chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 after after initial dose I woke up with nausea, fever, chills, Aches, fatigue, puking. It last non stop for 36 hours. I couldn't keeo anything down so we went to the doctor. They sent us to the ER. Nothing helped there so I was sent home and returned shortly later the next day. Again, nothing really gave me relied so I left yet again. The third day I still was so incredibly sick I went to a different hospital. They helped alot more here. Total, I was in the ER 3 times, one ambulancE ride, 2 hospitals and 3 overnights.
sick; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via social media.  This case involves male patient (unspecified age) who was sick (illness) while he received vaccine Influenza Vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got a flu shot got sicker than a dog (illness).  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown. There will be no information available regarding batch number in this case.
Information has been received from a physician's office staff member concerning a 4 year old boy who on 22-MAY-2008 was vaccinated with the second dose of VARIVAX (Merck) 0.5ml subcutaneously (lot# was either 660219/0154X or 660280/1997U). The patient developed swelling with warmth and redness from shoulder to elbow after receiving VARIVAX (Merck). Subsequently, the patient recovered. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information is not expected.
I am in peri-menopause and had not had a period in 5 months.  Three days after the shot, I got a very heavy period.
04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I began feeling so weak I could barely talk, I couldn't hold my eyes open. I took 3 Aleve. At 8pm, I started with shortness of breath just going downstairs plus my entire body felt like I was hit by a truck. My 3lb. Chihuahua would get on me and it felt like I was hit by a bat with a ripple effect into the surrounding area. I took 2 Tylenol PMs. On 04/07, at 6am, I woke up to my limbs extremely swollen and throbbing, this included both feet and especially both wrists and hands. My hands were worse than my feet. My left wrist/hand also had tingling. I was so weak I could barely get out of bed or talk, this continued through to 5:30pm same day. I called an Urgent Clinic and told her all my symptoms, she said were all "normal" until I got to my wrists/hands and limbs. Urgent Care told me it would be best to be seen in ER and evaluated. I immediately went to ER . This approximate time was 6:30pm on 04/07/21.
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: sub-- hemorrhagic bleed in eye-Severe, Additional Details: patient started with red dot on eye on thursday 8/12 a few minutes later her eye was completely red.  Paient went to er and they did cat scan and everything turned out normal
Severe pain in left arm traveling up into neck and down to elbow lasting 3 days.  Fatigue lasting 3 days Headache lasting 3 days  Body aches lasting 3 days
Left deltoid area red, swollen, warmer than normal to touch. No fever. Mother had given a foreign medication, that she stated was similar to Tylenol, and applied a cold compress.
I felt funny. I started to shiver but I was sweating. My blood pressure rose and I was rushed to the ER and was given fluids, Benadryl and steroids and an epipen.
After 30 minutes. Began to have trouble swallowing. Then short of breath. I called 911. The came 5 minutes later and began treatment.
Arm swelled, turned red, bumpy and itchy. Took epsom salt bath.
my blood pressure, it was up to 217; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 13Jan2021 at 12:00 PM at a single dose for COVID-19 immunization .  The patient's medical history and concomitant medications were not reported.  On 13Jan2021, the patient  received the first shot then had no problems. On 14Jan2021, 24 hours afterwards, the patient had two doctors supposed to get her iron injections and they checked her blood pressure, it was up to 217, they got it down a little and finally gave the iron. They recommended the patient went over the ER and be checked. The patient spent a good 10 hours there having medications to get it down. Finally, it went down: 187/92 and everything fine there. The patient was given injection through the IV and finally got one that worked; got the lowest it would come. The patient came home on 15Jan2021 at 3:00 AM, went to bed then got up and her husband took her blood pressure: 127/65 and informed that it has not been taken since 8:00 AM. The patient was told by doctors that they did not think it was related to the COVID-19 vaccine. The outcome of the event was recovered on 15Jan2021.  Information on lot/batch number has been requested.
Information has been received from a physician via forwarded e-mail from the female reporting on many kids who on an unknown dates were vaccinated with unknown number of doses of GARDASIL (doses, routes and lot numbers not reported). It has been reported that many girls and now boys, had redness, soreness, fainting, headaches and other minor issues immediately following the shot. Many kids had neurological issues that result in numbness and tingling, twitching, pain and seizures. In addition muscular soreness, headaches, stomach pains, vision issues, hair falling out, menstrual irregularities, ovarian cysts and chronic fatigue had been reported. To date there were 24,000 adverse events and 108 deaths from the shot. At the time of the report the patients' outcome was unknown. Upon internal review seizures considered to be an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
While administering the Janssen Vaccine to the patient, the needle fell apart from the barrel, Therefore, not administering the complete dose.
Suspected Vaccination Failure; I´ve had shingles 3 times since I got the vaccine; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had shingles 3 times since from vaccination and these were always at the same place, on his/her back. This case was considered as suspected vaccination failure, since the details regarding the completion of vaccination schedule, the time to onset for event and laboratory confirmation for herpes zoster were not provided
My throat was a little scratchy during the 20 minute wait. Didn?t give it to much concern as not much reaction after first shot. When I got home  And approximately 35  minutes my left  side of face and behind my ear started to tingle, or buzz or felt strange when touching it. Returned to normal after about a total of 60 minutes. Next day noticed a heightened awareness on my left leg below knee like it was super sensitive. This is still going occurring. Today 4/1 also had sensation on outer thigh of left leg. Left arm the sensation feels like flushed skin or heat. Leg at time also.
Patient received Vaxelis plus PEDVAXHIB in error. PREVENAR was intended to be given instead of PEDVAX; Received 2 doses of HIB (Vaxelis and PEDVAXHIB); This spontaneous safety report was received by the partner on 22-Nov-2021 and forwarded on 23-Nov-2021 from a health care professional.  Due to the nature of the event, the causality between "patient received Vaxelis plus PedvaxHIB in error" and Vaxelis was not applicable.  No further information is expected.  FOLLOW-UP INFORMATION was received by partner on 02-DEC-2021 and forwarded on 03-DEC-2021 and ADDITIONAL INFORMATION was received by partner on 06-DEC-2021 and forwarded on the same date.   A 2-month-old female patient was vaccinated with Vaxelis (batch# U7124AA) and PEDVAXHIB (batch# T042015) in error. The reporter stated that Prevnar 13 was intended to be given instead of PEDVAXHIB.  Therefore, the patient accidentally received 2 doses of HIB. No adverse event was experienced by the patient.   Due to the nature of the event, the causality between "received 2 doses of HIB (Vaxelis and PEDVAXHIB)" and Vaxelis is not applicable.  No further information is expected.
As soon as I got the shot, I experienced the following, I felt really dizzy and about to pass out, heart palpitations. Shortness of breath, Legs were tingling for 12 hours. Feverish, chills, body aches and a headache. I took Tylenol to suppress my symptoms and after 5 days my symptoms subsided and started feeling better.
Per patient: rash on face (peeling, red) burning cough sweating referred him to see doctor 12-16-09
burning sensation at injection site that radiates to left neck and left side of head behind ear. dizziness. chest tightness. foreign body sensation in back of throat.
Received Td injection after a squirrel bite to right index finger. 24 hours post vax, the injection site became reddened, warm, and very painful. 7 days later, the injection site measured 6 cm x 6 cm with a 2 1/2 cm hardened bluish area. Pt also reported nausea.
Patient said she was nauseated.  Her doctor was contacted, and doctor recommended that she goes to the ER.  However, after 10-15 minutes, patient felt better and went home.  Patient was encouraged to contact doctor.  There was another patient (patient's sister) who got the same shot at the same time and also claimed she had similar symptoms (nausea and couldn't see well).
Swelling and rash on the face (Lips, eyes, and cheeks) and fever.
Injection site redness; RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PAIN (RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Intestinal resection in 2016. Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF,Solution for injection in pre-filled pen. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PAIN (RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown and INJECTION SITE PAIN (RIGHT ARM SORENESS DUE TO COVID-19 SHOT/INJECTION SITE SORENESS) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2016, Endoscopy small intestine: The patient had a surgery for take out section of intestines.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced right arm soreness due to COVID-19 shot, Injection site redness and Injection site soreness. In 2016, The patient had a surgery for take out section of intestines.  The reporter's causality for the events of TAKE OUT SECTION OF INTESTINES, RIGHT ARM SORENESS DUE TO COVID-19 SHOT and INJECTION SITE REDNESS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of INJECTION SITE SORENESS was not provided. RA's opinion is that there is no reasonable possibility that the events of TAKE OUT SECTION OF INTESTINES and RIGHT ARM SORENESS DUE TO COVID-19 SHOT are related to HUMIRA(ADALIMUMAB). RA's opinion is that there is a reasonable possibility that the events of INJECTION SITE REDNESS and INJECTION SITE SORENESS are related to HUMIRA(ADALIMUMAB).  No treatment medication were reported.  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.
Swelling at injection site, hard llump under skin, skin at injection site is hot to touch, injection site is painful, injection site is itching and burning
"Pain in shoulder Dr said has brusitis as a reaction to receiveing the shot high near the shoulder"
I started having pain in my right side on May 6. I noticed red spots on May 8 and went to an urgent care facility on May 9 where the doctor there confirmed I had the shingles.  She prescribed antiviral medication to be taken for the next 7 days.
had shingrix vaccine had couple cases/suspected vaccination faliure; had shingrix vaccine had couple cases mild; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had shingrix vaccine had couple cases/suspected vaccination faliure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingrix vaccine had couple cases mild). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAR-2023 The case was received from the patient via interactive digital media. The patient got the Shingrix vaccine and have had a couple of mild cases. The case was linked with case US2023AMR057460, reported by same reporter for his/her mother. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR057460:same reporter
Itching at injection site, head congestion, red and itchy eyes with yellow drainage from eyes, headache, fever with chills
< 24 hrs after PNEUMOVAX and flu vaccine pt became ill - body aches, facial swelling. States she had fever, but no thermometer to verify.
severe myalgias, fever of 100.6*F, malaise, fatigue for the past 12 hours (approximately 12-18 hours after receiving the vaccine). Patient of note, had COVID19 infection in July 2020. She tested negative for COVID19 this morning (screening done/ordered after reporting her initial symptoms).
He had a bad flare up; This is a spontaneous report from a contactable nurse. A 63-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 26Apr2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication(s) included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 2019 to an unspecified stop date. It was unknown, whether the patient was pregnant at the time of event. On an unspecified date, in April 2021, patient stated "I had to hold my xeljanz when I received my covid vaccines per my doctor. She had to stop Xeljanz a week Before, the week of and the week after both vaccines. Last vaccine was 26Apr2021". She had a bad flare up and Had to go to doctor to get a shot to help. She has appointment to go back and see doctor next week." doctor aware. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of rheumatoid arthritis flare up. The case will be reassessed once new information is 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
skin starting to peel at the injection site; dry at the injection site; raised welt; arm sore; arm red; arm swollen/hard; arm itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE DRYNESS (dry at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history found).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE DRYNESS (dry at the injection site). At the time of the report, VACCINATION SITE DRYNESS (dry at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication and treatment provided
Client's mother called to report patient stated she felt some dizziness and passed out "later in the evening" on day she received rabies vaccination. Stated mother did not witness this and that could have been from "low blood sugar" as she experienced this one other time in past. Mother stated she saw MD this am (prior appointment) and "he wasn't too concerned."
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 3; Moderna, Dose Number: 4; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 13:00 as DOSE 1, SINGLE (batch/lot number: unknown), administered in the left arm; on 14Apr2021 at 13:00 as DOSE 2, SINGLE (batch/lot number: unknown), administered in the left arm; and on 05Nov2021 at 14:00 as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 44 years, administered in the  left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 04May2022 at 14:00 as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown), administered in the left arm and on 09Sep2022 at 15:45 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "Known allergy: stone fruits" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction: "Known allergies: Demerol." The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04May2022 at 14:00, outcome "unknown" described as "Pfizer / BioNTech, Dose Number: 3; Moderna, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Menactra stored at minus 1 degrees C due to an unstable refrigerator and exact temperature not in a specific time frame; Initial information received on 05-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone.  This case was linked to case 2019SA184495 (same reporter).  This case involves a patient of unknown demographics was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to product storage error temperature too low because Menactra stored at minus 1 degrees C due to an unstable refrigerator and exact temperature not in a specific time frame.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on batch number was requested.  Documents held by the sender: none.
EMPLOYEE RECEIVED IMMUNIZATION AND REPORTED DELAYED REACTION OF DIZZINESS, ABDOMINAL CRAMPING. EMPLOYEE ATE AND LAID DOWN AND STATED SHE WAS FINE AND RECOVERED.
Information has been received from a physician concerning a 4 month old patient who on 05-APR-2010 was vaccinated with the first dose of ROTATEQ at 4 month of age. No adverse effect reported. Additional information has been requested.
60 hours after the second dose of Moderna I had extreme heart pain. Urgent care reported no heart attack. Nothing in the bloodwork showed any signs of heart issues.   1 hour after the vaccination my finger tips pruned. And are still pruned as of this entry.
Patient presented with right parotitis 3 days after MMR vaccine. No treatment - but excluded from daycare.
Patient recevied Pfizer bivalent dose as her second dose when she should have received the Pfizer monovalent dose as her second dose