chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Pruritus, Varicella virus test
Clinical narrative: Pruritic vesicles on erythematous bases started weeks after vaccination with varicella vaccine. Tx: loratadine, acyclovir.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Faeces soft, Pain, Pyrexia
Clinical narrative: Mild fever 99.4-100.4, chills, body aches, soft bowel movements.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Feeling cold, Gastric disorder, Headache
Clinical narrative: Dizzy, dyspnea, stomach, freeze, shaking and high blood pressure in ten minutes. Two nurses and one doctor put the patient on one medical bed to save her, giving her a blue bag on her mouth. It lasted about 20 minutes. After getting home, her arm hurt, vomit, headache, neck hurt and high blood pressure.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Hypertension, Neck pain, Pain in extremity, Tremor, Vomiting
Clinical narrative: Dizzy, dyspnea, stomach, freeze, shaking and high blood pressure in ten minutes. Two nurses and one doctor put the patient on one medical bed to save her, giving her a blue bag on her mouth. It lasted about 20 minutes. After getting home, her arm hurt, vomit, headache, neck hurt and high blood pressure.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Back pain, Burning sensation, Mobility decreased, Neck pain, Pain
Clinical narrative: Extreme pain and soreness, burning, inability to move arm.  Pain in neck and back.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a two patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 24-JUL-2015, the patients were vaccinated with improperly stored doses of M-M-R II lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm deltoid area injection site swelling/redness warm touch c/o painful after received DTaP/IPV
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer on 07 October 2015. This case involves a adult female patient who was vaccinated with a dose of Fluzone (batch number: UH898AC, expiration date: 30 June 2014, dose, dose number, route and site of administration were not reported) on an unspecified day in 2013. It was reported that patient received Fluzone as required by her employment. The patient had several flu vaccines in the past and had the flu after each vaccine. Concomitant medication was not reported. On an unspecified date, four to five months following the vaccination, the patient experienced flu. Laboratory investigation and corrective treatment were not reported. The patient recovered from the event on an unspecified date. Upon internal review, company assessed the event of flu as serious and important medical event. List of documents held by sender: none. Sender's Comments: As with any other vaccine, INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE may not protect 100% of susceptible individuals. However, there is very little information in this case to confirm vaccine failure. No testing was done for flu strain identification. Information on the tests performed to confirm flu infection, the strain identified, as well as the patient's immune status at the time of vaccination (medical history, concomitant medications) would be needed to further assess this case.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Rash
Clinical narrative: Initial unsolicited report received from a non-health care professional (patient) on 8 October 2015. This case involves a 68 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number, dose, dose number were unknown) via intramuscular route in left deltoid on 7 October 2015. Patient's medical history includes Allergies to penicillin, various metals, sulfa drugs, nitro iodine and concomitant medications was not reported. It was reported that, on 7 October 2015 (same day after vaccination), on an unspecified time patient developed facila rash and eye swelling. The patient had received Fluzone HD vaccine last year (unspecified). Lab data was reported as unknown and benadryl, zyrtec were the corrective treatment. The outcome of the events were unknown at the time of this report. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood culture, Chills, Dizziness, Full blood count, Injection site swelling
Clinical narrative: Swelling and warmth of site, fevers, dizziness, chills, nausea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Metabolic function test, Nausea, Pyrexia
Clinical narrative: Swelling and warmth of site, fevers, dizziness, chills, nausea.
Age: 19.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Fainted. No injury resulted.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Right arm remains sore and not able to use; feels warm to touch.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Ocular hyperaemia, Swelling, Urticaria
Clinical narrative: Received vaccine 7/11/16 and after going home right eye became red and stayed red until 07/13/16. Red raised area developed evening of 7/11/16. On 07/13/16 hives on inner thighs appeared.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Neck pain, Urticaria
Clinical narrative: Hives on face and stomach, Pain in left arm and neck (Deltoid and Trapezoid).
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Mild local redness and swelling.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Body temperature increased, Chills
Clinical narrative: 07/27/16 chills and temp 101. 07/28/16 AM feeling better, PM temp and chills. 07/29/16 4:45 AM: seen in ED, BP 90/80 and weak. Given Fluids and prescribed LEVAQUIN. BP 100/50. Discharged to home.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Back pain, Dyspnoea, Malaise, Pain, Pyrexia
Clinical narrative: 07/27/16 chills and temp 101. 07/28/16 AM feeling better, PM temp and chills. 07/29/16 4:45 AM: seen in ED, BP 90/80 and weak. Given Fluids and prescribed LEVAQUIN. BP 100/50. Discharged to home.
Age: 49.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Tachycardia
Clinical narrative: 07/27/16 chills and temp 101. 07/28/16 AM feeling better, PM temp and chills. 07/29/16 4:45 AM: seen in ED, BP 90/80 and weak. Given Fluids and prescribed LEVAQUIN. BP 100/50. Discharged to home.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Body temperature increased, Chills
Clinical narrative: Started when general malaise and aching. Next day severe pain in lumbar region (Wed). Beginning at 8pm Wednesday evening fever up to 102.5 (felt higher. I couldn't find the thermometer to recheck) on Thursday general malaise and on Friday morning woke up with 99.4 temp. Tachycardic and short of breath.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Back pain, Dyspnoea, Malaise, Pain, Pyrexia
Clinical narrative: Started when general malaise and aching. Next day severe pain in lumbar region (Wed). Beginning at 8pm Wednesday evening fever up to 102.5 (felt higher. I couldn't find the thermometer to recheck) on Thursday general malaise and on Friday morning woke up with 99.4 temp. Tachycardic and short of breath.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Tachycardia
Clinical narrative: Started when general malaise and aching. Next day severe pain in lumbar region (Wed). Beginning at 8pm Wednesday evening fever up to 102.5 (felt higher. I couldn't find the thermometer to recheck) on Thursday general malaise and on Friday morning woke up with 99.4 temp. Tachycardic and short of breath.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Anaphylactic reaction, Rash generalised, Urticaria
Clinical narrative: Rash and hives from top of her head to her feet. Clinical diagnosis of anaphylaxis.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Cardiac arrest, Cholecystectomy, Chronic inflammatory demyelinating polyradiculoneuropathy, Endotracheal intubation
Clinical narrative: Developed numbness/tingling in hands/feet on 10/18. Went to PCP 10/19 who sent to hospital ER. Sx's got worse, went back on 10/20 and got admitted. Had lap chole. Sx's worse saw neuro who dx'd with CIDP. to f/u outpt. Sx's worse with increased pain in arms, legs, back. Taken to ER. Unresponsive when arrived to ER. Intubated, then had cardiac arrest. LP done and dx'd with Guillain Barre.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Laparoscopic surgery, Lumbar puncture, Pain in extremity
Clinical narrative: Developed numbness/tingling in hands/feet on 10/18. Went to PCP 10/19 who sent to hospital ER. Sx's got worse, went back on 10/20 and got admitted. Had lap chole. Sx's worse saw neuro who dx'd with CIDP. to f/u outpt. Sx's worse with increased pain in arms, legs, back. Taken to ER. Unresponsive when arrived to ER. Intubated, then had cardiac arrest. LP done and dx'd with Guillain Barre.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Unresponsive to stimuli
Clinical narrative: Developed numbness/tingling in hands/feet on 10/18. Went to PCP 10/19 who sent to hospital ER. Sx's got worse, went back on 10/20 and got admitted. Had lap chole. Sx's worse saw neuro who dx'd with CIDP. to f/u outpt. Sx's worse with increased pain in arms, legs, back. Taken to ER. Unresponsive when arrived to ER. Intubated, then had cardiac arrest. LP done and dx'd with Guillain Barre.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Aggression, Aphasia, Asterixis, Electroencephalogram, Insomnia
Clinical narrative: Child who was verbal became non-verbal total 180 degree in personality. Flapping, screaming, biting people, no sleeping for 2-4 days.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Laboratory test, Personality change, Screaming
Clinical narrative: Child who was verbal became non-verbal total 180 degree in personality. Flapping, screaming, biting people, no sleeping for 2-4 days.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nausea
Clinical narrative: Pt received PREVNAR-13 vaccination. Later that day pt had severe headache with nausea. We must stress that the vaccine may have been the cause. The MD's could not determine a probable cause; they could only infer the possibility.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 21-JUL-2016, the patient was simultaneously vaccinated with a dose of  PROQUAD and a dose of VARIVAX (lot#, dose, route and site of vaccination were not reported for both). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, 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, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II [lot # K009192, Exp. date 27-JUN-2016] subcutaneously; dose, dose number and anatomical location were not provided. No adverse effects were reported. A product quality complaint was not involved. The outcome of product use issue was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a Pharmacist, via a company representative, referring to two patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX injection (dose, route, anatomical location and lot # were not reported). On an unknown date, "a month after vaccination", the patients had an outbreak of shingles. A product quality complaint was not involved. At the time of reporting the outcome of herpes zoster was unknown. The reporter did not provide the causality assessment between the outbreak of shingles and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) regarding a patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PEDVAXHIB injection, intramuscularly, lot # L035880, expiration date: 11-AUG-2016 (dose and anatomical location of administration were not reported), which was improperly stored at 34.5 F for 10 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: 16x29 cm area of tender swelling and erythema and warmth (R) medial arm-humerus-forearm-started within 30 minutes of immunization.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On 25-JUL-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L003188 expiration date 06-JUL-2016, (Dose, route and anatomical location were not provided. No product quality complain was involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Injection site Rxn: Redness and swelling Flu like symptoms for 24 hours.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 5.5X2.5 inch area of induration, eurythmic and warm (R) deltoid.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Paraesthesia
Clinical narrative: Immediate nauseousness, dizziness after vaccination. Nausea lasted approx. 20 min. BP 55/32 pulse 60. Lied ptn. on floor, elevated feet, rechecked BP every 5-10 min. until pt. felt signif. better. BP (2nd) 76/52. (3rd) 80/53. Ptn. now seated. BP 73/55. Ptn. left store 12:45p. Called at 15:45 pm. tingly hands before lying down.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site (adverse event reported by Pt. today 7/23/16. No record of ER treatment on file).
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia, Vaccination site warmth
Clinical narrative: Hot red vaccination site, fever and chills.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction. Right upper Extremity (deltoid).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Patient c/o feeling numbness and feels like fingers get jammed on his left hand (Pinky and ring finger) thought it was due to strong shot but still feeling the same after 1 month. Patient's dad mentioned it to us after getting his second men B vaccine today.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash on arm and some swelling from injection spot to elbow - lasted about a week.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Seen 7/12/16 at family practice. Pt received Varicella 7-8-16 in R arm. The next morning she noted redness, warmth, edema at site. She called office on 7-9-16 and reported she was applying ice and utilizing ALEVE. Family practice concurred and pt instructed office visit if not improved.
Age: 20.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: On 6-15-16 patient noted tingling in face. On 6-22-16 went to the ER. On 6-23-16 saw Cardiology. On 6-27-16 saw Primary Care physician. On 6-28-16 saw neurology to rule out Guillain-Barre syndrome.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Erythema, Feeling hot, Hot flush
Clinical narrative: Hot flashes, feeling hot, dizzy and nauseated, felt faint, very red painful knot - size of baseball and growing and spreading, and bruised. Most came one-two days after shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nodule, Pain
Clinical narrative: Hot flashes, feeling hot, dizzy and nauseated, felt faint, very red painful knot - size of baseball and growing and spreading, and bruised. Most came one-two days after shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Paraesthesia
Clinical narrative: Tingling burning pain in area where patient previously had shingles.
Age: 0.36
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, redness on complete upper arm, very warm, sore.
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain in extremity, Therapeutic procedure, Varicose vein
Clinical narrative: PATIENT DEVELOPED PAIN IN HER RIGHT CALF ON 07/22 THAT DID NOT SUBSIDE. NOTE: PATIENT HAD A PROCEDURE DONE ON HER CALF TO TREAT HER VERICOSE VEIN.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site urticaria, Vaccination site erythema
Clinical narrative: Patient reported via phone erythema, and hives at site of vaccine one hour later post second dose of Hepatitis B vaccine, stated on 7/22/16 that she had mild erythema after dose one.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Swelling
Clinical narrative: PAIN, SIGNIFICANT SWELLING, REDUCED RANGE OF MOTION IN SHOULDER.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: "Severe" pain and couldn't move arm.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Discomfort, Injection site rash, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Rash/heat localized to site of injection, rash enlarged slightly over period of 3 days before fading; mild fever for 2 days (6/15-6/16); general malaise. Fever and apparent discomfort treated with infant TYLENOL and cool rag to head.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Inflammation, Pyrexia
Clinical narrative: He said that he was fine the day that he got the vaccine but when he woke up the next day in the morning he said that his arm was swollen to the point that the arm with the injection was huge in comparison to his other arm. Also he said that he was running a fever from the morning he woke up and for a few days after. The arm remained inflamed for close to a week.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability
Clinical narrative: Irritability and fussiness that lasted for 7-10 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Injected limb mobility decreased, Nausea
Clinical narrative: I noticed my left arm becoming quite sore within 2 hours of the injection, and not able to raise my arm by the evening time. At 1:30 AM I was letting the dog outside and became dizzy, then became nauseated and diaphoretic, then vomited. The pain was quite severe. I noticed a large hive forming yesterday which is very sore to the touch, like a bad bruise. I had a 'washed out' feeling all day yesterday. The soreness in my arm is better today and I can raise my arm up now.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Tenderness, Urticaria, Vomiting
Clinical narrative: I noticed my left arm becoming quite sore within 2 hours of the injection, and not able to raise my arm by the evening time. At 1:30 AM I was letting the dog outside and became dizzy, then became nauseated and diaphoretic, then vomited. The pain was quite severe. I noticed a large hive forming yesterday which is very sore to the touch, like a bad bruise. I had a 'washed out' feeling all day yesterday. The soreness in my arm is better today and I can raise my arm up now.
Age: 0.35
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: My daughter received the wrong vaccine. We were not notified at the time of the vaccination. We received a call hours later stating that she would be fine and that the health department had been notified. I contacted the health department and was informed that they were NOT notified. I am completely unsure how this is going to impact my daughter and I am livid that I was misled and lied to by my physician's office.
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 9 October 2015. This case involves a female patient (age not reported) who was vaccinated with an intramuscular dose of FLUZONE HD (batch number UI486AA, expiry date 24 May 2016, site of administration not reported) on 9 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none, Illness at time of vaccination was none and concomitant medications were not reported. On 9 October 2015, few minutes after the vaccination the patient's right deltoid swelled up like a goose egg. No other symptoms reported. Laboratory investigations were reported as none and corrective treatments were not reported. The final outcome was reported as not recovered. Documents held by sender: none Follow-up information received from a pharmacist on 30 November 2015. The patient received FLUZONE HD vaccine in right arm on 9 October 2015. It was reported that, patient waited approximately 15 minutes and swelling went down to almost normal in that time, no other outcome seen or reported. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 09 October 2015. This case involves a 34-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: U5310DB, dose, dose in series and site of administration were not reported) intramuscularly on 06 October 2015. The patient's illness at time of vaccination reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergy to house dust and pollen. Concomitant medications were not reported. On 07 October 2015, one day following the vaccination, the patient had experienced body aches, felt like she had a fever (temperature not measured). The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none. Follow up information received from a nurse on 22 December 2015. The patient had received 0.5ml dose of vaccine on left deltoid. It was reported that, previously on an unspecified date, the patient had received prenatal vitamins as previous medication. On 11 October 2015, four days after the onset of events, the patient was recovered from the events.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Capillary nail refill test abnormal, Shock, Throat tightness, Wheezing
Clinical narrative: Sensation of throat closure, wheezing, delayed cap refill and compensated shock. Was given an albuterol treatment and epi (10:33 AM). Transported to local hospital.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of injection site pain, swelling, redness. She also had loss of appetite, insomnia, fatigue, and difficulty moving her arm.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Mobility decreased
Clinical narrative: Patient complained of injection site pain, swelling, redness. She also had loss of appetite, insomnia, fatigue, and difficulty moving her arm.
Age: 70.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PAIN AT INJECTION SITE AND REDNESS, REDNESS AREA JUST GOT LARGER AND LARGER SO PATIENT WENT TO THE DR ON 7/29 AND WAS PRESCRIBED A MEDROL DOSE PAK.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: Swelling, redness, itching, low grade fever. Pt applied hydrocortisone cream, aloe vera, ice, and took acetaminophen.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Nausea, Pallor, Syncope
Clinical narrative: Almost immediate fainting after GARDASIL vaccine. Still sitting on exam table so caught by me/Mom as she fell forward. Vaccination nurse helped position on back on table. Four nurses and doctor came in after.  Some stiffened muscles (straight legs) with fainting. Came back around shortly after nurse rubbed her closed eyelid. Very pale. Provided juice, water, and Nutri-Grain bar. Some nausea on drive home after waiting a bit to leave clinic.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Vaccine record mis-read and repeat vaccines (Kinrix, MMRV) administered.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site reaction, Skin hypertrophy
Clinical narrative: Hard lump under the skin at site of injection. Remained localized tightly at injection site on 7/26 and the hard lump had diffused outward in an even circular pattern to about 2-3 inches in diameter by 7/27. Patient experienced pain at injection site with the tissue thickening.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches in back and neck, headaches throughout the day, lightheadedness and dizziness starting in the late afternoon and worsening, as did the muscle pains. Got a fever and chills in the evening, around 9:00 PM, so I took Ibuprofen and went to sleep. Woke up this morning (07/29/2016) with no symptoms other than some minor muscle ache in my lower back. No other symptoms have returned.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: He had a headache, muscle ache, dizziness, nauseous, neck ache, "felt like some one was pinching his brain", sweats and chills, felt hot to the touch but did not register a fever. The symptoms lasted for about 12 hours. At approximately 9:00 PM he had 2 ADVIL after talking to the nurse at the Dr's office and that helped. He slept for about 18 hours.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Hypersomnia, Myalgia, Nausea, Neck pain, Skin warm
Clinical narrative: He had a headache, muscle ache, dizziness, nauseous, neck ache, "felt like some one was pinching his brain", sweats and chills, felt hot to the touch but did not register a fever. The symptoms lasted for about 12 hours. At approximately 9:00 PM he had 2 ADVIL after talking to the nurse at the Dr's office and that helped. He slept for about 18 hours.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Injection site rash, Mobility decreased, Myalgia
Clinical narrative: I have high fevers 102-103, limited arm movement, a huge rash at the injection site, muscular pain, joint pain and chills all over my body. I seriously regret getting this vaccine.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: I have high fevers 102-103, limited arm movement, a huge rash at the injection site, muscular pain, joint pain and chills all over my body. I seriously regret getting this vaccine.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: PER PT, REDNESS, SWELLING, HARD TO TOUCH, PAINFUL.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Knot on injection site, red and swollen ...was told to give Benadryl every 4 hours.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Itchy and sore too on day of shot and next day even more sore (or painful) and swollen.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site pain
Clinical narrative: Extreme leg pain, even to gentle touch.
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PPV
Symptoms: Crying, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, swollen area around shot greater than one inch radius; 100 degree Fahrenheit fever for 4 days after shot, and again 10 days after shot; inconsolable crying at 10 days.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Tachycardia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tachycardia in a 66-year-old female patient who received BOOSTRIX (batch number 9GE5D, expiry date unknown). On 28th June 2016, the patient received BOOSTRIX .5 ml. On 28th June 2016, 6 hrs after receiving BOOSTRIX, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the outcome of the tachycardia was unknown. The reporter considered the tachycardia to be possibly related to BOOSTRIX. Additional details were received as follows: The reporter did not have the expiry date of BOOSTRIX. The batch number reported for BOOSTRIX (9EGE5D) did not exist and was updated to be 9GE5D as per sales database.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were inadvertently vaccinated with 2 doses of RECOMBIVAX HB injection, intramuscularly, lot # L038018, expiration date: 13-SEP-2017 (dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality was involved. This is one of two cases received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an adult dose of VAQTA, intramuscular instead of a children/adolescents dose (Dosage, dose number, lot number and expiration date were not reported). No other suspect or concomitant therapies were reported. No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patient was vaccinated with GARDASIL 9 dose 1 and dose 2 (dose, route, anatomical location, lot number and expiration date were not provide). The patient was in the office to receive her 3rd dose, but informed that she was currently 11 weeks pregnant. The patient became pregnant with Last Menstrual Period of 11-MAY-2016 and Estimated Delivery Date of 15-FEB-20176. No other suspect medications or concomitant therapies were reported. No product quality complaint was involved. Then, on an unknown date the patient experienced maternal exposure before pregnancy. The Medical assistant stated that the patient did not received a vaccine during pregnancy.  The outcome of the event was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Syncope
Clinical narrative: This spontaneous report as received from Registered Nurse (RN) refers to a 17 year old female non-pregnant patient. The patient's medical history included infectious mononucleosis. There were no drug reactions/allergies. On 16-MAR-2015 the patient was vaccinated with a dose of GARDASIL (lot # K011492, expiry date: 22-JUN-2016), intramuscularly. On 03-FEB-2016, 10 months 19 days after onset of therapy the patient experienced headache, dizziness, syncope and abdominal pain, dizziness, syncope and headache. The causality between abdominal pain, dizziness, syncope and headache and GARDASIL was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. No information on patient's pertinent medical history, drug reactions or allergies was reported. On 15-JUL-2015, the patient was vaccinated with GARDASIL, first dose, (route of administration, dose, lot number and expiration date were not reported). The patient was then vaccinated with the first, second and third dose of GARDASIL 9 (route of administration, dose, lot number and expiration date were not reported) on 19-AUG-2015, 17-FEB-2016 and 13-JUL-2016, respectively. No concomitant medications were 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 registered nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with VARIVAX (dosing details were not reported) (lot # L048462 with expiry date of 02-DEC-2017) which was improperly stored at 7 F for a time frame. of 3 hours and 49 minutes, which was having a previous temperature excursion of 28 F for 4.5 hr. The call was made due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-JUL-2016 the patient was vaccinated with ZOSTAVAX, subcutaneously (Dose, anatomical location, lot number and expiration date were not provided. Concomitant therapies included BOOSTRIX. On 17-JUL-2016, the patient developed a "Bulls Eye" type rash (erythema) that was itchy(rash pruritic) and painful(rash). The patient did not sought medical attention, other than discussing with pharmacy staff. Additionally, the patient stated that she was concerned that her rash may be contagious and cause problems for her newborn grandson. It was no product quality complain involved. The outcome of the events was reported as not recovered. The causality between the therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site swelling
Clinical narrative: Bump on (L) thigh.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient given meningococcal IZ in left deltoid on 7/27/16 in AM. On 7/28/16 in AM awoke with red, warm, hard, swollen area on left upper arm - approx. 7 cm x 7 cm. Pt says is itchy. RX for MOTRIN; suggested cool compresses.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt had 4 year vaccine shots, Dtap, IPV, MMR, Varicella. The day after vaccines, patient had fever from 103.5 to 104.7 rectal.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Nausea, Rash macular, Vomiting
Clinical narrative: The day following vaccine administration the pt. developed "a blotch rash at the left deltoid region and more slightly distal to the injection site." She also reported nausea and vomiting.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous report concerning a 12 years old patient of an unknown gender was received from a nurse. The patient's concurrent conditions and medical history were not reported. On 22-JUL-2016, the patient was inadvertently vaccinated with a dose of 1 ml of VAQTA lot # L031196, expiration date 05-FEB-2017, (strength and route were not provided)(accidental overdose). There were no concomitant medications and adverse events reported. No product quality complain was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: None-Pt received DTAP instead of Tdap. No need to repeat. No reactions.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Decreased activity, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Erythema, minimal swelling, slight tenderness around injection site. Max size around 2.5-3 inches. Fever for 1 day (101.5F) Decreased activity and eating during time of fever. Improving when seen in clinic. Fever resolved, erythema decreasing. Eating and drinking. Continue to monitor.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with improperly stored dose of VARIVAX lot # K003409, expiry date 13-MAY-2017 (dose number, dose units, route and anatomical location were not reported). Concomitant medications were not reported. There was no Product Quality Complaint (PQC) involved. This case is linked to MARRS# 1607USA001599 (same reporter link). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concurrent conditions were unspecified by the reporter. On 11-JUL-2016 the patient was vaccinated with ZOSTAVAX (Dose, route, anatomical location, lot number and expiration date were unspecified by the reporter. No other suspect medications or concomitant therapies were reported. Subsequently, in July 2016, the patient developed injection site reactions, followed, on 13-JUL-2016, by the diagnosis of Shingles. The patient sought medical attention and received unspecified treatment. No product quality complain was involved. The outcome of the events were reported as not recovered. The causality between the events and the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were inadvertently vaccinated with 3 doses of VAQTA injection, intramuscularly, lot # M009377, expiration date: 17-JUN-2017 (dose and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of two cases received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with PROQUAD (dosing details were not reported) (lot # M004889, with expiry date of 25-JUL-2017) which was improperly stored at 7 F for a time frame of 3 hours and 49 minutes, which was having a previous temperature excursion of 28 F for 4.5 hr. The call was made due to data logger (therapy type: digital data logger). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of an unknown gender and age. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, route, lot and expiration date were not provided), one dose, then, On 19-JUL-2016, the patient went to her physician and forgot she had already been vaccinated and received another dose of ZOSTAVAX (strength, route, lot and expiration date were not provided). There were no concomitant medications and adverse events reported. No product quality complaint was involved. Additional information is not expected as the reporter did not consent for follow-up attempts.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Erythema, Induration
Clinical narrative: No fever, but day after injection developed area of erythema and induration over (L) tricep and several small vesicles.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Diarrhoea, Dizziness, Hot flush, Nausea, Vomiting
Clinical narrative: At 0100 on 07/20/16, developed hot flashes and nausea, vomiting, and dizziness. Unable to keep fluids down. Diarrhea started at 0900 7/20/16. Symptoms still occurring.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient reported pain, swelling, warm to touch at vaccination site. Patient to take Diphenhydramine 50 mg for reaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning to a 70 years old female patient. Medical history, concurred conditions and concomitant therapies were not reported. On 13-JAN-2009, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles. Dose, route, frequency and lot number were not provided. The pharmacist reported that the patient developed a case of shingles on an unknown location approximately in MAY-2016, reported as "about two months ago". The patient visited the physician and the patient was treated with VALTREX, TYLENOL with codeine and capsaicin cream. The outcome of herpes zoster was reported as not recovered/not resolved. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Diarrhoea, Nasal congestion, Nausea
Clinical narrative: Abdominal pain, nausea, diarrhea nasal congestion.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Rash erythematous
Clinical narrative: Redness, swelling, fever in arm at injection site. Red bumps/itching on scalp.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report from a pharmacist refers to a patient of unknown age. The pharmacist reported on 11-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 lot # K019386, expiration 09-JUN-2016.  No adverse effects. No additional information provided. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the L. ant. thigh with 10 x 7 cm border, started hours after the vaccine and gradually increased. Also 2 cm erythematous area at MMRV site. Not swollen.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JUL-2016 (reported as today), the patient was inadvertently vaccinated with a dose of PROQUAD and a dose of VARIVAX (lot#, dose, route and site of vaccination were not reported for both). No adverse effects were reported. Additional information is not expected as the reported refused further contact.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Product use issue
Clinical narrative: This spontaneous report as received from a consumer refers to a 12 year old female patient. The patient has none medical history or drug reactions. On an unspecified date in November 2015, the patient was vaccinated with the second dose of GARDASIL (Dosage, route of administration, lot # and expiration date were not reported), additionally it was stated that the patient received GARDASIL with the wrong gauge needle. It was also reported that there was no specific information on the first or third dose of GARDASIL. No other suspect or concomitants therapies were reported. On the same date (reported as within "a couple of hours of administration"), the patient's arm was sore. Additionally, it was reported that an unspecified treatment was given for sore arm, that no laboratory diagnostics were performed, that the patient did not sought medical attention and also was stated that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of sore arm was reported as recovered. The relatedness between sore arm and GARDASIL was not reported. Additional information has been requested. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt stated swelling, itching over torso waist up to head left side (large area) redness at injection site and shoulder to elbow. Tender to touch 5-28 and 5-29. Took BENADRYL to set side affects to reduce.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: Red, swollen and hot with rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Rash 15x5cm warm, pins, no constitutional.