chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe body ache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe body ache), PYREXIA (fever) and CHILLS (chills) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (severe body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, MYALGIA (severe body ache), PYREXIA (fever) and CHILLS (chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
My son developed symptoms of what we now know is COVID on 4/26/2022. He indicated that he felt tired and under the weather, so we administered a home test, and the result was positive. He developed a cough, which lasted for about 2 weeks. He also tested positive for COVID for about 2 weeks. He finally tested negative on 5/7/2022. He also tested negative on 5/8/2022 and 5/9/2022, so we were confident afterwards that he was finally COVID-free. During the time he was recuperating, we occasionally gave him ibuprofen. We also sometimes gave him water with honey and lemon to treat his cough, which was pretty persistent. The treatments seemed effective. At the time of this writing, pt. is completely symptom-free.
Vaxnuevance was administered in error at 18 month well exam.  Child was to Hep a and DTaP, but received Hep A and PVC 15
Red inflamed 4 cm area on left leg. Pt given KEFLEX and BENADRYL on follow on 5/20/11 pt improving.
Bad taste in my mouth for about 48 hours.  I'm reporting only because I've heard that others have had the same experience and believe people should be told that (like they do for Lunesta which also had the same effect on me).
Body chills and shivering and cramping that wouldn't let up until I got in hot bath. Fever overnight 102.6°-103° Nausea, headache and body ache, and a little vomiting. Fever finally breaking this morning.
this is 1 of 6 pt from this site to inadventently recv TD rather than PPD;pt devel an inj site rxn characterized by swelling, reddness, pain, itching, & warmth;
Concerned about Mercury in flu shots caused "zombie"-like state in her child. MMR - has mercury in it. This causes autism later in life. Why is there mercury in MMR and Flu shots. Senator has been concerned.
pt recvd vax;16jan92 1st sz then collapsed;eyes rolled back,blue lips;did not think was breathing;took to hosp then relesed,t of 103;17jan94 2nd & 3rd sz;was shaking; to hosp;meds given;rash appeared;state of hallucinations;t 106;ear infect
Case number PHEH2013US021885 is an initial spontaneous report received from a consumer on 18 OCT 2013, with a follow-up received on 13 NOV 2013. This report refers to a 50-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: unknown) intramuscularly on 16 OCT 2013. On the same day after vaccination, she experienced swollen lymph nodes under her left arm. She had not consulted a physician at this time, but a nurse recommended placing warm packs under the arm to help with the swelling. Consumer stated that the swelling bothered her day before, but it worsened the next morning with some pain and was getting worse. Consumer added that she had received flu vaccines in the past, and this experience had never happened previously. Outcome was reported as condition worsening. No further information about seriousness and causality was mentioned. Treating physician stated that the patient had not received the vaccine at their clinic and had not seen the patient since Feb 2013.  Follow-up was received on 13 NOV 2013. Treating physician statement was updated.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a pharmacist, concerning a 36-year-old, adult, female patient. The patient had no medical history or any concomitant medications. On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: right deltoid, batch number: 195227, expiry date: 31-May-2018). The PTC (product technical complaint) number provided was 1025704). It was reported that, at the time of administration, the plunger got stuck and stopped (explicitly coded as syringe issue). When it was pulled out the vaccine spilled out, but was not exposed to the vaccine. The patient received only half of the dose (explicitly coded as Incomplete dose administered) and had no adverse events. The QAIR (quality assurance investigation report) for the PTC (product technical complaint: 1025704) concluded that FLUCELVAX Batch 195227 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch or for the 2017/2018 FLUCELVAX Commercial Season for plunger rod issues. The reporter assessed the events as non-serious. Follow-up received on 27-Nov-2017: Added date of vaccination. No adverse event was deleted from the screen. The narrative was amended accordingly. Follow-up received from QA (quality assurance department) on 15-Dec-2017: Added PTC number (1025704) and the QAIR (quality assurance investigation report). Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195227 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch or for the 2017/2018 FLUCELVAX Commercial Season for plunger rod issues. Narrative amended accordingly.
His primary doctor has been experiencing ringing in the ear after receiving vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (His primary doctor has been experiencing ringing in the ear after receiving vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (His primary doctor has been experiencing ringing in the ear after receiving vaccine). At the time of the report, TINNITUS (His primary doctor has been experiencing ringing in the ear after receiving vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Pt recvd 1st & 2nd dose of vax & later booster dose HIB vax; On 4JUL91 pt found not breathing; rescusitation was unsuccessful; during intubation, formula noted in trachea;
she had a 102°F temperature/her temperature that went up to almost 102; headache/bad headache/horrible headache; nausea; chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), second dose via intramuscular in upper left arm on 09Feb2021 at 16:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot number: EL3249) via intramuscular in upper left arm on 19Jan2021 at 17:30 as single dose for COVID-19 immunization. In Feb 2021, about 30 hours after the second vaccine, the patient experienced 102 degree Fahrenheit/her temperature that went up to almost 102, headache/bad headache/horrible headache, nausea and chills. The patient underwent lab test and procedures which included body temperature was 102 degree Fahrenheit. Therapeutic measures were taken as a result of the events include baby aspirin. Then three hours later she took two more baby aspirin and her temperature went down after each time she took aspirin, states everything went down after the aspirin, the chills, nausea, and headache went down. She was reading literature and it looks like by taking an aspirin she may have stopped the production of antibodies. She is asking if this is true and if she has to be revaccinated or what she has to do. By the time she stared to go to bed she started to get a headache. She clarified that all of her other symptoms started in the middle of the night the same day she received the second dose. By 11Feb2021, in the early morning around 01:30am or 04:30am (both of the times she took aspirin) she recovered from all the side effects except she still has a very slight temperature. By 09:00 on 11Feb2021, her temperature was down to 100 or 99. The outcome of the event pyrexia was recovering, and was recovered for headache, nausea and chills.
Fever/Low-grade fever about 99.8 to 101.2; Chills; A little sore in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever/Low-grade fever about 99.8 to 101.2), CHILLS (Chills) and PAIN IN EXTREMITY (A little sore in the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     The patient had no food allergies.  The patient's past medical history included COVID-19 (tested COVID positive) on 01-Apr-2022. Previously administered products included for COVID-19 vaccination: Pfizer (First dose) on 23-Feb-2021, Pfizer (Second dose) on 16-Mar-2021 and Pfizer (Third dose/1st booster dose) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Hypertension (high blood pressure started at age 55) and Drug allergy (Patient has allergies with high doses of Advil 800mg).    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced PYREXIA (Fever/Low-grade fever about 99.8 to 101.2), CHILLS (Chills) and PAIN IN EXTREMITY (A little sore in the arm). At the time of the report, PYREXIA (Fever/Low-grade fever about 99.8 to 101.2) and PAIN IN EXTREMITY (A little sore in the arm) had not resolved and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 06-May-2022, Body temperature: 99.8 to 101.2 (High) 99.8 to 101.2 (low grade fever).         No concomitant medication information was provided.  On 06-May-2022, the patient received the second booster dose of Moderna COVID-19 Vaccine.  The reporter (patient's husband) wanted to know if the patient was contagious and if it was fine to have a COVID-19 test even if they got the vaccine.  On the previous night of 06-May-2022, the patient developed fever and chills which the reporter read as being the general side effects of the Moderna vaccine.  The patient also mentioned that the pharmacist had told the patient that the patient could get the vaccine after 2 weeks of testing positive with COVID-19.  The patient had not received any medical care yet.
Information has been received from a physician concerning a 38 year old male with hypertension who on 13-FEB-2009 was vaccinated with a dose of GARDASIL.  On 15-FEB-2009, the patient noticed "foaminess" to his urine.  The patient was evaluated in the office on 16-FEB-2009 and a dipstick check of the urine revealed the presence of protein.  Complete blood count, comprehensive metabolic panel, urinalysis, serum and urine protein electrophoresis, sed rate, ANA, urine microalbumin, and protein/creatinine ratio have been ordered but at the time of report, the results was pending.  At the time of the report the patient was not recovered.  The patient sought unspecified medical attention in the office.  Additional information has been requested.
Muscle ache manifested ~11 hours after initial injection, Temperature increase as well. Temperature subsided within an hour, muscle ache persistent
Pt reported redness, swelling and itching at injection site (posterior RUE). He states he has also develeoped an "boil". Pt was out of town when reaction was reported to our office 08/25/15, so he sent in photos of the reaction. Initial photo revealed small area of swelling, no pustule or vesicle formation with surrounding erythema. He drew pen marks at the edge of redness and later photo revealed spread of erythema in addition to what appears to be small abscess. He c/o of low grade fever 99-101.1 for which he used Paracetamol. Other c/o included headache, nausea without vomiting and right hand numbness. When I spoke to the pt 08/26/15 I told him I would call in a prescription for the skin infection. He will be seen in our office when he returns from out of town 08/28/15. He states all symptoms other are improved over last two days.
Pain at injection site with and without touch, soreness with arm movement, difficulty using the arm due to pain.
I felt a sensation immediately after the injection. Ten minutes later I began to feel  fuzzy but not that noticeable.  The left muscle in my left side of my neck stiffened.  As we left the area and headed down the street I was getting anaphalactic:  numb jaw, swelling tongue, closed throat, eyes closing, inner cheeks numb - as if I was severely novacained from the dentist.  I was able to breathe ok to  get home hoping it would pass and drank wanter to keep things fluid.  I was there for one hour.  On advice, I went to the ER to get checked out.
Soreness of Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of Arm). At the time of the report, PAIN IN EXTREMITY (Soreness of Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Pt woke up with confusion, fevers, chills, nausea, myalgias, fatigue.  Did not have any specific vision/hearing/motor or sensory deficits.
Patient at chair for 10 minutes when she began to flag the attention of medical staff, she complaint of dizziness stating "I feel like I'm going to faint".  Patient was asked if she have eaten, she responded "yes".  Patient states a history of vasovagal syncope causing her to faint.  Patient was asked if she need to lay down, she responded "yes".  Patient taken to east portion of the room, provide privacy and vital taken.  @3:17 Temp.  98.6, O2 98%, HR 82, B/P (L/A) 125/90, patient continues to lay on the ground for 11 minutes before sitting up in a criss/crossed leg position.  At this point patient complaint of increase dizziness, patient was allowed to sit in this position for an additional seven minutes before being moved to a chair allowing both feet to be planted on the ground while the rest of the body in an upright position, patient started to feel better while in this position.  last vital: T-98.6, O2 98%, HR 85, B/P 140/95.  It was decided that the co-worker would take the patient home as the patient stated "I am too dizzy and do not feel well enough to drive".  Patient left her Hyundai Santé vehicle in the parking lot to be retrieved at a later time.  Patient help to a wheelchair, taken to check out, then wheeled out by three staff to the vehicle of the co-worker, to leave.
A non-serious spontaneous report of gave H1N1 vaccine to a 55-year-old man was received from a registered nurse/other health professional concerning a 55-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
No adverse event at this time - patient was given 0.6ml of vaccine instead of the indicated 0.3ml
Dry mouth shortly after shot and still present Second day: weak arm- inability to grasp and hold things easily in the arm the vaccine was administered. Also arm was a bit shaky especially holding items roughy 5+ pounds.
14mins post vaccination pt had a syncopal episode w/ associated flushing/sweating and dizziness.  Pt mother stated that the pt saw blood and syncopized.  Pt did not hit head.   Vitals: 82/64, 70, 18, 100% -- > 78/61, 72, 18, 100% Pt laid down, feet elevated.  Pt stating that he is feeling better.  Pt stable and released from the vaccination site.
Myalgia, Fever, Rash, R Axillary Lymphedema, chills Narrative:  Other Relevant History:
swollen lymph nodes/Swollen Glands on right side Neck, Shoulder blade, behind ear; her glands in her neck are large and they ache really bad; headache; earache; shoulder blade pain; gland and the neck swelling; pain gets worse at night and early in the morning; she cant hardly turn her head to the right side which is the side she received the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in arm right on 09Apr2021 08:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient relevant medical history includes cardio myopathy, high blood Pressure, Spastic colon, glaucoma and diverticulosis; all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration in right arm on 19Mar2021 08.00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient received the second dose of the Pfizer COVID vaccine Friday morning at 08:00 and had problems ever since. On 09Apr2021, the patient experienced headache, swollen glands on right side neck, shoulder blade, behind ear. Caller states the patient read all the information and knows that it states swollen lymph nodes was a side effect but how long was it suppose to go on? Caller states her glands in her neck was large and they ache really bad and the patient did not hardly turn her head to the right side which was the side the patient received the vaccine. Caller states the patient had a headache, earache and shoulder blade pain as well and taking extra strength Tylenol for the pain and uses cool compresses on her neck. The pain gets worse at night and early in the morning. The patient concerned and her family was concerned also and the patent was not getting better and it aches. During the week the patient did not get out of bed and had a bad headache, still had headaches behind the ear and the gland swollen was real bad on the same side also. Her headache and the swelling of the glands on the neck, shoulder blade, behind the ear all on the right side is still ongoing. The patient thought it was getting better by yesterday (12Apr2021), but she woke up today and started trouble again, like with cold or virus, it usually gets worse at night then in the morning, it was persisting. The patient followed direction as to not had medications before the vaccine and tried Tylenol Extra Strength after wards but its not doing anything for it. The patient was rubbing Blue Emu cream that was over the counter for joints and muscles. The patient had prescription medicine she regularly takes but nothing new. The seriousness of the events was assessed as non-serious. The outcome of all events was not resolved.  No follow-up attempts are needed. No further information is expected.
Developed itching and redness all over body. Eyes itchy and developed hemorrhage; Jaw pain. Patient had COVID-19 a few months ago.
Caller reporting VARIVAX was administered after a temperature excursion that occurred on 10/13/2022. This excursion was supported.; 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 concomitant medications were not reported.  On 13-OCT-2022, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursions of -12.04 degree Celsius (C) for time frame 45 minutes, no previous temperature excursion was reported. On 30-NOV-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U015847, expiration date: 19-MAY-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA004483:
Patient's mother came up to pharmacy and said her daughter called her while she was waiting the 15 min and started to feel faint and felt like she was going to pass out. After a few minutes she said she felt better and I had her sit down and gave her some water in which she said she felt much better and felt well enough to go home. She did mention that she had a donut earlier. Her mom also said she has fainted with other vaccines before.
On 2/18/03 PT reported cervical neck and upper thoracic pain, axillary and cervical lymph node enlargement and tenderness, headache, joint aches; feels feverish but did not have thermometer; smallpox pustule 10 mm and beginning to dry. Tx - rest, missed 1 day of work.
CHEST SPASMS; 104 FEVER; HEADACHE; APPROX 3 DAYS AFTER VACCINATION IN ICU FOR 3 DAYS; RHABDOMYOSIS.  Nurse follow up on 10/20/04 states: "Hospital d/c summary reviewed. Final diagnoses were rhabdomyolysis and dehydration. Shivering and fatigue."
pt admitted to hospital with altered mental status and increasing SOB; positive for COVID; O2 sats 82% on RA; provided O2 supplementation via NC; given Decadron, Lovenox, Remdesivir; pt suffered acute respiratory decline probably due to pulmonary embolus; anticoagulation therapy given; rapid response called for hypotension, resuscitated; developed A Fib with again worsening respiratory failure; intubated; experienced cardiac arrest; family chose to terminate resuscitation and pt died in the hospital
Patient not experiencing any symptoms; unspecified dose of ROTATEQ that was improperly stored; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number R016792, expiration date: 29-APR-2020) orally for prophylaxis (exact dose was not provided) that was improperly stored on 07-NOV-2019. The patient did not experience any symptoms.  Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion of 8.8 degree Celsius for 1 hour 30 minutes. The previous temperature excursion of 51.6 degree Fahrenheit for 7 hours was reported. The digital data logger was involved.