chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DAPTACEL was inadvertently given instead of Adacel with no reported adverse event; DAPTACEL was inadvertently given instead of Adacel with no adverse event; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional via Media Information (under reference 00833274).  This case involves an 11 year old female patient who was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) [wrong product administered and product administered to patient of inappropriate age].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  28-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Total, lot 65829BA and expiration date: 01-Mar-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  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 of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose, with no reported adverse event; Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case from an other health professional via consumer via phone call (under  Medical Information Inquiry Number: 00834434) in a specific country.  This case involves a 48 years old female patient who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 29-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled) (lot number: UT7108KA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "How do we handle it; health care professional (HCP) reporting a patient who received an expired dose of FLUZONE QUADRIVALENT (prefilled); caller would like counselling on revaccination process and adverse effects to look out for."  At the 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 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: FLUR4, FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient administered with Flublok instead of the regular flu shot , no reported adverse event; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professionals via Regulatory Authority (under reference number 00837217).  This case involves 6 child (unknown gender) patients who were administered with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of the regular INFLUENZA VACCINE (wrong product administered).   The medical history, past medical treatment(s), vaccination(s) ,concomitant medication(s) and family history were not provided.  On 01-Nov-2021, the patients received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number QFAAZ150 and expiry date 30-Jun-2022) instead of the regular INFLUENZA VACCINE via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (same day latency).  It was reported "Practice Manager states when the pharmacy provider sent the Flu shot to them they didn't realize it was FLUBLOK instead of the regular flu for a pediatric office and they administered 6 children the dose. Caller would like to know what to do?"  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: F
Vaccine: HIBV, MMR
Symptoms: Product preparation error
Clinical narrative: administering ACTHIB on  saline diluent for ACTHIB was not used for reconstitution; diluent from MMR was used with no adverse event; Initial information regarding an unsolicited non-valid non serious case was received from other health professional via Medical Information (MI) (Reference number: 00838515) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 7-month-old female patient administering HIB (PRP/T) VACCINE [ACT-HIB] on  saline diluent for HIB (PRP/T) VACCINE [ACT-HIB]  was not used for reconstitution; diluent from MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR VACCINE] with the use of medical device FLUZONE QUADRIVALENT PRE-FILLED SYRINGE (Product preparation error).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT).  On 01-Nov-2021, the patient received a fourth dose of 0.5 mL total dose of suspect HIB (PRP/T) VACCINE [lot UJ579AA, expiry date 09-Oct-2021] via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient started using MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  This was actual medication error case due to wrong solution used in drug reconstitution (latency same day).  It was reporter "Caller reports administering ACTHIB on 01Nov2021; saline diluent for ACTHIB was not used for reconstitution; diluent from  MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE was used."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was 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 was 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 had 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 FLUZONE QUADRIVALENT.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Mobility decreased, Peripheral swelling, Viral infection
Clinical narrative: LEFT ARM SWELLING TO THE POINT UNABLE TO RAISE ARM IN LATERAL MANNER. CALLED INTO WORK SICK CAUSE COULD NOT LIFT EITHER  1 YEAR OLD TWIN.  Also viral illness set in causing patient to miss 2 days of work.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Eating disorder, Hypophagia, Speech disorder, Trigeminal neuralgia
Clinical narrative: The symptoms of the trigeminal neuralgia very suddenly became worse in the month following the shot. Before attacks would be every few months and we?re controlled by medication. After October attacks came multiple times a day and medicine no longer worked. Eating, talking, and drinking at times have been impossible.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: My son has had a constant fever since 11/08/21, Monday night. Fever was 102.6. He was not able to sleep during the night. Fever came down to 102.0 with Tylenol. After six hours, I have him Motrin and his fever stayed between 102.3 and 101.0. He had fever readings within that range throughout the day. On 11/09/21 at 7pm, gave him Motrin again.  On 11/09/21 he went to bed with a  temperature of 99.5.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Severe nausea, vomiting, aches, fever, weakness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blindness, Blood cortisol, Blood immunoglobulin A
Clinical narrative: Immediately: site soreness, erythema at injection, lethargy 14 days post vaccine: diaphoresis, severe epigastric pain, nausea, vomiting, diarrhea,  severe lethargy, severe weakness, unable to tolerate PO x 6 days until clear fluids but chronic inability to tolerate solid PO until medical intervention, near syncope with loss of vision and visual disturbances, bounding pulse and increased pulse rate, hypertension with diaphoresis and night sweats x 5 months with interventions from PCP and referral to cardiologist for rule out cardiac origin. Medical disabled from work. Cardiologist ruled out cardiac origin. Medications started and helping but overall s/s not resolved, new referral to neurologist.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood test, Blood thyroid stimulating hormone, C-reactive protein, Diarrhoea
Clinical narrative: Immediately: site soreness, erythema at injection, lethargy 14 days post vaccine: diaphoresis, severe epigastric pain, nausea, vomiting, diarrhea,  severe lethargy, severe weakness, unable to tolerate PO x 6 days until clear fluids but chronic inability to tolerate solid PO until medical intervention, near syncope with loss of vision and visual disturbances, bounding pulse and increased pulse rate, hypertension with diaphoresis and night sweats x 5 months with interventions from PCP and referral to cardiologist for rule out cardiac origin. Medical disabled from work. Cardiologist ruled out cardiac origin. Medications started and helping but overall s/s not resolved, new referral to neurologist.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram ambulatory, Fibrin D dimer, Full blood count, Heart rate increased
Clinical narrative: Immediately: site soreness, erythema at injection, lethargy 14 days post vaccine: diaphoresis, severe epigastric pain, nausea, vomiting, diarrhea,  severe lethargy, severe weakness, unable to tolerate PO x 6 days until clear fluids but chronic inability to tolerate solid PO until medical intervention, near syncope with loss of vision and visual disturbances, bounding pulse and increased pulse rate, hypertension with diaphoresis and night sweats x 5 months with interventions from PCP and referral to cardiologist for rule out cardiac origin. Medical disabled from work. Cardiologist ruled out cardiac origin. Medications started and helping but overall s/s not resolved, new referral to neurologist.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Immediate post-injection reaction, Impaired work ability, Injection site erythema
Clinical narrative: Immediately: site soreness, erythema at injection, lethargy 14 days post vaccine: diaphoresis, severe epigastric pain, nausea, vomiting, diarrhea,  severe lethargy, severe weakness, unable to tolerate PO x 6 days until clear fluids but chronic inability to tolerate solid PO until medical intervention, near syncope with loss of vision and visual disturbances, bounding pulse and increased pulse rate, hypertension with diaphoresis and night sweats x 5 months with interventions from PCP and referral to cardiologist for rule out cardiac origin. Medical disabled from work. Cardiologist ruled out cardiac origin. Medications started and helping but overall s/s not resolved, new referral to neurologist.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Metabolic function test, Nausea, Night sweats
Clinical narrative: Immediately: site soreness, erythema at injection, lethargy 14 days post vaccine: diaphoresis, severe epigastric pain, nausea, vomiting, diarrhea,  severe lethargy, severe weakness, unable to tolerate PO x 6 days until clear fluids but chronic inability to tolerate solid PO until medical intervention, near syncope with loss of vision and visual disturbances, bounding pulse and increased pulse rate, hypertension with diaphoresis and night sweats x 5 months with interventions from PCP and referral to cardiologist for rule out cardiac origin. Medical disabled from work. Cardiologist ruled out cardiac origin. Medications started and helping but overall s/s not resolved, new referral to neurologist.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pulse abnormal, Urine analysis, Visual impairment, Vomiting
Clinical narrative: Immediately: site soreness, erythema at injection, lethargy 14 days post vaccine: diaphoresis, severe epigastric pain, nausea, vomiting, diarrhea,  severe lethargy, severe weakness, unable to tolerate PO x 6 days until clear fluids but chronic inability to tolerate solid PO until medical intervention, near syncope with loss of vision and visual disturbances, bounding pulse and increased pulse rate, hypertension with diaphoresis and night sweats x 5 months with interventions from PCP and referral to cardiologist for rule out cardiac origin. Medical disabled from work. Cardiologist ruled out cardiac origin. Medications started and helping but overall s/s not resolved, new referral to neurologist.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Malaise, Pain
Clinical narrative: Was Horrible. I couldn't breathe. Like 6 months feeling Bad. Body pain, headaches. I was like dieing. Crazy and without health Insurance.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on complete R arm and R lower extremity especially the calf, foot. Ambulation was possible but slower than usual. Walking and continuing activity as usual appeared to help. The numbness did not start improving until the 5th day, first resolved in the arm.  The numbness continued in the lower extremity, there was slight improvement progressing from the 5h day and resolving by the end of the 9th day. This adverse reaction was not reported to my Nurse Practitioner until the next visit possibly in January 2020. I do not recollect that we went into any of the details mentioned here. Only my concern that I would not be able to receive the flu vaccine again. I do not recollect that there were notes taken to include in my chart.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Undiluted Pfizer COVID 19 vaccination for patients age 5-11 was administered. 0.2ml of undiluted vaccine was administered to the patient. Patient was monitored for over 15 minutes with no adverse reaction. Followed up with the patient 6 hours later and patient was still without any adverse reaction. Manufacturer was contacted and sent guidelines stating that dose did not need to be re-administered and may receive 2nd dose 21 days after.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Undiluted Pfizer COVID 19 vaccination for patients age 5-11 was administered. 0.2ml of undiluted vaccine was administered to the patient. Patient was monitored for over 15 minutes with no adverse reaction. Followed up with the patient 6 hours later and patient was still without any adverse reaction. Manufacturer was contacted and sent guidelines stating that dose did not need to be re-administered and may receive 2nd dose 21 days after.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Dizziness, Dysgeusia
Clinical narrative: I was feeling fine the day of the vaccine other than the pain. Next day the pain was bad but bearable. The problems began when I started feeling sick at around 5:30-6ishpm and I progressively got worse. I got a headache, felt very weak, got a itchy painful bump on my arm, painful soreness on my legs, painful eye movements, weird bitter medicine like taste, brain "zaps", nausea, numb lips, weird painful feeling throughout my body when I get up and walk. I can barely walk places without help, it makes me light headed and feel extremely weak. I also got really cold and got chills which then lead to an anxiety attack? I thought that was odd. I was shaking a lot feeling cold.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling cold, Headache, Hypoaesthesia oral, Malaise
Clinical narrative: I was feeling fine the day of the vaccine other than the pain. Next day the pain was bad but bearable. The problems began when I started feeling sick at around 5:30-6ishpm and I progressively got worse. I got a headache, felt very weak, got a itchy painful bump on my arm, painful soreness on my legs, painful eye movements, weird bitter medicine like taste, brain "zaps", nausea, numb lips, weird painful feeling throughout my body when I get up and walk. I can barely walk places without help, it makes me light headed and feel extremely weak. I also got really cold and got chills which then lead to an anxiety attack? I thought that was odd. I was shaking a lot feeling cold.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nodule, Pain, Pain in extremity, Pruritus
Clinical narrative: I was feeling fine the day of the vaccine other than the pain. Next day the pain was bad but bearable. The problems began when I started feeling sick at around 5:30-6ishpm and I progressively got worse. I got a headache, felt very weak, got a itchy painful bump on my arm, painful soreness on my legs, painful eye movements, weird bitter medicine like taste, brain "zaps", nausea, numb lips, weird painful feeling throughout my body when I get up and walk. I can barely walk places without help, it makes me light headed and feel extremely weak. I also got really cold and got chills which then lead to an anxiety attack? I thought that was odd. I was shaking a lot feeling cold.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Tremor
Clinical narrative: I was feeling fine the day of the vaccine other than the pain. Next day the pain was bad but bearable. The problems began when I started feeling sick at around 5:30-6ishpm and I progressively got worse. I got a headache, felt very weak, got a itchy painful bump on my arm, painful soreness on my legs, painful eye movements, weird bitter medicine like taste, brain "zaps", nausea, numb lips, weird painful feeling throughout my body when I get up and walk. I can barely walk places without help, it makes me light headed and feel extremely weak. I also got really cold and got chills which then lead to an anxiety attack? I thought that was odd. I was shaking a lot feeling cold.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: Floater in right eye onset 3/17/21 and ever since.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pyrexia, Vomiting
Clinical narrative: Patient woke up at 11:30 pm 11/08/2021 with fever of 101.9, headache and stomach ache. She threw up about 10 minutes later on the floor on her way to restroom; twice when she got to the toilet she threw up again. I gave children's Tylenol chewable to get the fever down. That worked. She went to sleep and woke up without fever. Stomach still ached but she ate normal. 11/09/2021 around 1:30 pm, I took her temperature since I had been monitoring it all day with it normal; however at 1:30 her temp read 100.4. I gave her children's Tylenol and she said she did not feel bad her stomach was fine. No headache. Fever went away by 2:30 pm.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Right axillary tender lymphadenopathy.  Resolving with Tylenol and Ibuprofen.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Five days after my first COVID vaccine shot I began experiencing an intense feeling of my heart beating out of my chest. The feeling was more noticeable when laying down and prevented me from sleeping soundly most nights. I also experienced unusual breaths where I felt like I had to continually breath deep but was prevented from taking a full breath. Finally, my blood pressure has been at a constant elevated level (135/80) even though I've never had signs of high blood pressure before.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Sleep disorder
Clinical narrative: Five days after my first COVID vaccine shot I began experiencing an intense feeling of my heart beating out of my chest. The feeling was more noticeable when laying down and prevented me from sleeping soundly most nights. I also experienced unusual breaths where I felt like I had to continually breath deep but was prevented from taking a full breath. Finally, my blood pressure has been at a constant elevated level (135/80) even though I've never had signs of high blood pressure before.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Affective disorder, Alice in wonderland syndrome, Borrelia test negative, Diplopia, Dysstasia
Clinical narrative: Arm swollen red, hot to touch, leg weakness, fatigue, unable to stand, fever 102.2, headache on the night she received vaccine. Arm remained and swollen for several days. Headaches were daily for 6 weeks, during which she experienced double vision and other visual disturbances, sleep issues, mood issues and brain fog.  She was seen by ophthalmologist, nothing wrong with eyes. Visual disturbances increased, began to lose control over limbs. Could not walk, would "lose" limbs. Seen by neurology after no improvement. Diagnosed with Alice in Wonderland Syndrome as an adverse reaction to the vaccines she received.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Electroencephalogram, Erythema, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Arm swollen red, hot to touch, leg weakness, fatigue, unable to stand, fever 102.2, headache on the night she received vaccine. Arm remained and swollen for several days. Headaches were daily for 6 weeks, during which she experienced double vision and other visual disturbances, sleep issues, mood issues and brain fog.  She was seen by ophthalmologist, nothing wrong with eyes. Visual disturbances increased, began to lose control over limbs. Could not walk, would "lose" limbs. Seen by neurology after no improvement. Diagnosed with Alice in Wonderland Syndrome as an adverse reaction to the vaccines she received.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Gait inability, Headache, Muscular weakness, Pyrexia, SARS-CoV-2 antibody test negative
Clinical narrative: Arm swollen red, hot to touch, leg weakness, fatigue, unable to stand, fever 102.2, headache on the night she received vaccine. Arm remained and swollen for several days. Headaches were daily for 6 weeks, during which she experienced double vision and other visual disturbances, sleep issues, mood issues and brain fog.  She was seen by ophthalmologist, nothing wrong with eyes. Visual disturbances increased, began to lose control over limbs. Could not walk, would "lose" limbs. Seen by neurology after no improvement. Diagnosed with Alice in Wonderland Syndrome as an adverse reaction to the vaccines she received.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Sleep disorder, Streptococcus test negative, Underdose, Vaccination complication, Visual impairment
Clinical narrative: Arm swollen red, hot to touch, leg weakness, fatigue, unable to stand, fever 102.2, headache on the night she received vaccine. Arm remained and swollen for several days. Headaches were daily for 6 weeks, during which she experienced double vision and other visual disturbances, sleep issues, mood issues and brain fog.  She was seen by ophthalmologist, nothing wrong with eyes. Visual disturbances increased, began to lose control over limbs. Could not walk, would "lose" limbs. Seen by neurology after no improvement. Diagnosed with Alice in Wonderland Syndrome as an adverse reaction to the vaccines she received.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Blood ethanol normal, Computerised tomogram head normal, Electrocardiogram normal, Full blood count normal, Human chorionic gonadotropin normal
Clinical narrative: New Onset Seizure
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Seizure, Toxicologic test normal, Ultrasound scan normal, Urine analysis normal
Clinical narrative: New Onset Seizure
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Hypertension, Pharyngeal swelling, Wheezing
Clinical narrative: Throat started to swell, wheezing, headache, high blood pressure.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Mobility decreased
Clinical narrative: The second day after receiving the vaccine, I had painful lymph nodes at the right axillary and left shoulder pain. I took iBuprofen. Five day after, the lymph node pain went away. But, the shoulder pain continued with reduced movement and progressively became worse. I cannot abduct my shoulder as a result.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Chills, fatigue, body aches, headache, injection site arm pain, nausea
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills, fatigue, body aches, headache, injection site arm pain, nausea
Age: 52.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; Valtrex 1 gm po TID x 7 days; Prednisone Taper 60 mg, 40 mg, 20 mg po qDay x 10 days; Symptoms slowly improving
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Gait inability, Mobility decreased, Muscle tightness
Clinical narrative: I woke up not being able to speak in clear words nor could I walk because my hip flexor muscles were so tight and painfully sore.  I hadn?t a clue as to where i was starting the night after the dose until three days later. I was unable to walk , unable to communicate clearly, was confused to the point or not recognizing my own vehicle.  My joints and muscles have been so sore since and was unable to cross my legs for two months after.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Speech disorder
Clinical narrative: I woke up not being able to speak in clear words nor could I walk because my hip flexor muscles were so tight and painfully sore.  I hadn?t a clue as to where i was starting the night after the dose until three days later. I was unable to walk , unable to communicate clearly, was confused to the point or not recognizing my own vehicle.  My joints and muscles have been so sore since and was unable to cross my legs for two months after.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Heavy menstrual bleeding
Clinical narrative: Heavy menstrual flow; bleeding that has not stopped; anemia.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Chills, Diarrhoea
Clinical narrative: About 2 hours post-injection I started to feel very strange. I felt some psychological effects like derealization and I felt like I might lose control and start screaming (that feeling lasted only a few moments). Heart racing, heart is beating "heavily" like there's some abnormality, shortness of breath, increased blood pressure, dizziness, disoriented, panic, anxiety, diarrhea, nausea, body feeling extremely hot but no fever, chills, trembling, fullness in chest, thumping in chest
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: About 2 hours post-injection I started to feel very strange. I felt some psychological effects like derealization and I felt like I might lose control and start screaming (that feeling lasted only a few moments). Heart racing, heart is beating "heavily" like there's some abnormality, shortness of breath, increased blood pressure, dizziness, disoriented, panic, anxiety, diarrhea, nausea, body feeling extremely hot but no fever, chills, trembling, fullness in chest, thumping in chest
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Panic attack, Tremor
Clinical narrative: About 2 hours post-injection I started to feel very strange. I felt some psychological effects like derealization and I felt like I might lose control and start screaming (that feeling lasted only a few moments). Heart racing, heart is beating "heavily" like there's some abnormality, shortness of breath, increased blood pressure, dizziness, disoriented, panic, anxiety, diarrhea, nausea, body feeling extremely hot but no fever, chills, trembling, fullness in chest, thumping in chest
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dyspnoea, Feeling cold
Clinical narrative: I received the booster shot on Monday afternoon. At first, I only felt a mild tingling at the injection site, and a cooling sensation. On Tuesday evening, however, I began to have trouble breathing, tingling in my arms, and pain in my chest. I took a Tylenol to settle the spasms in my arm, but I am still under the belief that I have experienced anaphalaxis and I am concerned that this is still going on 24 hours after injection. My arm is still jelly and my chest still feels heavy and I am having trouble taking deep breaths. I have not gone to the hospital. I took a COVID-19 test on Monday and it came back NEGATIVE today. My symptoms are the direct result of the Tdap booster.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Injection site paraesthesia, Limb discomfort, Muscle spasms, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: I received the booster shot on Monday afternoon. At first, I only felt a mild tingling at the injection site, and a cooling sensation. On Tuesday evening, however, I began to have trouble breathing, tingling in my arms, and pain in my chest. I took a Tylenol to settle the spasms in my arm, but I am still under the belief that I have experienced anaphalaxis and I am concerned that this is still going on 24 hours after injection. My arm is still jelly and my chest still feels heavy and I am having trouble taking deep breaths. I have not gone to the hospital. I took a COVID-19 test on Monday and it came back NEGATIVE today. My symptoms are the direct result of the Tdap booster.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain in arm that radiates to neck; swelling of lymph nodes in under arm.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Extreme pain in body.  Left chest and arms.  Leg pain below knee in calf area.  Tingling and loss of feeling in hands. This started about 24 hours post injection and continued constantly for almost 72 hours.  Since 4 days post injection pain in arms and chest occur for about 30 minutes every 3 to 4 hours.  Tingling and numbness in hands and forearms is sporadic and comes and goes without any pattern.  At night the pain wakes me up from Sleep 2 to 3 times a night.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Extreme pain in body.  Left chest and arms.  Leg pain below knee in calf area.  Tingling and loss of feeling in hands. This started about 24 hours post injection and continued constantly for almost 72 hours.  Since 4 days post injection pain in arms and chest occur for about 30 minutes every 3 to 4 hours.  Tingling and numbness in hands and forearms is sporadic and comes and goes without any pattern.  At night the pain wakes me up from Sleep 2 to 3 times a night.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Lymphadenopathy
Clinical narrative: 101.3 fever, chills, nausea, severe fatigue next day, moderate to significant fatigue subsequent days, muscle aches, loss of appetite, swollen lymph nodes on right side in neck area and armpit area, congestion, very severe headache particularly day after and 2nd day after.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 101.3 fever, chills, nausea, severe fatigue next day, moderate to significant fatigue subsequent days, muscle aches, loss of appetite, swollen lymph nodes on right side in neck area and armpit area, congestion, very severe headache particularly day after and 2nd day after.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Vaccination failure
Clinical narrative: DIED; COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a traditional media report concerned an 82 year old female of unspecified ethnicity. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered 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. It was reported that on 04-NOV-2021(Thursday), at about 2:00, the patient was died after contracting covid-19. The patient's son also reported that after receiving the JANSSEN COVID VACCINE, the patient was still felt ill (suspected clinical vaccination failure). Reporter also stated that the patient had been hospitalized for days before dying at about 2:00, on 04-NOV-2021 (Thursday). The patient died from unknown cause of death. On an unspecified date the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on 04-NOV-2021, had not recovered from covid-19, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000200900.; Sender's Comments: V0: 20211115285- Covid-19 vaccine ad26.cov2.s- Died, Covid-19. 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). V0: 20211115285- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness
Clinical narrative: LIGHT HEADED AND DIZZY; CHILLS; DIARRHEA; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: asthma, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: 20-MAR-2022) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced light headed and dizzy. On 08-NOV-2021, the patient experienced chills. On 08-NOV-2021, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light headed and dizzy, chills, and diarrhea. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: chills; tired; low-grade fever 98.7 F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (tired) and PYREXIA (low-grade fever 98.7 F) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Palpitation and Kidney disorder (to help kidneys filter better). Concomitant products included LISINOPRIL for Kidney disorder, ATENOLOL for Palpitation, FAMOTIDINE, CLONAZEPAM, LEVOTHYROXINE, ASPIRIN [ACETYLSALICYLIC ACID], FLUOXETINE, ATORVASTATIN, TAMSULOSIN, SUCRALFATE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-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 CHILLS (chills), FATIGUE (tired) and PYREXIA (low-grade fever 98.7 F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), FATIGUE (tired) and PYREXIA (low-grade fever 98.7 F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 (High) lowgrade fever 98.7 F.The patient did not had any reactions after first two doses.  The adverse events were treated with Tylenol, hot drinks.
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: 12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications are provided by the reporter. The patient reports that she knows of 12 patients who received a Covid-19 vaccine and got breakthrough infections of Covid-19. The patient did not know which brand of vaccine the patients had received.  Company comment This case concerns a patient of unknown age and gender with no relevant medical history provided, who experienced the unexpected event of VACCINE BREAKTHROUGH INFECTION (AESI). The event occurred on an unknown date after the dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable, since there is no information about the vaccines administered. The benefit-risk relationship of Moderna COVID-19    Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history provided, who experienced the unexpected event of VACCINE BREAKTHROUGH INFECTION (AESI). The event occurred on an unknown date after the dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable, since there is no information about the vaccines administered. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Vaccination complication
Clinical narrative: Could not breath; Tired; Very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Could not breath), FATIGUE (Tired) and VACCINATION COMPLICATION (Very bad reaction) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Could not breath) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Very bad reaction) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Could not breath), FATIGUE (Tired) and VACCINATION COMPLICATION (Very bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment medication information was not reported.  This is a spontaneous  case concerning a 92-year-old patient of an unknown gender, with no relevant medical history reported ,  who experienced the serious  unexpected events  of  DYSPNOEA , FATIGUE and VACCINATION COMPLICATION leading to hospitalization after receiving a dose of Moderna COVID-19 vaccine. Very limited information regarding clinical course of these events has been provided, and patient declines to further contact for follow up. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous  case concerning a 92-year-old patient of an unknown gender, with no relevant medical history reported ,  who experienced the serious  unexpected events  of  DYSPNOEA , FATIGUE and VACCINATION COMPLICATION leading to hospitalization after receiving a dose of Moderna COVID-19 vaccine. Very limited information regarding clinical course of these events has been provided, and patient declines to further contact for follow up. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucinating; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinating) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinating) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucinating) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected event of hallucination. The event occurred on am unknown date relative to the second dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-370248 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected event of hallucination. The event occurred on am unknown date relative to the second dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was 6 months after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was 6 months after the 1st dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (Stage 4 prostate cancer 11 years ago) and Bypass surgery (11 Years ago). Concomitant products included ATORVASTATIN CALCIUM (AVASTATIN) for Heart disease, unspecified, METOPROLOL for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was 6 months after the 1st dose). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was 6 months after the 1st dose) had resolved.            Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-370201 (Patient Link).