chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe left leg pain roughly 1 hour post injection which lasted approximately 72 hours. Moderate-Severe fatigue. Moderate abdominal pain. Moderate body chills. Mild fever. Mild headache.  Treatment was continued bed rest and hydration.
Unresponsive; extreme fatigue that is getting worse, not better; A spontaneous report was received from caregiver for an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme fatigue that is getting worse (fatigue), unresponsive (Unresponsive to stimulus) and barely speaks   The patient's medical history was not provided. No concomitant product use was reported.  On 24-Feb- 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 05-MAR-2021, 10 days after receiving the vaccine, the reporter stated that the patient became unresponsive and was taken to the ER (emergency room). She was taken to the ER and discharged twice on the same day. The reporter also stated that his mother had extreme fatigue that was getting worse, not better and that the patient barely speaks. The  The caregiver was headed to emergency room at the time of this report.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, extreme fatigue that is getting worse, unresponsive and barely speaks was unknown.; Reporter's Comments: 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.
Mild to moderate pain around the injection site; Flu like symptoms; Sorethroat; Epigastric pain; Diarreha; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 12 hrs after receiving Shingrix, the patient experienced sore throat, epigastric pain, diarrhea and influenza-like symptoms. On 20th September 2020, the patient experienced injection site pain. On an unknown date, the outcome of the sore throat, epigastric pain, diarrhea, injection site pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sore throat, epigastric pain, diarrhea, injection site pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 12 hours, the patient had sorethroat, epigastic pain and diarrhea.  On the second day of the vaccination, the patient had local mild to moderate pain around the injection site and later on followed by flu like symptoms.  The patient was covid19 negative 6 PTA.
Face stared to flush at 8pm, by 815pm face looks and feels like a sun burn.
Enlarged lymph nodes on axils initially walnut size then progressed to golf size edema/lump on Left breast
16 year old daughter received the 1st dose of Moderna covid-19 vaccin; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PATIENT RECEIVED PRODUCT (16 year old daughter received the 1st dose of Moderna covid-19 vaccin) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced WRONG PATIENT RECEIVED PRODUCT (16 year old daughter received the 1st dose of Moderna covid-19 vaccin). At the time of the report, WRONG PATIENT RECEIVED PRODUCT (16 year old daughter received the 1st dose of Moderna covid-19 vaccin) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications and treatment information were reported.
From the patient: "On 7/23/19 started with chills; as the day progressed I was freezing while at work.  By the time I got home at 5pm I was freezing and running a fever of 101, and by 6pm my fever was 102.4.  I took 800mg of Motrin at 5pm and 1500mg of Tylenol at 7pm then 800mg at 9 then tylenol at 11pm.  My fever remained around 102 - still freezing.  Sometime in the night I woke wet with sweat and fever broke.  I called and spoke to doctor on call from my family Dr's office around 9:30a.  She said it was rare to have a side effect but stated if no other symptoms such as cough or sore throat then it may not be viral.  I had no other symptoms.  My arm was sore but no extreme pain or swelling.  The next day I was very weak.  I returned to work on 7/25/2019."  This patient was given her Tdap through Employee Health.  This was the second employee who had an unusual adverse reaction from this same lot #.  (Other already was reported separately) It is rare that my Tdap recipients have more than a "sore arm".
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter informed about temperature excursions with freezer in the facility, where she works. It had been happening for weeks since April 2022. The storage condition at the time of the excursion was reported as frozen storage. The affected batch lot numbers were reported as 065K21A and 045L21A. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute. The vials were stored frozen. Visual inspection did not noted any vaccine state change. No treatment medication were provided.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
PT RECEIVED TDAP, MMR, VARM AND IPV ON 8-18-08 NOTED REDNESS, PAINFUL, WARM TO TOUCH AND EDEMA TO RIGHT ARM; LOCATION OF TDAP. PT WAS TAKEN TO URGRET CARE ON 8-19-08.  PT WAS REASSESSED IN OFFICE ON 8-20-08 AND TREATMENT ORDERED.
The patient developed atrial fibrillation the day after the first vaccination. She also developed it the day after the second vaccination (Lot #022C1A, May 12, 2021) Moderna for both. The atrial fibrillation which began after the second dose required hospitalization. The patient has a history of atrial fibrillation
Bladder infection; Viral infection; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 20Mar2021 (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunization. Medical history included arthritis and chronic obstructive pulmonary disease (COPD). Concomitant medication included paracetamol (TYLENOL) for arthritis. Patient was alright for a few days after vaccination and then all of a sudden, patient started getting infections on 28Mar2021, 8 days after she had the first vaccine. She got a really bad bladder infection then she went to the doctor and got medication for that. She was with bladder infection then she came down with the viral infection and she was not even been going anywhere because of the virus, she was been staying home, just to the grocery store and clinic to the doctor. Patient got medicines for the bladder infection: antibiotics (sulfamethoxazole) and she was not quite over that and then she got a virus infection. She went back to the clinic but they did not gave her any medication for that. It was just a viral infection, it was not the COVID-19. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning an unidentified 2-month-old child who received a 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on (date unknown). Medical History: Relevant medical history was not provided.  Product Details: Indication for Prevnar was immmunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant Therapy: Additional suspect therapy included Haemophilus b conjugate vaccine (manufacturer unknown) and Pediarix (diptheria and tetanus toxoid and acellular pertussis and hepatitis B vaccine, polio virus inactivated) (GSK).  Event Details: At a unspecified time post immunization, the child developed a fever of 101 deg. F. The fever resolved after an unspecified period of time. This report was received from GlaxoSmithKline, manufacturer of Pediarix (reference #A0412688A).  Related Case (s): See related case(s): HQWYE958911JUL03 (adverse event, non-expedited).
pt recv vax & devel a sinus infect; lab eval on 13JUN94 revealed alkaline phos 14 units above nl, SGOT 10 units above nl, SGPT 18 units above nl & GGPT 21 units above nl; MD felt inc liver function test D/T fat deposit on liver
Pt vaccinated with Influenza approx 1 hr later developed severe chills, headache & muscle aches lasting two days.
Fevers up to 101, dizziness, headache, extreme fatigue, body aches, metal taste in mouth (Day 1), chills, runny nose, sore throat,
8.5cmx 9.5cm reddened area on left thigh following DTap immunization.
1st dose 2 Feb2021 patient did not get 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 2 Feb2021 patient did not get 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 2 Feb2021 patient did not get 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 2 Feb2021 patient did not get 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Strong metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 13:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included ergocalciferol (VITAMIN D2) and glucosamine (MANUFACTURER UNKNOWN) both for an unknown indication, from unknown date and unknown if ongoing. On 07Mar2021 at 13:15, approximately 5 minutes after the injection the patient experienced a strong metallic taste in mouth and it went away approximately 30 minutes after that. No therapeutic measures were taken as a result of the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strong metallic taste in mouth was recovered on 07Mar2021.   No follow-up attempts are needed. No further information is expected.
Pt said the day after the shot he had mild flu symptoms, but the day after that he started feeling very tired, and had significant tiredness for over a month after getting the shot.  He is unsure if he wants to get the 2nd shot in the same series
Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Tetanus (Patient had similar reaction to tetanus shot a few years ago and she was told its an allergic reaction). Past adverse reactions to the above products included Allergic reaction with Tetanus.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment information was not provided.  Since vaccination the Right Arm became Red (3" wide and 2.4" Long), and getting worst. It looks like spreading to the back of the arm.  The patient had a similar reaction to Tetanus shot a few years ago and she was told that it was an allergic reaction.
PER PT ARM SWOLLEN 3 TIMES NORMAL SIZE, OVAL BLOOD RED AREA THE SIZE OF PALM OF HIS HAND AT ACTUAL INJECTION SITE, HOT TO THE TOUCH, UNABLE TO BEND ELBOW DUE TO SWELLING AND PAIN IN THAT ARM.  CALL TO MD AND PATIENT STATES IF CANNOT GET APPT WITH MD TODAY GOING TO ED TO BE EVALUATED.
Just as reported for the first vaccine at 24.5 hours after receiving second dose I had severe cramping and heavy vaginal bleeding . It lasted for approximately 2 days. I then had stomach pains/discomfort  for an additional 5 days.
A few hours after getting ZOSTAVAX shot, pt reports a "hard lump" under skin where shot was given 3" x 2" w/a small bruise in center. 4 days later there is still a red hard "lump" about size of 50 cent piece, but getting better.
The pt experienced a small blister noted at the site of injection and a small blister on anterior abdominal wall.
The Clinic knowing gave gave this vaccine to my 16 year old when it?s for ages 18+
Patient has experienced a mild rash on both hands/rash on patient's face; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13May2021 12:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, Since that time, Patient has experienced a mild rash on both hands. Patient woke up that morning to have the rash on hands gone but the rash was now present on patient's face on an unknown date. The outcome of event was unknown.  Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
Right deltoid has a raised red welt measuring 4.5 cm x 4 - Mom advised welt began to form on 5-23-16. Left deltoid has a small red circle measuring 2 cm x 1.5.
Approximately 15 minutes after vaccination, patient complained of tightness in her chest and difficulty breathing.  Nurse administered epi-pen 0.3 mg at 9:52 am. On call MD was called.  At 9:55 BP 150/80, pulse 125, RR 32.  At 10:05 BP 130/68, Pulse 100, RR 28.   No wheezing or rales noted.  Repiratory distress resolved post epi-pen.  Patient has a history of receiving flu vaccine in 2003 without incident.  EMS called and transferred patient to hospital.  Patient was evaluated and admitted at hospital with diagnosis of Sickle Cell Crisis and Asthma.
weakness; fatigue; trapezoidal pink area about 3 by 4 inches from; developed into a red spot, like a patch; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (trapezoidal pink area about 3 by 4 inches from) and VACCINATION SITE ERYTHEMA (developed into a red spot, like a patch) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (trapezoidal pink area about 3 by 4 inches from) and VACCINATION SITE ERYTHEMA (developed into a red spot, like a patch). At the time of the report, ASTHENIA (weakness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (trapezoidal pink area about 3 by 4 inches from) and VACCINATION SITE ERYTHEMA (developed into a red spot, like a patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  The first shot gave him a trapezoidal pink area about 3 by 4 inches from where the needle was injected and developed into a red spot. It was like a patch. He did not have ill effects to speak of other than fatigue and weakness.  Treatment medications were not provided.   This case was linked to MOD-2021-361014 (Patient Link).
pt recv vax & immed lost consciousness, followed by gen sz activity-tonic/clonic movements, posturing, urinary incontinence, followed by postictal drowsiness;
The first shot I was dizzy, ran a fever, nausea and chills for 36 hours- moderate to sick. But the second shot I was violently sick with fever, migraine, nausea, chills and extreme dizziness. I am still very dizzy and have an issue with my left ear blocking. I feel as if I have permanent sea sickness.
GARDASIL #1 given on 2-10-14. Hives on 2-12-14. Fever, angioedema on 2-13-14.
Pt recvd 1st dose of vax on 20JUL92 & on 28JUL92 pt devel hives over 1/3 of body; dx w/scabies treated w/Queils lotion & Atarax; pt's rash persisted & involved almost entire body;
Patient received vaccine and responded with swelling of face, arms and eyes, plus fever. Symptoms resolved after 3-5 days.
We administered the Moderna booster dose to a patient past the12 hours expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered the Moderna booster dose to a patient past the12 hours expiration) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 040B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered the Moderna booster dose to a patient past the12 hours expiration). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (We administered the Moderna booster dose to a patient past the12 hours expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Information has been received from a nurse in an OB/GYN office concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). On an unspecified date the patient experienced headaches that lasted for 30 days unspecified. Medical attention was sought. The nurse reported that when the patient called into the OB/GYN office, there were no documents stating that the patient had received the Gardasil and that the last patient visit was August 2006. The nurse believed that the patient may have received the vaccination for her primary care physician. The nurse was unsure the patient had received the vaccine in their OB/GYN office. At the time of reporting, it was unknown if the patient had recovered. Additional information has been requested available. Further information is not available.