chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Ecchymosis, Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site pain
Clinical narrative: She got her vaccine, it was very sore immediately after even when they got home.  Her husband got the same vaccine and had no reaction other than the sore arm.  The area on her arm when the injection was given was wrinkly and it was very painful, and still is.  On 9/11/24 she started having ecchymosis that was purple and extended from her shoulder bone on her arm to almost the elbow.  It just proceeded to continue to be ecchymotic.  It is dark purple still and it is still painful to touch.  The swelling is declining, and the color is started to wane very slowly, so she still has a large ecchymotic area above her elbow and at this moment still goes up to almost the middle of her left arm.  She is a thin person and her arms are very thin.  The ecchymosis was circling down on and inside the left arm.  It is very purple and quite painful, and this is weeks later.  She went into pharmacy and reported it to Pharmacy to the same person that gave the vaccination, who did not give her the vaccine.  She saw her doctor and saw her and she took an US on her, was not sure what was happening, 2 days after the injection.  It still has not subsided.  She is on a blood thinner every day but has never had any AE event in any time in her life, and is an RN and has never seen a AE that was this bad.  She saw her PCP on 9/19/24 and felt that it was from hitting a vein and possibly hitting the bone.  She did an US which did not show any inflammation and no infection.  She did not give her anything for her symptoms.  She was instructed to take Tylenol which is the only thing she can take due to her other medications that she has taken.  She has not ever had an AE from any medication or any vaccination and was a total shock to her.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site reaction, Injection site swelling, Pain in extremity, Skin discolouration, Skin wrinkling
Clinical narrative: She got her vaccine, it was very sore immediately after even when they got home.  Her husband got the same vaccine and had no reaction other than the sore arm.  The area on her arm when the injection was given was wrinkly and it was very painful, and still is.  On 9/11/24 she started having ecchymosis that was purple and extended from her shoulder bone on her arm to almost the elbow.  It just proceeded to continue to be ecchymotic.  It is dark purple still and it is still painful to touch.  The swelling is declining, and the color is started to wane very slowly, so she still has a large ecchymotic area above her elbow and at this moment still goes up to almost the middle of her left arm.  She is a thin person and her arms are very thin.  The ecchymosis was circling down on and inside the left arm.  It is very purple and quite painful, and this is weeks later.  She went into pharmacy and reported it to Pharmacy to the same person that gave the vaccination, who did not give her the vaccine.  She saw her doctor and saw her and she took an US on her, was not sure what was happening, 2 days after the injection.  It still has not subsided.  She is on a blood thinner every day but has never had any AE event in any time in her life, and is an RN and has never seen a AE that was this bad.  She saw her PCP on 9/19/24 and felt that it was from hitting a vein and possibly hitting the bone.  She did an US which did not show any inflammation and no infection.  She did not give her anything for her symptoms.  She was instructed to take Tylenol which is the only thing she can take due to her other medications that she has taken.  She has not ever had an AE from any medication or any vaccination and was a total shock to her.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Ultrasound scan normal, Vaccination site pain
Clinical narrative: She got her vaccine, it was very sore immediately after even when they got home.  Her husband got the same vaccine and had no reaction other than the sore arm.  The area on her arm when the injection was given was wrinkly and it was very painful, and still is.  On 9/11/24 she started having ecchymosis that was purple and extended from her shoulder bone on her arm to almost the elbow.  It just proceeded to continue to be ecchymotic.  It is dark purple still and it is still painful to touch.  The swelling is declining, and the color is started to wane very slowly, so she still has a large ecchymotic area above her elbow and at this moment still goes up to almost the middle of her left arm.  She is a thin person and her arms are very thin.  The ecchymosis was circling down on and inside the left arm.  It is very purple and quite painful, and this is weeks later.  She went into pharmacy and reported it to Pharmacy to the same person that gave the vaccination, who did not give her the vaccine.  She saw her doctor and saw her and she took an US on her, was not sure what was happening, 2 days after the injection.  It still has not subsided.  She is on a blood thinner every day but has never had any AE event in any time in her life, and is an RN and has never seen a AE that was this bad.  She saw her PCP on 9/19/24 and felt that it was from hitting a vein and possibly hitting the bone.  She did an US which did not show any inflammation and no infection.  She did not give her anything for her symptoms.  She was instructed to take Tylenol which is the only thing she can take due to her other medications that she has taken.  She has not ever had an AE from any medication or any vaccination and was a total shock to her.
Age: 79.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Vaccination site haemorrhage, Vaccination site pain, Vaccination site swelling
Clinical narrative: She got her vaccine, it was very sore immediately after even when they got home.  Her husband got the same vaccine and had no reaction other than the sore arm.  The area on her arm when the injection was given was wrinkly and it was very painful, and still is.  On 9/11/24 she started having ecchymosis that was purple and extended from her shoulder bone on her arm to almost the elbow.  It just proceeded to continue to be ecchymotic.  It is dark purple still and it is still painful to touch.  The swelling is declining, and the color is started to wane very slowly, so she still has a large ecchymotic area above her elbow and at this moment still goes up to almost the middle of her left arm.  She is a thin person and her arms are very thin.  The ecchymosis was circling down on and inside the left arm.  It is very purple and quite painful, and this is weeks later.  She went into pharmacy and reported it to Pharmacy to the same person that gave the vaccination, who did not give her the vaccine.  She saw her doctor and saw her and she took an US on her, was not sure what was happening, 2 days after the injection.  It still has not subsided.  She is on a blood thinner every day but has never had any AE event in any time in her life, and is an RN and has never seen a AE that was this bad.  She saw her PCP on 9/19/24 and felt that it was from hitting a vein and possibly hitting the bone.  She did an US which did not show any inflammation and no infection.  She did not give her anything for her symptoms.  She was instructed to take Tylenol which is the only thing she can take due to her other medications that she has taken.  She has not ever had an AE from any medication or any vaccination and was a total shock to her.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: We did not mix the Liquid Conjugate component with the Men A Lyophilized Conjugate compound powder together.  Was only given the liquid
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events at this time, received extra dose of seasonal flu vaccine
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: 2 days of fever, chills, nausea to everything ingested , headache, body aches/pains.  Day 2, hives, breathing issues
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: 2 days of fever, chills, nausea to everything ingested , headache, body aches/pains.  Day 2, hives, breathing issues
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient reports pain at the time of injection and still has pain 12 days later in the left shoulder/deltoid region.  Parent felt TdaP was given high on the shoulder and may have contributed to increased pain.  He c/o not being able to move his left arm above his shoulder for the first few days.  He has resumed school and competitive hockey activities but still c/o left shoulder pain
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate increased
Clinical narrative: PAtient stated around 3am on 9/7/24 they experienced accelerated heartrate that led to atrial fibriliation, but they self converted back to normal rhythem over the course of that morning - patient requested that they would like to have this data submitted to spread awareness
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Immunisation reaction, Injection site erythema, Injection site mass, Injection site swelling, Injection site urticaria
Clinical narrative: Stung and very very itchy soon after shot. Later develop large hive over injection  hard lump at site. Next day swollen upper arm large pink upper arm, COVID arm. Still have it today on September 23rd.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain, Pruritus
Clinical narrative: Stung and very very itchy soon after shot. Later develop large hive over injection  hard lump at site. Next day swollen upper arm large pink upper arm, COVID arm. Still have it today on September 23rd.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: received extra dose of seasonal flu
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of Fluzone instead of 1 dose of fluzone and 1 dose of COVID. Patient was made aware of situation and did not have any immediate effects.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria, Vaccination site pain
Clinical narrative: at 9:00 pm post vaccination, Patient reports pain at vaccination site as well as full body itching. By 11:30 pm she reports hives on face, chest and knees.  Patient took 20 mg Cetirizine and saw improvement in symptoms by 9/21 at roughly 02:00 pm
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, patient received an extra Prevnar.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: accident a third dose of Rotarix (liquid) on September 3rd 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix liquid formulation) (batch number 5F7L2, expiry date 08-MAY-2026) for prophylaxis.   Concomitant products included Rotavirus vaccine live oral 1v (Rotarix) and Rotavirus vaccine live oral 1v (Rotarix).   On 03-SEP-2024, the patient received the 3rd dose of Rotarix liquid formulation. On 03-SEP-2024, an unknown time after receiving Rotarix liquid formulation and an unknown time after receiving Rotarix, the patient experienced extra dose administered (Verbatim: accident a third dose of Rotarix (liquid) on September 3rd 2024). The outcome of the extra dose administered 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-SEP-2024 The medical assistant reported that they administered by accident a third dose of Rotarix (liquid) vaccine because they got confused with the Rotateq schedule, which led to extra dose administered.
Age: 51.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Erythema, Hypoaesthesia, Skin warm
Clinical narrative: Extremely hot red skin for more than 3 days in  right injection arm, slight numbness for more than 3 days in right injection arm.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, persistent positional headache. Fever/aches lasted a day. Positional headache (mostly felt when moving head, standing up) is ongoing.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Came back 3 days later complaining of fever, dizziness, and headache.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Peripheral swelling, Skin warm
Clinical narrative: Patient reported on 09/19/2024 that she received RSV shot within 9 months and had an adverse reaction to the second time she got the shot. She stated she forgot that she had already received the RSV shot (Arexvy) on 12/28/2023 and signed up to receive another RSV shot (Arexvy) and received on 09/01/2024. She stated the first time she received the RSV shot on 12/28/2023 she had no reaction but on 09/01/2024 when she accidentally received another dose of RSV her entire arm swelled up for 6 days and was very warm. Pt stated she did not report it to her MD.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Eye pruritus, Urticaria
Clinical narrative: Patient reports that she had itchy eyes 2 days after the vaccination and 4 days after vaccination reports that she had hives, "red spots" on her body including her stomach.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Hives on right cheek, left eyebrow. Rash on chest, arms, abdomen.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: hives
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: There was no adverse effect.
Age: 80.0
Sex: F
Vaccine: RSV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: The day after the shot, the area under the shot began to itch and turn red.  By that evening, the itching had progressed down toward the bicep, and over the following 2 days, it covered the entire bicep, becoming red, puffy and slightly bumpy.  For the next2 weeks, it began to itch occasionally during the day, and every evening after dinner.  On two occasions, there was a stabbing pain in the arm that woke me up.  Occasional paresthesias in the left hand.  It has continued to itch a little every day/ evening since then, buthas almost stopped.  Redness and bumpiness no longer visible after week 2.
Age: 80.0
Sex: F
Vaccine: RSV, TDAP, VARZOS
Symptoms: Paraesthesia, Skin texture abnormal, Sleep disorder
Clinical narrative: The day after the shot, the area under the shot began to itch and turn red.  By that evening, the itching had progressed down toward the bicep, and over the following 2 days, it covered the entire bicep, becoming red, puffy and slightly bumpy.  For the next2 weeks, it began to itch occasionally during the day, and every evening after dinner.  On two occasions, there was a stabbing pain in the arm that woke me up.  Occasional paresthesias in the left hand.  It has continued to itch a little every day/ evening since then, buthas almost stopped.  Redness and bumpiness no longer visible after week 2.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Flushing, Hypoaesthesia oral, Injection site pruritus
Clinical narrative: Anaphylaxis - started with itching at site of injection, followed by dizziness, facial flushing, perioral numbness/tingling, tongue swelling, and throat tightness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue, Throat tightness
Clinical narrative: Anaphylaxis - started with itching at site of injection, followed by dizziness, facial flushing, perioral numbness/tingling, tongue swelling, and throat tightness
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: vaccine recieved on thursday, arm became red and swollen below the administration site.  painful, rash below site, itchy, hot to the touch.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: vaccine recieved on thursday, arm became red and swollen below the administration site.  painful, rash below site, itchy, hot to the touch.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder
Clinical narrative: Pt had a CV event within a minute after shot.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: AFTER PATIENT RECEIVING MODERNA VACCINE (2024-2025 FORMULATION), PATIENT STARTED HAVING ANAPHYLACTIC REACTION OF DIFFICULTY BREATHING. VITAL SIGNS OF PATIENT DURING THE REACTION WERE AS FOLLOWS: BP 150/100, PULSE 96, RR 20, & O2 SATURATION OF 87%. PATIENT RECOVERED QUICKLY AFTER ADMINISTRATION OF EPIPEN ON HER LEFT THIGH INTRAMUSCULARLY. PARAMEDICS ARRIVED PER PROTOCOL AND PATIENT WAS TAKEN FOR FURTHER MONITORING. PATIENT RETURNED TO THE FACILITY AT 6PM FROM HOSPITAL SAME DAY, SEPTEMBER 15, 2024. NO FURTHER TREATMENT WAS NECESSARY.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: Patient lost consciousness while seated for 1-2 minutes after receiving fluzone and comirnaty shots in left arm after seeing her blood.  She urinated on the floor.  Dad moved her safely to clean area on floor, she regained consciousness and did not recall events but seemed ok.  EMS was called and she was taken to ER.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: Patient reported having a seizure several days after receiving the vaccine. Patient has a history of seizures so uncertain whether vaccine contributed to seizure occurrence.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Accidentally grabbed 12+ instead of 6-11 year old dose of covid vaccine. (Patient is actually 5'5" and 148.2 lbs, so it didn't register until I went to chart her vaccine).
Age: 87.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient had previously received a prevnar 20 vaccine on 10/13/2022 and received a second dose on 09/19/2024
Age: 20.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Dysstasia, Muscular weakness
Clinical narrative: Dizzyness, weakness in legs (could not stand up off of toilet), temperature (100.5)
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: and they got it again this year; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX3T4, expiry date 20-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (received Arexvy on 5th September 2023 with batch number 5AN52 and expiration date 20th October 2024). Concurrent medical conditions included immunocompromised and crohn's disease.   On 12-SEP-2024 09:12, the patient received the 2nd dose of Arexvy. On 12-SEP-2024 09:12, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: and they got it again this year). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2024 The pharmacist reported that the  patient received the Arexvy last year, and they got it again this year which led to extra dose administered.  The pharmacist just wanted to make sure like for safety purposes, like they want to be sure that was okay, the  pharmacist meant they were immunocompromised, so the pharmacist just wanted to get the information to be able to pass it to the patient. The Vaccine Administration Facility was the same as Primary Reporter. The pharmacist mentioned that this same patient had Crohn's disease.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: On Friday, her arm was red and itchy
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Soreness and pain in the injection site and shoulder x one month.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Heart rate increased, Insomnia
Clinical narrative: Patient reports insomnia, shakes, fatigue, chills, increased heart rate and weakness the day after vaccination and proceeded to urgent care for assessment 2 to 3 days later.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient reports insomnia, shakes, fatigue, chills, increased heart rate and weakness the day after vaccination and proceeded to urgent care for assessment 2 to 3 days later.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Joint dislocation
Clinical narrative: After a fall down two steps, I had a shoulder dislocation in the arm in which I received the vaccine (left arm)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came in 3 days later after receiving Comirnaty with the injection site area red, swollen, itching and painful to the touch.  She said she had put ice on it and had taken Tylenol and the area wasn't getting better.  I explained it may be infected and she should go the doctor and get an antibiotic since it wasn't getting better and it had been 3 days.  She said she would go the doctor.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: CELLULITIS TO THE LEFT ARM 3INX3IN
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: rash developed on her trunk/the rash spread from her trunk to her thighs; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number b94b3, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2023-2024 season (left arm). On an unknown date, 5 hrs after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced rash (Verbatim: rash developed on her trunk/the rash spread from her trunk to her thighs). The outcome of the rash was resolved (duration 1 month).   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the rash to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra 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 dat: 13-SEP-2024 The reporter was the patient who received a dose of Fluarix vaccine last year in (2023). After the dose, she went to the ER (Emergency room) due to a rash that developed on her trunk 5-6 hours after she received the dose.  The rash spread from her trunk to her thighs. The reporter mentioned that symptoms lasted for a month then resolved. The reporter did not consent to follow up.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; 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 47-year-old male patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 13-SEP-2024, the patient received Engerix B. On 13-SEP-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable.   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: 13-SEP-2024 The reporter reported that the they have a Engerix B (Hepatitis B) vaccine that they have here and they actually expired on 9th September 2024 and they did not realize that and it was given to a patient which led to Expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Covid; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Covid). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Covid) outcome was unknown.            No concomitant medications were reported. It was reported that patient had Long Covid for the past three and a half years. The patient received 4 vaccines (J and J, Moderna and 2 Pfizer) and all of them had presented similar results. All symptoms had resolved within two weeks but had returned a few months later. The patient had not reported COVID. No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nausea, Pyrexia
Clinical narrative: does not feel really well; feeling bad; fever; feeling nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (feeling bad), PYREXIA (fever), NAUSEA (feeling nauseous) and MALAISE (does not feel really well) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad), PYREXIA (fever), NAUSEA (feeling nauseous) and MALAISE (does not feel really well). At the time of the report, FEELING ABNORMAL (feeling bad), PYREXIA (fever), NAUSEA (feeling nauseous) and MALAISE (does not feel really well) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. The caller also shares that his wife was feeling bad as well. The caller stated that it was the first time for his wife to experience the fever. The caller narrates that his wife got the fever a day after she got the vaccine. Furthermore, the caller states that his wife can move around but does not feel really well and was feeling nauseous. Reporter causality was not reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-774018, US-MODERNATX, INC.-MOD-2024-774020 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774018:husband's case US-MODERNATX, INC.-MOD-2024-774020:husband's case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: Alphagal syndrome; This spontaneous case was reported by a patient and describes the occurrence of FOOD ALLERGY (Alphagal syndrome) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Tick bite (. Had a tick bite last week in March 2020) in March 2020. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (had vaccines every time they've been recommended and and all were Moderna). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Sep-2022, the patient experienced FOOD ALLERGY (Alphagal syndrome). At the time of the report, FOOD ALLERGY (Alphagal syndrome) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The symptom was diagnosed after receiving a Moderna vaccine. Patient had vaccines every time they've been recommended, and all were Moderna. The first year of COVID vaccines, had more than most people were getting due to immunosuppression. Patient did not get the Alphagal test until the next fall -2022. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774126 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774126:Same reporter different patient
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Visual impairment
Clinical narrative: lightheadedness; headache; problems with vision; This spontaneous case was reported by a physician and describes the occurrence of VISUAL IMPAIRMENT (problems with vision), DIZZINESS (lightheadedness) and HEADACHE (headache) in a 77-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1), Moderna COVID-19 Vaccine (Dose 4), Moderna COVID-19 Vaccine (Dose 3) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Hypertension (controlled and diagnosed prior to any Covid vaccine), Glaucoma (controlled and diagnosed prior to Covid vaccine) and Bladder cancer (diagnosed "well before" any vaccine).    On 14-Sep-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 16-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VISUAL IMPAIRMENT (problems with vision). On 19-Sep-2024, the patient experienced DIZZINESS (lightheadedness) and HEADACHE (headache). At the time of the report, VISUAL IMPAIRMENT (problems with vision), DIZZINESS (lightheadedness) and HEADACHE (headache) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction from the vaccine; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (had an allergic reaction from the vaccine) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (had an allergic reaction from the vaccine). At the time of the report, HYPERSENSITIVITY (had an allergic reaction from the vaccine) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported.   Reporter did not allow further contact
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: has experienced severe episodes of dizziness; vertigo; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (has experienced severe episodes of dizziness) and VERTIGO (vertigo) in an 81-year-old patient of an unknown gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 19-Sep-2024 at 2:30 PM, the patient experienced DIZZINESS (has experienced severe episodes of dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (has experienced severe episodes of dizziness) and VERTIGO (vertigo) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient experienced severe episodes of dizziness and vertigo. and still not feeling quite right. Reporter causality was not reported.  Treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Device leakage, Exposure via eye contact, Occupational exposure to product
Clinical narrative: some of the vaccine leaked on the syringe; Some of the vaccine went to the technician's eye; Some of the vaccine went to the technician's eye; This is a spontaneous report received from a Pharmacist from medical information team. A 25-year-old female patient was exposed to BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), (Lot number: LM2215, Expiration Date: 15Mar2025) at the age of 25 years for covid-19 immunisation while administering the vaccine. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), described as "some of the vaccine leaked on the syringe"; OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA EYE CONTACT (non-serious) and all described as "Some of the vaccine went to the technician's eye". Additional information: Pharmacist on the other line stated that they administered Comirnaty 12 and up. However, some of the vaccine leaked on the syringe and some of the vaccine contents went to the technician's eye. The technician was the one who administered the vaccine. The caller thought it was a problem with the syringe. When the vaccine was administered and the vaccine leaked. The caller wanted to know what to do, because some of the vaccine content that splatter went to the technician's eye. Their technician was the one who administered the vaccine.   Causality for "some of the vaccine leaked on the syringe" and "some of the vaccine went to the technician's eye" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).
Sex: U
Vaccine: RSV
Symptoms: Device breakage, Device defective
Clinical narrative: vial adaptor inside almost looked like it was defective; Went to put it on to the vial and went to inject the diluent into the vial but everything went into the vial adaptor; It did not go down; It looked like it blunts; Something has been broken off; This is a spontaneous report received from a Nurse.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9865, Expiration Date: Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 17Sep2024, outcome "unknown", described as "Went to put it on to the vial and went to inject the diluent into the vial but everything went into the vial adaptor; It did not go down; It looked like it blunts; Something has been broken off"; DEVICE DEFECTIVE (non-serious) with onset 17Sep2024, outcome "unknown", described as "vial adaptor inside almost looked like it was defective".  Causality for "vial adaptor inside almost looked like it was defective" and "went to put it on to the vial and went to inject the diluent into the vial but everything went into the vial adaptor; it did not go down; it looked like it blunts; something has been broken off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Nurse called regarding the Abrysvo vaccine kit and a defect that they experienced on 17Sep2024 was with the vial adaptor. The reporter stated that the vial adaptor inside almost looked like it was defective. So, they went to put it on to the vial and then went to inject the diluent into the vial, but everything went into the vial adaptor, because nurse guessed that it did not go down on all the way. When you look at it, it looked like it blunts something may have been broken off. So, they just pull the kit and left aside and pull another kit to use for the patient. It did not make it to the patient, it was all in the preparation.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pelvic pain, Vaccination site pain
Clinical narrative: pain in shoulder at injection point/in right arm; pain in pelvic area; down the right side, all around that joint; pain in pelvic area; down the right side, all around that joint; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke", start date: 2004 (unspecified if ongoing), notes: 20 years ago; "Blood pressure" (unspecified if ongoing); "to keep cholesterol in check/ keep cholesterol down" (unspecified if ongoing); "prostate check / help keep prostate in check" (unspecified if ongoing); "to keep blood thin" (unspecified if ongoing); "flu like symptoms" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement, start date: 2004 (ongoing); CLOPIDOGREL taken for blood cholesterol abnormal, start date: 2004 (ongoing); MYRBETRIQ taken for prostatic disorder (ongoing); BABY ASPIRIN taken for anticoagulant therapy, start date: 2004 (ongoing); TAMSULOSIN taken for prostatic disorder (ongoing); ROSUVASTATIN taken for blood cholesterol abnormal (ongoing); FISH OIL; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Moderna covid vaccines (Dose 1), for Covid-19 immunization, reaction(s): "never had reaction"; Moderna covid vaccines (Dose 2), for Covid-19 immunization, reaction(s): "never had reaction"; Moderna covid vaccines (Dose 3 (booster)), for Covid-19 immunization, reaction(s): "never had reaction"; Moderna covid vaccines (Dose 4 (booster)), for Covid-19 immunization, reaction(s): "never had reaction". The following information was reported: PELVIC PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Sep2024, outcome "unknown" and all described as "pain in pelvic area; down the right side, all around that joint"; VACCINATION SITE PAIN (non-serious) with onset 18Sep2024, outcome "unknown", described as "pain in shoulder at injection point/in right arm".  Additional information: The patient had Covid booster shot on 17Sep2024 and he did not like the reaction. He had 4 doses of Moderna Covid vaccines, never had reaction, never had this adverse effect. Woke up with pain in shoulder at injection point, occurring in his functional arm. Tried to walk, feels better but, recovering from stoke and, this is affecting the good side. Patient was hoping, after having breakfast, would take some Ibuprofen, to be free from feeling of pain, over the counter, 200mg Ibuprofen.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Eye pain, Headache
Clinical narrative: Binocular oblique deployia/ Double vision; Eye pain; headache; dizziness; This is a spontaneous report received from a Nurse from a sales representative.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIPLOPIA (disability) with onset 21Nov2021, outcome "not recovered", described as "Binocular oblique deployia/ Double vision"; EYE PAIN (disability) with onset 21Nov2021, outcome "not recovered"; DIZZINESS (disability) with onset 21Nov2021, outcome "not recovered"; HEADACHE (disability) with onset 21Nov2021, outcome "not recovered". Therapeutic measures were taken as a result of diplopia, eye pain, headache, dizziness. Clinical Course: It was unknown if patient received other vaccine same date or if other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the limited information currently available, the possible contribution of the administration of suspect vaccine BNT162B2 to the reported events cannot be completely excluded. This case will be re-assessed should new information becomes available. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria (hives) all over the body within approximately a week/continue to have hives 3 months later; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Jun2024 as dose 1, single (Lot number: LE1811) at the age of 40 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Occasional eczema (on palms)" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing), notes: allergic dermatitis reaction; "Lactose intolerance" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL XL, start date: Jan2021; DEXAMPHETAMINE, start date: Apr2022; NORETHISTERONE, start date: 01Apr2024. Past drug history included: Cephalexin, reaction(s): "Hypersensitivity"; Cephalexin, reaction(s): "Hives". The patient did not receive any vaccines on the same date as the vaccine(s). The patient did not receive any vaccines within 4 weeks prior to the vaccine(s). The following information was reported: URTICARIA CHRONIC (non-serious) with onset 15Jun2024, outcome "not recovered", described as "Chronic urticaria (hives) all over the body within approximately a week/continue to have hives 3 months later". Therapeutic measures were taken as a result of urticaria chronic. Treatment included dermatological and allergist appointments and over-the-counter and prescription antihistamines.
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Fatigue
Clinical narrative: Extremely fatigued; Does not have any energy; Just laying around; This is a spontaneous report received from a Pharmacist.  A female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 11Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset Sep2024, outcome "unknown", described as "Does not have any energy; Just laying around"; FATIGUE (non-serious) with onset Sep2024, outcome "unknown", described as "Extremely fatigued".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: There was a big red area underneath the injection site; looked like I had been sunburned; was about the size of the baseball, like surface area wise, really big; it was painful for the first week after; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "There was a big red area underneath the injection site; looked like I had been sunburned; was about the size of the baseball, like surface area wise, really big"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "it was painful for the first week after".  Batch/lot number is not provided, and it cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; itching; swelling; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 at 14:00 as dose 1, single (Lot number: 00069-2432-10) at the age of 38 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 19Sep2024 as dose number unknown, single (Lot number: 70461-0654-03), in left arm. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct2020. The following information was reported: ERYTHEMA (non-serious) with onset 19Sep2024 at 14:00, outcome "not recovered", described as "Redness"; PRURITUS (non-serious) with onset 19Sep2024 at 14:00, outcome "not recovered", described as "itching"; SWELLING (non-serious) with onset 19Sep2024 at 14:00, outcome "not recovered". Therapeutic measures were not taken as a result of erythema, pruritus, swelling. Additional information: patient had no known allergies. The patient did not received any other vaccine in four weeks. Redness, itching, and swelling lasting more than 48 hrs post injection. No follow-up attempts are possible.