chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got a shingles shot at Pharmacy about 11:45 AM  I have never had a reaction to a vaccine before this.  I got a large red welt about 3 inches by 4 inches at injection site, flushing, rapid heart beat, throat closing up, burning sensation in lungs, trouble breathing, upset stomach, headache, dizzy, amd diarrhea.  I have previously gone into anaphylaxtic shock with MSG in food.  I checked with my doctor before getting the vaccine and he recommended it.  I read the literature that was available from pharmacy & the CDC before taking the injection.  Neither of them mentioned MSG in the vaccine or anything else I know I am allergic to.  I told the pharmacist what my allergies are before taking the injection.  I got a delayed reaction.  I thought I was having an allergic reaction and asthma attack so I immediately took an antihistamine and put hydrocortisone cream on the welt.  I reread the literature I was given without finding anything.  I went online and found the FDA sheet that indicated that monosodium glutamate was in the inactive ingredients in the vaccine.  I called the pharmacist when the pharmacy reopened this morning.  She recommended reporting the reaction to you.  Neither the doctor, pharmacist or myself were aware that MSG was in the inactive ingredients before I took the injection. MSG is know to cause serious reactions in many people.  Why is it necessary to include this in a vaccine?  If it is in the vaccine, could you at least list it in the CDC literature so people like me know beforehand not to take the vaccine?  It took me about an hour online to find the inactive ingredients.  Can you make all of the ingredients more easily findable for the patients and doctors? I had a bad allergic reaction for about 24 hours.  The allergic reaction and welt are gradually going away slowly after 72 hours.
Itching hives , sever rash all over , anxiety  cough and chest congestion fever , bone ache
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, 1 day after receiving DTaP vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller declined identifiers and stated she didn't know specifics. The caller stated that she will report to VAERS, because she was not sure what product she received. The caller stated that she did report to her physician but he refused to report. The caller wanted to know length of time adverse event would be expected to last.  No information in the PI related to time of resolve. Referred to health care professional, then questions related to legally required to provide if the information is known by medical information. So the caller asked question if these questions were related to her or someone else and that was when she reported the adverse event.
"Casirivimab (part of Regeneron mAbs) under Emergency Use Authorization (EUA)" On 12-30-2020 at 17:01, Dr. was notified by medical personnel that 42 people who went to the vaccination site for those 80 years and above, inadvertently received 0.5 mL Regeneron antibody instead of Moderna vaccine by the nurse vaccinator. During the call, determined that it was the REGN10933 component which is casirivimab 300 mg/2.5 single-dose vials were in a box instead of Moderna vaccine. Mistake was noticed when the pharmacist vaccinators at three other vaccination locations that evening called the center to report they received incorrect vials. Upon notification, alerts went to other sites receiving vaccine and the error was identified. At the original storage site, vials of casirivimab and vials of Moderna vaccine were stored side by side in the refrigerator as both require refrigeration. It should be notified that the box of casirivimab was shipped separately from the rest of the Regenerol mAbs product without notification; therefore, arrival of this box was not anticipated. When the people came to pick up the vaccine, vials of both drugs were taken for re-distribution to vaccination site locations. It should be noted that the shipping boxes used for both drugs are identical on the outside; the packing list inside the box identifies box contents. The boxes for the vaccine inside the shipping boxes are marked. The labels for both of the Regeneron mAbs drugs (casirivimab and imdevirmab) are poorly label for identification having letters and numbers instead of the drug name on the vials: vials do say 2.5 mL. The Moderna vial does not list total volume of contents but rather (10 doses of 0.5 mL per dose). Both drug vials have a red top.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients was vaccinated with improperly stored PNEUMOVAX 23 (lot # K020215, expiration date reported as 15-MAY-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 53.2 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Large area of redness 10/25cm, warm to touch, no fever, started Claritin-Augmentin ES 600
Tested COVID positive 8/14/22 even  after receiving 2 vaccines and one booster. Was already in the hospital.
2FEB92 devel painful joints specifically ankles & wrists; ankles swollen; 7FEB92 wrists continue to be painful but not swollen; feet & ankles swollen & painful; Pt spoke w/MD in hosp hallway where pt prescribed Naprosyn & DPH;
Soreness and hurt her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness and hurt her arm) in a female patient of an unknown age 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 PAIN IN EXTREMITY (Soreness and hurt her arm). At the time of the report, PAIN IN EXTREMITY (Soreness and hurt her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported.
Within a few days of having the second shot Patient said that she could not hear out of her left ear. The Dr said that she had fluid in her ear. Patient is also having nasal congestion. Patient also stated that when she lays down she gets dizzy and she can hear whistling in her ear.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-JUL-2011, the patient was administered with a dose of VARIVAX (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Patient received pneumovax and influenza vaccine on 10-10-08.  Woke with fever, bodyaches, chills, swelling in L upper extremity on 10-11-08.  Developed cellulitis in L upper extremity.  10/31/08 Reviewed hospital medical records of 10/13-10/17/2008. FINAL DX: pneumonia, LUE injection site cellulitis Records reveal patient experienced fever, malaise, chills, fatigue, weakness, HA, reduced oral intake, left injection site cellulitis, pain, redness & warmth.  Tx w/IV antibiotics, improved & d/c to home on continued oral antibiotics & pain meds.
Patient received the Pfizer vaccine on 3/13/21 and 4/03/21.
Next day after shot-I have herpes and my mouth, tongue and genitals were broke out with blisters the worse I have ever had and bad cramps-still having the cramps that go with it a week later.  Worried about having the 2nd shot-my husband passed a yr. ago and I am alone.
83 yo F presents to the ER on 1/30/21 with complaints of worsening SOB and weakness. She was diagnosed with COVID-19 in 1/22/21, 7 days after receiving the first dose of COVID-19 vaccine. She had a fall on 1/25/21 and was evaluated in the ER, where she was placed on steroids and oxygen at home. She was admitted on 1/30/21 for hypoxia, generalized weakness, and A-Fib with RVR. Patient required oxygen supplementation and was treated with IV dexamethasone and inhaled budesonide. She also received treatment for afib/RVR with improvement upon treatment. Patient was discharged on 2/1/21 with recommendations to transfer to skilled nursing facility.
18MAR92 @ 4PM, mom noticed rash on abd p/a nap, brought her to clinic @ 430PM had macular rash on abd & upper thighs, referred to MD; On 19MAR92 mom brought pt back to clinic PMD visit pt had welts;
The first dose just resulted in soreness at the injection site. Twelve hours after the second dose, I reacted with a high fever, chills, headache, body ache, fatigue, etc. Those symptoms went away after 24 hours. Then on April 1st, I woke up from a sound sleep with chest tightness, pressure, and discomfort. After many tests, doctors diagnosed me with SCAD.
Patient has mild swelling and erythema of L arm aroung injection site.  No treamtment rendered, to follow up with PMD in 2-3 days, or return to Emergency room for increaed pain or fever.
Systemic: Fainting / Unresponsive-Severe, Additional Details: The patient received their vaccine today, and 5 minutes later while seated in the designated area, patient fainted and hit her head very hard on the floor.  I immediately ran to the patient, which I was administering another Covid vaccine to another patient, and check on her well being.  She was unresponsive at first for about 10 seconds.  Customers said she was shaking or convulsing.  911 was called immediately and the ambulance was on site in less than 5 minutes
Case previously recorded as MA2009-3638. Initial case report received from a physician via Vaccine Adverse Event Reporting System (VAERS), on 06 NOV 2009. A 70-year-old female patient was vaccinated with FLUVIRIN (batch no. 89684) into the left arm on 10 OCT 2008. She also received PNEUMOVAX 23 (batch no. 660685/0519X) 0.5 ml into the left arm on 04 NOV 2008. The physician reported that on 06 NOV 2008 the patient was seen at the physician's office because she had redness, swelling and pain in her left upper arm for two days. The patient had no fever or itching, her temperature was 98. The patient's left arm had erythema. Swelling warmthness, tenderness from mid deltoid to the elbow and there were tender left axillary nodes. The physician's impression was cellulitis and the patient was given ROCEPHIN i.m. into the office and was prescribed oral antibiotics (unspecified). The physician reported that the patient did not take the oral antibiotics, but instead she went to another physician who admitted her to the hospital for left arm cellulitis on 07 NOV 2008. A chest X-ray on her left arm was performed with no findings. Laboratory blood test results were normal with one exception: anion gap 16(normal range 5-14). The physician suggested correiation. Concomitant medication: Aspirin (acetylsalicylic acid), Caduet, Ambien, Alendronate sodium (MSD). The amount of data is insufficient to finally assess the causality. Unclear, if infectious case: most likely local reaction to vaccination with pneumococcal vaccine. . The physician suggested correlation. Addendum: On 13 NOV 2009 we received from Novartis Vaccines and Diagnostics the following further information: A batch review was performed. The batch review could not conclude the reason for the reported adverse reaction based on the data available. This batch was manufactured for the 2008/2009 campaign and dependent on the date of administration could have been expired. Follow up report received on 26 Apr 2010: Two requests for follow-up information were sent but no reply had been received. Hence the case was closed due to the lack of response.
States vision got blurry this morning and sees nothing out of left eye. Also swelling right side of face.
I got both my shingles shots / I've had horrible pain in my arm / My arm hasn't been the same since; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date,refer case US2021AMR140487).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine and experienced horrible pain in arm. The reporter stated that wish he/she would have never taken the shot and stated that his/her arm was not been the same since. This case was linked with US2021AMR140487, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR140487:same reporter
fever or 104F; This case was reported by a physician via call center representative and described the occurrence of fever in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever of 104 fahrenheit after the first dose of Shingrix that lasted 24 hours. The reporter did not consent to folllow up.      Lab Comments: On an unknown date, the lab test was performed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old patient received BNT162b2 (BNT162B2), on 12Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. 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.
patient states immediate excruciating pain with injection.  4 hours later unable to move arm. No redness or soreness noted.  1 week later, reports excruciating pain to move arm up  or side to side.
Scratchy throat (came and went quickly but was severe), aches and pains, fatigue, headache (severe) and I took pain medication for it. I took PAXLOVID for the 5 days. My wife got COVID-19 3 days ahead of me.
Information has been received from a registered nurse concerning an 18 month old female who on 22-JUL-2009 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck) (lot # 660665/0491Y), subcutaneously into the left arm.  The mother called the physician office on 18-AUG-2009 stating that her daughter started fever on 12-AUG-2009 that lasted 2 or 3 days, and on 18-AUG-2009 the patient had chickenpox on her stomach.  The patient was treated with oral BENADRYL.  No laboratories studies performed.  The patient was recovering.  Follow up information received on 16-SEP-2009 from registered nurse indicated that the patient had a medical history of murmur apical, umbilical hernia and food allergies.  The patient did not have any illness at the time of vaccination.  On 22-JUL-2009 at 11:40 the patient was vaccinated with a first dose of VARIVAX (Merck) (lot # 66435/0642Y, previously reported as (660665/0491Y), subcutaneously into the left deltoid.  It was also reported by the patient's father that on 12-AUG-2009 his daughter started with 2 or 3 days of fever-she was very crabby during the fever- they took her to a walk in clinic yesterday to have her ears checked but she did not have the rash yet and nothing was found wrong.  According to the father, she had chickenpox all over her abdomen, several bumps are vesicles and she was starting to itch-this happened all within the last hour- they were starting to itch-she was actually acting a little happier today.  Advised BENADRYL 3/4 tsp every 4-6 hours as needed.  The patient did not require an office visit, and no follow up needed unless concerning symptoms.  The patient recovered on 20-AUG-2009.  No further information is available.
Patient states about one hour after being given the flu vaccine developed shortness of breath, increased heart rate, burning joints, and chest pain.  Saw her PCP 10/22/21 and instructed that it was a vaccine reaction and I was notified.  States symptoms resolved except the burning joints.
Case number PHEH2015US026919, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 23-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 24 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse event was reported following this medication errors. Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
DAY AFTER COVID VACCINE, SEVERE RIGHT WRIST PAIN; PROGRESSED TO RED ITCHY SCALY SCALP; DIARRHEA; RASH TO NOSE, CHEEKS, CHEST; PROGRESSED TO SEVERY MUSCLE PAIN TO B/L ARMS/SHOULDERS/BACK; DIFFICULTY SWALLOWING, CHEWING AND LOSS OF 30 POUNDS. MUSCLE PAIN/WEAKNESS TO LEGS/FEET; UNABLE TO DO MOST ADL'S;EXTREMELY  DIFFICULT TO WORK AND SHOWER/DRESS. STARTED IVIG OCTAGAM AND MYCOPHENILATE 500MG 3 TABS TWICE DAILY.
Patient was administered a 2nd dose of anthrax due to technician seeing date vaccine was administered (5/21/2020) was the current day of the other vaccines she was suppose to administer (5/21/2020). When verifying what vaccines were to be given she stated 3 vaccines Dated 5/21/2020, however anthrax was administered at another facility that morning.
This was my second COVID dose, it felt completely different from the first one, which was given at a different pharmacy.  When it was being injected, it felt like the vaccine was pooling in my arm and the injection took much longer than the first one.  My arm felt heavy within 30 minutes of getting the vaccine.  About two hours later, I could not lift my arm more than 10% without terrible pain.  I could not sleep even taking Advil.  After three days, the intensity lessened some, but I still cannot lift my arm certain ways without a lot of pain and it is keeping me awake as it just aches.  I cannot lay on that side either, as the pain becomes intolerable.
Radiating injection site pain to back, neck, chest.  Itching, pain, swelling at site. Itching radiates up neck.  Feeling faint Palpitations  Feeling like blood pressure is extremely low. (Same as in morning from prazosin before hydrating) Neuropathy symptoms   ***** I have peripheral neuropathy in legs *****
Patient received flu shot for 1st time. Answered no to all screening questions. 10 minutes after vaccine, she was itching on face, legs, arms and chest. Redness on left eyebrow, chin and chest. Stated no respiratory symptoms. She was given 2 tabs (4mg each) of chlorpheniramine.
On 02/07/2020 generalized red itchy rash started on forearms, by 02/08/2020 patient woke to hives all over body except face, by 02/09/2020 hive came and went despite over the counter Benadryl use.  02/10/2020 all rash is resolved.
Patient came in to say he had "stroke like" symptoms 2-4 days after getting shot. Had neuralgia- spent a few days in hospital but Dr. found no problems. 10/28/09 Medical records received for DOS 9/29/09 . Final DX: Transient Ischemic Attack.  ED visit. C/O dizziness, blurry vision, slurred speech upon waking in am. Hand weakness x 2 days. Tingling bilat. L hand pain, edema x2 days. Dizziness and blurry vision resolved 1 hr after drinking orange juice. PE revealed R arm clumsiness, moderate grip R hand, weakness UE bil,  some sensory loss to superficial pain. Mild slurred speech.  DTRs normal. Slight unsteady Romberg. Redness, swelling L 3rd MCP. Edema bil hands. R hip/groin pain. Reflexes 2/4 biceps, triceps, patellae, Achilles.
a patient who was 9 weeks pregnant received Flublok Quadrivalent pre-filled syringe; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 26 years old female patient who was exposed to vaccine influenza quadrivalent recombinant vaccine [Flublok QIV]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported a patient who was 9 weeks pregnant received Flublok Quadrivalent pre-filled syringe occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had previous pregnancy was unknown.   On 25-Oct-2019, the patient received a dose influenza quadrivalent recombinant vaccine (Lot: QFAA1934 and Expiry date: 30-Jun-2020) via unknown route in the left deltoid.  On an unknown date (latency: unknown), after the administration of influenza quadrivalent recombinant vaccine therapy, it was reported that the patient did know she was pregnant at the time. Patient received no other vaccines concomitantly. Reporter stated that, as far as she was aware, the patient had experienced no adverse symptoms.  It was not reported if the patient received any corrective treatment.  Event outcome was not applicable.  No further relevant information was reported.
See description of events. Patient fainted, came to immediately, vomited, 911 called and dispatched stated was most likely anxiety attack and advised patient to be checked out at hospital. Patient taken to the Medical Center