chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Joint swelling, Oedema
Clinical narrative: This spontaneous report as received from a physician via Poison and Drug Center refers to a 60 year old female patient with allergy to codeine. There was no information about the patient's pertinent medical history reported. On 12-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route of administration were not reported) frequency reported as once (also reported as 1 shot) in the arm. Concomitant therapies included TRAMADOL and doxycycline. On 12-MAR-2016, the patient experienced swelling and pain in her arm at the injection site. The swollen area was 3 cm (also reported as 3 inches in length on arm). She developed hardness at the injection site, and her ankles and knees became swollen. She stated, the her ankles were double than the normal size. On 15-MAR-2016, the patient developed diffuse bilateral leg swelling, also described as severe swelling of both legs, knees and ankle joints and "4+" pitting edema. The outcome of the events was reported as not recovered. The patient sought medical attention and called pharmacist. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician via Poison and Drug Center refers to a 60 year old female patient with allergy to codeine. There was no information about the patient's pertinent medical history reported. On 12-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route of administration were not reported) frequency reported as once (also reported as 1 shot) in the arm. Concomitant therapies included TRAMADOL and doxycycline. On 12-MAR-2016, the patient experienced swelling and pain in her arm at the injection site. The swollen area was 3 cm (also reported as 3 inches in length on arm). She developed hardness at the injection site, and her ankles and knees became swollen. She stated, the her ankles were double than the normal size. On 15-MAR-2016, the patient developed diffuse bilateral leg swelling, also described as severe swelling of both legs, knees and ankle joints and "4+" pitting edema. The outcome of the events was reported as not recovered. The patient sought medical attention and called pharmacist. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Anger, Asthenia, Blood iron decreased, Depression
Clinical narrative: This spontaneous report as received from a patient's mother via a registered nurse refers to an 11 year old non-pregnant, female patient. The patient had no history of drug reactions or allergies. The patient's pertinent medical history and concomitant medications were not reported. On 12-FEB-2015, the patient received first dose of GARDASIL, lot# K005881, (route and site of administration and expiry date not reported). On 17-APR-2015, the patient received second dose of GARDASIL, lot# K005881 (route and site of administration, expiry date not reported). On 12-AUG-2015, the patient was vaccinated with GARDASIL 9, lot # L004741 (route and site of administration and expiry date not reported), last dose in the series. Patient's mom reported to nurse that, in approximately 2015, the patient experienced cold-like symptoms, fever and tiredness after first GARDASIL shot. Weakness, lethargy and fever after second GARDASIL shot (approximately in 2015) and depression, anger, lethargy, vomiting, and abdominal pain after last dose of GARDASIL 9 (approximately in 2015). Since approximately January 2016, also reported as in the last three months, patient lost a lot of weight and went from a happy, chubby child to skinny and depressed one. On an unknown date, the patient had blood work done which showed very low iron and vitamin B12 level. In approximately March 2016, also reported as last week, the patient visited the nurse in the office and was given intravenous vitamin called "Myers cocktail".  At the time of this report, the patient did not recover from the adverse events. The relatedness between the events and suspect therapies was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Pyrexia, Vitamin B12 decreased, Vomiting, Weight decreased
Clinical narrative: This spontaneous report as received from a patient's mother via a registered nurse refers to an 11 year old non-pregnant, female patient. The patient had no history of drug reactions or allergies. The patient's pertinent medical history and concomitant medications were not reported. On 12-FEB-2015, the patient received first dose of GARDASIL, lot# K005881, (route and site of administration and expiry date not reported). On 17-APR-2015, the patient received second dose of GARDASIL, lot# K005881 (route and site of administration, expiry date not reported). On 12-AUG-2015, the patient was vaccinated with GARDASIL 9, lot # L004741 (route and site of administration and expiry date not reported), last dose in the series. Patient's mom reported to nurse that, in approximately 2015, the patient experienced cold-like symptoms, fever and tiredness after first GARDASIL shot. Weakness, lethargy and fever after second GARDASIL shot (approximately in 2015) and depression, anger, lethargy, vomiting, and abdominal pain after last dose of GARDASIL 9 (approximately in 2015). Since approximately January 2016, also reported as in the last three months, patient lost a lot of weight and went from a happy, chubby child to skinny and depressed one. On an unknown date, the patient had blood work done which showed very low iron and vitamin B12 level. In approximately March 2016, also reported as last week, the patient visited the nurse in the office and was given intravenous vitamin called "Myers cocktail".  At the time of this report, the patient did not recover from the adverse events. The relatedness between the events and suspect therapies was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Depression
Clinical narrative: This spontaneous report as received from a registered nurse refers to 21 patients of unknown age and gender that were found on Vaccine Adverse Event Reporting System (VAERS website). The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unidentified Merck hpv vaccine (name and lot number were not provided). On unknown dates, patients experienced severe depression/ The outcome of severe depression was unknown. The relatedness between the event and suspect therapy was not provided. This is one of tow reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 16-MAR-2016, the patient was inadvertently administered an expired dose of M-M-R II lot # K003823, expiration date 14-MAR-2016 (dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-MAR-2016 the patient was vaccinated with expired ROTATEQ suspension 2 lot # K006457, expiry date of 09-MAR-2016, 2 ml, orally. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Skin tightness, Vaccination site reaction, Vaccination site warmth
Clinical narrative: On 3/11/16 pt presented to urgent care with mother reporting redness, heat and tightness at vaccine site no pain or fever. Dx: cellulitis Dr prescribed cephalexin. Pt presented to Dr for follow up on 3/18/16 with complete resolution.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: First reported in February.  States intermittent lump at injection site.  Comes and goes.  Sometimes warm to touch and painful.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site streaking, Pyrexia
Clinical narrative: Patient reported mild fever, moderate/severe pain in left upper arm (injection site), red streaking, edema.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Mother states problem began on left arm at injection site and then extended to shoulder and wrist of left arm. Area became red, hot, hard, raised, painful, and itchy over the course of a few days following vaccination. She states that after about 4-5 days post-vaccination these symptoms simply went away and there are no residual symptoms.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site warmth
Clinical narrative: Mother states problem began on left arm at injection site and then extended to shoulder and wrist of left arm. Area became red, hot, hard, raised, painful, and itchy over the course of a few days following vaccination. She states that after about 4-5 days post-vaccination these symptoms simply went away and there are no residual symptoms.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: FAINT.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Alopecia, Anxiety, Arthralgia, Fatigue, Headache
Clinical narrative: After the second vaccine on 2/19/16 patient began experiencing headaches, extreme fatigue, massive hair loss, joint pain, anxiety and general malaise.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Malaise
Clinical narrative: After the second vaccine on 2/19/16 patient began experiencing headaches, extreme fatigue, massive hair loss, joint pain, anxiety and general malaise.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Alopecia, Anxiety, Fatigue, Headache, Hepatitis B surface antibody negative
Clinical narrative: After the second vaccine on 2/19/16 patient began experiencing headaches, extreme fatigue, massive hair loss, joint pain, anxiety and general malaise.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Alopecia, Alopecia areata, Anxiety, Arthralgia, Fatigue
Clinical narrative: After the second vaccine on 2/19/16 patient began experiencing headaches, extreme fatigue, massive hair loss, joint pain, anxiety and general malaise.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Headache, Hepatitis B surface antibody negative
Clinical narrative: After the second vaccine on 2/19/16 patient began experiencing headaches, extreme fatigue, massive hair loss, joint pain, anxiety and general malaise.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pyrexia, Rash
Clinical narrative: 24 HOURS AFTER ADMINISTRATION PATIENT DEVELOPED A FEVER AND FLU LIKE SYMPTOMS. 48 HOURS AFTER ADMINISTRATION PATIENT BEGAN TO DEVELOP RASH THAT SPREAD FROM SHOULDER TO ELBOW. SEEN IN URGENT CARE AND DIAGNOSED WITH MILD CASE OF SHINGLES.
Age: 22.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: No report received from patient.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Fluid intake reduced, Lethargy, Malaise, Pyrexia, Rash generalised
Clinical narrative: High fever, lethargy, generally unwell, no desire to drink, followed by full body rash 3 days later.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on the 16th.  Worsened on the 18th. Fever spiked the 18th.  Fever worsened, rash worsened on the 19th.  Rash got better, but still present on the 21st, fever still present.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Sharp pain in left shoulder when raising arm in the same area where the flu shot was administered.
Age: 33.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Sharp pain in left shoulder when raising arm in the same area where the flu shot was administered.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dyspnoea, Lip swelling, Pruritus, Rash erythematous
Clinical narrative: DIARRHEA. RED BUMPS NEAR INJECTION SITE INITIALLY THEN SWELLING NEAR INJECTION SITE WITHIN THE SAME DAY. OVER THE NEXT TWO DAYS, LIPS STARTED SWELLING, HIVES ON THE FACE, ITCHY SCALP, TROUBLE BREATHING (USING INHALER MORE FREQUENTLY).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: DIARRHEA. RED BUMPS NEAR INJECTION SITE INITIALLY THEN SWELLING NEAR INJECTION SITE WITHIN THE SAME DAY. OVER THE NEXT TWO DAYS, LIPS STARTED SWELLING, HIVES ON THE FACE, ITCHY SCALP, TROUBLE BREATHING (USING INHALER MORE FREQUENTLY).
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Influenza like illness
Clinical narrative: Sore arm, fever, nauseousness, diarrhea, dizziness, flu like aches and pains, chills, extremely weak.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, nauseousness, diarrhea, dizziness, flu like aches and pains, chills, extremely weak.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Sensory disturbance
Clinical narrative: Swelling in arm in which the vaccine was administered as well as a bruised feeling but without any bruising. Patient was instructed by pharmacist to treat pain with Aleve to alleviate pain.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Arthrogram, Asthenia, Injection site pain, X-ray
Clinical narrative: The flu shot was injected high on the left arm near the shoulder resulting in left shoulder pain and weakness which progressively increased with time. No pain prior to flu shot.
Age: 3.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: High fever resulting in seizure. Spike in temp to 103 recorded by ear. Seizure lasting about 90 seconds. Treatment: rest, children's ibuprofen and Tylenol, pedialite.
Sex: U
Vaccine: RAB
Symptoms: Blood pressure increased, Inappropriate schedule of drug administration
Clinical narrative: Case number PHEH2015US009658 is an initial spontaneous report from nurse received on 14 May 2015. This report refers to a patient of unspecified age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: unknown) on an unknown date. The patient came for the repeat dose but it was held for 1 day because the blood pressure was elevated. The outcome, seriousness and causality was not reported.
Age: 60.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthenia, Headache, Limb discomfort, Pain, Paraesthesia
Clinical narrative: Case number PHEH2015US009845 is an initial spontaneous report received from a consumer on 19 May 2015 with a follow up information received from the consumer on 20 May 2015. This report refers to a 60 year old male patient. His medical history and concomitant medications were not reported. His vaccination history included complete post exposure series with RABAVERT, (batch number: not reported) 5 years ago after a bat attack and he experienced headache, feeling of heaviness in arms, weakness and soreness all over the body and tingling (see related case number: PHEH2015US010209). He had a bat exposure and was vaccinated with first dose of post exposure RABAVERT, (batch number: 556011A) intramuscularly on 12 May 2015 at 10:40 AM. On the same day, within hours after the administration of first dose, he felt weakness, headaches, feeling of heaviness in arms and soreness all over the body (not only limited to injection site). The consumer did not seek medical care or informed physician about the event. The events outcome, seriousness and causality were not reported. He was further vaccinated with second dose of post exposure (batch number: 556011A) intramuscularly on 19 May 2015 and experienced tingling (see related case numbers PHEH2015US010210 and PHEH2015US010211 (for schedule deviation)). No further information was provided.
Age: 60.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Paraesthesia
Clinical narrative: Case number PHEH2015US009845 is an initial spontaneous report received from a consumer on 19 May 2015 with a follow up information received from the consumer on 20 May 2015. This report refers to a 60 year old male patient. His medical history and concomitant medications were not reported. His vaccination history included complete post exposure series with RABAVERT, (batch number: not reported) 5 years ago after a bat attack and he experienced headache, feeling of heaviness in arms, weakness and soreness all over the body and tingling (see related case number: PHEH2015US010209). He had a bat exposure and was vaccinated with first dose of post exposure RABAVERT, (batch number: 556011A) intramuscularly on 12 May 2015 at 10:40 AM. On the same day, within hours after the administration of first dose, he felt weakness, headaches, feeling of heaviness in arms and soreness all over the body (not only limited to injection site). The consumer did not seek medical care or informed physician about the event. The events outcome, seriousness and causality were not reported. He was further vaccinated with second dose of post exposure (batch number: 556011A) intramuscularly on 19 May 2015 and experienced tingling (see related case numbers PHEH2015US010210 and PHEH2015US010211 (for schedule deviation)). No further information was provided.
Age: 46.0
Sex: F
Vaccine: MMRV, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Client is doing fine.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Erythema, Gait disturbance, Injection site pain, Skin warm, Swelling
Clinical narrative: Mom presented with 2 year daughter who received routine vaccinations on 1/12/16. Right leg received DTaP (SK, Lot #94F5K), Hib (Merck, Lot # L014426) and PCV 13 (lot # L62074) and left leg received flu vaccine (SK, 4J449) and Hep A (SKB Lot # 423SD). Mom advised redness and swelling began 24 hours after vaccination and increased to 2 in by 1.5 in oval hard red are that was warm to touch. There is a 3/4 inch circle bruise around one vaccine site. She advised child limped on right leg yesterday and c/o tenderness when first thing in morning. She denied any fever, rash, or other systemic symptoms. Mom gave her TYLENOL for pain with relief. Case 7171.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Vaccination site bruising
Clinical narrative: Mom presented with 2 year daughter who received routine vaccinations on 1/12/16. Right leg received DTaP (SK, Lot #94F5K), Hib (Merck, Lot # L014426) and PCV 13 (lot # L62074) and left leg received flu vaccine (SK, 4J449) and Hep A (SKB Lot # 423SD). Mom advised redness and swelling began 24 hours after vaccination and increased to 2 in by 1.5 in oval hard red are that was warm to touch. There is a 3/4 inch circle bruise around one vaccine site. She advised child limped on right leg yesterday and c/o tenderness when first thing in morning. She denied any fever, rash, or other systemic symptoms. Mom gave her TYLENOL for pain with relief. Case 7171.
Age: 4.0
Sex: F
Vaccine: HPV4, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: On accident grabbed the wrong vaccine. Until entering lot number in the computer realized it was the wrong vaccine. GARDASIL given instead of KINRIX.
Age: 14.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Extra dose given #6 dtap/#5 polio (KINRIX). This vaccine was given by myself, in error. I asked PSR to help me translate for this conversation. Had paperwork/immunizations orders  for a "specific named boy". A  young boy was sitting in lobby with parents. There was also another female parent sitting with a young girl in lobby. I called out "the boys name", the young boy with both parents turned  and looked at me and smiled, I called out "the boys name" a second time, to question if that was pt. Father nodded and stood up and followed me back to immunization area. Pt father then greeted me, I explained to father that school letter indicated that two vaccines were needed (Dtap/IPV) I told father that I was able to give a combo (KINRIX), so that he would only be receiving one vaccine. Father agreed and took VIS along with school note from my hand. I then proceeded to prep/give vaccine to child in Lt arm. After father walked out with pt, then it was brought to my attention that "the boy" just returned from being outside of the building and that he was ready to vaccinated. That is when I realized that there was another child that was waiting outside the building for vaccines and that I gave the incorrect vaccine to this pt. I quickly approached pt with father and explained to him that I gave his child, a vaccine by mistake. I explained to father that when I called out the boys name, both he and wife and child turned to look at me. When I called out the second time for the boy, they then stood up and walked towards me. Father acknowledges and understood what happened. He did not ask to speak with my supervisor/director. I reviewed school letter for boy that he brought. it indicated that he needed a second Hep A. Pt had vaccines in Jan 2026, Pt did not need any vaccines today. I printed and gave father all vaccines listed for his school. I reported this incident to my director, then to my providers, FNP and Dr. I then completed a VAERS form.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed some redness and swelling around the injection site 3-16-16 per ER notes. BP 131/103, other vitals "within normal limits". Normal range of motion. Lungs clear, no wheezes, rhonchi or rales. No rashes - area of redness approx size of baseball. Warm to touch, slightly painful to palpation - patient states painful to move arm - ER gave clindamycin for cellulitis 3-16-16. Cold compresses ibuprofen for pain/swelling suggested by office 3-17-16.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Patient noticed some redness and swelling around the injection site 3-16-16 per ER notes. BP 131/103, other vitals "within normal limits". Normal range of motion. Lungs clear, no wheezes, rhonchi or rales. No rashes - area of redness approx size of baseball. Warm to touch, slightly painful to palpation - patient states painful to move arm - ER gave clindamycin for cellulitis 3-16-16. Cold compresses ibuprofen for pain/swelling suggested by office 3-17-16.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 5 patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L039092, expiration date 06-OCT-2017, dose and route not reported). It was reported that the vaccine was exposed to the following conditions: 3.5 centigrade for 3 hours and 14 minutes. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 02-NOV-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as 1002873, expiration date: 27-JAN-2017, route and dose were unknown) which was improperly stored. There was no previous temperature excursion. No adverse reaction was reported. Lot number 100287 has been verified to be a non-valid lot number for MMR vaccine. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 06-NOV-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as 1002873, expiration date: 27-JAN-2017, route and dose were unknown) which was improperly stored. There was no previous temperature excursion. No adverse reaction was reported. Lot number 100287 has been verified to be a non-valid lot number for MMR vaccine. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a pediatric patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-MAR-2016, the patient was vaccinated with an expired dose of VARIVAX (Merck), the second dose in series, 0.5 ml expiration date 06-MAR-2016 (lot # unspecified), subcutaneously. No adverse effects were reported. It was also reported that therapy with VARIVAX (Merck) was continued. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a physician, via Pfizer (2014013743), referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). According to the reporter, on an unspecified date, the patient presented an allergic reaction to the therapy (drug hypersensitivity). The outcome of drug hypersensitivity was unknown at the time of this report. The reporter did not provide a causality assessment between the event and therapy with M-M-R II. This is one of two reports from the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 30 years old female patient. The patient previously had rubella antibody negative after receiving an unspecified number of doses of M-M-R II (captured in MARRS # 1602USA002598). On 03-FEB-2016, the patient received a dose of PROQUAD (Merck) at 10:56 am injection, lot# L033692, expiration date 28-FEB-2017 (Right arm, subcutaneously). The patient did not have any adverse effects from this vaccine. No product quality issues was involved. Additional information is not expected as follow-ups to complete the case have already been received.
Age: 29.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a 30 years old female patient. The patient previously had rubella antibody negative after receiving an unspecified number of doses of M-M-R II (captured in MARRS # 1602USA002598). On 03-FEB-2016, the patient received a dose of PROQUAD (Merck) at 10:56 am injection, lot# L033692, expiration date 28-FEB-2017 (Right arm, subcutaneously). The patient did not have any adverse effects from this vaccine. No product quality issues was involved. Additional information is not expected as follow-ups to complete the case have already been received.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Dyspnoea, Feeling hot, Flushing, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 38 year old female patient. The patient's medical history included a liver transplant in 2000. The patient did not have drug allergies or drug reactions. On 16-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular, in the left deltoid, lot number L019835, expiration date 23-MAR-2017, (dose not reported). The patient's concomitant therapies included tacrolimus and sirolimus. On 16-MAR-2016, a few hours after vaccination, the patient developed generalized warmth, facial flushing, tingling of lips, fever of 38.4 degrees C and backache. The patient was admitted in the hospital on the same date. It was reported that at the time of the report, the patient had not been discharged from the hospital. The reporter pharmacist required for lot check. At the time of the report, the outcome of the patient developed generalized warmth, facial flushing, tingling of lips, fever of 38.4 degrees C and backache was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. There was no PQC involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Feeling hot, Flushing, Paraesthesia oral, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 38 year old female patient. The patient's medical history included a liver transplant in 2000. The patient did not have drug allergies or drug reactions. On 16-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular, in the left deltoid, lot number L019835, expiration date 23-MAR-2017, (dose not reported). The patient's concomitant therapies included tacrolimus and sirolimus. On 16-MAR-2016, a few hours after vaccination, the patient developed generalized warmth, facial flushing, tingling of lips, fever of 38.4 degrees C and backache. The patient was admitted in the hospital on the same date. It was reported that at the time of the report, the patient had not been discharged from the hospital. The reporter pharmacist required for lot check. At the time of the report, the outcome of the patient developed generalized warmth, facial flushing, tingling of lips, fever of 38.4 degrees C and backache was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. There was no PQC involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. The nurse reported that the patient was inadvertently administered a dose of PROQUAD (Merck) (dose and route not reported, lot # L024125 with expiration date 30-DEC-2016) and a dose of VARIVAX (Merck) (dose and route not reported. lot # K007785 with expiration date 28-MAY-2016) (overdose) during the same office visit "today", on 18-MAR-2016. The nurse reported that the patient was supposed to receive a dose of M-M-R II (wrong vaccine administered) and VARIVAX (Merck), however, she inadvertently "grabbed the wrong vial". The primary reporter reported that both the M-M-R II vial and the PROQUAD (Merck) vial had "blue writing on the vials" and both had "measles - mumps - rubella" on the labels (product label confusion), but PROQUAD (Merck) also had varicella written on the label and she did not read the label completely. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot #, dosage and route not reported). On an unknown date the patient had allergic reaction to PNEUMOVAX23. It was not a severe allergic reaction. The outcome of the event was not reported. Action taken was not applicable. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event, Product reconstitution issue
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provide. On 07-MAR-2016 the patient was vaccinated with a dose of ZOSTAVAX (1 dose form (DF), lot #, expiration date and route unspecified), which was reconstituted with expired sterile diluent (Merck Sterile Diluent) (lot # L003601, expiration date 24-JAN-2016). No adverse effects were reported. This is one of two received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a pharmacist via company representative referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 10-MAR-2016 (reported as "one week ago"), the patient was vaccinated with a shot of ZOSTAVAX (dose and lot#, unknown) subcutaneously. The patient's concomitant medication was not reported. On 10-MAR-2016 (reported as "one week ago"), after the shot, the patient had developed spots and had to be hospitalized. Unspecified treatment was given. The patient had subsequently been discharged. The outcome of the event was reported as recovering/resolving. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No known adverse event at this time.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates starting on or after 23-FEB-2016") the patients were vaccinated with improperly stored VAQTA (dosing regimen unspecified) (lot L028666, expiry 04-NOV-2016; lot L023232, expiry 25-FEB-2017; lot L039659, expiry 15-MAR-2017; lot L041676, expiry 15-MAR-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 1C, Time frame: 25 hours, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. GARDASIL 9 and MMR II appear in the product list as these products were involved in the excursion, however no improperly stored doses of GARDASIL 9 or MMR II were administered. No additional information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist regarding a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies or concomitant medication reported. On 11-MAR-2016, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot# L024118 with expiration date of 26-MAR-2017), intramuscularly (dose was not reported), which were stored at 80 F for 12 hours. The vaccines did not have previous temperature excursion. No adverse effects reported. Additional information is not expected as no consent was provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (orally, dose was not reported, lot # L013192, expiration date 19-JAN-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information is not expected as there is no permission to contact the physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown demographics. Approximately in 2016 (also reported as "unspecified dates starting on or after 23-FEB-2016") the patients were vaccinated with improperly stored GARDASIL injection (dosing regimen unspecified) (lot L040459, expiry 06-APR-2017; lot K014191, expiry 10-MAY-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 1C, Time frame: 25 hours, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. GARDASIL 9 and M-M-R II appear in the product list as these products were involved in the excursion, however no improperly stored doses of GARDASIL 9 or M-M-R II were administered. No additional information was provided. This is one of the two reports from the same reporter. 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 health care worker regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (dose and route were not reported, lot # K018181, expiration date 04-JAN-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information is not expected as there is no permission to contact the physician.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-MAR-2016, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L008271, expiration date: 11-MAR-2017; dose and route were not provided), which was exposed to -14.6 degrees Celsius for 40 minutes on 18-FEB-2016. The reporter did not specify whether or not the patient experienced any adverse effects. 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 healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # K007781 with expiration date 28-MAY-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 77.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old patient of unknown gender. There was no information about concurrent condition, medical history or concomitant medication. On 05-MAR-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K007826 and expiry date 03-FEB-2016) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patient was vaccinated with GARDASIL (dosing details unspecified). On an unknown date, unspecified time after vaccination, the patient fainted. No Product Quality Complaint (PQC) was involved. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, public health consultant, referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (lot # L018501 and lot L027733, route, dose and expiration date were unknown) which were improperly stored (lot L027733 in 29.6 Fahrenheit (F) for 30 hours and 15 minutes, lot # L018501 in 30.6 F 69 hours). There was no previous temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of ROTATEQ (lot # L035508, expiration date 12-MAY-2017) (dosage and strength unknown, oral) that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes) were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician via a company representative, referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. The physician mentioned that the patient might have been vaccinated with PNEUMOVAX 23 (strength, dose, route, lot# and expiration ate were not reported) on an unknown date, and might have subsequently received another dose of PNEUMOVAX 23 on an unknown date approximately 3 months later. No adverse symptoms were reported. Additional information is not expected as the physician did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative concerning 2 or 3 patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were unknown). Concomitant medication was not reported. On unknown dates within 30 days following vaccination, the patients developed a mile case of shingles. Outcome of the event was unknown. Additional information is not expected as we have no consent to contact the pharmacist.
Sex: U
Vaccine: HEP, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (lot # L034370 with expiry date 08-SEP-2017) (dosage and route not reported) and RECOMBIVAX HB (lot # L027733 with expire date 13-SEP-2017) (dosage and route not reported). The patients received improperly stored (Oka/Merck) VARIVAX which was reconstituted with improperly stored RECOMBIVAX  HB. The conditions storage of (Oka/Merck) VARIVAX was 40 F for 100 hours then was back in range. The conditions storage of RECOMBIVAX HB was: maximum temperature 47 F for 21  hours and minimum temperature 29 F for 273 hours (multiple cycles, more than 3). There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter.  Additional information has been requested.
Age: 1.39
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's leg was slightly warm to touch, red localized color and some swelling. No fever or breathing issues. 3/17/16 Dr spoke with patient's father. Swelling resolved completely few hours after injection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On unknown dates, these patients were vaccinated with improperly  stored (temperature: 12 degrees Celsius, time frame: 8.5  hours) doses of M-M-R II injection (lot # L012482, expiry date: 10-APR-2017, albumin status: rHA; strength, dose, route and site of administration were unspecified). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapy was reported. On 17-MAR-2016, the patient was administered with a dose of improperly stored ZOSTAVAX injection (lot # reported L027327, expiration date 21-OCT-2016; dose and route of administration not reported). The previous excursion was reported as 12.2 F for 694 hours (cumulative) and the new excursion was reported as 7.7 F for 16 hours (new total cumulative was reported as max temperature 12.2 F, total time 710 hours). No adverse effect was reported. Lot number L027327 is an invalid lot number for ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.