chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began to feel flu-like the afternoon of the shot. I had chills, fatigue, muscle and joint aches. I slept all evening and the entire following day. The next day, Wednesday April 6th, I was still feeling the same symptoms. In the evening of that day I began to get shaky and sweaty  and feel a little light headed. I also had extremely severe cramping on top of my thighs and shins, to the point that I could not stand up and was in extreme pain. At that point I took 1/2 a hydrocodone tablet, which began to help with the pain, but decided to go to the ER because I wanted to make sure that the shaky, sweaty, light headed sensation was not related to any heart involvement, and also to ask about how to manage the pain without hydrocodone which I do not like. I was also experiencing nausea, and vomited prior to going to the ER, but that is a regular symptom of my vertigo and I believe it was caused by my vertigo being triggered from the pain.  I took 4mg of zofran prior to leaving for the ER. I believe I went to the ER around 7. I was started on an iv of saline with additional zofran after being taken to a room at the ER. The fluids and iv zofran helped alleviate the nausea. They sent a transmission from my pacemaker for review and no abnormal heart activity was found. As the hydrocodone began to wear off, the cramping in my legs began to return and I was given toradol via iv. This took the edge off the pain and I was discharged and able to sleep. The following day I still had extreme fatigue and muscle/joint aches but it was much more tolerable. I still have light fatigue but am mostly recovered at this point.
Headache, NauseaVomiting,  fatigue, sore right arm Narrative:
Painful lower left torso and waist and too sore to sleep; Sore left leg; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021, the patient experienced extremely painful lower left torso and waist, then very sore left leg which continued through whole day and at the time of this report and was too sore to sleep. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included steroid PAK and tylenol. The clinical outcome of the events too sore to sleep, sore left leg, painful lower left torso and waist was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Moderna Covid 19 Vaccination dose #2 given 8 days after receiving dose # 1. No adverse symptoms were noted
The afternoon after the Flu shot my left arm was painful I took acetaminophen. It was swollen for a couple of days and the area still sore. My shoulder still hurts when I lift my arm and certain movements. I have taken ibuprofen, hot and cold pads. I have done some stretching exercise even if it hurts. I feel relief while resting and don't raise my arm.
Patient got sicker than a dog; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who got sicker than a dog (illness), after patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date (year ago), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date (year ago), the patient got sicker than a dog (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Additionally, it was reported by reporter that, patient will never take it again.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  It was reported that, patient got sicker than dog for 2 weeks but event outcome was not reported for illness at the time of reporting. There will be no information available on the batch number for this case.
Patient reports extreme fatigue and has been sleeping all the time since receiving vaccine 2 days ago. Feels weak and slightly feverish. Not sure but believes its related to vaccine.
Patient experienced voice hoarseness and slight chest tightness about 15 minutes after receiving vaccination (history of experiencing following previous doses as well that was relieved with prednisone/Benadryl). Patient took a 100mg dose of Benadryl and remained in the pharmacy for a total of 45 minutes after vaccination. Symptoms subsided and patient went home. Followed up with patient 3 days later and stated no adverse reactions occurred.
fever up to 103.7 for 8 hours unconsolable crying for 8 hours vomiting x 20
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a (bottle-fed) female who on approximately 08-MAR-2008 was vaccinated with a dose of ROTATEQ. In approximately March 2008, the patient experienced diarrhea for about one month. The patient's parent contacted the physician's office via phone call for medical attention. The diarrhea resulted in about 10 diapers per day. The patient's diarrhea persisted. It was noted that the child was received NUTRAMIGEN. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporters registered nurse indicated that she had no more information as this was a random phone call for the event. The patient was referred to her pediatrician. No further information is available.
Extremely sore arm 3 days Redness and swelling at injection site Lump at injection site 3 days of nausea 9days post vaccination return of swelling and lump at injection site Itchiness at injection site
were sick from something they had ate; missed the second appointment; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (were sick from something they had ate) and PRODUCT DOSE OMISSION ISSUE (missed the second appointment) in a male patient of an unknown age 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 ILLNESS (were sick from something they had ate) and PRODUCT DOSE OMISSION ISSUE (missed the second appointment). At the time of the report, ILLNESS (were sick from something they had ate) and PRODUCT DOSE OMISSION ISSUE (missed the second appointment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.   Reporter did not allow further contact
pt recv vax & w/in 24hr post vax exp pruritus;sx cont
Hives (Urticaria) within 12 hrs initial onset. Developed into full body hives within 48 hrs and left sided facial swelling, eye swelling ptosis. Was given 4ml doses of BENADRYL 6 hrs apart. Patient was admitted to Hospital on 3/30/18 at approximately 10:30 pm by parents transport. Increased facial edema, tachycardia +, crying and increased fussiness present. Patient was given a EPIPEN (epinephrine shot) and 2 injections of DECADRON. Released from ER around 1am. Returned the following morning 3/31/18 due to lip swelling and increased hives. Not responding well to BENADRYL. New prescription of ZANTAC and increased frequency of BENADRYL given. Following morning 4/1/18 increased hives but no facial swelling. Symptoms began to dissipate on 4/2/18 and was cleared on 4/3/18. Saw pediatrician who stated it was OK to stop medications and ordered allergy specialist apt.
Pt recvd vax 1APR92 & pt had a neg anti-HBs; No further details were provided;
Chills the first day which wasn't bad. The second day, had headache in back of her head and the ringing in both ears started and has continued for 3 weeks.
Pt in ER 1/24/11 diagnosed with febrile seizure. In office 1/28/11 noted to have (R) OM.
Pt seen 6/14/14 presents with left upper arm and left forearm upper 1/3 with diffuse swelling and erythema (+). No pain, no tenderness. Neuro exam (NL). Difference in arm size Lt > Rt. Improving with time. Phone call 6/16/14. 7/17/14 5pm p. call swelling much better.
Pain at injection site within approximately 6 -8 hr of injection, then by following day developed erythema and induration along medial aspect of arm along with discomfort. Symptoms have gradually improved and today has only minimal hyperemia along medial aspect of arm.
This is a spontaneous report from a contactable Physician via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The doctor stated that she received body aches as an adverse reaction from her patient. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
After 30 minutes of evaluation, client began to cough and feel her throat swelling. She then retrieved her own supply of Benadryl and took it. After 15 minutes, the patient was still coughing but used her own inhaler which immediately had a positive response. Patient was observed an additional 30 minutes until symptoms resolved. Client agreed to follow up with PCP and follow recommendations. Client stable when departed.
No additional AE reported; A physician called to report that an expired dose of ROTATEQ was administered. No additional AE reported, no PQC reported. Vaccine did not experience a temperature excursion.; This spontaneous report was received from a physician referring to a 8-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 29-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral, lot number 1707467, expiration date 22-MAR-2022 (dose not provided) for prophylaxis (expired product administered). No adverse event was reported. The vaccine did not have any previous temperature excursion.
Child was giving the adult dosage of 0.3mL, was monitored with no adverse effects
Chills, high fever (102) first and second nights.  Tylenol helped.  Fever broke around 2 am second night.  Starting Mar 18, muscle aches in back.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild, Additional Details: Patient stated that she traditionally has needle phobia. She was very worked up after the shot and became feeling dizzy/light-headed. Walked patient over to the bench so she could lie down flat, but we did not make it to the bench before she became week and passed out. She never became unconscious. Pharmacist blunted the fall and held patient head. Soon patient immediately vomited. Felt better and did not want 911. She rested on the bench for 30 minutes and began to feel better and left.
Information has been received on a patient who was vaccinated with two doses of varicella virus vaccine live and failed to seroconvert. Unspecified medical attention was sought. Follow up information from a physician indicated that there was "no immunological response-titers negative. The patient did not have any adverse experiences.
62 years old patient received a Fluzone High Dose, no AE; 62 years old patient received a Fluzone High Dose, no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to cases 2020SA057096 and 2020SA057137.  This case involves a 62 year old patient (unknown gender) who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination, on an unknown date (PT: Overdose and Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.   It was actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Information on the batch number was requested.
Rash, all over body, erythema multiforme.  ? if related to vaccines.  No vomiting or diarrhea.
30 year old female reports left arm pain, swelling, itching on 1/8/21. She received the Moderna Covid-19 vaccine on 1/2/2021. She did not have any immediate reaction. On 1/8/21 she woke up with left shoulder and upper arm soreness. Over the next day pain worsened in her left shoulder, left upper arm to elbow. She then started having left wrist discomfort. + swelling in her left deltoid at site of injection with redness. + swelling at left axilla with tenderness. Pain was moderate to severe 6/10 pain on 1/9/21. No relief with Tylenol 1000 mg at that time. She reports + improvement the past 2 days. Improvement of pain and lymphadenopathy. Denies shortness of breath, wheezing, chest pain, palpitations, throat itching or swelling. She was able to exercise over the weekend, working out using both arms without difficulty. She is working full duty without difficulty.
As of a month later I have been experience bouts of pain in the nerves of my left elbow and my left ring finger going numb. I have no previous issues with this and the symptoms started the day of injection. While it has become less frequent I still feel it sometime (last as of this morning). It last for an hour or two then stops. There is no obvious pattern to when this pain will occur.
slight allergic, my lips were tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (slight allergic, my lips were tingling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA ORAL (slight allergic, my lips were tingling). On 08-Feb-2021, PARAESTHESIA ORAL (slight allergic, my lips were tingling) had resolved.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Cellulitis and Lymphangitis left arm. IV antibiotic 6/08-6/12, PO antibiotic until 6/21/06.
Developed pitting edema in BLE 1 week after booster vaccine with Pfizer. This worsened worsened to anasarca and SOB. After no improvement ran initial serum labs on 12/17 and urine labs on 12/21. After recognizing I was developing some sort of renal failure I was seen by doctor immediately on the 21st of December 2021.  I was started on 70mg of steroid daily, protonic 40mg daily, Lasix 20mg daily and potassium chloride 10mg daily, weekly lab work, and follow-up in 2 weeks. If my condition was to worsen, I was to go to contact him.  I was officially diagnosed that day with nephrotic syndrome. He stated that he also believes that givenI was healthy and w/o disease or infection before, this may be Minimal Change Disease.  Since then I have improved and an have no further proteinuria. Currently on 30mg of prednisone and to taper down starting next week. My renal labs are almost 100% normal again.
swollen eyes after first Covid vaccine, after 2nd dose of Covid vaccine, my entire face became swollen.  I took benedryl and saw my doctor on March 8, 2021, and was told to take Claritin & Pepcid and the swelling would go away.  By then, just my eyes were very swollen.  I have double vision and was diagnosed with Thyroid Eye Disease after several differenct doctor visits.
Information regarding Flumist nasal solution was received from a consumer regarding 7 year old female patient who experienced stuffy nose. At 7 years of age, the patient received a dose on 12/15/03. Patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. The patient experienced stuffy nose on 12/16/03. No additional information was available at the time of this report.
Babysitter called on 6/19/01 and explained patch of little tiny pinhead size blisters grouped together and area was reddened and warm to touch. Child was brought in on Monday 6/21/01, to have TB test read and it still looked the same but not as much and still warm. The patch was > 3" X 1" and still sore. On 6/25/01, still the same.
Pt broke out with hives on lower abdomen, lower back, and inner thighs. Given IM Benadryl and Epi at ER. PO Benadryl steroid Tx x 7 days
Symptoms began after 1st pill. She reports taking all four. Transfering sensation, abdominal cramps, diarrhea, nausea, ulcer rupture.
Tendon pain around major joints (knees, elbows, ankles, hands), muscle pain, joint pain, fatigue, sun sensitivity, chills and sweats, body temp regulation issues (in hot weather), weight gain, brain fog, arthritic appearing joints, hand and foot swelling, fingertip numbness, "mottled" red skin, rashes, dry skin, dry eyes, bruise easily, any skin injury takes forever to heal up
04/07/2021 in the morning,  I started feeling bad at night,  severe muscle aches,  really bad flu-like symptoms, I was extremely nauseated,   weak,  I just wanted to stay in bed. For 4 days, I really did not eat. I only got up to pee. On day 6,  I was sitting up,  I called my doctor. I told her the worse symptom was the nausea. She prescribed me ondansetron odt. I was left with weakness and muscle pain. The 1st night, I vomited and the next day I vomited. once I got rid of the nausea .  I was able to eat a piece of toast. By day 7, I was eating. I  did not feel good for 6 weeks.  By day 10 day and day  11,  I was trying to go back to work with a lighter load, I worked part-time, like 2 or 3 hours a day. That's all I could do. I would come into the house and just collapse. And by day 14, I was doing a full day but feeling pretty terrible.  At the 6 week mark,  I actually felt back to normal.
This spontaneous pregnancy report as received from a Licensed Practical Nurse refers to a 15 year old female patient with no drug reactions or allergies. On 16-AUG-2013 the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot # 673256/0629AE, exp date 16-DEC-2014) intramuscular. There was no concomitant medication. The patient learned that she was pregnancy on 22-AUG-2013 (LMP of 22-AUG-2013 and EDD of 29-MAY-2014). It was reported that the patient was in 6 weeks, 4 days gestation. The patient saw an unspecified Obstetrician/Gynecologist (OB-GYN) physician for her pregnancy. No treatment was given for the event. The pregnancy outcome was unknown. No adverse effect reported. Additional information has been requested.
pt states on 16JUN93 devel what thought was a typical shot react w/lt arm & shoulder soreness; soreness lasted for several wks & extended into the lt shoulder area; booster may have stimulated pre-existing inflammatory condition;
Patient has had severe radiating arm pain, especially when lying down. Has continued for the last three weeks Described as almost a muscle cramping feeling of severe pain. Has not been relieved by Muscle relaxers or heat. Somewhat relieved by Ibuprofen. Recommended patient try Lidocaine based OTC cream and Apply Sparingly at night Went to Orthopedic Doctor and may get MRI if unrelieved.
pt recv vax 19APR95 had onset of cough & wheezing @ 130AM 20APR95; pt was severely ill, requiring hourly nebulization of bronchodilators by 24 hr p/vax give; RR60, had diffuse wheezes, dec air entry, retractions;
This spontaneous report was received from a registered nurse who was notified by a field representative of a page referring to a male patient of unknown age. The patient's concurrent conditions or concomitant medications were not reported. It was reported that the patient was an active and healthy child. On an unspecified date, the patient got vaccinated with GARDASIL (dose number, dose, frequency, anatomical location, lot number and expiration date were not reported). It was reported that since receiving the vaccine, on an unspecified date, the patient could not go to school or play sports, some days he struggled to just get out of bed and that his life had changed. It was also reported that on a good day he has 5 seizures a day and that on a bad day he can have up to 30. He was in constant pain and had severe headaches. He also had issues where his throat closes up and he passes out because he could not breathe. His regular doctors and the hospital said they could not help the patient or did not know how to treat his vaccine injury. Therefore, the parents were seeking for homeopathic treatment. They did not have choice and felt that it was on the patient's best interest. However, that route was extremely expensive. The patient was from a one income family and had 4 siblings. He can not be left alone, and they have had to completely change his diet which causes the grocery bill to double, and they were beginning to receive the mounds of bills from his doctor and hospital visits. The outcome of the events was unknown. Upon internal review, can't go to school or play sports, struggles to just get out of bed. Live for his active child has changed was considered to be disabling and loss of consciousness and Seizures were considered to be medically significant events. Additional information is not expected as the reporter did not give consent for follow up.