chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On day/evening of administration, patient became fussy and irritable crying a lot, consolable but hard to quiet.  Sleeps max of 1 hour at a time.  In today, for exam.  He continues to be fussy, exam essentially normal, is consolable.  Taking Pedialyte was refusing formula.  Fussying today may be b/c of hunger pains.  Took sips of formula today.
Approximately 1.5 hours post vaccination patient reported coughing that was persistent, dry, hacking. No report of rash, swelling, hives, syncopy, fever, or shortness of breath. Patient did report some dizziness due to cough and buring in the trachea due to continuous cough. Referred patient to provider for care immediately.
Short temporary paralysis in right hand and fingers lasting a minute or two on 3 separate occasions. Not sure if related to vaccine. Happened to receive vax in right shoulder. Only reporting cause of recent story of Guillain-Barré syndrome. Didn?t connect it to inoculation, but never had the sensation before shot. Haven?t really felt it again for last month or so. May be nothing related.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:41 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Storage condition at the time of the excursion: frozen storage. Excursion duration was 1 month. 19-Nov-2021 was when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions. Treatment information was not provided.   This case was linked to MOD-2021-402935 (Patient Link).
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:  day 1-2-pain at injection site day 1-chills;day 2-chills, bodyache,nausea,joint pain, fatigue, ha
This is in follow-up to report(s) previously submitted on 7/8/2008. Initial and follow up information has been received from a physician and the mother of a 15 year old female (98 lb; height not reported) with attention deficit/hyperactivity disorder, allergies to penicillin, erythromycin, amoxicillin, azithromycin (ZITHROMAX), PHENERGAN with CODEINE, SILVADENE, and PROMETHAZINE with CODEINE), who on 19-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659962/1740U; site not reported). On 18-APR-2008, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 660387/1967U; site not reported). Concomitant therapy included ADDERALL TABLETS and ORTHO EVRA. It was reported that the therapy with ORTHO EVRA started "concomitantly with the vaccine" (reported as on 18-APR-2008, 20-APR-2008 and 21-APR-2008). On approximately 25-APR-2008 (also reported as 27-APR-2008 and "within one week of the vaccine") the patient developed hives all over her body. The next morning, 26-APR-2008, the patient had swelling in her hands and feet and the patient was treated with ALLEGRA and prednisone (unspecified) (also reported as treatment occurring on 27-APR-2008 in the ER). On 27-APR-2008, the patient developed swelling on her face, mouth and lips. On 27-APR-2008, the patient went to the emergency room for outpatient treatment and received a "steroid shot" (not further specified), BENADRYL and ZANTAC. "The itching persisted for a little while and then all symptoms resolved" (date unspecified). On approximately 27-APR-2008, the patient discontinued therapy with ORTHO EVRA. It was reported that the patient had no adverse effects or problems with the first dose of GARDASIL. The physician suspected that the reactions were related to either GARDASIL or ORTHO EVRA. Additional information has been requested.
Strong headache at back of head and body aches from about 10 hours after vaccination until about 28 hours after vaccination.  Body ache cleared up and headache lessened but off and on present since (now 17 days).  I don't normally get headaches.  Head has felt cloudy as well.  About 4 days after vaccination I had itchy red bumps on my left arm between elbow and wrist for an hour or two then that cleared up.  The next day I had the same itchy red bumps on the right arm, also clearing up on its own after a couple of hours.  Day 7 or 8 after vaccination I had the same thing on my left leg between knee and ankle.  The next day it was on both legs.  Always clearing up within a few hours.
Pt. received vaccines on 11/30/09, then another set of vaccines on 12/14/09. Not enough time between sets of vaccines. Pt. parent reported no adverse reaction.
Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL vaccine.  The patient experienced migraines after vaccination.  Patient went to emergency room but it was not known if the patient was admitted.  Additional information has been requested.
Day one: Minor pain in upper arm;  Day after for a week or two, loss of strength and unable to lift or exert use of arm above the shoulder. April: do not remember the first time for pain in upper arm. The pain usually would hurt at night at varies times. Pain continue to get worse day to day. April 30, 2921: Gone to bed @ 11:00 pm, At 1:30 am woke up with very severe pain in upper left arm, continued for 30-40 minutes. Took 1000 mg Acetaminophen, 100 Antihistamine, Minor pain continues through 3:00 am
On 11/13/2000 the patient presented with chicken pox. Additional information has been requested.
The day after vaccine woke up with chills, no appetite, not nauseated until about 2:00 PM.  Then arm was swollen for about 3 days, had two large red splotches on the arm in general.  Called PCP and she said that it was side effects.   She bled quit a bit and bruising at the site of insertion but does take a baby aspirin for prevention.  Chills the next day were uncomfortable, but then cleared after that.  The swelling went down after about 3 days.  The arm is still bruised but is healing.
Red-elbow to shoulder outer aspects arm swollen-surrounding site sore-(L) arm.
This spontaneous report was received from a licensed vocational nurse via company representative, refers to a seven patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed that on an unknown date in March 2015, the patients were vaccinated with M-M-R II HSA (strength, dosage and route were not reported) lot# K020188, expiration date 22-OCT-2016, that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, and the temperature was unspecified. No adverse effects were reported. The licensed vocational nurse also informed that the shipment were 20 doses of M-M-R II HSA, however just 7 doses were administered. Additional information has been requested.
1/28/21 5am headache and dizzy, 1/28/21 7am whole body aches, fatigue, unable to get warm. Tried to sleep and drink water throughout the day. 1/29/21 7am woke up feeling better with just a massive headache.
Inconsolable crying lasting 2 hrs and 50 minutes, she wouldn't even nurse which is really odd for my baby, she stopped right as I started gathering things up to take her to the emergency room. Right leg was red and swollen starting the following morning and remained that way for about 48 hours.
Swelling, redness, hot to touch (R) deltoid. 85 X 90 mm.
I had a slightly stiff neck and a headache. I took TYLENOL and got better. The stiff neck and headache lasted for a day or two. The palpitations started a couple days after I got diagnosed with COVID (January 24). They were 25-30 palpitations on a bad day. 10 on an okay day. 4-5 on a good day. That occurred for a month after COVID. It slowly got better. Bad days now are about 10. Okay days are about 4-5. Good days are now 1-2 episodes. When I say palpitations, they're more like 1-2 fast beats that is not sustained. It beats fast twice and it tickles a bit then goes back to normal rhythm. Still having palpitations, but they're not bad.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 51-year-old female patient who received FLUARIX QUADRILVALENT (batch number AF29T, expiry date 25th June 2017). On 24th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 25 September 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced fever and general body pain. On an unknown date, the patient experienced pharmaceutical product complaint. In September 2016, the outcome of the fever and general body pain were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the fever and general body pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the nurse, who herself was the patient. The nurse reported that she experienced fever and body aches after receiving FLUARIX QUADRIVALENT in her left deltoid. The nurse reported that vaccine was given to 3 healthcare providers. She insisted AF29T particular batch of vaccine was defective as this batch was producing adverse symptoms, which were not experienced in previous year's vaccines. She was unable to credit per content. This was one of the 3 cases reported by the same reporter.
11:40: Called to the car, witnessed vasovegal response with tonic / clonic activity.   11:45: BP 89/34 HR 48 sats99% Alert and oriented x3  CO L arm pain 5/10 @ injection site CO nausea.  given 25mg Benedryl  11:48: Car pulled to the side  11:52: Ems called and charge nurse notified. 11:55 ems on scene and took over care.
Patient tested COVID+ 2/1, admitted 2/21 (20 days prior to admission). Vaccine 12/26, 1/20. Primary dx at DC Ecoli Sepsis from UTI. Treated PNA w/antibiotics. DCd
Patient reported to provider that after the 1st vaccine, administered 03/18/2020 he noticed some left eye droop. Not severe or alarming and resolved.  After receiving the 2nd Vaccine on 04/12/2021, pt reports going to ER on 5/14/2021 for what they diagnosed as Bells palsy.  He was seen for a follow up visit today 06/14/2021.
24 hours later - Fatigue lasting 3 days 24-48 hours later fever 102+ 24 hours to 5 days after swollen lymph nodes (under the right armpit) to the extent I over-utilized my left arm and ended up with a pinched nerve  3.5 weeks after booster - sinus congestion, cough - negative COVID test 5.5 weeks after booster shot - cough became productive. Negative COVID, Influenza Test. DX: Bronchitis. Prescribed Prednisone and Antibiotics - cleared up within 7 days
Female patient in the observation area reports feeling dizzy and head pain. Patient is taken to a paramedic who laid her down with legs elevated and takes her vitals. Patient tell me she suffers from vasovagal. Vitals are taken 110/60 BP Sat 98, 68P 102 Ext. Mother came to look for her.
Febrile seizure. 3-minute tonic clonic seizure associated with fever up to 102.4
PTS MOTHER STATES THAT SHE WAS EXPERINGCING SOME ITCHING AT THE SIGHT ABOUT 45 MIN AFTER THE VACCINE, PT STARTING TO NOTICE SWELLING, REDNESS AND PAIN DOWNHER FROM THE SHOULDER TO THE ELBOW THE NEXT MORNING.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-MAY-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H014561, expiration date 21-MAR-2014) 0.3 ml (route and anatomical location unspecified). The Registered Nurse reported that a PQC was filed for possibly underfilled PNEUMOVAX23 vial. No adverse effect reported. Additional infiormation has been requested.
Initial report was received on 27/Jul/2006 from a health care professional.  A female patient with no concurrent illness had received an intramuscular dose of Adacel, lot number C2457AA, in the deltoid muscle, on 14/Jun/2006.  It was not reported whether the injection was administered in the right or left deltoid.  Three days post-immunization, the patient experienced injection site pain, and soreness in the armpit area and neck.  Per the reporter, the patient did not seek medical attention, and no relevant diagnostic tests/laboratory data were performed.  It was reported that the patient had previously received a Tetanus Diphtheria vaccination over the two years ago, but less than five years ago.  No adverse were reported with that vaccination.  The recovery status of the patient was reported as recovered. The reporter for this case is the same as for case number, case number and case number through case number reported.
menopause for 1.5 years, 2-3 days later started her period; This spontaneous case was reported by a physician and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (menopause for 1.5 years, 2-3 days later started her period) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Menopause.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (menopause for 1.5 years, 2-3 days later started her period) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (menopause for 1.5 years, 2-3 days later started her period) 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 medication was reported. Patient has been in menopause for 1.5 years, 2-3 days post-vaccination  had her period Treatment medication was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Upon internal review on 04-Aug-2023, significant corrections performed to update event. On 03-Jun-2021: Follow up received on 03-Jun-2021,no new information was added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
rectal bleeding; pain; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RECTAL HAEMORRHAGE (medically significant), outcome "unknown", described as "rectal bleeding"; PAIN (non-serious), outcome "unknown", described as "pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Clinical summary: The reporter stated that three people complained of rectal bleeding, pain, and nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200343091 same reporter/drug/events, different patients;US-PFIZER INC-202200343092 same reporter/drug/events, different patients
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Global Medical Information (GMI) (Reference number- 00708715) and transmitted to Sanofi on 03-Aug-2021.  This case involves a 39-year-old female patient who received an expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 26-Jul-2021, the patient received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A25 and expiry date: 11-May-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was reported that "Caller wanted to know how soon she could give the patient a new vaccine. Call transferred from MIA Provider calling to get guidance on an expired Typhim dose."  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  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 by the regulatory authority. 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.
Immediate and continuing reaction within five minutes of shop.  Felt warm and tingling from knees to feet and hands, light headed, heavy chest, knot in throat, blood pressure and pulse elevated.  Blood pressure rose to 169/114.   no previous issues of high blood pressure.  I have continued to have many issues, my whole body is having multiple issues.  Hard to breathe, walk, talk, pains in head and body, coughing, chills, freezing hands and feet.
About  2.5 hours post vaccine pt had urticaria over face and body. Lungs clear. Also with some facial and eyelid swelling. Benadryl given po.
Fever (100.2) chills, aches, vomiting,  SHINGLES over left scalp forehead, nose and LEFT EYE. diagnosed 5/18 ------ON GOING as of 5/26 Treatment: VALACYCLOVIR, PREDNISOLONE DROPS, COMBIGAN DROPS
Vaccine temp excursion occurred. Dose administered was affected by improper storage before administration which was caught after the fact.
sore throat; running nose; stuffed up; achy all over; feels like crap; ear aches in both ears; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), NASAL CONGESTION (stuffed up), PAIN (achy all over) and FEELING ABNORMAL (feels like crap) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), NASAL CONGESTION (stuffed up), PAIN (achy all over), FEELING ABNORMAL (feels like crap), EAR PAIN (ear aches in both ears) and PYREXIA (slight fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), NASAL CONGESTION (stuffed up), PAIN (achy all over), FEELING ABNORMAL (feels like crap), EAR PAIN (ear aches in both ears) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
One day post vax, this pt was dxed with cellulitis per ER physician. He was on antibiotics for 2 weeks and sick in bed for one week.
Sneezing, coughing, wheezing, shortness of breath, sinus drainage, infection in maxillary area of face and lobes and runny nose.
Could not sleep; Very bad headache/Massive headache; body ache; Throwing up violently; Spent all day in bed; Did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good), BEDRIDDEN (Spent all day in bed), INSOMNIA (Could not sleep), HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 058H21A, 041L20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022 at 11:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022 at 11:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Did not feel good). On 01-May-2022, the patient experienced BEDRIDDEN (Spent all day in bed), HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache). 01-May-2022, the patient experienced VOMITING (Throwing up violently). On 01-May-2022 at 2:00 AM, the patient experienced INSOMNIA (Could not sleep). On 01-May-2022, VOMITING (Throwing up violently) had resolved. On 02-May-2022, BEDRIDDEN (Spent all day in bed) and INSOMNIA (Could not sleep) had resolved. On 03-May-2022, HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache) had resolved. At the time of the report, FEELING ABNORMAL (Did not feel good) outcome was unknown.            No concomitant medication information was provided by the reporter.  On 01-May-2022, by midnight, the patient had very bad headache and body ache and by 02.00 A.M., the patient was throwing up violently, had a massive headache and could not sleep.  The patient had informed the physician about the reactions and had not taken any medicine.  No treatment medication was reported.   This case was linked to MOD-2022-557681, MOD-2022-557486, MOD-2022-557549 (Patient Link).
On the evening of 2/3/21, patient did not feel well.  On 2/4/21, the patient became more unsteady than usual and felt weak.  By the evening of 2/4/21, the patient went to the restroom and could not get off the toilet.  every time she tried to stand up, her legs buckled underneath her.  Her caretakers called the squad and she was admitted to the hospital with possible transverse myelitis.
Fatigue onset 4 to 6 hours after receiving the shot (vaccine received Monday 1:30pm). Low fever, dizziness, and chills set in around 24 hours later (Sunday midday), including a change in color and consistency of nasal mucous (thicker, green). At about 40 hours post-vaccine (Monday morning) most of the symptoms had dissipated aside from the fatigue and an atypical level of brain fog, which has gradually improved over the course of the week and is still present.  No treatment taken. Normal amount of sleep & caffeine intake, normal daily dosage of Vyvanse 60mg since Monday.