chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 18 month old male patient received expired daptacel vaccine, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves an 18 month old male patient who received a 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the right thigh for prophylactic vaccination on 02-Mar-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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.
Sex: M
Vaccine: FLUR4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: have contracted A strain Influenza; have contracted A strain Influenza; Initial information received on 03-Mar-2020 regarding an unsolicited valid serious case from a consumer/non-hcp.  This case involves a 50 years old male patient who was diagnosed with strain A influenza (Influenza), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  In October 2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number not reported) via an unknown route at an unknown administration site.  On 03-Mar-2020, the patient have contracted A strain influenza (influenza) (latency about 4 months) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. It was also a case of vaccination failure.  Relevant laboratory test results included: On 03-Mar-2020, the influenza A virus test was positive.  Final diagnosis was influenza.  The patient started oseltamivir phosphate [Tamiflu] as corrective treatment.  The patient was recovering from influenza A.  Information on the batch number is requested.; Sender's Comments: This case concerns a 50 years old male patient who was diagnosed with influenza A virus infection after and despite of vaccination with FLUBLOK QIV. The time to onset is compatible. The lab data confirms the influenza strain A. The patient's past medical history, concomitant medications, immune status and lab tests ruling out predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: he had rash on his back, chest, legs and itching two days after the injection; itching two days after the injection; Initial information was received on 04-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves a 15 years old male patient who experienced he had rash on his back, chest, legs and itching two days after the injection and itching two days after the injection, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The medical history included allergy to chemicals, dermatitis contact, reaction to preservatives and contrast media allergy.  Past medical treatment, vaccination and family history were not provided.  On 02-Feb-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B (lot number and expiry date not reported) via an intramuscular route in the left arm for prophylactic vaccination.    On an unknown date, the patient developed non-serious rash on his back, chest, legs and itching two days after the injection (rash) and (pruritus) (2 days) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory data was not provided.  Final diagnosis was rash and pruritus.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]).  The outcome was reported as unknown for both the events.  Information on batch number was requested.
Age: 67.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states she has pain when lifting arm too high
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Nausea, Vision blurred
Clinical narrative: States Wednesday started experiencing dull headache that became progressively worse. Thursday experiencing dull headache, blurred vision, nausea, and dizziness. Presented to clinic on Friday 03/06/2020-states still has dull headache on top of head.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Since 03/06/2020 swelling and redness of arm, Pain at level 7, headache, low grade fever, nausea.  On 03/09 symptoms gone with exception of redness at injection site and swelling in upper left arm. Worst reaction I have ever had to a vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Since 03/06/2020 swelling and redness of arm, Pain at level 7, headache, low grade fever, nausea.  On 03/09 symptoms gone with exception of redness at injection site and swelling in upper left arm. Worst reaction I have ever had to a vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Scab, Varicella
Clinical narrative: Patient reports having 6 "chicken pox" blisters appearing 2 weeks after receiving the SHINGRIX vaccine. She said they scabbed over the next day and healed.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Pt reported redness, warm to touch, swelling present at injection site and collarbone.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt reported redness, warm to touch, swelling present at injection site and collarbone.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Breath holding, Crying, Eye movement disorder, Skin discolouration
Clinical narrative: I was giving vaccines to Patient, a six mold old child vaccines ordered was Pentacel, Prevnar 13 and Hepatitis B. Mother was present at all time child reacted well to the firs vaccine giving Pentacel did not cry, second vaccine was hepatitis B, patient started to cry. When the last vaccine giving Prevnar 13 patient cry excessively and hold his breath at the he was turning purple. My reaction was to blow air on his face pick him up from the table right away. He started to cry normal and look normal, but couple seconds later he look like he was going to pass out and was rolling his eyes backwards.So I call code blue and Doctor went in to the room and the LVN with the emergency kit and the oxygen tank. When everybody arrive to the room the child was crying and breathing normal there was no need for any oxygen. Doctor exam the child and said he is ok. By the time the mother was crying and scared and said he usually holds his breath but not for this long, patient waited for couple minutes in the room and leave.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: patient states swelling at injection site the size of softball, itching, reddness, feverish for 4 days. patient states she did not use any medications
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: redness/swelling/pain of left arm
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: The patient was administered Shingrix on 3/5/2020. The patient felt "warm, wet and Puff" at the site of injection. The patient ended up going to urgent care and was then diagnosed with cellulitis and prescribed Doxycycline. The patient also mentioned that her temperature was 99 Degree F. After getting her antibiotic, the patient said she started to feel better.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: All of the following adverse reactions were intense: Shivering, nausea, sensitivity to light, headache, runny nose, extreme lethargy, fever spikes to 102.7, extreme thirst, and extreme swelling with redness and heat at the injection site,  The symptoms began with a general feeling of nausea about 10 hours after injection. Within one hour the remaining symptoms emerged. I still have a low-grade fever of 99-100 degrees and lethargy as of this time (3/9/2020 - 4:09 p.m.)
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Lethargy, Nausea, Photophobia, Pyrexia, Rhinorrhoea
Clinical narrative: All of the following adverse reactions were intense: Shivering, nausea, sensitivity to light, headache, runny nose, extreme lethargy, fever spikes to 102.7, extreme thirst, and extreme swelling with redness and heat at the injection site,  The symptoms began with a general feeling of nausea about 10 hours after injection. Within one hour the remaining symptoms emerged. I still have a low-grade fever of 99-100 degrees and lethargy as of this time (3/9/2020 - 4:09 p.m.)
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Thirst
Clinical narrative: All of the following adverse reactions were intense: Shivering, nausea, sensitivity to light, headache, runny nose, extreme lethargy, fever spikes to 102.7, extreme thirst, and extreme swelling with redness and heat at the injection site,  The symptoms began with a general feeling of nausea about 10 hours after injection. Within one hour the remaining symptoms emerged. I still have a low-grade fever of 99-100 degrees and lethargy as of this time (3/9/2020 - 4:09 p.m.)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: patient developed hives/welts to the neck, breasts and abdomen. Had left facial swelling and lip swelling
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Rash, Sinusitis
Clinical narrative: Patient had rash at the injection site and on all around torso. Patient felt sick for 2 weeks. Patient now has sinus infection.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint movement impairment, Injection site pain, X-ray limb
Clinical narrative: 3-month right shoulder and proximal pain/tenderness with limited shoulder range of motion, limited by pain
Age: 1.25
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: The Hep A was not due until 6/9/20. The TDaP-IPV was the incorrect dose for a 15 month old.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Next evening had trouble lifting arm because of pain. Pain on touching not on vaccine site but lower up to elbow. Area was red, warm and swollen. Vaccine administered on 3/5, now it is 3/9 and I am able to move arm with no pain only sore when I touch area between shoulder and elbow. I have had one lymph node removed on that arm, could it have caused the reaction? I have never had any adverse reactions before with vaccines.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: PATIENT HAD REDNESS THAT SPANNED FROM ELBOW TO SHOULDER WITHOUT ITCHING OR PAIN THAT HAVE PROGRESSED SINCE THE VACCINATION DATE 2/28/20 TO PRESENT 3/9/2020
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient developed a raised, red, pinpoint, itchy, rash on her body approximately 11 days after receiving MMR, Varicella, and Vaqta vaccines.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: THE NIGHT OF THE VACCINE CLIENT EXPERIENCE HEADACHE. CHILLS, FEVER  (NO QUANTIFY). NEXT DAY HAD RASH  WITH ITCHY THAT STARTED  ON NECK AND EXTENDED TO THE CHEST, SIDES/ TORSO, INSIDE OF LEGS. VERY SORE ARM ON THE SIDE OF THE INJECTION.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: THE NIGHT OF THE VACCINE CLIENT EXPERIENCE HEADACHE. CHILLS, FEVER  (NO QUANTIFY). NEXT DAY HAD RASH  WITH ITCHY THAT STARTED  ON NECK AND EXTENDED TO THE CHEST, SIDES/ TORSO, INSIDE OF LEGS. VERY SORE ARM ON THE SIDE OF THE INJECTION.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Myalgia, Pyrexia
Clinical narrative: Low grade fever, achy muscles, upset intestinal system.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Aphasia, Decreased eye contact, Eczema
Clinical narrative: Eczema, loss of speech, no eye contact,
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received Hepatitis A shot at 2 months.  Patient is thriving well, no adverse effects of the vaccines was reported at the time. Patient continues to be doing well.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Patient stated that she experienced soreness the day following vaccination, and the area around the left upper arm (deltoid area) became red. Patient stated that she visited her doctor and was told that it was a result of bacteria on the skin infecting the injection site. She presented to the pharmacy with red, swollen skin in affected area, and picked up an antibiotic (doxycycline).
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Laryngitis
Clinical narrative: Cough and laryngitus
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: large patch of hives on left forearm 6" x 2", extending towards hand,  small bumps on back of  3rd and 4th fingers of right hand
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site redness, swelling, and pain. Treated with Ibuprofen. Still occurring.
Age: 72.0
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Oral discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Beginning about 1-1/2 days after the  vaccination I have been experiencing Hives (with bumps and severe itching) mostly on legs and a little on lower arms.  No hives elsewhere on body.   I am now in the 3rd day of these hives with no sign yet of abatement.    Also am feeling occasional mild burning sensation of lips and cheeks but not serious and no fever. There was no redness or swelling around needle injection site.
Age: 72.0
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Purulence, Rash erythematous, Rash pruritic
Clinical narrative: Beginning about 1-1/2 days after the  vaccination I have been experiencing Hives (with bumps and severe itching) mostly on legs and a little on lower arms.  No hives elsewhere on body.   I am now in the 3rd day of these hives with no sign yet of abatement.    Also am feeling occasional mild burning sensation of lips and cheeks but not serious and no fever. There was no redness or swelling around needle injection site.
Age: 72.0
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Burning sensation, Oral discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Beginning about 1-1/2 days after the  vaccination I have been experiencing Hives (with bumps and severe itching) mostly on legs and a little on lower arms.  No hives elsewhere on body.   I am now in the 3rd day of these hives with no sign yet of abatement.    Also am feeling occasional mild burning sensation of lips and cheeks but not serious and no fever. There was no redness or swelling around needle injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Patient broke out in hives around the injection site. It was very painful and red and took up a large area of the deltoid. Patient said they still hadn't gone away two days later.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Contusion, Injection site pain, Pain
Clinical narrative: Patient complained that experienced stomach aches, body aches, soreness at injection site  as well as bruising right after vaccination. Patient was concerned about bruising since is not on any blood thinners or has had that reaction to any vaccine in the past. About a week after administration, it appeared that the bruise on the arm was healing. Patient was not complaining of any severe pain at the time. Will continue to monitor.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PATIENT PRESENTS RED ARM AT THE SITE OF INJECTION, PAINFUL WHEN TOUCHING. PATIENT HAS BEEN TAKING TYLENOL FOR PAIN.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Oral discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Patient started with bumps that itched on both her legs on 3/6/20.  There were more bumps on her legs than she could count.  Then the bumps started to appear on her arms.  Now (3/9/20) there are less bumps but they are red and filled with puss.  She has about 30 bumps on her legs and 12 on her arms.  She will now start to take an antihistamine and use hydrocortisone cream.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Purulence, Rash erythematous, Rash pruritic
Clinical narrative: Patient started with bumps that itched on both her legs on 3/6/20.  There were more bumps on her legs than she could count.  Then the bumps started to appear on her arms.  Now (3/9/20) there are less bumps but they are red and filled with puss.  She has about 30 bumps on her legs and 12 on her arms.  She will now start to take an antihistamine and use hydrocortisone cream.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Burning sensation, Oral discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Patient started with bumps that itched on both her legs on 3/6/20.  There were more bumps on her legs than she could count.  Then the bumps started to appear on her arms.  Now (3/9/20) there are less bumps but they are red and filled with puss.  She has about 30 bumps on her legs and 12 on her arms.  She will now start to take an antihistamine and use hydrocortisone cream.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Pain, Shoulder injury related to vaccine administration, Tendonitis, X-ray limb
Clinical narrative: I was given a flu vaccine at work on my left arm. The administering nurse gave it too high up on my shoulder. When she gave it she said "Oh I think I got it in your bone, you are just too skinny." She didn't pinch the muscle. I had pain for a few days and it kept getting worse and worse. I couldn't move my arm without pain. I got a steroid shot a few weeks later on 10/14/19.. It helped for about a week or two then I was seen by my work's wellness center on 10/30 and 11/6 and was referred to occupation medicine and physical therapy for bursitis/tendonitis/SIRVA (shoulder injury related to vaccine administration). I went to 7physical therapy sessions and have seen occupational therapy every 1-3 weeks since November. I am finally feeling better and am able to move my shoulder without pain.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Arthritis, Dermatitis allergic, Dizziness, Headache
Clinical narrative: hives/ Wheals, urticaria, hives on back, neck, face/chronic urticaria; joint pain of hands, feet, knees, fingers/ arthritis/ swelling around the joints; shingles; sweaty; dizzy episodes; feeling sick; nausea; vomiting; headaches; This spontaneous report was received from a registered nurse who called on behalf of her 15 years old daughter. The patient's medical history included mild eczema. The patient had no known drug allergy and reported no concomitant medications.    On 29-DEC-2011, the patient was vaccinated with dose 1 quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot #, dose and expiry not reported). There was no concomitant medication. On 28-JAN-2012, the patient broke out in shingles. On 29-FEB-2012, the patient was vaccinated with dose 2 of quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot#, dose and expiry not reported). In the last week in March 2012 and beginning of April 2012, the patient developed hives. The nurse took her daughter for a doctor visit 06-JUN-2012 and she was told the hives was not due to the quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL). Patient received treatment with triamcinolone cream. The patient was then referred to an allergist. On 11-JUL-2012, patient was vaccinated with dose 3 of quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot#, dose and expiry not reported). In approximately 01-AUG-2012 (reported as "about three weeks post vaccination"), the patient developed wheals, urticaria, and joint pain of hands, feet, knees, fingers. Hives on her back, neck, face. The patient was taken to the emergency room twice once in September 2012 and another visit in October 2012. Unspecified test for vasculitis were performed which were negative. The patient was treated with prednisone and diazepam (VALUM) and released. On an unknown date in 2012, the patient also experienced dizzy episodes, sweaty and feeling sick, had nausea, vomiting and headaches. The patient's present status was reported as not recovered.   Follow up information was received from a physician, via social media. The patient was 14 when she had the reaction to the quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL) vaccine. It was reported that the patient suffered from chronic urticaria and arthritis, a severe skin allergy, after quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL) vaccination. She had had daily hives and continued to suffer from arthritis. It was reported that chronic urticaria could have been caused by quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL).
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Hyperhidrosis, Laboratory test normal, Malaise, Nausea
Clinical narrative: hives/ Wheals, urticaria, hives on back, neck, face/chronic urticaria; joint pain of hands, feet, knees, fingers/ arthritis/ swelling around the joints; shingles; sweaty; dizzy episodes; feeling sick; nausea; vomiting; headaches; This spontaneous report was received from a registered nurse who called on behalf of her 15 years old daughter. The patient's medical history included mild eczema. The patient had no known drug allergy and reported no concomitant medications.    On 29-DEC-2011, the patient was vaccinated with dose 1 quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot #, dose and expiry not reported). There was no concomitant medication. On 28-JAN-2012, the patient broke out in shingles. On 29-FEB-2012, the patient was vaccinated with dose 2 of quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot#, dose and expiry not reported). In the last week in March 2012 and beginning of April 2012, the patient developed hives. The nurse took her daughter for a doctor visit 06-JUN-2012 and she was told the hives was not due to the quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL). Patient received treatment with triamcinolone cream. The patient was then referred to an allergist. On 11-JUL-2012, patient was vaccinated with dose 3 of quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot#, dose and expiry not reported). In approximately 01-AUG-2012 (reported as "about three weeks post vaccination"), the patient developed wheals, urticaria, and joint pain of hands, feet, knees, fingers. Hives on her back, neck, face. The patient was taken to the emergency room twice once in September 2012 and another visit in October 2012. Unspecified test for vasculitis were performed which were negative. The patient was treated with prednisone and diazepam (VALUM) and released. On an unknown date in 2012, the patient also experienced dizzy episodes, sweaty and feeling sick, had nausea, vomiting and headaches. The patient's present status was reported as not recovered.   Follow up information was received from a physician, via social media. The patient was 14 when she had the reaction to the quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL) vaccine. It was reported that the patient suffered from chronic urticaria and arthritis, a severe skin allergy, after quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL) vaccination. She had had daily hives and continued to suffer from arthritis. It was reported that chronic urticaria could have been caused by quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL).
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Urticaria, Urticaria chronic, Vomiting
Clinical narrative: hives/ Wheals, urticaria, hives on back, neck, face/chronic urticaria; joint pain of hands, feet, knees, fingers/ arthritis/ swelling around the joints; shingles; sweaty; dizzy episodes; feeling sick; nausea; vomiting; headaches; This spontaneous report was received from a registered nurse who called on behalf of her 15 years old daughter. The patient's medical history included mild eczema. The patient had no known drug allergy and reported no concomitant medications.    On 29-DEC-2011, the patient was vaccinated with dose 1 quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot #, dose and expiry not reported). There was no concomitant medication. On 28-JAN-2012, the patient broke out in shingles. On 29-FEB-2012, the patient was vaccinated with dose 2 of quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot#, dose and expiry not reported). In the last week in March 2012 and beginning of April 2012, the patient developed hives. The nurse took her daughter for a doctor visit 06-JUN-2012 and she was told the hives was not due to the quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL). Patient received treatment with triamcinolone cream. The patient was then referred to an allergist. On 11-JUL-2012, patient was vaccinated with dose 3 of quadrivalent human papillomavirus (types 6,11,16,18) recombinant vaccine (GARDASIL) (lot#, dose and expiry not reported). In approximately 01-AUG-2012 (reported as "about three weeks post vaccination"), the patient developed wheals, urticaria, and joint pain of hands, feet, knees, fingers. Hives on her back, neck, face. The patient was taken to the emergency room twice once in September 2012 and another visit in October 2012. Unspecified test for vasculitis were performed which were negative. The patient was treated with prednisone and diazepam (VALUM) and released. On an unknown date in 2012, the patient also experienced dizzy episodes, sweaty and feeling sick, had nausea, vomiting and headaches. The patient's present status was reported as not recovered.   Follow up information was received from a physician, via social media. The patient was 14 when she had the reaction to the quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL) vaccine. It was reported that the patient suffered from chronic urticaria and arthritis, a severe skin allergy, after quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL) vaccination. She had had daily hives and continued to suffer from arthritis. It was reported that chronic urticaria could have been caused by quadrivalent Human papillomavirus (Types 6,11,16,18) recombinant vaccine (GARDASIL).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Pneumovax 23 was loaded into the database on 14-FEB-2020 at 1239 and was administered to this patient on 16-FEB-2020 at 1231. The vaccine was at room temperature; This spontaneous report was received from a pharmacy technician, and refers to a 80 year old patient of unknown gender. Information about the patient's medical history, concomitant medications and drug reactions or allergies was not provided. The patient was currently hospitalized for an unknown reason     On 14-FEB-2020 at 12:39 pm, the dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S028602 with an expiration date in 28-JUN-2021), was loaded into the database and was left at room temperature of 69 degrees Fahrenheit until 16-FEB-2020 at 12:31 (72 hours), when the patient was vaccinated via intramuscular (strength, dose and frequency were not provided), for prophylaxis. The patient received the vaccination right before discharge and was no longer in the hospital. It was also reported that there was no previous temperature excursion and that the digital data logger was not involved. No additional adverse effects were reported.  This is one of two reports received from the same reporter regarding different patients.; Sender's Comments:  US-009507513-2002USA007244:
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Gastrooesophageal reflux disease, Hepatitis B DNA assay negative, Hepatitis B core antibody negative, Hepatitis B e antigen negative
Clinical narrative: Hepatitis B surface antigen positive; Literature Report:.  This literature marketed report has been received from the authors of the published article, titled as stated above and refers to a 59 year old female patient. On 30-JUN-2018, Hepatitis B surface antibody (Hep Bs Ag) was negative and hepatitis B surface antibody (anti-hep Bs) was 3.3. On 11-JUL-2018, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot # not reported).       On 14-JUL-2018, the patient presented to the ED for gastrooesophageal reflux disease with atypical chest pain. The patient was found to be Hep Bs Ag positive. A blood work was performed a month later the vaccination on 09-AUG-2018, and it showed low surface antibody titer and no antigen al all: Hep Bs Ag was negative, anti-hep Bs was 3.5, hepatitis B core antibody was negative, hepatitis B e antigen was negative and Hep B Viral DNA was not detected  The outcome of Hep Bs Ag positive was considered to be recovered.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same article (MARRS 2003USA003205).; Sender's Comments:  US-009507513-2003USA003205:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: Hepatitis B surface antigen positive; Literature Report:.  This literature marketed report has been received from the authors of the published article, titled as stated above and refers to a 59 year old female patient. On 30-JUN-2018, Hepatitis B surface antibody (Hep Bs Ag) was negative and hepatitis B surface antibody (anti-hep Bs) was 3.3. On 11-JUL-2018, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot # not reported).       On 14-JUL-2018, the patient presented to the ED for gastrooesophageal reflux disease with atypical chest pain. The patient was found to be Hep Bs Ag positive. A blood work was performed a month later the vaccination on 09-AUG-2018, and it showed low surface antibody titer and no antigen al all: Hep Bs Ag was negative, anti-hep Bs was 3.5, hepatitis B core antibody was negative, hepatitis B e antigen was negative and Hep B Viral DNA was not detected  The outcome of Hep Bs Ag positive was considered to be recovered.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same article (MARRS 2003USA003205).; Sender's Comments:  US-009507513-2003USA003205:
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; Information has been received regarding a case in litigation concerning a female patient (pt) of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  In or around 29-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as routine health maintenance/prevention of shingles (dose, vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unspecified date (reported as shortly after zoster vaccine live (ZOSTAVAX) vaccination), the patient suffered and was diagnosed with pneumonia. It was reported that the pt's symptoms resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt had severe and permanent injuries; further, as a tragic consequence of Company's wrongful conduct, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company conduct, the pt had suffered and incurred damages, including medical expenses, the loss of accumulation and other economic and non-economic damages. At the time of the report, the pt had not recovered from pneumonia.  The event pneumonia was considered as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was considered as disabling and medically significant event.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 28-DEC-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The shingles was assessed as a disabling event by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chronic obstructive pulmonary disease, Discomfort, Dyspnoea, Facial paralysis
Clinical narrative: bilateral pneumonia; transient ischemic attacks; Chronic Obstructive Pulmonary Disease; Bell's Palsy/right facial droop; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 07-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered left facial droop, chest pain, discomfort, shortness of breath and was diagnosed with Bell's Palsy (facial paralysis) and chronic obstructive pulmonary disease. She was also diagnosed with bilateral pneumonia, right facial droop and transient ischemic attacks. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The above-mentioned injuries were assessed as disabling events by the reporter.  Upon internal review, the facial paralysis, pneumonia and transient ischaemic attack were considered medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Transient ischaemic attack
Clinical narrative: bilateral pneumonia; transient ischemic attacks; Chronic Obstructive Pulmonary Disease; Bell's Palsy/right facial droop; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 07-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered left facial droop, chest pain, discomfort, shortness of breath and was diagnosed with Bell's Palsy (facial paralysis) and chronic obstructive pulmonary disease. She was also diagnosed with bilateral pneumonia, right facial droop and transient ischemic attacks. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The above-mentioned injuries were assessed as disabling events by the reporter.  Upon internal review, the facial paralysis, pneumonia and transient ischaemic attack were considered medically significant events.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: the patient who is unsure how many doses of Gardasil she received as a child/ She is interested in receiving the vaccine/ may have had alternate dosing of either GARDASIL 4 or GARDASIL 9; the patient who is unsure how many doses of Gardasil she received as a child/ She is interested in receiving the vaccine/ may have had alternate dosing of either GARDASIL 4 or GARDASIL 9; the patient who is unsure how many doses of Gardasil she received as a child/ She is interested in receiving the vaccine/ may have had alternate dosing of either GARDASIL 4 or GARDASIL 9; No adverse effects reported; This spontaneous report was received from a physician, regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On an unknown date, (reported as "when she was a child"), the patient was vaccinated with either human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, vaccination scheme, route of administration, lot number or expiration date were not reported) as prophylaxis. The reporter mentioned that the patient was unsure about how many doses she received as a child, and it was reported that "she was interested in receiving the vaccine" (circumstance or information capable of leading to medication error, interchange of vaccine products and wrong product administered). No additional adverse events were reported.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received pneumococcal vaccine on 06-DEC-2006 and 13-APR-2010; This spontaneous report has been received from an health professional and a lawyer, referring to a 61 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported.      On 06-DEC-2006 and 13-APR-2010 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis (inappropriate schedule of vaccine administered).  The case is linked to case# US-009507513-1704USA011055 due to the same patient.; Sender's Comments:  US-009507513-1704USA011055:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 13-NOV-2013 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation (unknown date), he was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. Outcome of shingles was not provided. The lawyer considered the shingles to be related to zoster vaccine live(ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information was received from a lawyer regarding a case in litigation and refers to male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 23-OCT-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation, patient was treated for shingles.The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     As a direct and proximate result of patient use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B DNA assay positive, Hepatitis B core antibody positive, Hepatitis B e antibody negative, Hepatitis B e antigen negative, Viral load undetectable
Clinical narrative: positive isolated total core antibody (anti-HBc);   This literature marketed report has been received from the authors of the published article, titled as stated above and refers to a 62 year old male patient with type II diabetes mellitus and insomnia. On an unspecified date, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot # not reported).     On 27-APR-2015, the patient was found to have positive isolated total core antibody (anti-HBc) from his physical checkup. On 21-MAY-2015, the patient received a hepatitis b vaccine (recombinant) (manufacturer unknown) booster (dose, route and lot # not reported) and repeated blood work on 25-JUN-2015 found still isolated anti-HBc. Further blood work in August 2015, including hepatitis B e antigen and hepatitis B e antibody and viral load, verified the patient did not have an active infection. He finished the three dose vaccine series on an unspecified date.  Incidental hepatitis B panel drawn on 23-DEC-2015 found detectable DNA (< 20) with negative hepatitis B surface antigen and positive hepatitis B surface antibody. The outcome of positive anti-HBc was considered to be recovered.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same article (MARRS 2002USA009087).; Sender's Comments:  US-009507513-2002USA009087: