chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine helped, it gives me very slightly/Suspected vaccination failure; Broke out inside me, a few sprouted in back; Awful, horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that it also gave him/her but it broke out inside him/her and the acyclovir took them away, just a few sprouted in his/her back but they were very awful pains. The vaccine helped the patient suddenly it gave him/her but very slightly they were horrible pains and worse inside because you could not heal them with anything. Additional supportive information: 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.
During 05/26/2022 Humira medication consult Patient reported Pfizer booster received 02/28/2022 caused body aches, rashes, diarrhea, migraine , nausea, heavy period with cramping and period to come on early.
patient developed sore throat and nasal congestion on 7/15/2021.  She tested positive for COVID on 7/19/2021
Started feeling flu-like symptoms close to 10 hours after I got the 2nd Pfizer shot, specifically aches and pains, chills, sharp shooting pains in parts of body, and headache. Had a low-grade fever (between 100-101) over 36 hour-period. Still feeling achy and tired within 48 hours of receiving the vaccine, but my fever is gone. I also have arm soreness and my lymph nodes under the armpit of the arm where I received the shot is swollen.
I had low-grade fever, body ache, sore throat, headache, chills, congestive, cough, loss of taste and smell. These lasted for about 5 days. On Nov 5th, I tested positive for COVID-19.
Pt c/o feeling flushed, loss of speech muscles not working correctly, can't get enough air, and might pass out".  Declined transport to hospital.  Pt informed to report to ER or notify PCP if his condition worsens.  called 3/3/2021@ 3:44 PM for follow up.    No answer .
Right arm with redness, and slight bruising at base of reaction; warm to touch. Pain at site. No induration at the injection site. Left arm with redness/warmth, small induration (3mm) at injection site. pain at site. LIDEX cream and CLARITIN were given for reaction. LIDEX/topically to treat skin inflammation and itching. CLARITIN as an oral antihistamine effect.
Initial report received on Nov 01 2005 from a health care professional. A female patient with no reported age and denies allergy to eggs felt hot and itchy in the right side, had nausea, dizziness, shortness of breath, media sternal chest pressure, right arm numbness, hypertension at 152/105, swelling of face and tongue at an unspecified time, the day she received the influenza vaccine (Fluzone SV 2005-2006) lot # U1754AA in the right deltoid on Oct 20 2005. She had received Ativan, Magnesium sulfate, Lopressor, H1 and H2 blockers, Benadryl and epinephrine during unspecified time frame. She was admitted and discharged from an ER at an unspecified time. The outcome was not reported at the time of the report. Of note that the reporter was not sure whether the patient received the influenza vaccine but she was receiving yearly vaccinations for the past five years. According to the reporter the above mentioned symptoms of the adverse events were not consistent with influenza vaccine specially the hypertension. Additional information received from a health care provider on Nov 7 2005. Per the reporter, the vaccine administrator confirmed that Fluzone was administered, and the facility was able to provide the lot number. Per the reporter, the patient had recovered.
8hrs after 2nd shot extreme fatigue  Followed by headache and arm ache with swollen and painful lymph nodes in left arm pit 24 hrs later 99.9 fever and body aches 2 days later extremely itchy and painful raised rash developed on left hand and left stomach  6th day fever and fatigue return  Day 12 rash starts to fade Day 15 rash reappears but on right arm and right lymph nodes are swollen and tender Today 4/15/21 the rash is still present but starting to fade slightly
A spontaneous, non-serious report of a cut on finger when the sprayer broke during administration of FLUMIST, concerning a female patient. On an unreported date, the nurse reported she removed the FLUMIST syringe from the package to administer to a patient and as soon as she began to push on the plunger rod, a portion of the finger flange snapped off cutting her finger. A bandaid was applied to the laceration. The outcome of the event is unknown.
Peripheral neuropathy; This is a spontaneous report from a Contactable Health Care Professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199) via unspecified route of administration, on 23Mar2021, 2nd dose, single for COVID-19 Immunisation. Medical history included Epstein-Barr viraemia. The patient's concomitant medications included Nicotine gum. The patient was allergic to Amoxicillin/clavulanic acid. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6200), via unspecified route of administration, on 01Mar2021, as 1st dose, single for COVID-19 immunisation. On 23May2021, the patient experienced Peripheral neuropathy. The patient did not received any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.   Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information currently available the causal association between the event peripheral neuropathy and the usage of the vaccine BNT162B2 cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Left arm numbness lateral side of arm down to the wrist. Left side of face numbness, down left side of neck extending to left temple. Also tingling in areas previously addressed.
PRETTY BAD HEADACHE SUCCESSFULLY TREATED WITH TYLENOL; LETHARGY; MINOR SORENESS AT INJECTION SITE
After injection roughly approx 7 hours later my arm got hot to the touch, by 8:00 pm I had a fever over 100 with intense body aches. At 9:30 pm I started severely vomiting, had fever of 102 and severe body aches that prevented me from moving.
pt had t103.3 R 5AM 7FEB95 & was irritable; parents called MD 830AM & was advised by MD to give APAP & take pt off the waterbed; t105 R reports MD-lt leg was tender w/induration; pt on amoxicillin for URI;
The information was presented by his granddaughter. He was scheduled to come in for his second vaccination with his granddaughter on 4/14/21, however, he passed away on 4/13/21.  His granddaughter stated he experienced a severe nose bleed just under a week post vaccination (1st dose/Pfizer). The nose bleed lasted a few hours and had to be controlled by the Hospital. The incident reoccurred a week later and again, the bleeding had to be controlled by nasal clamp and lasted for a few hours. The patient began having pain in his stomach and feet, and stayed pale and  nauseous. On 4/13/21 the patient was found in his bed saturated in blood and had soiled himself. His family called EMS and the patient went to Hospital. The patient coded and was not revived. The granddaughter stated  that he had an enlarge prostate that was discovered during one of his hospital visits in the past 3 weeks.
Significant tongue pain, swelling, blistering and bleeding. Patient reports minimal swelling after dose #1. Significant swelling, bleeding, pain, erythema and open wound after dose #2; requiring 2 urgent care visits.
Day after covid booster; malaise; general feeling of being unwell; swelling and lump at injection site; headache; warmth; itching at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 05:30 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), administered in deltoid right, administration date 04Jan2022 (Batch/Lot number: unknown) as unk unk, single. Relevant medical history included: "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported.  Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "Day after covid booster"; MALAISE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "malaise"; MALAISE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "general feeling of being unwell"; VACCINATION SITE SWELLING (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "swelling and lump at injection site"; HEADACHE (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "headache"; FEELING HOT (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "warmth"; VACCINATION SITE PRURITUS (non-serious) with onset 05Jan2022 19:00, outcome "recovered", described as "itching at injection site". Therapeutic measures were not taken as a result of immunisation, malaise, malaise, vaccination site swelling, headache, feeling hot, vaccination site pruritus. The lot number for bnt162b2 was not provided and will be requested during follow up.
01/09/22 present to EC ED for "abdominal pressure and pain, nausea and vomiting". PMHx of "HCV currently on the transplant list"
Headache, muscle/body aches, chills, fever (101.4), injection site soreness.
Shortness of breath because of my heart issue; Lot of diarrhea; Severe stomach pain; Severe pain in my chest with heart racing; Little bit of pain in my chest, nothing like a couple of hours after I got the vaccine, it was very severe in my chest and heart racing; Severe pain in my chest with heart racing; Little bit of pain in my chest, nothing like a couple of hours after I got the vaccine, it was very severe in my chest and heart racing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose for Covid-19 immunization. Medical history included heart failure. The patient's concomitant medications were not reported. The patient took the first vaccine last week and due for the second one on 25Jun2021. On an unknown date, the patient had severe pain in chest with heart racing. The patient had a heart failure and a lot of other things that were issues with heart. The patient had severe stomach pain, a lot of diarrhea (reported as on Friday, Saturday, Sunday and Monday and a few days this week, just a few days). The patient stated it seems to be okay (reported as Today). On an unknown date, the patient experienced a little bit of pain in chest that the patient had normally but nothing like a couple of hours after the patient got the vaccine. It was reported that it was very severe in chest and like the heart racing and some, the patient also had shortness of breath because of heart issue but this was even more. The outcome of events severe pain in my chest with heart racing (chest pain and heartbeats increased) was recovering while unknown for rest of the events.  Information on the lot/batch number has been requested.
patient received moderna first shot and accidently received pfizer the second time. There was a language barrier and pt said they received pfizer and actually had pfizer paperwork so was given pfizer vaccine
Patient presented with increasing head pain followed by nausea approximately 15 minutes after receiving the vaccine.  Throat was itchy, progressed to difficulty swallowing an patient became dizzy.  Patient was placed on a stretcher.  Benadryl 50 mg PO was administered.  911 call placed.  Vitals: BP 139/89 HR 89 O2 Sat. 97%  Lungs CTA .  EMS arrived on scene 25 minutes after patient received vaccine.  Vitals were checked again.  Patient was placed in an upright position on the stretcher.  Itchy throat and light headedness persisted.  Patient chose to go to the hospital to be assessed.
SUSPECT CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female of unknown race end ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 21-SEP-2021) dose, 1 total, was not reported, administered at left arm on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, patient started to had a congestion. On 22-SEP-2021, patient lost her taste and smell senses and started to had a a cough (suspected covid-19 infection). On 23-SEP-2021 patient tried home test for Covid-19 and resulted positive for Covid-19 virus infection (suspect clinical vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspect clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210949899- COVID-19 VACCINE AD26.COV2.S-Suspected Clinical Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Started feeling achy and arm was sore initially but really began hurting redness swelling at site. On 5/10/11 unable to attend work due to severe muscle aches and fever 100.5. Today on 5/11/2011 swelling redness at site is 3 inches by 3 inches feeling better but still very achy fever this am 100.1.
Patient received Pfizer vaccine on 3/8/2021 and 4/5/2021. He then received a Moderna booster (0.25mL) on 12/6/2021. He also started Advair on 12/18/2021. On 12/22/2021, he went into atrial fibrillation (treated in the ER). He will be scheduling with a cardiologist for follow-up.
urinary burning, urgency and frequency in addition to robust fatigue, myalgia.  No ascending paralysis, numbness or paresthesias.  Weight loss of 8lbs over 9d, rash and myalgias w/ night sweats.
Injection site warm; Injection site is hard; Muscles are painful / muscle pain; my injection site is sore; nausea; Joints are painful / joint pain / Muscle & joint pain all over; Felt awful; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), FEELING ABNORMAL (Felt awful), PAIN IN EXTREMITY (arm pain), INJECTION SITE INDURATION (Injection site is hard) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Doxepine), Drug allergy (Zyrtec), Perfume sensitivity (perfumes), Chemical sensitivity (chemicals), Smoke sensitivity (smoke), Asthma (Asthma) since 2010, COPD (COPD), Diabetic (Diabetic) since September 2006 and Sleep apnea (Sleep Apnea) since 1997. Concomitant products included ATENOLOL, FLUOXETINE, SPIRONOLACTONE, HYDROCHLOROTHIAZIDE, SITAGLIPTIN PHOSPHATE (JANUVIA), OMEPRAZOLE, MELOXICAM, VITAMIN D3, METFORMIN, GABAPENTIN, TRAZODONE, ATORVASTATIN, MONTELUKAST, LISINOPRIL and FENOFIBRATE for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced FEELING ABNORMAL (Felt awful), PAIN IN EXTREMITY (arm pain), NAUSEA (nausea) and ARTHRALGIA (Joints are painful / joint pain / Muscle & joint pain all over). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm), INJECTION SITE INDURATION (Injection site is hard), MYALGIA (Muscles are painful / muscle pain) and VACCINATION SITE PAIN (my injection site is sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, q6h; IBUPROFEN at a dose of UNK, q6h and CEFIXIME (FLEXERIL [CEFIXIME]) at an unspecified dose and frequency. On 20-Jul-2021, FEELING ABNORMAL (Felt awful), PAIN IN EXTREMITY (arm pain), NAUSEA (nausea) and ARTHRALGIA (Joints are painful / joint pain / Muscle & joint pain all over) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site warm), INJECTION SITE INDURATION (Injection site is hard), MYALGIA (Muscles are painful / muscle pain) and VACCINATION SITE PAIN (my injection site is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Omega-3 1080mg and Ropinerole 1mg am & 3mg pm was reported as concomitant medication  Patient has allergy to aerosols and wild flowers.  Patient had muscle & joint pain all over, arm pain, nausea, felt awful.  Patient took Tylenol and ibuprofen every 6 hours as needed also, took Flexeril two different times to try to get some relief.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 contains no new information. On 01-Aug-2021: Follow up received included: added reporter details, patients demographics, medical history, Product start date and batch number, treatment drugs, concomitant medication and events
Information has been received from an MT concerning a 21 month old male with no known allergies, who had not received vaccinations at the recommended times and/or interval. The child is frequently sick at the scheduled times of vaccination. The 3rd Hib-Titer was given in 3/01, the 1st Hep-B (Engerix) was given at 16 months, the 4th DPT (Infanrix) was 2 months late and the 3rd poliovirus (IPOL) was 2 months late. The MT plans to administer the MMRII on 8/9/01, if the child keeps the appointment. Follow-up information from the MT noted that on 8/24/01, the child was vaccinated with the 1st dose of MMRII (lot 637834/0696L), 0.5ml, SC, in the left arm. Concomitant therapy that same day included a dose of varicella virus vaccine live, 0.5ml, SC, in the right arm (lot 638246/0494L), the 1st dose of HIB, 0.5ml IM, in the left vastus lateralis (lot 638434/1639K) (it was reported that the pt had previously had 3 doses of HIB and 2 doses of Hep-B), the 5th dose (also reported as 4th dose) DPT (Infanrix), 0.5ml, IM, in the vastus lateralis (lot DTPa505A2) and the 4th dose of poliovirus vaccine (IPOL), 0.5ml, IM, in the left vastus lateralis (lot T12732). The MT reported that the child was "a little fussy" the next day. The child's mother reported that the child was "a little fussy" but that it was nothing that she was concerned about. No further information is available.
After I got the third dose of my vaccine the places where I got the first two doses of the vaccine were tender. Three weeks after getting the third dose of the vaccine I started to have a sore throat that lasted for one day. I started to run a low-grade fever and I tested Negative. I tested Negative the next day on a home test. My temperature was never over 99.7. I tested positive on day six which was the day that I started to sneeze consistently. Those symptoms lasted two weeks. I still have a little lingering cough. It was an antigen test. I had nasal congestion, coughing and sneezing that persisted. I did not lose my sense of taste or smell.
Patient was instructed to sit in waiting area of pharmacy after administration of vaccine.  He started feeling dizzy within a few minutes after administration.  Patient was being monitored and motioned for assistance.  He looked pale and was sweating and stated he felt like fainting and vomitting.  EMS was called and patient's vitals were taken and appeared within normal range.  He was taken by paramedics for observation in the ambulance.  I am not sure if patient was taken to hospital or if he went home with a family member.
patient parent informed vaccinating staff that pt DOB was 1/23/2009 which would have made her 12 years old and eligible to receive Pfizer Covid-19 vaccine. upon reviewing Alert iis- pt DOB is 1/23/2010 pt was 11 when given the vaccine.
This case was reported by a nurse and described the occurrence of expired vaccine used in a 8-week-old female patient who received PEDIARIX (batch number AC21B370AA, expiry date 16th August 2014). On 19th November 2014, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Nurse reports an expired vaccine was accidentally administered to a patient. No AEs reported as a result of the administration.
34 y.o. female who arrived on-campus presented to the emergency department for increasing facial swelling, associated with tongue swelling and hives over lips and tongue that appered approximately 3-4 minutes after receiving the Moderna vaccine around 1406 hours today. Patient endorses being allergic to antibiotics, menthol, and several nuts, however, patient has not had any allergic reactions to other vaccines. She further denies any hx of anaphylaxis or need of intubation secondary to an allergic reaction. She also reports currently having a sinus infection that may be developing bronchitis which are unrelated to her current symptoms.    Patient is currently on Augmentin for sinus infection diagnosed 1/23/21. Reports she has been having sinus drainage and "bronchitis".   Patient monitored in ED and given dipehenhydramine, famotidine, methylprednisolone, and lorazepam  Discharged from ED in stable condition.  Initial Vital Signs [01/28/21 1422] Blood Pressure 182/87 Heart Rate 105 Respiratory Rate 18 Temp 36.9 °C (98.4 °F) Temp src Oral SpO2 98 %
pt recv vax 24JAN96 & 10APR97 pt devel fifteen spots/vesicles on top of body, some of which were fluid-filled;