chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA - Fever, fatigue, body aches, headache, very sore arm (red, hot and swelled), itchy rash at injection site. Took tylenol at onset. Fever high of 101.5 reduced to about 100 over the next 12 hours and slowly dissipated. Fatigue and body aches lasted for approx 36 hours. Arm swelling and soreness lasted for 5 days.
Friday- complained of leg cramps and the sensation of "not being able to move"; Saturday- tired, complained of pain in legs, "feet were tingly" and "calves were tight"; Monday- worked, but Dr could not see until Tuesday afternoon; Tuesday- collapsed in bathroom, crawled to wall and pulled self up, went home from work at noon; Wednesday- MRI no new symptoms; Thursday- complained of arms tingling; "legs were like noodles" and "couldn't stand"; Friday- no strength in arms or legs, had trouble breathing,  called ambulance at 1:09 pm; died at 2 pm.
Booster dose of Moderna was given on day 165 instead of day 180 after second dose on 6/24/2021.  At time of reporting patient was not experiencing any adverse effects following the booster dose.
This spontaneous report was received from a medical assistant via field employee refers to two patients who were older than 65 years of age. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications were unknown. The patients were vaccinated with PREVNAR 13 on unspecified dates one year prior to being vaccinated to PNEUMOVAX 23. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dosing details were not provided) as per routine recommendation. Reporter stated that on unknown dates, both the patients developed swelling in the arm where the suspect vaccine was administered. The swelling lasted for a few days and went away (recovered). Causality assessment was not provided.
side effect from the first shot; Had a Covid arm; little sore; 10 days later, I had itching; small rash; feels like little bumps is reaction to immune system; became a large rash on my arm; A spontaneous report was received from a consumer concerning a 84-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events adverse reaction, injection site rash, pain, pruritus, rash, injection site reaction.       The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced events, side effect from the first shot, Had a Covid arm, rash on the arm where I got the injection, little sore, 10 days later, I had itching, small rash, feels like little bumps is reaction to immune system, became a large rash on my arm.  Treatment details included Hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, side effect from the first shot, had a covid arm,rash on the arm where i got the injection,little sore,10 days later,i had itching,small rash,feels like little bumps is reaction to immune system,became a large rash on my arm was unknown.
Morning after vaccinated - woke up with rash to face with severe itching, no SOB, wheezing, fever HA's noted. C/o pain to throat when swallowed - no difficulty breathing came to Clinic at 3:00p given Rx for BENADRYL.
Friday 01/08/2021 7-8 pm started to have chill, headache, bodyache.  Getting better by Sunday 1/10.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: Covid-19, and concurrent conditions included: allergies (a little bit of allergies), and other pre-existing medical conditions included: Patient was completely fine before the vaccine. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine used, and off label use. On an unspecified date, the patient experienced tonsil swelling up, tonsil covered with white stuff, extremely vomitting, haven't been able to eat in two weeks, bedridden for 2 weeks, and really bad headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really bad headache, tonsil swelling up, tonsil covered with white stuff, extremely vomitting, haven't been able to eat in two weeks, bedridden for 2 weeks, expired vaccine used and off label use was not reported. This report was non-serious.
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L018499 with expiration date of 25-FEB-2017; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
tenderness in the middle of left arm; nose bleed (spotting); redness of the left arm/redness in vaccinated arm spread beyond vaccination site; soreness of the left arm/arm sore for a week; fever of 102.9 degrees F; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (tenderness in the middle of left arm), EPISTAXIS (nose bleed (spotting)), INJECTION SITE ERYTHEMA (redness of the left arm/redness in vaccinated arm spread beyond vaccination site), VACCINATION SITE PAIN (soreness of the left arm/arm sore for a week) and PYREXIA (fever of 102.9 degrees F) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement on 12-Apr-2018. Concurrent medical conditions included Hypertension and Penicillin allergy. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and OLMESARTAN for Blood pressure high, FUROSEMIDE from 12-May-2018 to an unknown date for Fluid retention, APIXABAN (ELIQUIS) from 12-May-2018 to an unknown date and GABAPENTIN from 12-May-2018 to an unknown date for Surgery, ROSUVASTATIN and VITAMIN D3 for an unknown indication.   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 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever of 102.9 degrees F). On an unknown date, the patient experienced TENDERNESS (tenderness in the middle of left arm), EPISTAXIS (nose bleed (spotting)), INJECTION SITE ERYTHEMA (redness of the left arm/redness in vaccinated arm spread beyond vaccination site) and VACCINATION SITE PAIN (soreness of the left arm/arm sore for a week). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 11-Apr-2021, PYREXIA (fever of 102.9 degrees F) had resolved. On 16-Apr-2021, TENDERNESS (tenderness in the middle of left arm), EPISTAXIS (nose bleed (spotting)), INJECTION SITE ERYTHEMA (redness of the left arm/redness in vaccinated arm spread beyond vaccination site) and VACCINATION SITE PAIN (soreness of the left arm/arm sore for a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.9 (High) 102.9F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-075659 (E2B Linked Report). This case was linked to MOD-2021-076715.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received.HCP phone number updated. Primary reporter occupation updated. Patient gender updated. Medical history added. Concomitant products added. New event nose bleed added. Event outcome updated.; Sender's Comments:  MOD21-075659:
On 3/11/2021, mother of patient documented that he was 18 on vaccination documents. I confirmed that he was 18 at clinic check-in. We realized he was underage when we tried to enter his data into vaccine system and were unable to because of his age. I spoke to the mother about the situation, she said that she did it because he would be 18 the following day on 3/12/2021.
Sprain in neck; hard to move my head; immense pain; This is a spontaneous report from a contactable other health professional (himself). A 39-years-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, in arm left on 10Feb2021 14:00 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication(s) included naproxen sodium (ALEVE). Patient did not take other vaccine in four weeks. Patient took other medications as a aleve in two weeks. On 12Feb2021 08:00 The patient experienced sprain in neck, hard to move my head and immense pain. Patient did not take treatment for events. Patient did not take vaccine prior to Covid and not tested post vaccination. The outcome of the events was not recovered.
Fetal demise around 15/16 weeks. Did not discover fetal demise until week 23 of pregnancy; still birth followed the discovery of no heartbeat. No official cause of miscarriage was determined, but the baby had not grown in size since about week 14.  First dose of Moderna was around 5 weeks; second dose of Moderna was around 9 weeks of pregnancy.
Broke in papular lesions started the day prior to being seen, and has continued to spread.
Loud intense cry with screaming for 1 1/2 hrs.  Seen next day, child  normal.
Shortly following vaccination, developed redness, skin rash, itchiness, dizziness and anxiety. Was given diphenhydramine 25mg with no relief and began worsening - walked over the Emergency Department in same building and treated there with the following: Solu-Medrol 125 mg IV Push, Diphenhydramine 50mg IV Push, and Prednisone 40 mg by mouth. Symptoms began to improve within about an hour and was given a prescription for Prednisone 20 mg Po X 3 days.
Died; A spontaneous report was received from a reporter concerning a unknown patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient passed away. No treatment information was provided.  Action taken with RNA-1273 in response to the event was not applicable.  The patient died on unknown date. The cause of death was reported as unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided.  The fatal, unexpected event of death occurred on an unknown date after the administration of the first dose of mRNA-1273 on an unknown date. The cause of death was reported as unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the event, a causal relationship cannot be excluded. Additional information regarding the autopsy report, date of the mRNA administration, day of death, medical information and details of concomitant product are all required for further assessment of causality.; Reported Cause(s) of Death: Unknown cause of death
FEVER, BACK HURTS, NAUSEA, SORE THROAT, BODY ACHE, HEADACHE,STUFFY NOSE, RESOLVED IN TWO WEEKS. FEVER IN  THE FIRST 2 DAYS MAXIMUM 102 F THAN LOW GRADE FEVER ON AND OFF REST OF THE TWO WEEKS AND RESOLVED.
Developed significant nausea, chills and fatigue about 6-7 hours  after injection.
C/O ITCHY ERYTHEMATOUS MACULOPAPULAR ERUPTION WHICH IS DISCRETE AND SCATTERED IN BILATERAL AXILLARY REGION FIRST NOTICED TODAY. TENDER AXILLARY NODES.  INOCULATION IS LOCATED ON LEFT DELTOID REGION 1.5 CM, MACERATED WITH MILD SURROUNDING ERYTHEMA. NO LYMPHANGITIS, FEVER, CHILLS, SOB, CP OR DOE. PT TREATED WITH MOTRIN 800MG TID, CLARITIN 20MG QD AND BENADRYL 50 MG QHS.  F/U IN 2-3 DAYS OR SOONER IF LESIONS SPREAD, HEADACHE, FEVER OR CHILL OR OTHER CONCERNS.
pale and lost consciousness; fell from seated position; hit head causing a two inch laceration behind ear; pale and lost consciousness; This is a spontaneous report from a contactable healthcare professional. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in Arm Left on 08May2021 (Batch/Lot Number: ER8731) as 2nd dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 17Apr2021 (Batch/lot number: EW0162) for covid-19 immunisation. On 08May2021, the patient walked to observation area and sat down. After about five minutes, the patient became pale and lost consciousness. The patient fell from seated position onto concrete ground and hit head causing a two-inch laceration behind ear. Ambulance was called and evaluated patient. The patient refuse to sign with AMR. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported loss consciousness which subsequently led to a fall resulting in a two-inch laceration behind ear and the use of BNT162B2 cannot be fully 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Third shot at the end of June. Went to the ER on July 3, 2012. Legs started going numb and tingly. Her arms and hands are all numb. It is hard to squeeze her hands. When walking it feels like her legs are noodles.
A consumer report has been received. The report concerns a 7 year old, male consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient reported that the FLUMIST QUADRIVALENT was accidentally squirted into his eye when their head was turned which started on 18-Sep-2013. The outcome of the event of SQUIRTED INTO A PATIENT'S EYE is unknown. The report was considered to be non-serious.
Fever (highest 102.3), chills, severe headache and body aches, mild nausea, diarrhea. Sore arm.
Pt rec VARICELLA vaccine on 4/20/09 - On 5/9/09 developed some itchy spots on truck with eye pain and frontal headache - On 5/11/09 Dx'd with chicken pox
Pronounced dead 1/9/2021 at 12:42.  Received first dose of vaccine 1/8/2021
Patient said as she was walking out of store after shot - she felt itchy all over. She went home - put a cold pack on her sore arm & took a pain reliever. Was still itchy - took a Benadryl. She also had redness & pain 3 1/2" down & 1" forward from injection site. Pt. informed me 6-6-19 of adverse event. Felt better next day.
Patient immediately experienced pain, tremors in the injection arm. Went to ER, made appt with her PCP, and is still experiencing severe pain
About 15 mins after pt received her vaccine she reported that she was having trouble swallowing .  The EMS crew immediately took her vitals and they were WNL BP 120/80 and SpO2 was 98% and remain that way for the duration of her time in observation.  Pt stated that she felt like she was getting worse so she was administered Benadryl 50 mg IM by the EMS crew at 1215. at 1230 pt stated her throat was feeling mostly better and She could now swallow but that the inside of her mouth felt like it was swelling. The EMS crew stated that due to them giving her Benadryl their protocol was to call an ambulance. The ambulance arrived and evaluated pt and recommended that she be seen at the hospital. Pt refused stating that she would have her husband that was with her drive her there.  Pt was then released to drive herself to medical center.
I had severe joint pain, headache, nausea, and extreme fatigue. And symptoms that went on for a month were dizziness and brain fog.
Injection site pain; Extreme fatigue; Mild headache; Muscle pain; Chills; Flushed; Dizzy; Loss of appetite; Feel unwell; This is a spontaneous report from a consumer, the patient. A 64-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration on left arm on 13Mar2021 at 11:00, (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included epstein barre virus and high blood pressure. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), LIVALO and metoprolol (MANUFACTURER UNKNOWN) and hydroc (MANUFACTURER UNKNOWN) for unknown indication. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Mar2021 at 11:30, the patient experienced injection site pain, extreme fatigue, mild headache, muscle pain, chills, flushed, dizzy, loss of appetite (colon cleanse at 3rd night) and the patient felt unwell until 6th day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatments were taken for any events. The clinical outcome of the events injection site pain, extreme fatigue, mild headache, muscle pain, chills, flushed, dizzy, loss of appetite was resolved on an unknown date in Mar2021 and for event feeling unwell was resolved on 19Mar2021 (day 6).   No follow-up attempts are needed. No further information is expected.
Acute pericarditis. 4 days of worsening substernal chest pain. Diffuse ST elevations on ECG. Large pericardial effusion on CT and ultrasound. Troponins negative. ESR and CRP elevated. No previous history of viral illness or autoimmune disease. Treated with course of Colchicine and Indomethacin with close Cardiology follow up outpatient. Patient otherwise afebrile and hemodynamically stable.
Laparoscopy exploratory general surgery. Hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of GARDASIL. The patient experienced two episodes of fainting after administration of the GARDASIL. The patient sought medical attention with a physician. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported a temperature excursion dated 02-AUG-2014 of 0 degrees Centigrade for 8 hours affecting RECOMBIVAX HB. The excursion was supported. The nurse reported that RECOMBIVAX HB was administered post excursion (dose, routes and lot numbers not provided), (approximately in 2014). The nurse did not have access to specific patient or product information. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
swollen; like someone punched her; hard; medium red; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (like someone punched her), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (medium red) and VACCINATION SITE SWELLING (swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ra05798) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (like someone punched her), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (medium red). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen). At the time of the report, MALAISE (like someone punched her), VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA (medium red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Redness; Tenderness; Cellulitis; Itching; Swelling.
30 min after the vaccine, she had tightness and numbness sensation in the R chest wall and R shoulder. felt dizzy.
A day after the shot I felt somewhat like I had the beginning of a flu: chilled but with a slight fever, tired, slightly nauseated. The next morning I felt considerably better, only slightly tired. However my arm hurt more on the 3rd day and I developed some pinkness in the shot location. The 4th day my arm is still tender and itches, and the shot area is more pink and warm.
Swelling under both eyes - right more pronounced ~ where filler had been injected in October 2020
injection site reaction; Last two days "feeling bad; pain in left arm, heart area and ribs, bottom; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), FEELING ABNORMAL (Last two days "feeling bad) and MYALGIA (pain in left arm, heart area and ribs, bottom) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site reaction), FEELING ABNORMAL (Last two days "feeling bad) and MYALGIA (pain in left arm, heart area and ribs, bottom). At the time of the report, VACCINATION SITE REACTION (injection site reaction), FEELING ABNORMAL (Last two days "feeling bad) and MYALGIA (pain in left arm, heart area and ribs, bottom) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal. On an unknown date, Electrocardiogram: normal. On an unknown date, Urine analysis: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       patient reported experienced no symptoms from his first dose of Moderna covid-19 vaccine but after 24 days he experienced injection site reaction, last two days "feeling bad", pain in left arm, heart area and ribs, bottom. He reported his GP ruled out any problem heart related stuff, yesterday took blood work, urinalysis and EKG and nothing came out.