chrisvoncsefalvay/vaers-outcomes huggingface dataset:
QUADRACEL was administered to a patient post temperature excursion after it was not suitable to use with no reported AE; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old female patient to whom experienced Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was administered post temperature excursion after it was not suitable to use with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller was reported a temperature excursion. The temperature excursion was caused by a refrigerator malfunction. 1 dose of QUADRACEL, 1 dose of IPOL and 1 dose of DAPTACEL were administered to patients after the excursion (Max/low temperature reached: 30.6 F Duration out of labelled range: 2 hours 46 minutes Human error: No) (Total of 3 patients). This situation was reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  On 23-Aug-2022, the patient received 0.5 ml, 1st dose of suspect Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine lot T5970AA via intramuscular route in the left deltoid for immunisation. QUADRACEL was administered to a patient post temperature excursion after it was not suitable to use (poor quality product administered) (latency: same day).    Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Client pale, sweaty, and dizzy after vaccination. Loss of consciousness noted for 15-20 seconds with a right arm jerk and pelvic thrust.  Client held up/ supported by RN during event. Client came to and moved to floor with legs elevated on chair.
Moderna COVID-19 Vaccine EUA.  Muscle aches and headache resolved within 24 hours starting on second day post vaccine. Tylenol and Advil taken as recommended for 24 hours.
Developed lump under left arm/armpit area/lymph node area. Scheduled mammogram for 2/16/21. Called pcp advised me this could be a side effect of  vaccine.
Within 13 hours of the second dose of the covid 19 vaccine, patient started to have tachycardia. She got a notification from her watch that her heart rate was elevated for an extended period of time. Patient states it has gotten over 200 at times. Heart rate can increase with walking or going up stairs. Patient unable to do normal activities due to this. This does seem to be improving, but still present four weeks after the second vaccine.
Felt numbness; Achiness in left bicep down to elbow; This case was reported by a pharmacist and described the occurrence of numbness in a patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date unknown) for prophylaxis.   On 3rd January 2019, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced numbness and pain in arm. On an unknown date, the outcome of the numbness and pain in arm were recovering/resolving.   It was unknown if the reporter considered the numbness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and felt numbness and achiness in left bicep down to elbow. At the time of this report, the felt numbness and achiness in left bicep down to elbow was persisting.
INFLAMED LYMPH NODES IN THE NECK AND UNDER THE ARM AND BREAST ( ALONG THE SIDE ); WARM AT SITE OF INJECTION; CHILLS; RED AT SITE OF INJECTION; TIRED; HEADACHE; LOW GRADE FEVER OF 98F; MORE NERVOUSNESS; FEELING MORE ANXIOUS; DIZZINESS; DEHYDRATED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety disorder, panic disorder, chronic fatigue disorder, and fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 on Right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dehydrated. Laboratory data included: Body temperature (NR: not provided) 98 F. On 19-MAR-2021, the subject experienced more nervousness. On 19-MAR-2021, the subject experienced feeling more anxious. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced warm at site of injection. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced red at site of injection. On 19-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced low grade fever of 98F. On 20-MAR-2021, the subject experienced inflamed lymph nodes in the neck and under the arm and breast ( along the side ). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 20-MAR-2021, dehydrated, warm at site of injection, red at site of injection, and headache, and inflamed lymph nodes in the neck and under the arm and breast ( along the side ), chills, and low grade fever of 98F on 21-MAR-2021, had not recovered from more nervousness, and tired, and the outcome of feeling more anxious was not reported. This report was non-serious.
Extreme Hunger stomach pains; Headache; Eye ache; Facial twitching; Leg pain; Cough; Slight wheeze; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 08Apr2021 at 15:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy, penicillin allergy and allergy to chemicals (silfur). Concomitant medications included levothyroxine sodium (TIROSINT) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both from unknown dates for unspecified indications. The patient previously took ceftriaxone sodium (ROCEPHIN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 16:15, the patient experienced extreme hunger stomach pains, headache, eye ache, facial twitching, leg pains, cough and slight wheeze. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme hunger stomach pains, headache, eye ache, facial twitching, leg pains, cough and slight wheeze were not resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Breakthrough case admission after 2 vaccines Pfizer 5/14/21 lot# EW0177;  Pfizer 6/4/21 lot# EW0178
Patient scheduled and came to the pharmacy to receive second dose of Moderna vaccine.  First dose was given at health vaccination site earlier (April 10, 2021).  Vaccinating pharmacist reviewed state IIS system prior to administration of the vaccine to verify that Moderna vaccine had been given for the first vaccination.  However, the exact date had not been noticed prior to vaccine administration.  After administration it was determined that 23 days rather than the 24 day minimum interval had lapsed.
Vaccine administered 20 days after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 20 days after puncturing the vial) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 20 days after puncturing the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 20 days after puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-332843 (Patient Link).
10/7/05: swelling on right eye (mild). 10/18/05: rash on face (temple area) and neck, increased swelling at right eye. 10/9/05 - 10/11/05: rash, increased swelling. Treatment: Benadryl as needed/ Zyrtek as needed.
Client in nursing home and had documentation and at nursing home as having 2 Moderna vaccines.  A Moderna vaccine was given and upon entering into state Registry that afternoon a 3rd dose had been entered by a pharmacy that day from 11/24/2021. Family and Nursing home contacted.  No adverse reaction as of 1/27/2022
About 12 hours later, he woke from sleep, and spent an hour vomiting and having diarrhea.  He was able to eat by 6 hours later, light food.  His body still ached, and tummy was sore for 24 hours.
Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and COVID-19 (Tested positive for COVID 19) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID 19). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) and COVID-19 (Tested positive for COVID 19) outcome was unknown. Not Provided      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.
About 2 days after vaccine my arm developed a red rash, not raised, just within the tissue . Oval in shape and slight spread down bicep area . Not itchy, but a slight warm as well as slight burning sensation. 5 days later still present but slowly disappearing.
Patient reported 12 hours post vaccine administration he had tea colored urine with sediment. Patient had worked out, but nothing exceptionally strenuous/outside of his normal exercise plan. Patient noted some mild body aches, 2/10 pain. No other symptoms or concerns.
Pt received vaccine on Mon 7/13/09. Pt called on 7/16 saying that Tues afternoon after playing golf she noticed her arm was swollen, red, itchy, , had fever of 102 degrees. Took ADVIL says she's OK just wanted to notify me b/c  I asked her to if any SX.
Narrative:  This was an employee who received his first COVID vaccine on 1/14/21. He had to go to the emergency room for anaphylaxis that required treatment with epinephrine. This patient had "change in voice and tightness to throat approx 45 mins after receiving 1st Covid vaccine." Per ER records, patient had the following treatment pathway: 1535- Ambulatory to TX area in no distress Placed on cmonitor Seen and examined by Dr. Epinephrine 0.3mg IM given left deltoid 1540- IV access established by ICT 18G LAC Labs drawn and held 1545- Solumedrol 125mg IV given States feels much better, throat not so tight/irritated 1550- Benadryl 50mg IV given 1555- Famotidine 20mg IV given Will monitor x approx 2 hrs per MD 1610- ID RN at bedside 1630- Reassessed by Dr. Awaiting dispo 1700- No change, NAD 1730- No change, respirations even and unlabored Awaiting dispo 1800- No change, NAD 1835- IV access DC'd intact DC instr reviewed by Dr. with pt. Verbalized understanding Left ED ambulatory in no distress
Vaccine administered at 10am. Possible side effects explained and patient instructed to wait following administration. Approximately 2 minutes later mom called out for help. This RN entered patient room and witnessed patient had lost consciousness and appeared to be convulsing.  Consciousness was regained soon after (3-4 seconds later). At this time patient was alert, but endorsing continued lightheadedness and a headache. Patient was helped onto exam table, feet elevated. Tried to sit up to take sips of water, but patient c/o "heaviness" and blurred vision so was encouraged to lie back down. Vitals at this time: HR in the high 40s, BP 90/40; vitals approximately 10 minutes later: HR 70s, BP 110/60. Patient stable, alert at this time (approximately 15 minutes from onset of LOC). While patient was being monitored, patient's mother fainted in the hallway. Paramedics were called (arrived at 10:13am) and both patient and mother were escorted via ambulance. Dr., patient's PCP, was present at time of event and agreed to contact family to discuss any additional follow up actions required.
Patient complained of nausea for 3 days after vaccine was given. Had weight loss as well, no local reaction on arms, no rash, no other significant symptoms.
Approximately 6 hours after receiving the booster dose of Moderna, patient's right lower lip started swelling and doubled in size. He took 25mg of oral Benadryl and the swelling went away. No additional issues.
At 4:00PM the client alerted EMT that they felt "warm" and pressure on the left side of the chest. RNs responded. The client was seated in the anti-gravity chair. The client states she felt pressure and warmth within seconds of getting the vaccine. The client localized the pressure to one spot and stated it felt hot as if there was heat inside her body at that location. Vitals obtained at 4:01PM were as follows: BP 126/86, HR 97%, O2 92%. The client stated she was nervous prior to receiving the vaccine. The client denied feeling any fluttering or palpitations. Vitals obtained at 4:06PM PM were as follows: BP 138/91, HR 94. The client denied any history of anxiety. The client denied any chronic conditions, current medications, or known allergies. Vitals obtained at 4:12 PM were as follows: BP 131/87, HR 94, O2 92%. The client stated she was "feeling better." Vitals obtained at 4:25 PM were as follows: BP 128/87, HR 95, O2 95%. RN  provided education regarding signs and symptoms of anaphylaxis and when to seek EMS. The client voiced understanding of this education. The client ambulated unassisted with a steady gait out of the observation area at 4:32PM.
Injection site hot, tender. 7/29/12 low-grade fever, tired. 7/30/12 started coughing, very tired. 7/31/12 coughing worse, low-grade fever; went back to clinic; said I'd picked up something, not from vaccine; very tired but managed to work my job. 8/1/12 coughing worse; left work early; clinic unable to see me; sent me to another clinic; said I had bronchitis & gave me an inhaler & cough syrup but not from vaccine. 8/2 & 8/3/12 missed work; slept continually since evening of 8/1/12; coughing & fever continued. 8/4/12 Symptoms continue to worsen; saw Dr.; said follow previuos recommendations; gave me antibiotic Rx but said not to take it; it's a virus or something but not from vaccine. 8/6/12 started antibiotics as not getting better; dragged myself through week of work. 8/10/12 felt a little better & thought I could go to work; at 4:15 pm I started to cough & cough; syrup & inhaler didn't stop them completely; when I told my husband he immediately took me to emergency room for chest xray but not pneumonia; continue antibiotics.
Injection site raised slightly and turned into a small bump. Area just below site pink and warm, abnormal shape, slightly raised. Better the next morning.
after 10 minutes after vaccination patient said he felt  flushing in the forehead, dizzy, had a unsusual taste in mouth,  tightness in throat. Patient was given 10 ml of beandryl oral liquid 12.5mg/5ml , monitored  . After 5 minutes of oral benadryl administration patient said he was feeling better , his throat was getting better and dizziness was gone. patient was monitored was additional 30 minutes before he left.
Approximately 9 hours after shot sore arm, 15 hours after increased am temperature 100.3, erythema and swelling.  9" by 7" arm tender to touch.  Treated with KEFLEX 500 three times a day for 7 days.  8/30/06 decrease arm swelling, no fever.  8/31/06 nausea, dizziness feels syncopal, decrease erythema of arm.  Hospitalized. 9/28/06 Received medical records from hospital which reveal patient admitted from 8/31-9/2/06 with orthostatic lightheadedness, weakness & cellulitis of right arm unsuccessfully treated with oral antibiotics at home.  Redness improved with 2 days of IV antibiotics & was switched to oral antibiotics at d/c to home.  Also had bowel incontinence for approx 1 mo & colonscopy was done which revealed small polyp & few scattered nonreactive sigmoid diverticula.
pain in my arm; 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 PAIN IN EXTREMITY (pain in my arm) 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) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in my arm). At the time of the report, PAIN IN EXTREMITY (pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
On 10/22/00, the pt developed idiopathic pancreatitis. No apparent cause, non-drinker.
Patient received first does of Pfizer on 4/10/2021 and second dose on 4/21/2021. Dosage interval less than CDCs recommended 17 day time frame.
The morning after my shot 1/15, I felt similar symptoms to when I had Covid in March 2020. I woke up feeling fatigued, achy and had a low-grade fever. Then that night, I woke up at 3:30 am 1/16 with severe chills, full-body aches, and high fever (although I was unable to walk to get the thermometer). During the day 1/16, as I write this, I continue to feel similar symptoms to when I was Covid positive in March 2020. Tylenol and Motrin help the symptoms to subside.
Apparent seizure that evening after receiving vaccines in office.  Dad report stiffening & shaking episode < 1 min while in highchair at restaurant.  Then he cried & wanted to be held for a minute.  Sz X 3-4 events prompting visit 5/29/09 Fever up to 101 X 2 days post vaccines.
On 1 16, 2020 I got flu like symptoms fever chills achy. Then on 1- 18, 19 2020 I got a rash around my right ankle then followed left ankle a splotchy rash,  as of now 2-28-2020 spreading up my legs to my knees. .
Per orders of Dr., injection of PCV13 given by MA Extern and supervised by CMA. Patient had slight immediate adverse reaction. Shot was given in the right deltoid.  Patient bled more than normal (Pt on blood thinner).  Immediately, the area swelled up and a soft lump formed about 30 mm.  No redness.  Patient stated he felt fine.  Dr. was asked to look at the site.  Doctor cleared the patient to leave and requested the patient to call us if the reaction got any worse, if there was pain, more redness or if it became hot to the touch.  Patient agreed to do so.
Information has been received from a pharmacist concerning a male who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in the past and had negative rubella titers. The pharmacist stated she had no other information on the patient. There was no product quality complaint. Additional information has been requested.
Suspected vasovagal response to vaccine -- "tunnel" vision, syncope, -- EMS called
Immediately after administrating GARDASIL, pt felt some pain at injection site, felt dizzy and c/o unable to see/ and hear.  Pt was placed flat on table, compresses applied.  After about 15 minutes pt felt better & dizziness.  She also had pain after which resolved also.
patient was administered a second dose of PREVNAR 13 instead of PNEUMOVAX 23; No adverse effects were reported; This spontaneous report was received from a pharmacist regarding a 69-year-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On an unspecified date, when the patient was 69 years old, received a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). Then, on an unspecified date, at age 70, received a second dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (strengths, doses, routes of administration, lot numbers and expiration dates were not provided). No adverse effects were reported.
OFF LABEL USE; PEDIATRIC ADMINISTRATION; This spontaneous report received from a health care professional concerned a 17 year old female. 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: Unk) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 25-MAR-2021, the subject experienced pediatric administration. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pediatric administration and off label use was not reported. This report was non-serious.
Child was taken to ER on 8/30/08 due to a large, red, swollen area on right upper arm. Mother states red area was the size of a baseball and dark. Elevated temperature.
Extreme pain in the arm from the first day of vaccination, inability to move the arm the next day and for the next 4 days, fever from the day of vaccination and for the next 2 days, dizziness, weakness in the lower extremities, nausea and stomach pain.