chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown   This case was linked to MOD-2021-060448 (Patient Link).
Red, swollen, warm to touch area on rt. upper arm approximately  6" x 5.5"
vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Pneumovax 9/27, pain 9/28, hospitalized for pain control and IVF 9/29, WBC 26000, usual SBP 105, minimum of 79mmHg through 5 liters of LR IVF. 10/12/06 Received medical records from PCP which reveal patient seen for vax on 9/27 & had rash on RLE for approx 2 weeks.  Visit note of 9/28 indicates patient had "bad reaction" to pneumonia shot & was sent to hospital for pain control.  Notes indicate she received IVF, tylenol & MSO4 along with steroid & pain was controlled. 11/1/06 Received medical recorsd from hospital which reveal patient experienced severe 10/10 left arm & back pain, HA, tachycardia, heavy sweating, nausea.  Left arm noted to be reddened & tender. After several hours observation & IV pain meds, patient with very little improvement & was admitted for further w/u.   Dx: Pneumovax reaction & hypotension.
August 17, 2020: Prevnar 13 given R. arm (IM?).   August 19-21, 2020: Noticed redness below & adjacent to injection site approx. 4cmx6cm in size. August 22-23, 2020: Progressively growing redness with edema noted extending from injection site to elbow.  I have photos. August 24, 2020: Called Dr. and was seen same day.  Put on Keflex for one week. *This Prevnar 13 vaccination is the first time I have ever had an adverse reaction to any vaccination!
Client just had the HPV vaccine, and after 5 minutes approximately, she had a seizure of about 20 seconds. She was sweating, and had blurry eyes. She was sitted and Nurse was holding her. She complained of numbness in the left hand, the same arm where HPV was given. At 13:13 she complained again of dizziness.
Immediate "hot" feeling in left shoulder at point of injection of vaccine. Surface skin numbness sensation to the touch that has lasted for months in shoulder where the vaccine was injected, minor muscle soreness in shoulder where vaccine was injected
had a fever for like 1 day; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (had a fever for like 1 day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025S20A) for COVID-19 vaccination.     The patient's past medical history included Coronavirus infection (had coronavirus at the end of October 2020) in October 2020. Concurrent medical conditions included Hyperthyroidism (Her Thyroid T3 was elevated). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hyperthyroidism.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (had a fever for like 1 day). In 2021, PYREXIA (had a fever for like 1 day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported Her Thyroid T3 was elevated but the doctor said that's normal since she takes Synthroid.  The treatment information was unknown.   This case was linked to MOD-2022-468527, MOD-2022-468597 (Patient Link).
itchiness at the injection site; swelling in bicep and shoulder area; swelling in bicep and shoulder area; a rock-hard ball swelling; Dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd August 2022, immediately after receiving Shingrix, the patient experienced dizziness. On 4th August 2022, the patient experienced muscle swelling, swollen joints and induration. On 12th August 2022, the patient experienced injection site itching. On 3rd August 2022, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the injection site itching, muscle swelling, swollen joints and induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, muscle swelling, swollen joints, induration and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The reporter was the pharmacist. The reported stated that a patient received Shingrix and experienced dizziness immediately and it resolved while in the pharmacy waiting room. The reported stated that the next day patient had swelling in her bicep and shoulder area. The swelling was described as a rock-hard ball. The reported stated that on the day of reporting, the patient experienced itchiness at the injection site. The reported stated that he felt the injection site may be low and had nothing else to report. The reporter consented to follow up with Healthcare professional (pharmacist). The patient received Shingrix on an unknown arm. Additional supportive information: 1 day after receiving Shingrix, the patient experienced muscle swelling, swollen joints and induration 9 days after receiving Shingrix, the patient experienced injection site itching.
Constipated; "Usual stuff"; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipated) and ADVERSE REACTION ("Usual stuff") in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ADVERSE REACTION ("Usual stuff"). On 11-Feb-2021, the patient experienced CONSTIPATION (Constipated). At the time of the report, CONSTIPATION (Constipated) and ADVERSE REACTION ("Usual stuff") outcome was unknown. Not Provided          Concomitant medications reported were unknown hypertension medication, unknown cholesterol medication, unknown anxiety medication for drug use for unknown indication. No treatment information was provided.
Pt. C/O red area over vaccine site. Approximately 8 cm diameter. Red and warm painful.
Numbness and tingling of fingers and tones within 5 hours after receiving the vaccine. Progressed to numb feet and hands, very weak legs and arms, numbness in shoulders and teeth.  Next day could barely walk. 48 hours afterwards symptoms still present and eyes hurt. Went to the emergency room and after multiple tests was diagnosed with Guillian Barre Syndrome.  In ER they did a CRP, ESR (sed rate), head CT, MRI of spine, MRA & MRV of head, MRI of brain, comprehensive metabolic blood test, complete blood count with differential, Sars-Cov-2 test which was negative, and other blood work was done.  A spinal tap was done and I was diagnosed with Guillian Barre Syndrome and admitted to the ICU.
Recurring heart palpitations, chest burning,  and shortness of breath, in addition to the more common side effects.
He received his shot Thursday afternoon around 4:30pm. He woke up at 3am on Saturday complaining of something hurting on his back.  I noticed 2 very large and 2 small rashes on his back.  We have been treating the spots with hydrocortisone. Today is Monday and they are still very tender but not as bad.
A few hours afterwards I had a fever of 102. I rarely get sick. I dehydrated out, I could not keep on top of the fever. I was extremely fatigued. My arm hurt. I had muscles aches everywhere. Joint pain. It progressed to the left side of my body, ear ache, swollen nodes, extremely sore throat, and my teeth hurt only on the left side. I could not stay awake. I cancelled patients for like a week and a half which I never do. I shipped the dogs to a pet sitter because I could not take of them. I could not eat or drink anything. The fever went away after a couple of days but the pains did not. I called the doctor and she said to stay on Tylenol.  I have never been that sick in my life.
Patient complain of scratchy throat with cough within 15 minutes after vaccination. Given water to drink. Assess blood pressure, pulse. Patient stable within 15 more minutes and felt fine to leave.  Precautions given to seek medical attention if signs and symptoms worsens.
This spontaneous report as received from a nurse practitioner refers to 18 patients who might have been vaccinated with doses of GARDASIL (Lot # J008423, expiration date 21-JAN-2016) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 0-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Temperature 8.2F/ Time frame: 1 hours and 30 minutes; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 21-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number U020238 has been verified to be valid, expiration date reported and established as 28-JUN-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 8.2 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes (product storage error). There was no previous temperature excursion.
Approx 3 days after Rotateq was administered to infant he began having bloody stools. This lasted for 1 month. No other symptoms noted. It was recommended that infant try nutramigen or alimentum formula. Infant did not like these formulas and mother continued to nurse. Mom was also advised to stop dairy products since baby had been breastfeeding. Pt's stool was sent to lab, stool culture neg, positive for occult blood. Pt was also referred to gastroenterologist for consult. Symptoms resolved after 1 month, no medication given.
Information has been received from a nurse concerning a 24 month old female with a history of liver transplant who was vaccinated with a dose of VARIVAX (Oka/Merck).  Concomitant therapy included RAPAMUNE.  Subsequently the patient developed one small chicken pox lesion on  her forearm.  Subsequently, the patient recovered from one small chicken pox lesion on her forearm.
Patient reported that she developed redness to the deltoid area of her right arm on 4/14/2021 where she received Moderna vaccine.  She came to office today to have nurse to check her arm.   The area is approximately 3 inches x 2 inches.  It is slightly red but not hot.   Advised cold compresses every 2 hours and observe area.  Advised to see PCP if increased redness, swelling, or fever.
PATIENT MOVED ARM AS  I INSERTED NEEDLE. I HAD TO INJECT AGAIN AT OTHER SITE . NO VACCINE GIVEN WHEN PT MOVED ARM
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 24-APR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Tingling/numbness of left foot. Improving after half an hour of waiting.  No weakness.  Pt has diabetes and has had similar symptoms from that as well. He has a nuerologist he follows with and will schedule a follow up .   #9 please add atrovast.  and hydocchlorothiazide. #21. refer to his neurologist.
Rash, erythema, pitting edema of the lower right leg,  and pain with palpation, Fever of 101F tachycardia, dehydration, heart palpitation (skipping heart). Condition occurs after 20 days of SPV inoculation.
IM injection to left deltoid (0.5ml) on 7/27/06. Had redness and tenderness to left deltoid extending to elbow and left chest wall. Returned to office on 8/10/06. Symptoms had resolved but still having some pain to arm. Stated duration of redness/swelling approximately 6 days.
Patient got vx on 3Sep2021 and 1Oct2021; patient born 30Apr2012 received Pediarix; patient born 30Apr2012 received Pediarix; This case was reported by a nurse via call center representative and described the occurrence of drug administration duration too short in a 9-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd September 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 3rd September 2021, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 10th October 2021, the patient experienced drug administration duration too short and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug administration duration too short, inappropriate age at vaccine administration and inappropriate age at vaccine administration were 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: 01-APR-2022 Reporter's comment: The patient received Pediarix on 3rd September 2021 and 10th October 2021. The reporter did not consent to follow up. Additional Supportive Information: The 9 years old patient received 1st and 2nd dose of Pediarix, which led to inappropriate age at vaccine administration. Also, 2nd dose received too early, which led to shortening of vaccination schedule.
pt recv 1st dose of varivax 1/11/96 & in 5/98 pt exp very mild breakthrough w/less than 50 vesicles. was exam in m.d. ofc  5/6/98 & indicated pt recovered
High fever, headache, stiff neck, throat, heart beating fast, laying around, crying. 1-1-10 in & out of Doctor - office did not know what was going on. 2 week it stop 2nd shot - 1-21-10. 1-23 headache, 1-24 high fever, stiff neck. Heart beating fast Doc. connected the two together.
May 5, 2022 felt ill sore throat, runny nose. Used home covid test kit tested positive contacted my Primary Care doctor who prescribed Paxlovid for 5 days.
About 10 minutes after receiving shot, she had shortness of breath and began to cough. She continued to have shortness of breath, coughing for about 30 minutes. She gave herself 2 puffs of SYMBICORT which improved her breathing. Had some residual problems during the night but was fine the next morning.
First dose administered 06/11/2021. Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in 11th June 2021).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported 2nd dose of Engerix-B greater than one month and 2nd dose not yet given till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Initial and follow up information has been received from a parent and from a certified medical assistant, respectively, concerning a 6 month old male (birth weight 6#, 13 oz.), with no known drug allergies, who on 08-AUG-2006 (previously reported as 25-AUG-2006), was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot # unknown) instead of PREVNAR. It was initially reported by the parent, that the infant had no adverse effect, however the certified medical assistant reported in follow up that the mother called the office the next day and reported that the patient developed a small knot at the injection site, as well as injection site redness. The parent was instructed to put a warm pack on the injection site first, and then follow with ice pack applications. As of 05-SEP-2006, the patient had since recovered (date not specified). The certified medical assistant reported that the inadvertent vaccination with Pneumovax 23 "was a mistake made by one of the staff members, who had been counseled regarding the event". Follow-up information has been received on 06-OCT-2006. The physician's office reported that on 11-AUG-2006 at 15:15, the patient's right leg was hurting, bruised, had a hard knot and was swollen. The physician prescribed TYLENOL, PRN and warm compress as treatment. Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 at 12:00 as dose 1, single (Lot number: EL1283), on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9264), in left arm, on 28Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 30Mar2022 at 12:00 as dose 4 (booster), single (Lot number: FS9943) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (18Jul2022) Positive, notes: still testing positive on the home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Systemic: Fainting / Unresponsive-Mild, Systemic: She was dizzy and fell to the floor on her bottom in a sitting postion. She did not bump her head and no injuries noted.-Mild, Additional Details: Patient waited an additional 20mins in the clinic after episode and blood pressure was monitored and within normal limits and was A&O x3. Never lost consciousness during the event. After event provider waited with the patient took blood pressure twice at 105/64 & 106/60. Patient asked to stand and no dizziness noted and she was walked to the care. Patient verbalized when she go to her car she was not dizzy or feeling faint.
Pt reported sudden onset of painful swollen lymph node under her jawline that developed 15-30 minutes after receiving COVID-19 vaccine. No further symptoms reported.
None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985.
pt recv vax & pt exp an elevation in liver enzymes;the nurse reported two patients;they were assigned WAES 96071016 and 96071017;
Had severe headache, runny nose , scratchy throat,bad leg pain, stomach pain,and loss of taste on certain things,and still have symptoms to this day,and very tired all the time
drug used for unaproved indication; no adverse event; This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's medical history and concomitant medications were not reported. Current condition included alpha-1 anti-trypsin abnormal. Yearly on unspecified date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiry date were not reported) for alpha-1 anti-trypsin disease (product use in unapproved indication). It was reported that while on the call, pharmacist asked the patient, who was at the pharmacy, if she would like to complete safety report but the patient refused. No additional adverse event reported.