chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was received from a physician regarding a patient of unknown age and gender, with no historical conditions, concurrent conditions, or concomitant medications provided. On 30-JAN-2018, the patient received an expired dose of PNEUMOVAX, intramuscular, lot: M026317, expiration date: 11-JAN-2018, for prophylaxis purposes. There were no known adverse effects after the vaccination with the expired dose of PNEUMOVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The reporter did not mentioned that the patient had current condition, concomitant medication or prior medical history. No past drug history or allergies were reported. On 30-JAN-2018 the patient was vaccinated with an expired dose of ZOSTAVAX lot # M041085 and expiration date 03-JAN-2018, for prophylaxis (strength, route, dosage and schedule was not provided). "No adverse effects" were reported.
Sex: F
Vaccine: HPV9
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 27 year old female patient. On an unknown date/dates the patient was vaccinated with dose 1 and dose 2 of GARDASIL 9 (dosing regimen, lot number and expiration date not reported) intramuscularly for prophylaxis. On 29-JAN-2018 (reported as recently) the patient had a positive pap smear which was performed by an unknown practitioner. The patient was seen at the provider's office for this event but no treatment was given. There was no product quality complaint involved. The status of the patient and the outcome of the event was unknown at the time of the report. Causality assessment was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 31-JAN-2018, the patient inadvertently received an expired dose of ZOSTAVAX (strength, dose and frequency were not reported) (lot # M041087, expiration date: 03-JAN-2018) subcutaneously for prophylaxis. The administered dose of ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). No adverse effects were reported. There was no product quality complaint (PQC) reported.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED APPROXIMATELY 15-20 MINUTES AFTER INJECTION.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, throwing up, arm soreness and tenderness where injection was given.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Chest discomfort, Hypoaesthesia, Nausea, Vomiting
Clinical narrative: An hour after receiving vaccine patient had numbness in her arm, neck, back, and face. After about 5 hours member started having chest tightness, nausea, and vomiting. Member went to the urgent care center and was given steroids and sent home. Patient will be getting with her primary care physician to talk about whether or not she will receive anthrax in the future.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Cellulitis, Erythema, Inflammation, Insomnia, Tenderness
Clinical narrative: Red, inflamed, sore to touch, cannot sleep on that arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection site produced a large red swollen and warm to touch from deltoid down to middle of arm.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient report to her mother that her left arm hurt after vaccinations given on 11/22/17. Initially patient had pain and swelling at site. Subsided. In January 2018 patient tells mom that her left arm has begun to hurt again. Mom states "there's a nodule at the injection site. Denies redness, fever, warmth or drainage. Seen at Family Physicians and was prescribed Azithromycin.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: MD ordered FLUZONE 0.25ml IM but FLUZONE 0.5ml IM instead. Parent called today 24H later (today) and child had no symptoms and no injury.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING WITH DISCOMFORT DUE TO SWELLING RANGING FROM INJECTION SITE DOWN TO ELBOW.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Extensive Upper Arm Swelling and Pain by 02/02/2018 6:00 pm. Swelling and Pain Moved to Elbow Area by 02/03/2018 8:00 am. Swelling and Pain Moved to Forearm Area by 02/04/2018 8:00 am.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoaesthesia, Vision blurred
Clinical narrative: Client received flu vaccine and 24 hours later experienced dizziness, blurred vision, and numbness to hand and nose which lasted approximately 5 minutes per report from MD clinic MD per nurse reports no symptoms since that time and there was no notable redness or swelling to the site. MD per nurse states that the client presented to the clinic as she had never experienced those symptoms with previous flu vaccines.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Generalized tonic-clonic seizure. No adverse outcomes. Lasted less than 5 minutes. Evaluated in the ER following the seizure and no abnormalities on exam. She had no other symptoms prior to or after the seizure and remained afebrile throughout.
Sex: F
Vaccine: PPV
Symptoms: Blood test, Full blood count, Injection site cellulitis, Injection site reaction, Local reaction
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age with hypertension, chronic obstructive pulmonary disease and diabetes mellitus. The patient's medical history included cerebrovascular accident. On 22-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030111, expiration date: 21-APR-2019, for prophylaxis (strength, dosage and route were not provided). Concomitant therapies included atorvastatin, carvedilol, LASIX, LANTUS, PRINIVIL, metformin, potassium chloride, XARELTO and PEPCID. The registered nurse reported that on 23-JAN-2018, the patient was hospitalized due to a localized reaction at the injection site. Subsequently, the patient had a blood work, comprehensive metabolic panel and complete blood count but the results were not provided. After that the patient was diagnosed with sepsis secondary to cellulitis on an unspecified date in January 2018 and began treatment with intravenous vancomycin and then switched to ANCEF on an unspecified date. Finally, the patient was discharged from hospitalization on 25-JAN-2018. At the time of this report, the outcome of sepsis and injection site cellulitis was recovering. The causality assessment between the events and PNEUMOVAX 23 were not provided. The reporter considered the events to be life threatening and disabling. Upon internal review sepsis was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Sepsis
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a female patient of unknown age with hypertension, chronic obstructive pulmonary disease and diabetes mellitus. The patient's medical history included cerebrovascular accident. On 22-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N030111, expiration date: 21-APR-2019, for prophylaxis (strength, dosage and route were not provided). Concomitant therapies included atorvastatin, carvedilol, LASIX, LANTUS, PRINIVIL, metformin, potassium chloride, XARELTO and PEPCID. The registered nurse reported that on 23-JAN-2018, the patient was hospitalized due to a localized reaction at the injection site. Subsequently, the patient had a blood work, comprehensive metabolic panel and complete blood count but the results were not provided. After that the patient was diagnosed with sepsis secondary to cellulitis on an unspecified date in January 2018 and began treatment with intravenous vancomycin and then switched to ANCEF on an unspecified date. Finally, the patient was discharged from hospitalization on 25-JAN-2018. At the time of this report, the outcome of sepsis and injection site cellulitis was recovering. The causality assessment between the events and PNEUMOVAX 23 were not provided. The reporter considered the events to be life threatening and disabling. Upon internal review sepsis was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Insomnia, Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a nurse referring herself as 63 year old female patient. The patient's historical condition included Pneumonia 3 times in her past (unspecified dates). The patient's concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 20-JAN-2018, patient was vaccinated with PNEUMOVAX 23 (dose, units, frequency and route not reported) (lot number and expiration date not reported) at an unspecified clinic. Reporter stated that, the vaccination was done incorrectly in that it was administered into the bursae in her shoulder. It was also reported that, immediately, on 20-JAN-2018, patient was feeling pain and it was severe by evening. Reporter stated that patient was not being able to sleep for 4 days due to pain, shaking, throwing up, swelling of the arm (reported as unspecified) and finger, and inability to move her arm. The patient did not seek medical attention and no received the treatment for the events. On 24-JAN-2018, patient was seen by orthopedic surgeon (reported as unspecified Surgeon), prescribed hydrocodone (unspecified brand/manufacturer) for the pain. On an unknown date in January 2018, by day 5 post vaccination the pain subsided and day 7 post vaccination she regained range of motion in the affected arm/shoulder (unspecified). The outcome of the events pain and dyskinesia was reported as recovered/resolved. The outcome of the events sleep disorder, tremor, vomiting and peripheral swelling was unknown. The causal assessment for the events was not provided. No product complaint required. The reporter assessed the events sleep disorder and dyskinesia were determined as serious due to significant disability and incapacity.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Tremor, Vomiting
Clinical narrative: This spontaneous report was received from a nurse referring herself as 63 year old female patient. The patient's historical condition included Pneumonia 3 times in her past (unspecified dates). The patient's concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 20-JAN-2018, patient was vaccinated with PNEUMOVAX 23 (dose, units, frequency and route not reported) (lot number and expiration date not reported) at an unspecified clinic. Reporter stated that, the vaccination was done incorrectly in that it was administered into the bursae in her shoulder. It was also reported that, immediately, on 20-JAN-2018, patient was feeling pain and it was severe by evening. Reporter stated that patient was not being able to sleep for 4 days due to pain, shaking, throwing up, swelling of the arm (reported as unspecified) and finger, and inability to move her arm. The patient did not seek medical attention and no received the treatment for the events. On 24-JAN-2018, patient was seen by orthopedic surgeon (reported as unspecified Surgeon), prescribed hydrocodone (unspecified brand/manufacturer) for the pain. On an unknown date in January 2018, by day 5 post vaccination the pain subsided and day 7 post vaccination she regained range of motion in the affected arm/shoulder (unspecified). The outcome of the events pain and dyskinesia was reported as recovered/resolved. The outcome of the events sleep disorder, tremor, vomiting and peripheral swelling was unknown. The causal assessment for the events was not provided. No product complaint required. The reporter assessed the events sleep disorder and dyskinesia were determined as serious due to significant disability and incapacity.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pallor, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for herself. This 66 year-old female patient of an unspecified race and ethnicity received PREVNAR 13 at single dose intramuscular in the arm on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced a red spot and swelling around the red spot on an unspecified date. Events were described as follows: five days after the vaccination with pneumococcal 13-val conj vac (dipht crm197 protein) the patient experienced a red spot on the same arm but not right where she got the shot. It was an inch wide and 2 inches long. It was red but not itchy. She has had a localized injection site reaction to the flu shot (influenza vaccine) taken for immunization in the past, but this was nothing like that. The following day the red spot was bigger and around the red spot it was swollen around the perimeter and the swelling was the same color as her skin. Then it continued to grow, so she marked it. Again it was not itchy and it never looked like hives. Before it started going away, it went from the 1 by 2 inches to 5 inches by 4 inches. When it finally started going away, it went away from the center and it became less red, she could still see the edges advancing. It took four days to go away. She thought it was from the shot because she has done nothing else different, and if it was anything else, it would not have just been on her arm. The red would kind of blanche when she pushed on it. She was a pediatric emergency room nurse, she has seen all kinds of reactions and hives, but this was not itchy and it was kind of flat. When it started it was flat. She would like to know if this was a reaction to the vaccine. She thought it was strange that it happened where it did. With her flu shot reaction, they told her it was a localized reaction, but it was different this time. The patient recovered on an unspecified date.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age, race and ethnicity received PREVNAR 13, (lot 574424, expiry date 30Dec2019, NDC 00005-1971-02) via an unspecified route of administration in the arm on 15Jan2018 at 0.5 ml, single for immunization. The patient medical history and concomitant medications were not reported. In 2008 she had a severe allergic reaction to the over the counter product ALEVE. The patient experienced pain of the injection site, injection site was really deep red and warm and arm started to peel on an unspecified day in Jan2018. Events were described as follows: besides the pain, by 17Jan2018 or 18Jan2018, she noticed that her arm was really deep red and warm. She mentioned that she did not usually receive inoculations. Eventually her arm started to peel. The pharmacist had warned her that the injection site might be painful. The reporter classified these events as reactions to pneumococcal 13-val conj vac (dipht crm197 protein. Outcome of events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient previously received a pneumococcal vaccine and experienced peripheral swelling. The patient experienced her arm "blew up" (peripheral swelling), arm sore, headache on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unknown age and race/ethnicity received a dose of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose on unknown date, via an unspecified route of administration for immunization. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced that she can lift her arm but it hurts and she noticed that her arm blew up for three days. The outcome of the event was unknown. Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Age: 1.25
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Drug administered to patient of inappropriate age, Nausea, Vomiting
Clinical narrative: Initial unsolicited report received from a physician via phone on 23 Jan 2018. This case involves a 15-month-old male patient who was vaccinated with 0.5 ml second intramuscular dose of FLUZONE (Frequency: once, batch number, expiry date and site of administration were not reported) on 19 Jan 2018. Patient's medical history and concomitant medications were not reported. On an unspecified date (also reported as last night), following the vaccination, the patient had developed a temperature of 102 degree Fahrenheit with nausea and vomiting. They are treating the child as appropriate for age. It was also a case of actual medication error due to overdose. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as not recovered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 10.0
Sex: F
Vaccine: HEP, IPV, MMRV, TD
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Urinary incontinence
Clinical narrative: Patient received four vaccinations, tolerated them well, waited to leave until time elapsed, walked out to the waiting room, client sat down, per family member she stiffed up and peed her pants, he eyes rolled back to her head, but she did not lose consciousness per family, client knew where she was and aware of what happened, 911 called, BS 122, BP 85/45, temp 97, family declined to go to the hospital, per Mother they will follow up with a doctor, possible seizure that happened.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: PATIENT RECEIVED FLU SHOT AT APPROX. 11:58AM AND 10 MINUTES AFTER ADMINISTRATION, PATIENT PRESENT WITH URTICARIA ONLY ON FACE. 2 ML OF BENADRYL WAS ADMINISTERED TO PATIENT AT 12:10PM AND AN ADDITIONAL 1 ML WAS ADMINISTERED AT 12:18PM. PATIENT WAS OBSERVED IN OFFICE FOR 20 MINUTES, URTICARIA RESOLVED.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives presented on, face, abdomen, back, and R/L legs. Local Allergy Doctor contacted and alerted of situation. Parent told to administer children's zyrtec. Parent educated on s/sx of anaphylaxis/when to seek medical attention. Local Allergist office will call and schedule appointment for child.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: C/o pain and swelling all down right arm for several days. Today, swelling has gone down but arm still remains painful.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Depression, Insomnia, Mood swings
Clinical narrative: Both my sons had the GARDASIL vaccines, my one son has been permanently changed by it. He experiences anxiety, mood swings, depression, trouble sleeping ever since he was given vaccines.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Somnolence
Clinical narrative: I had the SHINGRIX vaccine on Tuesday, Jan, 30, was told side effects were confined to the injection site: For two days I felt like I had the flu, with headache, achiness, fatigue, sleepiness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Influenza like illness, Influenza virus test negative, Mobility decreased
Clinical narrative: Had SHINGRIX 50MCG SUSR vaccination on afternoon of 1/18/18. So weak the next morning I could not get out of bed. Weak and flu like symptoms for several days. Had to cancel appointments and could not get up the strength to get dressed. Went to Urgent Care on 1/24/18 and tested for the flu and strep. Tests were negative but given Rx for TAMIFLU as a precaution. Returned to Urgent Care on 1/26/18 as illness had not abated. Blood work done that day showed nothing unusual. Made an appointment to see my Primary Care provider the following Thursday 2/1/18. Doctor seemed to think that my illness was a reaction to the vaccine and asked me to contact FDA. She is doing the same. I am still very weak but getting a little stronger each day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Streptococcus test negative, Vaccination complication
Clinical narrative: Had SHINGRIX 50MCG SUSR vaccination on afternoon of 1/18/18. So weak the next morning I could not get out of bed. Weak and flu like symptoms for several days. Had to cancel appointments and could not get up the strength to get dressed. Went to Urgent Care on 1/24/18 and tested for the flu and strep. Tests were negative but given Rx for TAMIFLU as a precaution. Returned to Urgent Care on 1/26/18 as illness had not abated. Blood work done that day showed nothing unusual. Made an appointment to see my Primary Care provider the following Thursday 2/1/18. Doctor seemed to think that my illness was a reaction to the vaccine and asked me to contact FDA. She is doing the same. I am still very weak but getting a little stronger each day.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Hypersomnia, Lethargy, Mobility decreased
Clinical narrative: Had a very bad reaction from PNEUMOVAX vaccine I as not able to lift my arm from shoulder to elbow swelling and really painful 1st night chills and fever 2nd ay lethargic slept alot arm swollen and painful 3rd day starting to feel better but not great I had the PREVNAR 13 Jan 2016 no side effects hv flu shot every year no side effects just a little soreness at injection site wanted to report this grateful didn't get worse alot of joint pain as well.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Had a very bad reaction from PNEUMOVAX vaccine I as not able to lift my arm from shoulder to elbow swelling and really painful 1st night chills and fever 2nd ay lethargic slept alot arm swollen and painful 3rd day starting to feel better but not great I had the PREVNAR 13 Jan 2016 no side effects hv flu shot every year no side effects just a little soreness at injection site wanted to report this grateful didn't get worse alot of joint pain as well.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: My son has a rash all over his body.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Pain, redness, swelling, decreased range of motion.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4
Symptoms: Peripheral swelling
Clinical narrative: Swollen upper leg/mother brought baby to ER/issues resolved.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt was awakened at 1 am with severe pain to right arm and decreased range of motion. Pain radiates to fingers, but worse in deltoid.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Eye swelling, Hypersensitivity
Clinical narrative: Post flu vaccine, allergic reaction around eyes, swelling, redness.
Age: 92.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SHINGRIX given SQ instead of IM, led to pronounced adverse affects namely pain at injection site, erythema, heat, and swelling.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abdominal pain, Arthralgia, Erythema, Infection, Injected limb mobility decreased
Clinical narrative: By 8 PM same day of vaccinations, whole body in extreme pain and could not lift or use left arm. Muscle and/or pain primarily in hips, shoulder and sharp pains in abdomen. Saturday arm very painful and still could not lift. Swollen and red at injection site, moving into armpit by evening. Took ibuprofen and BENADRYL at advice of on call Dr. Sunday urgent care nurse practitioner diagnosed as infected and prescribed cephalexin and diclofenac. Within 3-4 hrs. pain greatly reduced and mobility improved. Slightly better on Monday, but still red, warm, swollen on shoulder and in armpit.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Oedema peripheral
Clinical narrative: By 8 PM same day of vaccinations, whole body in extreme pain and could not lift or use left arm. Muscle and/or pain primarily in hips, shoulder and sharp pains in abdomen. Saturday arm very painful and still could not lift. Swollen and red at injection site, moving into armpit by evening. Took ibuprofen and BENADRYL at advice of on call Dr. Sunday urgent care nurse practitioner diagnosed as infected and prescribed cephalexin and diclofenac. Within 3-4 hrs. pain greatly reduced and mobility improved. Slightly better on Monday, but still red, warm, swollen on shoulder and in armpit.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: By 8 PM same day of vaccinations, whole body in extreme pain and could not lift or use left arm. Muscle and/or pain primarily in hips, shoulder and sharp pains in abdomen. Saturday arm very painful and still could not lift. Swollen and red at injection site, moving into armpit by evening. Took ibuprofen and BENADRYL at advice of on call Dr. Sunday urgent care nurse practitioner diagnosed as infected and prescribed cephalexin and diclofenac. Within 3-4 hrs. pain greatly reduced and mobility improved. Slightly better on Monday, but still red, warm, swollen on shoulder and in armpit.
Sex: U
Vaccine: HPV9, MMR, MMRV, RV5, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, VARIVAX, ZOSTAVAX, M-M-R II, PROQUAD (exact dose, route of administration, lot # and expiration date were not reported for any of aforementioned vaccines) and with improperly stored doses of ROTATEQ (administered orally; exact dose, lot # and expiration date were not reported). Administered vaccines were stored outside of the cardboard packaging and exposed to light for an unknown length of time. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. Concurrent conditions, medical history, historical and concomitant drugs were not reported. The registered nurse reported that on 09-JAN-2018, the patient was inadvertently vaccinated with a dose of PROQUAD subcutaneously in the left arm, lot # N010865, expiration date 01-OCT-2018, for prophylaxis (strength, dose and albumin status not reported), instead of the intended dose of M-M-R II (albumin status, lot # and expiration date not reported). The registered nurse also reported that on the same date (09-JAN-2018), the patient received her second dose of VARIVAX subcutaneously in the right arm, lot # M010480, expiration date 01-MAR-2018, also for prophylaxis. All vaccines were reconstituted with sterile diluent (MERCK). No adverse effects reported.
Age: 0.17
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 and refers to a 2 months old patient of unknown gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The medical assistant reported that on 09-JAN-2018, the patient was vaccinated with a pediatric dose of VAQTA Injection, 0.5 ml, lot # N020689, expiration date 22-OCT-2018, for prophylaxis (strength, route, dose number and anatomical location were not reported). The reporter denied any adverse effect on the patient.
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female patient. The patient's medical history included syncope. There was no known drug allergies. On an unknown date in December 2017 (reported as two weeks ago), the patient was vaccinated with first dose of GARDASIL 9 (lot # N017833, Expiry date: 16-NOV-2019) for prophylaxis. There was no concomitant medications administered. There was no lab tests performed. On the same day after few minutes after GARDASIL 9 administration, the patient experienced "near syncope". It was reported that the patient was brought back into the room, laid down on bed and given a Popsicle while observed the patient for 15 minutes. The outcome of the event was unknown. There was no product quality complaint involved. The reporting physician did not provide the causality assessment for the event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous and non valid report was received from a Registered Nurse concerning to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. Since 29-SEP-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# N000175, expiration date 20-SEP-2018 (dose was not reported) for prophylaxis. It was reported that the vaccines were exposed to temperature of 32 Fahrenheit grades (°F) range for a time frame of 23 minutes and previous temperature excursion was between 32°F (Fahrenheit) to 35°F (Fahrenheit) for 1 hour and 49 minutes. The data logger was involved. However, no adverse effects were reported and no product quality complaint was involved.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On unknown dates, when the patient was 26 years old, she was vaccinated with first and second GARDASIL 9 doses for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, when the patient was 27 years old,  she received the third dose of GARDASIL 9 lot number M035486 and expiration date of 05-JUN-2019, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-DEC-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, subcutaneous for prophylaxis, lot # M042504 and expiration date on 30-NOV-2017 (dose and anatomical location were not reported). The pharmacist reported that there were no adverse effects in the patient.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report has been received from a nurse, concerning a 24 year old female patient. The patient's medical history and concomitant medication were not provided. Concurrent conditions included significant mental disabilities. On 04-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 left deltoid, lot # N020688 and expiration date 09-MAR-2019 for prophylaxis (dose, frequency and route were not provided). On 04-JAN-2018, the patient experienced a reaction that was significantly large on left deltoid area where the patient received the vaccine of PNEUMOVAX 23, the reporter stated that the reaction was red, hard and warm. Furthermore, the patient had trouble putting her coat on an off. The patient sought medical attention and received an unspecified treatment for the adverse events. The outcome of reaction red, hard, warm and movement disorder was unknown. The causal relationship between the adverse events and PNEUMOVAX 23 was not assessed.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: This spontaneous report was received from a 88 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in 2003, the patient was vaccinated with ZOSTAVAX for prophylaxis (strength, dose, route, lot # and expiration date were not reported). Since an unknown date in 2015, the patient started to experience a nerve pain in her hands. Then, on an unknown date in 2017, the patient started having pain in her arms at night time. The patient sought medical attention and received an unspecified treatment for the adverse experiences. At the reporting time, the patient was not recovered from neuralgia and pain in extremity. The causality assessment between the events and vaccination with ZOSTAVAX was not provided.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician referring to a 16 year old male patient. The patient did not had any pertinent medical history, concurrent condition, drug reaction/allergy neither was taking any concomitant medications. On 12-JAN-2018, the patient was vaccinated with the first dose of his Human Papillomavirus (HPV) vaccination series with GARDASIL 9 lot # N007931, expiration date on 17-NOV-2019, for prophylaxis (strength, dose and route were not reported). On 13-JAN-2018, one day after vaccination, the patient developed 102°F fever. On this same date, the patient received a prescription for TAMIFLU 75 mg, 1 capsule, twice daily for 5 days. The physician reported that as of 16-JAN-2018, the patient had recovered from fever. The causality assessment between the fever and vaccination with GARDASIL 9 was not provided.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Neuralgia, Pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist, referring to a 20 year old female patient. The patient did not had medical history, concurrent conditions or concomitant medications. On 28-DEC-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N019921, expiration date on 05-JUL-2018, subcutaneously in the left arm for prophylaxis. On 30-DEC-2017 (reported as "2 days later"), the patient developed "shooting pain that extended up into her clavicle 2 days later, the pain became progressively worse and was intermittent. When the left arm was raised at a 20 degree angle the arm hurts and when raised at a 45 degree angle there was a shooting pain down the arm and across her clavicle." The reporting pharmacist stated that the pain was more like "nerve pain" and reported that the patient "had not been able to go to the gym and had difficulties performing her activities of daily living". It was confirmed that the patient did not receive any treatment for the events. The outcome of all the events was reported as not recovered/not resolved. The causality between the vaccination with ZOSTAVAX and the aforementioned events was not reported. Upon internal review, the events were considered as serious due to the disability for the patient.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information was received from a registered nurse referring to a 15 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergy were not reported. At the age of 12 year old (in approximately 2015), the patient received GARDASIL (dose, route, lot# and expiration date not reported) for prophylaxis. Now three years later(in approximately 2018), the patient was returning to receive GARDASIL 9 (dose, route, lot# and expiration date not reported) for prophylaxis to complete the series( inappropriate schedule of vaccine administrated and interchange of vaccine products). No adverse effects reported. No product quality complaint was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 26-JAN-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 14-SEP-2010, the patient was inoculated (by an unspecified person) at a clinic with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, he was treated (by an unspecified healthcare professional) at a dermatology office for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX and gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was reporting on himself. No prior medical history, concurrent conditions and concomitant medications were reported. On 23-JAN-2018 the patient was vaccinated with ZOSTAVAX, by parenteral route (reported as injection) for prevention of shingles. Later that day, after ZOSTAVAX administration, the patient developed redness and warmth at the injection site. Additionally, the patient stated that "at first, it was about the size of a fingernail and then, at reporting time, it was the size of a silver dollar". The outcome of the redness and warmth at the injection site was reported as not recovered.   Reporter's causality assessment between redness and warmth at the injection site with zoster vaccine live (ZOSTAVAX) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from an 80 year old female patient concerning herself. The patient did not have pertinent medical history, drug reactions or allergies, concurrent conditions or concomitant medications. On an unspecified date in April 2017, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On approximately 23-JAN-2018 (reported as "last week"), the patient developed mild case of shingles on both hands. The outcome of herpes zoster was unknown. The patient sought medical attention and received unspecified treatment. No laboratory studies were performed. The causality assessment between therapy with ZOSTAVAX and the event was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. It was reported that on 30-JAN-2018, the patient was vaccinated with PROQUAD lot # N015623, expiration date 15-NOV-2018, by intramuscular route rather than subcutaneous for prophylaxis (strength was not provided).
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from registered nurse referring to a 50 year old female patient. The patient had no pertinent medical history, drug reactions/allergies or concomitant medications. The reporter informed that an unspecified date (reported as "years ago"), the patient had negative titers (no further details provided) and for that reason on 29-JAN-2018, the patient was vaccinated with VARIVAX lot number: N021581 (expiration date: 09-AUG-2019), for prophylaxis (strength, route and dosage schedule were not reported). In January 2018, after receiving VARIVAX, the patient experienced a red and warm bump induration, with no blisters (induration). The patient did not seek medical attention and no treatment was given for the adverse event. The outcome of induration was reported as recovering. Causality assessment was not provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye inflammation, Lacrimation increased, Scab
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 58 year old female patient. The patient's concurrent conditions and medical history were not reported. On 07-MAY-2015, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and anatomical location were not reported) via subcutaneous route for the prevention of shingles. Concomitant therapies included atorvastatin, PLETAL and CHANTIX. On the same day, the patient developed tearing, crusting and inflammation in both eyes. The patient sought medical attention. The patient did not received any treatment for the adverse events. The outcome of the events was reported as not recovered. Causality assessment was not reported. No product complaint involved.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On an unknown date, the patient who had completed the GARDASIL (strength, dose, route, frequency, indication, lot # and expiration date were not reported) was inadvertently administered a dose of GARDASIL 9 lot # N007931, expiration date 17-NOV-2019, (strength, dose, frequency and indication were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report refers to a patient of unknown age and gender. The patient's medical history was not reported. On 21-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N015621, expiration date 15-NOV-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 4 hours and 25 minutes. Other temperature excursions included -14 to -10 degrees Celsius for 1 hour and 15 minutes and -2.8 degrees Celsius for 1 hour and 41 minutes. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA002591: US-009507513-1802USA002592.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report refers to a patient of unknown age and gender. The patient's medical history was not reported. On 29-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014632, expiration date 11-MAY-2019 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 4 hours and 25 minutes. Other temperature excursions included -14 to -10 degrees Celsius for 1 hour and 15 minutes and -2.8 degrees Celsius for 1 hour and 41 minutes. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA002592, US-009507513-1802USA001673.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Local reaction, Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 71-year-old female patient of an unspecified race and ethnicity received PREVNAR 13 in the deltoid (arm unspecified), on an unknown date, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient had a local reaction on her arm (her arm was red and swollen). She was treated for cellulitis. Clinical outcome of the adverse events was unknown at time of this report. Sender's Comments: Based on a drug event temporal association, it cannot be fully excluded that the vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of local cellulitis with red and swollen. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.