chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site cyst, Injection site pain, Lymphadenopathy
Clinical narrative: SWELLING OF LYMPH NODE; CYST NEAR INJECTION SITE; SORE JOINTS; CHILLS; SORE MUSCLES; INJECTION SITE SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced swelling of lymph node. On MAR-2021, the subject experienced cyst near injection site. On MAR-2021, the subject experienced sore joints. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced sore muscles. On MAR-2021, the subject experienced injection site sore. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from injection site sore, and the outcome of swelling of lymph node, cyst near injection site, chills, sore joints and sore muscles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: SWELLING OF LYMPH NODE; CYST NEAR INJECTION SITE; SORE JOINTS; CHILLS; SORE MUSCLES; INJECTION SITE SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced swelling of lymph node. On MAR-2021, the subject experienced cyst near injection site. On MAR-2021, the subject experienced sore joints. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced sore muscles. On MAR-2021, the subject experienced injection site sore. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from injection site sore, and the outcome of swelling of lymph node, cyst near injection site, chills, sore joints and sore muscles was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting  and , after 2nd dose on March 23, diarrhea daily
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Diverticulitis, Feeling abnormal, Malaise
Clinical narrative: Vomiting  and , after 2nd dose on March 23, diarrhea daily
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, Weight, Weight decreased
Clinical narrative: Vomiting  and , after 2nd dose on March 23, diarrhea daily
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test negative
Clinical narrative: It started three days after the first dose of the vaccine. I had a metallic taste in my mouth which lasted five weeks. It was there all the time. I was thirsty and trying to get rid of it all the time. It did not go away until after I got the second dose of the vaccine. It went away about a week after getting the second dose. It just went away suddenly.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, body aches, headache, fatigue
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: patient felt nauseated and dizzy following vaccination on 4/7/21.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Insomnia, Mobility decreased
Clinical narrative: At time of shot, felt stinging pain in the elbow and wrist of  left arm, later 5 mins. At some point the next day, I developed Spinal pain. Pain in SI joins, several distinct spots along the spine and the base of my skull, spinal stiffness, difficulty touching knees or putting chin to chest. Lasted 2 days. Night of 3/292021, I woke up with tooth pain  in multiple teeth on both upper and lower and right and left sids of mouth.  Pain great enough to wake me up and caused difficulty returning to sleep, after 600 mg ibuprofen, able to get to sleep and completely gone in the am. Starting 3/30, pain along nerve paths in upper right side back around scapula, felt like burning, intermittent. Now resolved to tingling / numb feeling and some tingling / decreased sensation in upper lip left side and under eye left side
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Rash, Spinal pain
Clinical narrative: At time of shot, felt stinging pain in the elbow and wrist of  left arm, later 5 mins. At some point the next day, I developed Spinal pain. Pain in SI joins, several distinct spots along the spine and the base of my skull, spinal stiffness, difficulty touching knees or putting chin to chest. Lasted 2 days. Night of 3/292021, I woke up with tooth pain  in multiple teeth on both upper and lower and right and left sids of mouth.  Pain great enough to wake me up and caused difficulty returning to sleep, after 600 mg ibuprofen, able to get to sleep and completely gone in the am. Starting 3/30, pain along nerve paths in upper right side back around scapula, felt like burning, intermittent. Now resolved to tingling / numb feeling and some tingling / decreased sensation in upper lip left side and under eye left side
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: At time of shot, felt stinging pain in the elbow and wrist of  left arm, later 5 mins. At some point the next day, I developed Spinal pain. Pain in SI joins, several distinct spots along the spine and the base of my skull, spinal stiffness, difficulty touching knees or putting chin to chest. Lasted 2 days. Night of 3/292021, I woke up with tooth pain  in multiple teeth on both upper and lower and right and left sids of mouth.  Pain great enough to wake me up and caused difficulty returning to sleep, after 600 mg ibuprofen, able to get to sleep and completely gone in the am. Starting 3/30, pain along nerve paths in upper right side back around scapula, felt like burning, intermittent. Now resolved to tingling / numb feeling and some tingling / decreased sensation in upper lip left side and under eye left side
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Somnolence
Clinical narrative: initial hours I was okay.  I took 500mg total of OTC Tylenol 10 minutes after the injection as a precaution.  I did that with the 1st dose too and had no issues that first time.  By 2pm I got very sleepy for no apparent reason. I took a 1 hr nap.  By 6 pm I had INTENSE stomach cramps. By 7pm I had non-stop cramps and diarrhea until 3am the next day at which point it abruptly stopped.  During that time I felt chills but I did not have a fever.  It was nothing I ate. We all practice great handwashing, hand sanitizing etc.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Pyrexia
Clinical narrative: Patient awoke early Wednesday morning feeling very feverish and had tightness in his lungs.   He did not have a thermometer  to take his temp, but felt feverish.  His symptoms have eased some as of his call into the pharmacy around noon.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Flushing, Paraesthesia, Pruritus
Clinical narrative: 9:10 am - After client received his 2nd dose of the Moderna vaccine he began complaining of tingling and itching in his hands and feet, feeling light-headed and dizzy and shaking .Client became red and flushed, he was  wheeled to the stretcher were he was advised to lay down.  BP-144/83; P-62 ,wife was at his side. 9:45am -Bp-160/102 ;P-57  Client still complaining  of feeling dizzy, throat itchy ,client was asked to remain on stretcher a little longer 10:00 am BP checked again 156/104 ;P-61 ,client feeling better no further complaints of dizziness. Client was advised to follow-up with primary care MD if he continued having mild  reactions and to call 911 if he began   experiencing chest pains ,difficulty breathing  or any other severe reactions. Client released with his wife and 2 other family members.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation, Tremor
Clinical narrative: 9:10 am - After client received his 2nd dose of the Moderna vaccine he began complaining of tingling and itching in his hands and feet, feeling light-headed and dizzy and shaking .Client became red and flushed, he was  wheeled to the stretcher were he was advised to lay down.  BP-144/83; P-62 ,wife was at his side. 9:45am -Bp-160/102 ;P-57  Client still complaining  of feeling dizzy, throat itchy ,client was asked to remain on stretcher a little longer 10:00 am BP checked again 156/104 ;P-61 ,client feeling better no further complaints of dizziness. Client was advised to follow-up with primary care MD if he continued having mild  reactions and to call 911 if he began   experiencing chest pains ,difficulty breathing  or any other severe reactions. Client released with his wife and 2 other family members.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blindness, Dyspnoea, Pain in extremity
Clinical narrative: Employee came at 1:30 to get vaccinated.  Three to five  minutes after administering the Johnson & Johnson vaccine, I asked the patient if he is feeling ok because he seemed nervous and sweaty. He responnded "yes, but I have a mental anxiety from vaccines, needls, doctors". one minute later he started complaining of pain in his left arm and feeling weak. . He then asked to sit on the floor and said that he can hardly breath, and lost vision. I administered Epipen injection to his left thigh while the store director was calling 911. He then complained about not being able to move his hand fingers. The ambulance came and took him to the ER. later in the day, his manager said that he spoke to hid family and they told him that he has been having anxiety from doctors, needls, and shots ever since he was little. He is feeling better now and the hospital will keep him for tomorrow.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ulnar nerve palsy
Clinical narrative: Employee came at 1:30 to get vaccinated.  Three to five  minutes after administering the Johnson & Johnson vaccine, I asked the patient if he is feeling ok because he seemed nervous and sweaty. He responnded "yes, but I have a mental anxiety from vaccines, needls, doctors". one minute later he started complaining of pain in his left arm and feeling weak. . He then asked to sit on the floor and said that he can hardly breath, and lost vision. I administered Epipen injection to his left thigh while the store director was calling 911. He then complained about not being able to move his hand fingers. The ambulance came and took him to the ER. later in the day, his manager said that he spoke to hid family and they told him that he has been having anxiety from doctors, needls, and shots ever since he was little. He is feeling better now and the hospital will keep him for tomorrow.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: FEVER; CHILLS; ACHY; VERY TIRED; MUSCLE PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination onleft deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced fever, chills, achy, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and muscle pain, and the outcome of fever, chills, achy and very tired was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; CHILLS; ACHY; VERY TIRED; MUSCLE PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination onleft deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced fever, chills, achy, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and muscle pain, and the outcome of fever, chills, achy and very tired was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Muscle spasms, Myalgia, Neuralgia
Clinical narrative: FEVER; CHILLS; ACHY; VERY TIRED; MUSCLE PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination onleft deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced fever, chills, achy, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and muscle pain, and the outcome of fever, chills, achy and very tired was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over my body. Not itchy the first day, starting to get itchy today (second day). This occurred about 60 hours (2.5 days) after receiving the second Moderna shot.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Pallor, Unresponsive to stimuli
Clinical narrative: Pt was brought to EMT area by EMT staff. Pt was lethargic, not answering question, sweaty, pallor, hard to arouse, slumped over.  Vital signed were taken and staff attended to pt to keep patient alert. pt slowly started to become more responsive after snacks and juice was given. he sat down 30minutes and become more alert and oriented. pt was arranging for someone to pick him up and dint want to leave car.  he stated that someone was going to pick him and left after he was feeling better.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Dry skin, Rash, Swelling face
Clinical narrative: Rash on neck and face, swelling and dry skin of face that began around 24 hours after vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Extreme fatigue Headache Nausea All lasted 2 to 3 days
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Fever, chills, joint pain, muscle pain, nausea, headache, diarrhea
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, chills, joint pain, muscle pain, nausea, headache, diarrhea
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Pharyngeal swelling, Tachycardia
Clinical narrative: Shortness of breath, chest discomfort, patient states feeling throat swelling, no visible swelling. Blood pressure elevated and tachycardia.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swollen tongue
Clinical narrative: Patient came for second dose of covid vaccine. Shortly after receiving the vaccine.  Patient reported of having tingling of hands and swelling of tongue.  Pharmacist gave patient a dose of 0.3mg EpiPen injection and call 911. Patient was alert and able to talk.  Patient went with paramedics to the hospital to get checked out.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Mobility decreased, Pain, Pyrexia
Clinical narrative: Site of shot was very painful more than just sore I couldn?t even put a sheet on me at night, I had a fever from 99 on Monday night the day of the shot to 102 up and until Wednesday morning, chills and aches
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Nausea
Clinical narrative: patient felt hot and clammy. nauseated.  watched patient and he improved.  no longer nauseated and feeling better
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 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 subject experienced achey, chills, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of fever, chills and achey was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Vaccine administered at 11:00 am at 11:10 client reported throat and tongue tingling, dizziness and difficulty breathing. Administered 1 mg epinephrine. EMS was called and transported client to the hospital where he was admitted under observation.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Loss of consciousness, Mydriasis
Clinical narrative: About 5 minutes after the patient was vaccinated, he felt weak and faint.  His pupils dilated and he began to profusely sweat.  He then blacked out for about 15-20 seconds.  By the time EMS arrived within 10 minutes , he was coherent and felt fully recovered.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Patient passed out and fell out of chair after receiving his second dose.  He hit his head when he fell.   We called 911 and he was transported to our local hospital. I spoke with his brother and he was released and doing ok.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vital signs measurement
Clinical narrative: SYNCOPAL EPISODE ~30 SECONDS RESP RATE - 18 PULSE - 92 SP02 - 99 BP - 122/86 GCS - 15
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Moderna arm - red rash circle around injection site and sensitivity appeared several days after the injection
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Hypertension, Injection site pain, Pharyngeal paraesthesia
Clinical narrative: 440, Pt arrives in observation, approx 5 min after receiving vaccine, observed sitting in chair comfortably, no apparent distress, no cough observed at this time, skin appears dry, appropriate skin color, no s/s increased respiratory effort, Smiling playing games on phone, denies any discomfort at this time.  500- Observed pt with intermittent dry cough Pt describes as "just a little tickle", lips pink (mask removed temporaily), talking without difficulty. Denies distress, Offered water, no obvious increased respiratory effort. Pt agrees to continued observation, Offered water, appears to be swallowing without difficulty. 5:05 pt reports "harder to talk without cough" observed increase in frequency of dry cough, pt reports that she wants to continue to be observed, does not want benadryl at this time. Pt agrees to plan that includes, if she feels worse, she will be offered benadryl, she agrees, that if she does receive benadry, she will not attempt to drive herself home.She reports that benadryl "makes me drowsy"She agrees to call family to have them come pick her up. Lead RN at pt;s side. 510- increased frequency in coughing, pt reports that "it's harder to talk without coughing, itchiness in throat increasing" she denies shortness of breath, but reports that she is concerned that she will become short of breath, therefore agrees to 50mg benadryl IM (r deltoid), still awaiting family arrival. Pt reports, "feel hot" No observed increase in respiratory Moved to bench couch(prior to recivng benadryl, , EMT present , vitals taken, bp 148/92,pulse=83, pulse ox 96-98%, pt reports that this BP reading is "higher than usual for me", denies pain except for pain at vaccine injection site,  5:20. No obvious change of status noted, skin remains pink, +cap refill, lungs cta no wheeze herd per EMT.  5:24- pt reports that she is "getting a little drowsy, but feeling better". Cough appears to be less frequent.Pt appears more relaxed, talking without effort, respirations appear to be without effort, relaxed.Conitues to agree not to drive herself home, awaiting her daughter to come get her and drive her home, Encouraged pt to have daughter come up to floor, did discuss with pt, although she is feeling better at this time, if she feels worse, once she is driven home by daughter, she will seek emergent care immediately. Pulse ox 98%, appears to be in no distress. Only occasional cough noted.  5:28, pt reports that she sees her daughter on floor and walks (with normal gait),towards a couple, went to offer to escort pt to car, but she walked away from couple, and left floor without coming back to observation.  5:30, pt observed (from 3rd floor window), talking to another adult woman presumptively her daughter, 5:35, pt observed (from 3rd floor window getting into a different car, by herself, sitting in drivers seat and drives off by herself, driving the car.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Speech disorder, Throat irritation
Clinical narrative: 440, Pt arrives in observation, approx 5 min after receiving vaccine, observed sitting in chair comfortably, no apparent distress, no cough observed at this time, skin appears dry, appropriate skin color, no s/s increased respiratory effort, Smiling playing games on phone, denies any discomfort at this time.  500- Observed pt with intermittent dry cough Pt describes as "just a little tickle", lips pink (mask removed temporaily), talking without difficulty. Denies distress, Offered water, no obvious increased respiratory effort. Pt agrees to continued observation, Offered water, appears to be swallowing without difficulty. 5:05 pt reports "harder to talk without cough" observed increase in frequency of dry cough, pt reports that she wants to continue to be observed, does not want benadryl at this time. Pt agrees to plan that includes, if she feels worse, she will be offered benadryl, she agrees, that if she does receive benadry, she will not attempt to drive herself home.She reports that benadryl "makes me drowsy"She agrees to call family to have them come pick her up. Lead RN at pt;s side. 510- increased frequency in coughing, pt reports that "it's harder to talk without coughing, itchiness in throat increasing" she denies shortness of breath, but reports that she is concerned that she will become short of breath, therefore agrees to 50mg benadryl IM (r deltoid), still awaiting family arrival. Pt reports, "feel hot" No observed increase in respiratory Moved to bench couch(prior to recivng benadryl, , EMT present , vitals taken, bp 148/92,pulse=83, pulse ox 96-98%, pt reports that this BP reading is "higher than usual for me", denies pain except for pain at vaccine injection site,  5:20. No obvious change of status noted, skin remains pink, +cap refill, lungs cta no wheeze herd per EMT.  5:24- pt reports that she is "getting a little drowsy, but feeling better". Cough appears to be less frequent.Pt appears more relaxed, talking without effort, respirations appear to be without effort, relaxed.Conitues to agree not to drive herself home, awaiting her daughter to come get her and drive her home, Encouraged pt to have daughter come up to floor, did discuss with pt, although she is feeling better at this time, if she feels worse, once she is driven home by daughter, she will seek emergent care immediately. Pulse ox 98%, appears to be in no distress. Only occasional cough noted.  5:28, pt reports that she sees her daughter on floor and walks (with normal gait),towards a couple, went to offer to escort pt to car, but she walked away from couple, and left floor without coming back to observation.  5:30, pt observed (from 3rd floor window), talking to another adult woman presumptively her daughter, 5:35, pt observed (from 3rd floor window getting into a different car, by herself, sitting in drivers seat and drives off by herself, driving the car.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: extreme fatigue, headache, arm soreness, and chills
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received 1st dose of Moderna Covid 19 at age 17. Moderna vaccination only indicated for 18 years of age and older
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Feeling cold, Nausea
Clinical narrative: FEELING SO MUCH COLD; BONE ACHES; SHAKY AND SHIVERING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 31-MAR-2021, the subject experienced feeling so much cold. On 31-MAR-2021, the subject experienced bone aches. On 31-MAR-2021, the subject experienced shaky and shivering. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.5. Treatment medications included: Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling so much cold, bone aches, nausea, shaky and shivering and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEELING SO MUCH COLD; BONE ACHES; SHAKY AND SHIVERING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 31-MAR-2021, the subject experienced feeling so much cold. On 31-MAR-2021, the subject experienced bone aches. On 31-MAR-2021, the subject experienced shaky and shivering. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.5. Treatment medications included: Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling so much cold, bone aches, nausea, shaky and shivering and fever was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Irregular breathing, Pruritus, Throat tightness
Clinical narrative: Allergic reaction , hives, close my throat no breathing and a lot itching, all my body red like fire
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Allergic reaction , hives, close my throat no breathing and a lot itching, all my body red like fire
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Person administering vaccine inadvertently gave Janssen instead of Pfizer Booster. Situation was immediately recognized and explained to the patient. Patient was informed of CDC recommendation to NOT give booster of Pfizer following cross-administration of vaccines. Patient as given printed copy of the VAERS form and told to contact VAERS and local health department with any noted adverse reactions.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in left ear very loud
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: Shingles. Very bad case with burning and internal shingles
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Hyperhidrosis, Pain in jaw, Pallor
Clinical narrative: Approximately 15 minutes after receiving injection, patient was sitting in chair and suddenly fell to the floor. According to witnesses, patient hit head first. Patient was wearing a thick winter coat which was immediately removed. Patient was diaphoretic, pale, BP 140/100, P 80. Boyfriend and family member accompanied patient and reported hx of anxiety and fainting with blood draws, NKA, no medications. Patient remained alert, responded appropriately to name, date and even stated time she received vaccine. Only c/o jaw pain. Denied headache, nausea and diploplia. Negative for swelling or bleeding of head and face or hives. Breathing without difficulty. BP taken 10 minutes later 156/90, P90. Activated 911, report given to paramedics, patient was transported by gurney by ambulance, accompanied by boyfriend and family member.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Emotional distress, Fall, Joint injury, Syncope
Clinical narrative: I felt dizzy and lightheaded stepping out of the shower ( March 20, 2021 at around 10:00 am) and I fainted and landed on the floor. When I came to, I was able to use the toilet to pull myself up and sit on the toilet seat until I got back in control of myself. I was lucky- I only had a few black and blue marks on my right knee, but it had potential to be serious- head injuries etc. I am 70 years old and this is the only time in my life that I have fainted. Very scary and has caused some emotional stress for me.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Myalgia
Clinical narrative: CHILLS; FEELING UNWELL; MYALGIA; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included botanical remedies, and nutraceuticals, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, The batch number was not reported and Expiry: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced feeling unwell. On 10-MAR-2021, the subject experienced myalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, feeling unwell, and myalgia. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: + nausea and vomiting
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: I had rash on my torso/stomach that was itchy. It was a faint rash but more itchy than visible.  There was a few spots on my back. It took a few days for the rash to go away. I used Hydrocortisone cream
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Erythema, Paraesthesia, Swelling face
Clinical narrative: Instructed patient to wait 30 minutes due to previous history of allergic reaction of  penicillin.  Patient waited 30 min period with no apparent symptoms. Pt was asked if she was ok,  pt stated she was.  Patient was then instructed she could leave.  Pt then returned in approximately 15 minutes and stated that when she removed her mask she noticed that her nose and around here eyes were red and possibly swollen.  She removed her mask for immunizer and it was noticed that her cheeks nose and lips did appear to be red and possibly swollen.  She stated that her nose felt tingly and her mouth and lips felt tight, but did not complain of a swollen tongue.  Immunizer administered 50mg of  liquid diphenhydramine .  Pt also given one dose of Famotidine 40mg. Took blood pressure and found it to be elevated to around 200/90 with pulse rate of 65 bpm. Instructed the patient that we would need to call medics to come check her out. She begged immunizer not to call due to the anxiety it would cause her  husband who has , possibly,  some issues understanding.  Pt was monitored for approximately with epipen on standby for approximately two hours by pharmacist immunizer.  Patient began to feel better redness and and puffiness subsided patient went home. Pt returned on 4/7/21 with normal blood pressure and no issues. Pt state BP  was high due to fear of  going to hospital.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Pain in extremity, Pruritus
Clinical narrative: Patient reported pain and numbness in the injected arm/shoulder. Patient also reported itching throughout the body.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: hot, dizzy
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperventilation, Neck pain, Pain, Pallor
Clinical narrative: Patient's husband alerted pharmacy staff that patient was having difficulty breathing with bright red pallor roughly 5 minutes following her second dose. She was slightly hyperventilating, had pain radiating from her neck superior to her ears and anterior down her back. She described the pain as "shooting" and moving downward. She was able to take deep breaths and converse with no issues so epinephrine was not administered. Paramedics were called to the scene to assess her condition. She was able to stand, showed no signs of dizziness or change in mental status, and her pallor began returning to baseline. EMS took her BP and oxygenation, she declined transport to a hospital and remained at the pharmacy for an extra 30 minutes.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Per pt, he reported history of feeling faint after vaccination because of fear of needles. Counseled pt prior to vaccination. After administration, patient felt dizzy and faint. Recommended that patient lay down with feet elevated in air.  Patient laid down until he felt comfortable sitting up.  He drank water and felt good after a few seconds. I offered him an ice pack but he refused.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Nausea, Pyrexia
Clinical narrative: Fever for 24 hours, headache for more than 24 hours, nausea, soreness of eyes
Sex: U
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: DIED FROM THE INTERACTION OF THE TWO PRODUCTS RISPERDAL AND COVID VACCINE; This spontaneous report received from a consumer who had heard that two people who took Risperdal and got a COVID vaccine died from the interaction of the two products. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient received risperidone (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, consumer heard that a few people who took Risperdal and got a COVID vaccine died from the interaction of the two products. The action taken with covid-19 vaccine ad26.cov2.s, and risperidone was not applicable. This report was serious (Death).; Sender's Comments: A report received from a consumer who had heard that "a few people who took Risperdal and got a COVID vaccine died from the interaction of the two products." The patients past medical history, concomitant medications were not reported. COVID-19 vaccine ad26.cov2.s date and dose administered were not reported. Risperidone dose, frequency, therapy dates and indication were not reported. There is insufficient information provided in this case to make a meaningful medical assessment.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Red spot on arm and swollen lymph node in neck after injection
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Coordination abnormal, Dizziness, Ear pain, Gait disturbance
Clinical narrative: Originally I only had a very sore arm.  On Friday afternoon, shortly after  getting off work my vertigo symptoms started - Bumping into doors and missing the countertop when trying to sit things down. By Saturday morning it was full blown Vertigo with dizziness and headache and severe ear pain. This continues to be a problem today.  Today is the first day of work I have missed with this and the symptoms have progressed so much that I can not drive at all and I can't walk in a straight line. I've had vertigo about 5 times in the lasat 10 years, but never this long or like this.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Loss of personal independence in daily activities, Pain in extremity, Vertigo
Clinical narrative: Originally I only had a very sore arm.  On Friday afternoon, shortly after  getting off work my vertigo symptoms started - Bumping into doors and missing the countertop when trying to sit things down. By Saturday morning it was full blown Vertigo with dizziness and headache and severe ear pain. This continues to be a problem today.  Today is the first day of work I have missed with this and the symptoms have progressed so much that I can not drive at all and I can't walk in a straight line. I've had vertigo about 5 times in the lasat 10 years, but never this long or like this.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Hypoaesthesia, Swelling face
Clinical narrative: Facial numbness and swelling entire right side of face and ear began at 11:50 after leaving the clinic. Symptoms not noted until in car.  No difficulty breathing noted.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Histamine intolerance, Injection site pain, Lip swelling, Pain in extremity, Peripheral swelling
Clinical narrative: None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swelling of face (lips) and hands, high histamine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: None at time of shot except tenderness in injection area and arm soreness. About 40 hours later, swelling of face (lips) and hands, high histamine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Head discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Pressure experienced in bridge of nose and head almost immediately after the vaccine was given. As of submission time patient still experiencing some pressure but having some improvement.  Also experiencing cheek numbness and tingling.  Counseled patient any sign of anaphylactic reaction should go into the ER and if she is experiencing any other reaction to let us know so that they can be reported by us and that she could use online reporting system to also self report
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Huge cold sores on mouth 8 to 10 days after vaccination
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: He began getting dizzy immediately after vaccine - pale, sweating, and felt like he was going to vomit.  He remained in the IMZ room for observation and applied a cool compress to forehead and back of neck.  Coloring came back after about 10-15 minutes and he said he felt better.  Also mentioned that this happened to him after he got a TDap vaccine about 15 years ago - he said it is a mental thing with him and does not like to get vaccines.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via a company concerned a 40 year old male. 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) 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 number. No concomitant medications were reported.  About 7 days after receiving the vaccine, the patient went to hospital regarding shortness of breath. On an unspecified date, the patient experienced heart attack and was hospitalized (date unspecified) and was later sent to intensive care unit (ICU). On an unspecified date, the patient died from heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: 20210403505    -Covid-19 vaccine ad26.cov2.s -Heart attack. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: HEART ATTACK
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: patient fainted for 30 sec the regained consciousness
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Fatigue, Hyperhidrosis, Pruritus
Clinical narrative: I first experienced fatigue for the two following days after the vaccine. On the third day, I woke up with a rash on the same of my face. This rash got worse over the following days -- my face burned as though fire aunts had bitten me all over. At first, it was red and swollen, then the hives began to become visible on the 6th day, The rash and hives are around the nose and inner yes, and the side of the forehead near the temple These areas are swollen, Hives are also on the checks and forehead. The face, when dry, is itchy and when wet has a burning sensation. Sweat, washing face and applying facial products (even gentle ones) yield unbearable burning sensation.  One week after the vaccine, I was prescribed hydrocortisone Cream USP 2.5% but when applying, my face burned. Thermal water, on the other hand soothed the skin and calmed the burning sensation. On day 7, at night, I tried applying cicapalst. My skin did not react this time. On day 8, I tried the hydrocortisone again, but it still burned. SO, I applied the cicaplast again and thermal water to soother the skin. In the evening of day 8, I was able to apply the hydrocortisone cream over the skin which had been treated with cicaplast first. There was a stinging sensation (thought, this time, not burning) which was soothed with thermal water. My face is still itchy and swollen.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: I first experienced fatigue for the two following days after the vaccine. On the third day, I woke up with a rash on the same of my face. This rash got worse over the following days -- my face burned as though fire aunts had bitten me all over. At first, it was red and swollen, then the hives began to become visible on the 6th day, The rash and hives are around the nose and inner yes, and the side of the forehead near the temple These areas are swollen, Hives are also on the checks and forehead. The face, when dry, is itchy and when wet has a burning sensation. Sweat, washing face and applying facial products (even gentle ones) yield unbearable burning sensation.  One week after the vaccine, I was prescribed hydrocortisone Cream USP 2.5% but when applying, my face burned. Thermal water, on the other hand soothed the skin and calmed the burning sensation. On day 7, at night, I tried applying cicapalst. My skin did not react this time. On day 8, I tried the hydrocortisone again, but it still burned. SO, I applied the cicaplast again and thermal water to soother the skin. In the evening of day 8, I was able to apply the hydrocortisone cream over the skin which had been treated with cicaplast first. There was a stinging sensation (thought, this time, not burning) which was soothed with thermal water. My face is still itchy and swollen.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Unresponsive to stimuli, X-ray
Clinical narrative: unresponsive episode
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: DEVELOPED A RASH AT INJECTION SITE, PATIENT ADVISED TO TAKE BENADRYL
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Approximately one day after vaccinations starting having subtle tinnitus in both ears. It is not overwhelming but has been consistent over last few days.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Blood gases, Coagulation test, Confusional state, Death
Clinical narrative: Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body..  After the respiratory  treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endocrine test, Endotracheal intubation, Full blood count, Laboratory test
Clinical narrative: Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body..  After the respiratory  treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Rash, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body..  After the respiratory  treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: For 2 days after receiving my first Covid-19 Moderna vaccination, I had a sore arm with redness and warmth at the injection site.  Sometime on April 3rd I began to experience slight itching at the injection site.  I did not notice redness at the site at that time because I itched the area before I looked at my arm.  There has been slight  pruritis at the same area since.  Today, April 7, I noticed a 4cm rounded pink area at the injection side with slight warmness.  The pink area still itched.