chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site rash, Injection site urticaria, Pruritus, Rash, Urticaria
Clinical narrative: Hives, Rash. Started on Upper Right arm then the next day was lower right arm. Next day and upper left arm. then lower left arm and back. Now a little on face. Seems to spread slowly. Very itchy. Hot water applied relieve the itch. Benadryl doesn't help much. Hydrocortisone cream does help some. I can't really tell if it is subsiding yet.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Less than an hour later, arm started to swell. By night time, swollen, red, itching and red spots, down to the elbow. Lasted for nine days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Redness, tender, warm to touch, no fever Area of tenderness approximately 2-3 inches.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Rd deltoid erythema and induration - Approximately 10 centimeters. after MCV4 IM injection.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Accidentally gave expired immunization. Monitored patient for 1 hour. No adverse effects noted. Informed patient to notify anything out of the ordinary. Patient voiced understanding.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports redness/swelling the size of a grapefruit at injection site as well as the site being hot to the touch, within 24 hours of injection.  States that it was painful.  Says that it has gone down and seems to be getting better.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Accidentally gave expired immunization. Monitored patient for 1 hour. No adverse effects noted. Informed patient to notify anything out of the ordinary. Patient voiced understanding.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Accidentally gave expired immunization. Monitored patient for 1 hour. No adverse effects noted. Informed patient to notify anything out of the ordinary. Patient voiced understanding.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Aphasia, Autism spectrum disorder, Bowel movement irregularity, Decreased eye contact, Laboratory test
Clinical narrative: Shortly following this vaccine (all vaccines actually, including his 2 month old one that resulted in skin issues, his MMR that resulted in loss of eye contact, following this one he stopped speaking, stopped drinking out of a cup, and has not had a regular bowel movement since.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Regressive behaviour
Clinical narrative: Shortly following this vaccine (all vaccines actually, including his 2 month old one that resulted in skin issues, his MMR that resulted in loss of eye contact, following this one he stopped speaking, stopped drinking out of a cup, and has not had a regular bowel movement since.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder Pain and reduced range of motion since immunization on 12/19/2019. Patient has been exercising to increase range of motion. Pain level has decreased but is still present.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Influenza, Pain
Clinical narrative: Started getting terrible headache in early evening the afternoon I received the vaccine.  Next morning (6/16/20) woke up with fever of 100.3 (my normal temp is 97.4) with sharp pains in my head, achy and exhausted.  I got up for one hour and went back to bed.  It felt like I had a terrible case of the flu.  Slept most of the day and could only eat applesauce and chicken noodle soup.  Fever went down 2 degrees by 9:00 PM.  Very slight fever when I woke up but it subsided as of 10:30 AM
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Started getting terrible headache in early evening the afternoon I received the vaccine.  Next morning (6/16/20) woke up with fever of 100.3 (my normal temp is 97.4) with sharp pains in my head, achy and exhausted.  I got up for one hour and went back to bed.  It felt like I had a terrible case of the flu.  Slept most of the day and could only eat applesauce and chicken noodle soup.  Fever went down 2 degrees by 9:00 PM.  Very slight fever when I woke up but it subsided as of 10:30 AM
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: unspecified patient received a dose of improperly stored VARlVAX; This spontaneous report as received from a vaccine coordinator and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 09-JUN-2020, the patient was vaccinated with one dose of improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032351, expiration date of 14-OCT-2021, for prophylaxis. STERILE DILUENT used for reconstitution of vaccine was properly stored.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2013, plaintiff was inoculated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) as prescribed and/or administered by a pharmacist for the long term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequently to Plaintiff's zoster vaccine live (ZOSTAVAX) inoculation, plaintiff was treated at a medical office for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX), Plaintiff had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not provided.  The lawyer considered shingles to be related to  zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain, Social problem
Clinical narrative: painfull; made me sick; first dose in November. Waited until March for the second dose but then we had a pandemic; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain, sickness and social problem. On an unknown date, the outcome of the pain, sickness and social problem were unknown.   It was unknown if the reporter considered the pain and sickness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient stated that 1st dose was very painful and made patient sick. The patient waited until march for the second dose but then had a pandemic and pharmacist could not give second dose. It had been 8 months and second shot was available. The patient wanted to know would it work or need to start over. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Eye pain, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: eye socket pain; vision changes, including a dark area in her left vision field/eye vision began to see "fireworks'; left-sided jaw pain; tenderness of scalp; temporal daily headaches; numbness on left jaw; optic nerve stroke; lost total vision in her left eye; Optic nerve swelling in her left eye; This case was reported by a lawyer and described the occurrence of loss of vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix.   On 15th November 2018, the patient received Shingrix (unknown). On 9th December 2018, 24 days after receiving Shingrix, the patient experienced optic nerve edema (serious criteria GSK medically significant). On 7th January 2019, the patient experienced loss of vision (serious criteria GSK medically significant). On 9th January 2019, the patient experienced optic nerve infarction (serious criteria GSK medically significant). On 21st January 2019, the patient experienced aching eye socket, scalp tenderness, temporal headache, numbness and sleep disorder. On an unknown date, the patient experienced visual disturbance. On an unknown date, the outcome of the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder were unknown.   It was unknown if the reporter considered the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder to be related to Shingrix.  Additional details: On or about 18 July 2018, plaintiff received the first dose of the Shingrix vaccine and about 15  November 2018, Plaintiff received the second dose of the Shingrix vaccine. Shortly after receiving the second dose, Plaintiff began noticing vision changes,including a dark area in her left vision field. On or about 9 December 2018, Plaintiff went for her annual eye exam. Optic nerve swelling in her left eye was found and an urgent referral was made to an neuroophthalmologist. After more testing was done, her left eye vision began to see fireworks and she experienced eye socket pain. She was told that the vaccine was so new that there were not any guidelines available for treatment. On or about7  January 2019, Plaintiff lost total vision in her left eye which was not recovered. On 9 January 2019, she was seen by Dr. and it was thought she had an optic nerve stroke. On 21 January 2019, Plaintiff began to experience new symptoms including tenderness of scalp, temporal pain While sleeping, numbness 0n left jaw, and temporal daily headaches. The plaintiff had left side jaw pain which was not recovered. These symptoms continued and it was opined by the medical professionals that the symptoms were a direct result of the Shingrix vaccine. Plaintiff to this day still experiences left-sided jaw pain, left-sided eye socket pressure, frequent headaches, and has permanent Vision loss in her left eye.
Sex: F
Vaccine: VARZOS
Symptoms: Ocular discomfort, Ophthalmological examination abnormal, Optic nerve infarction, Pain in jaw, Pain of skin
Clinical narrative: eye socket pain; vision changes, including a dark area in her left vision field/eye vision began to see "fireworks'; left-sided jaw pain; tenderness of scalp; temporal daily headaches; numbness on left jaw; optic nerve stroke; lost total vision in her left eye; Optic nerve swelling in her left eye; This case was reported by a lawyer and described the occurrence of loss of vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix.   On 15th November 2018, the patient received Shingrix (unknown). On 9th December 2018, 24 days after receiving Shingrix, the patient experienced optic nerve edema (serious criteria GSK medically significant). On 7th January 2019, the patient experienced loss of vision (serious criteria GSK medically significant). On 9th January 2019, the patient experienced optic nerve infarction (serious criteria GSK medically significant). On 21st January 2019, the patient experienced aching eye socket, scalp tenderness, temporal headache, numbness and sleep disorder. On an unknown date, the patient experienced visual disturbance. On an unknown date, the outcome of the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder were unknown.   It was unknown if the reporter considered the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder to be related to Shingrix.  Additional details: On or about 18 July 2018, plaintiff received the first dose of the Shingrix vaccine and about 15  November 2018, Plaintiff received the second dose of the Shingrix vaccine. Shortly after receiving the second dose, Plaintiff began noticing vision changes,including a dark area in her left vision field. On or about 9 December 2018, Plaintiff went for her annual eye exam. Optic nerve swelling in her left eye was found and an urgent referral was made to an neuroophthalmologist. After more testing was done, her left eye vision began to see fireworks and she experienced eye socket pain. She was told that the vaccine was so new that there were not any guidelines available for treatment. On or about7  January 2019, Plaintiff lost total vision in her left eye which was not recovered. On 9 January 2019, she was seen by Dr. and it was thought she had an optic nerve stroke. On 21 January 2019, Plaintiff began to experience new symptoms including tenderness of scalp, temporal pain While sleeping, numbness 0n left jaw, and temporal daily headaches. The plaintiff had left side jaw pain which was not recovered. These symptoms continued and it was opined by the medical professionals that the symptoms were a direct result of the Shingrix vaccine. Plaintiff to this day still experiences left-sided jaw pain, left-sided eye socket pressure, frequent headaches, and has permanent Vision loss in her left eye.
Sex: F
Vaccine: VARZOS
Symptoms: Papilloedema, Sleep disorder, Visual impairment
Clinical narrative: eye socket pain; vision changes, including a dark area in her left vision field/eye vision began to see "fireworks'; left-sided jaw pain; tenderness of scalp; temporal daily headaches; numbness on left jaw; optic nerve stroke; lost total vision in her left eye; Optic nerve swelling in her left eye; This case was reported by a lawyer and described the occurrence of loss of vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix.   On 15th November 2018, the patient received Shingrix (unknown). On 9th December 2018, 24 days after receiving Shingrix, the patient experienced optic nerve edema (serious criteria GSK medically significant). On 7th January 2019, the patient experienced loss of vision (serious criteria GSK medically significant). On 9th January 2019, the patient experienced optic nerve infarction (serious criteria GSK medically significant). On 21st January 2019, the patient experienced aching eye socket, scalp tenderness, temporal headache, numbness and sleep disorder. On an unknown date, the patient experienced visual disturbance. On an unknown date, the outcome of the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder were unknown.   It was unknown if the reporter considered the loss of vision, optic nerve infarction, optic nerve edema, aching eye socket, scalp tenderness, temporal headache, numbness, visual disturbance and sleep disorder to be related to Shingrix.  Additional details: On or about 18 July 2018, plaintiff received the first dose of the Shingrix vaccine and about 15  November 2018, Plaintiff received the second dose of the Shingrix vaccine. Shortly after receiving the second dose, Plaintiff began noticing vision changes,including a dark area in her left vision field. On or about 9 December 2018, Plaintiff went for her annual eye exam. Optic nerve swelling in her left eye was found and an urgent referral was made to an neuroophthalmologist. After more testing was done, her left eye vision began to see fireworks and she experienced eye socket pain. She was told that the vaccine was so new that there were not any guidelines available for treatment. On or about7  January 2019, Plaintiff lost total vision in her left eye which was not recovered. On 9 January 2019, she was seen by Dr. and it was thought she had an optic nerve stroke. On 21 January 2019, Plaintiff began to experience new symptoms including tenderness of scalp, temporal pain While sleeping, numbness 0n left jaw, and temporal daily headaches. The plaintiff had left side jaw pain which was not recovered. These symptoms continued and it was opined by the medical professionals that the symptoms were a direct result of the Shingrix vaccine. Plaintiff to this day still experiences left-sided jaw pain, left-sided eye socket pressure, frequent headaches, and has permanent Vision loss in her left eye.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Inappropriate schedule of product administration, Malaise, Oropharyngeal pain
Clinical narrative: second dose in error; fatigued / tired; sore throat; fever; was very sick; played very low all weekend; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 28-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Concomitant products included HBV (Engerix B adult).   On 4th June 2020, the patient received the 2nd dose of Engerix B adult. On 4th June 2020, the dose was an unknown dose. On 4th June 2020, unknown after receiving Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short. In June 2020, the patient experienced fatigue, sore throat, fever, sickness and weakness. On an unknown date, the outcome of the fatigue was not recovered/not resolved and the outcome of the sore throat, fever, sickness, weakness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fatigue, sore throat, fever, sickness and weakness to be related to Engerix B adult.  Additional details were provided as follows: The reporter stated that, after vaccination, the patient was very sick over the weekend with a fever, sore throat, very fatigued. The patient played very low all weekend. The patient received 1st dose on 1st June 2020 and 2nd dose on 4th June 2020, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: second dose in error; fatigued / tired; sore throat; fever; was very sick; played very low all weekend; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 28-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Concomitant products included HBV (Engerix B adult).   On 4th June 2020, the patient received the 2nd dose of Engerix B adult. On 4th June 2020, the dose was an unknown dose. On 4th June 2020, unknown after receiving Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short. In June 2020, the patient experienced fatigue, sore throat, fever, sickness and weakness. On an unknown date, the outcome of the fatigue was not recovered/not resolved and the outcome of the sore throat, fever, sickness, weakness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fatigue, sore throat, fever, sickness and weakness to be related to Engerix B adult.  Additional details were provided as follows: The reporter stated that, after vaccination, the patient was very sick over the weekend with a fever, sore throat, very fatigued. The patient played very low all weekend. The patient received 1st dose on 1st June 2020 and 2nd dose on 4th June 2020, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Pallor
Clinical narrative: Redness from right thigh to knee; Hives from right thigh to knee; Blanchness from right thigh to knee; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL) (PEDVAX HIB), PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) and ROTAVIRUS VACCINE (ROTATEQ).   On 8th June 2020, the patient received the 1st dose of Pediarix (intramuscular) .5 ml. On 8th June 2020, 5 min after receiving Pediarix, the patient experienced erythema, hives and blanching of skin. On an unknown date, the outcome of the erythema, hives and blanching of skin were unknown.   It was unknown if the reporter considered the erythema, hives and blanching of skin to be related to Pediarix.  Additional details were provided as follows: The patient was administered Pediarix in the right thigh and was also administered Pedvax Hib and Prevnar 13 in the left thigh and Rotateq was given orally. About 5 minutes after vaccination patient experienced redness, hives and blanchness from the right thigh down to her knee. The patient described blanchness as redness turning into white area upon touching. No other details were provided.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: CH3594, Expiry Date: Feb2022, injection, NDC number: 0005197101), intramuscularly on 04Jun2020 at 0.5 mL, single for immunization. Medical history and concomitant medications were none. The patient experienced cellulitis on 04Jun2020. The reporter stated that the patient was prescribed antibiotics which was used to treat the cellulitis. The reporter was unsure if this was still an ongoing problem for the patient. The outcome of the event was unknown.; Sender's Comments: A contributory role of suspect vaccine PREVNAR 13 could not be completely ruled out for the onset of cellulitis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Discomfort, Feeling abnormal, Feeling cold
Clinical narrative: report as per patient: Hi Dr:   Wanted you to know I had not a good reaction to the 2nd Shingrix vaccination yesterday.  And would like you to report this adverse reaction to the manufacturer, if that's the proper way  to do this.  It started with my left arm, where you injected it, beginning to feel sore by 6 PM, as I was returning home after visiting an old friend in your office's  neighborhood for a couple of hours outdoors.  I actually began to feel a bit cold before I left, bc the temperatures were dropping, but then in the subway back home, the AC was blowing quite hard, further adding to my feeling cold.    I got home a half hour later, and felt my whole arm now sore, but as the night wore on, I continued to feel cold, having inadvertently getting a cold drink bc I was thirsty and then having a ceiling fan blowing on me while I attended a Zoom meeting I had scheduled, so I couldn't really get up to turn it off.  I was still quite chilled by 8:30 as I began to make something for dinner, then later that night most of my joints began to feel achy and I felt like I was 100 lbs heavier till very late at night.  It was really strange, scaring me a bit, where I almost called your service to report how I was feeling.     What do you think about this?  Now bc of this reaction, I'm somewhat more concerned about getting on the Ocrevus and possibly having another adverse reaction, in July.  Your thoughts, please.  I will send this same email to Dr, so she knows what happened & my concerns.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: report as per patient: Hi Dr:   Wanted you to know I had not a good reaction to the 2nd Shingrix vaccination yesterday.  And would like you to report this adverse reaction to the manufacturer, if that's the proper way  to do this.  It started with my left arm, where you injected it, beginning to feel sore by 6 PM, as I was returning home after visiting an old friend in your office's  neighborhood for a couple of hours outdoors.  I actually began to feel a bit cold before I left, bc the temperatures were dropping, but then in the subway back home, the AC was blowing quite hard, further adding to my feeling cold.    I got home a half hour later, and felt my whole arm now sore, but as the night wore on, I continued to feel cold, having inadvertently getting a cold drink bc I was thirsty and then having a ceiling fan blowing on me while I attended a Zoom meeting I had scheduled, so I couldn't really get up to turn it off.  I was still quite chilled by 8:30 as I began to make something for dinner, then later that night most of my joints began to feel achy and I felt like I was 100 lbs heavier till very late at night.  It was really strange, scaring me a bit, where I almost called your service to report how I was feeling.     What do you think about this?  Now bc of this reaction, I'm somewhat more concerned about getting on the Ocrevus and possibly having another adverse reaction, in July.  Your thoughts, please.  I will send this same email to Dr, so she knows what happened & my concerns.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction. Parent was contacted and made aware of situation. No signs or symptoms have been reported at this time.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: on 6/17/2020  patient called the pharmacy to let us know that she was experiencing a localized reaction to a Pneumovax 23 shot she received on 6/16/2020.  Patient stated that the injection site was red and the area was swollen.  Patient stated no allergies on questionaire.    (Rph) initially spoke with patient about her concern and told the patient to take some Benadryl and to apply a compress for the swelling.  Also she would continue to follow up with her for a few days to monitor her reaction.  I administered the shot and called the patient back to ler her know we would also notify her family dr and report this reaction to VARES.  She thanked me for her concern.    on 6/17/2020:  I called patient's family dr and spoke to agent about the reaction.  She said she would let Dr. aware of the situation.    We will continue to follow up with the patient to monitor progress/reaction from the shot.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pain, Pyrexia, Rash, Skin lesion
Clinical narrative: 6/13/20- MOC brought in pt in clinic  c/o fever, rash a few days post vaccination. Rash started on neck and spread down to body per mom. Ibuprofen was prescribed for pain/fever. Triple antibiotic was also recommended for lesion. Pt was followed up on 6/15/20 via Telehealth. Provider prescribed Benadryl and Calamine lotion. Pt has another follow appt scheduled on 6/22/20.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored ROTATEQ was administered to a patient; No additional adverse effects were reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.    On 12-MAR-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S017642 (also reported as A017642, conflicting information) and expiration date 28-FEB-2021, 1 dosage form, oral (dose was not reported) for prophylaxis.   Temperature: 11.4 °C (Celsius degrees); Timeframe: 1 hour; no previous temperature excursions with digital data logger involved. No adverse events were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; improperly stored vaccines were administered to patient; This spontaneous report was received from a nurse referring to a 4 years-old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       It was reported that on 03-DEC-2019, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 04-MAR-2020, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-2006USA003314:same reporter US-009507513-2006USA005617:same reporter US-009507513-2006USA005620:same reporter US-009507513-1912USA001555:same reporter
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; improperly stored vaccines were administered to patient; This spontaneous report was received from a nurse referring to a 15 months-old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       It was reported that on 03-DEC-2019, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 09-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-1912USA001555:same reporter US-009507513-2006USA005616: US-009507513-2006USA003314: US-009507513-2006USA005620: US-009507513-2006USA005616:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; improperly stored vaccines were administered to patient; This spontaneous report was received from a nurse referring to a 12 months old, patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.       It was reported that on 03-DEC-2019, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and  the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 18-FEB-2020, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026719 has been verified to be a valid number; expiration date 17-MAR-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003313:same reporter US-009507513-1912USA001555: US-009507513-2006USA003314: US-009507513-2006USA005616: US-009507513-2006USA005620:
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; improperly stored vaccines were administered to patients; This spontaneous report was received from a nurse referring to a 3 years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.   It was reported that on 03-DEC-2019, varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138) was under temperature excursion at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (8.7 F), for a time frame of 50 minutes, and the previous temperature excursion was at 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees centigrade (C) to -10 degrees C) (6.9 F) for a timeframe of 50 minutes. On 06-DEC-2019 , the patient was vaccinated with improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R018138 has been verified to be a valid number; expiration date 25-JUN-2020) for prophylaxis (strength, dose, frequency, route of administration, anatomical location were not reported). It was reported that the call was due to data logger. No adverse symptoms were reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA001555:same reporter US-009507513-2006USA003314:same reporter US-009507513-2006USA005617: US-009507513-2006USA005616:same reporter US-009507513-2006USA005618: US-009507513-2006USA003313:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: arm became sore at the injection site.; headache; sweating; nausea; feeling cold; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th January 2021) for prophylaxis.   On 16th April 2020 16:30, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2020, 11 hrs after receiving Shingrix, the patient experienced headache, sweating, nausea, feeling cold and fever. On 16th April 2020, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, headache, sweating, nausea and fever were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, sweating, nausea, feeling cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and described that a couple of hours later, her left arm became sore at the injection site.   It was still sore at the same location. On 17th April 2020 at around 4.30pm, the patient woke up and was experiencing body aches, fever of 100.6, headache, sweating, nausea, and feeling cold.  The sweating and fever have resolved and the nausea is a little less.   However, she still has the other symptoms. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: arm became sore at the injection site.; headache; sweating; nausea; feeling cold; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th January 2021) for prophylaxis.   On 16th April 2020 16:30, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2020, 11 hrs after receiving Shingrix, the patient experienced headache, sweating, nausea, feeling cold and fever. On 16th April 2020, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, headache, sweating, nausea and fever were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, sweating, nausea, feeling cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and described that a couple of hours later, her left arm became sore at the injection site.   It was still sore at the same location. On 17th April 2020 at around 4.30pm, the patient woke up and was experiencing body aches, fever of 100.6, headache, sweating, nausea, and feeling cold.  The sweating and fever have resolved and the nausea is a little less.   However, she still has the other symptoms. The reporter consented to follow up.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient received two doses of the Dtap-IPV portion of Pentacel vaccine without Act-hib powder, no AE; Initial information received on 09-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a nine month old male patient who received a 0.5mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTaP-IPV portion: lot CH3594 and expiry date: 22-Feb-2022 received) and (ACT-HIB portion: lot U6218AA and UJ015AA and expiry date: 26-Oct-2020) via an intramuscular route at an unknown administration site on Jan-2020 and Mar-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) Lot number: CH3594, expiry date: 22-Feb-2022 on Jan-2020 and (Lot number and expiry date) on Mar-2020 for prophylactic vaccination.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the patient possibly received 2 doses of the Dtap-IPV portion along with due to having a missing Dtap-IPV portion, with out Act-Hib powder of Pentacel in Jan-2020.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 22.0
Sex: U
Vaccine: MMR, MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: a patient was given a third injection of Menactra, no AE; a patient was given a third injection of Menactra instead of a MMR vaccination, no AE; Initial information received on 10-Jun-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 22 year old patient who was given a 0.5 ml third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6576AB and Exp. Date 04-Apr-2021) via an unknown route in the left deltoid for prophylactic vaccination instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (extra dose administered and wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to extra dose administered and wrong vaccine administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: nurse accidentally gave Adacel as a 4th dose of Daptacel to a 14 month old female patient, no adverse event; nurse accidentally gave Adacel as a 4th dose of Daptacel to a 14 month old female patient, no adverse event; Initial information received on 11-Jun-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 14 month old female patient who was vaccinated with the 0.5 ml first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Prefilled Syringe, batch number: U6668AA and expiration date 30-Apr-2022) via an intramuscular route at an unknown administration site on 09-Jun-2020 for prophylactic vaccination instead of the fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient's concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]), HIB VACCINE CONJ (TET TOX) (ACT-HIB), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) and HEPATITIS A VACCINE INACT (HAVRIX) dose received on 09-Jun-2020 for prophylactic vaccination  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  There was no adverse event following medication error.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Acthib was administered to patient and sterile diluent was used, no AE; Initial information received on 12-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer/ non health care professional (Office staff).  This case involves patient (unknown demoghraphic) who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  It was an actual medication error case due to Wrong solution used in drug reconstitution (product preparation issue). It was reported that the Acthib was administered and sterile diluent was used and Sterile Water was used to reconstitute ActHIB and it was administered to a patient.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 1.5
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of Quadracel was inadvertently administered to an 18 month old/ No AE; Initial information was received on 15-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves an 18-month-old female patient who was inadvertently administered a first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [lot C5635AA, expiry date: 18-Jun-2021] via an unknown route and administration site for on 15-Jun-2020 prophylactic vaccination.  Medical history, medical treatment, previous vaccination and family history were not provided. It was reported that, on an unknown date, the patient received Hepatitis as concomitant vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.