chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Freezing to death; Feels that it has ruined my life; I don't know when I will be warm again; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing to death), FEELING ABNORMAL (Feels that it has ruined my life), FEELING OF BODY TEMPERATURE CHANGE (I don't know when I will be warm again) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included INSULIN, Vitamin D and LOVASTATIN.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1.   On 14-May-2021, the patient experienced FEELING COLD (Freezing to death), FEELING ABNORMAL (Feels that it has ruined my life), FEELING OF BODY TEMPERATURE CHANGE (I don't know when I will be warm again) and PYREXIA (Fever).   At the time of the report, FEELING COLD (Freezing to death), FEELING ABNORMAL (Feels that it has ruined my life), FEELING OF BODY TEMPERATURE CHANGE (I don't know when I will be warm again) and PYREXIA (Fever) 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.
Janssen 5/25/21 and 12/24/21. Positive on 1/18/22
Seen in ER same day as vaccines were given. C/O Temp 102.5 at home.
discharge summary "Patient is a 72 YO female history of liver cirrhosis from NASH, hypertension presented with cough and malaise. Labs reveal AKI and COVID 19 +. She was admitted for COVID 19 and AKI management. During her stay, she received IVF that resolved her AKI. She was also placed on decadron for her COVID 19 infection. Social worker has given extra resources to help with her financial stress at home. She was discharged in stable condition. Strict return precautions given".
Patient reported that about 4 hours after the event, patient had pain in the injection site arm. Throughout the night, the arm pain became worse and worse and "radiated to his whole body". He treated the aches with acetaminophen, which he said helped. He said the pain was worse in the middle of the night because he assumed that the acetaminophen had worn off at that point. The day after the vaccine, he reports muscle soreness, but he claims he is starting to feel better.
pt recvd vax & devel fever & cyanosis; to er spinal tap & cxr; fluid on lungs; to MD 28aug cardiac sphincter conts w/ circumoral cyanosis;
Adverse events were more applicable in the second dose of this vaccination. At 22:00 a low-grade fever began. At 03:30 on 3/3 a fever of 102 degrees had been achieved. Left axillary lymph node swelled. Generalized body aches mostly in wrists and ankles occurred. For the duration of 3/3 102 fevers persisted while taking Tylenol and slept for duration of day. On 3/4 low grade fevers of 100 degrees were maintained. Nausea and diarrhea occurred, aches continued throughout body particularly in shoulders. Lethargy so severe couldn't stay awake for more than 20 minutes. On 3/5 fevers reduced down to 99 degrees. Vertigo occurred with dizzy spells and ataxia. Heart rate periodically elevating to 120-140s for hour long durations. Only able to sleep for 2 hours at at time because of waking up from tachycardic episodes. Panic attacks ensued due to tachycardic episodes. On 3/6 psychotic thoughts and hallucinations began. First, racing thoughts about irrational an incontrollable events began. "Will I be able to father children?; I will sell my car tomorrow to sustain myself.; etc." Visions of insects crawling down a mountain side, flowers with eyeballs, etc. Panic so severe couldn't close eyes and mind always racing.
This case was reported by a consumer and described the occurrence of altered vision in a 65-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  A physician or other health care professional has not verified this report.  On 23 October 2007 at 16:00 the subject received a dose of Fluarix in the left arm.  On 23 October 2007, the same day of vaccination with Fluarix, the subject experienced left eye vision changes, swelling all over, sickness in the stomach and neck tightness.  All events resolved on 24 October 2007 with the exception of sickness in the stomach which remained unresolved at the time of reporting.
Flushing of face, neck and ears; felt hot, throat felt tickly. No treatment; resolved itself after several minutes.
autism spectrum disorder; severe damages /unspecified damages caused by the MMR vaccine/damages are compounding with every passing day and week; This initial spontaneous report was received from a patient regarding a case in litigation referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was administered unspecified vaccines (dose, route of administration, indication, lot # and expiration date were not reported). Since 1988, the patient experienced severe damages done as a result of the immunisations. On an unspcified date, the patient experienced autism spectrum disorder. It was unknown if the patient received any treatment. The outcome of the events was not reported. The reporter considered the events to be related to suspected vaccines.  Upon internal review, the event of autism spectrum disorder was determined to be medically significant.  Follow-up information was received from the male patient via e-mail on 17-AUG-2021. On an unknown date, when the patient was a child, he was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). On an unspecified date (reported as since 1988 in the previous document), the vaccine caused unspecified damages to a patient. He reached a threshold in his life where his damages were compounding with every passing day and week.
2 evenings p/flu shot pt exp severe abdo cramping, some diarrhea @ about 8PM on both 17OCT & 18OCT; also needle-like pains from waist to knees bilaterally;
not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 07Apr2021, outcome "unknown", described as "not feeling well".  Additional information: The reporter stated that his wife was supposed to be scheduled today, 07Apr2021 for her second dose of the vaccine but could not make it because she was not feeling well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent (lot# M046369, expiration date 07-JUL-2019). The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date (also reported as on 07-AUG-2018), the patient was vaccinated with improperly stored VARIVAX (lot # N020016, expiration date 17-JUL-2019; dose and route were unknown) for prophylaxis. No adverse effects reported. The vaccine was stored at 9.9 degrees Fahrenheit for 45 minutes. There was no previous temperature excursion. A data logger involved. No PQC presented. The medical assistant called with a new temperature excursion which is ongoing. The medical assistant will call back when the vaccines are back in proper freezer range. The medical assistant confirmed that no further administration VARIVAX.
Flush and Red Face, headache, left arm sore Friday Night Saturday chills and flushed face and headache continues also cannot sleep on left side  Sunday same symptoms as Saturday  Monday headache and need to take rescue inhaler  arm still sore headache still with me body warm but no fever
PAIN BELOW THE INJECTION SITE; LOSS OF APPETITE; SHAKY HANDS; FLU-LIKE SYMPTOMS; SLEPT ALL DAY; TERRIBLE CHILLS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included osteoporosis, high bad cholesterol, and varicose veins. The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced shaky hands. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced slept all day. On APR-2021, the subject experienced terrible chills. On 06-APR-2021, the subject experienced pain below the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and pain below the injection site on APR-2021, was recovering from loss of appetite, shaky hands, and terrible chills, and the outcome of slept all day was not reported. This report was non-serious.
Information has been received from a Registered Nurse concerning a 59 year old female patient who on 08-Jun-2009 was vaccinated with the first 0.1 mL dose of RECOMBIVAX HB (Lot # 662115/1647X) intramuscularly. It was reported that on 08-Jun-2009, the patient experienced chills, feverish sensations, achiness and cough after receiving her first doe of RECOMBIVAX HB. The patient sought medical attention via telephone call. There were no laboratory diagnostic tests performed. It was reported that the patient would feel better each morning, but each afternoon the symptoms would return. It was reported that on 16-Jun-2009 the symptoms resolved. Additional information has been requested.
At 8:30 Pm I became nauseous, chills, severe headache, so weak I could hardly stand, ached all over really bad., also stuffy nose.  This lasted until the nest day around 4 PM. I wasn't able to eat but drank hot tea for 2 days.
Chills, headache, weakness, nausea, fatigue.  Moderate the first night, then waning for 4 days.
Patient did not have a vaccine card a 3rd dose of vaccine was administered medical assistant gave this vaccine as a second dose.
02/03/22 presents to EC ED for "Heart fluttering". PMHx of "DM, HTN, HLD, neurocardiogenic syncope, PSVT, and pulmonary HTN"
Water retention and swelling in legs below knee; Water retention and swelling in legs below knee; Lower Limb Edema; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema). At the time of the report, FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) outcome was unknown.            Patient concomitantly takes pills for hypertension.   No treatment information was provided.   This case was linked to MOD-2021-044513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No new information added in the FU as Lower Limb edema Event persists before also with the patient .
Had Fever on day after shots was given on 08/06/09 but was told by nurse to refer to the VIS sheet for chickenpox for reaction and to treat with Tylenol for fever or discomfort. Then parent called into to CCHD on 08/13/09 at 5 pm stating the son now has a rash on his abdomin that began this week. Wanted to know the length of time to expect the rash. Pink Book referred to and the VIS sheet for Varicella dated 3/13/08. Rash can last for 1 month. Mother seemed satisfied with answer and no other questions or concerns were given.
I started to notice immediately tightness in chest and a slight chest pain. I woke up and felt like I was having Covid again. I had headaches, body aches, pain, total exhaustion, fatigue, vomiting, abdominal cramps, sweats and chills and fever. I took Tylenol and felt I had Covid again (I had Covid infections Sept 2020). The symptoms would come and go, and I could not work. This lasted for many weeks.  I contacted my doctor and was instructed to wait it out. I was most concern with chest pain and was scheduled for a stress test and was put on blood pressure medication (Lisinopril).  I was feeling well enough but still not 100% and went ahead and got the 2nd dose vaccine on 4/28/2021 (lot # ER8735 IMRA). The same symptoms started over again. It will come on for 2 days, then I would feel fine, and the cycle would start over again.  I am still having bouts of Covid/flu like symptoms and it will go away, and I would feel good, then it will come back. I am going in for more blood tests and lab markers for heart inflammation.
20FEB95 elevated temp;23FEB95 elevated temp, irritable, rash on arms & legs, dec appetite, also has around face-eyes areas w/white heads or pimples referred to MD
it was rpt fr RN concerning pt who in 1995 was vax & in 1998 pt was exposed to varicella & in 1998 pt devel varicella
pt recv vax SEP72 & w/in 1 to 3 days suffered stroke, aphasia nominal & Wernicke's;pt has impaired comprehension, & lack of speech & writing skills;lt side of brain diseased & blood vessels are abn;hyperactivity;irritable, crying, whining;
Shot sight red; Shot sight raised; Shot site tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 22May2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of the COVID-19 vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 22May2021 at 14:00, the patient experienced "shot sight red, raised and tender to touch". Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events "shot sight red, raised and tender to touch" was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Left thigh 2x2cm, warm, hives approximately 1/2 inch- 3/4 inch below injection site.  Tylenol as needed - pre-lone 15/5cc by mouth 4 times a day for 3 days, Benadryl cream as needed.
In February of 2023 I developed a prostate infection and was prescribed BACTRIM. I always have difficulties when I take BACTRIM but this time I had a more severe reaction. It always made me slightly nauseous but this time around I would immediately urinate. I was instructed to not use BACTRIM again.
The left anterior thigh area was notable for a 6.5x9cm raised, erythematous rash that was slightly indurated. The injection site is noted near the center of the lesion. The lesion is non tender to touch but is warm. No surrounding cellulitis is noted.
Joint pain; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself) communicated to Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Jan2021 (Lot number and Expiration date: unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as single for covid-19 immunisation. On an unspecified date in Jan2021, the patient experienced joint pain. The patient stated that the reason she called, 06Jan2021 was her second dose of the COVID-19 vaccine. She said she had some joint pain after the second dose, and it run away after three days and she was calling to see how long the vaccine lasts. She wanted to know if it is for 3 months or if a year. Patient stated the only thing that she wanted to know was it going to expire in 3 month or a year. The patient outcome of the event was resolved on an unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient is fully vaccinated and died in hospice care.   Case was previously living in a Long term care facility and recently relocated to hospice as in-patient in hospital. Case tested Covid positive at hospital and didn't show any signs and symptoms. Case was told his heart and kidney medical conditions were declining. Case had chronic conditions listed previously.  Case died about a week later after being admitted to hospice.
Fever noc of shot high 103; fever q evening since day of shot 6MAY seen by MD 9MAY face sl swollen, fussy, diarrhea; no BM day pt was in MD office;
Chills,fever,headache, frontal face pain,body aches, nausea, shooting pains in heels of feet,
Information has been received from a physician concerning an 8-week-old male with no medical history who on 13-MAR-2007 was vaccinated PO with the second 2.0 mL dose of Rotateq. Concomitant vaccinations administered on that same day included "other recommended vaccines given at the 2-month-old visit." There was no other concomitant drug therapy. The physician reported that on 16-MAR-2007, the patient developed bilious vomiting with abdominal tenderness and irritability. On 17-MAR-2007, the patient was evaluated in the Emergency Room (ER). The patient had diarrhea after a rectal examination. On that same day, he was sent to a different hospital for a possible obstruction and was subsequently admitted. While hospitalized, the patient had a Barium enema with a small bowel follow-through and underwent other unnamed tests. His stools also tested positive for rotavirus. On 20-MAR-2007, the patient was discharged in stable condition and was considered to be recovering. Additional information has been requested.   4/16/07 Received medical records from 2nd hospital which reveal patient experienced bilious vomiting, diarrhea, fussy & poor appetite.  KUB at initial hospital ER revealed dilated loops of bowel & bowel obstruction.  Admitted 3/18-3/20/07.  Exam revealed hyperactive bowel sounds, mildly hyperextended abdomen & explosive diarrhea on digitalization.  Progressed & was d/c to home.   FINAL DX: Rotavirus. 4/24/07 Received ER summary from transferring hospital which reveal patient experienced projectile vomiting progressing to bilious, malaise & dehydration.   ER DX: SBO & colonic distension.
Dad noticed bulging anterior fontanel approx. 14 hours after receiving Immunizations. Lgf earlier in evening treated with TYLENOL. Brought to ER and followed up in clinic in AM. Labs in AM WBC and CRP moderately elevated. Hgb/Hct WNL. Platelet count WNL. U/S head normal on 1-17-18. 1-18-18 baby is back to normal behavior baseline (previously not as happy or perky). Anterior fontanelle open and flat.
not feeling well; headache; CHILLS; myalgia; A spontaneous report was received from a consumer concerning a 48years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (chills, myalgia, headache, vaccination complication).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3feb2021, prior to the onset of the events, the patient received their first of second dose of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  Laboratory details not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event unknown.
1 Day after vaccination the injection site was sore. Later that night the rest of the body became sore. 4 days after vaccination the sore injection site stopped, but a headache began at night. 5 days after vaccination I got fever, chills, swollen lymph nodes, red throat, coughing, pain swallowing, and sore muscles. 6 days after vaccination fever was gone, but the rest of the symptoms remain.
pt recv vax 19DEC97 & immed p/vax pt head felt very hot, & feet felt very tingly;sx lasted for a few min then recovered;later that same noc pt exp itching on both arms;
This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A 18-year-old male patient of unknown ethnicity received on an unknown date first single dose of TRUMENBA and first dose of HPV 4 (Merck). The vaccines were administered in different sites. Concomitant medications and medical history were not reported. On unspecified date, the patient had severe back pain and the patient was incapacitated for three days. Outcome was unknown. Follow-up (14OCT2015): Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Tetanus vaccine with an associated reaction of lymphadenopathy (approximately 30 years ago, he got a Tetanus shot (unknown manufacturer)). On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, hot flashes, chills, pain and injection site tenderness. On an unknown date, the outcome of the influenza-like symptoms, hot flashes, chills, pain and injection site tenderness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, hot flashes, chills, pain and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient stated that he experienced flu-like symptoms, hot flashes, chills, and aches. The patient stated that the injection site was also tender. For the tolerability of 2nd dose, refer case US2018GSK195505 reported for same patient.