chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Vertigo
Clinical narrative: Vertigo.  Onset was sudden.  Head movement out of the vertical intensified the symptom.  Lasted remainder of day.  At bedtime it had subsided to the point that laying down did not aggrevate the vertigo.  The next day, I just felt out of sorts but did not have the vertigo.  By Oct 7th I was feeling better.  I did not have any treatment, nor did I see a doctor.  I've received flu vaccines the last 32 years and this is the first time vertigo was an issue.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling
Clinical narrative: Both of my eyes were swollen when I woke up the morning of 10/09/2014 about half shut. They have been lke this for about 48 hours now despite multiple doses of Benadryl.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache lasting 5 days.
Sex: M
Vaccine: MMR
Symptoms: Autism, Convulsion
Clinical narrative: This spontaneous report as received from a consumer refers to her son, who was a male patient of unknown age. On an unknown date, the patient was vaccinated by unknown physician with M-M-R II (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced autism and seizure (medically significant). The outcome of events was unknown. The causality of events was not reported. No product quality complaint (PQC) was reported. Upon internal review the event seizure was considered to be medically significant. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Influenza like illness
Clinical narrative: Received vaccine on 12-10-13 at 4:45 PM. I was in good health 12-22-13 flu like symptoms 2-5-14 feeling better 2-6-14 hands had numbness 2-7-14 hands and feet numbness trouble walking 2-8-14 In hospital with Guillain-Barre.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Oropharyngeal pain
Clinical narrative: Patient had shortness of breath, hoarse/sore throat drove to hospital - "pumped full of DEMEROL" stayed for 2 nights at hospital w/ IV fluids.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: About 10 min after administered, I felt lightheaded, hot, and nauseated.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: Malaise/fatigue/lack of energy, noticed when she received the shot for 1 week.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest X-ray abnormal, Cough, Headache, Hypotension
Clinical narrative: Within 36 hrs of injection - became very weak unable to get off the sofa achy - everywhere headache lasted 4 days rash all around neck low BP lowest 68/46 P 63 runny nose dry non-productive cough doc visit 9/8 chest x-ray done pneumonia - antibiotic started (right lower lobe) 9/30 re-examination chest x ray healing some pneumonia persists.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pneumonia, Rash, Rhinorrhoea
Clinical narrative: Within 36 hrs of injection - became very weak unable to get off the sofa achy - everywhere headache lasted 4 days rash all around neck low BP lowest 68/46 P 63 runny nose dry non-productive cough doc visit 9/8 chest x-ray done pneumonia - antibiotic started (right lower lobe) 9/30 re-examination chest x ray healing some pneumonia persists.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Injection site rxn, swelling, tenderness, redness.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Incontinence, Loss of consciousness
Clinical narrative: Passed out, complete loss of consciousness for over a minute, loss of control of bodily functions, occurred while driving home.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: The evening after the shot developed severe arm pain (L) unable to raise arm beyond 90 degrees of shldr flexion, abduction. Unable to rotate arm, also arm weakness.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration
Clinical narrative: 10.5 x 9.0 area of erythema near area of injection site. With mild induration. Afebrile.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 85 year old female patient. The history drug included vaccinated with PNEUMOVAX 23. On 22-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J004387, expiration date: 04-JAN-2015) injection 25/0.5 Y, (dose and route were unknown). On 23-SEP-2014, the patient developed cellulitis after receiving a 5 year booster dose of PNEUMOVAX 23. The patient sought medical attention. The patient was given clindamycin for the event. The outcome of cellulitis was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). On 17-SEP-2014, the patient was inadvertently administered with a dose of PNEUMOVAX 23 (lot # J004747, expiration date 20-JUL-2014, 0.5 ml, intramuscular. No adverse effects reported. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Red - big circle about 1 inch. No difficulty breathing or pain.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Next day muscles sore and swollen at site of injection. Today red at site injection and itchy. Putting antibiotic cream on it, took BENADRYL. Spoke to nurse. Similar to latex allergy reaction which usually takes 3 days.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted after shot. She was out for several seconds before opening her eyes. She recovered shortly after awakening and returned home with parents - follow-up Monday -> father reported patient was fine.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Light headedness, nauseous.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Painful respiration, Rhinorrhoea
Clinical narrative: Patient reported runny nose that started the next day after getting vaccine. And reported pain in rib cage 4 days later. She says the pain recurs when she breaths deep.
Age: 41.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Allergy test, Body temperature increased, Dyspnoea, Throat tightness
Clinical narrative: Patient experienced difficulty breathing and throat tightness. Patient took 50mg of BENADRYL and within 30 minutes the symptoms had dissipated. Later that day temp 101.5.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Vomiting
Clinical narrative: Chills, vomiting, stomach pain.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of MMR II injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of VAQTA that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of RECOMBIVAX HB, that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of ROTATEQ injection, route of administration not reported, defaulted to oral (strength, dose, indication, lot# and expiry date unspecified), that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 18-SEP-2014 the patient was inadvertently vaccinated with GARDASIL (lot#, exp. date, route of administration and vaccination site were not reported). No adverse events were reported. No laboratory tests were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patients were vaccinated with ROTATEQ (lot#, dose not reported, default route: oral) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. Follow up information was received from the nurse on 03-SEP-2014, reporting the lot number of the ROTATEQ that underwent a temperature excursion. Lot number K001194 expiration date 06-NOV-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of 56 or 57 year old. The patient's medical history included type II diabetes. There were no drug reaction/allergies. About 5 to 6 months ago (approximately in April 2014), the patient was vaccinated with a dose of ZOSTAVAX vial, subcutaneous (dose, lot # and expired date were not reported). There was concomitant medication, but unspecified by the reporter. On an unspecified date in 2014, the patient experienced a little pain and swelling around the injection site of the ZOSTAVAX. No treatment was given for adverse events. No lab diagnosis studies were performed. On an unspecified date in 2014, The patient was recovered from adverse events. The relationship between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown demographics. On 24-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J006921, expiry: 09-AUG-2014, dose: 0.5 ml (milliliters) injection. On 24-SEP-2014, patient received an expired dose of PNEUMOVAX 23. No adverse effect has been observed or reported. The pharmacist was hesitant to provide the patient's identifying for information due to corporate regulations. The outcome of received expired dose of PNEUMOVAX 23 and no adverse effect has been observed or reported is unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Insomnia, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old non-pregnant female patient with drug reactions/allergies to latex specified as "bandaid glue". On 01-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (route, dose and frequency not reported, lot # K005797, expiration date 21-MAR-2015) in the right deltoid and FLUVIRIN (route, dose, frequency and lot # not reported) in the left deltoid. On 01-OCT-2014 (also reported as last night) the patient experienced arm pain at injection site on right side. It was clarified to be severe muscular pain with redness (01-OCT-2014). The patient rated her pain as a 10 on a scale of 1 to 10 (on 01-OCT-2014). The patient reported to pharmacist that she could not sleep due to pain in her arm (on 01-OCT-2014). On 02-OCT-2014 (also reported as this morning the patient's pain was rated as an 8. There was no treatment given for the events. The outcomes of the events were reported as not recovered/not resolved. The patient sought medical attention by contacting the pharmacist. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old non-pregnant female patient with drug reactions/allergies to latex specified as "bandaid glue". On 01-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (route, dose and frequency not reported, lot # K005797, expiration date 21-MAR-2015) in the right deltoid and FLUVIRIN (route, dose, frequency and lot # not reported) in the left deltoid. On 01-OCT-2014 (also reported as last night) the patient experienced arm pain at injection site on right side. It was clarified to be severe muscular pain with redness (01-OCT-2014). The patient rated her pain as a 10 on a scale of 1 to 10 (on 01-OCT-2014). The patient reported to pharmacist that she could not sleep due to pain in her arm (on 01-OCT-2014). On 02-OCT-2014 (also reported as this morning the patient's pain was rated as an 8. There was no treatment given for the events. The outcomes of the events were reported as not recovered/not resolved. The patient sought medical attention by contacting the pharmacist. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On 03-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 (vial, lot #: J004332, intramuscular, dose, anatomical location not reported) that had expired on 26-SEP-2014. Concomitant medications were not reported. No known adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Malaise, Mobility decreased
Clinical narrative: This spontaneous report as received from a 68 year old male patient refers to himself. The patient did not have pertinent medical history. The patient did not have drug allergies.This spontaneous report as received from a 68 year old male patient refers to himself. The patient did not have pertinent medical history. The patient did not have drug allergies. On 23-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, lot# and expiration date were unknown) subcutaneous. Concomitant therapies included ADVIL. On 23-SEP-2014 the patient experienced exhaustion, feeling overall sick and pain at the injection site. The patient could not lift his arm due to the pain. No treatment was given for the adverse event. No lab diagnostics were performed. The patient sought for medical attention. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse of unknown age refers to herself. The nurse stated that she had received ZOSTAVAX twice. She was administered with the first dose of ZOSTAVAX on 17-JUN-2008 (dose, route and lot # unknown) and the second dose on 26-SEP-2014 (dose, route and lot # unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with unknown number of doses of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneous (lot # was not reported). No adverse effects were reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with VARIVAX (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 31 year old female patient. On 09-MAY-2014 at 11:21 am, the patient might have been immunized with a dose of VARIVAX (Merck) lot number J009165, expiration date 24-JUL-2015, in the right upper arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No current condition was reported. It was unknown if the patient had any relevant medical or past drug history. Approximately in 2014, as reported sometime after 26-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (unknown dose and frequency). No concomitant medication was reported. On an unknown date sometime after 26-SEP-2014 after the pharmacist administered the PNEUMOVAX 23 to the patient, he realized that the PNEUMOVAX 23 vaccine expired on 26-SEP-2014. It was unknown if any relevant tests were done. As of 05-OCT-2014 it was unknown if the patient will receive any additional PNEUMOVAX 23 doses and the outcome of receiving an expired vaccine was unknown. It was reported that the PNEUMOVAX 23 was possibly administered on 05-OCT-2014 but could not confirm because the pharmacist had patients waiting and did not have time to provide further information. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a female patient of unknown age. On 27-SEP-2014 the patient was vaccinated with a first dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) at her unspecified physician's office and then the patient received the second dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) at an unspecified pharmacy on 29-SEP-2014. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 28 year old female patient. The patient, who was indicated to receive a tuberculin skin test (PPD), received 0.1 ml of PNEUMOVAX 23 injection, intradermally (lot # K007773, expired date: 01-MAY-2015) in her left forearm in error on 01-OCT-2014. Concomitant therapy was not reported. The physician stated that the vial of PENUMOVAX 23 had been placed in the PPD vial's carton, and she didn't look at the label of the vial until after the 0.1 ml of PNEUMOVAX had been administered to the patient, when she was documenting the administration. The physician was certain that the PNEUMOVAX 23 vial was not supplied in the PPD carton, so there was no PQC. The physician stated that she did not confuse the PNEUMOVAX 23 with the PPD product; she didn't check the label of the PNEUMOVAX 23 vial prior to administration of the 0.1 ml dose of PNEUMOVAX intradermally. After the physician recognized the error, she administered the tuberculin skin test on the patient's other forearm during the same visit. No adverse effect has been observed or reported. The outcome of adverse event was not reported. The relationship between adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. On 24-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection, multi-dose vial (dose, route and frequency unspecified). No concomitant medications were reported. On 24-SEP-2014, the patient was injected with the entire contents of a PNEUMOVAX 23 multi-dose vial. No adverse symptoms reported. The outcome of patient was injected with the entire contents of a PNEUMOVAX 23 multi-dose vial and no adverse symptoms reported is unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Pain, Vulvovaginal dryness
Clinical narrative: This spontaneous report as received from a physician and medical assistant refers to a 23 year old female patient. Patient medical history and other previous drug allergic reactions were not reported. On an unknown date a long time ago the patient was vaccinated with series of GARDASIL (strength, dose number, lot number and expiry date unknown). No concomitant therapies were reported. Patient vaccinated with series of GARDASIL with different provider's office and patient had unprotected sex. On an unspecified date the patient experienced some pain and vaginal dryness. Patient was seen in office for medical attention to the events and an unspecified laboratory work was performed which showed that she was positive for unspecified human papilloma virus (HPV) Type. Action taken was reported as not applicable. The outcome of vaginal dryness, positive for unspecified HPV type and pain was unknown. The reporter did not provide the causality of vaginal dryness, positive for unspecified HPV type and pain to GARDASIL. No other information was available. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patients were vaccinated with ROTATEQ (lot#, dose not reported, default route: oral) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. Follow up information was received from the nurse on 03-SEP-2014, reporting the lot number of the ROTATEQ that underwent a temperature excursion. Lot number K001450 expiration date 18-NOV-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.22
Sex: F
Vaccine: MMR
Symptoms: Ear infection, Pyrexia, Rash morbilliform
Clinical narrative: This spontaneous report as received from a registered nurse refers to her currently 36 year old daughter with none medical history and none drug reactions/allergies. The nurse reported that in approximately February 1999, when her daughter (the patient) was 15 months old, she was a dose of vaccinated with M-M-R II (dose/frequency, route and lot number not provided) (therapy type: HSA). No concomitant medication had reported. And an unspecified amount of time later, the patient experienced a measles like rash, ear infection and high fever. The patient visited physician's office for seeking medical attention. No lab diagnostics studies were performed. The patient was treated with unspecified antibiotic. The outcome of measles like rash, ear infection and high fever was recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse who refers to a patient of unknown age and gender. Patient's medical history was not reported. On 15-SEP-2014 also reported as "today", the patient was vaccinated with a expired dose of PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported) (lot # J011651, exp date: 22-AUG-2014). Concomitant medication was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 lot # J004080, expiry date: 22-AUG-2014, intramuscular. No concomitant medication reported. On 26-SEP-2014, the patient was inadvertently administered a dose of PNEUMOVAX 23 which expired on 22-AUG-2014. No adverse effects reported. The outcome of she inadvertently administered a dose of PNEUMOVAX 23 which expired on 22-AUG-2014 and no adverse effects reported is unknown. There was no product quality complain involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 26-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection 25/0.5 Y, lot # K005957; expiry: 08-MAR-2015 in the right arm, subcutaneously (dose unspecified). Other suspect therapies included unspecified influenza virus vaccine (manufacturer unknown) in her left arm (dosing regimen unspecified). Concomitant therapies included oxycodone, AMBIEN, LIDODERM, CELEBREX, clobetasol propionate, dicyclomine hydrochloride, diltiazem hydrochloride, LOMOTIL, CYMBALTA, NEXIUM, estradiol, folic acid, lisinopril (manufacturer unknown), ATIVAN, SKELAXIN, metformin, RESTASIS, SILVADENE, tizanidine hydrochloride and VALTREX. On 26-SEP-2014, the patient returned to pharmacy and contacted pharmacist with redness at injection site and itching at injection site. Treatment given was BENADRYL. No laboratory tests done. The outcome of redness at injection site and itching at injection site was reported as not recovered/not resolved. Causality was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received form a physician and a licensed practical nurse (LPN) regarding a 4 year old (also reported as age 5, units not provided) female patient (child). On 07-APR-2014 at 4:00 pm, the patient might have been immunized with a dose of PROQUAD lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with VARIVAX (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding an 18 year old male patient. On 01-JUL-2014 at 1:30 PM, the patient might have been immunized with a dose of VARIVAX (Merck) lot number J009165, expiration date 24-JUL-2015, in the right upper arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 1.69
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 20 month old (also reported as age 2, units not provided) female patient (child). On 06-JUN-2014 at 11:57 am, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 6 year old male patient (child). On 25-JUL-2014 at 12:43 PM, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2014, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 5 year old female patient (child). On 26-FEB-2014 at 09:05 am, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Age: 1.54
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka-Merck) PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 18 month old (also reported as age 2, units not provided) female patient (child). On 10-JAN-2014 at 4:24 pm, the patient might have been immunized with a dose of (Oka-Merck) PROQUAD lot number J005179, expiration date 03-NOV-2014, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown demographics. On 25-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J007059; expiry: 31-JUL-2014 (dose regimen unspecified). On 25-SEP-2014, the patient received an expired dose of PNEUMOVAX 23. No adverse effect has been reported. The outcome of received an expired dose and no adverse effects reported is unknown. There was no product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of PNEUMOVAX 23 injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 13 month old (also reported as age 1, units not provided) female patient (child). On 14-APR-2014 at 3:18 pm, the patient might have been immunized with a dose of PROQUAD (Merck) lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of GARDASIL injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Skin warm
Clinical narrative: Extreme itching, flushed, ears were warm.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site reaction, Rash, Urticaria
Clinical narrative: Rash and welps developed all over left arm from shoulder to wrist.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm, Swelling
Clinical narrative: Red rash 4 inches x 3 inches. Raised a little, little warm to the touch. No soreness.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Dyspnoea, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Patient was anxious immediately after injection. She began sweating, feeling dizzy, anxious and lightheaded after about 10-15 minutes. About 15 min after inj. patient became SOB. Emergency personnel arrived and administered EPIPEN x 2.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: Patient said her arm was sore immediately after getting vaccine. Came back to pharmacy the next morning with a big bruise on arm. Said her arm was very sore the night after getting vaccine and still sore the next day. Counseled her to visit her doctor because she said the soreness was also in her neck, but she didn't feel that it was severe enough to go to doctor.
Age: 1.3
Sex: F
Vaccine: FLU3, HEPA, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Shots administered in A.M. 10/8/14. Child presented at clinic at 5PM with rash/fever. Mom gave TYLENOL at home.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Hallucination
Clinical narrative: Patient experienced hallucinations. Husband reports patient has been acting strangely since receiving vaccine. Husband came back one month approximately after vaccine administration to tell us this about wife.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Pain
Clinical narrative: Patient experienced redness that went down arm and "spread" like an infection. With soreness. Patient went to doctor because thought it might be an infection.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Fall
Clinical narrative: Patient fell down and had to go to ER.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Flu vaccine administered in left deltoid. Swelling around site about 100 mm with redness surrounding about 130 mm by evening. Sought opinion of PHN 10/6/14. Suggested icing swelling. Today definitely improving. No c/o of pain just itching.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt received flu shot on 9-22-14 - presented back to pharmacy on first of Oct. Stating arm was still in a lot of pain and unable to raise his arm. He was advised to see MD. He went, got a pain medicine, and is currently undergoing physical therapy twice weekly.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: Pt reported itching at injection site immediately following injection. Pt was given 50mg BENADRYL to be safe. Pt reported no further itching that day or next day.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Sore, swelling and redness - recv'd injection 10-7-14 approx 8 AM - on 10-8-14 showed to administrating RN - swelling up to 3 1/4 inches in diameter still red and tender to touch.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Pt has large red hot lump on (L) thigh where vaccine was given.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Morning after PNEUMOVAX and FLUZONE, pt says can't raise left arm and is extremely sore. PNEUMOVAX was given in this arm. The arm wasn't red or swollen, just extremely sore.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Throat tightness
Clinical narrative: Patient rec'd flu vaccine. Instructed to wait in waiting area to continue assessment of any adv. rxn. Asked if feeling okay to which she replied, "Yes, I'm fine" 5 minutes she returned w/ c/o tightness in throat sweating and feeling weak. V/S taken BP 110/72, HR = 55 O2 sat = 98%, resp even and unlabored with no signs of resp distress. Offered and accepted BENADRYL 50 mg liquid.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site warmth, Lip swelling
Clinical narrative: Had flu vaccine on 10-7. States upper lip started swelling about 8:00 pm-9:00 pm last night. No rash. LUA warm to touch. C/O slight headache. Took ASA. Had flu vaccine last 2 yrs. no reaction.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lip swelling, Oropharyngeal pain, Paraesthesia
Clinical narrative: Flu shot received on 10/7/14 about 1600 - at 10 pm I had chills - and sore throat -this am (about 0700) my (Rt) side of my face became tingly and swelling of the (Rt) side of my lips.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Uncontrollable shaking x approximately 30 seconds. Color good, A and O, no resp difficulty, VS stable D/Ced home from ER.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 10-8-14 noted redness on (L) upper arm as well as warmth 2 days after having Flu shot. Also notes itching to area. Not sure if it is related to Flu vaccine or not.
Age: 13.0
Sex: U
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Severe muscle soreness day of injection. Patient took MOTRIN to alleviate pain.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Gout
Clinical narrative: Patient has on history of gout. He informed immunizer that his toe was of concern. He came in 10/8/14 stating he required an ER visit due to gout flare evening after vaccinated.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Tenderness
Clinical narrative: Swelling to (R) side of neck with tenderness at and just above collar bone.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt came to pharmacy and asked me to look at his left arm. There was redness, pain and warm to touch. I told him to start ice on the area and take TYLENOL for pain. Also told him to see his Md. His MD gave him cefaclor 500 mg and Md told pt if not better he may have to go to the hospital.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hyperhidrosis, Pain in jaw
Clinical narrative: Diaphoresis and severe jaw pain - mostly in joints pt had been on prednisone 80 mg QD for 5 days by other provider for work related injury. Not disclosed until today when collecting info for report.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Bandaemia, Blood test abnormal, Blood urine present, Chest X-ray, Chills
Clinical narrative: At midnight (Sun into Mon.), patient said she had vomiting and diarrhea. She then started having nerve pain from her butt down her legs, starting on her left side then down both sides of her body. Severe left arm pain at site of injection and left bicep. Very warm to the touch. At 6 a.m. she was brought to the ER, given morphine and TORADOL and discharged 3 hours later. She had chills throughout Mon. after and is still tired and has (L) arm pain.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Electrocardiogram, Fatigue, Injection site pain, Injection site warmth
Clinical narrative: At midnight (Sun into Mon.), patient said she had vomiting and diarrhea. She then started having nerve pain from her butt down her legs, starting on her left side then down both sides of her body. Severe left arm pain at site of injection and left bicep. Very warm to the touch. At 6 a.m. she was brought to the ER, given morphine and TORADOL and discharged 3 hours later. She had chills throughout Mon. after and is still tired and has (L) arm pain.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Neuralgia, Pain in extremity, Urine analysis abnormal, Vomiting
Clinical narrative: At midnight (Sun into Mon.), patient said she had vomiting and diarrhea. She then started having nerve pain from her butt down her legs, starting on her left side then down both sides of her body. Severe left arm pain at site of injection and left bicep. Very warm to the touch. At 6 a.m. she was brought to the ER, given morphine and TORADOL and discharged 3 hours later. She had chills throughout Mon. after and is still tired and has (L) arm pain.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint movement impairment, Injection site pain, X-ray limb
Clinical narrative: Pain during administration of vaccine. No tingling or radiation down arm. Pain in shoulder joint of left arm and increased since time of vaccination. Range of motion decreased. Saw ortho MD 9/30/14 - had cortisone injection into shoulder area. To be seen again in 6 weeks, sooner if no improvement.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, hives, itching.
Age: 34.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Erythema, Skin discolouration, Skin warm, Swelling
Clinical narrative: Given Tdap (ADACEL) on 9-30-14 at 11:20 am. Swelling dark pink to red skin color change. Warm to touch.