chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient stated a few hours after receiving the vaccination, her arm was red, sore and inflamed. The soreness and inflammation covered the front and under her arm (opposite the deltoid muscle). It was painful for her to move her arm. She was unable to sleep the first night due to the discomfort. Each day, it has gotten a little bit better. She did not take any medication or apply any topical preparations to ease the discomfort. She will contact her doctor to follow up with them on Monday 2/12/18.
Soreness in hand; Got second vaccine for COVID and got sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in hand) and ILLNESS (Got second vaccine for COVID and got sick) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in hand) and ILLNESS (Got second vaccine for COVID and got sick). At the time of the report, PAIN IN EXTREMITY (Soreness in hand) had not resolved and ILLNESS (Got second vaccine for COVID and got sick) had resolved. No concomitant medication provided. No treatment information mentioned. Patient experienced soreness in hands on an unknown date. He got the second COVID vaccine and got sick for one week.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Both my ears will not stop ringing. They have been ringing consistently for months now. I haven't been around any loud sounds or have any other ailments. I also do not take any medications.
Patient experienced swelling at injection site, described as a hard knot, sore only when touched (not when moving or at rest). It lasted a week before it resolved on its own.
No adverse reaction; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse reaction) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; Area of injection site has become very large, swollen, hot to touch, and firm in the middle; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 53-year-old female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 17Jan2021 12:45 at single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included piroxicam (PAXIL), thyroid (ARMOUR THYROID), both from an unspecified date for unspecified indication. The patient previously took the first dose of bnt162b2 on 27Dec2020 at 01:00 PM on her left arm for covid-19 immunisation. On 17Jan2021 at 14:00, the patient experienced that the area of injection site has become very large, swollen, hot to touch, and firm in the middle. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reaction.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route and lot number unspecified), which underwent a supported temperature excursion. No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
After vaccinated Pt immediately got dizzy and felt like vomiting.  Pt stayed 20-30 min and then was able to leave.
Breakthrough case after two vaccines Moderna 5/21/21 Lot# 048B21A;  Moderna 6/24/21 Lot# 048B21A
very mild pain in left arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (very mild pain in left arm of injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cholesterol and Hypertension.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (very mild pain in left arm of injection). At the time of the report, VACCINATION SITE PAIN (very mild pain in left arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Blood pressure went incredibly high 208/108; Shaking uncontrollably; Aches; Extremely high anxiety; Emergency said it was probably side effects from the vaccine; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went incredibly high 208/108) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced HYPERTENSION (Blood pressure went incredibly high 208/108) (seriousness criterion medically significant), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HYPERTENSION (Blood pressure went incredibly high 208/108), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood pressure measurement: 208/108 (High) Blood pressure 208/108 incredibly high.. On 28-Oct-2021, Blood test: normal (normal) blood test normal..         Concomitant product was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Patient describes nausea, very close to vomiting and also reports diarrhea. Also reports arm soreness
Blurred Vision; Rapid Heart Rate; Tingling in extremities; This is a spontaneous report from a contactable healthcare professional. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via intramuscular route in the right arm on 26Mar2021 at 09:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via intramuscular route in the right arm on 05Mar2021 at 12:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 09:45, the patient experienced tingling in extremities, blurred vision, and rapid heart rate. The adverse events resulted in emergency room/department or urgent care. It was unknown if the patient had received any treatment for the events tingling in extremities, blurred vision, and rapid heart rate. The clinical outcomes of the events tingling in extremities, blurred vision, and rapid heart rate were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
red arm; body aches; fever; Sore arm; urine color, pale yellow to pale tan; This case was reported by a consumer via call center representative and described the occurrence of urine discoloration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced urine discoloration, erythema of extremities, general body pain, fever and pain in arm. On an unknown date, the outcome of the urine discoloration was recovered/resolved and the outcome of the erythema of extremities, general body pain, fever and pain in arm were unknown.   It was unknown if the reporter considered the urine discoloration, erythema of extremities, general body pain, fever and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via. The patient received dose of Shingrix vaccine in April and experienced a change in urine color from pale yellow to pale tan. The patient also experienced red arm, sore arm, body aches, and fever. The color change lasted 2 days. The patient asked if she should receive the second shot given the change in urine color. The patient asked what was her protection with one shot. The patient also asked if most people do experience worse or milder side effects with the second shot. The patient asked if there was any 2nd shot data for people who experienced harsh side effects with the first shot.
sore arm; headache; Fatigue; feeling drugged; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via unspecified route of administration in the left arm on 22Mar2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included mild osteoporosis and herpes. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. It was unknown if the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced fatigue and feeling drugged on 22Mar2021 at 19:00. The patient experienced sore arm and headache on 23Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events fatigue, feeling drugged, sore arm and headache was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected
Pfizer-BioNTech COVID-19 Vaccine EUA:  Administration error, improper injection technique. Vaccine recipient was stuck 3 times with same needle. Vaccine recipient was revaccinated with a new syringe/needle.
Approximately 5 hours after receiving the vaccine(2pm est) this writer noticed a slight cough, similar to post nasal drip and soreness at injection site. Approximately 3 hours later, injection site much more soreness, unusual for this writer comparing to previous vaccinations. When taking of the face mask, this writer experienced a feeling of "relief" in face, such as a removal of an "Ace" bandage from an ankle strain. Face was symmetrical, but felt swollen. At approx. 8pm, this writer felt "cold" unusual since this writer is going through menopause. This writer proceeded to add a sweatshirt to warm up, then added a jacket then a blanket and began to have noticeable chills, but didn't feel "sick" as one would with such pronounced trembling, chills. This writer had a low grade fever, abnormal. At approx. 9pm this writer noticed that left side of face was less swollen and now an asymmetrical appearance was evident in this writer's face. this writer decided to take Tylenol 1000mg po and Benadryl 25mg po. At approx. 10pm, all symptoms were gone, no swelling in face noted, no cough/post nasal drip , chills, with the ability to raise arm of injection site with little discomfort. *NOTE, this writer had facial fillers and Botox injections place 8/3/20 and swelling was noted at these areas. Next day, no side effects noted, arm tender at injection site if touched.
PATIENT WAS ADMINISTER A GARDASIL 9 (HPV) VACCINE AT THE TIME OF HER PHYSICAL BY THE MEDICAL ASSISTANT WHICH WAS REQUESTED BY THE PROVIDER.  THE VACCINE WAS ADMINISTERED WITH NO SIDE EFFECTS OR ISSUES.   ONCE THE PATIENT HAD LEFT THE OFFICE THE ERROR WAS NOTICED BY THE MEDICAL ASSITANT AND SHE ALERTED THE VACCINE BACK-UP COORDINATOR OF HER ERROR.   PATIENT HAS NO ADVERSE REACTION OR SYMPTOMS TO THE VACCINE  VACCINE WAS ADMINISTERED AT APPROXIMATELY 10:15AM THIS MORNING ON 3/8/23
This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL dose 1, .5ml, intramuscular for prophylaxis. The physician reported that he had a patient who experienced skin itching and hives after the first injection of GARDASIL. The physician reported the patient returned for the second injection; and, upon administration, again exhibited signs of hives and itching. The onset date of the AE was reported as 20-JUN-2013 (it is not clear if the onset date is related with the first or second injection of GARDASIL). The outcome of skin itching, exhibited signs of hives, hives and itching is unknown. The reporter did not assess the relationship between the events and GARDASIL. Additional information has been requested.
Because of reaction on the  first shot, when I got home after getting second shot I took a Benadryl. In the early afternoon I began to feel shortness of breath, breathing not normal and it steadily increased towards early evening when I took 2 more Benadryl which then quieted down the breathing reaction. Also that day I experienced a sore arm. The next day, breathing problems were almost all gone but decided to take 1 more Benadryl. During the day I felt flu like symptoms. The third day I feel like myself again.
After flu vaccine, patient developed a high fever for 48 hours, controlled with TYLENOL. Three weeks following the shot she complained of no vision in her right eye. Admitted to hospital. After being admitted to hospital on 1/29/16, patient stayed for 6 days on steroid treatment. She was discharged on oral steroids on a tapering dose of 25 mg. Patient was readmitted to hospital following a doctor's visit due to no significant changes in eyesight. She stayed in the hospital for 5 days for IVIG treatment. Patient to this day has 90% vision loss in her right eye due to the effects of the swollen optic nerve (optic neuritis).
On Sunday, November 21, the patient woke up with mild headache, body aches, and vomiting every time she ate food or drink liquids.  She did have temperatures in the range of 99-100 that day.  On Monday, November 22nd, she had a nosebleed that parents report was uncontrollable and continued for about 30 minutes.  She has not had this previously.  She also developed neck pain on Nov 22 as well, primarily and neck flexion.  She had a temperature to 101 on Monday evening.  The following day, November 23rd, she continued to have an extremely poor appetite with mild headache, she vomited once in the morning after Tylenol and continued to complain of stiff neck.  She continued to have temperatures in the 99 range.  They did take her to urgent care who referred her to ED,  discharged after supportive care. The following day, Wednesday November 24th, she seemed to improve to about 75% of normal.  This continued until Nov 28. On Sunday, November 28th, she awoke with severe neck pain and stiffness as well as a 10/10 headache, the worst of her life.  She vomited x1 prior to eating but may have had a few sips of water at that point. She was subsequently identified as having an arterial venous malformation in the medulla with apparent focus of hemorrhage.
don't feel good; sleeplessness; dry throat; no energy; runny nose; sneezing; she experienced body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-AUG-2023, the patient received the 1st dose of Arexvy. On 18-AUG-2023, 1 days after receiving Arexvy, the patient experienced feeling unwell (Verbatim: don't feel good), sleeplessness (Verbatim: sleeplessness), dry throat (Verbatim: dry throat), loss of energy (Verbatim: no energy), runny nose (Verbatim: runny nose), sneezing (Verbatim: sneezing) and general body pain (Verbatim: she experienced body aches).  The outcome of the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain were not resolved.   It was unknown if the reporter considered the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain to be related to Arexvy.     It was unknown if the company considered the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain to be related to Arexvy.   Additional Information: GSK receipt date: 25-AUG-2023 The patient called to complain of symptoms follow the new flu shot.  After some discussion, the patient was asked if she meant the RSV shot and she said yes.   She stated that she received the vaccine on Thursday.  Beginning about 24 hours later, she experienced body aches, sneezing, runny nose, no energy, dry throat, sleeplessness, and she did not felt good.  The symptoms had not yet dissipated. The patient suggested calling the Clinic and speaking with the nurse. The reporter consented to follow up.
I woke up with dizziness - huge dizziness  also, my sugar was extremely high in the 300
It was reported, The mother of a 2 month old male reported that her son received his 1st doses of Rota Shield, DPT, IPV, HIB and Hep-B vaccines on 7/2/99. On 7/4/99, the infant developed a fever of 102F and decreased appetite and activity."
Pt stated her left arm by the injection site of PNEUMOVAX 23 got reaaly big, swollen, inflammed & painful.  It spread all the way to the back side.  She also developed high fever, chills until Sunday.
had shingles; had shingles; had shingles; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program support. A 70-year-old male patient received BNT162B2(PFIZER BIONTECH COVID19 vaccine, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date (At the age of 70-year-old) as dose 3(booster) single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. The patient received BNT162B2(PFIZER BIONTECH COVID19 vaccine, Solution for injection), dose 1 and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced shingles. The patient experienced had shingles, Booster and off label use on an unspecified date. The patient also mentioned taking eye drops because it affected his vision and he would like to know when to get the booster dose since he just had shingles. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After vaccine administered, patient had symptoms of fainting. Dilated pupils, cold sweats, loss of consciousness (briefly on 2 occasions). Paramedics came to evaluate patient. Patient recovered and left under own power - 30 minute time course.
stroke; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. The patient experienced stroke 17 hours later of vaccination of second dose, on an unknown date in Feb2021. The patient went through extensive testing which revealed no other cause, tied the shot directly to the stroke. The patient also reported that on 05Jan2021, the patient was extensive and perfect physical. It was also reported that the patient recovered somewhat but will have to live with symptoms for a lifetime. The outcome was recovered with sequel for the reported event.  Information about lot/batch number has been requested.