chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she wakes up with her back muscles exhausted; Her muscles continue to be bad; she wakes up with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MUSCLE DISCOMFORT (Her muscles continue to be bad) and FATIGUE (she wakes up with fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MUSCLE DISCOMFORT (Her muscles continue to be bad) and FATIGUE (she wakes up with fatigue). The patient was treated with IBUPROFEN for Adverse reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MUSCLE DISCOMFORT (Her muscles continue to be bad) and FATIGUE (she wakes up with fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications was not provided.   This case was linked to MOD-2021-214683 (Patient Link).
01/06/22 presents to ED for "Anemia" "evaluation of low hemoglobin". PMHx of "diabetes, hypertension"
Infant had approx 40sec apneic episode while being held in mom's arms;no hx of convulsive movements,fever,vomiting or crying spell with assoc. Spontaneous resolution of breath holding spell occurred;pt then seemed nl.
Patient experienced neck/shoulder/jaw/mouth stiffness and chest tightness. Patient went to see Dr. and received a muscle relaxer.
Shortly after second shot I started having heart palpitations, shortness of breath.  Also pain on my left  hip/leg.  After several tests we also found out my thyroid had gone hyper which wasn?t allowing nutrients to get to my body.  Especially calcium which quickly turned my hip/femur into liquid edema within weeks.  Diagnosis with Transient osteoporosis with no previous history of osteoporosis or family members.
3 hrs p/shot pt woke up high pitch screaming, collapsed, lips turned blue-skin gray; pt could not be aroused; 1-2 mins jerking; eyes rolled back sz; 105-106 temp; very tired 3-4 days; 5 sz following; very sick following-resp pro, allergies;
I had a really bad day after the second dose. Horrible migraine headache that built as the day moved on.  As a rule, I do not get migraines and whenever I have gotten a headache I've not had a  sensitivity to light or sound, like I did yesterday.  It was just miserable. Lots of body ache and a generalized feeling of sickness, similar to influenza or food poisoning.  I had no energy.   My arm at the injection site hurt constantly without even being touched all day and I could not sleep on my left side due to arm pain around the injection site. The arm pain from the injection site, occasionally radiated to my elbow joint , depending on how I moved my arm.  It is still sensitive today, two days later, and has a sensitive swelling in the area where the injection occurred. I do not feel bad today, but I do feel like I am 100% yet, either, but I feel a LOT better than I did yesterday.
One day post vax left upper arm became pink, swollen and warm to touch from shoulder to elbow. Treated with oral Benadryl and ice. Pt seen by ER physician to make sure it was not cellulitis. Pt continued to treat with oral Benadryl and swelling started to decrease. Six days post vax the pt is doing much better but still some swelling present.
Second dose.  Pt is severely intellectually disabled at baseline but can walk.  W/in 12 hours had fatigue and sleeping 2- hours per day.  W/in 5-7 days had legs collapse, can't walk, severe pain in legs/feet, tremors, myoclonus.  Has feet swelling and is losing hair.  Responding to time and GPN + Doxepin.  My working diagnosis is auto-immune small-fiber PN.  (Variant GBS)
Patient reporting multiple oral sores and fever blisters on lips  3 days after co-administration of flu and covid vaccine
Pt ok for 2 days after vaccine admin. aft 2 days pt. developed rash/itchy/hot swollen area. Went to ER and had cellulitis. Treated with KEFLEX and getting better.
I went to my physician's office to receive the Shingrix vaccination.  I received the immunization  at approximately 2:00 pm.  By 8:00 pm the same day, I had chills and went to bed.  During the night, I woke up with a 103.6 temperature.  I took over the counter medication to reduce my fever.  The second day, I would have chills and run a temperature at around 101.  Again, I took over the counter medication.  The second night, I had a night sweat that was so fierce, my entire bed including sheets, blankets and comforter were completely soaked.  Today is day 3 and no fever, but now I feel cold and weak.  I sincerely regret taking this vaccination and will recommend to family and friends to refrain from taking it.  I don't think I had a "mild" reaction is a fever of 103.6.  If it went any higher, I would have gone to the emergency room.  I had shingles in my early 20's.  I'd take that again any day over this vaccination.  I hope I am going to feel better soon.
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  The vaccines had remained in the freezer at -24 degrees F,  up until the day of the vaccine clinic, then each vial  was added to refrigerator as needed. The temp of the refrigerator was 4 degrees C.  No Treatment information was reported.   This case was linked to MOD-2021-412773 (Patient Link).
After taking the Vivotif (Typhoid vaccine) on Monday, September 16th and Wednesday, September 18th, I began to feel stomach cramps at approximately and then had a low grade fever after going to be that evening at approximately 11:30PM.
50 year old female with h/o breast cancer s/p b/l mastectomy and reconstruction came to ER with AMS and breast pain. S/P recall of implants, underwent expanders and reconstruction in September of 2021. She was recently admitted with cellulitits and removal of implant complicated by left percutaneous drain sinking into the S/C tissue. She was noted to be Covid positive .
Pt states after receiving PREVNAR 13, he developed swelling, itching, and rash in testicle/scrotum area. The itchy swelling has now subsided, but states he still has a raised rash (like vesicles) no drainage.
I had a Missed Miscarriage diagnosis about four weeks after the vaccine. I went to my doctor and it looked like the Embryo had not made it past six weeks. It was my eight-week appointment. I was diagnosed with evidence of Thyroiditis in 09/07/2021. My TSH was 2.4 and on 10/16/2021 it was 2.9.  My positive pregnancy test was on I had not had any bleeding or anything it was discovered during a regular scheduled appointment. Due Date: June 2022 Pregnancy :2nd
w/in 24hr of vax pt had a positive breathalyzer test for alcohol;pt adamantly states that did not drink alcohol;
This spontaneous report was received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Mild nausea; Weird odor in her nose that smells like gasoline; Mouth food tasted sour; Dizzy; Black dot in her right eye; Muscle face ache; Chills; Toothache; Generalized muscle ache; 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 41 year-old female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Lot number: 30145BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Black dot in her right eye" (ongoing), notes: in the past she has had complaints of a black dot in her right eye. There were no concomitant medications. The following information was reported: NAUSEA (non-serious), outcome "not recovered", described as "Mild nausea"; NASAL ODOUR (non-serious), outcome "unknown", described as "Weird odor in her nose that smells like gasoline"; DYSGEUSIA (non-serious), outcome "recovered", described as "Mouth food tasted sour"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy"; EYE DISORDER (non-serious), outcome "unknown", described as "Black dot in her right eye"; FACIAL PAIN (non-serious), outcome "recovered", described as "Muscle face ache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; TOOTHACHE (non-serious), outcome "recovering", described as "Toothache"; MYALGIA (non-serious), outcome "unknown", described as "Generalized muscle ache".  No follow-up attempts are possible. No further information is expected.
Had the injection early AM, by 2:00 pm feeling ill BP dropped increased temp nausea called 911 and was transported to hospital.
pt recv vax 8MAR96 & 15MAR96 pt devel  fever 105, looked pale, was very ill & had runny nose & breathing heavily;21MAR96 broke out into a characteristic measles-like rash;MD also saw koplik spots;pt recovered from severe case of measles;
Case number PHEH2015US026932 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 24 Oct 2015. It was reported the FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Somnolence, pain in left arm, pain of left side of the body, problems with eyesight, feeling warm, annoyance, dizziness, weakness, liver and gallbladder pain.
a few minutes p/vax pt became pale began vomiting, lethargic, eyes rolled back; no pulse;
Onset: 4/28/2021 Sx: fever, chills, cough, SOB, fatigue, myalgias, h/a, loss of taste & smell, sore through, runny nose & congestion. Brief LOC today with brief mild disorientation and confusion immediately after.  Social: no reported exposures Immz: Pfizer #1 = 1/19/2021 & Pfizer #2 = 2/10/2021
Sore arm; Slight temperature; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Slight temperature) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (MSG), Blood pressure high, Arrhythmia, Diverticulitis and Anemia.   On 12-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Slight temperature) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Mar-2021, CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Slight temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. treatment to the event given as rest , fluid drink.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Patient demographic details, medical history, product lot/ batch no and event stop date of chill  was updated from not recovered to recovered..
Extremely high fever, 104+ for over 8 hours, hallucinations, entire body almost seizing.  Couldn?t move arms or legs at times.  Could not get out of bed or even reach for my phone, was difficult to talk from body uncontrollably shaking.  Took Advil 2 right after the shot, 3 around 9pm 3 around midnight another 3 at 4 am.  Nothing brought down the fever.
She presented to me nearly in tears, using a cane on 12/12/17. She has been in terrific pain, to the point of not being able to move since she was discharged from the hospital. She has required more of her medications (which she had previously been on very low doses) and has required prednisone just to be able to move. She is very angry and upset that she was forced to have the flu shot and the pneumonia (PREVNAR 13) at the same time and feels the combination has caused a prolonged flare of her discoid lupus which had previously been very stable. She felt better on 12/18/17 and was walking without her cane on this date. She was doing much better. However she was taking prednisone. On 1/24/17, pt presents to the office again for terrible pain and she is incredibly frustrated with her pain and lack of mobility, she does not want to be on any more medications, but she can't move without pain unless she is on prednisone. She would like me to report this to the vaccine administration personnel. She has been in pain now for 4.5 months, only able to move if she is taking the prednisone. She is very weak, she continues have limited movement and pain. Hospital could not tell me which flu vaccine the pt received. I have scanned in the information provided. There were 2 Seqirus vaccines options in the drop down menu on this site. I chose the quadrivalent AFLURIA. The other was one I had not heard of in this area, which is why I did not chose it. My nurse spoke with staff at hospital and she could not provide us with the information we asked for.
Patient is immunocompromised due to being on Humira for Crohns. Patient got her 3rd Pfizer Covid vaccination on Monday at 11am at the pharmacy. At 4am the following morning patient states arm started to hurt and she developed painful red swelling the size of a quarter on Tuesday. Patient was seen on Wednesday at 230ish with swelling and well defined ertyehma on left arm at injection site measuring 5cm x 6cm. Patient concerned for infection, provider and collaborating physican concerned for allergic reaction. Treated for both with Keflex 50mg QID x 10 days and Prednisone 40mg Daily x 5 days. Patient told to follow up with PCP asap and ER if symptoms worsen.
red bump; headache; Red; little bruise; swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (little bruise), VACCINATION SITE MASS (red bump), HEADACHE (headache), VACCINATION SITE SWELLING (swelled) and VACCINATION SITE ERYTHEMA (Red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U06M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE BRUISING (little bruise) and VACCINATION SITE SWELLING (swelled). On 21-Feb-2021, the patient experienced VACCINATION SITE MASS (red bump), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOCAINE HYDROCHLORIDE (NEOSPORIN + BURN RELIEF) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE BRUISING (little bruise), VACCINATION SITE MASS (red bump), HEADACHE (headache), VACCINATION SITE SWELLING (swelled) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.
A very pointed headache just above my left eyebrow. Has lasted about 2 days. No treatment this far. No further treatment has been followed, waiting for the headache to diminish. Which had begun slightly.
Sharp pain, "achiness", with discomfort that has not gone away. Muscle weakness with loss of range of motion. Physical therapy with massage.
Contracted COVID-19 badly; Contracted COVID-19 badly; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. This consumer reported similar events for two patients (her parents). This is the first of two reports. A female patient (reporter's mother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as singe dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hospitalized for 5-10 days in mid Feb2021. The patient had to receive antibiotics as well as plasma during treatment process. The patient's concomitant medications were not reported. The reporter stated the patient was, as of about 3 weeks ago, fully vaccinated with the Pfizer vaccine. She was trying to be cautious since her mother contracted COVID-19 badly. The outcome of the event was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021888506 same reporter/drug/AE, different patient
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received Pfizer-BioNTech COVID Vaccines on 1/30/2021 and 2/20/2021.Pt presented from outside residential facility after sliding out of wheelchair and presented to ED with SOB. Pt was hypoxic en route with EMS, and was tachypneic, tachycardic, and hypoxic in ED. Was placed on 2L NC. Workup revealed Lactic 2.2, BNP 140, VBG O2 sat 43%, INR 1.3, Hgb 9.0, and COVID+ swab. Pt was admitted to floor and experienced significant deconditioning. He was unable to wean from oxygen.  Pt was to be discharged to hospice as dyspnea worsened and pt was transitioned to comfort care. Pt expired 7/8/22. Pt given decadron.
After receiving the vaccine the patient had fever, loss of speech, irritability. Before receiving the vaccine the patient was talking and saying words like a normal child would do at that age. After receiving the vaccine the patient would not speak and many ear infections. The patient had multiple ear tube surgeries and adnoid removal and attended years of speech therapy. The mother also developed recurring shingles around the time of the vaccine was administered to the child.
Arm sore, arm swollen down to elbow, red, hot to touch for 3 days. Day 4 started to resolve. No medical treatment sought.
Erythema multiforme; Swelling on the face; Full body rash; Joint pain; A spontaneous report  was received from a HCP concerning a 47 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events - Swelling on the face, Joint pain, Full body rash, and Erythema multiforme (medically significant event).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07-Feb-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  Four days after receiving the vaccine the oatient started experiencing swelling on the face, joint pain, full body rash and erythema multiforme.  Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events, swelling on the face, Joint pain, Full body rash, and Erythema multiforme were unknown.; Reporter's Comments: Based on the information provide which includes a strong temporal association and excluding other etiologies, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Joint pain, rash and facial swelling are consistent with the known safety profile of the product.
pt on 4/17/98 recv varivax.  rpt ``pt preg'' w/triplets prior to vax. 5/26 pt delivered premature, but otherwise healthy normal triplets
pt recv vax in FEB & MAR96 & pt level of varicella antibodies on 26JUN96 was 0.45 (not immune);
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium
Pharmaceutical product complaint; Tired; drowsy; Nauseous; Low grade fever; Arm Aching; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number K9L3M, expiry date 29th October 2021) for prophylaxis. This case was associated with product complaint.  On 31st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2019, less than a day after receiving Shingrix, the patient experienced tiredness, drowsiness, nausea, low grade fever and pain in arm. On an unknown date, the patient experienced pharmaceutical product complaint. On 2nd August 2019, the outcome of the tiredness, drowsiness, nausea and low grade fever were recovered/resolved. On an unknown date, the outcome of the pain in arm and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the tiredness, drowsiness, nausea, low grade fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient felt very tired, nauseous, had a low grade fever, and her arm ached. The reporter stated that, her mother-in-law reports the events started the same night and lasted about two days, with the exception of her arm which continued to hurt through the  weekend. The reporter consented to follow up. The reporter questioned batch number, stating three patients experienced sides effects to the same batch number. pharmaceutical product complaint filed for this reason.
Vaccine administration error. Pfizer (dose age 5-11) given instead of ordered Moderna (age 6 mo-5 years). Patient has experienced no adverse side effects 24 hours following injection when error discovered and disclosed.
Swelling and redness. Swelling (lump) about 2" in diameter. Redness in swatch about 2-3" wide and 7-8" long extending downward from point of injection. Moderate itching over entire swollen/red area.