chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case previously recorded as MA2009-5233. Initial case report received from a physician via MedCom on 19 NOV 2009. A patient 3-year-old female was vaccinated inadvertently with S-OIV FLUVIRIN (batch no. 102124P1) once i.m. on 13 NOV 2009. No adverse event was reported.  MedCom reference no: NA09-008308
Information has been received from a 74 year old female retired nurse with drug reaction/allergy to BACTRIM and no other pertinent medical history, who on 29-APR-2011 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included simvastatin (MSD), atenolol, calcium (unspecified), vitamins (unspecified), loratadine (MSD) and omega-3 marine fish oil. The nurse reported that on 30-APR-2011 she developed redness at the injection site; the red area was oblong and approximately 6 inches long. The red area became itchy on 01-MAY-2011. Subsequently, on an unspecified date, the patient stated there was a little sore right in the spot where it was injected. The nurse also stated that her arm was "much better", on 02-MAY-2011. The patient did not seek medical attention. It was unspecified if any treatment was given for the adverse event or if any lab studies were performed. Additional information has been requested.
Pt states that she is fully vaccinated for COVID-19. Unable to obtain manufacturer information or dates of vaccines at this time. Pt admitted to hospital with COVID-19 on 2/3/2022
On 06/15/1998, child received vax and one day post vax experienced soreness at the injection site and nausea and vomiting. The pt's symptoms lasted 4 days. On an unspecified date, the pt recovered from the soreness at the injection site and vomiting. It is not known if the pt recovered from nausea.
A 48-year-old female patient, had received first dose of FLUZONE ID (lot number: UT4474AA, site of administration: "right:) intradermally on 16 October 2012. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown and illness at time of vaccination was reported to be none. No concomitant medications were reported. On 18 October 2012 i.e. 2 days after the vaccination, the patient experienced right upper arm and torso pain which persisted till the time of reporting. It was reported that, the patient required emergency room/doctor visit. Corrective treatment and relevant diagnostic tests/laboratory data were not reported. At the time of this report, the patient had not recovered from the events. Follow up information received from a healthcare professional on 25 April 2013. The patient address, responsible physician and reporter details were updated. Documents held by sender: none.
Patient became dizzy, collapsed, and was unconscious for approximately 30 seconds. Called 911. Patient became aroused, still complained of lightheadedness, had an irregular heartbeat, remained laying down until EMS arrived, very pale in the face. Remained with the patient until EMS arrived. Patient went to the hospital.
In approximately 10 minutes after the vaccine was administered, Patient indicated that she was feeling warmth (hot flash), ringing in the years, dizzy, and nauseated. She vomited little bit of milky white fluid and wanted to lay down. Initial BP after symptoms began was 90/64 HR was 104, then in 5 minutes the BP went up to 103/91 with HR 109, called 911 immediately when she started having symptoms,  Paramedics came right around the time when I took the second BP reading,  They took over, gave her fluids to bring BP up and gave her Zofran for nausea and took her to ER for further workup.
This case was reported by a consumer and described the occurrence of weight gain in an adult female subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included Flagyl, taken at the time of the first vaccination with Twinrix. On 12 March 2007, September 206 and August 2006 the subject received 3rd dose, 2nd dose and 1st dose of Twinrix in the left arm. At an unspecified time after the 1st vaccination with Twinrix, the subject experienced weight gain, headache, lethargy and nausea. The weight gain continued with the 2nd and 3rd doses of Twinrix. No life style changes were reported. The exact amount of weight gained was not known by the subject. Headache and lethargy resolved at an unspecified time. The outcome of nausea was not reported. The subject reported that the 3rd dose of Twinrix was administered to her without being shaken first. This was reported as a medication error.
Moderna COVID-19 vaccine EUA- Patient came to the pharmacy on 1/30/21 at 9:15am. Her left arm was red, itchy and swollen. The red area extended 5.5" wide and 3.5" tall. Patient states that this began on Monday 1/25/21, 5 days after receiving the Moderna COVID-19 vaccine and was getting red and bigger each day. I marked the margins with pen and told her she needed to see her primary care doctor or go to an emergency care center as I was concerned about it being possible cellulitis or an allergic reaction. I also wrote her a note to have her doctor make a determination if she should receive the second vaccine if this was an allergic reaction, and if so, if she should have it in a hospital or doctors office better equipped to handle a severe allergic reaction if one was to occur. She was able to see a Nurse Practitioner at her doctors office. He prescribed Cephalexin 500mg three times a day and took pictures of her arm. NP told her he could not tell if it was cellulitis or an allergic reaction. The "clinical visit summary of today's visit diagnosis" was "cellulitis of left upper limb, adverse effect of vaccines and biological substances". NP was going to forward the picture and information to her primary doctor Dr. She was told that Dr. would be contacting her on Monday or Tuesday and would make a determination if she should receive the second dose in the Moderna series and if so, if she would have to have it in a hospital type setting.
On the first day of the shot, my arm had minor soreness, which is considered normal for shots. Then, approximately a week later, I began to form bruises on my inner thighs. The bruises were round in shape, red in color, and approximately the size of  quarter. There were several bruises lined along my thigh. I have taken pictures as a form of documentation.
Same day post vax, the child had non-consolable crying. Mother reported the crying lasted 2-3 hours.
mom states pt given vax d/t outbreak of measles;w/in 5" pt became glassy eyed grabbed chest-fell to ground-mom caught pt a/hit the ground then jerking over entire body x 15sec;no incontinence;pt awake immed c/o being tired;
Patient reported tingling, numbness, and pain in the arm and leg after receiving the Gardasil Vaccine. Pt was unable to identify which arm but remembers it was the side where the vaccine was given. Patient was unable to give an onset or duration but estimated that it lasted 30-40 minutes. Patient also reported a headache.
Headache, Myalgia, Arthralgia, NauseaVomiting, Chills, left arm painful Narrative:
I've had diarrhea and only 1 loose/semi-formed bowel movement for the last 6 days. No other symptoms, other than disrupted sleep pattern due to overnight trips to the bathroom. I am staying hydrated by drinking at least 102fl.oz. of water per day, and eating 6 small meals per day.
Symptoms: progressive loss of breath over the course of ~ 2 weeks when doing normal activities such as walking up the stairs or walking to the back of a grocery story, fluttering/elevated heart rate, inability to to breathe, low energy. Progressed to fainting that resulted in a 911 call and transportation to a hospital.   Diagnosis: Pulmonary embolism (blood clots in the lungs, across both lungs), this also produced an enlarging of heart valves dealing with the pressure  Treatment: Emergency thrombectomy on 1/17/2022. Roughly ~10 large clots removed from lungs, Dr. said they looked very fresh, formed within the few weeks. continued treatment after release from hospital with the use of blood thinners
Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in an 82-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Administration of expired vaccine, 4 days after the 30-Day. Number of doses/vials: 6 doses.  Vial was initially stored in the refrigerator on 17-Mar-2022. Vial did not undergo any temperature excursions.   This case was linked to MOD-2022-531823, MOD-2022-531831, MOD-2022-531839, MOD-2022-531692, MOD-2022-531803 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 13-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
my health issues got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "my health issues got worse".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SIDE EFFECTS; MAJOR HEADACHE; SOME FATIGUE; This spontaneous report received from a patient via a company representative concerned a 21 year old female. 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 subject experienced side effects, major headache, and some fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects, major headache, and some fatigue. This report was non-serious.
Patient developed hives around the injection site. Patient was given Benadryl 3 times. Hives are improving.
After vaccine was given I started to have lower back pain that was a 8 out of 10. Had to leave work early because of the pain.
Mother called HD on 8/4/05 to advise child had swelling of left extremity and warmth to touch in left arm from shoulder to elbow.  Had vomited 5 times -- once severly, then "a little" 4 times thereafter.  Child had received Tripedia DTaP #5 and IPV #4 in the afternoon of 8/2/05.  Mother reported no problems with previous immunizations.  Check with mother later indicated child quickly recovered witout further incident.
sore arm; didn't have any energy; nauseous; head hurt; temperature was 99.8°F; low blood sugar; very dizzy; could hardly stand up; weak felt she couldn't function; achy all over; didn't felt too much like eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DECREASED APPETITE (didn't felt too much like eating), BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy) and DYSSTASIA (could hardly stand up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, PANTOPRAZOLE, EZETIMIBE, RAMIPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DECREASED APPETITE (didn't felt too much like eating). On 16-Mar-2021, the patient experienced BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), ASTHENIA (weak felt she couldn't function), PAIN (achy all over), NAUSEA (nauseous), HEADACHE (head hurt) and PYREXIA (temperature was 99.8°F). On 17-Mar-2021, the patient experienced ASTHENIA (didn't have any energy). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Mar-2021, DECREASED APPETITE (didn't felt too much like eating) had resolved. On 16-Mar-2021, BLOOD GLUCOSE DECREASED (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), ASTHENIA (weak felt she couldn't function), PAIN (achy all over), NAUSEA (nauseous), HEADACHE (head hurt) and PYREXIA (temperature was 99.8°F) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (didn't have any energy) outcome was unknown.            Treatment included paracetamol   Reporter did not allow further contact
Awoke from sleep with chest pain, rigors, fever 103F, muscle pain. These symptoms lasted 72 hours. Severe fatigue, muscle pain, and intermittent chest pain lasted 7 days.
Patient received a Pfizer dose on 3/5/21 and was accidentally given a Moderna dose on 3/25/21.  He didn't experience any adverse effects at the time of vaccination.
BLISTERIING, HYPERPIGMENTED INDURATION AT INJECTION SITE WITH SURROUNDING CELLULITIS AND VESICLES WITHIN AREA OF CELLULITIS.
No adverse event; Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with dose of 0.25 mL instead of 0.50 mL of bivalent booster).    Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391, US-MODERNATX, INC.-MOD-2022-662390, US-MODERNATX, INC.-MOD-2022-662385 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662391:same reporter US-MODERNATX, INC.-MOD-2022-662390:same reporter US-MODERNATX, INC.-MOD-2022-662385:Same reporter
Narrative:  Pt is 81y.o. male who died on 03/30/2021 w/ h/o chronic diarrhea, BPH, HLD, HTN, hypothyroidism, T2DM, hemiplegia.  Pt received Moderna Covid-19 vaccination 2/2 on 2/23/26. Pt died at home with family present. Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
This report describes arthralgia in a 61 year old male who received Lyme disease vaccine recombinant OspA (Lymerix). It was received from the vaccinee's wife and has not been verified by a physician or other healthcare professional. The medical history, concurrent conditions and concurrent medications were not specified. The vaccinee had not experienced any adverse events following previous vaccinations. Following the second Lymerix injection, in 03/99, the vaccinee received his third injection of Lymerix in March 2000 and in March 2000, the pain in his hips and shoulders reportedly worsened. The vaccines was reportedly seen by his physivcian. As of 05/25/02, the hip and shoulder pain persisted. The adverse event "arthralgia" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter.
09/03/22 presents to ED for "cough and overall malaise myalgias". PMHx of "chronic left lower extremity thrombosis not on anticoagulation"
4 hours after receiving shots developed L leg pain, low grade fever and screamed for next 16 hours.
Myalgia, Arthralgia, Rash, Chills, pain at the injection site Narrative:  Other Relevant History:
Expired kinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Sept-2022 Reporter's comment: The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: The patient receive an expired dose of Kinrix, which led to expired vaccine used.
Head stopped up and severe headache,  left arm sore at injection site, body aches all over, extremely tired.
Narrative: ON 3/9/21--RECEIVED VACCINE DOSE#1 OF THE MODERNA,APPROX. 0915AM PT STATED HE WENT STRAIGHTHOME--THAT EVENINGPATIENT STATED HAD COLD CHILLS--PT STATED HE THOUGHT IT WAS THE BEGINNING OF THE FLU, BODY WAS HOT. ON 3/10/21-- IN THE AM FEELING SLLUGGISH/WEAK/NO ENERGY, WAS BABYSITTING GRANDSON, IN THE AFTERNOON WENT TO LAY DOWN. (PATIENT DOES NOT REMEMBER THE REST OF THE EVENTS--REPORTED TO HIM LATER BY SPOUSE OF WHAT HAPPENED) PT FOUND GURGLING BY SPOUSE, WIFE CALLED SON-IN-LAW, HE CAME IN BUT AT THE TIME PATIENT HAD STOPPED BREATHING, HE STARTED CPR ON THE PATIENT, AND SOMEONE CALLED 911. PATIENT WOKE UP IN THE AMBULANCE.