chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a 4 year Quadracel vaccine (Tdap and Polio) in lieu of a 1 year vaccine of Hep A  Medical Assistant inadvertently pulled a quadracel vaccine instead of Hep A and administered to patient. When mistake was discovered MA told the Doctor on staff about the mistake. Doctor explained pt would have received similar vaccine at upcoming 15 month appointment. In addition explained it would not be harmful for patient. Patient would still need to receive the Hep A vaccine which was not given.  Patients father was called. Mistake was explained. Father reassured no adverse harm should come from the Quadracel as the same components would be in next 15 month appointment, but that patient would still need to receive his Hep A. Parent understood and was thankful for us calling him and was sure to ask a few times whether vaccine would be harmful. He was assured all times that it was not. He was okay with that information. Doctor was standing by if parent wanted to speak with him.
After 7 days, a red rash near my injection site appeared.  Minimal itching.  No pain.
allergic reaction with the first shot; This case was reported by a consumer and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. Shingrix was interrupted. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient was told not to receive the second shot due to an allergic reaction with the first shot. It was reported that Covid-19 shots were becoming available, the patient wanted to know what the ingredients were in the Shingrix shot.  The patient didn't know if the patient should get Corona virus shot?
SWELLING, ITCHING AND WATERING ON EYES, SWELLING ON THROAT.
Client's wife called and reported that client had a heart attack 5 days after receiving the vaccine. He also had blood clots.
RIGHT ARM CELLULITIS FROM INJECTION SITE TO BELOW ELBOW. INTERESTING WHEN MY HUSBAND PICKED UP MY PRESRIPTION I WAS THE 3RD PATIENT SHE HAD HEARD OF WITH THESE SYSTEMS.
Two days after getting my 2nd dose I started heavy vaginal bleeding that is gushing more than I have ever experienced and is going on now for the 2nd day.  I contacted my OB/GYN and she said that she has had a few patients with this and if it does not get any better to let her know in a few days.  I have bled more in the last 2 days than ever having my period.
This spontaneous report was received from a nurse regarding a 4 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-MAR-2018, the patient was inadvertently administered M-M-R II lot# N045392 with expiry date of 14-NOV-2018, VARIVAX lot# N009768 with expiry date of 24-MAR-2019 and VAQTA lot# N020689 with expiry date of 22-OCT-2018 earlier than the recommended age for prophylaxis. No adverse effects were reported. No product quality complaint was present.
This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Pt received MMR on 7/20/01 and came to ER on 8/6/01 with a temperature of 105F and a seizure.
Psoriatic arthritis more intense; extremely tired; swelling of legs feet; extreme pain in joints; psoriasis which became much more severe; dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 320308D) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "flu like symptoms"; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 12May2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "administration date=15Mar2021/ dose administration date=12May2021". No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 29Oct2021, outcome "unknown", described as "dose received: 3"; PSORIATIC ARTHROPATHY (medically significant) with onset 30Oct2021, outcome "recovering", described as "Psoriatic arthritis more intense"; FATIGUE (non-serious) with onset 30Oct2021, outcome "recovering", described as "extremely tired"; PERIPHERAL SWELLING (non-serious) with onset 30Oct2021, outcome "recovering", described as "swelling of legs feet"; ARTHRALGIA (non-serious) with onset 30Oct2021, outcome "recovering", described as "extreme pain in joints"; PSORIASIS (non-serious) with onset 30Oct2021, outcome "recovering", described as "psoriasis which became much more severe". The events "psoriatic arthritis more intense", "extremely tired", "swelling of legs feet", "extreme pain in joints" and "psoriasis which became much more severe" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of psoriatic arthropathy, fatigue, peripheral swelling, arthralgia, psoriasis. These events finally calm down 18Nov2021 and Outcome was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 20-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K022993, expiration 20-JUL-2016, dose was not reported) orally. No adverse effects was reported. This is one of several cases received from the same source. Additional information has been requested.
Red rash on upper arm, swelling, hot to touch, mild soreness, and itch. Started with a 2" X 4" area on 4/10/21 and expanded to a 5" X 6" area covering the bicep and inner arm from just below the injection site to 1.5 inches above the elbow. As of 4/14/21 (4 days) swelling and soreness has subsided but some redness remains.
Severe headache x 4 days; body aches x 5 days; nausea x 2 days; vomiting x 1 day; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2022 at 14:00 as dose 1, single (Lot number: FP7138) at the age of 37 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medications included: PEPCID; SYNTHROID. Past drug history included: Trazodone, reaction: "Known allergies: Trazodone". The following information was reported: HEADACHE (non-serious) with onset 25Aug2022 at 15:00, outcome "recovered" (Aug2022), described as "Severe headache x 4 days"; PAIN (non-serious) with onset 25Aug2022 at 15:00, outcome "recovered" (Aug2022), described as "body aches x 5 days"; NAUSEA (non-serious) with onset 25Aug2022 at 15:00, outcome "recovered" (Aug2022), described as "nausea x 2 days"; VOMITING (non-serious) with onset 25Aug2022 at 15:00, outcome "recovered" (Aug2022), described as "vomiting x 1 day". The events "severe headache x 4 days", "body aches x 5 days", "nausea x 2 days" and "vomiting x 1 day" required physician office visit. Therapeutic measures were taken as a result of headache, pain, nausea, vomiting .  Additional information: Patient did not receive other vaccine in four weeks. Adverse event treatment included pain control. Patient was not tested for COVID post vaccination.
Woke up with very stiff neck   Neck sprain, subsequent encounter Breast pain in male Unclear etiology, no obvious mass on exam no axillary adenopathy, mamogram pending  Patient's axillary and shoulder pain may be secondary to Covid vaccination.
This is a spontaneous report from a Pfizer Sponsored Program, from a contactable consumer (the patient). A 69-year-old female patient received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient reported that after the vaccine shot  "my arm was killing me for a few days afterward" on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Information has been received from a nurse practitioner concerning a patient who on 24-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The nurse reports the products were stored in the wrong spot in the office and varicella virus vaccine live (Oka/Merck) was given inadvertently. She does not feel that this was product confusion it was a case of human error. No adverse events reported. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Skin is bumpy/ skin felt leathery; Red skin; Digging at back, upper legs, and arms; Red rash; Itchy rash; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-JAN-2023, the patient received the 1st dose of Shingrix. In FEB-2023, between 1 and 2 weeks after receiving Shingrix, the patient experienced red rash (Verbatim: Red rash), itchy rash (Verbatim: Itchy rash) and rash (Verbatim: Rash). On an unknown date, the patient experienced skin disorder (Verbatim: Skin is bumpy/ skin felt leathery), skin red (Verbatim: Red skin) and pruritus (Verbatim: Digging at back, upper legs, and arms). The patient was treated with steroids nos (Steroids). The outcome of the red rash, itchy rash, rash, skin disorder, skin red and pruritus were not resolved.   The reporter considered the red rash, itchy rash, rash, skin disorder, skin red and pruritus to be possibly related to Shingrix.     The company considered the red rash, itchy rash, rash, skin disorder, skin red and pruritus to be possibly related to Shingrix.   Additional Information: GSK Receipt Date:16-May-2023 The reporter was the wife of the patient. The reporter reported that the patient received 1st dose of Shingrix and about one and half weeks after received Shingrix vaccine the patient experienced an itchy and red rash on the left side of his lower back and the back of his legs.  The rash then spread across the middle of his back and then to his shoulder blade and was on both the left and right side.  The nurse could not determine what the rash was and prescribed a topical steroid cream, steroid shot, oral steroids, and also took oral allergy pills. The patient was changed laundry detergents to a sensitive skin laundry detergent and tried oral hair, skin and nail gummies to help with the rash, and nothing was worked. The reporter stated the patient rash was continues to be there today and seems to be traveling his body.  The rash was appeared on the backs of both of his upper legs and inner thighs, the side of his stomach and also the fronts of his legs and on both of his arms. afterwards some areas will clear up for a couple of days, and then comes back blood red and the patient skin was bumpy, red and felt leathery when the rash was going on.  The rash flairs up, it might be in the same spot or a new spot. The last couple of days the patient had been digging at his back, upper legs and arms and this was all still going on. The reporter did not know the location where the patient injection was administered but stated that she thought the arm. The reporter thinks all this came from the vaccine as the patient did not have any of this before the vaccine, and nothing else changed. The reporter did consent to follow up.
RA; Substernal CP; mild SOB; CP / pressure 5/10 radiating to neck; This is a spontaneous report from a contactable Nurse. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in Right Arm on 19Feb2021 14:15 (Lot Number: EL9262) as single dose for covid-19 immunisation. Medical history included enlarged prostate and asthma. Concomitant medications in two weeks included salbutamol (ALBUTEROL); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY, reported as triogy); morniflumate (FLOMAX, reported as flowmax). If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Facility type vaccine Other (as reported). The patient experienced RA (rheumatoid arthritis), substernal cp (chest pain), mild SOB (Shortness of breath), CP/pressure 5/10 radiating to neck, all on 19Feb2021 14:15 with outcome of unknown.  The patient underwent lab tests and procedures which included chest pressure: 5/10 on 19Feb2021, oxygen saturation: 97% on 19Feb2021. Clinical course: Substernal CP (Chest pain) approx 10 min post vaccine with mild SOB. Patient denied scratchy throat or throat swelling no swelling noted patient speaking in full sentences O2 sats 97 %, RA, no hives noted, no rash, no difficulty swallowing. Patient reported CP / pressure 5/10 radiating to neck. No pain on palpation lungs clr bi laterally EMS called patient care transfered to paramedics. The events resulted in Emergency room or department or urgent care. No treatment received for the events.; Sender's Comments: The reported RA (rheumatoid arthritis) was more likely an intercurrent disease, and less likely causally related to the use of  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  This 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.
I had a fever starting after the shot, and it increased nerve pain from my chronic condition escalating into a flare up where I was incapacitated and immobile due to pain. I started having seizures everyday for about 1 week after the injection, and then again on weeks 3-5 post injection. The pain flare lasted for over 5 weeks. I continue 7wks after the shot to have a fever, and still have not fully recovered from the complications of my flare up.
13 hours after shot administered: 102 fever, severe shaking and chills, sweating, nausea. Throughout the next day: extreme fatigue, chills, fever, body aches, joint aches and swelling.  2 days after: overall body soreness, fatigue. All symptoms mimc that of the ones I had when sick with Covid.
BURNING AND ITCHY SENSATION, 3X3 INCH DIAMETER REDNESSSLIGHTLY TENDER TX-APPLY COLD COMPRESS
Since I received my 2 covid vaccines last year I have been losing hair, it's also happening to my other family members/ slowly going bald; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 64-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: 2021, for Covid-19 immunisation. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Since I received my 2 covid vaccines last year I have been losing hair, it's also happening to my other family members/ slowly going bald".  Additional information: Patient stated, since she received her 2 covid vaccines last year (2021) she has been losing hair, it was also happening to her other family members. Was there something could do to help her, woman slowly going bald.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
On 04/08/2021 red splotchy areas on left and right arms just above the inside crook of the elbows and on both upper legs on the inside  areas close to the groin. On 04/09/2021 more red splotchy areas on lower back, more areas on the legs and arms. Did not c/o of itching on 4/8 but did on 4/9 Temp not taken on 04/08/2021 but skin was cool.  Temp taken 04/09/2021 and was 98.6 Doctor offices closed so no one was called.
One hour after shot red splotchy rash six inches around injection site. By 5pm, matching rash on right leg. By 6pm rash visible on wrists. By 7pm legs covered in rash, upper arms and neck. Monitored all night for breathing okay. The next morning rash spread up entire trunk and around front. Subsided by 10am follow up appointment but still on every area of body during exam. Anti-histimine prescribed. A single 2.5 dose of zyrtex given at noon. Rash still visible on legs, arms and diaper area at bedtime but largely cleared. Faintly visible at follow up next morning at 10am.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The reporter stated the administration of expired vaccine were given as booster shot to patient.  The vaccines were stored in freezer, they take out one or two vials and placed it in fridge each day as needed.  No treatment given on the patient.
The patient was given the wrong vaccine for COVID-19. The patient has had not side affects or health issues.
Body aches leading into flushing and nausea. Then vasovagal event. Unconscious for an unknown period of time.  Symptoms occurred at approximately 02:30am, no treatment sought at time of event. Dizziness and weakness continued for about another hour. No further episodes of fainting. Body aches and fatigue continued into the next day for approximately 24 hours in total, pain managed with Motrin.  All symptoms then resolved.
Red area on right arm that pt. states was swollen but is better now.  Was about 3-4cm per pt.  Possible reaction to tetanus.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Apr-2021 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 58.16.  No concomitant medications were reported.  On 03 Apr 2021, 20 vials were moved to clinic.   The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29 Apr 2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 03 Apr 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
Chills, fever up to 102.5, headache, fatigue, mild nausea, muscle aches, joint pain, minor shortness of breath, feeling of lightheadedness/dizziness, feeling like my vision was off/blurry and was... crowded, like the edges of my vision weren't entirely there?