chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm swelled significantly red area > 10 cm. Malaise, loss of appetite. Temperature of 101-102 degrees 1-2 days later lump in arm for 3 weeks.
April 22, I started out the day with fatigue I noticed around 9am (the day after my 2nd shot). That quickly progressed into chills. Then throughout the day progressed into constant extreme chills,  body aches, swimmy head, dizziness, extreme weakness, headache and fever (100 degrees). Slight nausea toward the evening. I didn't take any medication for the symptoms. Went to sleep around 8:30pm and woke up around 7am April 23) feeling much better. Still slightly weak and tired but no other symptoms.
Increased irritability and feeding difficulties following administration of vaccine (had a similar reaction after the first dose of the vaccine at 2 months).
Per individual, received dose 1 of Moderna Vaccine on 1/7/21 at workplace clinic. 'Over weekend' experienced a 'body rash' (fine red points/petechiae)that encompassed trunk area of body and became increasingly uncomfortable along with sense of nausea and continuous sore arm at site of injection. Patient states use of benadryl has helped with the discomfort of the rash however when medication wears off, itching begins again. Denies any respiratory affects requiring emergency intervention at this time. Patient able to perform duties at workplace. Patient was instructed to talk with the Employee Health Nurse regarding situation.
Horrible leg cramps multiple times a day 1 week after first shot; Restless leg syndrome multiple times a day  1 week after first shot; Numb Legs multiple times a day  1 week after first shot; Can not sleep at nights multiple times a day  1 week after first shot; Sick as a dog for 2 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Horrible leg cramps multiple times a day 1 week after first shot), RESTLESS LEGS SYNDROME (Restless leg syndrome multiple times a day  1 week after first shot), HYPOAESTHESIA (Numb Legs multiple times a day  1 week after first shot), INSOMNIA (Can not sleep at nights multiple times a day  1 week after first shot) and ILLNESS (Sick as a dog for 2 days after the first shot) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced MUSCLE SPASMS (Horrible leg cramps multiple times a day 1 week after first shot), RESTLESS LEGS SYNDROME (Restless leg syndrome multiple times a day  1 week after first shot), HYPOAESTHESIA (Numb Legs multiple times a day  1 week after first shot), INSOMNIA (Can not sleep at nights multiple times a day  1 week after first shot) and ILLNESS (Sick as a dog for 2 days after the first shot). At the time of the report, MUSCLE SPASMS (Horrible leg cramps multiple times a day 1 week after first shot), RESTLESS LEGS SYNDROME (Restless leg syndrome multiple times a day  1 week after first shot), HYPOAESTHESIA (Numb Legs multiple times a day  1 week after first shot), INSOMNIA (Can not sleep at nights multiple times a day  1 week after first shot) and ILLNESS (Sick as a dog for 2 days after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that he explained his side effects to his pharmacist and the pharmacist told him that his side effects are not normal that he should call Moderna. He declined providing the pharmacist's information. He states that his pharmacist told him that there are other patients whom received the Moderna COVID-19 vaccine and ended up with leg cramps and restless leg syndrome.          Patient states that he wants to take legal action and  requested the case number and MI agent provided it to him. Concomitant medication use was unknown Treatment information was unknown
fainted; mildly ill; couldn't stand on her own; flu-like symptoms; no appetite; heart rate of 116; sore arm; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 21-Jun-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SYNCOPE (fainted), VACCINATION COMPLICATION (mildly ill), DYSSTASIA (couldn't stand on her own), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HEART RATE INCREASED (heart rate of 116), MYALGIA (sore arm) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2021, Body temperature: 103 High and 101.6 High. On 20-Jun-2021, Heart rate: 116 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient temperature reached 103 degrees that fever was last measured at 101.6 (unspecified unit). The patient fainted around 3:30 AM, couldn't really stand on her own, had a sore arm, flu-like symptoms, nausea, no appetite, and a heart rate of 116 (unspecified unit). The patient heart rate was usually 60-80.  The patient took two ibuprofen that morning which lowered her fever, but did not feel much improved.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Right thigh increased circumference 12 5/8 in, lower right leg 8 3/4 in and ankle swelling, warm to touch with erythema.
Patient reported feeling faint, pale, sweaty & experiencing numbness in her left 4th and 5th fingers, muscle aches, and decreased BP and heart rate. She went to doctor who advised her to go home and rest.
20% overall energy reduction, abnormal sweating while walking in 60 degree weather, Abnormal Shortness of breath upon exertion , Tinnitus tone change, Intermittent occasional chest wall cramping  that goes away
patient is not currently experiencing signs/symptoms of a reaction; pacient receiving a dose of VARIVAX and PROQUAD; This spontaneous report was received from a registered nurse referring to a 3-years-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 01-SEP-2020, the patient was vaccinated with the first doses of varicella virus vaccine live (VARIVAX), lot# S024367, expiration date on 06-AUG-2021, in the right thigh, and measles, mumps, rubella and varicella virus vaccine live (PROQUAD) (albumin status rha) in the left thigh lot# S031704, expiration date on 06-APR-2021, both administered intramuscularly (strength and frequency were not reported) for prophylaxis (accidental overdose).   It was reported that the medication error did not occur due to product confusion. The nurse stated, "That a new nurse pulled the medication to be given;" and the medication error was likely due to the other nurse's inexperience with pediatric vaccines. Additionally, it was reported that patient was not currently experiencing signs/symptoms of a reaction to her knowledge (no adverse event). No additional details were provided.
Mom called to notify Health Dept. that child has water blisters on various parts all over body.
Mother states took child to hospital ER due to complaints of throat sore and scratchy feeling and complaints of burning/tingling feeling in extremities.  Was told in ER, allergic reaction to vaccines and was given prescription for steroid and told to give him Benadryl.
Patient woke up in the middle of the night due to her chin quivering and then noticed facial numbness, specifically the left side of her chin and lip. The left side of her jaw was numb and tingling. When she woke up this morning, she noticed that her arm felt heavy, numb, and somewhat tingly. As of late morning today, her arm is still a little tingly and numb. This sensation goes from the top of her arm to her fingertips, specifically her 4th and 5th fingers. She does not notice any facial paralysis or drooling and she was able to suck out of a straw this morning. She will notify her doctor and seek follow-up care if it does not improve.
went limp, pale w/circumoral cyanosis for few minutes (2-3) soon p/the shots;
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccine failure. On an unspecified date, patient did an antibody test and the results came out to be negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20211006267-Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a physician concerning the physician's daughter with not reported drug reactions/allergies and medical history who on 08-JUN-2009 was vaccinated with a first dose of GARDASIL (0.5ml, route unspecified). The physician stated that her daughter had a virus which resulted in a "post-viral tic" and she stayed in the hospital in Intensive care unit (ICU) for two days (from 18-JUL-2009 to 20-JUL-2009). The physician felt that the patient's virus was not related to the GARDASIL. The patient was recovering. Additional information has been requested.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 years old female patient with no pertinent medical history who on 25-JUN-2012, was vaccinated with the first dose of GARDASIL (route and lot# not reported). Concomitant therapy included prenatal vitamins. It was reported that the patient received the first dose of GARDASIL and subsequently found out she was pregnant. No treatment information was reported. LMP: 08-JUN-2012. EDC: 22-JUN-2012. EDD: 15-MAR-2013. At the time of the report, the patient's outcome was unknown. She sought medical attention per office visit. Follow up information was received from the nurse. She reported that this patient was seen in the office on 27-AUG-2012 and should have gotten the second dose of GARDASIL but did not get it because she was pregnant. The next day, 28-AUG-2012, she was seen for bleeding and it was reported that she miscarried that day. It was not reported if any procedures were done. Upon internal review, miscarriage was considered to be medical significant. Additional information is not expected.
This case was reported by a nurse via call center representative and described the occurrence of hives in a adult male patient who received SHINGRIX. The patient's past medical history included allergy. Concomitant products included Vitamins. On 27th April 2018, the patient received SHINGRIX. On 2nd May 2018, 5 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with BENADRYL and Calamine Lotion. On an unknown date, the outcome of the hives was recovering/resolving. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The hives were confined to the back between the shoulder blades and on the sternum. The patient used BENADRYL and calamine lotion and noted some improvement.
Information has been received from a nurse concerning a female with an allergy to aluminum hydroxyphosphate who was vaccinated with Gardasil. The patient developed blood in urine after receiving her second dose. It was unknown if she had any problems after her first dose. An ultrasound and tests to rule out urinary tract infection and kidney infection were performed. The patient did not have a kidney or urinary tract infection. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007.  Information has been received from a nurse concerning a female with an allergy to aluminum hydroxyphosphate who was vaccinated with Gardasil. The patient developed blood in urine after receiving her second dose. It was unknown if she had any problems after her first dose. An ultrasound and tests to rule out urinary tract infection and kidney infection were performed. The patient did not have a kidney or urinary tract infection. At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
5-6 jerking episodes w/in approx 1hr 15min following vax administration
Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 diagnosed prior to vaccination. Patient had no allergy to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ADDERALL and CLOMID for an unspecified indication on an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Mar2021 at 17:00, the patient experienced headache, fatigue and sore arm. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the headache, fatigue and sore arm was resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
pt recvd vax 22JUL94 & on 25JUL94 noticed swelling @ site of vax lt deltoid area, followed by tenderness, blister formation; no fever, no SOB; area erythematous, indurated, w/blister formation
Swelling and redness covering upper arm for 3dYs. Cold compresses, Zyrtec. Singular, ipubrophen
Excruciating headache, violent vomiting, diarrhea, Excessive sweating at first, followed by chills. Vomiting and diarrhea lasted about 12 hours. Severe headache lasted about 60 hours
Information has been received from a pharmacist, referring to (two) unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) for immunization. On unspecified dates, the patients experienced a rash around injection site after receiving the dose of ZOSTAVAX, and also developed 5 or 6 bumps around injection site. The reporting pharmacist recommended using hydrocortisone (manufacturer unknown) cream for the rash and when she followed up with patients, both patients reported that rash was resolved with the treatment. It was reported that the unspecified patients did not seek medical attention. The outcome of the 5 or 6 bumps around injection site was not reported. The causality between the vaccination with therapy with ZOSTAVAX and the events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Client received vaccine at 10am presented to PMD office at 2pm c/o arm pain, shaking and burning on bottom of feet. Temp 100.6 orally. MD DX with local reaction, tender to palpation with redness or swelling. was given Decadron IM. RTC this am for recheck arm improved, no fever.
retention of fluid, hypertension, vomiting, diarrhea, blood in stool, unable to urinate & abnormal ECG - DX with severe sepsis, tachycardia unspecified, hypokalemia & noninfective gastroenteritis & colitis. was in the hospital from 7/12/22 to 7/18/22 and discharged in fair condition.
Severe muscle aches and soreness of muscles. Fatigue and fever. I took ibuprofen and felt some relief.
Rhegmatogenous Retinal Detachment OD; nuclear sclerosis OU; Vitreous OU; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 04-JUL-2017, patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), patient experienced rhegmatogenous retinal detachment OD, nuclear sclerosis OU and vitreous OU. The patient continued to suffer and received treatments for her injuries As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of rhegmatogenous retinal detachment OD, nuclear sclerosis OU and vitreous OU was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling. Upon internal review, the events of rhegmatogenous retinal detachment OD, nuclear sclerosis OU were considered to be medically significant.
pt devel urticaria p/vax; several welts present over back, given DPH;
Nausea, vomiting, diarrhea. Pale and fatigued on exam. No vomiting observed in office. Temp rectal=97 degree F.
injection site erythema; blisters around the injection site; Injection site swelling; Injection site pain; This case was reported by a physician and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site blisters, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site blisters, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site blisters, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had no previous reaction to vaccination. After vaccination with Shingrix, the patient had local reactions. The patient asked if that was an allergic reaction and if she should get 2nd dose of Shingrix or not.
I had a intense headache, nausea & vomitting, body aches, joint pain and fatigue.
itchy rash resembling pityriasis rosea and diagnosed as such by me,  sudden onset itching at 36 hours after vaccine with progression of rash from buttocks to all over the trunk and extended to neck and extremities after 1 week
Five minutes after the vaccine was administered, my 11 year old son  was walking around. Then he fainted and hit the ground hard. Then he recovered and was ok, but he was dizzy and nauseous throughout the day.
Chills Body Aches Very Tired lasted 20 hours Left Arm Pain lasted 3 days 10 days after the vaccine I and other that were with me the same day developed a bronchial cough.
pt recvd vax & 8MAR95 8AM pt's rt thigh was red, swollen & warm to touch @ site of inj;pt was crying & screamed when picked up;high pitched & cont crying until 10AM;pt taken to MD who stated rxn to DTP-to have DTAP next time;would not walk
Patient experienced Nausea and Dizziness, BP 143/85 HR91 RR18, then repeat BP 130/83 HR91 RR18. Patient stable and released from vaccination site
Patient returned day after vaccination with notable swelling , redness, and warmth at injection sites. She reported it starting the day of vaccination.
After the 2nd shot I got a rash on my back to my chest and top of arms and feet. I went to my PCP and they prescribed me Steroids'.
experiencing full or pressure on her head; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Feb2021, the patient experienced full or pressure on her head and wanted to know if she could take Aleve because she didn't have Ibuprofen or Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
1/8 Friday: Developed sore arm and body aches about 3 hours after injection. 1/9 Sat: Worsening of arm soreness, body aches, Temp 100.6F 1/10: Sun: Arm soreness much improved, lingering pain to touch. No body aches or fevers. Overall felt well.  1/11 Mon: awakened with rash all over upper body (chest, back, upper arms), worse around injection site. It is itchy.
patient experienced fever, chills and swollen arm from shoulder to elbow. These symptoms lasted about 1 week