chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tuesday (7/20, AM, after waking up) - Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Wednesday (7/21, AM, after waking up) - Same as the day before, Tight chest, slight shortness of breath while standing, lasting for about an hour. In the afternoon/early evening, short episode of feeling overheated and had to sit down during work. Thursday (7/22, AM, after waking up) - Chest pain on the left side, specifically heart throbbing accompanied by hot flashes, persisted for about 45 min while standing.
Patient presented to ED on 7/31/21 with dyspnea and cough with covid infection. Patient was fully vaccinated. Patient was treated for covid and was discharged on 8/5/21.
Pt received pneumococcal vaccination on 10/22/13 at 08:39. Pt stated at 1400 her arm was itchy, achy, swollen and red. No c/o pain. Site 16 cm x 16 cm.
Patient received COVID 19 Pfizer vaccine IM in right deltoid and remained on site ot be monitored.  20 minutes later post-vaccine, the patient (accompanied by her mother and aunt) reported feeling itchy around the neck, mouth, and upper extremities.  EMS on site assessed the patient, and she (and family) was transported to Hospital.
Syncope episode; Lightheaded; This is a spontaneous report from a non-contactable nurse. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscularly on 19Mar2021 at 13:00 (01:00 PM) (Batch/Lot Number: ep6955) at the age of 58-years-old as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. There was no other vaccine in four weeks. The patient's medical history and patient's concomitant medications were not reported. The patient experienced lightheaded/syncope episode on 19Mar2021 at 13:15 (01:15 PM). The events resulted in emergency room/department or urgent care. It was unknown if the patient received treatment for the events. The patient had no COVID prior to vaccination and has not been tested for COVID post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event syncope episode cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Day after vaccine I felt flu like symptoms. Body aches and headache.  Second day was better. Third day normal until the evening. My arm just below the shoulder started itching and hurting at the same time.  Today is one week since initial injection and my arm still itches.
Pt recvd 1st dose of Hep B vax in 1990; pt exp a local reaction consisting of a swollen arm & edema, which extended up into the axilla, neck, breast areas; pt recovered;
No signs of adverse events or reactions after administration of the flu vaccine or the T-dap on 11/14/14. It was reported by agency infection control RN the patient was dx with Transverse Myelitis 2 weeks after administration.
About five hours after the vaccine injection, at around 11 PM, I began to feel cold and achy, which soon led to body chills all over. It felt like I could not get warm no matter how many extra blankets I added. This soon led to a fever. I was in an out of sleep for the next few hours and woke up around 2:30 AM. At that point the fever had broken and I was sweating. I still had body aches, which I think was due to my body being tensed up for some many hours, and I had a splitting headache, as well. At around 4:30 AM, I woke up again, with a very sore arm a terrible headache still. I got up and took 400 mg of Ibuprofen and went back to sleep. At 7 AM my alarm went off and all adverse effects seemed to be gone other than a sore arm. The sore arm last for about 6 days.
I developed a fungus in my mouth similar to thrush. I've never had that before. Also on my eyelid I have developed an itchy burning rash.
Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, feet extremely cold Narrative:
Case number PHEH2011US02367 is an initial spontaneous report received from a pharmacist on 18 Aug 2011. This report refers to an adult male patient. The patient received only an intramuscular dose of MENVEO (batch no: M10047) MenCWY liquid conjugate component without being reconstituted with Men A on 17 Aug 2011. No adverse reaction was reported.
Pt given dose 1 past 14 weeks 6 day of age. No known adverse reaction. Dr aware. Parent informed. Merck notified and case filed. Lead MD informed as well.
SWELLING AT INJECTION SITE INVOLVING ENTIRE UPPER ARM, ITCHING, HEAT, REDNESS, DISCOMFORT.
Gave Varivax Sub-Q in left forearm.  When patient came in to have TB skin test read, stated that site itched.
Itching around injection site, slight knottiness, some sharp pain, and then twinges of sharp pain over the next weeks and more general pain in the area of injection, continues to this day, certain movements of arm seem to cause pain or twinge in the injection area.
R. arm injection site raised, red swollen, hot to touch 10cm round. Arm was achey.
immediate soreness at injection site and worsened as time went on. Pain severe on shoulder movements at times, arm feels asleep and a lump developed on the inner aspect of the elbow.
After the vaccination (I got Seasonal and H1N1 flu vac. together), I experienced significant pain all over the body. The pain included excruciating myalgia and aching. Mild grade fever running 99 F while taking NSAIDs. The problem has gotten worse over the weekend (from 10/31. My neck, chest, left extremity including left arm became stiff and painful. The symptoms has been unchanges over last 10 days. I have been unable to work this weekend (11/7) because of the muscle pain and stiffness.
Ear ache started on 1-19-21 and started antibiotics.  Rash on ear started 1-22-21 Facial paralysis on right side of face on 1-25-21 Went to ER on 1-25-21. Diagnosed with herpes zoster oticus.  Started treatment of Valacyclovir and Prednisone.  Treated by ENT on 1-29-21.  Had hearing test and no hearing loss was detected. Prescribed stronger dose of prednisone because there was not any improvement in facial paralysis.   Still experiencing facial paralysis on the right side. It?s unknown if it will be permanent.
Right arm was numb day after vaccine was administered. Pt felt weak; like passing out. Also, pt coughed x 4 days. (Vaccine was given (R) arm).
Arm pain, nausea, dizziness, chills, exhaustion, extreme weakness.
Patient was given a monovalent Moderna Booster dose on 08/31/2022 around 2:00 PM. We were unaware the FDA had modified the EUA for booster doses until around 6:00PM that evening when we received a notification via email. When I became aware of the issue I submitted a request to the Covid-19 program for guidance. I was advised to fill out this form as I am doing now. The patient was contacted about the issue and advised that he would be eligible for a additional bi-valent booster dose 2 months from the previous dose.   Overall we only gave one booster dose that day and have given no others since the modification to the EUA. All staff were advised of the changes in protocol and advised that no other booster doses would be given until the bi-valent doses were delivered.
Developed hives approximately 12hr after PEDIARIX, Hib, PCV7, ROTATEQ.
Mother called to report hives on arms, 9 on one- 3 on other. 7/17/08 - resolved with benadryl
Client reports severe back pain and stomach pain, N&V on Wednesday July 4th starting in the afternoon and persisted until today and still effecting her.  Went to the ER and had a urine sample given and a x-ray of her back (urine was negative.  Awaiting results for x-ray.
Patient developed a red scaly eczema like spot about 1/2 inch in diameter where the vaccination was given.
Developed redness, tenderness and tingling of right forearm shortly after receiving vaccines. Was treated with antibiotics after office visit on 12/12/17, diagnosis: cellulitis.
Narrative: Patient says he got the 1st Pfizer COVID vaccine on 10/6/21, then went in to respiratory arrest 10/9/2021. He says he was admitted to an outside hospital for 3 days and will have records sent to the facility. He says he was treated with steroids and a zpak. He says he was not intubated.
Pt broke out in rash at injection site, right ankle and left leg itchy and a little painful. Did not go to dr. Occurred day after injection. Talked with pt on 5-25-13. Still itchy.
Typical sore arm similar to flu shot. Following day, had minor low half body aches and chills.
PATIENT REPORTED SHORTNESS OF BREATH FOUR HOURS AFTER RECEIVING VACCINE.
tunnel vision for a bit which then went away; felt like fainting; tinging in his toes and left arm and fingers.; This spontaneous case was reported by a consumer and describes the occurrence of TUNNEL VISION (tunnel vision for a bit which then went away) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A217) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TUNNEL VISION (tunnel vision for a bit which then went away) (seriousness criterion medically significant), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.). At the time of the report, TUNNEL VISION (tunnel vision for a bit which then went away), PRESYNCOPE (felt like fainting) and PARAESTHESIA (tinging in his toes and left arm and fingers.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment information were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender (patient identifier: 7716594). On an unspecified date the unspecified patient was administered RECOMBIVAX HB (Lot# H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed Shingles on right side of face - Intense headache starting on 10/2/22 with shooting pain that felt like electric shocks.  Pain radiated to the right side of the cranium, lower right cranium and neck, ear canal, and right lower jaw.  Pain developed into shooting pain in teeth on lower right jaw.  Singles lesions developed on right side chin starting on 10/5 and spread along through right lower face up to lower ear by 10/7.
Severe Charlie horse feeling at injection site occasional numbness at fingers muscle always has discomfort NSAID for 2 weeks, no results physical therapy no results.
Shortly after I woke up the morning after having received the vaccine, I noticed humming/buzzing in my ears, consistent with tinnitus symptoms, and also "medicine head" or "brain fog". This was about 24 hours after receiving the injection. The symptoms have persisted since the initial onset and have not improved.  I originally received both doses of the Pfizer Covid vaccine April 9th 2021 and April 30th 2021. This was my booster dose and I chose Moderna based on the higher effectiveness rate.
Initial report received on 05 February 2009 from a health care professional.  A cluster of 10 to 15 patients out of an unspecified number of vaccines had received a deltoid injection of ADACEL, lot number C2865AA (route and date of administration not reported) and an unspecified amount of time later, developed local reactions at the injection site consisting of arm swelling, half dollar size knots, reddened areas and soreness.  One patient was reported to have had cellulitis (location of cellulitis was unknown at the time of the report).  According to the  reporter, they did not have the patient records and did not know the patients that had the reactions.  No additional information was available at the time of the report.  Follow-up information was received 16 March 2009 from a health care professional who reviewed the case and had no additional information to provide at the time of the report.  Follow-up information was received 24 April 2009 from a health care professional who stated that she can not identify specific patients and only the reactions were documented.  No additional information was provided.  Documents held by sender:  none.
p/vax pt became very lightheaded;pt laid down & was given cold water;examined by NP;pt began having chest pain;EKG was OK but very weak;transferred to ER;
Sore arm, stinging pain in left arm on day following injecting. Lasted 24 hrs.  Migraine started day after injection, lasted 7 days with mild to moderate relief through use of Advil, Tylenol, fioricet (prescribed by neurologist for migraine). Required Rx of decadrone from neurologist to break migraine cycle
Redness, edema, pain, inability to lift arm within 1 hr of injection. Ice, Benadryl, NSAIDs to relieve. Improved by next day.
PT REPORTED RASH, IE HIVES TO BOTH OF HER FOREARMS FROM HER 1ST COVID VACCINE. PT WAS TREATED BY DR. WITH TOPICAL STERIOD PER PT. MD CLEARED PT TO RECEIVE HER 2ND DOSE. ADVISED PT TO TAKE BENADRYL PRIOR TO SECOND VACCINATION AND TO CONTINUE FOR A FEW DAYS AFTER HER 2ND COVID VACCINE.
Night sweat; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweat) and VACCINATION SITE PAIN (Injection site pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 25-Jan-2021, the patient experienced NIGHT SWEATS (Night sweat). On 25-Jan-2021, NIGHT SWEATS (Night sweat) and VACCINATION SITE PAIN (Injection site pain) had resolved.            No concomitant medications were provided. Treatment information provided mentioned Tylenol, Zyrtec, and hydrocortisone 2.5%.  Action taken with mRNA-1273 in response to the event was not applicable as patient received both doses of the vaccine.   This case was linked to MOD-2021-058663 (Patient Link).
had it twice even after the shot/suspected vaccination failure; had it twice even after the shot; so painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The reporter stated that, shingles was so painful had it twice even after the shingles shot. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
shingle / uspected Vaccination failure; Sales rep submitted via CRM: Doctor has seen patients who have developed shingle post completion of the two dose series of shingrix.; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 22-AUG-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Sales rep submitted via CRM: Doctor has seen patients who have developed shingle post completion of the two dose series of shingrix.).  The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 22-AUG-2023 A physician reported that he/she had seen patients who had developed shingle, post completion of the two-dose series of Shingrix. The vaccine administration facility was the same as primary reporter. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Standard sore arm started within a few hours; other muscle aches and headache started as the day went on. These were expected. Potentially more unusually, I woke up on 4/17 with a wheal on my face, which could just be my chronic hives acting up independently, but then in the evening of 4/17 I noticed a raised red mark on my arm near the injection site, which also looks like a wheal, as well as a wheal in the shape of the sticky portion of the bandaid used post-vaccination (which I?d removed before bed on 4/16). I?d had a similar wheal on my arm a few days after the first shot (given 3/19), so seeing another one now makes me believe it may be connected to the vaccine. The wheal is below the injection site (about 7 o?clock if you?re standing looking at the injection site) and seems to be raised like a bump and is both hot and tender to the touch . It is unlike my normal wheals in location (more commonly I get them on the underside of my forearm), size, and characteristics, and because it is NOT itchy like they usually are. The wheal on my face was darker than usual, more a wine than bright red, and not in a typical location (it was high on the cheekbone just under my right eye; I most often get one on the left cheekbone near my nose). However, it was itchy in the way my wheals usually are. It is faded but still present and no longer itchy as of this submission, which is normal for my facial wheals.
Patient called pharmacy complaining of severe soreness shortly ( i believe the next day ) after receiving the immunization. I did not speak with her but am basing this on the patient's history. She still has pain and difficulty moving the arm. She has been seen by her physician and is now being referred to a specialist.
patient already received a flu vaccine before administering the second dose with no AE; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (Reference number- 00903066).  This case involves a 83-year-old female patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for prophylactic vaccination.  On 08-Oct-2021, the patient received a 0.7 ml first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 18-Nov-2021 the patient received a 0.7 ml second dose of the same vaccine (batch number and expiry date: not reported) (Frequency once) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported "patient received 2 doses of FLUZONE HIGH DOSE; states the patient received 2 doses because the nurse did not check to see if the patient already received a flu vaccine before administering the second dose. Medical assistant asks if there could be any effects from this".  At the time of report, no adverse event was reported.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be 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.  There will be no information available on the batch number for this case.
Injection site assessed and found to be without redness, swelling or tenderness. On the same arm, below injection site near elbow and tricep there is raised papular type lesions with surrounding erythema and redness in two areas. Slightly warm and tender. Possible insect bite.
This non-serious spontaneous case, was initially received from other non-health professional on 02-Oct-2017, concerning a 08-year-old, child, female patient. The patient's historical vaccine included unspecified influenza vaccine. The patient's medical history included allergies to animal, pollen, pine straw, shellfish and she did not receive any concomitant medications. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210, expiry date: 31-Mar-2018, route of administration: assumed as intramuscular (as reported) anatomical location: left deltoid). On the same day, the patient developed a mild allergy, which included bit swollen of right eye on the same side, where she had the injection and mild rash around the injection site on her shoulder, which were watery blisters. No treatment was taken for the event. It was reported that, patient's symptoms disappeared after 24 hours (on Sunday morning) (as reported). On 01-Oct-2017, the patient had recovered from the event. The reporter assessed the case as non-serious. Follow-up received on 09-Oct-2017: The route of administration of the vaccine was reported as intramuscular (assumed by reporter) and the anatomical location was reported as was left deltoid. Narrative was amended accordingly. Non-significant case correction received 02-Oct-2017: Batch number (195210) was added on the screen and updated expiry date. The narrative was amended accordingly.
pt recv vax & exp h/a, tingling on lt side;pt also c/o dizziness & nightmares which woke up at noc;