chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pruritus generalised, Pyrexia, Swelling
Clinical narrative: Twenty minutes after administration, patient experienced itching all over. Patient took 50 mg BENADRYL and within 60 minutes itching subsided and no further itchiness occurred. Two hours after administration, patient started having redness at the site, swelling, pain, high fever and fatigue. Today raised, warm, red erythematous areas are noted at right deltoid one is 4 inches by 3 inches with a second medial to the first that just started this morning, measuring 1 1/2 " x 1 ".  Patient states this second one is getting bigger.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Crying, Decreased appetite, Dehydration, Diet refusal, Electroencephalogram
Clinical narrative: He got his shots around 11am on November 2, 2018. At 3am November 3, 2018 he started crying persistently for hours. He was inconsolable. He stiffened his neck, arched his back and made fists and just screamed. He would not eat. He fell asleep and slept for 6 hours straight without moving. He woke up, screaming and severely dehydrated cause his febrile soft spot was sunken in. He kept going stiff and around 5pm I noticed he was going cross eyed and just would stay in a shock like state, frozen. He had a 102.5 fever, persistent inconsolable crying, loss of appetite, shock like state and silent seizures. 20 mins after arriving to the ER he had 2 more seizures and was put to sleep for further testing. A few hours later, they tell us he has meningitis. So 48 hours after receiving vaccines and the PVC vaccine, he gets meningitis. They said it was related to vaccines. I know better. It's not just a coincidence. My baby almost died. He lived and beat the disease miraculously but he is now happy and healthy and vaxx free.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Fontanelle depressed, Human rhinovirus test positive, Lumbar puncture, Meningitis, Meningitis pneumococcal
Clinical narrative: He got his shots around 11am on November 2, 2018. At 3am November 3, 2018 he started crying persistently for hours. He was inconsolable. He stiffened his neck, arched his back and made fists and just screamed. He would not eat. He fell asleep and slept for 6 hours straight without moving. He woke up, screaming and severely dehydrated cause his febrile soft spot was sunken in. He kept going stiff and around 5pm I noticed he was going cross eyed and just would stay in a shock like state, frozen. He had a 102.5 fever, persistent inconsolable crying, loss of appetite, shock like state and silent seizures. 20 mins after arriving to the ER he had 2 more seizures and was put to sleep for further testing. A few hours later, they tell us he has meningitis. So 48 hours after receiving vaccines and the PVC vaccine, he gets meningitis. They said it was related to vaccines. I know better. It's not just a coincidence. My baby almost died. He lived and beat the disease miraculously but he is now happy and healthy and vaxx free.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Opisthotonus, Pyrexia, Rhinovirus infection
Clinical narrative: He got his shots around 11am on November 2, 2018. At 3am November 3, 2018 he started crying persistently for hours. He was inconsolable. He stiffened his neck, arched his back and made fists and just screamed. He would not eat. He fell asleep and slept for 6 hours straight without moving. He woke up, screaming and severely dehydrated cause his febrile soft spot was sunken in. He kept going stiff and around 5pm I noticed he was going cross eyed and just would stay in a shock like state, frozen. He had a 102.5 fever, persistent inconsolable crying, loss of appetite, shock like state and silent seizures. 20 mins after arriving to the ER he had 2 more seizures and was put to sleep for further testing. A few hours later, they tell us he has meningitis. So 48 hours after receiving vaccines and the PVC vaccine, he gets meningitis. They said it was related to vaccines. I know better. It's not just a coincidence. My baby almost died. He lived and beat the disease miraculously but he is now happy and healthy and vaxx free.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Screaming, Seizure, Shock symptom, Strabismus, Streptococcus test positive
Clinical narrative: He got his shots around 11am on November 2, 2018. At 3am November 3, 2018 he started crying persistently for hours. He was inconsolable. He stiffened his neck, arched his back and made fists and just screamed. He would not eat. He fell asleep and slept for 6 hours straight without moving. He woke up, screaming and severely dehydrated cause his febrile soft spot was sunken in. He kept going stiff and around 5pm I noticed he was going cross eyed and just would stay in a shock like state, frozen. He had a 102.5 fever, persistent inconsolable crying, loss of appetite, shock like state and silent seizures. 20 mins after arriving to the ER he had 2 more seizures and was put to sleep for further testing. A few hours later, they tell us he has meningitis. So 48 hours after receiving vaccines and the PVC vaccine, he gets meningitis. They said it was related to vaccines. I know better. It's not just a coincidence. My baby almost died. He lived and beat the disease miraculously but he is now happy and healthy and vaxx free.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch with temp of 101 F.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions included asthma. She had contact dermatitis at the time of vaccination. She did not have any pre-existing physician-diagnosed allergy or birth defects. Concomitant therapies included VENTOLIN and ZYRTEC. Historical vaccine included VAQTA. On 14-SEP-2018,  the patient was vaccinated with (rHA) M-M-R II, lot # R008196, expiration date: 16-SEP-2019, (dose not provided) subcutaneously (SC) in the left tight (LT); and with QUADRACEL, lot # C5325BA (dose and expiration date not provided), intramuscularly (IM) in LT. Both vaccines were administered for prophylaxis. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002764: US-009507513-1809USA010598: US-009507513-1901USA002763: US-009507513-1901USA002753: US-009507513-1901USA002765: US-009507513-1901USA002754.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs were not provided. On 18-JAN-2019, two patients were vaccinated with improperly stored doses (also capture in 1901USA010528) of VARIVAX Lot # R022116, expiration date 02-AUG-2020, subcutaneously (strength, dose, dose number, and anatomical location were not provided) for prophylaxis. The sterile Diluent used to reconstitute the VARIVAX was stored properly. The vaccines were exposed to a temperature of 15 Fahrenheit degrees to 46 Fahrenheit degrees (18.9 Fahrenheit degrees) for 30 minutes. There was a previous temperature excursion from 15 Fahrenheit degrees to 46 Fahrenheit degrees (16.7 Fahrenheit degrees) for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees (23.3 Fahrenheit degrees) for 50 minutes, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 minutes, and 15 Fahrenheit degrees to 46 Fahrenheit degrees (25 Fahrenheit degrees) for 50 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This is one of two cases reported, received from the same reporter. Sender's Comments: US-009507513-1901USA010528: Same reporter Link.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal renal imaging abnormal, Prenatal screening test abnormal
Clinical narrative: This is a serious observational study case initially received from other health professional on 17-Jan-2019, concerning a 29-year-old adult female pregnant subject (center ID: 002) of body weight: 152.8 lbs, height: 65 inches and body mass index (BMI): 25.4, enrolled in V130_11OB, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had 3 previous pregnancies with two spontaneous abortions and one full term live birth. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. After first pregnancy, the subject had post-partum depression for two months (on an unspecified date) and the current condition included migraines (since an unspecified date). The subject's last menstrual period (LMP) date was 21-Aug-2018. The type of pregnancy was singleton. The subject's concomitant medication included Prenatal vitamins [minerals nos; vitamins nos] for pregnancy. On 20-Oct-2018, the cystic fibrosis mutation analysis and the blood work (PNBW) were performed and on an unspecified date, first trimester screening was performed, the results showed no congenital malformation. On 06-Nov-2018, at gestation age of 11 weeks (first trimester), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF41708, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded to vaccine exposure during pregnancy) for an unknown indication. On 07-Jan-2019, 2 months and 1 day after vaccination, the anatomic scan was performed, which showed hydronephrosis of right fetal kidney (abnormal). At the time of this report, the outcome of the event (prenatal screening test abnormal) was unknown. The estimated delivery date (EDD) was reported as 02-Jun-2019.; Reporter's Comments: A 29-year-old pregnant patient subject was administered Flu Vaccine Egg Split QIV CSL at gestation age of 11 weeks (first trimester) as part of observational safety study (coded to Exposure during pregnancy). Two months after vaccination the anatomic scan performed showed hydronephrosis of right fetal kidney. Despite plausible temporal relationship, there is no evidence for a biological mechanism that could cause the event and therefore the event of hydronephrosis of right fetal kidney was considered not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine.The company assessed the event (prenatal screening test abnormal) as serious (medically significant).
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Exposure during pregnancy, Subchorionic haematoma
Clinical narrative: This is an observational study case initially received from other health professional on 17-Jan-2019, concerning a 35-year-old adult female pregnant subject enrolled in a prospective observational safety study. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had 1 previous pregnancy which got spontaneous abortion. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medication included Prenatal vitamins [minerals nos; vitamins nos] for pregnancy. The subject's pregnancy complication (risk factor) included advanced maternal age. The subject's last menstrual period (LMP) was on 05-Sep-2018. The type of pregnancy was singleton. On 29-Oct-2018, the pre-natal tests, the ultrasound was performed, the results showed no congenital malformation. On 05-Nov-2018, at gestation age of 08 weeks (first trimester), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF41708, dose, route of administration, anatomical location and expiry date: not reported) (coded as vaccine exposure during pregnancy) for an unknown indication. On 12-Nov-2018, the blood work (PNBW) and cystic fibrosis mutation analysis were performed, the results showed no congenital malformation. On 26-Nov-2018, 21 days after vaccination, the subject developed subchorionic hematoma. On 10-Dec-2018, the subject had recovered from the event subchorionic hematoma. The estimated date of delivery was reported as 12-Jun-2019.; Reporter's Comments: A 35-year-old pregnant subject with history of previous spontaneous abortion experienced subchorionic hematoma, 21 days after receipt of study vaccine (considered as vaccine exposure during pregnancy). Despite plausible temporal association of the event subchorionic hematoma to vaccine administration, there is no evidence for a biological mechanism that could cause the event and other factors such as patient's age and an early stage of pregnancy (both increasing the risk) and pregnancy history of spontaneous abortion provide a more plausible explanation of the event. Hence, causality assessed as not related to study vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The sponsor assessed the events (subchorionic hematoma) as serious (medically significant).
Age: 1.08
Sex: M
Vaccine: YF
Symptoms: Rash pruritic
Clinical narrative: Mother states that patient has a itchy rash on the back of his hand although vaccine was administered in his thigh. Advised her to call the pediatrician for follow-up. We called the pediatrician and notified them of her concerns.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient reports continued muscle ache with movement and touching of shoulder. Reports pain is not constant and is very mild but has not subsided after almost 3 months.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Blood glucose normal, Dyspnoea, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: 09:15 AM Patient had a syncope episode immediately right after the vaccine was administered. Patient skin color looked pale and he took a while to catch his breath right after the syncope episode occurred. PA was notified and she examined the patient and after 22 minutes the patient was doing better and was released. T 98.4 F (tympanic) P 121 bpm (finger clip, sitting), O2 Sat: 97% (room air) Glucose Level: 75 Test done at 0942 mg/dl.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Culture, Erythema, Fungal test, Gram stain, Incisional drainage
Clinical narrative: Patient is a 47-year-old male who is seen in consultation for Dr. for evaluation of left arm injection site reaction. Patient states he had the influenza vaccination injection given on 10/3/18 in his proximal left upper extremity. Patient states about 2 weeks following the injection, he noticed a knot in the proximal left upper extremity. States he noticed the knot increase in size and become red and inflamed. States on 12/3/18, about 3 weeks ago, staff at Dr.'s office performed an I&D on the proximal left upper extremity lesion. States he packed it once a day for 6 days, and has been packing every other day since then. Patient reports that the wound is still draining purulent drainage. Reports that the area is tender to touch, and rates pain 3/10. States that he currently has the flu. States he has been on 2 rounds of antibiotics including BACTRIM and KEFLEX. I&D performed, cultures obtained, wet-to-dry dsg BID.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Inflammation, Influenza, Mycobacterium test, Nodule, Pain
Clinical narrative: Patient is a 47-year-old male who is seen in consultation for Dr. for evaluation of left arm injection site reaction. Patient states he had the influenza vaccination injection given on 10/3/18 in his proximal left upper extremity. Patient states about 2 weeks following the injection, he noticed a knot in the proximal left upper extremity. States he noticed the knot increase in size and become red and inflamed. States on 12/3/18, about 3 weeks ago, staff at Dr.'s office performed an I&D on the proximal left upper extremity lesion. States he packed it once a day for 6 days, and has been packing every other day since then. Patient reports that the wound is still draining purulent drainage. Reports that the area is tender to touch, and rates pain 3/10. States that he currently has the flu. States he has been on 2 rounds of antibiotics including BACTRIM and KEFLEX. I&D performed, cultures obtained, wet-to-dry dsg BID.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Purulent discharge, Tenderness, Wound
Clinical narrative: Patient is a 47-year-old male who is seen in consultation for Dr. for evaluation of left arm injection site reaction. Patient states he had the influenza vaccination injection given on 10/3/18 in his proximal left upper extremity. Patient states about 2 weeks following the injection, he noticed a knot in the proximal left upper extremity. States he noticed the knot increase in size and become red and inflamed. States on 12/3/18, about 3 weeks ago, staff at Dr.'s office performed an I&D on the proximal left upper extremity lesion. States he packed it once a day for 6 days, and has been packing every other day since then. Patient reports that the wound is still draining purulent drainage. Reports that the area is tender to touch, and rates pain 3/10. States that he currently has the flu. States he has been on 2 rounds of antibiotics including BACTRIM and KEFLEX. I&D performed, cultures obtained, wet-to-dry dsg BID.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Patient reports swollen arm and cellulitus that needed to be treated with antibiotics.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Fungal test, Gram stain, Incisional drainage, Mycobacterium test positive, Swelling
Clinical narrative: Patient reports receiving Hepatitis A injection in Rt. upper arm on 10/3/18. States swelling developed a month prior to coming to office. I&D performed, Cultures obtained, wet-to-dry dsg BID.
Age: 32.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called and stated back of Right arm at immunizations site was reddened and swollen-patient went to MD-received antibiotics, BENADRYL, MOTRIN - MD stated normal AR. reaction. No temperature.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Generalised erythema, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever of 101-102 degrees F started and lasted 5 days total. Head to toes redness started and lasted 5 days total. Patient out of school for fever for 3 days total 08/20/2018-08/22/2018.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a registered nurse refers to a 4 year old male patient with no illness at time of vaccination. The patient's concurrent conditions included autism and café au lait. Historical conditions and concomitant therapies were not reported. On 12-SEP-2018, the patient was vaccinated with the second dose of M-M-R II, subcutaneously in the left thigh, lot # R008196 (expiration date: 16-SEP-2019), for prophylaxis; and with the fifth (number of previous doses was reported as "4/3") of QUADRACEL lot # C532BA (expiration date was not provided), intramuscularly (IM) in the left thigh. Both vaccines were purchased with public funds. On unknown dates, the administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger, which occurred at the time of storage in clinical practice. No patient experiences were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002765: US-009507513-1809USA010598.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs were not provided. On 18-JAN-2019, two patients were vaccinated with improperly stored doses (also capture in case # 1901USA007807) of  VARIVAX Lot # R022116, expiration date 02-AUG-2020, subcutaneously (strength, dose, dose number, and anatomical location were not provided) for prophylaxis. The sterile Diluent used to reconstitute the VARIVAX was stored properly. The vaccines were exposed to a temperature of 15 Fahrenheit degrees to 46 Fahrenheit degrees (18.9 Fahrenheit degrees) for 30 minutes. There was a previous temperature excursion from 15 Fahrenheit degrees to 46 Fahrenheit degrees (16.7 Fahrenheit degrees) for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees (23.3 Fahrenheit degrees) for 50 minutes, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 minutes, and 15 Fahrenheit degrees to 46 Fahrenheit degrees (25 Fahrenheit degrees) for 50 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This is one of two cases reported, received from the same reporter. Sender's Comments: US-009507513-1901USA007807: Same reporter.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This is a serious observational study case initially received from other health professional on 17-Jan-2019, concerning a 33-year-old adult female pregnant subject of body weight: 169 lbs, height: 623 inches and body mass index (BMI): 29.9, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with AFLURIA QIV, a seasonal quadrivalent vaccine, during pregnancy. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject's obstetrical history included one ectopic pregnancy and two full term live birth. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medication included Prenatal vitamins [minerals nos; vitamins nos] for pregnancy. The subject's last menstrual period (LMP) date was reported as 16-Sep-2018. On 09-Nov-2018, the ultrasound prenatal test was performed, and the results showed no congenital malformation. On 20-Nov-2018, at 09 weeks of gestational age (first trimester), the subject was administered CSL AFLURIA QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On 20-Dec-2018, 1 month after vaccination, the patient had spontaneous abortion at 12.1 weeks of gestational age. At the time of this report, the outcome of the event (spontaneous abortion) was unknown. The estimated delivery date (EDD) was reported as 05-Jul-2019.; Reporter's Comments: A 33-year-old pregnant subject with medical history of one ectopic pregnancy experienced spontaneous abortion, one month after administration of AFLURIA QIV at 09 weeks of gestation (coded to Exposure during pregnancy). Despite the plausible temporal relationship between vaccination and reported event, there is no evidence for a biological mechanism that could cause the event and therefore the event was assessed as not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the event (spontaneous abortion) as serious (medically significant).
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site rash, Irritability
Clinical narrative: Patient seen in office 1/28/19. Started with fever on Saturday night. Runny nose since Saturday. Tmax to 101. Loose stools. Red spot appeared on leg on Saturday night. No significant cough. No other ill contacts. Slightly decreased appetite. Clingy. 2 cm erythematous rash on the upper left thigh. For the rash on the leg - Cool compress to the area (bag of frozen peas or corn works well). Topical hydrocortisone (1%) for redness and itching.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pruritus, Pyrexia, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Patient seen in office 1/28/19. Started with fever on Saturday night. Runny nose since Saturday. Tmax to 101. Loose stools. Red spot appeared on leg on Saturday night. No significant cough. No other ill contacts. Slightly decreased appetite. Clingy. 2 cm erythematous rash on the upper left thigh. For the rash on the leg - Cool compress to the area (bag of frozen peas or corn works well). Topical hydrocortisone (1%) for redness and itching.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called and stated back of right arm at immunization site was reddened and swollen. Told the patient to go see her primary MD. Primary MD gave her antibiotics, BENADRYL, and MOTRIN, the patient stated. The patient also stated that the MD said this is a normal adverse reaction. No increase in temperature. Called and checked on the patient at 16:00 PM and patient stated was better.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperventilation, Nausea, Oxygen saturation decreased
Clinical narrative: Dizziness, nausea, low oxygen from hyperventilating for 20 minutes solumedrol 125 mg administered im to right vastus lateralis patient was sent to er for observation and was released home on the same day.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on bilateral shoulders.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Limb injury, Ultrasound scan normal
Clinical narrative: She has been having pain in the left upper arm since the vaccines were given, tender to touch, no redness, no swelling, no fever, no difficulty moving the arm, no weakness in the arm. She does report several of her friends punched her in the arm several times after she received the vaccines.  Mom waited two weeks to come in as she hoped that it would resolve.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient describes as having continuous pain in her arm 2-3 times per week.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JAN-2019, the patient was vaccinated with one dose of improperly stored ROTATEQ lot # R016271, expiry date 25-MAY-2020, oral (dose number was not reported) for prophylaxis. The temperature excursion and time frame were not reported. There was no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 18 year old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 24-JAN-2019, the patient received first dose of adult formulation of VAQTA 50/0.1 u/ml, lot # R006341 with expiry date 21-APR-2019 for prophylaxis, instead of pediatric formulation of VAQTA. No adverse effects were reported. No product quality complaint was present.
Sex: U
Vaccine: PNC13
Symptoms: Incorrect route of product administration, Local reaction
Clinical narrative: This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a patient that: a patient of unspecified age  and gender received PREVNAR 13, subcutaneous on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was given the shot subcutaneous instead of intramuscular and had a local reaction on an unspecified date with outcome of unknown. The information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age received TRUMENBA; (Lot number and expiration date: Unknown), via an unspecified route of administration, in the left arm on Feb2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. Patient had first dose of TRUMENBA in Feb2018 and in her left arm she has a 2 x 2 cm knot that has been there since she received the vaccine; it is not red or tender unless really messed with. The outcome of the event was not recovered. Information on the lot number has been requested.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: 1/15 broke out in hives at night. Hives were all over body, mostly on back. Mother gave BENADRYL and used hydrocortisone cream. Hives have since resolved. No other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to left arm for 2 days per MD give BENADRYL, CLARITIN  for 2-3 days.
Age: 38.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Erythema, Swelling
Clinical narrative: SWELLING AND REDNESS GREATER THAN 30MM IN DIAMETER.
Age: 87.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Death, Hepatitis A
Clinical narrative: Vaccines provided on 01/24/2019 due to contact of acute hepatitis A. Patient died on 01/27/2019.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient notice soreness when went to bed on Sunday (01/27/2019) but no redness at area. Patient reported to pharmacy on Tuesday (01/29/2019) with redness and tenderness on right upper arm. Pharmacist recommended diphenhydramine and ibuprofen until patient could get in to see Physician. Pharmacist called Dr. office for patient and consulted with on call Physician who recommended patient come in to be evaluated on 01/29/2018. Patient agreed to go to Physician's office for evaluation.
Age: 80.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Computerised tomogram, Contusion, Dizziness, Eye contusion, Feeling abnormal
Clinical narrative: I started feeling bad, dizzy, headache immediately after the injections. After normal meal, I went to sleep about 10:00. I woke up about 4:30 AM on 01/03/2019 lying on floor, with my left eye, forehead and eyebrow all bruised. I was lying on the floor, opposite direction of my bed pillow.
Age: 80.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Haematology test, Headache, Immediate post-injection reaction, Laboratory test, Scan brain
Clinical narrative: I started feeling bad, dizzy, headache immediately after the injections. After normal meal, I went to sleep about 10:00. I woke up about 4:30 AM on 01/03/2019 lying on floor, with my left eye, forehead and eyebrow all bruised. I was lying on the floor, opposite direction of my bed pillow.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Feeding disorder, Feeling abnormal, Influenza, Malaise
Clinical narrative: Rash started 2 days after flu shot, face and chest, moved to hands and arms--peeling itching hot red rash, moved to entire body--back chest legs. 10/29/18 to clinic for salve for itch and med to sleep. No relief. 01/7/2019 flu symptoms, could not eat, feeling sick, 01/10/19 right eye swollen shut in am followed the next day with second and face swollen. 10/11/19 at clinic, pictures of face taken, she consulted with allergist, prednisone regime and antibiotics and home. Very, very ill, could not think straight. Better after 2 weeks of meds. I had not felt like myself since the flu shot on 10/02/18. This was my time of stronger dose. Good now.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Mental impairment, Rash erythematous, Rash generalised, Rash pruritic, Skin exfoliation
Clinical narrative: Rash started 2 days after flu shot, face and chest, moved to hands and arms--peeling itching hot red rash, moved to entire body--back chest legs. 10/29/18 to clinic for salve for itch and med to sleep. No relief. 01/7/2019 flu symptoms, could not eat, feeling sick, 01/10/19 right eye swollen shut in am followed the next day with second and face swollen. 10/11/19 at clinic, pictures of face taken, she consulted with allergist, prednisone regime and antibiotics and home. Very, very ill, could not think straight. Better after 2 weeks of meds. I had not felt like myself since the flu shot on 10/02/18. This was my time of stronger dose. Good now.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Swelling face, Swelling of eyelid
Clinical narrative: Rash started 2 days after flu shot, face and chest, moved to hands and arms--peeling itching hot red rash, moved to entire body--back chest legs. 10/29/18 to clinic for salve for itch and med to sleep. No relief. 01/7/2019 flu symptoms, could not eat, feeling sick, 01/10/19 right eye swollen shut in am followed the next day with second and face swollen. 10/11/19 at clinic, pictures of face taken, she consulted with allergist, prednisone regime and antibiotics and home. Very, very ill, could not think straight. Better after 2 weeks of meds. I had not felt like myself since the flu shot on 10/02/18. This was my time of stronger dose. Good now.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Patient experienced pain to the injection site, cool items relieved pain. By 1/24/2019 patient said she was 50% better.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Influenza vaccine given 1 month earlier than recommended time. NO localized reaction, No fever or other adverse reaction noted after giving the vaccine as verbalized by father during a telephone interview on 1/18/2019. Father verbalizes understanding of the incident and recommended to follow-up with any question or concerns. (Interview done by RN, MSN, Nurse Manager). Reported to VAERS as per protocol.
Sex: F
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 16-month-old female patient received the fourth dose of PREVNAR 13 at single dose for immunization on unknown date. The patient had received three doses of the same vaccine on unknown dates. The patient had a medical history of recurrent respiratory infections under immunology w/u has low IgA not needing therapy. Concomitant medications were not reported. On unknown date the patient experienced antibody test abnormal. The patient is now on preventive 3 times a week Azithromycin.
Sex: M
Vaccine: PNC13
Symptoms: Blood immunoglobulin G decreased, Ear infection, Inappropriate schedule of product administration
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received the first dose of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) (Lot. R19477, Expiration date: 31Jan2018) on 09Dec2016, at single dose, for immunization. The patient's second dose (Lot. R41774, Expiration date: 30Apr2018) was received on 20Feb2017; the third dose (Lot. R49357, Expiration date: 31May2018) was received on 21Apr2017 and the fourth dose (Lot. T08483, Expiration date: 30Sep2019) was received on 27Oct2017; all at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient had ear infections and his IgG levels were low. Inappropriate schedule of vaccine was reported. Clinical outcome of the adverse events was unknown at time of this report. Pfizer is Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)has submitted the same report to the regulatory authorities.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Injection site got hot and swollen, w/red ring around 3 inch swelling. Swelling continued until entire arm was 2 inch larger in diameter than right arm. Redness moved down arm to elbow and around arm to armpit. Unable to raise or use arm for 2 days. Pain and tenderness continued for 5 days. Lower limb tingled w/slight swelling for 12 hrs. Patient took 1 ADVIL 3x/day beginning at 6p on 1-15-19 until 12pm on 1-19-19. Symptoms ended o n1-19-19. Itching began on 1-16-19 and continued until 1-19-19.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Injection site got hot and swollen, w/red ring around 3 inch swelling. Swelling continued until entire arm was 2 inch larger in diameter than right arm. Redness moved down arm to elbow and around arm to armpit. Unable to raise or use arm for 2 days. Pain and tenderness continued for 5 days. Lower limb tingled w/slight swelling for 12 hrs. Patient took 1 ADVIL 3x/day beginning at 6p on 1-15-19 until 12pm on 1-19-19. Symptoms ended o n1-19-19. Itching began on 1-16-19 and continued until 1-19-19.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Computerised tomogram, Cough, Hypoxia, Impaired work ability
Clinical narrative: Began with a cough, gradually became so debilitating that I called out of work for 3 wks, saw my doctor 3x in that time span, the last time Nov. 16, 2018. She sent me to the hospital for hypoxia. I was hospitalized for 5 days - could not return to work until 7 wks later. Addendum - beside time away from work, this hospital stay cost me over $600 secondary to my insurance. How do I get compensation for this fee?
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, X-ray
Clinical narrative: Began with a cough, gradually became so debilitating that I called out of work for 3 wks, saw my doctor 3x in that time span, the last time Nov. 16, 2018. She sent me to the hospital for hypoxia. I was hospitalized for 5 days - could not return to work until 7 wks later. Addendum - beside time away from work, this hospital stay cost me over $600 secondary to my insurance. How do I get compensation for this fee?
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Glassy eyes, Seizure, Vomiting
Clinical narrative: Patient went to the ER after getting a flu injection. Patient was in for a flu shot at 10:00 on Oct 9th. Patient was taken to Medical Center by ambulance. Patient's spouse reported at ER that at 15:30 on Oct 9, that the patient was sitting on the couch when she went to the bathroom and had an episode of emesis. When she returned to the couch, she was "glassy-eyed" and soon began seizing. Her arms were convulsing and she was "breathing hard". This lasted for 30 seconds and then the patient spouse call 911.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Drooling, Hemiparesis, Pyrexia, Seizure, Tremor
Clinical narrative: Patient woke up at 12:30am with fever 101.9 then had seizure, shaking all over with drooling. Lasted 1 minute. Parent gave TYLENOL and called 911. Medic came and cleared her. She was leaning to left side and had left side weakness for a hour after episode. Patient woke up normal the next day. Advised parents to make a f/u with her neurologist.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This is the second dose and the adverse reactions duplicated the first back in October 2018.  Several hours afterward, I start to feel achy, then within an hour or two after that, I am fevered, chilled, achy all over. It lasts a day and a half. Fever usually breaks then comes back the evening of the next day, and residual headache and body ache continues for the 2nd day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Pain
Clinical narrative: 2nd Shingles shot. When I woke up the next morning, I felt like I had come down with the Flu. Every joint ached, 8 on a 1-10 scale. Even laying still in bed was painful. I bathed in 100+ degree tub and felt a little better. I also took ADVIL, Tramadol 50mg and Chlorzoxazone 500mg. Went back to bed for a couple of hours and pain level down to a 3.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Patient experienced peripheral edema with warmth and pain approximately 9 hours following vaccination. Patient was seen at urgent care and prescribed ibuprofen 800 mg by mouth three times a day. The following day, patient reported that edema had spread further down her arm with increased redness. She saw her primary care provider who initiated cephalexin 250 mg every 6 hours for 10 days.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypersomnia, Pyrexia, Vomiting
Clinical narrative: Starting 24 hours after receiving vaccines, patient developed a fever and then slept 18 hours, waking up only to vomit twice during that time. Fever resolved afterwards.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Chills, muscle aches, fatigue.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reported pain in arm after injection on 10/2/18. Pain continued, went to physician on 10/31/2018. Physician prescribed medications and physical therapy. Patient has been reports receiving treatment since.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Aching muscles, severe shivers and teeth chattering, temp 100.7, headache (8/10; 10 worst), next day fever between 99 and 100, loose stools, nausea, slight headache. All symptoms improved over 2nd day and were minimal by 3rd day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Aching muscles, severe shivers and teeth chattering, temp 100.7, headache (8/10; 10 worst), next day fever between 99 and 100, loose stools, nausea, slight headache. All symptoms improved over 2nd day and were minimal by 3rd day.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Infection, Urticaria
Clinical narrative: Pt has red welt on right arm, extending just above where vaccine was given, extending to just above elbow region. Patient states she went to doctor's office on 1/29/19, doctor took one look at arm from across room and said, "Your arm is infected." Dr. lined borders with Sharpie and told patient to monitor for 24 to 48 hours and if welt exceeded borders, to proceed to er for iv antibiotics.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Muscular weakness, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: I got my flu shot on October 1, 2018. My arm is in constant pain. I thought the pain would go away in a couple of days but it hasn't. I can move my arm but I have to be very careful with it. I feel like I have lost all strength in that arm. It hurts to put my bra on, it hurts to take off my blouse or any top clothing. I'm constantly rubbing my arm. At night I have the worse pain at night. I can't sleep. I tried using liniment that made the pain worse had me up most of the night.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Presents w/redness and increased warmth over (L) upper thigh 2 days after receiving routine vaccination. No fevers, systemic symptoms. Diagnosed cellulitis, treated with IM ceftriaxone at mom's request for IM vs PO meds. F/U 2-3 day if not improved.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Urticaria
Clinical narrative: Patient fainted and had hives all over chest and both arms. Gave BENADRYL.
Age: 50.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Shoulders, left breast, left pec on back down my arm and tingling in finger. Very bad pain in shoulder and whole arm. Shot given in left arm.
Sex: U
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves an unknown patient who ended up in the hospital after receiving the vaccine, FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient was hospitalized for an unknown reason. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hospitalization. List of documents held by sender: none.; Sender's Comments: Patient was hospitalized for unknown reason after vaccination. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, reason for hospitalization,  laboratory investigations excluding any underlying etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Vaccine received 1/22/2019.  Pt experienced 3 days of expected injection site soreness followed by 3 days of normalcy (no reaction). On 6th day pt noticed redness, warmth and swelling below the injection site equal to a spot the size of the palm of her hand. Doctor was notified. Pt was instructed to watch the site for increase of symptoms and to use cold packs and/or analgesics.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Difficulty in range of motion and severe soreness in R arm after getting PNEUMOVAX 23 yesterday. Deltoid area swollen, red last night. Hot to touch. Advised pt this can sometimes occur with the vaccine. Advise icing the area to reduce inflammation. Ibuprofen as needed for pain. If it doesn't continue to get better, please have pt contact us and schedule an appt to be seen.