chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Allergy alert test negative, Antinuclear antibody negative, Blood creatinine normal, Blood electrolytes normal
Clinical narrative: About 7 weeks after receiving the 2nd vaccine, I woke up on 7/6/21 with one red welt on the side of my neck and little bumps on  the rest of my neck. It initially didn't itch and wasn't painful. Each day that passed it got more red. Could not figure out what caused it. W/o 7/19 I thought it could be some skincare product I put on my face. I eliminated it just in case. But rash kept getting worse. Four days of Benadryl didn't help at all. Within 2 weeks, I had more welts and the small bump rash on my neck and nowhere else. By end of July,  the rash started calming down. Then after eating a meal one day the rash came back worse than before - more red, itching and hot.  I noticed that I was reacting within 1-2 hours after eating. It took some time before I realized I was reacting to food: e.g. garlic, onions, spinach, goat cheese, pineapple. A random assortment of foods that are not related. I started a very strict elimination diet and tested one food every 4 days to confirm all the foods I just mentioned I was reacting to. As I was trying to figure out which foods I was reacting to, the rash got worse. It moved to my mouth, eyelids, bridge of nose, with water bumps on my forehead. It dried out my skin to the point of it peeling and incredibly painful. Just eating 5 leaves of spinach set the rash off again all over my face. Same happened with just 1/2 tsp of grilled onions. This kept going on for months. Eventually my hands and feet started itching and tingling intermittently throughout the day. Then it moved to my arms, legs. IT wold move around my body throughout the day. Sometimes consistently itching and other times not.  I saw an allergist, who sent me to dermatology. The dermatologist sent me back to the allergist, which is when we agreed to test for food allergies... even though my symptoms were not indicative of food allergies. So something else it causing my immune system to be overstimulated. Since I don't react to vaccines, except a sore arm, and I eat a super healthy diet (no processed foods), the only thing that was different in my system was the vaccine. I have discussed with this 4 doctor and no one has any idea. I asked if infectious disease could help, and they don't think so. I think it was either the vaccine itself or the batch I had was contaminated. This reaction I'm having is just too strange.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Differential white blood cell count normal, Dry skin, Full blood count normal
Clinical narrative: About 7 weeks after receiving the 2nd vaccine, I woke up on 7/6/21 with one red welt on the side of my neck and little bumps on  the rest of my neck. It initially didn't itch and wasn't painful. Each day that passed it got more red. Could not figure out what caused it. W/o 7/19 I thought it could be some skincare product I put on my face. I eliminated it just in case. But rash kept getting worse. Four days of Benadryl didn't help at all. Within 2 weeks, I had more welts and the small bump rash on my neck and nowhere else. By end of July,  the rash started calming down. Then after eating a meal one day the rash came back worse than before - more red, itching and hot.  I noticed that I was reacting within 1-2 hours after eating. It took some time before I realized I was reacting to food: e.g. garlic, onions, spinach, goat cheese, pineapple. A random assortment of foods that are not related. I started a very strict elimination diet and tested one food every 4 days to confirm all the foods I just mentioned I was reacting to. As I was trying to figure out which foods I was reacting to, the rash got worse. It moved to my mouth, eyelids, bridge of nose, with water bumps on my forehead. It dried out my skin to the point of it peeling and incredibly painful. Just eating 5 leaves of spinach set the rash off again all over my face. Same happened with just 1/2 tsp of grilled onions. This kept going on for months. Eventually my hands and feet started itching and tingling intermittently throughout the day. Then it moved to my arms, legs. IT wold move around my body throughout the day. Sometimes consistently itching and other times not.  I saw an allergist, who sent me to dermatology. The dermatologist sent me back to the allergist, which is when we agreed to test for food allergies... even though my symptoms were not indicative of food allergies. So something else it causing my immune system to be overstimulated. Since I don't react to vaccines, except a sore arm, and I eat a super healthy diet (no processed foods), the only thing that was different in my system was the vaccine. I have discussed with this 4 doctor and no one has any idea. I asked if infectious disease could help, and they don't think so. I think it was either the vaccine itself or the batch I had was contaminated. This reaction I'm having is just too strange.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin normal, Lipids normal, Pain of skin, Paraesthesia, Pruritus
Clinical narrative: About 7 weeks after receiving the 2nd vaccine, I woke up on 7/6/21 with one red welt on the side of my neck and little bumps on  the rest of my neck. It initially didn't itch and wasn't painful. Each day that passed it got more red. Could not figure out what caused it. W/o 7/19 I thought it could be some skincare product I put on my face. I eliminated it just in case. But rash kept getting worse. Four days of Benadryl didn't help at all. Within 2 weeks, I had more welts and the small bump rash on my neck and nowhere else. By end of July,  the rash started calming down. Then after eating a meal one day the rash came back worse than before - more red, itching and hot.  I noticed that I was reacting within 1-2 hours after eating. It took some time before I realized I was reacting to food: e.g. garlic, onions, spinach, goat cheese, pineapple. A random assortment of foods that are not related. I started a very strict elimination diet and tested one food every 4 days to confirm all the foods I just mentioned I was reacting to. As I was trying to figure out which foods I was reacting to, the rash got worse. It moved to my mouth, eyelids, bridge of nose, with water bumps on my forehead. It dried out my skin to the point of it peeling and incredibly painful. Just eating 5 leaves of spinach set the rash off again all over my face. Same happened with just 1/2 tsp of grilled onions. This kept going on for months. Eventually my hands and feet started itching and tingling intermittently throughout the day. Then it moved to my arms, legs. IT wold move around my body throughout the day. Sometimes consistently itching and other times not.  I saw an allergist, who sent me to dermatology. The dermatologist sent me back to the allergist, which is when we agreed to test for food allergies... even though my symptoms were not indicative of food allergies. So something else it causing my immune system to be overstimulated. Since I don't react to vaccines, except a sore arm, and I eat a super healthy diet (no processed foods), the only thing that was different in my system was the vaccine. I have discussed with this 4 doctor and no one has any idea. I asked if infectious disease could help, and they don't think so. I think it was either the vaccine itself or the batch I had was contaminated. This reaction I'm having is just too strange.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular, Red blood cell sedimentation rate normal
Clinical narrative: About 7 weeks after receiving the 2nd vaccine, I woke up on 7/6/21 with one red welt on the side of my neck and little bumps on  the rest of my neck. It initially didn't itch and wasn't painful. Each day that passed it got more red. Could not figure out what caused it. W/o 7/19 I thought it could be some skincare product I put on my face. I eliminated it just in case. But rash kept getting worse. Four days of Benadryl didn't help at all. Within 2 weeks, I had more welts and the small bump rash on my neck and nowhere else. By end of July,  the rash started calming down. Then after eating a meal one day the rash came back worse than before - more red, itching and hot.  I noticed that I was reacting within 1-2 hours after eating. It took some time before I realized I was reacting to food: e.g. garlic, onions, spinach, goat cheese, pineapple. A random assortment of foods that are not related. I started a very strict elimination diet and tested one food every 4 days to confirm all the foods I just mentioned I was reacting to. As I was trying to figure out which foods I was reacting to, the rash got worse. It moved to my mouth, eyelids, bridge of nose, with water bumps on my forehead. It dried out my skin to the point of it peeling and incredibly painful. Just eating 5 leaves of spinach set the rash off again all over my face. Same happened with just 1/2 tsp of grilled onions. This kept going on for months. Eventually my hands and feet started itching and tingling intermittently throughout the day. Then it moved to my arms, legs. IT wold move around my body throughout the day. Sometimes consistently itching and other times not.  I saw an allergist, who sent me to dermatology. The dermatologist sent me back to the allergist, which is when we agreed to test for food allergies... even though my symptoms were not indicative of food allergies. So something else it causing my immune system to be overstimulated. Since I don't react to vaccines, except a sore arm, and I eat a super healthy diet (no processed foods), the only thing that was different in my system was the vaccine. I have discussed with this 4 doctor and no one has any idea. I asked if infectious disease could help, and they don't think so. I think it was either the vaccine itself or the batch I had was contaminated. This reaction I'm having is just too strange.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Skin warm, Urticaria
Clinical narrative: About 7 weeks after receiving the 2nd vaccine, I woke up on 7/6/21 with one red welt on the side of my neck and little bumps on  the rest of my neck. It initially didn't itch and wasn't painful. Each day that passed it got more red. Could not figure out what caused it. W/o 7/19 I thought it could be some skincare product I put on my face. I eliminated it just in case. But rash kept getting worse. Four days of Benadryl didn't help at all. Within 2 weeks, I had more welts and the small bump rash on my neck and nowhere else. By end of July,  the rash started calming down. Then after eating a meal one day the rash came back worse than before - more red, itching and hot.  I noticed that I was reacting within 1-2 hours after eating. It took some time before I realized I was reacting to food: e.g. garlic, onions, spinach, goat cheese, pineapple. A random assortment of foods that are not related. I started a very strict elimination diet and tested one food every 4 days to confirm all the foods I just mentioned I was reacting to. As I was trying to figure out which foods I was reacting to, the rash got worse. It moved to my mouth, eyelids, bridge of nose, with water bumps on my forehead. It dried out my skin to the point of it peeling and incredibly painful. Just eating 5 leaves of spinach set the rash off again all over my face. Same happened with just 1/2 tsp of grilled onions. This kept going on for months. Eventually my hands and feet started itching and tingling intermittently throughout the day. Then it moved to my arms, legs. IT wold move around my body throughout the day. Sometimes consistently itching and other times not.  I saw an allergist, who sent me to dermatology. The dermatologist sent me back to the allergist, which is when we agreed to test for food allergies... even though my symptoms were not indicative of food allergies. So something else it causing my immune system to be overstimulated. Since I don't react to vaccines, except a sore arm, and I eat a super healthy diet (no processed foods), the only thing that was different in my system was the vaccine. I have discussed with this 4 doctor and no one has any idea. I asked if infectious disease could help, and they don't think so. I think it was either the vaccine itself or the batch I had was contaminated. This reaction I'm having is just too strange.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: Delayed period of over a week; heavy period once it finally came.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hours had redness and swelling at injection site. It has worsened over the past 6 days with the redness wrapping around my arm and extending to the elbow. Hot, swollen and now painful.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Tremor
Clinical narrative: Had shortness of breath while doing everyday active over multiple days multiple times a day. Avoided exercise as a result, was usually active but afraid to exercise due to the reaction.  Initially had a terrible reaction to the 2nd dose the night of the second dose had some trouble breathing, fever, shakes, felt as bad as I've ever felt, but slowly disappeared over a about 4 days.... Then had issues of shortness of breath after these episodes. I don't remember exactly when the shortness of breath started but remember it clearly two weeks after may have started earlier.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness bilateral, Tinnitus
Clinical narrative: Tinnitus/Hearing loss in both ears but it more prevalent in my left ear.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site warmth, Pain, Pruritus, Rash
Clinical narrative: Itching and rash, painful, warm and  hardend at injection site
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Feeling abnormal, Palpitations, Photophobia
Clinical narrative: General feeling of being weak, light sensitive, and in a fog persisted 11/30-12/02; Chest pain felt mainly in the sternum area and racing heart rate despite being relaxed started at 11pm 11/29 and lasted in decreasing strength to 3am; only treatment taken was relaxing and drinking fluids, although chest pain was self monitored in case it was deemed hospital worthy
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Interchange of vaccine products, Palpitations
Clinical narrative: Patient had first two COVID vaccines that were Moderna. Booster vaccine is Pfizer. Patient present to ER on 12.8.2021 with shortness of breath, dizziness and palpatations.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Broke out in hives on arms, shoulder, abdomen, left leg, and face with swollen lips. After going to the Clinic at the facility I received the vaccine, I was prescribed a Medrol dosepak, told to keep taking Benadryl, and to continue using Calamine lotion for the itch.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Disorientation, Flatulence, Pain
Clinical narrative: Fever 102, body aches, GI discomfort(bloat and excessive gas), disoriented
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102, body aches, GI discomfort(bloat and excessive gas), disoriented
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 15:30 (Lot number: EW0182) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ASPRIN; GINKO BILOBA [GINKGO BILOBA LEAF]; FISH OIL. Vaccination history included: Bnt162b2 (dose 1, lot number: EW0162, administration time: 03:30 PM,, vaccine location: Left arm), administration date: 16Apr2021, when the patient was 61 years old, for COVID-19 immunization.The following information was reported: BACK PAIN (non-serious) with onset 07May2021 19:00, outcome "recovered" (2021), described as "Severe Lower Back Pain"; GAIT DISTURBANCE (non-serious) with onset 07May2021 19:00, outcome "recovered" (2021), described as "could barely walk.". Therapeutic measures were not taken as a result of back pain, gait disturbance. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Sinus pain
Clinical narrative: Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; This is a spontaneous report received from a contactable Consumer via COVAES. A 42-year-old non-pregnant female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection Lot number: EW0186), via unspecified route of administration, administered in arm left on 19May2021 16:00 at the age of 42 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history included Asthma and sulfa (Sulfonamide allergy). Concomitant medications included: escitalopram oxalate (LEXAPRO) and (cetirizine hydrochloride) Zyrtec. Patient previously took Codeine and Aspirin, experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 20May2021, 02:00, patient woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired. Therapeutic measures were not taken as a result of fatigue, nausea, sinus pain, malaise. Outcome of the events was recovered on an unknown date. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, COVID-19, Fall, SARS-CoV-2 test positive, Vaccination complication
Clinical narrative: This case involves a 91-year-old male patient who experienced at that time, and he got really weak and fell and was weak for days (Fall), had a terrible reaction to the flu shot last year (vaccination complication) and at that time and he got really weak and fell and was weak for days (asthenia) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's past medical history included weight loss and chemotherapy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Hypertension NOS with 5-Oct-2021, chronic kidney disease stage 3 with 5-Oct-2021), renal cell carcinoma with diagnosed in 2014, malignant melanoma stage III with diagnosed in 2013, and Lymphoma. Concomitant medications included PARACETAMOL (TYLENOL [PARACETAMOL]). On 12-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ517AA, expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious at that time and he got weak and fell and was weak for days (fall), had a terrible reaction to the flu shot last year (vaccination complication) and at that time and he got weak and fell and was weak for days (asthenia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "the patient did not get the flu vaccine this year and he had a terrible reaction to the flu shot last year and had the quadravalent shot and that was new at that time and he got really weak and fell and was weak for days; states she did not report this to VAERS and she was really concerned at the nursing home and did not want him to get that one and thought he could get the one for under age 65 and did not do that and he did not do too well with the quadravalent flu shot; states the flu shot was the Fluzone High dose administered on 120ct2020 with lot UJ517AA and he got that at pharmacy and is not sure where it was administered but is sure it was his arm." Relevant laboratory test results included: On 25-Aug-2021 and 25-Sep-2021: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test -Positive It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the reported events.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick as hell; Initial information was received on 30-Nov-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory Authority (under reference number - US-SA-SAC20211206000078)..  This case involves Adult and unknown gender patient who experienced got sick as hell (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got sick as hell (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Age: 75.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient received an expired Act-Hib with no reported adverse event; Initial information received on 29-Nov-2021 regarding an unsolicited valid  non-serious case from a pharmacist and other health care professional via regulatory agency (under reference 00875926).  This case involves a 75 year old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MENINGOCOCCAL VACCINE and PNEUMOCOCCAL VACCINE (lot numbers and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 24-Nov-2021, the patient received a dose of suspect HIB (PRP/T) VACCINE (once, lot UJ351AAB and expiry date: 09-Aug-2021) via unknown route in an unknown administration site for prophylactic vaccination (it was stated that they did not document).  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. The caller reported that a patient received an expired Act-Hib and she wanted to know what to do now."  At time of reporting, no adverse event was reported.  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 guidelines. 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: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: A patient received two doses of Fluzone HD Quad no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00878921) and transmitted to Sanofi on 30-Nov-2021.  This case involves a 88 year old male patient was received two doses INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 18-Nov-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AA, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (latency same day).  It was reported "The caller is asking for direction regarding administering a double dose of FLUZONE HD QUAD to a patient."  No other adverse event was reported.    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.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: This case involves a patient (unknown demographic) receiving YELLOW FEVER VACCINE - US [YF-VAX] she accidentally administered YF-vax in the patient's deltoid (product administered at inappropriate site). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TYPHOID VACCINE and MENINGOCOCCAL VACCINE for Prophylactic vaccination. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. It was reported "Caller stated that she was administering vaccines to a patient who will be traveling outside of the United States. Caller stated while administering vaccines, she accidentally administered YF-VAX in the patient's deltoid. Caller asking if this is okay or what she should do. The caller states that she is not sure what to ask. She states that the YF-VAX may not have been given subcutaneously and she is concerned. She states that the patient is going outside of the US and she wanted to make sure the patient is going to be safe with the yellow fever vaccine and that she is still going to get immunity even though the vaccine was given in her deltoid." It was a case of an actual medication error due to Vaccine administered at inappropriate site (latency same day). At the time of report, no adverse event reported. 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. There will be no information available on the batch number for this case.
Age: 12.0
Sex: F
Vaccine: FLU3, FLUR4
Symptoms: Wrong product administered
Clinical narrative: This case involves a 12-years-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications, and family history were not provided. On 19-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2136, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to wrong product administered. (Latency: same day). At time of reporting, no adverse event reported. 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. 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: 85.0
Sex: M
Vaccine: FLUA4
Symptoms: Pruritus
Clinical narrative: Pruritus in left arm; This spontaneous case was received on 08-Nov-2021 from a pharmacist via Agency (reference number: SEQW21-05159) and concerned an 85-year-old, male patient.  The patient's concurrent conditions included high blood pressure and sugar. The patient's concomitant medications included lisinopril, finasteride, levothyroxine and glimepiride, all used for unreported indication.  On an unspecified day in Oct-2021, a month ago as reported the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 312841 and expiry date was 19-May-2022.  On an unspecified date in 2021, after receiving Fluad Quadrivalent, the patient experienced pruritus in left arm. The pharmacist suggested treatment with Benadryl (diphenhydramine hydrochloride), but patient did not want it due to other medications he was taking.  At the time of initial reporting on 08-Nov-2021, the patient had not recovered from the event. He was experiencing it at the time of reporting.  The reporter did not provide a causality assessment.  The reporter assessed the event was assessed as non-serious.  Company comment: The event of 'localised pruritus' is assessed as unassessable to Fluad Quadrivalent .; Sender's Comments: The event of 'localised pruritus' is assessed as unassessable to Fluad Quadrivalent .
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was received on 10-Nov-2021 from a pharmacist via Med Communications (reference number: SEQW21-05255) and concerned a 72-year-old, male patient. The patient's medical history was not reported. The patient's concomitant medications included Crestor (rosuvastatin calcium), lisinopril, Propranolol (propranolol hydrochloride) and Xanax (alprazolam), all used for an unreported indication. On 25-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left deltoid and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 312828 and expiry date was 23-Apr-2022. On the same day, after receiving Fluad Quadrivalent, the patient experienced pain in the arm. On an unspecified date in 2021, the patient went to see his doctor who put him on steroids, prednisone at a dose of 20 mg, that worked for a while, but the pain came back fairly quick. At the time of initial reporting on 10-Nov-2021, the patient had not recovered from the event. The reporter did not provide a causality assessment. The reporter assessed the case as non-serious. Company Comment: A 72-year-old, male patient was vaccinated with Fluad Quadrivalent. On the same day following vaccination, the patient experienced pain in the arm. Information regarding medical history was not provided. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: A 72-year-old, male patient was vaccinated with Fluad Quadrivalent. On the same day following vaccination, the patient experienced pain in the arm. Information regarding medical history was not provided. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. B07C21A and D33R21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Jun-2021 and the estimated date of delivery was 11-Mar-2022. On 22-Apr-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information was not provided. Patient believes she became pregnant on 15JUN2021 and believes that she was 25 weeks pregnant.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Peripheral swelling
Clinical narrative: fluttering heart; shortness of breath; legs started to swell; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering heart) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 011J20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced CARDIAC FLUTTER (fluttering heart) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (legs started to swell). At the time of the report, CARDIAC FLUTTER (fluttering heart), DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (legs started to swell) had not resolved.            No concomitant medication were reported. No treatment medication were reported.  Company comment: This case concerns a patient, unknown gender and age, with medical history of pulmonary embolism, who experienced the serious, unexpected,  event of cardiac flutter. The event occurred  4 days after booster dose of mRNA 1273 vaccine. The patient's leg swelled up and experienced difficulty of breathing and fluttering heart, patient went to the ER where an ultrasound was done, no blood clots were found. The rechallenge is not applicable as there is no additional dose expected. The patient's history of pulmonary embolism remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-400023 (Patient Link).; Sender's Comments: This case concerns a patient, unknown gender and age, with medical history of pulmonary embolism, who experienced the serious, unexpected, AESI event of cardiac flutter. The event occurred  4 days after booster dose of mRNA 1273 vaccine. The patient's leg swelled up and experienced difficulty of breathing and fluttering heart, patient went to the ER where an ultrasound was done, no blood clots were found. The rechallenge is not applicable as there is no additional dose expected. The patient's history of pulmonary embolism remains a confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from an office manager via a medical assistant referring to a female patient of unknown age. The Patient's medical history, concurrent conditions and concomitant therapies were not provided.       On 03-DEC-2021, the patient was vaccinated with an expired dose of (expired vaccine used) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live  (M-M-R-II) (rha recombinant human albumin) 1 time dose (route of administration was not provided) (lot # S036664, expiration date: 14-NOV-2021) for prophylaxis. No additional information was provided.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Diabetes mellitus
Clinical narrative: SPONDYLITIS ANKYLOSING FLARE; DIABETES; This spontaneous report received from a patient concerned a 42-year-old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On SEP-2021, the patient experienced diabetes (diabetes mellitus). On NOV-2021, the patient experienced spondylitis ankylosing flare (aggravated). It was unknown if patient was enrolled in a Covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from diabetes mellitus, and spondylitis ankylosing aggravated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211215456-COVID-19 VACCINE AD26.COV2.S-diabetes mellitus. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211215456-COVID-19 VACCINE AD26.COV2.S-spondylitis ankylosing aggravated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217672.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Ear, nose and throat examination, Electrocardiogram, Magnetic resonance imaging, Nausea
Clinical narrative: Vertigo; nausea; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 039K20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) (seriousness criterion hospitalization) and NAUSEA (nausea). The patient was hospitalized for 1 day due to VERTIGO. The patient was treated with MECLIZINE [MECLOZINE] for Nausea, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo) had not resolved and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Ear, nose and throat examination: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 08 Feb 2021, the patient got the first dose of Moderna COVID-19 vaccine (lot 039K20A) and second dose (lot 029A21A) was administered on 08 Mar2021. On 17 Aug 2021, the patient had the Moderna booster. Then she developed vertigo suddenly. It put her in the hospital for a day and put her on MECLIZINE for nausea. She was been to her internist, ENT, and audiologist. She had 3 hours of audiology testing, EKG, MRI, CT scan, and ENT full examination. All the tests were negative. It was considered as a side effect of the vaccine.  No concomitant medications were reported.; Sender's Comments: This case concerns a 77-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected event of vertigo. The patient had vertigo after third dose of mRNA 1273 vaccine which required the patient to be hospitalized for 1 day. The patient underwent audiology testing, EKG, MRI, CT scan and full ENT examination which was all negative. Patient was given meclizine for nausea. The rechallenge is not applicable as patient received treatment for the events. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; nausea; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 039K20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) (seriousness criterion hospitalization) and NAUSEA (nausea). The patient was hospitalized for 1 day due to VERTIGO. The patient was treated with MECLIZINE [MECLOZINE] for Nausea, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo) had not resolved and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Ear, nose and throat examination: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 08 Feb 2021, the patient got the first dose of Moderna COVID-19 vaccine (lot 039K20A) and second dose (lot 029A21A) was administered on 08 Mar2021. On 17 Aug 2021, the patient had the Moderna booster. Then she developed vertigo suddenly. It put her in the hospital for a day and put her on MECLIZINE for nausea. She was been to her internist, ENT, and audiologist. She had 3 hours of audiology testing, EKG, MRI, CT scan, and ENT full examination. All the tests were negative. It was considered as a side effect of the vaccine.  No concomitant medications were reported.; Sender's Comments: This case concerns a 77-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected event of vertigo. The patient had vertigo after third dose of mRNA 1273 vaccine which required the patient to be hospitalized for 1 day. The patient underwent audiology testing, EKG, MRI, CT scan and full ENT examination which was all negative. Patient was given meclizine for nausea. The rechallenge is not applicable as patient received treatment for the events. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.