chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, HPVX
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Case number PHHY2015US069160 is an initial spontaneous report received on 03 Jun 2015. The author discussed about the safety profile of pregnancy exposures to the quadrivalent human papillomavirus vaccine (qHPV) by acquiring and analyzing post marketing data on pregnancy outcomes from GARDASIL/SILGARD pregnancy registry. The registry enrollment criteria included an identifiable patient, exposure to human papilloma virus vaccine within one month prior to the date of onset of last menstrual period (LMP) or at any time during pregnancy, identification of health care provider and residency in a country where the registry was active. This report refers to a 32 to 33 weeks old neonate whose gender was not reported. Past medical history and concomitant medications were not reported. The baby's mother was vaccinated with qHPV (other manufacturer, batch number: not reported) on an unknown date when she was pregnant (see related case number: PHHY2015US068689). It was reported that the exposure to human papilloma virus vaccine occurred 1 week and 5 days from LMP. The baby's mother concomitantly received influenza virus vaccine (manufacturer and batch number: not reported), ferrous sulphate (unknown manufacturer) and cannabis at 8 to 9 weeks of gestation. The baby's mother had twin gestation and the baby and the twin was delivered at 32 to 33 weeks of gestation. The baby was born live with no abnormalities. The death of the twin occurred at 22 weeks of gestation which was diagnosed at 28 weeks and there were no abnormalities on autopsy. The author concluded the article stating that the rates of spontaneous abortions and major birth defects were not greater than the general population rates. Due to the nature of voluntary spontaneous reporting, no definitive conclusions could be made about the potential effects of exposure to qHPV vaccine during pregnancy and hence qHPV vaccine was not recommended for use in pregnant women.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5/28 pt with sig pain to her left upper arm at the site of injection of Tdap she received 2 days ago at our office. Pain, erythema, warmth. No systemic sx. Rx-BACTRIM.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt with sig pain to her left upper arm at the site of injection of Tdap 20-25cm in length pain, erythema, warmth. No systemic sx. Rx-BACTRIM.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Injection site erythema, Injection site swelling
Clinical narrative: (L) shoulder swelling 10cm (asthmatic). Erythema. Patient give MOTRIN.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Impaired healing, Insomnia, Sleep disorder, Snoring, Urticaria
Clinical narrative: A week later, started having sleep difficulty, sleeping from 8-9 hours a day to 2 hours. Has had sleeping problems for about 3 1/2 weeks. 1/2 week later welts started moving on right side from arm to abdominal area, right leg. Have been sleeping on back side, very unusual, usually sleeps on right side. Was snoring and woke himself up. Started using homeopathic remedy for welts, improved after a few days. Sleeping patterns have changed so had to double dose of trazodone. Patient delivers pizza so was very sleepy driving since couldn't sleep normally. Also having problems with alpha interferon PEGASYS therapy. Also had problems with skin healing. Grabbed shovel which created red lines, veins, on hand. Lately have been doing body cleanse and taking Golden Seal root tablets. In terms of sleep had to increase dose of trazodone to be able to sleep.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Gait disturbance, Inflammation, Joint dislocation, X-ray limb normal
Clinical narrative: 8/20/14 Mom states child limping on right leg-that hip was pulled out of socket somehow when we were holding for vaccines. 8/25/14 Mom phoned again - says xray of knee negative. Child better and walking around. Took Ibuprofen for inflammation.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Erythema, Nodule, Pain in extremity, Pyrexia
Clinical narrative: Pt received pneumonia and flu vaccine on 10/27. Later that night she started having soreness in arm and large red spots appeared on right arm almost in a band around arm, redness on chest. The next morning she had high fever and chest pain. She came back to clinic on 10/29 and told us of symptoms and she also had a swollen knot on chest midsternum. She was sent to medical provider for treatment. Tried to call pt and left message.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Pt received pneumonia and flu vaccine on 10/27. Later that night she started having soreness in arm and large red spots appeared on right arm almost in a band around arm, redness on chest. The next morning she had high fever and chest pain. She came back to clinic on 10/29 and told us of symptoms and she also had a swollen knot on chest midsternum. She was sent to medical provider for treatment. Tried to call pt and left message.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Haemorrhage, Heart rate irregular, Injection site discolouration, Injection site swelling
Clinical narrative: Flu vaccine given to left deltoid. Pt's arm started bleeding. Alcohol pad used to wipe blood off pt's arm. Saw that arm had swollen and turned blue/brown where injection had been given instantly. Also complained of dizziness. Vitals monitored: pt had irregular heart beat.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Cellulitis, Erythema, Fatigue, Feeling of body temperature change
Clinical narrative: On Friday 11/21/14 around 4:00 AM, woke up with pain/redness/swelling to left arm. Throughout the course of the day, pain/swelling/redness worsen. Felt hot/cold. Also extreme fatigue. ER visit around 10:00 PM 11/21/14. Temp reported 99.1 degrees F. Dx with acute cellulitis. Tx KEFLEX 500 mg BID 10 day. Pain reached from shoulder blade to elbow. Along with redness/swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: On Friday 11/21/14 around 4:00 AM, woke up with pain/redness/swelling to left arm. Throughout the course of the day, pain/swelling/redness worsen. Felt hot/cold. Also extreme fatigue. ER visit around 10:00 PM 11/21/14. Temp reported 99.1 degrees F. Dx with acute cellulitis. Tx KEFLEX 500 mg BID 10 day. Pain reached from shoulder blade to elbow. Along with redness/swelling.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reports pain in the (R) arm that was very bad Thursday after receiving the vaccine-she reports redness and some swelling. She advised that it has gotten better. This pt called 2/17/15-PM. I have advised the pt to follow-up with her primary care provider, she advised she was going to call him today.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth, Nodule, Pain, Pruritus
Clinical narrative: Pt reports child got a knot on his arm after they vaccine and she thought it was normal but it has continued to get bigger. She has tried giving TYLENOL the child has pain and itching. Pt has area on LD that is approx. 8 x 3 1/2 " bright red and warm to the touch.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt's mother phone 6/3/15 at 3pm. States site where MCV given at 2pm 6/2/15 is red, itchy and swollen. Asked about SOB, denies; no fever, no dizziness, slight sweating. Told to take daughter to physician if she doesn't improve. Also apply cold compress to affected area. It is noted pt weighs 411 lbs.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction 15 minute S/P Flu injection.
Age: 22.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Balance disorder, Burning sensation, Dizziness, Ear pain, Headache
Clinical narrative: 6/4/15 9:30AM - Patient called clinic stating awoke around 3-3:30AM with burning/hurting at base of skull in back of head. Unable to lie head back on pillow due to pain. States pain worsened and spread to both ears, especially left ear; hurt to turn head side-to-side, esp. to left side; having some lightheadedness and balance issues. No fever. I contacted Sanofi Pasteur and spoke with medical rep - advised patient to go to Emergency Room for evaluation. Spoke with patient 6/5 - she states did not go to ER - took TYLENOL and "head eased off". Today has "general headache."
Age: 22.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Pain
Clinical narrative: 6/4/15 9:30AM - Patient called clinic stating awoke around 3-3:30AM with burning/hurting at base of skull in back of head. Unable to lie head back on pillow due to pain. States pain worsened and spread to both ears, especially left ear; hurt to turn head side-to-side, esp. to left side; having some lightheadedness and balance issues. No fever. I contacted Sanofi Pasteur and spoke with medical rep - advised patient to go to Emergency Room for evaluation. Spoke with patient 6/5 - she states did not go to ER - took TYLENOL and "head eased off". Today has "general headache."
Age: 22.0
Sex: F
Vaccine: HEPA, MNQ, TYP, YF, HEPA, MNQ, TYP, YF
Symptoms: Injection site pain, Pain
Clinical narrative: 6/4/15 9:30AM - Patient called clinic stating awoke around 3-3:30AM with burning/hurting at base of skull in back of head. Unable to lie head back on pillow due to pain. States pain worsened and spread to both ears, especially left ear; hurt to turn head side-to-side, esp. to left side; having some lightheadedness and balance issues. No fever. I contacted Sanofi Pasteur and spoke with medical rep - advised patient to go to Emergency Room for evaluation. Spoke with patient 6/5 - she states did not go to ER - took TYLENOL and "head eased off". Today has "general headache."
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was given the vaccine on 5-31-15. She called on 6-2-15 and reported dizziness and nausea since the vaccine.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: 6-9-15 Reaction brought to clinic attention area 10 x 10cm reddened-instructed to use ice-hydrocortisone cream and BENADRYL-returned to clinic 6-12-15 area increased in size remains red-SOLU-MEDROL given R.D.
Age: 1.08
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt. has varicella.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Urticaria
Clinical narrative: Face got red on trip home. Developed hives and erythema to abdomen during a nap immediately after vaccines. Gave 3rd BENADRYL in office, advised to give every 6 hours for 24 hours and CLARITIN 2.5 ml a d x 5 days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Ultrasound scan normal
Clinical narrative: Persistent pain at injection site x2 weeks.
Age: 26.0
Sex: M
Vaccine: FLU3, MMR, TDAP
Symptoms: Gaze palsy, Hyperhidrosis, Immediate post-injection reaction, Seizure like phenomena, Tonic clonic movements
Clinical narrative: No problem noted after administering Tdap and MMR to pt, then wanted to discuss influenza and administered same at 10 mins later immediately after administration of same and removing needle from patient's arm, his eyes became fixed and developed seizure like tonic and clonic movements which lasted briefly about 5-6 sec. Immediately after, he was alert and oriented x 3, diaphoretic but in no apparent distress.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiration date were not provided) that were improperly stored. Concomitant therapy was not reported. No adverse experience was reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Previously received Tdap in 7/27/10 duplicate Tdap received on 9/29/14.
Age: 1.21
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Papule, Rash vesicular, Varicella post vaccine
Clinical narrative: Varicella disease (breakthrough) -day 1 today 6/16/15-41 spots, widespread papules vesicula discrete lesions. Afebrile, no exanthema.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 5 unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. The nurse reported that, on an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot number, expiration date and route were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Injection site pain, Injection site swelling, Nausea, Rash
Clinical narrative: Nausea (no vomit), fatigue, injection site arm swollen and sore, local rash appeared a few days later. Took 2 acetaminophen for aches (no fever). Pt also took a Claritin 10mg via ongoing rx for allergies. Rash is still lingering.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Zoster vaccine on two seperate occasions. 12/13/2012 at 1PM, and 06/12/2015 at 3PM. Patient displayed no physical adverse reaction to vaccine. Spoke with the patient today via telephone, and patient states at this time she feels fine, and has no symptoms. I will be contacting patient weekly for the next consecutive 4 weeks to check on her status.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Diarrhoea, Irritability, Vomiting
Clinical narrative: Patient became very cranky had 8 episodes of vomiting and 1 bout of loose stool.  Reported temp of 100.0.  After approximately 2 hrs was back to normal self.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Pruritus
Clinical narrative: Localized reaction with itching.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Musculoskeletal pain, Pyrexia
Clinical narrative: Feverish, chills, right shoulder pain, redness at injection site.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Fatigue
Clinical narrative: My 25 year old daughter received her 2nd GARDASIL shot and began experiencing extreme fatigue and hair loss. She has multiple bald spots all over her head the size of quarters and is thinning with the loss of about 1/3 of her hair. She is very tired. I believe this to be the side effects of having the GARDASIL vaccine. HELP PLEASE...who can I talk to???? Please contact me.
Age: 34.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site rash, Injection site warmth, Local swelling
Clinical narrative: Local swelling onset 01/14/2012, heat radiating from injection site onset 01/14/2012, rash at injection site, approx size 2.5" diameter onset 01/15/2012, rash grew approx size 5-6" diameter 01/17/2012.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Local reaction, Pruritus, Swelling
Clinical narrative: Localized reaction with swelling, itching and hard spots.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Influenza like illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Redness and swelling in arm, bodyaches similar to flu, fever of 101, emesis.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Vomiting
Clinical narrative: Redness and swelling in arm, bodyaches similar to flu, fever of 101, emesis.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of left arm pain and swelling at injection site. Area was noted as warm, swollen but no redness.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness of left arm where vaccine was given continues on and off x 8 months.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying, Musculoskeletal stiffness
Clinical narrative: Parent states child cried for a few hours and "stiffened up" the evening after he received his immunizations. The same thing happened after his 2nd round of immunizations on 12/15/2014.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Adverse Event as a result of the Menactra vaccine.  Arm pain and swelling that got worse over 4 days.  Hives on trunk and rash on shoulder in area of vaccine administration.  Prophylactic antibiotics prescribed, and Benadryl and Advil given to try to reduce pain and swelling.  Symptoms decreased after 4 days, but still not resolved after 7 days.  Some swelling and pain remains.
Age: 1.34
Sex: F
Vaccine: MMR
Symptoms: Otitis media acute, Pyrexia
Clinical narrative: Fever 102-104 degrees. Diagnosed bilateral otitis media-acute.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling, Pruritus generalised
Clinical narrative: Swelling/itching/ tingling in arms, legs and top of insteps   some itching chin nose.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Oropharyngeal discomfort, Pyrexia
Clinical narrative: The patient began with feelings in her throat as well as fever, and nausea beginning the next day after receiving the vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reports deep, sharp pain at site of injection.  Chronic x 2 months, intermittent. No visable signs of infection, no TTP.
Age: 50.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Chills, Dizziness, Dyspnoea, Hyperhidrosis, Pyrexia
Clinical narrative: Rash with tenderness, fever of 99.5F, chills, sweating, faintness and shortness of breath.
Age: 50.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Rash, Tenderness
Clinical narrative: Rash with tenderness, fever of 99.5F, chills, sweating, faintness and shortness of breath.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: She has a 2x2 inches rash about 3 inches from the injection site. It is red and warm to touch. Pt also said it itches.
Age: 0.42
Sex: M
Vaccine: DTAP, PNC
Symptoms: Cough, Eye movement disorder, Wheezing
Clinical narrative: Eyes rolled in head...thought child might not have been breathing for a min...coughing and wheezing came after.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Tonic clonic seizure.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Still have excruciating pain in both shoulders. Shoulders lock up, cannot reach, extend arms or carry groceries. In 2013 I received the flu shot at the outpatient clinic. When I got the shot my right shoulder was sore for 2 weeks and I could not move my shoulder or arm. The shot has severely injured my right shoulder, it is now 2 years later and my shoulder still locks up, excruciating pain 100% of the time in my right shoulder while sleeping, excruciating pain 50%-80% of the time in my right shoulder while trying to extend my arm. Excruciating pain most of the time in my right shoulder while carrying groceries. In 2014 the outpatient clinic gave me the flu shot in my left shoulder. 1-3 months later I had excruciating pain in my left shoulder. I have excruciating pain 100% of the time in my left shoulder. I have excruciating pain 50%-80% of the time in my left shoulder trying to extend my left arm or carrying groceries. OTC and prescription pain meds do not help at all and I have tried many of them. I do not ever sleep. I roll around in the floor in pain. I only rest....
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. The nurse reporter that, on an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (HPV4) (lot number, expiration date and frequency were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several r4eports from the same source. Additional information has been requested.
Age: 1.28
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 15 month old patient with no pertinent medical history, drug allergies or reactions reported. On 27-FEB-2015, the patient was vaccinated with the first dose of VAQTA (dose, lot number and expiration date were not provided) intramuscular. On 05-JUN-2015, the patient was vaccinated with a second dose of VAQTA (dose, lot number and expiration date were not provided) intramuscular. Concomitant therapy was not reported. No known adverse effects reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Haematochezia, Irritability
Clinical narrative: Mom reported that patient became very fussy with a shrill cry after receiving vaccines. He calmed after he was given TYLENOL, but was abnormally fussy for 24-48 hours. He had one episode of blood in his stool.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Red, inflamed, swollen, warm to the touch. Recommended BENADRYL, anti-inflammatory. Referred to doctor. Patient had Rx from MD.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Parent reported unconsolable crying for 2 hours at home on day of vaccination (4 hours after vaccination).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Vaccine administered on 6/9/15. Rash developed on 6/10. By 6/12 red, itchy rash spread down entire right arm. Patient went to walk-in clinic. Diagnosed with cellulitis. Treated with KEFLEX, rash resolved completely.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Somnolence, Swelling
Clinical narrative: Vaccine adm 6-5-15 in afternoon. After 2 days inj site red. Over 1 wk area remained red, swelling occurred. 1 week after vaccine adm - went to ER, received shot for swelling and antibiotic for 10 days. then slept for 2 days. 6-16-15 presents at clinic to report event.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles rash day after vaccine. Started small with quarter size. Now (6/16=3pm) about 3" across.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Computerised tomogram, Parotid gland enlargement, Parotitis, Salivary gland pain
Clinical narrative: Parotitis-right parotid gland swelling and pain better on antibiotics. Started 6/14/15 MMR given 6/5/15. Had MMR #1 5/5/15.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. The nurse reported that, on an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiration date and route were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia
Clinical narrative: Arthralgia.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified Medical Assistant and from a certified medical assistant staff refers to a patient of unknown age and gender who on 16-APR-2015 was vaccinated with an improperly stored dose of PEDVAXHIB from the lot K015462, expiration date not reported (dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist as part of a market research, refers to a 71 year old female patient with no relevant medical history. In June 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported). There was not concomitant therapy. In June 2011, two years after vaccination, the patient developed a mild case of shingles (coded as herpes zoster). The patient recovered in less than 1 week (on an unknown date in 2011). The reporter considered herpes zoster to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a certified medical assistant and a certified medical assistant staff, referring a patient of unknown age and gender. Information about medical history and concurrent conditions were not reported. On 16-APR-2015, the patient was vaccinated with a dose of PEDVAXHIB from the lot K015462, expiration date not reported. It was also confirmed that no adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Vaccines were administered on June 2, 15. Call from parent 6/12/15 that there was a red hard lump at inj. site. Parent went to urgent care and started KEFLEX for dx cellulitis. Fever: None; Location: Left; Onset: 3-7 days; Duration: Acute; Severity: Mild; Quality: Worsening. Possible reaction to vaccines. Left leg swelling with fevers (102-103), treated as a cellulitis at office (taking KEFLEX). Was warm to touch, swollen etc with some excoriations.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Skin warm
Clinical narrative: Vaccines were administered on June 2, 15. Call from parent 6/12/15 that there was a red hard lump at inj. site. Parent went to urgent care and started KEFLEX for dx cellulitis. Fever: None; Location: Left; Onset: 3-7 days; Duration: Acute; Severity: Mild; Quality: Worsening. Possible reaction to vaccines. Left leg swelling with fevers (102-103), treated as a cellulitis at office (taking KEFLEX). Was warm to touch, swollen etc with some excoriations.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. The medical assistant reported that, on unknown dates, doses of M-M-R II (lot # K009957; expiration date reported as 14-JUL-2016) were administered post temperature excursion to multiple anonymous patients with no adverse effects reports by any patient. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 26-MAY-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX, (0.65 ml/once), subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, the patients were vaccinated with a improperly stored dose of PROQUAD (Merck) lot # K010213, 0.5 ml, subcutaneous, expiration date 17-JAN-2016 and lot # K020750, expiration date 30-APR-2016, 0.5 ml, subcutaneous. No adverse effects reported. The dates of the temperatures outside of the recommended range were 11-APR-2015 to 09-JUN-2015. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, the patients were vaccinated with a improperly stored dose of VARIVAX (Merck) lot # K016128, expiration date 23-SEP-2016 (dose and route were not reported). No adverse effects reported. The dates of the temperatures outside of the recommended range were 11-APR-2015 to 09-JUN-2015. This is one of two reports from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea vomiting & decreased energy, sweating.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling in his arm, resolved with ice.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: Patient received GARDASIL #1. Left office with no complaints. Mom called back 1 hour later saying she was having chest pain and anxiety. Spoke to Dr. who told her to give MAALOX and if no better in 15 minutes to go to ER. Went to ER given EKG and chest x-ray all normal. Patient discharged.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Mobility decreased, Paralysis, Wheelchair user
Clinical narrative: Paralysis from 10/18/2012 to present after 32 months, confined to wheelchair. Very limited use of legs and hands. Treatment IVIG x 2 and rehabilitation.
Age: 5.0
Sex: F
Vaccine: MMR, DTAP, IPV, MMRV
Symptoms: Measles, Pyrexia
Clinical narrative: Patient developed fever to 102F. Fever lasted 2 days, then developed generalized papular measles like rash that was very pruritic in nature. Also developed nasal congestion, pharyngitis, and Koplik's spots in mouth.
Age: 5.0
Sex: F
Vaccine: MMR, DTAP, IPV, MMRV
Symptoms: Measles, Nasal congestion, Pharyngitis, Pyrexia, Rash generalised
Clinical narrative: Patient developed fever to 102F. Fever lasted 2 days, then developed generalized papular measles like rash that was very pruritic in nature. Also developed nasal congestion, pharyngitis, and Koplik's spots in mouth.
Age: 5.0
Sex: F
Vaccine: MMR, DTAP, IPV, MMRV
Symptoms: Rash morbilliform, Rash papular, Rash pruritic
Clinical narrative: Patient developed fever to 102F. Fever lasted 2 days, then developed generalized papular measles like rash that was very pruritic in nature. Also developed nasal congestion, pharyngitis, and Koplik's spots in mouth.
Age: 1.0
Sex: M
Vaccine: MMRV, HEPA, MMR, PNC13, VARCEL
Symptoms: Chest X-ray, Cyanosis, Electrocardiogram, Full blood count, Pyrexia
Clinical narrative: Febrile seizure 10 hours after receiving 12 month vaccine series.
Age: 1.0
Sex: M
Vaccine: MMRV, HEPA, MMR, PNC13, VARCEL
Symptoms: Respiratory arrest, Urine analysis
Clinical narrative: Febrile seizure 10 hours after receiving 12 month vaccine series.
Age: 1.0
Sex: M
Vaccine: MMRV, HEPA, MMR, PNC13, VARCEL
Symptoms: Chest X-ray, Febrile convulsion, Full blood count, Urine analysis
Clinical narrative: Febrile seizure 10 hours after receiving 12 month vaccine series.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Cardiac disorder, Cardiac stress test normal, Chest pain, Dizziness
Clinical narrative: Flu like symptoms, fever, dizziness, muscle pain, headache, vomiting, chest pain, weakness x 3 weeks. Congestion. ER visit for cardiac issues, Echo, stress test etc was normal however chest pain continues. Hypertension.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Echocardiogram normal, Headache, Hypertension, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms, fever, dizziness, muscle pain, headache, vomiting, chest pain, weakness x 3 weeks. Congestion. ER visit for cardiac issues, Echo, stress test etc was normal however chest pain continues. Hypertension.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Flu like symptoms, fever, dizziness, muscle pain, headache, vomiting, chest pain, weakness x 3 weeks. Congestion. ER visit for cardiac issues, Echo, stress test etc was normal however chest pain continues. Hypertension.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test, Swelling
Clinical narrative: Received Menveo immunization in Right deltoid in the Clinic.  Mother reports on 03/21/2015 her son after baseball practice C/O an swollen armpit, in "the hollow area was filled with fluid and bouncy." Saw PCP same day and placed on a 10 day course of antibiotics.  Denies fever, chills or diarrhea.  Recovered with side effects reported by mother.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient describes itching and rash on back (in a few spots). Rash is not reported at site of injection. Patient is applying topical cortisone and advised to consider Benadryl..caution drowsiness.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site same pm as injection.  Following AM, site swollen and reddened.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Mild fever fatigue chills muscle pain.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: C-reactive protein normal, Full blood count abnormal, Injection site macule, Injection site pain, Injection site pruritus
Clinical narrative: Symptoms began as itching which progress to painful, pruritic, pustules and macules to bilateral elbows, hands/palms, buttock, lower legs, and feet.  Patient was given Ibuprofen and Zyrtec for symptomatic treatment.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pustule, Macule, Monocyte count increased, Pain, Polymerase chain reaction
Clinical narrative: Symptoms began as itching which progress to painful, pruritic, pustules and macules to bilateral elbows, hands/palms, buttock, lower legs, and feet.  Patient was given Ibuprofen and Zyrtec for symptomatic treatment.
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash pustular, Red blood cell sedimentation rate normal, Viral test
Clinical narrative: Symptoms began as itching which progress to painful, pruritic, pustules and macules to bilateral elbows, hands/palms, buttock, lower legs, and feet.  Patient was given Ibuprofen and Zyrtec for symptomatic treatment.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Nausea, Headache, Chills, Sore Injection Site, Body Aches, Fever, Sleepiness - began that evening and got worse at nighttime and following day was in bed - fever 100.8 - called doctor and took Tylenol to relieve symptoms.  Today I am feeling better - symtoms less but still present- fever at 99.7.  Had to cancel social events.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Nausea, Headache, Chills, Sore Injection Site, Body Aches, Fever, Sleepiness - began that evening and got worse at nighttime and following day was in bed - fever 100.8 - called doctor and took Tylenol to relieve symptoms.  Today I am feeling better - symtoms less but still present- fever at 99.7.  Had to cancel social events.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Endotracheal intubation, Lethargy, Sepsis
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 89-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date single dose. The patient medical history included multiple myeloma and the patient's concomitant medications were not reported. The patient's temperature was 103 Fahrenheit and became lethargic within 1 hour after vaccination. The patient became septic too and was hospitalized and intubated. The outcome of the events was unknown.
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 9 June 2015. This case linked to 2015SA082766. (Same suspect same events). A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number- C4714AA, expiration date- 8 April 2017) in left deltoid on an unspecified date. On an unspecified date, after vaccination, the patient experienced pain, erythema, swelling, warm to touch, area at injection site. The patient was diagnosed with cellulitis. The patient required emergency room/doctor visit. Laboratory investigations were not reported. The patient was treated with BACTRIM. At the time of this report outcome of event was unknown. Upon medical review, the case was considered as serious due to important medical event: cellulitis. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 9 June 2015. This case linked to 2015SA083655. (Same suspect same events). A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number- C4714AA, expiration date- 8 April 2017) in left deltoid on an unspecified date. On an unspecified date, after vaccination, the patient experienced pain, erythema, swelling, warm to touch, area at injection site. The patient was diagnosed with cellulitis. The patient required emergency room/doctor visit. Laboratory investigations were not reported. The patient was treated with BACTRIM. At the time of this report outcome of event was unknown. Upon medical review, the case was considered as serious due to important medical event: cellulitis. Documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Pyrexia, Sepsis
Clinical narrative: This is a spontaneous report from a contactable nurse. An 84-year-old female patient started to receive PREVENAR 13 (Lot # 31685, Exp. Date 30Sep2016), intramuscular at 0.5 ml single dose in the right deltoid on 04May2015. The patient medical history and concomitant medications were not reported. On 05May2015, the patient developed weakness, fever and dizziness. She was seen in the emergency room, at that time, and her temperature was 102.1 degrees Fahrenheit. On 05May2015, she was admitted to the hospital and discharged on 07May2015. Admitting diagnosis was sepsis. Follow up visit 14May2015, at the reporter's clinic, patient was completely recovered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: (R) upper arm had swelling and warmth at injection site.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient got the immunization on 6/9/15 and is complaining of her left arm tingling and going to sleep (6/12/15). Didn't notice redness or pain at injection site.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, TD
Symptoms: Dizziness, Dyskinesia, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: 2 hrs after receiving (GARDASIL, Hep A, TENIVAC) vaccines pt felt lightheaded, nauseous and was sweating a lot. Pt passed out for a few seconds, per dad he was jerking arms and legs. Pt doing fine now.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient developed redness, itching and swelling after receiving a ZOSTAVAX immunisation. Patient saw her PCP and was prescribed betamethasone 0.05% ointment and hydroxyzine 25mg capsules which has helped to relieve her reaction.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Small red rash on area of right thigh where vaccine was given.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Day after vaccine-patient developed red itchy swollen arm (same arm as injection). Continued to grow to larger area in next few days. Not painful goes from elbow to halfway up arm and about 6" diameter. Not overlapping injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Patient says bruising appeared at injection site.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Personality change, Pyrexia, Screaming
Clinical narrative: Per mom-immediate fever, child could not be touched or moved, fever of 102 for 5 days with constant screaming, personality change and child could not handle being touched, changed or held.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Within 24 hrs of receiving PREVNAR 13 vaccine patient had swelling redness which was hot to the touch. Patient went to the urgent care and was put on KEFLEX. Swelling and redness are improved with mild redness, and itching. Patient came into PCP office 6-16-15 for acute follow up. Mild erythema of the left upper arm 20cm by 5cm area. No blistering. Mometasone Furoate 0.1% external cream prescribed.
Age: 62.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Pain, Rash, Skin lesion
Clinical narrative: On 6/17, patient contacted clinic about a dermatomal painful rash on trunk that developed over past 48 hours. She recalls a small skin lesion present at the time she received vaccines on 6/15. Going to primary care physician for evaluation for possible herpes zoster.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Eye movement disorder, Hypoaesthesia, Loss of consciousness
Clinical narrative: Approx 5-10 min after shot, patient's arm felt numb. She started feeling nauseas, her ears were ringing, and her vision started fading, eyes rolled backed in head, she lost consciousness and had seizure-like activity fro 5-10 seconds. She then regained consciousness but remained light headed, shaking and clammy.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Seizure like phenomena, Tinnitus, Tremor, Visual impairment
Clinical narrative: Approx 5-10 min after shot, patient's arm felt numb. She started feeling nauseas, her ears were ringing, and her vision started fading, eyes rolled backed in head, she lost consciousness and had seizure-like activity fro 5-10 seconds. She then regained consciousness but remained light headed, shaking and clammy.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (route, dose, anatomical location, lot # and expiration date were not reported). There was not concomitant therapy reported. No adverse effects reported. The reporter did not have the lot numbers of GARDASIL at the time of this report. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to six unspecified patients of unknown demographics. Pertinent medical history and drug reactions/ allergies were not reported. On an unspecified date, all these patients received improperly stored VARIVAX (Merck) which were exposed to -3 degree Celsius (C) for 12 hours (dose/ frequency, lot #, expiry date unspecified). Concomitant medications were unspecified. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On 09-JUN-2015, the patient was vaccinated with a single dose of GARDASIL lot # K023432, expiration date: 18-JUN-2016, 0.5 ml, intramuscular which was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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, concurrent conditions, drug reactions or allergies were not reported. On 09-JUN-2015 the patient was inadvertently vaccinated with an expired dose of VARIVAX (Merck), subcutaneous, expiration date 27-MAR-2015, (dose number, anatomical location and lot number were unspecified). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.