chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Really bad, painful muscle spasms; Right big toe is still sore; Had a bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Really bad, painful muscle spasms), PAIN IN EXTREMITY (Right big toe is still sore) and ADVERSE REACTION (Had a bad reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced MUSCLE SPASMS (Really bad, painful muscle spasms), PAIN IN EXTREMITY (Right big toe is still sore) and ADVERSE REACTION (Had a bad reaction). The patient was treated with Physical therapy (massaged) for Muscle spasms. At the time of the report, MUSCLE SPASMS (Really bad, painful muscle spasms) and ADVERSE REACTION (Had a bad reaction) outcome was unknown and PAIN IN EXTREMITY (Right big toe is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment information was reported.  Patient stated that she had a bad reaction to the initial vaccination. On 11-Sep-2021, she developed really bad, painful muscle spasms in her right leg and stated that she massaged it to try and get it to reduce.   Patient stated she has never had this happen before and was afraid she will have more of a reaction with the second shot and patient doesn't think she will get a second shot.
A two-month-old patient (gender not reported) had received an injection of PENTACEL, sanofi pasteur Ltd. (lot number, date, route and site not reported) and an unspecified amount of time later experienced redness, swelling, ecchymosis, irritability and crying for several hours. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
This case was reported by a healthcare professional and described the occurrence of skin lesion at injection site in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk) (Sanofi Pasteur MSD; unknown) given on 26 August 2013. On 26 August 2013 at 15:00 the subject received 5th dose of INFANRIX (.5 ml, intramuscular, unknown site). On 27 August 2013, 1 day after vaccination with INFANRIX, the subject experienced skin lesions. The healthcare professional reported that the event was a local injection site reaction (skin lesion at injection site). The subject was seen by the health care professional at a physician's office on 30 August 2013 and a physician was consulted to "look at her arm". At the time of reporting the event was unresolved. Follow up was received from the medical assistant on 01 October 2013. The medical assistant reported that the case had been reported to the regulatory authority of the CDC; however, a reference number was not provided. On 27 August 2013, the subject experienced a diagnosis of "rash on arms" (arm rash) and the outcome was unknown. The reporter identified the suspect product as INFANRIX. The medical assistant did not consider this case serious. There was no alcohol or tobacco use per the reporter. The reporter clarified the lot number as AC14B182BA which was previously reported as AC148182BA. Per the medical assistant, the immunization series was not delayed or discontinued. It was unknown if symptoms recurred with subsequent administration. The subject had not experienced any adverse events to previous vaccinations.
loss of appetite; Headache; Nausea; Fever; Body Aches; Large rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body Aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body Aches) and VACCINATION SITE RASH (Large rash at the injection site). At the time of the report, DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body Aches) and VACCINATION SITE RASH (Large rash at the injection site) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.   This case was linked to MOD-2021-265445 (Patient Link).
a 59 year old patient received the Flublok vaccine twice/No AE; Initial information was received on 11-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 59-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] twice.  Medical history, medical treatment, vaccination and family history were not provided.  On 22-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE twice; lot QFAA1920 via intramuscular route in the right deltoid and on the same day another dose via intramuscular route in the left deltoid.  It was a case of actual medication error due to extra dose administered.  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 holder's 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.
Patient had a Seizure 6- or 7-weeks post 2nd dose. Patient has never had a seizure before.   My wife and I are just curious if it could be possible that she could have a seizure due to the shot. We are all vaccinated and have been very safe through this pandemic.  Patient also has Turners Syndrome, a genetic disorder.
Patient given Pfizer Bivalent dose in-home. No reaction during 15min observation period. Team was about to depart when relative came running for them for assistance. Lead RN saw that patient seemed to be having some hyperventilation and a nervous disposition. Incident protocol activated.  VS ~1130: HR 65, RR 17, O2 89%, BP 90/70. VS ~1135: HR 90, RR 18, O2 90%, BP 108/72. Pulses strong, PMHx AFib, PMHx Congestive Heart Failure.  Family gave in-home supplemental oxygen, PRN Rx albuterol, & PRN Rx anxiolytics. Bed elevated to 30+ degrees. Lead RN considered VS and assessments within context of PMHx. Team remained with patient for an additional 30minutes. VS stable and no assessment of anaphylaxis or cardiorespiratory failure. Family educated to call 911 if S/S resume.
ice packs 5min every hr same day of vax approx 1hr later significant swelling of lt thigh & constant crying;t98.0 A;
Pt had collapse spell at home. EMS was called & Pt transferred to Med. Ctr for observation. This happened after office hours.
Severe cough, severe headache, chills, aches, weakness, and feeling of being "off balance" beginning 3 days after being vaccinated.  Patient had doctor visit where they gave him a prescription to treat the cough and said they will follow up with him in 3 days.
Diarrhea; Vomiting; Given an incorrect dose; Overdosed; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), INCORRECT DOSE ADMINISTERED (Given an incorrect dose) and ACCIDENTAL OVERDOSE (Overdosed) 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 DIARRHOEA (Diarrhea), VOMITING (Vomiting), INCORRECT DOSE ADMINISTERED (Given an incorrect dose) and ACCIDENTAL OVERDOSE (Overdosed). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown and INCORRECT DOSE ADMINISTERED (Given an incorrect dose) and ACCIDENTAL OVERDOSE (Overdosed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information were reported.
pt recvd vax & "passed out & limp"; pmd said pt had a vaso vagal rxn w/ hypotension; fully recovered;
Information has been received from an adult female registered nurse who in 1997 was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (lot number not available). She indicated that two weeks after vaccination, the pt developed the flu. She treated with antibiotics. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
This case was reported by a healthcare professional and described the occurrence of soreness in a 11-year-old male subject who was vaccinated with PEDIARIX.  Concurrent medical conditions included cystic fibrosis. On 05 June 2008, the subject inadvertently received a dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced soreness. This was considered to be vaccination error, as the subject was an inappropriate age for vaccination with PEDIARIX. At the time of reporting, the outcome of the events was unspecified.
Vertigo starting on day 5 and continuing day 6. Ears ringing as well.
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn.   I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines.  I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better.  Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office.  Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
No adverse event; Administered dose of expired vial to patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient).    No concomitant medications were provided. It was reported that 2 vials were transferred to another site this morning and vaccines were showing expired. Vaccines expired on 11-Feb-2023. Site administered 3 doses from these expired vials to patients this morning. It was unknown if they experienced symptoms. No treatment medication was provided. This case contains information for the 2nd of 3 child patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-718082, MODERNATX, INC.-MOD-2023-718085 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-718082:Patient 1 out of 3 patients MODERNATX, INC.-MOD-2023-718085:Patient 3 out of 3 patients
I received my second dose, around 09/2021 and had pain in my abdomen which got worse in October 2021. I had fever, chills, fatigue, headaches, body aches lasting about 5 days. I went to an ER to get checked out. I had chest x-ray showed a nodule in my lung and don't know if it was from having Covid in July 2020 which took me a month to get better. I also had an ultrasound of my stomach which showed fatty liver.
hot to touch (vaccination site); injection site turned darker in color; next day it was sore; redness at night, redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color), VACCINATION SITE ERYTHEMA (redness at night, redness at injection site) and VACCINATION SITE PAIN (next day it was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 010A21A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at night, redness at injection site). On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color) and VACCINATION SITE PAIN (next day it was sore). At the time of the report, VACCINATION SITE WARMTH (hot to touch (vaccination site)), VACCINATION SITE DISCOLOURATION (injection site turned darker in color), VACCINATION SITE ERYTHEMA (redness at night, redness at injection site) and VACCINATION SITE PAIN (next day it was sore) outcome was unknown.            treatment medicine include antihistamine and Tylenol   This case was linked to MOD-2021-026687 (Patient Link).
I lost my near sighted vision. I didn't have this issue beforehand. It has been almost four weeks and my vision hasn't improved.
This was the pt's first shingrix. She reported swelling, warmth, erythema, and a lump after one day. She returned three days later (7/1/22) and stated that it is improving.
Information has been received from a physician concerning a 17 year old female who was vaccinated (date, route and site not reported) with a dose of the Gardasil vaccine (lot# not reported).  Subsequently the patient fainted post vaccination (exact date not reported).  It was unknown at the time of this report if the patient received medical attention or recovered.  Additional information has been requested.
Pt devel eosinophilia following vax w/Hep B; No further details were provided;
The symptoms began 10 minutes after administration of the vaccine.  The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip.  The treatment of the reaction was:   o Epinephrine: x1 Transferred to ED
itchy rash covering the upper part of his arm around the injection site; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp and additional information was received on 03-Oct-2019.  This case is linked to cases 2019SA277288 and 2019SA278150 (same reporter).  This case involves a 8 years old male patient who experienced itchy rash covering the upper part of arm around the injection site (rash pruritic), while he received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ237AB.  On an unknown date, The patient developed a non-serious itchy rash covering the upper part of arm around the injection site (rash pruritic) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  No lab test reported.  Final diagnosis was rash pruritic   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome is reported as Recovering / Resolving for itchy rash.
This spontaneous report as received from a nurse refers to  an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot #, expiration date, strength, dose and route not reported). No symptoms reported. The improperly stored doses were administered 27-AUG-2014 and 28-AUG-2014. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated on unspecified dates with all three doses of GARDASIL vaccine (yeast) (lot #'s not reported). Subsequently the patient was diagnosed with being high risk for HPV. The patient's outcome was not reported. Additional information has been requested.
After first shot I started my period early and bled heavy for about 16 days.  I was off for about 2 weeks and which I had the second dose between there. A week  or so after my second dose on the 24 of April I started again, again very heavy and still ok it as of 5/16/21. At 45 yrs old I have been regular my whole life. Usually 4 days and very light bleeding. I don?t even wear pads just liners.  Not sure how much longer this is going to go on but it shows no signs of easing up any.
This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2 month old male pt who became apneic and was placed on a ventilator. At 2 months of age, the pt received the first dose on 10Jul06. The pt also received the first dose of Pedvax Hib (haemophilus influenzae type b polysaccharide) on 10Jul06 and a dose of Pediarix (diphtheria/tetanus/acellular pertussis/hepatitis b vaccine/polio virus inactivated) on 09Jul06. The pt has a past history of ventilator dependence since birth, low birth weight and intracranial haemorrhage (reported as bleed in head). Indication for Prevnar was immunization. Product was administered on 10Jul06. Dose regimen was 1 dose 1 time per day (IM). Concomitant therapy included Diuril (chlorothiazide), Caffeine and Potassium Chloride w/sodium chloride (potassium chloride/sodium chloride). The pt, a low birth weight baby, had been in the neonatal unit since birth. He had been on a ventilator but had come off; he was feeding and growing well. The baby was given his first dose of Prevnar and Pedvax Hib on 10Jul06. He had previously received a dose of Pediarix 24 hrs prior. Within 15 mins of receiving Prevnar and Pedvax Hib, he became apneic and had to be placed on a ventilator. After the reaction, he remained on the ventilator for 2 days, came off and is doing well. No additional information was available at the time of this report.
I had a very bad dream over night. It was a nightmare. I woke up and went back to sleep 3 times and the night continued each time until about 4am. Then I couldn't sleep again.
Sore arm at injection site, night of, resolved with ibuprofen Sore arm at injection site, day after, partially resolved with ibuprofen Fatigue the 2nd day after
Left upper arm red, hot to touch, swollen. Vomiting onset 07/18/2002. Low grade fever, no pain at injection site.
11/14/02 - Left arm painful to lift after receiving shot, spoke w/PT on 2/6/03. Arm is fine - took a couple of wks to get better - case closed.
Had swollen lymph glands in the right breast that showed up in the mammogram that I got today.  I then had a breast ultrasound to check it out. I have another ultrasound scheduled for 6 weeks following my second vaccine.
The pt experienced swelling of the left arm from the shoulder to elbow, with redness, hot to the touch, tenderness and unknown if pt had a fever.
15 minutes after receiving the injection, the patient reported tingling in both hands. There was no redness or swelling observed at the injection site. O2 sat was 97% and HR was mid 70s. The patient had no other symptoms or side effects. He was monitored an additional 15 minutes and stated he felt fine and good to leave. He was instructed to seek medical attention immediately should any further symptoms develop.
Pt developed acute onset of nausea and vomiting. Vaccine injection at 10:20 and at 10:30 am pt had acute onset of nausea and vomiting. Which lasted for 60 minutes. Pt  had an accu check done her blood sugar was 406. She was given an ice pack to the back of the neck and zofran 8m SL once.
Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved within 15 minutes.
Pt recvd DTP/OPV @ approx 1130AM mom called @ 415PM to report pt had broken out w/rash covering body; stated it was red, small bumps;