chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Mobility decreased, Peripheral swelling
Clinical narrative: redness of injection site, swelling of whole arm to finger, dizziness, not able to move , can not raise hand.  numbness of left hand
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling abnormal, Feeling cold, Hyperhidrosis, Nausea
Clinical narrative: Minutes after receiving the hpv vaccine, which came last in the series, patient broken into a profuse sweat with chills. He became dizzy, lightheaded, and very nauseous. The nurse had just left the room right before the symptoms started and we had been cleared to leave. Patient ended up vomiting into the garbage can. We stayed another 15-20 minutes after the injection because he felt too awful to leave the room.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Minutes after receiving the hpv vaccine, which came last in the series, patient broken into a profuse sweat with chills. He became dizzy, lightheaded, and very nauseous. The nurse had just left the room right before the symptoms started and we had been cleared to leave. Patient ended up vomiting into the garbage can. We stayed another 15-20 minutes after the injection because he felt too awful to leave the room.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered
Clinical narrative: Administered a vaccine to a child and did not notice until after I was done and putting the safety on that it was expired. We notified the patients mother and she was okay with it. We will re-administer another vaccine to the patient  at a later date. We are going to have a calendar with all vaccine expiration dates hanging up in the vaccine room to prevent from happening again.  Every time I log temperatures I will look at the calendar and look and see if any expired vaccines need to be removed.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient was erroneously given Dtap in place of Tdap.
Age: 21.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient answered "no" on could you be or possibly be pregnant questionnaire prior to receiving vaccines.  Patient contacted Immunizations department this afternoon after taking a home pregnancy test which tested positive.  Patient
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's mother reported localized swelling and erythema to injection site 7 days after immunization given. Older sister with similar reaction 2 days after same vaccination received. Per mother, older sister had history of reaction to DTaP as infant so had not given any more doses, this was patient's 1st dose of DTaP.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Shot was received and patient said now she has a rash around the area was the shot was administered. no significant swelling, itching. just a visible rash that has spread around the shoulder.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: ON 6/1/2020 at 3pm PST,My arm were shot was administered was sore. On 6/2/20, 4am PST, I started having a fever and body aches. These persistent for at least 14 hours. I took 1 Excedrin  Around 6am PST but fever persisted, and I had body aches. Took another Excedrin at 10am. Took my temp at noon, it was 101*F. Still had body aches. Took 1 Tylenol at 5pm, And 1.5 hours later,  fever reduced to 100*F, lesser body aches. It is 7:15pm PST, feel less feverish and achy. Arm at shot location still hurts.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Five minutes after receiving the vaccine, patient had to lean against the register counter of the store and close his eyes.  The pharmacist was called to examine the patient.  The patient had his eyes closed and he was breathing. 911 was called. The patient was asked if he had trouble breathing and he said no.  The patient was instructed to sit down but the patient refused.  The patient said "This is just how I am."  The patient and the patient's mother waived off any additional assistance and decided to leave.  The patient appeared normal and was speaking when he decided to leave.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Extreme pain in left arm.  Could not lift arm at all and it had throbbing pain.  Almost 3 weeks later still can?t lift my arm up without pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash vesicular
Clinical narrative: 5/29/2020 AM. Patient called office regarding eruptions on lower groin area with blisters like lesions, burning pain feeling. Patient had the 2nd shot of Shingrix, 5/28/2020 PM time. Rx was written for acyclovir 800 mg 1 tab 5 x per day & gabapentin 100mg tid. Primary doctor tried contacting pharmacy they stated being unable to get vaccine Lot Manufacture info.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: None stated.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, UrticariaPruritus & RASH
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Received Quadracel (R) thigh 5/28/20 - caregiver noted erythema + swelling in (R) thigh 5/28/20 evening 5/29/20 evening - patient with edema to right knee erythema, warmth, taught skin. Sent to ED by on call provider. Patient monitored in ED x 6 hours. Benadryl + Motrin temp max 100.4. Seen in clinic 5/30/20, 5/31/20, 6/2/20. Slow resolution of symptoms Edema to knee remains.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin tightness
Clinical narrative: Received Quadracel (R) thigh 5/28/20 - caregiver noted erythema + swelling in (R) thigh 5/28/20 evening 5/29/20 evening - patient with edema to right knee erythema, warmth, taught skin. Sent to ED by on call provider. Patient monitored in ED x 6 hours. Benadryl + Motrin temp max 100.4. Seen in clinic 5/30/20, 5/31/20, 6/2/20. Slow resolution of symptoms Edema to knee remains.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: 1) Severe joint pain in both knees  2) Severe swellness in Right knee
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Joint swelling, X-ray
Clinical narrative: 1) Severe joint pain in both knees  2) Severe swellness in Right knee
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea; Chills; Welt on arm; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 31st December 2021) for prophylaxis.   On 24th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 25th May 2020, 1 days after receiving Shingrix, the patient experienced fatigue, headache, nausea, chills and welts. On an unknown date, the outcome of the fatigue, headache, nausea, chills and welts were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, nausea, chills and welts to be related to Shingrix.  Additional information was provided as follows: The patient expereinced welt on her arm, chills, nausea, headache and fatigue. It was advised that side effects usually last 2 to 3 days but may last longer for some individuals. Suggested patient to follow up with her health care professional if symptoms continued or were bothersome. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Urticaria
Clinical narrative: Nausea; Chills; Welt on arm; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 31st December 2021) for prophylaxis.   On 24th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 25th May 2020, 1 days after receiving Shingrix, the patient experienced fatigue, headache, nausea, chills and welts. On an unknown date, the outcome of the fatigue, headache, nausea, chills and welts were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, nausea, chills and welts to be related to Shingrix.  Additional information was provided as follows: The patient expereinced welt on her arm, chills, nausea, headache and fatigue. It was advised that side effects usually last 2 to 3 days but may last longer for some individuals. Suggested patient to follow up with her health care professional if symptoms continued or were bothersome. The reporter consented to follow up.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; experienced a temperature excursion.; A medical assistant states that "on an unspecified date last week" a patient was administered MMRII (unknown lot/expiration) with STERILE DILUENT (lot S026378 expiration 05/15/2022) that experienced a temperature excursion.; This spontaneous report was received from a medical assistant, referring to a patient of an unknown gender and age.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On approximately an unknown day in May 2020 (also reported as "on an unspecified date las week") the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, vaccination scheme, anatomical site of vaccination,  lot number and expiration date were not reported) as prophylaxis, it was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, frequency, and route of administration were not reported; and lot # S026378 , which has been verified to be valid, expiration date reported and validated as 15-MAY-2020) that experience a temperature excursion (product storage error and product preparation issue), as record by a data logger, it was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored at proper storage range. Information about temperature excursion and time frame was not specified. No additional adverse effects were reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant medications were not provided. On or about 02-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported) at a pharmacy, as prescribed by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. Shortly after vaccination, she was diagnosed with herpes zoster caused by zoster vaccine live (ZOSTAVAX). As a result, the patient claimed damages of injury, loss of consortium, loss of services and economic losses. The outcome for herpes zoster was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: shingles; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 17-AUG-2017, he pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered a burning rash on the left side of the back and left buttocks and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the company's product. The pt also experience 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 of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).   The reporter considered herpes zoster to be a disabling event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; improperly sotred dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided.     On 29-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031702 with an expiration date on 06-APR-2021, for prophylaxis. Vaccine was improperly stored at a temperature of 32.7°F during a time frame of 4 hours. The call was because of a data logger and no previous temperature excursions neither additional adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; A medical assistant states that on 05/29/2020 an improperly stored dose of PROQUAD was administered to a patient.; Information has been received from a Medical Assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-MAY-2020, the unspecified patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S030093 with expiration date on 24-MAR-2021 as prophylaxis.  No additional adverse effects reported. It was confirm that a digital data logger was involved, also the temperature was reported as 32.7 degrees Fahrenheit (F) during a time frame of 4 hours without a temperature excursion.   This is one of two reports received from the same source.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia
Clinical narrative: Within a couple hours of receiving the vaccine I experienced tenderness at the site of the injection. As the day wore on, I also experienced widespread muscle and joint pain as well as a severe headache. Additionally, overnight, while trying to sleep, I experienced calf and foot muscle cramps about 8 times.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes simplex
Clinical narrative: herpes simplex keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 14-JAN-2017 , the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for  the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient was diagnosed with herpes simplex keratitis. The patient's symptoms resulted in physical limitations which were not present prior to using zoster vaccine live (ZOSTAVAX). It was also specified that 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 and physical impairment. The event herpes simplex keratitis was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.   Upon internal review,ophthalmic herpes simplex was considered to be medically significant. The event was considered to be disabling due to the severe, permanent and incurable injuries.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On 29-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant Human albumin)) (lot # S031702, expiration date 06-APR-2021; vaccine dosage detail and route of administration not reported) for prophylaxis (product storage error). Current temperature excursion was 32.7 Fahrenheit degrees for 4 hours. There was no previous temperature excursion. No additional adverse effects reported (no adverse event). No product quality complaint (PQC) was involved in this case. Data logger was involved.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness neurosensory, Deafness unilateral, Hypoacusis
Clinical narrative: On Jan 8 I received the first Shingrix vaccine and on Jan 15 I completely lost my hearing in my left ear.  Right ear seems fine.  I wasn't doing anything significant at the time, just usual work on pc in the morning.  I went to an ENT (Dr) on Jan 17.  He confirmed the hearing loss and prescribed Prednisone which I took in decreasing doses for 1 week.  The follow-up hearing test found a minor improvement in hearing but still very impaired.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Large swelling, erythema, and pain on right arm.  Led to follow up office visit
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored VARIVAX was administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 08-MAY-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/ merck) (VARIVAX), lot #S012036, expiration date: 17-APR-2021 (exact dose, strength, route of administration and anatomical location were not reported), for prophylaxis. The data logger registered a temperature excursion of 48.2 (unit not provided) for the time frame of 4 hours. There was no previous temperature excursion. No information about the diluent was provided. There were no adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; a 39 year old patient received a dose of PROQUAD; This spontaneous report as received from a nurse refers to a 39-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 27-MAY-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of ROTATEQ on 5/22/2020; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-MAY-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660704, expiration date 20-MAR-2021 (exact dose, dose number, dose site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes on an unknown date. There was no previous temperature excursion. Digital Data Logger was involved.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose of ROTATEQ on 5/19/2020; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies, or concomitant therapies was provided. On 19-MAY-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1660941, expiration date 12-FEB-2021 (strength and dose were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 12.1 Celsius degrees (C) for 16 hours and 11 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot # 1660704, expiration date 20-MAR-2021 (exact dose was not reported) for prophylaxis. The vaccine was stored in a temperature of 12.1 degrees Celsius for 16 hours and 11 minutes. There was no previous temperature excursion. The digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: A medical assistant states that an improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  recombinant Human albumin (rHA(PROQUAD) (strength, route, dose, frequency, and anatomical location were unknown) with lot # S031702 and expiration date for prophylaxis.         The administered dose of vaccine experienced the temperature excursion of 32.7 °F degrees Fahrenheit for 4 hours. There was a digital data logger invloved, but there was no previous temperature excursion. No additional adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: arm is in great pain well below the injection site; I am feeling very sick; feeling ber; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2020, the patient received the 2nd dose of Shingrix. On 21st May 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, malaise and feeling abnormal. On an unknown date, the outcome of the pain in arm, malaise and feeling abnormal were unknown.   It was unknown if the reporter considered the pain in arm, malaise and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was fine after first dose of Shingrix. On 21st May 2020, the patient received 2nd dose of Shingrix and felt very sick and arm in great pain well below the injection site. The patient asked is this a normal reaction. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. After receiving the Shingles vaccine, the patient experienced all side effects and they were nasty. The reporter reported that why was the Shingles vaccine not given by sex and weight as her husband had no side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm stll hurts; This case was reported by a pharmacist via patient support programs and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. 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 not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient's arm was still hurting after receveing vaccine. The reporter consented to follow up. This case had been linked to US2020AMR090636, reported by same reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: loss of skin pigmentation at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site discoloration in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included estrogen nos (Oestrogens) and progesterone.   On 17th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The patient had no known drug allergies. On an unknown date between 17th May 2020 to 19th May 2020, the patient developed a loss of pigmentation about the size of a quarter at the injection site. At the time of this report the event was reported not recovered. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pruritus, Rash, Scratch
Clinical narrative: the area itches; scratches; severe pain down her back; severe case of shingles; rash larger than the palm of her hand; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2022) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th November 2019, less than a day after receiving Shingrix, the patient experienced shingles. On 18th November 2019, the patient experienced back pain and rash. On an unknown date, the patient experienced pruritus and scratch. The patient was treated with CORTISONE (NON-PROPRIETARY) (CORTISONE CREAM). On an unknown date, the outcome of the shingles and scratch were unknown and the outcome of the back pain and pruritus were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles, back pain, rash, pruritus and scratch to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed severe pain down her back, on the side she received the injection. She also had a rash larger than the palm of her hand in the area where she had pain. She saw her health care professional and was told to put cortisone cream on the rash, but it did not do anything.  The pain was at level 10 for 2-3 weeks, and it has continued, though less severe since. The rash finally resolved about 1 month ago. The pain was always preset at level 3-4. Sometimes the area itches and if she scratches it the pain would flare up more severely. The reporter told if her clothes rub on the area the pain also flares up.  The reporter stated that this has been a severe case of shingles. The reporter consented to follow up. Emergency room visit required.
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concurrent medical conditions included alcohol allergy (allergic to alcohol ).   On an unknown date, the patient received Boostrix at an unknown dose and Twinrix at an unknown dose. On an unknown date, unknown after receiving Boostrix and Twinrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Boostrix and Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was allergic to alcohol. On the same day the patient received Boostrix and Twinrix and experienced an adverse reaction, did not know exactly the nature of the reaction. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: pain and swelling at the injection site/ swelling in the arm; pain and swelling at the injection site/ pain in the arm; fever; CHILLS; DIZZY; FATIGUE; HOT; increased heart rate; NAUSEA; Sweating; burning up; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation. On an unknown date, the outcome of the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation to be related to Shingrix.  Additional information was provided as follows: The reporter was the wife of the patient. The patient had vaccine in an unknown arm. The first symptoms that presented on the day of the vaccine in the early evening was pain and swelling at the injection site. The patient woke up in the middle of the night with all the other symptoms.  The patient had hot symptom and was described as he was burning up and sweating. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Hyperhidrosis, Injection site pain, Injection site swelling, Nausea
Clinical narrative: pain and swelling at the injection site/ swelling in the arm; pain and swelling at the injection site/ pain in the arm; fever; CHILLS; DIZZY; FATIGUE; HOT; increased heart rate; NAUSEA; Sweating; burning up; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation. On an unknown date, the outcome of the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation to be related to Shingrix.  Additional information was provided as follows: The reporter was the wife of the patient. The patient had vaccine in an unknown arm. The first symptoms that presented on the day of the vaccine in the early evening was pain and swelling at the injection site. The patient woke up in the middle of the night with all the other symptoms.  The patient had hot symptom and was described as he was burning up and sweating. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pain and swelling at the injection site/ swelling in the arm; pain and swelling at the injection site/ pain in the arm; fever; CHILLS; DIZZY; FATIGUE; HOT; increased heart rate; NAUSEA; Sweating; burning up; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation. On an unknown date, the outcome of the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation to be related to Shingrix.  Additional information was provided as follows: The reporter was the wife of the patient. The patient had vaccine in an unknown arm. The first symptoms that presented on the day of the vaccine in the early evening was pain and swelling at the injection site. The patient woke up in the middle of the night with all the other symptoms.  The patient had hot symptom and was described as he was burning up and sweating. The reporter consented to follow up.
Age: 14.0
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a dose of Ipol was given to a patient that had expired/no AE; Initial information received on 28-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old male patient who on 27-May-2020, received an expired 0.5 mL second single dose of vaccine IPV (VERO) [IPOL] (lot P1A371m and expiry date 27-Apr-2020) via intramuscular route in the right deltoid for prophylactic vaccination (expired vaccine administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and HPV VACCINE (HPV VACCINE).  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse effects had been observed.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Injection site cellulitis
Clinical narrative: Patient states  later in the evening, she had experience generalized weakness and dizziness.  The dizziness got worse as the evening progressed.  She had bodyaches, decreased appetite and felt nauseated due to the headache.  She also had cellulitis on her right upper arm when the vaccine was administered.  Patient returned to office on 6/2/2020 and was treated for the cellulitis of right upper arm.  Patient contacted on today, 6/3/2020, states that symptoms are improving.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nausea, Pain
Clinical narrative: Patient states  later in the evening, she had experience generalized weakness and dizziness.  The dizziness got worse as the evening progressed.  She had bodyaches, decreased appetite and felt nauseated due to the headache.  She also had cellulitis on her right upper arm when the vaccine was administered.  Patient returned to office on 6/2/2020 and was treated for the cellulitis of right upper arm.  Patient contacted on today, 6/3/2020, states that symptoms are improving.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported swelling and redness at the injection site on second day after receiving the vaccine . She claimed that the second series side effects are way more intense than the first series she received couple months before. Pharmacist on duty consulted that these are known side effects, however the severity of the side effects i(redness and swelling of the injection site) was about the tennis ball size, thus pharmacist recommended her on taking OTC Tylenol for pain and OTC Benadryl for redness and swelling. Pharmacist followed up after 3 days of recommendation and she reported that symptoms were lessened after couple days of taking those OTC drugs.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site bruising
Clinical narrative: Pt grandmother called to inform us that patient had some bruising at the injection site and some red spots..the red spots then traveled to the stomach area and Dr. advised for pt to take some benadryl and use topical hydrocortisone cream.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pain around injection site followed by rash and swelling and redness beginning 24-48 hours later.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Chills, shivering, headache, injection site soreness, fever (102.4),  GI upset, muscle soreness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, shivering, headache, injection site soreness, fever (102.4),  GI upset, muscle soreness
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal, Blood urea nitrogen/creatinine ratio, Blood urea normal
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: C-reactive protein normal, Coordination abnormal, Dizziness postural, Eosinophil count normal, Eosinophil percentage increased
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Free thyroxine index normal, Gait disturbance, Globulin, Glomerular filtration rate normal, Haematocrit normal
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Haemoglobin normal, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Mean cell volume normal, Mean platelet volume increased, Monocyte count normal, Muscular weakness, Neutrophil count normal
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Neutrophil percentage decreased, Platelet count normal, Protein total normal, Red cell distribution width normal, Tandem gait test abnormal
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Thyroxine, Thyroxine normal, Tri-iodothyronine uptake, Vitamin B12 normal
Clinical narrative: 1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Influenza, Injection site pain, Myalgia
Clinical narrative: 10 hours post injection: severe headache, muscle aches, severe nausea,  (hit by a truck or bad flu symptoms), tiredness and injection site pain. Took Advil at 24 hour mark. Still feel awful. The materials given by the pharmacy did not mention whether Tylenol or Advil would help with the symptoms. Neither does the vaccine's website. For patients getting vaccinations at pharmacies, we need more info on treatments to try in the middle of the night when nothing is open! I was wary of using Advil as it often irritates my stomach.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: 10 hours post injection: severe headache, muscle aches, severe nausea,  (hit by a truck or bad flu symptoms), tiredness and injection site pain. Took Advil at 24 hour mark. Still feel awful. The materials given by the pharmacy did not mention whether Tylenol or Advil would help with the symptoms. Neither does the vaccine's website. For patients getting vaccinations at pharmacies, we need more info on treatments to try in the middle of the night when nothing is open! I was wary of using Advil as it often irritates my stomach.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Nausea, Pain
Clinical narrative: 10 hours post injection: severe headache, muscle aches, severe nausea,  (hit by a truck or bad flu symptoms), tiredness and injection site pain. Took Advil at 24 hour mark. Still feel awful. The materials given by the pharmacy did not mention whether Tylenol or Advil would help with the symptoms. Neither does the vaccine's website. For patients getting vaccinations at pharmacies, we need more info on treatments to try in the middle of the night when nothing is open! I was wary of using Advil as it often irritates my stomach.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: 10 hours post injection: severe headache, muscle aches, severe nausea,  (hit by a truck or bad flu symptoms), tiredness and injection site pain. Took Advil at 24 hour mark. Still feel awful. The materials given by the pharmacy did not mention whether Tylenol or Advil would help with the symptoms. Neither does the vaccine's website. For patients getting vaccinations at pharmacies, we need more info on treatments to try in the middle of the night when nothing is open! I was wary of using Advil as it often irritates my stomach.