chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Skin exfoliation, Skin warm
Clinical narrative: I did not feel well the morning following the injection.  I attributed it as a mild side effect and went to work on 9-6.  Early in the afternoon I began experiencing severe chills and by 5:00 pm I was on the couch.  My arm was sore and had a large red lump.  I checked my temperature at approximately 9:30 pm and had a fever of 102.4.  I treated the fever with ibuprofen and it persisted throughout the night.  My temperature came down to around 99 by 8:00 am on 9-7.  I phoned the clinic and advised medical staff of the problem.  I was told to use ice on the injection site and continue with ibuprofen if needed.  The redness and swelling in my arm continued to increase and remained hot to the touch. By the morning of 9-8 redness began developing in a secondary area of my left arm approximately 4" below the injection site.  The initial spot was approximately the size of a quarter and continued to spread throughout the day.  Both areas remained red, sore and hot to the touch.  I continued applying ice to the arm as instructed.  On the morning of 9-9, I awoke to find the secondary area had grown in size to be approximately 4" wide and 2 1/2" to 3" tall.  The areas were still very red, sore and hot to the touch.  I phoned the clinic once again to advise the medical providers of the change in the condition and was told I should be seen.  I visited the clinic that morning and was seen by two providers.  I was told that this was merely an injection site reaction and that it was "normal".  I was told to take antihistamines and continue icing.  An appointment was made for 9-13 if needed.  The pain in these areas did not subside and remained hot to the touch throughout 9-11.  The initial injection site was less red on 9-12 and I cancelled the appointment with the clinic.  The secondary site has been slow to recover with the lump and redness persisting through 9-23.  The skin then became flaky and discolored and there is an indentation approximately 1" high and 4" wide across my bicep with a lump directly below.  It appears there has been some type of tissue damage in this area and I do have continued pain and discomfort at this secondary site on my left arm.  I do not believe proper protocol was utilized in the administration of this vaccine.  The person administering the vaccine brought an uncovered syringe into the room, set it on the counter to look for a band aid, and stuck the opened band aid on her finger.  She was not wearing gloves and did not swab the injection site.  My deltoid was pinched tightly and the vaccine administered.  It was painful from the outset.  This was a stark contrast to the easy painless experience I had with the first vaccine two months prior.  I do not believe that large red hot areas encompassing most of the upper arm can be deemed a normal injection site reaction.  I was repeatedly told that the reaction was "better than having the shingles".  I disagree - I have had the shingles twice in the last four years and the fever and lingering pain in my arm has been worse.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: I received a flu shot, FLUZONE HD 20129-20 #0.5, NDC# 49281-0405-65, Mfg: SANOFI PASTEUR, on October 3, 2019, about 3:30 pm, I awoke at 4 am (on October 4th with chills, and a fever of 99.9', which is persisting. The pharmacy dispensing it.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pulmonary congestion, Syncope
Clinical narrative: Got Pneumovax 23 injection. 10 hours later experienced swelling and pain in my arm; nausea; fainting; and my lungs filled with fluid. Took Benadryl. Symptoms subsided over the next 2-4 hours except for the arm pain and swelling.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Electrocardiogram, Headache, Hyperhidrosis
Clinical narrative: On 9-26/2019 I received the first Shingrix 50mg vaccine at 8 am. Through the day I continued to feel light headed and migraine type headache, during the night I battled chills, sweating and headache. At 7:30 am on 9/27/2019 I went to Urgent Care could not sit up do to light headiness and nausea. They measured my BP 85/60 I was sent in ambulance to ER for EKG hydration and given ondansetron 4mg and prochlorperazine 5 mg intravenously and released 4 hours later. I still felt light headed slept the rest of the day. It took until 3pm 9-28-19 where I felt I was myself again.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersomnia, Migraine, Nausea
Clinical narrative: On 9-26/2019 I received the first Shingrix 50mg vaccine at 8 am. Through the day I continued to feel light headed and migraine type headache, during the night I battled chills, sweating and headache. At 7:30 am on 9/27/2019 I went to Urgent Care could not sit up do to light headiness and nausea. They measured my BP 85/60 I was sent in ambulance to ER for EKG hydration and given ondansetron 4mg and prochlorperazine 5 mg intravenously and released 4 hours later. I still felt light headed slept the rest of the day. It took until 3pm 9-28-19 where I felt I was myself again.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dry skin, Rash, Rash maculo-papular, Rash pruritic, Skin disorder
Clinical narrative: Telederm: The Patient has the following medical/social history Hyperlipidemia, Hypertension, osteoarthritis. Meds include atorvastatin,metoprolol,diclofenac gel, asa, omeprazole. This skin condition been present for 6 days- started 1 day after receiving pneumovax 23 vaccine. The rash has been treated with loratadine. The skin condition had the following response to treatment no change. HPI with Clinical question 65 yow with R flank, bilate LE macules-papules coalescing into patches both inner,outer thighs up R leg into flank. Is itchy and rough to touch. The patient does not have the following no HIV, no hepatitis. Will hold aspiring starting 9/21/19.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Bedridden, Chills
Clinical narrative: I am 70 years old female and had the SHINGRIX 50MCG/0.5ML SUSR 6-month booster. I had several side effects within 24hrs of the dose that left me bed-ridden for 36 hrs. They were flu like symptoms and included feeling tired/weak, headache, shivering, upset stomach, nausea, stomach pain, diarrhea. The symptoms passed by the 3rd day after the injection. I did NOT have these side effects with the first dose taken 6 months earlier.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: I am 70 years old female and had the SHINGRIX 50MCG/0.5ML SUSR 6-month booster. I had several side effects within 24hrs of the dose that left me bed-ridden for 36 hrs. They were flu like symptoms and included feeling tired/weak, headache, shivering, upset stomach, nausea, stomach pain, diarrhea. The symptoms passed by the 3rd day after the injection. I did NOT have these side effects with the first dose taken 6 months earlier.
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Watery diarrhea within 8 hours of administration of flu shots, lasting 2 hours persistently, aches, nausea, fatigue, malaise lasting 1 week
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Shingrix shingles vaccine caused hives that have lasted for weeks. Doctor gave me a shot and 2 prescriptions after OTC meds did not work. Three weeks after the second dose and I still have hives. Very painful. What should I do now to end this nightmare? I do not have any other medical issues nor am I on any meds other than eye drops for glaucoma.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received SHINGRIX vaccine on 10/2/19 and on 10/4/19 the injection site was extremely red, swollen, painful, and warm. He came into the pharmacy and was told to go to urgent care to be seen. He returned to the pharmacy later that day with a prescription for an antibiotic and a diagnosis of infection.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Lip discolouration
Clinical narrative: My 11 year old daughter got the HPV vaccine on 10/01/19 the next day she woke up with a dark spot on her upper lip. That won't go away, I read that HPV vaccine may cause "skin discoloration" but was rare. Well my daughter did get the "skin discoloration" on her upper lip. It looks really bad. How long does it stay & what can I do so that it goes away?
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Nurses please be on the alert as you give flu vaccine, today we had one that seemed to have a broken spot under the end piece where you have the screw hub meet the smooth syringe. When the nurse went to inject a spray came out sideways across the room. We are confident this was not the needle but rather something in the syringe. Please if you see anything further let me know. We have looked at the rest of the box with no indication of issue- so possibly it was when the nurse pushed down to twist the needle on it caused a slight crack?
Sex: U
Vaccine: FLUA3
Symptoms: Syringe issue
Clinical narrative: "I have another nurse in my office now that is telling me that when she went to put the needle on the syringe she heard a click. Because she had just read my email below she checked the integrity and did not find a leak but when she went to administer the med the med sprayed out of the syringe area. These are not novice nurses they have done these for years, and they are both surprised by these issues. I am looking at the syringe and I think they plastic leur lock device may be the culprit."
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cough, Injected limb mobility decreased, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Friday had shingles shot in L arm flu & pneumonia in R. I "think" my bad reaction was with pneumonia. When received shot pharmacist said my skin at injection site moved with little bumps. He'd never seen it before. Later pain made it difficult to sleep. (Expected) Took ibuprofen. Next day arm from elbow up was very red, swollen where I couldn't bend my arm. Very painful. I called to let pharmacy know. Fever up to 101. I took ibuprofen all day. Sunday eve was going to go to walk-in but they were closed. Talked with ER and considered going. Took photo of my arm. Monday fever was gone. Redness less. Stopped by Dr's Office so they would know about it. Saw staff. Called pharmacy again to update them. Tuesday arm better but needed to use my inhaler two times. Very very rarely need to use. Coughed a lot. Wednesday (today) breathing better but not normal. Some chest congestion. Throat scratchy, general malaise. Arm almost back to normal. Contacted pharmacy again and they suggested I contact you. I feel now I should have gone to see someone right away.
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Insomnia, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Friday had shingles shot in L arm flu & pneumonia in R. I "think" my bad reaction was with pneumonia. When received shot pharmacist said my skin at injection site moved with little bumps. He'd never seen it before. Later pain made it difficult to sleep. (Expected) Took ibuprofen. Next day arm from elbow up was very red, swollen where I couldn't bend my arm. Very painful. I called to let pharmacy know. Fever up to 101. I took ibuprofen all day. Sunday eve was going to go to walk-in but they were closed. Talked with ER and considered going. Took photo of my arm. Monday fever was gone. Redness less. Stopped by Dr's Office so they would know about it. Saw staff. Called pharmacy again to update them. Tuesday arm better but needed to use my inhaler two times. Very very rarely need to use. Coughed a lot. Wednesday (today) breathing better but not normal. Some chest congestion. Throat scratchy, general malaise. Arm almost back to normal. Contacted pharmacy again and they suggested I contact you. I feel now I should have gone to see someone right away.
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Respiratory tract congestion, Throat irritation
Clinical narrative: Friday had shingles shot in L arm flu & pneumonia in R. I "think" my bad reaction was with pneumonia. When received shot pharmacist said my skin at injection site moved with little bumps. He'd never seen it before. Later pain made it difficult to sleep. (Expected) Took ibuprofen. Next day arm from elbow up was very red, swollen where I couldn't bend my arm. Very painful. I called to let pharmacy know. Fever up to 101. I took ibuprofen all day. Sunday eve was going to go to walk-in but they were closed. Talked with ER and considered going. Took photo of my arm. Monday fever was gone. Redness less. Stopped by Dr's Office so they would know about it. Saw staff. Called pharmacy again to update them. Tuesday arm better but needed to use my inhaler two times. Very very rarely need to use. Coughed a lot. Wednesday (today) breathing better but not normal. Some chest congestion. Throat scratchy, general malaise. Arm almost back to normal. Contacted pharmacy again and they suggested I contact you. I feel now I should have gone to see someone right away.
Sex: U
Vaccine: FLUA3
Symptoms: Syringe issue
Clinical narrative: Today we had a flu vaccine that seemed to have a broken spot under the end piece where you have the screw hub meet the smooth syringe. When the nurse went to inject a spray came out sideways across the room. We are confident this was not the needle but rather something in the syringe. We have looked at the rest of the box with no indication of issue- so possibly it was when the nurse pushed down to twist the needle on it cause a slight crack?
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Swelling
Clinical narrative: pt complained of swelling and pain of the underside of the arm where the vaccine was given and went to urgent care.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Vomiting
Clinical narrative: 14AUG2019: Receive & shot 11:30AM. 1600PM without warming severe direah began for 3 hours. 1700 without warning, 2-3 stomach contractions causing vomiting. I was very weak. Could not arise from floor. Direah ceased. recovery slow but complete.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site pruritus, Skin warm, Swelling
Clinical narrative: Localizing swelling, redness Approx. area 3.5 inches width x 2.25 length. Warm to touch. Pt. reported itching & scratching @ site. Tx with ice, Keflex 250mg/ml PO 10ml x 10 days + Hydroxyzine 5ml PO PRN 10 mg/ml
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Immediately after injection site red & itchy increased warmth today to Lt deltoid. reddened 5"x7" area of redness Lt deltoid muscle pain with movement of arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Immediately after injection site red & itchy increased warmth today to Lt deltoid. reddened 5"x7" area of redness Lt deltoid muscle pain with movement of arm.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Had the shot ~ 10am, ran errands, had lunch, came home got severe vertigo. Called 911. They came out & checked her vitals, which was normal. No hospital needed. She took a meclizine and felt better.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: (R) upper arm: 5 in x 2.5 in red warm area
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Head discomfort, Headache, Pain, Pyrexia
Clinical narrative: Moderate to severe body aches Low grade fever Headache and head pressure near spine Approximately 3 hours after receiving vaccine
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chills, Dizziness
Clinical narrative: I was given a pneumonia and flu shot one in each arm.  After about 20 minutes my throat got a little hoarse and I had a slight head ache which has happened before.  Later that early evening I was extremely chilled with my feet and arms going numb.  I started feeling "sick" all over with aches in my joints and muscles.  I went to be early then woke up a few hours later with discomfort in my chest and very dizzy.  I rushed to the bathroom with violent retching.  I started to feel a little better after that.  I was weak and achy for the next day then slowly got better.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Dysphonia, Headache, Hypoaesthesia, Malaise, Myalgia
Clinical narrative: I was given a pneumonia and flu shot one in each arm.  After about 20 minutes my throat got a little hoarse and I had a slight head ache which has happened before.  Later that early evening I was extremely chilled with my feet and arms going numb.  I started feeling "sick" all over with aches in my joints and muscles.  I went to be early then woke up a few hours later with discomfort in my chest and very dizzy.  I rushed to the bathroom with violent retching.  I started to feel a little better after that.  I was weak and achy for the next day then slowly got better.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Retching
Clinical narrative: I was given a pneumonia and flu shot one in each arm.  After about 20 minutes my throat got a little hoarse and I had a slight head ache which has happened before.  Later that early evening I was extremely chilled with my feet and arms going numb.  I started feeling "sick" all over with aches in my joints and muscles.  I went to be early then woke up a few hours later with discomfort in my chest and very dizzy.  I rushed to the bathroom with violent retching.  I started to feel a little better after that.  I was weak and achy for the next day then slowly got better.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: There have been no reported adverse side effects at this time.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; Patient received unspecified dose of ROTATEQ on 9/5/2019 after temperature excursion on 8/30/2019.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported.  On 05-SEP-2019, the patient received an unspecified dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R026541, expiration date: 11-JUL-2020, orally for prophylaxis after temperature excursion on 30-AUG-2019. The vaccine was exposed to the temperature of 34.1 degrees Fahrenheit (F) for 20 minutes and 47.6 F for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; patient inadvertently received an expired dose of properly stored pneumovax 23; This spontaneous report as received from a medical assistant refers to a 69-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-SEP-2019, the patient was inadvertently vaccinated with an expired, properly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # N024384, expiration date 18-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: that was delivered late and deemed not viable by the wholsaler; no adverse effect reported; patient was inadvertently administered, was delivered late and deemed not viable; This spontaneous report has been received from a Medical Assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported.  On 20-SEP-2019, the patient was inadvertently administered a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), valid lot number S006159, expiration date 10-NOV-2020 (also reported as 10-NOV-2010, conflicting information), orally as prophylaxis (strength, anatomical location and dose  were not provided) That was delivered late and deemed not viable (product distribution issue) by the wholesaler (poor quality product administered). No adverse effect reported.  Information about the product temperature, time frame, use of data logger and previous temperature excursion was not provided.  The outcome of product distribution issue was unknown.  The causality assessment between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and product distribution issue was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; A patient received improperly stored dose of ROTATEQ; This spontaneous report was received from the Office Manager referring to an unspecifed patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 21-SEP-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (Strength, dose, frequency, and anatomical location were unknown) with lot # S005874 and expiration date 31-OCT-2020 for prophylaxis  The administered dose of vaccine experienced the temperature (48°F) degrees Fahrenheit  total time and highest temperature above 47°F/9°C for 24 minutes. There was a digital data logger involved. No previous temperature excursion or adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: on multiple unspecified dates, multiple unspecified patients may have been administered improperly stored GARDASIL 9; No adverse effects reported; This spontaneous report was received from a pharmacy technician referring multiple unspecified patients of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On multiple unspecified dates, multiple unspecified patients may have been administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (product storage error). No adverse effects were reported. The vaccine underwent temperature 50 Fahrenheit, highest temperature above 47 degrees Fahrenheit/9 degrees Celsius for a duration of 21 days. There was no previous temperature excursion and data logger.   This is a non-valid case due to lack of patient identifier.
Age: 4.0
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: The patient received doses of VARIVAX, MMR, and TDaP, and has since developed a rash described as red spots near the vaccination site.; This spontaneous report was received from a pharmacist, who is also the patient's mother, referring to a 4-year-old male patient. The patient's pertinent medical history, concomitant medications, previous drugs reactions and allergies were reported as none.  On 20-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); both vaccines were administered subcutaneously. Also on the same day, the patient was vaccinated with diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (manufacturer unknown) (route of administration was not reported). All therapies were administered as vaccination (strengths, dose numbers, doses, and anatomical locations of vaccination were not reported; lot number, and expiration dates were unknown by the reporter).  On 26-SEP-2019, the patient experienced a  rash described as red spots near the vaccination site (vaccination site rash). The treatment given to the patient due to the event was ibuprofen (unspecified dose and frequency). Laboratory diagnostic or studies were not performed to the patient. It was reported that the patient did not sought medical attention.  At the time of this report, the outcome of the event vaccination site rash was reported as not recovered.  The causality assessment between the suspect therapies and the aforementioned event was not reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a 55-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-OCT-2017, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis in the clinic. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 22-OCT-2017, she was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions she required and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that she would in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome of the event was not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of shingles was considered to be disabling by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; This spontaneous report was received from a pharmacist and concerns to a 66 year old female patient. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included: influenza virus whole virion 3v vaccine inactivated (FLUZONE (INFLUENZA VIRUS WHOLE VIRION 3V VACCINE INACTIVATED)).     On 13-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscular, lot # R012976 and expiration date 25-JAN-2020, for prophylaxis (dosage schedule, and anatomical location were not reported).      On 14-SEP-2019 (reported as within 24 hours), the patient developed a red (erythema), sore (pain in extremity), swollen rash (rash and peripheral swelling) from her elbow up to the injection site on her arm. The patient received treatment with diphenhydramine hydrochloride (BENADRYL). No laboratories were performed. The patient sought for medical attention with the pharmacist.   The outcome of pain in extremity, rash, peripheral swelling and erythema was reported as recovered/resolved.   The causality between the aforementioned event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA002594: US-009507513-1910USA002818: US-009507513-1910USA002780:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to an 73-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 28-OCT-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) in the pharmacy for prevention of shingles. As a result of administration of zoster vaccine live (ZOSTAVAX), from an unknown date (reported as within three months after receiving the vaccine) she was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), and as a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions she required and/or would require more health care and services and did incur medical, health, she would in future be required to obtain further medical and/or hospital care, attention and services. The outcome of the event was reported as not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling by the reporter.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects reported; female patient received an extra dose of properly stored gardasil 9; This spontaneous report was received from a medical assistant refers to a 15 year old female patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On 02-OCT-2019, the patient was vaccinated with extra dose of properly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S008154  with expiry date 20-NOV-2021 (dose, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis (extra dose administered). No adverse effects reported (no adverse event). The outcome of the events was unknown.
Sex: F
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 female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 05-OCT-2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2015 (reported as shortly after the vaccination), the patient suffered a bad case of the shingles, a severe and permanent personal injury. As the result of 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. She also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of herpes zoster was not recovered/not resolved. The reporter considered herpes zoster to be disable and related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; patient was vaccinated with Recombivax on 10/3/2014and 7/30/2019, and the patient would like to receive a third dose now.; This spontaneous report was received from a medical assistant, referring to a 5 year old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, concurrent conditions, previous drug reactions or allergies were not reported.    On 03-OCT-2014, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (strength, dose, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported).  On 30-JUL-2019, the patient received the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (inappropriate schedule of product administration) (strength, dose, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported).  The reporter stated that the patient would like to receive the third dose now. No adverse symptoms or events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; An expired dose of VARIVAX was administered to a patient; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 04-OCT-2019, an expired dose (expired product administered) of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot number N026999, expiration date 28-SEP-2019 was administered to a patient for prophylaxis. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered with properly stored sterile diluent that was not expired. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Malaise
Clinical narrative: Felt very tired; Heavy in mind and body; This case was reported by a consumer and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included atorvastatin calcium (Lipitor).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness and feeling unwell. On an unknown date, the outcome of the tiredness and feeling unwell were unknown.   It was unknown if the reporter considered the tiredness and feeling unwell to be related to Shingrix.  Additional case details were provided as follows: Age at vaccination was not reported but it could be 71 years r 72 years. The patient stated, she was a normally healthy women who only takes lipitor 3 times per week and who was not overweight and does lots of exercise. The patient felt very tired and heavy in mind and body after receiving Shingrix. This case has been linked to US2019AMR176896, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Fatigue, Fear of falling, Gait inability, Nausea
Clinical narrative: Have no desire to eat; Terrible vertigo/ Just moving my head at all while laying down caused the room to spin/ Unable to bend over; Nausea; Vomited; Unable to walk without assistance from fear of falling; Unable to walk without assistance from fear of falling; Was tired that night; This case was reported by a consumer and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (and heavy in mind and body after receiving 1st dose, for tolerance refer case US2019AMR176889). Concomitant products included atorvastatin calcium (Lipitor).   On 25th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 26th September 2019, the patient experienced vertigo, nausea, vomiting, unable to walk and fear of falling. On 28th September 2019, the patient experienced decreased appetite. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite were unknown.   It was unknown if the reporter considered the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite to be related to Shingrix.  Additional case details were provided as follows: Age at vaccination was not reported but it could be 71 or 72 years. The patient stated, she was a normally healthy woman who only takes lipitor 3 times per week and who was not overweight and does lots of exercise. On 25th September 2019 at night, the patient was tired. On the next morning, 1 day after receiving a dose of Shingrix, she had terrible vertigo, nausea and vomited. She was unable to walk without assistance from fear of falling. The patient felt that her head was just moving at all while laying down caused the room to spin. The next day on 27th September 2019, the symptoms were still present but less severe and the patient did not vomit.  On the third day (the day of reporting), 3 days after receiving a dose of Shingrix, she was experiencing moments of vertigo and did not have the desire to eat. The patient was unable to bend over and periodically no matter what she was doing, vertigo and nausea momentarily overwhelm her.  The patient stated, while dizziness was listed as a possible side effect, her reaction seemed severe and she was hoping the vertigo would abate shortly. She did call the pharmacy and they suggested her to take benadryl. The patient wanted to alert GlaxoSmithKline to her seeming over-reaction and wanted to receive information on to what to expect as the days passes. She would like to know if vertigo would going to stop or not.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge, Vertigo, Vomiting
Clinical narrative: Have no desire to eat; Terrible vertigo/ Just moving my head at all while laying down caused the room to spin/ Unable to bend over; Nausea; Vomited; Unable to walk without assistance from fear of falling; Unable to walk without assistance from fear of falling; Was tired that night; This case was reported by a consumer and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (and heavy in mind and body after receiving 1st dose, for tolerance refer case US2019AMR176889). Concomitant products included atorvastatin calcium (Lipitor).   On 25th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 26th September 2019, the patient experienced vertigo, nausea, vomiting, unable to walk and fear of falling. On 28th September 2019, the patient experienced decreased appetite. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite were unknown.   It was unknown if the reporter considered the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite to be related to Shingrix.  Additional case details were provided as follows: Age at vaccination was not reported but it could be 71 or 72 years. The patient stated, she was a normally healthy woman who only takes lipitor 3 times per week and who was not overweight and does lots of exercise. On 25th September 2019 at night, the patient was tired. On the next morning, 1 day after receiving a dose of Shingrix, she had terrible vertigo, nausea and vomited. She was unable to walk without assistance from fear of falling. The patient felt that her head was just moving at all while laying down caused the room to spin. The next day on 27th September 2019, the symptoms were still present but less severe and the patient did not vomit.  On the third day (the day of reporting), 3 days after receiving a dose of Shingrix, she was experiencing moments of vertigo and did not have the desire to eat. The patient was unable to bend over and periodically no matter what she was doing, vertigo and nausea momentarily overwhelm her.  The patient stated, while dizziness was listed as a possible side effect, her reaction seemed severe and she was hoping the vertigo would abate shortly. She did call the pharmacy and they suggested her to take benadryl. The patient wanted to alert GlaxoSmithKline to her seeming over-reaction and wanted to receive information on to what to expect as the days passes. She would like to know if vertigo would going to stop or not.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cognitive disorder, Dizziness, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: Have no desire to eat; Terrible vertigo/ Just moving my head at all while laying down caused the room to spin/ Unable to bend over; Nausea; Vomited; Unable to walk without assistance from fear of falling; Unable to walk without assistance from fear of falling; Was tired that night; This case was reported by a consumer and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (and heavy in mind and body after receiving 1st dose, for tolerance refer case US2019AMR176889). Concomitant products included atorvastatin calcium (Lipitor).   On 25th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 26th September 2019, the patient experienced vertigo, nausea, vomiting, unable to walk and fear of falling. On 28th September 2019, the patient experienced decreased appetite. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite were unknown.   It was unknown if the reporter considered the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite to be related to Shingrix.  Additional case details were provided as follows: Age at vaccination was not reported but it could be 71 or 72 years. The patient stated, she was a normally healthy woman who only takes lipitor 3 times per week and who was not overweight and does lots of exercise. On 25th September 2019 at night, the patient was tired. On the next morning, 1 day after receiving a dose of Shingrix, she had terrible vertigo, nausea and vomited. She was unable to walk without assistance from fear of falling. The patient felt that her head was just moving at all while laying down caused the room to spin. The next day on 27th September 2019, the symptoms were still present but less severe and the patient did not vomit.  On the third day (the day of reporting), 3 days after receiving a dose of Shingrix, she was experiencing moments of vertigo and did not have the desire to eat. The patient was unable to bend over and periodically no matter what she was doing, vertigo and nausea momentarily overwhelm her.  The patient stated, while dizziness was listed as a possible side effect, her reaction seemed severe and she was hoping the vertigo would abate shortly. She did call the pharmacy and they suggested her to take benadryl. The patient wanted to alert GlaxoSmithKline to her seeming over-reaction and wanted to receive information on to what to expect as the days passes. She would like to know if vertigo would going to stop or not.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza, Magnetic resonance imaging, Pain in extremity, Scan with contrast
Clinical narrative: Have no desire to eat; Terrible vertigo/ Just moving my head at all while laying down caused the room to spin/ Unable to bend over; Nausea; Vomited; Unable to walk without assistance from fear of falling; Unable to walk without assistance from fear of falling; Was tired that night; This case was reported by a consumer and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (and heavy in mind and body after receiving 1st dose, for tolerance refer case US2019AMR176889). Concomitant products included atorvastatin calcium (Lipitor).   On 25th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 26th September 2019, the patient experienced vertigo, nausea, vomiting, unable to walk and fear of falling. On 28th September 2019, the patient experienced decreased appetite. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite were unknown.   It was unknown if the reporter considered the tiredness, vertigo, nausea, vomiting, unable to walk, fear of falling and decreased appetite to be related to Shingrix.  Additional case details were provided as follows: Age at vaccination was not reported but it could be 71 or 72 years. The patient stated, she was a normally healthy woman who only takes lipitor 3 times per week and who was not overweight and does lots of exercise. On 25th September 2019 at night, the patient was tired. On the next morning, 1 day after receiving a dose of Shingrix, she had terrible vertigo, nausea and vomited. She was unable to walk without assistance from fear of falling. The patient felt that her head was just moving at all while laying down caused the room to spin. The next day on 27th September 2019, the symptoms were still present but less severe and the patient did not vomit.  On the third day (the day of reporting), 3 days after receiving a dose of Shingrix, she was experiencing moments of vertigo and did not have the desire to eat. The patient was unable to bend over and periodically no matter what she was doing, vertigo and nausea momentarily overwhelm her.  The patient stated, while dizziness was listed as a possible side effect, her reaction seemed severe and she was hoping the vertigo would abate shortly. She did call the pharmacy and they suggested her to take benadryl. The patient wanted to alert GlaxoSmithKline to her seeming over-reaction and wanted to receive information on to what to expect as the days passes. She would like to know if vertigo would going to stop or not.