chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Balance disorder, Fall, Heart rate irregular, Hyperhidrosis, Mydriasis
Clinical narrative: Patient was wobbly/falling down and describing vision being "pixelated". Pupils were dilated and I was not able to find a steady pulse. He became sweaty and was complaining of extreme thirst. I had staff call 911 and gave 1 EPIPEN IM in left thigh and 50mg diphenhydramine in right thigh. Medics arrived and took over situation. Patient picked up by a friend about half hour later. Medics advised him to go to ER if symptoms returned.
Age: 21.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Thirst, Visual impairment
Clinical narrative: Patient was wobbly/falling down and describing vision being "pixelated". Pupils were dilated and I was not able to find a steady pulse. He became sweaty and was complaining of extreme thirst. I had staff call 911 and gave 1 EPIPEN IM in left thigh and 50mg diphenhydramine in right thigh. Medics arrived and took over situation. Patient picked up by a friend about half hour later. Medics advised him to go to ER if symptoms returned.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Haemorrhage, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Pt's right arm bled, felt like it hit bone. About 6 hours after, the pt's arm itched, felt hot, and hurt. This continued for about 24 hours. No medical treatment sought, no fever.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Dry skin, Rash generalised, Skin exfoliation
Clinical narrative: All over body rash resulting in dry, peeling skin.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure increased, Dizziness, Gait disturbance, Malaise, Skin odour abnormal
Clinical narrative: Approximately 10 minutes after vaccination, the client complained of dizziness, shakiness, difficulty walking, and blurred vision. Blood pressure was 144/104. Patient reported a history of high blood pressure and that she had not eaten prior to vaccination. While attending to the client after she began feel ill, I noticed that she smelled like marijuana. After approximately 30 minutes the client had a small improvement in symptoms but her blood pressure remained elevated at 142/98. She called family for a ride home and required 2 staff members to walk her to the car. On 11/9/17, the client called the clinic and told us that she went to the hospital and was admitted due to her elevated blood pressures.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Tremor, Vision blurred
Clinical narrative: Approximately 10 minutes after vaccination, the client complained of dizziness, shakiness, difficulty walking, and blurred vision. Blood pressure was 144/104. Patient reported a history of high blood pressure and that she had not eaten prior to vaccination. While attending to the client after she began feel ill, I noticed that she smelled like marijuana. After approximately 30 minutes the client had a small improvement in symptoms but her blood pressure remained elevated at 142/98. She called family for a ride home and required 2 staff members to walk her to the car. On 11/9/17, the client called the clinic and told us that she went to the hospital and was admitted due to her elevated blood pressures.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Adverse Event: Swelling of right upper arm from injection site down to elbow (19 cm lateral arm) with redness. Treatment: Benadryl every 6 hours as needed. Outcome: To be determined.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Red, swollen, inflamed and splotchey area around the injection site was noticed about 36-48 hours after the vaccinations. The thigh that had the reaction had the HepA and PCV13 vaccines. The Varicella did not cause any reaction because it was given by itself in the opposite thigh. After 72 hours, the red, swollen, inflamed area had grown to double the size and was larger than the size of my fist. The pediatrician was notified 3/10/17 and I was informed to give benadryl, motrin and warm baths to work the leg out. The reaction started to subside about 4 to 5 days after the vaccines were given.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Clinical staff person reconstituted vaccine using sterile diluent instead of correct liquid reagent that is provided in the MENVEO package. Patient was informed and came back to get revaccinated.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Reaction to 6/14/17 shots seen 6/15/17 and called pediatrician immediately. Red, swollen, inflamed and splotchy area around the injection site was noticed about 24 hours after the vaccinations. The thigh that received the MMR vaccine did not have a reaction, it was the thigh that received the Hib that showed the reaction. After 48 hours, the red, swollen, inflamed area had tripled in size and was the size of a large grapefruit. The reaction grew larger and faster than the reaction that was produced with the 03/08/17 vaccinations. The pediatrician was notified 6/15/17 and I was informed to give BENADRYL, MOTRIN and warm baths to work the leg out. The reaction started to subside about 4 to 5 days after the vaccines were given. They gave the shots in the opposite thigh that had the reaction to the 03/8/17 shots and Band-Aids were not used to rule that out. Was told to give BENADRYL, MOTRIN, baths and cream to prevent cellulitis or infection.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given MENVEO when they should have been given MMR. No adverse reaction happened. Pt was notified and correct MMR vaccine was given.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: Reaction to 09/06/17 shots seen 09/07/17/17 and called pediatrician immediately. Red, swollen, inflamed and splotchy area around the injection site was noticed about 16 to 18 hours after the vaccination and was about the size of a large grapefruit. The reaction grew larger and faster than the reaction that was produced with the 03/08/17 and 06/14/17 vaccinations. The pediatrician said to give benadryl, motrin and warm baths to work the leg out. The reaction started to subside about 1 to 2 weeks after the vaccine was  given and there was still a knot or nodule in my son's thigh after 1 month.  The pediatrician again did not have us come into the office to evaluate the reaction.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Rash macular
Clinical narrative: Reaction to 09/06/17 shots seen 09/07/17/17 and called pediatrician immediately. Red, swollen, inflamed and splotchy area around the injection site was noticed about 16 to 18 hours after the vaccination and was about the size of a large grapefruit. The reaction grew larger and faster than the reaction that was produced with the 03/08/17 and 06/14/17 vaccinations. The pediatrician said to give benadryl, motrin and warm baths to work the leg out. The reaction started to subside about 1 to 2 weeks after the vaccine was  given and there was still a knot or nodule in my son's thigh after 1 month.  The pediatrician again did not have us come into the office to evaluate the reaction.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dental examination, Oral disorder, Swollen tongue
Clinical narrative: Tongue swelling, mouth lesions.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported that his upper arm became red around the injection site and "ached" for about the next day. He said the pain was now gone but the redness was still evident on 11/12/2017.
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 12-month-old male patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 23-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 11-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Age: 1.08
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 13-month-old male patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 3-year-old male patient. Pertinent medical history or concurrent conditions were not reported. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Age: 1.25
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 26-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Age: 2.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 2-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 27-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 16-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 31-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 12-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 05-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 15-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 13-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 27-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient states she has half dollar sized bruise.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient was administered MENVEO. Within 5 min the patient fainted in an aisle in store. By the time I was informed and got to patient (>30sec) she was awake and coherent. 911 was called. When ambulance arrived she declined treatment.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Patient was administered varicella vaccine that had unknowingly been in a temperature excursion too warm.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dysphagia, Peripheral swelling
Clinical narrative: Patient had localized swelling left arm and difficulty swallowing. Patient went to E.R and had antibiotics.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Granuloma, Induration, Swelling
Clinical narrative: Local swelling and redness. Hardened area approximately 5 mm x 10 mm. Granuloma formation approximately 1 week post vaccination.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Patient described a rash in midsection plus both arms beginning the evening after administration. Began fading within 24 hours. Patient contacted his doctor. Tried BENADRYL for symptoms. Trending toward full recovery.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Hurts when she raises/lifts her arm she feels a sharp pain at injection site.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Polka Dot rash all over her body. Not itchy or bothersome.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Constipation, Diarrhoea, Fatigue, Pain
Clinical narrative: Pt described diarrhea, constipation, fatigues and aches a few days after receiving the vaccine. Went to primary care physician who attributed it to vaccine.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Eye pruritus, Generalised erythema, Ocular hyperaemia, Oral pruritus, Pruritus generalised
Clinical narrative: Pt is not pregnant. Pt received the vaccination around noon on Wednesday. Saturday she reports developing itching "everywhere" especially on hands and face. Redness everywhere especially eyes.  She took Benadryl and that helped quite a bit, but as of Monday she still had rash on face, itchy eyes, forehead, and mouth.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Pt is not pregnant. Pt received the vaccination around noon on Wednesday. Saturday she reports developing itching "everywhere" especially on hands and face. Redness everywhere especially eyes.  She took Benadryl and that helped quite a bit, but as of Monday she still had rash on face, itchy eyes, forehead, and mouth.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO REACTIONS TO THE VACCINE. VACCINE WAS GIVEN BY MISTAKE TO A CHILD THAT WAS TO OLD FOR THE VACCINE.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Woke up the morning of 11/9/17 with a severe outbreak of hives. I have had this type of outbreak in the past, but it usually builds to this level of severity. I did have a couple of hives earlier in the week, so I started taking the over-the counter antihistamine to help, and it seemed to be working. On the morning of the 9th, I woke up to find myself covered in hives. (But mainly on my extremities.) There were none on my face and I had no swelling of my eyes or mouth; I also did not experience a problem breathing or feel my airway was swollen in any way. Since this did not appear to be an emergency, I took a couple of Atarax pills that I had from the last time I had such a reaction. They have been helping with the.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Allergy test positive, Cow's milk intolerance, Crying, Irritability, Screaming
Clinical narrative: Extreme fussiness. He was screaming & crying & inconsolable for hours before finally falling asleep only to wake up every 20 to 30 minutes to start again. This went on for a week. I eliminated dairy from my diet after him all of a sudden having an issue with it after his 1 month vaccine. Breast milk seems to be the only thing he can digest ok. I've  tried several foods & his gut just can't handle them. He has seemed to be ok with sweet potatoes finally at 6 months. His digestive system seems to have been damaged by the vaccines.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: Ever since I received my flu shot, I have serious shoulder pain . The shot was administered on 10/31 and my symptoms have not improved. I have difficulty with range of motion. For example, putting on deodorant or a pull over shirt is painful and difficult.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash generalised, Swelling face
Clinical narrative: Patient woke up morning after receiving vaccine with swollen face and rash all over body.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Patient received the vaccine on 10/25/2017 in the evening, the patient felt feverish, area was sore and painful and very red.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, fevered arm.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLULAVAL QUADRIVALENT.  Additional details were reported as follows: The age at vaccination was not reported. The caller reported that she spoke with a nurse at her physician's office. The nurse stated to the reporter that she had received her flu vaccine that year and her arm hurt for 2 days. She stated that this was unusual and she did not usually had any problems with the flu vaccine. The reporter was told that the physician's office used FLULAVAL QUADRIVALENT and that they did not have flu vaccines without thimerosal.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Accidental underdose, Drug administered to patient of inappropriate age, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 33-year-old female patient who received ENGERIX B PEDIATRIC (batch number D344L, expiry date 1st June 2018). Co-suspect products included ENGERIX B ADULT and MMR vaccine. On 24th October 2017, the patient received ENGERIX B PEDIATRIC (intramuscular) .5 ml. On 1st November 2017, the patient received ENGERIX B ADULT and MMR vaccine, the patient experienced accidental underdose and adult use of a child product. On 2nd November 2017, the patient experienced generalized pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the generalized pruritus was recovering/resolving and the outcome of the accidental underdose and adult use of a child product were unknown. The reporter considered the generalized pruritus to be possibly related to ENGERIX B ADULT and MMR vaccine. Additional details were reported as follows: The patient was inadvertently given a pediatric dose of ENGERIX B in left deltoid, which led to accidental underdose and adult use of a child product. The patient came back on 1st November 2017 and received an adult dose of ENGERIX B in left deltoid along with MMR in right deltoid. The patient experienced generalized, intense itching on the evening of 2nd November 2017, after receiving ENGERIX-B and MMR vaccine. The patient woke up during the night and took BENADRYL, which improved her symptoms.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 33-year-old female patient who received ENGERIX B PEDIATRIC (batch number D344L, expiry date 1st June 2018). Co-suspect products included ENGERIX B ADULT and MMR vaccine. On 24th October 2017, the patient received ENGERIX B PEDIATRIC (intramuscular) .5 ml. On 1st November 2017, the patient received ENGERIX B ADULT and MMR vaccine, the patient experienced accidental underdose and adult use of a child product. On 2nd November 2017, the patient experienced generalized pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the generalized pruritus was recovering/resolving and the outcome of the accidental underdose and adult use of a child product were unknown. The reporter considered the generalized pruritus to be possibly related to ENGERIX B ADULT and MMR vaccine. Additional details were reported as follows: The patient was inadvertently given a pediatric dose of ENGERIX B in left deltoid, which led to accidental underdose and adult use of a child product. The patient came back on 1st November 2017 and received an adult dose of ENGERIX B in left deltoid along with MMR in right deltoid. The patient experienced generalized, intense itching on the evening of 2nd November 2017, after receiving ENGERIX-B and MMR vaccine. The patient woke up during the night and took BENADRYL, which improved her symptoms.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site burning in a 39-year-old female patient who received BOOSTRIX. On 31st October 2017, the patient received BOOSTRIX (subcutaneous) .5 ml. On 31st October 2017, immediately after receiving BOOSTRIX, the patient experienced injection site burning and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site burning was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site burning to be related to BOOSTRIX. Additional details were reported as follows: The patient received BOOSTRIX at her personal OBGYN physician office. The patient was a healthcare provider and felt that, the vaccine was administered subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. Immediately after receiving the vaccine, the patient had burning and stinging at the injection site. On 3rd November 2017, 3 days later, the patient still had pain at the injection site which was noticeable enough to be out of the ordinary. The patient did not seek medical attention. The patient thought that, the administration of BOOSTRIX caused her pain at the injection site. The reporter gave consent to be followed up.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Employee did not immediately report the adverse reaction to me. When she came in for her second dose for MMR (9/18/17), she reported that she had a bad reaction to the last vaccine. She stated she had a "Knot in my arm and it was red and warm for days." After 30 days, there is still a palpable knot in her arm that measures 9mm X 9mm. Second dose of MMR was not given.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: It was a flu shot performed by staff (Hospital) and the next day my arm started hurting at the injection site and had severe swelling. The swelling went down after a few days but the pain kept increasing at the injection site. Within a week, I had severe pain down my right arm, numbness in my fingers and then reached a point where I could not move my arm above my head nor hold any weight. This has continued for a month. I have used TYLENOL and ice and heat to treat and get through the nights, but the pain is bad.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Weight bearing difficulty
Clinical narrative: It was a flu shot performed by staff (Hospital) and the next day my arm started hurting at the injection site and had severe swelling. The swelling went down after a few days but the pain kept increasing at the injection site. Within a week, I had severe pain down my right arm, numbness in my fingers and then reached a point where I could not move my arm above my head nor hold any weight. This has continued for a month. I have used TYLENOL and ice and heat to treat and get through the nights, but the pain is bad.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Employee sent photos of her arm. It was raised, hot to touch and reddened.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Pt became lightheaded, dizzy, short of breath within a few hours after receiving flu vaccine. She vomited and began shaking. She also developed a fever and increased heart rate.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Pt became lightheaded, dizzy, short of breath within a few hours after receiving flu vaccine. She vomited and began shaking. She also developed a fever and increased heart rate.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Redness starting below vaccination site and extending all the way around the arm and down to the elbow. Red area was hot and tender to the touch. Started the evening after the vaccine and started to improve by 11/13/17.
Age: 0.5
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: PT came into office on 11/10/2017 for a 6MO WBC. Mom does alternate vaccine schedule and settled on DTAP and Rotavirus. Employee drew up vaccines and laid out on the tray for nurse to administer. Nurse administered and realized when documenting that TDAP was given instead of DTAP by mistake.  FNP was immediately notified as well as Dr. M.D. Tried to notify mom by phone, however not answering. CCMA spoke with Pt's mom on November 13, 2017 8:59 AM and explained the above. Recommended to mom that we need to add another DTAP to the schedule to cover. Advised to mom that it will not hurt him at all and apologized again. Mom understands and agrees. Pt is doing fine with no reaction to the TDAP. Did documented in Pt's chart as well.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Pain in extremity, Pallor, Pruritus
Clinical narrative: Patient had the FLUZONE vaccine on 10/4/17. She came to report a reaction on 10/5/17. States her arm is sore and very itchy. The area is blanched in color and firm to touch.  Area measures 1.5 inches long and 1 inch wide.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Lethargy, Malaise, Pyrexia
Clinical narrative: He felt sick & was lethargic & had a fever for 3 days.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to me 10/17/2017, to show me her arm. 2 inches below the injection site, her arm is red, raised, itchy and warm to the touch. The area that has the reaction, is approximately 3 inches  X 5 inches.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Patient came to see me the day after her flu vaccination. She had a reaction to the vaccine.  Approximately 2 inches below the vaccine administration, there is an area approx. 3inches X 5 inches that is red, raised and itchy.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, fevered arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Feeling abnormal, Injection site swelling, Limb mass, Pain
Clinical narrative: Fever 103 degrees, arm swelling at site (Prox. 3" by 4" patch) felt awful, achy, tired - went back to the doctor (9/14). CIPRO 9/12 - 9/16. CIPRO 9/18 - 9/22. 10/12/2017 still have a small lump (hard) on right arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever 103 degrees, arm swelling at site (Prox. 3" by 4" patch) felt awful, achy, tired - went back to the doctor (9/14). CIPRO 9/12 - 9/16. CIPRO 9/18 - 9/22. 10/12/2017 still have a small lump (hard) on right arm.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt reports her arm where she received the flu shot was painful and swollen the next morning.
Sex: F
Vaccine: PNC13
Symptoms: Angle closure glaucoma, Pleural effusion
Clinical narrative: This is a spontaneous report from a contactable physician reported for herself. This female patient of unknown age and race/ethnicity received a single dose of PREVNAR 13 for immunization on an unknown date. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced pleural effusion and acute angle glaucoma with PREVNAR 13 and had to go to the ER. Outcome was unknown. She was wondering if it was safe to get the flu vaccine. Sender's Comments: The information is very limited and does not allow a medically meaningful evaluation, especially lack of the following: patient's demographics, complete medical history, concomitant medications and clinical course for both events. Based on the information currently available, the serious event acute angle glaucoma more likely represents an intercurrent medical condition unrelated to the vaccination with PREVENAR 13. Currently no details is provided on pleural effusion as to the specific medical condition leading to pleural effusion. Full diagnostic workup for pleural effusion such as the isolation of infectious pathogen due to lung infection, being cancerous, or coming from leakage of origin secondary to heart, liver and kidney failure, are needed for further medical assessment. 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.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for her/himself. A patient of unspecified age, race/ethnicity and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified trade name), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. The patient was hospitalized due to the event for 8 days. No follow-up attempts possible. No further information expected. Pfizer is marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Drug intolerance
Clinical narrative: This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report is in regards to events reported in the patient's past medical history. A currently 68-year-old female patient of an unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), at a single dose for immunization, ZITHROMAX, at an unspecified dose for an unspecified indication, gabapentin (MANUFACTURER UNKNOWN), at an unspecified dose for an unspecified indication, and metformin (MANUFACTURER UNKNOWN) at an unspecified dose for an unspecified indication; all via unspecified routes of administration on unspecified dates. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced drug allergies and intolerance to azithromycin, gabapentin, metformin, and pneumonia shot. The action taken in response to the events for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable, for azithromycin was unknown, for gabapentin was unknown, and for metformin was unknown. The clinical outcome of the events, drug allergies and intolerance to azithromycin, gabapentin, metformin, and pneumonia shot, was unknown. Pfizer is the Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and gabapentin in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder(s) of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and gabapentin has/have submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting on herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose on 06Nov2017 for pneumonia, immunisation. The patient medical history and concomitant medications were not reported. On 06Nov2017 an hour after the injection the patient experienced her arm swelled up, was hot and was sore about an hour after the injection. After a few days, the swelling went down, but it still hurt and was hot.
Age: 82.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Dizziness, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: Injection given around 9 AM; chills around 6 PM; awoke at 1130 PM with fever 101.8, skin hot to touch; runny nose; headache over eyes; a little dizzy; some facial swelling.
Age: 82.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin warm, Swelling face
Clinical narrative: Injection given around 9 AM; chills around 6 PM; awoke at 1130 PM with fever 101.8, skin hot to touch; runny nose; headache over eyes; a little dizzy; some facial swelling.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old male patient received PREVNAR 13 (lot S51635, expiry date 31Oct2018, NDC number 00005197102) on 25Oct2017 at 10:52, at 0.5 ml single dose, intramuscular, in right upper arm, for pneumococcal prevention and the first dose of FLUZONE (lot UI882AA) on 25Oct2017, intramuscular, for immunization. Medical history included hypertension. Past drug history included muscle soreness after administration of the first dose of AFLURIA (lot WT51805, expiry date 24May2017) on an unspecified date in 2016, when he was 64 years old. Concomitant medications included unspecified drugs (reported as maintenance medications, he was not on any other injectable). The patient felt sore at injection site on 26Oct2017 but it went away by the next day. About a week later (on 02Nov2017 or 03Nov2017), he experienced muscle soreness in his right arm that spread over a couple of days down his right arm to his pinky and middle finger. He experienced this muscle soreness for 3 days and then it subsided; the patient recovered 95% from the muscle soreness. At the time of report he was experiencing tingling and numbness at the injection site which had developed on an unspecified date in 2017. There were no investigations. No emergency room or physician office visit were required. The reporting pharmacist considered that all the reported events were related to PREVNAR 13.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Muscle twitching, Pain, Pruritus
Clinical narrative: 220 PM (10-26-2017) pt. came back to clinic with co-worker. Described symptoms of itching, twitching of left arm, headache, body aches. Said he has BENADRYL. Said he will take some. Said he also has EPIPEN. Told him to follow up if worse. Follow up with clinic manager. She said he took BENADRYL and all is well at 415 PM.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Product storage error
Clinical narrative: Patient was administered PROQUAD (MMRV) vaccine that had unknowingly been in a temperature excursion too warm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Post flu vaccine patient returned to lobby brought daughter and grand daughter to room for flu dose. Pt. shortly C/O feeling warm and tingling in arms and hands. Pt. lied down and EMT called.
Sex: F
Vaccine: HPV9
Symptoms: Fear, Hypoaesthesia, Insomnia, Mobility decreased, Nervous system disorder
Clinical narrative: 1 week after getting the second dose of the GARDASIL vaccine, my feet would go numb as well as my hands. The numbness would spread up and down my arms. I woke up about 2 weeks after the vaccine one night because my right arm had no feeling in it. I couldn't lift it either. It was very frightening. I lost sleep because I was so afraid of that happening to my arm again or that I would stop breathing. I would go entire days with my feet numb after that vaccine. 1 year later, I still wake up with numb hands and now my hands tremble on their own. It's cost me time and money. I've gone to several healthcare providers, including a neurologist. I've had to go to the ER too, twice. This vaccine has ruined my life. I went from no neurological problems to tons with one vaccine. When I told my nurse, they minimized it and said the vaccine didn't cause it. No one reported it or documented it. This vaccine is more insurance crap. It's hurting people. I'm afraid to get something as simple as a flu shot now because I don't know if it will harm me. I was never even told this could be a side effect. I'm very disappointed more action wasn't taken. This vaccine ruins people's lives.
Sex: F
Vaccine: HPV9
Symptoms: Quality of life decreased, Tremor
Clinical narrative: 1 week after getting the second dose of the GARDASIL vaccine, my feet would go numb as well as my hands. The numbness would spread up and down my arms. I woke up about 2 weeks after the vaccine one night because my right arm had no feeling in it. I couldn't lift it either. It was very frightening. I lost sleep because I was so afraid of that happening to my arm again or that I would stop breathing. I would go entire days with my feet numb after that vaccine. 1 year later, I still wake up with numb hands and now my hands tremble on their own. It's cost me time and money. I've gone to several healthcare providers, including a neurologist. I've had to go to the ER too, twice. This vaccine has ruined my life. I went from no neurological problems to tons with one vaccine. When I told my nurse, they minimized it and said the vaccine didn't cause it. No one reported it or documented it. This vaccine is more insurance crap. It's hurting people. I'm afraid to get something as simple as a flu shot now because I don't know if it will harm me. I was never even told this could be a side effect. I'm very disappointed more action wasn't taken. This vaccine ruins people's lives.
Age: 51.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Expired product administered
Clinical narrative: Pt was inadvertently administered an expired PNEUMOVAX 23 on 10/20/2017 (NDC 0006-04943-01 lot # L029073, expired on 04/19/2017). Spoke to staff/state immunization program, she states vaccine viability is a concern and pt will need to be revaccinated at next visit. Pt has appt scheduled for 12/20/2017. Pt will be advised at appointment as we need Translator to communicate with pt. Provider aware and ok with this plan.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Blood test normal, Electroencephalogram abnormal, Febrile convulsion, Intensive care, Lumbar puncture normal
Clinical narrative: My son had a 3 seizures. The first on 11/6 and the other two on 11/7. He was admitted to ICU with Doctors thinking the seizures were febrile related. He was taking motrin and tylenol to prevent fever and keppra for seizures. We stayed two nights in ICU. On 11/9 he broke out in a rash from head to toe. We were seen on 11/10 in the peds office and advised to stop Keppra as Dr was unsure if the rash was an allergic reaction to Keppra or if it was viral. The doctor advised me to put fill out this form at that appointment. We were seen in the office again 11/13. Rash is improving but is still present on his entire body. With having an abdnormal EEG in the hospital, the specialist was unable to say if seizures were viral or if my son has an underlying seizure disorder. We are to follow up with the pediatric neurologist and have a repeat EEG.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Nuclear magnetic resonance imaging normal, Rash generalised, Seizure, Urine analysis normal
Clinical narrative: My son had a 3 seizures. The first on 11/6 and the other two on 11/7. He was admitted to ICU with Doctors thinking the seizures were febrile related. He was taking motrin and tylenol to prevent fever and keppra for seizures. We stayed two nights in ICU. On 11/9 he broke out in a rash from head to toe. We were seen on 11/10 in the peds office and advised to stop Keppra as Dr was unsure if the rash was an allergic reaction to Keppra or if it was viral. The doctor advised me to put fill out this form at that appointment. We were seen in the office again 11/13. Rash is improving but is still present on his entire body. With having an abdnormal EEG in the hospital, the specialist was unable to say if seizures were viral or if my son has an underlying seizure disorder. We are to follow up with the pediatric neurologist and have a repeat EEG.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Some swelling at injection site, but it occurred about 2 weeks after the shot. Never had reaction to previous vaccine.