chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Foggy memory; Arm soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Foggy memory), MYALGIA (Arm soreness) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Foggy memory), MYALGIA (Arm soreness) and FATIGUE (Tiredness). At the time of the report, CONFUSIONAL STATE (Foggy memory), MYALGIA (Arm soreness) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
CHF within 15 minutes of vaccine. Couldn't breathe, BP 224/188, heart rate 136, throwing up mucus. Was given benadryl, steriods, lasix, and 5 liters of O2. O2 levels decreased and I was transferred to ICU unit and placed on 8 liters of O2. I was there for 5 days. EKG showed slight heart enlargement.
This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 57 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
PT was supposed to receive moderna bivalent but instead received a 0.5mL dose of the regular covid vaccine. His Moderna covid vaccine dates are 2/17/21, 3/16/21, 11/5/21, 4/28/22.
arm was just hurting for at least 2 days; broke out  with a rash; burning rash like hot rash; feeling hot; feeling kinda painful.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was just hurting for at least 2 days), RASH (broke out  with a rash), BURNING SENSATION (burning rash like hot rash), FEELING HOT (feeling hot) and PAIN (feeling kinda painful.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was just hurting for at least 2 days), RASH (broke out  with a rash), BURNING SENSATION (burning rash like hot rash), FEELING HOT (feeling hot) and PAIN (feeling kinda painful.). At the time of the report, PAIN IN EXTREMITY (arm was just hurting for at least 2 days), RASH (broke out  with a rash), BURNING SENSATION (burning rash like hot rash), FEELING HOT (feeling hot) and PAIN (feeling kinda painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.   This case was linked to MOD-2021-332641 (Patient Link).
rash worsened following the 2nd injection. Rash then spread all over body and increased in size; Extremely itchy; Diagnosed as possible pityriasis; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received 2nd dose of BNT162B2 (lot number: EL3249), via an unspecified route of administration in left arm on 20Jan2021 13:45 at single dose for covid-19 immunisation. Medical history known allergies: eggs, shellfish, peanuts. Concomitant medication included desogestrel, ethinylestradiol (APRI). The patient previously received 1st dose of BNT162B2 (lot number: EL0140) in left arm on 30Dec2020 for COVID-19 immunization and experienced rash/mainly on stomach two days after the 1st injection. On an unspecified date of Jan2021, the rash worsened following the 2nd injection. Rash then spread all over body and increased in size. Extremely itchy. Diagnosed as possible pityriasis.  Treatment steroid cream received for the adverse events. The outcome of events was not recovered. This case was reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Patient developed pleuritic chest pain. Was found to have ECG changes consistent with pericarditis. Troponin was elevated, high sensitivity Troponin-I was 7,272 and trending up to 17,120. He was also found to have mildly reduced ejection fraction 45-50% on TTE. Symptoms resolved after 2 days, and patient is now doing well.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant information was provided.
Warm, red, large swelling one inch below the injection site.(the size of 3 large eggs per patient). and hives all over her body
Patient received the vaccine, and was watched for 15 minutes.  Patient was approximately 30 minutes away from clinic when he started feeling nauseous.  Patient stated that he threw up three to four times while driving.  Upon reaching his destination, the staff at his facility noticed that he looked pale.  He began to complain of chest pain on the right side and EMS was called.  Patient was transported to Hospital.
pt recvd vax 7OCT92 & 2 days later exp myalgia,muscle aches &stiffness of lt shoulder & chest;3rd dose of vax was w/held since pt testes anti-HBs pos on 12MAR93;@ the time of report arthralgias persisted; No further details were provided;
still feeling a little tingling of the face; not feeling normal; Mouth was tingly; Heart rate was fast; Mouth was numb/Numbness spread to the face and tongue; Numbness spread to the face and tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Mouth was tingly), HEART RATE ABNORMAL (Heart rate was fast), PARAESTHESIA (still feeling a little tingling of the face), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue) and HYPOAESTHESIA (Numbness spread to the face and tongue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Patient was allergic to penicillin (rash).).   On 14-Feb-2021 at 8:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021 at 6:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEART RATE ABNORMAL (Heart rate was fast), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue) and HYPOAESTHESIA (Numbness spread to the face and tongue). On 14-Feb-2021 at 9:05 PM, the patient experienced PARAESTHESIA ORAL (Mouth was tingly). On 16-Feb-2021, the patient experienced PARAESTHESIA (still feeling a little tingling of the face) and FEELING ABNORMAL (not feeling normal). On 14-Feb-2021, HEART RATE ABNORMAL (Heart rate was fast) had resolved. On 16-Feb-2021, PARAESTHESIA ORAL (Mouth was tingly) had resolved. At the time of the report, PARAESTHESIA (still feeling a little tingling of the face), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue), HYPOAESTHESIA (Numbness spread to the face and tongue) and FEELING ABNORMAL (not feeling normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographics updated- initial and follow up will be submitted to regulatory authority together
COVID Positive; COVID Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID Positive, reporter husband had 2 Pfizer doses and had it as well.  Clinical course: The reporter stated she had all 3 doses and she was that she had COVID positive, her husband had 2 Pfizer doses and has it as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
COUGH, SORE THROAT, FEVER, CHILLS, AND DIARRHEA.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/15/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 8/15/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Fever, diarrhea, nausea and vomiting, body aches, fatigue within minutes of getting flu shot. No problem with flu shot previously.
Felt lousy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced MALAISE (Felt lousy) and PYREXIA (Fever). At the time of the report, MALAISE (Felt lousy) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.
Patient reported during her routine checkup (3/30) with PCP  that she has had continuous back pain since receiving the second dose of the Moderna COVID-19 Vaccine on 3/5.  Pt requested PCP to send in an additional prednisone taper in addition to scheduled daily prednisone, which she reported helped her with the pain.
CHEST TIGHTNESS; PERSISTENT HEADACHE; ELEVATED HEART RATE OF 90-100 BEATS PER MINUTE AT REST; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies, no drug abuse nor illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 27-OCT-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On 27-OCT-2021, the patient experienced elevated heart rate of 90-100 beats per minute at rest. Laboratory data included: Heart rate (NR: 50 - 60) elevated at 90-100 beats per minute. On 28-OCT-2021, treatment medications included: ibuprofen. On 29-OCT-2021, the patient experienced chest tightness. On 29-OCT-2021, the patient experienced persistent headache. Additional treatment medications (dates unspecified) included: pseudoephedrine, naproxen sodium, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate of 90-100 beats per minute at rest on 28-OCT-2021, and had not recovered from chest tightness, and persistent headache. This report was non-serious.
The patient is a 66-year-old woman, followed by Dr.  She presents with 1 day of abdominal pain.  She also was exposed to COVID, her husband has had COVID, she developed COVID symptoms on January 2, 2022, was diagnosed on January 3, 2022. Her symptoms were mainly what she called all the COVID symptoms including fever, myalgia, cough.  She says that her doctor called in some steroids for her, which she has finished.  Her symptoms would have been over 2 weeks ago.  She states that about 3 or 4 days ago, she had some right upper, right mid abdominal pain that lasted for a couple of hours and went away.  She was in her usual state of health until today when she developed some upper abdominal pain with nausea and vomiting. She had also noticed decreased ileostomy output.  She was evaluated in the ER and CT scan diagnosed her with a pancreatitis.  She has also tested positive for COVID. Most of her symptoms have resolved.  She has some mild cough, but has some chronic cough due to her COPD.   PT IS STILL INPATIENT AT THIS TIME.
Soreness at site of injection, slight headache and nausea, general body aches and pains. Lasted for two days then subsided. Temperature 100.7 degrees F at 7 AM on 04/16/2021 declined to 97.6 degrees F. by 4 PM 04/17/2021 (normal for me)
This case was reported by a physician via sales rep and described the occurrence of headache in a 63-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, fever, chills and fatigue. On an unknown date, the outcome of the headache, fever, chills and fatigue were recovered/resolved. It was unknown if the reporter considered the headache, fever, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headache, fever, chills and fatigue after receiving SHINGRIX vaccination. The symptoms resolved in 2 to 3 days. The reporter agreed to contact for follow up. This case has been linked with case US2018GSK153148, reported by the same reporter.
Pt was seated in the observation area and slid to the floor from a chair. Pt had a witnessed seizure (mild jerking of body, eyes rolling into back of head) for approx 30 seconds. Pt was post-ictal. Pt was arousable after approx 1 minute however was slightly disoriented. Pt became more alert, assisted into wheelchair, and escorted to a private area. Fire/EMS arrived to resume care. Pt refused transport to local ER.
Pain in his arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his arm) and FATIGUE (Fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (Fatigue). On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm). On 01-Mar-2021, PAIN IN EXTREMITY (Pain in his arm) had resolved. On 06-Mar-2021, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt states she had pain in neck, maybe a swollen lymph node. She stated that it happens everytime she gets a flu shot.
Red and warm to the touch 1 1/2" x 2" vertical oval at injection site. Painful to touch. Pt denies any other s/s.
hives; red blotches on the arm; did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good), URTICARIA (hives) and ERYTHEMA (red blotches on the arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced MALAISE (did not feel good). On 21-Feb-2021, the patient experienced URTICARIA (hives) and ERYTHEMA (red blotches on the arm). At the time of the report, MALAISE (did not feel good), URTICARIA (hives) and ERYTHEMA (red blotches on the arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021 at 10:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Jun-2021 at 10:18 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.69  for dose administered on 04-Jun-2021. No concomitant medications were reported. Batch number  026C21A underwent temperature excursion on 04-Jun-2021  with temperature 35 degrees Fahrenheit from 10:00 Am. This vial was moved to fridge on 18-May-2021. beyond use date for the vial was reported as 17-Jun-2021. Product moved to clinic on 04-Jun-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Patient received vaccine around 430pm. As she was sitting for post-vaccine observation she told an associate to call over Rph due to side effects. After speaking with patient she stated that her arm was numb (vaccinated arm) and that it hurt more than when she got her flu shot. I assessed both arms an her vaccinated arm was slightly swollen. I described the signs of anaphylaxis to her and told her that i would like for her to stay longer for extra monitoring and to alarm me or one of my associates if any anaphylaxis symptoms occur. Patients blood pressure was taken reading - 132/96. Patient was unsure of her baseline so i explained i will check again shortly. Patient was given water and one dose of Benadryl (25mg) at 5:25pm as well as an ice pack to place on her arm. At 6:00pm patients blood pressure was retaken (124/82) and patient stated she was well enough to go home. Her grandma was with her and stated she didn't have Benadryl at home, I recommend her to get some and gave the patient another dose (25mg) before her grandma took her home.  Patient has no primary care physician.
The medication/ vaccine was expired at the time of administration, We discovered this after the patient had left.
Approximately 20 minutes post vax pt had trouble talking, was having hot flashes, pain shooting up her neck, experiencing disorientation, and some chest discomfort. Pt was seen in the ER and given an unspecified medication. Pt experienced extreme fatigue daily.
Muscle aches; overnight chills; This is a spontaneous report from a non-contactable pharmacist. A 41-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient describes muscle aches and overnight chills after receiving the 2nd COVID19 vaccine injection on 25Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initially had fever, chills, extreme fatigue and lightheaded/dizzy spells. The lightheadedness/dizzy episodes have continued to occur since having my 2nd Pfizer vaccine on 5-21-2021. Most of the time they do not last long but I have had days where it happens on and off all day. I never had these episodes until I got the vaccine.