chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (body aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) and MYALGIA (body aches) 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.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age. On 21-JUL-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) IM. On 22-JUL-2013, the patient received another dose of PNEUMOVAX23 (Lot # not reported) IM and on 23-JUL-2013, received one more dose of PNEUMOVAX23 (Lot # not reported) IM. No adverse effect was reported. Additional information has been requested.
Vaccination administered at approx. 2:40pm. Pt. instructed to remain seated in waiting room while sibling was being vaccinated. At about 2:50pm, pt. passed-out while sitting in chair. Pt. slid between 2 chairs rolling on to her stomach and struck head either on chair or floor striking head along head-band just left of center top of head. Ice applied. Pt. was able to leave clinic at 3:20pm.
Post - injection waited recommend minimum 15 minutes walked out of vaccination area and had syncopial episode. BP 180/110.  Pulse 62. Respiratory Rate 20. O2 sat 99% on room air. EMS transfer to Medical Center.
After taking the first dose of the vaccine with 19 hours felt very tired and felt too much heaviness on  chest and chest pain.; After taking the first dose of the vaccine with 19 hours felt very tired and felt too much heaviness on  chest and chest pain.; After taking the first dose of the vaccine with 19 hours felt very tired and felt too much heaviness on  chest and chest pain.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: er:8737) via an unspecified route of administration in the arm left on 05Apr2021 at 14:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included bronchial allergies, environmental allergy and allergy to chemicals products such as (paint, cleaning products). Concomitant medications included esomeprazole magnesium (NEXIUM) tablets on an unknown date and for unspecified indication. 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 06Apr2021 at 12:00 within 19 hours of vaccination, the patient experienced very tired, felt too much heaviness on chest and chest pain. The patient reported that she had bronchial allergies and was very sensitive to even smell, any cleaning chemicals products or paint. They made her sick. Because of the events she called the center where she got the vaccine and informed them and they told her to go to the ER(emergency department). She went to the ER and after all the tests made in 8 hours the doctor informed her that the tests are fine but he said to contact Pfizer because she might not be able to get the second dose. Until 09Apr2021, she was feeling a bit better but was tired even though she was using the Ventolin inhaler as the doctor advised. The adverse event resulted in emergency room/department or urgent care. The patient received Ventolin inhaler as the treatment for the reported events. The clinical outcome of the event very tired, felt too much heaviness on chest and chest pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
tested positive to COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive to COVID 19) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive to COVID 19). At the time of the report, COVID-19 (tested positive to COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported This is a spontaneous case reported by a female consumer (no other patient details reported), with no medical history, who experienced the unexpected non serious AESI of COVID-19, 2 days after the first dose of mRNA-1273 vaccine given on 13 Jan 2021 with unknown route of administration.  The subject was tested positive to COVID 19 test on 15 Jan 2021, At the time of this report no concomitant medications and no treatment medications were reported. The outcome of the event was not reported. The consumer wanted to know if she can still receive her second shot scheduled on 10 FEB2021, after this event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2021: Significant follow-up included Reluctant to give information, defensive.; Sender's Comments: This is a spontaneous case reported by a female consumer (no other patient details reported), with no medical history, who experienced the unexpected non serious AESI of COVID-19, 2 days after the first dose of mRNA-1273 vaccine given on 13 Jan 2021 with unknown route of administration.  The subject was tested positive to COVID 19 test on 15 Jan 2021, At the time of this report no concomitant medications and no treatment medications were reported. The outcome of the event was not reported. The consumer wanted to know if she can still receive her second shot scheduled on 10 FEB2021, after this event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient received  covid vaccine #1  ~11 am today at facility.  Within 20 minutes she noted facial flushing and now reports tiny raised blister like areas on face and spreading to neck. Denies throat swelling of dsypnea.  Instructed her to take long-acting antihistamine and Pepcid and seek immediate medical attention for any respiratory distress.
PT HAD SYMPTOMS OF CHEST PRESSURE AND A GENERAL SENSE OF FEELING UNWELL APPROXIMATELY 10 MINUTES AFTER RECEIVING VACCINE. VITAL SIGNS WERE STABLE, PT WAS CONSCIOUS, HOWEVER BEGAN TO HAVE FACIAL TINGLING AND LABORED BREATHING. EPINEPHRINE (EPI PEN AUTO INJECTION) GIVEN X1 DOSE. SYMPTOMS IMPROVED BUT NOT RESOLVED. PT SENT TO EMERGENCY DEPT VIA EMS TRANSPORT.  SHE WAS IN STABLE CONDITION AND CONSCIOUS DURING THE  EVENT WITH STABLE VITAL SIGNS. HEART RATE MAX WAS 107. B/P WAS 130/88, O2 SAT 100%.
pain in the arm where he received the vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on Arm on 24Feb2021 08:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included ongoing chronic myeloid leukaemia (Treatment was ongoing by "Bosulif"). Concomitant medication included ongoing bosutinib (BOSULIF) taken for chronic myeloid leukaemia, start date was not reported. The patient only had a little problem which was pain in the arm where he received the vaccine. He would like to know since he had no other problems or much pain, if the vaccine will have almost no effectiveness. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"Had a fever of 101.3, chills and a headache. Tylenol and Ibuprofen did not bring his fever down." "Felt like jello- was tired on second day." "No reaction after his first Hep A shot or HPV shot."
a 16 year old patient received a dose of Fluzone QIV / No adverse event; Initial information regarding an unsolicited valid non-serious case received from a pharmacist via nurse on 24-Oct-2019.  This case is linked to cases 2019SA304580, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced any adverse 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 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.
Information has been received from a registered nurse concerning a white female patient who's child was vaccinated with MMR. Subsequently, the vaccine splashed into mother's eye while she was holding the child. The mother complained of burning and the eye was washed out. No additional information was available. Follow up information indicated on 12/16/04 at 14:30 the child was receiving the vaccine and the needle came off the needle hub and splashed the mother in the eye with vaccine. Her right eye was irrigated immediately. She complained of slight burning and it was irrigated again. No burning, redness, or swelling was noted. Follow up the next day indicated no problems. The patient recovered. No further information is expected.
Thursday- Sept. 10 6pm - vaccine; 11 pm - stomach discomfort; 3 am- vomiting - 3 times; Fri - Sun - dull headache, severe diarrhea, unable to do anything. No fever. Any activity made heart race.
Pneumococcal vaccine given on 2/11/04 at 5:30PM> fever of 101.2/chills reported by preschool staff and request to pick up at 8:30AM on 2/12/04. Child experiencing fever as high as 104.2 later that evening and chills. At injection site, redness and swelling present at the time of first reports of fever. Child reporting tenderness, pain at injection site and overall muscle aches with first reports of fever. Physician that administered injection contact at 0900 on 2/12/04 with this writer concerns that this was an adverse reaction to the vaccine give only hours before. No office visit at this time, instructed to provide child dose of Mortrin 5 cc every 4-6 hrs. Due to continued high fever (as high as 104.2), increasing sleepiness, some compliants of "hard to breathe"  and continued swelling/redress at injection site the child was taken to local emergency room at 6:20PM on 2/12/05. At ER, drug reaction dx with increase in children's dose of Mortrin to 8cc alternating with children's dose of Tylentol 8cc every 3 hours and instructions to return if arm became worst or other symptoms appeared. Returned to ER after telephone call with nurse to return at 2:20AM on 2/13/2004, fever of 103.9, increasing compliants of arm pain. Arm at injection site redress and swelling 2 times the sign of normal.  Cellulitis dx provided with instructions to stop Cefazil given for ongoing sinus infection (21 day course on day 14 at the time), add Augmentin, Zyrtec and continue alternating Tylenol/Mortin as needed for pain/fever. Attempts to reach physician that administered vaccine and provided course of antibiotics unsuccessful until late on 2/13/04 6:00PM (after hours office visit). Treatment changed to Keflex 10 day course to stop Cefazil, added 6 day course of Orapred with Benadryl, and Mortrin for itching/pain. Likely dx of drug reaction or serum sickness. The child did well until 2/19/04 (when Orapred last given on morning of 2/18) redness reappeared with c/o of itching on 2/19/04 at 6:00AM. Physician contacted again and another course of Orapred started for next 7-10 days. The child has also been given Benadryl daily for c/o of itching at injection site and arm. The arm continues to become red with very marked area about 6X10 inches in diameter.
11-15-17 Tingling in thumb and first two fingers-both hands-within week progressed to severe pain in both hands and wrists-EMG showed myotonia also had absence of reflexes in both arms and legs. Dec. 13th legs gave out-unable to walk. Hospitalized 12-13-17 -> 2-12-18. Severe electrolyte abnormalities. Cardiac issues from those. Extremity weakness-especially left side. Too weak to walk for some time. No feeling in both hands. Atrophy and contractures of both hands. Extreme pain in both feet. Numbness on bottom of both feet. Poor balance. Ataxia. Altered voice sound. Thrombocytopenia. Treated with SOLU-MEDROL January 2018 caused blurry vision. Treated with IVIG in December 2017 and Plasma Exchange February 2018. Not much improvement. Consulted with Clinic March 5-9-2018 and April 5-6-2018. Recommended IVIG for 12 weeks-started treatment March 30, 2018. Also recommended IMURAN to start 5-7-18.
pt recvd vax & had swelling at site of inject; w/in next 5 hrs, pt had pain & soreness extending into shoulders & back; pt c/o headache;
Upper arm was swollen, red and hot; Upper arm was swollen, red and hot; Upper arm was swollen, red and hot; Heart rate was fast; Chest tight; Itching; This spontaneous case was received on 13-Jun-2021 from Communications (reference number: SEQW21-01429), reported by other non-health professional (consumer) and concerned a 24-year-old, female patient.  The patient had no medical history and was not taking any concomitant medications.  On 13-Nov-2017, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: deltoid, route of administration: intramuscular and dose: 0.5 ml) for influenza prophylaxis. The batch number reported was 01644611A.   On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching.  On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment.  On 22-Nov-2017, the patient recovered from the events.  The reporter assessed the event to be related to Afluria Quadrivalent. The reporter stated that the patient had reaction to 2017 vaccine.   The case was assessed as non-serious.  Company comment: A 24-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching. On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment. Causality is assessed as possibly related for all events. The events of erythema, peripheral swelling and feeling hot may suggest cellulitis, however, Brighton collaboration criteria for cellulitis at injection site could not be assessed due to insufficient information provided.; Reporter's Comments: Consumer had reaction to 2017 vaccine.; Sender's Comments: A 24-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day, after receiving Afluria Quadrivalent, patient's upper arm was swollen, red and hot, her heart rate was fast, chest tight and she developed mild itching. On an unknown date, at urgent care, the patient received prednisone, Bactrim DS (sulfamethoxazole, trimethoprim) and Benadryl (Diphenhydramine hydrochloride) as treatment. Causality is assessed as possibly related for all events. The events of erythema, peripheral swelling and feeling hot may suggest cellulitis, however, collaboration criteria for cellulitis at injection site could not be assessed due to insufficient information provided.
Allergic- Hives, tachycardia, shortness of breath.  Asthma exacerbation. Elevated D. Dimer.
On the day of the vaccine I had chills, very prominent chills and they lasted for about 24 hours. I self medicated with Tylenol and Ibuprofen at home. Had some muscle aches as well.
per mother of patient , he developed redness and a subcutaneous bump on his L thigh in the location of ProQuad injection. Reaction began the day after vaccination and has then slowly decreased in redness and size of bump.
sleep paralysis, extreme fatigue, dx poss narcolepsy; major sx ended JUN89; fatigue cont despite excellent diet; high fever  & extreme fatigue in DEC87 lasted about 2 wks;
arrived to recovery stopped vehicle and became pale diaphoretic. pt stated and loopy. Assessment pt very diaphoretic, pale, no LOC near syncopal episode - N/V. able to answer questions. L Deltoid site benign. ice pack to back on neck, water to hydrate, medical called to assess. Pt stated he had not eaten all day. no further orders from medical. VS 122/70, HR 76 reg, Resps 16 reg non labored, SP 02 97%. After 5 min color back to facial area, stopped sweating was AAO. Refused to stay 30 min left 20 min stated I feel fine I would rather go. Explained V-safe site, OK'd to exit. RN
Fever 101.8, body aches, elevated heart rate 126 bpm. Symptoms cleared after 24 hours
Fever 102 degrees, nausea, diarrhea from 8/24/12 till current. Nurse notified & will have pt. go in for check.
pt recvd vax & devel shingles (herpes zoster) which later subsided;
Received Pfizer COVID 19 vaccine booster on 9/30/2021 at 11:50.  2 hours later, she noticed a HA. She took Tylenol with partial relief and was able to work the rest of the day. When she woke up the next day at 6:20 AM, she noticed swelling on both sides of her face in the maxillary area with the right side being more swollen than the left. She also noticed swelling in her lips and her nose feeling congested.  Denies any throat tightness, dysphagia, SOB or wheezing.  No lightheadedness or dizziness.  The facial/lip swelling and nasal congestion gradually resolved over the following 1-2 days.  4 days later (10/5/2021) she woke up with an intense cramp in her left calf.  The following day, she noticed a cramp in her right calf. The cramping has continued and is worse on the left side. She has also noted some mild swelling in both calves, left >> right.  She denies any redness in her legs or pallor in her feet. Reports prior h/o cramps in her feet that were much milder but no prior leg cramps.  US doppler to rule out DVT of bilateral lower extremities was negative.
The morning after my second shot, my blood pressure dropped to 110/60 and I was very dizzy and lightheaded.  It took me 5 hours to get it up to 115/70
Received both doses at 16 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both doses at 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Autoimmune disorder.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both doses at 16 years old). In 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both doses at 16 years old) had resolved.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-308656, MOD-2021-299882, MOD-2021-299844, MOD-2021-308669 (Patient Link).
Non-stop body aches for the past 16 days.  Headaches at least once per day lasting a few hours per day, without prior history of headaches, still occurring.  Chills for 2 days afterwards.  Constant fatigue since getting the vaccine.  CDC will not accept my comments.
Itch. Rash. Prickly feeling. Looked like hives trying to form on arms and thighs. Took Benadryl immediately in the car . Took another Benadryl after another half hours because rash was worse. Took Tylenol PM for 2 nights. Took one Benadryl Sat and Sun afternoons. Called dr. to ask about second shot. Reported to vsafe.cdc daily . Still feel very sluggish and nauseous, but rash  very slight since Weekend.
Itchy upper limbs; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy upper limbs) and RASH ERYTHEMATOUS (Red rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Itchy upper limbs) and RASH ERYTHEMATOUS (Red rash). At the time of the report, PRURITUS (Itchy upper limbs) and RASH ERYTHEMATOUS (Red rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Suspected vaccination failure/Vaccinated about 5 years ago, Aug2021 had Shingles; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix about 5 years ago and in August 2021, he had a case of shingles. The patient did not had information on the dates of 1st and 2nd dose. On an unknown date, symptoms resolved. The patient wanted to know if there was any information on patients taking antivirals or anti-leukemia drugs and the effect of that on vaccination. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation were unknown at the time of reporting. The reporter consented to follow-up.