chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Immediate post-injection reaction, Laryngitis, Pyrexia
Clinical narrative: Per pt states as soon as she was given the TDAP vaccine on 1/26/18 she felt dizzy and had diarrhea, fever, laryngitis right after.
Age: 76.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Erythema, Rash pruritic
Clinical narrative: Right arm had a mild rash at least 5 inches below the injection site. It has lasted about 6 days. The patient stated it was itchy at first, but isn't now. There is just a small patch of redness of the skin.
Age: 76.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Right arm had a mild rash at least 5 inches below the injection site. It has lasted about 6 days. The patient stated it was itchy at first, but isn't now. There is just a small patch of redness of the skin.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Crying, Cyanosis, Grunting, Hypersomnia, Hyporesponsive to stimuli
Clinical narrative: ED NOTE: 2 mo (almost 3 mo) former 38 patient here with episode of cyanosis and decreased responsiveness today. Got PREVNAR yesterday, got TYLNEOL preemptively. Was sleepy after, and slept for several hours before mom finally woke him to feed. He has had fussiness with other shots, but has not been this sleepy before. Then today, he had been sleeping in his swing for 5 hours, mom picked him up to feed. Was feeding for about 5 minutes and then he unlatched, was laying horizontal in mom's arms and shortly after, mom looked down and noticed that his hand and face were white, lips were blue, he was limp and mom stimulated him and he came to and cried. He was fussy for a few minutes, mom was holding him upright and this happened again -she stimulated him and he woke up and cried, but while mom was calling 911, this happened several times in quick succession. This happened at least 5 times and he woke up every time with stimulation. There was no spit up. Mom says that he was making a throat sound - kind of grunty. No rashes, no fevers, no vomiting or diarrhea. Of note, he does spit up at baseline - those episodes begin with a short cry and then he looks startled, extends his arms and his head, holds his breath and then mom suctions and he breathes and is better. Mom has strategically placed bulbs around the house to deal with such episodes. She had planned to talk to the PMD about this. They called 911 and the child has been fine since then. Mom and dad and 4 sibs has had cough and congestion. ED Plan: Former FT child here with unexplained episode of color change and limpness today after being immunized with PREVNAR yesterday. Given history of reflux, with worsening symptoms recently, possibly related to that. Ddx BRUE vs SBI vs immunization reaction (or combination). Low concern for SBI given no fever, otherwise well appearing on exam and normal vitals. Did not pursue labs here for that reason. Fed well with small spit up but no color or activity changes here. Per parents he is at baseline here. Mother very uncomfortable and traumatized by having to call 911 and the whole experience and multiple occurrences. Uncomfortable going home. Will admit to hospital medicine for overnight observation. Signed out to hospital medicine team.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Hypotonia, Immunisation reaction, Increased upper airway secretion, Irritability, Pallor
Clinical narrative: ED NOTE: 2 mo (almost 3 mo) former 38 patient here with episode of cyanosis and decreased responsiveness today. Got PREVNAR yesterday, got TYLNEOL preemptively. Was sleepy after, and slept for several hours before mom finally woke him to feed. He has had fussiness with other shots, but has not been this sleepy before. Then today, he had been sleeping in his swing for 5 hours, mom picked him up to feed. Was feeding for about 5 minutes and then he unlatched, was laying horizontal in mom's arms and shortly after, mom looked down and noticed that his hand and face were white, lips were blue, he was limp and mom stimulated him and he came to and cried. He was fussy for a few minutes, mom was holding him upright and this happened again -she stimulated him and he woke up and cried, but while mom was calling 911, this happened several times in quick succession. This happened at least 5 times and he woke up every time with stimulation. There was no spit up. Mom says that he was making a throat sound - kind of grunty. No rashes, no fevers, no vomiting or diarrhea. Of note, he does spit up at baseline - those episodes begin with a short cry and then he looks startled, extends his arms and his head, holds his breath and then mom suctions and he breathes and is better. Mom has strategically placed bulbs around the house to deal with such episodes. She had planned to talk to the PMD about this. They called 911 and the child has been fine since then. Mom and dad and 4 sibs has had cough and congestion. ED Plan: Former FT child here with unexplained episode of color change and limpness today after being immunized with PREVNAR yesterday. Given history of reflux, with worsening symptoms recently, possibly related to that. Ddx BRUE vs SBI vs immunization reaction (or combination). Low concern for SBI given no fever, otherwise well appearing on exam and normal vitals. Did not pursue labs here for that reason. Fed well with small spit up but no color or activity changes here. Per parents he is at baseline here. Mother very uncomfortable and traumatized by having to call 911 and the whole experience and multiple occurrences. Uncomfortable going home. Will admit to hospital medicine for overnight observation. Signed out to hospital medicine team.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: ED NOTE: 2 mo (almost 3 mo) former 38 patient here with episode of cyanosis and decreased responsiveness today. Got PREVNAR yesterday, got TYLNEOL preemptively. Was sleepy after, and slept for several hours before mom finally woke him to feed. He has had fussiness with other shots, but has not been this sleepy before. Then today, he had been sleeping in his swing for 5 hours, mom picked him up to feed. Was feeding for about 5 minutes and then he unlatched, was laying horizontal in mom's arms and shortly after, mom looked down and noticed that his hand and face were white, lips were blue, he was limp and mom stimulated him and he came to and cried. He was fussy for a few minutes, mom was holding him upright and this happened again -she stimulated him and he woke up and cried, but while mom was calling 911, this happened several times in quick succession. This happened at least 5 times and he woke up every time with stimulation. There was no spit up. Mom says that he was making a throat sound - kind of grunty. No rashes, no fevers, no vomiting or diarrhea. Of note, he does spit up at baseline - those episodes begin with a short cry and then he looks startled, extends his arms and his head, holds his breath and then mom suctions and he breathes and is better. Mom has strategically placed bulbs around the house to deal with such episodes. She had planned to talk to the PMD about this. They called 911 and the child has been fine since then. Mom and dad and 4 sibs has had cough and congestion. ED Plan: Former FT child here with unexplained episode of color change and limpness today after being immunized with PREVNAR yesterday. Given history of reflux, with worsening symptoms recently, possibly related to that. Ddx BRUE vs SBI vs immunization reaction (or combination). Low concern for SBI given no fever, otherwise well appearing on exam and normal vitals. Did not pursue labs here for that reason. Fed well with small spit up but no color or activity changes here. Per parents he is at baseline here. Mother very uncomfortable and traumatized by having to call 911 and the whole experience and multiple occurrences. Uncomfortable going home. Will admit to hospital medicine for overnight observation. Signed out to hospital medicine team.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered on 01/31/2018, vaccine expired on 01/27/2018. No adverse even noted to patient.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Rash
Clinical narrative: Some arm rash, red and swollen almost to elbow. Trouble breathing (more than normal). Patient stated was shoveling snow post immunization. Stated has COPD. He was advised to go to ER. Pharmacist called patient Tues morning to follow up and patient stated he did not go to the ER but took doses of diphenhydramine and was fine. All symptoms resolved as of 1/30/18.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Condition aggravated
Clinical narrative: Patient experienced raised blood pressure some time after administration of SHINGRIX. Patient started on blood pressure medications and had blood pressure controlled on the medications. Patient called us in the afternoon stating blood pressure rose to around 240. Later around 5:30pm came to pharmacy and I had rechecked his blood pressure at the pharmacy and it was still 223/93. Spoke with his interal medicine doctor's office and arranged for him to go see the doctor immediately.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site reaction, Rash pruritic
Clinical narrative: Patient's grandmother reported that the patient developed a quarter-sized, red, itchy rash at injection site. Patient did not report trouble breathing or rash spreading. Counseled grandmother to take patient to the doctor immediately if she has trouble breathing or if the rash does not improve or spreads. Also counseled grandmother that patient can take Benadryl for itchiness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received 1.5 years ago before the reporting date). Concomitant products included CRESTOR, amlodipine and trazodone. On 27th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, fatigue and injection site erythema. On 29th January 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site swelling, injection site pain, fatigue and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. On the reporting date, the patient and swelling had gone down a lot, though there was still redness.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dysgeusia, Dyspnoea, Feeling abnormal, Flushing
Clinical narrative: Pt was given PNEUMOVAX left arm first. Then Flushot right arm. Right after the flushot was given, pt was told to wait 15 mins, she got up and said she was having trouble breathing. She looked flushed.  Per Pt, she said she can taste the medicine in her throat. Pt was told to sit down as was given some water to drink. She then said she can feel the flushing radiating down to her kidneys. After about 3 mins she felt better and looks visibility better. She was given benadryl liquid 10ml just to be safe. She waited 35 mins and she was was feels ok but not herself. She waited 10 more mins before she said she was ok and wanted to leave.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Periarthritis
Clinical narrative: Patient first came to me today 2/1/18 complaining of immobility in left arm. She said it started about 10 days after her vaccine, and she's not sure if it's due to that or due to her hitting her arm around that same time period. She says she can only lift her left arm up about 1/3 of the way. She said she's seen her PCP Dr. about this, who said she has "frozen shoulder" according to pt.  Not sure when she first saw doctor for problem. She didn't mention trying anything for it as far as treatment. She will see orthopedic surgeon soon she said.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Pain, Swelling
Clinical narrative: Swelling and pain for 3 days. Used ice packs on left deltoid and acetaminophen for pain. Most painful vaccine I ever had.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: PT has not yet been contacted to evaluate if any adverse reactions were present. CDC was contacted, they stated there was no serious risk with giving the extra dose of KINRIX. CDC stated PT will not need the regular adolescent dose that is administered at the age of 11-12 of TDAP, will need a booster of TD at the age of 18.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt experienced severe swelling on the underside of the arm (same are as the injection but several inches away from the injection site). We contacted Merck and were advised that the reaction should diminish within 48 hours. Pt was consulted regarding any other symptoms (none were present) and informed to monitor the situation and contact MD if other symptoms arose. Reaction did go away within the 48 hour time frame.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cold sweat, Fall, Gait disturbance, Hyperhidrosis
Clinical narrative: SHINGRIX Zoster Vaccine. Symptoms: Injection site reaction 5p area inflammed from neck to right arm injection site, vomiting, nausea, body ache, fever, cold and hot sweats, reduced motor skills (cannot walk a few feet without tumbling down), ankles swollen, blister formation face
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Joint swelling, Motor dysfunction, Nausea, Pain
Clinical narrative: SHINGRIX Zoster Vaccine. Symptoms: Injection site reaction 5p area inflammed from neck to right arm injection site, vomiting, nausea, body ache, fever, cold and hot sweats, reduced motor skills (cannot walk a few feet without tumbling down), ankles swollen, blister formation face
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: SHINGRIX Zoster Vaccine. Symptoms: Injection site reaction 5p area inflammed from neck to right arm injection site, vomiting, nausea, body ache, fever, cold and hot sweats, reduced motor skills (cannot walk a few feet without tumbling down), ankles swollen, blister formation face
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Radiating arm pain after vaccination. last about 1 to 1& 1/2 weeks. Aching when lifting.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Cold sweat, Decreased eye contact, Eye pruritus, Eyelid oedema, Gait disturbance
Clinical narrative: Exactly 24 hours later, my son's eyes were red and puffy. He could not focus his eyes, they were looking everywhere, but would not look me in the eyes. He would rub his eyes and say "itchy". He had a fever at that moment as well, of 102.5. His leg where he got the injection was red, swollen, hard, warm to the touch and painful. He was unable to walk normal- he limped and walked crooked. I contacted the nurse who told me to put a cool compress over eyes and give TYLENOL. I gave him ibuprofen to keep fever down and monitored. His fever went away in 24 hours. His eyes were not swollen after 48 hours. Then he broke out into cold sweats the second night (01/28/2018). The leg inflammation continued for three days and he finally had no more red swelling and pain on the morning of 01/30/2018.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Exactly 24 hours later, my son's eyes were red and puffy. He could not focus his eyes, they were looking everywhere, but would not look me in the eyes. He would rub his eyes and say "itchy". He had a fever at that moment as well, of 102.5. His leg where he got the injection was red, swollen, hard, warm to the touch and painful. He was unable to walk normal- he limped and walked crooked. I contacted the nurse who told me to put a cool compress over eyes and give TYLENOL. I gave him ibuprofen to keep fever down and monitored. His fever went away in 24 hours. His eyes were not swollen after 48 hours. Then he broke out into cold sweats the second night (01/28/2018). The leg inflammation continued for three days and he finally had no more red swelling and pain on the morning of 01/30/2018.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site warmth, Ocular hyperaemia, Pyrexia, Vision blurred
Clinical narrative: Exactly 24 hours later, my son's eyes were red and puffy. He could not focus his eyes, they were looking everywhere, but would not look me in the eyes. He would rub his eyes and say "itchy". He had a fever at that moment as well, of 102.5. His leg where he got the injection was red, swollen, hard, warm to the touch and painful. He was unable to walk normal- he limped and walked crooked. I contacted the nurse who told me to put a cool compress over eyes and give TYLENOL. I gave him ibuprofen to keep fever down and monitored. His fever went away in 24 hours. His eyes were not swollen after 48 hours. Then he broke out into cold sweats the second night (01/28/2018). The leg inflammation continued for three days and he finally had no more red swelling and pain on the morning of 01/30/2018.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dysphonia, Eye pain, Headache, Musculoskeletal pain
Clinical narrative: Symptoms started with a stiff neck and a raspy voice shortly after injection. They continued throughout the day and into the evening became more intense. The next morning I had severe pain at the base of my skull that radiated through my head. My eyes hurt and it felt like I had skinny sticks piercing through the roof of my mouth and sinuses. My head felt like it was going to split open. The pain from the base of my skull radiated down my shoulders and down to the middle of my back. It only felt bearable to lay down on a heated mattress pad and flat. I was nauseous about an hour after the shot into the next day. Eventually I sat with a heating pad on my back and took 4 Ibuprofen. It helped slightly, but the pain in the neck (base of skull) lasted all day and into the next. I managed the pain by taking more Ibuprofen.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Nausea, Oral pain, Sinus pain
Clinical narrative: Symptoms started with a stiff neck and a raspy voice shortly after injection. They continued throughout the day and into the evening became more intense. The next morning I had severe pain at the base of my skull that radiated through my head. My eyes hurt and it felt like I had skinny sticks piercing through the roof of my mouth and sinuses. My head felt like it was going to split open. The pain from the base of my skull radiated down my shoulders and down to the middle of my back. It only felt bearable to lay down on a heated mattress pad and flat. I was nauseous about an hour after the shot into the next day. Eventually I sat with a heating pad on my back and took 4 Ibuprofen. It helped slightly, but the pain in the neck (base of skull) lasted all day and into the next. I managed the pain by taking more Ibuprofen.
Age: 74.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Red skin reaction on left upper arm with mild fever. Reaction began within hours of injection. (L) bicep swollen, red and induration area about 8 inches x 5 inch area . MD to treat with acetominophen and cold compresses. Call if not improved in 72 hours.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient received immunization on 1/31/18 in the deltoid. Patient reported adverse reaction of swelling and redness of bicep on 2/1/18 at 6:45pm. Counseled patient to seek medical attention from a provider.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came into pharmacy on 2-1-18 indicated that after administration of shot on left arm the area had been achy, had become red and hot. RPH looked at area and the area was Indeed red, called PCP, did not receive and immediate response, called back around 4pm and was informed PCP was gone for the day, another doctor at the practice indicated that patient should be seen, this was relayed to the patient and the patient made an appointment to be seen this evening.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age a gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JAN-2018, the patient was inadvertently vaccinated with VARIVAX lot number N022977 and expiration date of 23-AUG-2018 (dose, frequency and route were not provided) for prophylaxis, instead of ZOSTAVAX. No adverse effects. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1802USA000983.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Blood albumin, Blood glucose increased, Blood lactic acid normal, Crying, Electrocardiogram normal
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 41 year old female patient with uncontrolled diabetes. The patient had no concomitant medications or drug reactions/allergies to be reported. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (lot# N027624, expiration date: 11-MAY-2019). It was also reported that the patient received the PNEUMOVAX 23 due to diabetes. On 25-JAN-2018, the patient complained she was "being excruciating pain from above injection site down to elbow" (injection site pain, pain in extremity). The nurse also reported that the patient "was crying, saying that she could not lift arm" (crying, injected limb mobility decreased). The patient sought medical attention and she was advised to visit emergency room at health care system. It was unknown whether the patient received any treatment and no laboratory works were performed. At the time of the report, the outcome of injection site pain, crying, injected limb mobility decreased and pain in extremity was reported as not recovered. The causality assessment between therapy with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Full blood count, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 41 year old female patient with uncontrolled diabetes. The patient had no concomitant medications or drug reactions/allergies to be reported. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (lot# N027624, expiration date: 11-MAY-2019). It was also reported that the patient received the PNEUMOVAX 23 due to diabetes. On 25-JAN-2018, the patient complained she was "being excruciating pain from above injection site down to elbow" (injection site pain, pain in extremity). The nurse also reported that the patient "was crying, saying that she could not lift arm" (crying, injected limb mobility decreased). The patient sought medical attention and she was advised to visit emergency room at health care system. It was unknown whether the patient received any treatment and no laboratory works were performed. At the time of the report, the outcome of injection site pain, crying, injected limb mobility decreased and pain in extremity was reported as not recovered. The causality assessment between therapy with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Injection site swelling, Lymphocyte count decreased, PCO2 normal, PO2 normal, Rash macular
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 41 year old female patient with uncontrolled diabetes. The patient had no concomitant medications or drug reactions/allergies to be reported. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (lot# N027624, expiration date: 11-MAY-2019). It was also reported that the patient received the PNEUMOVAX 23 due to diabetes. On 25-JAN-2018, the patient complained she was "being excruciating pain from above injection site down to elbow" (injection site pain, pain in extremity). The nurse also reported that the patient "was crying, saying that she could not lift arm" (crying, injected limb mobility decreased). The patient sought medical attention and she was advised to visit emergency room at health care system. It was unknown whether the patient received any treatment and no laboratory works were performed. At the time of the report, the outcome of injection site pain, crying, injected limb mobility decreased and pain in extremity was reported as not recovered. The causality assessment between therapy with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Crying, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 41 year old female patient with uncontrolled diabetes. The patient had no concomitant medications or drug reactions/allergies to be reported. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (lot# N027624, expiration date: 11-MAY-2019). It was also reported that the patient received the PNEUMOVAX 23 due to diabetes. On 25-JAN-2018, the patient complained she was "being excruciating pain from above injection site down to elbow" (injection site pain, pain in extremity). The nurse also reported that the patient "was crying, saying that she could not lift arm" (crying, injected limb mobility decreased). The patient sought medical attention and she was advised to visit emergency room at health care system. It was unknown whether the patient received any treatment and no laboratory works were performed. At the time of the report, the outcome of injection site pain, crying, injected limb mobility decreased and pain in extremity was reported as not recovered. The causality assessment between therapy with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 41 year old female patient with uncontrolled diabetes. The patient had no concomitant medications or drug reactions/allergies to be reported. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (lot# N027624, expiration date: 11-MAY-2019). It was also reported that the patient received the PNEUMOVAX 23 due to diabetes. On 25-JAN-2018, the patient complained she was "being excruciating pain from above injection site down to elbow" (injection site pain, pain in extremity). The nurse also reported that the patient "was crying, saying that she could not lift arm" (crying, injected limb mobility decreased). The patient sought medical attention and she was advised to visit emergency room at health care system. It was unknown whether the patient received any treatment and no laboratory works were performed. At the time of the report, the outcome of injection site pain, crying, injected limb mobility decreased and pain in extremity was reported as not recovered. The causality assessment between therapy with PNEUMOVAX 23 and the aforementioned events was not reported.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2018, less than a month after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was not reported/not resolved. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: The patient had no significant medical history and any other medications. The patient received SHINGRIX a week ago at her pharmacy. The patient stated that she did not take the previous vaccine. The patient experienced shivers and chills and felt like it's down to the bone. She did not think that she had fever bit had not taken her temperature and also did not have any other symptoms. She also has not reported the symptoms to her doctor. The reporter was reviewed the appropriate personal information regarding adverse reactions and suggested that follow up with doctor. No batch number available as she was received the vaccine at the pharmacy. The patient has denied permission to contact their physician.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Pt arm got swollen pain and itchy. It also developed red welts. Pt took some BENADRYL last night.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: Fever over 103 degrees, nausea, weakness.
Age: 5.0
Sex: M
Vaccine: YF, YF
Symptoms: Deafness neurosensory, Deafness unilateral, Ear pain, Pyrexia
Clinical narrative: Following day patient complained of earache in left ear and had a tactile fever. He started reporting to mom that he could not hear out of his left ear.
Age: 5.0
Sex: M
Vaccine: YF, YF
Symptoms: Deafness neurosensory, Deafness unilateral, Ear pain, Middle ear effusion, Pyrexia
Clinical narrative: Following day patient complained of earache in left ear and had a tactile fever. He started reporting to mom that he could not hear out of his left ear.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events (medication error-administered wrong dose).
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Patient developed hives around the injection site. Patient was given Benadryl 3 times. Hives are improving.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Symptoms of injection site reaction including pruritus, swelling, and soreness. Patient describes as small in nature and uncomfortable, but not painful.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Irritability
Clinical narrative: Per mother, child had been incredibly fussy since vaccines given on 1/23/18. When mother went to change child's diaper 2/1/18 AM, she noticed a half-dollar size lump/redness on child's R thigh, at the area where MMR had been administered.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: 150cm in length and 110cm wide.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nasal stuffiness in a 87-year-old female patient who received Influenza vaccine. Previously administered products included Flu shot with an associated reaction of nasal congestion (she gets these symptoms from her flu shot every year). On 16th January 2018, the patient received Influenza vaccine. In January 2018, less than a month after receiving Influenza vaccine, the patient experienced nasal stuffiness and runny nose. On an unknown date, the outcome of the nasal stuffiness was not recovered/not resolved and the outcome of the runny nose was recovered/resolved. The reporter considered the nasal stuffiness and runny nose to be related to Influenza vaccine. Additional details were provided as follows: The patient recently had the flu shot. The patient does not know who was the maker of her flu shot. After her flu shot, the patient got a runny nose and now she had a stuffy nose.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 26th January 2018, the patient received the 1st dose of SHINGRIX. On 26th January 2018, 8 hrs after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was the patient for this adverse event. The patient received SHINGRIX in left deltoid.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional called to report that several patients had reported pain at the injection site after receiving SHINGRIX. No more information was obtained at the time of call.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: Patient reports cellulitis in arm of injections. She reported to the pharmacy, exact details unknown.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient did not have a reaction; I needed to notify state patient was given the wrong vaccine for his age.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Computerised tomogram normal, Culture urine positive, Syncope
Clinical narrative: Syncope episode after leaving clinic. Patient was taken to ER by parents, Negative CT, Urine culture with >100,000 colonies, treated with antibiotics with instructions to follow up with PCP.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Mild rash that included the injection site down the inner arm toward the elbow. Presented to the pharmacy 2/2/18 but unsure when the reaction occurred between time of injection and now. She said it wasn't bothersome now, but I recommended BENADRYL cream to apply if itching.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Malaise, fever and entire right leg pain for 3 days.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Pain in extremity, Paraesthesia, Rash erythematous, Skin discolouration
Clinical narrative: Within three hours of injection of HVP vaccine to left deltoid my daughter started experiencing "stabbing" pain (6/10) in her left wrist (palmer side) that was unrelieved with Ibuprofen, ice or heat. (She denied injury or changes, etc. since office visit) Upon waking up the next morning (0600) she reported bilateral "aching feet", 7/10 on pain scale. Upon examining her feet-she appeared to have a light red/un-raised rash/discoloration over the top of her feet-she denies any itching, burning, etc.-Just that the bottoms of both feet and the tops in some places ached. She was given Ibuprofen- a couple hours later the light red/pink rash was gone but the aching to both feet remain. Upon waking this morning (02/02/18) she said that throughout the night her bilateral hands "tingled" for "a couple of minutes"- she reports she is still experiencing "aching" pain in her bilateral feet, 3/10 this morning. I administered another dose of IBU and sent a message to PCP that pain continues and that we need to follow up. I contacted the CDC yesterday morning and they suggested I take her to her PCP-He had no available office or after hours appointments and suggested I take her to ER. ER attending and NP, reported the could not find a reason for the pain and did not think it was related to the HPV vaccine but "could not be 100%" suggesting that she have second vaccine in six months. NP stated that she didn't know what the VAERS reporting system was and that she had never done it. She refused to provide vaccine information until I requested to see hospital administrator.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Acoustic stimulation tests, Computerised tomogram head, Diarrhoea, Feeding disorder, Fluid intake reduced
Clinical narrative: Sudden severe unexpected vertigo. Unable to lay down, eat, drink or sleep for 1 week. Nonstop vomiting and diarrhea; blackout spells. Taken to ER for emergency hydration. Had to miss 2 weeks of work.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Impaired work ability, Insomnia, Loss of consciousness, Metabolic function test
Clinical narrative: Sudden severe unexpected vertigo. Unable to lay down, eat, drink or sleep for 1 week. Nonstop vomiting and diarrhea; blackout spells. Taken to ER for emergency hydration. Had to miss 2 weeks of work.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Neurological examination, Vertigo, Vomiting
Clinical narrative: Sudden severe unexpected vertigo. Unable to lay down, eat, drink or sleep for 1 week. Nonstop vomiting and diarrhea; blackout spells. Taken to ER for emergency hydration. Had to miss 2 weeks of work.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported an injection-site reaction, consisting of swelling, redness, and itching around the injection site. The site was also painful to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called to ask about insurance reimbursement. On an unknown date, the patient's body temperature was recorded as 102 degree F. The healthcare professional refused to answer any further questions and asked for insurance codes, when notified a transfer would need to occur to answer that question and asked if there were any other questions before that transfer asked for side effect information, VIS lack. Attempt was made to collect adverse events but the healthcare professional stated not having time and hung up. This case was 1 of the 2 cases, reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chromaturia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of urine discoloration in a 19-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 2nd January 2018, the patient received BEXSERO. On 23rd January 2018, 21 days after receiving BEXSERO, the patient experienced urine discoloration. On an unknown date, the outcome of the urine discoloration was recovering/resolving. The reporter considered the urine discoloration to be unrelated to BEXSERO. Additional details were reported as follows: The date of the first dose was not known. On an unknown date, 3 weeks after receiving the 2nd dose of BEXSERO, the patient developed dark colored urine.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Patient experienced fever, chills, headache, nausea and cellulitis. She was treated in ER and sent home on cephalexin, prednisone, and cetirizine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Nodule, Pain
Clinical narrative: Knot on arm. Barely can move arm. Patient is taking ADVIL for pain. By 1/22/18 patient fully recovered.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site rash, Pyrexia
Clinical narrative: Fever and chills, 24 hrs. Few days later, rash started at injection site, spread across my body-lasted 2 wks.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Area above elbow is elevated, red and painful. It is located little lower than the site of injection. Patient stated that symptoms started on 02/01 (2 days after the administration).
Age: 15.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Face injury, Fall, Syncope
Clinical narrative: Syncopal episode in Health Department lobby 5 minutes after vaccination. These were patient's first-ever vaccinations in her life. She was nervous, had not had breakfast, and reports previous "passing out" with phlebotomy and an intramuscular injection in the past. Patient fell against the wall and was escorted to the floor by her mother. Less than 1 minute later, patient walked on her own to a lobby chair and was given ice to her left cheek where contact was made with the wall. Patient also walked out of the Health Department.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: The patient called the pharmacy and complained that her arm has hurt ever since she received the flu vaccine.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Body temperature increased, Cough, Throat irritation, Urticaria
Clinical narrative: Approx 11:30 am 1/25/18, the SNT, contacted the VBYG nurse that approx 30 minutes after vaccination, student presented with hives on neck, back and chest and a scratchy throat.  SNT administered 25 MG BENADRYL. SNT called VBYG nurse again at 12:30 and stated she gave him EPI x2 due to high anxiety, cough and spreading of hives. EMT was called to the school and mom and dad were notified. EMT cleared student to go home and not go to hospital. Per SNT, pulse Ox was 99%, temp 101. Patient denied any illness prior to vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Irritated administration site. Red, swollen, itchy, warm to touch.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Dusky red induration, red ring measuring about 10 cm diameter. Treating for possible cellulitis now w/TMP/SMX for 7 day.
Age: 3.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant erythema and swelling around injection site of MMRV.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events have occurred at this time. Patient received a flu vaccine from MD office 11/1/17. Patient and mother came on 1/30/18 to get a flu vaccine and the vaccination was given. On 1/31/18, the MDs office called to let us know the patient had already received a flu vaccine in November.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Child's mother states that child had rash all over her body (front and back) that was itchy. Mother states that she spoke with child's doctor and child was given BENADRYL and is currently clearing the rash.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: This spontaneous report was received from a clinic office purchasing manager regarding a medical assistant of unknown age and gender. The medical assistant's medical history, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the medical assistant was handling a defective VAQTA 25U/0,5mL PED prefilled (PF) syringe (SYR) (lot # N020950, expiration date: 17-OCT-2018) that began leaking while a dose was being prepared for an unspecified patient. The reporter stated that it could not be ruled out the possibility that the medical assistant came in direct skin contact with the leaking product. The unspecified intended patient did not miss a dose since the patient was able to receive an injection from a different syringe. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Chills
Clinical narrative: This spontaneous report as received from a consumer refers to her 67 year old mother. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 16-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. On the same date, the patient experienced severe chills. The outcome of chills was reported as not recovered. The causal relationship between the event and PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 46 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 23-JAN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (strength, dose, route and lot number were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: CD4 lymphocytes abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's medical history, historical drugs and concomitant therapies were not reported. The patient's concurrent conditions included acquired immunodeficiency syndrome. On 05-JAN-2018, the patient was vaccinated with one dose of VARIVAX subcutaneously (dose, lot number and expiration date were not reported) for prophylaxis (contraindicated product administered). Other suspect therapies included sterile diluent (MERCK). On an unknown date in January 2018, the patient had a CD4 cell count which was in 48 (units not reported) (CD4 lymphocytes abnormal). The outcome of CD4 lymphocytes abnormal was unknown. The causal relationship between CD4 lymphocytes abnormal and VARIVAX was not reported.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Fatigue, HIV test positive, Headache, Influenza like illness, Laboratory test
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's medical history, historical drugs and concomitant therapies were not reported. The patient's concurrent conditions included acquired immunodeficiency syndrome. On 05-JAN-2018, the patient was vaccinated with one dose of VARIVAX subcutaneously (dose, lot number and expiration date were not reported) for prophylaxis (contraindicated product administered). Other suspect therapies included sterile diluent (MERCK). On an unknown date in January 2018, the patient had a CD4 cell count which was in 48 (units not reported) (CD4 lymphocytes abnormal). The outcome of CD4 lymphocytes abnormal was unknown. The causal relationship between CD4 lymphocytes abnormal and VARIVAX was not reported.