chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported onset of pain & stiffness in her legs. Joints stiff, with sore knees, ankle, shoulder, neck aching muscles in legs - feels like "spasms", in thighs. Waken up at night in pain - No rash, joint swelling, fever or chills. 2 weeks prior, had received a TDAP - Date of appt 6/29/12.
improperly stored vaccine administered to patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, (dosage regimen and route of administration were not provided), lot number S036635, expiration date 14-NOV-2021, as prophylaxis.   The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of -16.07 degree Fahrenheit (F) for a period of less than 25 minutes (reported as -25 minutes), without previous temperature excursion. The call was because a digital data logger.
Full blown chicken pox. Was vaccinate din 1999 w/ varicella vaccine.
Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Supraventricular tachycardia episodes; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Feb2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included trazodone (MANUFACTURER UNKNOWN) at a dose of 200 mg per night for unspecified indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Jan2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 19Feb2021 at 12:00, the patient had been having many supraventricular tachycardia episodes since February 2021. They occurred many times a day and the patient had none prior to February. The patient wore a heart monitor in August to confirm this. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had been tested for COVID-19. On 25Oct2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event many supraventricular tachycardia episodes since February 2021, they occur many times a day was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
the pain continues.; rash; first dose /October 21st 2019 /second dose/July 14th 2020/ Shingles/April 28th 2021/suspected vaccination failure; Shingles; first dose /October 21st 2019 /second dose/July 14th  2020; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2020, the patient received the 2nd dose of Shingrix. On 21st October 2019, the patient received the 1st dose of Shingrix. On 14th July 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 28th April 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and rash. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles and rash were recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient reported getting his 1st dose and 2nd dose of Shingrix vaccine in right arm.  Reporter stated that he just got the vaccine later than recommended schedule, which led to lengthening of vaccination schedule. Patient reported that he had an episode of Shingles that started on 28th April 2021. Patient stated the rash was gone but the pain continued. Patient stated the affected area was on the right side of the chest and on the right side of the back.  Patient reported he never had an episode of Shingles before the vaccine. Lot and expiration dates were unknown for both doses. The reporter consented to follow up. The reporter consent to follow up with health care professional (HCP). This case was considered as suspected vaccination failure as details regarding aboratory confirmation was unknown at the time of reporting.
pt recv vax 1230PM 17JAN97 & AM 18JAN awoke w/rt deltoid area swollen to 1 1/2 its size, red w/hard knot palpable, also severe pain;pt to ER for tx;given rx;
diffuse macular/papular Rash entire trunk.  No respiratory distress.  Rash very itchy.  No serious distress
Information has been received from a consumer and a physician concerning a 4 year old white female patient with a history of a severe febrile reaction to Haemophilus B conjugate vaccine (ActHIB) on 23SEP1998 (also reported as 28SEP2003) and who was well at the time of vaccination. On 06MAY2003 (reported as 03MAY2003 by consumer) the patient was vaccinated with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). The patient received the first dose on 18NOV1999. Secondary suspect therapy included vaccination in the other arm on the same day with a dose of diphtheria toxoid + pertussis vaccine + tetanus toxoid (manufacturer unknown). There were no other concomitant medications. On 16MAY2003 the consumer reported that her daughter was just diagnosed with mumps. Follow up information from the physician noted that the child was seen in the office on 16MAY2003 for massive swelling of her left parathyroid and submandibular glands which the physician stated looked like mumps. He reported that the child was not treated with anything and that he did not draw titers. Additional follow up information from the physician from the physician noted that the patient developed classical parotid and submandibular mumps and the onset date was reported as 16MAY2003 (also reported as 12 days after immunization). Follow up information from the consumer reported that the child did not have a fever, which the consumer stated was "after effects from the DPT shot." The consumer reported that her daughter had lost 8 pounds and had just started to get out of bed on 27MAY2003. On 29MAY2003 the child was seen in the physician's office for bilateral cervical adenopathy which the physician thought was related to a mild ear infection. On 29MAY2003 the physician reported that the patient had recovered from the mumps. The outcomes of the ear infection, weight decreased and fever were unknown. The consumer questioned if the measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) was somehow contaminated. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Patient stated she felt "dizzy, left arm numbness, hot flash and was going to pass out". Patient looked pale. Was stabilized and brought into private room for further evaluation. Patient was discharged at 11:45 stated she felt well Patient stable, no acute distress noted. Left in private car with husband who stated was the driver.
I have a sinus infection. Back in early December I had a cold that was not going away. By the end of the month there was an ache in my head and face. It was heavy mucus, and it was not getting better. I was not getting fever. I knew it could not be a common cold. I called an urgent care and he prescribed a Z-PAK. It was not working, and I called my PCP in another state, and she prescribed amoxicillin, and it seems to be getting better. But I never had a fever. I still have a little cough and postnasal drip.
Redness and induration, area 3cm in diameter to left thigh, not painful local reaction.
Fever and rash on face started on 08/16/17, still having intermittent fevers and rash is still has flat red rash on face. No other symptoms.
Information has been received from a health professional concerning a 4 year old male with a history of one undescended testicle who on 06-MAY-2008 was vaccinated subcutaneously in the left arm with pneumococcal 23v polysaccharide vaccine (lot# 656233/0200U). Concomitant therapy included measles-mumps-rubella vaccine, for the treatment of prophylaxis (duration and dose not reported) and varicella virus vaccine live, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and hepatitis A virus vaccine (unspecified). On 06-MAY-2008, the patient was inadvertently given pneumococcal 23v polysaccharide vaccine. This was a nurse error. He was suppose to receive tuberculin purified protein derivative. The patient experienced a red, raised, painful injection site reaction. The red, raised, painful injection site reaction persisted. The patient was seen in the office. He will not receive the tuberculin purified protein derivative until his arm heals. Additional information has been requested.
12-12-01 10:30-11:00 am vaccinated. Right leg, dime sized red area with knot underneath. Observed 12-13-01. Proximal 1/2 inch to injection site. Vomiting one time 12-12-01 at 8pm.
Parsonage Turner Syndrome R arm - C5-C6 distribtion. Pain, deltoid/biceps weakness 2/5. Weakness recovered to 4/5 in 48 hours. Pain persists.
Rash on right arm around where injection given.  Some redness.  Treated with Benadryl and warm packs.  Instructed to see PMD if does not improve or becomes worse.
Pt developed lip and tongue numbness and tingling sensation 45 minutes after vaccine.  Benadryl given PO with little to no improvement 30 minutes after dose.  Pt transferred to ED for further monitoring
Varicella - information has been received from a health care profesisonal concerning a caucasian female patient who on 17 Sep 1997 and 20 Oct 1997 was vaccinated with the first and second doses respectively.  of varicella virus vaccine live IM in the left arm.  On 27 Mar 2000 the patient broke out in about 15 pox.  No further information is available.
pt recvd vax & exp elevated liver enzymes; liver function test revealed everything was moderately elevated; No further details were provided
On 12/15/07, SM received AVA (2), TYPHOID (VICPS), and TWINRIX vaccines.  He recalls increased tenderness at vaccination sites lasting < 48 hours.  (He believes all vaccines were given in the same arm.)  SM was at military base preparing for deployment over seas between 6 December 2007 and February 2008.  In general, while he was there, he recalls "not feeling very well the whole time".  He traveled over the holidays (within 2 weeks of vaccine receipt) and recalls experiencing a disabling headache.  The remainder of the time, he experienced frequent "distracting" headache pain which was similar in character to previous "sinus - related symptoms.  On 2/6/08, SM received AVA (3).  He recalls increased tenderness, redness and taut skin surrounding the vaccination site, as well as a small nodule at the site.  His whole arm was sore and he "could hardly move it" for 3-4 days.  He did not experience any numbness or tingling in his affected extremity.  Systemically, he experienced increased fatigue around the same time and he can pinpoint a change in his headaches to this time period.  He began "living with mild headaches" which were similar to previous sinus headaches, but without other associated sinus-related symptoms.  Within 6-8 weeks, he started awakening in the middle of the night with headaches and sometimes the headaches would intensify to the point he would need to leave work.  He also experienced visual changes associated with headaches described as tunnel vision.  Around this same time, SM first noted numbness and tingling on the left side of the mid-thoracic area of his back.  At first it was on "spot" on his-mid back and then the area increased from waistline to lower scapular area, from midline to left mid-axillary area.  Soon after, hid left upper extremity and then lower extremity were affected.  He had no weakness, but had problems with grasp/gripping and dropping small objects.  No bowel/bladder dysfunction.  Around July or August 2008, SM noted left-sided facial numbness and tingling.  He had no drooping of his eyelid or mouth.  He was initially evaluated in theater, and then medi-evac'd to Medical Center and most recently, another Medical Center.
A report has been received from a Health Professional concerning a 14 year old, male subject who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 21-Jan-2014. The patient experienced EXPIRED FLUMIST ADMINISTERED which started on 21-Jan-2014. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious by the reporter. Corrected report 05-Mar-2014: key ingredient of the suspect product was corrected from FLUMIST to Q/LAIV.
Patient reported she experienced shaking, chills, and fever on the first night. She did not check her temperature but took a honey-lemon mixture. Patient experienced fatigue but reported was able to sleep it off. She also experienced loss of appetite and pain around kidney areas. Did have redness  around injection site and some whelps. Patient experienced an increase in heart rate of around 50 points greater than her normal of around 83. This lasted about 3 days but did not contact her doctor or be seen by a doctor due to symptoms resolving itself.
Pt received her first Covid Moderna vaccine on 3/29/21 and reported a rash the next day. Pt was seen at clinic and the rash was 4 in x5 in vertically. Warm to touch, red, hot raised. Pt was prescribed a Medrol Pak - 4mg PO and Bactrim 800-160 mg tab BID x 7 days
her booster shot; low grade fever; body aches; body aches, especially in the neck; swollen lymph nodes in her neck; swollen lymph nodes in her neck and in her right arm (the same arm the shot was given).; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine.), for COVID-19 Immunization, reaction(s): "symptoms after her booster shot that she did not experience with her first two doses of the same vaccine."; Bnt162b2 (Dose:2, experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine.), for COVID-19 Immunization, reaction(s): "with her first two doses of the same vaccine.". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "her booster shot"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; NECK PAIN (non-serious), outcome "unknown", described as "body aches, especially in the neck"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in her neck"; VACCINATION SITE LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in her neck and in her right arm (the same arm the shot was given)."  Additional information: it was reported that the patient experienced multiple symptoms after her booster shot that she did not experience with her first two doses of the same vaccine. Symptoms experienced after booster included a low grade fever, body aches, especially in the neck, and swollen lymph nodes in her neck and in her right arm (the same arm the shot was given). The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
From initial information received on June 27 2005 from a health care professional regarding an adverse event, it was reported that an 11 year old female patient received a dose of Menactra vaccine, lot number U1589AA, administered in the right arm and a dose of Decavac vaccine, lot number U1370BA, administered in the left arm at 11:20am on June 13 2005. Reportedly 40 minutes later the patient fainted in the car. She was only out for a few seconds. It was not reported if the patient needed treatment or if she was seen by a physician after this event. The patient's recovery status was reported as recovered. The reporter of this case is the same reported of cases: 2005-01236, 2005-01237, 2005-01238, 2005-01239 and 2005-01240.
Pt recvd 1st dose of Hep B vax & APR92 was dx w/multiple sclerosis; pt recvd 2nd dose of Hep B & exp exacerbation of disease; addtl info is being requested;
About 36hrs after my Moderna booster I noticed a large red area of skin, about the size of a baseball, at the injection site. The area flat, tender to touch, and blancheable.  It had not required any treatment and the tenderness is similar to or less than I experienced with the previous two doses.
I initially had a sore arm for a couple days after the first shot  but it went away and 9 days later that arm was sore and swollen and red. The next day it?s starting to itch.
I was notified within a few days that the batch had been left out of the cooler too long; feeling kind of cruddy; chills; sore arm; Extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long), EXTRA DOSE ADMINISTERED (Extra dose administered), MALAISE (feeling kind of cruddy) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 046A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long), MALAISE (feeling kind of cruddy), CHILLS (chills) and VACCINATION SITE PAIN (sore arm). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long) and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved and MALAISE (feeling kind of cruddy), CHILLS (chills) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The patient tested positive for COVID-19 upon admission to the hospital on 3/24/2021. CXR showed mild pulmonary vascular congestion. The patient was on 2L/min supplemental oxygen throughout admission.
Cataract surgery; hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery", start date: Aug2021 (unspecified if ongoing), notes: had cataract surgery in Mar2022 and before that in Aug2021.; "high blood pressure" (unspecified if ongoing), notes: She has high blood pressure. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9269, Expiry date: Unknown, Site: Unknown), administration date: 04Mar2021, when the patient was 81-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EP7534, Expiry date: Unknown, Site: Unknown, Event onset: Aug2021), administration date: 25Mar2021, when the patient was 81-year-old, for Covid-19 Immunization, reaction(s): "Cataract surgery". The following information was reported: CATARACT (medically significant) with onset Mar2022, outcome "unknown", described as "Cataract surgery"; ALOPECIA (non-serious) with onset 2022, outcome "not recovered", described as "hair loss".  Clinical course: It was reported that that her hair loss, "Started this at the end of February early March. The beauticians said lots of women are losing their hair at various ages. She has lost all her hair, and if she has to live with it, she has to live with it. We were scheduled to get our next booster, and she found the paper with your number on it. She just wanted to ask. satisfy my curiosity." Her hair loss started in the spring 2022 like late Feb2022 or Mar2022. She is curious as to why this happened. It may have nothing to do with it, but this was strange. She has had 4 doses of the Covid-19 Vaccine. 2 primary doses and 2 booster doses. Her last dose before she lost her hair was on 12Oct2021. Her last dose she had in May2022 after she had already lost most of her hair. Prior Vaccinations (within 4 weeks): Cataract surgery in Mar2022 and before that in Aug2021.
Pain soreness right arm after injection, moved to left shoulder later in day, joint pain, stiffness, and muscles aches followed, pain wakes her up at night.