chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Injection site urticaria
Clinical narrative: Patient developed small urticarial lesions proximal to injection site up towards neck.  No respiratory symptoms or other signs of an allergic reaction.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Injection site urticaria, Lip disorder, Mouth swelling, Urticaria
Clinical narrative: Patient developed small urticarial lesions proximal to injection site up towards neck.  No respiratory symptoms or other signs of an allergic reaction.
Age: 3.0
Sex: M
Vaccine: DTAP, FLUN4, HEPA, HIBV, PNC13
Symptoms: Flushing, Rash papular
Clinical narrative: Within 5 minutes of receiving vaccinations, he developed small erythematous papules (~0.5cm) mostly on the left side of his face, neck, and a few scattered papules on his back. He also developed facial flushing. No tongue or lip swelling. No difficulty breathing. Gave Benadryl 12.5mg PO. Pulse ox was placed, and his O2 sats remained within normal limits without desaturations. His vital signs were monitored over the course of one hour and remained within normal limits. After one hour of observation, his cheeks were less flushed. He had stopped developing new papules and was otherwise well-appearing w/o respiratory or GI distress. No other systemic symptoms.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Cough, Lymphadenopathy, Measles, Pyrexia, Rash
Clinical narrative: Fever, mild congestion, intermittent cough, Rash that began today 5/29/2015 that started at the nape of the neck and
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash macular, Respiratory tract congestion, Skin lesion
Clinical narrative: Fever, mild congestion, intermittent cough, Rash that began today 5/29/2015 that started at the nape of the neck and
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever, headache, chills, redness, soreness and swelling at injection site.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, headache, chills, redness, soreness and swelling at injection site.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea, Seasonal allergy
Clinical narrative: The patient reports runny nose, sinus drainage (typical seasonal rhinitis symptoms). She took Claritin to help with the symptoms and the Claritin worked well to treat these symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male patient of unknown age. Concurrent conditions, medical history and allergies were not reported. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The reporter indicated that on an unknown date in 2014, 3 to 4 days after the vaccination with ZOSTAVAX, the patient experienced a very bad case of shingles and had to be hospitalized on an unknown date in 2014. It was unspecified if treatment was given for the adverse event and if lab diagnostics studies were performed. The outcome of herpes zoster was unknown. The relatedness between herpes zoster and therapy with ZOSTAVAX was not reported. The reporter considered that the bad case of shingles was a medically significant event. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 40 year old male patient. The patient's concurrent conditions and medical history were not reported. On 05-MAY-2015, the patient was vaccinated with a first dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not reported). On an unspecified date in May 2015, the patient developed a nodular disseminated rash. The patient sought medical attention - he visited the physician on an unspecified date. The physician stated, that the rash was not vesicular in appearance and prescribed an unspecified antiviral medication (manufacturer unknown) to treat the rash. The outcome of rash was reported as not recovered/not resolved. The relatedness between the event and VARIAVAX (Merck) was not provided. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a Registered nurse refers to an approximately 31 year old female patient. Concurrent condition and medical history were not reported. No drug allergies was reported. On an unknown date, when the patient was a child she received first dose of M-M-R II. On 13-MAY-2015, a blood titer was drawn and found to be negative for measles antibodies. Patient went to see a nurse and sought medical attention. Thus on 15-MAY-2015, the patient decided to receive another dose of M-M-R II (lot # J003625 with the expiration date of 22-MAR-2015) subcutaneously (dose was not reported). No concomitant medication was reported. The patient's present status was unspecified. The reporter causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a two patients of unkown demographics. The information on patients' concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, these two patients received doses of improperly stored VARIVAX (Merck) (route of administratio, dose and lot # not reported). No adverse effect reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Disorientation, Head banging, Injection site mass, Injection site nodule, Memory impairment
Clinical narrative: 5/12/15 (received vaccine)-lump/knot at injection site, 5/13/15-headache, mental disorientation/trouble remembering things 5/17/2015-small, red, itchy rash appears-quickly spreads to cover whole upper left arm. Very painful when touched 5/19/15-evaluated at PCP office, using triamcinolone cream per patient, rash, itchiness has resolved.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: 5/12/15 (received vaccine)-lump/knot at injection site, 5/13/15-headache, mental disorientation/trouble remembering things 5/17/2015-small, red, itchy rash appears-quickly spreads to cover whole upper left arm. Very painful when touched 5/19/15-evaluated at PCP office, using triamcinolone cream per patient, rash, itchiness has resolved.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Acute kidney injury, Dehydration, Fatigue, Full blood count, Metabolic function test
Clinical narrative: Severe arm pain, fever, fatigue, leading to dehydration, acute renal failure.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Severe arm pain, fever, fatigue, leading to dehydration, acute renal failure.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to two patients of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. On 07-APR-2015 the patients were vaccinated subcutaneously with (Merck) PROQUAD (dose, lot# and expiration date were not reported) which underwent a supported temperature excursion. No adverse effects were reported. No PQC (product quality complaint) was involved. Telephone call attempt on 11-MAY-2015 to obtain follow-up information was unsuccessful. Follow up information has been received from the registered nurse on 21-MAY-2015, referring to one of the two patients, a 5 years old male patient with none drug allergy. On 06-APR-2015 3:45 PM the patient was vaccinated with the first dose of (Merck) PROQUAD (lot# K025765, intramuscular) which has been in shipment for 4 days. The vaccine was found to be viable per company representative. At the same time (on 06-APR-2015 3:45 PM) the patient was vaccinated with the first dose of (Vero) KINRIX (lot# TZ434, intramuscular). None lab diagnostic was reported. No treatment and follow up was necessary. This is one of several reports from the same reporter. Additional information is not expected. Reporter information, patient information, product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with the doses of improperly stored GARDASIL (doses, routes, lot numbers and expiration dates not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report a received from a certified medical assistant refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with the doses of the improperly stored PNEUMOVAX23 (doses, routes, lot numbers and expiration dates were not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to a currently 17 years old non-pregnant female patient. The patient had none pertinent medical history, none concomitant medications and none drug reactions or allergies. On 20-AUG-2012, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly (lot # H010649, expiration date 20-FEB-2015). On an unknown dates, after the administration of the first dose of GARDASIL, the patient experienced joint aches, backaches, dizziness, weakness, trouble walking, weak and tingly all over, felt limp, fatigued, "affected her ability to cope with things", "felt like everything in her body shut down", hips ache all the time and headaches. All of these events occurred intermittently except that her hips ache all the time. No treatment was given. On 23-AUG-2013, the patient was vaccinated with the second dose of GARDASIL, 0.5 ml, intramuscularly (lot # J006236, expiration date 25-FEB-2016). On 19-AUG-2014, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml, intramuscularly (lot # K001631, expiration date 06-NOV-2016). The patient sought medical attention and she visited the office of physician on 28-APR-2015. It was unspecified which adverse events the patient sought medical attention for on that date. The outcome of the adverse events was not reported. The relatedness between the adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, General physical health deterioration, Headache, Hypotonia, Paraesthesia
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to a currently 17 years old non-pregnant female patient. The patient had none pertinent medical history, none concomitant medications and none drug reactions or allergies. On 20-AUG-2012, the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly (lot # H010649, expiration date 20-FEB-2015). On an unknown dates, after the administration of the first dose of GARDASIL, the patient experienced joint aches, backaches, dizziness, weakness, trouble walking, weak and tingly all over, felt limp, fatigued, "affected her ability to cope with things", "felt like everything in her body shut down", hips ache all the time and headaches. All of these events occurred intermittently except that her hips ache all the time. No treatment was given. On 23-AUG-2013, the patient was vaccinated with the second dose of GARDASIL, 0.5 ml, intramuscularly (lot # J006236, expiration date 25-FEB-2016). On 19-AUG-2014, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml, intramuscularly (lot # K001631, expiration date 06-NOV-2016). The patient sought medical attention and she visited the office of physician on 28-APR-2015. It was unspecified which adverse events the patient sought medical attention for on that date. The outcome of the adverse events was not reported. The relatedness between the adverse events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report a received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-MAY-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose and route of administration were not reported, lot # H020255, expiration date 08-NOV-2014). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with the doses of improperly stored oral, ROTATEQ (doses, routes, lot numbers and expiration dates were not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 17 years old patient of an unknown gender. The patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of VAQTA (lot # K007791, expiration date 22-AUG-2016, dose, frequency and route of administration were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect was observed or reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Night sweats, Pruritus, Urticaria
Clinical narrative: Urticaria, pruritus and injection site pain, night sweats. Cephalexin.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and fender. On 12-MAY-2014, the patient received the first dose of GARDASIL (0.5ml, once, intramuscular, lot # and expiration date were unknown) and then received the second dose of GARDASIL 9 (lot # K026246, expiration date:28-JAN-2017, intramuscular, 0.5ml, once) on 20-MAY-2015. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 4 year old patient of unknown gender. On 28-MAY_2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported) instead of second dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 11 years old patient of an unknown gender. The patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of VAQTA (lot # K007791, expiration date 22-AUG-2016, dose, frequency and route of administration were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect was observed or reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 17 years old patient of an unknown gender. The patient's medical history and concurrent conditions were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of GARDASIL (lot# K007828, expiration date 02-MAR-2017, dose, frequency and route of administration were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect was observed or reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to an around 55 year old female patient. On an unknown dates, about 5 or 6 months before, the patient was vaccinated with two doses of ZOSTAVAX which was other than indicated in the Prescribing Information. It was not confirmed whether both shots were given on the same unspecified date or on different dates. The patient sought medical attention: visited an office. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: HPV4
Symptoms: Wernicke-Korsakoff syndrome
Clinical narrative: This spontaneous report has been received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, injection, (dose, route of administration, lot #, expiration date were not reported and dose in series was unknown). Concomitant medications were not reported. The mother of the patient stated that on an unknown date (reported as "within the last couple of months"), her child developed Wernicke-Korsakoff syndrome post vaccination with GARDASIL. The child was vaccinated by another health care provider and was treated for the adverse event (AE) with vitamin B12 injections. The physician did not have any more information. The outcome of the adverse event was reported as recovered. The relatedness between the adverse event and GARDASIL was not reported. Additional information is not expected, because the physician did not want to be contacted.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and warmth of medial aspect of left upper arm.
Age: 71.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Subjective fever and fatigue on 5/24 and 5/25. Erythema and pruritus at injection site starting 05/27/15. Advised to put cool compress to area and notify PCP.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: PREVNAR 13 was given IM on 5/19/15 to left deltoid. No complaints or distress noted. On 5/25/15 a warm red area was noted to left deltoid. Resident admitted to scratching area.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 06-MAY-2014 and on 03-JUN-2014, the patient was vaccinated with first and second doses of GARDASIL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On 18-MAY-2015, the patient was in the office for third dose of GARDASIL (inappropriate schedule of drug administration). No adverse symptoms were reported. The outcome of the event was unknown. The causality of the event with GARDSIL was not reported. Product quality issue was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of female patients of unknown age and gender. This is part of a Market Research. On unknown dates, the patients were vaccinated with GARDASIL (route, dosage schedule, lot # and expiration date were not provided). On unknown dates, several women faint or pass out in the minutes after receiving GARDASIL. At the time of report, the outcome of syncope and dizziness was reported as recovered as they all were fine. The physician also added that he had never seen this with boys receiving GARDASIL. The reporter considered the events to be related to the suspect therapy. Additional information is not expected as the reporter refused additional contact.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring a 64 year old female patient. The patient's medical history included diabetes mellitus and unspecified cholesterol problem. On 15-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot # K016320 Expiration Date: 24-DEC-2015) subcutaneously in left deltoid. The concomitant therapies included fish oil, aspirin (manufacturer unknown) 81 mg, metoprolol (manufacturer unknown), vitamin D3 and unspecified "diabetes and cholesterol" medications. On 15-MAY-2015, the patient reported she "felt fine". The following day, on 16-MAY-2015, the patient noticed that her injection site was red (injection site erythema), sore to the touch (injection site pain), and swollen in a 1 inch by 1 inch round area (injection site swelling). The patient also stated that her injection site was "black and blue" to indicate bruising (injection site bruising). At the time of this report, the patient stated she "felt fine' and that she did not see any evidence of a rash at her injection site. Additionally, it was stated that the patient did not receive any treatment for the adverse events. The outcome of injection site haemorrhage, injection site  pain, injection site erythema and injection site swelling was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring a 64 year old female patient. The patient's medical history included diabetes mellitus and unspecified cholesterol problem. On 15-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot # K016320 Expiration Date: 24-DEC-2015) subcutaneously in left deltoid. The concomitant therapies included fish oil, aspirin (manufacturer unknown) 81 mg, metoprolol (manufacturer unknown), vitamin D3 and unspecified "diabetes and cholesterol" medications. On 15-MAY-2015, the patient reported she "felt fine". The following day, on 16-MAY-2015, the patient noticed that her injection site was red (injection site erythema), sore to the touch (injection site pain), and swollen in a 1 inch by 1 inch round area (injection site swelling). The patient also stated that her injection site was "black and blue" to indicate bruising (injection site bruising). At the time of this report, the patient stated she "felt fine' and that she did not see any evidence of a rash at her injection site. Additionally, it was stated that the patient did not receive any treatment for the adverse events. The outcome of injection site haemorrhage, injection site  pain, injection site erythema and injection site swelling was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a currently 63 years old female pharmacist reporting on herself. Medical history included a corneal transplant. The patient's concurrent conditions and drug reactions or allergies were not reported. In December 2013, the patient was vaccinated with ZOSTAVAX, dose, route, anatomical location and lot number were not reported). There were no concomitant medications. On an unknown date, the patient experienced shingles, she had "100 dots" on an unspecified side of her body also, the patient experienced pain which was not bad but the itching on an unspecified side of her body was bad. The patient used an unspecified ointment which did not help with the itchiness and VALTREX and IVY DRY as treatment. No lab diagnostics studies were reported. The patient sought medical attention by visited the pharmacist. At the time of the report, the outcome of shingles, pain and itching ZOSTAVAX was not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-MAY-2015, the patient was vaccinated with a dose of M-M-R II lot # J003787, that had expired on 28-MAR-2015. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Myalgia, body aches, sore throat, fatigue, and generalized itching on 5/12/15. Reported at office visit on 5/13/15. Also at visit on 5/13/15 noted by dr that pt "feels better today." he does c/o nasal congestion, but sire throat and muscle aches, head aches are better. Advised by dr to mother via phone consultation 5/15/15 to monitor him over the week and mother agreed to see if further evaluation was needed.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain, Pruritus generalised
Clinical narrative: Myalgia, body aches, sore throat, fatigue, and generalized itching on 5/12/15. Reported at office visit on 5/13/15. Also at visit on 5/13/15 noted by dr that pt "feels better today." he does c/o nasal congestion, but sire throat and muscle aches, head aches are better. Advised by dr to mother via phone consultation 5/15/15 to monitor him over the week and mother agreed to see if further evaluation was needed.
Age: 1.29
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash x 2 days.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Electroencephalogram, Eye movement disorder, Musculoskeletal stiffness, Tremor
Clinical narrative: This 6 month old female presents for Well child and shaking episode. Mother states that after the pt's last appointment on 3/24 when they took her home, the pt had an episode of shaking that concerned her for a seizure. Mother says later that night after the visit, the pt was crying a lot. Then, she ended up having an episode of shaking and was unresponsive. Mother did not noticed what she was doing with her eyes. Mother says the pt stopped crying during the episode. She was not cyanotic. Mother says the shaking lasted for longer than a minute, and they considered taking her to the ER, but it stopped. She did not respond to touch. Father says the pt's eyes rolled every once in a while and were not fixed during the episode. After the episode, the pt fell asleep and nursed throughout the night. She was not sweating during or after the episode. Mother says the pt seemed to be stiff during the episode, and her arms were fixed and shaking. Mother cannot recall if the patient was holding her breath beforehand and does not know if the pt had a fever or not. The pt has not had any episodes since then. Mother says she cannot recall many details of what happened as she was very distressed by the episode. Mother watched a video online that her friend sent her of a baby having a seizure and felt that the pt's episode was worse than the baby in the video.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Ultrasound abdomen, Unresponsive to stimuli
Clinical narrative: This 6 month old female presents for Well child and shaking episode. Mother states that after the pt's last appointment on 3/24 when they took her home, the pt had an episode of shaking that concerned her for a seizure. Mother says later that night after the visit, the pt was crying a lot. Then, she ended up having an episode of shaking and was unresponsive. Mother did not noticed what she was doing with her eyes. Mother says the pt stopped crying during the episode. She was not cyanotic. Mother says the shaking lasted for longer than a minute, and they considered taking her to the ER, but it stopped. She did not respond to touch. Father says the pt's eyes rolled every once in a while and were not fixed during the episode. After the episode, the pt fell asleep and nursed throughout the night. She was not sweating during or after the episode. Mother says the pt seemed to be stiff during the episode, and her arms were fixed and shaking. Mother cannot recall if the patient was holding her breath beforehand and does not know if the pt had a fever or not. The pt has not had any episodes since then. Mother says she cannot recall many details of what happened as she was very distressed by the episode. Mother watched a video online that her friend sent her of a baby having a seizure and felt that the pt's episode was worse than the baby in the video.
Age: 65.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Headache, Nausea, Oropharyngeal discomfort, Pyrexia
Clinical narrative: Per telephone client c/o reaction to PCV (rt ) arm. Fever, headache, nausea, a lot pain (rt) arm and discomfort throat/trachea area. Breathing without problems. Called from urgent clinic being seen now 5/29/15 at 1:10 p.m.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Musculoskeletal stiffness, Pallor, Presyncope
Clinical narrative: Patient became pale and stiffened after pt received VARIVAX and PPD. Placed on oxygen via face mask, albuterol neb x 1, Epinephrine 0.2 ml IM to lateral thigh administered. Pt was transferred to ED for further monitoring.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eye movement disorder, Muscle twitching, Pyrexia
Clinical narrative: Pt received 4mo shots on 5/28 at approximately 12pm. That evening she had a mild fever and rcved TYLENOL. Mom noticed some mild twitching while she was nursing. On 5/29 approximately 2pm, she had a T 101.8 (temp scanner) and when dad laid her down, her arms and legs twitched and eyes rolled back for a few seconds.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt complains of increasing swelling, redness, aching left upper arm 7 days after receiving Tdap injection. Erythema present, swelling and tenderness from bicep to (L) elbow. Pt given scripts for clindamycin 300mg QID x 10 days and prednisone 5 mg PO Qday x 5 days.
Age: 1.28
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Erythema, Irritability, Tenderness
Clinical narrative: Rec'd PCV-13 in office 05/27/15; Seen for s/s 5/29/15-> 3.5 cm erythema to (lt) thigh; No streaks; tender to touch; 100.6 temp 5/28/15; Cranky; Tx with PRN TYLENOL/ibuprogen; BENADRYL; Increased fluids r/t fever; Return to office> streaking, increase size; Fever> 5d.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a male consumer of unknown age referring to himself. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not reported). After vaccination the patient experienced shingles around his stomach. The patient sought medical attention on an unknown date. The outcome of shingles was unknown. Therapy with ZOSTAVAX was not discontinued. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-MAY-2015, the patient was inadvertently administered the first dose of oral, ROTATEQ (strength, dose, route and lot number or batch number unspecified) (inappropriate schedule of drug administration). No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. The outcome of the event was unknown. The reporter's causality for the event was unknown. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Injection site bruising, Injection site movement impairment, Injection site pain
Clinical narrative: Child is 15 months not able to walk as of bedtime. Her right leg is bruised under the markings of the shots. Also the child is not able to put pressure on right leg. She is avoiding to stand on right leg. She is in a lot of pain regarding her right leg predominently.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Pain in extremity, Peripheral swelling
Clinical narrative: PT CAME TO THE PHARMACY A FEW DAYS LATER AFTER ADMINISTRATION OF PREVNAR SHOT WITH SORE ARM AND SWOLLEN.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Dysuria, Penile pain, Scrotal pain
Clinical narrative: My balls started to hurt me so god damn bad and the tip of my dick was in pain I could not piss at all for the entire night thought I would have to go to the hospital but I kept drinking some milk by early morning the pain went away it was the worst god damn feeling I ever experienced in my life.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Engerix B instead of Boostrix.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported a red, swollen, itchy area that was warm to touch at the injection site. The area was approximately 4 inches in diameter.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Muscular weakness, Pallor, Vision blurred
Clinical narrative: Pt felt dizzy, weak legs and blurred vision. He lost all color in his face. Pt was sat down, given a cold compress and water he felt better by 4:50p.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient received vaccine on 5/22/15. 3 days later she noticed a chick-pox type lesion on her left eyelid. The next day she had a row of very painful shingles type lesions on her right calf.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Per chart, pt received the PNEUMOVAX injection Friday AM, 9/21. He reports that by 1400-1500 that same day, he had the following sx which lasted 3 days: Lightheaded and dizzy, severe H/A, Left arm very painful with limited ROM, injection site red and warm, chills/fever. Denies having throat swelling, difficulty breathing. No tx used, just tried to remain hydrated. Today, 9/24, pt states he can use his arm and all other sx have resolved except as below: Observed his left deltoid is red and warm. Diphenhydramine mg PRN, acetaminophen mg PRN.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Per chart, pt received the PNEUMOVAX injection Friday AM, 9/21. He reports that by 1400-1500 that same day, he had the following sx which lasted 3 days: Lightheaded and dizzy, severe H/A, Left arm very painful with limited ROM, injection site red and warm, chills/fever. Denies having throat swelling, difficulty breathing. No tx used, just tried to remain hydrated. Today, 9/24, pt states he can use his arm and all other sx have resolved except as below: Observed his left deltoid is red and warm. Diphenhydramine mg PRN, acetaminophen mg PRN.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient was rechecked by nurse after 15 minutes after administering the HPV vaccine about 5:48pm per notes. Nursing reported to me that she complained of dizziness and that she had given her water and graham crackers and had her lying down on the exam table.  When I went in to evaluate her she was lying on exam table supine and said she felt "lightheaded".  She denied any vision changes, denies nausea or vomiting or shortness of breath or any myalgias.  On examination she was verbally communicating to me and non-distressed. Examination was normal and nursing was asked to obtain vital signs which were also stable.  She was asked to rest in the exam room.  Nursing was asked to recheck her in another 15 minutes.  At that time about 6:32pm she denied any nausea, dizziness, or lightheadedness.
Age: 10.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: The part on the shoulder was swollen very bad, big hand palm size red spot and very hot. Patient had pain as well.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Fatigue, muscle aches, joint pain from 5/30 and still on 5/31.  Took Tylenol Arthritis pain med.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Diarrhoea, Dyskinesia
Clinical narrative: Excessive diarrhea. Sticking tongue out.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Groin pain, Musculoskeletal stiffness, Walking aid user
Clinical narrative: My groin area became very sore to the point that I had to use a walking cane and take pain medication to move around. My gait was affected by the stiffness and soreness in my groin area. This situation lasted for at least a week and subsided overtime.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Went from having a regular period every month to not getting my period at all anymore. Confirmed not pregnant by doctor. Still no period 2 months later. Will be returning to doctor for answers but know it is because of the shot that my period stopped.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis (2 Weeks), Swelling/Redness/Pain/Tenderness/Lumps Under Skin at Injection Site (7 Months), Fever (10 Days), Vomiting (1 Morning).  Treated with Keflex and Bactrim (7 Days).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Ultrasound scan abnormal, Vomiting, White blood cell count decreased
Clinical narrative: Cellulitis (2 Weeks), Swelling/Redness/Pain/Tenderness/Lumps Under Skin at Injection Site (7 Months), Fever (10 Days), Vomiting (1 Morning).  Treated with Keflex and Bactrim (7 Days).
Age: 3.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Crying, Emotional distress, Screaming
Clinical narrative: Child became extremely emotionally distressed.  Screaming, crying, and inconsolable.  This lasted for 20 minutes.  This has happened at least once daily in the past 4 days.  The child has never behaved in this way, to this extent.  This was exceptionally abnormal.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: Swelling, redness, itching, no problems with breathing, fever of 102F (reported 5/30/15 by daughter).
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Adverse reaction
Clinical narrative: She also had an adverse reaction on 1-23-2006 her first round (second time receiving the first dose). It states only change was vaccines.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Certified Medical Assistant (CMA) concerning a 64 year old patient of unknown gender. Relevant medical history and drug reactions were not provided. On 18-MAY-2015, instead of being administered with ZOSTAVAX vaccine, the patient was inadvertently administered with a dose of VARIVAX (Merck) dose (0.5 ml, subcutaneous, lot number: K003421, expire date: 06-MAR-2016). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with unspecified number of doses of GARDASIL (dose, strength, lot # and route were not reported). On 22-MAY-2015, the patient was in the office and received a dose of GARDASIL 9 (dose, strength, lot# and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Activated partial thromboplastin time normal, Areflexia, Bacterial test positive, Basophil count decreased, Blood culture negative
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Blood glucose increased, Blood uric acid increased, Bronchitis, C-reactive protein increased, Chest X-ray abnormal
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.