chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Dark circles under eyes, Defiant behaviour, Diarrhoea, Erythema, Fatigue
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Feeling abnormal, Gait disturbance, Hallucination, Impulsive behaviour, Influenza like illness
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Irritability, Lethargy, Loss of personal independence in daily activities, Lymphadenopathy, Malaise
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Mobility decreased, Muscular weakness, Neck pain, Oropharyngeal pain, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Pain, Pyrexia, Rhinorrhoea, Screaming, Skin warm
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Stereotypy, Tenderness, Urinary incontinence, Urine analysis, Viral infection
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Weight bearing difficulty, X-ray limb
Clinical narrative: Child experienced urinary and bowel incontinence with loose stools one day following MMR, varicella and flu vaccines. Sent home from school. Child also experiences sore throat, aches, fatigue, fluctuating low grade fever, cough, red cheeks for 3-4 weeks. Child was simply not well from 11/9/16 through 4/23/17, with numerous flu-like symptoms and an inability to overcome them. Child woke on 4/23/17 with urinary incontinence. Complained of extreme fatigue after waking. Went right back to bed, slept for two hours and awoke screaming in excruciating pain. Stated his knees hurt, legs were weak, back of his neck hurt and had a hard time sitting up independently from a lying position. Child could not bear weight on legs. Would not let anyone touch them. Fever 101.8 after 6 mL ibuprofen. Visibly huge swollen lymph nodes in sides of neck, red cheeks, legs and knees extremely hot to touch. Child taken to ER, diagnosed with virus (unspecified) and given ibuprofen. Child able to wobble few steps with help of dr and mom. Child returned home. Child did not urinate for 14 hours, despite drinking fluids. Returned to ER on 4/24/17. Child had fever despite ibuprofen, swollen lymph nodes in neck, severe knee pain, unable to bear weight or walk, neck pain subsided by second day. Child also had dark urine, sensory hallucinations on tongue  felt like there was a hair on tongue, although we checked numerous times and it did not exist, performed constant odd repetitive hand-to-mouth movements stating he could not stop sticking fist in mouth, lethargic, dark eyes, spaced-out. Child placed on IV fluids and anti-inflammatory meds overnight. Child fever broke 4/15/17 and was able to walk. Child was discharged home but has not been the same since episode. Steady runny nose, extreme impulsivity, extreme defiance (never experienced before), irritability, occasional daytime loss of bladder and bowel, aggression and lingering cough to date. Just not back to normal self. On 5/22/17, along with older sister who was vaccinated at same time/day/place and is experiencing bizarre symptoms (separate report), child diagnosed with PANDAS/PANS due to vaccine injury triggering autoimmune response that is attacking the brain.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: She went to her personal physician and has shingles across the right side of her abdomen.
Age: 67.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Herpes zoster, Sunburn
Clinical narrative: 5/22 PATIENT RECIVED ZOSTAVAX VACCINE. 5/23 PATIENT RECIEVED RX FOR ACYCLOVIR 800MG 5XD FOR 10 DAYS FROM URGENT CARE DIAGNOSIS SHINGLES RASH ON THE STOMACH. THE PATIENT STATED THAT ON 5/22 BEFORE RECEIVING THE ZOSTAVAX VACCINE HE HAD WHAT HE DESCRIBED AS A SUNBURN ON HIS STOMACH. HE STATED HE DID NOT THINK ANYTHING OF IT AT THE TIME AND DID NOT MENTION IT TO US BEFORE RECEIVING THE VACCINE. THERE WAS NO LOCALIZED REACTION AT THE INJECTION SITE.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle disorder
Clinical narrative: Pt states shoulder/muscle issue that has persisted since administration on 12/20/2016.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Pt states shoulder/muscle issue that has persisted since administration on 12/20/2016.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Speech disorder, Trismus
Clinical narrative: Mild lock jaw. Difficulty speaking.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid oedema
Clinical narrative: Patient had extreme swelling of eyelids.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye infection bacterial, Eye swelling, Eyelid oedema
Clinical narrative: Patient had extreme swelling of eyelids.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Patient woke up with 101 degree fever and severe headache, did not take anything for it  and at the office visit at 11 am, temp was 98.6 but still had the headache.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: None reported.
Sex: U
Vaccine: UNK
Symptoms: Axillary pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: (R) arm pain swelling, axillary.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection
Clinical narrative: Injection site infection 5/13/17 patient came back to store with a prescription for BACTRIM DS due to injection site infection from PREVNAR 13 on 5/6/17. KEFLEX from PCP and shot of antibiotic still under MD care.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Flushing
Clinical narrative: Patient got lightheaded and flushed 5 minutes after receiving injections. Had patient lay down with feet propped for 15 minutes.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had 15 month vaccines on 5/10/17. Mom noticed redness on his thigh where he got the Hep A. The site was swollen, warm to the touch and the size of baseball.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine site red, swollen, hard, and hot to the touch. Received shot on Tuesday and reaction started Wednesday morning. Redness spread all day Wednesday. Treat with MOTRIN and warm compresses.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of two different lot # of VARIVAX: lot # M041513 and expiration date 11-OCT-2017 and/or lot # M045204 and expiration date 11-NOV-2017 (dose and route of administration were not provided) for prophylaxis. In addition, all vaccines were reconstituted with properly stored sterile diluent(DILUENT MRK).  The patients' concomitant therapies were not reported. On an unspecified date, the data logger registered a temperature ranges between 6° Fahrenheit (F) and 14°F during a time frame of 2 hours 15 minutes with no previous temperature excursion. Adverse effects were not reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA007841:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, frequency, lot/batch # and expiration date were not reported). On approximately May 2016, reported as "about a year ago", the patient experienced "at the injection site, vesicles (injection site vesicles) indicative of shingles (herpes zoster) that would come and go and come and go for quite some time" (unspecified dates).  The outcome of injection site vesicles and herpes zoster was unknown.   The causality between injection site vesicles and herpes zoster with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: This spontaneous report has been received from a physician via a company representative, referring to an unknown number of patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with ROTATEQ (strength, dose, lot # and expiration date were not reported) by oral route for prevention of rotavirus gastroenteritis. The physician reported that on unknown dates, the patients sought medical attention and were admitted to a hospital for an unknown number of days for treatment of rotavirus after the patients received ROTATEQ. It was unknown if laboratory diagnostic studies were performed. No further adverse event's information was available to report. The outcome and the causal assessment for the gastroenteritis caused by rotavirus with the suspect therapy were not reported. Upon internal review, the gastroenteritis caused by rotavirus was considered as a medically significant event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 18-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L032402 (expiration date: 26-NOV-2016), subdermally (dose, frequency and anatomical location were unspecified) for prophylaxis. No adverse effects were repored. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant concerning a two unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-MAY-2017, the patients were vaccinated with expired doses of VARIVAX (expiration date of 06-MAY-2017; strength, dose, route, anatomical location and lot number were not provided), for prophylaxis, which were diluted with sterile diluent (manufacturer unknown). No adverse effects were reported.  Additional information is not expected because there was no consent to contact the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a non-pregnant female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 22-MAY-2017, the patient was inadvertently administered intramuscularly rather than subcutaneously with a dose of ZOSTAVAX lot # M040144, with expiration date 26-DEC-2017, for vaccination (dose was not reported). The patient stated that the ZOSTAVAX "stung just a little bit" upon administration (injection site pruritus). No treatment was provided for the adverse event. At the time of reporting the outcome of the event was unknown. A product quality complaint was not involved. The causality assessment between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events no signs or symptoms of reaction after patient given adult dose of Hepatitis B
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events, no signs or symptoms of reaction after patient given adult dose of Hepatitis B.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB, MNQ, TDAP
Symptoms: Rash erythematous
Clinical narrative: Rash on face, localized to chin. Denies pain or other adverse effects. Rash is raised and slightly red. Advised to give BENADRYL PRN itching.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: A 0.5 cm in distal erythematous lump on Rt. (R) thigh.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient received Pneumovax-23 at PCP appointment on 5/22/17 at approximately 9am. Patient arrived to urgent care on 5/23/17 at approximately 6:52pm with complaints of left arm redness, warmth, swelling, and tenderness in the arm which was injected with the vaccine.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Local swelling, Nausea, Pyrexia, Tachycardia
Clinical narrative: 5 hours after Meningococcal vaccine, nausea, headache, fever, with localized swelling, "mild tachycardia". Pt called 911 went to ER given TYLENOL, ZOFREN and fluids. Feeling better today, vitals stable today. No swelling at INJ site.
Age: 17.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: 5-8-7 Pt came to immunization clinic for 3rd Rabies vaccination 5/4. Review of prior vaccination (Rabies #2) pt states that 2 days after vaccination she noticed hives on her stomach that itched. Pt stated she had been outside that day and was very hot and thinks that's where hives came from. After giving 3rd rabies vaccine, pt was instructed to wait at least 15 min to be monitored. At about 15 min mark, pt said she was itchy on arms and back. Inspection of back revealed no redness or bumps. Pt given 50mg liquid BENADRYL PO and monitored. Pt monitored for approx 30 min afterwards, and itching gradually decreased and itching ceased. Pts boss was contacted (she was going to work) and told of situation. After approx 45 min after getting vaccine, pt stated she felt fine and wanted to go to work. Pt instructed to call back tomorrow for update. Any swelling of throat or itching of tongue or lips, to ER. Called pt on 5-8-17, no answer. Pt called again 5-8-17, no answer.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest discomfort, Dizziness, Dysgeusia, Dyspnoea
Clinical narrative: Adverse events typed on 05/03/17 at 4:00 PM. Wednesday, May 3, 2017, approximately 3:15 PM: PNEUMOVAX 23 INJ 25 MCG/0.5 ML PF SYR IM left deltoid. The same pharmacist, who administered (adm.) the above PNEUMOVAX, also adm. PREVNAR 13 on 10/19/2016. No adverse effects. PREVNAR and PNEUMOVAX were each adm. once in my lifetime. Within seconds, after receiving the PNEUMOVAX, immediately felt the following: Sensation of tasting the drug, mouth watering; nausea, felt like I'd vomit, but didn't; faint, weak; facial tingling/prickling radiating down body; ears plugged, sound muffled and far away; walked short distance to Ladies Room (LR) feeling unsteady, dizzy; in LR: nonstop, rapid/deep/painful muscle twitching/spasms to right lateral back radiating down to mid-lower back, then to both upper front thighs where they meet the pelvic area. For comfort, bent at waist, pressed lower back against wall. Painful/difficult to ambulate; simultaneously, chest/throat tightness, some difficulty breathing, but able to talk with some difficulty; Sat down, bent at waist, head close to lap, symptoms slowly began to resolve. Extreme thirst, drank 16 ounces cold water without problems; Within 35 minutes symptoms resolved, continued to feel weak. Able to ambulate safely, went home - about 5 minute drive. Pharmacy staff too busy to closely monitor. Felt like I was going to die. Never felt symptoms like this before. Several times, came close to calling 911. In the future I will never go to a pharmacy for an immunization. At home checked vital signs: 112/73, 75 at 16:00; 115/71, 82 at 1645, within baseline. Remained fatigue throughout next day. Injection site: erythema, edema, warmth, soreness. Soreness radiated up to shoulder, not able to lift arm. Resolved in 4 -5 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Ear congestion, Fatigue, Feeling abnormal, Gait disturbance, Hypoacusis
Clinical narrative: Adverse events typed on 05/03/17 at 4:00 PM. Wednesday, May 3, 2017, approximately 3:15 PM: PNEUMOVAX 23 INJ 25 MCG/0.5 ML PF SYR IM left deltoid. The same pharmacist, who administered (adm.) the above PNEUMOVAX, also adm. PREVNAR 13 on 10/19/2016. No adverse effects. PREVNAR and PNEUMOVAX were each adm. once in my lifetime. Within seconds, after receiving the PNEUMOVAX, immediately felt the following: Sensation of tasting the drug, mouth watering; nausea, felt like I'd vomit, but didn't; faint, weak; facial tingling/prickling radiating down body; ears plugged, sound muffled and far away; walked short distance to Ladies Room (LR) feeling unsteady, dizzy; in LR: nonstop, rapid/deep/painful muscle twitching/spasms to right lateral back radiating down to mid-lower back, then to both upper front thighs where they meet the pelvic area. For comfort, bent at waist, pressed lower back against wall. Painful/difficult to ambulate; simultaneously, chest/throat tightness, some difficulty breathing, but able to talk with some difficulty; Sat down, bent at waist, head close to lap, symptoms slowly began to resolve. Extreme thirst, drank 16 ounces cold water without problems; Within 35 minutes symptoms resolved, continued to feel weak. Able to ambulate safely, went home - about 5 minute drive. Pharmacy staff too busy to closely monitor. Felt like I was going to die. Never felt symptoms like this before. Several times, came close to calling 911. In the future I will never go to a pharmacy for an immunization. At home checked vital signs: 112/73, 75 at 16:00; 115/71, 82 at 1645, within baseline. Remained fatigue throughout next day. Injection site: erythema, edema, warmth, soreness. Soreness radiated up to shoulder, not able to lift arm. Resolved in 4 -5 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Adverse events typed on 05/03/17 at 4:00 PM. Wednesday, May 3, 2017, approximately 3:15 PM: PNEUMOVAX 23 INJ 25 MCG/0.5 ML PF SYR IM left deltoid. The same pharmacist, who administered (adm.) the above PNEUMOVAX, also adm. PREVNAR 13 on 10/19/2016. No adverse effects. PREVNAR and PNEUMOVAX were each adm. once in my lifetime. Within seconds, after receiving the PNEUMOVAX, immediately felt the following: Sensation of tasting the drug, mouth watering; nausea, felt like I'd vomit, but didn't; faint, weak; facial tingling/prickling radiating down body; ears plugged, sound muffled and far away; walked short distance to Ladies Room (LR) feeling unsteady, dizzy; in LR: nonstop, rapid/deep/painful muscle twitching/spasms to right lateral back radiating down to mid-lower back, then to both upper front thighs where they meet the pelvic area. For comfort, bent at waist, pressed lower back against wall. Painful/difficult to ambulate; simultaneously, chest/throat tightness, some difficulty breathing, but able to talk with some difficulty; Sat down, bent at waist, head close to lap, symptoms slowly began to resolve. Extreme thirst, drank 16 ounces cold water without problems; Within 35 minutes symptoms resolved, continued to feel weak. Able to ambulate safely, went home - about 5 minute drive. Pharmacy staff too busy to closely monitor. Felt like I was going to die. Never felt symptoms like this before. Several times, came close to calling 911. In the future I will never go to a pharmacy for an immunization. At home checked vital signs: 112/73, 75 at 16:00; 115/71, 82 at 1645, within baseline. Remained fatigue throughout next day. Injection site: erythema, edema, warmth, soreness. Soreness radiated up to shoulder, not able to lift arm. Resolved in 4 -5 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Nausea, Pain
Clinical narrative: Adverse events typed on 05/03/17 at 4:00 PM. Wednesday, May 3, 2017, approximately 3:15 PM: PNEUMOVAX 23 INJ 25 MCG/0.5 ML PF SYR IM left deltoid. The same pharmacist, who administered (adm.) the above PNEUMOVAX, also adm. PREVNAR 13 on 10/19/2016. No adverse effects. PREVNAR and PNEUMOVAX were each adm. once in my lifetime. Within seconds, after receiving the PNEUMOVAX, immediately felt the following: Sensation of tasting the drug, mouth watering; nausea, felt like I'd vomit, but didn't; faint, weak; facial tingling/prickling radiating down body; ears plugged, sound muffled and far away; walked short distance to Ladies Room (LR) feeling unsteady, dizzy; in LR: nonstop, rapid/deep/painful muscle twitching/spasms to right lateral back radiating down to mid-lower back, then to both upper front thighs where they meet the pelvic area. For comfort, bent at waist, pressed lower back against wall. Painful/difficult to ambulate; simultaneously, chest/throat tightness, some difficulty breathing, but able to talk with some difficulty; Sat down, bent at waist, head close to lap, symptoms slowly began to resolve. Extreme thirst, drank 16 ounces cold water without problems; Within 35 minutes symptoms resolved, continued to feel weak. Able to ambulate safely, went home - about 5 minute drive. Pharmacy staff too busy to closely monitor. Felt like I was going to die. Never felt symptoms like this before. Several times, came close to calling 911. In the future I will never go to a pharmacy for an immunization. At home checked vital signs: 112/73, 75 at 16:00; 115/71, 82 at 1645, within baseline. Remained fatigue throughout next day. Injection site: erythema, edema, warmth, soreness. Soreness radiated up to shoulder, not able to lift arm. Resolved in 4 -5 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Salivary hypersecretion, Syncope, Thirst, Throat tightness
Clinical narrative: Adverse events typed on 05/03/17 at 4:00 PM. Wednesday, May 3, 2017, approximately 3:15 PM: PNEUMOVAX 23 INJ 25 MCG/0.5 ML PF SYR IM left deltoid. The same pharmacist, who administered (adm.) the above PNEUMOVAX, also adm. PREVNAR 13 on 10/19/2016. No adverse effects. PREVNAR and PNEUMOVAX were each adm. once in my lifetime. Within seconds, after receiving the PNEUMOVAX, immediately felt the following: Sensation of tasting the drug, mouth watering; nausea, felt like I'd vomit, but didn't; faint, weak; facial tingling/prickling radiating down body; ears plugged, sound muffled and far away; walked short distance to Ladies Room (LR) feeling unsteady, dizzy; in LR: nonstop, rapid/deep/painful muscle twitching/spasms to right lateral back radiating down to mid-lower back, then to both upper front thighs where they meet the pelvic area. For comfort, bent at waist, pressed lower back against wall. Painful/difficult to ambulate; simultaneously, chest/throat tightness, some difficulty breathing, but able to talk with some difficulty; Sat down, bent at waist, head close to lap, symptoms slowly began to resolve. Extreme thirst, drank 16 ounces cold water without problems; Within 35 minutes symptoms resolved, continued to feel weak. Able to ambulate safely, went home - about 5 minute drive. Pharmacy staff too busy to closely monitor. Felt like I was going to die. Never felt symptoms like this before. Several times, came close to calling 911. In the future I will never go to a pharmacy for an immunization. At home checked vital signs: 112/73, 75 at 16:00; 115/71, 82 at 1645, within baseline. Remained fatigue throughout next day. Injection site: erythema, edema, warmth, soreness. Soreness radiated up to shoulder, not able to lift arm. Resolved in 4 -5 days.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: In late 2010 I found I had some severe injuries in my left shoulder, upper arm areas. I hadn't been in an accident and we never knew what caused the injuries. I did respond well to Physical Therapy and cortisone shots and only felt a twinge now and again. In late 2014 the same set of injuries occurred in the right shoulder areas and, again, there was not an obvious cause. Treatment was Physical Therapy and cortisone shots and I experienced some stiffness and twinges but by mid 2016 there was no painful evidence at all of either of those two injuries. On November 14, 2016 I had an appointment with my Primary Care Physician. She recommended that I receive the flu and pneumonia shots, which I had never had before. I have had severe pain issues in both shoulders and up and down through the mid arm muscle areas and outer elbow pain ever since those shots. These effects did not decrease appreciably and I had an appointment with Dr. on January 14, 2017 and she ordered repeat X-rays and referred me to an osteo physician. Again I had the osteo cortisone shots this time with lidocaine. This helped for a short period of time but I was referred to a pain Doctor too. I saw the pain Doctor on February 20, 2017 and he prescribed Physical Therapy and a return visit to his office in three month's time. I saw his NP yesterday, May 15th, and, since the pains were again re-invasive I received the osteo cortisone with lidocaine shots in both shoulders again. I hope they do better this time!!! I am sending this information to FDA because I have heard from Physical Therapists about three other people who seem to have this problem right after taking the flu and pneumonia shots just in this past year. I am a retired Medical Technologist and my mind goes along the lines of "This pain from the past return after the vaccinations could be coincidence, but if there is a medical problem that might be connected with that recent procedure it should be reported and tracked."
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Red band (rectangle), hot to touch and somewhat swollen, sore, lasted a week getting better each day. Pt stated started to happen the day after vaccine administered.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Patient got a rash from at the injection site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: Intensity her nerve pain per patient and possible suspected Guillain-Barre Syndrome. Per her P.C.P. (according to the patient).
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain and weakness left arm from elbow entire arm to shoulder, no redness in the area of inj. treatment-heat, ADVIL and rest.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pruritus, Syncope
Clinical narrative: PNEUMOVAX 23 give at 1030Am on 03-29-17. Patient reported itching at about 11:20 AM and her Rt upper arm started swelling. She went to urgent care at 5pm that day while at urgent care had a syncope like episode. Given a steroid injection. BENADRYL, pain meds. Put ice pack on injection site. Discharged at 930pm that night.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Electroencephalogram, Laboratory test normal, Syncope
Clinical narrative: Syncopal event, possible seizure activity.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Large red welt to R deltoid where 1/2 of the dose was given. Warm to the touch. Welt approximately diameter of golf ball. Instructed to take BENADRYL. Provider advised steroids by mouth; and antihistamine. Advised pt. apply ice to area. Advised urgent care if needed.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Patient came in weeks later just to let us know he broke out in rash all over body the next day. He went to his Dr's and was treated for rash.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity
Clinical narrative: (L) arm redness and pain. Raised erythematous area in injection sie on 04-27-2017 day after PNEUMOVAX received. Denies itching, local swelling, throat closure, rash nausea, vomiting, sweats, lethargy. Patient given oral BENADRYL and dexamethasone in urgent care and discharged home with instructions.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pruritic hive rash on left side of neck and wrist.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pain at injection site - 48 hours. Mild fever, fatigue, headache, chills, muscle pain - 72 hours. Rest and ibuprofen for severe headache.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Pain at injection site - 48 hours. Mild fever, fatigue, headache, chills, muscle pain - 72 hours. Rest and ibuprofen for severe headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Nausea, Skin abrasion
Clinical narrative: Single 0.65 ml dose of SQ ZOSTAVAX given in (L) arm. Vaccine completed, patient reported feeling nauseated and dizzy. Provider had patient remain seated with daughter. Daughter left to get cold drink, patient fell down to floor. Provider roused patient to consciousness, had pt. remain lying down, 911 called. Minor abrasions bandaged, pulse taken.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) shoulder site of DTaP/IPV vaccine, became red, warm, and swollen. Pt. was seen 2 days later and I recommended BENADRYL, and MOTRIN or TYLENOL as needed. Asked to return to office for increased redness, increased pain, or fever.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Mother noticed a red, swollen whelp on both of the inside of thighs within 2-3 hours after receiving vaccines. They were 3x4 in. mother gave her a cool bath and ran to the store for BENADRYL. By the time she was home and received BENADRYL redness, swelling were gone.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: Soreness in (L) arm since vaccine on 5/17/17; increase in pain, swelling, warmth since 0200 AM on 5/19/17.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: 2/16/17 Employee at hospital contacted "will not hurt her, mother notified of s/s to watch patient for - verbalized understanding. 2-27-17 Mother stated patient had fevers (103 F) day 8, day 9, and day 10 after immunization, then temp's went to 94 F. (Previously had rxn to DTaP May 2015.)
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Hives appeared after approximately 2 days after vaccination. Still having them - possibly - chickenpox.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Visual swelling, pain and tenderness warm to touch.
Age: 73.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Right deltoid inflamed, swollen 9cm's x 15 cm's - redness, tender.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Induration, Peripheral swelling
Clinical narrative: Left arm became swollen under (towards hand) the injection site in an oblong shape, about size of golf ball. Two areas below swollen area were noted to be hard to palpation. Treatment included warm compresses, TYLENOL by mouth, and elevation of limb while lying down. Swelling has since subsided.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Lethargy
Clinical narrative: Patient lethargic following vaccine for almost 24 hours.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm red, swollen 2 days after vaccination of KINRIX and MMRV.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Left upper arm - Slight erythema w/some inner area,  1-2cm erythematous area no prox streaking.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: No adverse reactions reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site inflammation, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient complained of nausea and vomiting; swelling, pain, and inflammation at injection site, and headache.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient complained of nausea and vomiting; swelling, pain, and inflammation at injection site, and headache.
Age: 58.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Anhedonia, Anxiety, Confusional state, Hallucination, auditory, Irritability
Clinical narrative: Auditory hallucinations, paranoid, anhedonia, confusion, panic attacks, thoughts of suicide, anxiety irritability, enhanced sensory perceptions.
Age: 58.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Panic attack, Paranoia, Sensory disturbance, Suicidal ideation
Clinical narrative: Auditory hallucinations, paranoid, anhedonia, confusion, panic attacks, thoughts of suicide, anxiety irritability, enhanced sensory perceptions.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized swelling, redness, and pain at injection site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Vomiting and Diarrhea (mild dehydration).