) on 20Nov2014 intramuscular in the left arm at 0.5 ml, single dose. Medical history included hypertension, hypothyroidism, mixed hyperlipidemia, allergies, arthritic pain, reflux esophagitis since 2008, herpes, acquired polyneuropathy since 15Jul2013, benign hypertensive heart disease since 27Aug2013, COPD, gout (unknown episode) with hyperuricemia, left ventricular hypertrophy since 25Jul2013, medullary nephrocalcinosis since 1942, peripheral vascular disease since 14Aug2014, senile osteoporosis and temporal arteritis since 01Apr2014 all ongoing. Concomitant medications included amlodipine 5mg tablet once a day by mouth for hypertension; levothyroxine 50 micrograms tablet 2 tablets once a day on an empty stomach by mouth for hypothyroidism; pravastatin 40mg tablet once a day by mouth for cholesterol; WAL-ITIN 10mg tablet as needed by mouth for allergies; CENTRUM SILVER tablet one daily by mouth for vitamin supplementation; Ibuprofen 400mg tablet by mouth once a day and as needed for arthritic pain; PRILOSEC 40mg capsule once a day by mouth for acid reflux; VALTREX 1 gram tablet once a day by mouth for suppression of herpes; METOPROLOL ER 100mg tablet once a day by mouth for blood pressure; FORTEO 20 micrograms intradermal once daily for osteoporosis. The patient did not received concomitant vaccination nor vaccines in the 4 weeks prior to the administration of PREVNAR 13. On 18Dec2014 the patient experienced injection site severe cellulitis which required an emergency room and was treated with antibiotics. The patient was not hospitalized due to the event. The outcome of the event was resolving.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Facial pain, Hypoaesthesia, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the second of two reports. A 71-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Lot Number: J67643), via an unspecified route of administration on 08Dec2014. No other vaccinations were given at this time. The patient's medical history and concomitant medications were not reported. On an unknown date in Dec2014 within 24 hours after receiving the vaccination, the patient started to experience intense pain, then progressed to arm numbness radiating down the arm and through fingertips, and intense pain radiating up the neck, into the jawbone and cheek. The patient went to the emergency room and it was unknown if the patient was admitted. Lab tests were unknown. Therapeutic measures were taken in response to the events and included treatment with steroids. The clinical outcome for the events was unknown. It was reported the events were improved within a week from the time of initiating steroid therapy.
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Initial report was received via a search of the scientific literature on 28 December 2014. A total of 1596 out of 26,229 women experienced chorioamnionitis after receiving ADACEL or another Tdap vaccine during pregnancy. Lot numbers and dates of vaccination were not reported, however all pregnancies ended in live births between 01 January 2010 and 15 November 2012. Women were between the ages of 14 and 49 years of age, and "the majority of Tdap doses administered to pregnant women were ADACEL". Chart reviews were performed on a random sample of 220 of the patients: the median gestational week of vaccination was 28 weeks, 200 were treated with antibiotics, and 209 had an epidural. Outcome was not reported. The following is verbatim from the article: "IMPORTANCE In 2010, due to a pertussis outbreak and neonatal deaths, the Department of Health recommended that the Tdap be administered during pregnancy. Tdap is now recommended by the Advisory Committee on Immunization Practices for all pregnant women, preferably between 27 and 36 weeks' gestation. Limited data exist on Tdap safety during pregnancy. OBJECTIVE To evaluate whether maternal Tdap vaccination during pregnancy is associated with increased risks of adverse obstetric events or adverse birth outcomes. DESIGN AND SETTING Retrospective, observational cohort study using administrative health care databases from 2 Vaccine Safety Datalink sites. PARTICIPANTS AND EXPOSURES of 123,494 women with singleton pregnancies ending in a live birth between January 1, 2010, and November 15, 2012, 26,229 (21%) received Tdap during pregnancy and 97,265 did not. MAIN OUTCOMES AND MEASURES Risks of small-for-gestational-age (SGA) births (<10th percentile), chorioamnionitis, preterm birth (<37 weeks' gestation), and hypertensive disorders of pregnancy were evaluated. Relative risk (RR) estimates were adjusted for site, receipt of another vaccine during pregnancy, and propensity to receive Tdap during pregnancy. Cox regression was used for preterm delivery, and Poisson regression for other outcomes. RESULTS Vaccination was not associated with increased risks of adverse birth outcomes: crude estimates for preterm delivery were 6.3% of vaccinated and 7.8% of unvaccinated women (adjusted RR, 1.03; 95%CI, 0.97-1.09); 8.4% of vaccinated and 8.3% of unvaccinated had an SGA birth (adjusted RR, 1.00; 95%CI, 0.96-1.06). Receipt of Tdap before 20 weeks was not associated with hypertensive disorder of pregnancy (adjusted RR, 1.09; 95% CI, 0.99-1.20); chorioamnionitis was diagnosed in 6.1% of vaccinated and 5.5% of unvaccinated women (adjusted RR, 1.19; 95%CI, 1.13-1.26). CONCLUSIONS AND RELEVANCE In this cohort of women with singleton pregnancies that ended in live birth, receipt of Tdap during pregnancy was not associated with increased risk of hypertensive disorders of pregnancy or preterm or SGA birth, although a small but statistically significant increased risk of chorioamnionitis diagnosis was observed." Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Severe swelling and ternderness of left, underarm (arm pit) area, same side as shot was given.  Consulted doctor.  Took Benadryl.  Symptoms resolved after about 7 days.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Blood thyroid stimulating hormone decreased, Full blood count normal, Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician that reported three cases of severe cellulitis for three patients. This is the second of three reports. A 62-years-old female patient received PREVNAR 13 (lot J67645, exp. date 29Feb2016) on 17Dec2014 at 0.5ml single dose, intramuscular on left arm. Medical history included hypertension, chronic gastritis since 2012, coagulopathy, deep vein thrombosis, esophagitis since 2012, hyperlipidemia, obesity all ongoing and finger pain, hand pain, gastric polyps since 2012, thyroid nodule since 2011, unknown if ongoing. Concomitant medication included TOPROL XL 50mg tablet once a day by mouth for hypertension, PRADAXA 150 mg capsule one twice a day by mouth for coagulopathy and deep vein thrombosis, losartan 100mg tablet once daily by mouth for blood pressure, ASTEPRO 205.5 microgram nasal spray 2 puffs twice a day to each nares for allergies and CRESTOR 10mg tablet one daily by mouth for hypercholesterolemia. On 19Dec2014 the patient experienced sore and warm at injection site, it was recommended to ice and call if got worse. On 22Dec2014 the patient came to the office with big site reaction warm cellulitis. Lab data included TSH was little low and has been chronic, T3 and T4 were normal. Full blood count was normal and mean cell volume was a little microcytic. The patient was not recovered from all events.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Mean cell volume decreased, Microcytosis, Thyroxine normal, Tri-iodothyronine normal
Clinical narrative: This is a spontaneous report from a contactable physician that reported three cases of severe cellulitis for three patients. This is the second of three reports. A 62-years-old female patient received PREVNAR 13 (lot J67645, exp. date 29Feb2016) on 17Dec2014 at 0.5ml single dose, intramuscular on left arm. Medical history included hypertension, chronic gastritis since 2012, coagulopathy, deep vein thrombosis, esophagitis since 2012, hyperlipidemia, obesity all ongoing and finger pain, hand pain, gastric polyps since 2012, thyroid nodule since 2011, unknown if ongoing. Concomitant medication included TOPROL XL 50mg tablet once a day by mouth for hypertension, PRADAXA 150 mg capsule one twice a day by mouth for coagulopathy and deep vein thrombosis, losartan 100mg tablet once daily by mouth for blood pressure, ASTEPRO 205.5 microgram nasal spray 2 puffs twice a day to each nares for allergies and CRESTOR 10mg tablet one daily by mouth for hypercholesterolemia. On 19Dec2014 the patient experienced sore and warm at injection site, it was recommended to ice and call if got worse. On 22Dec2014 the patient came to the office with big site reaction warm cellulitis. Lab data included TSH was little low and has been chronic, T3 and T4 were normal. Full blood count was normal and mean cell volume was a little microcytic. The patient was not recovered from all events.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician that reported three cases of severe cellulitis for three patients. This is the third of three reports. A patient of an unspecified age, gender and ethnicity received the first dose of intramuscular PREVNAR 13 0.5 ml, single dose. The physician stated that injection was given at a pharmacy on 23Oct (year unspecified). Relevant medical history and concomitant medication were unknown. On an unknown date, the patient experienced severe cellulitis. Clinical outcome of the event was unknown at time of this report.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: 01/06/15 mentioned at office visit that his left arm (deltoid) is still sore (point tenderness) at site of injection. FLUVIRIN given 10/14/2014.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Eye pruritus, Eye swelling, Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after administering MMR and DTAP vaccine patient broke out in very small hives under both eyes and along sides of his face. He later had some swelling around his eyes and complained of itchy eyes 2 doses of BENADRYL given and oral steroid given and prescribed.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Pyrexia
Clinical narrative: Initial report of an unsolicited case received on 27 December 2014 from a consumer, who is also the patient. A 66 year-old male patient with a history of MS had received on an unspecified date in October 2014 an INFLUENZA VACCINE (manufacturer, lot number, route and site of administration not reported) and on 21 December 2014, experienced a fever. On 27 December 2014, the patient reported that he went to the ER yesterday and was diagnosed with the flu. Treatment included TAMIFLU and concomitant medication included AUBAGIO. According to the patient although he was diagnosed with the flu, he did not feel he had normal flu symptoms other than the fever. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Necrotising retinitis
Clinical narrative: Initial report received from literature on 28 December 2014. This case is linked to case number 2015SA000156, 2015SA000157 and 2015SA000159 (same literature report). The following is the verbatim for the article abstract: A number of medications have been associated with uveitis. This review highlights both well-established and recently reported systemic, topical, intraocular, and vaccine-associated causes of drug-induced uveitis, and assigns a quantitative score to each medication based upon criteria originally described. An unknown patient (age and gender was not reported), whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA VACCINE (manufacturer- unknown, batch number, route, dose number and site of administration was not reported) on an unspecified date. On an unspecified date patient had experienced reactivation of acute retinal necrosis after vaccination. It was reported that the influenza vaccination has been implicated in the development of secondary uveitis in several case reports, including bilateral panuveitis, recurrent panuveitis and acute posterior multifocal placoid pigment epitheliopathy (APMPPE). Anterior uveitis can be controlled with topical corticosteroids and a cycloplegic/mydriatic agent, whereas posterior involvement may require systemic corticosteroids. Laboratory investigation and corrective treatment was not reported. At the time of reporting, patient outcome was unknown. Upon medical review, the case was considered as serious due to important medical event: reactivation of acute retinal necrosis (ARN). List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: BCG
Symptoms: HLA marker study positive, Iridocyclitis
Clinical narrative: Initial report received from literature on 28 December 2014. This case is linked to case number 2015SA000158, 2015SA000156 and 2015SA000159 (same literature report). The following is the verbatim for the article abstract: A number of medications have been associated with uveitis. This review highlights both well-established and recently reported systemic, topical, intraocular, and vaccine-associated causes of drug-induced uveitis, and assigns a quantitative score to each medication based upon criteria originally described. A 72-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of BCG VACCINE (manufacturer- unknown, batch number, route, dose number and site of administration was not reported) on an unspecified date. On an unspecified date patient had experienced bilateral granulomatous anterior uveitis after vaccination. It was reported that for a polyclonal autoimmune reaction elicited by BCG as well as amino acid sequence homology between proteins from M. tuberculosis, BCG, and retinal antigens. The patient was negative for HLA (human leukocyte antigen) -B27 but positive for HLA (human leukocyte antigen) -B8 and HLA (human leukocyte antigen) -B38. Other laboratory investigation and corrective treatment was not reported. At the time of reporting, patient outcome was unknown. Upon medical review, the case was considered as serious due to important medical event: bilateral granulomatous anterior uveitis. List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: BCG
Symptoms: Iridocyclitis
Clinical narrative: Initial report received from literature on 28 December 2014. This case is linked to case number 2015SA000158, 2015SA000157 and 2015SA000159 (same literature report). The following is the verbatim for the article abstract: A number of medications have been associated with uveitis. This review highlights both well-established and recently reported systemic, topical, intraocular, and vaccine-associated causes of drug-induced uveitis, and assigns a quantitative score to each medication based upon criteria originally described. A 13-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of BCG VACCINE (manufacturer- unknown, batch number, route, dose number and site of administration was not reported) on an unspecified date. On an unspecified date patient had experienced chronic bilateral anterior uveitis after vaccination. It was reported that patient developed chronic bilateral anterior uveitis following BCG vaccination implicated her HLA-DR4 positivity, noting that HLA-DR4 is highly responsive to M. tuberculosis antigens. Laboratory investigation and corrective treatment was not reported. At the time of reporting, patient outcome was unknown. Upon medical review, the case was considered as serious due to important medical event: chronic bilateral anterior uveitis. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness, pain at lower (L) arm 20 x 30 cm.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Patient states hurts when area is pressed and tender when just sitting. She can feel pain when raising her arm. No treatment per patient. She has been taking tramadol for other reasons.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Tenderness
Clinical narrative: Localized redness 5 cm diameter with tenderness lasting 2 days.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: After vaccination, pt walked out to car, but came back in complaining of metallic taste and "tongue feels sick." Medical assistance denied by patient, she stated she felt better and willingly went home. Upon follow-up call, pt states she took BENADRYL, 20 mg of prednisone, and an old inhaler. Pt came back through DT and stated she was ok.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I got the shot Oct 22, 2014 for 5 days and present day shortness of breath. Arm on left side where shot given swell twice the size turned beet red and severe pain and immobile. Still have pain some today.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection sight over two month left arm. Could not raise arm.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Demyelination, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Ultrasound Doppler
Clinical narrative: Pt evaluated by neurology, sx reported suspected to be due to demyelinating lesion. Right side numbness.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Catheterisation cardiac, Fear, Feeling hot, Heart rate increased
Clinical narrative: I felt deathly ill - high blood pres, high pulse - felt very nervous - scared, hot, lot of anxiety - hospital performed a heart cath.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Hypertension, Malaise, Nervousness
Clinical narrative: I felt deathly ill - high blood pres, high pulse - felt very nervous - scared, hot, lot of anxiety - hospital performed a heart cath.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Unable to walk due to numbness and tingling in legs, sudden collapse. Unable to sit up without assistance. Diagnosed with transverse myelitis.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Posture abnormal, Syncope
Clinical narrative: Unable to walk due to numbness and tingling in legs, sudden collapse. Unable to sit up without assistance. Diagnosed with transverse myelitis.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Nausea, Rash
Clinical narrative: Patient complained of rash with bumps.  Patient was diagnosed with cellulitis at hospital ER. Patient filled prescription for antibiotic clindamycin and ondansetron for nausea.
Age: 1.51
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Noted 3 small bumps around the injection sites, which then progressed to redness, pain and swelling. Continuing to worsen. Area marked off last night with a pen, and is still spreading beyond. No fevers. Able to walk well.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: Intussusception - 6 days after vaccine given.
Age: 29.0
Sex: M
Vaccine: ANTH, IPV, TYP
Symptoms: Urticaria
Clinical narrative: Welts located under arms and upper arms.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH CRAMPS, EVEN 19 DAYS AFTER SHOT.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Diarrhoea, Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Patient present to ED with vomiting and diarrhea. She was initially suspected to have gastroeneteritis but then began to have bilious emesis and bloody stools in the ED. She was diagnosed via KUB and ultrasound with an intussusception. It was reduced with an air enema.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Urinary system X-ray, Vomiting, X-ray abnormal
Clinical narrative: Patient present to ED with vomiting and diarrhea. She was initially suspected to have gastroeneteritis but then began to have bilious emesis and bloody stools in the ED. She was diagnosed via KUB and ultrasound with an intussusception. It was reduced with an air enema.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Autonomic nervous system imbalance, Decreased appetite, Failure to thrive, Urinary retention
Clinical narrative: Patient began to complain of anorexia, unable to urinate, failure to thrive. She was in and out of the hospital 4 times. Eventually saw a Neurologist and was diagnosed with autoimmune autonomic ganglionopathy.
Age: 11.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Cough, Tic
Clinical narrative: When it was first noticed.  Tic of left eye that has gotten progressively worse.  Vaccines given against my judgement, despite my concerns for neurological adverse events given the history of sensory integration issues and apraxia, as well as undiagnosed signs and symptoms of autism spectrum disorder when he was younger.  Patient also developed a bad cough that lasted for 5 weeks following immunization (and this child has not been sick with a cold or cough in years!)
Age: 11.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Blood selenium increased, Unevaluable event, Vitamin B12 increased
Clinical narrative: When it was first noticed.  Tic of left eye that has gotten progressively worse.  Vaccines given against my judgement, despite my concerns for neurological adverse events given the history of sensory integration issues and apraxia, as well as undiagnosed signs and symptoms of autism spectrum disorder when he was younger.  Patient also developed a bad cough that lasted for 5 weeks following immunization (and this child has not been sick with a cold or cough in years!)
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain
Clinical narrative: Left shoulder muscle pain and weakness after receiving flu vaccine.
Age: 8.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Feeling abnormal, Feeling cold, Headache, Hot flush
Clinical narrative: Felt "miserable". Fever, cold and hot flashes, headache, weak, and extreme sensitivity to arm the received the shot. Could not properly lift arm for 7 days.
Age: 8.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pyrexia, Tenderness, Vaccination complication
Clinical narrative: Felt "miserable". Fever, cold and hot flashes, headache, weak, and extreme sensitivity to arm the received the shot. Could not properly lift arm for 7 days.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Headache, Malaise, Pharyngeal oedema
Clinical narrative: Incredibly injected conjunctiva and high fever with chills. Headache and malaise. Onset was nearly instantaneous and began with a cough and throat swelling 2.5 hours after vaccination for influenza (IM administration).
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Incredibly injected conjunctiva and high fever with chills. Headache and malaise. Onset was nearly instantaneous and began with a cough and throat swelling 2.5 hours after vaccination for influenza (IM administration).
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Persistent intermittent numbness and tingling of left dorsal forearm, beginning very soon after the immunization in that arm.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Bronchitis, Candida infection, Convulsion, Dizziness
Clinical narrative: Had rash at injection site, little purple dots on both legs, extreme fatigue, migraine headaches, seizures extreme spine pain, hip pain, vertigo, dizziness, extreme exhaustion and a constant case of thrush. The day after the first and only injection she came down with pneumonia, bronchitis, a sinus infection, 2 ear infections, throat infection, a common cold and thrush. This was constant for the first 2-3 months. She had 1 or more symptoms at any given moment after vaccinated. She had never had any of these symptoms EVER before the shot (except for the bronchitis and the cold). All of these symptoms started immediately and slowly got worse and worse. I took her to see her doctor 1-3 times per week for several months.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Ear infection, Electroencephalogram abnormal, Fatigue, Immediate post-injection reaction, Immunoglobulins abnormal
Clinical narrative: Had rash at injection site, little purple dots on both legs, extreme fatigue, migraine headaches, seizures extreme spine pain, hip pain, vertigo, dizziness, extreme exhaustion and a constant case of thrush. The day after the first and only injection she came down with pneumonia, bronchitis, a sinus infection, 2 ear infections, throat infection, a common cold and thrush. This was constant for the first 2-3 months. She had 1 or more symptoms at any given moment after vaccinated. She had never had any of these symptoms EVER before the shot (except for the bronchitis and the cold). All of these symptoms started immediately and slowly got worse and worse. I took her to see her doctor 1-3 times per week for several months.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site rash, Migraine, Nasopharyngitis, Nuclear magnetic resonance imaging normal, Pharyngitis
Clinical narrative: Had rash at injection site, little purple dots on both legs, extreme fatigue, migraine headaches, seizures extreme spine pain, hip pain, vertigo, dizziness, extreme exhaustion and a constant case of thrush. The day after the first and only injection she came down with pneumonia, bronchitis, a sinus infection, 2 ear infections, throat infection, a common cold and thrush. This was constant for the first 2-3 months. She had 1 or more symptoms at any given moment after vaccinated. She had never had any of these symptoms EVER before the shot (except for the bronchitis and the cold). All of these symptoms started immediately and slowly got worse and worse. I took her to see her doctor 1-3 times per week for several months.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Pneumonia, Rash, Sinusitis, Spinal pain, Vertigo
Clinical narrative: Had rash at injection site, little purple dots on both legs, extreme fatigue, migraine headaches, seizures extreme spine pain, hip pain, vertigo, dizziness, extreme exhaustion and a constant case of thrush. The day after the first and only injection she came down with pneumonia, bronchitis, a sinus infection, 2 ear infections, throat infection, a common cold and thrush. This was constant for the first 2-3 months. She had 1 or more symptoms at any given moment after vaccinated. She had never had any of these symptoms EVER before the shot (except for the bronchitis and the cold). All of these symptoms started immediately and slowly got worse and worse. I took her to see her doctor 1-3 times per week for several months.
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of throbbing pain in a male patient who received Influenza vaccine. On 23rd October 2014, the patient received Influenza vaccine. On 23rd October 2014, 10 min after receiving Influenza vaccine, the patient experienced throbbing pain. On an unknown date, the outcome of the throbbing pain was unknown. It was unknown if the reporter considered the throbbing pain to be related to Influenza vaccine. Additional information received: A patient reported getting a flu shot this morning at about 9 am. About 10-15 min afterwards the patient experienced aching, throbbing pain in his left arm that runs all the way down past his elbow. The patient said this comes and goes and seems to hurt most if he is walking or moving. No other details were provided.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt has decreased range of motion, numbness and pain in arm approximately 2 weeks after flu shot.
Age: 21.0
Sex: F
Vaccine: MMR, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: None.
Age: 21.0
Sex: F
Vaccine: MMR, VARZOS, VARZOS
Symptoms: No adverse event, Viral titre decreased, Wrong drug administered
Clinical narrative: None.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Breath sounds abnormal, Crying, Dyspnoea
Clinical narrative: Parents returned to office a few minutes after imm stating she was gasping occasionally. Upon re-exam, pt sleeping in car seat. Occasionally would breathe in noisily. Upon review with RN administering vaccine, before and after vaccine, crying a lot. Resp pattern seemed to be one of "post-crying". Monitored 20 minutes without resolution.
Sex: F
Vaccine: FLUX
Symptoms: Head discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a contact and descried the occurrence of swelling arm in a adult female patient who received Influenza vaccine. Previously administered products included flu vaccine. On 21st October 2014, the patient received Influenza vaccine. On an unknown date, less than a day after receiving Influenza vaccine, the patient experienced swelling arm, head pressure and painful arm. The patient was treated with BENADRYL. On an unknown date, the outcome of the swelling arm, head pressure and painful arm were unknown. It was unknown if the reporter considered the swelling arm, head pressure and painful arm to be related to Influenza vaccine.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: 1/6/15 1100 administered 6 mo immunizations. 5 minutes after noted red blotchy areas on R/side of head. L/side of nose, neck (anterior) lt red raised area at injection site. No difficulty with breathing. Appt. with allergist set up.
Age: 37.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: During the course of the month following the vaccination, my arm has been sore and gotten progressively worse. At the end of the month, I have limited range of motion. Here today with right shoulder pain since she got the flu shot on 12/3/14. Pain started initially in arm with flu shot, Tdap in other arm with no problems. The arm has progressively gotten worse is swollen at injection site and 4 inches surrounding, and now hard to lift her arm. Patient was given both antibiotics and steroids, she will follow up if not improved in 3 days. Vaccine report will be submitted.
Age: 3.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Rash
Clinical narrative: 10 min after receiving flu im and varicella sq child developed muscular rash on the face and chest.
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This case was reported by a physician and described the occurrence of increased lymph node size in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, unknown deltoid and batch number). In September 2014, at an unspecified time after vaccination with FLUARIX, the subject experienced increased lymph node size and increased lymph node tenderness in the axillary area. It was unknown if the events were localized to the arm of vaccination. At the time of reporting, the outcome of the events was unspecified. This is one of the 3 cases reported by the same reporter for the same vaccine and same events. Follow-up received on 25 September 2014. This case was reported by a physician and described the occurrence of enlargement of lymph nodes in a female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (intramuscular) .5 ml. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to Influenza vaccine. Additional information: The patient was the physician herself.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 18-DEC-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (injection, lot#, expiry date, dose and frequency were not provided) intramuscularly. No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old female patient. Medical history and current conditions were not reported. On 11-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old male patient. Medical history and current conditions were not reported. On 20-FEB-2014, the patient was vaccinated with VARIVAX (Merck) lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 29-DEC-2014, the patient was vaccinated with improperly stored ZOSTAVAX (Dose/Frequency: 0.65 ml) subcutaneously that was exposed to 8 Fahrenheit (F) for 12 hours. No adverse events were reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Age: 1.56
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 months old female patient. Medical history and current conditions were not reported. On 03-MAR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medications was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an 82 year old female patient. Patient medical history and current condition was not reported. Approximately in July-2014 (reported as about 6 months ago) the patient was vaccinated with ZOSTAVAX. It was reported that the patient received ZOSTAVAX about 6 months ago on an unspecified date was diagnosed with shingles on approximately OCTOBER-2014 (reported as about 3 months ago, on an unspecified date). Also reported that the patient was diagnosed with he shingles when she was seen by her primary care physician on an unspecified date. Cancer and overdose was not reported. Product quality complaint was not involved. The outcome od the event was reported as recovered. Causality assessment was not provided by the reporter. Additional information has been requested.