chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe side effects) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe side effects). At the time of the report, VACCINATION COMPLICATION (Severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Headache, Myalgia, Arthralgia & Fever Narrative: Employee got the second dose covid vaccine 02/03/21, 3pm employee claimed that he had worsening body ache started 4pm body ache fever weakness, flu like symptoms missed work 02/04/2021
PT HAD 9MO IMMUNIZATIONS ON 02/19/2004. TEMP 100.4 IN EVENING. GIVEN TYLENOL AND HAD RESPIRATORY DISTRESS. CLEARED AIRWAY AND SLEPT UNTIL AM 02/20/04 TEMP AGAIN 100.4 GIVEN TYLENOL SUPPOSITORY. PT STARTED TO HAVE RESPIRATORY DISTRESS AND BECAME FLOPPY WITH POOR COLOR. CALLED 911. AT ER PT'S BP DECREASED;RESPIRATION POOR INTUBATED AND AIR FLIGHTED TO ANOTHER HOSPITAL.  REMAINED ON ASSISTED BREATHING FOR 3 DAYS EXTUBATED AND DISCHARGED ON 4TH DAY (02/24/04)  Nurse follow up on 09/02/04 states: "Complete."
INCREASED IN LIBIDO; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced increased in libido. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of increased in libido was not reported. This report was non-serious.
Hives; Allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) 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 hives and allergic reaction. On an unknown date, the outcome of the hives and allergic reaction were not recovered/not resolved.   It was unknown if the reporter considered the hives and allergic reaction to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got shingles shot and got allergic reaction to it broken out in hives. The patient asked what to do anyone besides call doctor because it was weekend. The contact details were not reported hence follow-up not possible
Started with right knee pain, and has steadily increased to both knees, right arm joints (elbow, fingers, & wrist), both ankles, and feet.
Pfizer-BioNTech COVID-19 Vaccine EUA: 2nd dose Took 5 weeks after 1st dose.   Feel very tired, but trouble sleeping; achy, especially headache
Vaccinated 10/27/05. On 11/04/2005 came in with URI symptoms and DX with acute Otitis media. Started on amoxicillin returned 11/7/2005 with rash on upper body, face DX as most likely secondary to MMR, not due to amoxicillin.
Pain in left arm; Severe body aches - full body; Chills; Nausea; Headache; Earache (both ears); Sore throat; Temperature - 100.8; Dose received: 3/ Dose number=3/ Had the following symptoms/reaction after 3rd Vaccination (Booster); This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient. A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 at 13:15 (Lot number: FF8839) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL and PROPRANOLOL and CENTRUM VITAMIN. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3248, Anatomical location: Left arm), administration date: 21Apr2021 and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3248, Anatomical location: Left arm), administration date: 31Mar2021, for COVID-19 immunisation.The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 at 13:15, outcome "unknown", described as "Dose received: 3/ Dose number=3/ Had the following symptoms/reaction after 3rd Vaccination (Booster)"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Pain in left arm"; PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Severe body aches - full body"; CHILLS (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Nausea"; HEADACHE (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Headache"; EAR PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Earache (both ears)"; OROPHARYNGEAL PAIN (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Sore throat"; BODY TEMPERATURE INCREASED (non-serious) with onset 06Dec2021 at 19:00, outcome "recovering", described as "Temperature - 100.8". Relevant laboratory tests and procedures included body temperature test on 06Dec2021 and the result was 100.8 (unspecified units). Therapeutic measures were not taken as a result of pain in extremity, pain, chills, nausea, headache, ear pain, oropharyngeal pain and body temperature increased. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Information has been received from a registered nurse concerning a 10 year old female patient who on 29-OCT-1999 was vaccinated with a dose of VARIVAX (Oka/Merck), lot number 631301/0724J, 0.5 ml, subcutaneous. It was reported that on 04-DEC-2008 the patient developed rash and on 05-DEC-2008 the patient was at physician's office where was diagnosed with chickenpox. The nurse stated that the patient had about 30-30 "water filled blisters" scattered all over her body; patient was recently exposed to her grandfather who has shingles. Patient is recovering. Follow-up information received on 12-JAN-2009. A medical assistant stated that the patient developed "20-30 spots" after exposure to a grandparent with shingles "over weekend". Patient not recovered. No further information is available.
ACUTE MYOCARDiAL INFARCTION (STEMI) DUE TO THROMBOTIC OCCLUSION OF MiD LAD BiFURCATION/DIAGONAL BRANCH- STENTED AND DISCHARGED TO HOME 2 DAYS LATER, CONTiNUES WELL
pt recvd vax 10FEB93 pt devel generalized macular red rash, a fever, red wheal & tenderness @ the inject site, swollen glands; seen by MD following day & was dx as having measles;
Cellulitis right thigh 5 days.  Augmentin oral.  Redness, swelling.
Patient complained of feeling as if "everything had slowed down."  Pt. became diaphoretic, and c/o feeling like his hands were tingling. Pt. was placed on the floor with legs elevated.  BP was monitored and pulse.  His first b/p was 66/44.  Monitored over the next 30 minutes, and b/p readings were 134/89 and 115/79.  Heart rate was 44 at the beginning of episode and was monitored as well.  The heart rate was 72 bpm once his blood pressure had resumed to his normal range.  Pt. reported that he had a history of anxiety disorders and panic attacks.  Non labored breathing.  Ice pack was placed on patient's forehead.  Pt. declined the offer for any other follow up medical care.  Pt. appeared to have had a vasovagal response from having an injection.  Monitored closely for the next 30 minutes and given follow up instructions for if symptoms reappeared after leaving the site.
SORENESS; CHILLS; SMALL FEVER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness, chills, and small fever  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, chills, and small fever. This report was non-serious.
This study case was received from the investigator on 19 March 2013. A male subject (date of birth not reported) had received the following vaccinations on 05 March 2013: ACAM2000 (lot number, route and site not reported), Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Nine days later, on 14 March 2013, the subject was found to have an elevated Troponin level. Rapid results for blood draw were negative. The troponin lab values were drawn on 13 March 2013 with an elevated value of 0.12 ng/ml (<0.10). The subject had no cardiac symptoms. The subject also experienced bronchitis which included the symptoms of producing cough, nasal congestion and nasal draining which started on 06 March 2013 and swollen glands which started on 08 March 2013 and stopped on 09 March 2013. Treatment included MUCINEX 600mg twice daily (BID). The subject's troponin will be retested and an ECG will be done when the subject is well enough to come in. The subject's smallpox injection site looked normal. The subject's outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Documents held by sender: None.
Loss of consciousness; cardiologist assumes cardiac arrhythmias; Vertigo; Sweating; Nausea; pain in the shoulder; A spontaneous report was received from a physician  concerning a 72 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain (arthralgia), loss of consciousness, vertigo, nausea, sweating (hyperhidrosis) and cardiologist assumes cardiac arrhythmias(arrhythmias).  The patient's medical history included myocardial infarction and stent. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) on 29 Jan 2021 intramuscularly in his left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced shoulder pain. On 08 Feb 2021, the patient experienced loss of consciousness, vertigo, nausea, sweating and cardiac arrhythmias. Treatment information was not provided.  Laboratory data includes MRI, CT scan, X-RAYs and blood flow of carotids.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, shoulder pain was resolved on 31 Jan 2021 and loss of consciousness, vertigo, nausea, sweating, cardiac arrhythmias were considered unknown.; Reporter's Comments: This case concerns an 72 year old, male patient, with medical history of MI and stent placement, who experienced a serious unexpected event of Asthenia, confusional state, and impaired self-care, 11 days after receiving 1st dose of mRNA- 1273 (Lot# 004M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
On the morning of 04-16-2021 I had a syncope in my restroom at my home. When I awoke I had convulsions. On Friday night, I developed fever, shakiness of my legs. On Sunday I had blurred vision, had nausea and had trouble breathing. These symptoms lasted one month. I had vertigo, nausea and had trouble breathing. As of today, I still have difficulty breathing, the nausea and dizziness are not present today. I will not get my second vaccine due to my symptoms to my first vaccine.
My left arm (Injection site)  began to hurt (On a scale of 1 to 10, it was a 5). Turn red (4 3/4" X 4 1/2") Hot to the touch. I had a fever and became dehydrated.
lymph node under arm of inject site swollen & tender; local rxn @ site-itchy; malaise, low backache, nausea, lower abdominal discomfort, diarrhea;
Within 2 hours, hallucinations,  fainting and  falling down first two days. Total 4 times.  Muscle weakness in legs, mild confusion then and continues.
Fever, chills,body aches, headache. Shakey,  Body aches lasted  3 days.   Entire body is upset and fatigue.
Chills, fever 100.5 F, fatigued, pinching/shooting pain type headache, very sore left arm.  All of these symptoms lasted about 24 hours.  I took Tylenol for pain 2 times in this period.  However, the pinching/shooting pain type headache persisted on and off for two weeks.  I did not take anything for treatment of the headaches.
PATIENT GIVEN VACCINATION, NEW TO FACILITY AND RECEIVE CONSENT FROM GUARDIAN. RX GIVEN AND VACCINE THEN GIVEN. NOTICED PATIENT HAD VACCINES SERIES ADMINISTERED PRIOR TO ADMISSION AT THIS FACILITY. RECEIVED 3 COVID-19 MODERNA VACCINES.
No further AE; a temperature excursion/Improperly stored and administered; This spontaneous report was received from an other healthcare professional referring to a patient of an unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not provided.    On 26-FEB-2021, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose: 1 (unit unknown), lot # T026156, expiration date 22-MAY-2022, route and strength were not provided) for prophylaxis (product storage error). No adverse events reported.   Administered dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion above 49.3 Fahrenheit (F) for 1 hour. Digital data logger was involved. There were no previous temperature excursions reported.
Since i have had the shot i have had pain neuropathy over my entire body and the pain has not stopped yet.
Patient alleges vaccine administered too high and now patient is suffering from pain and disomfort in shoulder that has not subsided in over a month despite over the counter remedies. Patient f/u with PCP for evaluation.
March 25th I had my second dose of the covid vaccine.  Eight days later  on April 2nd, I started my period which was 10 days early. That has never happened in my life and I was shock. It was an extra heavy and VERY long period cycle.  Then on April 24th, I started ANOTHER period which would have been 10 days early once again!!! Repeat of the first period--heavy and long. As of May 2nd, I'm still on my period.
Patient received a second dose of Pfizer vaccine at 3 pm today 04/23/2021 at our store. After noticing some blood coming from the injection site patient became very worried and said she felt lightheaded. She was offered a chair to sit on but within 5 minutes of sitting down she said she was not feeling any better. While I was talking to her she seemed to have a mild seizure-like episode which lasted less than a minute. After she became alert she said her thumbs were cramping up and asked us to call 911 for her. Paramedics took her to the hospital.
2:13pm After 3rd injection pt turned a little pale 4th injection given, pt states lightheaded, lowered head between knees, possible seizure lasting approx 30 seconds, cold compress applied, remained alert, state able to leave facility approx 30 mins afterwards.
4/17/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 0903am. Alert and oriented, Anxious and dizziness.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by juice and water given. by RN 0903am- BP_ 140/87, P- 78, O2- 98%, 0910 , - BP- 143/94, P- 78, O2- 99%     Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/17/2021  8:36 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8730
very sick after getting my shot for two days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick after getting my shot for two days) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick after getting my shot for two days). At the time of the report, ILLNESS (very sick after getting my shot for two days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Arm soreness within 12 hours of vaccination.; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021, the patient experienced arm soreness within 12 hours of vaccination. The clinical outcome of the event arm soreness within 12 hours of vaccination was recovered on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, dizziness, pain, aches and fever. DVT in right leg causing extreme, unbearable pain. Has never had history of clotting.
chills; feeling tired; This is a spontaneous report received by Pfizer from Company via product quality complaint from a contactable other HCP reported for her mother-in-law (patient).  A 70-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, feeling tired on an unspecified date. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Case number PHEH2017US007591, is an initial spontaneous report received from a medical assistant on 09 Mar 2017. This report refers to 03 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 168905, Expiry date May 2017) at a dose of 0.5 ml intramuscularly on 08 Mar 2017. On the same day a 3.5 year old child patient received treatment with FLUVIRIN. No adverse event was reported following this medication error. The case was assessed as non-serious.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 18-MAR-2015 the patient was vaccinated with an expired dose of M-M-R II, 0.5 ml, subcutaneously, expiration date 12-MAR-2015 (lot# was not reported). The reporter stated that the dose was supported. No adverse experience was reported. Additional information has been requested.
Axilla lymphadenopathy on the side of injection of Gardasil (right deltoid injection with right axilla lymphadenopathy).
I received my COVID-19 booster shot on 10/22/2021 and experienced the typical soreness associated with it and was fine the following  day. However, on 10/24/2021 my left arm was extremely sore and tender, I had shortness of breathe, a fever, lots of sweating  and my left leg was also extremely sore and tender. The pain of my arm and leg can best be described as if I was lifting heavy objects all day or running.   This went on for about 20+ hours. All the symptoms disappeared the following day.
Swelling, redness at site- 3" X 5" hard painful to touch, pain in shoulder and neck like a pinched nerve which hasn't gone away.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ALLERGIC REACTION, INIT 6/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
No additional AE/PQC reported; Medical Assistant calling to report adverse event regarding patient being administered an expired dose of MMR II.  Medical Assistant reported that adult patient was inadvertently administered an expired dose of MMR II on 9/19/2023, in which the MMR I; This spontaneous report was received from a medical assistant, referring to a 50-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 19-SEP-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), at a dose of 0.5 milliliter (ml) of a two dose series (strength, anatomical site of vaccination and route of administration were not reported; lot number W011885, expiration date was reported and validated as 04-SEP-2023) as prophylaxis (expired product administered). Medical Assistant stated that this was the patient's first dose in the series and that the patient had not reported any medical concerns or symptoms related to the administration of the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Swelling, redness, warmth. Antihistamines, AUGMENTIN. Not yet resolved.
pt recv vax 27MAR96 & 27MAR96 pt exp sore arm for approx 24hr, h/a, sweats & mildly elevated temp for 2 days;4APR96 pt exp sx of herpes zoster w/rt lower back pain, rt flank pain & rt lower abd pain;pain was described as burning;
Nurse administers Moderna 0.5ml to an immunocompromised patient. The patient had received 3 previous doses, so the first reinforcement of Moderna 0.25ml corresponded.