chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Friday evening patient's arm was sore, had a really bad headache, fatigue and fever. Felt better by Monday morning. Then by Wednesday evening, she starting feeling ill again with headache and vomiting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Friday evening patient's arm was sore, had a really bad headache, fatigue and fever. Felt better by Monday morning. Then by Wednesday evening, she starting feeling ill again with headache and vomiting.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Mass
Clinical narrative: dime size lump several days later. not painful, not red,  can be felt under the skin
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Muscle twitching, Pallor
Clinical narrative: vaccine given around 915  around 1230pm was feeling faint, dizzy, color was off per mom (pale)  involuntary muscle twitching for approximately 2 hours from  1pm-3pm. Involuntary  twitching of all parts of body, including  both legs, both arms and abdomen. frequency of one muscle twitch every 5-10 minutes.   Resolved spontaneously with supportive care (time, ate a sandwich and drank fluids).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Eye complication associated with device, Injection site pain, Injection site reaction, Micturition urgency
Clinical narrative: 1. cramping and pain at site for 4-5 months, woke me from sleep. 2.I have invisilign braces and after the shot my mouth developed areas of irritation every time I used the elastics at night. I had to discontinue the elastics to clear the problem. (I am not allergic to latex)  3. I developed problem with my contact lenses.  I (have wore contacts for 59+ years) and they have not been a problem 4. increased urinary frequency, urgency and pressure with urination. Tingling up both arms post voiding.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Muscle spasms, Paraesthesia, Pollakiuria, Stomatitis
Clinical narrative: 1. cramping and pain at site for 4-5 months, woke me from sleep. 2.I have invisilign braces and after the shot my mouth developed areas of irritation every time I used the elastics at night. I had to discontinue the elastics to clear the problem. (I am not allergic to latex)  3. I developed problem with my contact lenses.  I (have wore contacts for 59+ years) and they have not been a problem 4. increased urinary frequency, urgency and pressure with urination. Tingling up both arms post voiding.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: left arm was red and hot  - rash continued spreading since day after immunization - right arm unaffected
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: stated had slight redness and swelling the first two days after injection in the arm. on the eve of the third day began getting hives on abdomen first and then spread to arms, ears and inside ears and thighs,  Pt called the nurse triage line and was told to take Diphenhydramine 50mgs.  She then called clinic as she was concerned about getting a second shot based on her current reaction. Durong that conversation she was told to take a Zyrtec which she had at home.  She did not have any shortness of breath just hives that were very itchy all over.  She used calamine on the skin for itching.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Blood creatine phosphokinase normal, Blood electrolytes normal, Crying, Dystonia, Gait disturbance
Clinical narrative: Approximately 2 hrs after immunization 18 month old baby had extreme pain as evidenced by crying, dystonic type cramping  located in toes and joints bilateramly, her ankle and knees became rigid. The next day she began limping. ER visit was sought 24 hours after the injections.  Child continues to exhibit pain
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Muscle rigidity, Muscle spasms, Pain
Clinical narrative: Approximately 2 hrs after immunization 18 month old baby had extreme pain as evidenced by crying, dystonic type cramping  located in toes and joints bilateramly, her ankle and knees became rigid. The next day she began limping. ER visit was sought 24 hours after the injections.  Child continues to exhibit pain
Age: 3.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Swelling face, Urticaria
Clinical narrative: Diffuse hives developed 1 day after vaccine administration. Parents also report facial swelling.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Lethargy, Pyrexia, Rash
Clinical narrative: High fevers that persisted despite use of medication for 3 days, lethargic, rash.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Axillary pain, Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: Severe itching, swelling and purple discoloration of the entire right shoulder, deltoid, and bicep with pain noted in the axilla.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site nodule, Injection site papule
Clinical narrative: Note MMR was #2, because first was given for travel previously. HPI: In March she was prescribed Amoxicillin.  In April, she was given Cefdinir, but developed rash with red dots a few days after the medication was given; she was switched to Azithromycin.  Unclear if truly an allergy vs drug reaction, as she had no wheezing or dyspnea or other symptoms.  In May she was prescribed Augmentin, and did develop a rash near the end of the 10 day course (05/31/2020).  Mom (a few days before todays visit) showed pictures of the rash to me.  There were three red lesions, that looked somewhat vesicular, two on the right chest and one on the right thigh (just looked like a red papule).  Dad notes that there is a subdermal induration in the thigh, and that is the same location where the Varicella #1 vaccine was given, the day she started antibiotics.  Today there is some crusting and shrinking of the lesions. EXAM:  Subcutaneous nodule in thigh, non-tender, ~1 cm in size. Small erythematous 1-2 mm papule over region, non-crusted and non vesicular. Above R nipple is a 1-2 mm slightly erythematous and crusted lesion, w/ few surrounding erythematous pinpoint papules. R lower chest has another erythematous papule, non-vesicular, not crusted.  Few pinpoint lesions, just slightly more erythematous than flesh colored, are scattered on R chest and R thigh (~5-10 total), that have no scale and no crust and no papules. ASSESSMENT: Patient has not fully recovered, but is recovering.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Papule, Scab, Skin lesion
Clinical narrative: Note MMR was #2, because first was given for travel previously. HPI: In March she was prescribed Amoxicillin.  In April, she was given Cefdinir, but developed rash with red dots a few days after the medication was given; she was switched to Azithromycin.  Unclear if truly an allergy vs drug reaction, as she had no wheezing or dyspnea or other symptoms.  In May she was prescribed Augmentin, and did develop a rash near the end of the 10 day course (05/31/2020).  Mom (a few days before todays visit) showed pictures of the rash to me.  There were three red lesions, that looked somewhat vesicular, two on the right chest and one on the right thigh (just looked like a red papule).  Dad notes that there is a subdermal induration in the thigh, and that is the same location where the Varicella #1 vaccine was given, the day she started antibiotics.  Today there is some crusting and shrinking of the lesions. EXAM:  Subcutaneous nodule in thigh, non-tender, ~1 cm in size. Small erythematous 1-2 mm papule over region, non-crusted and non vesicular. Above R nipple is a 1-2 mm slightly erythematous and crusted lesion, w/ few surrounding erythematous pinpoint papules. R lower chest has another erythematous papule, non-vesicular, not crusted.  Few pinpoint lesions, just slightly more erythematous than flesh colored, are scattered on R chest and R thigh (~5-10 total), that have no scale and no crust and no papules. ASSESSMENT: Patient has not fully recovered, but is recovering.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling, Joint swelling, Peripheral swelling
Clinical narrative: pt reported immediately feeling the injection travel to the fingertips in her left arm and  feeling swollen in her finger joints and at the injection site.  this morning she woke up and felt swelling in her joints throughout her body.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site swelling, Injection site warmth, Pain in extremity, Ultrasound scan
Clinical narrative: Patient reported immediate left arm pain/burning sensation with radiation down to hand, unable to lift/move arm due to pain. No numbness/tingling. Called the after hours on call, Dr, and was directed to ED. Rx for abx. Today, pt feels improved, can move arm. Pt reports still has some warmth, swelling of the injection site, but better than last night. Took ibuprofen and Tylenol, iced x 1. She was advised to take her abx, ice her arm for 15 min 3 x 1 day, closely monitor the area and contact us for a face to face encounter if not improving or worsening.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: *The spot was red, swollen, and itchy to the patient. *Ibu as needed, topical Benadryl during the day, and oral Benadryl before bedtime.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: It appears that someone got some sort of special dispensation to track me and my movements contingent upon a requirement for me to get a booster shot for my employment at the Department of Public Health. I tried to request a report in 2018. I did not know that someone was completely misrepresenting their intentions upon discussing certain matters with me to engage me in illegal human test subject experimenttion without disclosure and AFTER misrepresenting the legally-required processes with which one must engage in order to do what she was doing. I believe that due to a kickback scheme that I have been intentionally sabotaged and attempted for extortion into cooperation.  Event occured this morning.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: rash / rash is worsening; Red raised area; Large whelps; blisters; Very itchy; Have the appearance of Shingles; can't sleep at night; Dermal Hypersensitiviy Syndrome; This case was reported by a consumer via call center representative and described the occurrence of rash in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included rash (mild red pimple rash). Previously administered products included Zostavax (received 3 to 4 years ago).   On 27th January 2020, the patient received the 1st dose of Shingrix. On 31st January 2020, 4 days after receiving Shingrix, the patient experienced rash, erythema, hives, blister, pruritus, shingles, difficulty sleeping and cutaneous hypersensitivity. The patient was treated with emollients and protectives (Cerave), topical steroid nos (Topical Steroid) and prednisone. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved and the outcome of the erythema, hives, blister, shingles, difficulty sleeping and cutaneous hypersensitivity were unknown.   It was unknown if the reporter considered the rash, erythema, hives, blister, pruritus, shingles, difficulty sleeping and cutaneous hypersensitivity to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced a rash that was small red raised area that began on his back moved to his lower back then to chest were and at the time of reporting, large whelps and had spread to his arms, legs and ankles.  The patient states it was very itchy and when he did scratch it flared to blisters that had the appearance of Shingles.  The patient had not been told by his primary or his dermatologist that he had shingles.  The patient noted he could not sleep at night due to the itching and his life had become consumed with trying to find a cure for this as it had been going on for 4 months at the time of reporting.  The patient saw his primary physician on 11th February 2020 for itching. He was given a topical steroid, after 1 week it had not resolved. He then saw his Dermatologist on 21st January 2020 for the rash and itching. He was tried on a regimen of topical steriods, oral prednisone helped but was short lived. He was then given a prednisone injection on 06th May 2020 but noted no results with that. He had found one cream that helped, Cerave, and he noted that helped more in the beginning than it did at the time of reporting.  He believed the rash was worsening.  The patient also noted a biopsy was done by the Dermatologist on 11th March 2020 and shown not to be psoriasis, or eczema, the stitches for the biopsy were removed at the visit done on 25th March 2020. He stated he was told by his primary at the first visit this was dermal hypersensitiviy syndrome. The reporter was consented to follow up.      Lab Comments: Biopsy was done by the Dermatologist on 11th March 2020 and shown not to be psoriasis, or eczema, the stitches for the biopsy were removed at the 25th March 2020 visit.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pruritus, Rash, Urticaria
Clinical narrative: rash / rash is worsening; Red raised area; Large whelps; blisters; Very itchy; Have the appearance of Shingles; can't sleep at night; Dermal Hypersensitiviy Syndrome; This case was reported by a consumer via call center representative and described the occurrence of rash in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included rash (mild red pimple rash). Previously administered products included Zostavax (received 3 to 4 years ago).   On 27th January 2020, the patient received the 1st dose of Shingrix. On 31st January 2020, 4 days after receiving Shingrix, the patient experienced rash, erythema, hives, blister, pruritus, shingles, difficulty sleeping and cutaneous hypersensitivity. The patient was treated with emollients and protectives (Cerave), topical steroid nos (Topical Steroid) and prednisone. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved and the outcome of the erythema, hives, blister, shingles, difficulty sleeping and cutaneous hypersensitivity were unknown.   It was unknown if the reporter considered the rash, erythema, hives, blister, pruritus, shingles, difficulty sleeping and cutaneous hypersensitivity to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced a rash that was small red raised area that began on his back moved to his lower back then to chest were and at the time of reporting, large whelps and had spread to his arms, legs and ankles.  The patient states it was very itchy and when he did scratch it flared to blisters that had the appearance of Shingles.  The patient had not been told by his primary or his dermatologist that he had shingles.  The patient noted he could not sleep at night due to the itching and his life had become consumed with trying to find a cure for this as it had been going on for 4 months at the time of reporting.  The patient saw his primary physician on 11th February 2020 for itching. He was given a topical steroid, after 1 week it had not resolved. He then saw his Dermatologist on 21st January 2020 for the rash and itching. He was tried on a regimen of topical steriods, oral prednisone helped but was short lived. He was then given a prednisone injection on 06th May 2020 but noted no results with that. He had found one cream that helped, Cerave, and he noted that helped more in the beginning than it did at the time of reporting.  He believed the rash was worsening.  The patient also noted a biopsy was done by the Dermatologist on 11th March 2020 and shown not to be psoriasis, or eczema, the stitches for the biopsy were removed at the visit done on 25th March 2020. He stated he was told by his primary at the first visit this was dermal hypersensitiviy syndrome. The reporter was consented to follow up.      Lab Comments: Biopsy was done by the Dermatologist on 11th March 2020 and shown not to be psoriasis, or eczema, the stitches for the biopsy were removed at the 25th March 2020 visit.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes virus infection
Clinical narrative: Herpes outbreak; Herpes outbreak condition aggravated; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date 6th February 2022) for prophylaxis.   The patient's past medical history included herpes virus infection (outbreak of Herpes on July 7 1998).   On 12th February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 10 days after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   The reporter considered the herpes virus infection to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The batch number was reported as JRM5J, however it was changed to J3M5J as per sales sheet. The patient provided the NDC number as 5816082901. The patient received Shingrix and had an outbreak of herpes which had not stopped to date. The reporter at the time of reporting need to take the herpes medication for life. On 22nd April 2020, the patient received 2nd dose batch number H4H34, expiry date 27th November 2021 and NDC5816082801. There was no relation between the vaccine and herpes. But the reporter would like to know if there was a relationship between herpes and the vaccine.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Genital herpes
Clinical narrative: Herpes outbreak; Herpes outbreak condition aggravated; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date 6th February 2022) for prophylaxis.   The patient's past medical history included herpes virus infection (outbreak of Herpes on July 7 1998).   On 12th February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 10 days after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   The reporter considered the herpes virus infection to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The batch number was reported as JRM5J, however it was changed to J3M5J as per sales sheet. The patient provided the NDC number as 5816082901. The patient received Shingrix and had an outbreak of herpes which had not stopped to date. The reporter at the time of reporting need to take the herpes medication for life. On 22nd April 2020, the patient received 2nd dose batch number H4H34, expiry date 27th November 2021 and NDC5816082801. There was no relation between the vaccine and herpes. But the reporter would like to know if there was a relationship between herpes and the vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Dizziness, Nausea
Clinical narrative: severe headache/headaches; nausea; dizziness; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced headache, nausea and dizziness. On an unknown date, the outcome of the headache, nausea and dizziness were unknown.   It was unknown if the reporter considered the headache, nausea and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced a severe headache.  The next morning and day, the patient experienced debilitating nausea, dizziness, and headaches.  The reporter asked could GlaxoSmithKline please tell what the data show regarding the likelihood of having severe side effects because of taking the second shot, if you experienced severe side effects after having the first shot.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: severe headache/headaches; nausea; dizziness; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced headache, nausea and dizziness. On an unknown date, the outcome of the headache, nausea and dizziness were unknown.   It was unknown if the reporter considered the headache, nausea and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced a severe headache.  The next morning and day, the patient experienced debilitating nausea, dizziness, and headaches.  The reporter asked could GlaxoSmithKline please tell what the data show regarding the likelihood of having severe side effects because of taking the second shot, if you experienced severe side effects after having the first shot.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Eyelid injury, Fall, Head injury, Loss of consciousness, Skin laceration
Clinical narrative: passed out, he was seeing black and passed out again; fell on the ground and hit the back of his head; hit the back of his head, and there was blood on the back of his head; looked pale; Initial information received on 28-May-2020 regarding an unsolicited valid serious case received from non-healthcare professional (office staff).  This case involves an 18 year old male patient who passed out and fell on the ground and hit the back of his head, there was blood on the back of his head, he was seeing black and looked pale and passed out again (loss of consciousness, fall, head injury and pallor), while he received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE VLP RL1 4V (YEAST) [GARDASIL].  The patient's past vaccination included Menactra on 07-Jan-2013. The patient's medical history and past medical treatment(s) were not provided. The patient's step mom was immunocompromised.  On 28-May-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6486AC and Exp. Date 10-Jan-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On 28-May-2020, the patient received a dose of suspect GARDASIL (not produced by Sanofi Pasteur lot number and Exp. Date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On 28-May-2020, 10 minutes after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and GARDASIL, the patient passed out and fell on the ground and hit the back of his head. As he was on the ground docter checked the vital signs and there was blood on the back of his head, he was sitting in the chair for about 10 minutes and was fine but started saying he was seeing black and looked pale (few minutes after vaccinations) and passed out again (loss of consciousness, fall, head injury and pallor). Event loss of consciousness was assessed as medically significant.  The patient visited emergency room of the hospital due to these events.  Details of laboratory data not reported.  Final diagnosis were loss of consciousness, fall, head injury and pallor.  Patient was applied ice, sterile bandages, emergency medical technician (EMT's) assessed him.  At the time of this report, the outcome was unknown for all the events.; Sender's Comments: This case involves an 18 years old male patient who experienced loss of consciousness, fall, head injury and pallor after vaccination with MENACTRA and GARDASIL. The time to onset was compatible. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of an individual vaccine cannot be assessed.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: passed out, he was seeing black and passed out again; fell on the ground and hit the back of his head; hit the back of his head, and there was blood on the back of his head; looked pale; Initial information received on 28-May-2020 regarding an unsolicited valid serious case received from non-healthcare professional (office staff).  This case involves an 18 year old male patient who passed out and fell on the ground and hit the back of his head, there was blood on the back of his head, he was seeing black and looked pale and passed out again (loss of consciousness, fall, head injury and pallor), while he received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE VLP RL1 4V (YEAST) [GARDASIL].  The patient's past vaccination included Menactra on 07-Jan-2013. The patient's medical history and past medical treatment(s) were not provided. The patient's step mom was immunocompromised.  On 28-May-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6486AC and Exp. Date 10-Jan-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On 28-May-2020, the patient received a dose of suspect GARDASIL (not produced by Sanofi Pasteur lot number and Exp. Date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On 28-May-2020, 10 minutes after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and GARDASIL, the patient passed out and fell on the ground and hit the back of his head. As he was on the ground docter checked the vital signs and there was blood on the back of his head, he was sitting in the chair for about 10 minutes and was fine but started saying he was seeing black and looked pale (few minutes after vaccinations) and passed out again (loss of consciousness, fall, head injury and pallor). Event loss of consciousness was assessed as medically significant.  The patient visited emergency room of the hospital due to these events.  Details of laboratory data not reported.  Final diagnosis were loss of consciousness, fall, head injury and pallor.  Patient was applied ice, sterile bandages, emergency medical technician (EMT's) assessed him.  At the time of this report, the outcome was unknown for all the events.; Sender's Comments: This case involves an 18 years old male patient who experienced loss of consciousness, fall, head injury and pallor after vaccination with MENACTRA and GARDASIL. The time to onset was compatible. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of an individual vaccine cannot be assessed.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Fall, Haemorrhage, Head injury, Loss of consciousness, Pallor
Clinical narrative: passed out, he was seeing black and passed out again; fell on the ground and hit the back of his head; hit the back of his head, and there was blood on the back of his head; looked pale; Initial information received on 28-May-2020 regarding an unsolicited valid serious case received from non-healthcare professional (office staff).  This case involves an 18 year old male patient who passed out and fell on the ground and hit the back of his head, there was blood on the back of his head, he was seeing black and looked pale and passed out again (loss of consciousness, fall, head injury and pallor), while he received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE VLP RL1 4V (YEAST) [GARDASIL].  The patient's past vaccination included Menactra on 07-Jan-2013. The patient's medical history and past medical treatment(s) were not provided. The patient's step mom was immunocompromised.  On 28-May-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6486AC and Exp. Date 10-Jan-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On 28-May-2020, the patient received a dose of suspect GARDASIL (not produced by Sanofi Pasteur lot number and Exp. Date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On 28-May-2020, 10 minutes after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and GARDASIL, the patient passed out and fell on the ground and hit the back of his head. As he was on the ground docter checked the vital signs and there was blood on the back of his head, he was sitting in the chair for about 10 minutes and was fine but started saying he was seeing black and looked pale (few minutes after vaccinations) and passed out again (loss of consciousness, fall, head injury and pallor). Event loss of consciousness was assessed as medically significant.  The patient visited emergency room of the hospital due to these events.  Details of laboratory data not reported.  Final diagnosis were loss of consciousness, fall, head injury and pallor.  Patient was applied ice, sterile bandages, emergency medical technician (EMT's) assessed him.  At the time of this report, the outcome was unknown for all the events.; Sender's Comments: This case involves an 18 years old male patient who experienced loss of consciousness, fall, head injury and pallor after vaccination with MENACTRA and GARDASIL. The time to onset was compatible. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of an individual vaccine cannot be assessed.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV4, MNQ
Symptoms: Skin laceration, Visual impairment
Clinical narrative: passed out, he was seeing black and passed out again; fell on the ground and hit the back of his head; hit the back of his head, and there was blood on the back of his head; looked pale; Initial information received on 28-May-2020 regarding an unsolicited valid serious case received from non-healthcare professional (office staff).  This case involves an 18 year old male patient who passed out and fell on the ground and hit the back of his head, there was blood on the back of his head, he was seeing black and looked pale and passed out again (loss of consciousness, fall, head injury and pallor), while he received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE VLP RL1 4V (YEAST) [GARDASIL].  The patient's past vaccination included Menactra on 07-Jan-2013. The patient's medical history and past medical treatment(s) were not provided. The patient's step mom was immunocompromised.  On 28-May-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6486AC and Exp. Date 10-Jan-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On 28-May-2020, the patient received a dose of suspect GARDASIL (not produced by Sanofi Pasteur lot number and Exp. Date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On 28-May-2020, 10 minutes after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and GARDASIL, the patient passed out and fell on the ground and hit the back of his head. As he was on the ground docter checked the vital signs and there was blood on the back of his head, he was sitting in the chair for about 10 minutes and was fine but started saying he was seeing black and looked pale (few minutes after vaccinations) and passed out again (loss of consciousness, fall, head injury and pallor). Event loss of consciousness was assessed as medically significant.  The patient visited emergency room of the hospital due to these events.  Details of laboratory data not reported.  Final diagnosis were loss of consciousness, fall, head injury and pallor.  Patient was applied ice, sterile bandages, emergency medical technician (EMT's) assessed him.  At the time of this report, the outcome was unknown for all the events.; Sender's Comments: This case involves an 18 years old male patient who experienced loss of consciousness, fall, head injury and pallor after vaccination with MENACTRA and GARDASIL. The time to onset was compatible. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of an individual vaccine cannot be assessed.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Extremely tired, headache, joints very bad aches ( more than my usual arthritis), slight sore throat, chills
Sex: U
Vaccine: DTAP
Symptoms: Chills, Dyspnoea, Hot flush, Hyperhidrosis, Injection site rash
Clinical narrative: Swelling the size of a golf ball, rash at injection site down to elbow, extreme pain, even when not touching moving arm, nausea, hot flashes, sweating, cold chills, difficulty taking deep breathe
Sex: U
Vaccine: DTAP
Symptoms: Nausea, Pain in extremity, Swelling
Clinical narrative: Swelling the size of a golf ball, rash at injection site down to elbow, extreme pain, even when not touching moving arm, nausea, hot flashes, sweating, cold chills, difficulty taking deep breathe
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Soreness at injection sight. High Fever the next day. Sever pain in joints the next day. Headache and nausea the next day.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions and drug reactions or allergies were not reported.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot number S035100, which was verified to be a valid one, expiration date reported and validated as 03-MAY-2021 (strength, dose, vaccination scheme, route of administration and anatomical location were not provided), as prophylaxis (product storage error); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine was exposed to a temperature between 6 degrees Farenheit (F) to 14  degrees F for 20 minutes and 15 degrees F to 46 degrees F - 38.8 degrees F for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event information provided.
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No symptoms reported; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse, referring to a neonate female patient. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On 13-AUG-2018, the patient was vaccinated with the first improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S004251 with expiration date: 22-SEP-2020; dose, strength and route of administration) for prophylaxis (product storage error and inappropriate age at vaccine administration). On 17-DEC-2018 and 08-FEB-2019, the patient had received the rest two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration, lot# and expiration date were not reported).No symptoms reported.  Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.; Sender's Comments:  US-009507513-1911USA004865: US-009507513-2005USA007561: US-009507513-2005USA007562:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: No symptoms reported; Inappropriate schedule of vaccine administered; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; This spontaneous report was received from a nurse, referring to a 11 weeks old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 25-SEP-2019, the patient was vaccinated with the first improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S004251 with expiration date: 22-SEP-2020; dose, strength and route of administration were unknown) for prophylaxis (product storage error). On 13-JAN-2020, the patient had received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration, lot# and expiration date were not reported) (inappropriate schedule of product administration). No symptoms reported.  Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.  This is 1 of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA007560: US-009507513-2005USA007561: US-009507513-1911USA004865:
Age: 36.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Drug ineffective for unapproved indication, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: The patient had an unknown HPV vaccination history/ patient did not remember which HPV vaccine she was administered; Indication: positive hpv 16/ The patient had two pap smears in 2019 which were positive for HPV 16 and 18/ the patient had a pap  smear a week ago which came back positive for HPV 16; The patient had a bunch of abnormal pap smears, positive for HPV, most were benign, since 2007 and reported the patient, kind of cleared the HPV infection; This spontaneous report was received from a medical assistant, concerning a 36-year-old female patient. The patient's concomitant medication included ethinyl estradiol (+) ferrous fumarate (+) norethindrone acetate (TILIA FE). The patient's drug reactions or allergies included nuts. The patient did not have any pertinent medical history.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) ( for positive human papilloma virus (HPV) 16 (strength, formulation, dose schedule, anatomical sites of injection, route of administration, lot number and expiration date were not reported). Furthermore, the patient reported that, she did not remember which HPV vaccination she had or how many doses she was administrated (product origin unknown).  On an unknown date in 2007, the patient experienced a bunch of abnormal pap smears, positive for HPV (papilloma viral infection). On an unknown date in 2019, the patient had two pap smears which were positive for HPV 16 and 18 (drug ineffective for unapproved indication). On approximately 19-MAY-2020, the patient had a pap smear which came back positive for HPV 16. According to the medical assistant, medical assistant reported the patient did not seek for medical attention and had not received any treatment;  however it was reported that, she may need a colonoscopy.  The outcome of papilloma viral infection was reported as not recovered. Despite this, it was reported that, the patient kind of cleared the HPV infection. The outcome of drug ineffective for unapproved indication was reported as not resolved.   The causality assessment between the suspect vaccines and all the aforementioned events was not reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: rash on his face and back; rash on his back; he also has a fever of 100.9 degrees Fahrenheit; This spontaneous report was received from a patient's grandmother and refers to a 12-month-old male child. He was born prematurely and was allergic to whole peaches. The patient had no concomitant medications or pertinent medical history.  On 19-MAY-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis (also reported as "12 month well-visit".   On 27-MAY-2020 around 12 pm, 9 days after the vaccination, the patient's mother noticed a rash on his face and back. The patient had also fever of 100.9 Fahrenheit degrees. There was no treatment given for the events. The patient did not seek medical attention. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered.        The causality assessment between the events and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: shingles; neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified gender and age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 02-JUL-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 zoster vaccine live (ZOSTAVAX), the patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, neuropathy was considered to be medically significant. The reporter considered both events to be disability.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: no additional adverse events; an adult patient was administered a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 27-MAY-2020, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # R001530 wit an expiration date on 07-NOV-2020, for prophylaxis. No additional adverse events were reported. . combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R001530; expirationdate: 07-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; First dose of GARDASIL 9 was administered in November 2019 and second dose of GARDASIL 9 was given in 03-JUN-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant therapies were not reported.  On an unknown day in November 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route of administration, lot number and expiration date were not reported) for prophylaxis. On 03-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route of administration was not reported, lot number R029515 and expiration date: 08-JUL-2021) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms reported. No additional information provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent