chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Polycystic ovaries, Postural orthostatic tachycardia syndrome, Weight increased
Clinical narrative: As soon as received GARDASIL vaccine, had burning thru entire body. Felt different after that. Balance issues, concentration issues. Said her brain felt different. Soon after that, had a virus that was thought to be flu. Treated with antibiotics. Had a headache that would not go away for 45 days. Went from being a 115 lb athlete, to a 155 lbs and could not eat. Hospitalized at two hospitals. Also hospitalized other times and other places afterwards. She never got better--had terrible pain. Had multiple tests and saw many doctors and all tests were normal. They could never find the cause of the headaches, but she did have 2 surgeries to improve the headaches-decompression surgery in 2015 and removal of nerves in forehead in 2016. She was diagnosed with POTS and with polycystic ovarian syndrome after vaccination. Had possible seizures-saw over 200 doctors. Died in the bathtub due to drowning.
Age: 77.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: PATIENT RECEIVED VACCINE AROUND 9:50 am AND RETURNED 30 MINUTES LATER STATING THAT HIS FINGER ON HIS LEFT HAND WAS FEELING A BIT NUMB (WHICH IS THE SAME ARM WHERE THE VACCINE WAS ADMINISTERED...LEFT DELTOID).
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient arm was swollen and red around the injection site.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: SWOLLEN, HARD, RED, AND ITCHY UPPER ARMS. SPREAD TO RIGHT BACK AND RIGHT HAND. PT TOOK BENADRYL AND TYLENOL ON 5/16/17 AND WENT TO SEE DR ON 5/18/17. DR PRESCRIBED PREDNISONE AND CETIRIZINE.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling, Pruritus, Swelling
Clinical narrative: SWOLLEN, HARD, RED, AND ITCHY UPPER ARMS. SPREAD TO RIGHT BACK AND RIGHT HAND. PT TOOK BENADRYL AND TYLENOL ON 5/16/17 AND WENT TO SEE DR ON 5/18/17. DR PRESCRIBED PREDNISONE AND CETIRIZINE.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: High pitched inconsolable crying for greater than 2 hours.
Age: 31.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Anxiety, Cold sweat, Feeling cold, Hyperhidrosis, Hypotension
Clinical narrative: NAUSEA STARTED WITHIN 1 OR 2 MINUTES AFTER LAST VACCINATION. THEN PT FAINTED DUE TO HYPOTENSION SECOND TO ANXIETY. HE WAS SWEATING, CLAMMY FEELING AND COLD.
Age: 31.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: NAUSEA STARTED WITHIN 1 OR 2 MINUTES AFTER LAST VACCINATION. THEN PT FAINTED DUE TO HYPOTENSION SECOND TO ANXIETY. HE WAS SWEATING, CLAMMY FEELING AND COLD.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Cyanosis, Dizziness, Dyspnoea
Clinical narrative: Dizziness, turning blue, and trouble breathing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Cheilitis, Cough, Glossitis, Injection site abscess
Clinical narrative: On 5/1/17 I received the ZOSTAVAX (Zoster) single dose Vaccine. In the afternoon on 5/2/17 a welt appeared at the injection site and was red and swelled with severe itching, NEOSPORIN was used to reduce itching. On 5/10/17 the welt and itching had subsided to a minimum. On 5/10/17 my throat became raw. I had a cough that had phlegm. On 5/12/17 my throat was better. Not so raw, but I still coughed and the cough woke me up during the night several times (at least six times) during the night for over a week. On 5/13/17 my tongue became irritated on the right side like a huge canker sore. This lasted several days along with the cough. On 5/15/17 the canker sore disappeared but the cough still lingered. On 5/17/17 in the evening I noticed that I felt a cold sore on my lip. My cough remains and have two cold sores on the right, lower lip area and a cough.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Productive cough, Throat irritation
Clinical narrative: On 5/1/17 I received the ZOSTAVAX (Zoster) single dose Vaccine. In the afternoon on 5/2/17 a welt appeared at the injection site and was red and swelled with severe itching, NEOSPORIN was used to reduce itching. On 5/10/17 the welt and itching had subsided to a minimum. On 5/10/17 my throat became raw. I had a cough that had phlegm. On 5/12/17 my throat was better. Not so raw, but I still coughed and the cough woke me up during the night several times (at least six times) during the night for over a week. On 5/13/17 my tongue became irritated on the right side like a huge canker sore. This lasted several days along with the cough. On 5/15/17 the canker sore disappeared but the cough still lingered. On 5/17/17 in the evening I noticed that I felt a cold sore on my lip. My cough remains and have two cold sores on the right, lower lip area and a cough.
Age: 18.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Abdominal pain, Hot flush, Lip discolouration, Nausea, Syncope
Clinical narrative: (L) arm - Hepatitis B. (R) arm - TRUMENBA - developed hot flashes, nauseous abd pain - went to bathroom and fell from feet to floor receiving open wound to chin and pain premolar tooth. Received suture to close and tooth extraction.
Age: 18.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: (L) arm - Hepatitis B. (R) arm - TRUMENBA - developed hot flashes, nauseous abd pain - went to bathroom and fell from feet to floor receiving open wound to chin and pain premolar tooth. Received suture to close and tooth extraction.
Age: 18.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: (L) arm - Hepatitis B. (R) arm - TRUMENBA - developed hot flashes, nauseous abd pain - went to bathroom and fell from feet to floor receiving open wound to chin and pain premolar tooth. Received suture to close and tooth extraction.
Age: 18.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Blood potassium normal, Blood sodium normal, Blood triglycerides normal, Blood urea decreased, Fall
Clinical narrative: (L) arm - Hepatitis B. (R) arm - TRUMENBA - developed hot flashes, nauseous abd pain - went to bathroom and fell from feet to floor receiving open wound to chin and pain premolar tooth. Received suture to close and tooth extraction.
Age: 18.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Hot flush, Nausea, Protein total normal, Suture insertion, Tooth extraction
Clinical narrative: (L) arm - Hepatitis B. (R) arm - TRUMENBA - developed hot flashes, nauseous abd pain - went to bathroom and fell from feet to floor receiving open wound to chin and pain premolar tooth. Received suture to close and tooth extraction.
Age: 18.0
Sex: F
Vaccine: HEP, MENB, HEP, MENB
Symptoms: Toothache, Wound
Clinical narrative: (L) arm - Hepatitis B. (R) arm - TRUMENBA - developed hot flashes, nauseous abd pain - went to bathroom and fell from feet to floor receiving open wound to chin and pain premolar tooth. Received suture to close and tooth extraction.
Age: 76.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: I have a rash at the point of injection of the lower injection site (I think it is where the shingles vaccine was injected.) It is quarter sized and appeared yesterday evening. I applied NEOSPORIN and so far it itches but has not spread. Pt 4/11/17 secure msg.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site oedema, Injection site urticaria
Clinical narrative: Significant local hives, edema, induration decreased ROM (R) upper arm.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Exfoliative rash, Feeling abnormal, Headache
Clinical narrative: Right arm swollen, red painful to lift. Patient developed red scaly rash and felt "out of it". Headache, nausea, body aches, coughing, sore throat. Patient took BENADRYL after speaking with RN. Urgent care advised by RN.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oropharyngeal pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm swollen, red painful to lift. Patient developed red scaly rash and felt "out of it". Headache, nausea, body aches, coughing, sore throat. Patient took BENADRYL after speaking with RN. Urgent care advised by RN.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Right arm swollen, red painful to lift. Patient developed red scaly rash and felt "out of it". Headache, nausea, body aches, coughing, sore throat. Patient took BENADRYL after speaking with RN. Urgent care advised by RN.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Eating disorder, Lethargy, Pyrexia
Clinical narrative: May 15, 2017 began not feeling well in the evening. May 16 and 17 had fever of 101.6 degrees both days, not eating well and very lethargic. May 18, 2017 no temperature. Did not go to doctor. Gave fever reducing medication at home. No NVD. Was not around anyone that was ill.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Left arm is warm, tight and itchy, from shoulder down to elbow. Has red welts. Started itching after injection given. Other signs started that night.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Left arm is warm, tight and itchy, from shoulder down to elbow. Has red welts. Started itching after injection given. Other signs started that night.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Left upper arm cellulitis around area where VARIVAX vaccine given  S.C.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus
Clinical narrative: Redness/itching.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: He developed a red rash to both inner thighs and small red dots to abdomen. He denies itching, patient has a PMHX of allergies and carries an EPI-PEN with him. He denies shortness of breath, mouth or throat swelling or any feeling out of the ordinary. Rash and urticaria pruritus. Diphenhydramine 25 mg once.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Rash vesicular
Clinical narrative: Redness and blister like rash around injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Redness and blister like rash around injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Received KINRIX and MMR V on 5/15/17 during physical exam, on left thigh. Patient evaluated on 5/17/17 for cellulitis post vaccination. 8 cm erythema noted left distal injection site.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Pruritus
Clinical narrative: Patient had redness all around the arm, stiffness, and burning pain in arm. Reaction occurred within 12 hours and worsened. It was initially itching then it stopped and burning and pain began.
Age: 33.0
Sex: F
Vaccine: TYP, YF
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in right shoulder began 2/9/17 PM. Pain continued to increase each day to the point that I could not lift my right arm, operate my car, or wash my hair. Saw doctor 3/17/17 for steroid shot then went back on 4/7/17-prescribed PT and Naproxen.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 24 HR S/P vaccine, patient developed an enlarging area of erythema/heat - not around injection site but distal to this over deltoid muscle distribution. Mildly tender to pressure; no drainage.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Nasal congestion, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Developed fever 24 hrs after receiving Hep A vaccine. Bilateral rash on thighs on 5/19/17. Nasal congestion and runny nose developed 5/17/17. Supportive Care offered.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness and swelling in left arm located between lower bicep/tricep through elbow. Patient presented to pharmacy around 11:00 am. Arm warm to touch; no rash. Advised to take ADVIL, BENADRYL at bedtime, ice and if worsened go to urgent care.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Pt waited for 15 minutes and had a reaction to PROQUAD. Welt measured 1in by .5 in. Pt was given 3.75 of BENADRYL and kept for an additional 15 minutes.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Wrong drug administered
Clinical narrative: Redness and inflammation at the site of injection. Tdap 0.1 mL given in place of PPD.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Pt. had 102 degree rectal temperature within 24 hours of receiving 4 months vaccines. Pt. went to ER. Fever lasted 24 hours, then resolved. No seizure activity. Pt. previously had PEDIARIX and PEDVAXHIB.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Large local reaction (red raised area) around injection site that started within 12 hours of administration. Treated with cool compress, BENADRYL.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Decreased appetite, Lethargy, Vomiting
Clinical narrative: Patient became very lethargic after receiving vaccine, slept for 2 hours and woke up with temp of 102, vomiting. Temp lowered to 100.5 with TYLENOL and increased to 102 after 4 hours. Patient very lethargic, loss of appetite.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Blood pressure decreased, Pallor, Syncope
Clinical narrative: Pt was entering passenger side of car and had a vasovagal syncopal event.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Redness, bruising and swelling on left thigh where vaccination was administered.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Pain in extremity, Rash
Clinical narrative: Upper arm became very hard and hurt. The following day around 6:00 PM a rash developed. It was not itchy but hurt. I applied zinc oxide the next day and continued using it until today. The rash is now gone but the arm is still a little sore.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash on the right hand and on her Legs two days after getting vaccination. She got the vaccine to her left hand.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site reaction, Injection site swelling, Lethargy
Clinical narrative: Patient describes feeling very lethargic and heart feeling "funny". Swelling at injection site with some peeling and redness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Patient describes feeling very lethargic and heart feeling "funny". Swelling at injection site with some peeling and redness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Arthropod bite, Cellulitis, Injection site bruising, Injection site discolouration, Injection site erythema
Clinical narrative: Received 12 month vaccines on 5/2 (including varicella vaccine in right thigh) and initially had bruising and a small bump on his thigh, which he has had after other vaccines as well. 1 week after vaccines, however, he developed a red area on his right thigh which became itchy and then developed some an area that looked yellowish, some firmness, and a couple of small papules next to the red area. No apparent pain of this area, and the redness became lighter by the time of presentation to clinic 9 days after vaccination. Had "low grade fever" a couple of days before presentation but was also teething. No fever the past day or so. No other symptoms of illness. On exam on 5/11 there was an erythematous area on right lateral thigh with 2 papules close by, one that looks possibly to be a vesicle; and flat, larger, yellowish papule within area of erythema. Firm, indurated, elongated area 1- 1.5 cm long within area of erythema. Erythema not well-defined. Differential diagnosis included post-vaccine swelling along with mild rash from varicella vaccine, insect bites (possibly spider - looks like 3 bites close together), and cellulitis. Treated for potential cellulitis with cephalexin.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site papule, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Received 12 month vaccines on 5/2 (including varicella vaccine in right thigh) and initially had bruising and a small bump on his thigh, which he has had after other vaccines as well. 1 week after vaccines, however, he developed a red area on his right thigh which became itchy and then developed some an area that looked yellowish, some firmness, and a couple of small papules next to the red area. No apparent pain of this area, and the redness became lighter by the time of presentation to clinic 9 days after vaccination. Had "low grade fever" a couple of days before presentation but was also teething. No fever the past day or so. No other symptoms of illness. On exam on 5/11 there was an erythematous area on right lateral thigh with 2 papules close by, one that looks possibly to be a vesicle; and flat, larger, yellowish papule within area of erythema. Firm, indurated, elongated area 1- 1.5 cm long within area of erythema. Erythema not well-defined. Differential diagnosis included post-vaccine swelling along with mild rash from varicella vaccine, insect bites (possibly spider - looks like 3 bites close together), and cellulitis. Treated for potential cellulitis with cephalexin.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Teething
Clinical narrative: Received 12 month vaccines on 5/2 (including varicella vaccine in right thigh) and initially had bruising and a small bump on his thigh, which he has had after other vaccines as well. 1 week after vaccines, however, he developed a red area on his right thigh which became itchy and then developed some an area that looked yellowish, some firmness, and a couple of small papules next to the red area. No apparent pain of this area, and the redness became lighter by the time of presentation to clinic 9 days after vaccination. Had "low grade fever" a couple of days before presentation but was also teething. No fever the past day or so. No other symptoms of illness. On exam on 5/11 there was an erythematous area on right lateral thigh with 2 papules close by, one that looks possibly to be a vesicle; and flat, larger, yellowish papule within area of erythema. Firm, indurated, elongated area 1- 1.5 cm long within area of erythema. Erythema not well-defined. Differential diagnosis included post-vaccine swelling along with mild rash from varicella vaccine, insect bites (possibly spider - looks like 3 bites close together), and cellulitis. Treated for potential cellulitis with cephalexin.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient told that he felt warmth and soreness at injection site and rash at injection site.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash on neck, arm and face.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient developed soreness, tenderness, redness and inflammation (about the size of a ping pong ball) at injection site. The patient reported this to us on the 20th and most of the redness and swelling had gone down but it was still present.
Age: 76.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash, Skin warm
Clinical narrative: Patient stated she developed a circular rash at the site of injection evening post-injection. There were no additional symptoms to the rash (not itchy or painful). Rash slowly expanded the following day, Thursday 5/18/17, and felt warm on Friday 5/19/17. No additional symptoms upon report date of 5/20/17.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Disturbance in attention, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Low grade fever, nausea, complete fatigue, difficulty concentrating, whole body aches, headache, dizziness.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever, nausea, complete fatigue, difficulty concentrating, whole body aches, headache, dizziness.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Pyrexia
Clinical narrative: Kept getting fever on and off since the day she got the vaccines. Hospital emergency room and urgent care visits all in the same week. The highest temperature she got was exactly 103.8. The office then told me the vaccines were a "system error" almost a week later.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Biopsy skin, Pruritus, Rash
Clinical narrative: Rash on stomach, both upper thighs, neck, face and chest. Steroid shots and cream. Very itchy.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Syncope then brief tonic clonic movements, no treatment needed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Red inflammation 2" x 4" around injection site. Itch. Skin was hot to touch. Severity over fist 5 days. Slowly started to fade since. No other reactions anywhere else on body.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5
Symptoms: Dyskinesia, Emotional distress, Irritability, Motor dysfunction, Seborrhoeic dermatitis
Clinical narrative: Initially he became very irritable. He had multiple episodes of inconsolability within the week after the vaccine and would cry for hours. He also developed a severe case of seborrheic dermatitis within a week of the vaccine. He had gross motor changes including involuntary repetitive slapping movements of his right arm and bilateral wrist twirling.
Age: 0.5
Sex: M
Vaccine: DTAP, PPV
Symptoms: Nystagmus
Clinical narrative: Horizontal nystagmus.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Local reaction, Pruritus, Rash
Clinical narrative: PATIENT STATED THAT SHE HAD A LOCAL REACTION AT THE INJECTION SITE ALMOST IMMEDIATELY. THE RASH AND ITCHING HAS SINCE SPREAD (AS OF 5/20/17 AT 5:50PM). PATIENT HAS ALSO HAD A HEADACHE SINCE THE TIME OF INJECTION.  SHE HAS BEEN APPLYING HYDROCORTISONE CREAM AND WAS ADVISED TO TAKE BENADRYL.
Age: 65.0
Sex: F
Vaccine: HEPAB, PNC13, TDAP, VARZOS
Symptoms: Erythema, Infection, Skin warm
Clinical narrative: Patient received PREVNAR and BOOSTRIX vaccines on her right arm on 5/13/17. She came to the pharmacy on 5/17/2017 with a new prescription for KEFLEX and Prednisone after being told by her physician that the redness and warmth felt on her right arm where do to infections caused by the vaccines she received.
Age: 34.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Burning sensation, Dizziness, Rash, Rash erythematous, Skin warm
Clinical narrative: Red covering on upper stomach/chest area with tiny dots consistently spread out especially on mid stomach area, hot burning feeling on abdomen, light headed, violent vomiting.
Age: 34.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Vomiting
Clinical narrative: Red covering on upper stomach/chest area with tiny dots consistently spread out especially on mid stomach area, hot burning feeling on abdomen, light headed, violent vomiting.
Age: 44.0
Sex: F
Vaccine: FLUR3
Symptoms: Hypoaesthesia, Nerve conduction studies normal, Paraesthesia
Clinical narrative: Tingling and numbness in injection arm down to first and second fingertips. Occurred for 3 months occasionally and intensity weakened.  Detoxed with clay, exercise, visited workman's comp dr. for testing and treatment. Nerve test was given 1/27/17 with negative result findings of damage.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm, raised area on left bicep, immunization administered on left arm.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Severe Pain in Left Shoulder where shot, Pneumococcal Polysaccharide Vaccine, was given. Unable to move arm without great pain in Muscle.  Use of OTC Painkillers nearly useless in Relief.
Age: 25.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Arthralgia, Decreased appetite, Headache, Lethargy, Rash
Clinical narrative: Rash on his neck and down his chest, reported joint aches, headache, loss of appetite and lethargy since 5/16/2017.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: My toes started tingling.
Sex: F
Vaccine: FLU3, HEPA, HPV9, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 622868) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old female patient. The patient's concomitant therapies, concurrent illnesses, prior vaccinations, other medications and medical history were not reported. On 10-FEB-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L019297, lot expiration date 18-AUG-2017 (dose and frequency were not reported), intramuscularly in the left arm and second dose of VARIVAX subcutaneously on the left arm, lot# L026407, expiration date 15-JUL-2017; dose and frequency unknown) for prophylaxis. Other suspect therapies which were given on the same day included MENACTRA dose number: 1, intramuscularly in the left arm, lot# U5187AA; dose and expiration date was unknown), FLUARIX dose number: 2, intramuscularly in the right arm, lot# 3L9LD; dose and expiration date was unknown), and HAVRIX dose number: 2, intramuscularly in the right arm, lot# AD9Y4; dose and expiration date unknown) for prophylaxis. On 11-FEB-2016, the patient's left arm was swollen, red and painful at the site where varicella vaccine was administered. The patient was instructed to take ibuprofen for pain use ice pack at the site for swelling and irritation. The outcome of injection site erythema, injection site swelling and injection site pain was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 18 year old male patient with prophylaxis. The patient's medical history include acne. The patient had no current illnesses. The patient's other medications and prior vaccinations were not reported. On 11-MAY-2016, the patient was vaccinated with first dose of GARDASIL 9 in right bicep, (route of administration, dose number, dose, frequency, lot and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA vaccinated date: 11-MAY-2016, (route of administration unknown, dose number, dose, lot and lot expiration date unknown) and HAVRIX, vaccinated date: 11-MAY-2016, (route of administration unknown, dose number, dose and lot and lot expiration date unknown). On the same day, immediately after vaccination of GARDASIL 9 the patient became unconscious. The patient had already received MENACTRA and HAVRIX about 5 minutes earlier without incident. The outcome of immediate post-injection reaction and loss of consciousness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Inflammation, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 639108) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's concomitant therapies, concurrent illness, prior vaccinations other medications and medical history were not reported. On 08-JUN-2016 the patient was vaccinated with GARDASIL 9, (dose number, dose, frequency, lot #, lot expiration date, route of administration and site of administration were not reported) for prophylaxis. Other suspect therapies which were given on the same day, included BOOSTRIX (lot# 54L57; route and site of administration, dose number, dose and expiration date were unknown), and MENACTRA (lot# U5228BA; dose number, route and site of administration, dose and expiration date were unknown) for prophylaxis. On 10-JUN-2016, the mother of the patient took her to emergency room as the patient had cellulitis on the right arm. The patient had inflammation and pain on the arm. The patient had visited emergency room. The emergency room doctor prescribed acetaminophen 500 and Benadryl orally(10 each) for cellulitis. The outcome of cellulitis, pain in extremity and inflammation was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Condition aggravated, Culture negative, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640782) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included mild Tourette's and benign rolandic epilepsy of childhood. The patient's medical history, other medications, prior vaccinations, concomitant therapies and concurrent illnesses were not reported. On 25-MAR-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L045700 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the left arm for prophylaxis. On 04-APR-2016, patient's father called and stated that the site of injection was red with "wart-like" area and later got resolved. On 11-APR-2016, the patient visited the office for sore throat and stomach ache. Rapid strep and culture test was done which came out as negative, hence not treated. On 14-APR-2016, the patient experienced persistent sore throat/stomach ache and fever. The patient's strep test was positive and was treated with amoxicillin. On 20-APR-2016, the patient visited the office due to light head, dizzy and headache. Lab tests were ordered. On 22-APR-2016, the patient visited office due to positive Antistreptolysin test, which was treated with Amoxicillin. The patient saw neurologist (around 04-MAY-2016) for tics and was started on Tenex. The patient continued with no energy, pale and weak. The patient was encouraged to increase salt/fluid intake. The patient was on Zofran and Antivert. The patient consulted cardiologist on 11-MAY-2016. According to the patient's mother, the cardiologist could not find cause of symptoms. On 16-MAY-2016, patient visited the office for sore neck which was diagnosed as wry neck. The outcome of abdominal pain upper, torticollis, tic, streptococcus test positive, pyrexia, pallor, oropharyngeal pain, neck pain, injection site reaction, injection site erythema, headache, dizziness and asthenia was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Injection site erythema, Injection site reaction, Neck pain, Oropharyngeal pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640782) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included mild Tourette's and benign rolandic epilepsy of childhood. The patient's medical history, other medications, prior vaccinations, concomitant therapies and concurrent illnesses were not reported. On 25-MAR-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L045700 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the left arm for prophylaxis. On 04-APR-2016, patient's father called and stated that the site of injection was red with "wart-like" area and later got resolved. On 11-APR-2016, the patient visited the office for sore throat and stomach ache. Rapid strep and culture test was done which came out as negative, hence not treated. On 14-APR-2016, the patient experienced persistent sore throat/stomach ache and fever. The patient's strep test was positive and was treated with amoxicillin. On 20-APR-2016, the patient visited the office due to light head, dizzy and headache. Lab tests were ordered. On 22-APR-2016, the patient visited office due to positive Antistreptolysin test, which was treated with Amoxicillin. The patient saw neurologist (around 04-MAY-2016) for tics and was started on Tenex. The patient continued with no energy, pale and weak. The patient was encouraged to increase salt/fluid intake. The patient was on Zofran and Antivert. The patient consulted cardiologist on 11-MAY-2016. According to the patient's mother, the cardiologist could not find cause of symptoms. On 16-MAY-2016, patient visited the office for sore neck which was diagnosed as wry neck. The outcome of abdominal pain upper, torticollis, tic, streptococcus test positive, pyrexia, pallor, oropharyngeal pain, neck pain, injection site reaction, injection site erythema, headache, dizziness and asthenia was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Pyrexia, Skin papilloma, Streptococcus test positive, Tic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640782) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included mild Tourette's and benign rolandic epilepsy of childhood. The patient's medical history, other medications, prior vaccinations, concomitant therapies and concurrent illnesses were not reported. On 25-MAR-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L045700 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the left arm for prophylaxis. On 04-APR-2016, patient's father called and stated that the site of injection was red with "wart-like" area and later got resolved. On 11-APR-2016, the patient visited the office for sore throat and stomach ache. Rapid strep and culture test was done which came out as negative, hence not treated. On 14-APR-2016, the patient experienced persistent sore throat/stomach ache and fever. The patient's strep test was positive and was treated with amoxicillin. On 20-APR-2016, the patient visited the office due to light head, dizzy and headache. Lab tests were ordered. On 22-APR-2016, the patient visited office due to positive Antistreptolysin test, which was treated with Amoxicillin. The patient saw neurologist (around 04-MAY-2016) for tics and was started on Tenex. The patient continued with no energy, pale and weak. The patient was encouraged to increase salt/fluid intake. The patient was on Zofran and Antivert. The patient consulted cardiologist on 11-MAY-2016. According to the patient's mother, the cardiologist could not find cause of symptoms. On 16-MAY-2016, patient visited the office for sore neck which was diagnosed as wry neck. The outcome of abdominal pain upper, torticollis, tic, streptococcus test positive, pyrexia, pallor, oropharyngeal pain, neck pain, injection site reaction, injection site erythema, headache, dizziness and asthenia was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Torticollis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640782) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included mild Tourette's and benign rolandic epilepsy of childhood. The patient's medical history, other medications, prior vaccinations, concomitant therapies and concurrent illnesses were not reported. On 25-MAR-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L045700 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the left arm for prophylaxis. On 04-APR-2016, patient's father called and stated that the site of injection was red with "wart-like" area and later got resolved. On 11-APR-2016, the patient visited the office for sore throat and stomach ache. Rapid strep and culture test was done which came out as negative, hence not treated. On 14-APR-2016, the patient experienced persistent sore throat/stomach ache and fever. The patient's strep test was positive and was treated with amoxicillin. On 20-APR-2016, the patient visited the office due to light head, dizzy and headache. Lab tests were ordered. On 22-APR-2016, the patient visited office due to positive Antistreptolysin test, which was treated with Amoxicillin. The patient saw neurologist (around 04-MAY-2016) for tics and was started on Tenex. The patient continued with no energy, pale and weak. The patient was encouraged to increase salt/fluid intake. The patient was on Zofran and Antivert. The patient consulted cardiologist on 11-MAY-2016. According to the patient's mother, the cardiologist could not find cause of symptoms. On 16-MAY-2016, patient visited the office for sore neck which was diagnosed as wry neck. The outcome of abdominal pain upper, torticollis, tic, streptococcus test positive, pyrexia, pallor, oropharyngeal pain, neck pain, injection site reaction, injection site erythema, headache, dizziness and asthenia was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, IPV, MNQ
Symptoms: Cellulitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641356) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history included obesity and hyperlipidemia. The patient had no concurrent illnesses and other medications. On 15-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 dose 1 (unspecified dosage), intramuscularly in the left thigh (leg) for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5259AA (unspecified dose and dosage), intramuscularly in the right thigh (leg) for prophylaxis and poliovirus vaccine inactivated (unspecified) (unspecified dose, dosage and lot number), via an unknown route, in an unknown site for prophylaxis. On 23-JUN-2016, 6 -7 days after administration of the vaccine, the patient experienced mild cellulitis. The outcome of cellulitis was reported as recovered. The causality assessment for cellulitis with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643270) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses but said that he had a history of fainting with medical procedures. Information about the patient's prior vaccinations and other medications were not reported. On 13-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # K026246 (Expiration date: 28-JAN-2017) dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO lot # 153701 dose 2 (unspecified dosage) and MENVEO lot # M15068 dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient had fainted and was monitored for an additional 20 minutes. The patient had not eaten that day and was given juice and crackers. The patient was said to have left the clinic with his grandmother. The outcome of syncope was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Asthenia, Concussion, Face injury, Fall, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643271) on 02-MAY-2017. This spontaneous report refers to a 18 year old female patient. The patient had no concurrent illnesses and medical history. Information about the patient's other medications and prior vaccinations were not reported. On 21-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (Expiration date : 19-OCT-2017) (unspecified dose and dosage), intramuscularly in an unspecified site, for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA lot # M68769 (unspecified dose and dosage), intramuscularly in an unspecified site, for prophylaxis. On the same day, about 3 to 5 minutes after vaccination, the patient fainted (syncope) while sitting still on the exam table. The patient fell face down on the carpet, resulting in a face injury and rolled to her side, then back. The patient responded after a few minutes, but was weak (asthenia) for a few minutes. The patient also experienced a concussion but was eventually able to stand and walk. She left the office, accompanied by her mother and was rechecked by the doctor on 23-JUN-2016 and 27-JUN-2016. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site pruritus, Rash, Rash erythematous
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644004) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history, concurrent illnesses and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right deltoid, lot # L048237 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose number: 1, intramuscularly in the left deltoid, lot # U5278AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and MENACTRA (dose number: 1, intramuscularly in the left deltoid, lot # U5186AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On an unknown date, the patient developed cluster of red raised rashes which was half an inch in the neck, stomach and back. The injection sites (left and right deltoid) were itchy and painful. The outcome of the events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cyanosis, Paraesthesia, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644558) on 02-MAY-2017. This spontaneous report refers to a 14 year old male patient. The patient's medical history included asthma. The patient's other medication included Albuterol MDI. The patient's concurrent illnesses was reported as none. Information on the patient's prior vaccinations was not reported. On 21-JAN-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L023230 (dose number: 2; lot expiration date: 28-JUL-2017) for prophylaxis. On the same day, within 1 hour of vaccination, the patient developed hives and tingling sensation in his hands. The patient's hand became blue. The patient required emergency room (ER) visit. The outcome for the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Muscle twitching, Pallor, Unresponsive to stimuli, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656192) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 27-SEP-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm (reported as left deltoid), lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included sixth dose of ADACEL intramuscularly in the right arm (reported as right deltoid), lot # U5472AA (dose, frequency and lot expiration date were not reported) and MENACTRA intramuscularly in the right arm (reported as right deltoid), lot # U5282BB (dose, frequency and lot expiration date were not reported) for prophylaxis. On 27-SEP-2016, post administration of GARDASIL 9 in the left deltoid patient immediately  became pale, eyes unfocused, not able to respond to verbal questions, jaw and left leg twitched a few times. The patient was made to gently lay down on the carpeted floor, continued to ask her questions to observe her level of consciousness. Cool wash clothes were put over her forehead and neck. This lasted for approximately 30-60 seconds. The patient never had an experience like that before, came around quickly. The patient parents were decided to take her to the emergency room later that day just to make sure she was okay and she checked out with the attending physician. The outcome of immediate post-injection reaction, muscle twitching, pallor, unresponsive to stimuli, and vision blurred was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.