chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a 67 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not known. Patient was vaccinated with PREVNAR 13, 'one year ago' (approximately 2015). On unknown date, in approximately 2016, the patient was vaccinated with PNEUMOVAX 23 (dosing details not provided), intramuscularly. On an unknown date (approximately 2016) the patient experienced local injection site reactions including injection site pain, swelling and fever. Patient sought medical attention. Unspecified treatment was provided for the events. The patient recovered from the events after 1 week of receiving vaccine. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, erythema below injection site. It was recommended for patient to apply ice to the site and to take oral ibuprofen. The patient was asked to return tomorrow (9/29/2016) to check for resolution of her symptoms.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia
Clinical narrative: About 5 seconds after administration of the vaccine, the patient began to feel extremely dizzy. The patient did not lose consciousness, but could not safely stand. After about 5 minutes of waiting with the patient, he insisted he was no longer dizzy, and that he wanted to leave. After assessing his balance and his vision, it was determined he was no longer experiencing symptoms. The patient was monitored as he left to ensure he was stable.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot/batch# 1039660 with an expiry date 04-FEB-2018 and dosing details not known). No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1039660 is an invalid lot number for hepatitis B vaccine (recombinant). This is one of the four reports received from the same reporter. 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 nurse regarding unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (lot/batch #1024993 with an expiry date 17-OCT-2017 and dosing details not known. No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1024993 is an invalid lot number for GARDASIL 9. This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Skin induration
Clinical narrative: Pt experienced: *Tenderness at pneumonia injection site *Flu-like symptoms  *Upper arm where pneumonia shot was given is painful, red, swollen and skin is a little hard. *Redness is about the diameter of a baseball *no fevers
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Child blacked out. C/O dizziness and light headedness. Lowered to ground and unresponsive approximately 5 seconds and then responsive.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain
Clinical narrative: The pharmacist injected the shot into my upper arm and directly into the bursa sac resulting in tremendous pain, inflammation. Resulting in medication, PT, and potential cortisone shots and other methods.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Electrocardiogram, Oropharyngeal pain, Throat irritation
Clinical narrative: Chest tightness, throat felt like it was closing, throat itching/sore, dizziness.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Chest tightness, throat felt like it was closing, throat itching/sore, dizziness.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Skin reaction
Clinical narrative: Red spots on forearm on the arm I received the shot on. I noticed it 2 hours after the shot.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Chills, Headache, weakness, unusual tiredness, sleeping 12 hours or more daily, and nausea.  Physician prescribed medication on 09/26/2016.  Improved on 09/28/2016.  Absolutely without doubt this illness was brought on by the injection of the flu vaccination. I was healthy without any symptoms just hours before the injection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Chills, Headache, weakness, unusual tiredness, sleeping 12 hours or more daily, and nausea.  Physician prescribed medication on 09/26/2016.  Improved on 09/28/2016.  Absolutely without doubt this illness was brought on by the injection of the flu vaccination. I was healthy without any symptoms just hours before the injection.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed significant swelling, warmth, redness, and pain near injection site. Patient also reported shivering and diarrhea. Patient treated with cold compresses and acetaminophen.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient developed significant swelling, warmth, redness, and pain near injection site. Patient also reported shivering and diarrhea. Patient treated with cold compresses and acetaminophen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Eye swelling, Eyelid function disorder
Clinical narrative: Sudden onset of left eye swelling and his eye is almost swollen shut. No difficulty breathing, swallowing or drooling.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 6cm x 3.5cm red, swollen, warm.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Product preparation error
Clinical narrative: Only diluent for MCV administered.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Tremor
Clinical narrative: "Bilateral arm tremors". No alteration in mental status. Similar reaction after receiving 1 yo vaccines per mom.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Basal cell carcinoma, Injection site pain, Injection site reaction, Micrographic skin surgery, Rash erythematous
Clinical narrative: After 3/4 days. Severe pain in left shoulder that continues today. After 1 day a red rash appeared exactly on the injection site. This rash turned out to be basal cell carcinoma that required Mohs surgery treatment. Physical therapy and cortisone for shoulder.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Arthralgia, Back pain, Dizziness, Full blood count normal, Headache
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old female patient of an unspecified race received TRUMENBA (Batch/Lot # and expiration date: M95617, Exp date:Jul2017), via intramuscular route on 18Jul2016, at 0.5 ml in the right arm for immunization. The patient medical history and the patient concomitant medication was none. On the same date the patient also received the second dose of GARDASIL (Manufacturer: Merck, lot M014929, exp.date 27May2017) via intramuscular route in the arm left at 0.5ml single dose for immunization. The patient had received the first dose of human papilloma vaccine on unknown date. The patient experienced the next day of the shots, dizziness, low back pain, headache and pain in the right hand joints all with outcome unknown. The events required a physician visit. A Full blood count was performed on unknown date and was normal. Follow-up (16SEP2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (23Sep2016): additional information received from the same physician includes gender of the patient, lot and expiration date of the vaccines, dosage regimen and anatomical location of the administration of the vaccine, route of administration, date of vaccination. Headache added as adverse event.; Sender's Comments: Linked Report(s) : 2016356581 Legacy paper report number.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Chest discomfort, Headache, Oropharyngeal pain, Pain, Photophobia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An 18 year-old female patient of an unspecified race and ethnicity received for immunization the second dose of TRUMENBA (lot M77282, expiry date 29Jun2017) at 0.5 ml single intramuscular in the right deltoid on 31Aug2016 at 3.30 pm. On the same date the patient also received for immunization the third dose of GARDASIL 9 (Merck, lot M016193) and the second dose of INFLUENZA, (Sanofi, lot U55950A), both intramuscular in the left arm. Medical history included anemia since 29Dec2014 for which the patient took iron pills. Concomitant medications were not reported. The patient previously took the first dose of meningococcal group b rlp2086 on unknown date for immunization. On 01Sep2016 the patient experienced symptoms aching/generalized ache, pounding headache, light sensitivities, fever at 103 F, sore throat and heavy feeling in chest. The patient was visited by a physician due to the events but no treatment nor relevant tests were required. She recovered from fever on 03Sep2016, she was recovering from symptoms aching/generalized ache and pounding headache, outcome of the other reported events was unknown. The reporting nurse considered there a reasonable possibility that the events were related to suspect vaccine meningococcal group b rlp2086. Follow-up (23Sep2016): New information reported from the same contactable nurse includes: suspect vaccine details (dose, route, anatomical location and time of administration of meningococcal group b rlp2086, company, route and anatomical location of administration of human papilloma vaccine and influenza vaccine), further details on medical history, reaction data (updated outcome of events symptoms aching, pounding headache, details on physician visit for the events and no treatment/tests required).
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. An 18 year-old female patient of an unspecified race and ethnicity received for immunization the second dose of TRUMENBA (lot M77282, expiry date 29Jun2017) at 0.5 ml single intramuscular in the right deltoid on 31Aug2016 at 3.30 pm. On the same date the patient also received for immunization the third dose of GARDASIL 9 (Merck, lot M016193) and the second dose of INFLUENZA, (Sanofi, lot U55950A), both intramuscular in the left arm. Medical history included anemia since 29Dec2014 for which the patient took iron pills. Concomitant medications were not reported. The patient previously took the first dose of meningococcal group b rlp2086 on unknown date for immunization. On 01Sep2016 the patient experienced symptoms aching/generalized ache, pounding headache, light sensitivities, fever at 103 F, sore throat and heavy feeling in chest. The patient was visited by a physician due to the events but no treatment nor relevant tests were required. She recovered from fever on 03Sep2016, she was recovering from symptoms aching/generalized ache and pounding headache, outcome of the other reported events was unknown. The reporting nurse considered there a reasonable possibility that the events were related to suspect vaccine meningococcal group b rlp2086. Follow-up (23Sep2016): New information reported from the same contactable nurse includes: suspect vaccine details (dose, route, anatomical location and time of administration of meningococcal group b rlp2086, company, route and anatomical location of administration of human papilloma vaccine and influenza vaccine), further details on medical history, reaction data (updated outcome of events symptoms aching, pounding headache, details on physician visit for the events and no treatment/tests required).
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Impaired work ability, Influenza like illness, Injection site pain
Clinical narrative: This is a spontaneous report received from a contactable Physician via Pfizer sales representative. This Physician reported for a female patient (Daughter). A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at injection site, fatigue, flu like symptoms for 3 days on an unspecified date. She had to call in sick to work until she felt better. The outcome was unknown.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Local reaction, Rash
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that an infant patient of unspecified gender received PREVNAR 13 for immunization at single dose at the age of 2 and 4 months, date unspecified. The patient received also penicillin. Concomitant medications and medical history were not reported. The patient's mother said that the patient had local reactions at 2 and 4 months old with bumps. It was also mentioned that after unspecified 4-month vaccines, the patient got bumps on his backs. Outcome was not reported.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (lot/batch# 1035510 with an expiry date 13-MAY-2017 and dosing details not known). No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1035510 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent. This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Mobility decreased, Nausea, Peripheral swelling, Product quality issue
Clinical narrative: Could not move arm; Headache; arms swell; difficulty in speaking; Nauseous; This is a spontaneous report from a contactable consumer or other non HCP reporting for herself. A 78-year-old female patient (a retired paralegal attorney) received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation.  Medical history included drug allergy to Suplha.  The patient's concomitant medications were not reported.   On an unspecified date, 3 to 4 days before this report the patient had a very bad reaction. On an unspecified date she experienced headache, arms swell, difficulty in speaking, she was nauseous, she could not move arm. The events outcome was unknown.  A Product Complaint was filed.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Speech disorder
Clinical narrative: Could not move arm; Headache; arms swell; difficulty in speaking; Nauseous; This is a spontaneous report from a contactable consumer or other non HCP reporting for herself. A 78-year-old female patient (a retired paralegal attorney) received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation.  Medical history included drug allergy to Suplha.  The patient's concomitant medications were not reported.   On an unspecified date, 3 to 4 days before this report the patient had a very bad reaction. On an unspecified date she experienced headache, arms swell, difficulty in speaking, she was nauseous, she could not move arm. The events outcome was unknown.  A Product Complaint was filed.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Inflammation
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unspecified date at 0.5 ml single for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced joint pain and inflammation on an unspecified date with unknown outcome.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported on behalf of his 18-year-old daughter that received the second dose of TRUMENBA at 0.5ml single dose on unknown date for immunization. Medical history and concomitant medication were not reported. On unknown date the patient had received the first dose of the same vaccine. The patient experienced high fever and headache on unknown date 12 days after receiving her second dose of vaccine. The events were assessed as serious per hospitalization. The outcome of the events was unknown. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug contributed to the development of the reported events.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacy technician concerning a multiple unspecified patients (unknown ages and genders). The patients' pertinent medical history and concurrent conditions were not informed. It was reported that on multiple unspecified dates, the patients received improperly stored doses of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017, dosage and therapy route were not provided). Concomitant therapies were not informed. The temperature was 48F and the time frame 12 hours 20 minutes. There was no previous temperature excursion or call because of a data logger. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports from the same source (MARRS#1609USA009609).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients may have received improperly stored doses of GARDASIL injection (lot # K008931, expiration date 04-MAR-2017 or lot # K011325, expiration date 08-APR-2017, dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccine experienced the temperature excursion at 34 degrees Fahrenheit for 75 hours. Data logger was involved. There were no previous temperature excursions reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M004330, expiration date: 26-JAN-2018, exact dose and route of administration were not reported). Administered dose experienced the temperature excursion of 14 degrees Fahrenheit for 620 minutes and 14 degrees Fahrenheit for 45 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via Merck Vaccine Customer Care (MVCC) refers to two unspecified patients with unknown demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number and expiry date were unspecified). On an unknown date, it was reported that the patients experienced shingles after they were vaccinated at pharmacy. Product quality complaint (PQC) was not involved. The present status of the patients was unknown. Causality assessment was not provided by the reporter. Additional information is not expected as there is no consent to contact the reporter.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain in extremity, Skin warm
Clinical narrative: Patient reported her arm hurt "even when he gave it to me on Monday".  She did not have the red/ hot-to-the touch place until this morning.  She noticed the place on her arm after taking a shower.  I called her regular physician, made an appointment for her to be seen today at 2:15PM. She and I stepped next door to the urgent care to see the NP, who looked at the place and reported a localized reaction/possible cellulitis.  She prescribed Keflex bc of patient's history of pancreatitis and her arm being so sore. NP believes it is just a localized reaction but does not want to take a chance that it develops into anything further.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, RVX, UNK
Symptoms: Lethargy, Pallor, Screaming, Seizure, Somnolence
Clinical narrative: Lethargic (couldn't wake at all), pale, screaming, staring seizures.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Local swelling, Lymphadenopathy
Clinical narrative: Enlarged painful lymph clavicular lymph node, neck swelling, mild ear pain- same side as flu shot.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Dizziness, Dyspnoea, Facial spasm, Heart rate increased
Clinical narrative: Dizzy & disoriented. face 7 neck spasms, Extreme pain to touch on skin all over the body, stabbing pains in organs, lips and tongue swollen, gasping for breath, wheezing, rapid heartbeat. No treatment was provided when she went back to the ER.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Muscle spasms, Pain, Pain of skin, Swollen tongue
Clinical narrative: Dizzy & disoriented. face 7 neck spasms, Extreme pain to touch on skin all over the body, stabbing pains in organs, lips and tongue swollen, gasping for breath, wheezing, rapid heartbeat. No treatment was provided when she went back to the ER.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: Dizzy & disoriented. face 7 neck spasms, Extreme pain to touch on skin all over the body, stabbing pains in organs, lips and tongue swollen, gasping for breath, wheezing, rapid heartbeat. No treatment was provided when she went back to the ER.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on chest, groin, buttocks, arms treated with Benadryl and hydrocortisone cream with improvement.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Rash, Skin warm
Clinical narrative: Baseball sized rash, that is hard and gives off heat.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to 1 month old patient of unknown gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 22-SEP-2016, the patient was inadvertently vaccinated with VAQTA (lot # M032492, expiry date 02-MAR-2018, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further details were provided. This is one of two reports received from the same reporter. Additional information has been requested.
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. No information regarding the patient's medical history or concurrent conditions was provided. On 27-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot# L011534, expiry date 03-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The patient did not report any adverse experience to the pharmacist. There was no product quality complaint involved. Additional information is not expected as the reporter refused consent for follow-up.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Product lot number issue
Clinical narrative: This spontaneous report was received from an office manager and refers to a 19 year old male patient. The patient's concurrent condition included developmental delay, scoliosis, microcephaly, hydrocephaly and allergy to BACTRIM. The patient did not have any concomitant medications. On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 (expiration date: 19-FEB-2017, exact dose and anatomical location were not reported, intramuscular). The reporter reported GARDASIL 9 with lot # K006960 which was not valid for GARDASIL 9. However, Lot # K006960 is valid for GARDASIL. On 24-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # reported as M017983, expiration date 30-MAY-2018, exact dose and anatomical location were not reported, intramuscular). A few minutes after the patient was administered the second dose of GARDASIL 9, he became dizzy, pale and lightheaded. The patient was immediately laid down and monitored for several minutes. Once he recovered on the same day, he left the facility and had been fine since. There were no laboratory tests performed. The relatedness between pallor, dizziness, lightheadedness and GARDASIL 9 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with the first dose of VARIVAX injection (route and site of administration, dose, lot number and expiration date were not reported). She did not receive the second dose of the vaccine yet. On an unknown date in 2016 (reported as recently), after receiving VARIVAX, the patient was taking prednisone (manufacturer unknown). The reporter did not know why the patient was on prednisone (manufacturer unknown) therapy and refused to provide any further details about this event. The outcome of the unspecified adverse event, for which the patient was taking prednisone (manufacturer unknown) and the relatedness between this event and the vaccination with VARIVAX were not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Joint dislocation, Pain
Clinical narrative: Information has been received from a pharmacist referring to a 70 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On 02-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (subcutaneous; dose was unknown) by the pharmacist. The patient came back to the pharmacy on 09-SEP-2016 (reported as a week later), stated that he had to go to an unknown urgent care facility (unspecified date), due to his arm began feeling as though it was dislocated and he was in severe pain. The patient informed the pharmacist that, at the unknown urgent care facility, he was given MOTRIN and told to put ice on his arm. The outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple patients of unknown age. The patients medical history and concurrent conditions were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M022531, expiration date: 23-FEB-2018 (concentration, dose, frequency and via were not reported). Information regarding concomitant medication was not reported. Additionally, it was also reported a temperature excursion of 33.2 degrees Fahrenheit for 30 minutes due to a data logger. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician and refers to the two adult, twins patients (exact age unknown) of an unknown gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, when the patients were children, they were vaccinated with doses of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2016 (reported as "now"), the patients had blood work done to see titers against Hepatitis B virus and the tests were negative. The outcome of the event was unknown. The relatedness between the event and the RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, Weight bearing difficulty
Clinical narrative: Shingles vaccine - pain in left upper arm and neck unable to lift things. 9/22/16 - 9/27/16. Treatment: Sling, Naproxen, ice and stretches.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patient of unknown demography. On 24-AUG-2016, the patient was vaccinated with first dose of RECOMBIVAX HB. On 13-SEP-2016, the patient was vaccinated with second dose of RECOMBIVAX HB (Inappropriate schedule of drug administration). No adverse effect reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Large, warm, red welt; about 4 inches in diameter at injection site.
Age: 24.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Hypoaesthesia oral, Vision blurred
Clinical narrative: Patient called us 2.5 months after she had the vaccine stating that about 2 hours after the vaccine she had an episode of blurred vision and numbness in tongue and mouth. Episode lasted 10 minutes.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hyperaesthesia, Pruritus, Urticaria
Clinical narrative: Patient states he woke up the day following the vaccination with hives on his faces and both forearms. Face and arms were red and itching.  Patient reports taking Benadryl 50 mg by mouth for two days and using hydrocortisone cream on skin which was ineffective.  Patient reports symptoms resolved by day five after vaccination.  Patient denies seeking medical attention after event and reports skin sensitivity to sweat and sun after hives resolved.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient has swelling and redness on arm.
Sex: U
Vaccine: HPV9
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with GARDASIL 9. On an unknown date, the patient experienced unspecified adverse reaction. The outcome of adverse reaction was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the reporter does not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 25-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX (Merck) (lot # L001334 with an expiry date 13-JAN-2017 and dosing details not reported). No other doses were administered. These vaccines were exposed to temperature excursions of 56 degree Fahrenheit for two hours on 12-MAY-2016 and to 28 degree Fahrenheit for 28 hours on 15-AUG-2016. No doses of VARIVAX (lot # L037563, expiry date: 29-SEP-2017) were administered to any patients. There was no prior excursions, the call was because of a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacist refers to multiple unspecified patients of unknown demography. On an unspecified dates, multiple unspecified patients may have been administered improperly stored PNEUMOVAX 23 syringes. Nurse was not sure at the time of the call if she had PNEUMOVAX 23 syringes included in her temperature excursion so she has no lot number or expiration dates to provide. She states that the PNEUMOVAX 23 syringes may have reached -3.6 degree C for 92 hours and 6 minutes, but is unsure if they were actually involved in the office excursion. No adverse effects have been reported. No additional information provided. No product quality compliant (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple unspecified patient with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On unspecified dates in 2016, multiple unspecified patients received improperly stored RECOMBIVAX HB injection 2.5/0.5 (lot # M022077 with expiry date: 10-MAR2019), since the previous excursion on 30-JUN-2016. No adverse effects reported. Temperature/time frame: 1.6 C for 1 hour, 47 minutes. No previous excursions. Data logger involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant regarding unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA (digital logger) (lot # M011116, expiry: 17-JUN-2017; lot# L015460, expiry: 20-JUL-2017). The vaccines were exposed on 10-AUG-2016 at 28.9F for 3.8 hours, on 11-AUG-2016 at 31.8F for 1.7 hours and on 26-AUG-2016 at 31.1F for 3.75 hours. There was no previous temperature excursion. No adverse effects were reported. This is 1 of 3 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was given an additional (the third one) dose of M-M-R II (0.5 ml; route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant, refers to 27 year old female patient. Patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant therapies included amoxicillin. On 20-SEP-2016, pregnant (6 months of gestation) patient was vaccinated with one dose of VARIVAX, subcutaneously, (lot#/exp date unknown). On 20-SEP-2016, the patient came into the office with an upper respiratory infection and she was erroneously vaccinated. No adverse symptoms reported. The LMP and EDD was not known. No treatment was given for the adverse events. Lab diagnostics studies performed was reported as none. The outcome of the events was unknown. Patient sought medical attention by visiting physician's office. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX which had lot # M000997 with expiry date: 07-JAN-2018, lot # M003441 with expiry date: 19-JAN-2018, lot # M009764 with expiry date: 23-FEB-2018 and lot # M017290 with expiry date: 07-APR-2018, (dosing details not provided). The vaccines were exposed to a temperature of 26.6 Celsius Fahrenheit for 1 hour 36 minutes. The call was because of data logger. No adverse effects reported. No further information provided. This is one of two cases received from the same reporter. 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 nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 (lot#, expiry date, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 38 year old female patient. No medical history and concurrent conditions were reported. On 06-SEP-2016 the patient was vaccinated with PNEUMOVAX 23, (lot number and expiry date unknown) (dosing regimen and frequency unknown) intramuscularly. No concomitant medications were reported. On 07-SEP-2016 (also reported as the next day), the patient complained of arm was swollen, red and hot to touch (unspecified which arm). It was reported that the patient sought medical attention and went back to the pharmacy. No treatment was given for the events. There was no product quality complaint reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. On 09-SEP-2016 the patient stated that she felt much better. The outcome of the peripheral swelling, skin warm and erythema was reported as recovering. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Chills, Feeling cold, Influenza like illness, Nasopharyngitis, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to multiple patients of unknown age and gender. The patients medical history and concurrent conditions were unknown. On an unspecified date, multiple unknown patients were vaccinated simultaneously with ZOSTAVAX (lot number, expiration date, concentration, dose, frequency and route of administration were unknown) and PNEUMOVAX 23 (lot number, expiration date, concentration, dose, frequency and route of administration were unknown). Information regarding concomitant therapy was unknown. On an unknown date, multiple patients experienced flu like symptoms (influenza like illness) cold chills, cold (nasopharyngitis) and nausea. Additionally, it was also reported that the patients sought medical attention. At the time of the report, the outcome of flu like symptoms (influenza like illness), cold chills, cold (nasopharyngitis) and nausea was unknown. The causality between ZOSTAVAX and PNEUMOVAX 23 with flu like symptoms (influenza like illness), cold chills, cold (nasopharyngitis) and nausea was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization specialist regarding an unspecified patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified date, an unspecified patient received an improperly stored dose of either PROQUAD with lot# M026879, expiry date 27-NOV-2017 or VARIVAX with lot# M008171, expiry date: 16-FEB-2018 or VARIVAX with lot# M024683, expiry date: 18-MAY-2018 (dosing details not reported). It was unknown which of the three vaccines listed were administered to the unspecified patient. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored VARIVAX lot # M008171/expiration date-16-FEB-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Chills, Influenza like illness, Nasopharyngitis, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. On 08-SEP-2016, the patient was administered simultaneously PNEUMOVAX 23 (lot number, expiration date, concentration, dose, frequency and route of administration were unknown) and ZOSTAVAX (lot number, expiration date, concentration, dose, frequency and route of administration were unknown). Information regarding concomitant medications were unknown. On 09-SEP-2016, the patient experienced flu like symptoms, cold chills, cold and nausea. At the time of the report, the outcome of flu like symptoms, cold chills, cold and nausea was unknown. The causality between PNEUMOVAX 23 and ZOSTAVAX regarding the adverse events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patient was vaccinated with improperly stored at a temperature of 14.8 F for 30 minutes ZOSTAVAX lot # M023687 (expiry date: 28-JUN-2017), subcutaneously (dosage not reported). There was a previous temperature excursion for 19 hours at 18F. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the dose of GARDASIL (dose, route, lot # and expiration date were not reported). On 21-SEP-2016, the patient was vaccinated with the dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patient was vaccinated with GARDASIL at the age of 11 years, 12 years and 13 years with the first, second and third dose respectively via the intramuscular route. The patient also received a fourth dose of either GARDASIL 9 or GARDASIL (unspecified Merck HPV vaccine). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Rash, papular bilateral lower and upper extremities. Also on trunk, 2 ml BENADRYL given in clinic. Pt's mother did not notice rash until morning after vaccines given. Also with low grade fever of 99.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of PEDVAXHIB (lot #, expiry date, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were in advertently vaccinated with improperly stored doses of M-M-R II (lot #, expiry date, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling started up where vaccines were administered, now moved down arm now, tender, only a little sore now.