chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 103, profuse diarrhea and dehydration within 24 hours of vaccine administration. No gross blood in stool, but guiac-positive stools found in hospital. Stool culture negative to date. Admitted to hospital for 48 hours for rehydration.  6/12/07 Received hospital medical records which reveal patient experienced fever, vomiting & diarrhea x 1 day.  Seen by PCP on 6/1 who advised ER if condition worsened.  All symptoms increased & presented to ER on 6/2.  Admitted 6/2-6/4/07.  Tx w/IVF for rehydration.  Continued w/vomiting/diarrhea & fever in hospital.  Day before d/c, improved & was able to tolerate oral feeds.  D/C to home FINAL DX: Viral gastroenteritis. 7/12/07 Received vax records from pcp which confirm RO dose & lot # as reported.
did not receive his 2nd dose; shoulder pain; able to use his right arm, but does have pain in it.; but my right arm went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (but my right arm went numb), PAIN IN EXTREMITY (able to use his right arm, but does have pain in it.), PRODUCT DOSE OMISSION ISSUE (did not receive his 2nd dose) and ARTHRALGIA (shoulder pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     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 20-Feb-2021, the patient experienced HYPOAESTHESIA (but my right arm went numb). On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (able to use his right arm, but does have pain in it.). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive his 2nd dose) and ARTHRALGIA (shoulder pain). At the time of the report, HYPOAESTHESIA (but my right arm went numb), PRODUCT DOSE OMISSION ISSUE (did not receive his 2nd dose) and ARTHRALGIA (shoulder pain) outcome was unknown and PAIN IN EXTREMITY (able to use his right arm, but does have pain in it.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Two events , product dose omission issue and arthralgia were added.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with none pertinent medical history and none drug reactions or allergies. On 03-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX, lot # J002242; exp date: 21-MAY-2014 dose 0.65 ml, subcutaneous injection to the left arm. Concomitant therapies included montelukast sodium (manufacturer unknown), alprazolam, fluticasone propionate, Advair, Synthroid and lansoprazole. On 04-SEP-2013 the patient developed a red, raised bump at the site of injection. The patient stated the bump kept increasing in size and on 05-SEP-2013 she went to seek medical attention. An unspecified healthcare provided had blood work done on the patient. On approximately 05-SEP-2013, the blood work showed a raised white blood cell count and it was determined, by unspecified healthcare provider, that the patient had a bacterial infection. The unspecified healthcare provider prescribed Keflex. The outcome of adverse events was not reported. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
pt recvd vax;devel high fever & febrile convuls;concurrent URI; no local rxn,fever probably related ro ur9 or rxn to dtp;7nov had cough,cold;eyes rolled back up stiff; staring spell;MD impression febrile sz secondary to a viral infect;
dry cough; This is a spontaneous report via a Pfizer-sponsored program from a contactable consumer (patient) reported for self. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced dry cough on 16Jan2021. He was supposed to get his second on 06Feb2021, but they didn't give him a time. He was given the COVID vaccine by his local health department. Relayed to reach out to them, and they should be able to give him a time. While he was talking, he was coughing and stated he had a dry cough this morning. The outcome of event was unknown.   Information on the lot/ batch number has been requested.
diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "COVID", start date: 09Mar2022 (not ongoing), notes: tested positive for COVID, COVID resolved. The patient's concomitant medications were not reported. Vaccination history included: Xeljanz (Dose 11 mg, Daily, oral, she tested positive for COVID and was instructed to hold Xeljanz, she resumed taking Xeljanz 2 weeks), administration date: 08Mar2022, for Rheumatoid arthritis. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports she started Xeljanz 08Mar2022. on 09Mar2022 she tested positive for COVID and was instructed to hold Xeljanz. COVID was "not bad", she reports she has been vaccinated and boosted. COVID resolved. she resumed taking Xeljanz 2 weeks ago and has been having diarrhea since start of therapy. she takes Xeljanz with lunch and diarrhea starts 5-6 hrs later. she has been taking Imodium with Xeljanz to manage symptoms. she is advised to update md about diarrhea and verify whether she should be taking Imodium.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Within 48 hours - temp 104 - behavioral changes - extremely combative - i.e. biting, hitting, yelling. (R) outer thigh - local reaction - extremely swollen, red.
This spontaneous report was received from an administrator referring to multiple unspecified patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M043731, expiration date: 22-JUN-2019; dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine underwent the temperature excursion of more than 47 Fahrenheit degrees (F) but less than 77 F for 23 hours and 40 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000062.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 27-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurts; This is a spontaneous report from a contactable consumer via medical information team.A 73-years-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number :unknown) via an unspecified route of in Arm Right on 04Feb2021 07.00 as single dose for covid-19 immunisation. Medical history included asthma from 1971 , oesophageal spasm from 1981, diverticulitis ,concussion syndrome, anaphylactic shock .She has had anaphylactic shocks 4 times in her life. Concomitant medication included fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma, fluticasone propionate/salmeterol (WIXELA INHUB) taken for asthma. On 04Feb2021 the patient stated couldn't get out of bed. On 09Feb2021 the patient experienced oxygen level decreased, heart rate increased. In Feb2021 patient experienced tired , dizziness and joints hurts.It was reported that She didn't have any anaphylactic shock after the COVID-19 vaccine. She had no reaction. After receiving the vaccine, she sat there with her husband for half an hour. In fact, nothing was wrong with her for 2 hours after receiving the vaccine. Then all of a sudden later on that day, she couldn't get out of bed. It was like she was sleeping, but wasn't sleeping. This lasted from Thursday around 11 a.m. until Monday, that kind of thing. She went to the doctor that Tuesday because she had her physical already scheduled .When she went to the doctor, it was determined her heartrate was 120. Her heartrate sitting or resting is usually in the 80's. Then, her heartrate was 120's four days after the vaccine. She didn't realize a racing heartrate was one of the severe effects of the vaccine. She didn't feel her heart was racing. Her doctor instructed her to drink Gatorade and Pedialyte and she is still tired after doing all of that. Her doctor said she should have the shot, even though her blood heartrate went up 40. Her oxygen level is usually at 98 although she does have asthma, and her level was at 90. It was lower, under 98. She explains she had an EKG done at the doctors.She stated she was extremely dizzy in the beginning when she did get up and take a shower. Every day, her husband helped her get in the shower and take a shower. She received her first EKG when she went to the doctor on Tuesday 09Feb2021. The only thing wrong was her heart rate was 120. Her heart rate is usually high anyway usually 80 and sometimes 90. Thee has only been one time in the last 25 years, her heart rate went to 126. On 15Feb2021 EKG which showed HR as 106, oxygen was 96. The patient did not received prior vaccinations within 4 weeks. The outcome of the events dizziness was recovering, outcome of the event joints hurts was not recovered and outcome of the events were unknown
This case was reported by a nurse via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 1st June 2018, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site pain. In June 2018, the patient experienced headache, stomach pain, nausea and heart rate increased. The patient was treated with famotidine (Pepcid). In June 2018, the outcome of the heart rate increased was recovered/resolved. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the stomach pain, injection site erythema, injection site warmth, injection site pain and vaccine administered at inappropriate site were unknown and the outcome of the nausea and injection site swelling were recovering/resolving. The reporter considered the headache, stomach pain, nausea, heart rate increased, injection site swelling, injection site erythema, injection site warmth and injection site pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the nurse for herself. On 31st May 2018, at 1:30 pm the patient received SHINGRIX on left arm. On 1st June 2018, in the middle of the night, around 1:00 am, the patient started having a severe headache, stomach pain, nausea and fast heart rate. One day after receiving SHINGRIX the patient experienced the skin was swollen, red, hot to the touch and sore at the injection site. The patient's fast heart rate resolved about 3 days later from the time of the injection. The patient was unable to tell if her stomach pain and nausea had been resolved because she started taking Pepcid to treat that side effect and had continued to do so. The swelling, redness and soreness at the site had been gradually getting worse. The swelling at the site was as large as a softball, but as of reporting date, it was starting to look a little smaller. The patient had made her physician aware of her experience. The patient mentioned that she never had a reaction to any vaccines that she ever had. The person that gave the injection to the patient, gave it below the deltoid, which led to vaccine administered at inappropriate site. The patient was not able to speak quick enough to mention that the area where the injection should had been given was higher on her arm than it was given.
Gave patient Moderna Covid 19 vaccine which is only approved for 18 yrs and older.  No adverse reaction reported at this time
I developed moderately to severe diarrhea and weight loss with 2 different episodes in April and May. I went to the doctor in April and June. They ran stool samples and all were negative and I had a colonoscopy and was diagnosed with Collagenous Colitis. Doctor recommended steroids' but I am did not take treatment since my symptoms were gone. I am no longer having the symptoms that caused me to call the doctor but from my understanding this is a chronic condition.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site infection in a 60-year-old female patient who received MENVEO (batch number M16127, expiry date 31st July 2018). On 19th July 2017, the patient received MENVEO. On 19th July 2017, unknown after receiving MENVEO, the patient experienced inappropriate age at vaccine administration. On 20th July 2017, the patient experienced injection site infection, fever, injection site pain and injection site swelling. The patient was treated with antibiotics nos (Brand Names Not Known). On an unknown date, the outcome of the injection site infection, fever, injection site pain, injection site swelling and inappropriate age at vaccine administration were unknown. The reporter considered the injection site infection, fever, injection site pain and injection site swelling to be almost certainly related to MENVEO. Additional details were provided as follows: The 60 years old patient received MENVEO in the pharmacy, which led to inappropriate age at vaccine administration. On 20th July 2017, 1 day after vaccination, the patient experienced injection site infection, fever, sore arm and arm swelling. Later, the patient went to emergency room, subsequently she was prescribed an unknown antibiotic and was released. The patient reported that, the antibiotic did not work and she was presented to the emergency room again. The patient was examined, and released. The patient visited the emergency room again, and an unknown procedure was done on the arm.
A report received from a Health Professional via medical rep. concerning a female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received nasal FLUMIST Quadrivalent, 0.2 milliliters on 03-NOV-2015. The patient had influenza which started on 14-NOV-2015. FLUMIST Quadrivalent was continued. The outcome of influenza was unknown. The report was considered to be non-serious by company physician.
Edema to left side of face, swollen left axillary lymph nodes, left arm edema, neuropathy at left arm
THE PATIETIENT TESTED FOR COVID ON 7/29/2021 THE EESULT CAME POSITIVE COVID
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 41 years old male patient who received less than 0.5 mL dose of vaccine FLUZONE QUADRIVALENT lot UJ070AB, expiry date: 30-Jun-2019 via unknown route in the left arm on 07-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine underdose. It was also the case of syringe issue. It was reported that administering a prefilled syringe of FLUZONE QUADRIVALENT 0.5ml, when some of the vaccine leaked from the plunger stopper and 3/4ths of the vaccine go through, but some of it came out from the back of the syringe from the plunger. No reported symptoms. 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. Documents held by sender: none.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age less than 65 years, gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that FLUZONE HIGH DOSE administered in patient less than 65 y/o. It was unknown whether patient experienced any adverse reaction after the injection. 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 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. List of documents held by sender- none.
After first vaccination, I went to ER for heart palpitations, high blood pressure.  After second dose I am having the same symptoms of high blood pressure and heart palpitations, including feeling light headed and dizzy.
Day of vaccine 1/12/21-started having pain down all left arm and body aches with headache and nauseated.  Day 2-1/13/21-still having pain in left arm and body aches, headache and nausea, now having sharp pains in left shoulder radiating around to scapular area with limited ROM-soreness and stiffness. Day 3-1/14/21-no symptoms at all only mild soreness at injection site.
Information received concerning a 5-year old who received MMR, Hep B, Poliovirus vax. 03/13/95 at 13-months-of-age, the pt experienced a whole body intense rash which lasted for 2 days and a rectal fever of 103 F. Subsequently, the pt recovered form the rash and fever. No further information is available.
no other adverse events; patient received PROQUAD with VARIVAX in error; MMR II was intended instead of PROQUAD; patient received PROQUAD with VARIVAX in error; MMR II was intended instead of PROQUAD; This spontaneous report was received from a licensed practical nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 20-AUG-2021, the patient was vaccinated in error with varicella virus vaccine live (oka/merck) (VARIVAX) lot # T033166, expiration date 29-SEP-2022, 1 dose and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(albumin status: recombinant Human albumin (rHA)) (PROQUAD) lot # T034826, expiration date reported as 29-APR-2022 but upon internal validation established as 11-APR-2022 for prophylaxis. Caller reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was intended instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Caller did nor report error occurred due to product confusion. No other adverse events reported.