chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in chest area where she has scar tissue after 2nd dose; Joints hurt; exteremely tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Soreness in chest area where she has scar tissue after 2nd dose), ARTHRALGIA (Joints hurt), FATIGUE (exteremely tired) and PYREXIA (fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c21a) for COVID-19 vaccination.     The patient's past medical history included Hodgkin's lymphoma (Had scar tissue at chest area).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Soreness in chest area where she has scar tissue after 2nd dose), ARTHRALGIA (Joints hurt), FATIGUE (exteremely tired) and PYREXIA (fever). At the time of the report, CHEST PAIN (Soreness in chest area where she has scar tissue after 2nd dose), ARTHRALGIA (Joints hurt), FATIGUE (exteremely tired) and PYREXIA (fever) had resolved.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   This case was linked to MOD-2021-075323 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: No new information On 27-Jul-2021: significant follow up appended : outcome resolved
Information has been received from a nurse concerning a 20 year old female with no pertinent medical history who on 08-JUN-2007 received her first dose of Gardasil (lot #657868/0523U), 0.5 ml, intramuscularly. Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). After the receiving the vaccination, the patient began shaking and was confused. Her vital signs were assessed and the pulse rate was noted as low (48-52). The patient was transported to the emergency room and diagnosed with a vasovagal response. It was reported that she was discharged from the emergency room and experienced no further symptoms. Additional information has been requested.
sore arm; chest tightness; muscle pain; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: high (High) pulse 98-104 (usually 60s).         Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-210746 (Patient Link).
Pt. states that after receiving the 2nd dose of Phizer 08/28/2021, started experiencing symptoms 08/29/2021 of jaw pain, numbness in the jaw, cheek, and left Nostril. Still continuing with previous Prednisone treatment from 1st dose 08/07/2021, symptoms subsiding slowly. No noted Primary visit.
pt recv vax 11MAY95 & 5DEC97 pt devel over 200 lesions;no other signs & sx were noted;pt mom is dermatologist tx w/acyclovir;
Lightheaded, dizzy, headache, thirsty, diaphoretic. Uncontrolled insulin diabetic history per patient. States a.m. blood sugar 120. Did eat lunch prior to receiving vaccine, however, had not taken any insulin after eating. Ambulance was called to evaluate patient. Patient was taken to the emergency room by ambulance.
blacked out; fell; seizing on the ground; she was really out of it and non-responsive; when she fell she got a large laceration on her chin; This is a spontaneous report from contactable consumers. A 17-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO182/ UCFS), intramuscular on 01Jun2021 at 11:00 (at the age of 17-years-old) at dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. She was not diagnosed with COVID prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO182/ UCFS), intramuscular on 11May2021 at 11:45 (at the age of 17-years-old) at dose 1, single for COVID-19 immunisation. There were no other vaccines in four weeks. Vaccination facility type was reported as school or student health clinic. On 02Jun2021 at 14:00, the patient blacked out and fell. The reporter heard her fall and when he/she got to the patient, she was seizing on the ground which lasted about 2 minutes. The reporter was able to get her into a chair, but she was really out of it and non-responsive. The reporter had already called for an ambulance at that point. When the paramedics arrived, she was coming out of it but still was not able to stand up or really respond properly. When she fell, she got a large laceration on her chin, so they quickly bandaged that up and rushed her to the emergency room. The events required emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with intravenous sodium chloride, TYLENOL, and stitches for laceration. She was also seen by a pediatric neurologist. The patient was not tested for COVID post vaccination. The outcome of the event "blacked out" and "she was really out of it and non-responsive" was recovering; recovered on 02Jun2021 at 14:02 for "seizing on the ground"; and unknown for all other events.
On 06/17/21 patient complained of right eye pain and light sensitivity. It was not better the next morning. Took him to Eye Center. He was diagnosed with inflammation of the corneas and prescribed steroidal eye drops.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9D325, expiry date 15th June 2017). On 3rd October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb and localized erythema. The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb and localized erythema were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb and localized erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On next day of vaccination, the patient woke up with 12-inch redness and swelling from elbow to above the shoulder. The patient received BENADRYL as per primary care physician's order. Reporter spoke with the patient prior to calling GlaxoSmithKline at 2:55 pm. On 4th October 2016, the swelling had gone down a bit. The reported lot number (90325) for FLUARIX did not exist and was updated to 9D325 as per the sales database.
Heavier period, increased cramps. Upper right quadrant pain by the liver increased bloating and tenderness in the area. Resulting in discomfort and decreased appetite.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. This occurred on 3/13/21 due to subarachnoid hemorrhage. This also occurred on 4/17/21 for subdural hematoma.
Child feverish w/in 1 hr of immun; 5AM pt did not feel well; was incontinent; became non-responsive; had convulsions; to ER; lab work nl; released 10AM w/orders for APAP q4hrs; 03JAN94 pt has shaking type vibration of whole body, 0-3 x/day;
Information has been received on 14-JUN-2017 from a lawyer and a male patient of unknown age regarding a case in litigation.  It is complained and alleged that the patient was inoculated with ZOSTAVAX (dose, route, lot number and expiration date were not reported) on or about 28-SEP-2015 at a county health department as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-OCT-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed famciclovir (FAMIR) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Left side of neck got sore then stiff. Severe pain in left arm - neck and shoulder blade. Progressively worsened. By midnight, day of injection - excruciating pain - unable to move left arm or to rotate neck. Extreme pain for 8-10 hours, then gradually got better.
Information has been received from a physician concerning a 12 month old male with no pertinent medical history who on 09-JUL-2007 was vaccinated with PROQUAD (Lot # 656547/1530F) IM and VARIVAX (Lot # 654750/1256F) IM. There was no concomitant medication. The patient was suppose to be vaccinated with MMR II and VARIVAX. No symptoms have been reported. The patient sought unspecified medical attention. This error was a result of product confusion in which the labeling for PROQUAD and MMR II appeared similar. No laboratory or diagnostic studies were performed. No symptoms have been reported. Follow-up information from the physician indicated that a medical assistant on her staff gave the incorrect vaccine. The physician was unaware of the error until she was reconciling some counts and found the PROQUAD lot # registered for the supposed MMR II vaccine. Disciplinary action was taken. The physician reported that this will not be an issue in the future as PROQUAD will not be available (details not ascertained). The physician further mentioned that the labels are much too similar for the vaccines. The physician also reported that on approximately 21-JUL-2007 (within 21 days of 09-JUL-2007 vaccination date) the patient developed a "few dots" rash and diarrhea. These events were concurrent with some dietary changes. The patient recovered on an unknown date July 2007. This is one of two reports concerning the same patient. Additional information has been requested.
This spontaneous report as received from a nurse (L.P.N.) refers to an approximately 14 years old female patient with none of pertinent Medical History, none of drug Reactions/Allergies. The patient was vaccinated with dose 1, 0.5 ml GARDASIL (lot number reported as 0475AE, exp date: 13-DEC-2014) on 13-AUG-2012. No other co-suspects were reported. Concomitant medications included ANAPROX and BACTROBAN. The patient has lost 13 pounds in 15 days following vaccination (date unspecified). Patient experienced loss of appetite and nausea. Patient had called the office. No treatment was given. No lab diagnostics studies performed. The outcome of lost 13 pounds in 15 days following vaccination, loss of appetite and nausea were unknown. Additional information has been requested.
I had flu like symptoms and body ache on Saturday (day after vaccine). Then I began experiencing difficulty breathing, shortness of breathe, and low pulse oxygen levels with movement/exertion. Breathing difficulties have continued to worsen Over the last week and increased palpitations . Developed a skin infection at the injection site as well.
rash in the arm that was really itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash in the arm that was really itchy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NICOTINE POLACRILEX (HABITROL [NICOTINE POLACRILEX]) transdermal patch for Smoking cessation therapy.    The patient's past medical history included Stroke. Concomitant products included HYDROCODONE and GABAPENTIN (NEURONTIN) for an unknown indication.   On 20-Sep-2021, the patient started NICOTINE POLACRILEX (HABITROL [NICOTINE POLACRILEX]) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced RASH PRURITIC (rash in the arm that was really itchy). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash over arms, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash in the arm that was really itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had developed the rash on the opposite arm to the site of application of nicotine patch.; Sender's Comments: This case concerns a 59-year-old male patient with no relevant medical history, who experienced the unexpected event of Rash Pruritic. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 (Moderna COVID-19 Vaccine) and Co-suspect drug NICOTINE POLACRILEX (HABITROL [NICOTINE POLACRILEX]). The rechallenge was unknown since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Patient tolerated #2 Vaccine to left Deltoid. Patient to be monitored for 30 mins. Following vaccine. During the monitoring, patient developed scratchy throat - Pulse Ox 100% BP 135/78 RR 18 - Pt with some difficulty swallowing.  No SOB/DOB, Denies CP; Dr. notified - arrived- evaluated patient - No wheezing, No swelling of mouth or tongue. Per standing orders 50mg Benadryl PO given - Pt w/o difficulty swallowing. Monitoring continuous. 1235 Patient developed shivering - Afebrile. Dr. notified - Orders for Tylenol 100mg PO given. Patient able to swallow w/o difficulty. 1300 BP 135/94 RR 29 even/unlabored O2 Sat 100%; Dr. reevaluated patient - cleared for d/c.
No adverse event reported.  Date of birth was mis read and the patient is under 18 years of age.  {17 years, 10 months old}
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of colitis ulcerative (mucous in stool, bloody stool and diarrhea after receiving 1st dose, refer case US2018151930). On 20th August 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 20th August 2018, 30 min after receiving Shingrix, the patient experienced injection site pain and injection site swelling. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient received the 2nd dose of Shingrix in right arm. The patient stated that any follow up could be sent to him and he could forward the information to his physician. The patient did not provide health care professional information during the call.
None on adverse events - no signs & symptoms. Expired vaccine administered. Mother of pt informed; she would prefer to repeat dose after few mos. Pt in good condition before leaving facility.
Moderna COVID-19 Vaccine EUA: three days after vaccination patient presents to clinic reporting cough, chills, and over one month worsening of dyspnea on exertion, lower extremity edema, and orthopnea. Patient immediately transferred to hospital, diagnosed with acute on chronic volume overload and acute diastolic heart failure exacerbation, diuresed, and discharged to home medically stable. On outpatient follow-up patient is improved clinically.
1:45 pm on 6-15-12 Within 2 min. of HPV injection pt mom came out of exam room to report pt fainted. Pt fainted on floor - assisted to exam table, v.s. taken by staff & reported to pediatrician. Pt left alert in good condition.
Information has been received from a physician concerning an 18-month-old female with an egg allergy who on 06-MAR-2006, at 1000, was vaccinated SC with the first dose of MMR II. There was no illness at the time of vaccination. The physician reported that on 13-MAR-2006, the patient developed a fever of 102 and a rash. The patient was seen in the physician's office on 15-MAR-2006 as her fever and rash persisted. On 04-MAY-2006, the patient presented to the physician's office with angioedema, urticaria and anaphylaxis. 911 was called and the patient was seen in the Emergency Room (ER). Subsequently, the patient was hospitalized for recurrent angioedema, urticaria and rashes. At the time of this report, the patient was noted to be recovering. Additional information has been requested.
AFTER 1ST 10 MINUTES, PAIN IN UPPER RIGHT THIGH. LACK OF APPETITE, CONSTANT SLEEPING, CONSTANT SLEEPING, AND EXCRUCIATING HEADACHE THROUGHOUT THE WEEKEND ALONG WITH NAUSEA AND GOING TO BATHROOM..HEADACHE INTO MONDAY NOT LETTING UP NO MATTER WHAT..SEVERE MUSCLE PAINS IN LEGS AS WELL
C/O knot in muscle at injection site, redness, sore to touch, difficulty moving right arm, unable to rest on right side.
Flu Vaccine given at approximately 10:47 without concern or incident at time of injection. After leaving the office child complained of nausea and mom noted what looked like seizure like activity in the back seat. Returned to office Child examined in the car by PNP, she was responsive with even non-labored respirations. Vital signs checked BP was 87/58 pulse 56 oxygen saturation 100% Grips were equal  pupils were equal and reactive to light. Patient alert and oriented prior to being transported to ER via ambulance for further evaluation.
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Prevnar and Varicella given in left thigh at 01/14/04.  Cellulitis developed by 01/28/04.  No fever, no systemically ill.  Prescribed with Duricel.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine provided by the reporter was 07-May-2021.  No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-363032 (Patient Link).
Waited 30 min felt ok, took off mask in car saw  cheeks & nose were flushed. Approx 1 hr after injection had severe headache, severe sore throat, left side of face felt odd/tingly, left side of throat felt itchy & appeared red. Took Benadryl. Had taken Zyrtec 1.5 hrs prior to vaccine. Was drowsy, itching & throat started to feel less itchy, face still flushed.  Severe headache continued till next day as did sore throat. Took Tylenol at 5pm & again at 11pm. Symptoms resolved except for a sore throat & mild headache. Arm was sore but not severely so.  Napped, took it easy. Felt mostly normal by Saturday 1/23.
This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. On an unknown date, 2 months after the initial dose, the patient was vaccinated with the second dose of VAQTA (route of administration, lot number and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Two days, post vax, pt complained of shoulder pain and hip pain which she noticed the morning after vaccines were received. Three days, post vax, on 10/5/01, hip and shoulder pain is unchanged. Injection site is red, hard and swollen.
17:30 3/29/2021 - Severe Chills, Low Grade Fever (99.5), Tired 06:30 3/30/2021 - Chills gone, Fever (101.2) - Fever all day, Body aches 20:00 3/30/2021 - Low Grade Fever (100.0), Body aches 06:30 - 3/31/2021 - Low Grade Fever (100.1), Tired, Body aches
Two days post vax, the pt developed a rash on knees, ankle. Rash (erythema multiform) like target lesions on 3/9/00. No arthritis, no hives or allergic reaction.
Pt states took 1st oral dose of vaccine Friday night, became ill Saturday night with arthralgia, assumed fever (did not take temp), nausea, abdominal pain. Could not get out of bed secondary to symptoms until Monday AM. Rx: bed rest, fluids. Returned to work on Tuesday. Still has mild abdominal discomfort.
Contact tranfer from sharing towels/clothing with roomate vaccinated 27 Jan 2009.  Developed lesions along jawline  17Feb 2009.
pt recv vax 10NOV98 & w/in a few min arm became red around the inj site;the redness then spread up to lower neck area & down elbow;also devel a red area on the opposite upper arm that was itchy;
Patient's father completed COVID-19 form and pre-vaccination checklist answering 'no' to all questions except number 2. Patient given the 2nd pediatric COVID-19 Pfizer vaccination; however it was discovered the patient tested positive for COVID-19 on 1/11/2022. No notification made to family at this time due to non-working phone number. Immediately notified the patient's father who was outside the facility with his girlfriend, 3 children and a medical director.
Patient had previously gotten 1st and 2nd dose from another location. She registered with us saying this was her 1st dose and we gave her the shot. When we tried to call her after to verify, she never returned any calls.