chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fell; Felt like he was dying; couldn't taste, and had a terrible taste in his mouth; Could not smell; Stomach hurt; A spontaneous report was received from a consumer concerning a 92-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not taste and had terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall).  The patient's medical history included hospitalization due to COVID-19. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) an unspecified date.   On 22 Feb 2021, two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Two hours after the vaccination, the patient could not taste, and had a terrible taste in his mouth The patient could not smell and his stomach hurt. The patient felt like he was dying.   On 23 Feb 2021, the patient fell.  911 was called and the patient was hospitalized. Treatment for the event included electrolytes. The patient had an abnormal electrocardiogram (EKG  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, could not taste and had a terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall), were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Noting advance age is a risk factor. Noting the history of advance age and previous COVID infection may remain as risk factors. Further information has been requested.
Redness at polio site measuring 5 inches x 10 inches on left arm and at MMR sites on right arm measuring 2 inches x 3 inches. Atarax given.
on the verge of passing out; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 03Apr2021 08:00 (36-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included Known allergies to Milk and casein. Facility type vaccine, other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 on 14Mar2021 08:00 AM (36-years-old) on Left arm for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced on the verge of passing out, dizzy, and nausea on 05Apr2021 19:00. The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM; FATIGUED; SLEEPY; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM), FATIGUE (FATIGUED) and SOMNOLENCE (SLEEPY) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for RA.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM), FATIGUE (FATIGUED) and SOMNOLENCE (SLEEPY). In April 2021, VACCINATION SITE PAIN (WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM), FATIGUE (FATIGUED) and SOMNOLENCE (SLEEPY) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information were provided.  Onset 09 Apr 2021 with HUMIRA(ADALIMUMAB) was no reasonable  possibility.   This case was linked to MOD-2022-577123 (Patient Link).
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, improperly stored doses of VAQTA lot # K000943 with expiration date 24-SEP-2016 (dose and route of administration not reported) were administered to the patients. It was reported that the vaccines underwent a temperature excursion of 34.4 degrees Fahrenheit for 8 hours. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
1. RECURRENT COMPLEX SEIZURE W/ POSTURING & RESPIRATORY DEPRESSION; 2. FEVER; 3. ALTERED/ DEPRESSED LEVEL OF CONSCIOUSNESS.
oxygen saturation level is sometimes in the high 80s; feel sporadic tightness in my chest on a daily basis; blood pressure was low; heart started racing. It was between 135-150 bpm for a little over 12 hours/heart rate has never completely returned to normal. It will typically vary from 68-120 bpm; heart started racing. It was between 135-150 bpm for a little over 12 hours/heart rate has never completely returned to normal. It will typically vary from 68-120 bpm; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EN6198), via an unspecified route of administration in the right arm on 19Feb2021 at 14:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination, however, the patient believed she was a false negative for COVID-19. Concomitant medications included levothyroxine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318) in the right arm on 29Jan2021 at 12:30 (at the age of 56-years-old) for COVID-19 immunisation. The patient previously took tetracycline and experienced allergies. The patient did not receive any other vaccine within 4 weeks of the vaccination. On 20Feb2021 at 18:00, the day after the 2nd dose in the evening, the patient's heart started racing. It was between 135-150 bpm for a little over 12 hours. The patient finally went to urgent care, and by then the heart had slowed to a regular rate. But her blood pressure was low, so she received a saline IV. The EKG and some type of blood test were both normal on Feb2021. The events required an emergency room/department or urgent care visit. To this date (13Apr2021), the patient's heart rate had never completely returned to normal. It will typically vary from 68-120 bpm, and the oxygen saturation level was sometimes in the high 80s, as of an unspecified date. The patient felt sporadic tightness in the chest on a daily basis, as of an unspecified date. The patient was waiting to be seen by a cardiologist. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was resolved with sequel.
pt began to c/o feeling bad approx 20min post inj;pt said chest hurt & was nauseated;pt began to cry;pt took nitro tab that had w/her;EMS present @ hlth fair & responded w/in 1-2min;EKG showed some cardiac problems & inc BP;
This was the second shot in series of 2. First shot only gave me a sore arm at site & was administered on February 6, 2021.  Second shot was administered on March 3, 2021. Started feeling these adverse effects about 9 or 10 am the following morning, 3/4/2021. Symptoms were soreness at site, in muscle that goes to the neck, headache, soreness across upper back/shoulder to shoulder. By 4 pm on 3/4, my entire body was reacting with extreme joint pain in all joints, extreme joint stiffness, skin was tender to the touch, temperature of 100.1, sore/stiff neck, and continuing headache. Temperature ceased around 11:30 pm but all other symptoms remained upon going to bed at 1 a.m., 3/5/2021. Upon waking at about 7:30 am 3/5/2021, all symptoms had diminished enough for me to go to an appointment at 10:45 am. However, by the time I headed back home at about 1:30 pm, I was so sleepy I could hardly keep my eyes open. More stiffness and achiness had returned too, especially a sore left underarm. Not the extent of night before, but enough to be uncomfortable. Today, 3/6/2021, I have noticed a sore muscle traveling from my left underarm down to my waist.
Fever, CoughWheeze, Diarrhea, Body Ache Narrative:
High fever (102); chills; lymphadenopathy; headache; This is a spontaneous report from a non-contactable physician. A 36-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 11Jan2021 07:00 at a single dose for COVID-19 immunization. The 1st dose was received on 21Dec2020 07:00. The patient's medical history and concomitant medications were not reported. The patient experienced high fever (102), chills, lymphadenopathy, headache on 11Jan2021. Outcome of the events was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Headache since vaccine. Cloudy thinking. Ringing in the ears. Chest wall pain. Dizziness nausea
Information was received from a R.N. who stated that improperly stored MMR II (lot numbers not reported) might have been administered to a child. It was reported MMR II was exposed to 64 F for 18 hours. No adverse effects reported.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case included information of patient 172 out of 190 reported patients. No concomitant medication was reported. No treatment medication was reported.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-704335: Master case
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 31-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Swelling, redness and edema at vaccine site. Possible secondary cellulitis on Thursday, 4/30/15 after vaccine between 1:10 pm and 2 pm. At 7 pm, I had chills so bad, like shaking to have to hold onto any objects, had fever of 102 next day all day.
Patient presented to office 2 days after inoculation with his left injection site red, swollen and tender - Dr suggested Motrin and Benadryl in addition to topical cortisone prn.
On the 24th of March I had a severe sore throat and coughing and runny nose.  I did not have a temperature.  I did also have congestion in my chest.  Before I saw I went to the urgent care I started to treat with Mucinex.  That did not seem to work.  I went to the urgent care.  The NP at the urgent care, Z-pack a 6-day regiment and to continue with the Mucinex.  I took 2 COVID test and they came back negative.  I took another one after the urgent care visit and it was negative as well.   I am still coughing but it is not as bad.  I still have a little congestion.
The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Apr-2022.  The pharmacist reported that vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. The vial had not undergone any temperature excursions. The pharmacist does not have any other information on the patients at that time and would call Moderna when additional information was known. The health care professional further stated to provide missed information and mentioned that 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022. No treatment medications were reported.
muscle pain; Chills; severe headache; low grade fever; tired; swelling and redness on injection site; swelling and redness on injection site; This is a spontaneous report from a contactable consumer or other non-HCP.  A 61-year-old non pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, at on 05Apr2021 at 10:00 (Lot number was Ew0151, age at the time of vaccination was 61-year-old), administered in arm left as single dose for COVID-19 immunization. The patient's relevant medical history included fibromyalgia, migraine, nerve damage, Cipro and quinone allergies from an unspecified date. Past drug included ciprofloxacin (CIPRO) and quinone and had allergies from both on an unspecified date. The patient's concomitant medications included Synthroid (LEVOTHYROXINE SODIUM), Propranolol and Fluticasone taken for an unspecified indication. The patient had no other vaccines within 4 weeks. The patient did not have COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration administered in arm left on 15Mar2021 at 12:00 (Lot number was EN6208, age at the time of vaccination was 61-year-old), as single dose for COVID-19 immunization. On 05Apr2021 at 19:00, the patient experienced muscle pain, chills, severe headache, low grade fever, tired, swelling and redness on injection site. No treatment was received for the adverse events. The clinical outcome of muscle pain, chills, severe headache, low grade fever and swelling and redness on injection site was recovering, while the clinical outcome of tired was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient said she had tooth pain and inflamation. She made an appointment with her dentist, but by the time she was seen by her dentist, the inflamation had resolved. The patient's dentist informed her that he had two other cases in the previous 2 weeks besides her who had the same complaint after receiving the Shingrix vaccine.
Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes Zoster (shingles vaccines) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself or herself. The age at vaccination was not reported. The patient got the shingles vaccine and was so sick.
8/4/22 the patient developed redness and swelling on patients left thigh around the injection site.  The following day the redness around the injection site spread outward and the area became raised and with warmth to the touch.  The patient did not have fevers, full body rash, face/mouth swelling, or difficulty breathing.  Patient was seen in clinic 8/5/22 and was diagnosed with cellulitis and is being treated with Cephalexin 250mg/5ml (take 7ml by mouth TID for 5 days.)
Right thigh where varicella and MMR given was red. No swelling. Baby acting ok.  Waited another 15 minutes.  No change in redness.  No swelling. No itching.  Baby ok.
Side effects started day 2 after vaccine administration. Pt started with fever, vomiting, abdominal distension, spot where she had previous hernia surgery was bothering her. She spent a whole day in bed and then felt better. Just follow home care treatment.
Information has been received from a licensed practical nurse concerning a child who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient experienced an unknown adverse event. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. No further information is available.
On first period after vaccine, experiences heaviest bleeding I have ever had, huge blood clots the size of golf balls, and I had severe cramping and body aches for three days of my period. Previous to vaccine had heavy bleeding, but not this heavy and only one evening period period cycle of light cramping and mild body aches. I have become anemic since the vaccine.
Adverse events include runny nose and mucus discharge coming from nose every time I bend down or lower my head. The mucus is clear and I had no previous mucus production prior to the shot. These events occurred three full days shortly after I received the shot.
Approximately 11 minutes post COVID19 injection, client experienced syncopal episode per family member. Patient conscious and A+O x 4 at time of nurse response, client was noted to be pale and diaphoretic with c/o nausea, vital signs stable, lungs clear to auscultation bilaterally, no visible or verbal complaint of shortness of breath, edema to face/mouth, hoarseness/throat tightness, vital signs remained stable: 1351-HR 89, BP-92/64, SpO2-99%, R-18, 1353-HR 79, BP-102/74, SpO2-99%, R-18, 1400-HR 79, BP-108/78, SpO2-100%, R-18.  Client waited an additional 15 minutes in clinic for observations, at time of discharge patient reported resolved nausea, skin color within normal limits for race, no visible or verbalized distress from patient.
Received influenza vaccine yesterday to (L) thigh IM. Today presents with swelling warm, mild erythema to (L) knee. Pain with weight bearing.
itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE, ROSUVASTATIN, MELOXICAM, AMLODIPINE and DULOXETINE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included I put some Anti itch cream just before I called you.
Patient reports feeling dizzy, and auditory loss in both ears and chills. Vitals BP 70/50, P79, Sat 98, T36.0, Dxt 100.
A lot of burning at start of injected, general/normal arm pain starts within an hour. At 8pm major nerve pain from ulnar nerve begins and worsens, mostly in elbow and numbness in pinky and ring finger
The day after her second vaccine, she got a mild rash on her stomach but it quickly went away.  Six days later she developed a rash from the top of her knees up to her neck and then down both arms. No itching, No SOB. She went to the ER and the MD told her it was a reaction to the COVID Vaccine. She was sent home and told to take Benadryl. Rash started to resolve next day