chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Peripheral swelling, Rash erythematous
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a male patient who received SHINGRIX. On 31st January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling arm, bruising of arm and erythematous rash. On an unknown date, the outcome of the swelling arm, bruising of arm and erythematous rash were unknown. It was unknown if the reporter considered the swelling arm, bruising of arm and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 4th February 2018, the reporter stated that, he received his SHINGRIX shot on Wednesday evening and he had some swelling and bruising on the arm that he had the shot and a red rash. The reporter wanted to know if that was normal. On 5th February 2018, an attempt was made to contact the patient, however he did not answer.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection was very painful when received on 2/3. Arm was sore at and around injection site for 48 hours. Redness and minimal swelling developed on 2/5. Redness and swelling from injection site (right deltoid) to wrist. As of 2/6, arm is still red and warm to the touch.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site mass, Pain, Peripheral swelling
Clinical narrative: Lump at injection site, pain 2/5/18 - swelling in arm 2/6/18, given in (L) arm.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt called that after receiving PNEUMOVAX 23 on Sunday later she had severe upper arm pain, swelling, red hot area, had difficulty lifting arm, now on antibiotics.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pruritus, Insomnia
Clinical narrative: Pt called that after receiving PNEUMOVAX 23 on Sunday later she had severe upper arm pain, swelling, red hot area, had difficulty lifting arm, now on antibiotics.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt called that after receiving PNEUMOVAX 23 on Sunday later she had severe upper arm pain, swelling, red hot area, had difficulty lifting arm, now on antibiotics.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: Pt called that after receiving PNEUMOVAX 23 on Sunday later she had severe upper arm pain, swelling, red hot area, had difficulty lifting arm, now on antibiotics.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Heart rate increased, Malaise, Peripheral coldness
Clinical narrative: Pt complaint she doesn't feel well, doesn't want to do anything. Headache, chills (cold feet), runny nose, increase heart rate. Fainting spell. She only went to ER on 10/27/17 due to intense headache. She was sent home to take TYLENOL EXT STR. She also had F/U with primary care and again on Feb 1 2018 due to increase heart rate and headache. Dr called 911 sent to ER. Sent home with med to prevent stroke.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Syncope
Clinical narrative: Pt complaint she doesn't feel well, doesn't want to do anything. Headache, chills (cold feet), runny nose, increase heart rate. Fainting spell. She only went to ER on 10/27/17 due to intense headache. She was sent home to take TYLENOL EXT STR. She also had F/U with primary care and again on Feb 1 2018 due to increase heart rate and headache. Dr called 911 sent to ER. Sent home with med to prevent stroke.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PPV, RV5
Symptoms: Asthenia, Blood calcium increased, Blood chloride increased, Blood glucose increased, Blood potassium abnormal
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter a female patient who was 4 month old at the time of vaccination. The patient's medical history included ear infection, lost some weight and 10 days unspecified antibiotic administration. On 29-DEC-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported). On the same day, the patient was vaccinated with other suspect vaccines included ROTATEQ, pneumococcal vaccine (manufacturer unknown), PEDIARIX (dose, route of administration, lot # and expiry date were not reported for all). The patient was not taking concomitant medications. On an unknown date (reported as "right after given the vaccin"), the patient experienced, polyuria, dehydration and feeding difficulties, weakness, fatigue, lethargy, sense of malaise, glossy eyes, fever for 5 days and seizures, described as staring spells and lip smacking. On an unknown date in February 2017 (reported as "2 months after patient received vaccines"), the patient 's blood work was done and showed elevated liver enzymes, elevated sedimentation count, fluid and electrolyte disturbance, polyuria, loss of sodium, hypotonia, abnormal potassium, high chloride, high, calcium, high glucose, decreased Blood Urea Nitrogen. The reporter mentioned that this had led to a misdiagnosis of adrenal insufficiency, (unable to clarify further). Unspecified treatment was given. On an unknown dates, the patient was hospitalized four times. The patient's present status was reported as not recovered. The nurse reported that the events resulted in significant disability or incapacity and were life threatening were reported. The causality assessment was not provided. Upon internal review the event of seizures was determined to be medically significant.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PPV, RV5
Symptoms: Blood sodium decreased, Blood urea decreased, Dehydration, Disability, Electrolyte imbalance
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter a female patient who was 4 month old at the time of vaccination. The patient's medical history included ear infection, lost some weight and 10 days unspecified antibiotic administration. On 29-DEC-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported). On the same day, the patient was vaccinated with other suspect vaccines included ROTATEQ, pneumococcal vaccine (manufacturer unknown), PEDIARIX (dose, route of administration, lot # and expiry date were not reported for all). The patient was not taking concomitant medications. On an unknown date (reported as "right after given the vaccin"), the patient experienced, polyuria, dehydration and feeding difficulties, weakness, fatigue, lethargy, sense of malaise, glossy eyes, fever for 5 days and seizures, described as staring spells and lip smacking. On an unknown date in February 2017 (reported as "2 months after patient received vaccines"), the patient 's blood work was done and showed elevated liver enzymes, elevated sedimentation count, fluid and electrolyte disturbance, polyuria, loss of sodium, hypotonia, abnormal potassium, high chloride, high, calcium, high glucose, decreased Blood Urea Nitrogen. The reporter mentioned that this had led to a misdiagnosis of adrenal insufficiency, (unable to clarify further). Unspecified treatment was given. On an unknown dates, the patient was hospitalized four times. The patient's present status was reported as not recovered. The nurse reported that the events resulted in significant disability or incapacity and were life threatening were reported. The causality assessment was not provided. Upon internal review the event of seizures was determined to be medically significant.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PPV, RV5
Symptoms: Fatigue, Feeding disorder, Glassy eyes, Hepatic enzyme increased, Hypotonia
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter a female patient who was 4 month old at the time of vaccination. The patient's medical history included ear infection, lost some weight and 10 days unspecified antibiotic administration. On 29-DEC-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported). On the same day, the patient was vaccinated with other suspect vaccines included ROTATEQ, pneumococcal vaccine (manufacturer unknown), PEDIARIX (dose, route of administration, lot # and expiry date were not reported for all). The patient was not taking concomitant medications. On an unknown date (reported as "right after given the vaccin"), the patient experienced, polyuria, dehydration and feeding difficulties, weakness, fatigue, lethargy, sense of malaise, glossy eyes, fever for 5 days and seizures, described as staring spells and lip smacking. On an unknown date in February 2017 (reported as "2 months after patient received vaccines"), the patient 's blood work was done and showed elevated liver enzymes, elevated sedimentation count, fluid and electrolyte disturbance, polyuria, loss of sodium, hypotonia, abnormal potassium, high chloride, high, calcium, high glucose, decreased Blood Urea Nitrogen. The reporter mentioned that this had led to a misdiagnosis of adrenal insufficiency, (unable to clarify further). Unspecified treatment was given. On an unknown dates, the patient was hospitalized four times. The patient's present status was reported as not recovered. The nurse reported that the events resulted in significant disability or incapacity and were life threatening were reported. The causality assessment was not provided. Upon internal review the event of seizures was determined to be medically significant.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PPV, RV5
Symptoms: Lethargy, Malaise, Polyuria, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter a female patient who was 4 month old at the time of vaccination. The patient's medical history included ear infection, lost some weight and 10 days unspecified antibiotic administration. On 29-DEC-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported). On the same day, the patient was vaccinated with other suspect vaccines included ROTATEQ, pneumococcal vaccine (manufacturer unknown), PEDIARIX (dose, route of administration, lot # and expiry date were not reported for all). The patient was not taking concomitant medications. On an unknown date (reported as "right after given the vaccin"), the patient experienced, polyuria, dehydration and feeding difficulties, weakness, fatigue, lethargy, sense of malaise, glossy eyes, fever for 5 days and seizures, described as staring spells and lip smacking. On an unknown date in February 2017 (reported as "2 months after patient received vaccines"), the patient 's blood work was done and showed elevated liver enzymes, elevated sedimentation count, fluid and electrolyte disturbance, polyuria, loss of sodium, hypotonia, abnormal potassium, high chloride, high, calcium, high glucose, decreased Blood Urea Nitrogen. The reporter mentioned that this had led to a misdiagnosis of adrenal insufficiency, (unable to clarify further). Unspecified treatment was given. On an unknown dates, the patient was hospitalized four times. The patient's present status was reported as not recovered. The nurse reported that the events resulted in significant disability or incapacity and were life threatening were reported. The causality assessment was not provided. Upon internal review the event of seizures was determined to be medically significant.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HPV9, PPV, RV5
Symptoms: Seizure, Staring, Tardive dyskinesia, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter a female patient who was 4 month old at the time of vaccination. The patient's medical history included ear infection, lost some weight and 10 days unspecified antibiotic administration. On 29-DEC-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported). On the same day, the patient was vaccinated with other suspect vaccines included ROTATEQ, pneumococcal vaccine (manufacturer unknown), PEDIARIX (dose, route of administration, lot # and expiry date were not reported for all). The patient was not taking concomitant medications. On an unknown date (reported as "right after given the vaccin"), the patient experienced, polyuria, dehydration and feeding difficulties, weakness, fatigue, lethargy, sense of malaise, glossy eyes, fever for 5 days and seizures, described as staring spells and lip smacking. On an unknown date in February 2017 (reported as "2 months after patient received vaccines"), the patient 's blood work was done and showed elevated liver enzymes, elevated sedimentation count, fluid and electrolyte disturbance, polyuria, loss of sodium, hypotonia, abnormal potassium, high chloride, high, calcium, high glucose, decreased Blood Urea Nitrogen. The reporter mentioned that this had led to a misdiagnosis of adrenal insufficiency, (unable to clarify further). Unspecified treatment was given. On an unknown dates, the patient was hospitalized four times. The patient's present status was reported as not recovered. The nurse reported that the events resulted in significant disability or incapacity and were life threatening were reported. The causality assessment was not provided. Upon internal review the event of seizures was determined to be medically significant.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia
Clinical narrative: PT STATED THAT A COUPLE OF DAYS AFTER FLU SHOT, HE COULD NOT STAND AND WAS RUSHED TO EMERGENCY ROOM.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pallor
Clinical narrative: Very pale, whitish lips and dizziness.
Sex: U
Vaccine: VARZOS
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. On 04-JAN-2018, the patient was vaccinated with ZOSTAVAX lot # M041087 expiration date 03-JAN-2018 for prophylaxis. Other suspect therapies included sterile diluent. On 04-JAN-2018 the patient experienced expired product administered. The lot and expiration date of the properly stored sterile diluent was unknown. No adverse effects were reported. Follow-up was received from pharmacist on 29-JAN-2018. The pharmacist clarified that she was the reporter of the event and also stated that she did not vaccinate the patient with the expired product. The reporter also asked for a medical inquiry to be placed regarding this event. The reporter also confirmed that she had no additional information to share and was unaware of any adverse experiences with the involved patient. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date (reported as "about two years ago" and "over 2 years ago"), the patient was vaccinated with a dose of GARDASIL (exact dose, dose number, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, sometime after receiving GARDASIL (also reported as "over 2 years ago"), the patient developed inflammatory arthritis. The outcome of inflammatory arthritis was not reported. The causality assessment between the event and GARDASIL was not provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old male patient. The patient's medical history, concurrent conditions, and historical drugs were not reported. Concomitant therapies included aspirin (manufacturer unknown), and hydrochlorothiazide. On 22-JAN-2018, the patient was vaccinated with ZOSTAVAX subcutaneous route (dose, frequency and anatomical location were unknown) with lot # N021172 and expiration date 01-NOV-2018 indication reported as "recommended for Age". On 24-JAN-2018, the patient returned to the pharmacy with rash at the injection site, the pharmacist described the event as it was a small red area around the injection site just like what it was stated in the prescribing information. At the time of the report, the outcome of injection site rash and injection site erythema was reported as not recovered. The pharmacist did not mention the causality assessment between the events of injection site rash and injection site erythema, and ZOSTAVAX.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 24-JAN-2018, the patient was vaccinated inadvertently with PROQUAD (recombinant human albumin) subcutaneous for prophylaxis (lot # M017336; expiration date of 05-OCT-2017) (dose and anatomical location were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified patients of 49 and 50 year old. Information regarding the patients' medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included sterile diluent. On 30-JAN-2018, the patients were vaccinated with PROQUAD for prophylaxis (strength, dose, route, anatomical location, lot number and expiration date were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 03-FEB-2018, the patient was vaccinated with an expired dose of VARIVAX expiration date 02-FEB-2018, (strength, dose, route, anatomical location and lot number were not provided) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 17 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 21-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported). Two months after, on 21-DEC-2015, the patient received the second dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported). A third dose of GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported), was administered on 14-APR-2016.  On 05-FEB-2018, the patient was vaccinated with a fourth dose of GARDASIL 9 lot # N017686, expiration date on 02-FEB-2020 (strength, dose and route were not reported). All vaccines were administered for prophylaxis. No adverse effects were reported.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Injection site erosion
Clinical narrative: Patient sat in mother's lap while administering vaccine in Left Deltoid. Patient squirmed immediately prior to insertion of needle, causing the needle to scrape left upper arm, leaving an approximate 1 inch vertical abrasion. Site was cleaned and bandaged by staff. Staff instructed mother to monitor the site when child returned home from school, clean it and apply a topical "bacitracin" as necessary. Staff also notified patient's School Nurse (as patient at clinic for vaccination before the school day) to be aware of the situation and to monitor the site, clean and redress as necessary throughout the school day.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Ear injury, Erythema, Fall, Fear, Malaise
Clinical narrative: Patient responded well to vaccine and stated it that it did not hurt at all. Patient put her sweatshirt on and jacket on and stood up and was talking with mother and RN without problems. Mother and Rn were talking and patient fell into cabinet in nurses office. Rn immediately assessed patient who had her eyes open with a look of fear and carried her to exam table. Patient did not remember falling. Rn questioned patient on how she was feeling. Patient stated that she felt sick. Rn had her lay down on exam table for approx 10 minutes and then was provided some crackers and water. Patient stayed in nurses office for approx 20 min total until she was feeling better. Rn did assess child's head r/t fall. Patient had hit her left ear on cabinet with slight redness noted to ear. No further injury and patient denied any pain. Rn contacted mother the next day and left voicemail to check on patient with no response. Rn contacted mother again the following day and spoke with her. Mother states that child is fine and that she "rode" it out for a little bit  that evening but has had no further complications. Rn advised mother in the future to tell healthcare personnel that the child has history of passing out post vaccinations.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding patient's medical history and concurrent conditions were not reported. On 22-JAN-2018, the patient was vaccinated with an expired dose of VARIVAX, (lot # M002063, expiry date 12-JAN-2018). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This non valid spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapies were not reported. On 01-AUG-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX expiration date 27-JUL-2017 (dose, route, anatomical place of vaccination and lot# were not provided), for prophylaxis.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 18-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N000508 and expiration date 19-OCT-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). On an unknown date following the administration, the patient developed cellulitis. It was unknown by the reporter if the patient sought medical attention, if treatment was given for the adverse events or if lab diagnostics or studies were performed. The outcome of the event cellulitis and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. Upon internal review, cellulitis was considered to be medically significant. This is one of several cases from the same reporter.; Sender's Comments: US-009507513-1802USA002517: US-009507513-1802USA001892:
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 09-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 injection, lot # N029303 and expiration date 21-APR-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). On an unknown date following the administration, the patient developed cellulitis. It was unknown by the reporter if the patient sought medical attention, if treatment was given for the adverse events or if lab diagnostics or studies were performed. The outcome of the event cellulitis and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. Upon internal review, cellulitis was considered to be medically significant. This is one of several cases from the same reporter.; Sender's Comments: US-009507513-1802USA001892: US-009507513-1802USA002516:
Sex: F
Vaccine: PPV
Symptoms: Pseudocellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer concerning a 55 year old female patient. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dosing regimen, route, lot# and expiry date not reported). On an unspecified date, the patient experienced pseudocellulitis. It was reported that the symptoms had resolved after a week or so. The reporter's causality assessment was not provided.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 75-year-old female patient received first dose PREVNAR 13 (Lot#: S92741 and expiration date: Jan2020), on an unspecified date in Jan2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness in the injection site: it looked like patch around the injection site and was red and itching. Outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: FLUX, HEPAB, TDAP
Symptoms: Back pain, Bone pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 44-year-old female patient who received BOOSTRIX (batch number TF422, expiry date December 2019). Co-suspect products included TWINRIX (batch number Z75Y2, expiry date March 2020) and Influenza vaccine. Previously administered products included Novartis flu vaccine with an associated reaction of pain (aches and sniffles after receiving the dose in 2009). Concomitant products included iron, Vitamin B 12, vitamin D and Probiotic. On 18th January 2018, the patient received the 1st dose of BOOSTRIX, the 1st dose of TWINRIX and Influenza vaccine. In January 2018, 4 days after receiving BOOSTRIX, TWINRIX and Influenza vaccine, the patient experienced low back pain and bone pain. The patient was treated with ALEVE and Epsom Salt. On an unknown date, the outcome of the low back pain and bone pain were not recovered/not resolved. The reporter considered the low back pain and bone pain to be possibly related to BOOSTRIX and TWINRIX. Additional information was received as follows: The patient received BOOSTRIX and TWINRIX on the left arm, Influenza vaccine received on the right arm. The patient stated that low back pain got better but at the time of reporting it was worse again. The patient reported to her physician but the physician did not believe it to be related to the vaccines. The patient noted she had tried Epsom salt soaks, Aleve, heating pad, stretching and massage but still she was experiencing the issues. The patient was not sure whether she would complete TWINRIX series, she was referred to her physician. The patient stated that the back pain felt like it was not muscular but pain in her bones. The patient did not have the lot number and expiration date of the flu vaccine (non-GSK). The patient had provided contact details of her physician. The reported batch number of TWINRIX (275Y2) did not exist and was updated to Z75Y2, as per sales database.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). On 1st February 2018, the patient received SHINGRIX .5 ml. On 1st February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema (serious criteria other). The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site erythema was unknown. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated they have administered SHINGRIX to their first patient the day before reporting and on the day of reporting the patient called to state she had quarter size red area at the injection site. The reporter advised the patient to monitor the area and call MD if worsened. The reporter called to ask if this was a usual reaction or was there anything else recommended to do.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling of entire upper arm, with redness, tenderness and fever. Started evening of vaccine administration. Seen in office 2 days later, difficult to tell whether cellulitis or severe local reaction. Then developed respiratory symptoms triggering his asthma.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory symptom
Clinical narrative: Swelling of entire upper arm, with redness, tenderness and fever. Started evening of vaccine administration. Seen in office 2 days later, difficult to tell whether cellulitis or severe local reaction. Then developed respiratory symptoms triggering his asthma.
Age: 4.0
Sex: M
Vaccine: FLUR3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given 0.5 ml prefilled FLUBLOK syringe at age earlier than current recommended guidelines. No adverse reactions or symptoms noted.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Influenza like illness, Influenza virus test negative, Pain in extremity, Paraesthesia
Clinical narrative: Client called office on 1/26/18 at 5:50 PM stating a few days after receiving flu vaccine she began to experience flu like symptoms along with a hot, tingly sensation down arm that radiated into shoulder and neck. Per client she took ibuprofen and saw her Doctor on 1/22/2018. Client was awaiting influenza test results done at PCP. Follow up call with client on 2/2/2018 - client states she wake up with a numb, tingly cold arm this morning but that has since gone away. Client states she had the worst headache of her life for 2 weeks and is now experiencing temple pain. Per client PCP diagnosed her with a sinus infection and her influenza test results were negative. Client inquiring about vaccine ingredient list along with common allergens to ingredients. Client referred to CDC website for information.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Sinusitis, Skin warm
Clinical narrative: Client called office on 1/26/18 at 5:50 PM stating a few days after receiving flu vaccine she began to experience flu like symptoms along with a hot, tingly sensation down arm that radiated into shoulder and neck. Per client she took ibuprofen and saw her Doctor on 1/22/2018. Client was awaiting influenza test results done at PCP. Follow up call with client on 2/2/2018 - client states she wake up with a numb, tingly cold arm this morning but that has since gone away. Client states she had the worst headache of her life for 2 weeks and is now experiencing temple pain. Per client PCP diagnosed her with a sinus infection and her influenza test results were negative. Client inquiring about vaccine ingredient list along with common allergens to ingredients. Client referred to CDC website for information.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Reporting because 1st dose is to be given before 15 weeks of age. Infant was 6 months and 23 days old. Too old for 1st dose.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Asthenia, Cough, Facial paralysis, Fatigue, Headache
Clinical narrative: With in 15 minutes, we just left the dr office and were in the car ride home, he started to laugh/ cry that his left side of face was numb and droopy. Started to talk strange and I looked over and his left side of his face was droopy and he had tears in his eyes. I called the doctors office immediately. Once we got home, 15 minutes later it was gone but he was tired. The next day (Friday)around 1pm he complained of a headache and had a fever of 102.3. The remainder of the weekend, he had fevers from 101-103.7, was exhausted, weak. He was able to stay hydrated and still ate but mostly slept. That Monday I took him to doctors again. Complained. Dr was stumped and was going to do research on shots. Told me to continue with Motrin, advil. If still fever on that Wednesday to call again. His fever ended Wednesday but to this day he now has a dry cough and still exhausted. He plays soccer and is very active. He was perfectly healthy walking in for these shots and no one will convince me this was a fluke virus thing. A healthy person does not walk in for a shot and walk out with bells palsy.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Hypoaesthesia, Lacrimation increased, Pyrexia, Speech disorder
Clinical narrative: With in 15 minutes, we just left the dr office and were in the car ride home, he started to laugh/ cry that his left side of face was numb and droopy. Started to talk strange and I looked over and his left side of his face was droopy and he had tears in his eyes. I called the doctors office immediately. Once we got home, 15 minutes later it was gone but he was tired. The next day (Friday)around 1pm he complained of a headache and had a fever of 102.3. The remainder of the weekend, he had fevers from 101-103.7, was exhausted, weak. He was able to stay hydrated and still ate but mostly slept. That Monday I took him to doctors again. Complained. Dr was stumped and was going to do research on shots. Told me to continue with Motrin, advil. If still fever on that Wednesday to call again. His fever ended Wednesday but to this day he now has a dry cough and still exhausted. He plays soccer and is very active. He was perfectly healthy walking in for these shots and no one will convince me this was a fluke virus thing. A healthy person does not walk in for a shot and walk out with bells palsy.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: 2 days after vaccine he had lower lip swelling. Treated at private hospital with MEDROL dose pack. Today Feb 7 he was again treated with 60mg po of prednisone, 40mg po of PEPCID, he deferred the diphenhydramine.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Pain in extremity, Rash
Clinical narrative: Patient stated on Sunday 2/4/18 in the evening her arm was sore. She then said she felt like she was coming down with the flu. Her son then rubbed her arm in the area of the vaccination on 2/6/18 and she said since then a rash developed from the top of her arm down her arm. Advised the patient to see her primary care doctor to look at it.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Dyskinesia, Feeling abnormal, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: Patient has rash, right upper deltoid area with papular rash oval in shape 3x1.5 cm. Slightly tender to touch. Patient had fever to 102 after PROQUAD on 1/29/18-2/6/18. History of shaking and arm flapping after DTAP/HIB/IPV shots at 6 months of age along with fevers to 104. Also, "spaced out" look. Questionable absence seizures.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Rash papular, Tremor
Clinical narrative: Patient has rash, right upper deltoid area with papular rash oval in shape 3x1.5 cm. Slightly tender to touch. Patient had fever to 102 after PROQUAD on 1/29/18-2/6/18. History of shaking and arm flapping after DTAP/HIB/IPV shots at 6 months of age along with fevers to 104. Also, "spaced out" look. Questionable absence seizures.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: By mistake I gave the patient Hepatitis B and PEDIARIX (DTap-HepB-IPV).
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea and Nausea Vomiting.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 42-year-old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 30-JAN-2018, the patient was vaccinated with the first dose of VAQTA (exact dose was not reported; lot # N031940 with the expiration date of 23-NOV-2018), intramuscularly for prophylaxis. Concomitant therapies included ATIVAN and SOMA. Since 30-JAN-2018 (also reported as "ever since she was vaccinated"), the patient was experiencing nausea and headache. She sought medical attention for these events in the form of office visit, and received unspecified treatment. No lab diagnostics or studies were performed. The outcome of the events was reported as not recovered at the time of this report. The causality assessment between the events and VAQTA was not reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Excessive cerumen production, Genital herpes, Hypoacusis, Injection site erythema
Clinical narrative: Had the known effects of 1) very sore arm. Not being able to lift arm. Site felt warm to touch and was red and swollen. 2) 1 day after vaccine I had a really bad bout of genital herpes. I hadn't had an occasion of herpes for over 4 years prior to this. 3) Also, my ear on the left side clogged up with wax to the point that I couldn't hear and needed to go see the doctor. No issue prior.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased, Pain in extremity
Clinical narrative: Had the known effects of 1) very sore arm. Not being able to lift arm. Site felt warm to touch and was red and swollen. 2) 1 day after vaccine I had a really bad bout of genital herpes. I hadn't had an occasion of herpes for over 4 years prior to this. 3) Also, my ear on the left side clogged up with wax to the point that I couldn't hear and needed to go see the doctor. No issue prior.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, increase in warmth to touch, and erythema at injection site.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased, Rash, Swelling, X-ray limb
Clinical narrative: Constant dull pain at injection site, swelling, rash. Limitations of left arm movement.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Red, warm, swollen, painful arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Oedema peripheral, Peripheral swelling, Pruritus, Rash
Clinical narrative: Pt states left arm became swollen, hot to the touch, a rash developed on the arm which went down to the forearm. Also pt states her underarm was swollen and painful. Furthermore, pt states that she experienced itching so took BENADRYL. Pt iced the arm and took pain relievers. Pt presented to the pharmacy on 2/7/2018 because she was out of town.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Pt states left arm became swollen, hot to the touch, a rash developed on the arm which went down to the forearm. Also pt states her underarm was swollen and painful. Furthermore, pt states that she experienced itching so took BENADRYL. Pt iced the arm and took pain relievers. Pt presented to the pharmacy on 2/7/2018 because she was out of town.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient received AFLURIA flu shot 1-30-18. Sad got hot - dizzy - went away within 15 minutes.
Age: 62.0
Sex: F
Vaccine: MENB, MNQHIB, PNC13
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral
Clinical narrative: I went into the doctors for a pre-physical exam for an operation I was going to have on my foot. I was perfectly healthy. I do not have a spleen so the nurse practitioner said I needed these shots. She gave me the ones above. I am not sure of the name of the Meningocacal shots. It says Serogroup B Meiningococal Vaccine (MenB). She said there were three in the series and she would just give me two. The pneumon shot was also given at the same time. I woke up on May 12th and was completely deaf in my left ear.  This is the only thing that could have made this happen. I had no cold at the time.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Musculoskeletal stiffness, Skin warm, Swelling
Clinical narrative: PT STATED HE HAD LOCALIZED SWELLING, WARMTH, REDNESS AND STIFFNESS ON ARM, FOLLOWING DAY SWELLING HAD GONE DOWN BUT STILL INDURATED, PT TOOK TYLENOL WITH RELIEF. ON EVENING OF 2-6-18 ALL SYMTPOMS DISSIPATED.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Shingles vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Aggression, Decreased appetite, Developmental delay, Lethargy
Clinical narrative: This was my daughter's 3rd set of vaccinations. After each vaccine appointment, she became extremely sick with a fever over 101.0 and was lethargic. She wouldn't eat and she was not herself. After the first vaccine appointment when she was 2 months old, we took her into the emergency room only to be told that it was "normal" After this 3rd vaccine appointment, about 2.5 weeks later, I noticed that my daughter was acting different and would start to do this involuntary like movement with her neck bobbling her head to one side-almost like a seizure. She did this multiple times that I documented with my cell phone video on July 5, 2017. I made her an appointment with her pediatrician who told me that she didn't know what it was on the video but that it was possibly a tantrum. To my surprise, after I left and looked at my checkout documents, I saw that she diagnosed my daughter with "gross developmental delay" which is astounding to me since she started crawling at 6 months, walking at 9 mo etc. I then decided to take her for a second opinion the next day with a different pediatrician- she also didn't know what this seizure like activity was so I asked for a referral to a neurologist. I went the following week as scheduled only to be told by the neurologist that " this must be my first child" and that there was absolutely nothing wrong with her and that it was her throwing a tantrum. This happened only once or twice more and then never again with no explanation whatsoever.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Malaise, Pyrexia, Seizure like phenomena
Clinical narrative: This was my daughter's 3rd set of vaccinations. After each vaccine appointment, she became extremely sick with a fever over 101.0 and was lethargic. She wouldn't eat and she was not herself. After the first vaccine appointment when she was 2 months old, we took her into the emergency room only to be told that it was "normal" After this 3rd vaccine appointment, about 2.5 weeks later, I noticed that my daughter was acting different and would start to do this involuntary like movement with her neck bobbling her head to one side-almost like a seizure. She did this multiple times that I documented with my cell phone video on July 5, 2017. I made her an appointment with her pediatrician who told me that she didn't know what it was on the video but that it was possibly a tantrum. To my surprise, after I left and looked at my checkout documents, I saw that she diagnosed my daughter with "gross developmental delay" which is astounding to me since she started crawling at 6 months, walking at 9 mo etc. I then decided to take her for a second opinion the next day with a different pediatrician- she also didn't know what this seizure like activity was so I asked for a referral to a neurologist. I went the following week as scheduled only to be told by the neurologist that " this must be my first child" and that there was absolutely nothing wrong with her and that it was her throwing a tantrum. This happened only once or twice more and then never again with no explanation whatsoever.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Circumstance or information capable of leading to medication error, Injection site reaction, Scratch
Clinical narrative: Injection administered; pt grabbed at needle with hand. Pt did not get hurt; no skin punctured but vaccine was wasted. Pt had tiny scratch on left leg from needle. Vaccine readministered.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: Sore Muscle at injection site, Chills that Night.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a register nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and drug reactions was not provided. On 19-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD, (lot # M039447, expiry date 20-MAR-2018) (route of administration and anatomical location were not reported) for prophylaxis. The PROQUAD was reconstituted with properly stored sterile diluent (manufacturer unknown), (lot # M017324, expiry date 25-SEP-2018). No adverse effects were reported. The temperature excursion for the PROQUAD was 12°F during 42 minutes. The previous temperature excursions for the vaccine were 6°F to 14°F for 1 hour 46 minutes and then 15°F to 46°F (24°F) for 10 hours and 14 minutes. The call was made because of a data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a "healthy" female patient currently in her 50's. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date (reported as "a couple of years ago"), the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), and the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), for prophylaxis (dose, route of administration, lot # and expiration date were not reported  for any of those two products). On an unknown date, the patient developed Guillain-Barre syndrome. It was stated that the patient received an unspecified treatment from an unspecified neurologist on an unspecified date. The reporting physician also stated that the patient was having some residual side effects (adverse event) for which the patient was receiving an unspecified treatment. It was unknown by the reporter if any lab diagnostics were performed to the patient. At the time of reporting, the outcome of the events was reported as not recovered.  The causality assessment between the events with ZOSTAVAX and sterile diluent (MERCK STERILE DILUENT) was not provided. Upon internal review, Guillain-Barre syndrome was determined to be a medically significant event.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (manufacturer control number: NUS2018US020679). A contactable consumer (spouse) reported for a 31-year-old patient experienced allergic reactions to the pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein). Clinical outcome was unknown at time of this report. Pfizer is Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.