chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Body aches; pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included QUERCETIN from November 2020 to an unknown date for Allergy, ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from January 2021 to an unknown date for Vitamin D deficiency.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm). On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 02-Feb-2021, PAIN IN EXTREMITY (pain in my arm) had resolved. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Patient temperature was taken throughout the night and never went over 99.5.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: follow up received on 02-MAY-2021 Contains patient demographic details added, concomitant medications was added,  new events was updated, dosage information was updated.
Client received her first dose of the Pfizer Covid-19 Vaccine (lot # EW0185 exp. 08/2021) at 14:58. At approximately 15:14 the client walked over to the EMT station. The client was a 33-year-old female alert and tracking with her eyes. The chief complaint was arm numbness. The client stated that she started noticing arm numbness approximately 4 minutes after receiving her first Pfizer vaccination. The client was alert and oriented to person, place, time, and event. The primary assessment revealed that the client's airway, breathing, circulation were intact. The client denied any pertinent medical history such as medications and allergies. The client did not present with any hives, swelling, discoloration, signs, and symptoms of shortness of breath, or other signs of anaphylaxis. The client stated that her arm numbness started gradually and was only present on her inner forearm without any discomfort around the injection site. After the primary assessment was done the client agreed for EMTs to take a set of vital signs in a seated position. Vital signs are as follows: blood pressure 118/84, pulse 70, O2 saturation 99%, respirations 14. After the first set of vital signs was taken, EMT recommended the patient stay an additional 30 minutes for observation and the client consented. However, approximately 5 minutes into observation the client stated that she was feeling better and refused to remain for the remainder of the 30-minute observation. It was recommended that she contact her primary care doctor and received all pertinent information before her next dose. The client was instructed to call 911 if a severe allergic reaction were to occur. The client then departed in a positive disposition with steady gait at 15:20.
(L) upper arm with erythema surrounding the injection site extending up to 4-5 inches below and 3-4" above up to the upper posterior part of (L) shoulder. Induration for about 1-2" diameter around the injection site.
patient received the second dose of shingrix at our pharmacy on 05/15/2020. patient had an extreme case of vertigo on 05/16/2020 morning and as the result she fell in her bathroom and fracture her right elbow and three ribs. patient was sent to er.
Burning in center of chest, red, hot cheeks, neck & chest, heart rate 122bpm, blood pressure 169/93, felt like I was breaking into a sweat but skin dry
5/12 Along with Flu-like symptoms I had swollen lymph node under right arm. Sought care via Telehealth with my usual hospital but not my PCP. Was advised to take Tylenol and pack ice for swelling. No medical test or Labs were done and after 2 days I felt better.
No immediate reaction. Received a call today specifying that later the day of administration and continuing into today, patient experienced severe headache, ear pain, left arm/shoulder pain (opposite to location of administration), neck pain, and back pain (which she believes may or may not be related). Pain is relieved by sitting upright and aggravated by laying down. Patient has taken 2 aspirin (325 mg she believes) for the pain. Symptoms seem to be persisting. I recommended Tylenol (acetaminophen) in addition for pain and recommended she call her doctor as well for symptomatic recommendations or if symptoms persist. She reports that she just got off the phone with her doctor who told her to call us and report it.
Uncontrolled Diarrhea  Heavy Sweating Shaking Fever of 101 Weakness Dizziness  Muscle Pain Throughout Body Headache  Fainting
tinnitus non-stop ringing, pulsing in the ears unable to sleep on concentrate due to this constant sound/feeling.
This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (has lost of sense taste), ANOSMIA (has lost of sense smell), ILLNESS (does not feel good), COVID-19 (symptoms of covid,) and DYSPNOEA (breathing off) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes since 01-Jan-2012. Concomitant products included METFORMIN from 01-Jan-2012 to an unknown date for Diabetes, TAMSULOSIN from 01-Jan-2019 to an unknown date for Enlarged prostate, EMPAGLIFLOZIN (JARDIANCE) from 01-Jan-2013 to an unknown date for HbA1C, GABAPENTIN from 01-Jan-2010 to an unknown date for Neuropathy, TIZANIDINE from 01-Jan-2020 to an unknown date for Sprain and Cervical pain. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (symptoms of covid,) and DYSPNOEA (breathing off). On 27-Jan-2021, the patient experienced AGEUSIA (has lost of sense taste), ANOSMIA (has lost of sense smell) and ILLNESS (does not feel good). In March 2021, COVID-19 (symptoms of covid,) had not resolved. At the time of the report, AGEUSIA (has lost of sense taste), ANOSMIA (has lost of sense smell) and ILLNESS (does not feel good) outcome was unknown and DYSPNOEA (breathing off) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) POSITIVE. Patient reported in follow up, he went for a COVID-19 test in the same week as experiencing COVID symptoms, which was positive and he is still suffering from breathing difficulties(breathing off) at the time of report. No treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Medical history, patient details, concomitant medications and therapy details were updated. added event breathing off.
Pt recvd 1st dose Recomb 5SEP90 w/no adverse rxn; On 5OCT90 pt recvd 2nd dose of vax & exp soreness @ inject site which lasted until 10OCT90; On 15OCT90 pt exp nausea, chills, fever 99.5; also body aching & joint aching, cold sores;
Patient stated she had injection yesterday and it began to hurt around 11 pm. She now  has limited mobility and pain in her left arm.
Patient was given Varicella immunization in Right arm, subcutaneously with 5/8" needle on 2/7/07. On 2/8/07, patient awoke with welt in spot where immunization had been given. Patient stated it was "hot and swollen". Patient was advised to observe, ice arm, take Tylenol and Benadryl and report to us any changes. Patient is fine now with no more irritation.
Patient was at work on 1/15/21 after having received the vaccine on 1/12/21.  She complained of being diaphoretic and her heart rate was 156.  She was taken to Hospital.  She is being admitted to hospital and has reported that her heart rate is 122 and she has a temperature of 99.4 and elevated lactic acid levels.
Severe stomach pain, nausea, heartburn. Stomach illness. No vomiting No diarrhea No fever. 5am - slept until about 2pm.  Felt better.  Ate dinner at 7pm and was sick again; same as earlier.
"when I become inflamed, pain in neck to under arms, to elbows and 3-4 fingers  in right hand"   zoster recombinent
Patient received his second dose of covid vaccine on 07/12/21.  He seemed fine and left our immunization area.  Approximately 5 minutes later, his brother came back to the pharmacy to inform us that the patient was sitting down near the restrooms and not feeling well.   I, along with another pharmacist, went to assess him.  He said he was lightheaded and was feeling nauseous.  We sat with him for approximately 10 minutes and checked his blood pressure twice.  His blood pressure was high the first time we took it, but it returned to normal after a few minutes when we took it the second time.   We subsequently found out from his mother that he fell/fainted in the restroom due to his dizziness.  He was unhurt from the fall.  After approximately 10 minutes he said he was feeling fine and was able to continue shopping with his mother.
death ALTERED MENTAL STATUS FACIAL DROOP G45.9 - Transient cerebral ischemic attack, unspecified
Pt given CPX vaccine (#1 dose) on 7-5-11. On 7-20-11 pt noticed 4 x 2 inch area of redness with pinpoint swelling at injection site. Negative itching.
He got air bubbles on the brain ... he had a high fever slept all day long minus 3 hours a day
c/o feeling hot;skin hot to the touch;c/o eyes burning, sclera red;also c/o tongue feeling numb;t97.9, gait unsteady 20min p/onset;DPH given 20min later still c/o feeling strange; epi given;
FEVER UP TO 102; SEVERE COUGH/ SORE THROAT/WATERY EYES/BODY ACHES/SINUS DRAIN/SORE THROAT. STILL SOME SAME SYMPTOMS BUT REDUCING AS OF 12/22/2014.
Pt received his first Shingrix vaccination 5/29/2020 and had a confirmed case of shingles 7/30/2020. He has not yet received the second vaccination.
Vaccine picked-up on 12/07/2021 and stored in fridge with used-by date of 01/07/2022. Patient received this dose a day past the vaccine usage date.
Information has been received from a registered nurse concerning an approximately five year old male patient, who on an unspecified date in May 2005, was vaccinated with MMR. It was noted that after being vaccinated in May 2005, the child started to cough, became short of breath, and developed hives all over his entire body. He was treated with epinephrine and diphenhydramine. The patient recovered. There was no product quality complaint reported. Cough, became short of breath and hives over entire body were considered other important medical events by the reporter. Additional information has been requested.
Severe headache beginning 2 hours post immunization and lasting 48 hours. .  Extreme body aches beginning 4 hours post immunization and lasting 48 hours. Intermittent nausea beginning 4 hours post immunization and lasting 36 hours.  Extreme exhaustion for 72 hours post immunization.
Information has been received concerning a pt who in 1990 and approximately 1995 or 1996 was vaccinated with the first and second dose of varicella vaccine. The pt developed full blown chickenpox all over her body, roof of her mouth, the whole nine yards. However, the reporter noted that she needs to identify the varicella, it may be hives.
March 8th - Dizziness, heart palpitations, skipped beats, tunnel vision, hypotension. This was followed by 2 weeks of regular PAC's and PVC's noted by my self. This did not seem to be related to any kind of anxiety since I have never had anxiety problems.   I eventually had an echo cardiogram on  03/30/2021 which resulted as normal I also wore a Ziopatch for 2 weeks from 03/30/2021 which resulted as normal. By the time I was able to be tested most of my symptoms had resolved.
This spontaneous report as received from a healthcare worker refers to a 16 years old male patient with drug allergy to amoxicillin and without pertinent medical history. The patient was vaccinated intramuscularly with 0.5 ml GARDASIL (lot number unknown) on 03-JUL-2012. No other co-suspects were reported. There is no concomitant therapy. The patient developed fever and chills after receiving GARDASIL on 03-JUL-2012. No laboratory diagnostic studies were performed. The patient had contacted HCP office for medical attention. MOTRIN and TYLENOL were given as treatment for the events. The outcome was reported as recovered on 5-JUL-2012. Additional information is not expected.
Expired vaccine(31-January-2022) was administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th May 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th May 2022, unknown after receiving Bexsero and Bexsero 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:18-May-2022 Reporter's comments: The practice administrator reported that an expired Bexsero vaccine was administered to the patient. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Phone call from father on 8/24/00. The next day, post vax, child had blisters in mouth, on lips and rash on body. Called local ER. Gave Benadryl and symptoms improved. Father had original IZ record at home. Child was up to date per father's report. No record in clinic on date of administration. On 8/18/00 child was "off schedule" and vaccinated.
Information has been received from a company representative concerning a patient who in approximately 1997 was vaccinated with varicella virus vaccine live. Subsequently the patient experienced breakthrough chicken pox. It was also reported that 4 children at the patient's daycare had a similar experience following exposure to varicella virus vaccine live. Follow up information from the registered nurse indicated that the adverse experience occurred at a local daycare who indicated that there have been several cases of breakthrough varicella in the past weeks or couple of months. At least 4 children have had active lesions and all have retrieved varicella virus vaccine live in the past. It was reported that the physician's office did not administer any of the vaccines. No further information is available.
Pt experienced left arm discoloration, loss of muscle tissue occurred, some stinging/tingling sensation occur regularly. Lidocaine was prescribed.
Pt was pale and weak for approximately 4 hours post vax. Blood pressure without orthostatic change. Resolved with treatment.
Severe Aches all over the body, High Fever (102 F), Violent Chills, Violent Spasms (on legs), Weakness
after receiving the vaccine pt felt sweaty and lightheaded and wanted to lay down, so the nurse directed and walked with pt to move him by the privacy area so he can lay there. while walking to the privacy area pt fell on the floor. when i examined the pt his body felt hot at touch and he stated that he was feeling dizzy.  after few minutes the pt felt better and after waiting for 20 minutes pt stated he is feeling better again.
Dizziness, BP 101/63 (pulse 70), 100% O2 sat. Water given.
Five hours after receiving the injection I developed severe cold chills and visual disturbance in right eye lasting one to two minutes. Also had localized swelling and redness at site.
Ongoing Random intense hive outbreaks over different body parts including, but not limited to, thighs, legs, arms, feet, and head. Treated with otc Benadryl, Xyzal, and cortisone cream. Pills and cream offer temporary relief but symptoms return at random times and last for random periods of time. Events are ongoing daily. No professional treatment has been sought at this time.
Dizziness, headache, and ear blockage/popping setting in 8 days after first Pfizer shot.  Dizziness not incapacitating but noticeable and persistent. Consulted primary physician who diagnosed as ear canal pressure issue and prescribed Flonase.  No relief after a week.  Consulted ENT who diagnosed as BPPV and performed Epley Maneuver.  Prescribed home Epley Maneuver treatment for a week.  5 days into those treatments and no relief (typically, 90% of patients suffering from BPPV will be cured by just one Epley Maneuver treatment).
Fever, chills, headache, pain and inflamation in left arm,neusa, diarriah
A report was received from a health care professional on 10/30/2001 and a follow up was received on 11/26/2001, concerning a 73 year old female patient who experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 11 days apart, on 10/19/2001 and 10/30/2001. On 10/30/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 11 days after the first vaccination on 10/19/2001. No adverse effects were reported at time of report. There was insufficient information to determine the causality assessment of the reporter.
Part of the vaccine ran out at time of injection.  The night of the injection my arm started itching.  I was awakened at 4;00 a.m. the next morning with a very stiff, sore, cramping arm.  I had the normal reactions: slight headache, low temp, itchy, swollen, hot red arm, but very stiff and sore. This lasted 3-4 days with the most noticeable reaction being the sore arm from shoulder to elbow.  On Feb 10, one week later, my arm started itching again in the afternoon and by evening was swollen, red, hot, and hurting  just like the first 3-4 days or slightly worse.  It gradually got better after 4-5 days, returning to normal by 2/20.  The only other symptom the second time were blisters on my left hand above my pointer finger and ring finger.  I'm not sure if they were related or not since I walk outside or if I may have been exposed to poison ivy since the blisters looked similar.
One day after body aches. 3 days after moderate joint pain  - difficult to walk down stairs.  4 weeks after unexplained most of  body hives. No environmental or other allergy factor noted. Hives lasted over 2 days.  All 3 have resolved.
Vaccine was administered 7 days earlier; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered 7 days earlier) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered 7 days earlier). On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine was administered 7 days earlier) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. No concomitant medications were reported.
Fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 at the age of 73-year-old at SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020. Concomitant medications were reported as none. Patient mentioned she had COVID-19 last Dec2020, received the Pfizer-BioNTech COVID-19 Vaccine first dose this Mar2021. Patient reported to have the "normal reaction" of the vaccine (fever, chills, muscle ache). Patient mentioned that she saw doctors on TV that said it would be okay to not get the second dose if had COVID-19 before and experienced the "normal reaction" to the vaccine. Patient was seeking information on this. Treatment was received for fever, chills, muscle ache. Outcome of events was unknown.  Information on Batch/Lot number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, 2 days after receiving SHINGRIX, the patient experienced headache, pain in arm, fatigue and generalized muscle aches. In July 2018, the outcome of the headache, pain in arm, fatigue and generalized muscle aches were recovered/resolved. It was unknown if the reporter considered the headache, pain in arm, fatigue and generalized muscle aches to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The patient experienced muscle aches all over the body, headaches, arm pain and fatigue. It was stated that, all the symptoms started on the 2nd or 3rd day and lasted for total of 2 days. The patient gave permission to contact her physician. No further details were provided.
Ongoing fatigue that has been increasing in severity. Ongoing joint pain that has been continuing in severity making daily activities extremely challenging.  Ongoing twice daily migraine level headaches that are no longer responding to OTC pain meds. 9ngoing muscle pain that has been increasing in severity making daily activities challenging.  Moderate to severe nausea that began two days ago.
pt recv vax 2MAY95 & pt reported that in the arm that recv vax lymph node under armpit was swollen;
Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced caller states an expired MENACTRA vaccine was administered yesterday, while he/she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BEXSERO for Immunization. On 10-Jul-2018, the patient received a 0.5 ml second booster dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine, lot U5567CA via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. (Other relevant tests included No lab data.) It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for caller states an expired MENACTRA vaccine was administered yesterday. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.