chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: M
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine used; This spontaneous report was received from a registered nurse referring to a 19 month old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.  On 19-MAY-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S002460 (expiration date: 15-MAY-2020) for prophylaxis (no additional dosage regimen information was reported). No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S002460; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: No; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.  On 21-MAY-2017, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S020241 (expiration date: 23-AUG-2020) for prophylaxis (no additional dosage regimen information was provided). No adverse event was provided.  The vaccine was exposed to a temperature of 12 Celsius degrees for a timeframe of 16 hours and 11 minutes. It was found because of a digital data logger. There were no previous excursions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: No; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a nurse referring to a patient of unknown age. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not reported.  On 26-MAY-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S013890 with expiration date 14-FEB-2021, oral for prophylaxis. The vaccine was exposed to a temperature of 12.1 centigrade (C) during a time frame of 16 hours and 11 minutes, which was detected by a digital data logger. There were no previous temperature excursions.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, for prophylaxis (lot number 1660704 which has been verified to be valid, expiration date reported and validated as 20-MAR-2021) (dose and vaccination scheme frequency were not reported).   The administered dose of the vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes, as recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered an improperly stored dose of ROTATEQ on 5/26/20; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies was not provided.   On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S013890, expiration date: 14-FEB-2021 (strength, dosage schedule and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to a temperature of 12.1 degrees Celsius (C) for 16 hours and 11 minutes (as recorded by digital data logger). No previous excursion was noted. No additional adverse event information was provided.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose ofVAQTA; This spontaneous report was received from a Registered Nurse 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 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S032055 and expiration date 09-NOV-2020 for prophylaxis.    The administered dose of vaccine experienced the temperature excursion of 12.1 °C degrees Celsius for 16 hours 11 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a Registered Nurse 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 26-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S020241 and expiration date 23-AUG-2020 for prophylaxis.    The administered dose of vaccine experienced the temperature excursion of 12.1 °C degrees Celsius for 16 hours 11 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020241; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 26-MAY-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (therapy type: digital data logger) lot # 1660704 and expiration date reported as 20-MAR-2021 for prophylaxis (product storage error). The administered dose of the vaccine was stored at a temperature of 12.1 degree Celsius for 16 hours and 11 minutes as recorded by a data logger. The vaccine had no previous temperature excursion. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: celullitis at the injection site; the site of injection was big / size of a baseball, it was elevated; the site of injection was uncomfortable; injection site was red; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In October 2012, the patient received Boostrix. On an unknown date, less than a day after receiving Boostrix, the patient experienced injection site cellulitis, injection site swelling, injection site discomfort and injection site erythema. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site cellulitis, injection site swelling, injection site discomfort and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site swelling, injection site discomfort and injection site erythema to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix around October 2012 and noticed at the site of injection was uncomfortable and red.  She called her physician and her physician told her keep an eye on the event. The next day she saw her physician and the site of injection was big. It was the size of a baseball, it was elevated. The patient physician diagnosed her with cellulitis at the injection site.  The patient had antibiotics prescribed.  The physician drew with a pen around the reaction and told her to go immediately to the hospital if it grew but it did not. The reporter consented to follow up. Emergency room visit required. The patient did not had further information on the physician at the time of the call but she welcomed safety to call her back and she might be able to pull additional information from her files or provide more information on her physician's contact information. For tolernace of Flu vaccine, refer case US2020AMR087869.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported, however captured age group as Adult. The patient received 1st dose of Shingrix 7 months prior to this report and was very sick and due to this was unable to receive 2nd dose. The reporter consented for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 68-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 17-APR-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at the pharmacy, as prescribed by a healthcare provided for the long-term prevention of shingles and zoster-related conditions. As a result of zoster vaccine live (ZOSTAVAX), the patient suffered a painful blistering rash and was diagnosed with herpes zoster and post herpetic neuralgia. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Lethargy, Limb discomfort, Myalgia
Clinical narrative: Fatigue, lethargy, headache, minor muscle ache in various parts of body, heaviness and soreness in injected arm
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Fatigue, lethargy, headache, minor muscle ache in various parts of body, heaviness and soreness in injected arm
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Swollen tongue, Urticaria
Clinical narrative: Patient called and reported hives on skin beginning the day of the injection, followed by extreme arm soreness at injection site, and swelling of the tongue that developed the next day.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Cerumen removal, Headache, Hyperacusis, Pain in extremity
Clinical narrative: Mom called stating after they returned home, patient started having a headache and complaining that her   hands and feet hurt.  she also reported that everything sounded extra loud.  Patient also had an ear wash while in the office to removed impacted ear wax.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, RV1
Symptoms: Alopecia, Dry skin, Eczema, Erythema, Pruritus
Clinical narrative: severe eczema all over the body 2 days after vaccines of 2 months visit. The baby also started loosing his hair and now currently almost 6 months and bold. still suffering from serious skin problems. His face and scalp are red itchy dry and flaky every day and every night no matter how much cream or moisture I put on. Before the vaccines his face were perfect no eczema whatsoever.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, RV1
Symptoms: Skin disorder, Skin exfoliation
Clinical narrative: severe eczema all over the body 2 days after vaccines of 2 months visit. The baby also started loosing his hair and now currently almost 6 months and bold. still suffering from serious skin problems. His face and scalp are red itchy dry and flaky every day and every night no matter how much cream or moisture I put on. Before the vaccines his face were perfect no eczema whatsoever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Severe chills for 2 plus hours
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant 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 18-MAY-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S028771, expiration date 09-APR-2021 (exact dose, strength and route of administration were not reported), for prophylaxis. The vaccine was stored at the temperature below 36 (F) for 16 hours which was registered by data logger. There was no previous temperature excursion. No additional adverse effects were reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA008265:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported in the patient.; patient received an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant concerning to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-MAY-2020, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml, (route and frequency not reported. Lot No. R029816 was reported and has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent. Expiration date reported and validated as 09-MAY-2020) for prophylaxis. No other adverse effects were reported in the patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pain in extremity
Clinical narrative: Knot in muscle; Arm Soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced nodule. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the nodule was unknown.   It was unknown if the reporter considered the pain in arm and nodule to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient reported arm soreness with the first dose of Shingrix, that did not resolved.  The patient also reported having a "knot in muscle" that she had to stretch out. Patient was unable to provide lot number and expiration date. The reporter did not consent to follow-up. This case was linked to case US2020AMR089212 for same patient. This case was linked to case US2020088762 by same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Pain in extremity
Clinical narrative: weakness; entire arm pain; pain on injection site; This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date 19th September 2021) for prophylaxis.   On 25th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced weakness, pain in arm and pain injection site. On an unknown date, the outcome of the weakness, pain in arm and pain injection site were unknown.   It was unknown if the reporter considered the weakness, pain in arm and pain injection site to be related to Shingrix.  Additional details were received as follows: The patient had pain in injection site,then she experienced entire arm pain and weakness. It was reported that the friend of patient also experienced the same adverse events. This was 1 of the 3 cases from same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Pain in extremity
Clinical narrative: Pain in injection site; Entire arm pain; Weakness; This case was reported by a pharmacist via call center representative and described the occurrence of pain injection site 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 injection site, pain in arm and weakness. On an unknown date, the outcome of the pain injection site, pain in arm and weakness were unknown.   It was unknown if the reporter considered the pain injection site, pain in arm and weakness to be related to Shingrix.  Additional details: The age group was not reported but it was selected as adult as per the vaccine indication.  The pharmacist reported that the patient after receiving Shingrix experienced pain in injection site, then experienced entire arm pain and weakness. The reporter consented to follow up. This was one of the 3 cases reported by same reporter.
Age: 1.33
Sex: F
Vaccine: DTAPIPV, HIBV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Kinrix vaccine was given to patient  in error . Patient should have only received DTAP (infarix) . Patient is not having any side effects or symptoms to the vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: I missed work; common side effects; my arm was very sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, activities of daily living impaired and adverse drug reaction. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the activities of daily living impaired and adverse drug reaction were unknown.   It was unknown if the reporter considered the pain in arm, activities of daily living impaired and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and experienced all of the common side effects to the point where the patient missed work and the patient's arm was sore for a week. The patient felt like overmedicated and body of the patient had difficulty processing the drug. The patient also enquired about the percentage of immunity would the patient have if the patient did not take the second dose. Consent to follow up was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Achy arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). 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 provided as follows: The reporter reported for her friend. The age at vaccination was not reported. The patient had achy arm pain in her right arm after Shingrix injection. The reporter did not consent to follow-up. This case was 1 of the 3 cases reported by same reporter.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient is reporting a sore arm lasting up to 05/29/2020.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt has red area  on injection site and swollen.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: pain in area of injection,  described as dull muscle ache.  Started within day after injection, continues to present time (5/29/20).  She mentioned the pain when 2nd dose was given 1/23/20, but she wanted 2nd dose in same arm.  2nd dose caused no pain, even as area where 1st dose pain persisted.  Patient denies any redness or swelling at any point after 1st injection.  Patient states that she has only had a couple of days in a row in the last month that she has not had any pain in the arm and she thought it was getting better. Pain returned with movement in a couple days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Rash pruritic, Swelling
Clinical narrative: Patient was given 2nd dose of shingrix subcutaneously instead of intramuscularly.  Caused a large, itchy rash on patients arm that spread to their back and required prednisone.  By the time they needed prednisone, 4 days after injection, swelling was reduced but still spreading and less itchy
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions at the time of administration
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Seizure
Clinical narrative: pt had a seizure today. was found to be febrile 103.9 but no obvious source of fever.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Flushing, Palpitations, Skin warm, Throat irritation
Clinical narrative: After receiving vaccination, patient was driving home and began feeling face flushed, ears hot, shaky and palpitations.  Went to ED.  After some time symptoms began resolving.  Stated throat felt itchy.  States ED MD examined tongue and throat and did not appreciate any significant edema.  No hives.  Went home with Rx and slept.  When woke up this afternoon right eye is very swollen.  States feels ok.  Will begin taking Prednisone and "something for itching."
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: After receiving vaccination, patient was driving home and began feeling face flushed, ears hot, shaky and palpitations.  Went to ED.  After some time symptoms began resolving.  Stated throat felt itchy.  States ED MD examined tongue and throat and did not appreciate any significant edema.  No hives.  Went home with Rx and slept.  When woke up this afternoon right eye is very swollen.  States feels ok.  Will begin taking Prednisone and "something for itching."
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Feeling abnormal, Gait disturbance, Sensory disturbance, Tinnitus
Clinical narrative: Pt sat for vaccine, admin into L deltoid, bandaid and ice pack put on arm, pt walked out to car and stumbled upon minivan then rollder and fell and dad and I caught him, he complained that the arm was ok but his legs felt funny and his ears felt funny(reported to parent ringing in the ears for few minutes). Pulse ox gotten and was 97% pulse:67(earlier @beginning of visit pulse was 104), bp 110/70 pt felt funny sat for few minutes drank some water then helped to front seat of van, felt better and temp taken was 98.8, pt stated felt ok so family left, will plan to check on pt later
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Dizziness, Nausea
Clinical narrative: Severe Dizziness, Severe Nausea -- Both lasting 24 hours; resulting in being bedridden the entire time.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Severe Dizziness, Severe Nausea -- Both lasting 24 hours; resulting in being bedridden the entire time.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dysstasia, Pyrexia
Clinical narrative: He reported felling weak. He couldn't stand up. He didn't remember events. He had a fever. He was worked up at the hospital and no other underlying conditions were identified. He received acetaminophen at the hospital and reported "coming out of it" after that. Symptoms resolved after that (36-48 hours after dose of vaccine was given)
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Pain, Swelling
Clinical narrative: Patient received the 2nd dose of Shingrix on 5/26/2020 via IM . Patient call the pharmacy on 5/29/2020 complaining about  soreness, little swelling, and pinkish skin color at the site of the infection. The swelling size is about 3x3. Patient reports no warmth at the site of the infection.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The Right thigh (pcv) reaction site  redness and swelling .
Age: 38.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: vaccine administered after expiration date
Age: 38.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine administered after expiration date
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient complains of ongoing pain in his arm
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dyspepsia, Hiccups, Injection site erythema, Musculoskeletal chest pain, Oesophageal spasm
Clinical narrative: Patient received Pneumovax 23 on 6/3/08 with no reaction. Lot # 1541U Merck Route -IM Body Site- LD Thursday had vaccination for pneumovax- 5-21-20 Friday evening had heartburn and hiccups. Heartburn was severe with spasm if eats Saturday had hiccups with heartburn. Sunday red site of injection on arm. Still spasm in esophagus area with hiccups. More hiccups and heartburn yesterday and stated oral anti-acid Hiccups this afternoon minimal. Still some acid. Worsens if eats. Pain in right lowermost rib area if moves around.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient received Pneumovax 23 on 6/3/08 with no reaction. Lot # 1541U Merck Route -IM Body Site- LD Thursday had vaccination for pneumovax- 5-21-20 Friday evening had heartburn and hiccups. Heartburn was severe with spasm if eats Saturday had hiccups with heartburn. Sunday red site of injection on arm. Still spasm in esophagus area with hiccups. More hiccups and heartburn yesterday and stated oral anti-acid Hiccups this afternoon minimal. Still some acid. Worsens if eats. Pain in right lowermost rib area if moves around.
Age: 15.0
Sex: M
Vaccine: DTAPHEPBIP, HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt did not have an adverse reaction. After injection was completed, error in administration was noted as the incorrect vaccine to give. Mother was notified immediately and is keeping watchful eye over patient. Patient had no previous problems with previous dosed of pediarix.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Erythema, Skin warm, Swelling
Clinical narrative: PT with immunization in day and now with redness and swelling and warmth. Baby crying.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, muscle pain, tiredness, slight headache
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Muscular weakness, Nausea
Clinical narrative: Nausea, fatigue, muscle weakness
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Rash around injection site. Rash predominantly .around immunization area, 6cm in diameter about 0.5 cm outside existing bordering of immunization. No fluctuance, pustules, or increased warmth. No fevers or difficulty walking.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: SWELLING IN THE ARM INCRASED TO UP ON CHEST UNDER CLAVICLE AND TO THE BACK ON SCAPULA AND ELBOW. NO SHORTNESS OF BREATH OR TONGUE SWELLING. WENT TO ER. SWELLING SPREAD TO HAND AND WRIST. PT GOT STEROID AND PEPCID FROM ER.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient had fever of 100 degrees and muscle aches.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: Dizzy, weak in the knees, and trouble breathing for a minute.  Medics came by and observed him and released him the same day.  I called the patient the following day and he was fine.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, HIBV, PNC13
Symptoms: Autism spectrum disorder, Hyperacusis, Language disorder, Lethargy, Stereotypy
Clinical narrative: Patient had a seizure in February 2013 and was having light fevers with her teething.  After her shots in March she became lethargic and began repetitive behavior and lost language skills.  She also became severely sound sensitive.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Blood thyroid stimulating hormone normal, Dizziness, Dizziness postural, Full blood count normal, Metabolic function test
Clinical narrative: Patient reports initially swelling in the arm, but has had dizziness and especially with position change since that vaccine. It is now 6 months and symptoms are resolving.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: Patient reports initially swelling in the arm, but has had dizziness and especially with position change since that vaccine. It is now 6 months and symptoms are resolving.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: My leg arm continued as the day progressed to get sorer, around 8:30 I hit a wall and was exhausted and felt I couldn't continue with what I was doing and laid down on the couch. I was cold and covered up with a wool blanket, but just couldn't get warm and the chills started and continued. I could tell I had a fever and was warm throughout the night, I never took my temperature, but I am sure it was well over 100 degrees. I was even laying on a heating pad and continued to have the chills during the night. I did take two tylenol around 11:30 and kept dozing on and off.  Sometime during the night my fever broke because when I woke up, I no longer had a temperature,  the chills or felt exhausted. My left arm continues to be sore, but I have taken tylenol to help with that.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN LASTING 6 MONTHS
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Pt called to report that she had a pink area about the size of a golf ball about two inches away from where she received the Shingrix vaccination on Friday 5/29.  She said that the area is warm and sore to the touch.  She had some stiffness in the shoulder on Saturday but didn't notice the pink area until today.  She said she was going to ice the area today and come to the pharmacy on Monday.  I informed her to call her Dr or go to the ER if any of the symptoms worsen.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5/8/20 Within 5 hours of vaccine administration, shot location was swelling, red, sore, and warm to touch.  Administered ice pack. By bedtime body aches developing. 5/9/10 arm still red, swollen, sore, additional head ache and muscle aches, and development of hives 5/10/20 Hives very pronounced, red, swollen, itching in a shingles pattern from neck around torso, to waist. 5/10/20 went to Urgent care, administered an injection of solumedrol, started Prednisone 20 mg, and Triamcinolone 0.1 % Cream
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain, Pruritus, Swelling
Clinical narrative: 5/8/20 Within 5 hours of vaccine administration, shot location was swelling, red, sore, and warm to touch.  Administered ice pack. By bedtime body aches developing. 5/9/10 arm still red, swollen, sore, additional head ache and muscle aches, and development of hives 5/10/20 Hives very pronounced, red, swollen, itching in a shingles pattern from neck around torso, to waist. 5/10/20 went to Urgent care, administered an injection of solumedrol, started Prednisone 20 mg, and Triamcinolone 0.1 % Cream
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 5/8/20 Within 5 hours of vaccine administration, shot location was swelling, red, sore, and warm to touch.  Administered ice pack. By bedtime body aches developing. 5/9/10 arm still red, swollen, sore, additional head ache and muscle aches, and development of hives 5/10/20 Hives very pronounced, red, swollen, itching in a shingles pattern from neck around torso, to waist. 5/10/20 went to Urgent care, administered an injection of solumedrol, started Prednisone 20 mg, and Triamcinolone 0.1 % Cream
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Neck pain, Pyrexia, Swelling
Clinical narrative: Continued fever  from 11 p.m. of the date of injection all the way until midnight the following night.  The first time i took my temperature , in the morning on 05/30/20, it was 101.3 and it had already gone down from the hottest I felt.  I continued to take Tylenol which lowered my fever to 99.6.  When the Tylenol wore off, it returned back to 101.0.  The glands in my neck are still painful to the touch and it spread from one nodule to 2 nodules in my right neck and also to a node in my right armpit.  My neck is still visibly swollen on 5/31/20 on the right side and still hurts, although when i awoke on 05/31/20, my fever was gone.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV1
Symptoms: Asthenia, Crying, Decreased appetite, Discomfort, Pyrexia
Clinical narrative: After my baby received the vaccines, he got fever at 100.94F at Feb 25 ,2020, 2:00AM. I gave him the infant Tylenol oral suspension. Then he temperature back to normal after he received the 1.25ml does.  At Received the vaccine 48 hours , my baby feet weak and lost appetite . cried a lot than usual. At two days later after 48 hours period time, my baby feel uncomfortable, cried lots ,lost appetite.
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Boostrix with an associated reaction of injection site cellulitis (received a dose of Boostrix in October 2012. For tolerence of a dose, refer linked case US2020087414).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Flu vaccine.  Additional details were provided as follows: The patient received Flu vaccine in about 2013. After receiving Flu vaccine, the patient was sent to the ER because she experianced itching. She was told that it could be the latex at the stopper that might have caused a reaction. The patient did not have further information on the physician. The reporter was consented to follow up. This case was linked with case US2020087414, reported by the same reporter for the same patient.
Age: 51.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Chills, Erythema, Induration, Pain, Papule
Clinical narrative: Vaccination site rash; Varicella-like rash; Unspecified fever; Rash moved to the chest/abdomen; Vaccination site induration; Vaccination site warmth; This spontaneous report was received from a physician concerning to a 51-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, previous drugs reactions and allergies were not reported.   On an unknown date, the patient performed a low immunoglobulin (IgG) titer: 44 (units not provided).   On 18-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous route, lot # R018143 expiration date not reported, but upon internal validation established as 25-JUN-2020, for prophylaxis (strength, formulation, dose schedule and anatomical site of injection were not reported).  On approximately 01-MAR-2020,  the patient developed a varicella-like rash (rash vesicular). The rash initially was around the injection site (vaccination site rash) with unspecified fever (pyrexia) and then the rash moved to the chest and abdomen (rash). On an unknown day in March 2020, the patient experienced vaccination site induration and vaccination site warmth. On 03-MAR-2020, the patient sought medical attention and spoke on the phone with the physician, then on 04-MAR-2020, the patient was seen by the physician. The fever was improving but there was still warmth and induration at site. The physician prescribed ice packs and antihistamine to assist with the discomfort.   The outcome of vaccination site rash, rash, pyrexia, rash vesicular, vaccination site warmth and vaccination site induration was reported as resolved, approximately on 13-MAR-2020.        The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and the aforementioned events were not provided.
Age: 51.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Peripheral swelling, Pyrexia, Rash, Sensitive skin, Skin warm
Clinical narrative: Vaccination site rash; Varicella-like rash; Unspecified fever; Rash moved to the chest/abdomen; Vaccination site induration; Vaccination site warmth; This spontaneous report was received from a physician concerning to a 51-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, previous drugs reactions and allergies were not reported.   On an unknown date, the patient performed a low immunoglobulin (IgG) titer: 44 (units not provided).   On 18-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous route, lot # R018143 expiration date not reported, but upon internal validation established as 25-JUN-2020, for prophylaxis (strength, formulation, dose schedule and anatomical site of injection were not reported).  On approximately 01-MAR-2020,  the patient developed a varicella-like rash (rash vesicular). The rash initially was around the injection site (vaccination site rash) with unspecified fever (pyrexia) and then the rash moved to the chest and abdomen (rash). On an unknown day in March 2020, the patient experienced vaccination site induration and vaccination site warmth. On 03-MAR-2020, the patient sought medical attention and spoke on the phone with the physician, then on 04-MAR-2020, the patient was seen by the physician. The fever was improving but there was still warmth and induration at site. The physician prescribed ice packs and antihistamine to assist with the discomfort.   The outcome of vaccination site rash, rash, pyrexia, rash vesicular, vaccination site warmth and vaccination site induration was reported as resolved, approximately on 13-MAR-2020.        The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and the aforementioned events were not provided.
Age: 51.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Discomfort, Injection site rash, Pyrexia, Rash, Rash vesicular
Clinical narrative: Vaccination site rash; Varicella-like rash; Unspecified fever; Rash moved to the chest/abdomen; Vaccination site induration; Vaccination site warmth; This spontaneous report was received from a physician concerning to a 51-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, previous drugs reactions and allergies were not reported.   On an unknown date, the patient performed a low immunoglobulin (IgG) titer: 44 (units not provided).   On 18-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous route, lot # R018143 expiration date not reported, but upon internal validation established as 25-JUN-2020, for prophylaxis (strength, formulation, dose schedule and anatomical site of injection were not reported).  On approximately 01-MAR-2020,  the patient developed a varicella-like rash (rash vesicular). The rash initially was around the injection site (vaccination site rash) with unspecified fever (pyrexia) and then the rash moved to the chest and abdomen (rash). On an unknown day in March 2020, the patient experienced vaccination site induration and vaccination site warmth. On 03-MAR-2020, the patient sought medical attention and spoke on the phone with the physician, then on 04-MAR-2020, the patient was seen by the physician. The fever was improving but there was still warmth and induration at site. The physician prescribed ice packs and antihistamine to assist with the discomfort.   The outcome of vaccination site rash, rash, pyrexia, rash vesicular, vaccination site warmth and vaccination site induration was reported as resolved, approximately on 13-MAR-2020.        The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and the aforementioned events were not provided.
Age: 51.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: Vaccination site rash; Varicella-like rash; Unspecified fever; Rash moved to the chest/abdomen; Vaccination site induration; Vaccination site warmth; This spontaneous report was received from a physician concerning to a 51-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, previous drugs reactions and allergies were not reported.   On an unknown date, the patient performed a low immunoglobulin (IgG) titer: 44 (units not provided).   On 18-FEB-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous route, lot # R018143 expiration date not reported, but upon internal validation established as 25-JUN-2020, for prophylaxis (strength, formulation, dose schedule and anatomical site of injection were not reported).  On approximately 01-MAR-2020,  the patient developed a varicella-like rash (rash vesicular). The rash initially was around the injection site (vaccination site rash) with unspecified fever (pyrexia) and then the rash moved to the chest and abdomen (rash). On an unknown day in March 2020, the patient experienced vaccination site induration and vaccination site warmth. On 03-MAR-2020, the patient sought medical attention and spoke on the phone with the physician, then on 04-MAR-2020, the patient was seen by the physician. The fever was improving but there was still warmth and induration at site. The physician prescribed ice packs and antihistamine to assist with the discomfort.   The outcome of vaccination site rash, rash, pyrexia, rash vesicular, vaccination site warmth and vaccination site induration was reported as resolved, approximately on 13-MAR-2020.        The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and the aforementioned events were not provided.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Pruritus, Vaccination complication
Clinical narrative: swollen and tender RT upper  arm that progressively worsened distally. + some itching. Was treated preemptively on 5/26/20 per telemedicine encounter as cellulitis w/ PO keflex + prednisone, after 1 dose of keflex patient's swelling and tenderness reduced. Was seen in office on 5/27/20.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional  adverse effects reported; received one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and drug reactions/allergies were not reported. On 15-MAY-2020, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously (lot# S022756 with expiration date of 22-JUL-2021 and lot# R020654 with expiration date of 18-JUL-2020) for prophylaxis (Product storage error)(anatomical location was not reported). Concomitant therapies included sterile diluent which was reported to be stored properly. No additional adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 5.7 degree Fahrenheit (F) and had previous temperature excursion from 13.3 degree Celsius (C) to 13.2 degree Celsius (c) for 18 minutes. Data logger was involved. No product quality complaint (PQC) was associated with this report.