chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Pain
Clinical narrative: The evening of 12/16/2019 he reports tired and achy feelings. Assumed he needed to go to bed early. Upon waking up 12/17/2019 he states that he had a fever 99.7, chills, sweating, and coughing with fatigue.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: The evening of 12/16/2019 he reports tired and achy feelings. Assumed he needed to go to bed early. Upon waking up 12/17/2019 he states that he had a fever 99.7, chills, sweating, and coughing with fatigue.
Age: 89.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient's arm was numb the night of the vaccination day per daughter of patient. Was seeking treatment from neurologist which is pending response.
Age: 0.67
Sex: F
Vaccine: DTAPIPV, DTAPIPV, HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Infant is 8 months old. Infant is on a modified vaccine schedule as mother has opted out of the HiB, Influenza, and PCV 13 vaccines. Mother wanted only the DTaP, IPV, and Hep B vaccines administered. PHN administered Kinrix as a combo vaccine. Kinrix is not recommended for the infant's age group, however, according to Dr. at the Immunization Branch, the doses of DTaP and IPV count as valid. The infant had no adverse reaction during the 20 minute observation period following the vaccine administration, Mother was called at approximately 3:00pm for notification, however, there was no answer. Left message to return call.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haematoma, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient bled after injection was given and developed small hematoma at injection site.  Patient was not in pain and bleeding was stopped in less than minute, but had a bump/bruise at injection site.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Patient has a very sore arm with redness that has persisted for 2 weeks after administration also tingling in the left hand started 10 days after administration.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Laboratory test, Periarthritis, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: Patient received an influenza vaccine at an off-site flu clinic on October 6, 2019.  Patient indicated she experienced pain (extreme soreness in the shoulder and arm) at the time of her influenza  injection with has not resolved.  She told her primary care provider of the issue on 10/21/19.  She went to the walk-in clinic on November 22, 2019  where an X-ray and lab work was done.  She was told at that time it was a frozen shoulder and referred her to an orthopedic.   The orthopedic determined the problem was SIRVA and put her on an oral steroid for 6 days.  She returned to the orthopedic for a follow up on December 16, the oral steroid had not helped the issue, so she was given a steroid injection and was then referred for physical therapy.  She will start the physical therapy on December 23, 2019 and has a follow-up appointment with her orthopedic in January.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site pain, Injection site reaction, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Right shoulder weak, painful to move, interfering with sleep even after  2 1/2 months! Even with the help of gym trainer and owner of the gym I have been going to for 6 years.  Changing exercise program, sleep position, daily activities. Seriously affecting  daily activities.  Some clear ooze two weeks after injection. .  not painful, not pus
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Right shoulder weak, painful to move, interfering with sleep even after  2 1/2 months! Even with the help of gym trainer and owner of the gym I have been going to for 6 years.  Changing exercise program, sleep position, daily activities. Seriously affecting  daily activities.  Some clear ooze two weeks after injection. .  not painful, not pus
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Inflammation, Pain, Pyrexia
Clinical narrative: came into pharmacy 12/17/19 c/o pain, fever/chills, visible inflammation/redness
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site reaction, Joint effusion, Musculoskeletal pain
Clinical narrative: flu like symptoms, sore joints and body aches, welt at injection site, frozen shoulder, bursas on the elbow (water on the elbow for no reason), shoulder, arm and neck pain is still occurring.  Started seeing a physical therapist in October 2019
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Periarthritis, Urticaria
Clinical narrative: flu like symptoms, sore joints and body aches, welt at injection site, frozen shoulder, bursas on the elbow (water on the elbow for no reason), shoulder, arm and neck pain is still occurring.  Started seeing a physical therapist in October 2019
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated he started experiencing shoulder and arm pain three days after receiving vaccine and had been persisting since seeing me and reporting it to me a month later. Had gotten prevnar 13 vaccine in other arm the same visit and no complaints. Difficulty lifting shoulder, favors right arm getting out of bed, pain is from shoulder down to arm. Advised patient to see doctor to get assessed and have not been able to reach patient to obtain results of physician followup
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: The patient reported pain at the time of injection, and lingering pain since receiving the vaccine. She saw a doctor, and got a prescription for prednisone for pain and inflamation. She said she thought the pharmacist gave the injection too high on the arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at injection site days later, injection site is raised, red and hot to the touch
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient received the shot on 11/18/2019. At the time of administration patient had no reactions. Per patient the pain started later on in the evening around the injection site only. Few weeks later patient still complains about pain around the injection site but also now radiating to shoulder area. Patient also complains worsen at night.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Developed Red swollen, hot area 24 hrs after shot, in (R) arm, Kinrix. Seen at Urgent Care & diagnosed w/cellulitis, started on Keflex. Seen 12/16/19 w/continued severe localized reaction.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Upon rising on 10/26/2019, I noticed my left shoulder had developed a circular patch of about 8" and crowning over and around the shoulder. The pain level is stable at 2-3 and feels to be in only the epidural area. This area has the feeling of tightness as in the use of "tough skin" used by sports players. To date, it gets no better or worse.
Age: 51.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Headache, Lymphadenitis, Pain
Clinical narrative: starting sunday he felt achy, on monday he had headache and swelling in armpit, then progressed to marble size bump on lymph node on armpit and now is swelling down rib cage, patient has been to doctor today and was put on keflex antibiotic
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: soreness in her shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shoulder soreness. On an unknown date, the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After received Shingrix the patient experienced soreness in her shoulder for 2 days. The follow up consent was not granted.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Staring
Clinical narrative: Intermittent episodes of gazing off and mom was unable to break the stare and Staring episodes lasted for 2 to 3 hours each episode approx. 10 minute; Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient (24 cm and 5.44 kg) who experienced intermittent episodes of gazing off and mom was unable to break the stare and staring episodes lasted for 2 to 3 hours each episode approx. 10 minute, while she received vaccines ROTATEQ, PREVNAR 13 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 14-Jun-2017, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot C5316AA and expiry 13-Feb-2018) via intramuscular route in the left thigh. On 14-Jun-2017 at 15:47 hours, the patient received a 0.5 ml dose of suspect PREVNAR 13 not produced by Sanofi Pasteur (lot R48402 and expiry 30-Apr-2018) via intramuscular route in the right thigh. On 14-Jun-2017, the patient received a dose of suspect ROTATEQ not produced by Sanofi Pasteur (lot M035456 and expiry 10-May-2018) via oral route.  On 14-Jun-2017 at, the patient developed a non-serious intermittent episodes of gazing off and mom was unable to break the stare and staring episodes lasted for 2 to 3 hours each episode approx. 10 minute (staring) on the same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, 16 hours and 15 minutes following the administration of PREVNAR 13 and on the same day following the administration of ROTATEQ.  (Other relevant tests included No lab data reported.)  Final diagnosis was intermittent episodes of gazing off and mom was unable to break the stare and staring episodes lasted for 2 to 3 hours each episode approx. 10 minute.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for intermittent episodes of gazing off and mom was unable to break the stare and staring episodes lasted for 2 to 3 hours each episode approx. 10 minute.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fall, Gait disturbance, Malaise
Clinical narrative: Intense pain in arm started a few hours after injection, moved its way to my back within 2 more hours, then involved overall muscular pain a few hours later.  I began to feel very nauseated and started vomiting by early evening.  I then lost the ability to feel when I needed to urinate and I was incontinent of large amounts of urine, not being aware until I could feel my clothes getting wet- this continued until the following day.  By late evening, I felt hot to touch, had severe chills that didn?t resolve for about 16 hours and felt very ill overall.  I became unable to walk without falling and my husband had to get me into bed.  All of these symptoms became lesser the next day and I was functional by the 3rd day.  I?ve never experienced anything like this and it was horrifying.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Skin warm, Urinary incontinence
Clinical narrative: Intense pain in arm started a few hours after injection, moved its way to my back within 2 more hours, then involved overall muscular pain a few hours later.  I began to feel very nauseated and started vomiting by early evening.  I then lost the ability to feel when I needed to urinate and I was incontinent of large amounts of urine, not being aware until I could feel my clothes getting wet- this continued until the following day.  By late evening, I felt hot to touch, had severe chills that didn?t resolve for about 16 hours and felt very ill overall.  I became unable to walk without falling and my husband had to get me into bed.  All of these symptoms became lesser the next day and I was functional by the 3rd day.  I?ve never experienced anything like this and it was horrifying.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Intense pain in arm started a few hours after injection, moved its way to my back within 2 more hours, then involved overall muscular pain a few hours later.  I began to feel very nauseated and started vomiting by early evening.  I then lost the ability to feel when I needed to urinate and I was incontinent of large amounts of urine, not being aware until I could feel my clothes getting wet- this continued until the following day.  By late evening, I felt hot to touch, had severe chills that didn?t resolve for about 16 hours and felt very ill overall.  I became unable to walk without falling and my husband had to get me into bed.  All of these symptoms became lesser the next day and I was functional by the 3rd day.  I?ve never experienced anything like this and it was horrifying.
Age: 18.0
Sex: M
Vaccine: FLUR4, HPV9
Symptoms: Dyspepsia, Feeling cold, Headache, Hot flush, Pyrexia
Clinical narrative: Woke up the following morning at 4:30 am w/ headache, hot flashes, and burning stomach. Woke up again at 7:00 and still had a headache and burning stomach, and a low-grade fever had developed (99.2 degrees). Stomach got better throughout the day as I ate, but headache and fever are still present that night. I have also started developing cold flashes.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site starting approximately two hours after injection. This pain increased in severity over the course of the next two hours and remained at that intensity (approximately a 5 out of 10) for about 48 hours and then decreased to non-detectable over the following 48 hours. Pain was well managed with Aleve.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received her 2nd Menactra 2 years to early.   Patient had no symptom or signs of any adverse events.
Sex: M
Vaccine: MMR, PPV
Symptoms: Antibody test negative, Blood homocysteine increased, Blood immunoglobulin G decreased, Diarrhoea, Hypotonia
Clinical narrative: undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines;   This literature marketed report has been received from authors of published article referring to a 2.5 years old male patient. The patient was a full-term male infant born with undetectable T cell Receptor Excision Circles (TRECs) remained asymptomatic with decreased absolute T cells (895 cells/micro-L) and appropriate mitogen response by age 2 months.       On unknown dates, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided). By 2.5 years, he developed hypotonia, recurrent respiratory infections, and chronic diarrhea. On unknown dates (reported as "concurrently"), his labs demonstrated absolute T-cell lymphopenia (708 cells/micro-L), immunoglobulin G (IgG) deficiency (235 mg/dl) and undetectable titers to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). Unexpectedly, he demonstrated a persistently elevated mean cell volume (MCV) (92.3 cells/micro-L) and elevated serum homocysteine (20.6 micro-mol/L). The outcome of the event was unknown. The causality assessment was related.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: MMR, PPV
Symptoms: Lymphopenia, Mean cell volume increased, Respiratory tract infection, T-lymphocyte count decreased
Clinical narrative: undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines; undetectable titers to measles, mumps, rubella and pneumococcal (0/14) vaccines;   This literature marketed report has been received from authors of published article referring to a 2.5 years old male patient. The patient was a full-term male infant born with undetectable T cell Receptor Excision Circles (TRECs) remained asymptomatic with decreased absolute T cells (895 cells/micro-L) and appropriate mitogen response by age 2 months.       On unknown dates, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided). By 2.5 years, he developed hypotonia, recurrent respiratory infections, and chronic diarrhea. On unknown dates (reported as "concurrently"), his labs demonstrated absolute T-cell lymphopenia (708 cells/micro-L), immunoglobulin G (IgG) deficiency (235 mg/dl) and undetectable titers to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). Unexpectedly, he demonstrated a persistently elevated mean cell volume (MCV) (92.3 cells/micro-L) and elevated serum homocysteine (20.6 micro-mol/L). The outcome of the event was unknown. The causality assessment was related.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects; the administration of one dose of PROQUAD to a 17 year old patient; the dose was reported to have been administered outside of the Prescribing Information; This spontaneous report as received from a physician refers to a 17-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions and medical history was provided.  On 12-OCT-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, one time subcutaneously for prophylaxis (lot # S012501, expiration date 20-OCT-2020); also one dose of sterile diluent (lot # S024968, expiration date 28-FEB-2022) was used to reconstitute the vaccine.  The suspect vaccine was reported to have been administered outside of the prescribing information. Primary reporter reported no adverse effects for the patient. Primary reporter reported that both the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the sterile diluent were stored in the correct temperature storage according to the prescribing information.  Lot number S012501 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: confirmed pregnant by an "at home pregnancy test."; This spontaneous report was received from an office manager, referring to a 16-year-old female patient. The patient's medical history, concomitant medication and drug reactions/allergies were reported none.   In November 2019 (reported as sometime last week), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (intramuscular, dose, lot# and expiration date were unknown) for prophylaxis (reported as preventative route vaccine). Other suspect therapy included "VEXERO" (route and dose detail were unknown)  In November 2019 (reported as earlier this week), the patient was confirmed pregnant by an "at home pregnancy test" (maternal exposure during pregnancy). The last menstrual period (LMP) was estimated to be 2019 and the estimated date of delivery (EDD) was unknown. The pregnancy outcome was pending. The fetal outcome was unknown.
Age: 39.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Pain
Clinical narrative: Patient complained second subcutaneous injection was more painful.; first dose was administered in her deltoid (intramuscular).; Patient complained of soreness on first VARIVAX dose; This spontaneous report was received from a pharmacist referring to a 39 years old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was reported as none. The patent was not pregnant.   On 20-OCT-2019, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R018141, expiration date 25-JUN-2020; strength and dose were not reported) intramuscularly in her deltoid (incorrect route of product administration) for prophylaxis.  The patient complained of soreness on first varicella virus vaccine live (oka/merck) (VARIVAX) dose injection (onset date: unknown date in 2019). On 20-NOV-2019, the patient was vaccinated with second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# R018141, expiration date 25-JUN-2020; strength and dose were not reported) subcutaneously for prophylaxis. The patient complained second subcutaneous injection was more painful. Both vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot# and expiration date were not reported). The patient didn't seek any medical attention and no treatment or intervention was given for the events. The outcome of first dose injection soreness and second dose injection more painful was recovered. The causality between the events and varicella virus vaccine live (Oka/Merck)(VARIVAX), sterile diluent(MERCK STERILE DILUENT) was not provided.
Sex: F
Vaccine: HEP, HEPA, IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient did not experience any symptoms; An adult patient received second dose of VAQTA one month after receiving their initial dose/ given 1 month after 1st one instead of 6-12 months; This spontaneous report was received from a registered nurse and refers to a 43 year old female patient. The patient concomitant therapies included benztropine mesylate, perphenazine, vitamin d (unspecified), lithium and the first dose of hepatitis b virus vaccine.The patient's concurrent conditions included depression, dermatitis, vitamin D deficiency, lipids increased, hyperhidrosis, overweight, altered mental status, and allergy to sulfas, penicillins and nitrofurantoin. The patient was not ill at time of vaccination.  On 19-SEP-2019, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated(VAQTA) intramuscular lot # S012250, expiration date 07-JUL-2020 (dose and anatomical location were not provided); and the first dose of poliovirus vaccine inactivated (unspecified) intramuscularly, lot # PIA2420 expiration date 26-APR-2020, for prophylaxis. On 24-OCT-2019, the patient was vaccinated with a second dose of with hepatitis a vaccine, inactivated(VAQTA) (dose, route, anatomical location, lot # and expiration date were not provided). On the same date, the patient was additionally vaccinated with second dose of hepatitis b virus vaccine (unspecified) intramuscularly, lot #9N259 expiration date 04-DEC-2021 and second dose of poliovirus vaccine inactivated (unspecified) intramuscularly, lot # PIA25IM expiration date 22-MAY-2020.  It was reported that the person who applied the vaccines was a medical assistant, who was trained. No prescription drug treatment was required. No adverse effects were reported.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant, referring to a 3-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-NOV-2019, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5 (units not reported), lot # S009562, expiration date on 05-MAY-2019 (anatomical location, route of administration and dose were not reported) which was improperly stored. The Hepatitis A Vaccine, inactivated (VAQTA) vaccine underwent temperature excursions above 47°F (52.09 °F) for 1.39 hours. The previous temperature excursions were above 47°F (64.83 °F) for 13.35 hours. This call was by the digital data logger. There were no additional adverse effects reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: patient experienced sharp, stabbing, intermittent pain around the injection site; This spontaneous report has been received from a registered nurse concerning a 12-year-old female patient. The patient was allergic to amoxicillin and bacitracin. Pertinent medical history and concomitant medications were reported as none.  On 05-NOV-2019 the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, intramuscular, (lot number 1621931, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 26-JAN-2022) (concentration, dosage, vaccination scheme frequency and anatomical location were not provided) as prophylaxis (reported as routine physical).   On approximately 12-NOV-2019 (also reported as one week after), the patient's father sought medical attention as he called the office to report the patient experienced sharp, stabbing, intermittent pain around the injection site. The nurse recommended ibuprofen (MOTRIN), heat, and gentle massage as treatment. On 05-DEC-2019, the pain was worsening and seemed to be in the joint, not the muscle, the pain lasted for 10 minutes, and it was intermittent (injection site joint pain). No laboratory diagnostics or studies were performed. At the time of reporting, the patient had not recovered from the event.  The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event injection site joint pain was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has reported no symptoms; patient received unspecified dose in VAQTA series that was improperly stored; patient received unspecified dose in VAQTA series that was improperly stored/Lot Number: S009562; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 12-NOV-2019, the patient was vaccinated with dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009562, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019; route was unknown; unspecified dose in series) for prophylaxis (product storage error, expired product administered).   The storage temperature of the vaccine was 48 degrees Fahrenheit for a time frame of 30 minutes. Previous temperature excursions were 50.4 degrees Fahrenheit for 30 minutes and 47.3 degrees Fahrenheit for 30 minutes. The call was due to a data logger. The patient had no symptoms. No product quality complaint presented.
Sex: F
Vaccine: HPV9
Symptoms: Adverse reaction, Loss of personal independence in daily activities
Clinical narrative: such a bad reaction that the daughter has to drop out colleage; This spontaneous report was received from an unspecified reporter who saw online that a mother came up to company representative and reported regarding a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reaction/allergies were not unknown by the reporter. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiry date, dose number, anatomical location and route of administration were unspecified) for prophylaxis. On an unknown date, the patient experienced such a bad reaction that she had to drop out of college. The outcome and causality of the event were not reported. Product quality complaint was not involved.  Upon internal review, the event bad reaction was considered to be serious due to disability.
Sex: F
Vaccine: VARZOS
Symptoms: Heart injury
Clinical narrative: cardiac injuries; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On 17-MAY-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On or about 22-MAY-2016, shortly after receiving the vaccine, the pt experienced cardiac injuries, including but not limited to hospitalization and extensive medical treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work. Moreover, as a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and disfiguring personal injuries and serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was not recovered.   The reporter considered that cardiac injuries were caused by zoster vaccine live (ZOSTAVAX).  Upon internal review, cardiac injuries was considered to be a medically significant and disabling event.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events; The Medical Assistant reports the patient will receive the second dose on 12/12/2019.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.     On 29-DEC-2016, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, lot # and expiration date were not provided) for prophylaxis. The patient would receive the second dose on 12-DEC-2019 (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: The patient had seizures; This spontaneous report was received from the patient's parent referring to his/her son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis and on an unknown date, he experienced seizures.  At the reporting time, the patient was not recovered from seizures. The causality assessment was not provided.  Upon internal review, seizure was considered a medically significant event.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA008006:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; reported that an administered dose of PNEUMOV AX underwent a temperature excursion on 11/27/2019; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.      On 02-DEC-2019, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S026366 has been verified to be a valid lot number, expiration date was reported and validated as 17-SEP-2020) (product storage error). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 51 degrees Fahrenheit for a time frame of five hours on 27-NOV-2019, without any previous temperature excursion; which was detected by a digital data logger.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; a patient (who is one of a set of twin children) received a dose of PROQUAD and a dose of VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 14-DEC-2019, the patient (who is one of a set of twin children) was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S013712, expiration date 01-NOV-2020; strength, dose and route were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S004862, expiration date 18-FEB-2021; strength, dose and route were not reported)for prophylaxis(inappropriate schedule of product administration).  No known adverse effects.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA007892:
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: balance problems; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 26-JUL-2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), pt suffered from balance problems. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The event balance problems was considered as disability.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Nauseous; dizzy; This case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. In the morning of reporting day, the patient was nauseous and dizzy. The patient asked if the events were related to the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st March 2019 in left deltoid and experienced arm pain for 2 days which resolved).   On 23rd August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid of arm. The patient stated that, after vaccination had left arm pain till the elbow which subsequently resolved. The reporter consented to follow up. This case has been linked with cases US2019220403 and US2019AMR221733, reported by same reporter for same patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2019, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid of arm. The patient stated that, after vaccination, the patient had pain in arm for 2 days which resolved. The patient consented to follow up. This case has been linked with case US2019AMR221727 andUS2019220403 reported by same reporter for same patient.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: fever is now 102; bad headache; body aches; lots of pain around the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced fever, headache, general body pain and injection site pain. On an unknown date, the outcome of the fever, headache, general body pain and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, general body pain and injection site pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's wife. The patient had most of the side effects from the 2nd shot. The patient experienced a really bad headache, fever, body aches and lots of pain at and around the injection site. The patient wanted to know how long would be the symptoms last. At the time of this report, the 2nd day the patient still had all the symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2019, the patient received Shingrix. On 4th December 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, the day before reporting the patient received dose of Shingrix and on the day of reporting had arm pain. The reporter did not consent to follow up. This case was 3 of 3 linked cases.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Hives from head to toe / Hives as very itchy and uncomfortable; Hives as very itchy and uncomfortable; Hives as very itchy and uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a month after receiving Shingrix, the patient experienced generalized urticaria, pruritus and discomfort. The patient was treated with prednisone (Prednisone (Oral)) and fexofenadine hydrochloride (Allegra). On an unknown date, the outcome of the generalized urticaria, pruritus and discomfort were unknown.   It was unknown if the reporter considered the generalized urticaria, pruritus and discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that after vacination, at the end of September 2019, had hives from head to toe. The patient stated that, the hives were very itchy and uncomfortable and that it came and went but continued to come back. The patient seen by the physician and prescribed oral prednisone and Allegra but they did not help the hives. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Itching; Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site pain. On an unknown date, the outcome of the injection site itching and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received the second dose of the Shingrix and till the time of reporting she was still experiencing itching and soreness at the injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Non-Localized rash distal to injection site side; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The physician stated that the patient experienced a non localized rash reaction distal to injection site side after 1st dose of Shingrix. The follow up consent was not granted.
Age: 65.0
Sex: F
Vaccine: PNC, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles in the right upper arm; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix and PREVNAR. On 5th December 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Prevenar in her left arm. The patient  was diagnosed with shingles in the right upper arm. No additional information was provided. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Pain in deltoid; This case was reported by a other health professional via call center representative and described the occurrence of localized muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received Shingrix. On 10th December 2019, less than a day after receiving Shingrix, the patient experienced localized muscle pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the localized muscle pain was unknown.   It was unknown if the reporter considered the localized muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in deltoid after receiving Shingrix. The patient was treated with icepack and Tylenol, with some relief. The reporter consented to follow up. This case has been linked with case US2019226007 reported by the same reporter.