chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Joint range of motion decreased, Limb discomfort, Nerve compression
Clinical narrative: Immediately, felt a pinch that encompassed entire arm; it felt like bucket of ice water was going down armit took 5 minutes to dissipate. Site of vaccination was not at right location--it went on top of bicep near shoulder joint. Mentioned to the nurse but did not think it was anything out of norm. Within a couple of hours the pain continued; it was finite burning pain not muscle achesit felt like fingernails torn off with pliers. Called the doctor but no appointment available so decided to go to the ER on 11/6. Patient followed up with an orthopedic doctor 11/13 who then sent her to neurologist 12/1. Second apt with neurologist a week later for nerve conductivity test; test found that there was a minor pinch on wrist but it had nothing to do with shoulder. Has 3rd appointment with neurologist because no pain relief on 1/19. Pain getting worse and doesn't have full rotation in shoulder--hard to even lift a glass of water. Patient is a massage therapist. Pain is at 5 or 6 even before taking Bayer (Back & Body).
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve conduction studies abnormal, Pain, Pain in extremity
Clinical narrative: Immediately, felt a pinch that encompassed entire arm; it felt like bucket of ice water was going down armit took 5 minutes to dissipate. Site of vaccination was not at right location--it went on top of bicep near shoulder joint. Mentioned to the nurse but did not think it was anything out of norm. Within a couple of hours the pain continued; it was finite burning pain not muscle achesit felt like fingernails torn off with pliers. Called the doctor but no appointment available so decided to go to the ER on 11/6. Patient followed up with an orthopedic doctor 11/13 who then sent her to neurologist 12/1. Second apt with neurologist a week later for nerve conductivity test; test found that there was a minor pinch on wrist but it had nothing to do with shoulder. Has 3rd appointment with neurologist because no pain relief on 1/19. Pain getting worse and doesn't have full rotation in shoulder--hard to even lift a glass of water. Patient is a massage therapist. Pain is at 5 or 6 even before taking Bayer (Back & Body).
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: AREA IS RAISED, RED, SORE, AND HOT UNTILL 1-16 WITH NO SIGN OF GETTING BETTER. FEVER AND CHILLS THE NIGHT AFTER, FEVER REMAINED FOR A FEW DAYS.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: AREA IS RAISED, RED, SORE, AND HOT UNTILL 1-16 WITH NO SIGN OF GETTING BETTER. FEVER AND CHILLS THE NIGHT AFTER, FEVER REMAINED FOR A FEW DAYS.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Hive like rash originating at the site of injection on left thigh, spreading to other leg, trunk, and face. 2 doses of Benadryl given, rash lasted for 2 days.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyskinesia, Dyspnoea, Flushing
Clinical narrative: Felt dizzy. A few minutes after shot, she was conscious, flushing (shortness of breath) and lying down (jerking movement). 911 contacted, but no First responders requested due to recovery in a few minutes according to her. Water bottle was given.
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 71 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. In approximately October 2017 (reported as October or November 2017, "after the hurricane"), the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, route and site of administration were not reported) for prophylaxis. In 2017, the patient experienced redness, but not in the vaccination area. The redness was closer to the elbow. The patient self-treated with ice. The outcome of redness was reported as resolved in approximately 2017. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Pharmacist reported that on 02-JAN-2018, the patient was vaccinated with VARIVAX (lot # N019839, expiration date 17-JUL-2019) (dose and frequency were not reported) reconstituted with sterile diluent (lot # and expiration date were not provided) by the intramuscular route rather than subcutaneous route. There was no adverse effect reported. No further information provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs or vaccines were not reported. The nurse reported that on 10-JAN-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 Injection, lot # M043424, expiration date 06-JUN-2018, for prophylaxis (strength, dose, dose number, route and anatomical location were not reported). The nurse informed that the dose was exposed to a temperature from 47 F to 77 F, for 15 minutes, and there was no previous temperature excursion. No adverse effects were reported. This call was made because of a digital data logger.
Age: 1.33
Sex: M
Vaccine: PNC13
Symptoms: Aphasia, Immediate post-injection reaction
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for her grandson.  A 16-month-old male patient of an unspecified ethnicity received the fifth dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first to fourth doses of PREVNAR 13 for immunization, starting infancy through the toddler years as per the vaccination schedule. The reporter stated that her grandson (patient) received a total of 5 shots of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). After the fifth vaccination she reported that immediately her grandson stopped talking or couldn't talk anymore. This happened in 2016 when the child was about 1 year old and 4 months between Dec2016 and Jan2017. Prior to this event, the child had already started talking but as she said on the fifth shot, the child was not able to talk anymore. Now the child is 2 years old and still unable to speak with continuous speech therapy as prescribed the doctor.
Sex: U
Vaccine: PNC13
Symptoms: Back pain
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVENAR 13 on an unknown date, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced back pain. Clinical outcome of the adverse event was unknown at time of this report. The information on the lot number has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: First Noted slight red area around vaccination site which has now grown to about a baseball size over 4 days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) UE swelling, redness, pain, from shoulder down into forearm. Seen in office 1-8-18 then patient admitted for IV fluids, antibiotics, BENADRYL, ice, elevation -> improved overnight.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Red patches in the abdominal area and in the back. Small hives in the arms and legs, including feet. Itchiness from head to toe
Age: 45.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Balance disorder, Dizziness, Dyspnoea, Fatigue, Nausea
Clinical narrative: 5-10 min post vaccination patient began to experience the following symptoms: nausea, dizziness, fatigue, intermittent syncope, loss of balance, and shortness of breath. Patient was then provided oxygen via mask 10 L/min with initial vitals of BP:149/91 HR: 81 Temp (oral) 97.9 PluseOx: 100. Member experienced a similar issue one week ago (12JAN2018) due to the medication Topamax and was admitted into the ER. No prior hx of adverse reactions to immunizations. Emergency protocol was initiated at clinic and emergency medical services transported member to a local hospital. PT did not lose consciousness during the encounter. Immunization sites were inspected by physician, prior to transport, with no routine signs of an adverse reaction: NO erythema, pruritus, rash or pain at injection sites.
Age: 45.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Syncope
Clinical narrative: 5-10 min post vaccination patient began to experience the following symptoms: nausea, dizziness, fatigue, intermittent syncope, loss of balance, and shortness of breath. Patient was then provided oxygen via mask 10 L/min with initial vitals of BP:149/91 HR: 81 Temp (oral) 97.9 PluseOx: 100. Member experienced a similar issue one week ago (12JAN2018) due to the medication Topamax and was admitted into the ER. No prior hx of adverse reactions to immunizations. Emergency protocol was initiated at clinic and emergency medical services transported member to a local hospital. PT did not lose consciousness during the encounter. Immunization sites were inspected by physician, prior to transport, with no routine signs of an adverse reaction: NO erythema, pruritus, rash or pain at injection sites.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt said the injection stung a lot at injection and kept hurting. The next day she removed the Band-Aid and had a red circle and pain at the site to touch. Pt has not done anything for the pain, but it is getting better with time. Shot received 01/11/18 - reported 01/16/18 there is still an approximate 1 inch red circle and painful to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and redness to left deltoid that extended down to left elbow, patients father denies any SOB, wheezing, or difficulty breathing. Symptoms started Saturday 01/13/2018 per patients father, patient seen today in clinic for a sick visit, father showed provider patients arm and the redness an swelling are better with very minimal reaction left.  Patients father advised to alternate ice/heat to site to help with redness and swelling and to call 911 or go to ER is any SOB or wheezing should occur.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Patient reported redness on arm that she received the injection in. Inspected redness and it appears to be very mild and is not at the site of injection, but lower on the arm. Doesn't appear to be related to the injection. Recommended observing and taking Benadryl or applying hydrocortisone cream if needed. Contact primary care physician if worsens or persists.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test, Contusion, Gait inability, Pain in extremity, Peripheral swelling
Clinical narrative: My daughter complained of leg pain the night of vaccine was administered.  She complained an increase in pain throughout the night. Next day she would not walk and I notice her feet and are a bit swollen and bruised then we went to ER at 2:20. In the ER her feet were swelling even more turning purple w bruises. She said the pain was terrible. And dots formed both feet up to calf.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Skin discolouration, Urine analysis, X-ray
Clinical narrative: My daughter complained of leg pain the night of vaccine was administered.  She complained an increase in pain throughout the night. Next day she would not walk and I notice her feet and are a bit swollen and bruised then we went to ER at 2:20. In the ER her feet were swelling even more turning purple w bruises. She said the pain was terrible. And dots formed both feet up to calf.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report has been received from a nurse, concerning a 46 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown by reporter. In approximately 1993 (reported as when he was either 22 or 23 years of age), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and on the same date in 1993, the patient was also vaccinated with another unspecified vaccine (manufacturer unknown) (dose, frequency, route, lot# and expiration date not reported for any vaccine) for prophylaxis. On an unknown date after receiving the vaccines of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and the another unspecified vaccine, the patient got very sick. The patient sought medical attention and received an unspecified treatment. There was unknown if any laboratory or study were performed. The outcome of got very sick was reported as recovered. The causal relationship between got very sick and the therapies was not assessed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Injected limb mobility decreased, Pain in extremity
Clinical narrative: After 4 hours, patients left arm became extremely sore and immobile. Loss of appetite due to pain. Pain persisted for two days then gradually lessened over the next two days. No swelling or bruising.
Age: 21.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Urticaria
Clinical narrative: Per student- " I got Hives over the weekend all on my arms and back, I had to put ice."  According to student, hives self resolving/improved and student did not seek treatment or take any medications.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain, Pain in extremity
Clinical narrative: Sore, red, inflamed bicep all along upper arm (armpit to elbow), painful when extending arm.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: Pt states she had pain in neck, maybe a swollen lymph node. She stated that it happens everytime she gets a flu shot.
Age: 9.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Anxiety, Erythema, Local reaction, Peripheral swelling, Pyrexia
Clinical narrative: Child awoke with redness and swelling to left arm. Mom gave Ibuprofen. Later at school, her temp had risen and the school nurse recommended she be brought in to the clinic. Her temp here is 101 and the redness and swelling is approx. half dollar sized. She was very anxious.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at left deltoid area. Treating with ibuprofen prn.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness is still existing from injection site down to elbow.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dysphagia, Nausea, Pruritus, Swelling face
Clinical narrative: Several hours after receiving BEXSERO injection, patient noticed facial swelling, nausea, dizziness, and difficulty swallowing. Later she developed itchy, painful hives on hands, shoulders, and chest. She sought treatment about 24 hours after the injection due to continued difficulty swallowing and hives. She had taken 400mg of ibuprofen for symptom relief at home and was given cetirizine 10mg po in the clinic. Evaluated by MD: vital signs were stable, exam was normal, and lungs were clear. Discharged home with instructions to continue taking cetirizine. Follow up call 2 days later confirmed resolution of symptoms.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Several hours after receiving BEXSERO injection, patient noticed facial swelling, nausea, dizziness, and difficulty swallowing. Later she developed itchy, painful hives on hands, shoulders, and chest. She sought treatment about 24 hours after the injection due to continued difficulty swallowing and hives. She had taken 400mg of ibuprofen for symptom relief at home and was given cetirizine 10mg po in the clinic. Evaluated by MD: vital signs were stable, exam was normal, and lungs were clear. Discharged home with instructions to continue taking cetirizine. Follow up call 2 days later confirmed resolution of symptoms.
Age: 52.0
Sex: F
Vaccine: FLU3, HEPAB, PPV, TDAP
Symptoms: Injection site hypersensitivity, Skin reaction
Clinical narrative: Hypersensitivity reaction at injection site. Patient went to er due to skin reaction. Pt received prophylactic antibiotics to prevent skin infection.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Abdominal pain upper, Alopecia, Altered state of consciousness, Angiogram, Chest X-ray
Clinical narrative: On 2/1/17 we noticed a 1 1/2 inch bald spot on the back of her head. Started complaining of tingling in her hands and feet and chest pains. 05/17 started complaining of extreme fatigue and started with a cough. Went to pediatrician in June and they noticed her BP was high and sent us to ER they treated her with an IV and sent us home. 07/17 started to get rashes from the sun and hot water, felt nausea, had stomach pain, her feet and hands started turning purple, lost weight, could not eat, got heart palpitations, felt dizzy and everything would get black and she almost passed out.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Chest pain, Computerised tomogram head, Computerised tomogram thorax, Cough, Dizziness
Clinical narrative: On 2/1/17 we noticed a 1 1/2 inch bald spot on the back of her head. Started complaining of tingling in her hands and feet and chest pains. 05/17 started complaining of extreme fatigue and started with a cough. Went to pediatrician in June and they noticed her BP was high and sent us to ER they treated her with an IV and sent us home. 07/17 started to get rashes from the sun and hot water, felt nausea, had stomach pain, her feet and hands started turning purple, lost weight, could not eat, got heart palpitations, felt dizzy and everything would get black and she almost passed out.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Feeding disorder, Hypertension
Clinical narrative: On 2/1/17 we noticed a 1 1/2 inch bald spot on the back of her head. Started complaining of tingling in her hands and feet and chest pains. 05/17 started complaining of extreme fatigue and started with a cough. Went to pediatrician in June and they noticed her BP was high and sent us to ER they treated her with an IV and sent us home. 07/17 started to get rashes from the sun and hot water, felt nausea, had stomach pain, her feet and hands started turning purple, lost weight, could not eat, got heart palpitations, felt dizzy and everything would get black and she almost passed out.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Laboratory test, Loss of consciousness, Nausea, Nuclear magnetic resonance imaging abdominal, Nuclear magnetic resonance imaging thoracic
Clinical narrative: On 2/1/17 we noticed a 1 1/2 inch bald spot on the back of her head. Started complaining of tingling in her hands and feet and chest pains. 05/17 started complaining of extreme fatigue and started with a cough. Went to pediatrician in June and they noticed her BP was high and sent us to ER they treated her with an IV and sent us home. 07/17 started to get rashes from the sun and hot water, felt nausea, had stomach pain, her feet and hands started turning purple, lost weight, could not eat, got heart palpitations, felt dizzy and everything would get black and she almost passed out.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Palpitations, Paraesthesia, Postural orthostatic tachycardia syndrome, Rash, Scan with contrast
Clinical narrative: On 2/1/17 we noticed a 1 1/2 inch bald spot on the back of her head. Started complaining of tingling in her hands and feet and chest pains. 05/17 started complaining of extreme fatigue and started with a cough. Went to pediatrician in June and they noticed her BP was high and sent us to ER they treated her with an IV and sent us home. 07/17 started to get rashes from the sun and hot water, felt nausea, had stomach pain, her feet and hands started turning purple, lost weight, could not eat, got heart palpitations, felt dizzy and everything would get black and she almost passed out.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Skin discolouration, Ultrasound kidney, Weight decreased
Clinical narrative: On 2/1/17 we noticed a 1 1/2 inch bald spot on the back of her head. Started complaining of tingling in her hands and feet and chest pains. 05/17 started complaining of extreme fatigue and started with a cough. Went to pediatrician in June and they noticed her BP was high and sent us to ER they treated her with an IV and sent us home. 07/17 started to get rashes from the sun and hot water, felt nausea, had stomach pain, her feet and hands started turning purple, lost weight, could not eat, got heart palpitations, felt dizzy and everything would get black and she almost passed out.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX DTaP+IPV should be administered to children 4 through 6 years of age. The patient was 3 years of age at time of vaccination.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP, FLU3, PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed redness and raised bump at injection site, followed by red circle around the site and pain.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP, FLU3, PNC13, TDAP
Symptoms: Erythema, Peripheral swelling, Pertussis, Pneumonia, Skin warm
Clinical narrative: Patient developed redness and raised bump at injection site, followed by red circle around the site and pain.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling 11cm. x 11cm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Erythema, Feeding disorder
Clinical narrative: As you describe in your literature, my arm was quite sorea and red and could not raise over head for about 2  days. But the most troubling reaction was tat  I literally could not get out of bed for 24 hours, could not  eat, had upset stomach...almost like a severe case of mono. After 24 hours, I started to regain energy, but still fit wiped out and, appetite and ability to eat came back in a couple of days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: As you describe in your literature, my arm was quite sorea and red and could not raise over head for about 2  days. But the most troubling reaction was tat  I literally could not get out of bed for 24 hours, could not  eat, had upset stomach...almost like a severe case of mono. After 24 hours, I started to regain energy, but still fit wiped out and, appetite and ability to eat came back in a couple of days.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Cough, Decreased eye contact, Disturbance in social behaviour, Ear infection, Headache
Clinical narrative: 102 degree fever. Very bad headache. Loss of eye contact and poor social function prior to receiving round of first vaccines. 2 older brothers have history of heightened sensitivity to many preservatives and ingredients, but we were assured that vaccines would not be harmful. Both of our older sons are now autistic, and were not born so. Patient was a happy baby. After receiving the vaccines, he was fussy, and since has stopped sleeping normally, and has had more fevers and rashes and lack of eye contact. He stopped trying to roll over or move on his own for about a month post vaccination. This is a huge concern as he was hitting milestones wonderfully prior. We did not seek immediate help. We decided to wait and decided to see if he would feel better after a few days. Then he was so sick. Seemingly with one cold virus after another, and then with a horrible cough and ear infection, which we saught treatment for at Health Center in December, No injury report was filed. I felt like no one would listen to my concern. I'm not anti vaccines. I am just concerned about my baby. With so many cases of aubism and other disorders in our genes, I am worried that I we may be too sensitive for these shots. I really would like someone to respond via Email or telephone. Thank you for your time.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Irritability, Malaise, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: 102 degree fever. Very bad headache. Loss of eye contact and poor social function prior to receiving round of first vaccines. 2 older brothers have history of heightened sensitivity to many preservatives and ingredients, but we were assured that vaccines would not be harmful. Both of our older sons are now autistic, and were not born so. Patient was a happy baby. After receiving the vaccines, he was fussy, and since has stopped sleeping normally, and has had more fevers and rashes and lack of eye contact. He stopped trying to roll over or move on his own for about a month post vaccination. This is a huge concern as he was hitting milestones wonderfully prior. We did not seek immediate help. We decided to wait and decided to see if he would feel better after a few days. Then he was so sick. Seemingly with one cold virus after another, and then with a horrible cough and ear infection, which we saught treatment for at Health Center in December, No injury report was filed. I felt like no one would listen to my concern. I'm not anti vaccines. I am just concerned about my baby. With so many cases of aubism and other disorders in our genes, I am worried that I we may be too sensitive for these shots. I really would like someone to respond via Email or telephone. Thank you for your time.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Regressive behaviour, Sleep disorder, Viral infection
Clinical narrative: 102 degree fever. Very bad headache. Loss of eye contact and poor social function prior to receiving round of first vaccines. 2 older brothers have history of heightened sensitivity to many preservatives and ingredients, but we were assured that vaccines would not be harmful. Both of our older sons are now autistic, and were not born so. Patient was a happy baby. After receiving the vaccines, he was fussy, and since has stopped sleeping normally, and has had more fevers and rashes and lack of eye contact. He stopped trying to roll over or move on his own for about a month post vaccination. This is a huge concern as he was hitting milestones wonderfully prior. We did not seek immediate help. We decided to wait and decided to see if he would feel better after a few days. Then he was so sick. Seemingly with one cold virus after another, and then with a horrible cough and ear infection, which we saught treatment for at Health Center in December, No injury report was filed. I felt like no one would listen to my concern. I'm not anti vaccines. I am just concerned about my baby. With so many cases of aubism and other disorders in our genes, I am worried that I we may be too sensitive for these shots. I really would like someone to respond via Email or telephone. Thank you for your time.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eczema
Clinical narrative: Eczema.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Nuclear magnetic resonance imaging, Salivary hypersecretion
Clinical narrative: Excessive saliva.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: L shoulder pain started at time of the injection and has persisted to this date, approximately 3 weeks later. Pain with shoulder motion, lifting objects, and laying on left arm. I have been taking 2 tabs OTC ALEVE twice/day and/or 1000 mg acetaminophen twice/day, massaging, heat packs. Just got a physical therapy referral today, 1/16/18.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Amnesia, Burning sensation, Computerised tomogram, Confusional state, Electrocardiogram
Clinical narrative: On the 11th she noticed in the evening that the injection site was hard. Over the next few days she noticed the hardness spreading around the injection site towards her body. (Right arm) On the 15th around 10pm she did not feel well. Arm hurt and hardness had spread approximately 5" top to bottom and around the arm in a band at injection site; with burning sensation in the fingers, numbness and tingling across arm. 11pm the room was spinning and she could not stand. She was able to sit up onto the edge of bed. She said her heart was pounding as if she was running a marathon but we had been only lying in bed watching TV. I felt her chest and she had a severe wheeze In her upper chest but was taking in shallow breaths easily. By 11:30pm I had gone out to start the car to take her to the ER and I came back inside right away and she was slumped over unconscious. She was out for about 5 minutes. Her pulse was faint and she was completely non responsive. When I got her to wake up she was confused and could not move any body part independently except her fingers which she could move with great effort. EMTs came and took her to ER. She lost 2 years of memory through the next day. She also sporadically lost up to 6 years of memory in waves it would come and go.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Hypopnoea, Induration, Injection site induration, Loss of consciousness
Clinical narrative: On the 11th she noticed in the evening that the injection site was hard. Over the next few days she noticed the hardness spreading around the injection site towards her body. (Right arm) On the 15th around 10pm she did not feel well. Arm hurt and hardness had spread approximately 5" top to bottom and around the arm in a band at injection site; with burning sensation in the fingers, numbness and tingling across arm. 11pm the room was spinning and she could not stand. She was able to sit up onto the edge of bed. She said her heart was pounding as if she was running a marathon but we had been only lying in bed watching TV. I felt her chest and she had a severe wheeze In her upper chest but was taking in shallow breaths easily. By 11:30pm I had gone out to start the car to take her to the ER and I came back inside right away and she was slumped over unconscious. She was out for about 5 minutes. Her pulse was faint and she was completely non responsive. When I got her to wake up she was confused and could not move any body part independently except her fingers which she could move with great effort. EMTs came and took her to ER. She lost 2 years of memory through the next day. She also sporadically lost up to 6 years of memory in waves it would come and go.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Mobility decreased, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: On the 11th she noticed in the evening that the injection site was hard. Over the next few days she noticed the hardness spreading around the injection site towards her body. (Right arm) On the 15th around 10pm she did not feel well. Arm hurt and hardness had spread approximately 5" top to bottom and around the arm in a band at injection site; with burning sensation in the fingers, numbness and tingling across arm. 11pm the room was spinning and she could not stand. She was able to sit up onto the edge of bed. She said her heart was pounding as if she was running a marathon but we had been only lying in bed watching TV. I felt her chest and she had a severe wheeze In her upper chest but was taking in shallow breaths easily. By 11:30pm I had gone out to start the car to take her to the ER and I came back inside right away and she was slumped over unconscious. She was out for about 5 minutes. Her pulse was faint and she was completely non responsive. When I got her to wake up she was confused and could not move any body part independently except her fingers which she could move with great effort. EMTs came and took her to ER. She lost 2 years of memory through the next day. She also sporadically lost up to 6 years of memory in waves it would come and go.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Pulse abnormal, Unresponsive to stimuli, Wheezing
Clinical narrative: On the 11th she noticed in the evening that the injection site was hard. Over the next few days she noticed the hardness spreading around the injection site towards her body. (Right arm) On the 15th around 10pm she did not feel well. Arm hurt and hardness had spread approximately 5" top to bottom and around the arm in a band at injection site; with burning sensation in the fingers, numbness and tingling across arm. 11pm the room was spinning and she could not stand. She was able to sit up onto the edge of bed. She said her heart was pounding as if she was running a marathon but we had been only lying in bed watching TV. I felt her chest and she had a severe wheeze In her upper chest but was taking in shallow breaths easily. By 11:30pm I had gone out to start the car to take her to the ER and I came back inside right away and she was slumped over unconscious. She was out for about 5 minutes. Her pulse was faint and she was completely non responsive. When I got her to wake up she was confused and could not move any body part independently except her fingers which she could move with great effort. EMTs came and took her to ER. She lost 2 years of memory through the next day. She also sporadically lost up to 6 years of memory in waves it would come and go.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Antinuclear antibody negative, Full blood count normal, Loss of personal independence in daily activities, Metabolic function test normal, Pruritus
Clinical narrative: For 2 days after receiving vaccine area was very swollen and itchy - to point where he did not go to school. No respiratory distress. Had a similar reaction to HPV vaccine a few years prior, but physical reaction was stronger and mother will not get any additional HPV vaccines. I am not sure if these are just exaggerated responses or (due to itching) allergic reaction to a component. Will refer to allergy as well.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Red blood cell sedimentation rate normal, Swelling
Clinical narrative: For 2 days after receiving vaccine area was very swollen and itchy - to point where he did not go to school. No respiratory distress. Had a similar reaction to HPV vaccine a few years prior, but physical reaction was stronger and mother will not get any additional HPV vaccines. I am not sure if these are just exaggerated responses or (due to itching) allergic reaction to a component. Will refer to allergy as well.
Age: 14.0
Sex: F
Vaccine: IPV, TD
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy. Prednisone taper.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Apparent cellulitis with systemic complaint, red, swollen, warm, feverish. Treating w/antibiotics.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Cough, Eye discharge, Eye irritation
Clinical narrative: Cough, tight upper chest, stiffened upper body, headache, major chills/cold feet, drippy nose, thick mucus, swollen glands, red burning matted runny eyes, stuffed sinus much better AM 1/4, PM 1/4 feeling drained, fine by AM 1/5/18. Called Nurse advisory # AM 1/4; will relay info to Dr. who had her nurse call me that PM saying I contacted a virus which I said I could not be convinced of that.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Increased viscosity of upper respiratory secretion, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Cough, tight upper chest, stiffened upper body, headache, major chills/cold feet, drippy nose, thick mucus, swollen glands, red burning matted runny eyes, stuffed sinus much better AM 1/4, PM 1/4 feeling drained, fine by AM 1/5/18. Called Nurse advisory # AM 1/4; will relay info to Dr. who had her nurse call me that PM saying I contacted a virus which I said I could not be convinced of that.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Peripheral coldness, Rhinorrhoea, Sinus congestion, Viral infection
Clinical narrative: Cough, tight upper chest, stiffened upper body, headache, major chills/cold feet, drippy nose, thick mucus, swollen glands, red burning matted runny eyes, stuffed sinus much better AM 1/4, PM 1/4 feeling drained, fine by AM 1/5/18. Called Nurse advisory # AM 1/4; will relay info to Dr. who had her nurse call me that PM saying I contacted a virus which I said I could not be convinced of that.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Erythema, tenderness, "knot" to left deltoid. Worsening erythema spread to entire anterior of left upper arm.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: Administered influenza vaccine on 1/12/18 pt started seeing bruise, swelling on (L) deltoid. Swollen 35 mm painful, itching. No discharge, no fever. Patient feels malaise.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Day of injection c/o slightly swollen arm, pain with movement, cannot raise arm over head. Increased pain with turning arm outward. No tingling or numbness.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: 1-10-18 noted lump, red ring about 3" diameter around site of varicella. Some itching described as "sore itch". No fever. No breathing difficulties. 1-12-18 review site of reaction. Pt. said was fading in color, less sore. Still about 3" diameter.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Chills, Joint stiffness, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever, chest tightness, chills, muscle and joint stiffness.
Age: 64.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: A 64 year old woman received an injection of MassBiologics' Td vaccine (Lot #A096A) on July 17, 2017 in her right deltoid. That same visit, she also received the following vaccinations: Tuberculin Purified Protein Derivative, Lot #C5039AA, manufactured by Sanofi Pasteur and PNEUMOVAX, Lot #N011491, manufactured by Merck & Co., in her right deltoid. On July 24, 2017, the patient's daughter informed the provider's office that the patient had experienced tenderness, soreness, inflammation, redness and swelling around the site of administration (right deltoid) for Td and PNEUMOVAX starting on July 20, 2017. Several follow-up attempts were made but recovery status remains unknown. The provider's office does not have any record of the patient's prior immunizations. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled. The patient is reported to have received a second immunization (PNEUMOVAX) at the same site (right deltoid) on the same day, which may have increased the risk for inflammation at the site. MassBiologics sent letters containing information regarding this event to the manufacturer of PNEUMOVAX, Merck & Co., and the manufacturer of the Tuberculin Purified Protein Derivative, Sanofi Pasteur, on September 7, 2017. Please note that reports 'US-MassBiologics-AE1703' and 'US-MassBiologics-AE1704' have been linked to this report. These three adverse events were reported to MassBiologics at the same time by the same primary source reporter.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: The patient took her routine medication, Synthroid, the same day as administration. On May 6, 2017, the patient experienced swelling and redness at the site of Td administration (right deltoid), with increasing redness; shooting pain down the right hand, numbness, tingling, weakness, neck pain, neck stiffness, feeling sore and feeling lethargic. The patient visited the doctor's office one month post-administration where it was noted that the redness and swelling at the site of Td administration had subsided but the patient continued to experience neck pain and neck stiffness; the recovery status for all other events is unknown. The reporter did not have any record of prior immunizations for this patient. On August 28, 2017 the reporter informed MassBiologics that she was unable to make contact for a recovery status and no further attempts to would be made.; Sender's Comments: All adverse events reported in this case were assessed as non-serious. Swelling and redness around the site of administration and pain in the extremity are described in the Td vaccine package insert. The report of feeling sore and lethargic are also labeled reactions in the Td vaccine package insert as "musculoskeletal stiffness or pain" and "malaise", respectively, and have similar meanings to the verbatim terms. Unexpected events reported are numbness, tingling, weakness, and pain and stiffness of the neck. It is not clear from the reporter's description if the numbness, tingling, and weakness are in the right extremity or generalized. It is also unclear whether the neck pain and stiffness are localized to the right side or are more generalized. MassBiologics sent letters containing information regarding this event to the manufacturer of the MMR vaccine, Merck & Co., and the manufacturer of the Tuberculin Purified Protein Derivative and Polio Vaccine, Sanofi Pasteur, on September 7, 2017. Please note that reports 'US-MassBiologics-AE1704' and 'US-MassBiologics-AE1705' have been linked to this report. These three adverse events were reported to MassBiologics at the same time by the same primary source reporter.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: The patient took her routine medication, Synthroid, the same day as administration. On May 6, 2017, the patient experienced swelling and redness at the site of Td administration (right deltoid), with increasing redness; shooting pain down the right hand, numbness, tingling, weakness, neck pain, neck stiffness, feeling sore and feeling lethargic. The patient visited the doctor's office one month post-administration where it was noted that the redness and swelling at the site of Td administration had subsided but the patient continued to experience neck pain and neck stiffness; the recovery status for all other events is unknown. The reporter did not have any record of prior immunizations for this patient. On August 28, 2017 the reporter informed MassBiologics that she was unable to make contact for a recovery status and no further attempts to would be made.; Sender's Comments: All adverse events reported in this case were assessed as non-serious. Swelling and redness around the site of administration and pain in the extremity are described in the Td vaccine package insert. The report of feeling sore and lethargic are also labeled reactions in the Td vaccine package insert as "musculoskeletal stiffness or pain" and "malaise", respectively, and have similar meanings to the verbatim terms. Unexpected events reported are numbness, tingling, weakness, and pain and stiffness of the neck. It is not clear from the reporter's description if the numbness, tingling, and weakness are in the right extremity or generalized. It is also unclear whether the neck pain and stiffness are localized to the right side or are more generalized. MassBiologics sent letters containing information regarding this event to the manufacturer of the MMR vaccine, Merck & Co., and the manufacturer of the Tuberculin Purified Protein Derivative and Polio Vaccine, Sanofi Pasteur, on September 7, 2017. Please note that reports 'US-MassBiologics-AE1704' and 'US-MassBiologics-AE1705' have been linked to this report. These three adverse events were reported to MassBiologics at the same time by the same primary source reporter.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood test, Burning sensation, Chromaturia, Rash generalised, Skin exfoliation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general pruritus in a 65-year-old male patient who received FLULAVAL QUADRIVALENT. The patient's past medical history included hyperlipidemia. Concurrent medical conditions included type II diabetes mellitus (has had it a long time) and hypertension. Concomitant products included AFRIN, atenolol, Atorvastatin, Metformin, Pioglitazone Hydrochloride and glipizide. On 27th December 2017, the patient received FLULAVAL QUADRIVALENT. In December 2017, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced general pruritus, musculoskeletal stiffness, hematuria, weakness, skin inflammation and skin peeling. The patient was treated with BENADRYL. On an unknown date, the outcome of the general pruritus, musculoskeletal stiffness, hematuria, weakness and skin inflammation were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. The reporter considered the general pruritus, musculoskeletal stiffness, hematuria, weakness, skin inflammation and skin peeling to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The health care professional was the daughter of the patient, and had no vaccine lot or expiry date. The patient stated that his physician did not think it was vaccine related but the patient saw a dermatologist who thought it might be vaccine related, and not related to his comorbidities. The patient had narrated the events like itching all over his body, inflamed skin that felt like it was on fire, reddish urine and inability to close his hands. The peeling skin had not resolved. The patient was only treated with BENADRYL injection at Emergency Room and sent home with antihistamines that he stopped taking because they made him drowsy.