chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 03 October 2008 from a health care professional. An 18-year-old male patient with no pre-existing medical conditions had received a first dose, right deltoid intramuscular injection of ADACEL, lot number C2996AA and a first dose left deltoid intramuscular injection of MENACTRA, lot number U2580AA on 12 August 2008 and 48 hours later, he developed increased fatigue, a sore throat, headaches, and general body aches which were continuing "on and off" at the time of the report. The patient had not been ill at the time of vaccination. The patient had been evaluated twice by his physician (evaluation results not reported). At the time of the report, the patient had not recovered from the event. Follow-up information was received 06 October 2008 and 13 October 2008 from a health care professional. Based on this new information received, it was determined this case meets seriousness criteria and has been upgraded. From information received on 06 October 2008, the reporter stated the patient had received MENACTRA and ADACEL vaccines on the same day. The following day (also reported as 14 August 2008), the patient developed fevers, headaches and myalgias which lasted four to five days. At the time of the report on 06 October 2008, the patient had been experiencing fatigue and headaches for two months. Additional information pertaining to the symptoms of sore throat, fever, and myalgias was not provided. Extensive blood work-up had been performed which was negative and the physician believed the reported events were secondary to the vaccinations. From follow-up information received on 13 October 2008, laboratory tests performed on 03 October 2008 had been normal with the exception of CBC findings for RDW 11.1% (ref 11.5-15) and MPV 11.70fL (ref 7.40-10.40); Chem 14 were normal with the exception of ALP 75U/L (ref 98-317), ALT 29U/L (ref 30-65), TBIL 1.2mg/dL (ref 0.0-1.0) and NA 132 mmol/L (ref 136-145). TSH (0.88) was normal and a MONO screen was negative. The patient had an echocardiography performed on 10 October 2008. Per the report, the echocardiography was indicated due to fatigue and exertional dyspnea. Results of the echocardiography indicated the chamber sizes, wall thickness and left ventricular function appeared normal. Valvular morphology and function appeared normal. There had been no mass, thrombus or effusion. Doppler results: pulse wave, continuous wave and color flow Doppler demonstrated normal antegrade velocities. There were no significant regurgitant lesions. The patient had no illnesses, no pre-existing medical conditions and had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not recovered. Documents held by sender: Lab and diagnostic test results.
Directly after injection patient became blank faced. When I asked if she was ok, she started crying saying that she was just overly emotional. Provider went in the room to talk with patient (pt)family during their 15 min waiting period. When she came out the timer had gone off for the pt to able to leave. She stated that the pt had become pale and stated she felt light headed. Pt did not lose consciousness but remained lightheaded and pale faced for over 10 min. Once she regained color and felt better they were released to go home.
1 hour after receiving vaccine throat became extremely sore and slightly swollen with swollen glands. Sore throat lasted 5 days. Swelling of throat went away after 2 days.
Diarrhea, aches, slight fever for the first 2 days, now vomiting and headache.
This spontaneous report as received from a nurse refers to a 10  months 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) Liquid PEDVAXHIB, injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contaca6t details were provided.
Pfizer 3/8/21, 3/29/21, 10/13/21. Positive on 9/28/22
After receiving the vaccine, the client passed out briefly while in the vaccinators chair, he came back in about 30 seconds, wife was with him and gave him some sugar pills she had. Client had not eaten breakfast, but had been drinking water. Wife stated client was a diabetic and had not eaten breakfast. Client never mentioned diabetes to vaccinator, only told her he had high blood pressure only. Client remained in my seat for about 15 minutes, when he stood up, he had urinated in his pants. He waited another 15 more minutes and advised to eat something and continues drinking water.
Post vax, the pt developed erythema, edema-a localized reaction. It looked like hives around the injection site. Also, pain in arm.
Body sore; Fatigue; Joint sore; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body sore), FATIGUE (Fatigue), ARTHRALGIA (Joint sore) and HEADACHE (Mild headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body sore), FATIGUE (Fatigue), ARTHRALGIA (Joint sore) and HEADACHE (Mild headache). At the time of the report, PAIN (Body sore), FATIGUE (Fatigue), ARTHRALGIA (Joint sore) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information included non significant information. Patient was doing fine.
SX began 8/1/21 with: Congestion, HBP (more than normal), cough, SOB, headache, fatigue, weakness, leg swelling, wheezing, back pain, loss of balance. She could not wlk when her daughter came to get her to take her to the hospital. She was admitted to the hospital in a reg room 8/2/21.  Patient is fully vaccinated.
Day 1 of shot- immediate dizziness and headache. Headache lasted 7 weeks straight nonstop.  Day 4- 7 weeks after- dizziness came daily. Day 10 after shot- Day 17- Along with headache and dizziness, heart palpitation, diarrhea, tremors, chills, feeling of malaise.  Heart palpitations, headache, and dizziness became intermittent every few weeks after the 7 weeks post-shot, lasting for about 3 weeks then going away so I thought it was getting better. At the end of July, my symptoms got worse- my heart palpitations became worse and more frequent and also being triggered by heat, sugar, and high carbs and becoming increasingly faster, irregular and paired with angina like sharp pain and squeezing of my heart, fatigue in legs and arms, frequent urination, high blood pressure. Before the shot I did not have these symptoms.
Information has been received from a nurse concerning her 6 month old female daughter with no allergies or pertinent medical history who on an unspecified date was vaccinated by mouth with a first dose of ROTATEQ. There was no concomitant medication. The nurse reported her daughter was administered her first dose of ROTATEQ at 6 months of age. No adverse effect was reported. No laboratory diagnostics were done. A product quality complaint was not involved. No additional informational information was provided.
Vaccine at 10:15 am. Answered all the screening questions and cleared. Vaccine administered. Walked to monitoring area. To wait 15 minutes based on questions. 10:30 am complain of shortness of breath, anxiety, and not feeling right. Instructed to do purse lip breathing. Removed masked. 10:35-10:37am complain felt throat closing up. EPI injected in right thigh at 10:40 am/911 called benadryl given at 10:45 am. Pt transported by ambulance to ER.
Case number PHEH2014US017356, is an initial spontaneous report from a physician received on 26 Aug 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unknown date. On the same day, she was also vaccinated with tetanus vaccine (manufacturer and batch number unknown) and PREVNAR (batch number: unknown, other manufacturer). It was reported that she experienced fever with temperature of 103.5 degrees Fahrenheit about 5 hours after receiving vaccinations. Seriousness, outcome and causality of the event were not reported.
A non-serious report of "we gave a partial (1/2) of H1N1 Vaccine to 5" was received from a physician concerning a four-year-old female. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Felt serious hormonal fluctuations after injection. Felt almost sad. Around noon  I started my period. I just had my period a week ago.  This is not normal for me.
some 24 hours after the second dose, I was having all the symptom listed, fever, chills, upset stomach, body aches, headache. I had heart symptoms much like A-Fib for three days.
Information has been received on 2/18/02 from a physician concerning a 33-year-old female who was vaccinated with a dose of measles virus vaccine live. Concomitant therapy included propranolol, which the patient had been taking "for about 6 months." On 2/16/02 the patient developed a headache, that reportedly on 2/18/02 "seems to be getting better now." On 2/18/02, the patient reported to the physician because she had a papular rash on her face, trunk and arms and also had a fever. The patient was instructed by the physician to discontinue the propranolol. The physician had no explanation for the rash other than the measles virus vaccine live. It was noted on 2/18/02 that "no new medications were introduced recently."  Additional information has been requested.
1st dose 2018; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received dose 1 in 2018 in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2018). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter was the pharmacist.  Reporter stated that the patient missed second dose.  No other information provided.  Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Fever; didn't feel well; This is a spontaneous report from a non-contactable Nurse. This female Nurse reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history, family medical history relevant to adverse events and concomitant medications were unknown. The investigation assessment was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect was unknown. Prior vaccination within 4 weeks and adverse events following prior vaccination was unknown. On an unspecified date, the patient experienced fever and didn't feel well for some time after the vaccination. It was unknown if any relevant tests were performed for the events. It was unknown if the patient visited emergency room of physician office for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache lasting for 48 hours. Low grade temp of 99.8,36 hours later.
Shortness of breath, flushing, administered EPIPEN 0.3 mg IM and called 911. Transported to hospital for follow-up.
Pfizer vaccine was not removed from the freezer at the 14 day cutoff when it is supposed to be moved to warmer fridge temperature. THis vaccine was kept in the  freezer and thawed at the 19 day mark. The vaccine does not have stability data published after 17 days but was not yet expired or out of freezer temperature at any time other than to thaw.
Patient stated arms felt warm and then started to develop hives 2 to 3 minutes after receiving vaccine. Then stated arms, shoulder and back felt achy.  Patient was given 50mg or Benadryl orally and monitored.
Feeling unwell and lousy; Feeling warm; Nausea; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at left arm on 21Jan2021 at 12:30 single dose for COVID-19 immunization. The patient medical history included asthma (diagnosed 11 years ago, family history of asthma on mother's side) and pain, both from an unknown date and unknown if ongoing. The patient's concomitant medication included methadone at 75 mg once a day for pain. On 21Jan2021, the patient experienced nausea at 19:00, feeling unwell and lousy and feeling warm at 21:00. The patient's outcome of the events was not recovered.
Fever of 101.8, chills, and pain and mild swelling at injection site all lasting around 24 hours.
The next day, 3/3/21 my right arm, from my neck to my arm was in severe and agonizing pain.  The pain is so severe I am unable to move my arm.  It is now, 3/7/21,  5 days after, and I am still in pain, and unable to move my arm.
Vaccine given in left thigh. Swelling in thigh and lower leg the night that vaccine was given. Injection site warm and red. Painful to touch.
I was working with my partner an EMT as mobile vaccinators, we drive to patients houses to administer vaccines. I was trained by the agency that the EMTs duties is the person verifying the patients vaccines in the ALERT system and helping the patient with paperwork and monitoring for reactions. The duties for the LVN as trained was vaccine withdrawal, administration and temp recording of vaccine cooler.  The roster for the day stated 5 Moderna booster vaccines were scheduled for the address where patient was. Upon arrival, my partner received vaccine cards from all the patients, signatures, and verified vaccines in the ALERT system giving me the green light to vaccinate. Moderna booster 0.25 mL was given to patient of 15 years of age on  01/28/2022 without me realizing the patient was under 18 years of age as I sign the paper authorization after vaccine administration. Mom was notified of event and had no concerns or questions for me. I advised to monitor for any changes, reactions, or side effects and report them to patients physician.
Pt developed itching across chest, left leg, and back approximately 10 minutes after vaccine administered. She also had mild redness noted across her upper chest and lower back. Patient was given Benadryl 25mg PO liquid upon onset. Vitals 110/80, HR 63, O2 sat 99. 15 minutes post Benadryl, patient reports itching is improving as is redness. She was observed for 45 minutes after Benadryl was administer. Vitals remained unchanged. Patient reported no more itching/redness and was sent home via driver.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 77-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Redness/Hives @ site. Resolved with Benadryl 25 mg PO after 10 min time, med vs bandaid adhesive reaction.
Patient signed in for 2nd vaccine and found out she had Moderna for first dose after receiving Pfizer 2nd dose today.  According to CDC recommendation, notified patient that no repeat doses needed.  Patient is aware of receiving incorrect vaccine. None
Mother called to report child has hx of asthma and father forgot to mention it when brought in the clinic. Child received FLUMIST. No reaction to vaccine at time of this report.
Pt states, received the vaccine 10/1/2021, about 9 am, waited 15 minutes following vaccine, felt okay.  Awoke the next morning  10/2/2021.about 430 am from symptoms tachycardia, bounding pulse, chest tightness/discomfort. Pt states she doesn't describe as chest pain. No Shortness of breath. Went back to sleep.    At about 11am, symptoms felt: no energy, not feeling right. Decided to check blood pressure 238/152. Took PRN medication Clonidine, in addition to relaxed, non-pharmacy interventions to bring blood pressure down.   Clonidine and Baby ASA (81 mg).  Denies symptoms of chest pain, jaw pain, shortness of breath.   Pt reported the hypertension symptoms improved. Did not report actual numbers.    Does not believe symptoms were related to anxiety of getting the vaccination.    10/4/2021: symptoms: energy is not back. checked blood pressure today, still slightly elevated but much improved.  "doing what I need to do to keep it down. Denies chest pain, shortness of breath. "I manage my blood pressure without medications, my doctor works with me to manage without medication,. I made some lifestyle changes".  Pt "does not feel at risk" to go to the ED or be seen at this time, wanted information documented. Taking action at home to bring blood pressure down.    Clinic provider notified for review.  Recommend office visit for blood pressure check. Per patient, sounds like symptoms are under control.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients may have received GARDASIL. The GARDASIL was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011939, 1405USA011938 and 1405USA009508 (same reporter link). Additional information has been requested.
Site soreness, headache, within 5 hours,  Fever (100.7), muscle pain, aches, chills, sweating at 16 hours after vaccine and lasting through the next 24-36 hours.  After this time large, swollen, very tender lymph nodes u under left armpit (same as injection) and slight tenderness under right armpit.  This lasted another 2 days.  Muscle pain in my lower back was the most intolerable of the symptoms as this continued well after my fever broke.
This is a spontaneous report from a contactable consumer or other non healthcare professional. A 32 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of the vaccine on 24Jul2021 and was supposed to get his second dose but he tested positive for COVID-19. He asked if he could still get the second shot or if he needs to wait or start over. He stated that he tested positive, but has no symptoms and last year he also had Covid before he received his first dose. He tested positive for covid-19 leading to drug ineffective on 2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test on 2020 last year he also had Covid before he received first dose, sars-cov-2 test positive on 2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Entire deltoid area of left arm is red, swollen, firm and warm to touch. Also very painful. Pt. told to use warm compresses and take BENADRYL.
Hot to touch; Redness; Injection site pain; Rash 8 days post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), ERYTHEMA (Redness), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE RASH (Rash 8 days post vaccination) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Rash 8 days post vaccination). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch), ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE WARMTH (Hot to touch), ERYTHEMA (Redness), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE RASH (Rash 8 days post vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.