chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Hive noted on 2/11/18 which spread to abdomen and thighs, off and on for about 7 days and resolved without any specific treatment.
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypotension, Syncope
Clinical narrative: Patient momentarily fainted after immunization was given. She was very Hypotensive with a of BP 74/54 mmHg. Had patient sit down and continued to monitor her over the next 20 minutes until her blood pressure returned to a normal level. Last BP taken was 104/72 mmHg.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, HEPA, HPV9, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was accidentally given HPV vaccine instead of IPV vaccine. No adverse event noted.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blister, Body temperature, Erythema, Myalgia, Ulcer
Clinical narrative: Several hours after receiving the vaccine, pt developed myalgia and temp to 99.6 (not unusual for a vaccine), but then developed a 1.5cm vesicle which ruptured and became an ulceration, then had surrounding 3 other areas of erythema. It has not been nearly a week and she is improving but the ulceration has not totally resolved.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states that right after receiving the vaccinations she felt burning, and pain, as she's had vaccinations previously, she assumed the pain would go away after a day or two. When the patient woke up the next morning, she had pain, burning, and swelling that ran down her arm. After a few weeks, that patient's pain was so severe she went to her MD, and was prescribed Gabapentin and PERCOCET. She states that after a week of Gabapentin and PERCOCET, her pain continues and she has numbness in her index finger.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt came in as thigh was swollen red and warm to touch.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Blood test, Crying, Electrocardiogram, Pain
Clinical narrative: Pt was in extreme pain. 5 hours after receiving imz arm hurt. Went to ER crying. BP 220/81, BG 394, EKG, X-ray, and other blood work taken. Pt given pain medication.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Pt was in extreme pain. 5 hours after receiving imz arm hurt. Went to ER crying. BP 220/81, BG 394, EKG, X-ray, and other blood work taken. Pt given pain medication.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Injection site erythema, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Patient reported injection site redness and soreness x 6 days. On 2 or 3rd day post vaccine patient states he woke up with full body flushing that improved throughout the morning and did not return. On the seventh day, soreness at injection site was gone, still red, but now a "crusty rash" around the injection site has also appeared. Also on the seventh day the patient states both legs and entire back are "itchy".
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Scab
Clinical narrative: Patient reported injection site redness and soreness x 6 days. On 2 or 3rd day post vaccine patient states he woke up with full body flushing that improved throughout the morning and did not return. On the seventh day, soreness at injection site was gone, still red, but now a "crusty rash" around the injection site has also appeared. Also on the seventh day the patient states both legs and entire back are "itchy".
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: I am still having pain in my upper arm. It hurts to put a shirt on, jacket even putting my purse in the car on the passenger seat hurts. It especially gets sore at night while sleeping and repositioning. Upper arm has deep pain like in the bone. It's not sharp just deep and hard pain.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Condition aggravated, Haemorrhage, Orchidectomy, Pyrexia
Clinical narrative: The night after the vaccine I awoke with fever and chills. The next morning I awoke to severe pain in my scrotum. The Pain continued for several days. I went to the Emergency Room on February 5th. They conducted an ultrasound, gave me a prescription for antibiotic and pain, and released me. The condition continued to worsen and began bleeding. The condition continued to worsen. On February 18th. I went to hospital where they admitted me and performed an Orchiectomy.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Scrotal pain, Ultrasound pelvis
Clinical narrative: The night after the vaccine I awoke with fever and chills. The next morning I awoke to severe pain in my scrotum. The Pain continued for several days. I went to the Emergency Room on February 5th. They conducted an ultrasound, gave me a prescription for antibiotic and pain, and released me. The condition continued to worsen and began bleeding. The condition continued to worsen. On February 18th. I went to hospital where they admitted me and performed an Orchiectomy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Patient's arms swelled up the day and it was red and hard to touch after she received SHINGRIX. She had just applied ice and took BENADRYL for it. She called her doctor and he said to continue applying ice and take BENADRYL. Symptoms resolved after 3 days.
Age: 75.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rash, Swelling
Clinical narrative: PATIENT RECEIVED ZOSTAVAX AND PREVNAR AND 3 HOURS LATER SHE HAD A SEVERE RASH ON HER FACE, NECK, AND ARMS. SHE ALSO COMPLAINED OF HER NECK BEING SWOLLEN. SHE WENT TO THE HOSPITAL AND THEY PRESCRIBED BENADRYL AND PREDNISONE BUT DID NOT ADMIT HER. 12 HOURS LATER SHE FEELS FINE EXCEPT THE RASH ON HER ARMS.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Mom reports that dose of flu given was the third of the second. Did get 3 doses, 12/01/2017, 01/02/2018, 02/28/2018.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Patient was very delayed on well child visit and vaccinations. Gave MMR dose 1, varicella dose 1, DTaP dose 4, Hep A dose 1, Hib dose 4, PCV13 dose 4 yesterday in office. Today at 3 AM he developed a febrile seizure, taken to ER by EMS. Seen at Hospital. No lab work needed. Seen today in office.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Feeling abnormal, Peripheral swelling
Clinical narrative: Patient reports T103 for 36 - 48 hrs. S/P PNEUMOVAX. Arm was red and swollen. Felt "miserable". This was not reported until next office visit approximately 8 months later. Sx are all resolved.
Age: 15.0
Sex: M
Vaccine: HEP, HIBV, MMRV
Symptoms: Erythema
Clinical narrative: (R) arm redness.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Bacterial test positive, Bladder catheterisation, Blood lactic acid, Blood lactic acid increased, Culture urine
Clinical narrative: Pt presents to ED on 9/21/17 c/o n/v, C/O N/V, urinary retention, difficulty urinating, and fever after receiving influenza vaccine. Pt developed nausea and vomiting (4-5 episodes) overnight. Initially on admission she was tachycardic, leukocytosis and lactate was elevate. elevated. Given these findings it was thought that she might have an infection, however, there was no source of active infection. Urinalysis performed was negative. Foley cath pulled off 1L. Pt. started on IV ROCEPHIN for suspected UTI. She received antibiotic for 48 hours. Her urine culture came back showing mixed flora. ROCEPHIN was subsequently discontinued. Pt also experienced hypovolemic hyponatremia hyponatremia which resolved with IV fluids. Patient was observed for 24h and Foley catheter was removed. Pt successfully voiding spontaneously and returned to baseline. Pt d/c D/C 9/23/17 and instructed to follow-up with primary care physician in one week. Etiology noted as unclear but potentially related to influenza vaccine.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Dysuria, Hyponatraemia, Hypovolaemia, Leukocytosis, Nausea
Clinical narrative: Pt presents to ED on 9/21/17 c/o n/v, C/O N/V, urinary retention, difficulty urinating, and fever after receiving influenza vaccine. Pt developed nausea and vomiting (4-5 episodes) overnight. Initially on admission she was tachycardic, leukocytosis and lactate was elevate. elevated. Given these findings it was thought that she might have an infection, however, there was no source of active infection. Urinalysis performed was negative. Foley cath pulled off 1L. Pt. started on IV ROCEPHIN for suspected UTI. She received antibiotic for 48 hours. Her urine culture came back showing mixed flora. ROCEPHIN was subsequently discontinued. Pt also experienced hypovolemic hyponatremia hyponatremia which resolved with IV fluids. Patient was observed for 24h and Foley catheter was removed. Pt successfully voiding spontaneously and returned to baseline. Pt d/c D/C 9/23/17 and instructed to follow-up with primary care physician in one week. Etiology noted as unclear but potentially related to influenza vaccine.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Tachycardia, Urinary retention, Urinary tract infection, Urine analysis
Clinical narrative: Pt presents to ED on 9/21/17 c/o n/v, C/O N/V, urinary retention, difficulty urinating, and fever after receiving influenza vaccine. Pt developed nausea and vomiting (4-5 episodes) overnight. Initially on admission she was tachycardic, leukocytosis and lactate was elevate. elevated. Given these findings it was thought that she might have an infection, however, there was no source of active infection. Urinalysis performed was negative. Foley cath pulled off 1L. Pt. started on IV ROCEPHIN for suspected UTI. She received antibiotic for 48 hours. Her urine culture came back showing mixed flora. ROCEPHIN was subsequently discontinued. Pt also experienced hypovolemic hyponatremia hyponatremia which resolved with IV fluids. Patient was observed for 24h and Foley catheter was removed. Pt successfully voiding spontaneously and returned to baseline. Pt d/c D/C 9/23/17 and instructed to follow-up with primary care physician in one week. Etiology noted as unclear but potentially related to influenza vaccine.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Pt presents to ED on 9/21/17 c/o n/v, C/O N/V, urinary retention, difficulty urinating, and fever after receiving influenza vaccine. Pt developed nausea and vomiting (4-5 episodes) overnight. Initially on admission she was tachycardic, leukocytosis and lactate was elevate. elevated. Given these findings it was thought that she might have an infection, however, there was no source of active infection. Urinalysis performed was negative. Foley cath pulled off 1L. Pt. started on IV ROCEPHIN for suspected UTI. She received antibiotic for 48 hours. Her urine culture came back showing mixed flora. ROCEPHIN was subsequently discontinued. Pt also experienced hypovolemic hyponatremia hyponatremia which resolved with IV fluids. Patient was observed for 24h and Foley catheter was removed. Pt successfully voiding spontaneously and returned to baseline. Pt d/c D/C 9/23/17 and instructed to follow-up with primary care physician in one week. Etiology noted as unclear but potentially related to influenza vaccine.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Pt hospitalized 2/25/18 requiring supplemental O2 and TYLENOL for fever 103.4 degrees F, alb. neb treatments. Discharged 2/27/18 at 10:17. Follow up call 2/28/18 mother states "patient is back to her old self ".
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-FEB-2018, the patient was vaccinated with an expired dose of GARDASIL 9 injection, expiration date 20-JAN-2018 for prophylaxis (dose, route of administration and lot number were not reported). However, no adverse events were reported and no product quality complaint was involved. Follow up information has been received from a pharmacist on 22-FEB-2018 , concerning a 21 year old female patient. The patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left deltoid, lot# M007764 with expiration date: 30-JAN-2018, for prophylaxis. The reporter stated that the patient was notified about the expired dose that she received, and after asking about stability, it was confirmed that the vaccine dose was within limits.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-FEB-2018, the patient was vaccinated with an expired dose of GARDASIL 9 injection, expiration date 20-JAN-2018 for prophylaxis (dose, route of administration and lot number were not reported). However, no adverse events were reported and no product quality complaint was involved. Follow up information has been received from a pharmacist on 22-FEB-2018 , concerning a 21 year old female patient. The patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left deltoid, lot# M007764 with expiration date: 30-JAN-2018, for prophylaxis. The reporter stated that the patient was notified about the expired dose that she received, and after asking about stability, it was confirmed that the vaccine dose was within limits.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Crying, Decreased eye contact, Eye movement disorder, Irritability, Lethargy
Clinical narrative: Received oral vaccine for Rotavirus only that day. Had a full physical checkup that morning at doctor for 5 month well check. Everything was perfect, he was acting completely normal. Two hours after vaccine was administered our child started showing symptoms. Crying and excessive fussiness but more markedly was starting to appear very lethargic. No eye contact at all for almost 12 hours. Eyes rolling in back of head, not able to focus on our voice or face. Groaning in and out of sleep over and over. Like this for hours. Looked severely ill. Had to end up taking him to the ER bc we believed his life was in danger.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Moaning
Clinical narrative: Received oral vaccine for Rotavirus only that day. Had a full physical checkup that morning at doctor for 5 month well check. Everything was perfect, he was acting completely normal. Two hours after vaccine was administered our child started showing symptoms. Crying and excessive fussiness but more markedly was starting to appear very lethargic. No eye contact at all for almost 12 hours. Eyes rolling in back of head, not able to focus on our voice or face. Groaning in and out of sleep over and over. Like this for hours. Looked severely ill. Had to end up taking him to the ER bc we believed his life was in danger.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash
Clinical narrative: 1 hour after the shots patient started with rash on the back of neck and sacral area, then pat got rash on arms and legs too.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring a patient of unknown age and gender. Information regarding pertinent medical history, concurrent therapies and drug reactions or allergies was not provided. On 19-JAN-2018, the patient was vaccinated with a dose of VARIVAX which had a lot # N021581, with expiration date on 09-AUG-2019, subcutaneously (dose, strength and anatomical location were not provided) for prophylaxis, also the patient received a dose of PROQUAD which had a lot number reported as N009171 and sterile diluent (STERILE DILUENT) all administered together (overdose), however no adverse effects were reported. Lot # N009171 was not valid for PROQUAD.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, and refers to a 4 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 31-JAN-2018, the patient received an improperly stored dose of VARIVAX lot # reported as N019838 (dose, route of administration and expiration date were not reported) and M-M-R II for prophylaxis. The temperature range was from 6 degrees Fahrenheit (°F) to -14 °F for a time frame of 6 hours , with no previous temperature excursion. The temperature excursion was called because a data logger. There was not adverse effect or product quality complaint involved. Lot Number N019838 is NOT valid for VARIVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 23-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX with lot # N012131, expiration date on 17-APR-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of -14°C to -10°C (-13.5C) degrees Celsius for 17 minutes, and temperature excursion of -9°C to 8°C (2.5C) degrees Celsius for 96 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported. The outcome was reported as Supported.
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers to a 16 months old female patient (Reporter's daughter). No pertinent medical history, no concomitant medications, no drug reactions or allergies were reported. On 20-FEB-2018, the patient was vaccinated with VARIVAX injection subcutaneously (Lot # unknown, Exp date: unknown) in the left thigh for prophylaxis. On 25-FEB-2018, the patient had red dots all over the face after receiving VARIVAX and patient was treated for this event. Reporter's daughter was seen by physician (sought to medical attention) on 26-FEB-2018 and still had not recovered. No lab diagnostics or studies were performed. There was no intervention to prevent seriousness criteria and no product quality compliant (PQC) was present. No further information was provided. The reporter did not report the causal relation of event with respect to varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: RV5
Symptoms: Drug dose omission, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern, referring to a 9 month old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On unknown dates, the patient was vaccinated with the first and second doses of ROTATEQ orally, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). On an unknown date, the patient missed the third dose of ROTATEQ.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Dizziness, Injection site joint pain, Injection site pain
Clinical narrative: This spontaneous report as received from a Pharmacy Technician refers to a 45 year old female patient. Patient's drug reaction/allergies (current conditions) included hydrocodone allergy and penicillin allergy. No pertinent medical history was reported. On 27-FEB-2018, the patient was vaccinated with PNEUMOVAX 23, 1 dosage form (DF), unknown frequency into right arm, lot # N013521, Exp date: 23-JAN-2019 for vaccination. Concomitant medications included ibuprofen and PROZAC. On 28-FEB-2018, the patient experienced dizziness and pain in the right part of her body (pain started in the right side of arm pit, up to the joint of the shoulder, radiating down to the elbow and on to the back of the shoulder), (dizziness, arthralgia, irradiating pain, pain in right arm). No further information was provided. No treatment was given for the events. No lab diagnostics/studies were performed. There was no sought to medical attention and no intervention to prevent seriousness criteria. No product quality compliant (PQC) was present. The outcome of events were reported as not recovered. The reporter did not report the causal relation of events with respect to PNEUMOVAX 23.
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Delusion, Dementia, Paranoia
Clinical narrative: My father received a FLUCELVAX QUADRIVALENT 2017-18 inj. 0.5 no on 2/2/18 and 2 days later had worsening signs of dementia, and began having delusions and paranoia. He already had dementia before the injection but has never had the other problems. His doctors have now added 2 more medications and are running more test. I've spoken with others who's loved ones have had similar reactions. I want to know why people aren't being warned of this! He would not have received it knowing these side effects!
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection of SHINGRIX IM to patient's left deltoid on 2/21/18 and patient developed reaction 2/23/18 with symptoms of pain, redness, itching, warmth that migrated down from injection site. Only 2/26/2018, pt says that the warmth has gone away, and that the redness is getting better.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Patient developed severe Bacterial Cellulitis at the injection site 12-24 hours post injection. Patient was counseled by the nurse giving the injection that it would be sore which delayed the patient getting treatment until a septic state set in.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Bacterial test positive, Cellulitis, Inadequate aseptic technique in use of product
Clinical narrative: Patient developed severe Bacterial Cellulitis at the injection site 12-24 hours post injection. Patient was counseled by the nurse giving the injection that it would be sore which delayed the patient getting treatment until a septic state set in.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction covering 80% of anterior thigh.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Mobility decreased, Nausea, Vomiting
Clinical narrative: Nausea/vomiting, diarrhea, unable to move, severe headache.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: ~17 hours after injection onset of worse headache I've ever had, violent shaking/shivers/chills, extreme fatigue, temperature 100 degrees. Violent shaking subsided after about 40 minutes. Headache /fatigue mostly resolved after 12 hours, though not completely. Also pain at injection site.  I wasn't counseled nor did I receive any information mentioning the extremely high incidence of side effects as well as severity. They were so severe I'm contemplating not receiving the second shot of the series. ONLY in the package insert which patients don't typically receive is the side effect profile described in adequate detail. I was only told "your arm may be sore." Even CDC's own website downplays the incidence by saying "About 1 out of 6 people who got SHINGRIX experienced side effects that prevented them from doing regular activities.' Again, my side effects, while not life threatening,  were SEVERE. I suspect an extremely number of people will forego the second in the series. And with vaccine on demand, how will you know how many drop out?
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: ~17 hours after injection onset of worse headache I've ever had, violent shaking/shivers/chills, extreme fatigue, temperature 100 degrees. Violent shaking subsided after about 40 minutes. Headache /fatigue mostly resolved after 12 hours, though not completely. Also pain at injection site.  I wasn't counseled nor did I receive any information mentioning the extremely high incidence of side effects as well as severity. They were so severe I'm contemplating not receiving the second shot of the series. ONLY in the package insert which patients don't typically receive is the side effect profile described in adequate detail. I was only told "your arm may be sore." Even CDC's own website downplays the incidence by saying "About 1 out of 6 people who got SHINGRIX experienced side effects that prevented them from doing regular activities.' Again, my side effects, while not life threatening,  were SEVERE. I suspect an extremely number of people will forego the second in the series. And with vaccine on demand, how will you know how many drop out?
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, tenderness and redness in the arm, emanating to shoulder and neck; very bad headache; fatigued. Began around 9 pm day of injection for approximately 36 hours. After this time, just some redness and tenderness at injection site. Took acetaminophen for the pain and discomfort.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain, tenderness and redness in the arm, emanating to shoulder and neck; very bad headache; fatigued. Began around 9 pm day of injection for approximately 36 hours. After this time, just some redness and tenderness at injection site. Took acetaminophen for the pain and discomfort.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Alopecia, Alopecia areata
Clinical narrative: My daughter got her weekly allergy shot and then the flu shot. Four days later her hair started falling out in patches. She was diagnosed with an extreme case of alopecia areata. She had almost complete hair loss by the end of November.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination complication
Clinical narrative: Employee returned to Employee Health office at 12:00 p.m. stating she started noticing swelling of the left arm, redness and itching of skin on both arms, chest, abdomen around 11:15-11:30 a.m. Denied any shortness of breath or throat constriction. Employee stated she took BENADRYL 50 mg at approximately 11:40 a.m. Employee was instructed to go to occupational medicine office for evaluation. Was seen there at 1:30 p.m. Diagnosed as reaction to the MMR vaccine and symptoms were nearly resolved when seen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Pain, swelling and baseball sized lump at injection site-told to expect pain & redness by pharmacist. Abrupt onset of chills, fever which began approximately 28 hours after 1st dose of SHINGRIX. Lasted from approximately 5:30pm (day after initial dose) until 1:00am culminating in a break in fever and complete drenching of body in "cold sweat". Intense headache then began and continued until 6:00am. After that, all symptoms resolved with the exception of the pain, redness and swelling at the injection site; area has become more diffuse but continues to be red and very tender.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, swelling and baseball sized lump at injection site-told to expect pain & redness by pharmacist. Abrupt onset of chills, fever which began approximately 28 hours after 1st dose of SHINGRIX. Lasted from approximately 5:30pm (day after initial dose) until 1:00am culminating in a break in fever and complete drenching of body in "cold sweat". Intense headache then began and continued until 6:00am. After that, all symptoms resolved with the exception of the pain, redness and swelling at the injection site; area has become more diffuse but continues to be red and very tender.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: After receiving the flu shot my arm got sore beyond the normal tenderness of getting a vaccine. I felt as though I had been hit in my arm with a hard object. There was no swelling, redness or heat. It was not a bad reaction to the vaccine itself but the way it was administered. I let a few days go by thinking maybe it would getting better as people assured me some soreness was ok. This wasn't like a normal soreness though. As the days passed the pain got worse. I was unable to get clothes on and off, brush my hair or so any other motion that required me to lift my arm. The should joint ached and my mobility was limited. After weeks of this pain getting worse and not better I address with with my chiropractor who looked at it and then made an appointment with my general physician to have it looked at.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Product preparation error
Clinical narrative: First time ever using PENTACEL did not mix the HIB, so patient was only given DTaP and polio portion. (Had no idea I needed to mix the solution and neither did second nurse verifying shots).
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient did not have any drug reactions/allergies. On 16-DEC-2017, the patient was vaccinated with a dose of VARIVAX (dose, units, frequency not reported) lot # N014631, expiration date: 11-MAY-2019 via subcutaneous route and a second dose on 18-JAN-2018 (dose, units, frequency not reported) lot # N014631, expiration date: 11-MAY-2019 via subcutaneous route. On an unknown date, the patient was found to be pregnant (exposure during pregnancy). The last menstrual period (LMP) was 30-NOV-2017 and estimated date of delivery (EDD) was determined to be 06-SEP-2018. No known adverse effects were reported (no adverse event). It was unknown if any lab diagnostics/studies were performed. The patient did not require any intervention. The events did not result in any significant disability/incapacity or hospitalization. No further information was provided. At the time of the report the outcome of pregnancy was unknown. No product quality compliant (PQC) was present.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70-year-old male patient received PREVNAR 13 (lot number: T35176, expiration date: Jan2020) intramuscular in right deltoid on 18Feb2018 at 16:30 at 0.5 ml, single to prevent pneumonia. Medical history included blood pressure abnormal from an unknown date. Concomitant medication included amlodipine taken for blood pressure. It was reported that no other vaccine was given on the same day. On an unspecified date in Feb2018, the reporter stated that the patient was displaying a rash about a size of a soft ball so it was probably about 6 inches rash and it's tender to touch and radiating heat. It was also reported that the patient had a rash about 2 or 3 days after a shot and further reported that it was still growing and confirmed it was getting worse. It was reported that the patient has not had any rash from any vaccination of any kind. The patient has not recovered from the events. The pharmacist assessed that there was a direct correlation from getting the shot with the events; the pharmacist assessed as events related to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein).
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Child had a questionable febrile seizure 1/27/18. Was taken to the ER. An MMR was ordered and MMRV was given in error. This was not discovered until a monthly vaccine audit. The child also had a history of a febrile seizure 1/11/2018.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid oedema, Sluggishness, Vision blurred
Clinical narrative: Patient noted eyes (both) puffy, swollen and vision blurry approximately 24 hours after shot, also sluggish. No injection site reaction or other symptoms. Following day only right eye affected. Patient tried allergy eye drops and reports better on 2/24.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test normal, Pain in extremity
Clinical narrative: Numbness/pain in arm.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient developed fever and redness of left upper arm. Treated with BACTRIM and KEFLEX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait inability, Injection site swelling
Clinical narrative: Same night after patient received patient had swelling of whole thigh - generalized, although injection site was not red or swollen but entire thigh was swollen. No fever. Pt. refused to walk.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Pt, received vaccine at 4:15 PM and at 4:20 PM started to get hives on (R) upper arm spreading across her face and back. Informed Dr. and had her evaluated. Administered 2.5 mls of CLARITIN per Dr. Informed pt. we will keep her for another 30 minutes to monitor her. Pt. cleared hives and was released to go home after 30 minutes.
Age: 30.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: Left deltoid ecchymosis/ erythema 12-24hrs after vaccination.
Age: 30.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Injection site discolouration, Injection site erythema, Injection site macule, Injection site reaction, Injection site swelling
Clinical narrative: Left deltoid ecchymosis/ erythema 12-24hrs after vaccination.
Age: 30.0
Sex: M
Vaccine: JEV1, JEV1
Symptoms: Rash papular, Skin test negative
Clinical narrative: Left deltoid ecchymosis/ erythema 12-24hrs after vaccination.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Axillary pain, Burning sensation, Erythema, Groin pain, Papule
Clinical narrative: Symptoms presented within 24hrs of inoculation, presented to clinic at 72-hr mark. Consolidated rash of firm papules 1-3mm diameter, erythema involving bilateral axillae, inguinal folds, sparing areas of dense hair growth. Individual, discrete lesions on bilateral upper extremities, lower extremities, torso. No discharge noted from lesions. Mildly pruritic, pain/burning sensation in axillae, groin. IM dexamethasone provided in clinic, topical 1% hydrocortisone PRN for axillae, groin. Treatment efficacy unknown at this time (24hr post treatment).
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pruritus
Clinical narrative: Symptoms presented within 24hrs of inoculation, presented to clinic at 72-hr mark. Consolidated rash of firm papules 1-3mm diameter, erythema involving bilateral axillae, inguinal folds, sparing areas of dense hair growth. Individual, discrete lesions on bilateral upper extremities, lower extremities, torso. No discharge noted from lesions. Mildly pruritic, pain/burning sensation in axillae, groin. IM dexamethasone provided in clinic, topical 1% hydrocortisone PRN for axillae, groin. Treatment efficacy unknown at this time (24hr post treatment).
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Burning sensation, Insomnia, Papule, Pruritus, Rash generalised
Clinical narrative: Symptoms presented within 24hrs of inoculation, presented to clinic at 72-hr mark. Consolidated rash of firm papules 1-3mm diameter, erythema involving bilateral axillae, inguinal folds, sparing areas of dense hair growth. Individual, discrete lesions on bilateral upper extremities, lower extremities, torso. No discharge noted from lesions. Mildly pruritic, pain/burning sensation in axillae, groin. IM dexamethasone provided in clinic, topical 1% hydrocortisone PRN for axillae, groin. Treatment efficacy unknown at this time (24hr post treatment).
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash pustular, Skin irritation
Clinical narrative: Symptoms presented within 24hrs of inoculation, presented to clinic at 72-hr mark. Consolidated rash of firm papules 1-3mm diameter, erythema involving bilateral axillae, inguinal folds, sparing areas of dense hair growth. Individual, discrete lesions on bilateral upper extremities, lower extremities, torso. No discharge noted from lesions. Mildly pruritic, pain/burning sensation in axillae, groin. IM dexamethasone provided in clinic, topical 1% hydrocortisone PRN for axillae, groin. Treatment efficacy unknown at this time (24hr post treatment).
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Chills, Contusion, Headache, Hyperhidrosis, Nausea
Clinical narrative: She received a STAMARIL Yellow Fever vaccine 2/3/18 at clinic. 2/21 severe headache, 2/25 chills, sweats, nausea, unusual bruising on legs, low platelets, 3/1 emesis and photophobia.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Photophobia, Platelet count decreased, Vomiting
Clinical narrative: She received a STAMARIL Yellow Fever vaccine 2/3/18 at clinic. 2/21 severe headache, 2/25 chills, sweats, nausea, unusual bruising on legs, low platelets, 3/1 emesis and photophobia.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Peripheral swelling, Pruritus
Clinical narrative: Swelling and fluid build up in vaccinated arm lasting several days, redness, itching evaluated by MD as possible allergy.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient concomitant medication included sterile diluent (STERILE DILUENT). On an unknown date the patient was vaccinated with improperly stored dose of PROQUAD (dose, units and frequency not reported) (lot# N024562 and expiration date: 06-MAR-2019), subcutaneously at temperature excursion from -9 degree celsius (°C ) to 8 °C for 52 hours and 10 minutes and temperature excursion from  -l4°C to -10°C for 13 hours and 45 minutes. It was reported that there was no previous excursion. Digital data logger was involved. No adverse effects reported and no additional information was provided. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX 0.5 ml, once, lot # N017399, expiration date 07-JUN-2019, for prophylaxis (strength, route and frequency were not reported) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 15 Fahrenheit degrees (°F) to 46 °F (33.8°F) during 7 hours 15 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of  VARIVAX 0.5 ml, once, lot # N017399, expiration date 07-JUN-2019, for prophylaxis (strength, route and frequency were not reported) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 15 Fahrenheit degrees (°F) to 46°F (33.8°F) during 7 hours 15 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1803USA000994:
Age: 61.0
Sex: M
Vaccine: HEP, HEPA, IPV, PPV, TDAP, TYP, VARZOS
Symptoms: Erythema, Malaise, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Received 7 vaccines on 2/27/18. Reports not feeling well on 3/1 with redness, warmth, and pain in left arm. Redness reported as 6" elipse with redness extending to elbow. Reports 100F - 101F fever. Reports taking tylenol and ibuprofen intermittently with some effectiveness on fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: Vaccine error. No adverse effects noted.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Urticaria
Clinical narrative: Severe and multiple welts accompanied with stinging. Welts covered bicep and underarm area. Symptoms resolved with use of BENADRYL.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Flushing, Rash, Rash erythematous, Vaccination site rash
Clinical narrative: After vaccines patient had flushed pink confluent rash on face and left upper leg where vaccines were done. No hives and no difficulty breathing. Gave 2.5 ml of BENADRYL and watched patient. Rash resolved.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Pt voiced became lighted while walking and fainted. Patient quickly gained consciousness and responded to commands correctly.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Crying, Muscle contractions involuntary
Clinical narrative: Hand clenching, crying, inability to open hands.
Sex: M
Vaccine: BCG
Symptoms: Mycobacterium tuberculosis complex test positive, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors in a published literature article title as stated above, concerning a 68 years old male patient with dyspnea, hyperlipidemia, prostate enlargement and hypothyroidism. On an unknown date, the patient started therapy with BCG live (manufacturer unknown) (dose, route, lot# and the expiration date were not reported) for prophylaxis. On an unknown date (reported as 1 year ago), the patient underwent a Quantiferon Gold test with a positive result (Mycobacterium tuberculosis(TB) antigen response 0.91, reference range in <0.35) (vaccination failure), but he had not received treatment for this. At the time of reporting the outcome of vaccination failure and mycobacterium tuberculosis complex test positive was unknown. A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: PPV, PPV
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # N003993 with expiration date 20-OCT-2018, intramuscularly in the left deltoid, for prophylaxis (dose was not reported). On 28-FEB-2018, the patient experienced tingling in her left arm down to her fingertips. No treatment was given for the event and no laboratory/diagnostic tests were performed. At the time of reporting, the outcome of paraesthesia was reported as not recovered. The causality assessment between paraesthesia and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Headache, Paraesthesia, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # N003993 with expiration date 20-OCT-2018, intramuscularly in the left deltoid, for prophylaxis (dose was not reported). On 28-FEB-2018, the patient experienced tingling in her left arm down to her fingertips. No treatment was given for the event and no laboratory/diagnostic tests were performed. At the time of reporting, the outcome of paraesthesia was reported as not recovered. The causality assessment between paraesthesia and PNEUMOVAX 23 was not reported.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Dyspnoea, Haemoptysis, Hypopnoea, Pneumonia
Clinical narrative: Five to six hours after getting a pneumonia vaccination my husband said he felt like he had a branding iron on his right lung. His breathing was shallow for two days because of pain. He continued to get very winded doing simple household tasks like walking from the living room to the kitchen. He just lived with getting very winded for about 3 weeks when his left lung began to feel the same branding iron pain. February 16, 2018 he saw Dr who ordered X-rays and blood work done. February 19, 2018 patient returned to the Doctor who said he had double Pneumonia. She prescribed 10 days of levofloxacin. February 17 was the first day coughing up blood. After taking 8 days of levofloxacin, patient returned to the doctor and she prescribed another 10 days of levofloxacin. He has 9 days remaining on the 2nd prescription, and he still continues to cough up blood and is winded doing simple tasks.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pulmonary pain, X-ray
Clinical narrative: Five to six hours after getting a pneumonia vaccination my husband said he felt like he had a branding iron on his right lung. His breathing was shallow for two days because of pain. He continued to get very winded doing simple household tasks like walking from the living room to the kitchen. He just lived with getting very winded for about 3 weeks when his left lung began to feel the same branding iron pain. February 16, 2018 he saw Dr who ordered X-rays and blood work done. February 19, 2018 patient returned to the Doctor who said he had double Pneumonia. She prescribed 10 days of levofloxacin. February 17 was the first day coughing up blood. After taking 8 days of levofloxacin, patient returned to the doctor and she prescribed another 10 days of levofloxacin. He has 9 days remaining on the 2nd prescription, and he still continues to cough up blood and is winded doing simple tasks.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Cough, Herpes zoster, Malaise
Clinical narrative: Patient states night following administration of vaccine experienced chills and chest pain. Patient felt sick enough to go to bed. In next 1-2 days developed a cough and post nasal drip. Approximately 5-6 days later developed shingles out break in right corner lower lip.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper-airway cough syndrome
Clinical narrative: Patient states night following administration of vaccine experienced chills and chest pain. Patient felt sick enough to go to bed. In next 1-2 days developed a cough and post nasal drip. Approximately 5-6 days later developed shingles out break in right corner lower lip.