chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered an improperly stored PROQUAD; no additional adverse events; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 17-DEC-2019, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot # S022913 and expiration date 19-JAN-2021 (dose, route and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 36.86 °F in a timeframe of 9 hours and 49 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ) was administered to the patient.   It was reported that previous temperature excursion occurred with a temperature of 15 °F within 1 hour and 30 minutes.   No adverse symptoms were reported for the patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; the patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 16-JAN-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S006018, expiration date 27-FEB-2021 (strength, dose, route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) on the same day. It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 9 hours and 49 minutes in the temperature range between 15 degrees Fahrenheit and 46 degrees Fahrenheit on unknown date prior to administration. There was also previous temperature excursion reported with the time frame of 1 hour and 30 minutes in the temperature range between 15 degrees Fahrenheit and 46 degrees Fahrenheit on unknown date. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Fatigue, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: itchy; Muscle ache; very tired the day after the shot; bones and muscles ached; very red area at shot site; swollen/also raised; raised round lump in the red area; Silver dollar sized lesion; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received Shingrix 8year ago and had  really light case of shingles.).   On 27th May 2020, the patient received Shingles vaccine. In May 2020, less than a day after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, injection site lump and skin lesion. On 28th May 2020, the patient experienced tiredness, musculoskeletal pain and muscle pain. On 29th May 2020, the patient experienced pruritus. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, tiredness, musculoskeletal pain, pruritus, skin lesion and muscle pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, tiredness, musculoskeletal pain, pruritus, skin lesion and muscle pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient received Shingrix at 3pnm and had tennis ball sized very red area at injection site also raised round lump in red area. The patient was very tired the day after the shot and all my bones and muscles ached and went to sleep. The patient still feels tired, red, swollen and itchy at the time of reporting. The reporter asked would it be ok to get the 2nd dose in several months. The patient only had one silver dollar sized lesion.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Pruritus, Skin lesion
Clinical narrative: itchy; Muscle ache; very tired the day after the shot; bones and muscles ached; very red area at shot site; swollen/also raised; raised round lump in the red area; Silver dollar sized lesion; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received Shingrix 8year ago and had  really light case of shingles.).   On 27th May 2020, the patient received Shingles vaccine. In May 2020, less than a day after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, injection site lump and skin lesion. On 28th May 2020, the patient experienced tiredness, musculoskeletal pain and muscle pain. On 29th May 2020, the patient experienced pruritus. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, tiredness, musculoskeletal pain, pruritus, skin lesion and muscle pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, tiredness, musculoskeletal pain, pruritus, skin lesion and muscle pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient received Shingrix at 3pnm and had tennis ball sized very red area at injection site also raised round lump in red area. The patient was very tired the day after the shot and all my bones and muscles ached and went to sleep. The patient still feels tired, red, swollen and itchy at the time of reporting. The reporter asked would it be ok to get the 2nd dose in several months. The patient only had one silver dollar sized lesion.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis; Swelling at injection site; Redness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On 14th May 2020, the patient received Kinrix (intramuscular) .5 ml. On 14th May 2020, 6 hrs after receiving Kinrix, the patient experienced injection site cellulitis, injection site swelling and injection site erythema. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the injection site cellulitis, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling and injection site erythema to be related to Kinrix.  Additional information was received as follows: About 6 hours after Kinrix vaccination, the patient experienced swelling and redness at the injection site.  The Patient went to the emergency room the following day.  The patient was diagnosed with Cellulitis and was put on 10 days course of Keflex. At the time of report, the patient was now completely recovered. The reporter consented for follow up. This is 1 of 3 cases reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091764:Same reporter US-GLAXOSMITHKLINE-US2020091771:Same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature fluctuation, Coronavirus infection, Fatigue, Heart rate increased, Injection site pain
Clinical narrative: Coronavirus; Tiredness/ extreme tiredness; Temperature fluctuations; Rapid heart rate; Site of injection and the entire arm was painful; Site of injection and the entire arm was painful; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, between 3 and 5 months after receiving Shingrix, the patient experienced coronavirus infection (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced injection site pain, pain in arm, tiredness, body temperature fluctuation and heart rate increased. On an unknown date, the outcome of the coronavirus infection was recovered/resolved and the outcome of the injection site pain and pain in arm were unknown and the outcome of the tiredness, body temperature fluctuation and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the coronavirus infection, injection site pain, pain in arm, tiredness, body temperature fluctuation and heart rate increased to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine in left arm and her site of injection and the entire arm was painful after getting the first dose of Shingrix. This lasted for about 4 days. She came down with coronavirus in March of 2020, due to which she was hospitalized for a week. She recovered from coronavirus. After discharge from hospital she had been experiencing extreme tiredness, temperature fluctuations, and rapid heart rate. She stated it was getting better but at time of reporting she was still experiencing it. The reporter consented to follow up. The outcome for event coronavirus was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Coronavirus; Tiredness/ extreme tiredness; Temperature fluctuations; Rapid heart rate; Site of injection and the entire arm was painful; Site of injection and the entire arm was painful; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, between 3 and 5 months after receiving Shingrix, the patient experienced coronavirus infection (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced injection site pain, pain in arm, tiredness, body temperature fluctuation and heart rate increased. On an unknown date, the outcome of the coronavirus infection was recovered/resolved and the outcome of the injection site pain and pain in arm were unknown and the outcome of the tiredness, body temperature fluctuation and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the coronavirus infection, injection site pain, pain in arm, tiredness, body temperature fluctuation and heart rate increased to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine in left arm and her site of injection and the entire arm was painful after getting the first dose of Shingrix. This lasted for about 4 days. She came down with coronavirus in March of 2020, due to which she was hospitalized for a week. She recovered from coronavirus. After discharge from hospital she had been experiencing extreme tiredness, temperature fluctuations, and rapid heart rate. She stated it was getting better but at time of reporting she was still experiencing it. The reporter consented to follow up. The outcome for event coronavirus was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Colon cancer, Incomplete course of vaccination
Clinical narrative: developed colon cancer; is late getting his second dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of colon cancer in a adult male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   The patient's past medical history included prostate cancer (had prostate cancer prior to getting Twinrix.).   On an unknown date, the patient received the 1st dose of Twinrix and the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced colon cancer (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the colon cancer and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the colon cancer to be related to Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had prostate cancer prior to getting twinrix. After receiving the first dose of twinrix, patient developed colon cancer and will be starting chemotherapy. Pharmacist reported that a patient was late for his second dose of twinrix. Till the time of reporting patient did not receive 2nd dose of twinrix which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2020092763, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092763:same reporter
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient was given dose of influenza that is expired
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Periarthritis
Clinical narrative: patient had prolonged muscle soreness in arm following administration of vaccination, lasting months. Doctor diagnosed as frozen shoulder.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt only needed DTAP vaccine , HIB, and Prevnar. Nurse administered DTAP plus IPV (quadracel) vaccine, Prevnar and HIB. So patient has received an extra IPV vaccine.  No ADRs reported in chart.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of PROQUAD was administered to a patient; No additional adverse effects reported.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 29-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  injection (route of administration, dosage regimen and anatomical location were not reported, lot number S031702, which has been verified to be valid, expiration date reported and validated on 06-APR-2021) as prophylaxis (product storage error).  The vaccine was stored at a temperature of 32.7 degrees Fahrenheit (F) for a timeframe of 4 hours, as record by data logger. No previous temperature excursion was reported. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site; Swelling at injection site; Warmth at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On 29th May 2020, the patient received Kinrix (intramuscular) .5 ml. On 30th May 2020, 1 days after receiving Kinrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Kinrix.  Additional details were provided as follows: Later on the day of vaccination patient experienced redness, swelling and warmth to touch at the site of injection. It was no longer warm to touch. The swelling and redness had improved, but it was still present. No other details were provided. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091774:Same reporter US-GLAXOSMITHKLINE-US2020091771:Same reporter US-GLAXOSMITHKLINE-US2020091771:Same reporter
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Extensive swelling of vaccinated limb, Gait disturbance, Injection site erythema, Injection site pain
Clinical narrative: Difficulty walking; redness is present on most of the upper thigh; temperature of 100 degrees; Swelling at injection site; Redness at injection site; Warmth at injection site; area is tender to touch; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On 29th May 2020, the patient received Kinrix (intramuscular) .5 ml. On 30th May 2020, 1 days after receiving Kinrix and an unknown time after starting ibuprofen, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site tenderness. On 1st June 2020, the patient experienced walking difficulty, redness of legs and fever. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, injection site tenderness, walking difficulty, redness of legs and fever were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, injection site tenderness, walking difficulty, redness of legs and fever to be related to Kinrix.  Additional details were provided as follows: On 30th May 2020 at 10AM, the patient reported the redness, swelling and warmth to touch at the injection site. The swelling was of a baseball size. On 1st June 2020, 3 days after the vaccination the patient experienced the redness had gotten worse, and the patient had and the temperature of 100 degrees F. The redness was present on most of the upper thigh now the area was tender to touch and patient had difficulty walk. The patient had been taken Ibuprofen, ice and Benadryl. This case was 2 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091774:Same reporter US-GLAXOSMITHKLINE-US2020091764:Same reporter
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Difficulty walking; redness is present on most of the upper thigh; temperature of 100 degrees; Swelling at injection site; Redness at injection site; Warmth at injection site; area is tender to touch; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On 29th May 2020, the patient received Kinrix (intramuscular) .5 ml. On 30th May 2020, 1 days after receiving Kinrix and an unknown time after starting ibuprofen, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site tenderness. On 1st June 2020, the patient experienced walking difficulty, redness of legs and fever. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, injection site tenderness, walking difficulty, redness of legs and fever were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, injection site tenderness, walking difficulty, redness of legs and fever to be related to Kinrix.  Additional details were provided as follows: On 30th May 2020 at 10AM, the patient reported the redness, swelling and warmth to touch at the injection site. The swelling was of a baseball size. On 1st June 2020, 3 days after the vaccination the patient experienced the redness had gotten worse, and the patient had and the temperature of 100 degrees F. The redness was present on most of the upper thigh now the area was tender to touch and patient had difficulty walk. The patient had been taken Ibuprofen, ice and Benadryl. This case was 2 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091774:Same reporter US-GLAXOSMITHKLINE-US2020091764:Same reporter
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling, Rash, Rash erythematous
Clinical narrative: Red rash and swelling at injection site. Rash extended down patients arm to mid forearm. Rash also extend upwards onto the left side and front  of the face.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Headache, Nausea
Clinical narrative: Shortness of breath several days in a row, nausea several days, headaches several days.  Went to emergency room on June 2, 2020 to be treated for symptoms.
Age: 1.33
Sex: M
Vaccine: DT, FLUR4, PNC13
Symptoms: Blood glucose increased, Diabetes mellitus, Pyrexia
Clinical narrative: High fever , desenes, high blood sugar , and he became diabetes
Age: 3.0
Sex: F
Vaccine: DTAP, FLU4, HEP, IPV
Symptoms: Aphasia, Dysphemia, Feeling abnormal, Pyrexia
Clinical narrative: Child's grandma/guardian stated that client began stuttering her speech almost immediately after receiving vaccine. Child is also in a "daze" off and on and has difficulty finding the words to speak per grandma's report. Child also had a 102.0 fever that was treated with Tylenol.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope
Clinical narrative: 1150 shot given 1200 stood up to walk out, said she felt faint, pale face, fainted while standing while staff at side, brought to floor via staff, regained consciousness after about 1 min, maintained airway, cool wash cloth provided, juice given to drink once awake, sitting up and talking
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Impaired work ability, Loss of consciousness, Nausea
Clinical narrative: Around 2000 patient reported that she developed a bad headache that worsened throughout the evening, at 2240 she lost consciousness at home, her sister was there and she regained consciousness within  1-2 minutes. The patient herself doesn't remember. After that she reports feeling dizzy, and nauseated and almost vomited several times through the night, on 6/6/2020 she reports feeling very dizzy and nauseated, she had to leave work early Saturday due to feeling dizzy. 6/7/2020 she continued to feel dizzy, Tylenol helped. 6/8/2020 she reports feeling great.  The Patient did not go to the doctor.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Malaise, Pyrexia, Rash papular
Clinical narrative: fever, papular rash, mild malaise.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Ear pain, Fatigue
Clinical narrative: Sore arm traveling under arm, ribs, breast and other arm, headache ear pain on 06/05/2020 . Went to hospital by ambulance from work. On day two , 06/06/2020swollen face, sore ears, headache, flushing and itchy face, itchy throat, muscle aches, stomach ache, ears ache,fatigue, dizziness, weakness. Went to hospital the second day and given IV meds.  Day three 06/07/2020 still low energy and weak with facial flushing , headache  and ears ache, stomach pain, in afternoon. Day 4, 06/08/2020 still weak and dizzy, body rash headache and ears ache. Went to doctor for follow up and being referred to allergist.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Headache, Myalgia, Pain in extremity, Rash
Clinical narrative: Sore arm traveling under arm, ribs, breast and other arm, headache ear pain on 06/05/2020 . Went to hospital by ambulance from work. On day two , 06/06/2020swollen face, sore ears, headache, flushing and itchy face, itchy throat, muscle aches, stomach ache, ears ache,fatigue, dizziness, weakness. Went to hospital the second day and given IV meds.  Day three 06/07/2020 still low energy and weak with facial flushing , headache  and ears ache, stomach pain, in afternoon. Day 4, 06/08/2020 still weak and dizzy, body rash headache and ears ache. Went to doctor for follow up and being referred to allergist.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Sore arm traveling under arm, ribs, breast and other arm, headache ear pain on 06/05/2020 . Went to hospital by ambulance from work. On day two , 06/06/2020swollen face, sore ears, headache, flushing and itchy face, itchy throat, muscle aches, stomach ache, ears ache,fatigue, dizziness, weakness. Went to hospital the second day and given IV meds.  Day three 06/07/2020 still low energy and weak with facial flushing , headache  and ears ache, stomach pain, in afternoon. Day 4, 06/08/2020 still weak and dizzy, body rash headache and ears ache. Went to doctor for follow up and being referred to allergist.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Injection site bruising, Pain in extremity, Peripheral swelling
Clinical narrative: PAINFUL FOR THE 1ST 2 DAYS THEN SWELLING STARTED 4 DAYS AFTER, FOLLOWED BY BRUISING THAT STARTED ON THE INJECTION SITE AND EXTENDED TO THE WHOLE RIGHT ARM. TO DATE, 06/08/20, THE SWELLLING AND PAIN IS ON THE FOREARM BUT THE WHOLE ARM IS STILL BRUISED.PX JUST INFORMED US ABOUT HIS REACTION TODAY. PX IS JUST TAKING IBUPROFEN,ADVISED PX TO PUT ICE AND SEE HIS PRIMARY DR FOR CHECK UP AND WILL FF-UP WITH PX
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had pain and redness at injection site
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Evening of injection - pain at injection site.  Restless sleep.  Woke up next morning (June 6)  with pain throughout entire body, including toes and fingers.  Also severe headache.  Fever started mid-morning and went from 99.0 to 102.0 by late afternoon.  Fever of 101.5 continued through evening and into sleep.  Slept throughout the day and evening.  Slept through night.  Woke up next morning (June 7) and everything was normal again.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: Evening of injection - pain at injection site.  Restless sleep.  Woke up next morning (June 6)  with pain throughout entire body, including toes and fingers.  Also severe headache.  Fever started mid-morning and went from 99.0 to 102.0 by late afternoon.  Fever of 101.5 continued through evening and into sleep.  Slept throughout the day and evening.  Slept through night.  Woke up next morning (June 7) and everything was normal again.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: pt fainted and hit head
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in left arm after vaccination
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Haematoma, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: swelling, bruising, pain x 1 wk at site of injection, no fever.  Most likely hematoma
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Six months after Shingrix injection I still have some pain, no more like a pain spider web under the injection site spreading down my arm. It is not debilitating but very annoying.  I did have several episodes that felt like a wasp sting at the injection site for about 3 weeks after the shot, one of which was so painful that I almost dropped to my knees, each of those  episodes  lasted about 20 seconds. I've been to see my doctor and she seems to think the injection may have into the dura of the muscle.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Chicken pox virus (fever, rash head to toe). Friday 6/5/2020 fever 102 started. Saturday 6/6/2020 telehealth appointment for fever and spreading rash on knees, dx. idiopathic. Urgent care appt. 6/8/2020 after spreading of rash head to toe and fever persistent (dx of chicken pox).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient  developed  itchy red  bumps on the  left  arm in the  area  of the  injection  site on 6/5/20  which was  one  day  after  vaccination.  She  presented to the office on  6/8/20 with  persistent  rash localized only to the injection  site.    Mom had  applied  hydrocortisone  without improvement.   Pt was  well beyond  mildly pruritic  rash.  She  was prescribed  fluticasone cream  and  oral  benadryl.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: & RASH
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEP, PNC13
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: -Patient was supposed to received first round of imms. -Physician ordered Pentacel (Hib-IPV-DTaP), Hep B, and PCV13. -Instead, pt was given Pediarix (HEP B-IPV-DTap), Hep B, and PCV13. -This occurred in Feb 2020. Noticed by office on June 3, 2020. -Baby had no adverse effects, signs, symptoms, etc.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: June 1-3 Fever 101-103.4 June 4th Macular papular rash on trunk which spread to extremities June 4th in afternoon stiffened extremities & whole body, eyes rolled back - lasted Approx 5 seconds
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site urticaria, Pallor, Vaccination site reaction
Clinical narrative: Had redness blanchable with hives about 1 inch area near vaccine - reaction seen 5 min after administered then resolved by 8 min after administered
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood potassium decreased, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: The night of the vaccine, the patient developed fever, chills emesis and lethargy. He improved in about 2 days but by 3 days later developed sudden onset left sided chest pressure which improved somewhat that day with ice to chest but by next day (now 4 days after vaccine) developed sharp chest pain, with radiation to left shoulder and shortness of breath. In ER, he showed EKG changes, elevated troponin and was diagnosed with myopericarditis; no other cause yet found.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment depression, Electrocardiogram change, Injection site pain
Clinical narrative: The night of the vaccine, the patient developed fever, chills emesis and lethargy. He improved in about 2 days but by 3 days later developed sudden onset left sided chest pressure which improved somewhat that day with ice to chest but by next day (now 4 days after vaccine) developed sharp chest pain, with radiation to left shoulder and shortness of breath. In ER, he showed EKG changes, elevated troponin and was diagnosed with myopericarditis; no other cause yet found.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Lethargy, Myocarditis, Pain, Pyrexia, Troponin increased
Clinical narrative: The night of the vaccine, the patient developed fever, chills emesis and lethargy. He improved in about 2 days but by 3 days later developed sudden onset left sided chest pressure which improved somewhat that day with ice to chest but by next day (now 4 days after vaccine) developed sharp chest pain, with radiation to left shoulder and shortness of breath. In ER, he showed EKG changes, elevated troponin and was diagnosed with myopericarditis; no other cause yet found.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: The night of the vaccine, the patient developed fever, chills emesis and lethargy. He improved in about 2 days but by 3 days later developed sudden onset left sided chest pressure which improved somewhat that day with ice to chest but by next day (now 4 days after vaccine) developed sharp chest pain, with radiation to left shoulder and shortness of breath. In ER, he showed EKG changes, elevated troponin and was diagnosed with myopericarditis; no other cause yet found.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: fever to 103'F
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Joint swelling, Peripheral swelling, Vaccination complication
Clinical narrative: pain redness swelling that extended below the elbow to mid forearm hot to the touch
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: pain redness swelling that extended below the elbow to mid forearm hot to the touch
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blister, Hypersensitivity, Influenza like illness, Rash erythematous
Clinical narrative: Patient developed flu-like symptoms the day after the injection.  She subsequently noticed an axillary rash on the left side, which was not contiguous with the injection site.  The rash consisted of a large area of confluent erythema with several bullae.  Biopsy was performed by dermatology showing many eosinophils consistent with an allergic reaction.  The patient had not received any additional vaccinations or new medications at the time of or shortly prior to onset.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 5/19/2020.; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, concomitant therapy, drug reaction, and allergies was not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, administered by oral route (dose, and vaccination scheme were not reported; lot number S013890, which has been verified to be valid, expiration date reported and validated as 14-FEB-2021) as prophylaxis (product storage error).  The administered dose of the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in a temperature of 12.1 degrees Celsius for 16 hours and 11 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 21-MAY-2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot number 1660704 which has been verified to be valid, expiration date reported and validated as 20-MAR-2021; route, dose and vaccination scheme frequency were not reported) (improper storage of product in use). No additional adverse event (AE) information provided.  The administered dose of the vaccine was exposed to temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. Data logger was involved. There was no previous temperature excursion. The outcome of the event improper storage of product in use was unknown.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; Administered improperly stored VARIVAX; Information has been received from a certified medical assistant concerning to a 4 year old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 18-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration not reported), Lot No. S024369, exp. date 06-AUG-2021 or S032356, exp. date 14-OCT-2021 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot number S016837, exp. date 01-FEB-2022, S032591, exp. date 16-AUG-2022 or T000495, exp date. 03-JUN-2022 (the report did not know exact used lot numbers, so she reported all possible numbers). No adverse event was reported.   Temperature/timeframe: -9°C to 8°C: -7.18°C for 30 hours Previous temperature excursion: Yes, -14°C to -10°C: -10.44°C, multiple for 2 hours; -50°C: -14.79°C, multiple to -15°C for 1 hour. Call was made because of data logger.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces, Dermatitis diaper, Diarrhoea, Eczema, Flatulence
Clinical narrative: Eczema; Diaper rash; puffy eyes; Mucous poop; Mucous poop that had vinegar like smell; Irritability; Gas; Daytime sleepiness; Inconsistent sleep; Vomiting; Diarrhea; This spontaneous report was received from the patient's mother and refers to her 9-week-old male son. The patient's concurrent conditions included acid reflux, dairy allergy and allergy to cows milk and protein. No information was reported regarding the patient's historical conditions. Concomitant therapies included famotidine.  On 11-MAR-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally as standard vaccination for rotavirus (lot number and expiration date were not reported).  Then on 12-MAR-2020, the patient began to experience multiple symptoms such as vomiting for a week and a half, diaper rash (normally he did not have diaper rash), puffy eyes, diarrhea, mucous poop that had vinegar like smell, irritability, gas, daytime sleepiness and inconsistent sleep (he would wake up about 5 times a night). Patient then recovered on unspecified date in March 2020 reported as "about a week and a half after receiving first dose". Subsequently, on 07-MAY-2020, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ). Then on 08-MAY-2020, the patient experienced the same symptoms listed above as well as a little bit of eczema on unspecified body part. Patient fully recovered from second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) on 17-MAY-2020. The patient's mother did not seek medical attention for her son and no treatments were administered for the events. No laboratory tests were conducted. Causality assessment was not reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Irritability, Middle insomnia, Mucous stools, Periorbital swelling, Somnolence
Clinical narrative: Eczema; Diaper rash; puffy eyes; Mucous poop; Mucous poop that had vinegar like smell; Irritability; Gas; Daytime sleepiness; Inconsistent sleep; Vomiting; Diarrhea; This spontaneous report was received from the patient's mother and refers to her 9-week-old male son. The patient's concurrent conditions included acid reflux, dairy allergy and allergy to cows milk and protein. No information was reported regarding the patient's historical conditions. Concomitant therapies included famotidine.  On 11-MAR-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally as standard vaccination for rotavirus (lot number and expiration date were not reported).  Then on 12-MAR-2020, the patient began to experience multiple symptoms such as vomiting for a week and a half, diaper rash (normally he did not have diaper rash), puffy eyes, diarrhea, mucous poop that had vinegar like smell, irritability, gas, daytime sleepiness and inconsistent sleep (he would wake up about 5 times a night). Patient then recovered on unspecified date in March 2020 reported as "about a week and a half after receiving first dose". Subsequently, on 07-MAY-2020, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ). Then on 08-MAY-2020, the patient experienced the same symptoms listed above as well as a little bit of eczema on unspecified body part. Patient fully recovered from second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) on 17-MAY-2020. The patient's mother did not seek medical attention for her son and no treatments were administered for the events. No laboratory tests were conducted. Causality assessment was not reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Eczema; Diaper rash; puffy eyes; Mucous poop; Mucous poop that had vinegar like smell; Irritability; Gas; Daytime sleepiness; Inconsistent sleep; Vomiting; Diarrhea; This spontaneous report was received from the patient's mother and refers to her 9-week-old male son. The patient's concurrent conditions included acid reflux, dairy allergy and allergy to cows milk and protein. No information was reported regarding the patient's historical conditions. Concomitant therapies included famotidine.  On 11-MAR-2020, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally as standard vaccination for rotavirus (lot number and expiration date were not reported).  Then on 12-MAR-2020, the patient began to experience multiple symptoms such as vomiting for a week and a half, diaper rash (normally he did not have diaper rash), puffy eyes, diarrhea, mucous poop that had vinegar like smell, irritability, gas, daytime sleepiness and inconsistent sleep (he would wake up about 5 times a night). Patient then recovered on unspecified date in March 2020 reported as "about a week and a half after receiving first dose". Subsequently, on 07-MAY-2020, the patient received a second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ). Then on 08-MAY-2020, the patient experienced the same symptoms listed above as well as a little bit of eczema on unspecified body part. Patient fully recovered from second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) on 17-MAY-2020. The patient's mother did not seek medical attention for her son and no treatments were administered for the events. No laboratory tests were conducted. Causality assessment was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; improperly stored doses of MMRII and VARIVAX; This spontaneous report has been received from an administrator reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (M-M-R II) for prophylaxis lot number S014430  and expiration date 09-MAY-2021 (dose and route of administration were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis lot number S032354 and expiration date 14-OCT-2021 (dose and route of administration were not reported). No additional adverse effects reported.  It was reported that on an unspecified date, the vaccines were exposed to an unspecified temperature for 20 hours. The reporter stated that there was no previous temperature excursion. The call was not placed because of a Digital Data logger report.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: On an unspecified date a nurse administered MMRII and VARIVAX to an unspecified 5 month old child; No adverse effects reported; This spontaneous report was received from a registered nurse concerning a 5 month old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route of administration, lot number and expiration date were not provided) and with varicella virus vaccine live (oka/merck)(VARIVAX)  (strength, dose, frequency, route of administration, lot number and expiration date were not provided), both vaccines for prophylaxis (product administered to patient of inappropriate age).       No adverse effects reported.
Age: 77.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Pt was administered two shots at same time. During Pneumovax  injection a needle malfunction happened in which the medication was not able to be ejected.  New needle was applied and then administered with no issues.  Pt said she then went shopping for approximately 45 minutes.  Upon returning home began to unpack groceries at which time her arm became extremely sore from her "collarbone to the palms of her hand" of the arm she got the vaccines in.  Swelling and bruising have occurred at injection site.  Pt stated that she had a mild fever, maxing out at 100.1F.  Pain was self described as an 8 out of 10.  Arm was still bruised and swollen on 6/8/20.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient developed fever of 101.7 in addition to injection site redness, bruising, swelling and warmth.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash, Rash & UrticariaPruritus
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Dehydration, Dizziness, Erythema, Headache
Clinical narrative: His appointment was at 10:30 am by noon his arm was completely swollen to the size of a tennis ball. It was hard and red, complained about feeling lightheaded and having a headache. I gave him the Benadryl around 5:30 when I got off work. before that he had taken some Motrin because that was all we had at home. He is still complaining say his stomach hurts and he feels dehydrated.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Induration, Peripheral swelling
Clinical narrative: His appointment was at 10:30 am by noon his arm was completely swollen to the size of a tennis ball. It was hard and red, complained about feeling lightheaded and having a headache. I gave him the Benadryl around 5:30 when I got off work. before that he had taken some Motrin because that was all we had at home. He is still complaining say his stomach hurts and he feels dehydrated.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Disorientation, Dizziness, Eye movement disorder, Pallor
Clinical narrative: Patient was given vaccine and felt dizzy, disoriented, eyes rolled, and she was pale. We encouraged her to lay down and we monitored vitals and patient status for 30 minutes. Patients vitals were WNL and patient received follow up phone call from dr that evening and patients mother reported patient is doing well.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pain, Paraesthesia
Clinical narrative: Woke up around midnight with chills and fever.  Took my temperature and it was 102.2.  My legs and arms were also tingling and my body was very achy.  I also felt weak and tired.  I took 2 500 MG Acetaminophen and went back to bed.  Woke up a few hours later and took my temperature and it was down to 100.  Woke up in the morning and took my temperature and it was back to normal.  I felt better and the reactions to the Zoster vaccine had subsided.