chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning). On 26-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given from an expired vaccine this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter had stated that the vial did not undergone any temperature excursions and the vial was initially stored in the refrigerator on 28 Dec 2021. No Concomitant information was reported. No Treatment information was reported.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications was not provided by the reporter.  HCP said that 606 doses were given after expiration date. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code is scanned. On 17 Nov 2021, the vial was initially stored in the refrigerator. The vial doesn't undergone any temperature excursions.  Treatment information was not provided.
Approximately 30 minutes after vaccines given, mother reported that patient had an episode of jerking. Mother called on 4/16/01 to report that patient had no more episodes, but she had taken her to the ER, and the ER doctor started patient on anti-seizure medication. Patient was to be seen by a neurologist.
08/08/02, RN called from clients house and stated that child had a swollen, red area on his left upper arm-extending almost from shoulder to elbow. Child's mother had taken him to ER on the morning of 8/8. Child rec'd DTaP IM and IPV SQ in the left arm on 08/06. I spoke with the mother and stated that child had no generalized fever, no blisters or red streaks, and the child stated that arm "was not sore". I asked the mother what advice the ER Dr. gave her and she said he told her to apply cool compresses and 'watch the area" that he had marked with a marker for worsening. She stated that the area had grown larger since returning from the ER. I asked her if she had been applying the cool compress to the child's arm and stated "No". I advised her to apply the cool compress, and administered Tylenol to the child's for the pain. She then stated "he says it doesn't hurt, and and he's up running around and playing." She then started that she was told to take the child the next morning to Urgent Care to have bloodwork done I asked her why the doctor thought the child needed bloodwork and she said "I don't know." I told her to be sure and use the cool compress and to call us back when she saw the doctor at Urgent Care.
Not feeling 100%; Diarrhea; Fatigue; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling 100%), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Mild headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Not feeling 100%), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Mild headache). At the time of the report, FEELING ABNORMAL (Not feeling 100%), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Mild headache) outcome was unknown.            Before receiving the booster dose patient was taking antibiotics as she was experiencing an urinary tract infection 1 day before No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-374165 (Patient Link).
Case number PHEH2015US026833, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 66-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into right deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Patient received dose of vaccine. About 2 minutes later he started coughing. A minute later he started to hunch over in his chair. I went over to make sure if he fainted that he would not fall. He described numbing and tingling in both arms and face. He was having difficulty seeing complaining of seeing white. We took his Bp it was 116/70 and pulse of 63. Ge appeared pale and white. We called for ems, and by the time EMS arrived he was feeling better his color had returned in his face. Patient was able to walk and leave store under his own power and didn't need to be transported.
Severe headache, fatigue, muscle aches, and brain fog.  Treated with 400mg ibuprofen twice Saturday, 4+ hours apart and bed rest.  Lesser headaches and fatigue with worsened brain fog ongoing through Wednesday afternoon. No treatment after Saturday.
Face numbing, right hand numbing, brain fog, hypersensivity in scalp, 1st dose 2nd dose, lemon-sized lump in left arm -site of administration
No additional AE information provided; patient was inadvertently administered an expired dose of VARIVAX (Lot R011807 Exp 4/23/2020) on 5/1/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. The concomitant medication included sterile diluent which was not expired.  On 01-MAY-2020, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) one dosage form, lot number R011807 with an expiration date on 23-APR-2020 (strength, anatomical location of injection, vaccination scheme, and route of administration were not reported) for prophylaxis (expired product administered). No temperature excursion was reported for the vaccine, no additional adverse events nor quality complain involved.
pt recv vax JAN96 & pt had 2 titers drawn & one titer was 0.5 & the other was negative;no further details were provided;
Received injection on 03/13/06. Mother noted one bump and injection site reaction yesterday and brought patient into office today.  Upon exam noted injection site to be red, warm and slightly hard to touch circumference of approximately 5cm. Pt has six rash areas on trunk of body, which she complains of itching. Pt is alert & orientated as to the orientation of a three year old. Afebrile.  No seizures or respiratory distress.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
had injection site pain upon receipt of the shot.  The next day the pain expanded up and down my arm and continued to spread over the next couple of days.  It extended into my left chest and left scapula.  Pain lasted in extended areas for a couple f weeks.  The pain had gradually reduced but was present near the injection site for over 7 weeks.
top of arm was hurting went all the way down to her hands, lymph node under arm is swollen and painful
BIVALENT PFIZER COVID VACCINE GIVEN AS DOSE 2 OF PRIMARY SERIES RATHER THAN MONOVALENT
Feb 18 - 2 days after he stared having staring spells.  Feb 24 - noticeable seizures  Feb 26 - emergency room for seizures (lasting 1 min) March 1 - diagnosed with infantile spasms
after receiving my first #1 covid shot, Feb. 22, 2021, about one week later on approx, March 1 st. i felt a movable lump in my left side of my neck. I had a dr. appointment on March 17 and waited to report this found lump to my dr, on march 17, 2021. She ordered a  scan and i had the scan done and it showed an enlarged lymph node where i felt it. She ordered Methylprednisone tablets , medrol pack .She stated it was from receiving my covid shot.  There was not a swelling / lump noticed till after my 1st. covid shot.
The first one was OK. This second one gave me hard chills, no fever, severe nausea and the worst headache I've ever had. Photphobia present with that headache and bodyaches all over. Started 5 hours after I received the vaccine and continued until this morning-46 hours in length.
ADMITTED 12032021: Pt arrives via EMS from home c/o increasing SOB x1 wk. Pt tested neg for covid on 11/28. Pt has hx copd. pt was on 4L nc at home at 76%, normally only wears O2 at night. History of Present Illness: Patient is a 65 y/o female with hx of COPD on 4L home O2, hypothyroidism who presented to the ED with SOB. History is limited from patient as she is on Bipap. She reports she initially became ill earlier this week. She reports dry cough with SOB and fever to 102. She endorses N/V and diarrhea. She denies loss of taste or smell. She reports myalgias. She has completed 2 doses of COVID vaccine. She has had family who have tested positive for COVID-19.   In the ED, patient is noted to have O2 saturation in the 70s upon arrival on CPAP. Patient was placed on Bipap with improvement in O2 saturation to 90s. She was noted to be febrile to 101.5 and otherwise hemodynamically stable. Laboratory studies are significant for WBC 2.7, platelets 122, bicarbonate 19, glucose 120, procalcitonin 0.1. ABG reveals pH 7.43, pCO2 26, pO2 69 on 80% FiO2. CXR reveals diffuse bilateral alveolar infiltrates consistent with COVID-19 pneumonia. Patient was trialed on HHFNC but was unable to maintain O2 saturations and was placed back on Bipap. Hospitalist service is asked for admission.  PT CONTINUES TO BE AN INPATIENT AT THIS TIME.
getting the two part shingle shot / I still break out in shingles / get the two dosage shot and they keep coming back/Suspected vaccination failure; getting the two part shingle shot / I still break out in shingles; just a pain in the butt. That's where mine break out; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had before the 1st shot of vaccination).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient had shingles and then ended up getting the 2 shot of Shingles vaccine. The patient still breakout in shingles after receiving shingles vaccine. The patient said luckily it did not hurt, but just the pain in the butt, that was where his/her breakout was. The physician told the patient that this happens as the shot are not 100 percent, but the patient was glad that working out for others. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Patient c/o shaking/chills, with associated neck pain x15min after receiving the flu vaccine. Occurred ~ 5 mins. after receiving vaccine. "Uneasy feeling" continued for several hrs. Symptoms resolved by next day.
Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. Pt given 25 mg of diphenhydramine tab, and she refused 2nd diphenhydramine tab. Pt reported cessation of itchiness and tingling 20 minutes after receiving diphenhydramine.
MILD HEADACHE; MILD NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested .No concomitant medications were reported. On an unspecified date, the patient experienced mild headache, and mild nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the mild headache and mild nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210829201.
Rash; itching in the skin; one leg from the knee side was red like if you get the sunburn; didn't have any kind of marks, but had this almost looked like measles, but it's only on the upper leg and one arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Relevant medical history included lung cancer, which was currently in remission. The patient's concomitant medications were not reported. The patient got the first shot (Covid-19 vaccine) on Thursday. All of a sudden on Sunday night, on an unspecified date, the patient started getting a rash and at the time of the report on 23Feb2021, had just started itching in the skin just on the arm and one leg from the knee side was red like if you get the sunburn and it started itching so the patient just took a cloth and wet it and wipe it down with cool water and that's seem to cool it down. At the time of the report on 23Feb2021, the patient didn't have any kind of marks, but had this almost looked like measles, but it's only on the upper leg and one arm. The patient didn't know and didn't feel bad as it only itched a little bit and it's not really serious, but the patient called both of his/her doctor's, the oncologist and the primary, and all they told the patient was it was okay to get the second shot and that it was something that the patient did not have to worry about as long as the patient was not feeling bad. The patient stated that it quits itching when he/she put some lotion for edema last night and that seemed to help it. The patient was asking if he/she was doing the right thing or was it just something he/she had to worry about. Therapeutic measures were taken as a result of itching in the skin. The patient recovered from the event "itching in the skin" on an unspecified date, while the outcome of the rest of the events was unknown.  Information on the batch/lot number has been requested.
Client reports significant dizziness, was found clutching a cement pole. She stated "the room is spinning." Patient refused to change to recovery position.  She states she premedicated with Zyzol and pepcid. She requested Benadryl, it was relayed to her we had Epi for anaphylactic reactions, and she promptly said "no epi."  Patient responded she was "told by her doctor we would have benadryl. The patient was assessed for signs of anaphylaxis, but she had no clinical signs of anaphylaxis, Repeat questioning to evaluate for anaphylaxis was conducted. Patient denied rash, itching, difficultly breathing. Client spoke in complete sentences and had good capillary refill in her nail beds. Decision to call EMS was made, client refused., stating she wanted to wait for her husband. EMS call still made.  EMS arrived, conducted an evaluation and no medications were administered on site. Patient assisted to stretcher where she started gagging, as if she were going to vomit,  Patient taken by EMS to ambulance. At the time of this report, it is unclear if patient was transported to hospital or released to her husband.
Abdominal pain (5 out of 10), nausea without vomiting. History of IBS and took medications this morning. Stable, released from vaccination site.
Pt went home and was extremely drowsy. Arm was red and swollen. Pt. went to Primary care doctor and was diagnosed with cellulitis and was given an antibiotic.
After shots or blood withdrawals, I frequently feel light headed.  So after the shot I sat in my car for about 10 minutes.  I headed home about 10-15 minutes later while on a divided highway I began to feel weird & I drifted off the road & scraped up against a guardrail., I attempted to right the car but scraped the guardrail a 2nd time. I could see things but nothing seemed to register. And then I was fully conscious.  I continued on home but about 5 minutes later I began to  feel nauseous.  On the exit ramp waiting for a green light I threw up everywhere.  I continued home but not before entering into our subdivision when the police pulled me over for suspected drunk driving.  At this point, I had broken out in the cold sweats even though it was rather chilly.  The police quickly determined that I was sober but having a medical emergency so they called the EMS.  BP 140/78, normal heart rate & whatever they also checked.  I refused transport to the hospital.  The police went and got my wife who drove me home.  I returned to normality the very next day.  Called my doctor to report this & he recommended not having  the 2nd shingles shot in December.
The day after vaccination I had big welts that itched. I went to the doctor 3 days later and was diagnosed with Varicella and given treatment. The welts began to spread throughout my body and the itching became worse and accompanied with a burning sensation. The symptoms still persist and have gotten worse.
Pt came in with complaint of body rash and pain associated with rash.  She stated that she has not started anything new since the vaccination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that, on 17-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K010968, expiration date 07-NOV-2015) 0.65 ml once (strength and route were not provided). Concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
I had nasal congestion which turned into sinus infection. I also have asthma. My asthma has not returned to base line.
I had little to no symptoms at all the first 36 hours since administration--there was no apparent sign of any discomfort in the site of injection nor any bodily changes. However, after 36 hours of no adverse effects, NOW I am feeling a sudden level of soreness and pain in and near the area of injection: armpit, pectoral, some of shoulder blade, and arm down to the elbow.  I am curious as to why my body is reacting nearly two days after the initial injection.
I would like to report a possible adverse effect of Covid 19 because I have never experienced this kind of effect before until after COVID-19. I experienced an abnormal heart palpation or abnormal heart rhythm like no other palpations.   I have experienced abnormal palpations before but sporadically.  This recent heartbeat was fast and unusual.  I was placed on another pill called Bisoprolol which I never had to take before and I am concerned about this effect because it appears I may have to take this medicine forever, and I don't want to take it at all.  I want to know why there is a new fast palpation instead of being put on medications and left without any answers.
COVID Breakthrough. Patient came in on 12/31/21 with mild fevers, fatigue, and bradycardia.
Information has been received from a nurse practitioner concerning a 11 year old female who on 3/20/96 was vaccinated with a dose of varicella virus vaccine live. On 8/19/04 the patient seen in the doctor's office and scarring was noted on her upper torso. When questioned the mother reported that the patient had varicella in January 2004 after the child was exposed to shingles. Over 200 lesions from the waist up were noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
p/vax pt presented w/approx 20-30 lesions in various stages of varicella;the reporting MD noted that on an unspecified date pt recovered;
pt was rated 9.7 health & weight;  pt was in excellent care; mom did not use alcohol or drugs of any kind; pt had never been ill, even a cold x/for the shots; pt was fretful the day he died & did not take naps;