chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 30 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: En6206), on 01Apr2021 as dose 2, single (Lot number: Enr8733), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: Uag13725) and on 20May2022 as dose 4 (booster), single (Lot number: Fnol73), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Sulfa antibiotics; "Thyroid Cancer" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Asthma" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment Paxlovid from 07Aug2023 to 12Aug2023. Patient tested positive for covid.
Headache  Fever  Muscle pain Chills Fatigue  Sinus watering
1st Injection with slight erythema and edema. 2nd Injection noted slight edema and erythema, then next am woke with swollen area over most of deltoid area, continue to increase over next 24 hours - arm swollen from elbow to shoulder and continues for 8 days. Resolved completely.
Patient did not receive full dose of vaccination due to leakage from the syringe.  He received less than half of the dose.  Patient had to be revaccinated with full dose of the same lot number
COVID symptoms started 02/10/2022 at night. He got the chills late at night, took a hot shower, went to bed, woke up before midnight with a fever and was hallucinating which is normal for him when he gets a fever. I gave him Tylenol 500 mg and he went back to bed and slept through the night and still had a fever in the morning. It was about 100.5 in the morning and stayed that way for 2 days. On Saturday the 12th, he developed a slight cough but never felt congested or felt like he couldn't breathe or anything. We didn't give him any fever reducer on Saturday and typically that works for him if it's a low-grade fever. By Sunday he felt fine and fever was gone. He had a lingering cough but few and far between. That's the day we got the positive COVID test back but we took the test on Friday. He plays a lot of sports, so he was more lethargic than usual and he felt like he had to struggle to keep up for another week but nothing bad. He did seem to maybe get a head cold last week as well.
Pt is 36 yo female with complaint of head cold symptoms starting on 7/16. She reports chills, body aches, congestion, headache, and new onset cough. She denies known exposure to COVID. She is s/p full Pfizer COVID-19 vaccination: first dose 4/8, second dose 4/29. COVID test resulted positive on 7/19. Patient is 10 weeks pregnant at time of test result. Patient received casirivimab/imdevimab infusion on 7/21.
14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms .  At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea .  I messaged my Dr the next AM.  By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine.  It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches  and nausea as well.
I started having knee pain in my right knee 1 hour after receiving the vaccine. That night it was hurting really bad so I looked at it and it was swollen, red, hot to the touch, it was the size of a goose egg hanging off my knee. It was midnight or 1am of the next day and I went to the emergency room. I was diagnosed with knee bursitis. I was given antibiotics and anti-inflammatories and a referral to a orthopedic surgeon to see if I could get it drained. The swelling has gone down and the heat from it is subsiding. I still have pain but its not as bad as it was. I would say I am 75% better at this point. Any pressure or walking causes discomfort.
pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of vax on 18AUG92 & w/in an hr following vax, pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
This spontaneous report was received from a registered nurse, referring to a 54 year-old male patient. The patient's medical history, concurrent conditions, drug and allergy history were not provided. On 17-NOV-2017, the patient was vaccinated with a dose of M-M-R II (recombinant human albumin (rHA)) subcutaneously (strength, dose, frequency and dose number were not reported), lot number N008366, expiration date 13-MAR-2019, for prophylaxis; instead of the prescribed ZOSTAVAX. Concomitant therapies included an sterile diluent (lot number and expiration date were not provided). No adverse effect was reported.
Following the first shot in the series of the Gardasil vaccine on 10/20/2006, within a week, I broke out in hives on my back that were unexplainable.  I went to the doctor, they told me to take Benadryl and apply Cortisone cream.  There were no other causes for the hives such as clothing, soap, detergent, etc.  The hives would come back up on different parts of my body for the following weeks. I received my second shot in the series on 1/19/2007, the hives have gotten worse and continue to stay longer and cover more of my body.  I then received the final dose on 5/7/2007.  From this point, I have seen a dermatologist, several allergists, an infectious disease specialist regarding why I am having systemic hives that are not controlled by allergy medications.  I underwent many tests and procedures including a biopsy of my skin hive, and a test that came back as markers for Lupus were present.    I was taking several allergy medications, Predisone steroids long term, and  Zantac for the awful heartburn and indigestion that felt like I was having a heart attack- I also have dental enamel damage from those years of intense acid indigestion. I was prescribed an epipen because my throat and tongue would swell up so bad.  My face would swell so much that I couldn't see due to my eyes being swollen shut.  I could not walk because the hives covered the bottoms of my feet.  I spent the last part of my high school career and much of the first part of my college life miserable and covered in hives.  I also gained 40-50 pounds due to the steroids I had to take daily.
second dose on 27Jan. Caller stated on 11Feb she was tested positive for covid.; second dose on 27Jan. Caller stated on 11Feb she was tested positive for covid.; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer . A 90 (age unit unknown) old female patient received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route of administration on 06Jan2021 and 27Jan2021 respectively both at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient reported that she received her first dose of the Pfizer covid vaccine on the 6Jan2021, second dose on 27Jan2021 and 11Feb2021 she was tested positive for covid. She wanted to know if she can go see her family, will she be contagious after being quarantined for 10days. Reporter assessed the case as non-serious. There was no PQC present. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (different dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter. It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Wrong dose was given to adults mistakenly and were reported to VAERS, and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. No treatment information was provided.  This case contains information for the  18 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
ITCHING ARMS, SMALL HIVES, TIGHT THROAT AND  BURNING ALL OVER TREATMENT-  BENADRYL 25 MG,  ICE PACK OUTCOME- WENT HOME FEELING FINE
blood clot; he woke up with a numb hip up to his calf and his foot has been tingling; he woke up with a numb hip up to his calf and his foot has been tingling; chills and fever; chills and fever; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 04Jun2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history not reported. Concomitant medications included ongoing apixaban (ELIQUIS) as blood thinner. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14May2021 for COVID-19 immunisation. The caller (name withheld) said that she and her husband received the Pfizer Covid-19 Vaccine 1st dose on 14May2021 and 2nd dose on 04Jun2021. Last Saturday (on 05Jun2021), her husband (name withheld) started to experience side effects like chills and fever. Yesterday (on 07Jun2021), he woke up with a numb hip up to his calf and his foot had been tingling. She also mentioned that her husband was taking a blood thinner called apixaban and they thought he had a blood clot. They were asking if they should go to the hospital. The outcome of all events was unknown.   Information about batch/lot number has been requested.
Initial report received from a patient on 01 November 2007. A 72-year-old female with history of allergies to multiple medications had received a dose of flu vaccine (trade name, manufacturer, lot number, route/site of administration not reported). The symptoms progressed until the patient was hospitalized for two weeks on oxygen and breathing treatments. The patient indicated that they were unable to find the cause, but she also reported being that it was probably due to bronchitis No additional information had been provided at the time of this report. The reporter of this case is the same as for case 2007-03697, which involves increasing difficulty breathing, wheezing and cough experienced by the same patient following receipt of Fluzone SV 2007-2008, lot number unknown.
Miscarriage of pregnancy - conception occurred around the time of first dose. Shot given 5/7/21, miscarriage occurred 7/5/21.
Ocularmotor nerve palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 55 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced ocularmotor nerve palsy. On an unspecified date, the patient was treated by a physician for the event. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
12/22/2020 Reported to ER rash on right arm and trunk/neck, heaviness on chest, tingling in face. Instructed to take 50mb Benadryl every 6 hours as needed. DX: Adverse Reaction to Coronavirus vaccine 12/30/2020 Reported to ER possible infection to right arm. Pain and redness around injection site. X-ray completed-No abscess noted. DX: Cellulitis around injection site. Instructed to use hot compresses. Bactrim Ds  and Doxycycline prescribed.  12/31/2020 Reported to ER with complaint of right arm pain, general malaise, body aches, fever. No evidence of cellulitis at this time, no worsening erythema, no evidence of hives. DX: Protracted reaction to the vaccination. Prescription for Prednisone  given and advised to take Pepcid twice a day for 5 days. Continue Benadryl as needed.  Instructed to follow up with primary care doctor.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received DTPa (DTPa vaccine) (batch number 9HP9Z) for prophylaxis.   On 19-JAN-2023, the patient received DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR060653:Original Case : US2023AMR056407
My hair is falling out and I have alopecia now; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Feb2021 the patient experienced hair was falling out and had alopecia. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events (unspecified). On an unknown date, the patient underwent Sars-cov-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event hair was falling out and had alopecia was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd 2nd dose of Hep B vax on 13MAR92 & exp sl fatigue for a couple of days; @ the time of report pt had recovered;
Severe upper arm pain, large red area, hard lump under injection site, fever, muscle aches, fatigue
This case was reported by a consumer via call center representative and described the occurrence of unwell in a 78-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to the 1st dose, refer case US2018GSK096993). Concomitant products included LOVAZA and vitamin D. On 25th May2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 25th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced unwell, fever and confusion. On 26th May 2018m the patient experienced sweating. On 26th May 2018m the outcome of the unwell, sweating, fever and confusion were recovered/resolved. The reporter considered the unwell, sweating, fever and confusion to be related to SHINGRIX. Additional details were provided as follows: The case was reported by GlaxoSmithKline employee who reported for her mother. The patient was receiving blood pressure medication concomitantly. At around 4:00 pm, the patient received SHINGRIX on the left arm. At around 6:00 pm, the patient became ill and had a fever of 101.5 degree F. The patient's normal body temperature was 97.6 degree F. The patient's fever broke by 5:00 and all of the side effects have since resolved and she felt better by Saturday, 26 May 2018. The patient had denied permission to contact their physician.
Cellulitis vs Local Inflammatory Reaction. Treated with antibiotics (KEFLEX).
Around  6 hours after eating I started getting stomach cramps and it went on for 3 hours. First I thought it was something I ate but my husband was fine and he ate the same thing. Then I had severe diarrhea it was the worst stomach cramps I've ever had. Then I got the shakes and was cold. When I finally felt like everything was out of me, I went to sleep. When I got up at 5pm I went again and looked in the toilet and it was all blood. I've never passed blood. It was literally like I just had a period. I called my GI Dr. and they thought it might have caused an ischemic colitis. My lower left colon was so very painful and inflamed. I bled for 3 days and when it stopped, I never had it again. I would have sporadic diarrhea but with no blood. My bowel movements were extremely soft and not normal. Finally towards end of the month it started getting normal. And it was time for my 2nd dose. Drs. said to take the 2nd dose and just not eat a lot. And I eat very health anyway. So I ate really light and drank a lot of water and took the 2nd dose. And I was fine after the 2nd dose this time. I made it a point to not do anything to aggravate my system this time. So I made it through I thought. Then 2 months at the end of May I ended up in the hospital with temporary heart failure.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 72-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 Celsius. On 16-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805462 was crossed linked to original case 201804863 due to same reporter.
pts recvd Engerix-B series; 8 pts tested neg (3 pts tested post p/1st booster dose, 1 pt borderline p/1st booster dose; retested p/1 six wk period, 1 pt awaiting 1st booster dose;
11/4 had varicella shot R arm.  11/5 developed redness & blisters on R arm below injection site- pt here 11/6/09
This spontaneous report was received from a registered nurse refers to an unspecified number of unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB at a temperature excursion of above 46F below 50F for 383 hours and 18 minutes (strength and dosage not reported), lot # M001578 (expiry date: 21-NOV-2018) for prophylaxis. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000002:
Angioedema of the lips.  She had carpal tunnel surgery on 1/8/2021 and received lidocaine, propofol, and septra.
At about 1143 patient was placed on gurney by  LVN after patient vomited in the restroom soon after receiving first dose of pfizer today. Nausea was the only complain patient had along with some anxiety.  Oxygen 2 litter n/c applied, vitals taken, ice pack placed on patient's forehead. Within couple of minutes patient started complain of tingling in fingers, followed by right shoulder pain, right arm pain, right side neck pain, and bone pain. Patient's face appeared flushed with increased anxiety. At about 1151 called 911. While on the phone with 911-patient started coughing, complain of throat closing, and showing some signs of respiratory distress. Subcutaneous epi pen injected to left outer thigh by RN, oxygen switched to 15 litter NB mask by RN , vitals taken. Patient continues to be responsive, able to communicate, with some shortness of breath and anxiety. Son present at bedside. supervisor and security were notified. At about 1205, fire department arrived and took over patient care.  At about 1217 patient was transferred to emergency room via ambulance with son by patient's side.  RN
fever of 102.2 for 18 hours  followed by  98.6 for 24 hours, joint pain, nausea increased need for insulin to control blood glucose levels.