chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event   On 11/03/2021 the Vaccine Refrig data logger showed a temperature excursion occurred on 10/29/2021 at 10:48 a.m. of +50.7 (F). The timeframe documented is 13 mins with n 5 min alarm notification totaling 18 min. The vaccine providers were not aware that the vaccine needed to be used within a 24 hour timeframe of the excursion prior to discussion with the health department on 11/3/2021. A clinic was scheduled for Moderna Booster doses at a High School for their employees for 11/1/2021. This clinic did occur with the Moderna Vaccine with Lot # 076C21A between the hours of 3:00-5:00 p.m. A total of 16 people received Moderna Booster shots 0.25ml.  The vaccine provider learned on 11/3/2021 in conversations with the health department that due to the excursion, the vaccine should be discarded if not used within 24 hours of the temperature excursion. With the instructional education provided via the health department, all remaining doses of Moderna with Lot# 076C21A was wasted.
I developed an itchy rash which felt hot and was swollen to the touch. The rash persisted for two weeks. At times it seemed the rash was receding,  but about a week after receiving the vaccine, the injection site became swollen and raised again, and began spreading on my arm. It was very noticeably red, extremely itchy.  Now, about a full two weeks after receiving the vaccination, it seems to have subsided.
Chills, fever of 100.4, skin burning, prickly feeling all over body, groggy, fatigue, SOB.
The injection site went burning hot, from shoulder to fingertips was tingling, felt like a blow to head headache, back of neck hurt, couldn't breathe.  She no sooner said to wait 30 mins, I turned to look at clock and bam! everything hit at once.   I was told to go to ambulance on site. They put me in ambulance, covered me, gave me oxygen,  and fluids via iv. Blood pressure was 189/115, heart rate was 40.  Dr said I was very flushed. I was having difficult time breathing.   Oh, they gave me benadryl and I believe? steroids.  Had to wait for another ambulance as the one there had to stay onsite. I was taken to emergency room at hospital where I stayed on oxygen and new iv of steroids. Was at hospital for 4 hrs till bp was considered safe enough to release me.   I still have head ache and neck pain, back of neck.  Also sleeping much more than usual.6  Before getting shot I had asked the person giving shot if my allergies to penicillin and morphine would prevent my getting shot.  I had listed these on the paperwork necessary to getting shot.  She said they were looking for reactions to like the flu shot.
Swollen red lump on left arm at injection site, no treatment, itches and mildly sensitive to touch
18 year old otherwise healthy male, with mild asthma,  and history of vasovagal syncope with prior vaccinations, IV's and any type of injection on multiple occasions.  He has no history of prior seizures or seizure disorder.  He received his vaccine at about 9 AM and walked to our 15 minute observation area.  Within 5 minutes of sitting down,  he stated he was not feeling well, became unresponsive, and had a series of 3 very brief, witnessed tonic clonic seizure activity, each lasting 5 seconds or less, with only a few seconds between.  Following this he was minimally responsive, still sitting up, eyes opened, and only mumbled in response to questions.  He was pale, confused, mildly diaphorectic, BP was 119/99 pule was 61, O2 sat was 96% and resp rate was approximately 20.  He was NOT incontinent of stool or urine.   He was fully conscious and oriented to person place time and situation within 5 minutes.  He soon regained his color and vitals continued to be stable.   He does have a history of "low blood pressure" per his report.   He was feeling well, but because of the history witnessed seizure activity the decision was made to transport to hospital.   He was transported by Ambulance Service to  Hospital.   Prior to vaccination today was feeling well.  He was accompanied by his girlfriend.   Diagnosis per supervising MD, was Post vaso-vagal syncope seizure activity.  Or seizure activity related to vaso-vagal syncope.
large raised red bump at injection site; flu-like symptoms; tired; sore joints; injection site redness; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (large raised red bump at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (tired), ARTHRALGIA (sore joints) and VACCINATION SITE ERYTHEMA (injection site redness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drug.).    On 29-Jan-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE MASS (large raised red bump at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (tired), ARTHRALGIA (sore joints) and VACCINATION SITE ERYTHEMA (injection site redness). The patient was treated with IBUPROFEN for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (large raised red bump at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (tired), ARTHRALGIA (sore joints) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications used were not provided.
Lymph node by left clavicle got painful and swollen, I returned to pharmacy and spoke with man that gave me the shot, he made notes in my file. Lump went away in about a month. My arm has tender at injection site. I took ibuprofen for pain, used ice and heat. My arm and muscles are still hurting and keeps me awake at night, very painful. This was only the second flu shot in my life, the last one was over 20 years ago. I received a pneumonia shot on January 22, 2018, first pneumonia shot in my life, Dr. talked me into getting this shot. Injection shot hurt for over 2 weeks and now I have right arm pain in the muscles and it hurts all day off and on and aches a lot at night. I have told my primary care physician and also a second Doctor in the same office, on 2 different visits.  I now have been in constant pain since November 2017 and I have trouble sleeping at night and it hurts to raise my arms and do much of anything during the day without pain. I have been to PT, although Dr. only put my back pain on form for PT, she did not address arm pain, back pain has since gone, I believe it was a pinched nerve but both arms are still very painful. I have tried ice, heat, TENS treatments, prescription Diclofenac Sodium Topical Gel 1%,  prescribed by Dr., Ibuprofen, ALEVE, prescription ALEVE, bought 2 new different bed pillows to try and relieve pain in arms and shoulders, hot baths, Epsom salts, Chiropractor, Massage therapy weekly. 4 days ago I tried CBD oil, 1 drop a day for 2 days and 2 drops yesterday.  I will be seeing an orthopedist tomorrow. Running out of ideas for this constant pain!!
Initial misuse report received from a health care professional on 10 March 2014.A 07-uear old patient had received a dose of FLUZONE ID on an unspecified date. It was reported that the vaccine was administered to a 07 year old patient. No adverse event was reported. List of documents held by sender: none
I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.
11/23/21 presents to radiology for "post biopsy left sided pneumothorax ". PMHx "HTN, HLD, h/o brain aneurysm s/p surgery, depression/anxiety, left breast cancer"
pt recv 1 dose of varicella vax 4/3/98 & 4/16/98 pt exp a localized react, 1''x1'' rash at the inject site & 1 red bump on the calf lasting approx 2wk, no itching, fever or rashes elsewhere
continued soreness as if was given vaccine yesterday. Has not noticed any improvement. No redness, swelling, or hot to touch just muscle soreness as expected after vaccine however not continued for months post vaccine.
This is a spontaneous case initially received from other health professional on 30-Oct-2018, concerning a 2-year-old, male child patient. The patient's historical condition included otitis media. On an unspecified date, the patient underwent frenulectomy. The patient did not administer any concomitant medications. On 26-Oct-2018, the patient (underage of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252672 and expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported after administration of the vaccine. The reporter assessed the case as non-serious.
No additional AE; patient was administered expired PNEUMOVAX23 as confirmed by nurse; This spontaneous report was received from a nurse referring to a 18 year old female patient. Patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 05-OCT-2020, at 12:50, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) non-valid lot #S002528 (expiration date reported as August 2020) and non-valid lot # updated N-638557, for prophylaxis. No adverse experience (AE) was reported.
Inappropriate age for Vaccine Administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for Vaccine Administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for Vaccine Administration). On 15-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age for Vaccine Administration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.
tinnitus in left ear since second shot, still present. no treatment. severe petechia on face began one week after second shot, resolved on it's own. no treatment.
Had 3rd Pfizer Vaccine booster on 9/27/21 Lot #FF2588 Sever pain in Rt. leg and went to Urgent Care on 10/15/21. Treated with Robaxin. Pain got more intense. C T Spine Lumbar on 10/22 at Hospital. Developed edema in both legs and feet. Unable to walk. Leg scan on 12/2 revealed blood clots in both legs. Vaccine info. Pfizer #EL9269 on 2/11/21. Pfizer #EN6205 on 3/4/21. Pfizer booster FF2588 on 9/27/21.
Pt received H1N1 injection, post inoculation student experienced nausea and vomiting.
Patient approached the consultation window approximately 30 minutes following her vaccination stating that her arm was tingling and numb.  I asked questions to ensure that she was not having an allergic reaction and she was not experiencing any itching, swelling, shortness of breath, trouble breathing, or angioedema.  I offered to call EMS and the patient declined.  She also said she was having palpitations immediately following the vaccine but those had stopped.  I directed her to contact her MD if the symptoms increased or persisted.
pt in hospital; pt had a positive COVID test on 1/6/22 in the facility; pt passed away in the facility on 1/23/22
Information has been received from a registered nurse concerning a 5 year old male who was vaccinated with one dose of VARIVAX (Merck) at 12 months of age.  In January 2009, the patient developed shingles.  The patient sought medical attention by unknown contact.  Subsequently, the patient recovered from shingles.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # not reported) about a week before the time of reporting, on approximately 13-AUG-2012. It was reported that a couple of days later the patient got Zoster and developed shingles. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
local rxn 9 1/2 x 8cm lt thigh ant/lat pain, swelling inc warmth, induration or lump w/o abscess;
only received 1 dose 2 years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, 2 years ago, ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-FEB-2023 Reporter's comment:  The reporter asked as if someone only received one dose of shingrix 2 years ago, should they restart the series. They disconnected the chat without giving additional information. Additional Supportive Information: Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow up would not possible, as no contact details were available.
Information has been received from a physician concerning her daughter, who in September 2006, was vaccinated in the buttocks with the first dose of Gardasil, in November 2006, with the second dose of Gardasil, and in March 2007 with the third dose of Gardasil, in the arm. The physician reported that in March 2007, following the third vaccination, her daughter experienced slight pain in her arm at the injection site. At the time of this report, it was unknown if the patient had recovered from the injection site pain. Additional information has been requested.
Pt has severe bruising from right shoulder to half of his arm 10 days later. It has a yellow ring around it. It is not swollen or hurt. Pt. complain of headache ever since. Pt did not seek any medical for further evaluation. Call pt on 9/30/16 pt say he is fine just his head hurts.
COVID POSITIVE; SORENESS AFTER CLEANING; TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID POSITIVE), PAIN (SORENESS AFTER CLEANING) and FATIGUE (TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced FATIGUE (TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH). On an unknown date, the patient experienced COVID-19 (COVID POSITIVE) and PAIN (SORENESS AFTER CLEANING). At the time of the report, COVID-19 (COVID POSITIVE) had resolved and PAIN (SORENESS AFTER CLEANING) and FATIGUE (TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. On unknown dates, the patient experienced COVID POSITIVE and SORENESS AFTER CLEANING. In 2021, the patient experienced TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH. On an unknown date, COVID POSITIVE resolved.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID POSITIVE and TOOK VACCINE FOUR DAYS FOLLOWED EXPERIENCED TIREDNESS AND COULD NOT DO MUCH was not provided. The reporter's causality for the event(s) of SORENESS AFTER CLEANING with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
The next day I noticed a dry spot on the back of the right ear and a dry spot on the back of the right shoulder. When I reported it, via phone call, I was told that there is no way that can be from the vaccine.  Over a month or so it covered his arms and became a little more scaly. Then progressively traveled to both legs and varies in severity.  The doctor never noticed it in following visits and based on the phone conversation I didn?t feel comfortable bringing it up again. Then finally around 8 months I asked her how to help it and mentioned the vaccine again. She adamantly reported it is not possible to be caused by that and she told me it?s a result of bathing him too much. (He would sit in his little pool/tub -without soap, 4-5 nights a week before bed. 1 night a week I would use Baby Dove on his hair. ) She diagnosed it as eczema.   *****On my take home paper the only things written are: PEDIARIX and rotavirus.  I was unsure of which Rotavirus to pick, there were two options.
This spontaneous report as received from a consumer refer to an approximately 7-year-old male patient. Current conditions included eosinophilic esophagitis and allergy to nuts. Approximately on an unknown date in 2005 (when the patient was 1 year old) was vaccinated with dose 1 VARIVAX (Merck) (lot# and expiration not reported) dose and route not reported. On 26-SEP-2012 he was re-vaccinated with dose 2 VARIVAX (Merck) (lot # and expiration date not reported) dose and route not reported. Concomitant medications included FLONASE. Titers were drawn approximately on an unknown date in 2011 (reported as 5 to 6 years later) which did not show immunity to Varicella, titers drawn showed less than 1 unit. Patient's mother stated that her son had been re-vaccinated but titers have not been drawn yet. Outcome of the event was unknown at the time of the report. The patient sought unspecified medical attention for the events. No further information is available.
Patient was pregnant and received her FLUVIRIN around 5 pm - At 6pm she called the pharmacy saying she had hives on her arms and legs. Because she was pregnant, I recommended she go to the ER. She had no difficulty breathing.
Headache; Heart rate rose to 88 Beats per minute; This case was reported by a consumer via call center representative and described the occurrence of headache in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix. On 24th September 2019, less than a day after receiving Shingrix, the patient experienced headache and heart rate increased. On an unknown date, the outcome of the headache and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the headache and heart rate increased to be related to Shingrix.  Additional details were provided as follows: A patient reported that he received the 1st dose of Shingrix yesterday and developed a headache not resolved by the next day.  He also stated that his heart rate rose to 88 Beats per minute. The reporter consented to follow up.
pt recvd vax; exp shaky chills; bad h/a, n for 24 hrs;
Chest pain. Shortness of breath. Elevated heart rate. Fatigue. Abnormal EKG, elevated troponin. Started on Aleve twice a day, without relief. Started on colchicine by his cardiologist. Missed several weeks of work.  Between July and October he had an urgent care visit, ER visit, several cardiology visits, primary care visit,  multi EKG's 2 ECHO's with the last one finding an abnormality which we will be following up on.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Allergy"; Tylenol, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: two negative tests 48 hours apart on Day 6 and Day 8. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid from 04Mar2023 to 09Mar2023 for COVID 19 Treatment. Lot number of Comirnaty was unknown since it was misplaced/ discarded.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107925 Same reporter/patient, different drug/event.;
Received telephone call from subject. She reports a local reaction to her right arm cirrounding the injection site of Tdap injection.  Symptoms developed within 12 hours of injection and woke her from sleep. Symptoms included limb pain, swelling, redness the size of a "thumb tack" where injection was given and generalized redness approximately 1 1/2" X 3" in size around injection site.  Subject has been self medicating with Ibuprofen which has provided pain relief.  Symptoms recur without medication.
Headache and nausea starting day one and continues today. I have called out sick from work on 3 occasions where the headache was so severe it caused me to vomit.  Painful at top or back of head and/or temples. I have rarely experienced headaches throughout my life. I am fairly healthy and very active.