chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 32 year old female patient with asthma, chronic sinusitis, allergy to penicillin and syncope. On 13-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (lot # K009105 exp 21-JAN-2016) for severe asthma, intramuscularly. Concomitant therapies included albuterol and Vitamin d (unspecified). The nurse reported that on 14-OCT-2014, the patient experienced swelling, redness, warmth to touch and soreness and pain of her upper arm from the elbow to the shoulder after receiving PNEUMOVAX23. The patient was treated with ibuprofen and applied ice. There were no lab diagnosis or studies performed. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant via a field employee regarding a female patient in her 20's. No information about medical history, drug reactions and allergies was specified. On an unknown ate in 2006, about 8 years ago, the patient was vaccinated with GARDASIL (dose, route not reported)(medical assistant believes that "all 3 doses were given about 8 years ago"). No concomitant medications were reported. The reporter reported to the field employee, "that an adult female patient in her 20's" received an extra dose of GARDASIL), (a 4th dose on an unspecified date). No adverse effects were reported. The outcome of the event is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
Pt fainted approximately 5-10 minutes after vaccine administration; pt  had symptoms of light-headed, dizzy, loss of vision and hearing briefly, numbness and tingling in face and hands. Pt was very pale. Pt's feet were elevated and given a drink. Paramedics were called and assessed patient; paramedic reported normal blood pressure but slightly pulse. Pt was released without recommendation to transport. Pt mother told to call 911 if symptoms of allergic reaction occurred such as nausea, vomiting, diarrhea, rash, hives, or swelling in face, eyes, or tongue.
p/vax pt w/sore arm-noted to have lt deltoid area swollen & warm from just below the shoulder to above the elbow;advised on comfort measures to see MD;seen by MD-sl swelling-no redness, no signs of infect;no tx x/comfort measures;
COVID-19, mRNA, LNP-S, PF (PFIZER-BIONTECH) 5/19/2021 (17 Y) , 4/28/2021 (17 Y)   Severe chest pain,  Requiring hospitalization for pain management and MI/Myocarditis therapy.
Blood pressure had increased; Felt lightheaded; Bilateral shoulder pain; Neck pain; Pain also involving the joints in neck and shoulders; headache; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension and hypercholesterolemia. Concomitant products included nebivolol hydrochloride (Bystolic), losartan and atorvastatin.   On 18th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2019, couple of hours after receiving Shingrix, the patient experienced injection site pain, shoulder pain, neck pain, arthralgia and headache. On 20th November 2019, the patient experienced increased blood pressure and dizziness. On an unknown date, the outcome of the injection site pain and headache were recovered/resolved and the outcome of the increased blood pressure, dizziness, shoulder pain, neck pain and arthralgia were unknown.   It was unknown if the reporter considered the injection site pain, increased blood pressure, dizziness, shoulder pain, neck pain, arthralgia and headache to be related to Shingrix.  Additional details were provided as follows: The patient stated that as of recently before taking the Shingrix his regular blood pressure had been 135/85 for which he was on two anti-hypertensive medications, Bystolic 5 mg and losartan 100 mg, both once a day. He was also on atorvastatin 40 mg for preexisting hypercholesterolemia. The patient states after the Shingrix vaccine, later that day, the patient was experiencing bilateral shoulder and neck pain also involving the joints in his neck and shoulders. On 20 November 2019, at work he felt lightheaded and was seen by the nurse at the work place who took three blood pressure readings which were 170/90, 180/90 and 190/90. He was instructed to go to the Urgent care. About 1.5 hours later at the Urgent care, his blood pressure was reported as 154/86, which was considered normal for him. On 21 November 2019, the customer states his blood pressure has been normal. The reporter was consented to follow up.      Lab Comments: On unkown date, blood pressure was 135/85
After 11.5 hours of receiving my vaccination I had loud incessant ringing in ears; so much so that I could not sleep that night.
Starting about 8:30pm on 3/13/21 I started with all over body aches. Took a couple of Tylenol and tried to sleep.  In the morning around 7 am took 2 more Tylenol.  I continued to have sore throat and cough.  By Tuesday the 16th the body aches were gone but I could hardly swallow and coughing a lot so I checked online and they said I should be checked for strep throat. Went everyday care and test was negative. They could see how raw my throat was and starting of ear infection and cough so they gave me a RX for antibiotic and cough meds.
Dermatomal reaction (shingles-like rash) on left side.  Two pustules.  No itching, stinging or pain.  Also, fever, body aches, headache, fatigue, injection site pain and stiffness.
Flue like symptoms  from 8 am (20 hours after injection)  Cold shivering, no appetite, aching everywhere.   Symptoms lasted 24 hours
Patient returned to pharmacy on 08/26/2018 to report that she experienced a delayed reaction on the evening of the 8/25 which involved generalized rash and swelling of the lips. She reportedly self medicated with BENDARYL 25mg and the reaction at that time appeared to be resolving. Patient was instructed to contact PCP who had recommended the immunization for possible further treatment.
Fever that lasted for 3-5 days in addition to swollen mandibular glands that lasted for 1-2 weeks post fever onset.
First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and lasting until ~36 hours after. The subsequent illness I reported in V-safe seems unrelated to my vaccination. I experienced fever (up to 102 degrees) and general malaise for three successive nights starting on June 4th, 2021 (2+ months after second dose). The fever only came at night and broke in the early morning each night. I had two COVID screenings on June 7th, both came back negative. The final fever occurred the night of June 6th. I continued experiencing malaise and general weakness and had some bloodwork done. My bloodwork came back indicating Fe deficiency anemia, and I have been experiencing this condition since. The cause is suspected to be due to overuse of NSAIDs in dealing with a bulging disc in my cervical spine from early March onward. I am scheduled for endoscopy to further investigate whether I am having bleeding issues causing the anemia. as previously mentioned, seems unrelated to vaccination.
Approximately 3 hours after receiving vaccine pt started having muscle aches, fatigue, diarrhea, and vomiting which lasted approximately 48 hours. Pt reported no illness prior to vaccine administration.
Influenza (IM) administered on 10/03/11. Developed rash & redness, pus, to site on 10/07/11. Diagnosed with cellulitis. Treated on 10/07/11 with KEFLEX 250 po TID x10 days.
Pt. developed sore throat approximately 48 hours after given H1N1 Flu Mist.  On 11/20, he developed fever (101.5) and chills and sent home from school.  Took him to pediatrician same day and told it may be a side effect.  On 11/21, fever normal.
Had the shot that a.m. 11/13/09 Fri. @ 2pm school called her mom and said she was having trouble breathing. GM picked her up 3pm - said her "lungs hurt".  GM took her straight to urgent care with a RNP - gave her shot of epinephrine and watched x 45 min. Then sent home with BENADRYL PO 25mg 1 qd
Patient had received second dose of Pfizer on 9/14/2021. I healthcare professional administered the booster shot on 1/13/2022. One month earlier than the CDC recommendation of 5 months after the second shot. I administered the booster shot 4 months after the second dose.
Information has been received from a medical student concerning a 60 year old male consumer with a history of hypertension, and no known allergies who on 06-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). The patient had flu-like symptoms at the time of vaccination. Subsequently, on 12-MAR-2008 the patient developed severe anterior pressure in his right leg after the administration of zoster vaccine live (Oka/Merck). The patient experienced difficulty walking and had sharp pain in his right leg. The medical student felt that it may be zoster although no rash developed as of yet. Medical attention was sought via a telephone call. There were no lab studies performed. At the time of the report that patient had not recovered. The medical student was not interested in VZV Analysis by PCR but may be interested in the future if a rash develops. She has already received information through email. There was no product quality complaint involved. No further information is available.
REPORTING DUE TO PATIENT RECEIVING TWO PREVNAR 13 VACCINATIONS ONE ON 7/9/18 AT MD OFFICE AND ONE FROM THE PHARMACY 10/27/18 PATIENT HASN'T REPORTED ANY ADVERSE EVENTS.
1day post vax entire arm was swollen, distal to the inject site, no redness, some soreness;
Patient described symptoms as being the injection site arm was in extreme pain, had bright red spot at the injection site, and fever/chills in the evening. Patient took VICODIN to help sleep due to the extreme pain. Did not complain of any difficulties breathing and red spot did not increase since the time of administration until the morning of 7/24/16 where patient came back to pharmacy to ask for more recommendations.
Redness and itching at site of injection first noticed in the shower. The redness has continued to enlarge and itching is still occurring as of Saturday 9/17/16.
Itchiness at injection site  on Saturday, Rash on Sunday, patient instructed to monitor and should improve within next couple of days.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N026075 with expiration date of 20-SEP-2018 (strength, dose, frequency, route, and anatomical location) for prophylaxis which was reconstituted with a properly stored sterile diluent (MERCK). The vaccine was exposed to a temperature range between 15°F to 46°F, during a time frame of 43 hours, which was called by a data logger. No previous excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1806USA008094.
20 mins after vaccine patient had itching from head to toe, whelps on the back of legs. 25mg Benedryl was taken and symptoms subsided to minimal after an hour of taking medicine. Patient continues to have mild to moderate itching 14 hours after vaccination.
site of the injection was warm; site of the injection was warm intense itching; Redness; swelling of the site of the injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (site of the injection was warm), VACCINATION SITE PRURITUS (site of the injection was warm intense itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling of the site of the injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE WARMTH (site of the injection was warm), VACCINATION SITE PRURITUS (site of the injection was warm intense itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling of the site of the injection). On 31-Dec-2020, VACCINATION SITE WARMTH (site of the injection was warm), VACCINATION SITE PRURITUS (site of the injection was warm intense itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (swelling of the site of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: no new information On 15-Apr-2021: Patient is a physician and did not seek medical attention for the side effects.
Pt is 24 year old and was to  get boostrix, but was given Infanrix.   No know symptoms
arm soreness-4 days, fatigue, feeling tired, body aches, muscle soreness x 1.5 days- took Ibuprofen
I had a sore throat, runny nose, slight headache, body aches, and brain fog. I woke up feeling very unwell. I had a low-grade fever of 100.1F which went away on its own after a day. My husband and son had already tested positive for COVID-19 so I was sure I contracted it from them, but tested to be sure. I took an at-home COVID-19 on 12/19/2022, and it came back positive. I called my doctor who prescribed me PAXLOVID for treatment. Since beginning my treatment, all of my symptoms have subsided other than minor body fatigue.
Developed hives on legs the morning of 9/16 while at school. By the end of day legs were covered in hives. Some were itching. Had some relief with Benadryl after home from school. 9/18 hives spread to knuckles and face. Was evaluated at an urgent care clinic and administerd 16 mg Dexamethasone and given steroid dose pack. Pt returns to office today reporting hives had improved until today when new hives erupted on legs again.
This spontaneous report was received from a nurse refers to an currently 72 year old female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 04-NOV-2009, the patient was vaccinated with PNEUMOVAX 23 injection (lot number and dosage not reported). On an unknown date, the patient developed a large, local, red and itchy rash at the injection site. The outcome of all the events was unknown. The reporter did not provide any causality assessment between events and PNEUMOVAX 23. Additional information has been requested.
Rapid heart rate, high blood pressure, itching of tongue and back of throat, hoarseness, slight wheezing, and difficulty breathing.
The next day, patient experienced productive cough, throat and mouth swelling. No treatment. Symptoms have since resolved but patient wanted to make us aware.
Fluttering of the heart; Premature ventricular contractions; Arm hurts at injection site/hurting again at the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program COVAX US support. A 42-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and via an unspecified route of administration, administered in Arm Left on 23Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization at the age of 42-year-old . The patient's medical history was not reported. The patient was taking unspecified medication concomitantly. The patient experienced fluttering of the heart, premature ventricular contractions and arm hurts at injection site/hurting again at the injection site in Sep2021. The patient has had PVC'S which are premature ventricular contractions. The patient clarifies he has had fluttering of the heart, basically it's almost like he is running a marathon. He has been given high blood pressure medication and Diazepam and nothing is working. Name of blood pressure medication is unknown by the caller, it started with an M, but he doesn't know. He confirms he has no NDC, Lot or expiry date for the blood pressure medication or the Diazepam, he doesn't know where it is. He makes the statement later in the call, that it wasn't a bad batch of Diazepam or anything like that. The patient explains the PVC's began immediately after receiving the first one, he clarifies the small dosage on 01Sep2021. He clarifies it was not immediately, but within a day or so. He doesn't understand why Pfizer is not telling the people on the news about the complications of the vaccine to make people aware of it. The American people should know about this. He confirms the PVC's have not improved. He adds that his arm started hurting him again. It was hurting and then it stopped, but now its hurting again at the injection site. This started about 3 weeks ago. The events resulted in doctor's visit. The patient had seen a doctor beforehand who said he was good to go and ever since he had the Pfizer vaccine, he had to go back. It's like because of his heart, he is not getting rest since he has that other heartbeat in between. He's beating double. He has his regular heartbeat, then another one, then a regular heartbeat, and then another one. He states they thought it was from anxiety, but it's not anxiety. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Developed waves of tingling and numbness  in feet and hands. Developed lower back pain night of vaccination. Next day developed continuous numbness in left side of face, periodic numbness in left neck, left shoulder, and left side of head.   The tingling escalated for about 6 days to the point it felt like my entire nervous system was vibrating. Lower back pain persisted more frequently, likely sciatic nerve pain.  Around day 21 the tingling began to get better, but developed pain in fingertips and toes. Pain came in waves but was transient.   Today is almost day 39 post vaccination, still have minor transient tingling in feet and hand. Transient less frequent pain in fingertips and toes. Numbness in face/head seems to be gone.
Pfizer 2/4/21, 2/25/21, 12/9/21. Positive on 7/15/22
Right after the shot, within 10 minutes, as I waited in the car, I started to get nausea, vertigo and lightheaded.  My arm also was in pain. I waited in the car and waited to feel better and drove to my husband's house a mile away. I laid down for a little while to rest for about 5 hours. I woke up and I felt disorganized, memory fog, weak, fatigued, a little nausea (not as bad as before), my arm was still in pain and the vertigo was on and off. I consulted with the doctor and was given a prescription for Zofran. It took about 10 days for most of the symptoms to resolve. I am still suffering from fatigue, weakness, tiredness, a little memory fog and loss of appetite.
Information has been received from a physician concerning a 27 month old female patient who on 01/24/2004 was vaccinated subcutaneously once with a 0.5ml dose of varicella virus vaccine live.  On 02/11/2005 the patient was seen in the physician's office.  She had less than 50 lesions and no fever.  The physician reported that she had a breakthrough case of varicella.  No treatment was given.  It was noted that therapy was discontinued on 01/24/2004.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
Dtap 0.5cc IM given instead of Tdap vaccine.  Fluid up with patient 3/5/08, no complaints from patient.
pt recvd vax; 24 hrs later, devel hives on lt arm which progressed to all body; pt reports chronic urticaria w/ angioedema since vax;
Patient reports that the following evening after her vaccine her arm began to hurt and she lost her range of motion.  Patient was concerned at the time and how high on her arm we administered her vaccine.  Patient is still having problems and has followed up with her physician already.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild
Information has been received from a health professional referring to a patient of unknown age and gender. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On 31-JUL-2015, the patient was vaccinated with second dose of ZOSTAVAX (strength, dose, frequency, lot # unspecified). Concomitant medications were not provided. On 17-JUN-2015, patient received the first dose of ZOSTAVAX. No adverse experience was reported. Additional information has been requested.
2 hours after injection I had blurred vision, which led to a migraine. Prior to the vaccine, I haven't had a migraine in over 10 years. While having blurred vision, sat down with tea and lost my sense of taste and could not taste anything until my vision got back to normal. (approximately an hour later.) I took Ibuprofen as soon as blurred vision started.  Next morning I woke up to mouth sores all over the inside of my mouth.
presented to ER on 9/28 with dyspnea. EMS noted a SP02 of low 80's on room air. On arrival, vitals wnl except for Sp02 of 86% on room air and tachypnea to 24. Patient was started on bipap 55% Fio2 with an improvement in Sp02 to 91%. CTPE performed which showed no evidence of PE, but multifocal pneumonia. Rapid COVID was negative. Labs were unremarkable. Pulmonary consulted and accepted admission to ICU for bipap therapy for AHRF.   Patient reports that her nurses aide tested positive for Covid recently.  Patient reports onset of sore throat starting 2 weeks ago.  She also endorses a cough productive with "green gobs " which also started 2 weeks ago.  Few days later she developed vomiting and diarrhea, which have now resolved.  Starting 1 week ago patient developed shortness of breath and chest pain.  She endorses some mild rhinorrhea as well.
administration of expired Fluzone HD to a patient; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 years old female patient who received an expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy taken.   On 08-Apr-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI993AB (expiry date: 18-Mar-2019) via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was observed.  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 and Module VI of the 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.