chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Feeling abnormal, Food allergy, Pyrexia, Vaccination complication
Clinical narrative: Was down for two weeks; Could have been allergic to the egg in the vaccine; Diarrhea; Vomiting; Fever 105.7; Felt horrible; This is a spontaneous case, initially received from other health professional via Med Communication (reference number: SEQ20-00490) on 03-Feb-2020, concerning a 18-year old female patient. The patient was 63-year-old at the time of this report.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date in 1975, the patient was administered unspecified flu vaccine [influenza vaccine, dose, route of administration, batch number, expiration date and anatomical location: not reported] for an unknown indication.   On the same day, minutes after vaccination, the patient experienced a horrible reaction to the flu vaccine and was sent to the emergency room (ER). The patient described that she experienced a fever 105.7 F, vomiting, diarrhea and felt horrible. She was discharged home, where she was down for two weeks.  It was reported that ER doctor thought the patient was possibly allergic to the egg in the vaccine, the patient reported that they really did not know what the patient had reaction to.  On an unspecified date, the patient was recovered from the events.  The reporter assessed case as serious.  The reporter stated that a horrible reaction, which she experienced was due to the flu shot.  The reporter did not grant the permission for follow up.  Company comment: The patient experienced depressed mood, food allergy, diarrhoea, vomiting, pyrexia and feeling abnormal after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Reporter's Comments: The reporter stated that a horrible reaction, which she experienced was due  to the flu shot.; Sender's Comments: The patient experienced depressed mood, food allergy, diarrhoea, vomiting, pyrexia and feeling abnormal after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Was down for two weeks; Could have been allergic to the egg in the vaccine; Diarrhea; Vomiting; Fever 105.7; Felt horrible; This is a spontaneous case, initially received from other health professional via Med Communication (reference number: SEQ20-00490) on 03-Feb-2020, concerning a 18-year old female patient. The patient was 63-year-old at the time of this report.  The patient's relevant medical history and concomitant medications were not provided.  On an unspecified date in 1975, the patient was administered unspecified flu vaccine [influenza vaccine, dose, route of administration, batch number, expiration date and anatomical location: not reported] for an unknown indication.   On the same day, minutes after vaccination, the patient experienced a horrible reaction to the flu vaccine and was sent to the emergency room (ER). The patient described that she experienced a fever 105.7 F, vomiting, diarrhea and felt horrible. She was discharged home, where she was down for two weeks.  It was reported that ER doctor thought the patient was possibly allergic to the egg in the vaccine, the patient reported that they really did not know what the patient had reaction to.  On an unspecified date, the patient was recovered from the events.  The reporter assessed case as serious.  The reporter stated that a horrible reaction, which she experienced was due to the flu shot.  The reporter did not grant the permission for follow up.  Company comment: The patient experienced depressed mood, food allergy, diarrhoea, vomiting, pyrexia and feeling abnormal after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Reporter's Comments: The reporter stated that a horrible reaction, which she experienced was due  to the flu shot.; Sender's Comments: The patient experienced depressed mood, food allergy, diarrhoea, vomiting, pyrexia and feeling abnormal after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as related.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Middle insomnia, Myalgia
Clinical narrative: Patient has deep pain inside deltoid muscle so severe it is waking him up at night. No reports of swelling, bruising, edema, or redness/erythema. Patient had hernia surgery on 1-7-2020 and admits to limited movement (voluntary) since then. Patient reported adverse events on 2/3/2020 at 3:47PM.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient has deep pain inside deltoid muscle so severe it is waking him up at night. No reports of swelling, bruising, edema, or redness/erythema. Patient had hernia surgery on 1-7-2020 and admits to limited movement (voluntary) since then. Patient reported adverse events on 2/3/2020 at 3:47PM.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella virus test positive
Clinical narrative: Rash developed - beginning on scalp and then proceeding to arms, legs, torso three weeks after receiving the Varicella shot
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient received both shingrix vaccinations to complete the 2 dose series Dose 1 completed on 08/15/2019 Dose 2 completed on 12/28/2019 Patient reported rash on 02/10/2020 Patient saw primary care physician on 2/12/2020 and was diagnosed with shingles Patient does not report pain or widespread rash associated with case of shingles
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Respiratory tract congestion
Clinical narrative: Patient said Dizziness, Congestion lasting for 1 week
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Dysphonia, Erythema, Headache
Clinical narrative: rash and red swollen arm with headache, chills and hoarsness and wheezing and tightness of chest
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash, Wheezing
Clinical narrative: rash and red swollen arm with headache, chills and hoarsness and wheezing and tightness of chest
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Woke up the next morning with arm swollen and red. The day after the swollen and red traveled past my elbow so I went to the doctor's weekend clinic who diagnosed it as cellulitis and prescribed cephalexin. The next day after the taking the medication the swelling and redness went away.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain, redness, swelling at injection site. Overall body aches, shivering, fever, and nausea. Still ongoing 24 hours post injection and not letting up yet.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site. Overall body aches, shivering, fever, and nausea. Still ongoing 24 hours post injection and not letting up yet.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient reported diagnosis 2/9/2020 of shingles.  Was seen at emergency room
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Electrocardiogram, Facial paralysis, Magnetic resonance imaging
Clinical narrative: patient developed bells palsy and was taken to hospital 8 days after injection
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation decreased
Clinical narrative: Patient desated shortly after receiving vaccines that ultimately required respiratory support.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt was administer havrix,Menveo and Bexero today in office at 2:17 pm.After the vaccine were administer pt turn white and pass out.Pt was laid  down  and Dr was call to evaluated the pt.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Menstruation irregular, Pregnancy test urine positive
Clinical narrative: GARDASIL 9 was inadvertently given to a patient who was pregnant; therapy start date: 13-MAR-2017/ was given GARDASIL 9 before the office gave her an urine pregnancy test/ AE Onset date: 31-JAN-2020; GARDASIL 9 was inadvertently given to a patient who was pregnant; patient came into office for irregular bleeding; This spontaneous prospective pregnancy report was received from a medical assistant (also reported as nurse) referring to a currently 14-year-old female patient. The patient's concurrent conditions included depression and suicidal ideation. The patient's concomitant medication included medroxyprogesterone acetate. The patient had no previous drug allergies or reactions.       On 13-MAR-2017, 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) 1 intramuscular injection as prophylaxis (strength, anatomical location, lot number and expiration date were not reported).  On an unspecified date, the patient experienced irregular bleeding (menstruation irregular).  On an unknown date, the patient became pregnant. The last menstrual period (LMP), the estimated date of delivery (EDD), and the estimated date of conception were not reported.   On 31-JAN-2020, the patient went to the physician's office due to the irregular bleeding, and was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 intramuscular injection as prophylaxis (dose number, strength and anatomical location were not reported; lot number R029512 has been verified to be valid, expiration date reported and validated as 08-JUL-2021) (inappropriate schedule of product administration) before the office gave her an urine pregnancy test which came back positive (vaccination error and exposure during pregnancy).   It was reported that the patient did not sought medical attention (conflicting information), did not received any treatment for the events, and that the therapy would be continued.  The outcome of the menstruation irregular was reported as recovered.  The causal relationship between the suspect therapy and the menstruation irregular was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 05-FEB-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection, lot number S009760, expiration date on 27-SEP-2020 (concentration, dose number, and anatomical location were not reported) as prophylaxis, that had been improperly stored in a temperature of -14 Celsius degrees to -10 Celsius degrees -13.5 Celsius degrees for 41 minutes, there was not a previous temperature excursion. It was reported that the sterile diluent lot number S031278, expiration date on 16-JUN-2022; used to reconstitute the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) was properly stored. No additional adverse event was reported, and the temperature was recorded by a data logger.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: The patient began to experience mucus and blood in their stool.; The patient began to experience mucus and blood in their stool.; This spontaneous report was received from a nurse prescriber via company representative referring to an approximately 6-week-old male patient. Patient had no pertinent medical history and drug reactions/allergies. Patient was not on any concomitant medications. On 05-NOV-2019, the patient was vaccinated with first dose (also reported as first dose in the series) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, batch/lot# and expiry date were not reported) via oral route for routine vaccination. On 06-NOV-2019, 24 hours later, the patient began to experience mucus (mucous stools) and blood in the stool (hematochezia). On the same day, the patient sought medical attention in the physician's office. The patient did not receive treatment for the reported events. It was unknown if the patient had recovered as the patient moved. The outcome of haematochezia and mucous stools was reported as unknown. The causality assessment was not provided.  Upon internal review, the event hematochezia was determined to be medically significant.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation decreased
Clinical narrative: Infant had multiple desats shortly after vaccines were administered that eventually required respiratory support.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Hypoaesthesia, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Client received both bexsero and menveo in L arm on 2/4/20. 3 hours later she developed a severe headache that necessitated a trip to ER 8 hours from vaccination. Arm started to swell. By morning, 2/5/20 client had head splitting headache then could not feel or move her L arm. Child went to ER twice more in next 2 days and was told that this was an inflammatory response and would get better in a few weeks. Today mother called me to report that child still cannot feel or move arm. Mother is seeking neuro consult.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: The patient had a round circular redness about 6 inches in diameter on the arm . the redness spread almost all the way around the arm but lightened in color. small tender knot at injection site and rash is almost gone per patient today. 2/12/2020
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature fluctuation, Bradycardia
Clinical narrative: Infant experienced increasing events of periodic breathing, desaturation, bradycardia, and temp instability that required need for respiratory support.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has swelling at the injection site. Injection site is also red and warm to the touch. Recommended Ibuprofen to the patient and applying ice to affected area. Told patient if it progressed or didn't get better in a couple of days, see provider.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Headache, Influenza like illness, Pain
Clinical narrative: pain, dizziness, light headed, difficulty standing up, flu-like symptoms (headaches in back of head, cold hand/feet, fever)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: pain, dizziness, light headed, difficulty standing up, flu-like symptoms (headaches in back of head, cold hand/feet, fever)
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt was administer Boostrix,Menveo,Fluzone and Gardasil today in office at 2:03pm. After vaccine were administer,pt turn white and pass out .Pt was immediately laid down and Dr. was brought to the room.Pt was evaluated by Dr and  was cleared to go home.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Pain, Pyrexia, Rash
Clinical narrative: Patient reported fever, whole body aches, rash including on face, swollen eyes
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Injection site redness and soreness immediately after administration lasting 2+ days. Low grade fever, moderate to severe muscle and joint aches and fatigue lasting 36 hours; starting approx. four hours after administration.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Injection site redness and soreness immediately after administration lasting 2+ days. Low grade fever, moderate to severe muscle and joint aches and fatigue lasting 36 hours; starting approx. four hours after administration.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site nodule
Clinical narrative: Small nodule at site of injection (Left thigh) non tender to touch. Pts father reports ongoing since Hep A  injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Arm sore, still tingling from shot
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt came into the pharmacy. Arm was red and swollen, but pt reports symptoms are improving. Counseled pt to use ice/ibuprofen/tylenol if needed.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Eye swelling, Lip swelling, Penile swelling, Urticaria
Clinical narrative: Pt. developed swelling to up and bottom lips,  left eye swelling and hives to neck and as per mother child had swelling to penis too. Child received Epinephrine 0.4ml IM and Benadrly 1ml  IM. Pt. was alert and talkative with no trouble breathing. Mother states she will follow up with their Doctor.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: (A dose of expired vaccine should usually not be counted as valid and should be repeated. In general, doses of non-live (for example, inactivated, recombinant, or polysaccharide) vaccines may be repeated immediately. Repeat doses of most live vaccines should be given at least 4 weeks after the expired dose, because of the possibility that the vaccine antigen could still be viable. The above recommendation applies to live oral rotavirus vaccine, but with this caveat: the last dose of rotavirus vaccine should not be given to a child older than 8 months 0 days. Space a repeat dose less than 4 weeks if necessary to not exceed this maximum age.  If a capsule of expired live oral typhoid vaccine is taken, the entire 4-dose series should be repeated. There is no need to wait 4 weeks. As an alternative, a dose of the injected typhoid vaccine may be given.  Contact your immunization program and/or the vaccine manufacturer for specific guidance on revaccination. A manufacturer could recommend a "grace period" during which a dose of expired vaccine could still be counted.    ***Feedback about your experience with CDC-INFO is important to us and will help us continue to improve. Please rate your interaction by completing this short survey: No Physical symptoms reported, recommended to repeat dose in 4 weeks.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Intensive care, Pneumonia pneumococcal, Seizure, Syncope
Clinical narrative: Patient called and stated had been in ICU and diagnosed with "pneumococcal pneumonia ammonia" according to patient. Described symptoms as either fainting or seizing. Patient released from hospital on 2/11/2020
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: (A dose of expired vaccine should usually not be counted as valid and should be repeated. In general, doses of non-live (for example, inactivated, recombinant, or polysaccharide) vaccines may be repeated immediately. Repeat doses of most live vaccines should be given at least 4 weeks after the expired dose, because of the possibility that the vaccine antigen could still be viable. The above recommendation applies to live oral rotavirus vaccine, but with this caveat: the last dose of rotavirus vaccine should not be given to a child older than 8 months 0 days. Space a repeat dose less than 4 weeks if necessary to not exceed this maximum age.  If a capsule of expired live oral typhoid vaccine is taken, the entire 4-dose series should be repeated. There is no need to wait 4 weeks. As an alternative, a dose of the injected typhoid vaccine may be given.  Contact your immunization program and/or the vaccine manufacturer for specific guidance on revaccination. A manufacturer could recommend a "grace period" during which a dose of expired vaccine could still be counted.    ***Feedback about your experience with CDC-INFO is important to us and will help us continue to improve. Please rate your interaction by completing this short survey: No physical Symptoms reported. Recommended to repeat dose in 4 weeks.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Injection site urticaria, Lip swelling, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient developed a large hive on his right arm after about 36hours just under the area where he received the vaccine, then developed full body hives, lip swelling, fever and cough/congestion in the next few days
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient developed a large hive on his right arm after about 36hours just under the area where he received the vaccine, then developed full body hives, lip swelling, fever and cough/congestion in the next few days
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Pain in extremity, Pyrexia, Swelling
Clinical narrative: SHOOTING PAIN GOING DOWN RIGHT ARM, COLD ALL OVER GOLF BALL SIZE SWELLING AND REDNESS, FEVER OF 100 DEGREES.   PAIN SUBSIDED AFTER USING DIAZEPAM.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Panic attack
Clinical narrative: Patient had a minor panic attack 15 minutes after vaccine was given. Paramedics were called, patient was evaluated by paramedics and was stable and release home.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Pt had syncopal episode after flu vaccine. Pt was monitored for 30 mins. Both Mom and pt felt ok to leave. Pt will be called tomorrow to inquire how they're feeling.
Age: 0.58
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Given vaccine for 4 years and up, inappropriate for age No side effects occurred.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine was administered 3 cm from the elbow. Per provider's note: "Patient presents 2 days after receiving 4 year old immunizations. Patient's mother states that immunization was administrated near the elbow. Mom states over past 48 hours the immunization site has become red and swollen. Patient with some pain overnight, none currently. No fever. No loss of mobility of left arm/elbow"
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Rash, Skin discolouration
Clinical narrative: After two days post injection, injection site became extremely red and swollen, this lasted until the 8th of February. On Sunday the 9th a bumpy rash appeared and has lasted up until today the 12th. Surrounding the affected area there is possible vasoconstriction because of there being a whitening to the skin around the rash.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Influenza like illness, Injection site pain, Malaise, Toothache
Clinical narrative: The flu shot was painless and easy.   The side effects started in the next day or two.  Flu like symptoms, feeling low energy and sick.  Developed a bad toothache that persisted for some days, and a pain in the arm where the vaccine was administered.   The other syptoms subsided after about a week, but the pain in the arm persisted day after day, week after week, month after month, and is still present today, 2/12/2020,  In addition, the pain has increased lately and is worse now than it was initially.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site rash, Malaise, Pyrexia
Clinical narrative: Pt has rash an pain from injection site downward to 1-2 inch above elbow, malaise, mild fever--All started second day (2/7/2020) after injection.  Patient felt the worse on 2/11/2020.  Patient saw her doctor and was given ibuprofen 600mg TID.  Pt came to the pharmacy today.  Advised pt: to ice the area,  if rash or pain gets worst see her doctor.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Pt describes a "tire track" mark appx 2-3 inches wide across upper arm, not itchy, red or swollen. Pt states that the appearance looked "blotchy".
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Fall, Feeling abnormal, Loss of consciousness, Nausea
Clinical narrative: I felt a little poorly in the evening of the vaccines, queasy and a little light headed.  When I got up at 3:45 a.m. I went to the bathroom and after voiding I felt like I was going to vomit.  I reached across for the sink and passed out.   My husband heard me fall and found me unconscious.  He called my name and slapped my face but I did not respond.  He grabbed the bedroom phone and came back and tried once again to rouse me.  He started to dial 9-1-1 when he heard me start to moan.  I gradually regained consciousness.  I had no recollection of feeling as if I were going to faint.  I just blacked out.
Age: 54.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Feeding disorder, Headache
Clinical narrative: side effects began with severe chills/shivering, followed by nausea (I could not eat anything for 40 hours), pounding headache, soreness in all major muscle groups (esp. legs), weakness in right leg (which is already weakened by MS, but seemed to be enhanced), a "full stomach" feeling near the top of my stomach that borderlined painful, extreme fatigue, bizarre racing thoughts when I tried to sleep.
Age: 54.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Muscular weakness, Myalgia, Nausea, Tachyphrenia
Clinical narrative: side effects began with severe chills/shivering, followed by nausea (I could not eat anything for 40 hours), pounding headache, soreness in all major muscle groups (esp. legs), weakness in right leg (which is already weakened by MS, but seemed to be enhanced), a "full stomach" feeling near the top of my stomach that borderlined painful, extreme fatigue, bizarre racing thoughts when I tried to sleep.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Patient reported pain in her arm beginning immediately when she received the vaccine. Pain has been constant since then at rest and while moving her arm.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Blood thyroid stimulating hormone normal, Chest pain, Chills, Culture urine negative
Clinical narrative: Patient woke up at 3 AM feeling chills and chest pain, reported fever. She went to the emergency room and was admitted until the 24th. She had tachycardia and leukocytosis and was treated with broad spectrum antibiotics because of suspected sepsis. Blood and urine cultures returned negative.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Leukocytosis, Neutrophil count increased, Pyrexia, Sepsis, Tachycardia
Clinical narrative: Patient woke up at 3 AM feeling chills and chest pain, reported fever. She went to the emergency room and was admitted until the 24th. She had tachycardia and leukocytosis and was treated with broad spectrum antibiotics because of suspected sepsis. Blood and urine cultures returned negative.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient woke up at 3 AM feeling chills and chest pain, reported fever. She went to the emergency room and was admitted until the 24th. She had tachycardia and leukocytosis and was treated with broad spectrum antibiotics because of suspected sepsis. Blood and urine cultures returned negative.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Swollen arm from elbow to shoulder with rash. Sore to touch. Felt Hard per patient. Lasted about 6 days and has been getting better daily.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom states day after inj., pt. with red, hot, raised area. Today area still red, warm to touch & pt. states itchy. 7x14cm area
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Ultrasound scan
Clinical narrative: Patient got the flu shot in Nov'2019. We called him in January for his shingle shot and at that time patient informed us about the slight bump and a dull pain at the injection site We advised him to see the MD. and was advised ultrasound and MD did not find any signs of infection or tissue etc. and no further treatment recommended.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Decreased appetite, Dizziness, Eyelid margin crusting, Fatigue
Clinical narrative: 01/09, @ 5:35PM, pt. working Felt dizzy and didn't feel right. Dec. appetite, later on that night=> waist-down legs felt like the weren't there. Went to bed, slept most of 01/10, Legs better, pt. very tired and had troubles sitting up. 1/11 -> felt fine. 1/12 -> cough, runny nose in AM (1/13). 1/13/20 red, crust left eye - getting better -> 2/7/20: resolved
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Hypoaesthesia, Mobility decreased, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: 01/09, @ 5:35PM, pt. working Felt dizzy and didn't feel right. Dec. appetite, later on that night=> waist-down legs felt like the weren't there. Went to bed, slept most of 01/10, Legs better, pt. very tired and had troubles sitting up. 1/11 -> felt fine. 1/12 -> cough, runny nose in AM (1/13). 1/13/20 red, crust left eye - getting better -> 2/7/20: resolved
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2/5/20 PNEUMOVAX given into (R) deltoid without difficulty 2/6/20 pt called saying evening of 2/5 developed pain, swelling to (R) elbow, (R) upper arm hard red & warm to touch with limited range of motion; Urgent office Appt made. Provider recommended ice, rest & ROM exercises, provider noted. "no injection site reaction noted" 2/7/20 pt called, no improvement. Ordered Stat RUE Ultra sound which was Negative for DVT 2/10/20 I called pt to check status, states she was 100% back to normal by 2/7/20 in evening, No further pain or swelling of (R) upper arm, ROM fully returned
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint swelling, Ultrasound scan normal
Clinical narrative: 2/5/20 PNEUMOVAX given into (R) deltoid without difficulty 2/6/20 pt called saying evening of 2/5 developed pain, swelling to (R) elbow, (R) upper arm hard red & warm to touch with limited range of motion; Urgent office Appt made. Provider recommended ice, rest & ROM exercises, provider noted. "no injection site reaction noted" 2/7/20 pt called, no improvement. Ordered Stat RUE Ultra sound which was Negative for DVT 2/10/20 I called pt to check status, states she was 100% back to normal by 2/7/20 in evening, No further pain or swelling of (R) upper arm, ROM fully returned
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, MNQ, RV5
Symptoms: Wrong product administered
Clinical narrative: Patient was here for 2 month well. Provider circle correct vaccines to be administer. MA grab MCV4 instead of HIB and administer MCV4 intramuscular on Right thight.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: pt presented with redness around left deltoid am hour latter after vaccination
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes simplex, Pain, Pruritus
Clinical narrative: Patient received the vaccine late morning.  Every week or so, patient breaks out in a large red blister that is painful, itchy and has little bumpsshe has never had this before.  Symptoms started the morning after shingles vaccine.  On 1/24/20, dermatologist said it was Herpes Simplex and wanted to know if patient was worried or under stress (which she was not). Doctor prescribed Valtrex 500mg and triamcinolone acetonide 0.1% topical ointment. Patient is not sure if the provider that examined her at the office really knew what it really isprovider was not her usual one.   Medicine helped and it cleared completely but got more episodes on 1/11 and 2/11.   The blisters have primarily been on the right side of trunkon different spots--except on this last episode for which it is on the left.   Patient received the Flu shot on 10/23/2019 Patient is worried that this will keep happening. She keep breaking out with 1 or 2 blisters every few weeks never had anything like this ever.  Patient is supposed to get the 2nd shot but she is leary and afraid- she does not know what to do.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient received the vaccine late morning.  Every week or so, patient breaks out in a large red blister that is painful, itchy and has little bumpsshe has never had this before.  Symptoms started the morning after shingles vaccine.  On 1/24/20, dermatologist said it was Herpes Simplex and wanted to know if patient was worried or under stress (which she was not). Doctor prescribed Valtrex 500mg and triamcinolone acetonide 0.1% topical ointment. Patient is not sure if the provider that examined her at the office really knew what it really isprovider was not her usual one.   Medicine helped and it cleared completely but got more episodes on 1/11 and 2/11.   The blisters have primarily been on the right side of trunkon different spots--except on this last episode for which it is on the left.   Patient received the Flu shot on 10/23/2019 Patient is worried that this will keep happening. She keep breaking out with 1 or 2 blisters every few weeks never had anything like this ever.  Patient is supposed to get the 2nd shot but she is leary and afraid- she does not know what to do.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pre-eclampsia
Clinical narrative: Vaccine exposure during pregnancy; preeclampsia with severe features; This spontaneous retrospective pregnancy report was received from a physician referring to a female patient of unknown age. The patient's medical history included obesity, anaemia, anxiety and depression.  Concomitant therapies included prochlorperazine (COMPAZINE), amoxicillin, clavulanate potassium (AUGMENTIN) and iron.    On 13-MAY-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (5 mi, lot # R023609, expiration date not reported, but upon internal validation established as 30-APR-2021) for prophylaxis.  The patient became pregnant with  last menstrual period (LMP) of 09-APR-2019 and estimated date of delivery (EDD) of 14-JAN-2020 (exposure during pregnancy). The patient delivered two female infants weighing 5 Ibs. The pregnancy outcome was live birth. The infant's APGAR score was 8 at one minute. The APGAR score was 9 at five minutes. The patient's complication during pregnancy included pre-eclampsia.  The outcome of pre-eclampsia was unknown. Causality assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional adverse symptoms reported.; 1 expired dose of MMR II administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 16-JAN-2020, the patient was vaccinated with 1 expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot number reported as R017800 with expiration date 19-DEC-2019 (dose, route of administration were not provided), for prophylaxis. The outcome of the event was unknown.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Extra dose administered
Clinical narrative: The patient experienced no symptoms; patient was administered a dose of PROQUAD and a dose of VARIVAX at the same time; patient was administered a dose of PROQUAD and a dose of VARIVAX at the same time; This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.       On 24-JAN-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R035226, with an expiration date in 04-DEC-2020) (strength, dose, frequency and route were not provided) for prophylaxis. On the same date (reported as "at the same time"), the patient was also vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot #S021325, with an expiration date in 05-JAN-2021) (strength, dose, frequency and route were not provided) for prophylaxis.   Other suspected therapy included sterile diluent.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered a dose of improperly stored Varivax; No additional adverse effect reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 28-JAN-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneously, lot # S024364, expiration date reported as 06-AUG-2021 (dose and frequency were not reported), for prophylaxis.  Administered doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion from -14 to -10 C (-12.6C) for 9 hours 53 minutes. There was previous temperature excursions reported. The administered doses of the suspect vaccine experienced the temperature excursion from -14 C to -10 C(-13.00C) for 14 hours 22 minutes. The digital data logger was involved to capture the temperature excursion. No additional adverse effects were reported.   The is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001517: US-009507513-2002USA001358: US-009507513-2002USA001459:
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Unspecified patients were inadvertently administered doses of Pedvaxhib, Gardasil 9 and Rotateq on unspecified dates that had been improperly stored; No addiitonal adverse event; This non-valid spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. There was no information provided about the patients' concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On an unspecified date, unspecified patients inadvertently received improperly stored vaccines (Product storage error). The patients were vaccinated with doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# 1637641, expiration date reported as 16-FEB-2022, lot# S008154, expiration date reported as 20-NOV-2021; with doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) Lot# S021458, expiration date reported as 27-FEB-2022, lot# S030965, expiration date reported as 03-APR-2022; and with doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot# S017630, expiration date 06-DEC-2020, lot# S004401, expiration date 15-NOV-2020 (exact doses, routes of administration, and anatomical sites for all vaccines were not reported). All vaccines were administered for prophylaxis.   The doses of the vaccines were stored at a temperature reported as -40 degrees Fahrenheit (F) for 4 hours and 50 minutes. There was no previous temperature excursion. Digital data logger was involved. No additional adverse effects were reported.  This case is non-valid due to lack of patient identifiers.
Sex: F
Vaccine: HIBV, HPV4, HPV9, UNK
Symptoms: Syncope
Clinical narrative: fainted after the administration; Information has been received from a field representative, referring to a female teenage patient between the age of 11-12 years old. The patient's concomitant medication and drug reactions/allergies were unknown. The patient had no pertinent medical history.  On an unknown date, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTap), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as unspecified meningitis vaccine) and final dose of unidentified Merck hpv vaccine (name, strength, dose detail, route of administration, lot number and expiration date of all suspect drugs were not reported) for routine vaccination.  On the same date after the administration, the patient fainted. It was unknown whether any lab diagnostics or studies were performed or not. The patient did not seek medical attention. It was reported that the vaccines were not discontinued. The outcome of faint was reported as recovered after resting on the exam table. The causality assessment was not provided.  Upon internal review, the patient fainted was considered as medically significant. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA003067:
Sex: F
Vaccine: HIBV, HPV4, HPV9, UNK
Symptoms: Syncope
Clinical narrative: fainted after the administration; Information has been received from a field representative, referring to a female teenage patient between the age of 11-12 years of old. The patient's concomitant medication and drug reactions/allergies were unknown. The patient had no pertinent medical history.  On an unknown date, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTap), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as unspecified meningitis vaccine) and final dose of unidentified Merck hpv vaccine (name, strength, dose detail, route of administration, lot number and expiration date of all suspect drugs were not reported) for routine vaccination.  On the same date after the administration, the patient fainted. It was unknown whether any lab diagnostics or studies were performed or not. The patient did not seek medical attention. It was reported that the vaccines were not discontinued. The outcome of faint was reported as recovered after resting on the exam table. The causality assessment was not provided.  Upon internal review, the patient fainted was considered as medically significant. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA003051:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). This is one of two cases concerning the same patient.; Sender's Comments:  US-009507513-1208USA007626:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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. In 2016, the pt was inoculated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).