chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sick after the injections; This is a spontaneous report from non-contactable Other-HCP. This Other-HCP reported similar events for six patients. This is second of six reports (6 coworkers). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 20Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was very sick after the injections on an unspecified date. The outcome was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076655 same reporter, same drug/event, different patient;US-PFIZER INC-2021076654 same reporter, same drug/event, different patient;US-PFIZER INC-2021076551 same reporter, same drug/event, different patient;US-PFIZER INC-2021076656 same reporter, same drug/event, different patient;US-PFIZER INC-2021076654 same reporter, same drug/event, different patient
no symptoms till 26 hrs after 2nd shot.  severe heart palpitations - felt like heart was going to explode.  went to ER, normal EKGs and nothing found in ER.  since episode - have had mild heart flutters for 10 days now.  during covid illness - had 1 hard palpitation - and some mild flutters.  nothing nearly as severe as after the shot.
4 inch in diameter/circular red itchy patch at injection site; 4 inch in diameter/circular red itchy patch at injection site; redness at the injection site; sore arm - 18 Feb 2021 , duration "a few days"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"). On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site). On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site). At the time of the report, PAIN IN EXTREMITY (sore arm - 18 Feb 2021 , duration "a few days"), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE RASH (4 inch in diameter/circular red itchy patch at injection site) and VACCINATION SITE PRURITUS (4 inch in diameter/circular red itchy patch at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated events outcome to recovered/resolved.
Pfizer vaccine vial was incorrectly diluted with 1.6ml of sterile 0.9%sodium chloride instead of 1.8ml. Pt was injected with 0.3ml of diluted vaccine. Vaccine administrator was informed of vaccine dilution error as soon as error was realized (before vaccine was administered). Patient was stable after administration and left clinic after observation. Clinic manager and supervising MD were notified on same day. I was advised to report event to VAERS per manager. Patient was not contacted for status follow-up per manager recommendation on 4/30.
Inflammation; Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, INFLAMMATION (Inflammation) and MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving.            No Concomitant medication was provided by reporter. The patient had less stiffness and improved sleep. The second injection was what triggered the Rheumatoid arthritis to be diagnosed. She developed inflammation within twelve hours that would not go away. She was improving. No Treatment medication was provided by reporter.
This spontaneous report as received from a Doctor of Pharmacist refers to a 68 year old patient. No medical history or drug reactions/allergies were reported. The pharmacist reported that on 29-AUG-2013, a nurse administered the enrite volume of a multi-dose vial of PNEUMOVAX23 (Lot # not provided), the patient received 5 doses of PNEUMOVAX23, 2.5 ml, intramuscularly. It was unknown to which area of the patient's body, the 5 doses were administered. The pharmacist reported that she was not aware of any adverse effects at this time. Additional information has been requested.
back pain; strained her muscle; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer or other non hcp reported that a female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 02Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included muscle strain from 23Mar2021 to 23Mar2021. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced back pain, strained her muscle. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Irregular period/spotting for two weeks after second dose. Also, felt ill with a fever of 100.8, nausea, body aches, and headache the day after shot. Sore arm for three to four days.
Adverse Events Experienced: Chills, Soreness in Arm, Rash (small red itchy bumps) on upper Chest area, persistent (dry) cough, shortness of breath/difficulty breathing, and body aches.   Treatment: During time of adverse reaction/severe symptoms I used Delsym Cough Syrup and Advil Dual Action (acetaminophen & ibuprofen). These remedies did not work well so I went to my primary care, Dr. After consulting with my doctor at the time of the appointment, I was prescribed by him - Fluticasone Propionate Nasal Spray USP, Benzonatate 100mg capsules, and Cetirizine 10mg tablets on 04/16/21.   Time Course: Adverse reaction / severe symptoms began 04/06/21 in the late afternoon (around 2:00 pm) (with a sore arm, chills, and body aches for the following 48 hrs.) Then, these symptoms after 48 hours went away however, the following symptoms occurred - severe rash, dry cough, and shortness of breath.
I got sick Friday 7/1/22. I was very very tired, I had just arrived home that previous Tuesday night. That Wednesday we received an email saying we had been exposed to COVID-19 on the trip. I was having some allergy symptoms so I didn't think anything of it- I was still feeling fine. On Friday I went to the store early evening and when I came out of the  store I was exhausted that I didn't think I would make it to the car. It was so extreme. I made it back home and took a home test and it was positive. The next few days i was taking at least two naps a day for a few hours at a time. I was congested but didn't have a cough, never lost taste/smell. Mostly just extremely extremely tired. I stayed home for five days, then took another home test but it was still positive. I called my doctor  telehealth and they prescribed Paxlovid. I started feeling better, still congested but not nearly as tired. I took a test the following Saturday and it was finally negative. So about 10 days I was sick.
Information has been received from a nurse concerning a patient who on 17-JUN-2008 was vaccinated with VARIVAX (Merck).  The nurse reported that on 17-JUN-2008 the patient inadvertently received VARIVAX (Merck) instead of ZOSTAVAX (Merck).  No symptoms reported. There was no product quality complaint.  Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat and hot at the injection site.), VACCINATION SITE PRURITUS (arm itches like a bee sting itch), VACCINATION SITE ERYTHEMA (Patient have redness soreness, heat and hot at the injection site) and VACCINATION SITE PAIN (Patient have redness soreness, heat and hot at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat and hot at the injection site.), VACCINATION SITE PRURITUS (arm itches like a bee sting itch), VACCINATION SITE ERYTHEMA (Patient have redness soreness, heat and hot at the injection site) and VACCINATION SITE PAIN (Patient have redness soreness, heat and hot at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat and hot at the injection site.), VACCINATION SITE PRURITUS (arm itches like a bee sting itch), VACCINATION SITE ERYTHEMA (Patient have redness soreness, heat and hot at the injection site) and VACCINATION SITE PAIN (Patient have redness soreness, heat and hot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
At the end of observation period, patient began crying and expressed anxiety, pmh of hospitalization for panic attacks. Patient assessed and triage notified, while triage en route, pt expressed SOB and feeling of impending doom. Vitals: elevated BP 178/110, RR 20, HR 78. 911 called, paramedics assessed patient. Patient declined transport and called a friend to drive her home.
Starting late after noon of 9/27/19 patients arm was extremely sore.  9/28/19 arm was still extremely sore.  When patient woke up 9/29/19 she was ad a red hot swollen rash starting about 3-4 inches away from injection site (injection site clear) and ran all around elbow.  Elbow extremely puffy/swollen.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report was received 10 September 2008 from a health care professional.  A 12-year-old male patient with a history of allergies to CEFTIN and FORTAZ, had received a first dose intramuscular right deltoid injection of ADACEL, lot number C2998BA on 20 August 2008 and three days later, he developed a lump on his arm (site not reported).  On 24 August 2008, four days post vaccination, he developed a generalized red flat rash from "head to toe", which had also been present orally.  The rash progressed to blisters.  The patient was seen at the emergency room and was administered steroids for an allergic reaction.  The patient was subsequently evaluated by his physician that same day (on 24 August 2008) who diagnosed the patient with Stevens Johnson Syndrome.  The patient recovered from the event.  No additional information was provided at the time of the report.
Approximately a few hours after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Cough, Fatigue, Muscle Aches and Chills. After I tested positive - I took Tylenol, Cough Syrup and Nyquil to help ease the symptoms. 2 days after, I consulted with my doctor and was given some alternatives and I was still in the window to take medications and since I do not have tightness in my chest or any severe COVID-19 symptoms - he advised me to let my symptoms run its course and if it did not improve 2 days after he gave me an emergency hotline number to contact. So far as of today, 06/13/2022 my symptoms are almost gone, my energy level has gone back to normal.
pt called the doctor on cal and stated she had redness, in her arm with swelling  that went into her lymph nose under arm , reaction did last for 2 days
hives around my neck; on the shoulder little bumps/ welts on my neck and shoulders; I woke up i was hot; I got welts on my neck and shoulders and itching; Chills; Bone aching and that's sort of things; Stomach upset; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at the age of 66-year-old as dose 2, single for covid-19 immunisation. Medical history included blood pressure high. Concomitant medication included metoprolol taken for hypertension, start and stop date were not reported; chlortalidone, vitamin d nos, calcium, potassium chloride and apixaban (ELIQUIS) taken for hypertension, start and stop date were not reported.  The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, unspecified date at the age of 66-year-old as dose 1, single for covid-19 immunisation. On 24Mar2021 (Wednesday) which on midnight patient had the chills and bone aching and that's sort of  things and stomach upset but on 25Mar2021 it went away but on 26Mar2021 morning when he woke up he felt hot then had chills and patient have hives around neck and on the shoulder little bumps have like/ welts on my neck and shoulders and itching. Patient Tylenol on 25Mar2021 but this morning (on 26Mar2021) when he woke up with the bumps and took Benadryl. The outcome of the events chills, bone aching, stomach upset was recovered while the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
Complained of racing heart (pulse 74). BP 156/85, O2 sat 99%.
AS SOON AS THE VACCINE WAS ADMINISTERED I WAS WINDED AND FELT TINGLING AROUND MY MOUTH.  ON FRIDAY NIGHT I HAD A RACING HEART, WAS HAVING TROUBLE CATCHING MY BREATH AND BLURRY VISION.  THAT SETTLED DOWN AFTER 3 HOURS.  I WENT TO BED.  SATURDAY MORNING AFTER BEING UP FOR ABOUT 1 1/2 HOURS MY HEART STARTED RACING, SHORTNESS OF BREATH AND BLURRY VISION STARTED AGAIN.  I WENT TO THE ER .  I WAS GIVEN INTRAVENOUS DRUGS TO HELP WITH THE ANXIETY.  WAS EXHAUSTED BUT OK FOR SATURDAY AFTERNOON AND EVENING.  I DIDN'T TAKE ANY cold medicine OR STEROID MEDICATION ON SATURDAY.  SUNDAY MORNING AFTER BEING UP FOR 1 1/2 HOURS IT ALL STARTED AGAIN AND I WENT BACK TO THE ER FOR MORE INTRAVENOUS DRUGS FOR ANXIETY.  I WAS GIVEN AN EKG ON BOTH SATURDAY AND SUNDAY TO MAKE SURE I WASN'T HAVING A HEART ATTACK.  ON SUNDAY I WAS ALSO GIVEN A CHEST XRAY.  SUNDAY I WAS SENT HOME WITH A PRESCRIPTION FOR VALIUM.
On 07/14/2022 I had a sore throat in the afternoon. On 07/15/2022 I had congestion. On 07/16/2022 I had all the symptoms of COVID-19 such as fever, runny nose, fatigue, congestion, headache, and body aches. On the same day I went to the urgent care they prescribed me with PAXLOVID for 5 days and I also took over the counter medications. Most of my symptoms were gone after few days of the medication but I had cough for 5 weeks. I had elevated heart rate for about 2 months which I've never experienced before.
Received Flu shot from Pharmacy workplace clinic at roughly 8:30am on 10/16/2019. Shivering Fever started roughly at 1:30 pm day of vaccination. Roughly at 6pm body aches set in. The aches last through the night into the morning (10/17/2019).
Chills 12 hrs after vaccine dose Fever of 100-101 in the morning Body ache, headache persistent for 24 hours post dose
6 Days after the second shot, I had symptoms of a heart attack, heart palpatations, extreme fatigue. I saw my family doctor, they performed an EKG in office, then had a stress test ordered, then I got referred to a Cardiologist. They performed a heart Cath to look for blockage, no blockage was found, and he stated it was more then likely an adverse reaction to the Covid Vaccine. I had a 24 hour heart monitor put on, and sent to a Pulmonary Specialist,  She ordered up an breathing challenge test, all came back negative, Dr. stated it was an adverse reaction to he Covid Vaccine and Added to my Medical Chart. Now I am currently wearing a 30 day heart monitor.
shingles-like rash; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th May 2019, the patient received the 2nd dose of Shingrix. On 11th May 2019, 5 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: On 4th March 2019, the patient received 1st dose of Shingrix. After vaccination, the patient experienced a shingles-like rash.
pt w/pallor & lethargy 3-4 hrs p/vax, hospitalized for observation; No LOC sz, vomiting, screaming or fever;
I started getting symptoms of a sore throat and head congestion. I developed a cough then to a fever for 2 days. I felt like I had a really bad cold. I had a lot of shortness of breath. I took an at home COVID-19 test and then went to ER to get a test that were both positive and was prescribed Paxlovid. After Paxlovid, my symptoms went away shortly after. My symptoms lasted a total of 9 days. I still do have shortness of breath and I am getting treated by my cardiologist. I have also lost most of my taste and smell.
Extremely sore  arm at injection site, runny nose , chills, achiness. I felt these symptoms for approximately 36 hours.
Arm swelling, redness, and pain. Patient went to the urgent care and was prescribed prednisone.
that Kinrix was administered to a 6 month old, instead of Pediarix; Kinrix was administered to a 6 month old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The reporter stated that Kinrix was administered to a 6 month old, instead of Pediarix (should have been 3rd dose) which led to wrong vaccine administered and inappropriate age at vaccination. Reporter consented to follow-up by e-mail.
Right arm is sore near the injection site; This is a spontaneous report from a contactable consumer (the patient herself). A 44-year-olf female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247) intramuscularly in right arm on 09Mar2021 14:30 (at the age of 44-year-old) at single dose for COVID-19 immunisation. Relevant medical history was none. The patient did not have vaccine in four weeks nor COVID prior vaccination. Concomitant medications included esomeprazole sodium (NEXIUM), fexofenadine hydrochloride (ALLEGRA), cyanocobalamin (B12), bifidobacterium lactis (PROBIOTIC) and glucosamine. On 10Mar2021 09:00 the patient had right arm sore near the injection site. No treatment was received. The patient was not tested for COVID post vaccination. The event was non-serious and resolving.  No follow-up attempts are possible. No further information is expected.
is a 56 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - heart is racing like adrenaline rush episode post 1 minute vaccination. endorsed started on left hand then to the right hand. Denies weakness/numbness of hands, no dizziness, blurry vision, headache. No chest pain, SOB, tightness of throat. Had the same symptoms on first dose that went away after few minutes but didn't seek medical attention at that time. Denies anxiety. Patient is rushing to go home because she has another appointment at 10:30am. Physical exam unremarkable. Vital signs stable. Palpitations resolved after 3 minutes.  Sent home stable and in no distress. ED precautions given.
1 of 3 pts immunized from the same lot@ (same vial) who exp fever & crying; temp not taken for this pt;
Nauseas Palor skin Dizzinest Hypotension (90/80 mmHg)
Suspected Vaccination failure; 6 months ago, the patient had a mild case of shingles.; this week had shingles on his right arm, right chest, and left leg; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax with an associated reaction of herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: 6 months ago, the patient had a mild case of shingles.) and shingles (Verbatim: this week had shingles on his right arm, right chest, and left leg). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the vaccination failure and shingles were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 03-AUG-2023 The patient received Shingrix about 5 to 6 years ago and confirmed he received 2 doses, 6 months apart. About 6 months ago, the patient had a mild case of shingles. This week, the patient experienced shingles on his right arm, right chest, and left leg. The patient was prescribed antiviral medication ( for 7 days) for the shingles. The patient was vaccinated with Zostavax (date not given). After receiving Zostavax, the patient experienced shingles twice. The reporter/patient gave consent to follow up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Pt received SHINGRIX vaccine subq left arm on 4/26/18. Came to pharmacy 4/30/18 with large rash and swelling on left arm triceps injection site area. Per pt rash started 4/27/18, was red, painful and swollen, has improved but still swollen and painful.