chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2012US016524 is an initial spontaneous report received from a nurse on 16 Aug 2012 with a follow up information received on 07 Sep 2012: This report refers to a 17-year-old male patient. He was accidentally given only the CYW-135 liquid component of MENVEO (batch number: X10054) intramuscularly on 16 Aug 2012. No other adverse reaction was reported following this administration error. Follow up information received on 07 Sep 2012: Patient demographics captured (age, height and weight) updated.
Info has been received from a consumer concerning her 12 y.o. daughter w/no known medical history who was vax'd w/a first, 2nd and 3rd dose of Hep B vax recombinant in Jan 01, Apr 01, and Nov 01, respectively. There was no concomitant medication. W/in 2 mts of vax, w/the first dose the PT experienced weakness, loss of appetite, weight loss, depression and dizziness. The PT again experienced these Sx's w/2 mts of the 2nd dose of the vax. Subsequently, w/in 2 mts of the 3rd dose, the PT again experienced weakness, loss of appetite, weight loss, depression and dizziness. As of 8/19/02, the PT's mother reported that her daughter, "has continued to experience these Sx's since the last vax, and has been consistently ill since March". Unspecified medical attention has been sought. Add'l info has been requested.
PATIENT REPORTED NUMBNESS STARTING APPROXIMATELY 30 MINUTES AFTER VACCINATION,  STARTING IN FINGERS OF HAND ON THE SAME ARM SHE RECEIVED HER VACCINE. SHE STATED THE  NUMBNESS PROGRESSED UP HER SHOULDER. SHE SPOKE WITH HER FAMILY MEMBER  WHO IS A PHYSICIAN. SHE STATED THE NUMBNESS LASTED FOR APPROXIMATELY 1-2 HOURS.  THE FEELING RETURNED TO HER ARM AND HAS BEEN NORMAL FOR THE PAST 4 WEEKS. SHE ALSO REPORTED SWELLING, REDNESS AND ITCHING AT THE INJECTION SITE ABOUT 7 DAYS AFTER VACCINATION, REDNESS AND ITCHING WENT AWAY, BUT SHE STILL HAS A SLIGHT SWELLING IN THE AREA.
I started off with pain, redness and swelling at the site of the injection, the soreness I would compare to that of the soreness from a Tetanus shot, and the swelling, and soreness did subside after 2 days. On the evening of day 7 I noticed a hive looking rash on my left arm at the site of the vaccine/injection,  I immediately knew I was having some sort of allergic reaction to something. I have since had hives/urticaria on my left arm, front of my neck, my chest, and lower face, it is itchy and at times throughout the day of April 20th have felt warm to touch and a burning sensation along with the itching. I've had a severe headache and nauseated. I have taken 25 mg of Benadryl and  1500 mg of Tylenol twice to equal a total of 3000mg of Tylenol  on April 20th to help with the pain from the headache and the Benadryl for the hives. I did get some relief for the hives/ urticaria from taking the Benadryl but the hives are still present, red and itchy(I haven't had complete relief from the hives and no relief for the headache. I began to research and I believe I'm suffering from a delayed reaction to the Moderna Vaccine also known as Covid-Arm.
Pain, swelling, and redness for approximately 2 days beginning the day after the injection. Firmness and itching at the site beginning 6 to 7 days after injection.
The patient came into the pharmacy for the PREVNAR 13 vaccination and was given FLUZONE HD. This was their second dose this year. Patient received FLUZONE HD from MD office on 9/20/2018. No issues reported by patient at this time.
Fever, headache, ringing ears, body aches, sinus pressure, trouble breathing.
Patient admitted to Inpatient on 1/13/2021 after receiving vaccine on 1/6/2021. Diarrhea and dizziness. Since Sunday, corona vaccination last week. No headache, abdominal pain, nausea or vomiting, loss of taste or smell, muscle aches or general malaise. Patient was hypoxic at clinic visit, 84% on room air, transferred to ED for evaluation.
Pt said after receiving her Flu vaccine, she noticed the injection area became hot, red rash (about size of fist), hard muscle, some swelling, and pain (5-6 if touched, 3 if not touched), pain with movement. She said she did go see a doctor about it, and they say to take diphenhydramine.
General fatigue, extreme headache, bone pain, muscle pain, joint pain, could not stand, could not sit, entire body extremely sensitive to anything touched, severe nausea, awake all that night due to pain/nausea, felt really hot and sweaty. Alleviating: hot bath helped some of the pain, tried oxycodone but it did not relieve pain at all, took Zofran for nausea.
This spontaneous report was received from a pharmacist referring to an elderly female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). On an unknown date, the pharmacist stated that the patient was frail (asthenia), without much muscle mass or tissue at the injection site (muscle atrophy) and had to go to an unspecified hospital due to injection site pain. It was unknown whether the patient was admitted to the hospital as well as if she received any treatment for the adverse events or if any laboratory study was performed. At the reporting time, the outcome of muscle atrophy, asthenia and injection site pain was unknown (discrepant information also reported as "Dechallenge: yes"). The causality assessment between the aforementioned adverse events and PNEUMOVAX 23 was not provided.
Client went to our flu clinic on 10-11-07, was vaccinated with injectable flu vaccine using the Biojectat approx. 5:30 -6:00 pm. She stated that she felt fine and went to bed at 11:00 pm. She stated she woke up at about midnignt with severe itching on  top of her  right thigh and both elbows, she also had "welts".  SHe stated she did take a Benadrl that was expired and used wet cold cloths to soothe the areas. She eventually went back to sleep and woke up this morning and the welts and itching are gone and she feels better.
MUSCLE ACHES, FATIGUE, GENERAL MALAISE, FEVER 100.7 to 99.8, duration all day Wednesday 10/14/2020, treated with rest, hydration and Advil PAIN, SWELLING, REDNESS, AND ITCHING AT INJECTION SITE - this spread down my arm to my elbow. Treated pain for initial 24 hours with lidocaine patch. treated itching with topical diphenhydramine. These symptoms are decreasing at the time of this entry10/17 SWOLLEN LYMPH NODES IN NECK - made me feel like I had a 'sore throat' and my ear cannels felt achy.
Parent called clinic approximately 2 hours after receiving Menactra Vaccine stating client complaining of headache and shaking. Advised to follow up with MD or go to ER. Called client 2 days after incident she states she had headache- progressively got worse, shaking all over and nausea with vomitting shortly after receiving immunization. Went to ER had head X-Ray to R/O sinusitus. Client was told by ER staff she either had a Migraine (no previous Hx) or a reaction to Menactra. Received 2 shots in ER and symptoms gradully disapated.
01/20/22 presents to Birth Center Triage for "active labor".  PMHx "Diabetes mellitus"
Screamed alot x 4-6 hrs day of vax given APAP;
Initial reaction (2 days post): nausea, fever, chills, sore left arm, muscle aches 1month post-present time: hip and knee pain, stabbing right ear pain, chronic fatigue
SO THIS IS AN ADMINISTRATION ERROR - PATIENT CAME TO OUR PHARMACY TO GET SECOND DOSE, SO OUR STAFF INFORMED HER THAT WE HAVE ONLY MODERNA  VACCINE  AND SHE SAID OK SO WE GAVE MODERNA VACCINE TO HER, SO AFTER COUPLE WEEKS SHE CALLED US AND STATING THAT WE GAVE WRONG VACCINE, SO BASICALLY SHE GOT PFIZER VACCINE AS 1ST DOSE AND MODERNA VACCINE AS A SECOND DOSE.
Information has been received from a physician and a medical assistant referring to a 4 year old female patient with bladder exstrophy which was diagnosed in 2011 and latex allergy. On unspecified dates, the patient had multiple surgeries for the bladder exstrophy. On 11-MAY-2012, the patient received the first dose of M-M-R II 0.5 ML, (lot# and expire date were not reported), subcutaneously. On 21-MAY-2015 the patient received the second dose of M-M-R II 0.5 ml, (lot# was reported as 1002242, expire date was reported as 21-JAN-2017) subcutaneously as well as a dose of KINRIX. Other concomitant therapy included BACTRIM for daily prophylactical use. Within 10 to 20 minutes the patient went into anaphylactic shock. The patient was administered a dose of epinephrine in the office as well as given oxygen. Paramedics arrived to the office and took the patient to hospital and the patient was admitted. On the same day at the hospital, the patient was administered a second dose of epinephrine as well as given BENADRYL and SOLU-MEDROL and CLARITIN. Electrolytes and a tryptophan level lab test were done but results of the labs were unspecified. On 21-MAY-2015, the patient was recovered. In the afternoon of 22-MAY-2015 the patient was discharged from the hospital. At the time of reporting, the causality was not reported. The physician stated that the anaphylactic shock the patient experienced was life threatening. Upon internal review, anaphylactic shock was determined to be medically significant event. Additional information has been requested.
Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site.  MD assessed, O2 at 93%, O2 4L initiated by onsite Paramedics.  Pt vomited and stated he feels dizzy and has SOB.  Ambulance called, vitals taken: BP 159/96, HR 88, 98% 4L NC.  Last taken BP was 133/66, patient stated he was feeling anxious, recommended to go to the hospital for further assessment.  Patient was driven by his wife.
only liquid adjuvant of Shingrix; received only the liquid adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 4fk7y, expiry date 29th September 2023) for prophylaxis.   On 24th August 2022, the patient received Shingrix. On 24th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's comment: The pharmacist reported that the patient received only the liquid adjuvant component of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Rash faded into bruising; red rash on torso, legs, inner arms; swollen left wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on torso, legs, inner arms), JOINT SWELLING (swollen left wrist) and CONTUSION (Rash faded into bruising) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 043B21A) for COVID-19 vaccination.     no medical history was provided by the reporter.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash on torso, legs, inner arms) and JOINT SWELLING (swollen left wrist). On an unknown date, the patient experienced CONTUSION (Rash faded into bruising). At the time of the report, RASH ERYTHEMATOUS (red rash on torso, legs, inner arms), JOINT SWELLING (swollen left wrist) and CONTUSION (Rash faded into bruising) outcome was unknown. Not Provided          No concomitant medications was provided. patient received the treatment includes : steroid IV, prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNI , Non significant follow up
Tired; Arm was sore; Mild headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 43 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 11:30 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Known allergies: Adhesives" (unspecified if ongoing); "known allergies: sulpha drugs" (unspecified if ongoing); "idiopathic congenital growth hormone deficiency" (unspecified if ongoing). Concomitant medications included: NORDITROPIN; ALPRAZOLAM; FLUOXETINE. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm was sore"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Mild headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain in extremity and headache.  Additional information: On an unspecified date in Mar2021, after the first vaccination, the patient was tired and her arm was sore. The patient also had mild headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP developed fever and one convulsion; hospitalized 3 days; recovered;
Seizure episode reported at 8:00pm approx 8 hours following administration of vaccine. Resolved within 10 minutes and no residual effects noted.
This spontaneous report as received from a physician refers to a female patient of unknown age with an active case of shingles. The patient was vaccinated with a dose of ZOSTAVAX (lot number, route, dose and injection site were not known) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient a patient with shingles came to the office to be evaluated. The physician provided the patient with a prescription for ZOSTAVAX to be administered at a pharmacy "after the shingles had resolved." The patient misunderstood the physician's directions, went directly to a pharmacy after the office visit, and was administered ZOSTAVAX. The physician added that the shingles "became worse" after administration of ZOSTAVAX. The outcome was unknown at the time of report. The patient had visited the office for medical attention. Additional information has been requested.
Entire left half of body went numb 20 min after injection has continued to stay numb now 4 hours after injection
FEELING CROSS EYED ANXIOUS SEEING DOUBLE,OBSERVED FOR 20 MORE MIN. HAD HER DRINK WATER, S/S RESOLVED OWN, PATIENT STATED DID NOT EAT  WELL, ADVISED TO GO GET SOME FOOD, HAS CELIAC DZ DECLINED CRACKERS. 1314-150/96 98% 24 95  1132 130/86 96% 16 92
pt recvd vax & next day started w/5 small mosquito bites like lesions on chest over course of day devel inot rash; devel t 101 & rash;
arm was a little stiff; aches in body; fever; This is a spontaneous report from a contactable Consumer (Patient)  Via Medical Information Team. A 78-year-old female Consumer (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot : Not reported) Via an unspecified route of administration on left arm on 08Mar2021 as a single dose for COVID-19 immunisation. Patient medical history include hospitalization from Dec2020 for covid 19 and pneumonia. Concomitant medication were not reported. On an unspecified date She had a minor reaction: arm was a little stiff, heard a lot of people saying that. Next day aches in body and a fever. Third day she was fine. The patient underwent lab test SARS-CoV-2 antibody test positive on DEC-2020, 02Feb2021, and on 16Feb2021 had a negative covid test. Outcome of the events were recovered on 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt developed increasing fever and myalgias and rash below injection site. On the 4th day pt went to doctor's office.
Shingles L 4 Distribution Left leg (3 other cases in practice after shingles  in vaccinated linb)
This spontaneous report was received from a registered pharmacist refers two patients of unknown age who on 04-SEP-2012, were vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (routes not reported) (lot number 669579/0595AA) that was expired. The vaccine expired on 30-AUG-2012. No adverse symptoms were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Child was seen in clinic 9/16/2021 and RN administering vaccines did not document in system, so no record was made.  He received immunizations 2/18/2022.  Error was found after immunizations were administered 3/18/2022.  He received Td/Tdap 3rd dose 5 months too early on 3/18/2022. No Adverse events, treatment, and or outcomes were reported.
tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose (dose 1) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer BioNTech Covid 19 vaccine on 23Mar2021 and then 3-4 days later tested positive for COVID and had it for 8 days (as reported, pending clarification). He was scheduled to receive second vaccine on 20Apr2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive in Mar2021.  The outcome of the event was unknown.  Information about batch/lot number has been requested.
Pt has projectile vomited 4 x yesterday and 3 x today and pt is sweaty Pt had shots on Tuesday and had a fever of 101.5 rectally on that day.
Slight cough; Runny nose; Cold-like symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that:  A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history had included deaf. The concomitant were not reported. On an unspecified date the patient had experienced slight cough, runny nose and cold-like symptoms. The clinical course was reported as follows, caller stated he got his first vaccine and was fine until just a little bit. He developed a runny nose and slight cough and had cold like symptoms. His second dose was scheduled for today, it's like he has a cold and asked you know what I am saying. He did not think his first vaccine caused his sickness because it's so far apart, about 2-3 weeks, something like that. He just wants to know if he can get his second vaccine or not. Caller encouraged to reach out to his primary care doctor to discuss getting the second dose. Caller stated he just wanted to know if he could get his second dose if he was not feeling good, that's all.  The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Information has been received from a pharmacist concerning a 71 year old female with a sulfonamide allergy who on 17-FEB-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# 658605/1089U).  Concomitant therapy included alendronate sodium (MSD).  On an unspecified date, the patient developed an injection site reaction described as a "KNOT" or swelling.  It was indicated that the patient called the pharmacist, and was instructed to apply ice and use diphenhydramine (BENADRYL).  No laboratory or diagnostic studies were performed.  It was indicated that at the time of this report, the symptoms had improved, but not resolved.  A product quality complaint was not reported.  Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 21 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 11-JAN-2017, the patient was vaccinated with a dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported). On 12-JAN-2017, less than 24 hours after previous vaccination, the patient was vaccinated with a dose of VARIVAX injection, lot # M000996 with expiry date 07-JAN-2018 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Swelling, redness, warmth and itch of the arm surrounding the area where shots were given primary R deltoid area.
Bilateral splotches on lower extremities, primarily calves, with scattered non-blanching subdermal hemorrhagic patches, varying in size from tmm-1cm. Diagnosed with vasculitis. Advised it will resolve on its own. Told to return if rash worsens, joint swelling/pain, abdominal pain or change in urine color.
I received the Pfizer COVID-19 booster on 5/31/2022. On 8/31/2022, I developed a sore throat, post-nasal drip, joint pain, and fatigue. I pretty much felt like I had strep throat. The joint pain that I had was different from the joint pain I normally get when I have the flu. Whenever I get the flu, I get joint pain in my spine, but on 8/31/2022, I had joint pain in my shoulders, my hips, and across the upper portion of my chest. However, I didn't experience any pain in the spinal area. I took a home antigen test and got a positive result that day. I then called the doctor's office and got a prescription for PAXLOVID. I obtained the PAXLOVID on 9/1/2022 and began taking it at 3PM that day. On that day, I had a low-grade fever, pain in both ears, and a mild cough. I continued taking the medication as prescribed; while I took the PAXLOVID, I had to stop taking SYMBICORT and FLONASE on account of contraindications. The first 2 days of my illness were the worst. I felt lethargic and my cough got worse as time went on. I continued to run an intermittent low-grade fever. I still tested positive as of 9/10/2022. On 9/16/2022, I had mushy diarrhea. On 9/17/2022, I had yellowish liquid diarrhea. The cold-like symptoms resolved pretty quickly, but the fatigue, brain fog, and vertigo lingered. When I stopped taking the SYMBICORT and FLONASE, there happened to be forest fires in our area. I had an asthma attack that was likely triggered by the smoke from the forest fires, but it also may have been exacerbated by the COVID-19. Whenever I have an asthma attack, I always get a severe cough that lingers for weeks. The cough that I developed from this attack lasted until sometime in October 2022. On 9/18/2022, I took a home antigen test and got a negative response. I've recovered from most of the symptoms, but the time of this writing, I continue to deal with vertigo, brain fog, and fatigue.