chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Anger, Depressed mood, Exposure during pregnancy, Frustration, Hallucination
Clinical narrative: Based on addition information received on 04 May 2015, this case became medically confirmed. Initial unsolicited report received from a Consumer (Patient parent) on 19 September 2014. A 19-year-old female patient, had received an intramuscular first dose of IMOVAX vaccine (lot number: K1729-1, expiry date- 07 Dec 2016) in right deltoid on 14 Jan 2015 and had received an intramuscular second dose of IMOVAX vaccine (lot number: K1729-1, expiry date- 07 Dec 2016) in right deltoid on 22 Jan 2015. The patient had no illness at the time of vaccination. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions. It was reported that patient had experienced similar event at the age of 17 when she had to take percocet after an orthopedic procedure. Patient had the anger, sadness, and experienced hallucinations after the. On 14 Jan 2015 and 22 Jan 2015 i.e. 24 Hour after each vaccination patient had significant mood change. Patient becomes angry, doesn't feel like she was in control, was clearly frustrated, but has not acted out. Patient had also deep feeling of sadness. Corrective treatment was not reported and no laboratory details. On an unspecified date patient was recovered. Documents held by sender: None. Follow up information received from the healthcare professional (medical notes provided) on 04 May 2015. It was reported that patient had received third dose of Rabies vaccine (Batch number- K1729-1, expiry date- 07 December 2016) on 06 February 2015 in left deltoid. The patient was allergic to salmon- throat swelling, and difficulty (fish allergy) and history of pilonidal cyst removal 2010, knee surgery NOS (3 year ago). Social history: patient denied smoking, drug use and alcohol use. Family history: patient's father died at the age of 58, due to blood cancer. It was reported that the patient was not on any medication. On 06 February 2015 patients vitals were blood pressure 105/67 mmhg, pulse 71bpm, RESP(respiration)-14 breath/min, temperature 97.6 BMI-24.021, LMP-09 January 2015 and oxygen saturation at 11:17:00 was 97%. On 14 January 2015 patients vitals were blood pressure 111/68 mmhg, pulse 81bpm, RESP (respiration)-14 breath/min, temperature 97.6, BMI-24.021 and oxygen saturation at 11:17:00 was 95%. On 21 January 2015 patients vitals were blood pressure 99/69 mmhg, pulse 68bpm, RESP (respiration)-14 breath/min, temperature 96.9, BMI-24.021 and oxygen saturation at 11:17:00 was 95%. Last menstrual period was reported as 09 January 2015 and estimated date of delivery was not reported. Hence, an event of vaccine exposure during pregnancy coded as patient was exposed to vaccine during first trimester. Pregnancy outcome not reported. Documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Mood altered
Clinical narrative: Based on addition information received on 04 May 2015, this case became medically confirmed. Initial unsolicited report received from a Consumer (Patient parent) on 19 September 2014. A 19-year-old female patient, had received an intramuscular first dose of IMOVAX vaccine (lot number: K1729-1, expiry date- 07 Dec 2016) in right deltoid on 14 Jan 2015 and had received an intramuscular second dose of IMOVAX vaccine (lot number: K1729-1, expiry date- 07 Dec 2016) in right deltoid on 22 Jan 2015. The patient had no illness at the time of vaccination. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions. It was reported that patient had experienced similar event at the age of 17 when she had to take percocet after an orthopedic procedure. Patient had the anger, sadness, and experienced hallucinations after the. On 14 Jan 2015 and 22 Jan 2015 i.e. 24 Hour after each vaccination patient had significant mood change. Patient becomes angry, doesn't feel like she was in control, was clearly frustrated, but has not acted out. Patient had also deep feeling of sadness. Corrective treatment was not reported and no laboratory details. On an unspecified date patient was recovered. Documents held by sender: None. Follow up information received from the healthcare professional (medical notes provided) on 04 May 2015. It was reported that patient had received third dose of Rabies vaccine (Batch number- K1729-1, expiry date- 07 December 2016) on 06 February 2015 in left deltoid. The patient was allergic to salmon- throat swelling, and difficulty (fish allergy) and history of pilonidal cyst removal 2010, knee surgery NOS (3 year ago). Social history: patient denied smoking, drug use and alcohol use. Family history: patient's father died at the age of 58, due to blood cancer. It was reported that the patient was not on any medication. On 06 February 2015 patients vitals were blood pressure 105/67 mmhg, pulse 71bpm, RESP(respiration)-14 breath/min, temperature 97.6 BMI-24.021, LMP-09 January 2015 and oxygen saturation at 11:17:00 was 97%. On 14 January 2015 patients vitals were blood pressure 111/68 mmhg, pulse 81bpm, RESP (respiration)-14 breath/min, temperature 97.6, BMI-24.021 and oxygen saturation at 11:17:00 was 95%. On 21 January 2015 patients vitals were blood pressure 99/69 mmhg, pulse 68bpm, RESP (respiration)-14 breath/min, temperature 96.9, BMI-24.021 and oxygen saturation at 11:17:00 was 95%. Last menstrual period was reported as 09 January 2015 and estimated date of delivery was not reported. Hence, an event of vaccine exposure during pregnancy coded as patient was exposed to vaccine during first trimester. Pregnancy outcome not reported. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Documented hypersensitivity to administered product
Clinical narrative: Initial unsolicited report received from a healthcare professional on 18 March 2015. A 65-year -old male patient, whose medical history and concomitant medications were not reported, had received a dose of DIPHTHERIA AND TETANUS TOXOIDS (batch number, dose, dose number, expiry date and site of administration were not reported) via Intra Muscular route on unspecified date. It was reported that the Patent had a large reaction in childhood to horse serum and patient can't take tetanus or tetanus containing products." No information about prior exposure to vaccine was not reported. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was recovered. Documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Prostatic specific antigen increased
Clinical narrative: Initial unsolicited report received from a consumer on 28 April 2015. A male patient age not reported, whose concomitant medications were not reported, had received a dose of Imovax rabies on 12 March 2015 and a dose of Imogam on 28 February 2015 (batch number, expiry date, dose number, route and site of administration were not reported for both the vaccines). Medical history included prostatectomy four years ago on an unspecified date, XBRT and had spent two years on hormone replacement therapy. Prostate specific antigen test on 31 March 2015 showed 0.015 and again on 2 April 2015 showed elevation from 0.015 to 0.018. Laboratory investigations included prostate specific antigen test on 31 March 2015 and again on 2 April 2015 showed elevation from 0.015 to 0.018. Corrective treatments were not reported. At the time of report, the outcome of event was unknown. Documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: HEP, RAB
Symptoms: Blood pressure increased
Clinical narrative: Initial unsolicited report received from a Nurse on 14 May 2015. A 40-years-old male patient with medical history of hypertension (HTN) and no known allergies and whose concomitant medications were not reported, had received a second dose of Imovax (batch number as: K1729-1, expiry date: 07 December 2016, dose was not reported) intramuscularly in left deltoid on 06 May 2015. Patient did not have any illness at the time of vaccination. On 13 May 2015, seven day after vaccination, patient presented with elevated blood pressure (BP) and second vaccine was held for the patient. Patient required ER/doctor visit for the event. Laboratory investigations and corrective treatment were not reported. At the time of this report, the event outcome was not recovered. List of documents held by sender: none. Follow up report received from a Nurse on 14 May 2015. The patient received Imovax in right upper arm. The patient also received second dose of Hep B vaccine (Batch number 7529F, manufacturer-GSK) in left upper arm on 6 May 2015. It was reported that the patient did not received any corrective treatment. It was reported that the patient was forget to took his BP (blood pressure) medication on the date the vaccine was supposed to be administered and the dose was withheld because of high BP. Subsequent BPs were normalized. On an unspecified date, the patient recovered from the event.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Blood test normal, Headache, Inappropriate schedule of drug administration
Clinical narrative: Initial unsolicited misuse report received from a physician ion 04-Nov-2015. This case involves an 29-year-old female patient who was vaccinated with an intramuscular first dose of Imovax (batch number: K1057, K1729, site of administration was not reported) and an intramuscular first dose of Imogam (batch number: L1050-2, expiry date: 23-Jan-2017 and site of administration was not reported) on 15-Jul-2015. The patient was possibly vaccinated with RABAVERT on an unspecified date. It was reported that the patient had no illness at the time of vaccination, no known allergies and no medical conditions. Patient had no vaccination within 4 weeks of vaccination and concomitant medications were not reported. On 30-Jul-2015, 15 days after vaccination, the patient experienced daily headaches in parietal area. The patient was noncompliant with receiving the post exposure vaccines, had received 3 after receiving the second vaccine. Patient required an ER visit on 15-Jul-2015. It was a case of inappropriate schedule of vaccine administered. Laboratory investigation include blood tests which was within normal limits and did not had any studies to evaluate the headaches. It was reported that corrective treatment include over the counter medications to relieve headaches. The outcome of the event was reported as not recovered. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 20 November 2015. This case involves a 71-year-old female patient who was vaccinated with a dose of Fluzone (batch number and manufacturer was unknown, expiry date, dose, dose in series, route and site of administration were not reported) on 13 November 2015. Illness at time of vaccination and any other vaccinations within 4 weeks of vaccinations reported as didn't ask. Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as unknown. Concomitant medications were not reported. On 13 November 2015, few second following the vaccination, the patient had developed jaw swelling, may have had rash. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none. Follow up information received from non-healthcare professional on 09 February 2015. Patient received 0.5ml intramuscular dose of Fluzone (batch number U1487AA, manufacturer: SANOFI PASTEUR INC.) in left deltoid at 13:50.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Death, Decreased appetite, Nausea, Pneumonia
Clinical narrative: Weakness, tremors, loss of appetite.  My mother never really recovered after this. She was hospitalized a week or so after receiving the vaccine. She contracted a "community aquired pneumonia" in the hospital then had to go to a rehab center.  his was the beginning of the end for her. She was weak with tremors and loss of appetite and nausea for weeks.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Tremor
Clinical narrative: Weakness, tremors, loss of appetite.  My mother never really recovered after this. She was hospitalized a week or so after receiving the vaccine. She contracted a "community aquired pneumonia" in the hospital then had to go to a rehab center.  his was the beginning of the end for her. She was weak with tremors and loss of appetite and nausea for weeks.
Age: 33.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received a IM vaccination via SC route. As a result Patient's arm was warm, red, and swollen at the site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to an unspecified number of unspecified patients of an unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 17-FEB-2016, an unspecified patients were vaccinated with an unspecified number of improperly stored VARIVAX (Merck) lot # L040422 (15-OCT-2017) and lot # L042265 (26-OCT-2017) (dosage not reported). It was stored at 20F temperature and time frame was 599 hours. There was no previous temperature excursion. No adverse events reported. No product quality complaint reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date in 2015, an unspecified number of patients were vaccinated (Oka/Merck) VARIVAX Lot # K016129 and expiration date 23-SEP-2016, Lot # K006139 and expiration date 29-APR-2016, Lot # L005298 and expiration date 03-SEP-2017, Lot # L004653 and expiration date 11-FEB-2017, (dose number, strength, and route of administration were not reported), that were improperly stored and exposed to temperatures of 1.6 C for 2 hours and 40 minutes. At the time of this report, it was not reported any adverse event. This is one of two reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: 3-25-16 woke up to red swelling at site of DTAP, rt upper arm. Worse after day care at 4pm today. Pt. stated some itching. Warm to touch. No fever. No breathing problems
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Culture, Discomfort, Injection site pain, Irritability, Mobility decreased
Clinical narrative: Fever, fussy, uncomfortable. 102.1 at home 101.2 at clinic app. Tx: TYLENOL, MOTRIN 1-2 days. Failure to bear weight, acting like her legs hurts with touching legs, not wanting to walk/crawl. Expect 1-2 days of sx. (Evaluated by NP).
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pharyngeal erythema, Pyrexia, Streptococcus test negative, Weight bearing difficulty
Clinical narrative: Fever, fussy, uncomfortable. 102.1 at home 101.2 at clinic app. Tx: TYLENOL, MOTRIN 1-2 days. Failure to bear weight, acting like her legs hurts with touching legs, not wanting to walk/crawl. Expect 1-2 days of sx. (Evaluated by NP).
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Decreased appetite, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Patient took first oral Typhoid on an empty stomach the evening of 3/20/16. Patient states she woke up on 3/22 with nausea, fever of 100.0 F, and diarrhea which she had "2-3" episodes that day, pt reports decreased appetite and occasional diarrhea the rest of the week along with some  "loose stools". Fever only 0n 3/22. No vomiting. Denies rash. Denies other allergic sx's. Patient is currently tolerating food/fluids.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test normal, Chest X-ray normal, Dizziness, Dyspepsia, Electrocardiogram normal
Clinical narrative: I went to sleep at 10:00pm and felt totally fine. About 2:00am I would up with fast heart beat with heart burn feeling. I got up to walk around and felt very dizzy. This continued for 15 minutes and I realized it could not be walked off. I don't often go to doctors so this really scared me. Then I went to the Emergency Room.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate increased
Clinical narrative: I went to sleep at 10:00pm and felt totally fine. About 2:00am I would up with fast heart beat with heart burn feeling. I got up to walk around and felt very dizzy. This continued for 15 minutes and I realized it could not be walked off. I don't often go to doctors so this really scared me. Then I went to the Emergency Room.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Arthralgia, Chills, Cystitis, Fatigue
Clinical narrative: This is a spontaneous report from a contactable 80-year-old female consumer reported for herself. An 80-years-old female patient started to receive PREVNAR 13 Lot M69971; Exp. 01Dec2016, via an unspecified route of administration at single at right arm on 04Dec2015 10:00 or 11:00 a.m. as she had not spleen and so she has a low immune system. Medical history included splenectomy from 2002 to an unknown date spleen was punctured during a colonoscopy and so it had to be removed, had pneumonia on 29Jun2015 or 30Jun2015 which put her in the hospital for a week, had like to have died -Hurt very bad from an unknown date and unknown if ongoing, colonoscopy from an unknown date and unknown if ongoing. Concomitant medication included metoprolol started about 2 1/2 years before and ongoing for heart attack prevention, Vitamin B12 injection 1000 units once a month, Vitamin B12 oral 100mg tablet once a day ongoing. About 2 or 3 years before this report, her XANAX prescription was given to her for her nerves with orange pills instead of her usual pink pills. She does  not remember exactly how, but the orange alprazolam messed her up, maybe they hurt her stomach, and so she had to go to the pharmacy and specially order white alprazolam pills. She took 0.25mg pills, 2 in the morning, 2 at lunch and 2 at night, by mouth. She will not take the orange alprazolam again. The patient experienced hurting/epigastric pain/muscle pain/joint pain on 05Dec2015 with outcome of recovering, felt sick/very sick on an unspecified date with outcome of recovering, fatigue/like to have died fatigue/fatigue unspecified type on an unspecified date with outcome of not recovered, was more jittery on an unspecified date with outcome of recovering, feels a pin like sensation in her legs on an unspecified date with outcome of unknown, nausea on 24Jan2016 with outcome of not recovered, vaginal irritation on 13Feb2016 with outcome of recovering, acute cystitis without hematuria on 16Feb2016 with outcome of recovered, chill-rash on an unspecified date with outcome of unknown. The patient was hospitalized multiple times for hurting/epigastric pain/muscle pain/joint pain from 24Jan2016 to an unknown date, for sick/very sick from 13Feb2016 to an unknown date, and for fatigue/like to have died fatigue/fatigue unspecified type from 27Feb2016 to an unknown date. The patient was treated due to the events with amoxicillin 500 mg 3 times a day from 12Jan2016 to 15Jan2016, DIFLUCAN tablet 100 mg, ZOFRAN 4 mg-1-every 8 hrs from 24Jan2016 to 30Jan2016, MICATIN Cream from 13Feb2016 to 2016, Eucerin 2 time a day from 13Feb2016 to 05Mar2016, Vaseline 05Mar2016 and ongoing, MACROBID from 16Feb2016 one every 12 hrs for 17 days. Follow-up (14Mar2016): New information from the same contactable consumer includes: new events and outcome, hospitalization details, treatment.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling jittery, Malaise, Myalgia, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable 80-year-old female consumer reported for herself. An 80-years-old female patient started to receive PREVNAR 13 Lot M69971; Exp. 01Dec2016, via an unspecified route of administration at single at right arm on 04Dec2015 10:00 or 11:00 a.m. as she had not spleen and so she has a low immune system. Medical history included splenectomy from 2002 to an unknown date spleen was punctured during a colonoscopy and so it had to be removed, had pneumonia on 29Jun2015 or 30Jun2015 which put her in the hospital for a week, had like to have died -Hurt very bad from an unknown date and unknown if ongoing, colonoscopy from an unknown date and unknown if ongoing. Concomitant medication included metoprolol started about 2 1/2 years before and ongoing for heart attack prevention, Vitamin B12 injection 1000 units once a month, Vitamin B12 oral 100mg tablet once a day ongoing. About 2 or 3 years before this report, her XANAX prescription was given to her for her nerves with orange pills instead of her usual pink pills. She does  not remember exactly how, but the orange alprazolam messed her up, maybe they hurt her stomach, and so she had to go to the pharmacy and specially order white alprazolam pills. She took 0.25mg pills, 2 in the morning, 2 at lunch and 2 at night, by mouth. She will not take the orange alprazolam again. The patient experienced hurting/epigastric pain/muscle pain/joint pain on 05Dec2015 with outcome of recovering, felt sick/very sick on an unspecified date with outcome of recovering, fatigue/like to have died fatigue/fatigue unspecified type on an unspecified date with outcome of not recovered, was more jittery on an unspecified date with outcome of recovering, feels a pin like sensation in her legs on an unspecified date with outcome of unknown, nausea on 24Jan2016 with outcome of not recovered, vaginal irritation on 13Feb2016 with outcome of recovering, acute cystitis without hematuria on 16Feb2016 with outcome of recovered, chill-rash on an unspecified date with outcome of unknown. The patient was hospitalized multiple times for hurting/epigastric pain/muscle pain/joint pain from 24Jan2016 to an unknown date, for sick/very sick from 13Feb2016 to an unknown date, and for fatigue/like to have died fatigue/fatigue unspecified type from 27Feb2016 to an unknown date. The patient was treated due to the events with amoxicillin 500 mg 3 times a day from 12Jan2016 to 15Jan2016, DIFLUCAN tablet 100 mg, ZOFRAN 4 mg-1-every 8 hrs from 24Jan2016 to 30Jan2016, MICATIN Cream from 13Feb2016 to 2016, Eucerin 2 time a day from 13Feb2016 to 05Mar2016, Vaseline 05Mar2016 and ongoing, MACROBID from 16Feb2016 one every 12 hrs for 17 days. Follow-up (14Mar2016): New information from the same contactable consumer includes: new events and outcome, hospitalization details, treatment.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Rash, Vulvovaginal discomfort
Clinical narrative: This is a spontaneous report from a contactable 80-year-old female consumer reported for herself. An 80-years-old female patient started to receive PREVNAR 13 Lot M69971; Exp. 01Dec2016, via an unspecified route of administration at single at right arm on 04Dec2015 10:00 or 11:00 a.m. as she had not spleen and so she has a low immune system. Medical history included splenectomy from 2002 to an unknown date spleen was punctured during a colonoscopy and so it had to be removed, had pneumonia on 29Jun2015 or 30Jun2015 which put her in the hospital for a week, had like to have died -Hurt very bad from an unknown date and unknown if ongoing, colonoscopy from an unknown date and unknown if ongoing. Concomitant medication included metoprolol started about 2 1/2 years before and ongoing for heart attack prevention, Vitamin B12 injection 1000 units once a month, Vitamin B12 oral 100mg tablet once a day ongoing. About 2 or 3 years before this report, her XANAX prescription was given to her for her nerves with orange pills instead of her usual pink pills. She does  not remember exactly how, but the orange alprazolam messed her up, maybe they hurt her stomach, and so she had to go to the pharmacy and specially order white alprazolam pills. She took 0.25mg pills, 2 in the morning, 2 at lunch and 2 at night, by mouth. She will not take the orange alprazolam again. The patient experienced hurting/epigastric pain/muscle pain/joint pain on 05Dec2015 with outcome of recovering, felt sick/very sick on an unspecified date with outcome of recovering, fatigue/like to have died fatigue/fatigue unspecified type on an unspecified date with outcome of not recovered, was more jittery on an unspecified date with outcome of recovering, feels a pin like sensation in her legs on an unspecified date with outcome of unknown, nausea on 24Jan2016 with outcome of not recovered, vaginal irritation on 13Feb2016 with outcome of recovering, acute cystitis without hematuria on 16Feb2016 with outcome of recovered, chill-rash on an unspecified date with outcome of unknown. The patient was hospitalized multiple times for hurting/epigastric pain/muscle pain/joint pain from 24Jan2016 to an unknown date, for sick/very sick from 13Feb2016 to an unknown date, and for fatigue/like to have died fatigue/fatigue unspecified type from 27Feb2016 to an unknown date. The patient was treated due to the events with amoxicillin 500 mg 3 times a day from 12Jan2016 to 15Jan2016, DIFLUCAN tablet 100 mg, ZOFRAN 4 mg-1-every 8 hrs from 24Jan2016 to 30Jan2016, MICATIN Cream from 13Feb2016 to 2016, Eucerin 2 time a day from 13Feb2016 to 05Mar2016, Vaseline 05Mar2016 and ongoing, MACROBID from 16Feb2016 one every 12 hrs for 17 days. Follow-up (14Mar2016): New information from the same contactable consumer includes: new events and outcome, hospitalization details, treatment.
Sex: U
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Fatigue, Hypoaesthesia, Joint swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer (the patient). A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at a single dose. Relevant medical history and concomitant medications were not reported. The patient experienced psoriatic arthritis joints, a finger on the shot arm started to 'tingle' and feel numb, fatigue, exhaustion, odd aches/pains progressed/aches and pains in other joints, the back, tendons/plagued him with pain, swelling again in the fingers. The patient had a wrist he broke fifty some years before this report has started to hurt/intense ache. The patient experienced pain in extremity, vaccination site pain, twitching, generalized pain, muscle cramp, joint pain, back pain, tendons pain, muscles pain, swelling of wrists on unknown date. The patients described the events as follow: The numbness progressed with time to include parts of the thumb and second finger and a year later the numbness was more or less noticeable. The exercise tended to make it more noticeable as did 'awareness' of it. Rubbing it tended to make it less so. It was impossible to sleep on the vaccination side without numbness running the length of the arm to the fingers. The patient went from being a 8-10 hour sleeper to a 14-16 hour sleeper also needing additional naps during the day beyond that. For six months that continued and then started to let up some. Fatigue still comes on rapidly and many naps during the day run from a few minutes to a couple of hours. There were times when a thirty minute walk will leave me exhausted - an hour or two nap would not be unusual. The pain vary from generalized aches to sharp pin pricks and include throbbing areas that feel like sharp punches. Also included are 'twitches' and feelings of impending foot or calf cramps. Aches and pains in other joints, the back, tendons and muscles have developed on a lesser scale. The psoriatic arthritis joints that have been inflammation and pain free for years have acted up causing swelling again in the fingers. The wrist he/she broke fifty some years before this report has started to hurt like it did with a very intense ache that comes and goes. The wrist also got fluid 'bumps' on it that come and go. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer (the patient). A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at a single dose. Relevant medical history and concomitant medications were not reported. The patient experienced psoriatic arthritis joints, a finger on the shot arm started to 'tingle' and feel numb, fatigue, exhaustion, odd aches/pains progressed/aches and pains in other joints, the back, tendons/plagued him with pain, swelling again in the fingers. The patient had a wrist he broke fifty some years before this report has started to hurt/intense ache. The patient experienced pain in extremity, vaccination site pain, twitching, generalized pain, muscle cramp, joint pain, back pain, tendons pain, muscles pain, swelling of wrists on unknown date. The patients described the events as follow: The numbness progressed with time to include parts of the thumb and second finger and a year later the numbness was more or less noticeable. The exercise tended to make it more noticeable as did 'awareness' of it. Rubbing it tended to make it less so. It was impossible to sleep on the vaccination side without numbness running the length of the arm to the fingers. The patient went from being a 8-10 hour sleeper to a 14-16 hour sleeper also needing additional naps during the day beyond that. For six months that continued and then started to let up some. Fatigue still comes on rapidly and many naps during the day run from a few minutes to a couple of hours. There were times when a thirty minute walk will leave me exhausted - an hour or two nap would not be unusual. The pain vary from generalized aches to sharp pin pricks and include throbbing areas that feel like sharp punches. Also included are 'twitches' and feelings of impending foot or calf cramps. Aches and pains in other joints, the back, tendons and muscles have developed on a lesser scale. The psoriatic arthritis joints that have been inflammation and pain free for years have acted up causing swelling again in the fingers. The wrist he/she broke fifty some years before this report has started to hurt like it did with a very intense ache that comes and goes. The wrist also got fluid 'bumps' on it that come and go. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Paraesthesia, Peripheral swelling, Psoriatic arthropathy, Sleep disorder, Somnolence
Clinical narrative: This is a spontaneous report from a non-contactable consumer (the patient). A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at a single dose. Relevant medical history and concomitant medications were not reported. The patient experienced psoriatic arthritis joints, a finger on the shot arm started to 'tingle' and feel numb, fatigue, exhaustion, odd aches/pains progressed/aches and pains in other joints, the back, tendons/plagued him with pain, swelling again in the fingers. The patient had a wrist he broke fifty some years before this report has started to hurt/intense ache. The patient experienced pain in extremity, vaccination site pain, twitching, generalized pain, muscle cramp, joint pain, back pain, tendons pain, muscles pain, swelling of wrists on unknown date. The patients described the events as follow: The numbness progressed with time to include parts of the thumb and second finger and a year later the numbness was more or less noticeable. The exercise tended to make it more noticeable as did 'awareness' of it. Rubbing it tended to make it less so. It was impossible to sleep on the vaccination side without numbness running the length of the arm to the fingers. The patient went from being a 8-10 hour sleeper to a 14-16 hour sleeper also needing additional naps during the day beyond that. For six months that continued and then started to let up some. Fatigue still comes on rapidly and many naps during the day run from a few minutes to a couple of hours. There were times when a thirty minute walk will leave me exhausted - an hour or two nap would not be unusual. The pain vary from generalized aches to sharp pin pricks and include throbbing areas that feel like sharp punches. Also included are 'twitches' and feelings of impending foot or calf cramps. Aches and pains in other joints, the back, tendons and muscles have developed on a lesser scale. The psoriatic arthritis joints that have been inflammation and pain free for years have acted up causing swelling again in the fingers. The wrist he/she broke fifty some years before this report has started to hurt like it did with a very intense ache that comes and goes. The wrist also got fluid 'bumps' on it that come and go. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Tendon pain, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer (the patient). A patient of unspecified age, gender and ethnicity received PREVNAR 13 via an unspecified route of administration, on unknown date, at a single dose. Relevant medical history and concomitant medications were not reported. The patient experienced psoriatic arthritis joints, a finger on the shot arm started to 'tingle' and feel numb, fatigue, exhaustion, odd aches/pains progressed/aches and pains in other joints, the back, tendons/plagued him with pain, swelling again in the fingers. The patient had a wrist he broke fifty some years before this report has started to hurt/intense ache. The patient experienced pain in extremity, vaccination site pain, twitching, generalized pain, muscle cramp, joint pain, back pain, tendons pain, muscles pain, swelling of wrists on unknown date. The patients described the events as follow: The numbness progressed with time to include parts of the thumb and second finger and a year later the numbness was more or less noticeable. The exercise tended to make it more noticeable as did 'awareness' of it. Rubbing it tended to make it less so. It was impossible to sleep on the vaccination side without numbness running the length of the arm to the fingers. The patient went from being a 8-10 hour sleeper to a 14-16 hour sleeper also needing additional naps during the day beyond that. For six months that continued and then started to let up some. Fatigue still comes on rapidly and many naps during the day run from a few minutes to a couple of hours. There were times when a thirty minute walk will leave me exhausted - an hour or two nap would not be unusual. The pain vary from generalized aches to sharp pin pricks and include throbbing areas that feel like sharp punches. Also included are 'twitches' and feelings of impending foot or calf cramps. Aches and pains in other joints, the back, tendons and muscles have developed on a lesser scale. The psoriatic arthritis joints that have been inflammation and pain free for years have acted up causing swelling again in the fingers. The wrist he/she broke fifty some years before this report has started to hurt like it did with a very intense ache that comes and goes. The wrist also got fluid 'bumps' on it that come and go. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Rash, Wheezing
Clinical narrative: Developed a rash, shortness of breath, wheezing post immunization.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Eye pain, Headache, Injection site swelling, Pyrexia
Clinical narrative: FEVER, HEADACHE, EYES ACHING SWOLLEN SIGHT OF INJECTION CHILLS LOST OF WEIGHT.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Weight decreased
Clinical narrative: FEVER, HEADACHE, EYES ACHING SWOLLEN SIGHT OF INJECTION CHILLS LOST OF WEIGHT.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dysarthria, Loss of consciousness, Miosis, Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: While receiving the Gardasil 9 vaccine, patient began shaking, lost consciousness, and began demonstrating seizure-like activity with posturing and rigidity of the arms, legs, and neck.  Patient remained unconscious approximately 3 minutes.  Once awake, speech remained slow and slurred for approximately 5 minutes, patient complained of continued muscle stiffness.  Pupils were constricted and unreactive to light accommodation for approximate 5 minutes after regaining consciousness.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Nuchal rigidity, Posturing, Pupillary reflex impaired, Seizure like phenomena, Slow speech
Clinical narrative: While receiving the Gardasil 9 vaccine, patient began shaking, lost consciousness, and began demonstrating seizure-like activity with posturing and rigidity of the arms, legs, and neck.  Patient remained unconscious approximately 3 minutes.  Once awake, speech remained slow and slurred for approximately 5 minutes, patient complained of continued muscle stiffness.  Pupils were constricted and unreactive to light accommodation for approximate 5 minutes after regaining consciousness.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Tremor
Clinical narrative: While receiving the Gardasil 9 vaccine, patient began shaking, lost consciousness, and began demonstrating seizure-like activity with posturing and rigidity of the arms, legs, and neck.  Patient remained unconscious approximately 3 minutes.  Once awake, speech remained slow and slurred for approximately 5 minutes, patient complained of continued muscle stiffness.  Pupils were constricted and unreactive to light accommodation for approximate 5 minutes after regaining consciousness.
Age: 88.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Asthenia, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Severe pain in arm, from shoulder to elbow. Very limited use of arm. Not able to sleep on right side due to throbbing pain. Limited range of motion and strength. NSAIDS and prescription Naproxen (500 mg), and applied heat give no relief from pain. Doctor has referred to physical therapist.
Age: 88.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: X-ray
Clinical narrative: Severe pain in arm, from shoulder to elbow. Very limited use of arm. Not able to sleep on right side due to throbbing pain. Limited range of motion and strength. NSAIDS and prescription Naproxen (500 mg), and applied heat give no relief from pain. Doctor has referred to physical therapist.
Age: 88.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Severe pain in arm, from shoulder to elbow. Very limited use of arm. Not able to sleep on right side due to throbbing pain. Limited range of motion and strength. NSAIDS and prescription Naproxen (500 mg), and applied heat give no relief from pain. Doctor has referred to physical therapist.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Warm to touch, itchy, red welt.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Patient received shot on Friday and on Saturday afternoon noticed redness/itching and knot around injection site.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Following day patient reports fever, chills, achiness, redness at injection site, hardness and swelling around injection site, (swelling started and still hot).
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Following day patient reports fever, chills, achiness, redness at injection site, hardness and swelling around injection site, (swelling started and still hot).
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Diarrhoea, Injection site erythema, Malaise, Myalgia
Clinical narrative: 24 hours after vaccine on (R) deltoid, patient developed myalgias, temp to 101 F, malaise, nausea, diarrhea and redness and soreness at vaccine site tracking down her arm. Slowly improved over 2-3 days with ibuprofen, ice, supportive care.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Vaccination site pain
Clinical narrative: 24 hours after vaccine on (R) deltoid, patient developed myalgias, temp to 101 F, malaise, nausea, diarrhea and redness and soreness at vaccine site tracking down her arm. Slowly improved over 2-3 days with ibuprofen, ice, supportive care.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Child given 0.25 ml dose influenza instead of 0.5 ml dose - correct influenza vaccine given before family left - error noted immediately and explained to mother.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site vesicles
Clinical narrative: Pt presented with local site redness and small cluster of blisters. Recommend pt get checked out w/primary MD. Pt was seen on 12/7/15 determined was a allergic reaction and given BENADRYL.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5 days post injection pt. continues to have 170 x 160 area of redness surrounding injection site. Slightly swollen and warm to touch. (Began morning after injection).
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Injection site erythema, Local reaction, Malaise
Clinical narrative: Onset the evening of 1-28-16 with general malaise, T. 100, mild nausea, and occipital headache. Around 11 p.m. noted (? onset) area of redness 4 1/2 in. x 6 in. on lateral aspect of left upper arm distal from injection site at left deltoid. Also noted 2 50 cent size areas of redness posterior from larger reactions. Gen. S/S intermittent through 1-30. Local reaction through 1-31. Treatment: TYLENOL; ice packs locally.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Onset the evening of 1-28-16 with general malaise, T. 100, mild nausea, and occipital headache. Around 11 p.m. noted (? onset) area of redness 4 1/2 in. x 6 in. on lateral aspect of left upper arm distal from injection site at left deltoid. Also noted 2 50 cent size areas of redness posterior from larger reactions. Gen. S/S intermittent through 1-30. Local reaction through 1-31. Treatment: TYLENOL; ice packs locally.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site scar, Injection site vesicles, Pain in extremity
Clinical narrative: Arm soreness, blistering at injection site for 3 days post injection, residual scarring. No treatment.
Age: 1.29
Sex: F
Vaccine: MMR, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: Refusing to bear weight on leg. No redness, swelling, or knot.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Eosinophil percentage, Haemoglobin decreased, Malaise, Red blood cell sedimentation rate increased
Clinical narrative: Day after "Flu vaccine" generalized malaise 2 to 3 days later several generalized urticaria. Daily, difficult to control with antihistamines. Saw allergy sp. 2/4/2016. Work up negative. First episode. Has had flu shot in past.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Day after "Flu vaccine" generalized malaise 2 to 3 days later several generalized urticaria. Daily, difficult to control with antihistamines. Saw allergy sp. 2/4/2016. Work up negative. First episode. Has had flu shot in past.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Gait disturbance, Malaise, Walking aid user
Clinical narrative: Had shot 10:30. Felt bad in afternoon. Was sick by 8:00. Went to hospital. Stayed 5 days. Was hospitalized all week. Couldn't walk without help. Was sent to nursing home for rehab. I'm still on walker. I am permanently/disabled. I was allergic to something in shot. I saw a story about VAERS and flu shots in newspaper. I decided to tell you about myself.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein, Cytogenetic analysis abnormal, Delivery, Exposure during pregnancy, Hypertension
Clinical narrative: Initial unsolicited pregnancy report received from a nurse on 04-Dec-2015. This case involves a 39-year-old female patient, who was vaccinated with intramuscular first dose of ADACEL (batch number: U5263AA, expiry date: 21-Jan-2018 and site of administration was not reported) on 04-Dec-2015. The last menstrual period was not reported. Estimated date of delivery was reported as 08-Jan-2016. Pregnancy history reported as none, other medical history and concomitant medications were not reported. Information regarding fertility treatment were not reported. At the time of vaccination the patient was 38 weeks pregnant (Third trimester). At the time of this report, it was unknown whether the patient experienced any adverse events. Documents held by sender: none. Follow up information received from physician on 09 February 2016. Last menstrual period (LMP) was reported as 29 March 2015 and estimated delivery date was 3 January 2016. Week of gestation was 33 (reported as 37 week). Patient's medical history included HPV. The patient had immunization with Rubella and Toxoplasmosis was negative. The patient was former smoker. Concomitant medication included prenatal vitamin. It was reported that the patient had hypertension after delivery. The patient received corrective treatment with labetalol 100 mg oral twice a day for hypertension. Prenatal testing included alpha fetal protein (and other serum makers) on 28 July 2015, uterine ultrasound on 5 August 2015, genetic screening on 8 June 2015 revealed cystic fibrosis fragile X SMA (spinal muscular atrophy). Patient gave birth to live normal baby (male) on 13 December 2015 via normal vaginal delivery. Outcome of the event hypertension after delivery was not reported. Follow up information received from physician on 26 February 2016. It was reported that the patient had no hypertension prior to vaccination. No further information was provided.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Toxoplasma serology negative, Ultrasound antenatal screen
Clinical narrative: Initial unsolicited pregnancy report received from a nurse on 04-Dec-2015. This case involves a 39-year-old female patient, who was vaccinated with intramuscular first dose of ADACEL (batch number: U5263AA, expiry date: 21-Jan-2018 and site of administration was not reported) on 04-Dec-2015. The last menstrual period was not reported. Estimated date of delivery was reported as 08-Jan-2016. Pregnancy history reported as none, other medical history and concomitant medications were not reported. Information regarding fertility treatment were not reported. At the time of vaccination the patient was 38 weeks pregnant (Third trimester). At the time of this report, it was unknown whether the patient experienced any adverse events. Documents held by sender: none. Follow up information received from physician on 09 February 2016. Last menstrual period (LMP) was reported as 29 March 2015 and estimated delivery date was 3 January 2016. Week of gestation was 33 (reported as 37 week). Patient's medical history included HPV. The patient had immunization with Rubella and Toxoplasmosis was negative. The patient was former smoker. Concomitant medication included prenatal vitamin. It was reported that the patient had hypertension after delivery. The patient received corrective treatment with labetalol 100 mg oral twice a day for hypertension. Prenatal testing included alpha fetal protein (and other serum makers) on 28 July 2015, uterine ultrasound on 5 August 2015, genetic screening on 8 June 2015 revealed cystic fibrosis fragile X SMA (spinal muscular atrophy). Patient gave birth to live normal baby (male) on 13 December 2015 via normal vaginal delivery. Outcome of the event hypertension after delivery was not reported. Follow up information received from physician on 26 February 2016. It was reported that the patient had no hypertension prior to vaccination. No further information was provided.