chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: LARGE RED AREA BELOW SITE, FEVER
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9% sodium chloride. No adverse event noted.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9% sodium chloride. No adverse event noted.
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received incorrect diluent: sterile water for injection (SWFI) instead of 0.9 % sodium chloride. No adverse event noted.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: on or about 3-24-2024 she started experiencing redness, fever at the site and pain. She stopped by the pharmacy for her next injection of M-M-R on 3-29-2024.  After she told me of these side effects, I told her she needs to see a doctor at the nearest clinic
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Deep vein thrombosis, Superficial vein thrombosis, Ultrasound Doppler, Ultrasound scan abnormal
Clinical narrative: I am unable to find brand, and lot information. Patient developed very large SVT and beginning of DVT in right lower extremity within 18 hours of getting Tdap.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: The patient was fine during and after the vaccine - later that evening he started noticing a rash (red bumps) on his arms, trunk and legs, it progressively got worse over night. He took a zyrtec today and will be taking benadryl  this evening, that has helped the itching. He will go to the dr if he has any further concerns.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Hypoaesthesia, Mobility decreased
Clinical narrative: Per patient, she started experiencing lower back pain at 4pm. And around 2:30am, she was about to go to the bathroom her body felt numb and could hardly move (whole body). She started to get better and move better at 6am and onwards the next day.n?
Age: 2.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 13 cm x 7 cm erythema and induration surrounding injection site on (R) thigh TX: Augmentin 3 mL BID x 7 days Prednisone 11mL x 3 days*Pt did not show up to follow-up appointment. I called and left vm requesting call back.
Age: 23.0
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnancy; Initial report received on 18-Jan-2024.  A registered nurse reported to the HEPLISAV-B pregnancy registry that a 23 year old pregnant female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On 17-Jan-2024, the seven-weeks pregnant patient received dose 1 of HEPLISAV-B (Lot number 943007, expiration date 30-Sep-2025, and NDC number 43528-0003-05) intramuscularly in the left deltoid.   Concomitantly, the patient had COVID-19, flu, and TDAP vaccines during the same appointment (no details provided).   No adverse effects were reported by the patient. There was no further information.    No further follow-up will be conducted by the registry.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; administered a Engerix pediatric dose to an adult patient instead of the complete adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   On 12-MAR-2024, the patient received Engerix B pediatric. On 12-MAR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: administered a Engerix pediatric dose to an adult patient instead of the complete adult dose). The outcome of the underdose and adult use of a child product were 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: 18-MAR-2024 The practice manager reported that they administered a Engerix B pediatric dose to an adult patient instead of the complete adult dose, which led to an underdose and adult use of a child product. The practice manager called to inquire how to proceed. The reporter did not consent to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient was given only the diluent part; patient was given only the diluent part; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number J294K, expiry date 11-DEC-2025) for prophylaxis.   On 19-MAR-2024, the patient received the 1st dose of Shingrix. On 19-MAR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was given only the diluent part) and inappropriate dose of vaccine administered (Verbatim: patient was given only the diluent part). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-MAR-2024 The nurse reported that a patient was given only part of the Shingrix vaccine, he was given only the diluent part on the day of reporting, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; This is a spontaneous report received from a Physician from a sales representative.  An elderly female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain Barre Syndrome".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the current available information in the case provided and neuroinflammatory events expected as the labelling documents of suspect drug , the causal association between the event GUILLAIN-BARRE SYNDROME and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Atrial fibrillation, Echocardiogram, Electrocardiogram
Clinical narrative: developed Atrial Fibrillation - diagnosed on February 27,2024. Currently undergoing treatment.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Swelling of hands and feet. She says it started the night of vaccine administration and is not fully resolved.
Age: 81.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient came in on 3/30/24 to ask about a possible reaction she had after getting 2 vaccines on 3/28/24.  She had a shingles shot in the left arm and a tetanus shot in the right arm.  The right arm had several red, itchy bumps down the arm but not directly at the injection site. Patient stated the bumps started appearing the night of 3/28/24 (the same day she received the vaccines). To the pharmacist they appeared to possibly be hives.  There were no bumps or rash on the left arm.  Patient said she had been putting hydrocortisone cream on the bumps and was advised to continue and to take Benadryl and seek medical help if condition worsened.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dizziness, Headache, Loss of consciousness, Mobility decreased
Clinical narrative: Throbbing shooting sharp arm pain, that traveled to my back. Unable to lift arm at all. Unable to touch the arm at all. No function in arm or hand.  Terrible headache.  Dizziness and passing out
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity, Tenderness
Clinical narrative: Throbbing shooting sharp arm pain, that traveled to my back. Unable to lift arm at all. Unable to touch the arm at all. No function in arm or hand.  Terrible headache.  Dizziness and passing out
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient was afraid of the vaccine before administration. Upon injecting the needle the patient abruptly jerked her body back and squirmed her arm. This caused the needle to shift in the patients arm and she was reporting pain immediately after immunization.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: On 3/29/24 the patient returned to the pharmacy and reported that following the vaccine the injection site had a reaction with swelling, heat, and an intense red itchy rash approx. 4 inches in diameter.  It lasted 3 days.  The patient self treated with Benadryl and anti - itch cream.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Swelling of injection site, increasing daily. Currently measures 4× 6 inches on day 3. Welt developed on face this morning, day three.
Age: 69.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Computerised tomogram, Cough, Dyspnoea, Lacrimation increased, Nausea
Clinical narrative: Patient reported difficulty breathing, coughing, runny nose, water eyes, nausea, and chest congestion. Patient reported to the emergency department at ~03:30PM on 03/29/24 due to symptoms. Patient reports being given a breathing treatment and an IV steroid and was discharged at ~10:00PM on 03/29/24. Patient was discharged with a prescription for prednisone 50mg tablets PO QD for 5 days and doxycycline mono 100mg tablets PO Q12H for 10 days.
Age: 69.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Respiratory tract congestion, Rhinorrhoea, Scan
Clinical narrative: Patient reported difficulty breathing, coughing, runny nose, water eyes, nausea, and chest congestion. Patient reported to the emergency department at ~03:30PM on 03/29/24 due to symptoms. Patient reports being given a breathing treatment and an IV steroid and was discharged at ~10:00PM on 03/29/24. Patient was discharged with a prescription for prednisone 50mg tablets PO QD for 5 days and doxycycline mono 100mg tablets PO Q12H for 10 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash, Rash pruritic
Clinical narrative: 3 DAYS AFTER VACCINE ADMINISTRATION, ARM BROKE OUT IN PAINFUL AND ITCHY RASH
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, No adverse event, Vomiting
Clinical narrative: The patient began to feel nauseous about 5 minutes after vaccine administration. About 5 minutes after that, the patient had to vomit. After vomiting, the patient felt much better.  No additional interventions were needed on our part to care for the patient. We followed up with the patient 5 hours later. The patient reported no additional adverse reaction at that time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: TINNUTIS--starting with higher-pitched ringing in the ears the day after vaccination, now constant lower-pitched hum that is most noticeable when there is no other outside noise; I WOULD HAVE NEVER GOTTEN THE VACCINE HAD I KNOWN THERE WAS A RISK OF TINNUTIS!
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal stiffness
Clinical narrative: Pt reports back pain. "Feels like it is locked."
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Blood test normal, Exposure during pregnancy, Premature delivery
Clinical narrative: Preterm delivery at 35 weeks 4 days pregnant four days after receiving the vaccine. My daughter was born at 5lb 14oz. My due date was 4/25/2024. My first pregnancy I delivered at 39 weeks 3 days.  During both pregnancies I did not have any high blood pressure or low amniotic fluid levels to indicate any issue.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Irritability, Pallor, Rash maculo-papular, Respiratory tract congestion
Clinical narrative: Patient received vaccines on Thursday. Over the weekend developed a slight fever (99ish). Following Wednesday she developed a maculopapular blanching rash and fussiness. She had some very mild congestion but no other symptoms.
Age: 30.0
Sex: F
Vaccine: HEP, HEPA, HPV9, TDAP
Symptoms: Syncope
Clinical narrative: A 30 yo female got 4 IMZ from us. After 4th vaccine she fainted. I quickly shouted (RX tech) to call EMS. She also made overhead announcement and the front-end lead was here to help. Immediately I grabbed a water bottle for her and made a cold compress ready for her. She started talking again and slowly drank a sip of water. We gave her lollipop and starburst. I was about to give her Epipen 0.3mg but thank god she came back. The responder from EMS call asked questions which she was able to answer. The customer was asked to stay in Pharmacy for 30 min under observation and she did well and finally left.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Diagnosed with GBS. Treatmet included immune globulin therapy
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Fever (102-103), chills, headache, nausea, extreme arm pain (cannot move arm), and now (day 4) rash on arm
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever (102-103), chills, headache, nausea, extreme arm pain (cannot move arm), and now (day 4) rash on arm
Age: 3.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting, fever
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Acute onset of mild-to-moderate coughing and wheezing ten minutes after vaccination. Two doses of albuterol sulfate 90 mcg inhaler were given and symptoms resolved within ten minutes of onset.   Additionally, swelling and redness of the entire left thigh (including injection site) began the day after vaccination. Leg was also warm to the touch and tender. Swelling has not yet resolved as of time of this report, approximately 48 hours after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Wheezing
Clinical narrative: Acute onset of mild-to-moderate coughing and wheezing ten minutes after vaccination. Two doses of albuterol sulfate 90 mcg inhaler were given and symptoms resolved within ten minutes of onset.   Additionally, swelling and redness of the entire left thigh (including injection site) began the day after vaccination. Leg was also warm to the touch and tender. Swelling has not yet resolved as of time of this report, approximately 48 hours after vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had shingrix in 2019 both doses so she did not need 3rd dose - no adverse effects reported as of 3/31/24
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had shingrix in 2019 both doses so she did not need 3rd dose - no adverse effects reported as of 3/31/24
Age: 74.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered 2 Abrysvo vaccines.  One on 11/27/23 and a second on 3/21/24.  At this time patient has no reportable adverse effects.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient reported severe, diffuse, red rash after getting vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Patient reports having about a 1 degree increase in fever (roughly 99 degrees F), a metallic taste in his mouth, neck stiffness, and injection site pain from the vaccine starting the day after the vaccination (3/28/24). Patient was feeling better when reporting to me later in the day and advised to contact me or his primary care provider if any symptoms worsened. Has not contacted back regarding continuation of symptoms.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Alanine aminotransferase normal, Aspartate aminotransferase increased, Asthenia, Blood calcium
Clinical narrative: Pt admitted for rhabdomyolysis (CK >10k) and suspected myocarditis (trop 0.86, echocardiogram pending), as well as AKI, elevated LFT's, leukocytosis, weakness w/fall,
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood creatine phosphokinase increased, Blood creatinine increased, Blood fibrinogen increased, Blood phosphorus, Blood potassium decreased
Clinical narrative: Pt admitted for rhabdomyolysis (CK >10k) and suspected myocarditis (trop 0.86, echocardiogram pending), as well as AKI, elevated LFT's, leukocytosis, weakness w/fall,
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein increased, Fall, International normalised ratio increased, Leukocytosis
Clinical narrative: Pt admitted for rhabdomyolysis (CK >10k) and suspected myocarditis (trop 0.86, echocardiogram pending), as well as AKI, elevated LFT's, leukocytosis, weakness w/fall,
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Liver function test increased, Myocarditis, Prothrombin time prolonged, Red blood cell sedimentation rate normal, Rhabdomyolysis
Clinical narrative: Pt admitted for rhabdomyolysis (CK >10k) and suspected myocarditis (trop 0.86, echocardiogram pending), as well as AKI, elevated LFT's, leukocytosis, weakness w/fall,
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin I increased, White blood cell count increased
Clinical narrative: Pt admitted for rhabdomyolysis (CK >10k) and suspected myocarditis (trop 0.86, echocardiogram pending), as well as AKI, elevated LFT's, leukocytosis, weakness w/fall,
Age: 68.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient experienced redness and a subcutaneous  bump under (at) the injection site, symptoms have existed from 3/19/24 through today 3/31/2024.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia
Clinical narrative: constant muscle pain and weakness in left arm since the day of vaccination
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction, Urticaria
Clinical narrative: Rash skins all over the body. Can be relieved by claritin. I also took 3 moderna shots before (the reported one is the 4th). In my 3rd time, I got also rash skins, but the symptoms were much more severe than this time (need to use Steroid to relieve). And the doctor diagnosed it as hives. Last time, the symptom happened 2 weeks after the shot.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Glycosylated haemoglobin increased
Clinical narrative: Type 1 diabets
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: She has irregular cycles; Nurse calling to report an AE on behalf of the HCP. She reports that a pregnant patient was given the second dose of GARDSAIL-9 on 02/27/204 at unknown gestation. The date of administration for the first dose of GARDASIL-9 is unknown by the reporter.; bleeding and clots a week before; This spontaneous report was received from a nurse referring to a pregnant female patient, who at the time of the report was 29 years old. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, lot number, expiration date, vaccination scheme frequency, route of administration and anatomical location were unknown) for prophylaxis.   On unknown date, she experienced irregular cycles (Menstruation irregular). Also, her last menstrual period (LMP) was on an unknown date. On 20-FEB-2024 (reported as a week before 27-FEB-2024), she experienced bleeding and clots (Intermenstrual bleeding). Then, on 27-FEB-2024, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly with lot number: 2032274 and expiration date: 19-JAN-2026 (dose, vaccination scheme frequency, and anatomical location were unknown) as immunization (prophylaxis), while she was pregnant (unknown gestation weeks) (exposure during pregnancy). It was reported as no symptoms or side effects was reported after the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but she had sought medical attention. At the reporting time, the outcome regarding the events was unknown.   The causal relationship between the adverse events and the vaccine was not provided.
Sex: U
Vaccine: RSV
Symptoms: Cough, Headache, Musculoskeletal chest pain, Pain
Clinical narrative: They are painful; Cough; head is going to burst or your ribcage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain (Verbatim: They are painful), cough (Verbatim: Cough) and feeling abnormal (Verbatim: head is going to burst or your ribcage). The outcome of the pain, cough and feeling abnormal were not reported.   It was unknown if the reporter considered the pain, cough and feeling abnormal to be related to Arexvy.     It was unknown if the company considered the pain, cough and feeling abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter reported that was much better that the actual symptoms. They were painful. The reporter reported that the head was going to burst or ribcage when cough. The patient had literally has to roll into a (ineligible sentence).
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Tremor
Clinical narrative: I got the shakes; got the shivers; Headache; bodyaches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tremor in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 vaccine.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, 12 hrs after receiving Shingrix, the patient experienced tremor (Verbatim: I got the shakes), shivers (Verbatim: got the shivers), headache (Verbatim: Headache) and general body pain (Verbatim: bodyaches). The outcome of the tremor, shivers, headache and general body pain were resolved (duration 18 hrs).   It was unknown if the reporter considered the tremor, shivers, headache and general body pain to be related to Shingrix.   It was unknown if the company considered the tremor, shivers, headache and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2024 This case was reported by a patient via (Shingles) interactive digital media. The patient got his shingles shot the other day, they might not like this report, but patient also got the COVID shot one in each arm and the guy said, you know, this might lay up a little bit,' and the patient did not get the license plate of the truck document, but that thing slammed him. About 12 hours later he got the shakes, got the shivers, body aches, headaches and the whole episode lasted about 18 hours and then he was ok. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Insomnia
Clinical narrative: had shot yesterday and couldn't sleep last; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleeplessness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-MAR-2024, the patient received Arexvy. In MAR-2024, an unknown time after receiving Arexvy, the patient experienced sleeplessness (Verbatim: had shot yesterday and couldn't sleep last). The outcome of the sleeplessness was not reported.   It was unknown if the reporter considered the sleeplessness to be related to Arexvy.     It was unknown if the company considered the sleeplessness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The reporter reported that We had shot yesterday and could not sleep last. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: Site was (illegible) and swelled up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced swelling (Verbatim: Site was (illegible) and swelled up). The outcome of the swelling was not reported.   It was unknown if the reporter considered the swelling to be related to Arexvy.     It was unknown if the company considered the swelling to be related to Arexvy.   Additional Information: GSK Receipt date: 22-MAR-2024 This case was reported by consumer via interactive digital media. A reporter reported that site was (illegible) and swelled up. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not receive the 2nd 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date- 26-MAR-2024 The patient did not receive the 2nd dose of Shingrix vaccine. The reporter asked if they should restart the series or get the 2nd dose. It was appeared that the patient had not yet received the dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infertility female, Premature menopause
Clinical narrative: Premature Ovarian Insufficiency; lifetime of infertility; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PREMATURE MENOPAUSE (Premature Ovarian Insufficiency) and INFERTILITY FEMALE (lifetime of infertility) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Hormone replacement therapy.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PREMATURE MENOPAUSE (Premature Ovarian Insufficiency) (seriousness criteria disability and medically significant) and INFERTILITY FEMALE (lifetime of infertility) (seriousness criteria disability and medically significant). At the time of the report, PREMATURE MENOPAUSE (Premature Ovarian Insufficiency) and INFERTILITY FEMALE (lifetime of infertility) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided.  Patient had hormone replacement therapy and other symptoms (not specified) related to Pfizer/Moderna vaccines. It was reported that, patient received treatments like Endocrinology, Fertility, Rheumology. No other details provided.  Company Comment: This is a Spontaneous case concerning a female patient of an unknown age no medical history reported, who experienced the serious (per medically significant and disability) unexpected events of PREMATURE MENOPAUSE (Premature Ovarian Insufficiency and Infertility female which occurred on an unknown date and onset latency with an unspecified dose of SPIKEVAX NOS for COVID-19 Vaccination. A mother reported that her daughter faces lifetime of infertility and hormone replacement therapy along with other unspecified symptoms. The patient was treated by Endocrinology, Fertility and Rheumatology. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-763737 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763737:Same Reporter/ Teenage girls case
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Act-Hib vaccine was administered to a patient with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid non-serious case received via physician.  This case involves an unknown age and gender patient and reporter reported an expired HIB (PRP/T) vaccine [ACT-HIB] vaccine was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UJ855AB, expiry date: 22-Mar-2024) via unknown route in unknown administration site for prophylactic vaccination (immunization) and an expired act-hib vaccine was administered to a patient with no reported adverse event (expired product administered) (unknown latency).    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE and no PQC; inadvertently administered a GARDASIL 9 dose to a 7 year old patient; This spontaneous report was received from a "HBP" and refers to an unknown gender 7-year-old patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 22-MAR-2024, the patient was inadvertently administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No adverse event was reported (no adverse event).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Erythema, Peripheral swelling, Skin warm
Clinical narrative: swollen red arm/ left breast and by tonight it is red; extensive pain in my left breast and by tonight it is red and very painful; Arm warm to touch; swollen red arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-MAR-2024, the patient received Shingles vaccine. In MAR-2024, less than a week after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: swollen red arm) and skin warm (Verbatim: Arm warm to touch). On 15-MAR-2024, the patient experienced breast pain (Verbatim: extensive pain in my left breast and by tonight it is red and very painful). On 16-MAR-2024, the patient experienced redness in breast (Verbatim: swollen red arm/ left breast and by tonight it is red). The outcome of the swelling arm, redness in breast, breast pain and skin warm were not reported.   It was unknown if the reporter considered the swelling arm, redness in breast, breast pain and skin warm to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm, redness in breast, breast pain and skin warm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-Mar-2024 This case was reported by a consumer via call center representative. Patient had the Shingles vaccine on 13-Mar-2024. On 16-Mar-2024, patient stated that she experienced all of the symptoms, and a severe swollen red arm that was warm to the touch approximately a 3 by 3 size. These all seem to be mentioned side effects. However, a day before reporting patient started to feel extensive pain in left breast and by the day of reporting it was red and very painful. Patient asked, was that normal for the redness to now appear in a new area on the body. Patient had received the Shingrix shot at her physician's office. Patient gave consent for GSK to contact her doctor.
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Raspy cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: Raspy cough). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported the by a patient via interactive digital media. The patient stated after getting the RSV shot, the patient had developed a raspy cough.
Sex: U
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: High fever, in excess of 102 degrees Fahrenheit; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: High fever, in excess of 102 degrees Fahrenheit). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported via (Open field AE monitoring) interactive digital media. The reporter stated you forgot to mention high fever, in excess of 102 degrees Fahrenheit.
Sex: F
Vaccine: RSV
Symptoms: Swelling face
Clinical narrative: swelling along her left jaw line; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling of jaw angle in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-MAR-2024, the patient received Arexvy (intramuscular, left arm). In MAR-2024, less than a week after receiving Arexvy, the patient experienced swelling of jaw angle (Verbatim: swelling along her left jaw line). The outcome of the swelling of jaw angle was unknown.   It was unknown if the reporter considered the swelling of jaw angle to be related to Arexvy.     It was unknown if the company considered the swelling of jaw angle to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-MAR-2024 The reporter reported that a patient received Arexvy a day before the reporting date and on the day of reporting the patient complained of swelling along her left jaw line. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A nurse applied a Boostrix vaccine to a newborn baby instead of the Hep-B vaccine.; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-hour-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 35S2S) for prophylaxis.   On 19-MAR-2024, the patient received the 1st dose of Boostrix. On 19-MAR-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: A nurse applied a Boostrix vaccine to a newborn baby instead of the Hep-B vaccine.) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 20-MAR-2024 and 21-MAR-2024 The initials was from the parents last names, the patient did not had a name yet and was hours old instead of 1 day old. The nurse applied a Boostrix vaccine to a newborn baby instead of the Hepatitis B vaccine which led to wrong vaccine administered and inappropriate age at vaccine administration.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: giving Havrix for adolescents as an expired dose, it was expired on November 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number 3397T, expiry date 30-NOV-2023) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: giving Havrix for adolescents as an expired dose, it was expired on November 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2024 The reporter called and requested information on given Havrix for adolescents as an expired dose. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient had received an expired dose of Havrix vaccine, which had led to expired vaccine used.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Antiphospholipid syndrome, Cough, Dehydration, Dyspnoea
Clinical narrative: 4 months later, developed chronic cough, shortness of breath, intermittent heart palpitations. soon after, extreme swelling in legs and feet. visited numerous ers, not hospitalized. later developed kidney problems.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Haematocrit decreased, Palpitations, Peripheral swelling, Renal disorder
Clinical narrative: 4 months later, developed chronic cough, shortness of breath, intermittent heart palpitations. soon after, extreme swelling in legs and feet. visited numerous ers, not hospitalized. later developed kidney problems.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: 4 months later, developed chronic cough, shortness of breath, intermittent heart palpitations. soon after, extreme swelling in legs and feet. visited numerous ers, not hospitalized. later developed kidney problems.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was 15 and the vaccine is for 18 and older, pt has no reaction to the flu vaccine,
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Lymphadenopathy
Clinical narrative: Member had Right armpit swollen lymph node.
Age: 17.0
Sex: M
Vaccine: IPV, IPV, MMR, MMR
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired last the time of administration. Ordering provider notified and she advised that there would be no harmful interaction or events to the pt and he would just need to come in for revaccination.  Pt parent notified and all questions were answered.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: given too early at 12 years of age, should have been given Menveo, not Bexsero
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tinnitus
Clinical narrative: Fever, chills, headache behind eyes & sinuses, fatigue, & loud noise in inner ear.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine on 03/21/24 and the vaccine expired on 03/15/24
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Urticaria
Clinical narrative: Extreme arm pain (left shoulder) and hives over vast majority of upper body.