chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing tiredness after receiving the vaccine; A spontaneous report was received from a consumer concerning a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tiredness.  On 4/Feb/2021,  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:Unknown) for prophylaxis of COVID-19 infection.   On 10/Feb/2021 , after receiving mRNA-1273,  patient experienced tiredness. Also patient states she had Chron disease. Action taken with mRNA-1273 in response to the events was not reported.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), FEELING COLD (felt cold), ARTHRALGIA (achy joints), NAUSEA (nausea) and PYREXIA (slight fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ILLNESS (got really sick), FEELING COLD (felt cold), ARTHRALGIA (achy joints), NAUSEA (nausea), PYREXIA (slight fever) and CHILLS (chills). On 11-Apr-2021, ILLNESS (got really sick), FEELING COLD (felt cold), ARTHRALGIA (achy joints), NAUSEA (nausea), PYREXIA (slight fever) and CHILLS (chills) had resolved. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-074721, MOD-2021-074721.
Blurry Vision; dose_number=1 Johnson Johnson/ dose_number=2 product=COVID 19, brand=Pfizer; dose_number=1 Johnson Johnson/ dose_number=2 product=COVID 19, brand=Pfizer; This is a spontaneous report from a non-contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) and First dose of janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced blurry vision, off label use and Interchange of vaccine products. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot number cannot be obtained.
NAUSEA, BODY ACHES, FEVER, SNEEZING, HEADACHES, SORE THROAT
NO ADVERSE REACTYION..., JUST REPORTING THAT ;PATIENT GOT A BIT EXPOIRED VACCINE
Fever for over 4 days of 101...chills, shaky, sore throat, severe headache
Vaccine administered on 5/11/2021 but had expired on 5/6/2021.
woke up with chills, and shaking  for 1 hour, headache for 4 hours. joint pain lasting 8 hours
Throat tightness, lip and mouth tingling. No wheezing, nausea, urticaria or lightheadedness. Started 1 hr after shot, controlled with Benadryl, famotidine, steroid in the ED.
Client was present in the clinic on 6/15/2022 for her booster dose of adult Pfizer. She received the pediatric-formulation of Pfizer (lot number FL0007) to her LD. The client and her guardian were made aware and the physician was called. He recommended to follow the CDC guidance for such situations; the client may receive the adult formulation of Pfizer 21 days from the date of this vaccination if she and/or her guardian choose. The guardian was provided education on the occurrence, risks/benefits of revaccination, side effects and how to treat them. The guardian verbalized understanding.  The vaccinator, MA reported that the incident stemmed from a mis-communication. Another staff member, RN, reported that there were ?3 peds and 1 adult? in the group to be vaccinated, meaning that there was 1 child who was 12 years old and due to receive the adult formulation of the vaccine. The vaccinator took this to mean non-minor adult and thought that the 12 year old client was meant to receive the pediatric vaccine.   All staff were educated on procedures designed to reduce the risk of providing inappropriate vaccination types: ? Use the age of the client when announcing clients for vaccination and escorting them to the vaccination area from the registration area.  ? Verify the client?s name, DOB and vaccine type verbally with the client and/or scribe (staff member completing documentation) ? Verify the client?s age as displayed in the computer, ensure that it is appropriate for the type of vaccine to be delivered.
rash on neck, shoulders (not itchy) started on 8th day post vax; fever of 100 on 8th day post vax
Information has been received from a licensed practical nurse concerning a 6 months old patient of unknown gender who on 20-OCT-2014 was vaccinated with ROTATEQ (lot # J014868, expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Beginning 6 hours post-injection, left arm extremely sore, unable to raise without pain. Bouts of nausea came next, followed by body aches, chills, and fever. Took 2 pills (1 dose) Advil. Awoken ~0100 with extreme fever, body not sweating. Took 2 pills (1 dose) Advil and drank more water. By 0700, fever had broken and chills ceased. Arm soreness and body aches persisted, but less severe. General tiredness throughout the remainder of the day. By the following AM (~40 hrs post-injection) returned to normal health and activity.
Information has been received from a LPN concerning a 60 year old white retired male with penicillin allergy who on 01/06/2003 at 14:30, was vaccinated in the right deltoid with pneumococcal vaccine 23 polyvalent (Lot #644217/1026M).  Illness at the time of vaccination included conjuctivitis and upper respiratory infection.  The LPN reported that on 01/07/2003, the patient developed erythema at the injection area.  The area was also hot to the touch and a 17cm x 9cm section around the injection area was raised.  On 01/16/2003, the patient recovered from his events.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also reported that another patient developed erythema and peripheral swelling after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES # 0303USA00340).  Additional information is not expected.
pt recvd vax & devel onset of resp distress & wheezing requiring ER visit subsequent; admission to the hosp;
Pt recvd 2nd dose of Hep V vax 14JAN92 & exp h/a, rash around inject site; h/a tx APAP; reporter indicated that the rash was not as severe as the one that occurred p/1st dose; pt recovered;
pt recv vax 13FEB97 & 3DEC97 pt devel mult vesicular lesions w/some crusted, approx 30 lesions;
Acute on chronic combined systolic and diastolic CHF -  admitted for a week with cardiology working diligently to fine-tune his medications he is discharged on his current regimen. Hospital admission within 6 weeks of receiving the COVID vaccine.
Fever of over 101.  Nothing else.  Woke up at 2:00 with the same fever.  Gave some aspirin and fever went down in the night.  Woke up fine.
This spontaneous report was received from a physician via company representative refers to a 13 year old female patient. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose 1, dose and route of administration not provided). No concomitant therapy was reported. It was reported that the patient developed fever after getting vaccine. The patient did not sought medical attention. The patient plans to continue with the GARDASIL 9 vaccine series. The outcome of pyrexia was reported as recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Pt given Flu-mist approx 15-20 mins later she felt flushed, dizzy, and warm. During observation she developed a slight tightening of the chest and was given an EPI pen inj and transported to the clinic via ambulance. Remained stable and was released about an hour and half later.
Broke out in hives/rashes. Has been happening intermittently every day or every other day since vaccination. As time has progressed, the severity of rash breakouts has decreased and has gotten smaller but still has not stopped. Was recommended to take Benedryl by my doctor until the rashes stop.
Redness,pain,swelling and heat at injection sight.  Redness spreading on day 3 after first vaccine.
Sore throat; nasal congestion and fatigue for 2 days. I was prescribed 5 day course of PAXLOVID.
Developed hive rash on trunk and extremities itchy -6-15-16. Said he felt itchy on 6-14-16 afternoon after vaccines given but didn't mention to mom til 6-15. Mom gave BENADRYL 50mg at 12:30 p 6-15-16 and again at bedtime 6-15-16. Rash improving with BENADRYL.
sick; flu; unable to get out of bed; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: ILLNESS (non-serious), outcome "unknown", described as "sick"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; BEDRIDDEN (non-serious), outcome "unknown", described as "unable to get out of bed"; PYREXIA (non-serious), outcome "unknown", described as "fever". The events "sick" and "flu" were evaluated at the emergency room visit.  Additional Information: Patient reported being sick for the past 5-6 days with the flu. He is due for his second Pfizer Covid19 vaccine today and would like to know how to proceed. Should he get his dose? Patient stated he had presented to the ER for his flu symptoms, and "been exposed to the elements" and has been sick since then. He is currently unable to get out of bed. He is unable to go in to receive his dose, today as he is sick in bed and does not feel he is able to drive. The patient indicated his illness was the flu, but it occurred in between his 2 Covid vaccine doses. The patient did not say whether he was covid-tested or not. Explained that "fever" is listed something to discuss with HCP in "CONS-what should I mention to vaccination provider before getting the vaccine. The patient sick with the flu and unable to make his appointment for his second Pfizer Covid19 vaccine, today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I exp same pain in right arm as Dose 1. The next morning I had a migraine, joint pain and 103-104 fever lasted 3 days and I stayed in bed.
Patient had been experiencing ongoing shortness of breath for two weeks. He was seen at urgent care on 9/11 and was diagnosed with bronchiolitis and prescribed Augmentin. Patient went to ED on 9/12 for chest pain. Rapid COVID test was done in the ED which returned positive. Patient was admitted 9/12-9/14 and diagnosed with acute hypoxic respiratory failure due to COVID-19 with bilateral large pulmonary embolism. He was on supplemental oxygen during admission, however was able to be weaned to room air. Patient also diagnosed with COVID-19 infection and pneumonia; he was placed on Augmentin for possible bacterial on top of viral infection.  Patient has been vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Neurological symptoms- tremors, muscle twitches, hyper reflexes, severe muscle spasms in upper and lower back, gait abnormality, severe muscle fatigue, right arm weakness and awkward grip, tinnitus, eye redness, loss of taste, heart palpitations/pounding/racing heart, feeling faint when standing, headaches, diarrhea, sensations of needing to urinate all the time. I have seen a neurologist 4 times, 2 rheumatologist, a spine doctor, an ENT, worn a Holter monitor put on by a  cardiologist office, and my primary care doctor four times.
nauseous, swollen lymph nodes under right armpit, chills, fever of 102, joint pain.  5 days later same symptoms
The patient inadvertently received a dose of 0.51 to 0.52 ml as opposed to 0.5 ml. The manufacturer instructed us to reach out to the patient to let them know they have received a higher dose which may have the potential for increased local and or systemic side effects. Mariah reported that her period was 8 days late and she is normally very regular. No other side effects reported by Mariah.
Bump; broke out into rash; This is a spontaneous report from a contactable consumer (patients mother). This is report 3 of 3. A 47 years old female patient received bnt162b2 (solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced bump and broke out into a rash and bump with the first shot. The patient was fine later. The outcome of the events was recovered on an unknown date.  information about lot/batch number has been requested.
09/19--flu like symptoms (aches, pain, 102 degree fever, fatigue). 9/20-- All over body rash-- went to ER. 9/20-9/29--Fatigue, aches, rash, flare up of dermatomyocitis and Lupus symptoms.
She said she felt hot and dizzy, like the feeling of IVP dye for a MRI. We put a fan in front of her in a location where she could put her head down and prop up, we gave her a cold wet compress and one of my technicians stayed with her and talked to her and she said that she thought her nervousness caused it, she was very nervous about getting the vaccine, she stated that she has had previous reactions to flu vaccine and a serious reaction to MMR that hospitalized her. We asked her to stay 30 minutes and she was fine when she left.
After the first shot at 2 30pm on February 10th 2021, Wednesday my left arm hurt all night. the nurse said not to take any Tylenol after the shot so I didn't. My left knee and other joints also hurt, I was unable to sleep. Left arm was very sore all the next day on Thursday  2/11/2021. Chest tightness as well, but that was over by Friday.  On Friday, I took Tylenol that night and didn't feel as sore but I had a mild headache. That Saturday I woke up with a headache, I took some Advil to help with the body ache as well. Did not sleep very well that night. Woke up at 4 am unable to breathe, I think I was extremely congested. Went to bed with slight nausea feeling. Took Advil again on Sunday 2/14. Headache finally went away and overall body soreness went away, but I had another bloody nose. I don't remember what day the first bloody nose happened. Monday February 15th, I had two bloody noses and felt nauseous before and after I ate. I didn't write it in my notes, but I remember that I also had a fever at this time.  After the 2nd dose of Pfizer, two weeks later, It was not as bad. I had more arm soreness, lethargy for a few days. No fever or previous symptoms. Joints really hurt again. I got a COVID-19 test, negative. I noticed some numbness and tingly in my left foot and left hand. I had previously had a cortisone shot for my knee and after the 2nd dose Vaccine it negated the effectiveness of it. On May 26th 2021 I had an annual visit with my doctor and briefly discussed everything but didn't raise any alarms. A few weeks after that, on June 7th, I was instructed to go to ER my left face, from my mouth and ear it was numb and tingling. I had woken up and my upper left lip was slightly swollen and burning. The left part of my throat was numb. I also had left arm numbness starting from upper arm all the way down to hands. The ER ruled out a stroke, did not know what caused the numbness. While at the ER I also started to feel it in my right arm and foot. When I left ER I still had the numbness. Possible migraine explanation, but no definite answer from ER Doctor. Saw dentist on June 8th, he did not see any type of nerve damage, some slight gum redness. No medications prescribed. On June 9th I saw my doctor again for the numbness in my face, and she wasn't sure what it was. Possibly signs of shingles or bells palsy but no other rashes or drooping. Prescribed a virus medication for Bells Palsy and Shingles to help with numbness and an ointment for dryness and redness around corner of mouth. Follow up tele-health visit and wanted a cervical MRI. Vision became more blurry. Numbness in the right arm after taking antiviral on June 10th. By Thursday June 17th the right forearm and left forearm were matched in numbness. July 19th, had another MRI. Didn't really find anything significant that would explain the numbness. July 26th 2021- still having numbness continual in hands and feet and face, affecting my work and sleep. Doctor ordered EMG, everything was fine, no nerves were blocked. In March of 2022 I was still speaking with Neurologists, and she still was at a loss.
Neck and back pain, hand, wrist, knee, ankle and shoulders. X-rays were done on hands on 3/21/2000 plus blood tests which revealed I was HLA-DR4 (+). Also, positive for Lyme.
Patient complained of shortness of breath, heat to neck area, nauseated, patient appeared flushed. First set of v/s taken by Dr. at 2:45. BP checked by nurse at 150/80, rep at 22, O2 was administered 2.5 liters. Patient stated she felt better. Patient complained of dyspnea, patient looked flushed at this point EMS was called. Patient taken to hospital for further evaluation. last v/s taken at 2:55 pm bp @130/80, apical pulse at 68, resp at 22.
fever 104 max 2 1/2 inches lt arm w/2cm erythema & induration;
Approximately 2days after 2nd day of Pfizer I fe leopard a white noise sound in my ears . Went to ENT and he said it is Tinnitus. I have never had this before and it has been persistent since I received vaccination
With in 30 minutes I felt heart palpitations  and chest pressure.  Causing flushing of face and fullness in my head.  Being an ER nurse I went to my hospital and spoke with the charge nurse and got vital signs done.  Other than increase BP I was fine.  I opted not to be seen.  With in less than 30 minutes I was fine.  That night about 11 pm I had fever of 101 chills  and shaking, aching all over.  Lasting most of the night. Next morning I felt better taking Tylenol and Motrin.  The next night fever of about 101 chills and shaking.  Lasting several hours.  Again by morning I was fine,   I am A neg blood type.
Patient had just received a Flu vaccine followed by a Covid Vaccine. She told the vaccinator she was feeling dizzy . She was sitting in the chair and appeared to passout, never lost conciousness, conversive at all times. Patient reclined to floor, then moved to another room . BP =93/63 HR=70. Received water and graham crackers . Patient left with mother 30 minutes later.
No additional AE's noted; temperature excursion for frozen products; This spontaneous report was received from a nurse and refers 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 21-APR-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose 1, lot # T013536, expiration date: 17-OCT-2021 (strength, route of administration and exact dose were not reported) for prophylaxis.  On an unknown dates, the dose of the vaccine was exposed to temperature excursion at 14.1 Fahrenheit degrees (F) for 1 hour and at 26 F for 2 hours. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported (linked report: 2104USA007089).
Four hours after receiving the injection I developed pain in my arm. Not at the injection site but down my whole arm.  I took ibuprofen about seven pm. The pain lasted all night. It is still hurting today around noon, but is subsiding. I can now raise my arm about half way up without too much pain.
On January 12, at an unknown time, a family went  to receive COVID-19 vaccines.  They were told that everyone in the car could get vaccinated. The Pfizer BioNTech Covid-19 vaccine is not authorized for use in those who are less than 16 years of age.
Hot to the touch; Itch; Body aches; rashes on hands and face; Fever; Joint pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot to the touch), PRURITUS (Itch), PAIN (Body aches), RASH (rashes on hands and face) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia. Concomitant products included MILNACIPRAN HYDROCHLORIDE (SAVELLA), DICLOFENAC POTASSIUM (VOLTAREN ACTI) and TRAZODONE for Fibromyalgia.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING HOT (Hot to the touch), PRURITUS (Itch), PAIN (Body aches), RASH (rashes on hands and face), PYREXIA (Fever), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). At the time of the report, FEELING HOT (Hot to the touch), PRURITUS (Itch), PAIN (Body aches), RASH (rashes on hands and face), PYREXIA (Fever), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details pertained to the events were provided.
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. Link case: 2018SA396614 (same reporter). This case involves two patients of unknown demographics who experienced received vaccine PENTACEL there was a temperature excursion (fridge went down to 29 Fahrenheit for 75 minutes). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patients received a dose of suspect PENTACEL lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown if adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.