chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a patient wife concerning to a 55 years old male patient. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported) on 15-DEC-2011. . The patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported) in March 2012. The third dose of GARDASIL had not been administered. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of event was unknown. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient with 11cm x 14cm erythematous firm, indurated area to the left thigh 2 days after the influenza vaccine was administered - started the same day the vaccine was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an approximately 61-year-old (reported as over 60 years) female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number expiry date, dose and route was not reported). No concomitant medications were reported. On an unknown date, the patient complained of headache 1 hour after administration of ZOSTAVAX. The patient was treated with ibuprofen and the headache on an unknown date. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 67 years old female consumer refers on herself with allergies to eye drops. The patient had no pertinent medical history. On 13-DEC-2012, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number not provided). Other co-suspects were not reported. Concomitant medications were reported as vitamins. The patient reported she developed red, warm, swollen area at the injection site after receiving a dose of PNEUMOVAX23. Her arm was swollen from injection site down to her elbow. She also complained that it was itchy. The patient sought medical attention she talked to a nurse. The patient was treated with TYLENOL and ice. Labs diagnostics studies were not performed. The patient outcome was reported as recovering. The relatedness for the adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: This spontaneous report was received regarding a 86-year-old male patient was received from his wife. The patient had no pertinent medical history. The patient has drug allergies with penicillin and aspirin. On an unknown date in 2007, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). Concomitant medications included SYNTHROID, ALLEGRA and PLAVIX. On an known date in March 2011, the patient contracted shingles over his eye after receiving ZOSTAVAX. On an unknown date in 2012, the patient received an additional dose of ZOSTAVAX, (lot number, expiration date and route not reported). The reporter stated that the patient has had allergic reactions to several unspecified treatments he had received. There were no laboratory diagnostics performed. At the time of this report the patient had not recovered from the event. The patient had sought medical attention for this adverse experience on numerous unspecified dates. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Induration, Injection site reaction, Oedema peripheral
Clinical narrative: This spontaneous report as received from a 60 years old female patient regarding herself. The patient was allergic to pain killers, codeine, Prednisone (reported as prednizone), penicillin and morphine. On 11-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported), subcutaneously. No concomitant medications were reported. On 12-DEC-2012, the patient had a reaction to vaccine at the injection site. The patient experienced headache, left insertion arm was swollen, red, itchy and had a hard lump. Her pharmacist said that it would go away in several weeks but the consumer stated that it was swelling into her arm pit on her left arm. The patient sought no medical attention. No treatment was given. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Upper extremity mass
Clinical narrative: This spontaneous report as received from a 60 years old female patient regarding herself. The patient was allergic to pain killers, codeine, Prednisone (reported as prednizone), penicillin and morphine. On 11-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported), subcutaneously. No concomitant medications were reported. On 12-DEC-2012, the patient had a reaction to vaccine at the injection site. The patient experienced headache, left insertion arm was swollen, red, itchy and had a hard lump. Her pharmacist said that it would go away in several weeks but the consumer stated that it was swelling into her arm pit on her left arm. The patient sought no medical attention. No treatment was given. The outcome of all the reported events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Gastric ulcer
Clinical narrative: Information has been received from an unpublished literature article. Varicella zoster virus (VZV) becomes latent in the dorsal root ganglia (DRG), cranial nerve ganglia (CNG), and enteric ganglia (EG) following chickenpox and vaccination. Children and adolescents who develop herpes zoster (HZ) may have transient decreases in cell mediated immunity (CMI) to VZV, possibly due to preceding viral infections that were asymptomatic, or to stress. In addition to being latent in CNG and DRG, RNA transcripts of wild type (WT) and Oka VZV and associated proteins have been demonstrated in enteric neurons in fresh surgical specimens removed from the intestines of children and adults. The demonstration of latency of VZV in EG is important because reactivation in intestinal ganglia may lead to a number of gastrointestinal diseases ascribed to VZV, such as achalasia, gastric ulcers and colonic pseudoobstruction, also known as Oglivie's syndrome. With the identification of latency of VZV in the ENS, and the potential for reactivation there, the pathogenesis of gastrointestinal disease due to VZV becomes clearer. Both WT and the Oka strain become latent in the ENS. The author recently identified an adolescent male with a severe gastric ulcer caused by Oka VZV, which must have been due to reactivation from latency, following 2 doses of varicella vaccine (manufacturer unknown). The demonstration of VZV RNA transcripts in fresh intestinal neuronal tissues avoids the confounding possibility of reactivation of VZV after death in autopsy specimens. The molecular capacity to differentiate between vaccine and wild type VZVs was an important aspect of studies on recipients of varicella vaccine in documenting reactivation and reinfection. Reactivation of VZV can occur following stress. VZV reactivation usually presents with rash, but rash may not invariably occur. When there is no rash, the virus may be demonstrated by the presence of VZV DNA in saliva or cerebrospinal fluid (CSF). Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a doctors office manager via a company representative refers to an approximately 7 year old (reported as 7 or 8 years) male patient. On 26-JUL-2010, the patient was vaccinated with first dose of M-M-R II, (lot number, expiration date and route not reported). On 30-NOV-2012, the patient was given 0.5 ml (milliliters), second dose of M-M-R II, (lot number reported as 0233AE, expiration date and route not reported). The patient was given (Merck) VARIVAX concomitantly each time, (first dose was given on 26-JUL-2010, (lot number, expiration date and route not reported) and second dose on 30-NOV-2012, with lot number H011962, expiration date and route not reported). The patient received ACTHIB, which was administered on 22-SEP-2009, 23-NOV-2009 and on 26-JAN-2010. No adverse event was reported. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age (gender unspecified). On 04-DEC-2012, the patient was vaccinated with an expired dose of ZOSTAVAX, lot number reported as (671452/1124AA, expiry date: 12-OCT-2012, dose and route not reported). No concomitant medications were reported. No symptoms were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an 81 year old male patient with no pertinent medical history and no drug reactions/allergies. On 12-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were reported as 1947AA and 20-OCT-2013 respectively), intramuscularly in the arm. Concomitant medications included PLAVIX and atenolol. On 12-DEC-2012 (same day), the patient experienced pain in the upper arm where the PNEUMOVAX 23 was administered and it was so bad it kept him up last night. The patient sought medical attention (went to the pharmacy). It was unspecified if the treatment was given. No laboratory diagnostic tests were performed. The pain was better at the time of report and the patient was recovering from the event. The outcome of the event 'it was so bad that it kept him up last night' was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a male patient of unknown age. On an unknown date in December 2010 (almost two years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On unknown date in December 2012 (almost two years after receiving ZOSTAVAX), the patient experienced shingles on the torso. It was unspecified if the patient sought medical attention. The outcome of shingles on the torso was unknown. Treatment information was unspecified by the reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 months old patient of unknown gender. The nurse reported that a patient received a pediatric dose of VAQTA earlier than recommended. The patient born on 12-DEC-2012, received the first dose of VAQTA (Lot number, expiry date, dose and route were not reported) on 13-JUN-2012, and second dose of VAQTA (Lot number, expiry date, dose and route were not reported) on 13-DEC-2012. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patient of unknown age and gender. On an unknown date in 2012, the patients were vaccinated with a dose of LIQUID PEDVAXHIB (lot numbers were reported as H010726 and H013038, expiry date, dose and route were not reported) that had a temperature excursion of 26 Fahrenheit for 17.5 hours and unsupported. No concomitant medications were reported. This is one of the 2 reports received from the same reporter (MARRS-1212USA007932). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to two patients of unknown age (gender unspecified0. On 11-DEC-2012, the patient was vaccinated with an expired dose of ZOSTAVAX, lot number reported as (671452/1124AA, expiry date; 12-OCT-2012, dose and route not reported). No concomitant medications were reported. No symptoms were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant concerning a patient of unknown age who was vaccinated with dose 1 of VAQTA (dose, route and lot # not provided) on 17-JUL-2012 and a booster dose of VAQTA on 05-OCT-2012. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacy student refers to a unspecified number of patients of unknown ages and genders. On unspecified date, the patients were vaccinated with PNEUMOVAX 23 (route, dose and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The Pharmacy student reported that unspecified number of patients might have received two doses of PNEUMOVAX 23 about 5-6 months apart. No adverse effects reported. No additional information provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 23-DEC-2003 was vaccinated with the first doses of VARIVAX (Merck) and MMR II (dose, lot number and route not reported). No concomitant medications were reported. The patient's second dose of MMR II was administered on 24-OCT-2007 and the second dose of VARIVAX (Merck) was administered on 30-OCT-2007. No adverse effect reported. Patient's outcome unknown. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Swelling, numbness in vaccinated arm and hand, fever. Diagnosis of "Complex Regional Pain Syndrome". Not have full use of (L) arm after 4 months.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Complex regional pain syndrome, Hypoaesthesia, Injected limb mobility decreased, Injection site anaesthesia
Clinical narrative: Swelling, numbness in vaccinated arm and hand, fever. Diagnosis of "Complex Regional Pain Syndrome". Not have full use of (L) arm after 4 months.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swelling, numbness in vaccinated arm and hand, fever. Diagnosis of "Complex Regional Pain Syndrome". Not have full use of (L) arm after 4 months.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Periarthritis
Clinical narrative: Initial report was received from a consumer on 13 December 2012. An 88-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4491AA, on 20 September 2012. Following vaccination, the patient experienced shooting pains down the left arm and continued to have pain in arm. The patient was diagnosed with frozen shoulder from vaccination and was currently going for physical therapy for treatment. Outcome was not recovered. Documents held by sender: None.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Periarthritis
Clinical narrative: Initial report was received from a consumer on 13 December 2012. An 88-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4491AA, on 20 September 2012. Following vaccination, the patient experienced shooting pains down the left arm and continued to have pain in arm. The patient was diagnosed with frozen shoulder from vaccination and was currently going for physical therapy for treatment. Outcome was not recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Initial report was received from a consumer on 14 December 2012 who also reported this information to VAERS under temporary reference number E-67645. A 51 year-old female patient had received an intradermal injection in the left arm of FLUZONE Intradermal, lot number UT4467AA, on 08 September 2012. On 14 December 2012, the patient was diagnosed with having the flu (Type A) by her doctor's office. They performed a nasal swab. The patient had a history of asthma, hypertension and anxiety. The patient had no illness at the time of vaccination. Concomitant medications included citalopram, lisinopril and lorazepam. Outcome was recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Culture, Influenza, Influenza A virus test positive
Clinical narrative: Initial report was received from a consumer on 14 December 2012 who also reported this information to VAERS under temporary reference number E-67645. A 51 year-old female patient had received an intradermal injection in the left arm of FLUZONE Intradermal, lot number UT4467AA, on 08 September 2012. On 14 December 2012, the patient was diagnosed with having the flu (Type A) by her doctor's office. They performed a nasal swab. The patient had a history of asthma, hypertension and anxiety. The patient had no illness at the time of vaccination. Concomitant medications included citalopram, lisinopril and lorazepam. Outcome was recovered. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: 6VAX-F, FLUX, IPV
Symptoms: Diet refusal, Injection site swelling, Insomnia, Pain, Pyrexia
Clinical narrative: Fever for over 48 hours of 102F (tried children's --Tylenol as prescribed on prior to vaccine and after the vaccine did not work). Pain anytime her leg moved. Wouldn't sleep for more than 2 hours (7 days). Wouldn't eat solids and often refused bottle (force fed fluids) for one week (7days). Swollen 2x the size at the injection site (lasted 4 days on day 5 swelling started to go down but wasn't complete till day 7). Stopped babbling (said mom only) after vaccine (day of, baby talk) until 18 months (only says 1 word often knows how to say 4 others but only said them twice each). Possible disability, will be evaluated 1/3/13.
Age: 0.51
Sex: F
Vaccine: 6VAX-F, FLUX, IPV
Symptoms: Speech disorder developmental
Clinical narrative: Fever for over 48 hours of 102F (tried children's --Tylenol as prescribed on prior to vaccine and after the vaccine did not work). Pain anytime her leg moved. Wouldn't sleep for more than 2 hours (7 days). Wouldn't eat solids and often refused bottle (force fed fluids) for one week (7days). Swollen 2x the size at the injection site (lasted 4 days on day 5 swelling started to go down but wasn't complete till day 7). Stopped babbling (said mom only) after vaccine (day of, baby talk) until 18 months (only says 1 word often knows how to say 4 others but only said them twice each). Possible disability, will be evaluated 1/3/13.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort
Clinical narrative: Substernal chest pressure.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Bronchitis, Chills, Cough, Erythema, Oedema peripheral
Clinical narrative: Started with sore arm, red and swollen, sore throat, head and chest congestion, body aches, then developed into coughing, runny nose, chills. I have been sick ever since I was given the Tdap. I saw Family doctor on 12/26/2012 for the symptoms, he diagnosed me with bronchitis and prescribed Levaquin and cough med.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Started with sore arm, red and swollen, sore throat, head and chest congestion, body aches, then developed into coughing, runny nose, chills. I have been sick ever since I was given the Tdap. I saw Family doctor on 12/26/2012 for the symptoms, he diagnosed me with bronchitis and prescribed Levaquin and cough med.
Age: 0.56
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Vomited 5 times.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, PNC, VARCEL
Symptoms: Convulsion, Electroencephalogram
Clinical narrative: 2 minute afebrile seizure within 24 hrs of vaccinations.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Dose given 130 PM 12/19. 3 A 12/20 woke to sore, achy, burning at injection site. 12/20 Later noticed lump at inj. site, achy, burning, red, getting overall burning hot body feeling and took TYLENOL with relief. 12/21 9 AM Reported to me. Arm very sore, red and swollen.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Dose given 130 PM 12/19. 3 A 12/20 woke to sore, achy, burning at injection site. 12/20 Later noticed lump at inj. site, achy, burning, red, getting overall burning hot body feeling and took TYLENOL with relief. 12/21 9 AM Reported to me. Arm very sore, red and swollen.
Age: 48.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Arm swelled like a softball where shot was administered. Red lines & markings. Bad pain couldn't lift arm. Very sore.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unspecified age and gender who on unknown dates received GARDASIL (doses, routes and lot numbers not reported) exposed to 11 C for 96 hours. No adverse effect reported. This is one of several reports received from the same source. Attempts are being made to distinguish individual patients mentioned in this report.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Convulsion neonatal, Culture positive, Cytomegalovirus test positive
Clinical narrative: Convulsions in newborn on 2012-11-26, clinicial comment: +CMV culture.
Age: 50.0
Sex: F
Vaccine: PNC
Symptoms: Leukopenia, Neutrophil count decreased, Pyrexia
Clinical narrative: Neutrophils on 2012-12-03, clinician comment: Persistent fever peaking at 102.9F of 4 day duration with associated leukopenia (3500) and no other infectious etiology found per extensive work-up.
Age: 1.24
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Serum sickness
Clinical narrative: Ot serum react d/t vacc on 2012-11-30.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphocyte count decreased
Clinical narrative: Lymphocytes on 2012-12-03.
Age: 60.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Chest X-ray abnormal, Feeling abnormal, Pleural effusion, Pleurisy
Clinical narrative: Pleural effusion NOS on 2012-12-05, clinician comment: Patient notes brief episode of feeling like she had a viral illness with mild pleurisy and was found to have very small pleural effusions on CXR. This could be an unrelated viral illness as well.
Age: 18.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Serum sickness, Vaccination complication
Clinical narrative: Ot serum react d/t vacc on 2012-12-06.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hyperhidrosis, Injection site induration, Lymph node pain, Lymphadenopathy
Clinical narrative: According to ER Report - (pt. not reachable), (L) axilla lymph swelling w/ associated pain, redness and sweats, (4 cm swelling), dime sized induration at injection site. (Treatment Cephalexin antibiotic started.)
Age: 30.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Mild nausea;consistent vomiting, stopped, bad headache.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Convulsion, Pain
Clinical narrative: I was given the pneumonia shot and a flu shot told not to worry about side-effects - By midnite I was in extreme pain & then suffered a seizure!
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chills, Headache, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: S: 26 y/o M referred to clinic for evaluation of SPV site by MD. Patient presents to clinic at 10:09 on 17DEC12. Received primary SPV (LUE), AVA #1 & typhoid (RUE) on Thursday 06DEC12 at clinic, in preparation for work in FEB 2013. No other vaccines received in past month. Patient endorses URI sx - ST, congestion, cough, sneezing, HA as of 28NOV12. States cold will not go away. Has been self-medicating with DAYQUIL and NYQUIL, according to recommended dosing instructions on the box and prn ADVIL. Reports ALLERGY TO PCN- rash/hives since 2 yrs old. Denies difficulty wheezing, swelling face, lips or eyes or difficulty swallowing in first three hours s/p receipt of SPV, AVA #2 and typhoid on 06DEC12. Fine till SAT 15DEC12 (day #7 s/p SPV), when he noticed local redness and swelling at SPV site about the size of a 1/2 dollar. Redness increased over next 24 hours and yesterday evening (16DEC12), he began to experience chills, body ache, HA and noticed a red streak going from his SPV site on his LUE toward his left axilla. He denied any chest pain, pressure in the center of his chest or pleuritic SOB. This morning he saw his surgeon, who called the clinic and asked if we could see the patient. O: Local erythema and swelling 160 mm x 75 mm. + axillary lymphangitis. No palpable tender left axillary LAD. Jennerian Pustule is c/w 11-day evolution. A/P Last Updated by reporter at 19 Dec 2012 1936 1. Arm swelling left: 26 y/o M with Robust Take and left axillary lymphangitis on day # 11 s/p receipt of primary SPV (LUE), AVA#1 & typhoid (RUE) placed on 06DEC12 at clinic. 1. Robust take (LUE) at SPV site. Normal Variant. 2. Left axillary Lymphangitis w/o palpable left axillary LAD or tenderness. Normal Variant. 3. This is NOT cellulitis! No antibiotics necessary. This is a hyperimmune response to vaccine secondary to peak cytokine activity of SPV, which occurs between days 6-12 s/p immunization. Treatment is simply with anti-inflammatories. 4. Ibuprofen 800 mg po tid with meals x 5-7 days. Denies h/o gastritis  or ulcers. 5. Reviewed site care with patient. 6. To ED if any new onset CP, pleuritic SOB, or deep pressure in center of chest. 7. Establish relationship with PCM for primary care. 8. If Dx of Psoriasis is confirmed by provider when patient has another flare, NO MORE SPV IMMUNIZATIONS IN A PRE-EVENT SETTING. 9. Patient verbalizes understanding and compliance.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Lymphangitis, Oedema peripheral, Pain, Rash pustular
Clinical narrative: S: 26 y/o M referred to clinic for evaluation of SPV site by MD. Patient presents to clinic at 10:09 on 17DEC12. Received primary SPV (LUE), AVA #1 & typhoid (RUE) on Thursday 06DEC12 at clinic, in preparation for work in FEB 2013. No other vaccines received in past month. Patient endorses URI sx - ST, congestion, cough, sneezing, HA as of 28NOV12. States cold will not go away. Has been self-medicating with DAYQUIL and NYQUIL, according to recommended dosing instructions on the box and prn ADVIL. Reports ALLERGY TO PCN- rash/hives since 2 yrs old. Denies difficulty wheezing, swelling face, lips or eyes or difficulty swallowing in first three hours s/p receipt of SPV, AVA #2 and typhoid on 06DEC12. Fine till SAT 15DEC12 (day #7 s/p SPV), when he noticed local redness and swelling at SPV site about the size of a 1/2 dollar. Redness increased over next 24 hours and yesterday evening (16DEC12), he began to experience chills, body ache, HA and noticed a red streak going from his SPV site on his LUE toward his left axilla. He denied any chest pain, pressure in the center of his chest or pleuritic SOB. This morning he saw his surgeon, who called the clinic and asked if we could see the patient. O: Local erythema and swelling 160 mm x 75 mm. + axillary lymphangitis. No palpable tender left axillary LAD. Jennerian Pustule is c/w 11-day evolution. A/P Last Updated by reporter at 19 Dec 2012 1936 1. Arm swelling left: 26 y/o M with Robust Take and left axillary lymphangitis on day # 11 s/p receipt of primary SPV (LUE), AVA#1 & typhoid (RUE) placed on 06DEC12 at clinic. 1. Robust take (LUE) at SPV site. Normal Variant. 2. Left axillary Lymphangitis w/o palpable left axillary LAD or tenderness. Normal Variant. 3. This is NOT cellulitis! No antibiotics necessary. This is a hyperimmune response to vaccine secondary to peak cytokine activity of SPV, which occurs between days 6-12 s/p immunization. Treatment is simply with anti-inflammatories. 4. Ibuprofen 800 mg po tid with meals x 5-7 days. Denies h/o gastritis  or ulcers. 5. Reviewed site care with patient. 6. To ED if any new onset CP, pleuritic SOB, or deep pressure in center of chest. 7. Establish relationship with PCM for primary care. 8. If Dx of Psoriasis is confirmed by provider when patient has another flare, NO MORE SPV IMMUNIZATIONS IN A PRE-EVENT SETTING. 9. Patient verbalizes understanding and compliance.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Rash
Clinical narrative: Started itching in administered arm - then rash on arm which spread to trunk and whole body took BENADRYL and used Aveeno - was on chemo - steroid medicine helped.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Surgery
Clinical narrative: Abscess at site of injection surgically removed.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Minor soreness at injection site. Tingling from injection site to fingertips difficulty in grasping objects. Numbness along arm. Suggested use of APAP for pain, see Dr if needed. (Dr notified 12/21/12).
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: Initial report was received from a consumer on 11 December 2012. About ten unidentified patients had received an injection of FLUZONE Vaccine, Sanofi Pasteur (lot number, route, site and date of administration not reported) and about three to four weeks following vaccination had "the flu". Each patient tested positive for either type A or B flu strain. No additional information was provided. Outcome was not reported. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: Patient received vaccine and approximately 2 weeks later had a miscarriage - because gestational age of fetus, doctor said vaccine may have caused miscarriage.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Face oedema, Histology abnormal, Immunohistochemistry, Immunology test abnormal, Laboratory test abnormal
Clinical narrative: Initial report was received from the scientific literature on 12 December 2012. The following is verbatim from the article: "In this study, the case of a 48-year-old man with severe serum sickness reaction in response to H1N1 influenza immunization is reported. He presented with renal failure and several of the classic signs reported in early descriptions of serum sickness including lymphadenopathy, urticarial skin eruption and facial edema. Serum immunologic studies and tissue histology/immunohistochemistry assisted in firmly establishing the diagnosis in this case. With appropriate therapy, the patient's rash, edema and lymphadenopathy resolved and normal renal function returned. This first reported case of severe serum sickness to H1N1 vaccine is particularly important in light of the Centers for Disease Control and Prevention's recommendation for universal vaccination against influenza, including H1N1, in patients 6 months and older. With increasing numbers of patients receiving this vaccine, even rare adverse reactions may be experienced by numerous individuals. It is imperative that clinicians remain vigilant about possible reactions and quickly institute appropriate therapy." Outcome was not reported. Documents held by sender: None.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Lymphadenopathy, Renal failure, Serum sickness, Urticaria
Clinical narrative: Initial report was received from the scientific literature on 12 December 2012. The following is verbatim from the article: "In this study, the case of a 48-year-old man with severe serum sickness reaction in response to H1N1 influenza immunization is reported. He presented with renal failure and several of the classic signs reported in early descriptions of serum sickness including lymphadenopathy, urticarial skin eruption and facial edema. Serum immunologic studies and tissue histology/immunohistochemistry assisted in firmly establishing the diagnosis in this case. With appropriate therapy, the patient's rash, edema and lymphadenopathy resolved and normal renal function returned. This first reported case of severe serum sickness to H1N1 vaccine is particularly important in light of the Centers for Disease Control and Prevention's recommendation for universal vaccination against influenza, including H1N1, in patients 6 months and older. With increasing numbers of patients receiving this vaccine, even rare adverse reactions may be experienced by numerous individuals. It is imperative that clinicians remain vigilant about possible reactions and quickly institute appropriate therapy." Outcome was not reported. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Influenza, Pyrexia
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 13 December 2012. A 51-year-old female patient had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route and site not reported) on 10 October 2012 and on 23 November 2012 experienced the flu which lasted until 27 November 2012. She experienced chills, fever and cough. Outcome was recovered. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt. broke out in hives.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Face injury, Laceration, Syncope
Clinical narrative: Approximately 10 minutes after receiving flu shot patient got lightheaded & fainted, and fell to floor, bumping his chin on way down, resulting in laceration. EMS responded but pt refused to go to ER.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Malaise, Rash generalised
Clinical narrative: On 11/8/12 received flu shot and within few hrs developed rash all over body, flushed face and reported feeling ill, generally.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Nausea, Vertigo
Clinical narrative: Three hours after vaccine, extreme tiredness - took nap - woke up with extreme vertigo. Never had it in my life. Chiropractic adjustments have helped dizziness and nausea. Another bout of vertigo on 11/30/12 - more chiropractic.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Full blood count, Induration, Pain, Pyrexia
Clinical narrative: Rec'd vaccine 12/18 2:30 pm. That evening at 6 pm had sore (L) post lateral shoulder. 12/19 Fever to 101.5. Fever, felt achy, left work. Upper arm noted 12/19 am to be red with induration. Pt still feels achy. Took ibuprofen last night.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Rec'd vaccine 12/18 2:30 pm. That evening at 6 pm had sore (L) post lateral shoulder. 12/19 Fever to 101.5. Fever, felt achy, left work. Upper arm noted 12/19 am to be red with induration. Pt still feels achy. Took ibuprofen last night.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Patient received both vaccines on 12-17-12. Returned to office today 12-19-12 with pain, redness and streaking to right deltoid. Pt was given BENADRYL prescription and told to follow up if no better.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Patient diagnosed with Flu Type B on 12/18/12. Given TAMIFLU. Patient received FLUZONE on 10/06/2012.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Injection site erythema, Vertigo, Viral infection
Clinical narrative: Pt. states had reaction of 5 inch x 3 inch redness to injection site. One week after injection started with frequent falls that required an ER visit. Diagnosed with vertigo & a viral infection - required home care x 17 days. Stable now.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: After inoculation patient felt lightheaded. I seated him on a chair. In 2-3 minutes he said he was feeling fine. After about 7-8 minutes of original lightheadedness patient fainted onto the floor. His face lost color. He was this way for 2-3 minutes while we straightened him and called 911. Then he abruptly sat up, was coherent but sweating. Gave him water. He drank approx. 1 pint. Waited till his BP was 120/74 (approximately 45 minutes). He left feeling fine. Called him twice for follow up. No response.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Fixed papular pruritic rash started on 12/18/12, in-between thighs/legs, now all over. Hydrocortisone 2.5% 30Gm tube BID was prescribed; helps and relieves the itch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Pain, Skin warm
Clinical narrative: Patient received PNEUMOVAX on 12/11/12. Noticed some redness and pain later that night. Was seen at clinic 12/12/12, not treated. Seen by us 12/13/12 with palm sized redness, warmth, induration. Diagnosed with cellulitis and was treated with BACTRIM.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: 1443 Patient reported feeling dizzy and nausea. 1445 Report to staff. Snack at 1446, reported feeling zero symptoms at 1455. Observed for an additional 10 mins. Pt. left at 1505 on her own accord.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: See notes.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Local reaction (L) arm.
Age: 28.0
Sex: M
Vaccine: TTOX
Symptoms: Asthenia, Confusional state, Disorientation, Dizziness, Hyperhidrosis
Clinical narrative: Dizziness, blurred vision, confusion/disorientation, weakness, pallor & diaphoresis immediately upon receiving injection. Quick recovery (10 mins) with no intervention necessary.
Age: 28.0
Sex: M
Vaccine: TTOX
Symptoms: Immediate post-injection reaction, Pallor, Vision blurred
Clinical narrative: Dizziness, blurred vision, confusion/disorientation, weakness, pallor & diaphoresis immediately upon receiving injection. Quick recovery (10 mins) with no intervention necessary.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Disorientation, Fatigue, Heart rate irregular, Hyperhidrosis
Clinical narrative: One hour after receiving started with profuse sweating, irregular heart beat, continued next day, numbness & tingling of extremities, disorientation, weak & tired. Allergic to vaccine component, monosodium glutamate. This should be listed on patient info. sheet. Contains MSG!
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Reaction to preservatives
Clinical narrative: One hour after receiving started with profuse sweating, irregular heart beat, continued next day, numbness & tingling of extremities, disorientation, weak & tired. Allergic to vaccine component, monosodium glutamate. This should be listed on patient info. sheet. Contains MSG!
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced swelling, redness and itching of injection site and upper arm on which vaccine was administered which lasted for over a week.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt was given a ZOSTAVAX shot on 12/19/12. She presented today 12/21/12 at counseling window of pharmacy and made employee and I aware of the reaction she had experienced from this vaccine injection. Pt stated that after shot was given that she began to hurt at the injection site. She explained that the pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypotension, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt was achy & feverish morning after and had low blood pressure 90/40. Then her arm became so sore she could not raise above mid body. Ibuprofen & exercise & time helped.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: ZOSTAVAX vaccine given 8/30/12 patient called and reported arm pain 12/4/12 patient states arm pain has persisted since date patient received vaccine. Informed to follow-up with primary care provider.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Pain, swelling, redness at injection site/arm erythematous, temp.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 11 patients of unknown age and sex. The registered nurse reported that VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 31 F degrees on 01-OCT-2012 and GARDASIL (Lot Number: H013977, exp: 19-MAR-2015 and Lot Number: 0459AE, exp: 13-DEC-2014) was then, administered to 11 patients over a period of eight weeks. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Patient's outcome were unknown. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age who on an unknown date, was vaccinated with a dose of PROQUAD (Merck) and a dose of MMR II (doses, routes and lot numbers not reported). No known adverse effects were reported. Additional information has been requested.
Age: 37.0
Sex: U
Vaccine: VARCEL, YF
Symptoms: Rash maculo-papular, Rash pruritic, Varicella post vaccine
Clinical narrative: Developed diffuse macular papular rash in groin on post vaccine day 1, day 2 rash covered lower extremities bilaterally from knees to ankles, day 3 rash spread to arms and torso. Is pruritic. Initially started on steroids by PCM, discontinued by Allergy, sent to Derm who diagnosed the rash as varicella rash, gave antihistamines for itching at night and cortisone topical cream.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: On 12/19 pt. states she woke up with swelling in hands bilaterally. Pain in wrists & hand joints bilaterally. Called dr Wed 12/24. Prescribed CLARITIN & ENDOCRIN 3 mg x 2 days. Feels sx are slightly decreased at this time 12/27/12 at 0850.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Throat tightness
Clinical narrative: Throat tightening, facial itch, SOB. Treated in ED. Steroids 5 day following event.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patient came in on 12-20-12 at 3:30 pm with 4 x 4 redness & 3 x 4 whelp on left deltoid after receiving vaccines on 12-18-12. No pain with movement or touch. Mom instructed to give BENADRYL, apply cool compress, and give TYLENOL. Told to return to clinic or call if worsens or new sx.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site pruritus, Pain, Rash pruritic
Clinical narrative: Night of vaccines, sites started itching, rash on arms, chest, face. Painful and itchy. No fever.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came in on 12-22-12 with mother. Left arm red, itching and swollen. 4x2 red area above elbow. Mom instructed to give BENADRYL & TYLENOL by mouth & apply cool compress. If worsens or new sx to call or return to clinic.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous retrospective pregnancy report as received from an 18 years old female consumer with asthma, allergy to amoxicillin and OMNICEF reporting on herself for GARDASIL a Pregnancy Registry product. The consumer was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) on 26-NOV-2012. No other co-suspects were reported. Concomitant medications included folic acid. The consumer reported that on 01-DEC-2012, she found out she was pregnant and then later on 07-DEC-2012 miscarried. At the time of the report, the patient's outcome was unknown. Upon internal review miscarried was considered medically significant. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Information has been received from a patient's father in regards to his 8 year 6 month old son. On 05OCT2012, the child was scheduled to receive the second series of Hepatitis A Vaccine but mistakenly was administered GARDASIL. The patient's father reported he and his wife have researched the Quadrivalent Human Papillomavirus Recomb. Vaccine and the possible short term and long term side effects so they can support their son. Their concerns included that face that their son was under the age of the study group and he also had a diagnosis of autism. They were concerned that their son may not be able to inform them if he does experience possible long term effects> The parents have reviewed the Physician Desk Reference and saw there was a study of Quadrivalent Human Papillomavirus Recomb. Vaccine with REMOBIVAX vaccine and they were inquiring if there were any studies regarding Quadrivalent Human Papillomavirus Recomb. Vaccine and Hepatitis A and if there were any studies with persons with Autism or other developmental disabilities. The father stated he and his wife were not looking to assert a claim towards Merck & Co. They just wanted to determine if there was any reason for concern and to obtain as much information as they could. No further information is expected.
Age: 38.0
Sex: M
Vaccine: HPV4
Symptoms: Off label use
Clinical narrative: This spontaneous report as received from a 38 year old male consumer reporting on himself. The consumer was vaccinated with complete 3 dose regimen at the recommended intervals of GARDASIL (Lot # not reported) IM in 2002 when it was not approved in men. No other co-suspects were reported. No concomitant medications were reported. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache, nausea, shivering/chills, fever (max 101.2 at 7:15PM).
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Patient reported that had pain at injection site immediately and it has continued to this date.  Has some limited range of motion.  This occurred in his arm.  He reports that he tried to ignore it for awhile, then made an appointment with his doctor.  MRI was ordered by his doctor and is being done 12/27/12. Treatment is awaiting MRI reading.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Swelling and redness at right deltoid muscle. Benadryl 25 mg PO given to patient for treatment.
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal pain upper, Injection site rash, Pyrexia, Vomiting
Clinical narrative: Violently vomiting, severe stomach cramping, fever, rash on upper arm where vaccine was administered.