chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old patient who received vaccine FLUZONE HIGH DOSE lot UJ024AA, expiry date: 29-APR-2019 via intramuscular route in the left deltoid on 29-APR-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration, overdose and wrong vaccine administered. It was reported that she administered a FLUZONE HIGH-DOSE to a 63-year-old by mistake and mistakenly given the high dose instead of the lower dose quadrivalent. It was reported that No adverse symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect route of product administration, No adverse event
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old female pregnant patient who was exposed to vaccine ADACEL which was given subcutaneously instead of intramuscularly. The reported Vaccine exposure during pregnancy occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 25 weeks of pregnancy, during second pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 21-Mar-2018. The estimated due date is 26-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was not reported that No other vaccines given at the time. On 05-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5577AA expiry date: Feb-2021 via subcutaneous route in the left deltoid while she was pregnant. It was also reported that patient did not have one before. It was an actual medication error case due to Wrong route of administration. No adverse event was experienced. (Other relevant tests included No lab data). Final diagnosis was vaccine exposure during pregnancy. It was not reported if the patient received a corrective treatment. Additionally, at time of reporting, the pregnancy is still ongoing. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non serious case received from a Nurse Practitioner. This case involves female patient of an unknown age who was received vaccine ADACEL via subcutaneous route back in the arm (batch number, expiry date and dose were not reported) on 05 Oct 2018, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 28 weeks and 6 days pregnant when she received vaccine. It was an actual medication error due to Vaccine administered at inappropriate site and Inappropriate route of vaccination. The Medical Assistant who gave her the injection did not give the injection IM. It was given SC further back in the arm than the Deltoid muscle. It was unknown whether patient experienced any adverse reaction after vaccination. Pregnancy outcome was unknown at the time of report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient who experienced an expired ACTHIB vaccine to a 6 month old child and child is on a delayed immunization schedule, while he/she received vaccines DAPTACEL and ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI804AAA via unknown route, Expiry date- 22-Sep-2018 in the right thigh. It was a case of actual medication error due to expired vaccine used and Inappropriate schedule of vaccine administered. The patient outcome is reported as Not Applicable for an expired ACTHIB vaccine to a 6 month old child and as Not Applicable for child is on a delayed immunization schedule. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 08 years old female patient for whom nurse gave a 2nd dose of the FLUZONE QUAD to the female on 02Oct2018 at school flu clinic for which she had signed consent form without knowledge that the female had a prior FLUZONE QUAD vaccination at her PCP's office was reported, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient did not received any concomitant vaccines. On 02-Oct-2018, the patient received a second dose of suspect Influenza Quadrival A-B Vaccine lot, UJ025AC via unknown route in the left deltoid. On 21-Sep-2018 she also received a first dose of the same vaccine, lot U6260AA via unknown route in unknown administration site. The nurse gave a 2nd dose of the FLUZONE QUAD to the female on 02-Oct-2018 at school flu clinic for which she had signed consent form without knowledge that the female had a prior FLUZONE QUAD vaccination at her PCP's office (extra dose administered) unknown latency following the administration of Influenza Quadrival A-B Vaccine. No reactions reported and the child has attended school every day and has been fine. It was a case of actual medication error due to extra dose administered. Final diagnosis was nurse gave a 2nd dose of the FLUZONE QUAD to the female on 02Oct2018 at school flu clinic for which she had signed consent form without knowledge that the female had a prior FLUZONE QUAD vaccination at her PCP's office. It was not reported if the patient received a corrective treatment. The event outcome was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non serious case received from  other health professional. This case involves 3 patients who were given injections of suspect vaccine was ADACEL that had been frozen later after they gave the injections. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccines were given that day at their Well Check Up. On an unknown date, the patients received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5468A and expiry date: 30-Sep-2018) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to incorrect product storage. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, muscle aches.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 1 day after vaccine admininstered, patient exhibited swelling, redness, and soreness to touch. Pt reports maximum swelling diameter was about 1-1 and half inches. Patient reported to Medical 5 days after vaccine administration. Swelling and redness and drastically decreased when Patient reported to Medical with initial measurement of 1 inch diameter in swelling. Pt. has afebrile and has no other symptoms today, 16Oct18.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: She developed a fever on 10/10/18; which has continued. She also developed a rash on the back of her neck that is radiating down to her back. She has some muscle aches.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Blood test normal, Dry mouth
Clinical narrative: Loss of taste and dry mouth since august 8th 2018. Tried compound mouth wash and swallow (tetra/nyst/hydroc/ben/lido.1.5G) still no taste bud no other symptoms at all. Other wise healthy.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure during pregnancy, Injury associated with device
Clinical narrative: This spontaneous prospective pregnancy report has been received from a 32 year old female nurse referring to herself. The patient had no pertinent medical history or drug reactions/allergies. Concomitant therapy included VITERGAN PRE NATAL. The patient's concurrent condition was not reported. The patient reported that she was currently 22 weeks pregnant and "was stuck in her thumb by a needle that was attached to a syringe containing M-M-R II (lot # M048036; expiration date 08-DEC-2018; therapy type rHA) reconstituted with sterile diluent (MERCK) (lot # N000383; expiration date 26-JUN-2019)" at 9:50 AM on 04-OCT-2018. The pregnancy outcome was pending. The patient's estimated date of last menstrual period (LMP) and due date were 03-MAY-2018 and 07-FEB-2019 respectively. Trimester of exposure was the second. No treatment was given. No lab diagnostics/studies were performed. The patient did not seek medical attention. No cancer or overdose. The outcome of the events was unknown. The causality assessment was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concomitant medications, and medical history and drug reactions was not provided. On an unknown date the patient was vaccinated with VARIVAX (lot # and expiration date were not reported) for prophylaxis and PROQUAD (lot # and expiration date were not reported) (inappropriate schedule of drug administration). No adverse symptoms were reported.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Occupational exposure to product
Clinical narrative: Information has been received from a 28 year old female medical assistant referring to herself. There was no concomitant medication, pertinent medical history or drug reaction/allergy. On 03-OCT-2018, she was reconstituting VARIVAX (lot# R017635 with expiration date 20-JUN-2020) with sterile diluent(MERCK STERILE DILUENT) (lot# reported as R022411 with expiration date 10-NOV-2019), and the mixture came up thru the stopper splashing the Medical Assistant (Product quality issue and Occupational exposure while preparing product for administration). No adverse effect was reported. There was no treatment for the events. No lab diagnostics or studies were performed. The outcome of product quality issue was reported as recovered. The causality was not provided.
Age: 0.92
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse referring to a 11 months old patient of unknown gender. Concomitant therapies included MERCK STERILE DILUENT. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 16-AUG-2006, the patient received a dose of PROQUAD (strength, lot # and expiration date were not reported) subcutaneously for prophylaxis at an unspecified facility (inappropriate age at vaccine administration). No adverse effect was reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Presyncope, Urinary incontinence
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a 17 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in October 2016 (also reported as 2 years ago), the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) as a routine vaccination. Subsequently, on an unknown date in October 2016 (also reported as 2 years ago), the patient had an impressive vagal response, she lost consciousness for 1 minute and wet her pants. It was unknown if any treatment was given for the adverse events and if any laboratory diagnostics studies were performed. The patient recovered from the events on an unknown date. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of loss of consciousness for 1 minute was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-APR-2015, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated by a physician for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 25-SEP-2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2008 the patient was inoculated with ZOSTAVAX vaccine at a health center for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015 the patient was treated at a health center for onset of a severe vesicular rash, which was diagnosed as severe herpes zoster As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: PATIENT EXPERIENCE SIGNIFICANT SWELLING AND REDNESS AT INJECTION SITE. SWELLING EXTENDED THE CIRCUMFERENCE OF THE ARM FROM SHOULDER TO BICEP.  ALSO EXPERIENCED WELTS NEAR THE INJECTION SITE BUT NOT COVERING THE ENTIRE ARM.  PATIENT DID NOT REPORT SIGNIFICANT PAIN OR DISCOMFORT.  DID NOT SEEK TREATMENT. SYMPTOMS RESOLVED WITHIN 48 HOURS.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Upon injection there was immediate numbness and burning at the injection site. One hour post injection there was swelling and heat at the site, with the arm remaining numb. Four hours post injections a dark red circle appeared below the injection site, spreading down the arm, towards the elbow, and small hive like red bumps appeared. Over the next 48 hours this ring became larger and larger, reaching a maximum diameter of ~5 inches. After 72 hours the redness started to dissipate but area continues to be raised and swollen, and painful to the touch.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Upon injection there was immediate numbness and burning at the injection site. One hour post injection there was swelling and heat at the site, with the arm remaining numb. Four hours post injections a dark red circle appeared below the injection site, spreading down the arm, towards the elbow, and small hive like red bumps appeared. Over the next 48 hours this ring became larger and larger, reaching a maximum diameter of ~5 inches. After 72 hours the redness started to dissipate but area continues to be raised and swollen, and painful to the touch.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy test, Antinuclear antibody, Blister, Contusion, Full blood count
Clinical narrative: I received the first injection of SHINGRIX on May 21st 2018. I received the second injection of SHINGRIX July 27th 2018. Both were administered by a pharmacy June 26th, I broke out with a rash on my legs, back and stomach in random locations. Some of the "bumps/blisters" have been as large as pencil eraser. For the most part, it has been small red bumps. The itching is so severe I have scratched bruises and blood. I have seen a dermatologist and an allergist and so far, no one can identify a cause for my bumps and itching. For relief, I take ALLEGRA allergy medication and Cerave Itch relief Lotion. These do not stop the creation of bumps, but do control the terrible itching. My question to you: has anyone else reported a prolonged side effect such as mine? Your brochure says the "skin rash" will go away in a day or two. I have had it continuously since June 2018.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haemorrhage, Liver function test, Metabolic function test, Pruritus, Rash papular
Clinical narrative: I received the first injection of SHINGRIX on May 21st 2018. I received the second injection of SHINGRIX July 27th 2018. Both were administered by a pharmacy June 26th, I broke out with a rash on my legs, back and stomach in random locations. Some of the "bumps/blisters" have been as large as pencil eraser. For the most part, it has been small red bumps. The itching is so severe I have scratched bruises and blood. I have seen a dermatologist and an allergist and so far, no one can identify a cause for my bumps and itching. For relief, I take ALLEGRA allergy medication and Cerave Itch relief Lotion. These do not stop the creation of bumps, but do control the terrible itching. My question to you: has anyone else reported a prolonged side effect such as mine? Your brochure says the "skin rash" will go away in a day or two. I have had it continuously since June 2018.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tryptase
Clinical narrative: I received the first injection of SHINGRIX on May 21st 2018. I received the second injection of SHINGRIX July 27th 2018. Both were administered by a pharmacy June 26th, I broke out with a rash on my legs, back and stomach in random locations. Some of the "bumps/blisters" have been as large as pencil eraser. For the most part, it has been small red bumps. The itching is so severe I have scratched bruises and blood. I have seen a dermatologist and an allergist and so far, no one can identify a cause for my bumps and itching. For relief, I take ALLEGRA allergy medication and Cerave Itch relief Lotion. These do not stop the creation of bumps, but do control the terrible itching. My question to you: has anyone else reported a prolonged side effect such as mine? Your brochure says the "skin rash" will go away in a day or two. I have had it continuously since June 2018.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Contusion, Pruritus, Rash, Rash erythematous
Clinical narrative: I received the first injection of SHINGRIX on May 21st 2018. I received the second injection of SHINGRIX July 27th 2018. Both were administered by a pharmacy June 26th, I broke out with a rash on my legs, back and stomach in random locations. Some of the "bumps/blisters" have been as large as pencil eraser. For the most part, it has been small red bumps. The itching is so severe I have scratched bruises and blood. I have seen a dermatologist and an allergist and so far, no one can identify a cause for my bumps and itching. For relief, I take ALLEGRA allergy medication and Cerave Itch relief Lotion. These do not stop the creation of bumps, but do control the terrible itching. My question to you: has anyone else reported a prolonged side effect such as mine? Your brochure says the "skin rash" will go away in a day or two. I have had it continuously since June 2018.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scratch, Skin haemorrhage, Swelling
Clinical narrative: I received the first injection of SHINGRIX on May 21st 2018. I received the second injection of SHINGRIX July 27th 2018. Both were administered by a pharmacy June 26th, I broke out with a rash on my legs, back and stomach in random locations. Some of the "bumps/blisters" have been as large as pencil eraser. For the most part, it has been small red bumps. The itching is so severe I have scratched bruises and blood. I have seen a dermatologist and an allergist and so far, no one can identify a cause for my bumps and itching. For relief, I take ALLEGRA allergy medication and Cerave Itch relief Lotion. These do not stop the creation of bumps, but do control the terrible itching. My question to you: has anyone else reported a prolonged side effect such as mine? Your brochure says the "skin rash" will go away in a day or two. I have had it continuously since June 2018.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal distension, Abdominal pain, Abdominal tenderness, Eating disorder, Hepatic steatosis
Clinical narrative: Within a couple days of the 3rd vac, experienced fullness and cramping discomfort under lower right rib cage. Pain also radiated to the back and into the right shoulder. About 5 weeks in, I had a regular physical appointment and mentioned it to my internist. She ordered an ultrasound - which found no gallstones and a mildly fatty liver. However, the ultrasound aggrevated the area to the point I was unable to eat solid food for 4 days. The ultrasound was not unusually rough, the area is that tender - even now. Internist was informed of TWINRIX series and based on OK ultrasound has asked me to wait another 2 weeks before we proceed to further testing. She did NOT indicate what she thought the problem might be, but it is my body and I have had this pain since the last vac.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain, Ultrasound abdomen
Clinical narrative: Within a couple days of the 3rd vac, experienced fullness and cramping discomfort under lower right rib cage. Pain also radiated to the back and into the right shoulder. About 5 weeks in, I had a regular physical appointment and mentioned it to my internist. She ordered an ultrasound - which found no gallstones and a mildly fatty liver. However, the ultrasound aggrevated the area to the point I was unable to eat solid food for 4 days. The ultrasound was not unusually rough, the area is that tender - even now. Internist was informed of TWINRIX series and based on OK ultrasound has asked me to wait another 2 weeks before we proceed to further testing. She did NOT indicate what she thought the problem might be, but it is my body and I have had this pain since the last vac.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: The shot itself was very painful. More so than the first one, which only caused fatigue. By morning the next day I was dizzy and sick to my stomach. By 9AM I was full blown chills and could not get warm and had a headache. Took Ibuprofen, left work and went home and laid under blankets and high room temperature for 2 hours and slept. Continued with chills and fever until bedtime. Fatigued and went to be very early. Woke up the next morning (2nd morning after shot) with an extreme headache. Took more Ibuprofen had to stay in bed for a couple more hours, feeling sick to my stomach and chilled. The point of entry of the shot made my whole top of my arm lame and sore. Could not hardly lift it past shoulder height. Finally on Sunday, I was still fatigued but not sick. Slight headache still but not nearly as bad. Monday back to full function, no arm soreness just a bit of a headache still. All in all, if I do not get shingles it will have been worth it but 2 days of reactions to it seems like a bit much.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: The shot itself was very painful. More so than the first one, which only caused fatigue. By morning the next day I was dizzy and sick to my stomach. By 9AM I was full blown chills and could not get warm and had a headache. Took Ibuprofen, left work and went home and laid under blankets and high room temperature for 2 hours and slept. Continued with chills and fever until bedtime. Fatigued and went to be very early. Woke up the next morning (2nd morning after shot) with an extreme headache. Took more Ibuprofen had to stay in bed for a couple more hours, feeling sick to my stomach and chilled. The point of entry of the shot made my whole top of my arm lame and sore. Could not hardly lift it past shoulder height. Finally on Sunday, I was still fatigued but not sick. Slight headache still but not nearly as bad. Monday back to full function, no arm soreness just a bit of a headache still. All in all, if I do not get shingles it will have been worth it but 2 days of reactions to it seems like a bit much.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-OCT-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Arm swollen, hot to touch, fever, headache, malaise, difficulty moving right arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Arm swollen, hot to touch, fever, headache, malaise, difficulty moving right arm.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage subcutaneous, Injection site pain
Clinical narrative: Patient came in complaining of generalized aching pain in right arm between shoulder and elbow. Presented with a large yellowish bruised area and another large area of what appears to be bleeding under the skin. The area of all bruising is approximately 8 in x 3 in.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, lasting two days, peaking at 102.3 (oral); along with chills, also lasting two days; followed by elevated temperature, lasting one day, peaking at 99.9 (oral).
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Urticaria
Clinical narrative: Tdap / Dtap - but I don't know the manufacturer. Hives/blisters lasting for a week.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Rotavirus vaccine was administered IM vs orally. No immediate reactions.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiomyopathy, Cellulitis, Ill-defined disorder, Injection site reaction, Muscle operation
Clinical narrative: Cellulitis, Cardiomyopathy, and several other illnesses. Had partial removal of Left Deltoid. Still undergoing care/treatment.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: I received the vaccine and was instructed to wait in the clinic for 15 minutes in case of any immediate side effects. I did not have any symptoms at this time. I drove home and started to feel achy and unwell approximately 1-2 hours after injection time. By the evening, I had a fever of 103 degrees F which lasted for >24 hours. I was seen by my family physician during this time.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Before getting the flu shot, I was asked if I was allergic to Eggs, Gelatin or Latex. I've never been allergic before, so said no, and the shot was given. Shortly after- my face, tongue and lips started to tingle. I returned to employee health and told them what was happening and they said it sounded like I was having a slight reaction to the shot. Suggested either take Benedryl or if gets worse, go to Emergency. Opted for the Benedryl med and left work early because it made me sleepy. Returned to work the next day but went to Urgent Care that afternoon to be checked out. Face tingled for a day or so after the event.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain and numbness to left arm. Currently taking Steroid, NEURONTIN and is seeing a Chiropractor. Has been going on since 10/07/2018.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient has been having prolonged pain in her shoulder/arm area. Patient claims shooting pain during the night hours and inability to raise her arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, White blood cell count increased
Clinical narrative: Presented day after injection with a red, hot, swollen arm. WBC increased, treated for cellulitis with BACTRIM DS for 10 days.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine  for long-term prevention of shingles, The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses,and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 16-MAY-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Pyrexia, Urine analysis
Clinical narrative: Low grade fever - less than 101 degrees. Fevers still ongoing.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Injection site vesicles, Scar
Clinical narrative: Blister formed near the site of injection, within a week another blister formed about 1/2 inch of affected skin. Patient went to urgent care on 9/26 and started 10 days of BACTRIM for cellulitis. Patient has healing scar as of today.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported to us that patient was diagnosed with GBS at Medical Center via phone call from MD 10/16/2018.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warm, red, raised bump at injection site. Painful to touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Injection site pain, Myalgia
Clinical narrative: Severe injection site pain, muscle pain/body aches, fatigue, fever, chills, and headache. Headache persisted for days after.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Severe injection site pain, muscle pain/body aches, fatigue, fever, chills, and headache. Headache persisted for days after.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Back pain, Blood urine present, Glucose urine absent, Headache, Nausea
Clinical narrative: Headache and body aches. Afebrile. Nausea. Low back pain.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Nitrite urine absent, Pain, Protein urine present, Specific gravity urine normal, Streptococcus test negative
Clinical narrative: Headache and body aches. Afebrile. Nausea. Low back pain.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Urine abnormality, Urine bilirubin decreased, Urine ketone body present, Urobilinogen urine increased, White blood cells urine negative
Clinical narrative: Headache and body aches. Afebrile. Nausea. Low back pain.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: pH urine normal
Clinical narrative: Headache and body aches. Afebrile. Nausea. Low back pain.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm, raised, red bump at injection site. Treated with ice and motrin.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: Patient presented 10/7/18 to ER and clinic 10/9/18 with flu-like symptoms and left arm redness/swelling.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Broke out in rashes on his neck. He claims it was after he got the vaccine. He came in on 10/15/18  wanted to get the 2nd shot but was refused due to the fact that he still had the rashes on his neck. Was told to see his doctor to make sure he doesn't have the shingles.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: FLUZONEN QUAD 18-19 SDV (SANO) 1ml DK1809204586F1 NDC: 49281-0418-50; Severe site pain right upper arm radiating down to fingers. Progressively worse, 3 weeks out cannot grip hand tightly without significant pain and weakness. Cannot push, pull, open items of daily use without pain and weakness. Cannot move arm above head without pain and radiating weakness down entire arm.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient felt swelling and heat under applied bandaid. I asked if she was experiencing any shortness of breath or swelling of lips or tongue and she said no. I advised her to take BENADRYL for the pain and Acetaminophen or Ibuprofen for any pain or heat and to watch for any worsening of symptoms. By next morning her arm was swollen down to her elbow. She said still no shortness of breath or swelling of lips or tongue, but I advised her to keep taking BENADRYL and to see her doctor. On Monday, she said most of the swelling was gone and the heat/redness was getting better but I still recommended she see her doctor. She did finally go and the doctor told her to Take BENADRYL 4 times a day. I saw the patient on Monday, October 10th, her swelling was all gone, her arm had returned to normal size and she said she had no lingering effects.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Injection site pain, fatigue, headache, upset stomach, sweating, chills, lightheadedness, dizziness.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain, fatigue, headache, upset stomach, sweating, chills, lightheadedness, dizziness.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: At 28 weeks pregnant, I received the flu vaccine. The injection was given in my right lateral shoulder, I immediately felt that it did not feel like it was in the muscle and there was a sharp pain different than I've had in other injections. A month later, I continue to have pain in my right shoulder when lifting my arm above my head or bearing weight on the right arm.
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Cough, Pyrexia, Respiratory tract congestion, Sneezing, Upper-airway cough syndrome
Clinical narrative: In 72 hours, congestion, coughing, nasal drip. In 96 hours fever of 102F, continuing sneezing, coughing, nasal drip. Recovery on or around 10/14/2018.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Drug hypersensitivity, Hypertension, Urticaria, Vision blurred
Clinical narrative: 3 days after receiving the flu shot, patient presented to clinic (10/1/18) with hives. She was then put on prednisone and VISTARIL. She also complained of high blood pressure at same visit and was prescribed lisinopril, clonazepam, and atenolol. On 10/4/18, patient presented to same clinic and was prescribed a ZPAK, CLARITIN D, and ondansetron. She did not purchase the CLARITIN D and she claimed to have a reaction to the ondansetron. On 10/11/2018 she returned to same clinic and was prescribed to amlodipine. Patient presented to a different clinic (Urgent Care) on 10/15/18 and was prescribed BROMFED DM and doxycycline. She claimed to have blurred vision from the doxycyline and quit taking medicine after one dose. She returned to Urgent Care on 10/16/18 and was prescribed meclizine for dizziness and Cefdinir. She is allergic to Cefdinir and doctor is looking into a different medicine at this time.
Age: 42.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Chills, Inflammation, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's arm was warm to the touch and swollen; pain from shoulder to forearm with chills the night after injection. Patient sought medical advice and was told that he likely had a reaction to the pneumonia shot and that the inflammation/pain should go away after a few days. Patient reports that the arm in which he received his injection is getting progressively better.
Age: 42.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Patient's arm was warm to the touch and swollen; pain from shoulder to forearm with chills the night after injection. Patient sought medical advice and was told that he likely had a reaction to the pneumonia shot and that the inflammation/pain should go away after a few days. Patient reports that the arm in which he received his injection is getting progressively better.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient passed out after leaving the clinic causing him to hit his head.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: PATIENT ARRIVED WITH REDNESS AND EDEMA IN VACCINATED ARM.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Ear pain, Migraine, Musculoskeletal stiffness
Clinical narrative: The next day after receiving vaccination patient had stiffness in neck and pain under ear similar to a migraine that got worse and has not improved. Patient has seen chiropractor who has been performing heat treatments and adjustments.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported sharp pain in her shoulder joint area, moving outwards. she is also having difficulty lifting her arm.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Ecchymosis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth, pain, ecchymosis.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-JAN-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 20-DEC-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.