chrisvoncsefalvay/vaers-outcomes huggingface dataset:
whole body pain; sore throat; feels like her glands are swollen; body temperature reached up to 99.5 to 105.5; body temperature reached up to 99.5 to 105.5; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 18Mar2021 for COVID-19 immunisation. On an unspecified date, the patient experienced whole body pain, sore throat, feels like her glands are swollen, and body temperature reached up to 99.5 to 105.5. Therapeutic measures were taken as a result of body temperature reached up to 99.5 to 105.5 which included paracetamol (TYLENOL). The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports that within 3 hours she had tingling in arms progressing to pain in arms and legs and body aches. She reported that 48 hours post injection that the symptoms were much better, mostly resolved except for soreness at injection site.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 18-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
About 45 min after vaccine was given, patient felt dizzy, lightheaded & states "not ok".  an hour later feels more lightheaded & almost fainted,  was pale & diaphoretic.  Given Benadryl 50mg P.O. & to be followed on the next shift. Benadryl order 3x daily for 3 days  patient was called to medical but refused to be seen
Information was received on 30-JUN-2017 from a medical assistant regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients received improperly stored PNEUMOVAX 23 (lot # M037669, exp date 09-MAY-2018), PEDVAXHIB (lot # N000235, exp date 26-OCT-2019), VAQTA (lot # L017757, exp date 08-APR-2018), ROTATEQ (lot # M041765, exp date 05-MAY-2018; lot # M031807, exp date 02-APR-2018), GARDASIL 9 (lot # N000326, exp date 14-OCT-2019; lot # M43731, exp date 22-JUN-2019; and lot # N002720, exp date 12-MAY-2019), RECOMBIVAX HB 2.5/0.5 (lot # M039642, exp date 03-JUL-2019), and MMR-II (lot # M040558, exp date 03-OCT-2018; lot # M035389, exp date 02-AUG-2018). Temperature and time frame: 36 degrees Fahrenheit to 46 (46.4F) degrees Fahrenheit for 30 minutes. Previous temperature excursion? 22-MAY-2017 47 degrees Fahrenheit to 77 degrees Fahrenheit (55F) for 2 hours and 30 minutes. Was call because of a "data logger"? No. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tiredness
Initial unsolicited report received from a pharmacist on 29 September 2015. This case involves a 68-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI459AB, expiry date: 30 April 2016, dose and dose in series were not reported) intramuscularly in left deltoid on 29 September 2015. The patient's illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known allergy. Concomitant medications were not reported. On 29 September 2015, few minutes following the vaccination, the patient felt dizzy, shaking and cold. The patient had received many doses of FLUZONE HD previously. Laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received from a pharmacist on 02 November 2015. No new information reported.
This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 19-AUG-2016, the patient inadvertently was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II lot # K010319 with expiration date of 22-JUL-2016 (dose, route and anatomical location were not reported). No concomitant medications, adverse effects or product quality complaints were reported. Additional information has been requested.
Pt returned for 2nd dose 5/24 but was turned away due to allergic reaction.  Pt reported Dizziness, tongue swelling after first dose on 5/3.  Timeframe for development of allergic reaction is unclear.  Unknown if patient took any rescue medication.
This case was reported by a nurse via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not take temperature. The patient's wife said he was very hot. The reporter thought it was vaccine related. The reporter was agree to follow up from GlaxoSmithKline. This case was linked with the case US2018GSK178688, reported by the same reporter.
This case meets criteria for vaccine breakthrough review. Patient admitted for abdominal pain,  asymptomatic for COVID at time of admission but now worsening cough and "winded".
This spontaneous report as received from a nurse via company representative and refers to a 16 year old male patient. Patient's medical history and current conditions were not provided. On an unknown date the 16 year old male patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. No adverse effects were being reported. Additional information has been requested.
?Covid Arm?  - a 3 inch wide welt near vaccine site on left arm that itches , burns and is painful to the touch.
Enlarged painful liver. Low grade fever, joint swelling and pain, nausea, fatigue.
Information has been received from a registered nurse concerning a 14 month old male who on 11/30/01 was vaccinated with a dose of measles virus vaccine live. On 12/1/01 the patient developed a systemic rash described as "rash red pin prick, dry scaley." The rash started on the back and moved to the trunk. On 12/3/01 it was reported that the patient continues to have a rash. It was noted that the patient was afebrile. The patient sought unspecified medical attention. There was no other information available. Additional information has been requested.
430AM pt devel fever & vomiting t101.4 o; pt had chills earlier; given equate-temp went down 930 + up-vomiting- more equate given; 1030 temp down; rt arm is tender to touch & warm; mom does not find a knot;
The patient complained of pain/tightness in between his shoulder blades/upper back the following morning after receiving the Shingrix vaccine. He played golf that day for 3 days after. By the same afternoon (8/4/19) his left arm and side were sore. His middle two fingers were numb. His back was still sore. He went to the ER and they ran tests and a EKG to rule out heart issues. His diagnosis was 'muscular-skeletal.' On 8/5/19 to today (8/8/19), his inner elbow and middle 2 fingers are still numb. He will followup with his family Dr when he returns home.
This case was reported by a consumer and described the occurrence of white stools in a 70-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included cancer. Concurrent medications included Pravastatin, TOPROL, Multiple vitamins, NIACIN, Baby aspirin, Fenofibrate, Captopril + hydrochlorothiazide, Fish oil, NORVASC and Coenzyme Q10. On 11 November 2010 at approximately 12:00 the subject received a dose of FLULAVAL in the left arm. On 12 November 2010 (at approximately 03:00), 15 hours after vaccination with FLULAVAL, the subject experienced nearly white stools. She reported that her stools were lighter in color. At this same time, she experienced a swollen right wrist and wrist pain. The nearly white stools resolved within the same day, 12 November 2010. Stools lighter in color, swollen right wrist and right wrist pain resolved by 19 November 2010. The consumer noted that she thought that the wrist condition was arthritis, but then it went away after a week.
Patient came in for second dose, of Pfizer covid 19. He recieved 0.1 mL dose vs 0.3 mL dose. No adverse event noted.
I had my vaccination on 10/15/2022. I started to have pain on my right abdomen on 11/22/2022. This lasted for a few weeks. I went to the emergency room on 12/05/2022 as my blood pressure systolic number was 22/102 and pulse was 104. I was given an IV with blood pressure medication and tests were executed. All tests were negative and I was discharged home. I was given a prescription for blood pressure. On 12/16/2022 for a follow up with my primary physician and I am scheduled to see them in 03/2023 for a follow up.
rt arm upper inner aspect +erythema, +warmth non-tender;negative induration;10cm x 5cm area;negative upper arm edema;
Redness, swelling around injection site. 5 1/2 in x 2 1/2 in area (5 1/2 in down and 2 1/2 in across).
1 hr after receiving injection c/o headache, neck, arm and back pain. Symptoms increased as day went on went to Emergency Room. Temp 103 degrees.
Red, half dollar size, raised, non-itchy, non-painful but sore welt located on the back of the left arm.
Patient felt lightheadedness and headache after shot. Put pt up for legs elevated, patient felt better instantly,. She was monitored for an extra 10 minutes until symptoms subsided. Patient left with mother
17-year-old patient received the first dose of Moderna Covid-19 vaccine; A spontaneous report received from a pharmacist concerning, 17-year-old female patient who has received the first dose of Moderna COVID-19 vaccine    The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    On 01-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Reporter stated that a 17 year-old patient received the vaccine. No further information was provided. Treatment information was not provided/ unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.    The outcome of the event was considered resolved on 01 Feb 2021.; Reporter's Comments: This is a case of 17-year-old female patient who was administered mRNA-1273 (product administered to patient of inappropriate age) (Batch #: unknown). There was no associated adverse event reported  for the event of product administered to patient of inappropriate age.
pt recvd vax;devel "viral type rash that looked like roseola;fever of 104;fever 5 days before rash & mild fever 1 day before rash;
High fever for 2 days with rashes, treated with moldrin and Tylenol. 2nd reaction 6 days after the vaccines with no fever, but severe rashes lasting 5/6 days, treated with Benadryl for 2 days prescribed by doctor, but no changes.
Same day post vax, the pt experienced stomach pain and discomfort, aching muscles, headache, weakness, and dizziness. There was no fever and all other vital signs were normal. The pt was advised to take acetaminophen and increase her fluid intake.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-FEB-2012, the patient was inoculated with ZOSTAVAX by the physician 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 or shingles. On or about 12-JUL-2016, the patient was treated by the physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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.
Patient up to date on COVID vaccines who admitted with hypoxia and COVID detected PCR.  Provider d/c note:  "patient came in with increased SOB. He was found to have COVID pneumonia and COPD exacerbation.  He required oxygen initially.  Patient was noted to have an elevated D dimer.  Patient was weaned off his oxygen quickly.  He was discharged home.  He was sent with his inhalers from here as he has no medication coverage.  Pulmonary saw him and recommended an echo as there was some question of fluid overload.  This was not done and could be ordered as an outpatient.  The patient was not very compliant with care because of this.  Patient was very anxious to be discharge.  PFTs were also recommended after discharge and would need to be set up.  Patient would benefit from a LDCT yearly. Would benefit from checking for alpha 1 antitrypsin."
Patient developed a rash all over her body and felt warm to the touch. Benadryl administered after.
This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (couldn't taste it) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AGEUSIA (couldn't taste it). At the time of the report, AGEUSIA (couldn't taste it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI
Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (strength and route were unknown; lot# N034558, expiration date 05-DEC-2019) and properly stored sterile diluent (MERCK STERILE DILUENT) (lot# N031941, expiration date 03-AUG-2020) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine was stored at 14 to -10 Celsius degrees for 15 minutes, -9 to 8 Celsius degrees for 5 hours and 45 minutes and 9 to 25 Celsius degrees for 3 hours. Data logger was involved. The previous temperature excursions were -14 to -10 Celsius degrees for 30 minutes, -9 to 8 Celsius degrees for 25 hours and 9 to 25 Celsius degrees for 17 hours. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1810USA006601:
LVN witnessed "seizure like activity" within seconds of receiving vaccine. Lasted 20 seconds. No loss of bowel or bladder continence. Emesis x 1. Blank stare and fatigued after episode. Prior hx of syncope with previous vaccines/injections.
Chills and headache about 9 hours after injections Headache baby aches fever 102.6  about 10 hours post injection. Vomiting started and midnight and all throughout the day. Went to urgent care around 4 pm. Given anti nausea medicine and iv for dehydration
Fever, chills, pain at site of injection, swollen, warm to touch. Happened about 12-14 hrs later. 10 day antibiotic of Clindamycin 300 mg he thinks for cellulitis.
Approximately 6 hours after injection, injection arm (shoulder to elbow) experience severe pain and unable to use arm due to severe pain when trying to use.  I was unable to work or do normal functions. Pain relievers were used, but had no effect on pain. After 48 hours from injection, still suffering with pain but does seem to be decreasing now.
Left upper arm reddened and swollen the next morning when this client woke up for the day.  Mom monitored arm throughout the day.  Mom monitored arm over the next couple days before she called me and reported the reaction.  Advised mom to take her to her provider.  Mom called me on 5/20/2013 and stated patient was seen by the doctor on 5/17/2013.  Doctor had no concerns other than it was a normal reaction to vaccinations per moms phone statement.
Fever of 100.4 Degrees F. Muscle Swelling/Inflammation throughout body. Fatigue. Vertigo/Dizziness. 3/9 (31 Hours from Vaccination time) Fatigue and inflammation exist throughout body but temperature has normalized to 98.5 Degrees F.
Rash on arm in area by shot injection (Covid Arm) hot and itchy at times.
pt recv vax 2OCT96 & 3OCT96 lethargy, loos of appetite, c/o migraine h/a, dizziness;took med-vomiting x 10;4OCT96 vomiting, h/a less, syncopal episode & dizziness;c/o neck pain since syncopal episode;saw MD;feel weak & ankle swelling;
1 of 3 pts (out of 200 pts vaxd) who exp a red swollen arm; the edema extended below the elbow; treatment included APAP Q 4 hrs & warm soaks @ the site; pt recovered;
Pt received varicella vaccine 3/17/2006 on 3/23/2006 had red streak marks on right side with severe pain PCP told mother having reaction to vaccine.
Patient was given vaccine that was over 24 hours in room temperature. Patient will follow up with primary care doctor.
12-15hrs after injection, general fatigue, loss of appetite, and minor aches treated effectively with IBU, APAP, and sleep.  The second morning, itching sensation on forearms with ~6 minor welts forming on right fore arm. 18month prior, had a sever exposure to poision oak treated with high dose prednisone. Forearms were very red, welts, and itchy. Itchy sensation occurs occasionally with exposure to hot shower water, but only transient. Post vaccine, much more severe itching sensation with formation of small (<2mm) hives. Fatigue had subsided by this time.
Patient fainted at cheerleading practice and was transported to ER.  Patient continued to lose consciousness, shake, become extremely agitated and could not walk.  She complained of prickly feelings in legs.  Patient was admitted to hospital for further tests for 3 days.  Patient gained back use of legs during the last two days in the hospital.  Patient still is having dizziness and is seeking further treatment.  10/15/2007 MR received for DOS 8/21-23/2007 with D/C DX: Syncope.  Conversion Disorder.  Child had syncopal episode preceded by dizziness and lightheadedness.  Was passed out for 15 minutes.  (+) anxiety.  Had several syncopal episodes in the ER.  PE was WNL.  Per 60 day follow: The patient has been advised to not get the 2 remaining GARDASIL vaccinations. Possible medication induced long QT.
Hives all over my body from the tip of my toes to the tip of my scalp Swelling on lips and inside my mouth Chest pressure Paleness Occasional Cough
This case was received from a health care professional on 09 June 2008.  A five-year-old male patient with a history of asthma, chronic ear infections, and sinus infections, received his fourth dose of ACTHIB (lot number UE190AA; sanofi-pasteur SA lot number X0378-2) on 17 June 2004.  Concomitant medications included ALBUTEROL, FLOVENT, VERAMIST, SINGULAIR, and PRN STEROIDS.  He had previously received the following doses of ACTHIB: dose three (lot number UA8777AA; sanofi-pasteur SA lot number W1480-2) on 09 September 2003; dose two (lot number UA846AA; sanofi-pasteur SA lot number W1014-2) on 03 July 2003; and dose one (lot number UA812AA; sanofi-pasteur SA lot number W0878-2) on 01 May 2003.  He had a titer drawn on 01 May 2008, and the results were less than 0.15.  No additional information was provided. Follow-up information was received 11 August 2008 from a health care professional.  The reporter confirmed the patient had no illness at the time of vaccination and no additional medically significant information was provided at the time of the report.  Follow-up information was received 11 September 2008 from a health care professional.  In response to a query asking if the patient had an underlying condition which prompted the physician to test his HIB titer, the reporter answered, "No - later done by allergist."  As a result of the decreased titer, the patient received a subsequent booster dose on 09 June 2008.
Extremely painful when nurse was giving the shot. The nurse stated that it was difficult to push in the serum. The arm site was sore and had  pain in the right shoulder joint. Also had fever the day after her shot. She complained of loss of range of motion in the right arm and pain the was waking her up at night.
cough, facial flushing/edema, wheezing, SOB epiphora.
Patient was given one dose J+J vaccine about 8 minutes after injection- he felt weak and slumped a bit in his chair. In addition to this he felt pain in Right Pectoral Muscle. Patient was noticed with pale and diaphoretic appearance but within few minutes felt better with increased ventilation and cold compress.
I personally didn't witness the event, but a coworker reported that patient fainted after getting vaccine. Patient was shopping the store after receiving vaccine and while shopping, patient fainted. I was told after couple minutes, patient was feeling fine and continued with her shopping.