chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.
Vaccines were given to the patient on 10/13/20 in the same arm at request of the patient. As of 10/28/20, patient is currently experiencing significant arm pain which required a visit to his primary care physician. PT went to his primary care physician on 10/28 and was provided a script for an anti-inflammatory pain medication, patient states his PCP believes the patient is experiencing bursitis, most likely from receiving both vaccines in the same arm.
Initial report was received 30 June 2011 from a health care professional. A male patient (age not reported) had received an injection of FLUZONE HIGH-DOSE last year (during this current flu season) (lot number, route, site and date of administration not reported) and the next day, he felt like he was "on fire". Outcome was not reported. No additional information was provided at the time of the report. Follow-up information was received 12 August 2011 from a health care professional. The patient was identified as a 74-year-old male who had a history of hypertension, gout and high cholesterol. Concomitant medications consisted of Amlodipine, Metoprolol, Lisinopril, Naproxen, Colchicine, Omega-3, LIPITOR and Aspirin. The patient received a first dose intramuscular injection of FLUZONE HIGH-DOSE, lot number U3607AA on 22 September 2010. The reported event began at 5PM on the day of vaccination (previously reported as the next day). According to the reporter, the patient drank water and went to bed and was fine the next day. The patient had no concurrent illness at the time of vaccination and he had not received any other vaccinations within four weeks of FLUZONE HIGH-DOSE. Outcome was recovered. Documents held by sender: None.
Fever, chills, headache from 1 am through about 6 pm on day after vaccine, Thursday 4/29/21. Very sore injection arm, some swelling and rash on arm.
Shortly before going to bed I became feverish (102.5 degrees)  and had a headache.  Was able to sleep, and by morning the fever was down to 100 degrees.  I still felt very tired and headachy.  I got up and had a small dish of cereal and then slept most of the morning.  By the afternoon the fever was gone, however had a headache and fatigue.  Took a Tylenol about 4 pm (24 hours after receiving the injection).  Headache cleared by the end of the day.  Still somewhat fatigued  72 hours after receiving the injection.  Stayed hydrated through the whole period.
Severe ear pain and fluid on both ears started the day after the 1st Vaccine shot and still continuing almost 3 weeks later (still have issue). Taking of antihistamines, nasal spray, Advil, decongestants is not helping alleviate the symptoms.
Noted 45 minutes post injection that her face was red and this was rapidly  followed by a rash under chin, anterior chest, face and upper bilateral arms.
Lymphadenopathy - pain and swelling under left armpit; Lymphadenopathy - pain and swelling under left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 14:30 (Lot number: EL3247) at the age of 44 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELATONIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [VITAMIN D NOS]. Vaccination history included: BNT162B2 (Lot number: EL3247; Administration time: 09:45 AM; Vaccine location: Left leg; Dose number: 1), administration date: 02Mar2021, when the patient was 44 years old, for COVID-19 immunisation, reaction(s): "Vaccine location: Left leg". The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Mar2021 05:00, outcome "recovering" and all described as "Lymphadenopathy - pain and swelling under left armpit". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no allergies to medications, food, or other products. The patient's concomitant medications also included Birth control and magne. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was given in a workplace clinic.  No follow-up attempts are possible. No further information is expected.
Severe chills, fever, dizziness/vertigo (severe), tired. Muscle pain
Dizziness nauses Strong body ache I was resting for 24 hours and then I noticeably improved
soreness on my left arm at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness on my left arm at the injection site".  Additional information: Patient stated, "had the vaccine first dose Monday afternoon, had been told before I went to ask about the length of the needle. I did ask, they didn't seem to know there was a difference or anything to be concerned about. I had been told if you have a bigger arm, there are weight guidelines and to take a look at the arm." They told her at the vaccination site, that doesn't matter. "I checked guidelines. 1' to 1.5" needles. I only knew to ask because of my friend that I may need the 1.5" needle.  "I am not sure I got the correct size needle, it may be very wide spread, because there is not consistent knowledge. There seems to be a lack of knowledge regarding needle size".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cancer / cancer went into remission; received a late 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number HG4P3, expiry date 13th July 2020) and (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   On 1st May 2018, the patient received the 1st dose of Shingrix. On 6th November 2019, the dose was an unknown dose. On 6th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine and was later diagnosed with cancer. The cancer went into remission and the patient received a late 2nd dose of Shingrix. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthtening of vaccination schedule. The outcome of the event cancer was reported in source document as fatal, however it was reported as recovering/ resolving in database. No symptoms reported. after 2nd dose administration. The reporter consented to follow up.
Patient states he noticed a knot with red area on 11/02/06 on left arm. No drainage noted on left arm Td area. Patient also noticed lump at Flu site area 11-4-06. Observed 12mm ulcerated area on left arm approximately 3 inches below injection site. Red area with warmth noted. Patient states.
2 hrs after shot - 101 degrees, severe chills w/shaking, thought I was having a seizure, sore throat. Next day I couldn't bend any joints. I have RA and it affected all my joints. This lasted for 2 days. I was in severe pain.
Myalgia, Angioedema, SkinRash, Rash, flushing to face, chest pressure, and tongue swelling. Pt denies any soa or difficulty swallowing Narrative:  43 years old employee that developed reaction immediately after the covid vaccine on 1/22/2021. Employee related the flushing face , progressive's swelling tongue and chest pressure. she was giving Benadryl 25mg at the clinic , then transfer to ER At the ER the VS was normal , she was treated with epinephrine 1mg, solumedrol 125mg, Benadryl 50mg iv. Employee was observed for 2 hours and then discharged home The swollen tongue, skin rash subsided with no residual
Pt vaccinated with DTP/MMR/OPV within 1 hr after vaccine lt arm had a large amount of swelling. Seen at hlth dept given ice pack.
bad chills; low blood sugar; intense pain on both sides of his temples, temples felt squeezed in a vice and left temple pain; severe headache; Fever; This is a spontaneous report from a contactable consumer (patient himself). A 68-years-old male patient received BNT162bB2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWD170; Expiry Date: 31Aug2021), via an unspecified route of administration in Arm Left on 30Apr2021 as dose 2, single (at the age of 68-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162bB2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWD150; Expiry Date: 31Jul2021), via an unspecified route of administration in Arm Left on 09Apr2021 as dose 1, single for COVID-19 immunisation. On 01May2021, the patient experienced severe headache, fever and intense pain on both sides of his temples, temples felt squeezed in a vice and left temple pain. On 05May2021, the patient experienced bad chills and low blood sugar. He felt an intense pain on both sides of his temples which eventually sub-sided. 5 days later, he said the pain came back, but it was not as severe, and was only on one side. He said that he was worried because headaches are the start of a brain clot. With this, he wants to know if it is normal for a headache to reoccur after 5 days. It was reported that his temples felt squeezed in a vice lasted 2 days. It was reported that he expected that last night, which was almost a week later, he experienced such bad chills. He put on 2 sweaters, used a comforter, and heat. He stated it was very unusual. He caulked it up to be low blood sugar. Reporter stated he was watching his diet those days. On that morning he woke up with the pain again in his left temple. It was the pain he had the day after the vaccine. The same as the first time, but not as severe, only on one side. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
On 11/12/10 pt started having pain in her back, in the muscle between her shoulder blades.  The pain worsened and is described as "excruciating, almost incapacitating pain" which lasted for 2 weeks.  Pt. treated the pain with Advil, ice, and rest; no medical care sought.  Occasionally now notices a dull ache in the same region - very mild, almost imperceptible.  On 12/8/10 and 12/9/10, pt had soreness at the injection site.  (This is the first time she had soreness at the site since receiving the injection on 11/9/10.)
I was unable to get email thorough to local health department and felt I should report to someone. I did not see a physician or dentist (was trying to wait a day or two in case it was in response to the vaccine), but reaction in the mouth seemed unusual to me so I wanted to report. I do not use vsafe, smartphones pointing to codes but felt like I needed to alert someone about unusual reactions to my second Merderna vaccine. My first vaccine was on 2/26/2021 at #013AZ1A. I only had a slight sore arm. No other symptoms. My second vaccine #028AZ1A on 3/26/2021 had severe reactions. On 3/27/2021 I had a sore throat, sore arm, migraine, but the scary thing was I developed severe swelling in my mouth. Gums where wisdom teeth had been extracted years ago had two huge abscesses. My gums were there were gaps in my teeth were swollen and coming up between my teeth. My mouth was sore and sensitive. I couldn't even bite down on jello. On the third day I began using Orajel and gargling in warm salt water. By the 4th day my mouth was back to normal but I have sensitivity in lower and upper right teeth but improving daily. I am able to bite, chew and see no swelling. I had no problems with my teeth prior to the vaccine. Migraine disappeared after two days. I did not take tynol. It was as though the vaccine was trying to attack what it might have thought to be a problem in my mouth. (Only able to sip warm broth for two days). Very scary.
This spontaneous report was received from a Medical Assistant and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concomitant conditions and concomitant medications were provided. On unknown dates, multiple unspecified patients received doses of improperly stored M-M-R II (lot #K015375, expiration date: 18-SEP-2016, dose, route of administration and injection site were not reported). Administered doses of M-M-R II underwent temperature excursions at 58 Fahrenheit degrees, for 36 hours. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
08 year old patient received first booster dose of Menactra; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 8 years old female who received first booster dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patients' medical history and concomitant medications were not reported.   It was a case of actual medication error due to inappropriate schedule of vaccine administered( it was reported that 08 year old patient received first booster dose of Menactra )  It was not reported that if any adverse reaction was experienced.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested  Documents held by sender: none
Vaccine Candidate received vaccine approxat 2:30pm, was monitored for 15 min no complications at the time,  went home.  Around 5:30pm while walking into her home she became unresponsive, was assisted in a siting position, became incoherent, mumbling and started to convulse to the right side of her r upper extremity. Foaming at the mouth and stopped breathing, CPR was initiated for 1-2 min, EMS arrived was transported to Medical Center. She was admitted and  is currently hospitalized. MD reports this event is highly unlikely related to the vaccine given her medical history but suggested to report being its a new vaccine. Current status: stable.
Patient had Second Pfizer dose on 3/30/21 and on 4/26/21 was diagnosed with a right leg DVT.  She is undergoing hereditary hypercoagulation evaluation. She is otherwise up to date on her cancer screenings. No other provoking factors.
Beginning in Sept. 2021 I experienced a minor sinus infection that resisted treatment. Because I have had severe  Asthma all of my life I had it checked by my regular dr. and she gave me two nose swab tests, one deeper than the other. Both we negative. The MILD sinus infection has persisted despite several courses of antibiotics.   I do not believe that this is in anyway related to any form of the 'covid' virus but is just another fun aspect of my asthma and my age. Which is 68 despite what your auto generated logic form states. 2021 minus 1953 equals 68.
THE PATIENT NOTICED HIVES/WELTS  UPON WAKING THE NEXT DAY
Persistent L should pain.  Has been give ibuprofen, prednisone, PT and recently started naproxen as is not improving
got COVID; got COVID; This is a spontaneous report received from a contactable consumer (patient). This male patient of unspecified age received the first dose of bnt162b2 (COMIRNATY) on 18Dec2020 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNtech (COMIRNATY) vaccine on 18Dec2020 and got COVID, as well as was not able to get the second dose on his schedule. Reporter wanted to know if it is safe to restart the vaccination series. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; This is a spontaneous report from a contactable 79-year-old female consumer (patient).   A 79-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration in left arm on 28Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included embolism in 2012 and cardiac pacemaker insertion in 2019. Concomitant medication included warfarin (unknown manufacturer), levothyroxine sodium (THYROXIN) and lisinopril (unknown manufacturer). The patient previously took lidocaine and ciprofloxacin and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 for covid-19 immunisation and experienced four small raspberry type "burn" left arm and small taste in mouth. The patient experienced burning sensation on skin on feet on back on 28Jan2021 with outcome of recovering.  The patient was not treated for the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112990 Same reporter/patient/drug, different events
15 minutes after her second dose of the injection, patient reported ringing in both ears.  Very loud.  She also reports her parkinson symptoms are increasing.  Shaking of arms and legs were observed.   Patient also reported nausea.
Patient felt dizzy and faint after vaccine.  Lowering head and giving her a cold pack to place on her neck helped almost immediately.  Her husband was with her, and she waited shortly longer than normal, then left as she was recovered.
There's lump underneath, left arm; Left arm is a little bit pink; Left arm is itchy; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE MASS (There's lump underneath, left arm), VACCINATION SITE DISCOLOURATION (Left arm is a little bit pink) and VACCINATION SITE PRURITUS (Left arm is itchy) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), IBUPROFEN, SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE MASS (There's lump underneath, left arm), VACCINATION SITE DISCOLOURATION (Left arm is a little bit pink) and VACCINATION SITE PRURITUS (Left arm is itchy). At the time of the report, VACCINATION SITE MASS (There's lump underneath, left arm), VACCINATION SITE DISCOLOURATION (Left arm is a little bit pink) and VACCINATION SITE PRURITUS (Left arm is itchy) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up contains NNI On 22-May-2021: Additional information received and Outcome of the events updated from Unknown to recovering
Symptoms are chills, nausea, fatigue, and arm pain.  Still ongoing as of 32 hours after vaccine.