chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A:Exp Vaccine Pfizer Given  lot # FL8094. was documentary by pharmacy wrong  B called family (By Dr) no advice evert occurred  Vaccine had been mislabeled with expiration date (differently at time of dose used from pharmacy) Inadvertently administrator an day after expiration date. Called the CDC,Pfizer,and the Family. Only advice effect would be needed to Re-Immunize pt. Family aware, will discuss. but unlikely to wish would re-immunize (due in part to pt anxiety around Vaccines  MD 10/9/22
After I got the vaccine, it began to hurt on the site of the shot worse than the second, and I went to the dentist a week after, during the appointment I was given something to numb my mouth and a day after I was extremely nauseous. As of now I am still nauseous, fatigued, body aches, hot flashes on and off.
pt states that her right arm felt like it was burning. She stated that her arm was red and hot to the touch and has been that way 'for a week' (reported reaction 5 days post injection)
PATIENT DROPPED BY THE PHARMACY FRIDAY AFTERNOON 4/27/18 TO SHOW PHARMACIST ON DUTY HER LEFT ARM. SHE HAD GOTTEN A SHINGRIX VACCINE ON 4/26/18. SHE STILL HAD THE BAND-AID ON. THE SITE SHE SHOWED WAS CONNECTING FROM THE INJECTION SITE AND WAS MEASURED WITH A MEASURING TAPE. IT WAS APPROX. 1 3/4 " X 3" OF REDNESS. ON 4/27/18 IT DID NOT FEEL HOT TO THE TOUCH. THE PATIENT SAID SHE HAD NOT RUN A FEVER AND THAT THE SITE WAS NOT ACTUALLY BOTHERING HER, BUT THAT IT LOOKED STRANGE. THE PHARMACIST ON DUTY ADVISED HER TO USE AN ICE PACK ON IT AND TO TAKE SOME BENADRYL. SHE WAS ALSO ADVISED TO WASH HER HANDS, THEN REMOVE THE BAND-AID AND WIPE THE INJECTION SITE WITH AN ALCOHOL PAD. SHE STATED SHE DID NOT TAKE BENADRYL FOR IT CAUSED HER TO HAVE RESTLESS LEGS. SHE DID HAVE SOME LORATADINE IN THE HOME AND SAID SHE WOULD TAKE IT INSTEAD. SHE WAS ADVISED THAT IF SHE STARTED HAVING A FEVER, NAUSEA OR NOT FEELING WELL OR IF THE SITE APPEARANCE GOT WORSE THAT SHE SHOULD GO BE SEEN BY A NP OR MD. SHE WAS CALLED BY THE RPH ON 4/27/18 PM TO CHECK TO SEE HOW SHE WAS DOING. SHE STATED THAT SHE FELT OK AND HAD BEEN USING THE ICE AND HAD TAKEN THE LORATADINE. SHE MENTIONED THAT HER HOUSEKEEPER HAD DRAWN ON HER ARM TO MARK THE BORDER OF THE SITE SO SHE COULD TELL IF IT HAD GROWN BIGGER IN THE FUTURE. SHE WAS CALLED AGAIN ON 4/28/18. SHE SAID THAT SHE FELT OK, STILL NO FEVER, BUT THAT THE SITE HAD GROWN BEYOND THE PEN MARKS. SHE WAS ADVISED TO GO TO THE CLINIC TO BE SEEN. SHE WENT THERE AND THEN LEFT TO GO TO CONVENIENT CARE (FOR THEY WOULD FILE HER INSURANCE). SHE WAS DIAGNOSED WITH CELLULITIS. SHE CAME TO OUR PHARMACY TO PICK UP AN ANTIBIOTIC RX AND SHOWED THE ON-DUTY RPH THE SITE. IT HAD GROWN TO A SIZE OF APPROX. 3 1/4" X 5 1/2". IT WAS RED AND FELT HOT TO THE TOUCH. SHE WAS ASKED WHEN SHE FIRST NOTICED THE REDNESS. SHE COULD NOT REMEMBER.
My son woke up with couple marks on temple an thighs an about ten days later 6-26-2016 we noticed full body rash head to toe covered red warm bumps itching everywhere , then woke up 06-27-2016 eyes swollen we called doctor scheduled appointment they weren't to concerned said it's normal after varicella vaccine sent us home with Zyrtec.
received her first COVID vaccine (Pfizer) on 4/21/21.  She became ill with COVID and was hospitalized.  She missed her scheduled 2nd dose of Pfizer.   At discharge, her provider told her she could get her 2nd dose  of COVID vaccine at her earliest convenience.  She called public health and was placed on a Moderna clinic day instead of pfizer day.   She received Moderna on 5/17/2021 for her second dose of COVID vaccine.
Post Second dose, my right arm is numb from elbow down to the proximal side of my hand. My pinky finger and ring finger are numb. Restless arm.  Pain is all the way up to my neck.
REDNESS TO BILATERAL UPPER EXTREMITIES (BUE), CHEST, AND MILD ITCHINESS.  PATIENT PLACED ON 30 MINUTE OBSERVATION POST VACCINATION,  VITALS TAKEN, AND ASSESSED FOR ADVERSE REACTION SUCH AS SOB, HIVES, ANGIO EDEMA, AND RESPIRATORY DISTRESS.   PATIENT WAS NOTED WITH REDNESS TO CHEST.  SHE DENIED ANY SOB, ORAL MUCOSA WAS MOIST PINK, WITH NO SOB, AND NO RESPIRATORY DISTRESS NOTED.
Intense muscular pain in arm. Inability to move arm at all due to pain. Inability to sleep due to pain. Lethargy.
Patient returned 1/24/12 to pharmacy with s/sx of irritation/itchy injection site and redness and swelling/inflammation to elbow. Pt. counseled to seek medical attention at urgent care. Pt diagnosed by urgent care w/allergic rxn. Pt prescribed cetirizine, ranitidine and cephalexin.
Headache, Sedation, Myalgia, Arthralgia, Fever, Redness/Itching @ injection site, Chills Narrative:  Other Relevant History:
Moderate local reaction to Dtap / FLULAVAL administered in the R thigh on 12/18. Patient presented 7 cm area of swelling, redness, 1 1/2 day (yesterday morning) after vaccine administration. At the time of the visit (2 days after the vaccination) the erythema and swelling were decreasing. Mom has been applying cold compresses.
Hip joint pain, began 18 hours after shot, lasted 24 hours Pain under arm pit (swollen lymph nodes), started 36 hours after shot
Pt. reports severe muscle and back pain 15-18 hrs after injection "can't stand up straight". Arm of injection painful from inj site to hand. Fever unknown. "Blood blisters" nostrils and back of hands all lasting 6 or more days.
Patient reported to ER 05 February 2020 with left-sided facial weakness, difficulty closing his eye, asymmetric smile and decreased sensation to the left side of his face.  Patient received vaccines on 05 February 2020
16yo male c/o tingling (whole body), numbness (arms/hands), and pain (extremities) for 1 week. Symptoms first started in feet then spread to entire body, but not in ascending order. No recent/current illness or fever. Patient had presumed COVID19 infection 7/2020 (based on symptoms, NO positive test). No head/spine injury. No rashes. No known insect bites/tick bites. No medications - currently taking Aleve for symptoms and not helping. Patient received MenB #2 IZ last Monday, 1 day prior to onset of symptoms.  Symptoms persisted from 1/19/21 until ~2/2/21, at which time there was spontaneous resolution without treatment.
Mild macular rash over face, trunk and extremities, onset 5/10/04. Low grade intermittent fever: not measured by mother; no treatment.
Dizziness and rapid hearbeat within 15 minutes of getting the shot. Symptoms persisted for 7 days after the shot.
Shingles; stomach issues/pain in his stomach; constipation; He has lost a lot of weight.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received bnt162b2 (BNT162B2, Lot number: ER9731 and Expiration date: unknown), via an unknown route of administration, in left arm on 18Apr2021 (at the age of 67-years-old) as first dose, single dose for covid-19 immunisation. The patient had no medical history was not reported. The patient concomitant medications were not reported. Patient had not received any other vaccine within 4 weeks. On 23Apr2021, a week later after first dose of vaccine he got shingles. He had been to his family doctor. He was on medication for it at the time of reporting. On an unknown date in Apr2021, he lost a lot of weight. He was going for an ultrasound and they saw his side. They hold him that the ultrasound could not be done because that was shingles. He was getting the ultrasound because he was having stomach issues which started after the vaccine. He was having constipation and pain in his stomach that started on 21Apr2021 or 22Apr2021 (Wednesday or Thursday as reported). That part was getting better. He was put on Valacyclovir, 1 tablet a day for 10 days. He has three more prescriptions. They are all Prednisone. He was on tapered dose. He took on the first day, then drops down to a smaller dose after three days and then drops to an even smaller dose. Patient went to physician office. Therapeutic measures were taken as a result of shingles (herpes zoster), stomach issues/pain in his stomach (abdominal pain upper). Outcome of events constipation and weight loss was unknown while outcome of event abdominal pain upper was recovering and for event herpes zoster was not recovered.  No follow-up attempts are needed. No further information is expected.
Pulmonary embolism; specified as a Saddle pulmonary embolism,  after second vaccine; This is a spontaneous report from a contactable Nurse via Pfizer-sponsored program (patient reported for self). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 13May2021 (at the age of 63-years-old), as dose 2, single for COVID-19 immunisation. Medical history was reported as none. The concomitant medications were not reported. Patient had earlier received first dose of BNT162B2(Lot: ER, Reporter states it looks like 8731, handwritten on card), via unspecified route administered on left arm on 22Apr2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. The patient experienced pulmonary embolism, specified as a saddle pulmonary embolism in both lungs, after second vaccine on 09Oct2021. States she got the vaccine because it was work related. Reports that the doctors do seem to think that it was from the vaccine. She got out of the hospital on 13Oct2021, and is now on the medication Eliquis, for therapy. Seriousness was reported as hospitalization and life threatening. Outcome of events were resolved on 13Oct2021.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event saddle pulmonary embolism cannot be completely excluded.The case will be reassessed if additional information becomes 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.
Erythema and significant edema to the Right Deltoid area extending to the Right elbow associated with pain - large local reaction.
Pt recv vax on 2/10/98; on 2/11/98 pt exp arm swelling/itching/red vax site; tx=Keflex, Benadryl, hydrocortisone cream
1 week later I have a red, swollen, itchy rash in the area I got the shot.
Fever and chills, severe body aches and pain, loopy/dizzy, confused, swollen and red injection site, tired, confused, chest pains, headache.
Extreme body heat even while shivering. body turning red, face remains red, sunburned look, 48 hours later. No treatment beyond ibuprofen 24 hours after inoculation.
Sick to stomach. No vomiting. Migraine headache. Pt stated she gets these all the time. Had pt lie on floor with feet up. Cold pad to face/neck. Ice pop, crackers and water given when sitting up after nausea. Said she then felt better except migraine. Assisted to car and buckled in. C/o migraine still. To do as Dr. orders.
Fever 101-105 w/in 24hrs of receiving immunizations - fever above 101 for 5 days unconsolable crying, pain, diarrhea, about 5 days.  9/14/09 Received hospital medical records for 6/8/09 to 6/9/09. FINAL DX: febrile illness, viral vs vaccination related; altered mental status Records reveal patient experienced high fever x 4 days, loose stools x 1 day, irritability.  Seen in ER over weekend & received IM antibiotic.  Tx w/IVF, continued IV antibiotic.  ID consult done.  Transferred per parental request.  DTaP held at 4mo but patient developed unconsolable screaming/crying after other 4 mo vax.  Referred to Immunology Clinic. ICD9 Codes: 78060; 78097.  10/1/09 Hospital records received DOS 6/8/09 to 6/9/09. Assessment: Fever, Noninfectious Gastroenteritis/Colitis.  Patient presents with 2-3 day hx of fever, irritability, diarrhea, and intermittant vomiting. Decreased po. Temp 104.2, heart rate 200+/min. Rash.  ICD-9 Codes: 78060 Fever unspecified, 5589 Noninfectious Gastroenteritis/Colitis.
injection site reaction ( large, about 4 inch long red oblong rash, minor itch)
Arm (left) swelled up like size of a large egg. Area was very red and warm. Bruising, limpness in arm for two days 5-16-07 and 5-17-07 and severe pain.
Swelling of limbs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of limbs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of limbs). At the time of the report, PERIPHERAL SWELLING (Swelling of limbs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
Breakthrough case admission after two vaccines ; Moderna 1/15/21 lot# 027L20A; Moderna 2/15/21 lot# 032H20A
Pain in arm within an hour, swelling in arm within 3-6 hours; pain and swelling started to subside within 36 hours; rash at injection site developed between 36 and 48 hours of injection.  Sudden onset of intense chills/shivering and loss of appetite 12 hours after injection; fever symptoms started to subside after 12 hours of onset.
Contracted employee vaccinated with influenza vaccine per policy. Patient reported not feeling well and dehydration to employee health on 10/17/16. Stated started developing flu symptoms later in the week of 10/10/16. I instructed to report to her employer. Also, stated she was dehydrated and encouraged to go to ER immediately for evaluation on 10/17/16. Since not our employee we do not have access to medical records because of HIPPA. My understanding is there was discussion on whether this was related to her flu shot. She was admitted to hospital and then I believe transferred to another hospital. Records would need to be obtained through those facilities. We felt we should report it to VAERS to determine or in case there are other similar occurrences so that they can be tracked.
within minutes of taking the shot i felt my heart begin to race but soon subsided.  that evening begin to experience vertigo which last 4 days. On Sunday, May 9, 2021, experiencing high blood pressure, began slurring my speech.  This lasted roughly 4 hours.
fizer COVID vaccine with beyond use date (BUD) of 10/30/21 16:31 was erroneously dispensed for a patient. This was picked up from  pharmacy and brought to bedside for administration. RN administered at 17:30, an hour after 6 hour BUD assigned (7 hours after product drawn up). Confirmed that product was drawn up in ISO 5 environment and stored in fridge until dispense. Per Pfizer document with internal data, likely maintained potency. Repeat dose not given.
Woken up at approximately 3 am with what I can only describe as a back spasm down my entire spine, with what seemed like shoulder blades pulled back.   It did not go away by sitting up or standing.  As I was awake, I went to the bathroom, bringing my phone in case I felt I needed to call 911 while there.  I took an full 325 mg aspirin, and went back to bed, as the aspirin immediately got rid of the spasm/pain.  It could have been due to my recent increase in activity - steps/miles walked (from 1 to up to 4 miles/day).  I have not experienced any subsequent discomforts.  If I had, I would schedule a visit with my primary physician.  I am reporting now as the Nurse who administered my second vaccine shot said I should even though I felt it was not vaccine related. It could be  vaccine related, but it could also be just due to increased activity level. I signed up for v-safe after the incident and didn't attempt to figure out how to report a past event until today, the day after my second vaccine shot.
Severe pain in arm of injection.  Fatigue.  Headache. Vomiting.
RASH ALL OVER THE BODY; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (RASH ALL OVER THE BODY) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 RASH (RASH ALL OVER THE BODY). At the time of the report, RASH (RASH ALL OVER THE BODY) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment information provided no concomitent medication provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: no new information
Dizziness, fever, nausea, pain at injection site, inguinal lymph node swelling, chills, generalized weakness  Took 2 acetaminophen 500mg, but to no relief, symptoms passed on their own.
Patient is coming in with fever to 39 and chest pain that started about 4 hours after getting her third Covid vaccine.  The pain is retrosternal does not worsen with laying down and positioning is not significantly worse with deep inspiratory effort.  She has no significant cough or respiratory symptoms describe the pain as 7 or 8 out of 10 with worsening and progression.  No abdominal pain no nausea vomiting rash no joint pain.  She called cardiology who advised that she seeks medical attention Medical Decision Making   Troponin wnl. ESR normal, CRo mildly elevated, CXR near baseline  IV fluids and toradol given  cardiology consulted  pt safe for d/c to outpt care. further signs and symptoms may decalre themselves and require an additional assessment  Final Diagnosis  1. Fever R50.9 2. Chest pain R07.9 3. Tetralogy of Fallot Q21.3 4. Cardiac pacemaker in situ Z95.0
I had off and on body aches and a pretty severe headache for three days but no fever but nausea.
C/O tingling of head, lips, extremities, flushing of face, and ears. Rash on back and arms. Itching all over body and nose. EPI-PEN administered (L) thigh at 1432 - BP 160/90 Pulse 121 Resp. 25.
Shingles outbreak.   Burning, tingling sensation began on Saturday (2/27) evening. That sensation became painful and sensitive the following day (2/28). On Monday (3/1), small blisters began forming. On Tuesday (3/2) dermatomes appeared.   Location of dermatomes: Left side trunk. Mostly on the back with a few spots on the front.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-1.11 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 9 years old female patient who was vaccinated with a dose of IPOL, ADACEL and 0.5 ml dose of QUADRACEL (expiry date 17-Jul-2020 lot number C5497AA) instead of PROQUAD (route and site of administration was not reported), On 01-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE and INFLUENZA VACCINE. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was unknown whether patient experienced any adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
metallic taste in his mouth; soreness in [his] arm /the injection site was a little sore as; rash on his chest and down [his] arms a little bit; headaches; fever; This is a spontaneous report from a contactable consumer. This (Age: 59; Unit: Unknown) male consumer (patient) reported.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included flu vaccine. It was reported that the patient stated that after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine on 08Feb2021 (last Monday), the patient stated an hour after the shot, that the patient had a metallic taste in [his] mouth that lasted between 1-2 hours on 08Feb2021. The patient added he also had soreness in [his] arm on 08Feb2021. The patient specified nine days after the vaccination, the patient developed a rash on his chest and down [his] arms a little bit on an unspecified date in Feb2021. The patient also experienced headaches and a fever on an unspecified date in Feb2021. The patient explained that the headaches lasted for three days, and now it was a dull headache. The patient specified the fever started on the Wednesday night and lasted all the way through last night. The patient mentioned he checked his temperature that day and it was normal. The patient asked these were the side effects of the vaccine. The patient underwent lab tests and procedures which included body temperature: normal on 19Feb2021 (he checked his temperature today). Outcome of the events metallic taste in his mouth and soreness in [his] arm /the injection site was a little sore as, was reported as Recovered on an unspecified date, Outcome of the event rash on his chest and down [his] arms a little bit, fever was reported as recovering and outcome of the event headache was reported as not recovered at this time of the report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
First dose: mild headache for two days Second dose: severe pressure in head, leading to headache dizziness and confusion. Approx. 10 days after 2nd dose, pt experienced significant mental deterioration, mostly in the form of severe depression and anxiety. Crippling depression made working difficult to impossible. Mental confusion accompanied the deterioration. Pt experienced bouts of weakness and emotional breakdown that affected his work environment and home life.  Pt was put on probation at work and was eventually fired for inability to perform job to satisfaction.
Rash (widespread, red, blanching, maculopapular). No other symptoms. No specific treatment. Consistent with possible VARIVAX rash.
tired, fell asleep @ work, drained, exhausted, cold like sx, h/a, sore throat, lymph nodes, swollen 24hr post vax;