chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Sensory processing disorder
Clinical narrative: 7 or 8 days after the MMR vaccine, my daughter developed a very high fever (104.5), cough, and rash all over her body. We called her physician and she said it was normal and to call back if she still had a high fever in 2 days. 2 days later, her fever was still very high (103-104) and the rash was way worse and my daughter was very lethargic, weeping, not very responsive. I was scared and called her physician again. They said she might have measles and to bring her into the clinic through the back stairwell. She had blood work and the Department of  Health was contacted. They determined she did have a severe case of  measles and it was the exact strain from her vaccine (not wild-caught measles). We were told we had to be quarantined in our home for 7 days and to keep an eye out for secondary infections/illness. My daughter then developed an ear infection in both ears, which I treated her for at home naturally. Immediately after this episode, my daughter who had no behavioral or developmental issues, began having a really hard time at school and was sent home for aggressive behavior. We went to see a behavioral therapist to be evaluated and they determined she had ADHD and Sensory Processing Disorder. These behavioral issues literally happened overnight and prior to this vaccine had no indications of behavioral issues.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms x one week
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Hot flush, Pyrexia
Clinical narrative: Patient has been experiencing diarrhea, feverish symptoms, "hot flashes". She has been advised to take Imodium for diarrhea and Tylenol for the fever
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling the size of patient's palm at the injection site and minor pain. Reaction started appearing about 12 hours after injection and got progressively worse over 48 hours. Patient was advised to apply ice and take ibuprofen to help reduce the swelling.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Dyspnoea, Dysstasia, Feeling abnormal, Flushing
Clinical narrative: The patient first received her Pneumovax in her right arm, followed by the flu shot in her left. On the Pneumovax shot, I hit the patient's bone, withdrew slightly, and then injected.Two to three minutes after administration of both vaccines, the patient complained that she felt "funny." She tried to stand and found that she could not. I encouraged her to sit back and do her best to relax. Her breathing grew rapid and labored, and her face and chest grew flushed. Her son reported that she has been having more frequent panic attacks as of late, which could have exacerbated the situation. She complained of shortness of breath and that she "couldn't breathe", but denied symptoms of tongue swelling or feeling like her throat was closing. The patient also wasn't exhibiting any outward signs of anaphylaxis, with no swelling of the face or lips noted. An Epi-pen was procured as a precaution but not administered. Emergency services were called at the request of the patient's son due to her continued shortness of breath and anxiety complicated by underlying heart issues, including the presence of an internal pacemaker. Within a few minutes, the patient's color had returned to normal although she continued to have a rapid respiratory rate. This was eased in part by the patient's son getting her home oxygen from their vehicle, which was administered via her nasal cannula. EMS arrived within 15 minutes of incident onset. By that time, the patient had been able to stand and use the restroom with assistance from her son. EMS staff took the patient's vitals and found her blood pressure and oxygen saturation to be within normal levels, and the patient reported feeling much better. The entire incident lasted approximately 30 minutes, and concluded with the patient declining EMS transport to the hospital and returned home with her son.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Panic attack, Respiratory rate increased
Clinical narrative: The patient first received her Pneumovax in her right arm, followed by the flu shot in her left. On the Pneumovax shot, I hit the patient's bone, withdrew slightly, and then injected.Two to three minutes after administration of both vaccines, the patient complained that she felt "funny." She tried to stand and found that she could not. I encouraged her to sit back and do her best to relax. Her breathing grew rapid and labored, and her face and chest grew flushed. Her son reported that she has been having more frequent panic attacks as of late, which could have exacerbated the situation. She complained of shortness of breath and that she "couldn't breathe", but denied symptoms of tongue swelling or feeling like her throat was closing. The patient also wasn't exhibiting any outward signs of anaphylaxis, with no swelling of the face or lips noted. An Epi-pen was procured as a precaution but not administered. Emergency services were called at the request of the patient's son due to her continued shortness of breath and anxiety complicated by underlying heart issues, including the presence of an internal pacemaker. Within a few minutes, the patient's color had returned to normal although she continued to have a rapid respiratory rate. This was eased in part by the patient's son getting her home oxygen from their vehicle, which was administered via her nasal cannula. EMS arrived within 15 minutes of incident onset. By that time, the patient had been able to stand and use the restroom with assistance from her son. EMS staff took the patient's vitals and found her blood pressure and oxygen saturation to be within normal levels, and the patient reported feeling much better. The entire incident lasted approximately 30 minutes, and concluded with the patient declining EMS transport to the hospital and returned home with her son.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Sore left arm, headache, body aches, severe fatigue and loss of energy.  In bed for 2 full days.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Sore left arm, headache, body aches, severe fatigue and loss of energy.  In bed for 2 full days.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: The patient states that she got the shot on friday 9/6 and the next day (saturday 9/7) she felt very tired, could not get out of bed and very achy/exhausted which lasted for 2 days now.  She stated she had no injection site reaction or any problems besides mild soreness.  I do not think it is because of the vaccine persay but the patient states she has never had problems before after getting a flushot and wanted to report this problem.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: The patient states that she got the shot on friday 9/6 and the next day (saturday 9/7) she felt very tired, could not get out of bed and very achy/exhausted which lasted for 2 days now.  She stated she had no injection site reaction or any problems besides mild soreness.  I do not think it is because of the vaccine persay but the patient states she has never had problems before after getting a flushot and wanted to report this problem.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blood pressure abnormal, Herpes zoster, Nausea, Nervousness
Clinical narrative: After getting the first dose of the Shingles shot on Sunday, September 1, 2019,  I woke up on Thursday, September 5, 2019 with blisters.  I went to my dr on Friday, September 6, 2019 and he said I had shingles.  They appeared on the left side of my stomach.   Since Thursday, my blood pressure has been erratic, I've been having night sweats and an overall queasy feeling, nervousness.  Note:  my husband woke up this morning with a blister on the front of his stomach, he got his shot the same date and time I did.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Night sweats
Clinical narrative: After getting the first dose of the Shingles shot on Sunday, September 1, 2019,  I woke up on Thursday, September 5, 2019 with blisters.  I went to my dr on Friday, September 6, 2019 and he said I had shingles.  They appeared on the left side of my stomach.   Since Thursday, my blood pressure has been erratic, I've been having night sweats and an overall queasy feeling, nervousness.  Note:  my husband woke up this morning with a blister on the front of his stomach, he got his shot the same date and time I did.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: After getting the first dose of the Shingles shot on Sunday, September 1, 2019,  I woke up on Thursday, September 5, 2019 with blisters.  I went to my dr on Friday, September 6, 2019 and he said I had shingles.  They appeared on the left side of my stomach.   Since Thursday, my blood pressure has been erratic, I've been having night sweats and an overall queasy feeling, nervousness.  Note:  my husband woke up this morning with a blister on the front of his stomach, he got his shot the same date and time I did.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Dizziness, Hypersensitivity, Malaise
Clinical narrative: patient reported not feeling well ~ 2 hours after administration and reported feeling dizzy and having chest pain like something was sitting on his chest.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: itchy red hives on neck, back, ankles, and upper arm (all on left side only), starting 2 days after first shot and 2 days after second shot. all hives on left side of body. both shots in left arm. approximately 10-15 hives each time, continuing for several weeks.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Got imz 8/31 had some bruising.  Redness developed around 9/5.  Patient went to prescriber and they said it could be from imz could be bite of some kind and gave some antibiotics in case.  Redness was below the site of the imz by about 2 inches and was roughly 4 inches at its widest point.
Age: 83.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Loss of personal independence in daily activities, Memory impairment, Paralysis, Urinary incontinence
Clinical narrative: Per wife, Approximately 1 week post vaccination patient experienced paralysis, inability to control bladder, forgetfulness, and inability to perform daily activities such as operating television remote.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Golf-ball sized, painful, swollen area around injection site in the left arm still persisting one week after administration
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Back pain, Body temperature increased, Cardiac assistance device user, Chest discomfort
Clinical narrative: Patient received vaccine without flinching, stood up to watch his wife receive hers and said "i feel a little woozy" so I had him sit down. His face was flushed a very bright red and he looked uncomfortable. He said he had a pain in his chest and middle of his back and had a fullness feeling in his chest, like he couldn't get a good breath. EMS was called and his BP, HR, and EKG were all normal, but they recommended he be seen in the ER to be sure it wasn't a cardiac episode (he has a pacemaker for his a-fib). His labs showed no indication of a heart attack and he was discharged under the assumption that it was a reaction to the vaccine. His wife reported on the way home from the ER he began having violent shivering, and had a 102 temperature that evening, followed by multiple episodes of vomiting and extreme muscle weakness. He felt much better the following morning, but still rather weak.
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Chest pain, Chills, Discomfort, Dizziness, Dyspnoea
Clinical narrative: Patient received vaccine without flinching, stood up to watch his wife receive hers and said "i feel a little woozy" so I had him sit down. His face was flushed a very bright red and he looked uncomfortable. He said he had a pain in his chest and middle of his back and had a fullness feeling in his chest, like he couldn't get a good breath. EMS was called and his BP, HR, and EKG were all normal, but they recommended he be seen in the ER to be sure it wasn't a cardiac episode (he has a pacemaker for his a-fib). His labs showed no indication of a heart attack and he was discharged under the assumption that it was a reaction to the vaccine. His wife reported on the way home from the ER he began having violent shivering, and had a 102 temperature that evening, followed by multiple episodes of vomiting and extreme muscle weakness. He felt much better the following morning, but still rather weak.
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Electrocardiogram normal, Erythema, Flushing, Laboratory test normal, Muscular weakness
Clinical narrative: Patient received vaccine without flinching, stood up to watch his wife receive hers and said "i feel a little woozy" so I had him sit down. His face was flushed a very bright red and he looked uncomfortable. He said he had a pain in his chest and middle of his back and had a fullness feeling in his chest, like he couldn't get a good breath. EMS was called and his BP, HR, and EKG were all normal, but they recommended he be seen in the ER to be sure it wasn't a cardiac episode (he has a pacemaker for his a-fib). His labs showed no indication of a heart attack and he was discharged under the assumption that it was a reaction to the vaccine. His wife reported on the way home from the ER he began having violent shivering, and had a 102 temperature that evening, followed by multiple episodes of vomiting and extreme muscle weakness. He felt much better the following morning, but still rather weak.
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Patient received vaccine without flinching, stood up to watch his wife receive hers and said "i feel a little woozy" so I had him sit down. His face was flushed a very bright red and he looked uncomfortable. He said he had a pain in his chest and middle of his back and had a fullness feeling in his chest, like he couldn't get a good breath. EMS was called and his BP, HR, and EKG were all normal, but they recommended he be seen in the ER to be sure it wasn't a cardiac episode (he has a pacemaker for his a-fib). His labs showed no indication of a heart attack and he was discharged under the assumption that it was a reaction to the vaccine. His wife reported on the way home from the ER he began having violent shivering, and had a 102 temperature that evening, followed by multiple episodes of vomiting and extreme muscle weakness. He felt much better the following morning, but still rather weak.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Influenza like illness, Pain
Clinical narrative: flu like, all over body aches, temperature of 100.3.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: High fever followed by seizure
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Rash erythematous, Skin warm
Clinical narrative: There was a large red rash on the patient's upper arm about 3 inches in diameter. It was warm to the touch and the child said it was uncomfortable.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: Hep B (Engerix-B) vaccine was administered to a new employee on 9/4/19 around 1400 without immediate incident.  The following day, email was received from said employee reporting overnight insomnia, aches, chills, sweats, dizziness and nausea.  Employee's supervisor recommended employee follow up with Occupational Health and this nurse reinforced that recommendation.  In person interview occurred with employee on 9/6/19 at 1325 at which point employee reports that she feels greatly improved but still a little tired.  Employee reported that she had felt improved enough following the email on 9/5/19 that she had not felt a visit to Occupational Health was necessary.  At time of in person interview, employee stated her symptoms had onset around midnight and described her collection of symptoms as "like the flu but without fever or headaches."  Employee declines further injections in the vaccination series as she feels that the first injection was the cause of her symptoms.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Insomnia, Nausea, Pain
Clinical narrative: Hep B (Engerix-B) vaccine was administered to a new employee on 9/4/19 around 1400 without immediate incident.  The following day, email was received from said employee reporting overnight insomnia, aches, chills, sweats, dizziness and nausea.  Employee's supervisor recommended employee follow up with Occupational Health and this nurse reinforced that recommendation.  In person interview occurred with employee on 9/6/19 at 1325 at which point employee reports that she feels greatly improved but still a little tired.  Employee reported that she had felt improved enough following the email on 9/5/19 that she had not felt a visit to Occupational Health was necessary.  At time of in person interview, employee stated her symptoms had onset around midnight and described her collection of symptoms as "like the flu but without fever or headaches."  Employee declines further injections in the vaccination series as she feels that the first injection was the cause of her symptoms.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: PT GOT HER FLUSHOT AND PNEUMOVAX ON THE SAME ARM ON 96/19, PER PT REQUEST FOR LEFT.  THE NEXT DAY AFTER THE INJECTION, THE INJECTION SITE WASN'T AS RED BUT THEN LOWER PART OF THE ARM WAS.  WHEN SHE CAME TODAY, 9/8/19,  IT FELT WARM TO THE TOUCH, A BIT SWOLLEN, AND A BIT ITCHY.  PT THINKS THAT IT WAS GETTING REDDER.  PT HAS BEEN TAKING BENADRYL BID (FOR ALLERGIES) DAILY.  ALSO ADVISED HER TO TAKE TYLENOL AND USE COLD COMPRESS IF IT HELPS ANY.  SHE WILL SEE HER DERMATOLOGIST TOMORROW 9/89/19  AND LET US KNOW.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Pruritus, Rash erythematous
Clinical narrative: Patient presented to the pharmacy with a 4 inch by 3 inch rash.  Rash did not itch, but did itch if patient were to touch the rash.  Rash was red raised patch.  Rash was not warm to the touch.  Rash was a little sore.  Reaction was not affecting arm movement.  Patient also admitted to experiencing reactions to the tape on bandaids in the past.  Patient said bandaid was applied after vaccine, but patient took the bandaid off after undisclosed time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Peripheral swelling, Vomiting
Clinical narrative: PT DEVELOPED NAUSEA, VOMITING, SEVERE BODY ACHES, SWOLLEN ARM, FATIGUE
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Fairly severe pain at injection site - beginning approx an hour or so after shot, increasing and lasting for about 3 days, although it did diminish in severity somewhat after about 36 hours.  Ibuprofen relieved most pain.  Also, redness about 3" X 4" at injection site started 2nd day and lasted until end of 3rd day.  Itching started when redness disappeared.  Still minor soreness at site after 3rd day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient barely brought to our attention the reaction she had from the vaccination she had today, Sept 8th. But her initial reaction started the day after on Aug 26th ( 1 day after vaccination). She started to have redness, warmth, and very itchy. She didnt seek treatment until Friday September 30th. She had marked her arm and saw the redness spread to her elbow
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Chorea, Insomnia, Muscle spasms, Pain in extremity
Clinical narrative: Initially started out as leg/ joint pain, insomnia and involuntary muscle spasms. Progressed into acute chorea. The muscle spasms became more painful. She describes them as her muscles trying to come out of her skin.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Ear infection, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever of 103.5 the following morning after vaccine. continued to have fever up to 103.8 through the weekend. Improved with scheduled tylenol and motrin. Evaluated at Pediatricians on the Monday following vaccine. dx with ear infection but very faint rash noted on hair line at appointment. awoke the morning of the 27th a flat red rash to face, neck, trunk and back.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Hyperhidrosis, Hypotension, Pallor, Tachycardia
Clinical narrative: profuse sweating pale color tachycardia hypotension
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased
Clinical narrative: Pain at injection site and worsening pain over ~2wk period.  Pain radiating from shoulder to wrist and limited shoulder range of motion. Patient denies numbness or tingling.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Headache
Clinical narrative: ON 09/4/2019 PATIENT STARTED COMPLAINING OF VERY SEVERE UNEXPLAINED HEADACHE THAT IS GETTING WORSE AND WORSE, WAS SEEN BY SPECIALIST ON 09/08/2019 HAD CT SCAN DOSNE SAME DAY AND WAS ALL NORMAL. HIS SPECIALST THOUGHT IT MIGHT BE AN ADVERSE EFFECT TO FLUARIX.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Patient Received both prevnar & Fluad vaccinations. Fluad in (L) arm & Prevnar in (R) arm. 1st fluad w/no complications 2nd prevnar & said was extremely painful down to hand, called next day & said couldn't sleep Hurts in shoulder area. Advised tylenol & warm compress
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Pyrexia, Rash erythematous, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Red, erythematous, rash over entire area of vaccine. Was warm to touch, patient did not receive medical attention. Patient was also fevered and fatigued for a few days following Pneumovax administration.
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood test normal, Hypersensitivity, Pruritus
Clinical narrative: Patient was seen for travel concerns consult on 5/31/19 she went to the dermatologist noting a red Achy rash 4-5 days after vaccine. Patient complained at the time to her dermatologist of neck pain. The dermatologist concerned about meningitis sent the patient to ER on 6/3/19. Discharged with diagnosis of drug rash. Derm at ER felt not consistent with VZV zoster. Patient previously received Typhim overdose without any adverse reaction.
Sex: F
Vaccine: TYP, TYP
Symptoms: Drug eruption, Neck pain, Rash, Rash erythematous
Clinical narrative: Patient was seen for travel concerns consult on 5/31/19 she went to the dermatologist noting a red Achy rash 4-5 days after vaccine. Patient complained at the time to her dermatologist of neck pain. The dermatologist concerned about meningitis sent the patient to ER on 6/3/19. Discharged with diagnosis of drug rash. Derm at ER felt not consistent with VZV zoster. Patient previously received Typhim overdose without any adverse reaction.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Blood magnesium, Differential white blood cell count, Full blood count, Glomerular filtration rate, Heart rate increased
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Hypertension, Hypokalaemia, Injection site pain, Metabolic function test, Myalgia
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Myocardial necrosis marker, Pain in extremity, Platelet count, Troponin I
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Blood pressure increased, Blood test, Dyspnoea, Fear
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Frustration tolerance decreased, Hypertension, Hypokalaemia, Impaired driving ability, Injection site pain
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Lethargy, Loss of personal independence in daily activities, Malaise, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Product administered at inappropriate site, Respiratory distress, Vaccination complication
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pain
Clinical narrative: severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865), intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient medical history was not reported. There were no concomitant medications. The patient experienced severe pain on an unspecified date in 2019 with outcome of unknown.  Some said they had reactions to the shot too.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness; warmth; soreness; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd August 2019, 1 days after receiving Shingrix, the patient experienced localized erythema, localized feeling of warmth and pain localized. On an unknown date, the outcome of the localized erythema, localized feeling of warmth and pain localized were recovered/resolved.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth and pain localized to be related to Shingrix.  Additional information received were as follows: The patient experienced red circle that was sore and warm to the touch about 2 to 3 inches below the injection site. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: redness; warmth; soreness; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd August 2019, 1 days after receiving Shingrix, the patient experienced localized erythema, localized feeling of warmth and pain localized. On an unknown date, the outcome of the localized erythema, localized feeling of warmth and pain localized were recovered/resolved.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth and pain localized to be related to Shingrix.  Additional information received were as follows: The patient experienced red circle that was sore and warm to the touch about 2 to 3 inches below the injection site. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular). In November 2018, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose and experienced a slight shingles outbreak. The patient consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Flushing, Headache, Injected limb mobility decreased, Muscle spasms, Muscle twitching
Clinical narrative: Patient experienced shoulder pain that still hurts after adminstration of vaccine. Her left arm has full range of motion but hurts with movement.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Patient experienced shoulder pain that still hurts after adminstration of vaccine. Her left arm has full range of motion but hurts with movement.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Patient experienced shoulder pain that still hurts after adminstration of vaccine. Her left arm has full range of motion but hurts with movement.
Age: 75.0
Sex: U
Vaccine: PPV, FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Severe shoulder/ARM pain. Unable to move arm/shoulder. All Lasting 3 days. Took Pain meds, Started Frozen Shoulder exercises unable To sleep during the night since this happened, applying heat/cold foR relief. Family (Nep) seen on 8-23-19. Muscle relaxer given. Referrel to ortho Dr. AppT. on 9-17-19. Pain continues. Range of moTion about 30% at this Time.
Age: 75.0
Sex: U
Vaccine: PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity, Periarthritis
Clinical narrative: Severe shoulder/ARM pain. Unable to move arm/shoulder. All Lasting 3 days. Took Pain meds, Started Frozen Shoulder exercises unable To sleep during the night since this happened, applying heat/cold foR relief. Family (Nep) seen on 8-23-19. Muscle relaxer given. Referrel to ortho Dr. AppT. on 9-17-19. Pain continues. Range of moTion about 30% at this Time.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Vaccination at 2pm. By midnight, entire right arm painful and throbbing. By 2:30am, developed fever. Lethargy, malaise, headache for the following 24 hours.
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Diarrhoea, Jaundice, Pyrexia, Rash generalised, Screaming
Clinical narrative: Our son started with his VERY FIRST vaccine but I didn?t realize he was having reactions to vaccines period until he was nine months on an unintentional delayed schedule. The DAY AFTER receiving his ?6 month? shots (he was 9 months) he had it worse than before, the body rash, the puking, and in the middle of the night just started screaming for, now what I believe, was because his brain was starting to swell from the chemicals breaking through the blood brain barrier.  I tried reporting his jaundice that was caused not only by being medically neglected when I mentioned my water broke, but also because they failed to mention that our son would be at HIGHER risk of getting severe jaundice due to the vitamin K shot which also has a black box warning on it. So, at our sons two month check up, he got a full body rash and low grade fever, I was told that is normal, I now know that is NOT normal and is a reaction to the vaccines. At 4 months our son got diarrhea so bad along with a fever, at four months he received the exact shot to prevent that, Rotavirus.  At 9 months, since we traveled, he got his 6 months then and had the worse reaction of them all. When we decided to stop, that?s when his illnesses stopped.
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Vomiting
Clinical narrative: Our son started with his VERY FIRST vaccine but I didn?t realize he was having reactions to vaccines period until he was nine months on an unintentional delayed schedule. The DAY AFTER receiving his ?6 month? shots (he was 9 months) he had it worse than before, the body rash, the puking, and in the middle of the night just started screaming for, now what I believe, was because his brain was starting to swell from the chemicals breaking through the blood brain barrier.  I tried reporting his jaundice that was caused not only by being medically neglected when I mentioned my water broke, but also because they failed to mention that our son would be at HIGHER risk of getting severe jaundice due to the vitamin K shot which also has a black box warning on it. So, at our sons two month check up, he got a full body rash and low grade fever, I was told that is normal, I now know that is NOT normal and is a reaction to the vaccines. At 4 months our son got diarrhea so bad along with a fever, at four months he received the exact shot to prevent that, Rotavirus.  At 9 months, since we traveled, he got his 6 months then and had the worse reaction of them all. When we decided to stop, that?s when his illnesses stopped.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported in the patient; the patient received an expired dose of VAQTA (lot R010369 exp 3/25/2019) after its expiration date; This spontaneous report was received from a pharmacist regarding a patient with no name or other demographics provided. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  On 16-AUG-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), lot # R010369 and expiration date 25-MAR-2019 (expired product administered) (strength: 25/0.5 (units not provided); dose, frequency, route of administration not provided) as prophylaxis. No adverse effects were reported in the patient. No product quality issue was present.  The case is non-valid due to lack of patient's identifiers.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered PROQUAD that may have been improperly stored. The PROQUAD was reconstituted with Merck STERILE DILUENT that may have been improperly stored; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's current condition, concomitant medications, medical history and historical drugs were unknown. On 21-AUG-2019, the patient was administered with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) of lot number S003169, expiry date 30-JUL-2020, therapy type rHA (dose, strength, frequency, route of administration were unknown) for prophylaxis and it was reconstituted with improperly stored merck sterile diluent (product storage error) of lot number R022412, expiry date 14-NOV-2019 (dose, strength, frequency, route of administration, indication were unknown). There were no adverse effects reported (no adverse event). There was no Product Quality Complaint (PQC) identified.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported.; one patient was inadvertently administered PROQUAD and VARIVAX; This spontaneous report was received from a licensed practical nurse concerning a 14 months old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medication were not provided.    Simultaneously on 30-AUG-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S012472; expiration date 20-OCT-2020) (dose, frequency and indication were not provided) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S015459; expiration date 20-MAY-2021) (dose, frequency and indication were not provided).   No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a unknown age male patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On or about 08-MAR-2011, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related condition.  On an unknown date, the patient was treated for shingles. The event caused the patient hospitalization.  As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies;diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was considered as not recovered. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On or about 09-JUL-2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related condition.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The event caused the patient hospitalization. The outcome of event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bells' Palsey; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication. On or about 30-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a healthcare provider for Bells' Palsey . As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   Upon internal review, the event Bells' Palsey was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect; inadvertently administered the adult dose of VAQTA; This spontaneous report was received from a nurse practitioner regarding an 18 year old patient. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 31-AUG-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # R031045, expiry date: 18-NOV-2019) dose 1, intramuscular route, for prophylaxis. The patient was considered to be an adolescent, however he/she received an adult dose of hepatitis a vaccine, inactivated (VAQTA) (product administered to patient of inappropriate age). No adverse effects reported.