chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Middle of the first night following the administration of the vaccine, I woke up with notable lower back and hip pain that became increasingly severe over the next 7 days. On Days 5-Day 7 I also developed a rash on my torso and chest. Did not itch or cause discomfort and resolved within days of onset. By the end of the week, I was literally forced to lay flat on the floor all day.  I was completely floor-ridden Day 7-Day 10 .  Pain was predominantly on the lower right side, hip, glute, thigh...had some tingling on top of right foot. This pain most definitely interfered with my daily routine.  Could not get comfortable, could not exercise, could not sleep well. I eventually took my  meals on the floor....only up to use restroom and shower.  From Day 10- Day 12 things very slowly started to improve with complete resolution by the 2 week mark.  It was as if the shot caused my muscles to spasm so badly that my back was thrown completely out?  Or I had some kind of systemic inflammatory process that triggered my low back pain? I NEVER suffer from this kind of debilitating back pain . Typically hike 3- 5 miles per day.  Was extremely bizarre timing and perhaps it was a coincidence? However the sudden onset of this issue in conjunction with the timing of the shot seemed important. I was able to treat pain with Tylenol, muscle relaxers, and lots of rest.
I experienced Bell Palsy on the left side of my face. My forehead could not move and my mouth could not move. They gave me Prednisone medication for one week and two one week period of of Valtrex due to my facial pain and tip of ear was burning, with intense pain. I also had high stress also due to my mother passing which occurred on 12-02-2021. I still get teary eyes, my facial strength is close to normal, still slowly seeing some improvement. I'd say I am about 90% recovered.
Night sweats, Nausea, vomiting, muscle aches and joint pain. Adverse reaction subsided after 3rd day.
Got COVID mid-May. Fortunately, effects mild (fatigue, fever, thick mucus). Did, however, do video appointment with healthcare provider within first few days as was worried about asthma. Paxlovid was prescribed (am native with underlying conditions) on 4th day but did not need to take as asthma was manageable. Symptoms improved over few weeks.
Pt complained of pain and heaviness of right arm since day of vax. The etiology of the arm heaviness was questionable. X-ray of right upper arm ordered with follow-up with neurologist if symptoms did not resolve.
Information has been received from a nurse practitioner concerning a female patient "between 9 years and 26 years old" who on 16-NOV-2009 was vaccinated with a 0.5 ml dose of 0.5 GARDASIL. On 17-NOV-2009 the patient experienced muscle pain. The nurse practitioner believed that the pain "could be viral". Unspecified medical attention had been sought. The outcome of the event was unknown at the time of the report. Additional information has been requested.
Patient states her lip became red and itchy. Shortly after, 2 canker sores appeared and her lip became swollen.
A non-serious spontaneous report of patients over 49 years of age received H1N1 LAIV was received from a non healthcare professional concerning a 53-year-old female. No past medical history or concomitant medication was reported for this patient. On 23-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with the medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
A report has been received from a physician via medical rep, concerning an adult male patient. No relevant history, concomitant disease or concomitant medications of the patient were reported. The patient had received nasal FLUMIST (intranasal). It was reported that the spouse of the physician tested positive for flu. Action taken with influenza virus vaccine, intranasal was not applicable. The outcome of the event of tested positive for flu was unknown. The reporter assessed the event of tested positive for flu to be non-serious.
11/29/21 presents to ED for "fevers, chills, myalgias, cough, and diarrhea". PMHx of " idiopathic membranous glomerulopathy, hypertension, hyperlipidemia, prediabetes, GERD".
Hospitalized 2/21/22-2/26/22 SOB, nausea, vomiting, diarrhea, body aches, fatigue, cough, runny nose, tachypnea, PNA, hypoxia, respiratory failure,
pt recvd vax & initially reported no problems; pt fainted-exp gen sz;supportive care & 911 called appeared post ictal;
Following administration of PREVNAR 13 the patient experienced pain in the left shoulder, not at the injection site. Pain has continued since administration and patient can not raise her arm without pain.
I was at work after lunch. I was feeling fine then felt lightheaded and my heart rate was elevated.   I laid down to rest and felt worse after an hour so I asked to have my husband come get me. I sat up to drink some water and felt very ill. I said I didn?t feel right and laid down.  I wasn?t able to move my legs or arms. I could move my hands a little. I couldn?t speak, but was able to respond with yes/no for the majority of the time.  My coworkers called 911 while working me up in the clinic where I work.  I was evaluated and then admitted with a dx of hypotonia and near syncope.   I was very weak and couldn?t speak or use my hands for several hours.  A few after that I could wiggle my toes. I was able to lift my legs after a few more hours, but very weak. I was able get up for the first time before lunch the following day with assistance from a nurse using a walker.  I had a headache that wouldn?t go away and continued to be very weak. I was discharged from the hospital 4/9/21 and still was not walking on my own.  After an extensive work up I was diagnosed with POTS. This does not fully explain all my symptoms from that time, but does explain my current symptoms that are ongoing.
Pt presented with red raised, hot areas on both arms at injection sites. Stated it like burning. Pt placed on AUGMENTIN 500/125 BID x 10 days.
reported symptoms of dizziness, sweating, diarrhea one hour post vaccine administration. 2.5 hours post vaccine administration, chills, tongue swelling to one-half of tongue, diarrhea.  Benadryl 25mg cap, 2 capsules , present to ER for further evaluation of symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of swollen lymph nodes in a 33-year-old male patient who received BOOSTRIX (batch number X4J7D, expiry date 16th September 2017). On 7th September 2015, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 9th September 2015, 2 days after receiving BOOSTRIX, the patient experienced swollen lymph nodes. On an unknown date, the outcome of the swollen lymph nodes was unchanged. The reporter considered the swollen lymph nodes to be possibly related to BOOSTRIX. Additional detail were received as follows: On 9th September 2015, 2 days after receiving BOOSTRIX, the patient experienced swollen lymph nodes on left collarbone. The patient stated his partner had a baby and so he had been sleeping in funny positions in hospital chairs, the past several days and this might also contributed in the swollen lymph nodes at left collarbone. The pharmacist already had the prescribing information and was transferred to speak with MI about AE.
swelling to soft tissue over the right side of the jaw with CT scan showing enlargement of right parotid gland, and extensive edema infiltrating the adjacent soft tissue. Positive pain, sinus headache, face tingling. Went to ER on evening of January 16th because of increase in swelling, IV fluids given, CT scan obtained, antibiotics and pain meds prescribed.
Vaccine administration error.  Given to 17 year old when indicated for 18 and older.  No adverse outcome immediately observed.  Following CDC guidance, the 2nd dose was scheduled as off-label use. Patient and parent informed.
I gave an extra dose of MCV instead of give Men B. Pt and parent were informed.
Patient developed macular rash, which evolved into urticaria on face, torso, and extremities within 24 hours of vaccination.  She never developed anaphylaxis.  She was given antihistamines and the rash resolved within 1 week.  Parents are now vaccine hesitant.
Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the wife of the patient. The age at the vaccination was not reported. The reporter was checking to see how long side effects last, her husband got his shot yesterday (the day of reporting) and had started have a low grade fever.
I was very ill; balance issues; very unsteady; extreme fatigue,; loss of appeitie; fever of 99-100.3; This is a spontaneous report from a contactable consumer (patient herself). A 64-years-old non pregnant non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 14Apr2021 at 14:00 (at the age of 64-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included type 2 diabetes and covid-19. Patient had no known allergies. Concomitant medications included levothyroxine taken for thyroid hormones, colecalciferol (VITAMIN D [COLECALCIFER-OL]) taken for bone density abnormal and multivitamin. Patient did not receive any other vaccine in four weeks. Patient did not tested for covid post vaccination. On 19Apr2021 at 07:00, less than 1 week post vaccine, the patient reported she was very ill, balance issues, very unsteady, extreme fatigue, loss of appetite and fever of 99-100.3. This lasted about 3 weeks. The patient underwent lab tests and procedures which included body temperature which was 99-100.3 on 19Apr2021, antibody test: result not reported and many lab test: result not reported on an unspecified date. The patient received treatment for events which included many labs including antibody testing. The outcome of all the events was recovered on an unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
we have two different strains of covid going around in my town already and I caught it.; we have two different strains of covid going around in my town already and I caught it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I am a type one diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "we have two different strains of covid going around in my town already and I caught it.".  Clinical course: The patient stated Last year the patient had hard year and the patient was type one diabetic and as like housebound cause of all the real bad covid and he patient just recovered from it and out ran it but it was terrible. The patient was a real bad diabetic and the patient have been having a rough time. Patient later stated Now we have two different strains of covid going around in their town already and the patient caught it. The patient had vaccinations and reporter think that kept from getting really sick cause patient is a type one diabetic and that really scary and was sick for 14 days. Its a terrible thing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician refers to a patient of unknown demography. On 14-APR-2014, the patient was vaccinated with VARIVAX (Merck) Lot # J009729 (Expiry: 29-OCT-2014) (dose, route and frequency were not reported) and M-M-R II Lot # J003787 (Expiry: 07-JUN-2015) which were exposed to 13C for 68 hours. No adverse effects were reported. No further information was provided. This case is linked to the case 1404USA008994 and 1404USA010752 (same reproter link). Additional information has been requested.
Mom spoke with nurse 7/25/17, at clinic to get vaccines. Mom reported with last round of vaccines 3/27/17 daughters left arm swelled up. Daughter had high fever. Patient was taken to emergency room. Was administered Clindamycin. Language barrier mom could not recall why Clindamycin was given. Mom reports once daughter received antibiotic swelling went away she felt better.
Lactose intolerant; Acid reflux; Loss of appetite; Headache; Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LACTOSE INTOLERANCE (Lactose intolerant), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and PYREXIA (Low grade fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue). On an unknown date, the patient experienced LACTOSE INTOLERANCE (Lactose intolerant) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). In 2021, DECREASED APPETITE (Loss of appetite), HEADACHE (Headache), PYREXIA (Low grade fever) and FATIGUE (Fatigue) had resolved. At the time of the report, LACTOSE INTOLERANCE (Lactose intolerant) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had not resolved.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality for the events of lactose intolerant, headaches, acid reflux, low grade fever, loss of appetite and fatigue with Humira was no reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a Pharmacist (R.Ph.) concerning a "young lady" who on 09-JUN-2008 was vaccinated with a first dose of GARDASIL (lot # not reported). There was no concomitant medication. The Pharmacist reported that the "young lady received her first dose of GARDASIL at the physician's office around 10 am this morning and slept from around 12 noon to about 4:15 PM". She was awakened by her mother as recommended by the pharmacist to check her status. It was reported that "she felt a little warm". The patient sought medical attention by contacting the pharmacist. The patient's present status was reported as "sleepy". Additional information has been requested.
Patient had pain in injection arm then felt nauseous without emesis. Symptoms subsided after 15 minutes of rest.
Mom was fine day of incident.  After caregiver left, I come to her home around 6, but lost my keys and didn't get there until about 7pm and found her blacked out and appeared to be passed away and dead weight on the floor.  Called paramedics and took her to hospital admitted to ICU told she had profuse bleeding around the brain and something to do with her heart and she wouldn't make it through the night and she was in a coma.. Somehow, the neurosurgeon and staff saved her life. She is now in a skilled nursing home. Can't walk without walker and assistance and can't return home.
Rash; tiny little red bumps developed on chest, stomach, and back. 11/5 (Fever 100-101; 11/3 and 11/4; since resolved). Child remains playful and alert; not itching. No sore throat symptoms; only rash.
Information has been received from a registered nurse concerning an approximately 13 month old male with no past medical history and no known drug allergies who on 6/24/02 was vaccinated with a dose of MMR II (640792/1381L). There was no concomitant medication. On 7/2/02 the pt developed a rash and fever (101 F). The pt was treated with Tylenol and Motrin. The pt sought medical attention. Additional info has been requested. It was also reported that two other 13 month old patients (WAES0207USA00624 and 0209USA02718) had similar symptoms following vaccination.
Symptoms began early afternoon after receiving the vaccine that morning.  Severe disorientation-?brain fog?.  Was unable to think clearly or do any normal tasks, so I made myself go to bed and hopefully?sleep it off?.  The severity of it subsided by evening.  Since then, I?ve experienced ongoing memory issues (left my dog outside in the cold for over an hour! - I NEVER allow him out alone! because I literally forgot).  Ongoing issues with forgetting what I was going into another room to do...  not at all normal for me.  Ongoing issues with suddenly finding myself in another part of the house, not recalling getting there nor how long I had been standing there.  It was after I had forgotten my poor dog outside that I called to cancel the second vaccine.    This has been extremely concerning! as I?ve never had any memory or concentration issues before receiving this vaccine.
Left knee was swollen, bright red, and extremely painful the day after the vaccine. Patient thinks she had a clot, even though she stated she was on a blood thinner. Symptoms resolved naturally by the next day.
The morning of 9/10 I woke up feeling achy, extremely nauseated and diarrhea twice.  I started taking Zofram to avoid vomiting.  I experienced really bad upper stomach cramps and pain with a lot of gas and burping.  It continued the next day and I went to the urgent care on 9/11 because the pain and gas was constant.   Doctor advised that vaccine had caused inflammation in my stomach lining.  She provided medication there at the urgent care and we waited 15 minutes and we saw that the medication was helping.  She advised that I buy Gas-X and tums and she gave me a prescription for Omeprazole.  I went back to the urgent care on 9/14 and advised doctor that I still had stomach pain and burping but its not as constant nor as severe but comes on randomly.  As of 9/15 I feel better.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 11-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Tingling down her arm, in her finger and palm; Swelling; Redness; This spontaneous case was reported by a health care professional and describes the occurrence of PARAESTHESIA (Tingling down her arm, in her finger and palm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). On 09-Jan-2021, the patient experienced PARAESTHESIA (Tingling down her arm, in her finger and palm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. On 23-Jan-2021, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, PARAESTHESIA (Tingling down her arm, in her finger and palm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.