chrisvoncsefalvay/vaers-outcomes huggingface dataset:
REALLY COLD; SHIVERING; NUMBNESS IN THE INJECTED ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and  expiry: unknown) dose was not reported,1 total administered on 08-APR-2021 14:40 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 about two hours after vaccination, the patient had numbness in the injected arm. She took two paracetamol (Tylenol) to treat numbness and went to bed. The patient woke up at around 23:30 and she was really cold and put on as much blankets since she was shivering. The patient's arm was still numb; the coldness and shivering are not quite as bad. On an unspecified date, the patient died from shivering. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really cold, and shivering, and had not recovered from numbness in the injected arm. This report was non-serious
Information has been received from a 63 year old female who in October 2007, was vaccinated with PNEUMOVAX 23 (lot # not provided) 0.5ml. On 14-Oct-2008, the patient received the second dose of PNEUMOVAX 23 (lot # not provided) 0.5ml. The patient had no drug allergy. Concomitant therapy included influenza virus vaccine (unspecified), ALTACE, simvastatin (MSD) and PROTONIX. Several hours after receiving the second dose, the patient developed a lump the size of a baseball at injection site. The patient visited doctor and was given BENADRYL. Swelling was reduced in size. The patient stated she did not experience any events after first dose. At the time of the report, on 15-OCT-2008, the patient was recovering from the lump at injection site. Additional information is not expected.
Around midnight after my 2nd dose I had fever, fatigued, and congestion that lasted 24hrs.
Patient received the vaccine at approximately 10am on 6/21/21. Shortly after receiving the vaccine, he complained of a headache and arm pain. Patient was told to remain seated and was monitored by pharmacist and staff. After 20 minutes, he was still not feeling well. He was moved into a different observation area. Based on symptoms it appeared he was having a a vasovagal reaction. He did not want to lie down and elevate his feet. At approximately 1/2 hour, he became nauseous and threw up. We continued to monitor him. He still had a headache and said he felt off. He had no swelling in the face and was speaking without issue. No hives were noticed. Patient said he was having a hard time breathing- I suggested he remove his mask to get more fresh air. After removing the mask, he said it felt better to breathe. In total, patient was monitored for 3 hours. He did not lose conscience, exhibit facial swelling or hives.  Patient went back to work for 1 hour then left to go home.  Prior to receiving the shot, patient showed a lot of anxiety and was hesitant to get vaccine. In the end, he decided he wanted to get it. Per medical staff at his work, he does tend to be high stressed and anxious. I followed up with patient on 6/22/21. He stated that he was feeling a lot better. He did have redness at the injection site- I explained he could ice the area. He still had a headache= I instructed him he could take a pain reliever. He mentioned he had a purple spot on his back. I asked if he had any other spots and said he would have to check. I suggested he contact his PCP and make an appointment to be seen.
extreme lightheaded began approximately 2/28/21.  tingling in left ear at bedtime, feel like my ears are stuffed as well as my head feeling that way, unsure is I should receive the second shot
Approximately one minute after vaccines, patient was walking to checkout, felt like "every thing was black", then had brief syncopal event, followed by feeling shaky, sweating, nauseous with sitting up for a few hours following. BP, pulse, pulse ox all normal.
getting hot flashes; Aches in lower back/pain in lower back; Pain in back of legs; headache everyday; Had a fall; Hurt elbow; Pounding in ears; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (getting hot flashes), BACK PAIN (Aches in lower back/pain in lower back), TINNITUS (Pounding in ears), PAIN IN EXTREMITY (Pain in back of legs) and FALL (Had a fall) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M0A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchitis (January 2021). Concurrent medical conditions included Arthritis and Diabetes (2020). Concomitant products included GLIMEPIRIDE and METFORMIN for Diabetes, VITAMIN B12 NOS, MULTIVITAMIN FOR WOMEN and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced FALL (Had a fall) and JOINT INJURY (Hurt elbow). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HOT FLUSH (getting hot flashes), BACK PAIN (Aches in lower back/pain in lower back), TINNITUS (Pounding in ears), PAIN IN EXTREMITY (Pain in back of legs) and HEADACHE (headache everyday). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (getting hot flashes) and BACK PAIN (Aches in lower back/pain in lower back) had not resolved, TINNITUS (Pounding in ears) and HEADACHE (headache everyday) had resolved and PAIN IN EXTREMITY (Pain in back of legs), FALL (Had a fall) and JOINT INJURY (Hurt elbow) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: follow up was received on 18 may 2021 patient demographics, date of the events, other events ,events outcome, concomitant medication was updated.
Developed giant macular rashes on both upper limbs associated with itchiness, no fever, no difficult with breathing.
102 degree temp shakes chills body aches - severe  naproxen ceterizine acetaminophen
Ringing in the Ears, Nausea and Vertigo. Antibiotics 2 rounds, Steroid injection and zpack
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp.  This case is for 2nd patient of 37 patients. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318) as dose 2, single and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686) as dose 1, single both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Mar2021, the caller that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. The patient underwent lab tests and procedures which included NAAT Covid test positive on 14Mar2021. Outcome of events was unknown.   Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/AE, different patiens
I had a fever, chills, headache, muscle tightness, and nausea that started almost exactly 12 hours after my injection. That lasted about 5 hours, but the headache and muscle tightness has persisted all week. I have tried aspirin, naproxen, and 500 mg ibuprofen, but nothing has helped. I am a week out and still having a headache
On January 05, 2023, pt. came into our clinic for a 4 month well child check. At the time, she was due for DTap, Polio, and HIB.  During the time we were prepping the vaccine, I was unaware that we had to mix the DTaP-IPV vial with the HIB conjugate. We then  left the HIB portion of the vaccine out and just administered the DTaP-IPV to the patient.
12 hrs after vaccine pt reports sudden onset body aches and chills that lasted approx 8 hrs, by 11/6/14 - pt reports he was completely WNL.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, PERCOCET and MEDROL for management of her painful symptoms and excruciating pain. On or about 25-AUG-2016, the patient sought subsequent treatment for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Severe head pain, sinus infection, throbbing of the injection site, and arm pit throbbing and pain.
Information has been received from a LPN concerning her mother-in-law who in 2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed swelling of her injection site (not reported). No medical attention was sought. Subsequently, the pt recovered. No further information is available.
This spontaneous report has been received from a medical assistant referring to a 1 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 30-APR-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # N025931 with expiration date of 19-SEP-2018 (strength, dose, route, and anatomical location were not provided) for prophylaxis, which was reconstituted with MERCK STERILE DILUENT. No adverse events were reported. The vaccine was exposed to a temperature excursion between -14 °C to -10°C (-11.5°C), during a time frame of 25 minutes which was called because of a data logger. No previous temperature excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1805USA000930.
This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number Y79A5, expiry date unknown) for prophylaxis. On 19th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. On 19th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced shortness of breath, increased blood pressure, hives and headache. On an unknown date, the outcome of the shortness of breath, increased blood pressure, hives and headache were unknown. It was unknown if the reporter considered the shortness of breath, increased blood pressure, hives and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced some side effects like shortness of breath, headache, elevated blood pressure and hives. This is 1 of the 12 linked cases, reported by the same reporter.
1 day after vaccination, developed small patchy red area around site of injection, slightly warm to touch. Had 2-3 days of fatigue, body aches, arm soreness. Redness around site seemed to be fading/improving as time went by but redness did not fully go away. 13 days after vaccination (today), overnight the area became a large (4-5 cm at widest point) oval with well-defined red border, and lighter pink in middle. Warm to touch. No itching, pain or tenderness.  After being seen (today) was prescribed Cephalexin 500mg 3 times a day and advise to take Benadryl 2 times a day.
pt recv vax 21APR98 & 23APR98 pt exp soreness in arm & swollen lymph nodes under arm as well as hot, red, tender palm size area rt deltoid w/streaking into rt axilla & tender lymphadenopathy;
I just went for my 2nd vaccine on Wednesday.  The nurse said that I should submit a report that my arm is still hurting a month later.  I received the Moderna vaccine in my left arm and it hurts when I attempt to put on a sweater or a coat or reach backwards.  It does not hurt otherwise, but there is pain when I move it as described.  I now know this is a distinct aberration since I had my second Moderna vaccine in my right arm on Wednesday and already I barely feel soreness,  The first nurse squeezed the arm and inserted the needle.  The second (different) nurse did not (if that means anything.)
Intense chills that woke me up. Took tylenol and ibuprofen.  Chills lasted about an hour before falling asleep again then waking up to profuse sweating
Initial unsolicited report received from a healthcare professional via other company (Pfizer) on 01 February 2016. Manufacturer report number: 2016049631. This case involves a 64-years-old male patient who was vaccinated with a dose Flu Vaccine (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history was not reported. Concomitant medication included Lisinopril (20 mg Tablet, 1 tablet Orally Once a day), Amlodipine Besylate (10 mg Tablet. 1 tablet Orally Once a day), Cilostazol (100 mg Tablet, 1 tablet 30 minutes before or 2 hours after breakfast and dinner orally twice a day), Trazodone HCI (50 MG Tablet, 1 tablet at bedtime as needed Orally Once a day Start Date: 03 September 2015), Saline Wound Wash Solution (Wash with saline Externally Up to three times a day), Skintegrity Wound Liquid (A spray to wound externally after patient comes home from gym), Atorvastatin Calcium (40 mg tablet, 1 tablet Orally Once a day), Fluocinonide 0.05 percentage Cream (as directed Externally twice a day Start Date: 08 July 2014), Tizanldine HCI (4 mg tablet, 1 tablet as needed Orally every 8 hours), Oxygen Liters per Minute Gas, lpm Nasal Continuous at night, Probiotic (Daily Capsule, Orally,) Centrum Silver Tablet, Orally, DiphenhydrAMINE HCI (25 mg Capsule, 1 capsule as needed Orally every 6 hours), Lactulose (10 gm/15ml Solution, 15 ml as needed Orally Once a day Start Date: 09 October 2014), Hydrocodone-Acetaminophen (10-325 mg tablet, 1 tablet as needed for severe pain Orally Twice a day Start Date: 14 October 2014), Zolpidem Tartrate (10 mg tablet, 1 tablet at bedtime as needed Orally Once a day Start Date: 09 September 2015), Alprazolam (0.25 mg tablet, 1 tablet Orally Twice a day as needed), Lyrica (100 mg Capsule, 1 capsule Orally once a day at bedtime), Metoprolol Succinate ER (50 mg tablet Extended Release 24 Hour, 1 tablet Orally Once a day Start Date: 07 January 2016), Clopidogrel Bisulfate (75 mg tablet, 1 tablet Orally Once a day),Aspirin (81 mg tablet, 1 tablet Orally Once a day). On an unspecified date, following the vaccination, the patient experienced fever. Lab data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
She sometimes has fainting symptoms, Loss of hearing and sight, Dizziness a lot of time. Severe headaches all the time. Mostly 6 out of 10. Had an MRI of brain and Spine. Been on Migraine Meds. Now on TOPAMAX. Has been to ER 3 times, PCP, and Neurologist. Has used acupuncture and dry needling to try to alleviate the pain. Has tried so much and nothing has helped. It started with the fainting symptoms and then severe terrible headaches.
Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FC3183; Expiration Date: Oct2021), dose 1 via an unspecified route of administration on 04Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced itching on Sep2021. Reporter stated, " So, I have my vaccine yesterday actually, I got my first dose yesterday of the Pfizer and I wasn't sure whom to call all the pharmacy are closed and hospital are not giving me any answer so, I am not quite sure too I am having like itching, Is that normal? And itching everywhere. "Should I be worried about that I was reaction with itching? I am not having trouble in breathing, I am not having hives, I am just itching. Outcome of the event was unknown.
Patient was admitted to hospital on 2-9-21 for urinary tract infection and tested positive for Covid. Developed pneumonia and expired on 2-12-21.
Patient got 2 immunizations (1 Flublok on right arm and 1 Pneumovax 23 on left arm) on 09/16/19.  I tell every single customer that most common side effect with immunization is hot to touch, red to see and painful at injection for couple days.   She came back to pharmacy on 09/18/19 and complaining  about soreness, redness and hot area on triceps area of left arm which is away from injection site.  There was no sign of any visual adverse effect on injection site. She also complain about shoulder pain.  Patient also took ibuprofen 200 mg, 1 tablet by mouth 3 times a day yesterday.  I did call her doctor office and spoke to staff for follow up appointment.  There was not sign of infection, but md is treating her with antibiotic for skin infection.
redness on my right arm- soreness and tender to touch. light headed- slightly dizzy.
Vaccine injection site Cellulitis; diagnosed at Urgent Care, area red, warm, tender, entire arm swollen with open and fluid filled blisters noted; prescribed a course of oral antibiotics, to keep blistered areas clean and covered and recommended not receiving 2nd COVID vaccination.
he hadn't informed the vaccination provider about being on Xarelto; had soreness on the injection site/he had soreness on the injection site that lasted for a day after getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included rivaroxaban (XARELTO). The patient explained when reading the fact sheet after vaccination, he got concerned when he realized he had not informed the vaccination provider about being on Xarelto on an unspecified date. The patient added the vaccination provider did not ask him about allergies or his medical conditions. He asked why you should you tell the vaccination provider about all of your medical conditions, including if you have a bleeding disorder or on a blood thinner. He also asked if the combination of the two, the Xarelto and the COVID-19 vaccine can cause him to have side effects; and if so, which ones should he look at for. The patient had no bruising or bleeding after vaccination. He also reported that he had soreness on the injection site that lasted for a day after getting the vaccine. The sore was already little and not painful on an unspecified date in Feb2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. The lot number for BNT162B2, was not provided and will be requested during follow up.
Information has been received from a pharmacy technician referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On multiple unspecified dates, the patients received doses improperly stored VARIVAX (lot# L034368/expiry date 08-SEP-2017, lot # L046887/expiry date 23-NOV-2017, dose and route were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable Physician. This Physician reported similar events for fifteen patients. This is 12th of fifteen reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date 15 persons received pfizer vaccine from vials that had been reconstituted with 1.3 ml instead of 1.8 ml, they reported significant body aches. Many had GI symptoms (nausea, vomiting and diarrhea). They have reported this to VAERS and have reviewed how to avoid this issue going forward. The outcome of both events was unknown.   Follow-up (23Feb2021): This is a follow-up spontaneous report from a contactable physician. This physician reported in response to HCP letter sent to physician via telephonic follow-up activities that included:  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
still got covid; still got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "still got covid". The patient had the covid vaccine and all boosters.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366228 Same reporter/ drug/ patient, different AE;
Within hours : visual obscura - and increased bilateral tinnitus that is rampant and still is with me as of this writing, now some 18 post 2nd injection days latter!!  Then some 4 hours latter, dramatically reduced stamina, with onset of fatigue which lead to sleeping the next 72 to 84 hours and only being able to get up out of bed to urinate.  Body aches and sore injection arm during this time about 2 days total.  Used a Far Infrared heating pad to help mitigate the symptoms; unsure if it helped.  In the first 5 days, very weak and feeble feeling, physically and mentally (cognitively speaking).  Saw my doctor after that.