chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine of Menactra was given today, no AE; Initial information received on 20-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 year old female patient who received expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  No other vaccines were given the same visit.  On an unknown date, the patient received a dose of 0.5 mL (dosage interval: once) suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6208AD, expiry date: 08-Jul-2020] via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incomplete course of vaccination, Pain in extremity, Pyrexia
Clinical narrative: fever chills and aching in left arm.    The problem is I still have the same pain in my arm . It feels like someone punched me. this feeling bothers me very much. Because of this I am not getting the second dose.
Age: 25.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional adverse effects reported; first dose on an unspecified date in 2013; second dose on 05-MAR-2020; This spontaneous report has been received from a pharmacy technician regarding a 25-years-old of unknown gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On an unspecified date in 2013 (also reported as 7 years ago), 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) (dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. On 05-MAR-2020, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No additional adverse effects were reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site papule, Injection site pruritus, Injection site rash, Rash, Urticaria
Clinical narrative: Two days after vaccination rash developed.  Initially it was localized to the injection site.  The rash gradually spread down to the inner side of her arm (same arm as vaccine).  At the vaccine site she developed erythematous papules that were itchy.  On 7/9/20 pt called in to on-call provider in the evening that she had developed a rash on her opposite arm on the inner side abouve her elbow and it was spreading up towards her axilla and back.  No shortness of breath, difficulty swallowing or breathing.  She was advised by the on-call provider to take Benadryl every 6 hours, start hydrocortisone 1% cream, and continue with the Claritin she has already been taking.  She was instructed to go to the ED if any difficulty breathing.  Early AM of 7/18/20 patient went to local ED for rash that had spread to both arms, lower back, and groin.  Still no difficulty breathing or tongue swelling or throat swelling.  In the ED she was diagnosed with urticaria.  She was given a prescription for hydroxyzine, told to continue Claritin, and add Pepcid as an adjunct.  On 7/21/20 follow-up call was made to patient.  She reported that she was doing much better with the hydroxyzine, rash had resolved, and no more itching.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema
Clinical narrative: Two days after vaccination rash developed.  Initially it was localized to the injection site.  The rash gradually spread down to the inner side of her arm (same arm as vaccine).  At the vaccine site she developed erythematous papules that were itchy.  On 7/9/20 pt called in to on-call provider in the evening that she had developed a rash on her opposite arm on the inner side abouve her elbow and it was spreading up towards her axilla and back.  No shortness of breath, difficulty swallowing or breathing.  She was advised by the on-call provider to take Benadryl every 6 hours, start hydrocortisone 1% cream, and continue with the Claritin she has already been taking.  She was instructed to go to the ED if any difficulty breathing.  Early AM of 7/18/20 patient went to local ED for rash that had spread to both arms, lower back, and groin.  Still no difficulty breathing or tongue swelling or throat swelling.  In the ED she was diagnosed with urticaria.  She was given a prescription for hydroxyzine, told to continue Claritin, and add Pepcid as an adjunct.  On 7/21/20 follow-up call was made to patient.  She reported that she was doing much better with the hydroxyzine, rash had resolved, and no more itching.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Patient stated that rash began approximately 2 hours after the administration of the vaccine. Patient went to the hospital where Prednisone and Diphenhydramine were administered. Patient stated that the rash cleared up. On 07/21/2020 at around bedtime, patient stated that the itching began again. Patient was seen in our office 07/22/2020 for ER f/u and was prescribed Prednisone, Epi-pen, and Cetirizine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approximately 5 hours after vaccine administration: chills, severe headache, fever, nausea.  Injection site painful, swollen, erythematous.  Systems lasted throughout the night and into morning.  Fever and chills resolved by 11:00 am.  Took several doses of ibuprofen through out the course of the fever.  Fever never exceeded 100.4 F.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Approximately 5 hours after vaccine administration: chills, severe headache, fever, nausea.  Injection site painful, swollen, erythematous.  Systems lasted throughout the night and into morning.  Fever and chills resolved by 11:00 am.  Took several doses of ibuprofen through out the course of the fever.  Fever never exceeded 100.4 F.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, MNQ, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: patient was administered Menactra instead of HIB.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: 8 hours after receiving vaccine, pt developed fever up to 101F x 2 weeks.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Oral herpes, Rash, Taste disorder, Throat tightness
Clinical narrative: Patient  developed a rash almost right away after administration. The Wednesday after the shot was given she developed throat tightness . The Saturday after the shot was administered she developed a fever blister on her mouth. Patient said she also experienced stomach upset and an altered sense of taste.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: The patient describes muscle weakness especially when she walks. She received the vaccine on 07/14/20 and noticed weakness the following day on 07/15/20. She notified me on 07/22/20 that she is still experiencing these symptoms and that it has gotten worse.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chills, Injection site bruising, Injection site induration, Vomiting
Clinical narrative: Induration around site: 24 hours after shot Bruising around site 48 hours after shot Vomiting and chills 48 hours after shot
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: Paresthesia in upper extremities
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects Administered Pediatric dose of Hepatitis B vs adult dose.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Blood culture negative, Blood lactic acid normal, Chills, Coronavirus test negative
Clinical narrative: body aches, back ache, numbness in extremities, tremors ,  chills, delusional,  rapid hear rate, rapid breathing and seizure like activity followed by a fever
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Delusion, Differential white blood cell count normal, Full blood count normal, Hypoaesthesia, Metabolic function test normal
Clinical narrative: body aches, back ache, numbness in extremities, tremors ,  chills, delusional,  rapid hear rate, rapid breathing and seizure like activity followed by a fever
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia, Respiratory rate increased, Seizure like phenomena, Tremor
Clinical narrative: body aches, back ache, numbness in extremities, tremors ,  chills, delusional,  rapid hear rate, rapid breathing and seizure like activity followed by a fever
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Grip strength decreased, Immediate post-injection reaction, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: I experienced a sharp shooting pain down my entire arm to my finger tips immediately following injection. Since then my range of motion is cut down to a third and my right arm has had severe pain. I get a tingling sensation in my fingertips and elbow, and this worsens when it is aggravated. My grip strength is also weakened.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: I experienced a sharp shooting pain down my entire arm to my finger tips immediately following injection. Since then my range of motion is cut down to a third and my right arm has had severe pain. I get a tingling sensation in my fingertips and elbow, and this worsens when it is aggravated. My grip strength is also weakened.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Anxiety, Dizziness, Dysarthria, Feeling jittery, Headache
Clinical narrative: Approximately 10minutes after leaving the doctor's office began feeling a headache that got progressively worse. Pt felt jitter/dizzy and had a little numbness to arms/legs. Pt reports numbness in the past is usually a symptom set off by his anxiety. Pt felt as if he couldn't speak and both pt and guardian could tell pt was slurring his words.  After almost 2 hours following the vaccine pt began to notice symptoms calming down.  All symptoms of dizziness, headache, slurred speech, and anxious feeling lasted about 15-20minutes.  Pt had also not eaten anything since about 10:30am and had not taken any medication.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia
Clinical narrative: Approximately 10minutes after leaving the doctor's office began feeling a headache that got progressively worse. Pt felt jitter/dizzy and had a little numbness to arms/legs. Pt reports numbness in the past is usually a symptom set off by his anxiety. Pt felt as if he couldn't speak and both pt and guardian could tell pt was slurring his words.  After almost 2 hours following the vaccine pt began to notice symptoms calming down.  All symptoms of dizziness, headache, slurred speech, and anxious feeling lasted about 15-20minutes.  Pt had also not eaten anything since about 10:30am and had not taken any medication.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Extreme fatigue, muscle aches, joint pain, headache, dizziness
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Blood glucose normal, Loss of consciousness, Neurological examination normal, Pallor
Clinical narrative: Father stated that ~ 15 min after vaccines were given pt stated that his stomach was hurting then leaned forward, vomited, and then leaned back in his chair, passed out and upper body and arms started shaking (per father, shaking forcefully - not tremors, but father also admits everything happened so fast and he was scared so he isn't sure how to describe the shaking; when asked if it was like a seizure, dad says he thinks so but says legs were not shaking). Father ran to grab patient and caught him before pt could fall, pt did not hit head. Father called for help. No nurses or doctors were present during the actual event and did not witness whether pt was trembling or had a seizure; patient had already regained consciousness by the time nurses and doctors arrived a few seconds later. Pt appeared pale but was awake, alert, oriented x 3 and had normal neuro exam.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Tremor, Vomiting
Clinical narrative: Father stated that ~ 15 min after vaccines were given pt stated that his stomach was hurting then leaned forward, vomited, and then leaned back in his chair, passed out and upper body and arms started shaking (per father, shaking forcefully - not tremors, but father also admits everything happened so fast and he was scared so he isn't sure how to describe the shaking; when asked if it was like a seizure, dad says he thinks so but says legs were not shaking). Father ran to grab patient and caught him before pt could fall, pt did not hit head. Father called for help. No nurses or doctors were present during the actual event and did not witness whether pt was trembling or had a seizure; patient had already regained consciousness by the time nurses and doctors arrived a few seconds later. Pt appeared pale but was awake, alert, oriented x 3 and had normal neuro exam.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain, Rash
Clinical narrative: Patient was given a 3rd Shingrix vaccination upon request. Discovered it was third dose while documenting the dose.  Patient has reported arm soreness at the site of injection and a minor rash on her cheeks that lasted less than one day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, visual, Peripheral swelling, Vaccination complication
Clinical narrative: Pt. called in to report an adverse reaction to her recent shingles vaccine. She stated the day after she rcd the injection, she noticed her arm swollen on the side she received the injection.  Then she believes she had hallucinations, seeing things out of the corner of her eye.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Patient reports experiencing fever and chills following the vaccination for which he took Tylenol. The fever only lasted 2-3 hours. Patient also reports rash on his injection arm. It started the following morning after vaccination and it began getting larger. Patient will seek doctor care if condition does not improve in 1 day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Decreased appetite, Hypersomnia, Pain
Clinical narrative: Approximately 15 hours after I got my shot, I woke up with uncontrollable shivering.  That lasted 2 1/2 hours.  I took my temperature and it was 102.7.   I drank water & took Advil and my temperature went down to 101.  My upper left arm is EXTREMELY painful.  I cannot lift my left arm above my head without a lot of pain.  My entire body is very achy.  I slept a lot today as well.  My temperature now - almost 36 hours later is 99.0 ( which is a bit high for me.  I usually am around 97.2).  Not much of an appetite either
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Approximately 15 hours after I got my shot, I woke up with uncontrollable shivering.  That lasted 2 1/2 hours.  I took my temperature and it was 102.7.   I drank water & took Advil and my temperature went down to 101.  My upper left arm is EXTREMELY painful.  I cannot lift my left arm above my head without a lot of pain.  My entire body is very achy.  I slept a lot today as well.  My temperature now - almost 36 hours later is 99.0 ( which is a bit high for me.  I usually am around 97.2).  Not much of an appetite either
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Nasal congestion, Pain
Clinical narrative: low-grade fever, body aches, fatigue, nasal congestion - could be my allergies, sore arm at injection site  I started feeling rough last night after I got the shot, and work up feeling really bad.  I had a similar reaction to the first dose but didn't know that I was supposed to report it. I learned this from the medical clinic Site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low-grade fever, body aches, fatigue, nasal congestion - could be my allergies, sore arm at injection site  I started feeling rough last night after I got the shot, and work up feeling really bad.  I had a similar reaction to the first dose but didn't know that I was supposed to report it. I learned this from the medical clinic Site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Oral herpes
Clinical narrative: She had 4 to 5 cold sores that lasted for weeks beginning 3 days after the shot. Her redness at the injection site lasted for 1 week and she was so weak and fatigued the next day she stayed on the couch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fall, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: Patient passed out in bathroom at 5am and hit the floor.  She was not injured in the fall.  Passed out for a minute or two.  Had a fever of 101.7, got very sweaty, headache and lethargy.  Could not communicate very well. Could not walk on her own.  It took about 3-4 hours before she started feeling a bit better.  Was not able to go to work.  She is still lethargic at 8pm but is overall better.  Still does not care to eat much but mostly is drinking beverages. She is a nurse and we did not go to a medical facility
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Lethargy, Loss of consciousness, Pyrexia, Speech disorder
Clinical narrative: Patient passed out in bathroom at 5am and hit the floor.  She was not injured in the fall.  Passed out for a minute or two.  Had a fever of 101.7, got very sweaty, headache and lethargy.  Could not communicate very well. Could not walk on her own.  It took about 3-4 hours before she started feeling a bit better.  Was not able to go to work.  She is still lethargic at 8pm but is overall better.  Still does not care to eat much but mostly is drinking beverages. She is a nurse and we did not go to a medical facility
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: An area 2- 3 inches square right below the injection site is slightly red, raised, and sensitive to touch, more than 48 hours after I had the injection. Hopefully it will be better tomorrow. I've been taking 2 Bayer aspirin at least twice a day. I understand from what I read on line that this is the most common "adverse reaction" so I'm more annoyed than alarmed. But I thought I'd report it since it is considered an adverse reaction, albeit nothing too acute.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HIBV, RV1
Symptoms: Diarrhoea haemorrhagic, Eczema, Emotional distress, Infantile spitting up, Pain
Clinical narrative: Eczema type rash, diarrhea with blood specks, excessive spitting up, fever (Max 101.0) x24 hours, inconsolable at times, pain, itching It all started the evening after the vaccines.  Tylenol given to reduce temperature and alleviate discomfort.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HIBV, RV1
Symptoms: Pruritus, Pyrexia
Clinical narrative: Eczema type rash, diarrhea with blood specks, excessive spitting up, fever (Max 101.0) x24 hours, inconsolable at times, pain, itching It all started the evening after the vaccines.  Tylenol given to reduce temperature and alleviate discomfort.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site cyst, Injection site haemorrhage, Injection site nodule, Injection site pain
Clinical narrative: AT TIME OF INJECTION INTO THE LEFT DELTOID: A DROP OF BLOOD CAME OUT WHICH WAS WIPED OFF WITH A COTTON BALL  THE INJECTIONS SITE ALMOST IMMEDIATELY SWELL UP LIKE THERE WAS A LITTLE OVER A QUARTER SIZE BALL UNDER HER SKIN (KIND OF LIKE A FATTY CYST LOOKS). I MASSAGED THE AREA AND IT WAS STILL THERE (NOT RED). I CALLED THEN HAD HER MD LOOK AT IT HE TOLD HER TO PUT AN ICE PACK ON IT & TAKE BENADRYL 50MG THAT IT WOULD GO AWAY. I CALLED TO TOUCH BASE TODAY SHE DIDNT TAKE THE BENADRYL BUT USED THE ICE AND THE KNOT WENT DOWN AFTER A FEW HOURS. TODAY IT IS SORE AND BRUISED...MAYBE A LITTLE SWOLLEN COULDNT TELL BY EYE (WAS GOING TO MEASURE BUT I SAID THAT WASNT NECESSARY). TOLD PT TO CALL BACK WITH ANY OTHER ISSUES
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: AT TIME OF INJECTION INTO THE LEFT DELTOID: A DROP OF BLOOD CAME OUT WHICH WAS WIPED OFF WITH A COTTON BALL  THE INJECTIONS SITE ALMOST IMMEDIATELY SWELL UP LIKE THERE WAS A LITTLE OVER A QUARTER SIZE BALL UNDER HER SKIN (KIND OF LIKE A FATTY CYST LOOKS). I MASSAGED THE AREA AND IT WAS STILL THERE (NOT RED). I CALLED THEN HAD HER MD LOOK AT IT HE TOLD HER TO PUT AN ICE PACK ON IT & TAKE BENADRYL 50MG THAT IT WOULD GO AWAY. I CALLED TO TOUCH BASE TODAY SHE DIDNT TAKE THE BENADRYL BUT USED THE ICE AND THE KNOT WENT DOWN AFTER A FEW HOURS. TODAY IT IS SORE AND BRUISED...MAYBE A LITTLE SWOLLEN COULDNT TELL BY EYE (WAS GOING TO MEASURE BUT I SAID THAT WASNT NECESSARY). TOLD PT TO CALL BACK WITH ANY OTHER ISSUES
Age: 78.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt started to Feel tired on 07/17/2020 in evening. Then inside of arm (right) From arm pit to elbow had swelling, redness, and hot to touch. He reported fever of 100 degrees and was controlled with aspirin. Swelling and edema started to reduce on Sunday. He said the reaction was completely resolved on Tuesday.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient developed Hives the evening they received the vaccine shot & despite taking Benadryl & Zyrtec are still exhibiting hives, Patient waiting to hear back from her PCP.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary mass, Axillary pain, Burning sensation, Discomfort, Dry mouth
Clinical narrative: Shingles; rash on her arm and flank/rash on flank; burning, painful lesions on right arm and flank; painful lesions on right arm and flank; painful skin lesion; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes zoster.   On 2nd July 2020, the patient received the 1st dose of Shingrix. On 4th July 2020, 2 days after receiving Shingrix, the patient experienced shingles, rash, burning sensation skin, flank pain and skin lesion. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the rash, burning sensation skin, flank pain and skin lesion were unknown.   It was unknown if the reporter considered the shingles, rash, burning sensation skin, flank pain and skin lesion to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and 2 days later she developed a rash on her arm and flank and the diagnosis given by the HCP was shingles.  The patient received the injection in the left arm, but that had burning, painful lesions on right arm and flank. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dry throat, Erythema, Rash
Clinical narrative: Shingles; rash on her arm and flank/rash on flank; burning, painful lesions on right arm and flank; painful lesions on right arm and flank; painful skin lesion; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes zoster.   On 2nd July 2020, the patient received the 1st dose of Shingrix. On 4th July 2020, 2 days after receiving Shingrix, the patient experienced shingles, rash, burning sensation skin, flank pain and skin lesion. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the rash, burning sensation skin, flank pain and skin lesion were unknown.   It was unknown if the reporter considered the shingles, rash, burning sensation skin, flank pain and skin lesion to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and 2 days later she developed a rash on her arm and flank and the diagnosis given by the HCP was shingles.  The patient received the injection in the left arm, but that had burning, painful lesions on right arm and flank. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Flank pain, Herpes zoster, Rash, Skin burning sensation, Skin lesion
Clinical narrative: Shingles; rash on her arm and flank/rash on flank; burning, painful lesions on right arm and flank; painful lesions on right arm and flank; painful skin lesion; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes zoster.   On 2nd July 2020, the patient received the 1st dose of Shingrix. On 4th July 2020, 2 days after receiving Shingrix, the patient experienced shingles, rash, burning sensation skin, flank pain and skin lesion. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the rash, burning sensation skin, flank pain and skin lesion were unknown.   It was unknown if the reporter considered the shingles, rash, burning sensation skin, flank pain and skin lesion to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and 2 days later she developed a rash on her arm and flank and the diagnosis given by the HCP was shingles.  The patient received the injection in the left arm, but that had burning, painful lesions on right arm and flank. The reporter did not consent to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Pain, Pain in extremity
Clinical narrative: Sore arm, aches and pains, cough, chills
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; An administered dose of Rotateq underwent a temperatue excursion prior to being administered to a patient; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided.  On 30-JUN-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) injection, lot # 1661009 has been verified to be valid, expiration date reported as 25-MAY-2021, but upon internal review was established as 25-APR-2021 for prophylaxis (strength, dose, frequency, route of administration were not reported). Administered dose of vaccine experienced the temperature excursion with 51 Fahrenheit (F) for 45 minutes. Data logger was involved. There was no previous excursion reported. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a physician's medical office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at care centers for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a physician, referring to a 3-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 30-JUN-2020, the patient was administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S012036, expiration date: 17-APR-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number S033779, expiration date: 16-JUN-2022; lot number S030249, expiration date: 02-JUN-2022 or lot number S036204, which has been verified to be valid, expiration date reported and validated as 03-JUL-2022). No additional adverse effects reported.  On an unknown date, the vaccine experienced a temperature excursion between 15 degrees Fahrenheit (F) to 46F (32.9F) for 5 hours, as recorded by a data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA005592: US-009507513-2007USA005952:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by an audiologist for hearing loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt Plaintiff had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; on 20-JUL-2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 20-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (lot number S028925 which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK).  The administered dose of the vaccine on 17-JUL-2020, was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (9.0 F), during a time frame of 1 hour, 15 F to 46 F (45.9 F), during a time frame of 10 hours and 30 minutes, and starting at 10:07 p.m. of -47 F to 77 F (77 F), during a time frame of 15 hours. On 18-JUL-2020, the vaccine was stored at a temperature starting at 2:52 p.m. of -78 F/26 degrees Celsius or warmer (79.5 F), during a time frame of 32 hours. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: little sore arm in arm of injection; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The received Shingrix vaccine had a little sore arm in arm of injection, but minimal problems. For tolerance after 2nd dose refer case US2020AMR135171.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135171:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Soreness to left arm; a raised, red, bumpy rash all over her body; Itchy rash on Left side of body under breast.; red rash all over her body; bumpy rash all over her body; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included hydrocortisone and tramadol.   On 10th July 2020, the patient received the 1st dose of Shingrix. On 11th July 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, raised rash, itchy rash, red rash and generalized rash. On an unknown date, the outcome of the pain in arm, raised rash, itchy rash, red rash and generalized rash were recovering/resolving.   It was unknown if the reporter considered the pain in arm, raised rash, itchy rash, red rash and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient received dose late that night, and on next day the patient had soreness to left arm, a raised, red, bumpy rash all over her body, and a very itchy rash under her left breast. The doctor told to the patient not to get the 2nd dose, but the patient wanted to know opinion about this. The reporter conented to follow up.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Patient received the vaccine but was not planning on it. Patient complained of fevers the following morning. Patient also had a Shingrix vaccine on the same day.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Administration site pain, Fatigue, Hypoaesthesia, Loss of consciousness, Paraesthesia
Clinical narrative: 2 hours after administration, patient was stretching arm, when arm went numb and tingly which then radiated to chest, other arm then head.  Patient then had tunnel visition, LOC and observer said she was convulsing for about 10 seconds.  Now patient fatigued.  Soreness at administration site.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Seizure, Tunnel vision
Clinical narrative: 2 hours after administration, patient was stretching arm, when arm went numb and tingly which then radiated to chest, other arm then head.  Patient then had tunnel visition, LOC and observer said she was convulsing for about 10 seconds.  Now patient fatigued.  Soreness at administration site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Both arms became "itchy" due to small subcutaneous bumps on forearms.   After the 2nd shot (6/30/20)  it became more pronounced.  Still itches and bumps are present today  -7/23/20.    Asked Dr. about it as a "side effect" or maybe some form of shingles - he said no.   The itching at times is intense.   It's not a normal rash or poison ivy.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Blister
Clinical narrative: 1 cm clear vesicle without erythema or warmth discovered the morning after the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; an outbreak of herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an outbreak of herpes zoster, and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care at the time of report. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events of an outbreak of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX). The events of an outbreak of herpes zoster and post herpetic neuralgia were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information regarding concomitant medication, historical condition or current condition was provided. In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose detail, route, batch/lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider (HCP) for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Blister, Injection site pruritus, Peripheral swelling, Pruritus
Clinical narrative: arm swelling and itching at the injection site; arm swelling; lower back itchy blisters; lower back itchy blisters; back discoloration; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site itching, swelling arm, blister, itchy skin and skin discoloration. The patient was treated with steroids nos (Steroids) and steroids nos (Steroids). On an unknown date, the outcome of the injection site itching and swelling arm were recovered/resolved and the outcome of the blister, itchy skin and skin discoloration were recovering/resolving.   It was unknown if the reporter considered the injection site itching, swelling arm, blister, itchy skin and skin discoloration to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced arm swelling and itching at the injection site that were gone after the second week. The patient also reported lower back itchy blisters that caused back discoloration.  The patient reported that her healthcare professional performed two skin biopsies with normal results.  The patient also reported that her healthcare professional prescribed her oral steroids and steroid cream. The reporter was consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: arm swelling and itching at the injection site; arm swelling; lower back itchy blisters; lower back itchy blisters; back discoloration; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site itching, swelling arm, blister, itchy skin and skin discoloration. The patient was treated with steroids nos (Steroids) and steroids nos (Steroids). On an unknown date, the outcome of the injection site itching and swelling arm were recovered/resolved and the outcome of the blister, itchy skin and skin discoloration were recovering/resolving.   It was unknown if the reporter considered the injection site itching, swelling arm, blister, itchy skin and skin discoloration to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced arm swelling and itching at the injection site that were gone after the second week. The patient also reported lower back itchy blisters that caused back discoloration.  The patient reported that her healthcare professional performed two skin biopsies with normal results.  The patient also reported that her healthcare professional prescribed her oral steroids and steroid cream. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: big red patch / red blown up arm; fever; feeling uncomfortable; swollen arm; This case was reported by a consumer via call center representative and described the occurrence of skin red in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin red, fever, discomfort and swelling arm. On an unknown date, the outcome of the skin red, fever, discomfort and swelling arm were recovered/resolved.   It was unknown if the reporter considered the skin red, fever, discomfort and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had dose 1 and 2 of Shingrix. The patient experienced a day or two of feeling uncomfortable, a red blown up arm, fever, and a big red patch. This was 1 of 2 linked cases, reported by same reporter. The reporter did not consent to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020133241:same reporter
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Extremely sore in shot shoulder 2 days finally starting to ease.  Fever of 102.6 at highest for 14 hours now it is normal and moderate to severe body soreness muscle soreness body shivering and moderate headache side effects are almost completely gone now
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Extremely sore in shot shoulder 2 days finally starting to ease.  Fever of 102.6 at highest for 14 hours now it is normal and moderate to severe body soreness muscle soreness body shivering and moderate headache side effects are almost completely gone now
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Full blood count, Headache, Metabolic function test
Clinical narrative: C/O dizziness, weakness, nausea, & headache. Symptoms started 7/8-7/13/2020.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Nausea
Clinical narrative: C/O dizziness, weakness, nausea, & headache. Symptoms started 7/8-7/13/2020.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Blood creatine, Blood creatine phosphokinase increased, Blood glucose normal, Blood thyroid stimulating hormone
Clinical narrative: Injection at 10:00 by 4:00 pm she was dizzy felt like she was going to pass out. At 4:30 she started to have uncontrollable muscle spasms that quickly spread to tics over her entire body below the neck. She complained of nausea, severe stomach pains, fatigue, and loss of appetite. Tics continued in her arms, legs, and abdomen several days.