chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Rash in both arms, spreading to extreme pain in feet, hands, hips, arms, headache, vomiting. Child is still very sick.
Age: 14.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal pain, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Fatigue, dizziness, headache, malaise, abd. pain.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old male patient. Information about concurrent condition, medical history, drug reactions/allergies and concomitant medication were not provided. On 25-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, lot #, expiration date and route were unknown). On the same day, the patient passed out once and had one seizure. The patient did not seek medical attention. Upon internal review, the events of "passed out once" and "had one seizure" were determined to be medically significant. The outcome of the events was unknown. The causality assessment was not reported. Additional information is not expected as no consent was provided to contact the reporter.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: Tingling, burning sensation, itchy, raised pink/red bumps, and sore in general areas of receiving vaccination.
Age: 25.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site scab, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Obvious redness, swelling, and warmth of affected area of left upper outer arm. Flinches from pain upon touch, rates pain at this time about 1-2. Area measures about 3.5"" x 3.5" round edges. Scabbed area of injection site. Antibiotics ordered 11-03-2016.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer through a Pfizer sales representative. A 64-year-old female patient received PREVNAR 13, (lot # L04915, exp date Jul2016) IM at single dose at left deltoid on 24Mar2015 for immunization and asthma, at private Physician's office/hospital. The relevant medical history was not reported. No illness were present at time of vaccination. The and concomitant medication included FLU, (Sanofi, lot # UI190AF) IM at right deltoid on 24Mar2015 for immunization. No adverse events occurred following prior vaccination either in patient nor in siblings. On 24Mar2015 the patient experienced fever and deltoid muscle painful. On 25Mar2015, the patient experienced deltoid muscle red and swollen, and on 26Mar2015 hade swelling in her lymph nodes. The events were described as follows: By that night the deltoid muscle was red swollen, and painful and she had upstream lymph node was red and swollen. The AE did not require an emergency room or physician visit. The patient recovered on an unknown date. The reporter stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The Physician was unsure if there was a reasonable possibility that the event is related to suspect product.  The Physician was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts are completed. No further information is expected. Follow-up (07Apr2015): New information obtained from a contactable consumer via Pfizer sales representative includes: new events and details. Follow-up (03Jun2015): Follow-up attempts completed. No further information expected. Follow up (08Feb2016): New information from a contactable consumer included: patient's age, onset date and events outcome. Follow up (21Mar2016): Follow-up attempts completed. No further information expected. Follow-up (28Oct2016): New information reported from a contactable Physician included: suspect and conmed details; reporter informed regarding the adverse events; course of events; reporter event causality assessment; reporter further contactability.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Localised infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative. A female patient (in her 60s) of an unspecified ethnicity, received PREVNAR 13, via an unspecified route of administration on an unspecified date and PNEUMOVAX 23, via an unspecified route of administration on an unspecified date both as single doses for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced arm infection in the vaccinated arm and patient got PREVNAR 13 and PNEUMOVAX 23 on the same day on an unspecified date.  The outcome of experienced arm infection in the vaccinated arm and patient got PREVNAR 13 and PNEUMOVAX 23 on the same day was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, White blood cell count
Clinical narrative: Initial unsolicited misuse report received from consumer via other company (Pfizer) (Manufacturer Report Number: 2016466975) on 24-Oct-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of FLU SHOT (lot number, Expiration date, route of administration, site of administration and dose details were not reported) on an unspecified date in 2001. Patient's ongoing illness reported as chronic lymphocytic leukemia and had history of chemotherapy. Concomitant medications were not reported. On an unspecified date in 2001, following the vaccination the patient experienced flu. The patient's laboratory data reported as white blood count as 65000(units not reported). Corrective treatment was not reported. On unspecified date in 2001, patient recovered from event. List of documents held by sender: none.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Balance disorder, Chest discomfort, Headache, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a Physician Assistant on 26 October 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of Imovax (batch number: L126-3, expiration date: 16 June 2017) intramuscularly on 20 September 2016, 23 September 2016, 27 September 2016 and 02 October 2016 and a dose of Imogam (batch number and expiration date not reported) (dose and site of administration not reported for both vaccines) on 20 September 2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. It was reported that patient was previously seen in ER (emergency room) for chest tightness and diagnosed with anxiety. Any other vaccinations within 4 weeks of vaccinations were not reported. On an unknown date, following the vaccination, the patient experienced tingling, numbness in hand and feet, "lymphadenopathy bilateral axilla", joint pain, headache, foggy thinking, decreased balance, chest tightness. Patient was sent to the ER by primary care doctor for evaluation and was admitted in hospital on an unknown date. Lab data and corrective treatment were not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none. Sender's Comments: This poorly document case of patient who had anxiety, Lymphadenopathy axillary, Tingling of extremity, Numbness of extremities, joint pain, Headache and decreased balance following IMOVAX RABIES and IMOGAM vaccines. Time to onset is unknown, detail medical history, allergic history, and past vaccination history and its tolerance are needed to further assess the case.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Lymphadenopathy, Paraesthesia, Thinking abnormal
Clinical narrative: Initial unsolicited report received from a Physician Assistant on 26 October 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of Imovax (batch number: L126-3, expiration date: 16 June 2017) intramuscularly on 20 September 2016, 23 September 2016, 27 September 2016 and 02 October 2016 and a dose of Imogam (batch number and expiration date not reported) (dose and site of administration not reported for both vaccines) on 20 September 2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. It was reported that patient was previously seen in ER (emergency room) for chest tightness and diagnosed with anxiety. Any other vaccinations within 4 weeks of vaccinations were not reported. On an unknown date, following the vaccination, the patient experienced tingling, numbness in hand and feet, "lymphadenopathy bilateral axilla", joint pain, headache, foggy thinking, decreased balance, chest tightness. Patient was sent to the ER by primary care doctor for evaluation and was admitted in hospital on an unknown date. Lab data and corrective treatment were not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none. Sender's Comments: This poorly document case of patient who had anxiety, Lymphadenopathy axillary, Tingling of extremity, Numbness of extremities, joint pain, Headache and decreased balance following IMOVAX RABIES and IMOGAM vaccines. Time to onset is unknown, detail medical history, allergic history, and past vaccination history and its tolerance are needed to further assess the case.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 42 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M018766; dose, route of administration and expiration date were not reported) and a dose of influenza virus vaccine (unspecified) in the same arm. On an unknown date, the patient developed a rash that started at the injection site and spread to his abdomen. It was unspecified if the rash started at the PNEUMOVAX 23 or influenza virus vaccine (unspecified) injection site. The outcome of the adverse events was unknown. The relatedness between the adverse events and PNEUMOVAX 23 and influenza virus vaccine (unspecified) was not provided). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site discomfort, Injection site hypoaesthesia
Clinical narrative: After giving the client a Hepatitis A and Typhoid vaccine in the left deltoid muscle her left arm and hand went numb. Called in the morning and the numbness was gone but felt discomfort at site.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Rash
Clinical narrative: Itching overnight, but has resolved. only rash remains, above elbow, not just injection site.
Sex: F
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous report as received from a consumer via social media refers to a 15 year old female patient (reporter friend's daughter). The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient was vaccinated with all three doses of either quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), (dose, route, lot # and expiry date not reported). On an unknown date, the patient died after receiving all three doses of vaccine. The cause of death was unknown and it was not reported if an autopsy was performed. The reporter stated that, his/her friend did some research and she was convinced that the patient died because of this vaccine. The reporter also stated that his/her kids had received all other vaccines,  but this vaccine had many risks. Causality was not provided by the reporter. No product quality complaint was involved. Upon internal  review, death was determined to be medically significant. Additional information is not expected as contact details of the reporter are not available.
Sex: U
Vaccine: HPVX
Symptoms: Throat cancer
Clinical narrative: Information has been received from a physician assistant, via a company representative, concerning a 26 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not informed. On an unknown date, the patient was  vaccinated  with  an  unspecified  human  papillomavirus  vaccine  (manufacturer  unknown)  (lot  #,  expiration  date,  dosage  and  route  of  administration  were  not  provided).  On  an  unknown  date,  the  patient  developed throat cancer. No product quality complaint  (PQC) was involved. At the time of the reporting, the outcome of throat cancer was unknown. The causal relationship between throat cancer and the unspecified human papillomavirus vaccine was not reported. Upon internal review, the throat cancer was determined to be a medically significant event. Additional information is not expected as no consent for follow up was given.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 41-year-old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 31-OCT-2016, at the pharmacy, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # L012042, and expiration date 18-NOV-2016; route of administration was not reported). On the same day, the patient was vaccinated with influenza virus vaccine (unspecified) (dose and route of administration were not reported). It was unspecified in which arm the patient received PNEUMOVAX 23 and in which influenza virus vaccine (unspecified). Concomitant therapy was not reported. On an unknown date in 2016, after the vaccinations, the patient developed cellulitis around the injection site. She sought medical attention, spoke with the physician, and on an unknown date in 2016, she was hospitalized to treat the cellulitis. It was unspecified in which hospital the patient was treated and for how long. The outcome of the event was not reported. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Angiogram, Computerised tomogram, IIIrd nerve paralysis, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: 3rd nerve palsy..myalgias. Possibly second to vaccine, but more probably to DM.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: High fever 104, body aches, chills.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Acute respiratory distress syndrome, Critical illness, Dialysis, Dyspnoea, Endotracheal intubation
Clinical narrative: The patient was admitted to Hospital on 10/31/2016 with increase shortness of breath and O2 sat 64%. The patient is being treated for pneumonia. The patient then when into ARDS and required ventilation. The patient is still currently being treated at Hospital. He remains incubated and critically ill, he is now receiving dialysis. The patient's loved ones insist that the patient started to take a turn for the worse after he received the flu shot.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Mechanical ventilation, Pneumonia
Clinical narrative: The patient was admitted to Hospital on 10/31/2016 with increase shortness of breath and O2 sat 64%. The patient is being treated for pneumonia. The patient then when into ARDS and required ventilation. The patient is still currently being treated at Hospital. He remains incubated and critically ill, he is now receiving dialysis. The patient's loved ones insist that the patient started to take a turn for the worse after he received the flu shot.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fall, Flushing, Loss of consciousness
Clinical narrative: While standing behind her mother at the nurses desk with her winter jacket on - patient fell to the ground and passed out. This occurred approx. 10 - 15 minutes after her injection. She reported feeling fine and refused a chair when offered. She was unresponsive for a minute or two during which time her arms became stiff and wrist turned outward. Face was flush.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: While standing behind her mother at the nurses desk with her winter jacket on - patient fell to the ground and passed out. This occurred approx. 10 - 15 minutes after her injection. She reported feeling fine and refused a chair when offered. She was unresponsive for a minute or two during which time her arms became stiff and wrist turned outward. Face was flush.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Fever ranging from 101.1 - 103.2 degrees for a day and a half; chills; intense pain in arm at injection site and entire upper arm, loss of range of movement in arm do to pain; headache.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Sensory loss
Clinical narrative: Anesthesia of right arm and right leg with gradual improvement starting in right arm and then to right leg.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Dermatitis diaper, Rash generalised
Clinical narrative: On 11/3/2016, we noticed some rashing around the diaper region and assumed it was something of a diaper rash. This morning on 11/4 the rashing was all over the body, head to toe. Contact doctor and we are getting BENADRYL per doctors request to see if this will assist in the break out.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient was seen by her oncologist and found to have profound thrombocytopenia. Patient usually had a platelet count of 300,000-400,000, dropped to 1000 with symptomatic petechiae.  This occurred 2 weeks post flu shot with no other changes to medications. Has since returned to normal. Patient required hospitalization and received dexamethasone 40mg IV.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Insomnia, Pain
Clinical narrative: Reporting soreness, redness at first but after day 3 it became painful and continues to be painful on a daily basis.  Reports that certain sleeping positions cause her to awaken with pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a circular rash at injection site that was red and slightly swollen. Slightly warm to the touch. Patient stated they have not noticed any change in size or color.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: When receiving shot client felt burning at site of injection. By evening, left arm was painful to move in all directions. Disrupted sleep due to pain.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: ITCHING, SWELLING, REDNESS AND SORENESS.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Soreness at injection site. Pain when lifting arm above head or swing motion.
Age: 19.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Localized reaction to MENVEO - swelling, painful, warm to touch, onset about one hour after injection on 11-1-16 - improved at office visit on 11-4-16.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient given PNEUMOVAX 23 on 11/1/2016. On 11/4/16 she presented to office with (L) upper arm redness, swelling, warmth to touch, and fever. Redness 11 cm x 11 cm.
Age: 85.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient says arm was initially swollen, red, sore, and itching and the swelling and redness is gone but the arm still itches. Did not go to Dr. Spoke to him again today.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Paraesthesia
Clinical narrative: Hospitalized 11/2/16 with 1-2 WK HX progressive paresthesias and weakness. Diagnosed with AIDP following neuro consultation. Treated with IVIG.
Age: 68.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Received vaccine in the afternoon, developed redness, soreness down arm before bedtime. Reported to us 11/4/2016, symptoms persisting, but not worse.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Biopsy skin, Rash erythematous, Rash generalised, Skin lesion
Clinical narrative: Gradual onset of raised red papilate lesions, eventually covering entire body from neck to ankles.  Currently on 5th day of treatment with prednisone. Biopsy reveals eosinophile invasion.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Cough, Eyelid ptosis, Ocular hyperaemia, Sneezing
Clinical narrative: On the day of the vaccinations (ROTATEQ, PENTACEL, PREVNAR 13)the child "couldn't open his eyes, wouldn't bear weight, coughing and sneezing frequently, temp of 102F, red eyes, projectile puking 8oz of formula for 4 days" mother stated she called 3 different ER's and could not get a straight answer on what to do. Stated that her pediatrician called her back and told her to give TYLENOL. Mother did not take him in to ER anywhere.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting projectile, Weight bearing difficulty
Clinical narrative: On the day of the vaccinations (ROTATEQ, PENTACEL, PREVNAR 13)the child "couldn't open his eyes, wouldn't bear weight, coughing and sneezing frequently, temp of 102F, red eyes, projectile puking 8oz of formula for 4 days" mother stated she called 3 different ER's and could not get a straight answer on what to do. Stated that her pediatrician called her back and told her to give TYLENOL. Mother did not take him in to ER anywhere.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site cellulitis, Pain, Skin irritation, Swelling
Clinical narrative: Swelling, pain, redness, irritation - Patient went to Urgent Care and was diagnosed with systemic cellulitis at injection site. MD treated with an injection of ROCEPHIN at the office, and gave patient a prescription for cephalexin 500mg, to be taken TID for 10 days to treat the infection, with instructions to return if the infection doesn't improve.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: ARMS AND HANDS BOTH SHAKING UNCONTROLLED.
Age: 30.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Chest discomfort, Dyspnoea, Injection site reaction, Pallor, Vomiting
Clinical narrative: Patient presented to ER s/p being given EPIPEN injection, stated received flu vaccine to left delt at 0730, at 0800 felt tightness in chest, short of breath and had 1 episode of vomiting, given EPIPEN injection and brought to ER for evaluation.
Age: 30.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Pallor
Clinical narrative: Patient presented to ER s/p being given EPIPEN injection, stated received flu vaccine to left delt at 0730, at 0800 felt tightness in chest, short of breath and had 1 episode of vomiting, given EPIPEN injection and brought to ER for evaluation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe L shoulder pain and loss of range of motion.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Patient reported fever, itching, redness, and a sore left arm that occurred 4 hours post AFLURIA and PNEUMOVAX 23 vaccination. The patient stated that he was in bed for 1 and 1/2 days and the arm soreness lasted at least 2 weeks. He said that he took Ibuprofen 200 mg tabs every 6 hours and is now feeling better.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported a knot, swelling, warmth and redness at injection site.  Knot and swelling were mostly gone by 1pm but redness had spread across upper arm and was still warm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red swollen area below area of injection and itchy.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Contusion, Muscle spasms, Musculoskeletal pain
Clinical narrative: Left arm bruised and shoulder hurt with spasms bruise remained for a month. Presently, shoulder is still hurting and I have spasms.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site discolouration, Injection site pain, Muscle spasms, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm bruised and shoulder hurt with spasms bruise remained for a month. Presently, shoulder is still hurting and I have spasms.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Peripheral swelling
Clinical narrative: Left arm bruised and shoulder hurt with spasms bruise remained for a month. Presently, shoulder is still hurting and I have spasms.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site induration
Clinical narrative: This is a spontaneous report from a contactable consumer and follow-up from a contactable physician.  A 53-year-old female patient of an unspecified ethnicity received PREVNAR 13; (Lot Number: M73332; Expiration Date: Jul2017; Batch Number: 0000609988), subcutaneous in the left side of the abdomen on 01Oct2016 at 10:00 at a single dose for immunization.  The patient's medical history and concomitant medications were not reported.  On 01Oct2016, the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via subcutaneous injection in the left side of the abdomen instead of receiving PROLIA.  On an unknown date in Oct2016, the patient experienced cellulitis and injection site induration. The events did not require an emergency room or physician visit. The events also did not require hospitalization. Therapeutic measures were taken in response to the events and included treatment with unspecified medications. The clinical outcome of the events, patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via subcutaneous injection in the left side of the abdomen instead of receiving denosumab, cellulitis, and injection site induration, was recovered with sequelae on unknown dates in Oct2016. The physician stated that the events, cellulitis and injection site induration, were causally related to the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) as it was injected at the wrong site. Follow-up (28Oct2016): New information received from a contactable physician includes: patient demographics, suspect product data (added co-suspect denosumab); reaction data (added new events; cellulitis and injection site induration), outcome (recovered with sequelae), and causality (related).
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood test, Cough, Dizziness, Gait disturbance, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Insomnia, Malaise, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Productive cough, Visual impairment, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Condition aggravated, Cough, Decreased appetite, Diabetes mellitus
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Eructation, Hiccups, Hot flush, Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Insomnia, Malaise, Muscle spasms, Musculoskeletal pain, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Neck pain, Pain, Productive cough, Pruritus, Sinus disorder
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Vision blurred, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for herself. This 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 16Jun2016 in left shoulder at single dose for pneumonia immunisation. Medical history included ongoing diabetes mellitus, myocardial infarction from 29Oct2012, road traffic accident on an unknown date. Concomitant medication included metformin, acetylsalicylic acid (ASPIRIN), and simvastatin. The patient previously took SALONPAS and it did not help with shoulder since getting the vaccine. The patient experienced feeling sick, dizziness, nausea/ sick to her stomach on an unspecified date with outcome of not recovered. Also experienced vomiting, get phlegm in throat, cough more, her shoulder was bothering me more than it usually does on an unspecified date with outcome of unknown, pain, pain in her left shoulder, so that arm hurts a lot on an unspecified date with outcome of not recovered, her arm got completely numb at 3 O' clock in the same afternoon when she got the shot on 16Jun2016 with outcome of unknown, she stumble all over, it affects her vision too on an unspecified date with outcome of unknown, she has a hard time sleeping at night on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: B negative on an unknown date, and other blood test with unknown results.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Feeling of body temperature change, Hyperhidrosis, Increased viscosity of upper respiratory secretion
Clinical narrative: Weakness, hot and cold reaction for 5 days. Cough which later developed in chest congestion, expectorated thick mucous continues now 10/29/2016. Continued weakening and sweating.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Secretion discharge
Clinical narrative: Weakness, hot and cold reaction for 5 days. Cough which later developed in chest congestion, expectorated thick mucous continues now 10/29/2016. Continued weakening and sweating.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: C/O generalized itching and hives post injection. No egg allergy.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Received flu shot IM left deltoid at an off site clinic set up for city employee's. Nurses administering injections from the Public Health Dept. Patient states injection was painful, but the discomfort never dissipated and now progressed to a month later where her Left Arm ROM is being affected. She states she can only raise her arm to shoulder height and residual pain from near injection site radiates up to her shoulder causing her much discomfort.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: Tightness, redness and pain at injection site.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Gait disturbance, Guillain-Barre syndrome, Movement disorder, Muscular weakness
Clinical narrative: Tingling in  hands and feet and weaknesses in hands and feet. Problems climbing my stairs.  Difficulty walking severe back pain vomiting due to pain. Hospitalization.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Paraesthesia, Vomiting
Clinical narrative: Tingling in  hands and feet and weaknesses in hands and feet. Problems climbing my stairs.  Difficulty walking severe back pain vomiting due to pain. Hospitalization.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Rash, hard lump, red, fever at injection site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Fatigue, Feeling cold, Feeling hot
Clinical narrative: Throat felt swollen, no interference with breathing. Followed by severe nausea. Hour later continuous projectile vomiting and 1 bout of diarrhea. Followed by chills and shaking. Couldn't get warm. About an hour later got extremely warm. Temp was 100.9. By about 10pm symptoms began to subside and fever was slowly coming down. Next day symptoms gone but extremely fatigued and a little bit nauseated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pharyngeal oedema, Pyrexia, Tremor, Vomiting projectile
Clinical narrative: Throat felt swollen, no interference with breathing. Followed by severe nausea. Hour later continuous projectile vomiting and 1 bout of diarrhea. Followed by chills and shaking. Couldn't get warm. About an hour later got extremely warm. Temp was 100.9. By about 10pm symptoms began to subside and fever was slowly coming down. Next day symptoms gone but extremely fatigued and a little bit nauseated.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Nausea, Pyrexia
Clinical narrative: Mild rash, low fever, & nausea throughout afternoon and evening; inability to move arm at bedtime.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Alopecia, Thyroid function test normal
Clinical narrative: Started losing his hair in the front of his head. By June 28,2016 he had many bald spots all over his head. By July 23,2016 his hair was completely gone. By September 7, 2016 he had no hair anywhere on his body including eye lashes and eye brows. He is currently being treated with Clobetasol Propionate topical solution. He has been on this about 2 months it is not working thus far.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pain, Vaccination complication
Clinical narrative: Office visit on 10/28 for flu shot reaction: Symptoms began a day ago. Location is L arm. Had flu shot yesterday AM  w/ in 1 hr the area started swelling and has continued to swell, Pt states area of injection is a bit sore, but remainder of arm is "okay." Does hurt w/ movement. Assessment and Plan: Reaction to influenza immunization, initial encounter. Reviewed use medications and side effect profile, use TYLENOL as needed, and give BENADRYL three times daily, emergency precautions reviewed, including numbness and/ or tingling in the left lower arm. Return for recheck with pediatric provider on Monday (no showed appt). I called mother today 11/4/16, and she said arm is back to normal.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Sensation of foreign body
Clinical narrative: Was here for a nursing visit for her HPV. Did fine, although does not like shots. While in waiting room after shot started to feel wierd, lump on the left iof her throat feels funny when she swallows but is able to swallow.  Also brought to exam room, supne with head elevated. Had water , had juice. Benadryl given.ADVERSE REACTION TO HUMAN PAPILLOMAVIRUS VACCINE.  vs anxiety/ nervous about vaccine. Pt examined 3 times- at no time in distress, breathing fine, speaking fine, no rash or cough, exam normal. Mom comfortable. Pt given benadryl and eventually lump felt a little better. Pt still feeling dizzy and sl wierd. Upon standing stable but reported wierd feeling. MOm comfortble going home- good car and cell phone. ? now some fatigue and dizzy from the Benadryl. Discussed with mom no outward sign or anaphylaxsis. Second dose due in 6 months and has well visit at that time with Dr. We will check on her tonight and am, second dose depends on how she does but I feel safe to go home at this point. Observed and re examoned over at least 1/2 hour.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Discomfort, Peripheral swelling, Skin warm
Clinical narrative: HEAT AND SWELLING IN RIGHT ARM. SIGNIFICANT ENOUGH THAT PATIENT CALLED TO REPORT. STILL HAVING DISCOMFORT SEVERAL DAYS LATER THOUGH NOT WORSENING.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPAB, MMR, PNC13
Symptoms: Erythema, Eye swelling, Hypersensitivity
Clinical narrative: This is a spontaneous report from a non-contactable consumer (mother) reporting for a patient (son). A 12-months-old male patient of an unspecified ethnicity received PREVNAR 13 at single dose, MMR, HEPA-B and INFLUENZA, all via an unspecified route of administration on 24Oct2016 for immunization. The patient medical history and concomitant medications were not reported. The patient had an allergic reaction, the boy's face got red and his eyes got swollen on an unspecified date. The mother mentioned the boy had had a peanut butter sandwich and wasn't sure if it was an allergic reaction to the food. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: The patient came to the pharmacy to report that since the date of the immunizations he did not feel good. He said that his arms were still sore and that they did not feel good when hanging by his side. He said it felt better to keep his arms crossed. He was asking if this was a normal side effect from having 3 immunizations on the same day.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: One hour later injected area swelling warm and itching and pain Level-4.