chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiry date were not provided). There were no concomitant therapies reported. The pharmacist stated that she administered the ZOSTAVAX to the patient on 07-JAN-2016, and upon injection of the vaccine, some of the dose leaked out of the syringe and dripped down the patient's arm. The reporter also confirmed that she was not exposed to the ZOSTAVAX. No adverse effects were reported. There was no product quality complaint involved. Follow up information has been received from a pharmacist on 29-FEB-2016. The patient's demographics were updated. The patient was a retired, 84 year old female. The pharmacist stated that on 07-JAN-2016 in the afternoon, the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX injection, lot# L034726. The vaccine leaked from the needle/syringe connection, and some of the leaked dose dripped on the patient's arm. The pharmacist wiped it off with alcohol. On 05-FEB-2016 in the afternoon, also reported as 4 weeks later, the patient's vaccination with ZOSTAVAX injection (lot# L034726, route of administration: subcutaneous) was repeated due to not receiving a full dose on 07-JAN-2016. Additional information is not expected as all the required correspondence has been received. Reporter details, patient details, products, events and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 18-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # K007826, that had expired on: 03-FEB-2016) (route and dose were not provided). Concomitant medication was not reported. No adverse effect was reported. It was also reported that there was not product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates starting on or after 29-JAN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the medical assistant, who came on the line to report adverse event details, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours. There was no previous temperature excursion reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from the patient's husband referring to his wife of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated, in a pharmacy, with a dose of ZOSTAVAX subcutaneous for (lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter, 48 hours following vaccination, the patient developed injection site pain, injection site swelling and injection site erythema. The outcome of this events was unknown at the time of this report. The reporter did not provide a causality assessment between the event and therapy with ZOSTAVAX. Additional information is not expected, since there is no contact information to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a sales representative, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated, in the physician's office, with a dose of ZOSTAVAX (Administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On an unknown date, the patient experienced an outbreak of shingles. The patient went to the reporter's pharmacy to ask about the event. The outcome of herpes zoster was unknown at the time of this report. The reporter did not provided a causality assessment between the event and therapy with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug intolerance
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) concerning some unspecified patients of unknown age and gender. Pertinent medical history and concurrent conditions were not provided. It was reported that some clients "did not tolerate" the vaccine GARDASIL 9 as well as others, (Lot #, dose and frequency not provided). Concomitant medications were not reported. The outcome of drug intolerance was unknown at the time of the report. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. In April 2013, the patient was vaccinated with a dose of GARDASIL (dose number, route and expiration date were not provided). Other suspect therapies included GARDASIL 9 with the first dose on 23-DEC-2015 (route, lot number and expiration date were not provided) and the second dose on 23-FEB-2016, lot number L014198, expiration date 05-SEP-2017 (route was not provided). Concomitant therapy information was not provided. On 23-DEC-2015, there was an interchange of vaccine products as when the patient received the second dose of GARDASIL 9 on 23-FEB-2016, she informed the nurse that she found a vaccination record of receiving one dose of GARDASIL back in April 2013. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 vial 25/0.5 microgram/milliliter (mcg/ml) 1 standard package vial of 2.5, lot details and dosage regimen unknown. After the dose was administered it was realized that the patient had previously received a dose of PNEUMOVAX 23 on 06-FEB-2016. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 23-FEB-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L019128, expiration date 27-MAY-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 8F, Time frame- 3 hours and was back in range. There was no previous temperature excursion before and yes call was because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 09-DEC-2015, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (lot # L004466, expiry date 02-AUG-2016, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 15 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 29-FEB-2016, the patient who previously received two doss of MMR II, was inadvertently administered a third dose of MMR II (route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On multiple unspecified dates that patients received doses of improperly stored ROTATEQ (lot#/expiration date, dose were unspecified) orally. The reporter stated that the thermometer temperature were out of correct storage range for an unknown time frame. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 6 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 22-FEB-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L019128, expiration date-27-MAY-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 8F, Time Frame- 3 hours and was back in range. There was no previous temperature excursion before and yes call was because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On multiple unspecified dates the patients received doses of improperly stored GARDASIL (lot#/expiration date, dose and route were unspecified). The reporter stated that the thermometer temperatures were out of correct storage range (low of 30.2 F and high of 50 F) for an unknown time frame. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.57
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 18 months old patient of unknown gender. There was no information about concurrent condition and historical medication. On 23-FEB-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L19128, expiration date 27-MAY-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 8F, Time frame- 3 hours and was back in range. There was no previous temperature excursion before and yes call was because of the data logger. No PQC (product quality complaint) was involved. This si one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) anterior thigh swelling, redness, pain. No treatment prescribed at this time. Symptoms started 2 days after immunization.
Age: 1.23
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Otitis media, Upper respiratory tract infection
Clinical narrative: 8 days following MMR patient required ER visit for febrile seizure patient had evidence of upper respiratory infection and otitis media on exam.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Pt reports getting persistent headaches approximately 5 days post receiving ZOSTAVAX shot. She is aware this is side effect, but still getting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: A few hours after getting ZOSTAVAX shot, pt reports a "hard lump" under skin where shot was given 3" x 2" w/a small bruise in center. 4 days later there is still a red hard "lump" about size of 50 cent piece, but getting better.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Injection site erythema, Injection site inflammation
Clinical narrative: (R) upper arm 6 x 10 cm inflammatory erythema at injection site. T - 100-101.8. Had chills.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after vaccine (L) upper arm red, swollen, tender and hot. Improving but still painful.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy test positive, Burning sensation, Pruritus, Urticaria
Clinical narrative: Severe generalized hives, itching, burning sensation, 48 degree after Tdap admin. Tx with PO steroids and injection.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Pruritus, Vaccination site rash
Clinical narrative: Client states developed "tennis ball size area of redness" at vaccine injection site approximately one week after received vaccine. Area also with a "bumpy rash" (no pustules, fluid filled lesions per client). Pruritic. Took oral BENADRYL, applied hydrocortisone cream. States area now much improved - light pink color.
Age: 0.11
Sex: F
Vaccine: HEP
Symptoms: Erythema, Induration
Clinical narrative: Mild erythema, some induration; cold compresses every 2 hours. 1 day after injection.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Palpitations, Urticaria
Clinical narrative: Patient stated she developed hives 3-4 hours following Hepatitis B vaccination. She states no hives on face but had every where else. "Heart was racing" but patient denies any difficulty breathing or swallowing. Patient states she took dicyclomine morning of vaccination )1st and only dose).
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Urticaria
Clinical narrative: 1 hour post vaccination, patient developed hives, seen on 2/29, still having hives, no other symptoms. Refer to Allergist.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Upper extremity mass
Clinical narrative: Pt noticed red lump that went around arm the day after vaccine. Swelling resolved and still feels twinges once in a while.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None - Adult dose (1mL) give to pediatric.
Age: 1.99
Sex: F
Vaccine: HEPA
Symptoms: Postictal state, Tonic convulsion
Clinical narrative: Tonic seizure, a few minutes after Hepatitis A vaccine given. Seizure lasted about 1 minute then postictal. Given oxygen, transported to medical center by paramedics.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient completed a three-dose series of RECOMBIVAX HB with the third dose administered in February 2003. No other information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 22-FEB-2016, the patient was inadvertently vaccinated with a fourth dose of RECOMBIVAX HB injection, lot # L023387, expiration date 22-FEB-2016 (strength, dose and route of administration were not provided) instead of intended dose of VAQTA. No adverse effect was reported. No product confusion was reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash macular, Urticaria
Clinical narrative: Child developed redness, raised blotches on face and (R) leg where 2 of the shots were given, no breathing issues, monitored for 30 minutes, hives went away and child went home with father.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: <12h after IZ lt upper arm increased itching erythema then by day-> edematous warm erythema. Day 3 improving with less erythema edema.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Hypotonia, Pallor
Clinical narrative: Child went pale and limp for 30 min. later in the day vaccines were given.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dermatitis allergic, Disorientation, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Awoke from sleep the night of vaccine administration, disoriented, rapid breathing, skin hypersensitivity, dizzy, nausea, vomiting. Next day, diaphoresis. Sx resolved by day 2-3.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Respiratory rate increased, Vomiting
Clinical narrative: Awoke from sleep the night of vaccine administration, disoriented, rapid breathing, skin hypersensitivity, dizzy, nausea, vomiting. Next day, diaphoresis. Sx resolved by day 2-3.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Localized reaction at injection site with blisters. Red swelling warm to touch. Pain relieved ibuprofen x 4 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Localized reaction at injection site with blisters. Red swelling warm to touch. Pain relieved ibuprofen x 4 days.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a Physician on 10 December 2015. This case involves a 13-year-old female patient who was vaccinated with a dose of HEPATITIS B VACCINE (batch number U5304AA, expiry date was not reported) intramuscularly in left deltoid on 03 November 2015. Illness at time of vaccination was reported as none at time of vaccination but had had a "virus" 2 weeks prior to vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies. Patient had no other vaccinations within 4 weeks of vaccinations. On 1 December 2015, 28 days following the vaccination patient experienced symptoms of ascending paralysis and later diagnosed as Guillain Barre Syndrome. Patient required emergency room (ER)/doctor visit. On an unspecified date, patient was hospitalized. Laboratory investigation corrective treatment was not reported. The outcome of event was not recovered. List of documents held by sender: none. Follow up information received from Physician on 17 February 2016. It was reported that, the patient was recovering from the events. No additional information provided. Sender's Comments: Follow up received on 17-FEB-2016, dose not changes the assessment. Guillain Barre Syndrome is unlisted with the INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible with the role of the vaccine. As patient had medical history of viral infection that could be a causative factor for the event. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Intussusception.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Seizure
Clinical narrative: After receiving the Menactra vaccine in clinic on 2/29/16 (2nd dose), patient left the clinic with her mother around 5PM.  Her mother stated that patient had a seizure in the car about 10 minutes after leaving the clinic, with patient's arm extended and patient out of it for no more than 30 seconds.  Mother drove back to the clinic and told MD about the seizure.  MD examined the patient who was doing fine after the seizure.  MD called the patient's home at 0810 the next morning and spoke with patient's father.  Father reported that there was no additional seizure or other adverse effects overnight.  Patient recovered.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Seizure
Clinical narrative: Patient had a brief seizure lasting < 30 seconds at about 20 minutes after MENACTRA vaccine administered. No additional seizures. No prior seizure.
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthenia, Cough, Feeding disorder, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. Patient's concurrent conditions included anxiety, high blood pressure and neuropathy. Patient had no drug reactions/allergies. On 20-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 via intramuscular or subcutaneous route. Concomitant medications included unspecified pain medications and high blood pressure medications. After vaccination with PNEUMOVAX 23, for the next four days (from approximately February 2016), the patient could not move and could not hold her head up, could not eat, had no strength to bath, brush her teeth 'or anything'. She stated she could only go to the bathroom. The patient also reported a sore arm where the injection was administered and coughing and nausea. The patient did not seek any medical attention. No laboratory tests were done. No treatment was provided for the symptoms. She started to feel better on 25-FEB-2016 and recovered from the events on 26-FEB-2016. Causality assessment was not provided. Upon internal review, the events of asthenia, movement disorder and feeding disorder were considered serious since they caused disability. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Posture abnormal
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. Patient's concurrent conditions included anxiety, high blood pressure and neuropathy. Patient had no drug reactions/allergies. On 20-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 via intramuscular or subcutaneous route. Concomitant medications included unspecified pain medications and high blood pressure medications. After vaccination with PNEUMOVAX 23, for the next four days (from approximately February 2016), the patient could not move and could not hold her head up, could not eat, had no strength to bath, brush her teeth 'or anything'. She stated she could only go to the bathroom. The patient also reported a sore arm where the injection was administered and coughing and nausea. The patient did not seek any medical attention. No laboratory tests were done. No treatment was provided for the symptoms. She started to feel better on 25-FEB-2016 and recovered from the events on 26-FEB-2016. Causality assessment was not provided. Upon internal review, the events of asthenia, movement disorder and feeding disorder were considered serious since they caused disability. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Client called and stated  left arm very red, swollen and warm to touch. Hurt to move arm. Upper part of her arm. Told client to take Tylenol/Advil every 4-6 hours for pain, cool compress. If worse, call her doctor. Client needed an MMR and told HD that she needed a Varicella instead. Client had Chickenpox as a child.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: C-reactive protein increased, Cerebellar ataxia, Computerised tomogram head normal
Clinical narrative: Acute cerebellar ataxia diagnosed in ER.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed localized swelling in her right upper arm along with redness, warmth and pain.  Pt taking Tylenol for pain along with resting arm. no further treatment needed as pt's arm is better at the time she called the clinic to report this on 3/1/16.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient reported an area of raised bumps and redness around her injection site. She said the area of raised bumps was about the size of the bottom of a drinking glass with a light pink area expanding beyond that that had no bumps (only the pink discoloration). Upon follow up on 3/2/16 she said her symptoms were improving. She experienced no pain or itching and did not seek any treatment.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report was received from a female patient of an unknown age reporting on herself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, lot#, expiration date and route of administration were not reported). Other suspect therapies included an unspecified "flu shot" (formulation, dose and route of administration were not reported). On an unknown date, after receiving PNEUMOVAX 23 and an unspecified "flu shot", the patient experienced headache and "her arm felt sore and tender". The patient did not reported if the vaccines were given at the same time or on different dates. The outcome of the events was not reported. The causality assessment between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain
Clinical narrative: Patient complained of "bump" at immunization site and pain.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Severe pain upon receiving the vaccination in my left arm. Pain never went away and after 2 weeks I woke up in worse pain and I was unable to lift my arm. It felt like it was paralyzed.  I went to the Employee Health Department where I work and received the vaccination.  They referred me to a Health Clinic. After being seen at the Clinic, I was referred for 7 physical therapy treatments, I was able to slightly move my arm, but still had continuous pain.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Paralysis
Clinical narrative: Severe pain upon receiving the vaccination in my left arm. Pain never went away and after 2 weeks I woke up in worse pain and I was unable to lift my arm. It felt like it was paralyzed.  I went to the Employee Health Department where I work and received the vaccination.  They referred me to a Health Clinic. After being seen at the Clinic, I was referred for 7 physical therapy treatments, I was able to slightly move my arm, but still had continuous pain.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site urticaria, Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 69-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 20Nov2015, at 0.5 ml single. The patient's medical history and concomitant medications were not reported. The patient could not lift arm first day (20Nov2015). Patient's arm was very painful on 20Nov2015 night. The patient was hospitalized the same night for 9 days. On 21Nov2015 a small nodule came at the injection site and redness around it (got worse after day 2, nodule and redness 1 week/ day 2-9), small wheal appeared under the nodule (got worse day 2-9). Arm was extremely painful for 2 days. Redness progressively got worse, nodule and wheal continued to get larger and got worse. On day 5 the patient was told to take BENADRYL and use warm compress. Small wheal under the nodule got worse (wheal 2 inches and redness 3 and a half inches gradually receded after 9 days). Her nurse practitioner asked her to take CLARITIN and to put one compress on it. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL compress, BENADRYL on day 5 and local cortisone cream. The events recovered. Follow-up (23Feb2016): New information received from a contactable consumer includes: events details, events added, treatment details, hospitalization.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Asthenia, Back pain, Blood test, Candida infection
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting on behalf of her husband. A 77-year-old male patient received PREVNAR 13 on 15Dec2015 at 4:30 PM in the left shoulder at 0.5 ml single. The patient's medical history was not reported. Concomitant medications included vitamin B intramuscularly in the right hip and other medications (patient was on a lot of medications). On 15Dec2015, the patient experienced pain which began almost right away and into the next day across his shoulders and down his back; the pain stopped after he quit throwing up. On an unknown date in Dec2015, two and a half days after the vaccine, the patient experienced vomiting. On an unknown date, the patient felt sick from it, like his body was trying to reject it, with urinating and bowel movements, dehydration, lost weight, weakness all the time, tiredness and nausea. In Jan2016 the patient experienced thrush in mouth and nose, chest pain on 16Dec2015, stomach pain on 16Dec2015, high blood pressure on an unknown date. The patient was 77-years-old at the time of the onset for his adverse reactions, and turned 78-years-old a few days later. The patient was treated for nausea, vomiting, thrush in mouth and nose, chest pain, stomach pain, high blood pressure. The patient was not hospitalized. The patient visited the emergency room for the events of vomiting and lost weight. He was currently 139 pounds, he weighed 148 pounds when he received the vaccine. He lost about 10 pounds. The patient underwent blood tests taken twice on unknown dates after vaccination. Pain resolved on an unknown date. Dehydration resolved with sequelae on an unknown date. Weakness was resolving. Vomiting, nausea, high blood pressure, thrush in mouth and nose, chest pain, stomach pain and tiredness had not yet been resolved. Mouth and nose remained raw and red. Vomiting stopped after at least a week, but the patient continued to have dry vomiting or regular vomiting every morning for another week. Outcome of the events of felt sick from it, like his body was trying to reject it, with urinating, bowel movements, and lost weight was unknown. Follow-up (17Feb2016): New information from the same contactable consumer includes: previously reported events details, additional events with relative details, treatment received, events outcomes.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Dehydration, Fatigue, Hypertension, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting on behalf of her husband. A 77-year-old male patient received PREVNAR 13 on 15Dec2015 at 4:30 PM in the left shoulder at 0.5 ml single. The patient's medical history was not reported. Concomitant medications included vitamin B intramuscularly in the right hip and other medications (patient was on a lot of medications). On 15Dec2015, the patient experienced pain which began almost right away and into the next day across his shoulders and down his back; the pain stopped after he quit throwing up. On an unknown date in Dec2015, two and a half days after the vaccine, the patient experienced vomiting. On an unknown date, the patient felt sick from it, like his body was trying to reject it, with urinating and bowel movements, dehydration, lost weight, weakness all the time, tiredness and nausea. In Jan2016 the patient experienced thrush in mouth and nose, chest pain on 16Dec2015, stomach pain on 16Dec2015, high blood pressure on an unknown date. The patient was 77-years-old at the time of the onset for his adverse reactions, and turned 78-years-old a few days later. The patient was treated for nausea, vomiting, thrush in mouth and nose, chest pain, stomach pain, high blood pressure. The patient was not hospitalized. The patient visited the emergency room for the events of vomiting and lost weight. He was currently 139 pounds, he weighed 148 pounds when he received the vaccine. He lost about 10 pounds. The patient underwent blood tests taken twice on unknown dates after vaccination. Pain resolved on an unknown date. Dehydration resolved with sequelae on an unknown date. Weakness was resolving. Vomiting, nausea, high blood pressure, thrush in mouth and nose, chest pain, stomach pain and tiredness had not yet been resolved. Mouth and nose remained raw and red. Vomiting stopped after at least a week, but the patient continued to have dry vomiting or regular vomiting every morning for another week. Outcome of the events of felt sick from it, like his body was trying to reject it, with urinating, bowel movements, and lost weight was unknown. Follow-up (17Feb2016): New information from the same contactable consumer includes: previously reported events details, additional events with relative details, treatment received, events outcomes.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Nasal mucosal disorder, Nausea, Oral candidiasis, Oral mucosal erythema
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting on behalf of her husband. A 77-year-old male patient received PREVNAR 13 on 15Dec2015 at 4:30 PM in the left shoulder at 0.5 ml single. The patient's medical history was not reported. Concomitant medications included vitamin B intramuscularly in the right hip and other medications (patient was on a lot of medications). On 15Dec2015, the patient experienced pain which began almost right away and into the next day across his shoulders and down his back; the pain stopped after he quit throwing up. On an unknown date in Dec2015, two and a half days after the vaccine, the patient experienced vomiting. On an unknown date, the patient felt sick from it, like his body was trying to reject it, with urinating and bowel movements, dehydration, lost weight, weakness all the time, tiredness and nausea. In Jan2016 the patient experienced thrush in mouth and nose, chest pain on 16Dec2015, stomach pain on 16Dec2015, high blood pressure on an unknown date. The patient was 77-years-old at the time of the onset for his adverse reactions, and turned 78-years-old a few days later. The patient was treated for nausea, vomiting, thrush in mouth and nose, chest pain, stomach pain, high blood pressure. The patient was not hospitalized. The patient visited the emergency room for the events of vomiting and lost weight. He was currently 139 pounds, he weighed 148 pounds when he received the vaccine. He lost about 10 pounds. The patient underwent blood tests taken twice on unknown dates after vaccination. Pain resolved on an unknown date. Dehydration resolved with sequelae on an unknown date. Weakness was resolving. Vomiting, nausea, high blood pressure, thrush in mouth and nose, chest pain, stomach pain and tiredness had not yet been resolved. Mouth and nose remained raw and red. Vomiting stopped after at least a week, but the patient continued to have dry vomiting or regular vomiting every morning for another week. Outcome of the events of felt sick from it, like his body was trying to reject it, with urinating, bowel movements, and lost weight was unknown. Follow-up (17Feb2016): New information from the same contactable consumer includes: previously reported events details, additional events with relative details, treatment received, events outcomes.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Retching, Stomatitis, Vomiting, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting on behalf of her husband. A 77-year-old male patient received PREVNAR 13 on 15Dec2015 at 4:30 PM in the left shoulder at 0.5 ml single. The patient's medical history was not reported. Concomitant medications included vitamin B intramuscularly in the right hip and other medications (patient was on a lot of medications). On 15Dec2015, the patient experienced pain which began almost right away and into the next day across his shoulders and down his back; the pain stopped after he quit throwing up. On an unknown date in Dec2015, two and a half days after the vaccine, the patient experienced vomiting. On an unknown date, the patient felt sick from it, like his body was trying to reject it, with urinating and bowel movements, dehydration, lost weight, weakness all the time, tiredness and nausea. In Jan2016 the patient experienced thrush in mouth and nose, chest pain on 16Dec2015, stomach pain on 16Dec2015, high blood pressure on an unknown date. The patient was 77-years-old at the time of the onset for his adverse reactions, and turned 78-years-old a few days later. The patient was treated for nausea, vomiting, thrush in mouth and nose, chest pain, stomach pain, high blood pressure. The patient was not hospitalized. The patient visited the emergency room for the events of vomiting and lost weight. He was currently 139 pounds, he weighed 148 pounds when he received the vaccine. He lost about 10 pounds. The patient underwent blood tests taken twice on unknown dates after vaccination. Pain resolved on an unknown date. Dehydration resolved with sequelae on an unknown date. Weakness was resolving. Vomiting, nausea, high blood pressure, thrush in mouth and nose, chest pain, stomach pain and tiredness had not yet been resolved. Mouth and nose remained raw and red. Vomiting stopped after at least a week, but the patient continued to have dry vomiting or regular vomiting every morning for another week. Outcome of the events of felt sick from it, like his body was trying to reject it, with urinating, bowel movements, and lost weight was unknown. Follow-up (17Feb2016): New information from the same contactable consumer includes: previously reported events details, additional events with relative details, treatment received, events outcomes.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Acoustic stimulation tests abnormal, Deafness
Clinical narrative: This is a spontaneous report from a contactable nurse reported for herself. This 79-year-old female patient received PREVNAR 13, intramuscular at single dose on 20Jan2016. The patient medical history was not reported. Concomitant medication included metformin and HYDRODIURIL. On 27Jan2016, the patient woke up completely deaf/totally deaf. Nurse mentioned that she had a hearing test under the other doctor and added that it was 30 something, she did not know and then she went back, it was 80 and 70. Therapeutic measures were taken as a result of deaf/totally deaf included prednisone taper. The outcome of the event was recovered.
Sex: U
Vaccine: PNC13
Symptoms: Abdominal pain upper, Asthenia, Candida infection, Chest pain, Fatigue
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 17Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer on behalf of the patient. This contactable consumer reported similar events for three different patients. This is the second of three reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 on 15Dec2015, at 0.5 ml single, in left shoulder. The patient medical history was not reported. Concomitant medication included vitamin b complex injection. The patient experienced thrush in mouth and nose in Jan2016 with outcome of not recovered (mouth and nose remain raw and red), chest pains on 16Dec2015 with outcome of not recovered, stomach pain on 16Dec2015 with outcome of not recovered, vomiting in Jan2016 with outcome of not recovered, was weak all the time and tired on an unspecified date with outcome of unknown, high blood pressure on unspecified date with outcome of unknown, lost 10 pounds on an unspecified date with outcome of unknown, nausea on an unspecified date with outcome of unknown, did not feel well on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of chest pains, stomach pain, vomiting, thrush in mouth and nose, nausea. No admission to hospital was involved.
Sex: U
Vaccine: PNC13
Symptoms: Hypertension, Malaise, Nasal mucosal disorder, Nausea, Oral candidiasis
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 17Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer on behalf of the patient. This contactable consumer reported similar events for three different patients. This is the second of three reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 on 15Dec2015, at 0.5 ml single, in left shoulder. The patient medical history was not reported. Concomitant medication included vitamin b complex injection. The patient experienced thrush in mouth and nose in Jan2016 with outcome of not recovered (mouth and nose remain raw and red), chest pains on 16Dec2015 with outcome of not recovered, stomach pain on 16Dec2015 with outcome of not recovered, vomiting in Jan2016 with outcome of not recovered, was weak all the time and tired on an unspecified date with outcome of unknown, high blood pressure on unspecified date with outcome of unknown, lost 10 pounds on an unspecified date with outcome of unknown, nausea on an unspecified date with outcome of unknown, did not feel well on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of chest pains, stomach pain, vomiting, thrush in mouth and nose, nausea. No admission to hospital was involved.
Sex: U
Vaccine: PNC13
Symptoms: Oral mucosal erythema, Stomatitis, Vomiting, Weight decreased
Clinical narrative: The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 17Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer on behalf of the patient. This contactable consumer reported similar events for three different patients. This is the second of three reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 on 15Dec2015, at 0.5 ml single, in left shoulder. The patient medical history was not reported. Concomitant medication included vitamin b complex injection. The patient experienced thrush in mouth and nose in Jan2016 with outcome of not recovered (mouth and nose remain raw and red), chest pains on 16Dec2015 with outcome of not recovered, stomach pain on 16Dec2015 with outcome of not recovered, vomiting in Jan2016 with outcome of not recovered, was weak all the time and tired on an unspecified date with outcome of unknown, high blood pressure on unspecified date with outcome of unknown, lost 10 pounds on an unspecified date with outcome of unknown, nausea on an unspecified date with outcome of unknown, did not feel well on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of chest pains, stomach pain, vomiting, thrush in mouth and nose, nausea. No admission to hospital was involved.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Culture positive, Dyspnoea, Hyperhidrosis, Lung disorder, Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A 69-year-old female patient of an unspecified ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date in Apr2012 single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced sweating profusely, trouble breathing, lungs were full, pneumococcal pneumonia and lower lung damage. The patient was hospitalized. The patient reported: "I was sweating profusely, trouble breathing. Was hospitalized with antibiotics being pumped into me, but nothing was helping, lungs were totally full as well as chest cavity. Had to have surgery and they opened up my back to dig the mucus out and did culture and knew it was pneumococcal pneumonia, so gave me another type of antibiotic to help me. Was hospitalized for 2 weeks and doctor said if I would have waited 2 more days, this would be a whole different story I am telling." She also has lower lung damage due to the illness and was told to be very careful if she gets a cough or gets sick. The clinical outcomes of the events were unknown. The patient received PREVNAR 13 after the events on 08Dec2015. No follow up attempts possible. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Surgery
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A 69-year-old female patient of an unspecified ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date in Apr2012 single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced sweating profusely, trouble breathing, lungs were full, pneumococcal pneumonia and lower lung damage. The patient was hospitalized. The patient reported: "I was sweating profusely, trouble breathing. Was hospitalized with antibiotics being pumped into me, but nothing was helping, lungs were totally full as well as chest cavity. Had to have surgery and they opened up my back to dig the mucus out and did culture and knew it was pneumococcal pneumonia, so gave me another type of antibiotic to help me. Was hospitalized for 2 weeks and doctor said if I would have waited 2 more days, this would be a whole different story I am telling." She also has lower lung damage due to the illness and was told to be very careful if she gets a cough or gets sick. The clinical outcomes of the events were unknown. The patient received PREVNAR 13 after the events on 08Dec2015. No follow up attempts possible. No further information expected.