chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine, Oesophageal oedema
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016568457) on 23-Dec-2016. This case involves a female patient (age- unknown) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza tr-split 2005 VAC (PF)) (batch number, expiry date, dose, route and site of administration- were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date and unspecified time frame, following the vaccination patient developed allergies to suspect drug and reported that 'oesophagus swells shut'. Laboratory investigations and corrective treatments were not reported. The events outcome were not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dehydration, Malaise, Muscle spasms
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) via other company (Pfizer) (Manufacturer Report Number: 2016578249) on 23 Dec 2016. This case was linked with case 2016SA236043 (same vaccine). This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date and also received PREGABALIN (Lyrica) (Batch number, expiration date, dose and route of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, 12 days following the vaccination, the patient got sick. On an unknown date, unspecified timeframe following the vaccination, the patient had cramps all over her body and was also sick right now and was dehydrated. The patient had an appointment with her doctor. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. It was reported that the patient was not sure if the side effects were caused by the Lyrica or not. List of the documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016561769) on 23-Dec-2016. This case involves a 69 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot/high dose) (batch number, expiry date, dose, route and site of administration- were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date and unspecified time frame, following the vaccination patient developed allergies to suspect drug. Laboratory investigations and corrective treatments were not reported. The events outcome were not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2016568457) on 23 Dec 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza virus vaccines (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On 30 April 2013, unspecified timeframe following the vaccination, the patient had developed anaphylaxis. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the case as serious due to important medical event: anaphylaxis. List of the documents held by sender: none. Sender's Comments: Patient had anaphylactic reaction following INFLUENZA VACCINE. Time to onset is unknown, additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), patient has history of allergic reactin to previous influenza vaccine and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the available information, a role of the vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nephrolithiasis, Pelvic pain
Clinical narrative: SEVERE PELVIC PAIN. TOOK HER TO ER 11/7/16, WAS DIAGNOSED WITH KIDNEY STONES. SECOND VACCINE 12/27/16, SAME SYMPTOMS APPEARED 1/1/17. NOT YET TAKEN TO ER.
Age: 33.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Infection, Injection site erythema, Vaccination site bruising, Vaccination site induration, Vaccination site pain
Clinical narrative: Infection- antibiotics(keflex), vaccinated area is hard, red, swollen, painful, and slightly bruised
Age: 33.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Infection- antibiotics(keflex), vaccinated area is hard, red, swollen, painful, and slightly bruised
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Headaches on a regular basis since getting the flu shot, at least every other day. OTCs useless in treating the pain and migraine meds not recommended by PCP.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age via a company representative who reported on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, after receiving the ZOSTAVAX, she started to get "red spots and patches" and the affected area itched for a week after infection. The outcome of the events and the relatedness between the events and ZOSTAVAX were not reported.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided.  On 22-DEC-2016, the patient was vaccinated with an expired dose of VARIVAX injection, lot # K026385, expiration date 15-DEC-2016 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information is not expected because there was no consent to contact the reporter.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Paraesthesia
Clinical narrative: TINGLING IN FEET, HANDS AND FINGERS.
Age: 54.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cyanosis, Peripheral swelling
Clinical narrative: Arm turned blue, "puffed up".
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Red spot (erythema) about size of baseball at injection site. Decreased in size to about a silver dollar by 12/31/16 when she came in and told me about.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On an unknown date, approximately 10 minutes after administration of the vaccination, the patient felt dizzy and fainted. It was also reported that the patient sought medical attention at the physician's office at the time of the occurrence. The outcomes of the events were unknown.  The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. No information about medical history, concomitant medications, concurrent conditions and drug reactions and allergies was reported for any of the patients. On unknown dates the patients were vaccinated with unspecified number of doses of ROTATEQ orally (dose not reported lot M007301 expiry date 19-NOV-2017 or lot M019691 expiry date 02-NOV-2017. No adverse events were reported. On an unknown date, the vaccines were stored in an inappropriate temperature of 34 degrees Fahrenheit for 8 hours (reported as "worst case"). The Digital Data Logger was not involved. No previous temperature excursions were reported. 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 licensed practical nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported; lot # M027344, expiry date 01-JUN-2018, lot # M033906, expiry date 20-JUL-2018 and lot # M028553 with expiry date 07-JUN-2018). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009287.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 60 year old female pharmacist, who was also the patient reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 17-JUN-2016, the patient was vaccinated with ZOSTAVAX, lot # L040442 (anatomical route of vaccination and expiration date were not provided) for prophylaxis. Approximately in 2016 (reported as "soon after vaccination"), the patient developed a hard lump (injection site induration), that was itchy (injection site pruritus) and painful (injection site pain) for 3 to 4 days. Although the patient suffered this reactions, she did not seek for medical attention and did not received any treatment. She stated, she never had an injection site reaction as bad as the one she suffered after receiving ZOSTAVAX. Furthermore, no product quality issue was involved. The pharmacist also reported, that an unknown Nurse who was also vaccinated with ZOSTAVAX in July or August of 2016, developed similar reactions at the injection site (MARRS # 1701USA000773). At the time of the report, the outcome of injection site induration, injection site pain and injection site pruritus was reported as recovered in 2016. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA000773.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 10-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 07-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 or 67 year old female patient who was also a Nurse. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. In 2016 (reported as "in July or August of this year), the patient was vaccinated with ZOSTAVAX (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. Approximately in 2016, the patient experienced a hard lump (injection site induration), which was painful (injection site pain) and itchy (injection site pruritus) at the insertion site. At the time of the report, the outcome of injection site induration, injection site pain and injection site pruritus was unknown. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014627:
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Dizziness, Eye swelling, Herpes zoster, Lip swelling
Clinical narrative: Rash, dizzy, swollen lips and eyes.  Within 2 weeks broke out in Shingles rash and had light sensitivity and severe GI distress.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Photophobia, Rash
Clinical narrative: Rash, dizzy, swollen lips and eyes.  Within 2 weeks broke out in Shingles rash and had light sensitivity and severe GI distress.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Cough, Injected limb mobility decreased, Injection site induration, Injection site pain
Clinical narrative: 11/4/2016 Onset of Pain at injection site. 11/8/2016 Seen in Urgent Care c/o dull ache and deep pain in Right Bicep following injection.  11/10/2016 Seen in Urgent Care c/o cough, sinus pain, congestion. 12/27/2016 received report from patient that right arm feels "like concrete" and she has significant less range of motion and strength in that arm since the injection. Reports it has never been "normal" since the injection. At time of this report, patient indicates her symptoms have been permanent since the injection, and worsening.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Respiratory tract congestion, Sinus pain
Clinical narrative: 11/4/2016 Onset of Pain at injection site. 11/8/2016 Seen in Urgent Care c/o dull ache and deep pain in Right Bicep following injection.  11/10/2016 Seen in Urgent Care c/o cough, sinus pain, congestion. 12/27/2016 received report from patient that right arm feels "like concrete" and she has significant less range of motion and strength in that arm since the injection. Reports it has never been "normal" since the injection. At time of this report, patient indicates her symptoms have been permanent since the injection, and worsening.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Ear pain, Neck pain, Tenderness
Clinical narrative: Pt reports a raw, sensitive, painful area behind her left ear and neck area. No redness, blisters,or rash present.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB lot#L042836, expiry date:24-AUG-2018  lot#M034188, expiry date: 20-MAY-2019 (dosing details and route of administration were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature of 13 C (range:>8C and <25C) during a time frame of 14 hours. Previous temperature excursion included: at 12 C (range: >8C and <25C) during a time frame of 14 hours and 13 C (range:>8C and <25C) during a time frame of 62 hours. No adverse effects were reported. There was no digital data logger involved. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Chills, Conjunctivitis, Dizziness, Eye discharge
Clinical narrative: Headache started a few hours after shot. Dizziness and fatigue followed the following day, along with slight headache. Nasal congestion started on 12/30/2016. 12/31 Nasal and eye pain on right side of face. Fluid drained from right eye and pain worsened in Nasal passage. Sneezing and congestion in right Nasal passage. 1/1/2017 eye and Nasal pain on right side continued to get worse, burning, itching, headache, and irritability. Dizziness comes and goes. 1/2/2017, woke up with swollen eye and discharge that seemed to be conjunctivitis and nose raw and sore (still right side only). Blister developing on top right lip. Still fatigued and facial pain on right side of face. Chills all over body that started on 1/1/2017.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Eye pain, Eye swelling, Facial pain, Fatigue, Headache
Clinical narrative: Headache started a few hours after shot. Dizziness and fatigue followed the following day, along with slight headache. Nasal congestion started on 12/30/2016. 12/31 Nasal and eye pain on right side of face. Fluid drained from right eye and pain worsened in Nasal passage. Sneezing and congestion in right Nasal passage. 1/1/2017 eye and Nasal pain on right side continued to get worse, burning, itching, headache, and irritability. Dizziness comes and goes. 1/2/2017, woke up with swollen eye and discharge that seemed to be conjunctivitis and nose raw and sore (still right side only). Blister developing on top right lip. Still fatigued and facial pain on right side of face. Chills all over body that started on 1/1/2017.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Irritability, Lip blister, Nasal congestion, Nasal discomfort, Pruritus
Clinical narrative: Headache started a few hours after shot. Dizziness and fatigue followed the following day, along with slight headache. Nasal congestion started on 12/30/2016. 12/31 Nasal and eye pain on right side of face. Fluid drained from right eye and pain worsened in Nasal passage. Sneezing and congestion in right Nasal passage. 1/1/2017 eye and Nasal pain on right side continued to get worse, burning, itching, headache, and irritability. Dizziness comes and goes. 1/2/2017, woke up with swollen eye and discharge that seemed to be conjunctivitis and nose raw and sore (still right side only). Blister developing on top right lip. Still fatigued and facial pain on right side of face. Chills all over body that started on 1/1/2017.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Rhinalgia, Sneezing
Clinical narrative: Headache started a few hours after shot. Dizziness and fatigue followed the following day, along with slight headache. Nasal congestion started on 12/30/2016. 12/31 Nasal and eye pain on right side of face. Fluid drained from right eye and pain worsened in Nasal passage. Sneezing and congestion in right Nasal passage. 1/1/2017 eye and Nasal pain on right side continued to get worse, burning, itching, headache, and irritability. Dizziness comes and goes. 1/2/2017, woke up with swollen eye and discharge that seemed to be conjunctivitis and nose raw and sore (still right side only). Blister developing on top right lip. Still fatigued and facial pain on right side of face. Chills all over body that started on 1/1/2017.
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site pain
Clinical narrative: Arm at injection site is still sore after 2 months. Have tried warm compresses and nothing works. Talked with the pharmacist but they had no advice.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Dyspnoea, Glassy eyes, Headache, Impaired work ability
Clinical narrative: Start getting huge headache and ard breathing, pain in joints, and all over the body, running nose, glossy tear eyes, slow in the motions. Next day, couldn't go to work, called sick, high body temperature, sneezing, hard to breathe, pain all over the body. On Jan 2nd tried to visit a doctor, but everything close due to NY holidays. Was no any option just to go to E.R.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza A virus test positive, Lacrimation increased, Mobility decreased, Pain, Pyrexia
Clinical narrative: Start getting huge headache and ard breathing, pain in joints, and all over the body, running nose, glossy tear eyes, slow in the motions. Next day, couldn't go to work, called sick, high body temperature, sneezing, hard to breathe, pain all over the body. On Jan 2nd tried to visit a doctor, but everything close due to NY holidays. Was no any option just to go to E.R.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Start getting huge headache and ard breathing, pain in joints, and all over the body, running nose, glossy tear eyes, slow in the motions. Next day, couldn't go to work, called sick, high body temperature, sneezing, hard to breathe, pain all over the body. On Jan 2nd tried to visit a doctor, but everything close due to NY holidays. Was no any option just to go to E.R.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Crying, Emotional distress, Insomnia, Irritability, Malaise
Clinical narrative: My baby was fine for 2 weeks than he became very ill! Cried and screamed all the time, barely slept, doctors and pediatrician said he was fine and normal maybe a bit colicky but something was not right!! Irritable, seemed in pain, I could not comfort! This went on for 14.5 weeks straight!! Has gotten better and opted to hold off on ANY other shots until he is at least 2 and will get only what is necessary and 1 every 6 months. This has been so very hard to see my baby be so miserable 24/7 for over 3 months!!!! A baby being only hours old should. It be given a vaccination that is typically for those who share needles and live sexually unsafe lifestyle! That does not include my innocent baby!!
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Screaming
Clinical narrative: My baby was fine for 2 weeks than he became very ill! Cried and screamed all the time, barely slept, doctors and pediatrician said he was fine and normal maybe a bit colicky but something was not right!! Irritable, seemed in pain, I could not comfort! This went on for 14.5 weeks straight!! Has gotten better and opted to hold off on ANY other shots until he is at least 2 and will get only what is necessary and 1 every 6 months. This has been so very hard to see my baby be so miserable 24/7 for over 3 months!!!! A baby being only hours old should. It be given a vaccination that is typically for those who share needles and live sexually unsafe lifestyle! That does not include my innocent baby!!
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Erythema, Nausea, Skin warm, Swelling, Vomiting
Clinical narrative: Warm to touch, red, raised. Patient also reported nausea and vomiting, no fever, but wasn't sure if it was related to the vaccines or the stomach bug.
Age: 56.0
Sex: M
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain
Clinical narrative: Sore right arm at injection site. Large inflamed bruising radially around upper arm, right arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at injection site, also itching and arm swollen, joint pain in the back also reported.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site warmth, Nausea, Pruritus
Clinical narrative: Injection site hot to touch with red circle surrounding, ultimately grew to 2" diameter red and stayed that way for ~48 hours following injection. Nausea & vomiting starting 12/28/16 11pm, ending 12/29/16 10am. Fever of 99.5 degrees taken 12/29/16 9am. Itchy raised red hives in patches that appeared & disappeared in random locations all over entire body, starting 12/29/16 8am, ending by 12/30/16 7am, hives were almost always present somewhere on the body during this period of time.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Injection site hot to touch with red circle surrounding, ultimately grew to 2" diameter red and stayed that way for ~48 hours following injection. Nausea & vomiting starting 12/28/16 11pm, ending 12/29/16 10am. Fever of 99.5 degrees taken 12/29/16 9am. Itchy raised red hives in patches that appeared & disappeared in random locations all over entire body, starting 12/29/16 8am, ending by 12/30/16 7am, hives were almost always present somewhere on the body during this period of time.
Age: 20.0
Sex: F
Vaccine: HEP, YF
Symptoms: Fall, Pallor, Syncope
Clinical narrative: Pt fainted all of a sudden at the counseling window. She plopped her head down for split second then she fell on the floor. She woke up right away within few seconds. she didn't remember she fainted. She was pale. I provided her water and some biscuit, and she got better in 15 minutes or so.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: EXTREME PAIN AND SORENESS IN HER ARM WHERE SHE GOT HER HIGH DOSE FLU SHOT.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood test, Electroencephalogram abnormal, Eye movement disorder, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient woke up complaining her hand wouldn't stop shaking, eyes rolled to back of her head, followed by a major Grand Mal seizure, lasting roughly 45 mins, 911 called, patient then had another focal seizure- this one lasting 30 seconds. Paramedics took her to hospital for evaluation. ER observed her, blood drawn, released. Follow up with PCP next day for neurology consult and order tests.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Partial seizures, Specialist consultation, Tremor
Clinical narrative: Patient woke up complaining her hand wouldn't stop shaking, eyes rolled to back of her head, followed by a major Grand Mal seizure, lasting roughly 45 mins, 911 called, patient then had another focal seizure- this one lasting 30 seconds. Paramedics took her to hospital for evaluation. ER observed her, blood drawn, released. Follow up with PCP next day for neurology consult and order tests.
Age: 0.08
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV, DTAP, FLUX, HEP, HIBV
Symptoms: Crying, Eczema, Emotional distress, Head banging, Irritability
Clinical narrative: Patient had a fever and was very upset, i.e. crying and fussing much more than normal. He also hits his head against things since the vaccines. Also he got extremely bad eczema which has continued to be a ongoing problem. Nothing seems to help.
Age: 0.08
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV, DTAP, FLUX, HEP, HIBV
Symptoms: Pyrexia
Clinical narrative: Patient had a fever and was very upset, i.e. crying and fussing much more than normal. He also hits his head against things since the vaccines. Also he got extremely bad eczema which has continued to be a ongoing problem. Nothing seems to help.
Age: 0.08
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV, DTAP, FLUX, HEP, HIBV
Symptoms: Anger, Crying, Eczema, Head banging, Irritability
Clinical narrative: Patient had a fever and was very upset, i.e. crying and fussing much more than normal. He also hits his head against things since the vaccines. Also he got extremely bad eczema which has continued to be a ongoing problem. Nothing seems to help.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash on back of neck, itchy hives on arms and legs. Started with a few small bumps on injection arm. BENADRYL offers minor relief.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Dehydration, Dizziness, Dyspnoea, Human chorionic gonadotropin, Metabolic function test
Clinical narrative: Patient developed nausea, dizziness, SOB, blurred vision 30 minutes after receiving vaccine. Seen in Emergency Department. Provider did not feel symptoms a consequence of vaccine.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Urine analysis, Vision blurred
Clinical narrative: Patient developed nausea, dizziness, SOB, blurred vision 30 minutes after receiving vaccine. Seen in Emergency Department. Provider did not feel symptoms a consequence of vaccine.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Hyperhidrosis, Pain, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: Vaccines were administered, patient was alert. After leaving room to complete testing patient became pain and diaphoretic-upon returning to the room with results (within 30 seconds) patient became unresponsive and EMS was called. Patient had thready pulse at 50's, pulse ox was 98%. Patient became alert after a short time one became oriented x3. EMS cleared patient to leave.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Red irregular shaped rash at injection site. One week later a second irregular finger shaped rash occurred. Both have remained for 2 months.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient got flu shot on 12/16/16, 48 hours later she started feeling itchy, 60hrs later shot developed rash all over (not at site of injection). Went to clinic, started Rx for Prednisone on 12/22/16. Completed Prednisone on 12/28/16, still symptomatic. Also taking BENADRYL.
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Nausea, Pyrexia
Clinical narrative: Nausea/mild/loose stool/fever 99 - 100 degrees/malaise.
Age: 12.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen red painful right thigh - BENADRYL. Heat or cold. TYLENOL or MOTRIN, did resolve, couple days.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Abasia, Abdominal pain, Asthenia, Body temperature increased, Differential white blood cell count
Clinical narrative: 102 Temp, weakness, unable to bare weight or walk. Headache, abdominal cramps, swelling of hands and feet, blisters in mouth neck pain.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count, Headache, Metabolic function test, Neck pain, Oral mucosal blistering
Clinical narrative: 102 Temp, weakness, unable to bare weight or walk. Headache, abdominal cramps, swelling of hands and feet, blisters in mouth neck pain.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral swelling, Procalcitonin, Spinal X-ray, Weight bearing difficulty
Clinical narrative: 102 Temp, weakness, unable to bare weight or walk. Headache, abdominal cramps, swelling of hands and feet, blisters in mouth neck pain.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt allegedly fainted for less than 5 seconds. By the time the examiner entered the exam room Pt was conscious.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Pain in neck, shoulder and arm along with progressive marked decreased range of motion of shoulder/arm. Had steroid injection on 10-15-16 with no relief of symptoms. Had MRI on 11-18-16 which revealed adhesive capsulitis. Physical therapy started on 11-17-16 and am currently in physical therapy with little improvement.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Pain in neck, shoulder and arm along with progressive marked decreased range of motion of shoulder/arm. Had steroid injection on 10-15-16 with no relief of symptoms. Had MRI on 11-18-16 which revealed adhesive capsulitis. Physical therapy started on 11-17-16 and am currently in physical therapy with little improvement.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Reaction at the site of vaccination, redness and itching, feeling hot at injection site, severe swelling.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site cellulitis, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: Case number PHEH2016US033986, is an initial spontaneous report received from a consumer on 28 Dec 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly along with PNEUMOVAX vaccine (batch number: not reported) both on 24 Dec 2016. On the same day after vaccination, the patient experienced swelling at the site and by the evening had a fever of 101 to 103 F temperature. The patient reported that, the swelling in deltoid area grew as big as a baseball, there was also swelling of lymph nodes, nausea and vomiting. It was reported that the patient recovered from fever on 26 Dec 2016. On 27 Dec 2016, the patient experienced pain in arm. The patient visited the emergency room on an unknown date and the doctor diagnosed it as cellulitis from an injection caused by contamination. The patient was treated with MOTRIN, fluids (unspecified) and clindamycin. The erythema and swelling was much improved. The final outcome of the events nausea and vomiting was reported as complete recovery on 28 Dec 2016, for events swelling of arm at injection site and pain in arm was reported as condition improving and for other events was not reported. The seriousness of the event swelling of lymph nodes and erythema was not reported and for other events was reported as non serious by the consumer. The causality of the events was not reported. Seriousness assessment of the events vaccination site cellulitis and pyrexia was upgraded to medically significant based on the information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Product contamination, Pyrexia, Vomiting
Clinical narrative: Case number PHEH2016US033986, is an initial spontaneous report received from a consumer on 28 Dec 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly along with PNEUMOVAX vaccine (batch number: not reported) both on 24 Dec 2016. On the same day after vaccination, the patient experienced swelling at the site and by the evening had a fever of 101 to 103 F temperature. The patient reported that, the swelling in deltoid area grew as big as a baseball, there was also swelling of lymph nodes, nausea and vomiting. It was reported that the patient recovered from fever on 26 Dec 2016. On 27 Dec 2016, the patient experienced pain in arm. The patient visited the emergency room on an unknown date and the doctor diagnosed it as cellulitis from an injection caused by contamination. The patient was treated with MOTRIN, fluids (unspecified) and clindamycin. The erythema and swelling was much improved. The final outcome of the events nausea and vomiting was reported as complete recovery on 28 Dec 2016, for events swelling of arm at injection site and pain in arm was reported as condition improving and for other events was not reported. The seriousness of the event swelling of lymph nodes and erythema was not reported and for other events was reported as non serious by the consumer. The causality of the events was not reported. Seriousness assessment of the events vaccination site cellulitis and pyrexia was upgraded to medically significant based on the information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHEH2016US033986, is an initial spontaneous report received from a consumer on 28 Dec 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly along with PNEUMOVAX vaccine (batch number: not reported) both on 24 Dec 2016. On the same day after vaccination, the patient experienced swelling at the site and by the evening had a fever of 101 to 103 F temperature. The patient reported that, the swelling in deltoid area grew as big as a baseball, there was also swelling of lymph nodes, nausea and vomiting. It was reported that the patient recovered from fever on 26 Dec 2016. On 27 Dec 2016, the patient experienced pain in arm. The patient visited the emergency room on an unknown date and the doctor diagnosed it as cellulitis from an injection caused by contamination. The patient was treated with MOTRIN, fluids (unspecified) and clindamycin. The erythema and swelling was much improved. The final outcome of the events nausea and vomiting was reported as complete recovery on 28 Dec 2016, for events swelling of arm at injection site and pain in arm was reported as condition improving and for other events was not reported. The seriousness of the event swelling of lymph nodes and erythema was not reported and for other events was reported as non serious by the consumer. The causality of the events was not reported. Seriousness assessment of the events vaccination site cellulitis and pyrexia was upgraded to medically significant based on the information available in the source document.
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: This solicited report was received from a 56 year old male patient reporting on himself, as part of a market research program entitled "MRK211: Pharmacy Interactions" conducted by Research Group. The patient's concurrent conditions included blood pressure abnormal, depression and insomnia. The patient's medical history included blood cholesterol abnormal for which he took unspecified medication several years ago. The patient always got bruise when he got injections (needles). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for shingles prophylaxis. Concomitant therapies included unspecified medications for blood pressure, depression and insomnia. On an unknown date, the patient experienced bruising after vaccination at the pharmacy.     The outcome of the event was reported as recovered on an unspecified date in October 2016. The reporter considered the event to be related to ZOSTAVAX.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Underdose
Clinical narrative: Information has been received from a physician via a field representative referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On an unknown date the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (intramuscular; strength, lot#, dosage and frequency unspecified) for prophylaxis (accidental underdose and drug administered to patient of inappropriate age). Additional information is not expected as the physician refused to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the multiple unspecified patients were respectively vaccinated with improperly stored GARDASIL 9) lot # L024993, expiration date 17-OCT-2017), dose and route unspecified for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a representative of Health Agency Service and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unspecified dates, the patients might have been vaccinated with improperly stored doses of VARIVAX lot # L037565, expiration date: 29-SEP-2017 (doses, route of administration and formulation were not reported). It was reported that the vaccines were exposed to temperature of 13.2 Fahrenheit degrees for 112 hours and 30 minutes before possible administration to the patients. It was not reported if Digital Data Logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA004064:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age concerning herself. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and dose were unknown), intramuscularly for immunization against pneumococcal disease. On an unknown date, the patient experienced itchiness, swelling and redness at the injection site. The outcome of the events was reported as recovering. There was no reintroduced (also reported as "therapy with PNEUMOVAX 23 was continued"). The patient stated that she would address the matter through other means. No product quality complaint (PQC) was reported. The reporter did not assess the causality. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender.  The patients' concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. On unspecified dates, improperly stored doses of VARIVAX (dose, strength, frequency and route were unknown, lot # M010484 with expiration date 01-MAR-2018, Lot # L045955 with 17-NOV-2017, lot# L048467 with expiration date 02-DEC-2017) were administered to the unspecified patients for prophylaxis. The VARIVAX was exposed 7 Fahrenheit for a time frame of 7 days. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected since there is no consent for follow up.; Sender's Comments: US-009507513-1612USA006700:
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 75 years old female patient. The patient pertinent medical history was unknown. The patient did not have drug reactions/allergies. Concomitant medications included pravastatin and blood pressure medications. On 13-DEC-2016, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route not reported) for prophylaxis. On 14-DEC-2016, the patient developed a rash and redness below the injection site. The patient did not seek medical attention. The reporter recommended treatment with BENADRYL and ibuprofen. The outcome of the event was unknown. The causality between PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients might have received doses of improperly stored VARIVAX (lot # M023382, expiration date 06-NOV-2017; dose and route were unknown), for prophylaxis. The vaccines were exposed under temperature of 11 degrees Fahrenheit for 44 hours. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 60 year old female patient referring to herself. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 13-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and dose were not reported) subcutaneously in her "lower" deltoid muscle for prevention of herpes zoster. The injection was administered by a pharmacist. On the same day, the patient experienced injection-site soreness, itchiness, swelling, redness, warmth and headaches. No lab diagnostics studies were performed. Treatment was given for the events. The pharmacist told her that the symptoms would subside in seven days. At the reporting time, the patient didn't recover from the events. The causality was not reported. Additional information is not expected as there is no consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a 60 year old female patient referring to herself. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 13-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and dose were not reported) subcutaneously in her "lower" deltoid muscle for prevention of herpes zoster. The injection was administered by a pharmacist. On the same day, the patient experienced injection-site soreness, itchiness, swelling, redness, warmth and headaches. No lab diagnostics studies were performed. Treatment was given for the events. The pharmacist told her that the symptoms would subside in seven days. At the reporting time, the patient didn't recover from the events. The causality was not reported. Additional information is not expected as there is no consent to follow up.