chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced COVID-19 (COVID symptoms). At the time of the report, COVID-19 (COVID symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 47-year-old male  patient with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred 29 days after the first dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 47-year-old male patient with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred 29 days after the first dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No reaction on day of injection, 6/15.   Next day arm was very sore, but  improved as I worked outside.  Since then, skin has been warm to the touch.  Today, swelling; redness; warm to the touch.  Approximately 4.5 cm wide; 6 cm high.  Pictures sent to my physician,.   Also reported directly  to Pfizer.
Pt received both FLUAD and PREVNAR 13 on 10/17/2018. Husband reported pt passed out in the morning of 10/18/2018. Pt recovered with no injuries and did not seek medical attention.
Per charting "0525 - Called to room by mother for frank red blood that was coming from the mouth and nose of the baby. Dad had used the bulb syringe to extract some and discharged it into the toilet. There was a large amount of bright red blood noted in the toilet bowl, and blood continuing to come from the baby. The baby and family were immediately taken to the NICU for evaluation." Following reports per MD note " Was rooming in with parents. They noted that he was more fussy than normal. He was then found with blood in his mouth and nose. He was taken into the unit and was found to have apnea. nCPAP was started and I took him off several hours later to exam him. He did well and I had nursing take him off and place in mom's arms. He became apneic and bradycardic in mom's arms. CPAP was restarted and he continued to have apneic events. He was intubated by the NNP." Antibiotics and acyclovir were initiated (8/18-8/20 d/c with cultures neg). Multiple days of NPO and TPN required do to destaturations for copious secretions. Patient was extubated on 8/20, TPN d/c and diet restarted on 8/23, ready for transition home from 8/23-8/24. Of note no other changes in this patients medical treatment from a medication standpoint or otherwise were made near the event.
18-24 hours after vaccine administered child developed bloody diarrhea.  Child also had abdominal pain and irritability with fever to 104 degrees and bloating. She initially had one blood stool on 5/31/2012 at 1930 but no other symptoms.  Woke up at 400 am on 6/1/2012 screaming in pain.  Child taken to ER where she passed a second loose bloody stool.
Patient came in to pharamcy on 12/20/12 to state that since her vaccination she had had soreness in her left upper arm (near injection site.) This has also caused a limitation in her range of motion in that arm.  The soreness and limited range of motion of the arm has not yet ceased.  She will follow up with her Doctor in January and inform us of any updates.
This spontaneous report as received from a medical assistant refers to 3 patients of unknown demography. The reporter stated that on an unknown date, the 3 unspecified patients were vaccinated with improperly stored VARIVAX lot # L048465, subcutaneous. No adverse effects were reported. No further information was informed. No PQC involved. Additional information has been requested.
Approximately 9 hours after receiving the MMR vaccine patient reports feeling feverish ( temperature not taken), dizziness and shortness of breath.  Symptoms did not subside and he visited an emergency room the next day where he reports being given a "shot".  His symptoms have now resolved.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 74 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 19-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 19-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patient's will be contacted for revaccination.
Patient left exam room after receiving MenQuadfi vaccine and walked into waiting room to check out. There, a receptionist noticed patient was pale and called in two nurses from the office who responded to the event. Nurses obtained vitals and notified patient's provider, Dr, who suggested patient lie down on exam table with feet on stool and continue assessment of vital signs, vital signs stable. Patient remained in office for at least 15min, vital signs remained stable, Mom verbalized she felt comfortable taking patient home, Nurses advised parent to call office with any questions or concerns.
Unable to lift arm past waist high. Continued pain and restricted movement for 4 weeks+ (ongoing. Visit to PA 2 weeks post-injection, prescribed steroid, pain/anti-inflammatory and sleep aid. 4 Weeks post-injection, treatment at chiropractor for bicep tendonitis due to restricted movement of shoulder from pain.
Injection technique seemed poor as it was the most painful vaccination I've ever received, and upper arm became tight and achy immediately. Soreness lingered but the sharper pain went away shortly after. About 8-10 hours later I began feeling nauseous and lightheaded. 12 hours after vaccine I had trouble falling asleep, overcome with nausea and chills.  This turns into sweating and insomnia the rest of the night. The following day I felt better, but the next night (and following one) I continued feeling a bit sick. Currently (3 days later) my upper arm is still very sore and I have lots of muscle/joint aches throughout my whole body.
After injection I felt warm then weak then dizzy. Approximately one hour after that my tongue began to swell and tingle. I became tachycardic, sore throat, some SOB & tongue cont to have some swelling & tingling. Took 2 MOTRIN 400 mg- BENADRYL Albuterol inhaler.
Symptoms: Heart palpitations and/or feeling of heart skipping beats or pounding strongly. Feeling a shortness of breath or like I'm out of breath for 10-20 seconds while my heartbeat is feeling off.  Experiencing a cough sometimes during the episode. Extreme fatigue. I've never had any heart issues in the past.  My first day I had one episode lasting about 20 seconds, and then another episode 3-4 minutes later of the same thing. After that I've been having about 1 episode a day, sometimes two. It seems to be getting worse each day that goes by. I have an appointment with a cardiologist and have already seen an urgent care provider, talked with a tele-health doctor, and received a referral from my primary care physician.
The following history took place in about 5 minutes. Then to ER. History from 23 year old brother 1) Grandparents called, saying her arms were flailing/tremoring, 2) Brother arrived on scene, her eyes rolled back, 3) She stopped breathing, 4) Heimlich done, 5) She vomited twice 6) Mom reports she was febrile most of the day but didn't take temp. No thermometer to check.
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Patient passed out 5 minutes after first vaccine. He was very pale and weak. Patient was taken by ambulance to local hospital. Patient was able to walk to ambulance.
Received annual flu shot and it was given improperly. The RN administered the shot into the shoulder capsule and not into the meaty part of the bicep. I have had shoulder pain and limited range of motion ever since.
patient had ppsv23 on 12/13/2019 on left deltoid, patient had slight pinkness on inner left arm with skin warm to the touch. patient had no swelling on arm. patient did report the area feeling itchy. patient advised to take over the counter Benadryl to help subside itching. patient told if symptoms doesn't subside by Friday ( 12/20/2019) to contact Primary Care Doctor.
12/10,  5:00 p.m.  Loss of appetite, nausea (continued for next 18 hours), very sore right arm;  12/11, 3:00 a.m. Chills, all over body ache, headache, extreme fatigue, very sore arm; (continued for next 12 hours); 12/11, 12 noon, diarrhea, vomiting (one episode each); 12/12, 6 a.m. - 3 p.m. mild body ache, mild fatigue, mildly sore arm
On 11/10/2000 the patient broke out with a chickenpox like rash. The patient recovered from the rash on 11/12/2000. No further information is available.
12 hours after the vaccination, I woke up with severe chills, causing me to shake violently. I also felt dizzy and a bit confused. My gait was unsteady after I first got out of bed due to the dizziness. I had body aches, a headache, a head cold feeling, and fatigue. I also had slight soreness when raising the arm that received the injection, but less so than after the first dose or even my annual flu shot. I was able to work on Monday, 4/14, although I was less productive than usual (office worker). After work, I needed a nap before taking my son to a store. After 10 minutes of walking around the store, I had to sit down due to extreme fatigue. I slept from 8:30 pm - 6:45 am that second night, waking every few hours to drink, urinate, add a layer of clothing, etc. Somewhere in the middle of the night, I was aware I had sweat alot, and my thick clothes were wet. I was feeling slightly better after waking up on Tuesday morning, but still took cold medicine for symptoms. Around 12:30 pm on Tuesday, April 13th, I felt much better.  Now, on the evening of Tuesday, April 13th, I have only slight residual body aches remaining.
Tiredness/Exhaustion; Chills; Low grade fever; Muscle aches; Weakness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration, on an unspecified date in Jan2021 at 15:30, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose of the Pfizer BioNTech Covid-19 vaccine on Monday at 3:30 P.M. He woke up yesterday morning with exhaustion, tiredness, chills, low grade fever, muscle aches, and just weakness that hasn't stopped since yesterday morning. All these lasted for 48 hours. Patient then asked how long he will experience these. Outcome of the events was not recovered.
my wife had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my wife had a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (my wife had a sore arm). At the time of the report, VACCINATION SITE PAIN (my wife had a sore arm) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD21-046688 (Linked Report).; Sender's Comments:  MOD21-046688:Cross linked
c/o tightness of her left arm and jaw and also c/o facial numbness.  BP 150/101, HR 87, pt. went home after symptoms was resolved.
Patient reported a positive test result on the Abbot BinaxNow antigen test 4/22/21 through the University. Completed COVID vaccine series 1/29/21. Symptom onset 4/21/21. Recently attended a wedding 4/17/21.
Dizziness followed by fall in shower. No treatment. Bruising and abrasions not serious.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 15-year-old patient who received Hepatitis A vaccine (batch number 3397T) for prophylaxis.   On 20-FEB-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Chills, fever, general weakness/ tiredness, muscle aches,  and headache.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 10.5 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
INCREASE HR, FLUSHING, NAUSEA, PHLEGM IN THROAT-CONSTRICTING, TINGLING IN ARM. WENT FOR A WALK TO CALM THEMSELVES DOWN, DECREASE HR. SYMPTOMS INCREASED DURING THE DAY. PT TOOK BENADRYL BEFORE GOING TO BED. PER PT DID NOT FEEL THE NEED FOR AN EPIPEN. WOKE UP MONDAY MORNING FEELING MUCH BETTER, SYMPTOMS SUBSIDED EXCEPT SOME TINGLING STILL IN THE ARM. ALL OF THIS WAS REPORTED TO ME ON TUESDAY EVENING APPROX 5PM.
No dverse effects were reported; a 19 year old patient was administered a pediatric dose of VAQTA in error; a 19 year old patient was administered a pediatric dose of VAQTA in error; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown age. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 24-JUL-2019, the patient was administered a pediatric dose of hepatitis a vaccine, inactivated(VAQTA), lot number R030115 with expiration date 29-DEC-2019, (dose, route, and anatomical location were not reported) for prophylaxis.
Patient concerned small subdural hematoma following unwitnessed fall is secondary to his Johnson & Johnson vaccine
On Aug 5th symptoms began feverish, no energy, achy all over, coughing and sore throat. I took him to get tested and he was positive. The symptoms got worse. He couldn't walk every time he tried he'd fall. Also lost control of his bladder. I took him to the emergency room on Aug 11 he had high fever and was confused and couldn't walk, They sent us home 6-8hrs later after they got his temp down a bit because they didn't have any room. His symptoms continued and I took him to Hospital ER on Aug 17 they kept until  him Aug 21st, he was diagnosed with pneumonia and had to be on oxygen. I'm not sure what all happened there because I could not visit and I had a hard time getting a hold of him and the nurses were swamped. He came home with oxygen and was very weak. It took a long time for him to recuperate. He had to do breathing treatments, measure oxygen level and take temp,. He had a home nurse that came several times a week as well as OT and PT that lasted for about a month. He's still quite not back to normal, still has low energy, hair loss, and still has trouble walking.
It was discovered that the pediatric vaccine was not diluted prior to administration resulting in a higher dose administered.  adverse events are unknown, patient was not able to be reached. left message on 2/24/22 154pm
This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored LIQUID PEDVAXHIB (lot number, dose frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Severe throbbing headache - mostly one-sided with photophobia and sensitivity to sound started. Diagnosed as migraine. Required pain shot. Patient never had a migraine before.
Site of injection really hurts; Site and muscle were all inflamed; Site and muscle were all inflamed; This is a spontaneous report from a contactable consumer (patient). A 55-years old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 26Apr2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the site of injection really hurts and site and muscle were all inflamed. Caller stated that the site of the injection really hurts and she just wanted to know should she use a cold compress or warm compress. Clinical outcome of the events was unknown at time of this report.   No follow-up attempts are needed, information about batch number cannot be obtained.
~8 minutes after receiving her vaccine, pt approached pharmacy complaining of racing heart / sweating / mild trouble breathing / feeling faint, after assessing pt 1 dose of 0.3 mg epinephrine was administered. paramedics were called to complete a full work up of pt. After checking her vitals and monitoring heart rate, pt opted not to proceed to ER and go home instead.
Pt received Varicella vaccine (lot #0336Y) SC in L lateral thigh on 5/4/09, as well as Hep A vaccine IM. Separate areas of induration found on L thigh as probable injection sites. Induration greater on lateral aspect, site of Varicella vaccine.
Immediately after shot, my arm swelled and red.  Feels  hard at the site.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX. Concomitant products included Aspirin, Magnesium, METAMUCIL, Metformin, Probiotic, Vitamin B12, calcium citrate, Citracel Plus D, CENTRUM SILVER, SYNTHROID, Tumeric and TYLENOL. On 1st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was recovered/resolved. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were reported as follows: The reported stated in evening on the day of vaccination or by the next day the patient was experiencing joints hurting. The joint hurt resolved after a couple of days. The patient noted that she had that from time to time with the flu vaccine (manufacturer unknown) and she got a flu shot every year but it did not happen every year. Refer case US2018GSK065048. The reporter planned to get the 2nd dose on 1st May 2018. The reporter called today as her Dermatologist wanted her to start methotrexate, but her pharmacist was concerned with the vaccine. She was provided the information from the prescribing information on use of vaccine with immunosuppressive medications and decrease of efficacy of the vaccine with such drugs. She was referred to her Dermatologist for discussion. The primary care physician had retired and would accept authorization form and provide healthcare professional if one known at the time of follow up. This case has been linked with case US2018GSK065048 same patient.
Redness to left thigh 2 days after immunization, no fever. Keflex 500mg x 10 days BID given.
temp:max 102.3, fussy for 2 days, 2 bad nights-cried all noc & not nursing well;urinary output ok;
Approximately one month post vax the pt experienced varicella like lesions predominantly in the diaper area, though she did have a small number of lesions scattered over the body. The pt had at least 100 lesions total and physician noted typical varicella rash.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to children) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to children). On 15-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to children) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not specified.
The patient states 45 minutes after eating bagel with egg and salsa he became very dizzy, unable to drive his car, and then threw up 4 times. He stayed in bed the rest of the day. He had symptoms of becoming dizzy for several days.