chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fever cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
the patient is experiencing an ear ache; patient being sleepy; This is a spontaneous report from a contactable consumer. A 88-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: EW0170) as single dose vaccinated at the age of 88 years old for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the patient is experiencing an ear ache and sleepy on 21Apr2021. Caller reported that the lot number on her Covid-19 vaccine was EW0170 and that the patient probably had the same lot number for her Covid-19 vaccine since the caller and the patient got the vaccines at the same location on the same day, 20Apr2021. The patient does not take any medications at all and is a very healthy woman. Caller reported that the patient does not take a single pill. Caller reported that because the patient does not take any medications, it is probably the reason why the patient's body acted the way it did. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 18-Oct-2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event. No Concomitant information was reported. No Treatment information was reported.
Approximately one week post injection developed injection site redness and warmth as well as axillary, posterior cervical, and supraclavicular lymphadenopathy on the side of injection.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        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.   No concomitant medications were reported. No treatment related information has been reported.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up information received on 12-Apr-2021 contains non-significant information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-JAN-2015, the patient was inoculated with the ZOSTAVAX vaccine at physicians office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster, also known as shingles. Later in 2015, he was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt c/o feeling nervous, anxious and hot. V/s taken @ 12:05 and Doctor was informed of pt's sx's and v/s. Re-check pt's v/s again @ 12:33 pm. Pt reporting feeling better and was D/C @ 12:46 w/instruction to F/U w/PCP for F/U on HTN. and to monitor for the next 4  hrs if she worsen to
Vaccinated: 9:25AM Reaction: 9:27AM Pt reports syncope, vision changes <2 minutes, fainting, anxiety, buzzing in ears Vitals: @9:30: 108/55, 64, 14, 100% O2 -> @9:35: 108/54, 66, 14, 100% O2 -> @9:47: 111/71., 68, 14, 100% O2 Pt was given orange juice, graham crackers, water as patient had not eaten today, states feeling much better after intake. To inform PCP of today's events. Patient was stable and released from vaccination site.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of right jaw pain and chest pain 3/10. Her jaw did appear to look swollen as well. She was sent to the ED
Information has been received from a physician concerning a 41 year old male, with no medical history and no allergies, who, three weeks ago, on approximately 1/31/2006 was vaccinated with a dose of varicella virus vaccine live. there was no concomitant medication. It was reported that the patient came into the office with approximately 50 varicella like lesions, described as pseudovesicular on the anterior and posterior trunk, neck, and proximal lower extremities that were bilateral and diffuse, that appeared on 2/18/2006. The patient also had fatigue and left eye conjunctivitis. It was noted that the patient was to see an ophthalmologist. VZV cultures were done on the patients lesions by the physician. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. The patients reaction was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Information has been received from a physician concerning a 45 year old female with a history of three shingles outbreaks (two in early 2006 and in in May 2006) and no allergies or other medical history who on 7/1/06 was vaccinated SC with a dose of varicella Zoster virus vaccine live. It was noted that a physician gave the vaccination to boost the pts immunity. On 10/13/06, the pt experienced a fourth outbreak of shingles. The pt experienced less pain and the outbreak was less severe than the first three outbreaks. She was treated with triamcinolone Acetonide (Kenalog) 1cc and Famciclovir (Famvir) 500 mg TID since 10/13/06. No diagnostic lab test were preformed. At the time of the report, the pts case of shingles was less severe and she was recovering. A product quality complaint was no involved. Shingles was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Information has been received from a nurse practitioner concerning a 35 year old female, who on 20-OCT-2008, was vaccinated with the first dose of GARDASIL. On 21-OCT-2008, the patient's legs were itchy and she also developed tearing, itchy eyes and her throat felt swollen. The patient said it was similar to the reactions she has when she is around cats. The patient was seen in an office visit. Additional information has been requested.
Blood clot running from ankle to groin; entire leg swollen; still swollen after 6 weeks; received shot of heparin and put on Xarelto; blood clot was just short of where it could break off and go to heart or lungs.
1600:  Noted patient fanning herself with paper.  I approached and asked how she was feeling.  Pt stated she felt dizzy and hot.  Pt was given water, pt initially declined to lay on gurney in procedure room, but then changed her mind.  Pt was able to ambulate to procedure room without assistance.  Steady gait noted.  Pt was given juice and crackers as well.  Pt reported she was feeling slightly better as soon as she laid down.  Pt also reported she would be starting her menses in the next few days and she had not eaten well today. Has been having intermittent dizziness since this morning.  Pt stated she was nervous aobutNo rash, angioedema, difficulty breathing or throat closing sensation reported or noted.  Will continue to monitor. 1615:  Pt reports dizziness has resolved, continues to to feel hot though that has also improved.  Pt states she just started having abdominal cramping 7/10 on scale, constant.  BP 145/85 HR 67 SpO2 99% RA.   1624:  I have contacted Dr. and given report on patients complaints and vital.  Per Dr, pt will be kept in observation another 15-20 minutes and if she is feeling better she may be discharged home, if her condition does not change she will sent to urgent care. Read back completed.   1630:  Pt reports she is feeling better.  Cramping is now intermittent.  No other symptoms reported at this time.   1640:  Pt reports cramping continues to improve is almost resolved.   1643:  Vitals rechecked.  BP 111/76 HR 74.  Pt denies any symptoms at this time. 1647:  Pt discharged home. Pt was instructed to keep paperwork (EUA and What to Expect After Your Covid 19 Vaccination) in a safe place and to refer to it if she developed any sxs of severe allergic reaction such as swelling of the tongue, throat, face, difficulty breathing, SOB, generalized rash, abdominal pain, vomiting, dizziness and / or palpitations. In which case she should seek immediate medical attention.  Pt verbalized understanding and left in stable condition without any complaints of any symptoms.
An 18 month old male was enrolled in a open label study (208109232) for prophylaxis treatment of hepatitis A, had received a fourth intra muscular injection of ActHib, lot number UA858AA (SA lot number W12932), in the right lower thigh and a fourth intra muscular injection of another manufacturers diphtheria, tetanus, acellular pertussis vaccine (Infanrix lot number DTPA592A9), in the right thigh on Jan 15 2005. He also received a subsequent intramuscular injection of another manufacturers hepatitis A vaccine Havrix, batch number VHA776A2, (site not reported) on Feb 28 2005. On May 24 2005, four months after the fourth dose of Infanrix, four months after the fourth dose of ActHib, 85 days after the first of Havrix, this 18 month old subject was observed to experience delayed expressive language abilities. On Oct 26 2005, the child was evaluated with a cognitive delay of eight months of age, receptive delay at ten months level and expressive delay at thirteen months level. Per the reporter, after test results, it was decided to withdraw the subject from the study. The investigator considered that there was a reasonable possibility that the delayed expressive language abilities may have been caused by Infanrix, ActHib and Havrix. Per the reporter, this case is also linked to case B0400912A (twins) who suffered the same SAE. No information was received concerning the linked case with this report. The subject had recovered at the time of this report.
Pt recv vax on 2/22/99; on 2/25/99 pt exp cough, achiness, flu-like sx of chills, fever (102.4), exhaustion, legs felt like rubber; tx=Zithromax, Durahistine
States 1 1/2 hour after vax right arm began to swell and cause pain. No redness (swelling from deltoid to elbow) no fever. Took Ibuprofen without relief.
Reaction to the vaccine; This spontaneous report as received from a current 71-year-old female retired public health nurse on 05-OCT-2021.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (dose regimen details, indication, lot # and expiration date were not provided).         On an unknown date the patient experienced a reaction to the vaccine.The outcome of the event. Causality was considered related. .
sore, stiff neck w/immobility & tight jaw (causing difficulty w/oral intake) on 2nd day following vax also sore arm & low grade fever; neck & jaw sx wax & wane for 2 wk;
10/5/15 > got Flu vaccine, felt hot immediately then it was difficult to talk and hard to breathe. Epi given and brought to the ER. Prednisone and BENADRYL given in ER. Rx for prednisone 60 mg for 3 days. Seen by Dr in Employee health 10/7/15 and asymptomatic.
Fatigue, fever of 100-102, nausea, dizziness, headache, body aches, foggy thoughts.  Fatigue started about 12 hours post injection.  All symptoms are still present 48 hours post injection.
Swelling in right arm, warm to the touch, some redness noted and hives broke out to torso and arms. 25 mg of Benadryl given at Urgent Care and rapid strep test performed.
Within 24 hours of vaccine suffered shortness of breath then next day numbness tingling in injection site shooting down arm, area got extremely red, hot, inflamed and spread through the shoulder region on 9/29/21. Went to an urgent care once it began to spread on 9/30/21 where I was diagnosed with adverse reaction to vaccine product and cellulitis. Was prescribed betamethasone DP AUG 0.05% Cream and Cefadroxil 500 MG capsule for 7 days 2x a day.
Woke up with real bad muscle spasm in her right leg. She stated it felt like a golf ball behind her right knee. She had those spasms for about 2 days.  She found herself sleepwalking and having night terrors.  She had the shivers for about 2 days. She also had headaches for a few days
Vaccine done at (Emp. Health) due to an egg allergy. Normal soreness day of vaccine however the following evening soreness increased to pain with swelling (65-70mm) and redness. Reported next day to Infection Prevention seen by her and referred to Emp Health. They Dx cellulitis and Rx clindamycin 300 mg 3xday x 10 days.
Client tolerated vaccines well when administered.  After sitting for approx. 2 minutes post vaacination, client stood up and walked toward door.  Mom asked me a question and when I turned around, client fainted and fell face first onto floor.  Client caught himself with hands underneath him.  Episode lasted less than 1 minute.  Client states that he hit his head on the door when he fell, motioning to the back of his head.  No raised area or bleeding noticed at site.  Observed client for approx. 15 minutes.  Client ambulated from clinic with mother at side without difficulty. Instrusted mother to monitor client for signs of headache, dizziness, nausea or vomiting and any other complaints.  If needed, mother will proceed to ER.
pt returned 1 hr & 35 mins p/vax c/o nausea & dizziness; daughter-in-law stated that pt had been c/o arm hurting and becoming numb & tingling, prior to returning to ER;
Valor?s right shoulder has swollen up, there is about a 3 in circle of raised red tissue.  The tissue and muscle feels tight/hard and it is hot to the touch.  We noticed this about 24 hours after the vaccine was given.   I have called  Dr. office to report the Adverse reaction to the vaccination. They said to come in if it is not better by tomorrow.
just little bit soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 14Feb2021 (Lot number: EL33) at the age of 70 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "just little bit soreness at the injection site".  No follow-up attempts are possible. No further information is expected.
Patient wanted Janssen vaccine 0.5ml but Pfizer vaccine 0.5ml was given.  Patient did remain at the pharmacy for 30 minutes no adverse reactions reported
nearly 48 hours after vaccines, woke with marked swelling of axillae bilaterally, more on L than R, but more induration at vaccine site on R.  No systemic symptoms.  Was given benadryl.  When examined 48 hours later, was reported as improved, but still marked axillary swelling, with palpable lymphadenopathy on L, induration of vaccine site on R.
Fever; Aching; Generally feeling bad; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix. In May 2019, 1 day after receiving Shingrix, the patient experienced fever, pain and feeling bad. On an unknown date, the outcome of the fever, pain and feeling bad were unknown.   It was unknown if the reporter considered the fever, pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced fever, aching, and generally feeling bad after receiving Shingrix. The health care professional noted that the events began the next morning after the vaccine was given.  The fever was described as low grade.
Patient is a 31 week pregnant who received depo provera medroxyprogesterone instead of TDAP vaccine.
FEET SWELLING; lethargy; fever; soreness in shoulder near injection site,; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (FEET SWELLING), LETHARGY (lethargy), PYREXIA (fever), ARTHRALGIA (soreness in shoulder near injection site,) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (FEET SWELLING), LETHARGY (lethargy), PYREXIA (fever), ARTHRALGIA (soreness in shoulder near injection site,), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (FEET SWELLING), LETHARGY (lethargy), PYREXIA (fever), ARTHRALGIA (soreness in shoulder near injection site,), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided.  Treatment information not given.
Sever fever, chills, body ache, joint aches, head ache, fatigue, weakness.  I feel like I have a bad case of influenza. Tylenol, motrin.  Still ongoing
Head ache, nausea, injection site is swollen, hot, tender (FYI - I did note that the injection was given IM and not subq as per directions.)
Pt. had a varicella SQ injection left arm .  Localized red, warm, swollen reaction
Hives - initially under arm on side where I previously had radiation.  By 12/19/15, I had red rash behind knees and under both arms.  By 12/20/15, I had about 6 inches of raised red rash on tops of both thighs.  I treated with topical and oral OTC antihistamines.  Rash is still present on thighs today (12/30/15), but receding, darker brown, less raised.
immediately after getting flu shot , patient said to her mom "i think i am going to faint" ,went unconscious and her mom assisted her to the floor where patient looked to have a seizure for seconds then vomited and regained consciosuness. emergency personnel  checked patient out . bp 120/80 and glucose 80 . emergency  personnel then escorted patient to er for further evaluation.  patient did walk out of store on her own.
Pain at injection site and swollen glands. Next day: a lot more pain in upper arm region, swollen, red, hard lump on upper arm, very tender, painful with any movement of arm. Throughout the night: high fever, chills, stiff and aching joints, vomiting, dizziness malaise and fatigue.
(1) Body aches, head-to-toe, (2) body shivers and teeth chattering, (3) Feeling hot after taking 2 ADVIL 19 hours after injection.