chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 17.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
1st shot-pain lwr back, legs, lethargy, fatigue. dx w/viral meningitis 10 days after. 2nd time pt dx . 1st time Oct. '96 pt dx w/extreme fatigue,lack of coordination, focus. Vision blurred/resolved. 2nd vax 6/28,pain legs,sleeplessness.3rd
HEADACHE; This spontaneous report received from a consumer (patient's husband) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose and vaccination anatomical site not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
APPROXING TWO MINUTES  AFTER GIVING THE MODERNA VACCINE INTO THE LEFT ARM IM, PATIENT STARTED TO COMPLAIN OF HER HEART STARTING TO RACE AND FEEL LIKE IT WAS GOING TO POUND OUT OF HER CHEST.  I ADVISED PT TO CONTROL HER BREATHING WITH SLOW DEEP BREATHS, SO IT DOESNT TURN INTO ANYTHING ELSE. TOOK BP AT 9:57AM WITH 152/111 HR OF 85 PT WAS SITTING. STILL ABLE TO UNDERSTAND AND TALK WITH ME AND KNOW WHAT IS GOING ON. BP AGAIN AT 10:02 AM 129/107 HR 82, PT SAID FEELING A LITTLE BETTER, I ASKED IF SHE WOULD LIKE SOMETHING TO DRINK, SHE SAID SHE HAD A TEA WITH HER HUSBAND. PT ABLE TO TAKE 2 SMALL SIPS AND THEN FELT LIKE SHE WAS GOING TO VOMIT. ASKED PT AGAIN TO CONTROL BREATHING WITH SLOW DEEP BREATHS, PT WAS ABLE TO STILL DO THIS. ASKED PT IF SHE FELT OK ENOUGH TO STAND TO TAKE BP, SHE SAID SHE THOUGHT SO, I ADVISED IF SHE FELT LIKE SHE NEEDED TO SIT DOWN THE CHAIR WAS RIGHT NEXT TO HER. PT STOOD AGAINST WALL, TOOK BP WITH AUTOMATED CUFF,  BP 148/102 HR 85 STANDING.  PT SAID SHE WAS EXTREMLY DIZZY AND LIGHT HEADED AND FELT LIKE SHE WAS GOING TO PASS OUT. I HELPED HER TO THE CHAIR. ONCE IN THE CHAIR, PHARMACIST CAME IN TO CHECK ON PT AND  PT STATED TO HER THAT SHE WAS JUST VERY TIRED AND WAS GOING TO GO TO SLEEP AND STARTED TO NOD OFF, I CONTINUED TO TALK TO HER AND SHE WOULD STILL REPLY TO VERBAL COMMANDS BUT DIDNT LIKE TO OPEN HER EYES. CHECKED BLOOD GLUCOSE AT 10:15 AND WAS 117.  PT CONTINUED TO NOT RESPOND TO VERBAL STIMULI. PT CONTINUED TO DECLINE  AND WAS UNABLE TO RESPOND, GAVE EPI INTO LEFT THIGH AT 10:20AM. TRANSFERRED CARE TO FIRE AND AMBULANCE SERVICE
2 weeks after the vaccine patient developed a few scattered vesicles. Most went away, however the spot over the site of the immunization developed an open sore that has been present for 2 weeks.
Teeth started chattering in the middle of the night; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced teeth started chattering in the middle of the night in Jan2021. The patient did not receive any treatment from event. The outcome of event was unknown.  Information on the lot/batch number has been requested.
acute cellulitis rt arm; central portion 1" inf w/posterior to inject; inflammation approx 25mm; outer area of inflammation approx 4" diameter; very tender & hot to touch; placed on ATB therapy;
//Pt was given additional dose of Menactra in error.  She had already received her full 2 dose series on 4/27/16 & 6/28/21
SYMPTOMS CONSISTENT WITH ALLERGIC REACTION TO INCLUDE HIVES, WHEEZING AND TROUBLE BREATHING.
On day 8 after receiving the vaccine there was a red circle around my injection site along with redness, tenderness, a hive on injection site, and itchiness. No medications. Resolved in 3 days.
The patient reported a knot/bump in her arm at the injection site.; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 64-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. On an unknown date in Apr2021, the patient experienced a knot/bump in the arm at the injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of knot/bump in the arm at the injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event knot/bump in the arm at the injection site was unknown at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt admit 4/22/22 w/ AMS - found to be COVID+ with symptoms. Pt had already received 3 doses of Pfizer vax (1/3/21, 1/22/21, 10/7/21). Of note, pt had been on a steroid taper since at least 4/1/22 and lives in a facility. 1st positive COVID test on 4/13/22.
This serious case was received from a physician on 06 November 2008, and represents a cluster of "six or seven patients". SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A physician reported that "five or six" employees at a local hospital had experienced Bell's Palsy within two weeks of receiving FLUZONE SV (lot numbers, date of administration, and patient details not provided). Additionally, the physician reported that at least one employee at another local facility had also experienced Bell's Palsy. The physician, who was a pediatrician, had not seen any cases of Bell's Palsy in her own practice. Outcome was unknown. Documents held by sender: None.
After 1st shot, patient experience expected pain at injection site.  After the second shot, patient complained of generalized pain in Shoulder, Hip, and Opposite Arm of injection.  Patient additionally complains of decrease in O2 sat from baseline of 93% to 82% on exertion and 88% at rest.  Patient instructed to follow-up with primary care physician.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium.
pt seen in office 24SEP98 w/lt upper arm swelling & redness;recv vax 23SE98;cellulitis vs allerg rxn;
MUSCULOSKELETAL STIFFNESS. Information has been received from an emergency medical technician concerning a 34 year old patient who on 04-JAN-2004 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 644694/1048M). Subsequently 04-JAN-2004, the patient developed stiffness of the upper arm to the neck and back, which was described as a site reaction. Unspecified medical attention was sought, but treatment was not required. The stiffness lasted into a second day, 05-JAN-2004, and then resolved. A product quality complaint was not involved. The reporter also mentioned another patient who had an experience post vaccination with hepatitis b virus vaccine rHBsAg (yeast) (Lot #644694/1048M) (WAES #0401USA00224). Additional information has been requested. Follow up report received on 03/16/2005:  Approximately 2 hours after vaccination on 01/04/2004, the patient began getting pain in his tricep area.  As the day went on, the pain traveled up the patient's arm into the back of his neck.  On 01/04/2004, the patient also developed stiffness of the upper arm to the neck and back, which was described as a site reaction.  The patient had what felt like a stiff neck for two days.  Unspecified medical attention was sought, but treatment was not required.  The patient was not seen by a doctor.  The stiffness lasted into a second day, 01/05/2004, and then resolved.  It was noted that the patient recovered.  A product quality complaint was not involved.  The reporter also mentioned another patient who had an experience post vaccination wtih Hepatitis B virus vaccine rHBAg (yeast) (lot # 644694/104EM) (WAES # 0401USA00224).  Additional information is not expected.
Flushed face, tightening of jaw then difficulty/ inability to swallow (for a brief period - it went away then came back a few times, followed by numbness of left side of body. Went to the emergency clinic, they gave me Benedryl.
Patient presented at clinic for nurse visit to receive Covid vaccine. Covid vaccine ordered was Moderna 6mo-11yr. Patient was administered 0.25ml Moderna (Spikevax) 12+ in error at 2:40pm.
Dizzy, weak in the knees, and trouble breathing for a minute.  Medics came by and observed him and released him the same day.  I called the patient the following day and he was fine.
This case was reported in a literature article and described the occurrence of lymphoid hyperplasia in a 65 year old female subject who was vaccinated with influenza virus vaccine (influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of influenza vaccine (unknown, right deltoid). Within days of vaccination with influenza vaccine, the subject developed a pruritic nodule at the injection site. Within a few days after the injection the nodule grew to 2 cm in diameter. Despite therapy with antibiotics and warm compresses, the lesion continued to increase in size. A biopsy performed 6 weeks after initial presentation revealed granulomatous and mixed cellular infiltration that was interpreted as reactive in nature. No pathologist microorganisms were identified histologically or in cultures obtained from lesional tissue. Within a month after initial biopsy, the nodule had enlarged to 5 cm and had begun to ulcerate. The lesion was resected, and revealed a similar reactive histology compared to the initial biopsy. Over the next 2 years, the lesion continued to increase in size and ulcerate, despite numerous attempts at resection and various courses of oral and topical corticosteroid therapy. Cultures for infectious microorganisms were consistently negative. Ultimately, a course of low dose radiotherapy was administered three years after the initial presentations and resulted in complete regression of the lesions and healing of the overlying epidermis. The patient has not had a recurrence within a nine year follow up period after radiation treatment. Histologically, all tissues had similar findings. The epidermis was ulcerated, and the full thickness of the reticular dermis was effaced by a sheet of cells extending into subcutaneous fat. The inflammatory proliferation was comprised of a cellular, atypical but polymorphic lympho histiocytic population of mononuclear cells. The proliferation was characterized by mostly small to medium sized lymphocytes, some with a plasmacytoid appearance on a histiocytic background. Larger immunoblastic cells made up a small component of the infiltration. In addition, there were scattered area of necrotizing granulomatous inflammation within the cellular dermal. This case was assessed as medically serious my manufacturer (OMIC). At the time of reporting the events were resolved. The author considered the events were related to vaccination with influenza vaccine.
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, therapy route and vaccination schedule were not reported). On an unknown date the patient experienced shingles and swollen eye after receiving ZOSTAVAX. The outcome of shingles and swollen eye was unknown. The relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to a child patient of unknown age (also reported as pediatric patient). On 11-FEB-2014 the patient was vaccinated with VAQTA, 0.5 ml, intramuscularly (lot number 0368AA and expiry date 11-JAN-2014) (dosing regimen and frequency unknown) expired drug. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Starting 07/20/2022, I developed more sinus congestion, cough and fever with chills. I woke up soaking wet in the middle of the night. The next day, I thought it was the bronchitis getting worse (that I had been battling for the last month). So, I went into work that day but progressively felt worse and I had to leave work and went straight to urgent care. They did a flu test and a COVID-19 test. The next day I got the results that I was positive. I had the rx for prednisone and was told to keep doing what I was doing. By Friday 07/22/2022, I was feeling much worse and concerned about running out of time to start the PAXLOVID. I called the urgent care that Saturday to let them know how I was feeling and to ask about PAXLOVID. They prescribed it to me and I started it that evening. Each day with taking the PAXLOVID I was starting to feel slightly better. By Monday, I was feeling better but still fighting off the bronchitis and COVID-19. Today, I am feeling a little bit better but am still quite tired. If I try to exert myself, I get dizzy, chills and have to take a nap to recuperate. Also, I am experiencing some brain fog and not being able to remember things well.
Shingles recurrence, had previously 10/19.  Beginning course of acyclovir.
Vaccine was administered after the beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  The patient did not report any adverse reactions after the administration of vaccine.  Vaccine number 1 NDC code was reported as 80777-0273-99.   This case was linked to MOD-2022-542869 (Patient Link).
Approximately 2 hours after 1st dose Moderna, developed right sided facial numbness and tingling and right sided headache. Symptoms lasted approximately 2 hours, then disappeared.
Flu-like symptoms for 2+ days; 101 degree temperature and bad headache.
Within 5 minutes of receiving the vaccine, I felt tingling and slight numbness or pins and needles feeling in my left face/cheek. Today I have the same sensation and some in my left side of my tongue and lip. The only other reaction is pain at the injection site .
This spontaneous report as received from a registered nurse refers to her 18 years old daughter with possibly sulfa allergy and with no pertinent medical history. The patient was vaccinated with unspecified number of doses M-M-R II (Lot#, dose and route not reported) through a health department sometime in the past when she was a child (date unspecified). Concomitant therapy included unspecified allergy medication. The patient's titers were currently showing that she was "nonimmune" to rubella, date unspecified. The patient visited office for medical attention. At the time of this report the patient's status was noimmune to rubella. This is one of several reports received from a same source. Additional information has been requested.
Patient came in to get the Pfizer bivalent COVID 19 booster vaccine but the monovlent Pfizer COVID 19 vaccine was selected and administered to the patient. Both Vials were stocked next to each other in the fridge on the same shelf.
Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing,.thyroid issues, anaemia, vitamin b12 deficiency from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced nausea on an unspecified date with outcome of unknown, diarrhoea on an unspecified date with outcome of unknown and fever on an unspecified date with outcome of unknown.    Follow-up (15Apr2021): This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that: Husband and wife both had their 1st shot on 13Apr21. Wife had nausea, diarrhoea and fever. Wants to know if ok to have 2nd dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose number unknown, single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 04Mar2021, outcome "unknown", described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 04Mar2021, outcome "unknown", described as "temperature"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset 05Mar2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills on day 1 @ 20:00pm  Day 2 (2/6/21)- Headache, Body ache, Left eye swelling (ongoing for 2 days)-Treated with tylenol and Motrin, Xyzal taken daily. Day 3 (2/7/21)- Left eye swelling, decreased.
Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix to an adult age patient; Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix 720 Junior) for prophylaxis.   On an unknown date, the patient received Havrix 720 Junior. On an unknown date, an unknown time after receiving Havrix 720 Junior, the patient experienced adult use of a child product (Verbatim: Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix to an adult age patient) and wrong technique in product usage process (Verbatim: Administration of 2 720 unit Havrix as a single dose instead of 1440 unit Havrix). The outcome of the adult use of a child product and wrong technique in product usage process were unknown.   Additional Information: GSK receipt date: 18-May-2023 The reporter was a PharmD. The reporter did not consent to follow up. The adult patient was administered with 2 doses of Havrix 720 instead of Havrix 1440 unit, which led to adult use of a child product and wrong technique in product usage process.
significant hair loss/fall noticeable beginning at two weeks after 2nd vaccine dose, substantial daily loss continues as of 6 weeks post vaccination with no new hair growth observed
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 50-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 10-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles 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 reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
pt was to recvd 1/2 of a dose of influenza vax x 3 doses; on 26OCT93 recvd .16 cc of vax; called the office on 1NOV94 to report that on the noc of 26OCT94 had terrible chills & nausea on 27OCT94;
MMR/Varicella given out of recommendation range of 12 months or over. Flu vaccine given out of recommendation range (3 weeks early). No adverse reaction at this time.
Pt developed large 5cm reddened, swelling with hives on it as well as red area to R wrist and L elbow. Ice pack was placed w/min relief, given Benadryl which decreased redness/swelling/hives within 10 minutes.
Weakness and pt was admitted to hospital 3 days after vaccine administration and diagnosed with Acute Lacunar Stroke
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 11-JUN-2014 the patient was vaccinated with GARDASIL dose 2. This was "about two weeks" after her first dose of GARDASIL. There were no adverse effects reported. The outcome of inadvertent receipt of second dose only two weeks after the first dose is unknown. Additional information has been requested.