chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; tired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and FATIGUE (tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 immunisation.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced NAUSEA (nausea) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea) and FATIGUE (tired) was resolving.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 13-MAR-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
Information has been received from a medical assistant concerning a 14 year old female patient with penicillin allergy who on 01-MAY-2009 and 04-AUG-2009 respectively, was vaccinated IM with with first and second 0.5 ml doses of GARDASIL (Lot# of first dose: unknown) (Lot# of second dose: 663451/0216Y) (Expiration date: 17-SEP-2010). The medical assistant reported that on 04-AUG-2009 the patient experienced dizziness and fainting. The patient did not seek medical attention. At the time of the report, the patient had recovered from dizziness and fainting (date unknown). Additional information has been requested.
had pain in upper rt quadrant which inc @ school;parent took child to MD;findings were negative for abd/liver enlargement;PA felt it was emotional issue;pt refused blood tests;
Patient developed a severe left-sided sore throat and 2+ swollen left tonsil 48 hours after her 5th anthrax vaccine.  She also has a mild local reaction (4x3.5cm erythema) over her left deltoid at the vaccine site.  No fever or other symptoms.
Stiffness in left arm; Bruised shoulder; Bled pretty profusely initially-Pretty out of it for about a day and a half; Shoulder still hurts-3 weeks out; Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in left arm), CONTUSION (Bruised shoulder), INJECTION SITE HAEMORRHAGE (Bled pretty profusely initially-Pretty out of it for about a day and a half), ARTHRALGIA (Shoulder still hurts-3 weeks out) and MYALGIA (Soreness in left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Thyroiditis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in left arm), CONTUSION (Bruised shoulder), INJECTION SITE HAEMORRHAGE (Bled pretty profusely initially-Pretty out of it for about a day and a half), ARTHRALGIA (Shoulder still hurts-3 weeks out) and MYALGIA (Soreness in left arm). On 31-Mar-2021, INJECTION SITE HAEMORRHAGE (Bled pretty profusely initially-Pretty out of it for about a day and a half) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in left arm), CONTUSION (Bruised shoulder), ARTHRALGIA (Shoulder still hurts-3 weeks out) and MYALGIA (Soreness in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not  reported.
Has been experiencing headache, cold chills/sweats, nausea and fatigue for 7 days since vaccine
21JUL92 mom reported pt had a little temp on 8JUL92; 13JUL92 t102.9 was treated by MD for ear infect; mom states MD stated illness was not shot related; may cont vax series;
pt became ill about MN 10JUN92 w/fever (not measured) & vomiting; 7AM fever was 102; nausea diminished;
No adverse effects were reported; administered a dose of PROQUAD and a dose of VARIVAX on 07-MAR-2017; This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-MAR-2017, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: rHA) (PROQUAD) lot # M035689, expiration date not reported, but upon internal validation established as 06-FEB-2018 and varicella virus vaccine live (oka/merck)(VARIVAX) lot # M028549, expiration date not reported, but upon internal validation established as 07-JUN-2018 (route of administration was not reported), when the patient was between 12 and 14 months old. Concomitant therapies included sterile diluent. On 31-JUN-2019, at age 3 years old, patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) R018933, expiration date 02-JUL-2020. No adverse effect were reported.
Pt began to experience an allergic reaction ~30min post vaccination.  Pt devoloped dyspnea w/ itching.  Pt later felt ill w/ dizziness, chill and itchiness.  In several telephone visits on 5/18 and 5/19, staff recommended that the patient go to the ER for evaluation.  Pt declined.  On 5/19, the patient agreed to a telephone visit with a provider where the patient complained of chills, headaches with nausea with fatigue and body aches after covid 19 vaccine, also with itching occasionally.  Provider reiterated that the patient can go to the ER if symptoms do not improve.  On 5/20, pt indicates improvement though she still feels ill.  Of note, pt has previous known allergies to aspirin, eggs, and shellfish (all hives).
EYELID SWELLING. PEELING, WATERY EYES, EAR LOBE SWELLING. PATIENT HAD ALREADY SEEN AND WAS BEING TREATED BY A PHYSICIAN WHEN SHE CALLED TO TELL US HER SIDE EFFECTS.
Urticaria. Resolved with Benadryl Received flu shot at 1045 by 430pm patient had a generalized feeling of not feeling well. By 730pm patient started itching and by 830pm he had hives on his face at the injection site and his lips were dark red and swollen. Mother gave benadryl and by 1AM most hives were gone. Patient is still itching today 1/23/20. Patient taking Claritin and benadryl.
Rash on face, neck and ears seen by PMD on 12/5/09. Dx: Viral Erythema.
Received HBV2 DTAP1 HIB1 PCV1 ROTARIX1. Developed fever, had febrile seizure within 12 hrs.
one patient received a dose of Adacel after the temperature excursion from the stock/no AE; one patient received a dose of Adacel after the temperature excursion from the stock/no AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] after there was a temperature excursion from the stock.  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  It was of actual medication error due to incorrect product storage and Deteriorated drug administered.  It was reported that no adverse event was experienced.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
After receiving the vaccines in the morning, the patient was fussy throughout the day and the mother felt was running a fever though had no way of actually checking a temperature. Later that night, the mother placed the patient in his carseat and strapped him in to sit in a room in the house with the parents. The mother then noticed that he went limp, pale/green, and was unresponsive with eyes closed. The mother got him out of the car seat and immediately stimulated him. She noticed that he was breathing but with shallow breaths and "looked dead." The event lasted about 60 seconds before he came to. He was tired afterward. They then proceeded to take him to the ED and he was back to his normal self by the time they were observed in the ED.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was administered with Paxlovid from 22Jun2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from the mother of the patient refers to her 13 month old (currently 15 year old) daughter. On an unspecified date in 1999 the patient was vaccinated with a dose of M-M-R II (lot #, expiration, dose, route unspecified). In 1999 (exact date unspecified) within a few hours she developed a very high fever. None lab diagnostics studies performed. The patient had not sought medical attention. TYLENOL was given every 2 hours for treatment. The patient had not medical conditions at the time of the adverse event. The patient was taking no other medications at the time of vaccination. The patient currently has no medical conditions. At the time of report, the event outcome was reported as recovered. The patient did not seek medical attention. Additional information is not expected.
1/2hr arm pain;2hr p/shot dizzy, lethargic;5hr p/shot body aches & chills;
Red, patchy rash that is inflamed, hot, itchy, slightly painful, and encompasses the whole upper arm ("covid arm"). Appearing on day 2 for second dose.   Of note, also had covid arm during first dose of vaccine but it appeared 10 days after the shot.
Lost strength in his limbs, could not walk; Could not walk on his own; Arms and legs got swollen; Pain escalated; A spontaneous report was received from patient's daughter regarding her father who is a 92-year-old, male who experienced lost strength in his limbs and escalated pain to his chest, legs, shoulder, ankles, and hips/ MedDRA PT: [ Lost Strength in Limbs]  The patient medical history included Hypertonic and Diabetes. Products known to have been used by the patient, within two weeks prior to the event, included Cephalexin 500 mg for skin infection.    On 01 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID- 19 infection.  Patient was hospitalized for two days at the Falmouth Hospital where he underwent a battery of test for Muscular Weakness, could not walk on his own, Arms and legs got swollen, escalated pain to his chest, legs, shoulder, ankles, and hips, not relieved with stronger pain relievers. Daughter stated that her father is getting better but very slowly.  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was recovering.   The Outcome of the events was not reported/unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Within 48 hours a   severe case of hives developed eventually covering about 50-60% of my body.  Self administered OTC antihistamine for about 36 hours.  When the hives continued to get worse, sought medical attention the morning of 9/12/2020.  The MD visually confirmed hives and prescribed different antihistamine and pepcid. The hives subside over the next 48-72 hours.  Sought medical attention for dizziness and vomiting that began on 9/15/2020.  By the time of the televisit, I was feeling better.  No action was taken.
As sole person responsible for preparing COVID vaccines for our facility, I prepared a 5-11 bivalent booster dose for the patient instead of a 12+ bivalent due to not double checking the patient's age personally before preparation.  Vaccine was administered with no issues at approximately 10 AM today.  Patient was released to leave facility by HCP and reported no adverse reactions prior to leaving. Upon realization of the issue, I consulted the CDC recommendations, reported to the ordering HCP, and contacted the parent.  It was determined that she will come back today to receive the remainder of the appropriate dose in order to receive full protection against COVID-19.  Mother reported no symptoms when speaking to her on the phone.
Redness and swelling of thigh began day after vaccination. Continued to worsen over next 2 days.  Mom took child to clinic where she was started on a 10 day course of prednisone.
Fever x 2 days; Severe headache x 2 days; Severe body aches x 2 days
My heartbeat fast; Sweaty; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 22Jul2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Asking about lot number patient reported that my immunization card, 8733. (Further not clarified hence not captured tab). On an unspecified date in Jul2021, the patient experienced my heartbeat fast, sweaty. Reported that patient think this could be the side effects on people and want to know how long does it last. The outcomes of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Tingling in lips and tongue that started about 30 minutes from injection time (3:50pm) until about 6:00 pm.  I took 10 ml of Bendryl at 5:00 pm at my own discretion.
Numbness in upper lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness in upper lip) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness in upper lip). At the time of the report, HYPOAESTHESIA ORAL (Numbness in upper lip) 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.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up information was received on 22 Apr 2021, correct adverse event numbness of upper lip updated;
6 hours after receiving FLU shot developed 101 degrees fever.  Mom did not check body, but in the morning noticed child developed hives over body.  BENADRYL was given, no respiratory problems.
Pt received flu vaccine in L arm at 5:55 pm. Pt was Alert and orientated but very nervous prior to vaccine administration.  At 5:58 pt stood up and knees buckled, eyes rolled back and skin was pale. Lowered pt to floor and had regained consciousness in 5-8 seconds. Bp=100/48 P=60 at 6:00 pm, BP=98/50 P=62 at 6:06pm, BP=90/40 P=74 at 6:10pm. A&O x 4. Rescue called to assess and determined to be vasovagal reaction.  Mom refused transport to hospital. Pt went home with mom for followup  with PCP.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. Medical history and concurrent conditions were not reported. On an unspecified date in 2012, the patient started series of vaccinations with GARDASIL (dose, lot/batch number, expiration date and frequency were not reported). Concomitant medications were not reported. On an unknown date (also reported as "now"), the patient was vaccinated with the third dose of GARDASIL (dose, lot/batch number, expiration date and frequency were not reported). No adverse effect was reported. Additional information has been requested.
This Vial was punctured more than 20 times.  This client was #22 vaccinated with this same vial.
12:15pm: Complained of ringing in ears, denies dizziness, nausea.  BP 138/88, pulse: 80.  12:35pm: 138/95, pulse 64; 12:50pm: 137/87, pulse 58;
I got them a few months after I got the vaccine / worse case of shingles than the first case/ Suspected vaccination failure; I got them a few months after I got the vaccine / worse case of shingles than the first case; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. A few months after the patient got the vaccine, the patient experienced worse case of Shingles than the first case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
2 days after vaccine administered - came into pharmacy with rash red swollen at site of injection - and complained of headache, fever and aches since shot given.
After the first course of Pfizer's vaccine, in three hours, I had a severe headache, sore arm, and was rather tired. I went to sleep for the rest of the day. 24 hours from the time of the injection, I still had a headache, so I went back to sleep. Eventually, at 48 hours after the injection, the headache, muscle soreness, and fatigue no longer lingered.
After reclining in a chair, got up and noticed that hip was in pain (3/10). In the middle of the next night noticed knee was hurting. Knee is somewhat improved, hip is not improved. Is limping.
multiple times a day there are decreases in my mental capabilities, such as critical thinking, handling stress, common sense, forming sentences, thinking outside of the box, remembering things that were said a few minutes ago, problem solving, and memory
pt developed nodular and painful bumps on her legs and hands, she also had a headache and dizziness. At the time of her ER visit she was found to be anemic, which could account for her dizziness.  The lump went away and returned on 8/24/23, and appear to be erythema nordosum
5 hours later - extreme soreness of arm;  6 hours later - arm was very weak  6 1/2 hours later - unable to move arm "dead weight" - had to lift it with other arm; 7 hours later - alternating fever & chills 9 hours later - headache 24  hours later - dizziness
Initial symptom:  extremely itchy bumps  all over scalp. Next day:  itchy bumps/hives behind ears and on front/back of neck and near shoulders Day 3:  Hives under breasts, on stomach, bikini area, arms, neck.   Day 4-Week 4:  continued hives and dermatographia (eventually becoming flare-ups), managed with antihistamine (Zyzal 2 times daily) Week 6:  continued dermatographia and occasional hive flare-ups.  Triggers appear to be alcohol, sugar, chocolate, cheese (high histamine foods)
Left arm sore at injection site twelve hours after vaccine was received. Continued to be sore for four days but each day less sore. Left armpit sore with swollen glands 48 hours after vaccine Upper right chest above breast muscle  soreness for two days. On day 3 small rash on left side of neck. Faint blotchy redness on left upper arm around injection site on day 5. Both rashes only slightly itch. Stomach ache with loose stool 48 hours after vaccine
All the joints in both of my hands hurt. They were sensitive to touch. This was not extremely painful but lasted for days then got better and then came back. It has been off and on.
Reaction in left arm starting on 1/22/2021 with itching. Developed into large red, warm reaction. Area was warm to the touch, swollen and raised. Area encompassing left deltoid. Using Zyrtec, ice,ibuprofen. Unresolved
Resting heart rate of 103 upon waking and still lying in bed. Took ~30 min to get out of bed, slowly. As I got up it seemed to dissipate.  I feel as though my blood pressure is up, but do not have equipment to test.
Pain, swelling, redness, hot to the touch, itch began next morning.  Next evening I had chills, body aches, stomach ache, tiredness
I started feeling sinus pressure behind my eyes. a few days later I started experiencing vision loss in my left eye. Ophthalmologist diagnosed me with optic neuritis. auto immune disease which causes pain and vision loss in the eye. it is inflammation of the optic nerve.