chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Swelling and redness at site, fever, chills, headache,  bodyaches, body sweats, joint pain , diarrhea.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling and redness at site, fever, chills, headache,  bodyaches, body sweats, joint pain , diarrhea.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash, Skin irritation
Clinical narrative: Rash on trunk feels like like little bursts and then intense itching, burning soreness with red irritations
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Fever, chills, muscle and body aches, soreness/tenderness of arm where injection was given, swelling of arm where injection was given, raised, warm, itchy, red rash below injection site; duration of symptoms: more than 72 hours post injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain, Pyrexia, Rash erythematous
Clinical narrative: Fever, chills, muscle and body aches, soreness/tenderness of arm where injection was given, swelling of arm where injection was given, raised, warm, itchy, red rash below injection site; duration of symptoms: more than 72 hours post injection.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Muscle tightness
Clinical narrative: Persistent pain, tenderness and intermittent burning at injection site. Onset 2 days after injection. Slight diffuse fullness, "tightness" to muscle without redness or obvious induration.   Referred to PMD if heat, ibuprofen not helping.
Age: 75.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Rash, Rash erythematous, Tenderness
Clinical narrative: Patient developed red rash on left arm.  Rash is sized like a tennis ball, and is red, swollen and tender to touch.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Anti-thyroid antibody, Antinuclear antibody, Arthralgia, Blood creatine phosphokinase, Blood immunoglobulin A
Clinical narrative: Patient started to exhibit swelling and extreme pain in his knees, fingers, ankles, and elbows.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood thyroid stimulating hormone, C-reactive protein, Epstein-Barr virus antibody
Clinical narrative: Patient started to exhibit swelling and extreme pain in his knees, fingers, ankles, and elbows.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count, HLA-B*27 assay, Joint swelling, Pain in extremity, Parvovirus B19 test
Clinical narrative: Patient started to exhibit swelling and extreme pain in his knees, fingers, ankles, and elbows.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral swelling, Red blood cell sedimentation rate, Rheumatoid factor, Streptococcus test, Urine analysis
Clinical narrative: Patient started to exhibit swelling and extreme pain in his knees, fingers, ankles, and elbows.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Vitamin D
Clinical narrative: Patient started to exhibit swelling and extreme pain in his knees, fingers, ankles, and elbows.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Lymph node pain, Lymphadenopathy
Clinical narrative: Pt has a lump in her lymph node 3/4 inch by 1/2 inch under her arm where the IMZ was administered. The morning after the IMZ, 2-15-20, she saw the lump and it was painful. As of today, 2-20-20 the patient said there is no pain in the lump. She cannot say if the lump is decreasing from 2-15-20
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: patient stated arm was sore after several days. he kept monitoring for aseveral weeks. He called and was still sore so was goin to see the dr. Patient stated that vaccine was done just next to where that mark is from his vaccine when he was younger
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Neck pain, Pain, Pyrexia, Vertigo
Clinical narrative: Fever progressing to 101 degrees at 24 hours after injection. 800 mg Ibuprofen didn?t bring down fever.  Strong pain in back of neck. Body-wide  aches,  fleeting vertigo episodes, staggering, difficulty walking.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: PATIENT COMPLAINED OF EXCRUCIATING PAIN IN HER LEFT SHOULDER FOLLOWING A SHINGREX VACCINE. SHE THINKS THE SHOT WAS GIVEN AT THE TOP OF HER SHOULDER.  SHE SAID SHE TOOK A PERCOCET SHE HAD ON HAND FOR THE PAIN.  THE VACCINE WAS GIVEN ON 2/14/20 AND SHE CALLED THE STORE ON 2/17/20 TO COMPLAIN ABOUT THE PAIN. SHE SAID SHE DID NOT GO TO A DOCTOR/PROVIDER ABOUT IT. SHE WAS GIVEN A FOLLOW UP CALL ON 2/18/20 TO SEE HOW SHE WAS DOING. SHE SAID MUCH BETTER. A COMPANY REPORT WAS FILED.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Total body aches, chills, fatigue
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Ecchymosis, Immediate post-injection reaction, Pain, Pyrexia, Tenderness
Clinical narrative: developed immediate pain, tenderness followed by delayed reported fever of 104 F oral on the same day.  Pt was seen the next day with a purplish ecchymosis about 1 cm in size with palm sized surrounding tenderness without redness, warmth, swelling   Full ROM of the elbow and shoulder.  No fever.  Pt self treated with heat.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Swelling
Clinical narrative: Induration injection site with some swelling noted to (Rt) deltoid - no erythema
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Cough, Eye discharge, Urticaria
Clinical narrative: Hives all over the body Yellowish Discoloration under the eyes and Bridge of the nose. Cough
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Feeling hot, Injection site erythema, Injection site warmth
Clinical narrative: AM of 2/19/2020 felt very warm and fatigue/malaise, 2/19/20 noted arm where vaccine received warm & red. Also noted, blistered lesion on (L) arm
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: AM of 2/19/2020 felt very warm and fatigue/malaise, 2/19/20 noted arm where vaccine received warm & red. Also noted, blistered lesion on (L) arm
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Seizure like phenomena, Skin warm
Clinical narrative: Had flu shot, DTap, HiB at primary care appt @ 1330. Felt warm around 7pm. mom gave tylenol. Mom noted "seizure like activity" around 8pm. Mom called 911. Transported to ED. Child was given Ibuprofen at ED and sent home w/ parent. Child had F/u Appt w/ pediatrician on 2/18/20. VAERS reports requested by Dr.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pain in extremity, Rash, Skin warm
Clinical narrative: Patient reported and showed a rash that appeared a few hours after the vaccination. It is located on her chest, shoulders, neck, and lower scalp. She reports that her arm was very sore after the injection. She showed a red circular mark on her right arm which the injection was given. She stated it was hot to the touch as well as felt like there was a hard know under skin. She reported that this knot had become softer like it was going away. She stated that she went to the MD and was prescribed a Medrol dosepak b/c it looked like am allergic reaction. Patient still had a rash and the red circular mark on her arm on 2-20 but she reported that both were slowly getting better with time.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Muscular weakness, Pyrexia
Clinical narrative: Patient spouse, states that patient was rushed Emergency dept evening of administration of Shingrix. Pt had muscle weakness and fell. Fever Wife states that at about 4 hours after administration of 2nd dose  of Shingrix, patient was rushed to the Emergency Dept. Symtoms: muscle weakness that made patient to fall. - Fever
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Peripheral swelling
Clinical narrative: Patient came in the store on 02-19-20 and reported that her arm was swollen, and her shoulder was hurting after the flu shot. Her shoulder is still hurting now. I told her to contact her pcp to check it out. I also called PCP to report the adverse event. Patient said she will call her PCP to schedule appointment to treat her shoulder.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Herpes zoster, Pyrexia
Clinical narrative: Pt states that few hours after 2nd dose of Shingrix she experienced - fever, asthma attack, - mild case of shingle. Pt was prescribed Valtrex and prednisone
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer on 13-FEB-2020, regarding a case in litigation and refers to a 61-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 03-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen information was not provided) for prophylaxis. As a result of zoster vaccine live (ZOSTAVAX) vaccination on 11-OCT-2017, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of zoster vaccine live (ZOSTAVAX) vaccination, the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. At the time of the report, the outcome of herpes zoster was unknown.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chest pain, Headache, Paraesthesia, Regressive behaviour
Clinical narrative: Aegressive behaviors/behavioral changes; chest pain; headache; tingling of hands; Information has been received from the local regulatory authority (Agency # 809102) on 11-NOV-2019.  This spontaneous report as received from a registered nurse referring to a female patient of unknown age. The patient had a history of syncope. The patient's concomitant medications included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate (ADDERALL TABLETS) and guanfacine hydrochloride. The patient had no known allergies to medications, food or other products. The patient had no other diseases at the time of vaccination and up to one month prior.  On 27-MAR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency were unknown; lot # R016921 and expiration date 28-FEB-2021) intramuscularly (IM) for prophylaxis. On the same day, the patient was vaccinated with meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL).      In 2019, the patient's mother reported the patient experienced chest pain, regressive behaviors, headache and tingling of hands. The patient went to doctor or other healthcare professional office clinic visit and emergency room or department or urgent care. In 2019 (reported as when seen), chest pain recovered. The outcome of other events were unknown. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.   Follow-up information has been received from the registered nurse (reported as office manager) on 14-FEB-2020. The patient's demographics were updated. The patient was 11 years old. On 27-MAR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency were unknown; lot # R016921 and expiration date reported as 16-MAR-2020 (also auto generated as 28-FEB-2021) intramuscularly (IM) in left deltoid for prophylaxis. On 27-MAR-2019, the patient experienced chest pain, headache and behavioral changes. In 2019 (reported as now), it took her several weeks to get over them and the patient was fine now. The events was not attributable to with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 68.0
Sex: M
Vaccine: VARZOS, PPV, PPV, VARZOS
Symptoms: Erythema, Hypoaesthesia
Clinical narrative: Redness & Shakes for 4 days. The touch sensitive pain from Neck, for a week. Plus numbness and pain from touch from shoulder to elbow since then.  This has foreced wo the take pain medication and sleep aids to be able to sleep. Pain has lessened slightly over the last 2 weeks.  Now only rate the between 2 -3. I have also been to DR @ spine and pain center for a  cortisone injection 2 days ago and it did not help.
Age: 68.0
Sex: M
Vaccine: VARZOS, PPV, PPV, VARZOS
Symptoms: Arthralgia, Blood test normal, Erythema, Hyperaesthesia, Hypoaesthesia
Clinical narrative: Redness & Shakes for 4 days. The touch sensitive pain from Neck, for a week. Plus numbness and pain from touch from shoulder to elbow since then.  This has foreced wo the take pain medication and sleep aids to be able to sleep. Pain has lessened slightly over the last 2 weeks.  Now only rate the between 2 -3. I have also been to DR @ spine and pain center for a  cortisone injection 2 days ago and it did not help.
Age: 68.0
Sex: M
Vaccine: VARZOS, PPV, PPV, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Tremor, X-ray normal
Clinical narrative: Redness & Shakes for 4 days. The touch sensitive pain from Neck, for a week. Plus numbness and pain from touch from shoulder to elbow since then.  This has foreced wo the take pain medication and sleep aids to be able to sleep. Pain has lessened slightly over the last 2 weeks.  Now only rate the between 2 -3. I have also been to DR @ spine and pain center for a  cortisone injection 2 days ago and it did not help.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pruritus, Rash
Clinical narrative: allergic reaction; itching; headache; rash in arm/ rash in legs; not herself; dizziness; unable to work; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 1st dose of Shingrix. On 1st February 2020, less than a day after receiving Shingrix and not applicable after starting Hydroxyzine, the patient experienced allergic reaction, pruritus, headache, rash, dissociation and dizziness. In February 2020, the patient experienced inability to work. The patient was treated with hydroxyzine hydrochloride (Hydroxyzine) and loratadine (Claritine). On an unknown date, the outcome of the allergic reaction, pruritus, rash, dissociation and dizziness were not recovered/not resolved and the outcome of the headache was recovering/resolving and the outcome of the inability to work was unknown.   It was unknown if the reporter considered the allergic reaction, pruritus, headache, rash, dissociation and dizziness to be related to Shingrix.  Additional details were reported as follows: This casewas reported by patient herself. The same day of receiving Shingrix vaccine, the patient experienced itching, headache, and rash over arms and legs. The patient stated, she just was not herself because of these issues. On 2nd February 2020, the patient went back to pharmacy the next day, who advised her that she was having an allergic reaction and to take Claritin. The patient stated, this wasn not really helping, so she called her doctor and he advised her to take hydroxyxine three times daily. The patient had missed a week of work and was back on the week of time of reporting, but only on half days. The patientwas not able to drive on the medication she was given. After receiving hydroxyxine, the patient still had itching and headches but the headaches have improved, she was not herself at the time of reporting. The patient also complained of dizziness, which she noted she was sure if it was the medication or the reaction, so she was asked when it started and she noted the same day as the vaccine. The patient had not actually seen her doctor at the point of reporting, she has a appointment at the end of March. The patient was cutting down on the medication he gave, at her direction. The reporter consented to follow up. This was Potential legal case, caller seeking compensation for missed work. Was provided address and fax. The ouctome of the event itching in source document was reported as recovering and resolving, however it was reported as not recovered and not resolved. The ouctome of the event headache in source document was reported as fatal, however it was reported as recovering and resolving.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dissociation, Dizziness, Headache, Hypersensitivity, Impaired work ability
Clinical narrative: allergic reaction; itching; headache; rash in arm/ rash in legs; not herself; dizziness; unable to work; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 1st dose of Shingrix. On 1st February 2020, less than a day after receiving Shingrix and not applicable after starting Hydroxyzine, the patient experienced allergic reaction, pruritus, headache, rash, dissociation and dizziness. In February 2020, the patient experienced inability to work. The patient was treated with hydroxyzine hydrochloride (Hydroxyzine) and loratadine (Claritine). On an unknown date, the outcome of the allergic reaction, pruritus, rash, dissociation and dizziness were not recovered/not resolved and the outcome of the headache was recovering/resolving and the outcome of the inability to work was unknown.   It was unknown if the reporter considered the allergic reaction, pruritus, headache, rash, dissociation and dizziness to be related to Shingrix.  Additional details were reported as follows: This casewas reported by patient herself. The same day of receiving Shingrix vaccine, the patient experienced itching, headache, and rash over arms and legs. The patient stated, she just was not herself because of these issues. On 2nd February 2020, the patient went back to pharmacy the next day, who advised her that she was having an allergic reaction and to take Claritin. The patient stated, this wasn not really helping, so she called her doctor and he advised her to take hydroxyxine three times daily. The patient had missed a week of work and was back on the week of time of reporting, but only on half days. The patientwas not able to drive on the medication she was given. After receiving hydroxyxine, the patient still had itching and headches but the headaches have improved, she was not herself at the time of reporting. The patient also complained of dizziness, which she noted she was sure if it was the medication or the reaction, so she was asked when it started and she noted the same day as the vaccine. The patient had not actually seen her doctor at the point of reporting, she has a appointment at the end of March. The patient was cutting down on the medication he gave, at her direction. The reporter consented to follow up. This was Potential legal case, caller seeking compensation for missed work. Was provided address and fax. The ouctome of the event itching in source document was reported as recovering and resolving, however it was reported as not recovered and not resolved. The ouctome of the event headache in source document was reported as fatal, however it was reported as recovering and resolving.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: allergic reaction; itching; headache; rash in arm/ rash in legs; not herself; dizziness; unable to work; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 1st dose of Shingrix. On 1st February 2020, less than a day after receiving Shingrix and not applicable after starting Hydroxyzine, the patient experienced allergic reaction, pruritus, headache, rash, dissociation and dizziness. In February 2020, the patient experienced inability to work. The patient was treated with hydroxyzine hydrochloride (Hydroxyzine) and loratadine (Claritine). On an unknown date, the outcome of the allergic reaction, pruritus, rash, dissociation and dizziness were not recovered/not resolved and the outcome of the headache was recovering/resolving and the outcome of the inability to work was unknown.   It was unknown if the reporter considered the allergic reaction, pruritus, headache, rash, dissociation and dizziness to be related to Shingrix.  Additional details were reported as follows: This casewas reported by patient herself. The same day of receiving Shingrix vaccine, the patient experienced itching, headache, and rash over arms and legs. The patient stated, she just was not herself because of these issues. On 2nd February 2020, the patient went back to pharmacy the next day, who advised her that she was having an allergic reaction and to take Claritin. The patient stated, this wasn not really helping, so she called her doctor and he advised her to take hydroxyxine three times daily. The patient had missed a week of work and was back on the week of time of reporting, but only on half days. The patientwas not able to drive on the medication she was given. After receiving hydroxyxine, the patient still had itching and headches but the headaches have improved, she was not herself at the time of reporting. The patient also complained of dizziness, which she noted she was sure if it was the medication or the reaction, so she was asked when it started and she noted the same day as the vaccine. The patient had not actually seen her doctor at the point of reporting, she has a appointment at the end of March. The patient was cutting down on the medication he gave, at her direction. The reporter consented to follow up. This was Potential legal case, caller seeking compensation for missed work. Was provided address and fax. The ouctome of the event itching in source document was reported as recovering and resolving, however it was reported as not recovered and not resolved. The ouctome of the event headache in source document was reported as fatal, however it was reported as recovering and resolving.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Terrible pain in my arm for several days  unable to move my arm for 8 hours  throwing up low fever  still have arm pain 2 wks later  It was some of the worst pain ever
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Terrible pain in my arm for several days  unable to move my arm for 8 hours  throwing up low fever  still have arm pain 2 wks later  It was some of the worst pain ever
Sex: U
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no se; inadverently administered varivax too closely; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were not reported.      On 19-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, lot # and expiry date not reported) for prophylaxis. On 28-JAN-2020, the patient was inadvertently vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, anatomical location, lot # and expiry date not reported) too closely after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administered). No additional adverse events reported. No product quality complaint was involved in this report.
Sex: U
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no se; inadverently administered varivax too closely; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were not reported.      On 19-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, lot # and expiry date not reported) for prophylaxis. On 28-JAN-2020, the patient was inadvertently vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, anatomical location, lot # and expiry date not reported) too closely after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administered). No additional adverse events reported. No product quality complaint was involved in this report.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Fever, shakes and muscular pain. From 10:00 pm until now.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Acute generalised exanthematous pustulosis, Rash, Robust take following exposure to vaccinia virus
Clinical narrative: On day 10 after SPV, developed rash on chest and shoulder with appearance typical for non-viral pustolosis.  Seen at urgent care center, who contacted Health Dept, who contacted CDC, who contacted Healthcare team.  Healthcare team followed and rash resolved with observation over 2 days.  Patient remained well.  Notably, right arm vaccine site had robust take.  This was 2nd SPV for patient who received original SPV at same site in 2005 -- with typical take, Jennerian scar, and no problems.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient's arm got "really red" and "swelled up two minutes after receiving her second dose of GARDASIL 9"; patient's arm got "really red" and "swelled up two minutes after receiving her second dose of GARDASIL 9"; This spontaneous report as received from a medical assistant via field representative refers to a female patient of unknown age. The concomitant therapies included birth control pill. No information regarding the patient's medical history and concurrent conditions was provided.  On an unknown date, the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot# and expiration date were not reported) for human papillomavirus (HPV) prevention. The patient had no symptoms after the first dose. On 03-FEB-2020, the patient was vaccinated with second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prophylaxis. On the same day, two minutes after vaccination the patient's arm got really red and swelled up. No treatment was given for the adverse events. No lab diagnostics/studies performed. The patient did not seek for medical attention. No product quality complaint (PQC) was involved. The adverse events were not a cancer events and no overdose occurred.  The outcome of the events was unknown. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported; the patient inadvertently received an expired dose of VARIVAX; Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided. Concomitant therapies included sterile diluent.  On 07-FEB-2020, the patient inadvertently received an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R002508, expiration date 25-JAN-2020; strength, route, frequency unknown) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a nurse refers to a 10-week-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, route, lot/batch # and expiration date were not reported) for prophylaxis.   On 17-FEB-2020, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) dose 2, (lot # S023219 with expiry date: 03-MAR-2022) via intramuscular route for prophylaxis (product storage error). The vaccine was exposed to a temperature above 47 degrees Fahrenheit (51.87 Fahrenheit) for 2 hours and 15 minutes. There was no previous temperature excursion. It was reported that the call was because of digital data logger. The patient experienced no adverse event. No product quality complaint (PQC) was involved.  This is one of the two reports from the same reporter.
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: no known adverse effects; 21 year old received pediatric dose of vaqta; This spontaneous report was received from a nurse prescriber refers to a 21-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant therapies were not reported.   On 17-FEB-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, lot/batch # and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age). The patient experienced no adverse event. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects; patient received an expired dose of PNEUMOVAX; This spontaneous report has been received from a registered pharmacist, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 18-FEB-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dosage form, lot number R011632, expiration date on 02-FEB-2020 (concentration, frequency, administration route, and anatomical location was not reported) as prophylaxis. No known adverse effects reported.
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Influenza virus test negative, Mobility decreased, Nausea
Clinical narrative: arm pain; headache; chills "but no fever"; nausea; unable to lift his arm; "flu and strep" were both negative; "flu and strep" were both negative; This spontaneous report has been received from a physician, referring to a 19 years old male patient (the physician's son). The patient's concurrent condition included attention deficit/hyperactivity disorder (ADHD). The patient's concomitant medication and drug reactions/allergies were not provided.  On "either" 11-FEB-2020 or 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis.   On 12-FEB-2020 or 13-FEB-2020 (reported as the next day), the patient experienced headache, arm pain and chills "but no fever". On an unknown date in February 2020, "a couple of days" after receiving dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient then experienced nausea and was unable to lift his arm. The patient went to an unspecified Emergency Room on an unspecified date. The patient was tested for the "flu and strep" while in the Emergency Room and results for both the "flu and strep" were both negative. The patient received doses of ketorolac tromethamine (TORADOL) and ondansetron hydrochloride (ZOFRAN) while in the Emergency Room. On an unknown date, the patient was discharged to home from the Emergency Room. The patient sought medical attention. There was no intervention given to prevent serious criteria. The patient did recover on an unspecified date. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA007859:
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Streptococcus test negative
Clinical narrative: arm pain; headache; chills "but no fever"; nausea; unable to lift his arm; "flu and strep" were both negative; "flu and strep" were both negative; This spontaneous report has been received from a physician, referring to a 19 years old male patient (the physician's son). The patient's concurrent condition included attention deficit/hyperactivity disorder (ADHD). The patient's concomitant medication and drug reactions/allergies were not provided.  On "either" 11-FEB-2020 or 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis.   On 12-FEB-2020 or 13-FEB-2020 (reported as the next day), the patient experienced headache, arm pain and chills "but no fever". On an unknown date in February 2020, "a couple of days" after receiving dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient then experienced nausea and was unable to lift his arm. The patient went to an unspecified Emergency Room on an unspecified date. The patient was tested for the "flu and strep" while in the Emergency Room and results for both the "flu and strep" were both negative. The patient received doses of ketorolac tromethamine (TORADOL) and ondansetron hydrochloride (ZOFRAN) while in the Emergency Room. On an unknown date, the patient was discharged to home from the Emergency Room. The patient sought medical attention. There was no intervention given to prevent serious criteria. The patient did recover on an unspecified date. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA007859:
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Product storage error
Clinical narrative: Stomach ache; Took 1 dose of unrefrigerated Vivotif; Spontaneous report received on 16DEC2019.   Based on the information obtained from a caregiver (consumer's mother) two individual case safety report 19000468SP (PVX2019-3095-first child) and 19000469SP (PVX2019-3096-second child).   This case was (PVX2019-3095) for a male consumer who "took a dose of unrefrigerated Vivotif" (PT: Product storage error) and developed "stomach ache" (PT: Abdominal pain upper), while being oral Vivotif (Lot number: 3003279) for typhoid fever prophylaxis. On 15DEC2019, the consumer took first dose of Vivotif which was left unrefrigerated since 26NOV2019.On the same day following the administration of Vivotif, he developed stomach ache and did not receive any treatment for it. Action taken with Vivotif with respect to event "stomach ache" was unknown while, with respect to event "took a dose of unrefrigerated Vivotif" was not applicable. At the time of report, the outcome of the reported events was unknown.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Product storage error) and developed stomach ache. Considering the potential of Vivotif to cause abdominal pain, the event stomach ache is assessed as possible with Vivotif. The causality of product storage error is assessed as not related to Vivotif due to the nature of the event.  Follow up information was received on 26DEC2019  The follow up information received included outcome of the event.  The outcome of the event "stomach ache" was updated as resolved without any treatment.  Additionally, the stomach issue began 4 hours after taking the first dose of Vivotif.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Product storage error) and after 4 hours, had stomach ache. The event resolved without any treatment. Considering the potential of Vivotif to cause abdominal pain, the event stomach ache is assessed as possible with Vivotif. The causality of product storage error is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer took a dose of unrefrigerated Vivotif (Product storage error) and after 4 hours, had stomach ache. The event resolved without any treatment. Considering the potential of Vivotif to cause abdominal pain, the event stomach ache is assessed as possible with Vivotif. The causality of product storage error is assessed as not related to Vivotif due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: Nausea; Spontaneous report received on 26DEC2019.  A caregiver (consumer's husband) reported that a female consumer had nausea (PT: Nausea) while being on oral Vivotif for typhoid fever prophylaxis. On 25DEC2019, the consumer took first dose of Vivotif and had nausea. On 25DEC2019, the consumer took second dose of Vivotif and had nausea again. Action taken with Vivotif with respect to the reported event was unknown. The consumer was not recovered from the reported event at the time of report.  Company Comment: A consumer experienced nausea each time after taking first and second Vivotif doses. Considering the potential of Vivotif to cause nausea and the case information, the causality of the event is assessed as possible with Vivotif.; Sender's Comments: A consumer experienced nausea each time after taking first and second Vivotif doses. Considering the potential of Vivotif to cause nausea and the case information, the causality of the event is assessed as possible with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Vomited the whole solid capsule; Spontaneous report received on 02JAN2020.  A nurse reported that a 19-year-old female consumer vomited the whole solid capsule (PT: Vomiting). She was receiving Vivotif capsule for immunisation. On 23DEC2019, the consumer woke up in the morning and felt bad as she had stomach flu, but still she took first dose of Vivotif on the same day. After one hour of taking the first dose, she vomited the whole, solid capsule. Thus, she was advised to hold further doses because of stomach flu. Later, the reported event was resolved and she restarted the Vivotif course on 27DEC2019 and took three doses. Action taken with Vivotif with respect to the reported event was dose interrupted. She had recovered from the reported event.  Company Comment: A consumer with stomach flu took first dose of Vivotif and after one hour, vomited the whole Vivotif capsule (Vomiting of medication). In response to the event, consumer interrupted the next dose of Vivotif till the stomach flu and vomiting was resolved and then completed the remaining three doses of Vivotif. Considering patient's underlying stomach flu can cause vomiting and the case information, the causality of the event is assessed as unlikely with Vivotif.  Follow up information received on 06JAN2020.  The consumer confirmed that she had recovered from the event "vomited the whole solid capsule." Additionally, she updated that she restarted Vivotif on 27DEC2019 and took four doses as per schedule (27DEC2019, 29DEC2019, 31DEC2019 and 02JAN2020).  Company Comment: A consumer with stomach flu took first dose of Vivotif and after one hour, vomited the whole Vivotif capsule (Vomiting of medication). In response to the event, consumer interrupted the next dose of Vivotif till the stomach flu and vomiting was resolved and then re-stared the four dose Vivotif course and completed it. Considering patient's underlying stomach flu can cause vomiting and the case information (felt bad with stomach flu prior to taking first dose of Vivotif), the causality of the event is assessed as unlikely with Vivotif.; Sender's Comments: A consumer with stomach flu took first dose of Vivotif and after one hour, vomited the whole Vivotif capsule (Vomiting of medication). In response to the event, consumer interrupted the next dose of Vivotif till the stomach flu and vomiting was resolved and then re-stared the four dose Vivotif course and completed it. Considering patient's underlying stomach flu can cause vomiting and the case information (felt bad with stomach flu prior to taking first dose of Vivotif), the causality of the event is assessed as unlikely with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Influenza, Nausea, Vomiting
Clinical narrative: Flu with nausea and vomiting; Flu with nausea and vomiting; Flu with nausea and vomiting; Spontaneous report received on 03JAN2020.  A female consumer reported that she developed flu with nausea and vomiting (PT: Influenza, Nausea, and Vomiting), while being on oral Vivotif for typhoid fever prophylaxis. The consumer started taking Vivotif on 30DEC2019. At the time of call, she had already taken two doses of Vivotif and third dose was due on 03JAN2020. On 03JAN2020, in the morning she came down with the flu and had nausea and vomiting from the flu. The consumer received a shot at the doctor's office as a treatment for nausea and vomiting, but she did not know what kind of shot she had received. Moreover, she also started taking prescribed oral ondansetron (4 mg; two doses in every 8 hours) for nausea and vomiting on 03JAN2020. Action taken with Vivotif with respect to the reported events was unknown. The consumer had not recovered from reported events at the time of report.  Medical history included high blood pressure, diabetes and gout.  Concomitant medications included hepatitis A vaccine, hepatitis B vaccine, yellow fever vaccine and Measles, mumps and rubella vaccine (MMR vaccine), which were received on 30DEC2019. Other concomitant medications included Tribenzor (amlodipine/hydrochlorothiazide/olmesartan) and Bystolic (nebivolol) for high blood pressure, metformin for diabetes and Uloric (febuxostat) for gout.  Company Comment: A consumer took first two doses of Vivotif and on the morning when her third dose of Vivotif was due, she had flu with nausea and vomiting. The consumer received unknown injection at the doctor's office for treating nausea and vomiting, and also started taking ondansetron. Further details of the event and action taken with vivotif was limited. The consumer also took other vaccines (hepatitis A, hepatitis B, yellow fever, and MMR vaccines) on the same day when she took the first dose of Vivotif. Considering the infectious (Viral) etiology of Flu, and the consumer had nausea and vomiting because of the Flu, the causality of all the events is assessed as unlikely with Vivotif.; Sender's Comments: A consumer took first two doses of Vivotif and on the morning when her third dose of Vivotif was due, she had flu with nausea and vomiting. The consumer received unknown injection at the doctor's office for treating nausea and vomiting, and also started taking ondansetron. Further details of the event and action taken with vivotif was limited. The consumer also took other vaccines (hepatitis A, hepatitis B, yellow fever, and MMR vaccines) on the same day when she took the first dose of Vivotif. Considering the infectious (Viral) etiology of Flu, and the consumer had nausea and vomiting because of the Flu, the causality of all the events is assessed as unlikely with Vivotif.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: arm was sore the next day; felt tired; headache; flu like but without fever; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in May 2019 and experienced ache, headache and injction site pain, refer case US2020AMR024894.).   In July 2019, the patient received the 2nd dose of Shingrix and the 1st dose of Hepatitis A vaccine. In 2019, 1 day after receiving Shingrix and Hepatitis A vaccine, the patient experienced fatigue, headache and influenza-like symptoms. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fatigue, headache and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue, headache and influenza-like symptoms to be related to Shingrix and Hepatitis A vaccine.  Additional information was provided as follows: This case was reported by patient herself and she was an orthodontic employee. The patient received 1st dose of hepatitis A vaccine in right arm and 2nd dose of Shingrix in left arm. The patient's arm was sore the next day and she felt tired, headache, and flu like but without fever. The symptoms resolved in about 24 hours from the start of symptoms. In January of 2020, the patient received her second dose of hepatitis A and experienced no adverse effects.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Lymphadenitis, Nasal congestion, Secretion discharge
Clinical narrative: inflamed lymph nodes/ lump/ cluster of lymph node; lump in neck; viral reaction; mucous / a lot of thick mucous; stuffed up; post nasal drip; injection site lump; Injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of lymphadenitis in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (with post herpatic neuralgia) and post herpetic neuralgia. Previously administered products included Shingles vaccine (received on an unknown date).   On 28th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 5 weeks after receiving Shingrix, the patient experienced lymphadenitis, local swelling, viral infection, mucus discharge, nasal stuffiness, postnasal drip, injection site lump and injection site pain. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the lymphadenitis and local swelling were recovering/resolving and the outcome of the viral infection was resolved with sequelae and the outcome of the mucus discharge, nasal stuffiness, injection site lump and injection site pain were recovered/resolved and the outcome of the postnasal drip was unknown.   It was unknown if the reporter considered the lymphadenitis, local swelling, viral infection, mucus discharge, nasal stuffiness, postnasal drip, injection site lump and injection site pain to be related to Shingrix.  Additional details were received as follows: The patient found a lump in her right neck after vaccination. The lump was not in the gland but in front of the gland and below the gland. The patient went to her internist who recommended an ultrasound. The ultrasound showed inflamed lymph nodes and a cluster of lymph nodes and he recommended another ultrasound in a month.   The patient also reported that she had a bit of a reaction to the Shingrix vaccine including a viral reaction with a lot of mucous and she was stuffed up. The patient reported a lot of thick mucous and she took Mucinex and she has since stopped taking it but she still has post nasal drip remaining. The patient also experienced lump and soreness at the injection site. The patient consented to follow up.