chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L045678 expiration date 09-MAY-2017. The patient's concomitant medications were not reported. The pharmacist stated, that PROQUAD (Merck) was exposed to a temperature excursion of -4 degrees C for 1 hour time frame. There was not previous temperature excursion reported. At the time of the report, no adverse effects were reported and no product quality issues was involved. Additional information has been requested. This is one of several reports received from the same reporter. (1603USA010621).
Age: 0.76
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Urticaria
Clinical narrative: Hives on arms, trunk, legs and elbows.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Hypoaesthesia, Hypoaesthesia oral, Pallor
Clinical narrative: 12:10 Became pale, clammy. Asked for glass water. Then c/o numbness around (L) side of lip, and (L) side of face. Approx 5-10 minutes after giving vaccine. 12:14 pm BENADRYL 25 mg PO given 911 called. Sent to ER with paramedics-ambulance 12:39 pm.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Received GARDASIL and FLUZONE on 3/14/16. Woke up (on vacation) 3/28/16 with right sided facial paralysis. Seen locally by MD on 3/29/16 and diagnosed with Bells' Palsy - no treatment. Mom called our office 3/30/16 and put on PO steroids.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 17-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L030158 expiration date 11-AUG-2016. The patients' concomitant medications were not reported. The pharmacist stated that VARIVAX (Merck) was exposed to a temperature excursion of -4 degrees C for 1 hour time frame. There was not previous temperature excursion reported. At the time of the report, no adverse effects were reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter. (1603USA010554).
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 18 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 28-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 01-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported) , because a company representative mistakenly told that it was the Centers or Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 19 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 01-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 30-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 17 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 06-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old patient of unknown gender. No concomitant condition, medical history and concomitant therapies were reported. On 28-MAR-2016 the patient was administered with a dose of PNEUMOVAX 23 (lot # K010465 with expire date of 23-MAR-2016, dosage and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date in 2011, the patient was vaccinated with the first dose of GARDASIL (lot#, expiry date, dose and route unspecified). The patient then received the second dose of GARDASIL (lot#, expiry date, dose and route unspecified) on an unspecified date in 2012. On 23-MAR-2016, the reporting day, the patient received the third dose as either GARDASIL or GARDASIL 9 (lot#, expiry date, dose and route unspecified). No adverse effects were reported. Additional information is not expected as we are not permitted to contact the physician.
Sex: M
Vaccine: PPV
Symptoms: Cough
Clinical narrative: Information has been received from a male patient of unknown age concerning himself. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot# were not reported). On an unknown date the patient experienced cough. The outcome of the event was unknown. Causality was not reported. Additional information is not expected as no contact details were provided.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Vaccination site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 33-year-old female patient who received FLUARIX QUADRIVALENT (batch number DF4TX. expiry date 9th June 2016). On 11th February 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 12th February 2016. 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be relate to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was previously reported to a doctor. The nurse practitioner reported that both husband and wife developed arm soreness after vaccination (see case US2016043148 reported by the same reporter). The patient in this case concerned wife. On 21st March 2016, the patient called back the clinic and notified the reporter that they both are still experiencing arm soreness and both place to follow up with their primary care physician. The nurse practitioner has reported these events to VAERS CDC.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 33-year-old female patient who received FLUARIX QUADRIVALENT (batch number DF4TX. expiry date 9th June 2016). On 11th February 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 12th February 2016. 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be relate to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was previously reported to a doctor. The nurse practitioner reported that both husband and wife developed arm soreness after vaccination (see case US2016043148 reported by the same reporter). The patient in this case concerned wife. On 21st March 2016, the patient called back the clinic and notified the reporter that they both are still experiencing arm soreness and both place to follow up with their primary care physician. The nurse practitioner has reported these events to VAERS CDC.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Vaccination site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 34-year-old male patient who received FLUARIX QUADRIVALENT (batch number DF4TX, expiry date 9th June 2016). On 11th February 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 12th February 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was previously reported to a doctor. The nurse practitioner reported that both husband and wife developed arm soreness after vaccination (see case US2016043151 reported by the same reporter). The patient in this case concerned husband. On 21st March 2016, the patient called back the clinic and notified the reporter that they both are still experiencing arm soreness and both plan to follow up with their primary care physicians. The nurse practitioner has reported these events to VAERS CDC.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 34-year-old male patient who received FLUARIX QUADRIVALENT (batch number DF4TX, expiry date 9th June 2016). On 11th February 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 12th February 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was previously reported to a doctor. The nurse practitioner reported that both husband and wife developed arm soreness after vaccination (see case US2016043151 reported by the same reporter). The patient in this case concerned husband. On 21st March 2016, the patient called back the clinic and notified the reporter that they both are still experiencing arm soreness and both plan to follow up with their primary care physicians. The nurse practitioner has reported these events to VAERS CDC.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a non healthcare professional (medical assistant) on 23 March 2016. This case involves two patients (gender was not provided) who were vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number: U4939AA, expiry date:8 January 2017, dose number and site of administration was not reported) intradermally instead of a dose of TUBERCULIN PPD (PPD) (batch number, dose details, route and site of administration were not reported) on 21 March 2016. The patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 23 March 2016, two days following the vaccination, the patients came for a PPD vaccination however they were vaccinated with Adacel. When they returned, this error was discovered. Both patients had redness around the injection site, one the size of a baseball and the other the size of a softball, a hard pea size nodule at the injection site. Both patients stated the injection site felt itchy at first and then redness and swelling appeared. It was a case of wrong vaccine administered, wrong route of administration and product use issue. Patients required ER/doctor visit. Lab data and corrective treatments were not reported. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Pyrexia, Vaccination failure
Clinical narrative: Initial unsolicited report received from a consumer on 25 March 2016. This case is linked with 2016SA062160. This case involves a male patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number, expiry date, dose number, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient was diagnosed with having the elevated fever of 104 Fahrenheit, flu and had a positive flu test for A strain of Flu. It was reported that the patient required doctor visit. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none. Sender's Comments: This is a non-medically confirmed case. Reportedly, the patient was tested for Influenza type A approximately 4-5 months after vaccination. As with any vaccine, INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of vaccinated individuals. Further information including but not limited to patient's medical history, details of symptoms, test results confirming the diagnosis and the strain identified and immune status at the time of vaccination would be needed for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site swelling
Clinical narrative: Severe Headache, Loss of appetite, Mild Fever, chills, severe fatigue, swelling at shot site.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Severe Headache, Loss of appetite, Mild Fever, chills, severe fatigue, swelling at shot site.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Insomnia, Pain, Pain in extremity
Clinical narrative: Sharp, stabbing, throbbing pain radiating down right arm, pain when lifting, pushing, pulling, turning, difficulty sleeping and doing everyday chores.  The pain continues to this day.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Crying, Lethargy, Vomiting, Vomiting projectile
Clinical narrative: Projectile vomiting, throwing up bile, severe crying, and lethargic. Continued till 04/04/2016 still no improvement. Got prescribed Zantac 04/05/2016 and threw up 4 times twice at 6:00PM. Twice 7:30PM.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event. MMRV administered when patient was only due for an MMR vaccine; Varicella was administered when patient was 3 years 5 months instead of at 4. Administration error.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Dizziness, Full blood count, Headache
Clinical narrative: Sudden onset headache and dizziness following Gardasil 9 injection.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Thyroxine
Clinical narrative: Sudden onset headache and dizziness following Gardasil 9 injection.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) in on 6-April-2015. A female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) (batch number, expiry date, dose number and site of administration were not reported) and a intramuscular dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number, expiry date, dose number and site of administration were not reported) on an unspecified date (about four years ago). Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were not provided. On an unspecified date after vaccination, the patient experienced arm became swollen from the deltoid to the elbow. Laboratory investigation and corrective treatment were not provided. The patient was seen in the Emergency Room/ doctor visit. No further information was provided. On an unspecified date, the patient had recovered from the above mentioned event. Documents held by sender: none. Follow up information received from a Physician on 04-May-2015. The physician reported that he did not report any information about the event. There was no additional information provided.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial unsolicited pregnancy report received from a healthcare professional on 07 April 2015. A 47-year-old female patient (age not reported), whose concomitant medication were not reported, had received intramuscularly a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (batch number: C4714AA, expiry date: 08 April 2017) (cycle in series, number of dose and site of vaccination were not reported) on 06 April 2015. On an unspecified date vaccine exposure during pregnancy was reported with no adverse event. Medical history of the patient was reported as hypertension and was previously a smoker. Last menstrual periods was reported as 05 June 2014. Estimated date of delivery was reported as 12 April 2014. Treatment for infertility was reported as unknown. List of documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Claustrophobia
Clinical narrative: Initial unsolicited report received from a physician on 07 April 2015. A 13-year-old male patient had received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number, dose number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient felt claustrophobic in class. Corrective treatment and laboratory details were not reported. The event had cleared when he got outside and the patient had recovered on an unspecified date. Documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warm to touch.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Pain, Pyrexia
Clinical narrative: Extreme stomach pains with vomiting, body aches, lightheaded, generalized weakness, feverish.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Vomiting
Clinical narrative: Extreme stomach pains with vomiting, body aches, lightheaded, generalized weakness, feverish.
Age: 1.18
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Papulomacular erythematous rash to back, chest and face. No blisters.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Laboratory test normal, Peripheral swelling
Clinical narrative: On 03/04/16, 83 yo F presented to clinic for a Nurse Only visit for pneumococcal vaccination. Pt was administered 0.5 mL Pneumococcal Conjugate 13-Valent (Prevnar 13) IM in left deltoid (NDC: 0005-1971-01; Mfg: Wyeth-Ayerst; Lot #M51192). On 03/07, pt called and reported that her left arm was swollen and painful to the touch. Pt returned to clinic and MD evaluation found LUE redness, tenderness and warmth around vaccine injection in left deltoid. Pt prescribed cephalexin 250 mg PO 3 times daily x 7 days, diclofenac 50 mg PO daily after lunch and was instructed to apply warm compresses to the affected area. On 03/11, pt again returned to clinic for evaluation. Although LUE swelling continued, pt's pain had improved. Labs were collected and found to be negative for infection, rhabdo and inflammation. Pt was told to continue antibiotic as prescribed. No new treatment interventions ordered.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness, White blood cell count normal
Clinical narrative: On 03/04/16, 83 yo F presented to clinic for a Nurse Only visit for pneumococcal vaccination. Pt was administered 0.5 mL Pneumococcal Conjugate 13-Valent (Prevnar 13) IM in left deltoid (NDC: 0005-1971-01; Mfg: Wyeth-Ayerst; Lot #M51192). On 03/07, pt called and reported that her left arm was swollen and painful to the touch. Pt returned to clinic and MD evaluation found LUE redness, tenderness and warmth around vaccine injection in left deltoid. Pt prescribed cephalexin 250 mg PO 3 times daily x 7 days, diclofenac 50 mg PO daily after lunch and was instructed to apply warm compresses to the affected area. On 03/11, pt again returned to clinic for evaluation. Although LUE swelling continued, pt's pain had improved. Labs were collected and found to be negative for infection, rhabdo and inflammation. Pt was told to continue antibiotic as prescribed. No new treatment interventions ordered.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives, progressed to whole body urticarial. Seen in office 4/6/16, treated with Zyrtec and steroids.  Referred to allergist.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Patient still is experiencing some post herpatic neuralgia pain from the shingles.  Not sure if the vaccine affected this or if she was not symptom free at the time of the vaccine.
Age: 18.0
Sex: F
Vaccine: FLUN4, HEPA, MNQ
Symptoms: Allergy to animal, House dust allergy, Temperature intolerance, Urticaria
Clinical narrative: 5 hrs after vaccine harsh reaction, hives all over body. Symptoms continue to present day. Vaccine caused allergy to dust, heat, and cat.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient experienced significant cellulitis at the point of the shot on an unspecified date with outcome of unknown. The doctor attributed the significant cellulitis to PREVNAR 13.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient noticed the site of injection was red the morning after the injection (04/02/2016).  The area was a little itchy but mainly red. The redness decreased over the next 2 days and was completely resolved by 04/05/2016.  No treatment was given.  Benadryl was recommended.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness noted around and below injection site aprox 17cm X 26cm (at longest length). Hardness noted at injection site aprox 7cm X 12cm.  Advised to apply cold compresses and oral Benadryl. Pt to notify MD if redness enlarges area, swelling/pain/heat at site, or fever of 100.5 or greater. Pt verbalized understanding.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Injection site pain, Injection site warmth, Local swelling
Clinical narrative: Pt yesterday had nausea and some diarrhea, some redness to face and hot to touch, no lip swelling, no swollen tongue, no fever, no redness to other areas. Pt has slight red bump to lt shoulder that is painful 2/10 pain, skin is hot to touch to injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Skin warm
Clinical narrative: Pt yesterday had nausea and some diarrhea, some redness to face and hot to touch, no lip swelling, no swollen tongue, no fever, no redness to other areas. Pt has slight red bump to lt shoulder that is painful 2/10 pain, skin is hot to touch to injection site.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: PATIENT SAID THAT ARM WAS RED, TENDER AND SWOLLEN ON 4/2/16- PROGRESSED TO BE PAINFUL AND ITCHY-CALLED MD AND WAS PRESCRIBED AUGMENTIN 875 AND TRIAMCINOLONE.
Age: 25.0
Sex: F
Vaccine: HPV9, PPV
Symptoms: Urticaria
Clinical narrative: Patient develop hives 8 hours after receiving vaccinations. The patient called a nurse for advice. The patient took Benadryl 50 mg 2 times 6 hours apart. The next day the hives were gone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Per patient she had redness and pain on injection site and the pain radiates to her shoulder and upper arm. The redness was on her upper arm and lasted for 4 days. No fever and pt. didn't go for treatment (pt. was here in the clinic 06 April 2016 and she mentioned about the results of her injection site. (please note that the adverse event onset time was not sure, pt. didn't give me that info and unable to contact her at this time.)
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Blindness, Influenza like illness
Clinical narrative: Pt states she began experiencing flu like symptoms around 3:00. Pt states around 8:00 PM she lost vision. Pt states this lasted for approximately 24 hours.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Pharyngeal oedema
Clinical narrative: Mother describes patient with lost voice and sensation of throat swelling. Does not endorse respiratory distress or angioedema. Declines coming in for evaluation since no respiratory distress.
Age: 6.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Swelling, Weight bearing difficulty
Clinical narrative: Fever, swelling, erythema and pain in right thigh, pain and swelling increased and patient was unable to put weight on right leg.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: After initial pain immediately during and after vaccination, the next morning noted pain in shoulder joint of vaccinated arm. This pain persists (more than 3 months later) and shows no signs of lessening. My range of motion is affected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Patient began feeling a burning pain and itching at injection site the evening of the day she received the vaccine. She also developed a fever. The injection site was inflamed and red, and hot to the touch.  She used OTC hydrocortisone 1% cream on the area, but it did not provide relief. On 4/6/16, she started to develop two red spots on her forehead as well as the start of a blister on her upper lip. The injection site remains inflamed and red (roughly 2 inches in diameter), hot to the touch, itchy, and feels like a burning sensation.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Lip blister, Pyrexia
Clinical narrative: Patient began feeling a burning pain and itching at injection site the evening of the day she received the vaccine. She also developed a fever. The injection site was inflamed and red, and hot to the touch.  She used OTC hydrocortisone 1% cream on the area, but it did not provide relief. On 4/6/16, she started to develop two red spots on her forehead as well as the start of a blister on her upper lip. The injection site remains inflamed and red (roughly 2 inches in diameter), hot to the touch, itchy, and feels like a burning sensation.
Age: 39.0
Sex: F
Vaccine: FLU3, YF
Symptoms: Headache, Rash erythematous
Clinical narrative: Pt has about 4 quarter-inch red dots on the left side of her body. Two on her arm (not near the injection site) and one on her hip, and one behind her knee. They are not itchy but appear dry. Pt has no fever or any other signs of a reaction to date. She reports having headaches within the first 2-5 days but has since resolved. She was given advice to monitor and if more spots appear or if other symptoms occur contact her doctor. Benadryl was advised to see if the spots would disappear and to follow up with us in a week.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates in 2016 (reported as between 17-FEB-2016 and 07-MAR-2016), the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # L035124, expiration date 14-SEP-2017, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 17.42C for 24 hours. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported. Since 02-SEP-2015 or after the date, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # K020216 with expiration date of 17-SEP-2016 or L004754 with expiration date of 10-NOV-2016, dose and route unknown). The excursion was reported as temperature at 47 F for 23 hours and no previous temperature excursion was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 11-MAR-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L011537, expiration date 03-JUL-2016, dose, dose# and route unknown). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient in her 20s (who was the daughter of a receptionist in the office where the nurse practitioner practiced). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, at least a year ago, the patient was vaccinated with an unspecified number of doses of GARDASIL (exact dose, route, lot # and expiration date were not reported). Subsequently, on an unknown date in 2015 (reported as within the past year), the patient regional chronic pain syndrome. This regional chronic pain syndrome had been ongoing for the past year and the patient had seen several pain management physicians. There was no treatment given for the adverse event. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 31 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L023587, expiration date 26-JUN-2017, exact dose and route of administration were not reported). The vaccine was exposed to refrigeration temperature not exceeding 46F for 6 days. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (dosing regimen unspecified) (lot # L048237, expiry 08-MAY-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature 31.55 F, Time frame: 45 seconds, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (dosing regimen unspecified) (lot # L030870, expiry 10-JUN-2018). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 31.55 F, Time frame: 45 seconds, there was no previous temperature excursion, It was call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. On 2014 the patient developed shingles 2 years following administration of ZOSTAVAX on an unspecified date. The outcome of herpes zoster was unknown. The causality between the event and ZOSTAVAX was not 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 registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported. Since 02-SEP-2015 or after the date, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # K019370 with expiration date of 16-JUL-2016, dose unknown) orally. The excursion was reported as temperature at 47 F for 23 hours and no previous temperature excursion was reported. No adverse effect  was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, unit and route not reported, Lot# K023363 and Exp. date 20-MAY-2016). The vaccines were exposed to 6.65 F for 14 hours 15 minutes. There was previous temperature excursion reported, the vaccines had been exposed to 17 F for 1 hour and 6.05 F for 14 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with unidentified Merck HPV vaccine administered (name, dose, route of administration, anatomical location, lot number and expiry date were not specified). Other suspect therapies included ROTATEQ orally (dose, lot number and expiry date were not specified). On an unknown date, the patient experienced adverse event. The outcome of adverse event was unknown. The reporter did not provide the causality assessment. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: Information has been received via a field employee from a more than 70 year old physician with neuralgia from Guillain-Barre Syndrome referring to himself. In summer of 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were unknown). Around 20-MAR-2016, the patient developed a burning sensation on his forehead. The patient visited his dermatologist, who diagnosed the burning sensation as the beginning of shingles. VALTREX and prednisone (manufacturer unspecified) were given as the treatment. The burning sensation lasted for another week after starting therapy with VALTREX and prednisone (manufacturer unspecified) before it resolved in 2016. The patient said that he felt this would have been a lot worse if he had not received ZOSTAVAX,. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received via a field employee from a more than 70 year old physician with neuralgia from Guillain-Barre Syndrome referring to himself. In summer of 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were unknown). Around 20-MAR-2016, the patient developed a burning sensation on his forehead. The patient visited his dermatologist, who diagnosed the burning sensation as the beginning of shingles. VALTREX and prednisone (manufacturer unspecified) were given as the treatment. The burning sensation lasted for another week after starting therapy with VALTREX and prednisone (manufacturer unspecified) before it resolved in 2016. The patient said that he felt this would have been a lot worse if he had not received ZOSTAVAX,. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-MAR-2016, unspecified doses of PROQUAD (Merck) (dose, lot#, expiration date and route of administration were not reported) and VARIVAX (Merck) (dose, lot#, expiration date and route of administration were not reported) were administered simultaneously to the patient. There were no adverse events reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-JUL-2014, the patient was vaccinated with the first dose of GARDASIL, on 30-DEC-2015, with the second dose of GARDASIL, and on 03-MAR-2016, with the third dose of GARDASIL (route of administration, lot number and expiry date for all three doses were not reported). It was confirmed that, it was not GARDASIL 9. No adverse symptom was reported. Concomitant therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 injection (dosing regimen unspecified) (lot # L003227, expiry 13-OCT-2016). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 31.55 F, Time frame: 45 seconds, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.