chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022; Patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Feb-2022, expired on 01-Apr-2022 before the date of administration on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. It was reported that the 21 doses or vials were initially stored in refrigerator on 17-Feb-2022 at 10:00 am. The 21 patients had administered with expired vaccines and no patients had come out with adverse events. The vials had not undergone any temperature excursions. It was also reported that the 25 patient identifiers were updated for safety. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received includes no significant information.
Approximately 4 hours after receiving his first dose of the SHINGRIX vaccination, the patient began experiencing confusion and memory loss. He did not recall events that had happened approximately 30 minutes prior, and appeared confused to those he was with. The patient was seen in the Emergency Room shortly after the symptoms were identified, and was diagnosed with Transient Global Amnesia. His health care provider at the facility stated they did not feel it was due to the recent vaccination, however the patient and his wife would like this event recorded and requested the author's assistance in reporting the incident.
Very sore, feel warm, used ice Right arm. 10/7/17 7pm: S/W pt; (He is doing better).
Memory problems; Lack of energy; Mood swings; feeling depressed/ sad; This case was reported by a other health professional and described the occurrence of memory disturbance in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced memory disturbance, loss of energy, mood swings and depressed mood. On an unknown date, the outcome of the memory disturbance, loss of energy, mood swings and depressed mood were unknown.   It was unknown if the reporter considered the memory disturbance, loss of energy, mood swings and depressed mood to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's son got the Bexsero before going to college. The patient was an amazing student and after getting this vaccine, since the reporter could not relate his situation to anything else, he started having memory problems, he had to drop the university due to this. After researching what might have been the cause, this was the only chain the reporter could tie with his lack of energy, mood swings, and memory problems. The reporter's son was an honor student at high school, learned Russian language by himself, aside from German, English and Spanish. The patient was in a Magnet Engineering program and at the time of reporting he was feeling more than depress and sad because he could not even solve a small problem.
Bumps kind of like bug bites, that later make the skin dry and leathery. some are itchy and some just appear over night. the pop up locations are random.
No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 5/21/2020.; This spontaneous report was received from a registered nurse referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, concomitant therapy, previous drug reaction, and allergies was not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, administered by oral route as prophylaxis (information regarding dose, route of administration, vaccination scheme frequency and anatomical site of administration was not reported; lot number 1660941, which has been verified to be a valid lot number, expiration date reported and validated as 12-FEB-2021).  The administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in a temperature of 12.1 degrees Celsius (C) for a timeframe of 16 hours and 11 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
Pt states arm was sore and swelling after the vaccine. Patient said it have been three weeks and she is having a hard time with mobility / range in motion.
1hr p/vax pt devel h/a @ corner of head, followed by hypesthesia & fullnss of lt malar region & back to lt ear;described as novocaine @ the dentist;sx began diminishing p/2hr, completely gone p/11hr;never had significant neurologic de
Patient called pharmacy at 11:45am on 10/31/21 complaining of intense radiating pain from injection site upward towards jaw and neck. Patient also complained of swelling, redness and swollen glands in axilla.
Pain in the whole upper left arm that she couldn't lay on her left side after the 1st dose; Circle of pain around the injection site in her left arm after the 1st dose; Whole face and tongue numb and tingly after the 1st dose; Whole face and tongue numb and tingly after the 1st dose; Whole face and tongue numb and tingly after the 1st dose; whole face tingly; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Circle of pain around the injection site in her left arm after the 1st dose), HYPOAESTHESIA (Whole face and tongue numb and tingly after the 1st dose), HYPOAESTHESIA ORAL (Whole face and tongue numb and tingly after the 1st dose), PARAESTHESIA (Whole face and tongue numb and tingly after the 1st dose) and PARAESTHESIA (whole face tingly) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM, RIVAROXABAN (XARELTO), LITHIUM CARBONATE, PRAZOSIN, LOPERAMIDE, BUPROPION HYDROCHLORIDE (BUPROPION HCL), ATORVASTATIN, ROPINIROLE HYDROCHLORIDE (ROPINIROLE HCL), LISINOPRIL, GABAPENTIN, BACLOFEN, METOPROLOL SUCCINATE and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.    On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (Circle of pain around the injection site in her left arm after the 1st dose), HYPOAESTHESIA (Whole face and tongue numb and tingly after the 1st dose), HYPOAESTHESIA ORAL (Whole face and tongue numb and tingly after the 1st dose), PARAESTHESIA (Whole face and tongue numb and tingly after the 1st dose) and PARAESTHESIA (whole face tingly). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the whole upper left arm that she couldn't lay on her left side after the 1st dose). On 24-Apr-2021, HYPOAESTHESIA (Whole face and tongue numb and tingly after the 1st dose), HYPOAESTHESIA ORAL (Whole face and tongue numb and tingly after the 1st dose), PARAESTHESIA (Whole face and tongue numb and tingly after the 1st dose) and PARAESTHESIA (whole face tingly) had resolved. On 01-May-2021, VACCINATION SITE PAIN (Circle of pain around the injection site in her left arm after the 1st dose) and PAIN IN EXTREMITY (Pain in the whole upper left arm that she couldn't lay on her left side after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication has been provided by the reporter. No lab data has been provided by the reporter.   This case was linked to MOD-2021-162400 (Patient Link).
pt recvd vax; mom took pt to er,fever 103 that would not come down, crying for >3 hrs; rt leg swollen, red & hot; denied any szs, lethargy, etc..
Cough, short of breath, headache that started on the 14th of January and continued during doctor visit.
pt recv vax 8NOV95 & 9NOV95 devel itch @ site of inj & raised rash on lt arm & trunk;
Had the shot and had them 3 times; Had them 3 times lately; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had the shot and had them 3 times lately.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Coughing; Arm soreness; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US150245_NS.  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Coughing"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information : Patient reported she had put off doses due to Covid Vaccine and experienced coughing, arm soreness and headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient had bilateral neck pain radiating to his head. The Health Unit was called on 11/07/2001 and advised the patient to contact his own MD and to treat with Tylenol and Motrin.
Information has been received from a health professional concerning a 6 year old male patient who on 11/30/1998 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 04/22/2004, the patient developed breakthrough chickenpox with less than 50 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
Diffuse, erythema and SC edema peaking 24-48 hrs after injection. However circumferential in process of resolving.
This case was reported in a literature article and described the occurrence of WELL's syndrome in a 7-year-old male subject who was vaccinated with Hepatitis A (manufacturer unspecified), Varicella and Influenza. The boy presented with a 4-week history of rash and peripheral eosinophilia. He had received the three vaccines (dosages not stated) between 7 and 9 days before developing the rash that initially appeared on the sole of his left foot as a single, raised, pruritic lesion. It subsequently got larger and resembled cellulitis. The boy received oral antibiotics with no effect. The rash progressed to his face and extremities over several days and was pruritic and painful. Lesions varied in appearance and were up to 15cm in diameter; some lesions were flat and target-lesion-like and others were bright red, raised and urticarial. He had low grade fevers as the rash waxed and waned. Laboratory investigations revealed he had an increased WBC count of 23.7 x 109/L, with 59% eosinophils. Lesion biopsy showed eosinophilic cellulitis/WELL's syndrome. His symptoms and peripheral eosinophilia resolved without treatment within 8 weeks of diagnosis and he was asymptomatic at last follow-up. Author stated that the presented case brings to attention a less recognized condition of peripheral eosinophilia and rash that may be associated with immunizations.
Pt was given Smallpox vaccine and Anthrax vaccine. Pt did not know that she was pregnat at time of vaccine
Pt recv vax on unknown day; post vax pt exp tiredness-napped 4 hr daily x 3 -3.5 wk
Cannot move arm without pain. No redness or warmth at the site but persistent pain that worsens with movement
Information has been received from a Licensed Practical Nurse concerning a patient (age and gender not specified). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-JUL-2017 the patient was administered a dose of improperly stored VARIVAX, lot # M047660, expiration date 02-DEC-2018, for prophylaxis. Temperature: -9 degrees C to 8 degrees C. Time frame: 3 hours. No previous temperature excursions. Digital data logger was involved. The sterile diluent (manufacturer unknown) that was used to reconstitute the vaccine was properly stored. The outcome of the event was unknown. Additional information has been requested. This is one of two reports from the same source. Sender's Comments: US-009507513-1707USA005555.
Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes and depression. The patient had no known allergies to medications, food, or other products. The patient received unspecified concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration on the left arm on 12Feb2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 14:00, the patient experienced arm soreness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was resolved on an unknown date in Mar2021.    No follow-up attempts are needed. No further information is expected.
No longer get cold sores, be rid of them; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (had cold sores).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: No longer get cold sores, be rid of them). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK receipt date: 22-APR-2023 The case was received from the patient via interactive digital media. The patient was being over 50.  They both were from the same group of so the patient mentioned this to the physician and of course he said it was just a coincidence. Anyway one way or another the patient was happy to be rid of them. The follow-up could not be possible as no contact details were available. The patient had shingrix vaccine last year but had noticed that no longer get cold sores, which led to unexpected therapeutic effect.
quadracel given at 7 years in clinic. quadracel capped out at 4 years.
Patient became dizzy after injection.   We kept him here in the office lying down for  15 minutes after injection.  Patient  walked out of the office with his father once episode had passed.
I caught Covid. I had a scratchy throat, headache, runny nose, congestion, cough and fatigue. I felt feverish off and on, but haven't felt that way today. It hasn't gone over 98.
After my first shot, I was very tired and did not feel very good for about 10 days. My arm was also very, very sore. In addition,  I  had GI issues (lots of loose stools and some cramping) within the first six hours of taking the first dose. Those symptoms went away fairly soon, but when I ate dried cranberries again the same thing occurred so I think that might have been the issue. Around April 11th, I almost passed out twice in the night when I got up to go to the bathroom and I did not feel very good. I was in an office two days before where the staff had been fully vaccinated, but two of the staff were not wearing masks and I overheard one of them saying they had not been feeling good. I felt fine on the date of my second vaccine on April 20th so I went in for my shot.  Right after my first shot I felt fine. However, about eight to 10 hours later, I started running a temperature,  had chills, terrible muscle aches, felt terrible  generally, and started having ringing in my ears. All of my symptoms got much worse and I am sure my fever was at least 102 , but I never took it until my chills were better and at that point it was 101. I then took 500 mg of Tylenol and within about three hours my fever was reduced to 99. In about 30 hours, my fever was gone and I felt better, but was still very tired and had ringing in my ears. It has been almost two weeks since my second shot and I still have ringing in my ears and it is worse when I am lying down or am quite. I am also a little more tired than usual and my insomnia is worse than usual. My main concern is the ringing in my ears.
2 pts recvd Engerix-B vax & both failed to seroconvert p/receiving the complete series & 1 booster dose each;
Immediately after and the next day, I just had arm soreness and a bit of fatigue. Then 7 days after receiving the vaccination, I developed "covid arm" - an itchy, hard, circular rash at the vaccination site. Two days after developing it, it is still red and slowly growing.
Narrative:  COVID infection following completion of COVID vaccine series: 02/17/2021 COVID vaccine dose #1 03/10/2021 COVID vaccine dose #2 06/21/2021 Pt presented to ED with lower RL pain lasting 8 days s/p falling from standing while attempting to sit in a chair 06/22/2021 COVID negative screening and nasal swab test per pre-op protocol 06/25/2021 Pt arrived for endoscopy but was found to be in Afib with RVR from not taking his amiodarone and metoprolol. Transferred to ED, then admitted to hospital. 06/25/2021 Asymptomatic COVID positive based on plasma test 06/27/2021 Pt discharged from hospital following resolution of Afib. Pt able to self-care for COVID at home. 06/30/2021 Clinical resolution of COVID infection
Had a sinus headache at about 11pm, then throughout the night it began to worsen, started to get chills and had a fever. In the morning my fever reached up to 101.3, felt weak, could not sleep, felt dizzy and faint, had a cough, and was nauseous.
felt like he had kidney stones; couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass; almost turned blue; felt like his airway was closed up; felt deathly ill; he might throw up; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included the patient had "many health conditions" (unspecified) and was a smoker. Concomitant medications were not reported. On an unspecified date, after the first dose, the patient felt like he had kidney stones. On an unspecified date, the patient could not swallow his food and it felt like the food would not go down/ would not pass. His wife stated that he looked so uncomfortable and almost turned blue. The patient stated it felt like his airway was closed up. He said he laid in bed, feeling like he was deathly ill and like he might throw up for about 5 minutes, then the sensation passed. This happened at 4 meals following vaccination and has since resolved. The clinical outcome of felt like he had kidney stones was unknown; of "couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass", almost turned blue, felt like his airway was closed up, felt deathly ill, he might throw up was resolved on an unspecified date.   No follow-up attempts are needed; information about lot or batch number cannot be obtained.
Pt called about 2 hrs after receiving vaccinations reporting sharp, shooting pains in left wrist and tenderness to touch. Pt reported she did not have these symptoms before vaccine nor had she experienced any trauma to her wrist.
Information has been received from a healthcare professional referring to an 8 months old male patient. On 07-AUG-2015 the patient was inadvertently vaccinated with GARDASIL 9 (dose, strength and route were not reported, lot # reported as L011846, expiry date: 16-JUN-2017) (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Severe rash on legs.  Large, red clusters of blisters with water.  Many in a linear formation.
MODERNA COVID-19 Vaccine EUA   Swelling of the injection site.  Rash surrounding the site.  Soreness of the injection site.  For one week following the vaccination.  Took ADVIL twice a day for the first three days.  No other treatment.
SHE SAID AREA GOT RED (SIZE OF AN ORANGE) WARM AND ITCHY
Pt entered clinic 5/13/14 stating she developed a small bump near vaccine site that developed about a week after receiving vaccine. Area assessed by dr. No fevers or redness noted. Just tender pt had stated due to history and not being sure it was a reaction. Pt referred to PCP and to return in a week for a check. A week after pt returned stating she was seen in ED for an abscessed cyst and it was drained.