chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: I had was muscle pain for couple of days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingles vaccine. In JAN-2023, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: I had was muscle pain for couple of days). The patient was treated with paracetamol (Tylenol). In JAN-2023, the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine.   It was unknown if the company considered the muscle pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient received shingles shot last month (3 weeks ago).  The only side effect he/she had was muscle pain for a couple days and Tylenol helped. The reporter had a friend that had the shingles so bad she was sick and off from work for 3 months. The reporter told to get your shingles shot. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Took the shot and got it 2 days later; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Took the shot and got it 2 days later). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles shot and got shingles 2 days later. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: tingling pain in left leg (L3 Dermatome) Only happened on outer thigh; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in thigh in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In SEP-2022, 7 days after receiving Shingrix, the patient experienced pain in thigh (Verbatim: tingling pain in left leg (L3 Dermatome) Only happened on outer thigh.). The outcome of the pain in thigh was resolved.   It was unknown if the reporter considered the pain in thigh to be related to Shingrix.     It was unknown if the company considered the pain in thigh to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 In the 2022, the patient received Shingrix.   The tingling pain did not occurred after the second shot. The reporter was not sure if the event was related to the product.
Sex: F
Vaccine: HEPAB
Symptoms: Wrong technique in product usage process
Clinical narrative: vaccine not shake or mix; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong technique in product usage process in a female patient who received HAB (Twinrix) for prophylaxis.   On 04-MAY-2023, the patient received Twinrix. On 04-MAY-2023, an unknown time after receiving Twinrix, the patient experienced wrong technique in product usage process (Verbatim: vaccine not shake or mix). The outcome of the wrong technique in product usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2023 The patient self-reported this case. The reporter inquired if could get hepatitis or an infection from vaccine not shaken or mixed. The patient received a Twinrix and the healthcare professional did not shake or mix the vaccine correctly.  The reporter asked that what effects would this cause. The reporter did not consent to follow-up. The patient received Twinrix dose without shaking it prior to the administration as was indicated on the prescribing information, which led to wrong technique in product usage process.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Extra Shingrix administed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra Shingrix administed). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-MAY-2023 The reporter stated that it was a possibility that a patient received a 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consent to follow up.  The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patient received adult dose; Pediatric patient received adult dose; 1st dose: 06-MAR-2021; 2nd dose: 19-JUL-2021; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 2-year-old patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 4pg49) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 06th March 2021).   On 19-JUL-2021, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B adult. On 19-JUL-2021, an unknown time after receiving Engerix B and not applicable after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: 1st dose: 06-MAR-2021; 2nd dose: 19-JUL-2021). On an unknown date, the patient experienced overdose (Verbatim: Pediatric patient received adult dose) and adult product administered to child (Verbatim: Pediatric patient received adult dose). The outcome of the drug dose administration interval too long, overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter was pharmacist administrative assistant. The reporter reported that the pediatric patient was accidentally received an adult dose of Engerix-B vaccine. The reporter stated that they provided incomplete information about the patient and previous vaccinations and they accepted to be transferred to the second line. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received 2nd dose of Engerix B late than recommended time frame, which led to lengthening of vaccination schedule. The pediatric patient was administered a adult dose of Engerix B , which led to overdose and adult use of a child product.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Mouth swelling, Neck pain, Swollen tongue, Tongue discolouration
Clinical narrative: neck pain; back pain; green tongue; tongue became swollen; mouth became swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-APR-2023, the patient received the 1st dose of Shingrix (left arm). On 26-APR-2023, 1 days after receiving Shingrix, the patient experienced swollen tongue (Verbatim: tongue became swollen) and swollen mouth (Verbatim: mouth became swollen). On an unknown date, the patient experienced neck pain (Verbatim: neck pain), back pain (Verbatim: back pain) and tongue discoloration green (Verbatim: green tongue). The patient was treated with steroids nos (Steroids) and dramamine (nos) (Dramamine). The outcome of the swollen tongue, swollen mouth, neck pain, back pain and tongue discoloration green were unknown.   It was unknown if the reporter considered the swollen tongue, swollen mouth, neck pain, back pain and tongue discoloration green to be related to Shingrix.  It was unknown if the company considered the swollen tongue, swollen mouth, neck pain, back pain and tongue discoloration green to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter was the patient, who received her Shingrix last Tuesday in her left arm.  She stated that the next day, her tongue and mouth became swollen and she had neck and back pain.  Her tongue also turned green.  When she went to her doctor, she received steroids and Dramamine to help with the swelling.  The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   On 05-MAY-2023, the patient received Pediarix (right thigh). On 05-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter was enquired how to proceed, what to look for. The reporter reported a 2-month-old patient was inadvertently administered an expired Pediarix on the day of reporting in the Right thigh.  The reporter confirmed vaccine was administered in at facility.  The reporter did not consent to follow-up The patient received expired dose of Pediarix, which led to expired vaccine used.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 years old received a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 16-MAR-2023, the patient received Kinrix. On 16-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 years old received a dose of Kinrix ). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-MAY-2023 The Kinrix dose was the patient's 5th DTaP and 4th IPV.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up and stated that did not send any patient information to email address. The seven-year-old patient was given Kinrix, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 02nd December 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 08-MAY-2023 The reporter reported that the patient was not immunocompromised and received first dose of Shingrix but never received second dose. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29-APR-2023) for prophylaxis.   On 04-MAY-2023, the patient received Engerix B. On 04-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received a Engerix B which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose dec/2020, 2nd dose march/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on December 2020).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose dec/2020, 2nd dose march/2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-MAY-2023 The reporter wanted to know is this second dose of Shingrix vaccine is valid. The reporter did not provided other details such as lot numbers. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 1st dose of Twinrix on 4-November-2022 and 2nd dose of Twinrix on 4-January 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX ADULT).   On 04-JAN-2023, the patient received the 2nd dose of Twinrix adult. On 04-JAN-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: Patient received 1st dose of Twinrix on 4-November-2022 and 2nd dose of Twinrix on 4-January 2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The patient received the first dose of Twinrix on 4-November-2022 and the second dose of Twinrix on 4-January 2023.  The pharmacist wanted to know how to proceed for the third dose. The reporter consented to follow up. The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to drug dose administration interval too long.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix dose was accidentally given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 09-MAY-2023, the patient received the 1st dose of Havrix. On 09-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix dose was accidentally given to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was a medical assistant. The reporter reported that an expired Havrix dose was accidentally given to a patient.  They provided information about the vaccination, patient and vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter reported that an expired Havrix dose was accidentally given to a patient, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pt that only had 1st dose of Shjngrix. It has been 8 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received only had 1st dose of Shjngrix, 8 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pt that only had 1st dose of Shjngrix. It has been 8 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-MAY-2023 The reporter stated that patient only had 1st dose of Shjngrix.  It had been 8 months. The reporter asked whether the patient should patient get 2nd dose now or start 2-dose series over. Till the time of reporting patient did not received 2nd dose, which led to incomplete course of vaccination.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient's age was 5 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 18-MAY-2022, the patient received Kinrix. On 18-MAY-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: the patient's age was 5 months). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was medical assistant. The reporter called to inform that a patient was administered a dose of Kinrix at the age of 5 months.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter called to inform that a patient was administered a dose of Kinrix at the age of 5 months, which led to inappropriate age at vaccine administration.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Injection site erythema, Injection site warmth
Clinical narrative: expired drug used; local injection site reaction of redness; local injection site reaction of and warmth; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 1-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 05-MAY-2023, the patient received Infanrix (left thigh). On 05-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired drug used). In MAY-2023, the patient experienced injection site erythema (Verbatim: local injection site reaction of redness) and injection site warmth (Verbatim: local injection site reaction of and warmth). The outcome of the injection site erythema, injection site warmth and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Infanrix and Infanrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema and injection site warmth to be related to Infanrix and Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023. Nurse at a health department reported that two patients on 5th MAY 2023 received an expired dose of Infanrix which was already expired on 29 April 2023, which led to expired vaccine used One of the two patients had a local injection site reaction of redness and warmth on the left vastus lateralis.  The patient's mother called about the reaction the day after administration.  The reporter consented to follow up. This case has been linked to the case US2023066955 reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: blood clot
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Significant joint and muscle pain x 2 weeks + weeks from left side of neck, shoulder, hip, foot.  All left side of her body.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Fatigue, Malaise, Ocular hyperaemia, Tremor
Clinical narrative: Per patient caregiver: patient gets a shot for macular degeneration (not sure of name). Her right eye became swollen. No longer swollen now but still red. Patient is tired, shaking and not feeling well. Patient is going to see her doctor tomorrow. Patient caregiver wondering if Shingrix shot and macular degeneration shot caused the reaction because she got them close together
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland abnormal, Cancer surgery, Computerised tomogram abnormal, Condition aggravated, Diagnostic aspiration
Clinical narrative: In August 2022 I went to my ENT because I had a cold. He decided to do a scope and he saw a spot that he didn't like. I went back when I was well, and he did a biopsy of the spot and a CT scan. It showed I had something in the lymph node in my nasal cavity. It was a return of the cancer I had before but not in the same place. I had been cancer free for 8 years. The type of epiphyseal marrow blastoma that originates in olfactory nerve. This time it was found in the upper part of my throat but same type of cells as previous cancer. I had surgery to remove the cancer.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngitis, Neuroblastoma, Olfactory nerve disorder, Positron emission tomogram abnormal
Clinical narrative: In August 2022 I went to my ENT because I had a cold. He decided to do a scope and he saw a spot that he didn't like. I went back when I was well, and he did a biopsy of the spot and a CT scan. It showed I had something in the lymph node in my nasal cavity. It was a return of the cancer I had before but not in the same place. I had been cancer free for 8 years. The type of epiphyseal marrow blastoma that originates in olfactory nerve. This time it was found in the upper part of my throat but same type of cells as previous cancer. I had surgery to remove the cancer.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Recurrent cancer, Throat cancer
Clinical narrative: In August 2022 I went to my ENT because I had a cold. He decided to do a scope and he saw a spot that he didn't like. I went back when I was well, and he did a biopsy of the spot and a CT scan. It showed I had something in the lymph node in my nasal cavity. It was a return of the cancer I had before but not in the same place. I had been cancer free for 8 years. The type of epiphyseal marrow blastoma that originates in olfactory nerve. This time it was found in the upper part of my throat but same type of cells as previous cancer. I had surgery to remove the cancer.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Frozen left shoulder started the end of November 2022, stiff neck began about 2 weeks later, had cortisone injection Jan. 20 2023, things resolved for about a month then returned but not as severe, then in march 2023 my left wrist began to swell and be painful in the joint, then the right wrist developed the same symptoms and both wrists continue to be extremely painful and at times swollen.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Platelet count increased
Clinical narrative: Frozen left shoulder started the end of November 2022, stiff neck began about 2 weeks later, had cortisone injection Jan. 20 2023, things resolved for about a month then returned but not as severe, then in march 2023 my left wrist began to swell and be painful in the joint, then the right wrist developed the same symptoms and both wrists continue to be extremely painful and at times swollen.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event, but was given an invalid dose as it was repeated within the same season. Patient got flu vaccine on 10/01/22 and then again on 4/05/23.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: Mom reported to our office today on Mon 5/15/2023 that patient had experienced an allergic reaction 1 day after his initial HPV9 vaccine administered on 11/15/2022 at 4pm.  She did not call into our office to notify us of this initially. He developed lip swelling only. no angioedema or hives to other parts of his body.  He was scheduled for his #2 dose today and she mentioned it during his physical exam. We held off on administering his 2nd dose due to this new information.  Mom administered PO benadryl and reaction resolved. no UC or ED visit.  patient also did not develop anaphylaxis reaction.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient was here today for a 9 month well child check, in preparation for the visit I checked the state database for any immunizations the patient would be due for.  Database stated that the patient was due for their first COVID vaccination as well as their second booster for the Flu immunizations. I informed the mother of the patient that they were due for these immunizations and the mother decided to delay the covid immunization but go forward with the flu immunization today.   Later in the day, the patients mother called and informed us that she was looking through her personal records at home and saw that the patient actually had the second booster on 03/13/2023. When mom informed me of this i looked in system and found the documentation of when this vaccine was given. It was not charted and i did not look in system to confirm before giving the dose.   I reviewed with the mother of the patient any signs or symptoms of adverse reactions to look for and informed provider of the event. the provider confirmed with her that patient will be ok and more protected against the flu now.  Mother of patient verbalized understanding and had no further questions at this time.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a second bivalent pfizer covid shot before it was approved.  Patient did not have any adverese reaction to the vaccine
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Myalgia
Clinical narrative: 30 minutes after 2nd dose 2/20/23 major muscles, arms, thighs back flared as though on fire. Muscle pain continues.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: Shingles outbreak, mid left back - pain and rash/blisters.   Pain began on 5/12/23, rash appeared on 5/14/23, diagnosed as shingles by healthcare provider on 5/15/23.  Prescribed anti-viral (valtrex)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Neuropathy peripheral, Periorbital swelling, Vision blurred
Clinical narrative: Facial pausly, blurred vision, neuropathy, puffy eyes
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Rash erythematous, Swelling
Clinical narrative: For several days after the shot, I had swelling and a red rash that spread out over several days. It?s been almost a month and I still have a bruise/skin discoloration around the injection site.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Left hand swollen, red, painful. Patient applied warm compress, Tylenol & used Medrol Pack
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine improperly store
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine improperly stored
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Left pontine CVA 11/15/2021
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Blood creatinine abnormal, Blood electrolytes abnormal, Blood glucose abnormal, Blood urea abnormal
Clinical narrative: Acute DVT of proximal vein of right lower extremity
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic kidney disease, Deep vein thrombosis, Differential white blood cell count abnormal, Disability, Full blood count abnormal
Clinical narrative: Acute DVT of proximal vein of right lower extremity
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait disturbance, Metabolic function test abnormal, Pain in extremity, Peripheral swelling, Platelet count abnormal
Clinical narrative: Acute DVT of proximal vein of right lower extremity
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tenderness, Ultrasound Doppler abnormal
Clinical narrative: Acute DVT of proximal vein of right lower extremity
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B22A, 077C21B, 007M20A and 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient had the regular side effects - fever, chills, and all of that stuff. No treatment information was reported.   This case was linked to MOD-2023-723834 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deep vein thrombosis, Hearing aid user, Muscle tightness, Myalgia
Clinical narrative: Two days after my vaccine (Vaccine 18 FEB 21), SM noticed my left calf was swollen.  He thought it was a pulled muscle- tightness, pain, no redness, no swelling.  Went to the clinic and underwent an US that confirmed a DVT.  He was sent to the ER for treatment. Received Moderna booster on 30 MAR 21 and began experiencing tinnitus in the L>R ear later in the month.  Pt did not equate the tinnitus with vaccine until now  Significant shift in hearing documented on audiogram in APR 22 and SM currently wearing hearing aids.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tinnitus, Ultrasound Doppler abnormal
Clinical narrative: Two days after my vaccine (Vaccine 18 FEB 21), SM noticed my left calf was swollen.  He thought it was a pulled muscle- tightness, pain, no redness, no swelling.  Went to the clinic and underwent an US that confirmed a DVT.  He was sent to the ER for treatment. Received Moderna booster on 30 MAR 21 and began experiencing tinnitus in the L>R ear later in the month.  Pt did not equate the tinnitus with vaccine until now  Significant shift in hearing documented on audiogram in APR 22 and SM currently wearing hearing aids.
Age: 9.0
Sex: M
Vaccine: MMRV, MMRV, MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AE; Nurse reported that PROQUAD was inadvertently administered to the following patient after its labeled expiry date; This spontaneous report was received from a nurse referring to a 9-year-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 28-APR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: U029321, expiration date: 19-MAR-2023; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Age: 9.0
Sex: M
Vaccine: MMRV, MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse reported that PROQUAD was inadvertently administered to the following patient after its labeled expiry date; This spontaneous report was received from a nurse referring to a 9-year-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 28-APR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: U029321, expiration date: 19-MAR-2023; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance test, Blood test, Dizziness, Magnetic resonance imaging, Tinnitus
Clinical narrative: Chronic dizziness with movement, loss of balance, and constant ringing in left ear
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Blood test, Culture urine, Dizziness exertional
Clinical narrative: Chronic dizziness with movement, loss of balance, and constant ringing in left ear
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Ophthalmological examination, Tinnitus
Clinical narrative: Chronic dizziness with movement, loss of balance, and constant ringing in left ear
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Malaise
Clinical narrative: I woke up shaking with a fever; I woke up shaking with a fever; I awoke with a horrible headache; nauseous; vomiting; diarrhea; dizziness; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 at 11:15 as dose 6 (booster), single (Lot number: AJ5342) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "crohn's" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "anemia" (unspecified if ongoing); "double vision" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ANTIVERT [MECLOZINE HYDROCHLORIDE]; RABEPRAZOLE; CHOLESTYRAMINE; IMODIUM. Past drug history included: Z-pack, reaction(s): "Known allergies: z-pack"; Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 5, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "I awoke with a horrible headache"; PYREXIA (non-serious), TREMOR (non-serious) all with onset 01May2023 at 22:00, outcome "recovered" and all described as "I woke up shaking with a fever"; DIARRHOEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; NAUSEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "nauseous"; VOMITING (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; ASTHENIA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, tremor, headache, nausea, vomiting, diarrhoea, dizziness, asthenia. Additional information: The patient did not receive other vaccine in four weeks. The other medications in two weeks were Antivert, Rabeprazole, Imodium, cholestyramine. The night of the vaccine, the patient woke up shaking with a fever, a few hours later, the patient awoke with a horrible headache, then the patient became nauseous, vomiting, diarrhea, dizziness, weakness which remained for 4 days. The patient was in bed for 4 days. The patient had no COVID prior vaccination. The patient did not undergo COVID test post vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Mobility decreased, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: I woke up shaking with a fever; I woke up shaking with a fever; I awoke with a horrible headache; nauseous; vomiting; diarrhea; dizziness; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 at 11:15 as dose 6 (booster), single (Lot number: AJ5342) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "crohn's" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "anemia" (unspecified if ongoing); "double vision" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ANTIVERT [MECLOZINE HYDROCHLORIDE]; RABEPRAZOLE; CHOLESTYRAMINE; IMODIUM. Past drug history included: Z-pack, reaction(s): "Known allergies: z-pack"; Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 5, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "I awoke with a horrible headache"; PYREXIA (non-serious), TREMOR (non-serious) all with onset 01May2023 at 22:00, outcome "recovered" and all described as "I woke up shaking with a fever"; DIARRHOEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; NAUSEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "nauseous"; VOMITING (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; ASTHENIA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, tremor, headache, nausea, vomiting, diarrhoea, dizziness, asthenia. Additional information: The patient did not receive other vaccine in four weeks. The other medications in two weeks were Antivert, Rabeprazole, Imodium, cholestyramine. The night of the vaccine, the patient woke up shaking with a fever, a few hours later, the patient awoke with a horrible headache, then the patient became nauseous, vomiting, diarrhea, dizziness, weakness which remained for 4 days. The patient was in bed for 4 days. The patient had no COVID prior vaccination. The patient did not undergo COVID test post vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: I woke up shaking with a fever; I woke up shaking with a fever; I awoke with a horrible headache; nauseous; vomiting; diarrhea; dizziness; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 at 11:15 as dose 6 (booster), single (Lot number: AJ5342) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "crohn's" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "anemia" (unspecified if ongoing); "double vision" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ANTIVERT [MECLOZINE HYDROCHLORIDE]; RABEPRAZOLE; CHOLESTYRAMINE; IMODIUM. Past drug history included: Z-pack, reaction(s): "Known allergies: z-pack"; Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 5, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "I awoke with a horrible headache"; PYREXIA (non-serious), TREMOR (non-serious) all with onset 01May2023 at 22:00, outcome "recovered" and all described as "I woke up shaking with a fever"; DIARRHOEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; NAUSEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "nauseous"; VOMITING (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; ASTHENIA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, tremor, headache, nausea, vomiting, diarrhoea, dizziness, asthenia. Additional information: The patient did not receive other vaccine in four weeks. The other medications in two weeks were Antivert, Rabeprazole, Imodium, cholestyramine. The night of the vaccine, the patient woke up shaking with a fever, a few hours later, the patient awoke with a horrible headache, then the patient became nauseous, vomiting, diarrhea, dizziness, weakness which remained for 4 days. The patient was in bed for 4 days. The patient had no COVID prior vaccination. The patient did not undergo COVID test post vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: I woke up shaking with a fever; I woke up shaking with a fever; I awoke with a horrible headache; nauseous; vomiting; diarrhea; dizziness; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 at 11:15 as dose 6 (booster), single (Lot number: AJ5342) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "crohn's" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "anemia" (unspecified if ongoing); "double vision" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ANTIVERT [MECLOZINE HYDROCHLORIDE]; RABEPRAZOLE; CHOLESTYRAMINE; IMODIUM. Past drug history included: Z-pack, reaction(s): "Known allergies: z-pack"; Erythromycin, reaction(s): "Known allergies: erythromycin". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 5, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "I awoke with a horrible headache"; PYREXIA (non-serious), TREMOR (non-serious) all with onset 01May2023 at 22:00, outcome "recovered" and all described as "I woke up shaking with a fever"; DIARRHOEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "diarrhea"; DIZZINESS (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; NAUSEA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "nauseous"; VOMITING (non-serious) with onset 01May2023 at 22:00, outcome "recovered"; ASTHENIA (non-serious) with onset 01May2023 at 22:00, outcome "recovered", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, tremor, headache, nausea, vomiting, diarrhoea, dizziness, asthenia. Additional information: The patient did not receive other vaccine in four weeks. The other medications in two weeks were Antivert, Rabeprazole, Imodium, cholestyramine. The night of the vaccine, the patient woke up shaking with a fever, a few hours later, the patient awoke with a horrible headache, then the patient became nauseous, vomiting, diarrhea, dizziness, weakness which remained for 4 days. The patient was in bed for 4 days. The patient had no COVID prior vaccination. The patient did not undergo COVID test post vaccination.