chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of an injection site reaction in a pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date, the pt received the 5th dose of Infanrix. At an unknown time post-immunization, the pt experienced an injection site reaction characterized by a 3 inch area of redness and swelling. The outcome of the events is unknown. The reporting physician considered the events were probably related to vaccination with Infanrix.
blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk; Blood pressure (BP) 146/88; feeling hot and tingly on neck and all the way down to her legs; her throat feeling hot and tingly; her throat feeling hot and tingly; Heart rate (HR)-140- 150; not feeling well; Got a rush of feeling very warm and shaky; Got a rush of feeling very warm and shaky; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; patient is pale, diaphoretic and has a rapid bounding pulse; This is a spontaneous report from a contactable pharmacist. A female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Dec2020 09:45 AM at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Events onset date was 24Dec2020. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. Heart rate (HR)-140- 150, Blood pressure (BP) 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout. Medical response called. Continued to monitor and talk with patient until response team arrived. Patient transferred to Emergency room (ED). The outcome of event Feeling of warmth and tingly was not recovered. The outcome of Blotchy rash was recovering. The outcome of Blood pressure (BP) 146/88 was recovered on 24Dec2020. The outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported events were likely related to the first dose of bnt162b2 (Pfizer-BioNTech COVID-19) due to plausible temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
For 24 hours: Extreme headache, high fever, chills, sweats, extreme fatigue, delerious ( my son broke his arm during this time period, i was told at the time,  but i didn't even know about it the next day). Back to normal following day, except headache remained for 3 weeks, but lessened in steength and became more sporadic.
Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022 at 11:39 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Feb-2022 at 11:39 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The patient received vaccine past its 30 day expiry date on 19 Feb 2022 at 11.39 .07. Vaccine went into 2 to 8 degree Celsius thaw state on about 24 Dec 2021. The vaccine was administered up until its manufacturing expiry date of 04 Apr 2022. No treatment information was provided.
Pt had elevated fever of 102F-104F, cranky and not eating, post vax.
ears were burning; heavy stomach cramps that made her double over; really bad hot flashes that were on and off during the day; Ears were really hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (heavy stomach cramps that made her double over), HOT FLUSH (really bad hot flashes that were on and off during the day), SKIN WARM (Ears were really hot to the touch) and EAR DISCOMFORT (ears were burning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (to the flue Vaccine). Concomitant products included MELOXICAM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (heavy stomach cramps that made her double over), HOT FLUSH (really bad hot flashes that were on and off during the day) and SKIN WARM (Ears were really hot to the touch). On an unknown date, the patient experienced EAR DISCOMFORT (ears were burning). At the time of the report, ABDOMINAL PAIN UPPER (heavy stomach cramps that made her double over), HOT FLUSH (really bad hot flashes that were on and off during the day), SKIN WARM (Ears were really hot to the touch) and EAR DISCOMFORT (ears were burning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO treatment medication details were provided.
Second episode of fever; First episode of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA and PYREXIA in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CALCIUM, and VITAMIN D3 for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA. On 23-Mar-2021, the patient experienced PYREXIA. The patient was treated with TYLENOL for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA had resolved and PYREXIA outcome was unknown.            No concomitant medications were reported.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: after injection pain andswelling at injection site with mild itching and persistance for over 90 days
Warm tender, erythematous rash two days after Pneumovax Ix. heating pad, tylenol, NSAIDS
This is a spontaneous case, initially received from other health professional (nurse) on 25-Oct-2018, concerning a 57-year-old, adult male patient. The patient was allergic to peanuts which upsets his stomach. The patient did not receive any other vaccines or concomitant medications. On 24-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252667 and expiry date: 30-Jun-2019). On the same day, 2 hours after vaccination, the patient experienced allergic reaction on face, rash on right cheek, itchiness and swollen lips. The patient had no difficulty in breathing. The patient was treated with BENADRYL after which the events got improved but still ongoing. The outcome was recovering on an unspecified date. The reporter assessed the case as non-serious and related to the suspect vaccine (believed it was due to vaccine).
Information was received on 13-MAR-2017 from a pharmacist who was reporting on an unspecified patient of unknown age and gender. No medical history or concomitant medications were reported. The pharmacist reported that the  unspecified patient received an expired dose of PNEUMOVAX23 (lot, expiration, dose and site were not reported) on an unspecified date. No adverse effects reported. No other information is available. Additional information is not expected. No consent to contact the reporter.
Patient had redness circling left arm and at site of injection, hot to touch, complained of dizziness. Recommended she see MD. She took BENADRYL.
I am a four-year resident of facility and have never experienced a serious illness or traumatic injury in all of my adult life (I turn 86 this year). So on January 23rd I received my initial shot of the Moderna vaccine, for which I experienced no reaction, whatsoever. One month later I returned to hospital for my Moderna Booster shot on Saturday, February 20. I felt a few chills that evening, with nothing to speak about, but awoke on Sunday morning feeling so ill that I could barely sit up in bed. I borrowed my wife?s walker and managed to make it to and from the bathroom, and got back to bed again, whereupon I called my son, an emergency-room physician, who told me to take two Advil tablets (or its equivalent), and welcomed me to the club. I stayed in bed through the rest of Sunday and continued to sleep and rest throughout Monday morning, only feeling well enough to get out of bed without assistance by noon on Monday, thereby missing the February meeting of the monthly meeting that had been scheduled for that morning (and for which I had regularly been a member of and had attended every meeting for over three years). My personal takeaway from all this was that ?the cure was worse than the disease.?
Swollen lymph nodes Fever Nausea Diarrhea Chills Sweats Pain at injection site
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 7th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced rash and fever. The patient was treated with methylprednisolone. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the rash and fever to be related to SHINGRIX. Additional details were provided as follows: The case was received by the Medical Technician. The patient received SHINGRIX in left arm. Within a few hours, the patient began to experience a rash on the whole left side of her body and a fever of 100 degree F. As treatment, the patient was prescribed Methylprednisolone. On 13th August 2018, the healthcare professional reported that the fever was resolved and the rash was improving but not resolved.
Body aches, Tenderness under right arm - lymph node association, mid to lower back pain,
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 1:27 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. No treatment information was provided by reporter.   This case was linked to MOD-2021-402935 (Patient Link).
Dizziness that required to crawl to bed; Not a lot of energy; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient 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 25Feb2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included ropinirole (MANUFACTURER UNKNOWN) and an unspecified stool softener; both taken for unspecified indications from unknown dates and unknown if ongoing. On 25Feb2021 at 21:00, after 12 hours of having no side effects, the patient experienced dizziness that required him to crawl to bed. When he laid down or crawled on all fours, he was ok and the next day also he was ok. The dizziness had subsided. The last 5 days, he had no dizziness. On an unknown date in Feb2021, the patient had not had a lot of energy. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the dizziness was recovered in 2021; while that of the patient had not had a lot of energy was recovering.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 43 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 4/8/99 and 5/13/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "wrist and forearm pain and tingling in his feet." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued throught the litigation process and will be reported if obtained.
I started feeling chills. I took my temp and it was 99.7. I couldnt get warm. I got very achy in my joints. my skin hurts.
Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where he has "recent" injuries (vasectomy, back issues). No control over bowel movements. Disoriented/ motor skills severely lacking; couldn't walk down steps or down the hallway. had to call for help to family to do normal tasks. mild hallucinations. mental anguish; things were true in his head but not true in reality; mental dysphoria. Thinking this was the end; was able to recognize it but also very concerning.  3:30 am saturday this started; not all gone yet (7/14). Tension headaches (not prior). Extremely cold, clammy, sweaty; had to change clothes based on the amount of sweat. Not drug user, not alcohol, active military, not 48 hrs prior till recent. no pre workout. no medications. ibuprofen later saturday morning. First vaccine he just had local pain at shot site, some pain to the older issue sites and tiredness but nothing more than 24 hours. No mental illness dx at this time; possible ptsd but never diagnosed, not something he suffers from on a daily basis.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2016, starting on or after 28-JUN-2016, patients were vaccinated with (Oka/Merck) VARIVAX (lot number L032391 and expiration date 26-AUG-2017, lot number M003439 and expiration date 19-JAN-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 17.4F and the time frame was 1 hour 30 minutes. There was no previous temperature excursion. It was stated that the call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (-0.2C for 116 hours, 24 minutes and the data logger was involved) doses of GASDASIL 9 (dose, frequency and route were unknown, lot # M011117, expiration date 07-DEC-2017, another lot # L026602, expiration date 19-OCT-2017. The GARDASIL 9 didn't have previous excursions and currently backed in range. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Received the vaccine 27Aug2021 and 8 hours later felt chills, nausea, body aches, and severe headaches which limited me to just the bed for 48 hours.  I took some tylenol which cured most symptoms and was able to do normal activities after 72 hours on 30Aug2021.   Then the headaches came back within the next 24 hours with a throbbing pressure at the base of my cranium towards the rear, the temple areas, and sometimes radiating throughout my jaw.  I would take tylenol and it would temporarily relieve the pain, but would eventually come back.  I recognized that there was a problem and on 3Sept2021, I talked to the COVID19 Information hotline and they directed me to see a doctor. That same day I went to a walk-in clinic and the Doctor recommend I go to the ER to rule out any blood clots.  I then proceeded to the ER and received an IV cocktail - Benadryl, Compazine, Toradol.  The Doctor took some blood, urine, and a conducted a CT Scan of my head.  My vital signs were normal and the Doctor discharged me saying that there was no indication of blood clots from the CT Scan.  I still continue to have the headaches at least one a day which is remedied by tylenol.
Fever of 104 F; kidney pain; body aches; soreness in the injection site for more than 2 days; This is a spontaneous report from a Non contactable male consumer reported that. A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EL6198) as DOSE 2 SINGLE for covid-19 immunization (Age at vaccination 47 years). The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 25Feb2021, The patient experienced fever of 104 f, kidney pain, body aches and soreness in the injection site for more than 2 days. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on an unspecified date. The patient received treatment with Aspirin and Tylenol. The event outcome was Recovering.  No follow up attempts are possible. No further information is expected.
The patient self-reported the adverse event and has been experiencing stabbing left arm pain after the vaccine. The area is red and warm to the touch according to the patient. She has had to call out of work twice since receiving the vaccine.