chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. Patient's medical history and concurrent conditions information were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of PNEUMOVAX23 lot # K007826, expiration date 03-FEB-2016, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.55
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on both legs. Ibuprofen 100 mg every 6-8 hrs.
Age: 35.0
Sex: F
Vaccine: MNQ, TYP, YF, MEN, TYP, YF
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: Received immunizations at approx. 845 am 12/2/15. Pt called at 11:30 am saying she felt like she had a sore throat and her tongue was swelling. Advised to call 911 and go to ER. She received SOLUMEDROL, BENADRYL and PEPCID at ER. Sent home with EPIPEN and to follow up with PCP.
Age: 35.0
Sex: F
Vaccine: MNQ, TYP, YF, MEN, TYP, YF
Symptoms: Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Received immunizations at approx. 845 am 12/2/15. Pt called at 11:30 am saying she felt like she had a sore throat and her tongue was swelling. Advised to call 911 and go to ER. She received SOLUMEDROL, BENADRYL and PEPCID at ER. Sent home with EPIPEN and to follow up with PCP.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen 4 inch area around injection. Itchy also.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pustule, Injection site warmth
Clinical narrative: Cellulitis - 8" x 12" red area, pus at site of injection. Warm. Went to urgent care and given 3 prescriptions.
Age: 19.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came in 11/20/15, two days after vaccine admin. Back of arm had red hot patch of skin (diameter of about 3 x 3). Suggested patient apply heat and to notify if symptoms worsen.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female consumer (age not reported) regarding on herself. On an unknown date the patient was vaccinated with a "one time vaccination" dose of ZOSTAVAX (Lot number, dose and site not reported), route reported as "vaccine". On an unknown date, after getting the ZOSTAVAX the patient got shingles. The outcome of shingles was unknown. The relationship between shingles and therapy with ZOSTAVAX was not reported. Additional information is not expected as no contact information is available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unspecified dates, the patient was vaccinated with improperly stored dose of GARDASIL (lot # J009788, expiration date 17-MAR-2016; lot# K007264, expiration date unknown (dose, indication and route of administration were not reported). Concomitant therapy was not provided. No adverse effect was reported. Follow up information has been received from reporting nurse during a phone call on 23-NOV-2015. The nurse stated that she would have to research the requested information (patient identifiers, lot number, expiry date and dates of vaccination) and she may fax them later, if the information becomes available. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. Patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of ZOSTAVAX lot # L024999, expiration date 26-OCT-2016, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Erythema, Headache, Local swelling
Clinical narrative: Whole shoulder swollen and red, very weak, headache, nausea, achy joints and muscles.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea
Clinical narrative: Whole shoulder swollen and red, very weak, headache, nausea, achy joints and muscles.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dysphonia, Peripheral swelling, Urticaria
Clinical narrative: On 10/30 patient developed R arm swelling, hives to her back, hoarse voice.  Went to ER 11/1/15 and given Benadryl with resolution.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed moderate/severe injection site reaction to pneumovax. Was given in left arm. Injection site is swollen, red, warm to the touch, and painful. She took ibuprofen which helped a little. Told her to continue taking ibuprofen and try using a cold compress as well.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Pain in extremity, Skin warm
Clinical narrative: 12/3 arm began getting sore, on 12/24 an area approximately 3" x 5" became red, hot and inflamed.
Age: 0.18
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying, Pyrexia
Clinical narrative: Fever 103, Excessive Crying.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: SITE WAS LEFT ARM INTRAMUSCULAR INJECTION-REACTION WAS SWELLING, REDNESS BAND ALONG SITE, THROBBING.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pain in extremity, Skin warm, Swelling
Clinical narrative: Per patient: All symptoms started about 2:30am on Friday morning waking patient up. Swelling was first (with fever in injected arm) with "deep pain" and chils to follow. All symptoms lasted all day Friday (12/4/2015). Patient went to ER Friday at ~11pm. Patient feels "75%" better as of Saturday 12/5/2015 @ 3:30.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pain
Clinical narrative: Muscle pain in upper arm and joint in the shoulder (7.5-8 on pain scale). Could not lift her arm at all for 3 days on it's own. Pain radiated to elbow (5 on a pain scale). Pain gradually diminished - currently (4 weeks later) pain is 1 on pain scale and only occurs sporatically if moves a certain way.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: ARM WAS SORE, SWOLLEN AND WARM AFTER 8 TO 12 HOURS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Muscle, joint aches. Headache. Chills. Sore and red at injection site.  Still ongoing. Tylenol. Hot drinks.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Muscle, joint aches. Headache. Chills. Sore and red at injection site.  Still ongoing. Tylenol. Hot drinks.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Soreness at injection site of the left deltoid with increased soreness running down the arm and in the shoulder. Some numbness running down the arm and into the hand.  Feels a sore lump at injection site.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient was vaccinated in LEFT arm. Shortly after vaccination, patient's RIGHT arm started to shake uncontrollably. Patient called me (immunizing pharmacist) around 6 PM and I recommended patient go to Emergency Room immediately.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Since patient received her Fluzone HD and Pneumovax 23 immunizations in her left arm, her arm became tender from the shoulder to the elbow and she has developed a reddened area across the middle of her upper arm which is warm to touch.  This red area is about four inches below the injection sites.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Oropharyngeal pain, Throat irritation, Vomiting
Clinical narrative: Patient said she had a headache, chills, threw up bile, and sore scratchy throat. No Swelling noted as of 4:51PM. As of 5:37PM, the patient is feeling a whole lot better. Her throat is better but has a 2 degree temp.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Immediate post-injection reaction, Injection site inflammation, Injection site swelling
Clinical narrative: Immediately after receiving the vaccine there was swelling at the injection site.  After a few minute the swelling had gone down at the immediate injection site, but the entire deltoid area appeared inflamed.  Advised patient to apply ice.  If the the area got worse or didn't improve after an hour, I advised them to contact their physician.  The patient's wife called at 9:45 pm and said that the patient felt fine, but the area was still swollen.  The patient didn't have any shortness of breath.  She said that she talked to some nurses at the Emergency Room where she worked for advise.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Lt arm extremely painful, sore, throbbing with muscle throbbing; but for days after the vaccine, instead of improving, the arm increased in pain intensity with limited range of motion. Back to employe health the first week in November due to intensity of pain & limited range of motion & several visits since then.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Fatigue, Pyrexia
Clinical narrative: Fever and tired on 11/20/15. Arm was red and burning "like fire" on 11/21/15.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac disorder, Intensive care, Swelling
Clinical narrative: Case number PHEH2015US024762 is an initial report received from a consumer via patient oriented program on 23 Nov 2015. This report refers to a 76 years old female patient. Her family history included death of her mother and other maternal family members due to heart failure and she did not suspect that administration of influenza vaccines over the years was related to it. Her medical history was not reported. Her vaccination history included administration of influenza vaccine (manufacturer: Novartis, batch number: not reported) over the years in the past. Concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer: Novartis, batch number: not reported) on an unknown date. On 23 Nov 2015, the patient had heart problems (not further specified). She also had some swelling at the time of reporting (onset date not reported) and she had not yet informed her doctor. She was transferred in to the cardiac intensive care (CIC). The events outcome was unknown. The seriousness of the event was not reported, but the event heart problems was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported. The patient did not give permission to contact the doctor. No further information was provided.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Burning sensation, Erythema
Clinical narrative: Patients mother described redness and burning on the right arm. Provider prescribed anitbiotics.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient had welts appear on her abdomen 5 hours after the vaccination. She took diphenhydramine 75 mg. for 2 days to relieve symptoms. After the 3rd day symptoms persisted. I recommended she call dr.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Ptn came to Rx 12/4/15. Complaint of "achy" shoulder, arm, back. Recommend call MD.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Flu shot given just below acromian process too high on the left shoulder, immediately felt a shooting pain down to my left arm and into my hand followed by tingling and numbness into my fingers. My shoulder is becoming increasingly more painful and more difficult to move. My deltoid is screaming in pain everytime I try to use it and I'm losing sleep.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Flu shot given just below acromian process too high on the left shoulder, immediately felt a shooting pain down to my left arm and into my hand followed by tingling and numbness into my fingers. My shoulder is becoming increasingly more painful and more difficult to move. My deltoid is screaming in pain everytime I try to use it and I'm losing sleep.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness 6-7 inches in diameter and itching on site.
Age: 27.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Liver function test normal, Pruritus generalised, Urticaria
Clinical narrative: Intense itching any and everywhere on body with hives.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Myalgia
Clinical narrative: Extreme muscle and joint pain.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Myalgia
Clinical narrative: Extreme muscle and joint pain.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Dizziness, Skin discolouration, Syncope
Clinical narrative: Dizziness, Fainting, gray color. Sister and brother also felt dizzy and "not well" after Flu Mist administered on 12/05/2015.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: CHILLS, REDNESS AT THE ADMINISTRATION SITE IS INCREASING. SORENESS INCREASED AT THE SITE OF ADMINISTRATION. ON SUNDAY 12/06/2015 SITE HAS CONTINUED WITH REDNESS INCREASING IN SIZE AND FIRMNESS. SIZE IS APPROXIMATELY 8 INCHES IN LENGTH AND 4 INCHES IN WIDTH.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Hives all over body, severe on neck, around groin and joints.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain, Swelling, Tenderness
Clinical narrative: Swelling, hives, extreme tenderness and immobility.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Swelling, hives, extreme tenderness and immobility.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: 3 hours after receiving the flu vaccine in my left upper arm, I began to experience extreme pain and limited mobility in my left shoulder.  I was unable to move my arm more than 3-4 inches away from my body.  This severe pain lasted for 4 days and kept me from sleeping at night. The pain has slowly been diminishing but has not gone away, and now, 3 1/2 weeks later I still do not have full range of motion, certain arm movements cause moderate pain, and I can not sleep well at night due to pain. I saw a doctor 13 days after the injury and was diagnosed with shoulder impingement and was prescribed anti-inflammatories and physical therapy.  I start PT tomorrow 12/7.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Poor quality sleep, Rotator cuff syndrome
Clinical narrative: 3 hours after receiving the flu vaccine in my left upper arm, I began to experience extreme pain and limited mobility in my left shoulder.  I was unable to move my arm more than 3-4 inches away from my body.  This severe pain lasted for 4 days and kept me from sleeping at night. The pain has slowly been diminishing but has not gone away, and now, 3 1/2 weeks later I still do not have full range of motion, certain arm movements cause moderate pain, and I can not sleep well at night due to pain. I saw a doctor 13 days after the injury and was diagnosed with shoulder impingement and was prescribed anti-inflammatories and physical therapy.  I start PT tomorrow 12/7.
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Yellow fever in Left SQ area, experienced redness, warmth, swelling, and pruritis shortly after. Seen at clinic by MD.  Sent to Urgent care center.  Received medications and was sent via ambulance to local ER.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: My 3-year-old daughter was highly verbal and speaking in complete sentences. She received the flu shot and began stuttering two days later, though it was just first syllables and occasionally at that time. The next day the stutter is on almost every single word to the point that she can hardly get through her sentences.
Age: 1.12
Sex: M
Vaccine: HEPA, MMR
Symptoms: Diarrhoea, Irritability, Jaundice, Malaise, Pyrexia
Clinical narrative: Patient became fussy and had a temp of 101. I administered Tylenol and help him while he slept because he would not sleep alone as he normally does. Highest temp was 102.4. He dropped the fever on 12/03/14. After the fever went away his posterior and anterior torso and neck broke into a concentrated small red bumps and his skin turned a bit jaundice. The rash spread from the bottom of his butt to his hairline (posterior) and his pubic bone to his chin. He had diarrhea from 12/02-12/06. Still sick. Wanted to file this report before it ended.
Age: 1.12
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash erythematous
Clinical narrative: Patient became fussy and had a temp of 101. I administered Tylenol and help him while he slept because he would not sleep alone as he normally does. Highest temp was 102.4. He dropped the fever on 12/03/14. After the fever went away his posterior and anterior torso and neck broke into a concentrated small red bumps and his skin turned a bit jaundice. The rash spread from the bottom of his butt to his hairline (posterior) and his pubic bone to his chin. He had diarrhea from 12/02-12/06. Still sick. Wanted to file this report before it ended.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Fatigue, Injection site erythema
Clinical narrative: Stomach cramps, Chills, shivering, aching (fever?); next day, extreme fatigue, some achiness, and slightly upset stomach. Expanding red, swolleness at site of injection. (dime to 50cent piece by Sunday).
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Pain
Clinical narrative: Stomach cramps, Chills, shivering, aching (fever?); next day, extreme fatigue, some achiness, and slightly upset stomach. Expanding red, swolleness at site of injection. (dime to 50cent piece by Sunday).
Age: 1.16
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rash rubelliform
Clinical narrative: Fever of 102 degrees, followed by a red rash that appeared to be the rubella rash.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Initially nickle sized redness at injection site, continue to progress to baseball sized redness. Rash on face, back and chest. Pt advised to use Benadryl and to alert pcp. Pt selected to use Allegra otc to help with symptoms, to avoid drowsiness.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Type 1 diabetes mellitus
Clinical narrative: Got very ill and was diagnosed with Juvenile Diabetes type 1. No history of Diabetes in family members.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Bone pain, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Could not move arm the 1st day due to pain & swelling at shot site.  Swelling gone the next day but still bright red & sore.  The next morning (12/1/2015) diarrhea, chills all day & bones ache all day.  Extreme fatigue, weakness & exhaustion that continues for the whole week.  Some mild headaches, light sensitivity, some nausea, total loss of appetite.  12/2/2015 go to ER about 6 pm because I am totally exhausted and can't hardly move around.  Dr. suggests I go to ER - he wants blood work & vitals.  ER gives me 1 L normal saline with Toradol.  Arm still pale red at shot site but not bright red anymore.  Continue to have no energy level.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Could not move arm the 1st day due to pain & swelling at shot site.  Swelling gone the next day but still bright red & sore.  The next morning (12/1/2015) diarrhea, chills all day & bones ache all day.  Extreme fatigue, weakness & exhaustion that continues for the whole week.  Some mild headaches, light sensitivity, some nausea, total loss of appetite.  12/2/2015 go to ER about 6 pm because I am totally exhausted and can't hardly move around.  Dr. suggests I go to ER - he wants blood work & vitals.  ER gives me 1 L normal saline with Toradol.  Arm still pale red at shot site but not bright red anymore.  Continue to have no energy level.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Pallor, Photophobia
Clinical narrative: Could not move arm the 1st day due to pain & swelling at shot site.  Swelling gone the next day but still bright red & sore.  The next morning (12/1/2015) diarrhea, chills all day & bones ache all day.  Extreme fatigue, weakness & exhaustion that continues for the whole week.  Some mild headaches, light sensitivity, some nausea, total loss of appetite.  12/2/2015 go to ER about 6 pm because I am totally exhausted and can't hardly move around.  Dr. suggests I go to ER - he wants blood work & vitals.  ER gives me 1 L normal saline with Toradol.  Arm still pale red at shot site but not bright red anymore.  Continue to have no energy level.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Erythema, Pain, Skin striae, Skin warm, Swelling
Clinical narrative: Redness and slight swelling. Warm to touch.  Started out about the same size as small round bandaid 24 hours after vaccine.  By 48 hours after vaccine was 2-3 inches in diameter and hot to touch.  At 72 hours after, still 2-3 inches in diameter and warm to touch.  Is itchy to patient and now has scratch marks.  Patient otherwise does not seem too bothered, though complained "it hurt" for first 24-48 hours.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient received the flu shot on 12/3 and later that evening had severe pain in her hip bone.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, red, hot spot at injection site - itchy - feels pain like a bruise. Treatment with ice and has started to subside on day 4. Day 2 and 3 the spot grew bigger. No other sign of rash elsewhere or fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Swollen, red, hot spot at injection site - itchy - feels pain like a bruise. Treatment with ice and has started to subside on day 4. Day 2 and 3 the spot grew bigger. No other sign of rash elsewhere or fever.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash and red, itchy spots after getting ZOSTAVAX vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastroenteritis viral, Herpes zoster, Pneumonia
Clinical narrative: Pt. administered ZOSTAVAX. Developed shingles, stomach flu, then pneumonia. Required hospitalization for 1 week.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown demographics. No medical history was reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose and frequency unknown) (Lot no: L015049, Expiry date: 29-APR-2017). No concomitant therapy was reported. No adverse effects reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Lymphadenopathy, Mobility decreased
Clinical narrative: Injection site swollen, also Left armpit Lymph node painful starting evening of 11/7, reported to us on 11/8/15 morning. Pt had a history of lymphoma 13 yrs ago and was treated w/ radiation, in remission, didn't disclose to us. No treatment resolved as of 12/1/15.
Age: 51.0
Sex: M
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Computerised tomogram, Injection site swelling, Lymph node pain
Clinical narrative: Injection site swollen, also Left armpit Lymph node painful starting evening of 11/7, reported to us on 11/8/15 morning. Pt had a history of lymphoma 13 yrs ago and was treated w/ radiation, in remission, didn't disclose to us. No treatment resolved as of 12/1/15.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Laboratory test, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age, ethnicity and gender received PREVNAR 13 via an unspecified route of administration single dose on 27Feb2015. The patient medical history was not reported. The patient's concomitant medications were not reported. 24 hours after vaccination, on 28Feb2015, the patient came down with double pneumonia. The patient was down for 19 weeks and as a result had numerous side effects, e.g. blood clots, fatigue and the return of atrial fibrillation and as a result back and a blood thinner. The patient was completely healthy on 27Feb2015 before the shot. The outcome was unknown.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Atrial fibrillation, Condition aggravated, Fatigue, Pneumonia, Thrombosis
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age, ethnicity and gender received PREVNAR 13 via an unspecified route of administration single dose on 27Feb2015. The patient medical history was not reported. The patient's concomitant medications were not reported. 24 hours after vaccination, on 28Feb2015, the patient came down with double pneumonia. The patient was down for 19 weeks and as a result had numerous side effects, e.g. blood clots, fatigue and the return of atrial fibrillation and as a result back and a blood thinner. The patient was completely healthy on 27Feb2015 before the shot. The outcome was unknown.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Injection site nodule, Injection site pain, Injection site paraesthesia
Clinical narrative: Pain at site of injection' tingling sensation down to elbow joint, knot at site and sore to the touch.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a non-healthcare professional via Twitter website as part of market research and refers to 32 patients at the age of 18 years old of unknown gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot #, expiration date, exact doses and route of administration were not provided). On unknown dates, reported as 2 to 405 days after the last GARDASIL injection, the patients died. The cause of death was not reported. The reporter considered the event to be related to GARDASIL. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: YF
Symptoms: Peripheral swelling
Clinical narrative: Significant swelling in right upper arm, around where shot was given.  Am applied cortisone and Benadryl topical creme, taken antihistamine tablet.
Age: 0.13
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Victim of child abuse
Clinical narrative: Infant died by alleged abuse by mother's boyfriend.
Age: 35.0
Sex: F
Vaccine: MNQ, TYP, YF, MEN, TYP, YF
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: Swelling of throat and tongue. Hives.
Age: 35.0
Sex: F
Vaccine: MNQ, TYP, YF, MEN, TYP, YF
Symptoms: Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Swelling of throat and tongue. Hives.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Pruritus
Clinical narrative: After receiving flu vaccine, patient reported back to clinic complaining of severe itching and "hoarseness" in voice. Was given 50 mg PO BENADRYL and sent immediately to emergency dept. Received epinephrine and prednisone in ER.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Skin tightness, Swelling
Clinical narrative: Patient reported on 12/4/15. Patient reported having felt sore in the afternoon of 11/13/15. He noticed swelling that worsened over the next day or two. He said the arm felt tight and sore. He iced the arm and elevated it per a nurses instructions. He reported the swelling started to go down on 11/15/15.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune hepatitis
Clinical narrative: Adverse Event Onset Date shown above is an estimate.  Patient is unsure of date (September/October/November) of exact onset. Patient was recently diagnosed with Autoimmune Hepatitis. Per her doctor, this could have been triggered by medications, vaccinations, or environmental triggers. Per the patient, some symptoms could have appeared prior to the vaccine, but increased symptoms appeared after the vaccination.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Excessive eye blinking, Fall, Laboratory test, Loss of consciousness, Seizure
Clinical narrative: Pt has history of seizures but had not had one in 4 years (controlled by medication). Pt had received flu vaccine several times in the past with no adverse reaction. 10 minutes after administration, pt had seizure and fell to the floor convulsing. She required consciousness within a minute but was very drowsy with flickering eyes for the next 10-15 minutes. Monitored then sent to PCP.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: Pt has history of seizures but had not had one in 4 years (controlled by medication). Pt had received flu vaccine several times in the past with no adverse reaction. 10 minutes after administration, pt had seizure and fell to the floor convulsing. She required consciousness within a minute but was very drowsy with flickering eyes for the next 10-15 minutes. Monitored then sent to PCP.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Rash morbilliform
Clinical narrative: Patient arrives today for rash. Mom states rash appeared 2 days ago and has gotten worse. Dr diagnosed rash as measles type rash due to vaccine without complications.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Had flu shot 10/19 - complaint arm still sore at injection site.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient said cannot lift arm; had shot since 10/11/15 and is still experiencing problem. Came to me 11/24/15
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. developed redness, tenderness and pain at injection site w/swelling in region. Symptoms improved since injection placement. Started on Bactrim DS for abx coverage of cellulitis.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Mouth swelling, Oral pruritus
Clinical narrative: Swelling and itching around mouth, approx. 45 mins, treated with oral Benadryl 50 mg @ home after calling nurses line.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site swollen, raised, itchy, red and painful, size about 3 silver dollars.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Rash at site of injection that appears to be Shingles.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 55.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cervical radiculopathy, Injection site erythema, Injection site swelling, Neuralgia
Clinical narrative: Red, erythematous, swelling locally over injection (right SubQ). Also, deep nerve pain. C7 radiculopathy.
Age: 55.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cervical radiculopathy, Erythema, Pain, Rash vesicular, Swelling
Clinical narrative: Red, erythematous, swelling locally over injection (right SubQ). Also, deep nerve pain. C7 radiculopathy.
Age: 80.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None, No adverse affects.
Age: 4.0
Sex: M
Vaccine: FLUC3
Symptoms: Cough, Fatigue, Nausea, Pyrexia
Clinical narrative: Patient experienced cough, nausea, fever, fatigue.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 19 year old patient of unknown gender. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # L010596, expiration date: 06-APR-2017) (strength, dose and route were not provided) and on 20-OCT-2015, with a dose of improperly stored GARDASIL 9 (lot number L000610, expiration date: 31-JAN-2017) (strength, dose and route were not provided). NO adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 54 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via regulatory authority and described the occurrence of fever in 2-month-old male patient who received BEXSERO. In 2015, the patient received the 1st dose of BEXSERO (intramuscular). In 2015, several hours after receiving BEXSERO, the patient experienced fever (serious criteria hospitalization). The patient was treated with paracetamol. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: The fever started some hours after administration of BEXSERO and lasted for approximately 1 day. The fever required hospital urgency where the infant stayed one night by precaution. The fever resolved after receiving specific treatment with paracetamol. For tolerance after the 2nd dose, see case PT2015GSK167983.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a patient's wife referring to her 66-year-old husband. The patient's pertinent medical history was not reported. On 17-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 intramuscular administration in the unspecified arm (dose, lot# and expiration date were not reported). The patient's concomitant medications were not reported. On 18-NOV-2015, the patient complained on his arm hurting at the injection site and chills. The patient stated that his arm was swollen and red, from his shoulder down to his elbow. On 18-NOV-2015, the patient saw his (unspecified) neurosurgeon and advised of his symptoms. The neurosurgeon recommended to the patient visit at his primary physician. On the same day, the patient went to his primary physician, who recommended prednisone (manufacturer unknown) as a treatment. The patient's symptoms began improving the next day, after the first dose of prednisone (manufacturer unknown). The outcome of pain at the injection site, chills, swollen and red arm was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information is not expected as no contact details were included.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown gender and age. No information regarding the patient's medical history and concurrent conditions was provided. On an unspecified day in February 2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). On 23-NOV-2015, the patient was inadvertently administered a second dose of ZOSTAVAX lot # K020802, expiration date: 31-JAN-2016 (dose and route of administration were not reported). The patient's concomitant medications were not reported. There was no adverse effect reported. Product quality was not involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Rubella antibody negative
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to unspecified number of female, expectant mothers of childbearing age (exact ages were not reported). Patients' concurrent conditions and medical history were not reported. On an unknown dates in the past, patients were vaccinated with the first dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported). Other suspect therapies included RHOGAM (dose, frequency, route of administration, lot number, expiration date and indication were not reported) which was administered on an unknown dates. Concomitant therapy was not reported. On an unknown dates, patients became pregnant. The Last Menstrual Period (LMP) dates and Estimated Delivery Dates (EDD) were not reported. On an unknown dates, mothers were tested for rubella status and an unspecified number of mothers was found to have a diminished immunity to rubella component after receiving RHOGAM. The reporter stated that whether a mother was found to be immunodeficient to rubella component, mother was vaccinated with a second dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported) before leaving office to treat the immunodeficiency (dates not reported). The outcome of the event was not reported. The pregnancy outcome was pending. The relatedness between the event and M-M-R II and RHOGAM was not reported. Additional information is not expected as the reporter refused additional contact.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Interchange of vaccine products, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a health professional via field representative refers to a 12 year old male patient. No medical history, concurrent conditions and concomitant medication were reported. On 22-Sep-2015 the patient was vaccinated with the first dose of GARDASIL 9 lot # L014415 (dose, expiry date and route were not specified) with no adverse effect afterward. On 23-NOV-2015, the patient was administered with GARDASIL intramuscularly, 0.5 ml, lot # K016966, expiration date 10-MAY2015. Immediately after receiving GARDASIL, the patient "fainted" and "completely lost consciousness for 2 seconds". On the same day, he recovered completely and was discharged to home with no residual effects. No treatment was given and no laboratory tests were performed. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a multiple unspecified patients of unknown demographics. On an unspecified dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route unspecified). These were the possible lots/expiration involved: (L005299, 17-FEB-2017), (L001335, 13-JAN-2017), (L011083, 1-APR-2017), (L016127, 6-MAY-2017). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 04-SEP-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number, expiration date, dose and route of administration were not reported) 10 microgram/ml. Subsequently, the patient was vaccinated with the second and the third dose of RECOMBIVAX HB (lot number, expiration date, dose and route of administration were not reported) 10 microgram/ml on 03-NOV-2015 and 25-NOV-2015, respectively. No concomitant therapy was reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 71 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, FLUN4, MMRV, PNC13
Symptoms: Cellulitis, Rash vesicular
Clinical narrative: Vesicular rash - starting on 11/25 or 26th. Developed cellulitis on arm after scratching.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 60 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The information of concurrent conditions, medical history and concomitant medications was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 injection (lot # L013429, expiration date 21-JUL-2017; lot # L09287, expiration date 14-SEP-2017; lot # L027282, expiration date 21-SEP-2017) (dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a multiple unspecified patients of unknown demographics. Approximately in November 2015 (also reported as on or after 13-NOV-2015) the patients were vaccinated with improperly stored VARIVAX injection (L025206, 07-JUL-2017) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K020214, expiration date 25-MAR-2016; dose and route not reported). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 30-OCT-2015 the patient was vaccinated with the first dose of VAQTA (lot#/expiration date, dose and route were not reported). On 01-DEC-2015 the patient was vaccinated with the second dose of VAQTA (dose and route not reported, lot # reported as L009521 with expiration date 28-APR-2017), which was outside the recommendations per the prescribing information (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Developed ITP platelet count 2. Admitted to hosp for IVIG. Received MMR 9/21/15. Developed fever same day with diarrhea lasted approximately 5 days. Then fever returned approximately 2 weeks after receiving MMR which persisted. Rash with few petechia developed and sent for blood.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Developed ITP platelet count 2. Admitted to hosp for IVIG. Received MMR 9/21/15. Developed fever same day with diarrhea lasted approximately 5 days. Then fever returned approximately 2 weeks after receiving MMR which persisted. Rash with few petechia developed and sent for blood.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Inflammation
Clinical narrative: This spontaneous report was received from a physician and refers to a 21 year old female patient. The patient did not have pertinent medical history and drug reactions or allergies. On 13-AUG-2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, route of administration, lot and expiration date were not reported), as "she was of age and had not been vaccinated yet". On 14-SEP-2015 (also reported as then), the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route of administration, lot and expiration date were not reported). Concomitant therapies included LEVORA. "Sometime" on 14-SEP-2015, the patient developed redness and inflammation on her unspecified arm "that spanned from her elbow up to her shoulder". The patient did not receive the treatment and did not seek medical attention. On approximately 17-SEP-2015 (reported as the patient's reaction lasted "2 to 3 days"), the patient recovered from the adverse events. On 01-DEC-2015 (also reported as today), the patient was seen in the physician office for a "routine visit" and informed the physician about her reaction. No lab diagnostic studies were performed. The outcome of interchange of vaccine products was unknown. The relatedness between the events and GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.