chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: Sudden onset of chills about 12 hours after vaccination.  Uncontrollable shivering for 30 minutes before stabilized with hot bath. Fever of 99-101F the next morning. Headaches, congestion, fever,  and chills still present 36 hours after vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: 0946 Vaccination. Approximately 5 minutes after sitting in post vaccination area, began feeling shaky. Currenly recovering from chemo. Did not eat breakfast this morning and this is out of routine. Stated line was long. Reports to feeling similarly when she misses meals. 1000am BP 106/72 HR 78 R 18. Offered water and moved patient further away so she could eat the breakfast in her purse. Continued to feel better during the assessment. By 1100, reports feeling better. 1104 BP 114/72 HR 80. No complaints. Released to husband.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain in jaw, Stomatitis, Toothache
Clinical narrative: About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet.  Within about an hour of one tooth hurting, all of my upper molars and jaw hurt and had a nerve sensation.   It was like the roots of all the molars were irritated.  The nerve sensation also felt like it was in the upper jaw/face area.   My entire pallet became irritated.  This lasted for about two hours and then went away completely.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle pain, head ache  joint pain.  Treated with Tylenol.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pruritus, Injection site swelling, Sinus headache
Clinical narrative: Injection site swollen and itchy, all-over joint pain, sinus headache
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Minor Bell's Palsy- Increase in numbness/tingling of the tongue over the past two days. Lips started to numb today. Pain is increasing in left ear. No noticeable drooping of facial muscles yet, but symptoms may increase in the next 24 hours.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Just after being seated in the post vaccination area, reported a headache. Describes it as a throbbing feeling over forehead area. Rates pain 3-4 on 0-10 pain scale. Patient typically only gets headache around cigar or cigarette smoke. Offered water to drink, patient accepted. By 1300, reports headache getting smaller. By 1306, headache pain 1/10 on 0-10 pain scale. Reports feeling well. Released from post vaccination area at 1306.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sleep disorder, Urticaria
Clinical narrative: woke with uncontrollable itching, hives or welts, from ankles to head,  knees, inside thighs, outside thighs, buttocks, fingers, by underarm pits, chin, eyes, top of legs between knees and torso, urgent care at urgent care, Dr. concluded it was from vaccine,  gave me 3 pills of some type of cortisone , and 4 day course of cortisone tablets next four days, also OTC benedryl, to allow me to sleep
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea
Clinical narrative: 1 week After My 2nd dose , I feel abdominal cramps like My stomach is full of air and I have the urge to move My bowel like I?m having diarrhea. I can?t Control it. I?m honestly not sure if this was a side effect of the Vaccine but I didnt have this issue before I got the Vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Chills and fever along with dizziness, weakness, and joint pain started ~12 hours post vaccination lasting about 4-5 hours.  Persistent pain was treated with 200 mg ibuprofen 28 hours post vaccination.  48 hours post vaccination had mild nausea and fatigue.  All symptoms appeared resolved by 60 hours post vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills and fever along with dizziness, weakness, and joint pain started ~12 hours post vaccination lasting about 4-5 hours.  Persistent pain was treated with 200 mg ibuprofen 28 hours post vaccination.  48 hours post vaccination had mild nausea and fatigue.  All symptoms appeared resolved by 60 hours post vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache (4 of 10) chills muscle aches fever
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Sore arm at injection site, fever of 102°, chills, aches and headache
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Woke up at 2:00am after falling asleep around 12:00am. Experiencing feverish feelings with no fever (98.0). Nausea also began around this time. Took a zofran 8mg at 2:30am, didn?t really experience any relief. Then suddenly had to vomit (mostly bile) at 3:00am. Feeling slightly nauseous after vomiting but better than before.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 1420 recieved vaccination. When arrived at post vaccination area, reported a very mild pins and needles sensation from L shoulder down to hand and pinky and ring finger.  1426: BP 128/90 HR 62. 1420: Reports upper arm has returned to normal feeling; sensation of pins and needles to hand, pinky, ring finger. Reports that sensation remains at same intensity.  Over time, reports that the pins and needles sensation leaves his lower arm until at 1440 when tingling has resolved and everything feels "back to normal."  Released from post vaccination area.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Started menstruating 14 hours after both 1st and 2nd shot
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chest discomfort, Dry eye, Electrocardiogram normal, Irritable bowel syndrome
Clinical narrative: angioedema, lip paresthesia, tongue swelling, dry eyes, chest tightness
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: angioedema, lip paresthesia, tongue swelling, dry eyes, chest tightness
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: On 04 February 2021 during our COVID-19 Vaccine Drive we vaccinated one of the clinic?s staff with a dose of Moderna COVID-19 vaccine. This is her 2nd mRNA COVID-19 Vaccine dose. She is a new Clinic employee who received the first dose of Pfizer/BioNTech COVID-19 vaccine in December prior to moving. Referencing the CDC guidance and consulting with our provider on site, the team determined that this situation falls under exceptional situation due to the following reasons: ? The Pfizer/BioNTech COVID-19 vaccine is not available in our footprint. ? The vaccine recipient belongs to the Phase 1a population, an essential healthcare worker. ? The vaccine recipient was in the window to receive her 2nd dose.   There has been no adverse reaction from the patient receiving the second dose. Submitting report for awareness.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 1420 recieved vaccination. When arrived at post vaccination area, reported a very mild pins and needles sensation from L shoulder down to hand and pinky and ring finger.  1426: BP 128/90 HR 62. 1420: Reports upper arm has returned to normal feeling; senstaion of pins and needles to hand, pinky, ring finger. Reports that sensation remains at same intensity.  Over time, reports that the pins and needles sensation leaves his lower arm until at 1440 when tingling has resolved and everything feels "back to normal."  Released from post vaccination area.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated
Clinical narrative: Asthma became unpleasant about 30 hour following inoculation.  Noticeable improvement with an oral Montelukast pill, about 40% better.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Joint range of motion decreased, Lymphadenopathy
Clinical narrative: enlarged lymph node in armpit of the side the injection was on; uncomfortable; uneasy to keep her arm down; This is a spontaneous report from a contactable other healthcare professional (hcp). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ELI284, expiry date not reported), intramuscular on 29Dec2020 07:30 at a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Patient had no COVID prior vaccination and had no known allergies. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. Patient was just reporting symptoms experienced outside of normal symptoms that she was aware of: enlarged lymph node in armpit of the side the injection was on that began swelling about 7-10 days post vaccine and subsided after two days (Jan2021). Swelling of armpit lymph node was very uncomfortable and uneasy to keep her arm down. Again, went away after two consecutive days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the event "enlarged lymph node in armpit of the side the injection", uneasy to keep her arm down, and uncomfortable was recovered in Jan2021.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No additional AEs reported/ What was the patient's response? NO ADVERSE REACTION/ NOTIFIED EXCURSION; GARDASIL 9 was administered to a patient after experiencing a temperature excursion/ Temperature: 31.0 F/ Previous temperature excursion? Yes; 68°F/ Fridge temp went out of range/ Got as low as -0.28 for 30 minutes; This spontaneous report was received from a private doctor's office/hospital site manager regarding a 20-year-old male patient. The patient did not have any pre-existing physician-diagnosed allergies, birth defects, and medical conditions. Neither he had any illness at the time of vaccination.   On 19-JAN-2021, the patient was vaccinated with the first dose (reported as "# of previous doses 0") of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe of 0.5 milliliters (ml), in the left arm, intramuscularly, as prophylaxis, after it had experienced a temperature excursion (product storage error) (vaccination scheme was not reported; lot number 1687291 and expiration date 11-SEP-2022 were verified to be valid).   A healthcare professional operated the single-use vaccine and used it according to the instruction leaflet; however, the fridge temperature went out of range and got as low as -0.28 (units not provided) for 30 minutes as read from a Digital Data Logger (also reported as a temperature of 31.0 Fahrenheits (F) for a time frame of 1 hour and 15 minutes). A previous temperature excursion of 68 degrees F for 17 hours and 30 minutes was reported.   Regarding the patient's response, he was notified of the excursion, and there was no adverse reaction (no adverse event). The vaccines were quarantined, the probe was readjusted and secured better, the fridge was monitored for one week with stable results, and other monitoring devices were also adjusted. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Headache
Clinical narrative: Admitted to the hospital with multiple small strokes; Feeling fatigue; Headache; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being admitted to the hospital for multiple small strokes, fatigue and headache.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 21 Jan 2021, prior to the onset of the events, the patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On an unknown date, Shortly after the mRNA-1273 vaccine was given, the patient experienced fatigue and headache which was attributed to vaccine side effect. On 27 Jan 2021, the patient was admitted to the hospital with multiple small strokes.  No other treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fatigue, headache and being hospitalized with multiple small strokes, is unknown.; Reporter's Comments: This case concerns a 79 year-old, female patient, who experienced events of multiple small strokes, fatigue and headache. The events of fatigue and headache occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. The event of stroke occurred approximately 6 days after the first and last dose of mRNA-1273 vaccine administration.  Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Cough, Cyanosis, Dyspnoea
Clinical narrative: right sided pneumonia; having difficulty breathing; cyanotic; coughing; sounded congested; A spontaneous report was received from a nurse concerning a 92-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested.  The patient's medical history, as provided by the reporter included Alzheimer's, hypertension, arteriosclerotic heart disease, hyperlipidemia, benign prostatic hyperplasia, prostate cancer, covid-19, allergy to aricept and exelon. The concomitant medications reported included atorvastatin, tamsulosin hydrochloride, paracetamol, macrogol 3350, furosemide and ipratropium bromide/salbutamol sulfate for unspecified indications.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039k208) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient was on droplet isolation due to possible exposure of Covid 19 and received duoneb treatments for chronic nonproductive cough. The patient also received honey consistency fluids.  On 19 Jan 2021, the patient's droplet precautions were discontinued.  On 26 Jan 2021, after receiving the vaccine, the patient experienced difficulty breathing, cyanotic, cough and sounded congested following which the patient was repositioned. The  lab findings included oxygen saturation at 78 percent on room air, so oxygen was applied at 2L which increased oxygen saturation at 88 percent, so oxygen was increased to 4L and oxygen saturation increased to 95percent, body temperature at 103.1 degree Fahrenheit, blood pressure 188/110 mmHg, respiratory rate at 28 breaths per minute, pulse rate at 128 heartbeat per minute. The patient was then sent to the Hospital emergency room (ER) where he was diagnosed with right sided pneumonia.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested was unknown.; Reporter's Comments: This case concerns a 92-year-old, male patient. The patient's medical history od Alzheimer's, hypertension, arteriosclerotic heart disease, prostate cancer, covid-19, on duoneb treatments for chronic nonproductive cough remains as contributing factors. Very limited information regarding this event  has been provided at this time.  Further information has been requested.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Oxygen saturation, Pneumonia, Pulmonary congestion, Respiratory rate
Clinical narrative: right sided pneumonia; having difficulty breathing; cyanotic; coughing; sounded congested; A spontaneous report was received from a nurse concerning a 92-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested.  The patient's medical history, as provided by the reporter included Alzheimer's, hypertension, arteriosclerotic heart disease, hyperlipidemia, benign prostatic hyperplasia, prostate cancer, covid-19, allergy to aricept and exelon. The concomitant medications reported included atorvastatin, tamsulosin hydrochloride, paracetamol, macrogol 3350, furosemide and ipratropium bromide/salbutamol sulfate for unspecified indications.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039k208) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient was on droplet isolation due to possible exposure of Covid 19 and received duoneb treatments for chronic nonproductive cough. The patient also received honey consistency fluids.  On 19 Jan 2021, the patient's droplet precautions were discontinued.  On 26 Jan 2021, after receiving the vaccine, the patient experienced difficulty breathing, cyanotic, cough and sounded congested following which the patient was repositioned. The  lab findings included oxygen saturation at 78 percent on room air, so oxygen was applied at 2L which increased oxygen saturation at 88 percent, so oxygen was increased to 4L and oxygen saturation increased to 95percent, body temperature at 103.1 degree Fahrenheit, blood pressure 188/110 mmHg, respiratory rate at 28 breaths per minute, pulse rate at 128 heartbeat per minute. The patient was then sent to the Hospital emergency room (ER) where he was diagnosed with right sided pneumonia.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested was unknown.; Reporter's Comments: This case concerns a 92-year-old, male patient. The patient's medical history od Alzheimer's, hypertension, arteriosclerotic heart disease, prostate cancer, covid-19, on duoneb treatments for chronic nonproductive cough remains as contributing factors. Very limited information regarding this event  has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy after 7 days first dose; A regulatory report was received from a physician, concerning an unknown patient of unknown age and gender, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced "Bell's palsy after 7 days first dose".  The patient's medical history was not provided. Concomitant medication reported included metformin.  On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), for COVID-19 infection.  On an unknown date, after 7 days from first dose, the patient developed Bell's palsy. No treatment information was reported for the event.  Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event " Bell's palsy", was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender, who experienced a serious event of Facial paralysis approximately 7 days after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Injection site cellulitis, Pneumonia, Pneumothorax, SARS-CoV-2 test
Clinical narrative: Pneumonia; Partial left lung collapsed; Injection site cellulitis, red rash around injection site which was tender and itchy; A spontaneous report was received from a consumer, who was a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced injection site cellulitis, red rash around injection site which was tender and itchy (injection site cellulitis), cough, pneumonia, and partial left lung collapse (pneumothorax).  The patient's medical history was not provided. Concomitant medications were not reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for COVID-19 infection.  On an unspecified date, a few days after vaccination administration, the patient experienced red rash around the injection site which was tender and itchy and was diagnosed by a nurse as cellulitis, which later resolved.  On 14 Jan 2021, the patient began coughing.   On 18 Jan 2021, the patient went to urgent care for a COVID-19 test and the results came back negative. The patient was prescribed dexamethasone for three days, but symptoms did not improve. She again went to urgent care where X-rays was performed which showed pneumonia and partial left lung collapse, she was prescribed erythromycin.   On 24 Jan 2021, patient went to emergency room and was given amoxicillin and advised to see their doctor.   On 27 Jan 2021, her doctor prescribed prednisone and the symptoms started to get better.  Action taken with mRNA-1273 in response to the events was not reported, although the patient expressed concern about getting the second injection.  The outcome of events, cough, pneumonia, and partial left lung collapse (pneumothorax), was reported and resolving. The event, injection site cellulitis, red rash around injection site which was tender and itchy, was reported as resolved.; Reporter's Comments: Although a temporal association exist, the report lacks critical details such as the patient's medical history and concomitant medications.  Noting that cellulitis and pneumonia are usually caused by an infectious agent, both events are considered unlikely associated with mRNA-1273. Pneumothorax is confounded by the pneumonia.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Respiratory distress
Clinical narrative: Respiratory distress; Difficulty breathing; A spontaneous report  was received from a pharmacist concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory distress and difficulty breathing.  The patient's medical history, as provided by the reporter, included heart disease, osteoporosis, osteoarthritis, gastroesophageal reflux disease, hypothyroidism, hypertension and history of anemia. No relevant concomitant medications were reported.   On 26 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number:029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Jan 2021, within an hour of vaccination, patient had respiratory distress and difficulty breathing. The patient was treated with diphenhydramine and epinephrine, the patient was intubated and was taken to the hospital.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, respiratory distress and difficulty breathing unknown.; Reporter's Comments: This case concerns an 84-year-old female patient with medical history of heart disease,  who received their first of two planned doses of mRNA-1273 (Lot 029K20A), and who experienced the serious unlisted events of Respiratory distress and Dyspnoea.  The events occurred within one hour of vaccination.  Based on the current available information and temporal association between vaccine administration and the onset of events on the day of vaccination, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Fainted during the night; I had chills with a high fever; A spontaneous report was received from a female consumer, age not reported who experienced "chills with a high fever", and "fainted during the night" after receiving the second dose of mRNA-1273.  The patient's medical history was not reported. Concomitant product use was not reported.  On 27-Jan-2021 prior to the onset of symptoms, the patient received her second dose of mRNA-1273, route,  site and Batch number not reported, for prophylaxis of Covid-19 infection.  The patient reported a bad reaction approximately after ten or eleven hours after her immunization, she had chills with a high fever and then fainted during the night. She reported that she did come to a moment later. On 29-Jan-2021 she reported that she is feeling fine that day. The patient stated that she felt it was an unusual reaction that should be reported. Treatment for the event was not reported.  Action taken with the study drug due to the events "chills with a high fever", and "fainted during the night was not reported.  The events  "chills with a high fever", and "fainted during the night",  were considered recovered/resolved on 29-Jan-2021.; Reporter's Comments: This case concerns a female patient, who experienced events of chills with a high fever, and fainted during the night. The events occurred 10-11 hours after the second and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: began seeing hallucinations; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and began seeing hallucinations.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Feb 2021, about 4 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, about 4 hours after receiving the vaccine, the patient began seeing hallucinations. She was seeing moss grow on the walls and real bright turquoise colors that turn pink.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event began seeing hallucinations was unknown.; Reporter's Comments: This case concerns a 89 year-old, female patient, who experienced event of hallucinations. The event occurred 4 hours after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Seizure, Syncope
Clinical narrative: Rapid eye movement like "having a mini-seizure"; Fainted; Feeling warm; A spontaneous report (United States) was received from a pharmacist concerning a 21-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted and experienced to have rapid eye movement like "having a mini-seizure" and feeling of warmth.  The patient's medical history included historical seizures. Concomitant product use was not provided by the reporter.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 02 Feb 2021, a few minutes after the injection, the patient fainted then recovered but again fainted and was noted to have rapid eye movement like "having a mini-seizure". HCP managed her with ice pack as patient complained of feeling warm and she recovered in less than 30 minutes.  Treatment information was not provided.    The outcome for events fainted, rapid eye movement like "having a mini-seizure"" and feeling warm were resolved.; Reporter's Comments: This spontaneous report concerns a 21-year-old, female patient with historical seizures. who received experienced the patient fainted then recovered but again fainted and was noted to have rapid eye movement like "having a mini-seizure." The event occurred a few minutes after the administration of mRNA-1273 vaccine (Batch number: 026L20A, expiration date: unknown).   Treatment administered include Icepack and outcome is resolved.  Based on the information provided which includes a strong temporal onset between the vaccine administration and the event, a causal association cannot be excluded. However, event is confounded by the subject's history of seizures. Feeling warm is consistent with the safety profile of the product.
Sex: F
Vaccine: FLUX, PPV, TTOX
Symptoms: Unevaluable event
Clinical narrative: Allergic to the following: influenza shot, pneumonia shot, Solu-Medrol, tetanus shot, and penicillin; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received methylprednisolone sodium succinate (SOLUMEDROL) via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication, pneumococcal 13-val conj vac (dipht crm197 protein) lot/expiry: unknown, via an unspecified route of administration on an unspecified date at single dose for immunization, influenza vaccine (INFLUENZA), via an unspecified route of administration on an unspecified date at unknown dose for an unspecified indication, tetanus vaccine, via an unspecified route of administration on an unspecified date at unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient has many allergies. She said that she is allergic to the following: influenza shot, pneumonia shot, Solu-Medrol, tetanus shot, and penicillin. She asked if it would be safe to take the COVID-19 vaccine. The action taken in response to the event for methylprednisolone sodium succinate was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Nausea, Tinnitus, Vertigo
Clinical narrative: meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease.  The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease.  The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Vomiting
Clinical narrative: Throwing up foamy stuff; Oxygen saturation was in the 80%s; confused; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the right arm on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home. No other vaccine was given to the patient in four weeks. Medical history included Parkinsons, dementia, diastolic heart failure and known allergies: Iodine, Propranolol. Concomitant medication included paracetamol (TYLENOL), melatonin, quetiapine fumarate (SEROQUEL), ropinirole and sertraline hydrochloride (ZOLOFT).  On 26Jan2021 11:30 AM, the patient was throwing up foamy stuff and his oxygen saturation was in the 80%s and was confused. The events led to Emergency room/department or urgent care visit. Treatment was given for the events. The patient has no COVID-19 prior to vaccination. He was tested for COVID-19 on 26Jan2021 with Nasal Swab, Rapid Test and the result was negative. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Dizziness, Heart rate, Systolic hypertension
Clinical narrative: This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; feel light headed and it's been coming on and off/feeling dizzy and light headed; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EK4176, via an unspecified route of administration in his left upper arm, on 22Jan2021 at single dose for COVID-19 immunization. Medical history included surgery on aorta to put a stent in Nov2020. There were no concomitant medications. On 26Jan2021 at mid day the patient started to feel dizzy and light headed and this feeling has been coming on and off, so he decided to take his blood pressure. He didn't have his values from 26Jan2021. In the morning of 27Jan2021 at 6 am his blood pressure was 156/74, with 65 beats, then, at 7am, it was 167/76, with 65 beats and at 8:40 am, his blood pressure was 137/64, with 65 beats, so it was fluctuating. At the time of the report the events had not resolved yet.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile Dysfunction; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 62; Unit: Unknown) received bnt162b2 (BNT162B2), first dose (lot: EL0142) via an unspecified route of administration on 05Jan2021 at single dose, second dose (lot: EN5318) via an unspecified route of administration on 26Jan2021 (administered between 1:00-2:30PM) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced erectile dysfunction on an unspecified date. The patient asked What is the mRNA half life. He stated that he received the Pfizer vaccine on the 5th and the second on the 26th. He was asking if there were any reports of erectile dysfunction after receiving the vaccine. He also asked if the ingredient Hexane was a poison, if this is safe. The patient had some questions, he is really worried because he has seemed to be experiencing something. He is wondering if Erectile Dysfunction has been reported as a problem from the COVID vaccine. He seemed to be experiencing worsening of his sexual function, and the only thing that is new that he can think, is that he got the vaccination. He received the second dose of the product on 26Jan2021. He asked how long the MRNA last in your system,  how many people were involved in the study, When did it start, if the hexane solvent in the vaccine affect your testes. It was further reported that he was having a bad reaction he believe to the vaccination (Covid Vaccine) and asked if there were any reports of erectile dysfunction or sexual dysfunction regarding males from the vaccine. The patient had an article here it says your system mounts a response against the new protein, because they are seen as foreign invaders, developing antibodies that are specific to SARS-CoV-2 in the process. These infection fighters tick around to help your body fight a future case of Covid-19 but it's not yet understood for how long and this is the sense he wanted to talk to about that body will do its thing and eventually will get rid of the protein or mRNA on its own? The patient said since he had taken the COVID-19 Vaccine injections he has experienced worsening erective dysfunction. He asked if anyone else has reported having that issue since receiving the COVID-19 Vaccine. He was advised he would be transferred to Medical Information for further assistance. He stated he is so sad, and started crying while speaking with the agent. He declined to answer any further questions and asked to be transferred to Medical Information to have his question addressed. He asked the agent if she knew that Hexane is in the Pfizer COVID- 19 Vaccine. He said he did not realize Hexane was in the COVID-19 Vaccine before he got the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Facial paralysis, Feeling hot, Reduced facial expression
Clinical narrative: blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of blood flow, Tremor
Clinical narrative: blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination site warmth
Clinical narrative: a bit of warmth at site; Initial information received on 30-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involves a patient of unknown age and gender who experienced bit of warmth at site (vaccination site warmth), while he/she received vaccine INFLUENZA VACCINE.  It was reported that it was shot doing it was worked so no pain. Just tough it out . It beats hell. Alternative: would probably ask about Pneumonia shot too.  The patient's vaccination(s) included COVID-19 VACCINE and had side effects from it (felt like crap & got bumps in armpit). The patient's past medical history, concomitant therapy, medical treatment(s) and family history were not provided. At the time of the event, the patient had COVID-19 (Coronavirus disease) (he was recovering from COVID).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a bit of warmth at site (vaccination site warmth) (Unknown latency) following the administration of INFLUENZA VACCINE.  Patient stated that "he/she was stupid for decades because his folks got sick when they got shots. So he/she just got Flu & almost died twice. He/She got Flu shot between COVID shots. Did not feel Flu shot. It sucked his/her strength like a Vampire. Patient also mentioned "It was up to individuals to decide if they can Live with Guilt if they do not get shots & give these sickness to somebody who never recovers.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.