chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling cold; Feeling tired; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), FATIGUE (Feeling tired) and PAIN (Achy all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FEELING COLD (Feeling cold), FATIGUE (Feeling tired) and PAIN (Achy all over). On 29-Jan-2021, FEELING COLD (Feeling cold), FATIGUE (Feeling tired) and PAIN (Achy all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship is possibly related.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Upon internal review on 27 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was reported, which was an error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship is possibly related.
Wrong vaccine given. No reported adverse events. Patient notified. Will contact office if symptoms/reactions occur.
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 56 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. No known events were reported after vaccination (dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A  expiry: unknown) dose was not reported,1 total administered on 27-NOV-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.   On 27-NOV-2021, the patient received half dose for booster dose (captured as: vaccine under dose) and off label use (dose number in series 2). As described by reporter, HCP (health care provider) (from public health dept.) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients from unknown locations. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated that local distributor is the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports. (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211200675, 20211200717, 20211200723, 20211200769, 20211201179, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202371, 20211202379, 20211202469, 20211202515, 20211204104, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926 and 20211220155.
No adverse event; given an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (given an expired vaccine).    No concomitant medications were reported. The patient had not reported any adverse event at the time of the call. It was not asked if this were the patient's 1st or 2nd dose. No treatment medications were reported.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324604, 2018SA324609, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324605 and 2018SA324604 (same reporter). This case involves an elderly male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ048AB; expiry date: 31-May-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and Deteriorated drug administered. It was not reported whether the patient experienced any adverse events. 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 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. Documents held by sender: none.
Myalgia, Fever, SkinRash, Rah & ErythemaMultiform Narrative:
So that evening my left arm had minor discomfort, by the next morning I had a tennis ball size knot on my arm that was hard, tight, red and painful and it lasted until monday 03/15. The pain and discomfort subsided but on 3/21 it was hard and painful again.  its tight and large and uncomfortable. and has been that way consistently until today 3/24 so far. It is hot to the touch.
Swelling of face, upper and lower eyelids, upper and lower lips-unable to open mouth. Recovering.
Extreme  pain in the arm, extreme fatigue, headache not treatable with tylenol. Extreme fatigue. Flu like fatigue. Swollen  painful lymph node in left side in the armpit , blurry vision
The facility was located in a parking garage.  My daughter received the injection and we drove up to the 2nd floor to park and wait the 15 minutes for observation.  Before we even parked she began not feeling well.  As I was parking pulling in to park she said she felt like she was going to pass out.  I told her to put her chair back and I parked.  I got out to walk over to the passenger side of the car and when I opened her door she kicked out and hit me in the leg.  When I looked inside the car she was having a seizure.  She was arched back with her hands clenched in fists against her chest and her legs kicked out several  times kicking under the dash.  She was unresponsive and I called for the nurses on site.  When I went to the backseat I continued calling her name and got no response.  The nurses arrived and began calling her name.  She then came out of the seizure.  They checked her vitals and brought her juice.  We stayed for an additional 30 minutes of observation.  I mentioned this episode to a Dr at her Pediatrician's office and she said she had not heard of anyone having a seizure.  My daughter recently was diagnosed with a sinus infection on 1/10/22 and I described this experience to her because I had my daughter scheduled for the booster.  She advised me to report this and not have my daughter get the booster.
Patient reported that he developed symptoms within 24 hours of vaccination. Symptoms included productive cough, shortness of breath, gagging, "questionable" pneumonia (per chest xray). Patient had arm pain for 3 weeks. He was seen at urgent care clinic after vaccination (unknown timeframe) and was prescribed albuterol, tessalon perles, steroid, and zithromax for COPD exacerbation. He followed up with primary care on 11/02/2021 where chest xray was ordered. No additional medication/treatment was given.
pt recvd vax; BP 76/44 11:20; apprehesion; faint feeling; chest pressure; lungs hurt; warm; P 76; pale epinephrine given sc; 94/50 - 100 11:25; 136/66 P-84 11:30; ambulance personnel arrived; 11:40 to er per ambulance;
Sore arm neck; Sore arm neck; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on left arm on 30Jan2021 at 10:30 AM at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced sore arm neck on 30Jan2021 at 20:00. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was unknown.  The information on the Batch/Lot number has been requested.
c/o pain @ time of inj from neck to fingers;very painful since inj site redness w/induration of 2 1/2" hot to touch, not able to use arm;has had flu shot past 5 years w/o problems;
Heart palpitations, shortness of breath, stomach pain, muscle spasms in back stomach/chest, tingling in hands/feet, uncontrollable constant anxiety, brain fog/memory problems, decrease in cognitive ability, terrible fatigue, vertigo, hot and cold flashes.
One week after 2nd dose of Covid Vaccine I had an vasculitis outbreak on my legs.  After that I had several more vasculitis outbreaks about 3 weeks apart for 6 months.
administered a dose of Boostrix on 21Jun2023 from lot number 4M2EZ, which had an expiration date of 03Jun2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 21-JUN-2023, the patient received Boostrix. On 21-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Boostrix on 21Jun2023 from lot number 4M2EZ, which had an expiration date of 03Jun2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-Jun-2023 The pharmacist reported that an patient was administered with a dose of Boostrix The vaccine administration facility was the same as Primary Reporter Patient received a dose of Boostrix on June 21, 2023, which was expired on June 03, 2023, which led to expired vaccine used. The reporter consented to follow up.
Approx 18hrs post vax pt dev urticaria, blepharitis, & mild glossal edema;
I tested positive for COVID-19 on 12/11/22. I had a fever of 101 for two days and then it went down to 99. I also had a headache, cough, brain fog, and fatigue. I contacted my doctor and was prescribed PAXLOVID, but I decided not to take it because of all the rebound cases associated with it. I did take TYLENOL for aches and pains, and CLARITIN for stuffiness. I still have a hacking dry cough and was prescribed prednisone and albuterol.
I saw and evaluated the patient. I agree with the findings and the plan of care as documented in the Fellow note.  Of note patient is a 17yo male with no significant past medical history who received the second dose of his Pfizer COVID19 vaccine on 5/25/21. This morning he woke up with chest pressure and eventually was seen at an outside hospital ED. EKG was concerning for possible myocarditis and he was transferred further work-up of myocarditis. On arrival, echocardiogram was performed demonstrating grossly normal LV function with some suggestion of apex hypokinesis. EKG was repeated and showed ST elevation in lead I and V1. Troponin was elevated at 1.11. On exam, no murmurs rubs or gallops. No known family history cardiomyopathy. I personally reviewed the echocardiogram. Overall, patient is a 17yo male with what appears to be myocarditis that is temporally associated with the second dose of the MRNA Pfizer COVID19 vaccine. We have seen several of these patients with similar presentations over the past few weeks and most seem to respond well to treatment with IVIG and steroids. We will confer with our Rheumatology and ID colleagues. Plan will be to obtain cardiac MRI in the next 24 hrs. Ibuprofen PRN for pain. Will trend troponin and EKG.
Fever, flu-like symptoms (headache), excessive sleep (15+ hrs/day) about 6 days. Body ache/chills.
intermittent itching; Malaise; Chills; Headache; redness developed immediately/red patch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness developed immediately/red patch), PRURITUS (intermittent itching), MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 1994, Blood pressure high since 1994, High cholesterol since 1994 and Glaucoma since 2004. Concomitant products included VITAMIN D NOS, BIFIDOBACTERIUM LACTIS, LACTOBACILLUS ACIDOPHILUS (ULTRAFLORA BALANCE), LEVOTHYROXINE from 1994 to an unknown date, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) from 1994 to an unknown date, ROSUVASTATIN from 2016 to an unknown date, TIMOLOL MALEATE from 2004 to an unknown date, IBUPROFEN (ADVIL [IBUPROFEN]), CYANOCOBALAMIN (SUBLINGUAL B12), CALCIUM CARBONATE (CITRICAL [CALCIUM CARBONATE]), ASCORBIC ACID (VITAMIN C ACID), FLAXSEED, CENTRUM SILVER +50, UBIDECARENONE (COQ10 [UBIDECARENONE]) and FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) for an unknown indication.   On 10-Feb-2021 at 5:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 1:07 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (redness developed immediately/red patch), MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache). On 10-Mar-2021 at 1:17 AM, the patient experienced PRURITUS (intermittent itching). On 11-Mar-2021, ERYTHEMA (redness developed immediately/red patch) had resolved. On 24-Mar-2021, PRURITUS (intermittent itching), MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No Treatments were reported.   This case was linked to MOD-2021-020649 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up received on 23-OCT-2021 Updated Patients demographic, Initials, Date of birth, and Event stop details.
Large local reaction (erythema, swelling, tenderness) on injection site with blotchy skin all around deltoid muscle.
Fever started evening of vaccine, next day fever shot to 104 - then taken to emergency room where next 4 days fever kept going up and down. 2 antibiotics every 6 hours and pain meds by IV. Delirious at times injection site red and infected couldn't move.
Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster; Sick after booster; Fever after booster; Chills after booster; Headache after booster; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster), ILLNESS (Sick after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and HEADACHE (Headache after booster) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067421A, 027A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced ILLNESS (Sick after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and HEADACHE (Headache after booster). On 15-Dec-2021, the patient experienced COUGH (Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster). At the time of the report, COUGH (Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster) had not resolved and ILLNESS (Sick after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and HEADACHE (Headache after booster) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Received shot ~12:15pm on March 21st. Only symptom throughout the day was sore arm, but tolerable. Around 10:30 PM, I was in bed and noticed that I feel "agitated" and restless. Looked at my FitBit and noticed that my heartrate was unusually high and climbing. My normal resting heartrate is 60-70 bpm. Last night from 10 PM and onward, it rose from 75 pm up to 130  bpm while I was laying down in bed. Soreness in my arm became much worse and more uncomfortable. I focused on breathing slowly and deeply to try to relax myself but did not have any effect. Throughout the night I could feel my heart racing, fluttering and palpitating. Sometimes I could feel "pinching" like sensations too. Every time I was able to fall asleep, I was quickly jolted awake by those fluttering and racing sensations in my chest. I got up ~2 hours later to get a drink of water and had a low-grade panic attack (lost sense of hearing), felt very weak and light-headed, started sweating profusely. Those symptoms let up a bit around 4AM and I was able to sleep lightly. I continued to feel "agitated" and restless all morning until about noon today, a full 24 hours after the shot, 12 hours after symptoms started. My resting heart rate finally started to return to normal at about that time as well. Felt fine and pretty normal by about 1:30ish PM today.
After receiving the Flu vaccine on 10/25/07 at approximately noon, client felt unusually fatigued for the rest of the day. Upon waking, she felt 'like there was a 20 lb weight on her chest and increased swelling in throat and felt some difficulty breathing. Physical exam did not reveal any worrisome issues. recommended that she take diphenhydramine 50 mg QID prn swelling, sense of difficulty breathing. Reviewed emergency care available in area if needed later during weekend.
Fainting, shaking all body, difficulty breathing, hyperglycemia, convulsion, pain on shot area. Called 911 to translate  at emergency room.
pt recv vax & has not reacted to prev & 4 hr p/vax had edema, erythema of face & mouth;no other rash or wheezing noted by mom;
This was my 2nd shot and I developed two red, raised area on my arm. One was smaller at the site of the shot, the other was much larger slightly down from where the first one was. My arm hurt and was itchy.
Vaccine administered at approx. 6:30 PM 9/25/13. At about 3 AM 9/26/13 pt. had a hot flash followed by chills and severe tremors. Went to ER approx 4 AM. Tremors got less and less. Pt released. No previous reaction to flu vaccine.
Patient was given his 2nd Moderna vaccine 11 days before the recommended time between the 1st and 2nd dose.   Patient has been informed of the vaccine administration error.
A parent reported that her 2 month old daughter received poliomyelitis, DTP, and Hib vaccines and subsequently experienced shaking and uncontrollable crying for 24 hours. MANUFACTURERS COMMENT: The lot number for Hib vaccine was reported as M650SH, this is not a valid Lederle lot number. This report was received form Merck.
Starting the day of vaccination, the patient started experiencing nasal congestion, frequent sneezing, throat and chest discomfort. He did not have any shortness of breath or difficulty breathing. He treated with Benadryl and Zyrtec and symptoms resolved in 24 hours. At clinic visit 3 days later, he is only experiencing mild throat discomfort with no associated SOB.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. ON 18-MAY-2015 the patient was vaccinated intradermally, with a dose of M-M-R II (lot #, strength, dose and frequency were not reported). On the same day, the patient experienced little cellulitis (location not reported). The patient sought medical attention - visited office. The outcome of cellulitis was reported as recovering/resolving. The relatedness between vaccination with M-M-R II and cellulitis was not reported. Additional information has been requested.