chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of  death not otherwise specified (NOS) in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. Reported Cause(s) of Death: unknown cause of death.
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N) refers to unspecified number of unspecified patients of unknown age and gender. The patients were administered an unspecified number of improperly stored doses of PROQUAD (Merck) (subcutaneous injection, dose, frequency, lot# and expiration date were not reported) on unspecified dates since 01-FEB-2015. No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; Soreness; Chest Pain; Difficulty breathing; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, chills, pain, chest pain and difficulty breathing. On an unknown date, the outcome of the fever, chills, pain, chest pain and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the fever, chills, pain, chest pain and difficulty breathing to be related to Bexsero.  Additional details were provided as follows: This case was reported by patient's mother. The age at vaccination was not provided. The reporter stated that, after vaccination, the patient experienced fever of 103.4 degree C, which lasted for 5 days. The patient's physician recommended for emergency room visit. No further details were provided. The reporter did not want to provide any demographic or address information. For tolerance to the 2nd dose, refer case US2019AMR161774      Lab Comments: On an unknown date, lab test performed.
fainting, sweating, weakness was happening. treatment: laid down slowly and elevated legs, used cold compress. outcome: pt regained consciousness again after a few seconds and was ok.
After MMR shot on 8/2/02 at 16:00; at 23:00 started getting high fever of 103-104.7F constant.
Pt admitted to hosp w\ generalized weakness, weak from waist down for last 2-3 days, no chills/pain/cough/fever, 21Nov93 low grade T, 22Nov93 progressive weakness upper body on ventilator,subclavin line for feeding & meds, bowel fxn probs
Rash & fever, dry eyes, no photophobia, runny nose; No joint pain;
Lightheaded, dizzy  hypertensive 208/103    Sent to the emergency room for further evaluation
According to patient's wife approximately 2 weeks after receiving vaccine he developed Shingles.  Shortly after he developed "bilateral polyneuropathy in both legs" resulting in the loss of function of his legs.  Patient's wife states he could no longer support his weight on his legs.  He was hospitalized on 11-29-10 and also developed blood clots in his legs.  He is currently in rehabilatation.
Mild tiredness during first day after injection. Itching, swelling, and elevated temperature at injection site developed 8 days after injection.
I WAS NOT EXPECTING SYMPTOMS WITH THE FIRST SHOT, WAS TOLD IT "NORMALLY" DIDN'T HAPPEN, BUT TO EXPECT SYMTOMS WITH 2ND DOSE.  I WENT BED FEELING FINE, WOKE UP ABOUT MIDNIGHT WITH BODY ACHES IN EVERY PART OF MY BODY, CHILLS, FEVER, NAUSEA.  ARM IS VERY SORE, NOT EXPECTING THAT MUCH PAIN AT INJECTION SITE. I AM NOT ABLE TO WORK TODAY WITH THESE SYMTOMS WHICH HAVE SUBSIDED A LITTLE BIT, BUT NOT MUCH.
Client phoned health unit with c/o itching and redness to injection site. Client took BENADRYL and redness and itching decreased after 2 doses.
The client is a 15 year old unaccompanied minor who was given the dose in error by the vaccinating RN.  The client did not suffer any adverse reactions and reported no signs or symptoms of adverse reactions.
A red area about 1 x 4 inches, and soreness with mild swelling and warmth for about 2 days, which went away, except for intermittent soreness which continued. The redness then returned about 3 days later, to a size of about 4 x 4 inches, with mild itching. again slight swelling, and warmth which have persisted now into day 11.  It does seem to be improving / fading with warm soaks several times a day.  I have never had a response to a vaccine like this before.
On the consent form, mother wrote that patient is 12 years old so pharmacist quickly assumed that it was good to go without double checking the birthdate which was 2 days away from patient turning 12 years old. Today's date: 7/19/2021.
Tested positive for Covid-19; Dry cough; Fever; A little arm pain; freezing and cold not warm up; A report was received from a health care professional concerning a patient female who was participating in the mRNA-1273 Emergency Use Program and experienced multiple events of little arm pain, fever, dry cough and freezing and cold not warm up.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 026L20A). Soon after they experienced multiple events of little arm pain, fever, dry cough and freezing and cold not warm up. The treatment information included Tylenol.   On 08 Jan 2021, Patient called to inquire as to whether she can receive the second dose of the vaccine or not. Patient tested positive for Covid-19 on 06 Jan 2021. Her doctor does not know and told her to call Moderna. Caller angry and frustrated. Verbal Consent given.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the events, little arm pain and dry cough was considered recovered/ resolved.  The outcome for the events, fever and freezing and cold not warm up was considered not recovered/ not resolved.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 52 Y/O F who had a NS unexpected SARS-CoV-2 test positive, cough and NS expected fever, chills, injection site pain. Event onset occurred on Day 1 after first dose mRNA-1273, with SARS-CoV-2 test positive on Day 10.  Treatment not reported. Arm pain and dry cough resolved, and fever and chills ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt developed site reaction characterized by redness, swelling, pain and induration, the pt also experienced arm heaviness.
FOLLOWING DAY PATIENT CALLED PHARMACY TO REPORT HIGH FEVER, AND HARD BUMP ON HER ARM.
ACHES AND PAIN, BRUISING AT INJECTION SITE AND RASH (ERYTHEMA BELOW INJECTION SITE) ON LEFT ARM BIG AS A NORMAL SIZE HAND. WARM TO THE TOUCH
reports that on the sixth or seventh day she started to get achy; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 59 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "joints were swollen" (not ongoing), notes: Knees, ankles, knuckles, almost all joints were swollen.; "psoriasis" (not ongoing). The patient's concomitant medications were not reported. Past drug history included: Xeljanz for psoriasis; Xeljanz for joint pain. The following information was reported: PAIN (non-serious), outcome "unknown", described as "reports that on the sixth or seventh day she started to get achy". Therapeutic measures were taken as a result of pain.  Additional information: The patient reported that on the sixth or seventh day she started to get achy and took Tylenol. The patient "Xeljanz" had worked perfect. The patient could jump right out of bed now. The joint pain was much better. It was 8 or 9 out of 10, now it's about 1/10. The patient's knees, ankles, knuckles, almost all joints were swollen, it took about 3 months to fully kick in. The patient reports having psoriasis after being on previous medication, psoriasis went away after about 5 months on Xeljanz. Patient reported stopping Xeljanz for one week after receiving COVID vaccination, no date given. She stated, it wasn't too bad. It was tolerable. MD aware. Patient reported start of therapy about a year ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate local reaction in both arms after injection. LA - VARIVAX 6 x 4 cm redness with 1 hive. RA - MMR 2 1/2 x 2 1/2 cm redness with 1 hive.
Administered 0.5mL SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, Manufacture provided 0.5mL in the single dose vial instead of 0.25 ML.
feels like she has the flu; She has aches and pains; she feels cold; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like she has the flu), PAIN (She has aches and pains), FEELING COLD (she feels cold), FATIGUE (fatigue) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE, LOSARTAN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has the flu), PAIN (She has aches and pains), FEELING COLD (she feels cold), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (feels like she has the flu), PAIN (She has aches and pains), FEELING COLD (she feels cold), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            Treatment information was not provided. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Pt became dizzy and light headed shortly after receiving his Moderna shot today. He sat down, then dizziness became more intense and vision was becoming affected. Immediately gave him some water, symptoms were worsening so we moved him to the immunization room so he could lay down. Started fanning paper to cool him down and got ice packs. He started feeling better about 5 minutes later. He also received some almonds, chips and water, as he stated he did not eat breakfast and did work an overnight. He left without incident about 45 minutes later, felt fine and back to normal. He did mention he gets lightheaded previously giving blood.
I have Pseudogout the same hand where I got the shot in it gets super swollen and painful. I don't have a lot of information to add.
04/02/21 12:45 pm ? At approximately 12:45 pm I was called to vaccine tent #1 after reports from staff that a patient was feeling sick after receiving her Janssen injection. I discovered the patient slumped in her chair, head back with eyes closed, skin clammy and cool. Alert and oriented x3, speaking slowly but clearly. Per vaccine nurse, she administered the Janssen injection to patient at 12:41 pm  (Lot 1805020, exp 5/25/2021, Left Deltoid) and a few minutes later the patient started to close her eyes and leaned back in chair requiring assistance to sit up.  Nurse was able to stabilize patient in chair and then called for help and that is when I came to assist. Patient remained in this state for several more minutes. Activated EMS for further evaluation as patient did not stabilize immediately. Measured vital signs ? Blood Pressure 98/62, O2SAT 97, Pulse 68.  I continued to monitor the patient until EMS arrived. EMS evaluated patient and cleared but advised to continue to monitor for an additional 15 minutes before leaving the site. Patient verbalized understanding and agreed with plan. Patient remained in observation for an additional 15 minutes with no incident.
April 16 2021: fell asleep on plane and woke up with paralysis of left hand with numbnes. Numbness resolved within hours, but nerve paralysis from posterior interosseos nerve continued for 11+ weeks. At the same time also started numbness and tingling of feet and hands, intermittently. Most common was if anything bumped my skin would set off long lasting numbness and tingling. Also if sittiting funny lean on anything. All nerves seem hypersenitive. This still exists and comes and goes, not every day but several days a week. July 20, 2021 started heart palpitations, at first would come and go. One occasion of dizzy and needing to sit down. Saw primary care end of Sept and diagnosed with frequent PVCs, same day got a flu vaccine and cardiac symptoms worsened. Seen in the ER 5 days later. Follow up in cardiology. Diagnosed with PVCs and atrial arrythmia. Now taking metropolol to control symptoms.
2JUL92 very somnolent; couldn't keep pt awake enough to eat; pt sleeping since 8PM 1JUL & all day 2JUL; took pt to MD 1PM till 4PM; MD not sure why pt so sleepy;
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (Lot# K022265, exp. 22-OCT-2016 Lot# L014878, exp. 17-JAN-2018; Lot# K006262, exp. 17-DEC-2015) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
9/19/18 early AM (less than 24 hours after immunization)=soreness at site, chills, muscle aches, diaphoretic and severe headache.
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 17-DEC-2015, the patient was vaccinated with improperly stored dose of M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. No adverse events were reported. The administered dose was stored in 47F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Low grade fever; Severe arm pain in injection arm; A spontaneous report (United States) was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine and experienced a low grade fever and severe arm pain in injection arm.   The patient's medical history included COVID-19. No relevant concomitant medications were reported.  On 23 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced a low grade fever and severe arm pain in injection arm. No treatment for the events was reported.    The outcome of events, a low grade fever and severe arm pain in injection arm, were not reported.   Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious expected event of pyrexia and injection site pain. Event occurred 1 day after first dose of mRNA-1273 (Lot# Unknown) vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
SORENESS, REDNESS AND SWELLING; patient stated: "it started immediately, was swollen by that evening and now it's about size of flat egg."
R upper arm large red area hot and firm 2 days post vaccine and fever.  Rx-Augmentin
Rash on inside of left arm and buttocks, fever of 100 at 3:00pm at doctor's office, worse rash on buttocks and also back of legs after doctor's appointment at home 7:30 PM, the 7-10 day period for reaction has not been met yet so more reactions may come.
Woke up from sleep feeling extremely light-headed and dizzy and nauseous.  Had imbalance problems as well.  Vomited X2 during the day.  Symptoms lasted throughout the day.  Today (10/19) feel significantly better although still have mild headache and congestion in facial area.
Red itchy bumps running along from injection site.  Morning of 2/27/22 appeared to current. Informed PCM, took 1 Benadryl 2/27/22 in the evening.
Information has been received from a physician concerning a 6 year old female patient who in September 29, 1998, was vaccinated in the right thigh with a first dose of varicella virus vaccine live (lot number 526962/0849H). On 08MAR2004, the patient developed a typical chickenpox rash also described a varicella rash. It was noted that the child reported to the office on 09MAR2004. The physician described the rash as "probably 50-100 lesions", spread all over the body, including the torso, face, arms and legs and the lesions were "a bit more than other breakthrough cases" he had seen. The patient had a fever of 103 which resolved prior to the office visit. It was also noted that the parents of the child were educated on chickenpox care but there was no specific treatment. Unspecified medical treatment sought. There was no product quality complaint. Additional information has been requested.  Follow up information Subsequently on approximately 03/12/2004, approximately 5 days after the patient recovered. Unspecified medical treatment sought. There was no product quality complaint involved. No further information is requested.
could not raise her arm because was in so much pain; could not raise her arm because was in so much pain; Information has been received from a physician via a field representative referring to a 26 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.  On 19-JUL-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route, strength, dose, frequency, batch/lot # and expiration date were not reported) in the upper arm for prophylaxis (reported as human papilloma virus (HPV) prevention).         On the same date after administration, the patient "could not raise her arm because was in so much pain". Information about lab diagnostics/studies was unknown by the reporter. The patient went to physical therapy and received treatment for the events.   The outcome of both events was unknown. The causality was not reported.
sore throat; cough; weakness; This is a spontaneous report from a non-contactable consumer received via the Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore throat, cough, and weakness on an unspecified date in Feb2021. The consumer wanted to know if the second dose of vaccine administration could be delayed for medical reasons, since the patient was experiencing side effects from the first dose. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.