chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after vaccine pt developed some swelling to arm at injection site. 2 Days after administration Redness and Swelling to arm 10 cm x 17 cm. c/o painful to touch
Severe headache, nausea, vomiting, muscle and joint pain, weakness, fatigue and chills
Sore in back of mouth on right side, Itchy bumps X4 on left arm Itchy bumps X2 above left side of stomach and 2 more right side of lower abdomen
Patient received initial dose of HPV, TDaP and Menquadfi. It was reported by vaccine administrator, CMA, that shortly after administration of HPV (which was the last vaccine administered), patient smiled at the administrator and proceeded to fall forward from exam table. CMA attempted to hold patient up while falling down but did manage to hit forehead on linoleum flooring.  Mom called for help immediately and physician went into exam room to assess patient and was kept in clinic for additional hour for observation. Vitals were stable and patient and oriented when dismissed home with mother.
I feel like my throat and left ear has a chemical burn. I went to my Dr.'s office at 1 pm they said that I have a irritation to my throat and gave me a pain killer. Vicodin. The pain is so great that that is not relieving the pain.
approx 24hr p/vax dizzy x 2hr then had n/v & very fatigued few hr;later p/meal had GI cramping x 24hr;remained dizzy x 3 days;gradually other cleared of sx;
Could not find the second dose of vaccine on time, until 9 weeks later; A spontaneous report  was received from a 43 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and could not find the second dose of vaccine on time, until 9 weeks later.  The patient's medical history and concomitant medications were not provided.  On 06-JAN-2021, the patient received his first of two planned doses of mRNA-1273 (lot number: unknown) into the left arm for the prophylaxis of COVID-19 infection. On 10-MAR-2021, the patient received his second of two planned doses of mRNA-1273 (lot number: unknown) for the prophylaxis of COVID-19 infection.  The patient was expected to receive his second dose on 04-MAR-2021. However, the patient had second dose of vaccine after nine weeks from the first dose as pharmacy did not get shipment and when it did, pharmacy was only authorized to give first vaccine to patient, not the second dose, and was only recently authorize to give the second shot.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome for the event, inappropriate schedule of product administration, was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot# unknown, with no associated adverse events.
Pt recv vax 17JAN92 & on 25JAN92 pt awoke w/numbness on the rt side of face, drooping of rt eye & the corner of mouth; pt's exp was dx as Bell's Palsy;
vaccinated on 03/06/2020 / second dose is not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 6th March 2020).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The health care professional gave consent to follow up.
-Arm soreness started almost immediately, worsened within 8 hours, much improved by 48 hours -Bilateral trapezius myalgia, started about 10 hours later, unrelenting with heat/massage/oil/relaxation but still able to go out with a heavy backpack and hike, about 60% improved by 48 hours
Information has been received from a physician concerning a 13 year old male who on 24-DEC-1998 was vaccinated with first dose of MMR II (HSA route, site, dose and lot number not reported). On 04-DEC-2009 the patient experienced mumps (the diagnosis date was reported as 03-JAN-2010). The patient was febrile and had left parotitis. The outcome for mumps was not reported. Follow-up information was received from a physician. It was reported that the 17 year old (previously reported as 13 year old) patient experienced mumps on 05-DEC-2009. The diagnosis date was on 07-DEC-2009. On the same date, the patient had several tests performed: IgM was <1:10, IgG was 1.69 and serum amylase was 189. The patient was afebrile and had right parotitis. At the time of reporting, the patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
2 mo well infant recd 1st DTP/HibTITER/OPV on 14OCT91; 14 hours p/vax, pt died 15OCT91; cause of death diagnosed as SIDS;
11/27/2021 I began to notice itching on my scalp, right temporal area, it started to become a little tiny pustule as well. My heart rate increased from 100-110 until December and my sleep had been messed up as well. Reddish rash around the whole area. The back of my neck began to break out as well with similar symptoms. It has been continuing to persists till current day. Over the counter medication like Hydrocortisone and clindamycin to treat affected areas and the areas do get relief however it comes back again.
Itchy skin and mouth/throat, but no anaphylaxis, benadryl given
The first dose of Moderna was administered on August 31, 2021, I experienced very severe pain (in my arm) at the site of the injection for several days. The negative side effects were noted at the time of my second dose administered on September 30, 2021.  In addition to the severe pain in my arm, I had fever like symptoms in the evening of the second dose.  I also experienced a great deal of joint for several months after this second dose. I do have osteoarthritis and do get joint pain from time to time, but the joint pain was more severe and more often noted after the second Moderna dose.
Broke out in suspicious rash. Parent brought child in on 01/29/2013. Patient was diagnosed by another MD here at our practice with Chickenpox.
Approximately 10 minutes following the injection, patient was in observation area when she became pale and slumped over in her chair.   The vaccinating nurse, along with the help of her parents, lowered the patient to a supine position on the floor and I elevated her legs. . We applied ice packs to her neck and forehead and within 10 seconds, was able to respond appropriately to verbal stimuli.  Approximately 10 minutes later, the patient  felt well enough to sit up and drink water .  We continued to monitor the patient for another 25 minutes until she felt well enough to stand.  The patient was stable and discharged from the facility at 11:48 am in custody of her parents.  The patient ambulated without difficulty.  No further complaints of dizziness.   Skin pink, warm and dry.
Elevated blood pressure; Granulomas on elbow, chest, abdomen, confirmed as benign; This non-serious case was reported by a consumer via call center representative and described the occurrence of granuloma in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE BOOSTER) for prophylaxis.   The patient's past medical history included mastectomy (prior double mastectomy).   On 22-JUN-2022, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, the patient received Flu vaccine (right arm) and COVID 19 VACCINE BOOSTER (right arm). In JUL-2022, between 1 and 3 weeks after receiving Shingrix, an unknown time after receiving Flu vaccine and an unknown time after starting Cortison, the patient experienced granuloma (Verbatim: Granulomas on elbow, chest, abdomen, confirmed as benign). In JAN-2023, the patient experienced increased blood pressure (Verbatim: Elevated blood pressure). The patient was treated with cortisone (non-proprietary) (Cortison) and antifungals for topical use (Antifungal Cream). The outcome of the granuloma was not resolved and the outcome of the increased blood pressure was resolved.   It was unknown if the reporter considered the granuloma and increased blood pressure to be related to Shingrix and Flu vaccine.     It was unknown if the company considered the granuloma and increased blood pressure to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2023 The patient self-reported this case. The patient received flu vaccine and COVID booster around the time she received 2nd dose of Shingrix and stated that granuloma appeared just above the point of the right elbow around the beginning of July of 2022.  The granuloma got progressively bigger, as time passed.  The patient used fungal cream and cortisone on the spot, thought it was from a bug bite.  The patient saw dermatologist at the end of November/beginning of December of 2022, who diagnosed spot on elbow as a granuloma.  The dermatologist believed the granuloma was related to diabetes, but patient reported not being diagnosed with diabetes.  The patient reported experiencing elevated blood pressure in January of 2023, which resulted in pulmonologist ordering echocardiography and pet scan.  The patient reported granulomas in the chest and abdomen were discovered via the Pet scan.  The patient reported being referred to Oncologist, for biopsies of granulomas.  The patient reported granulomas were confirmed as benign.  The patient reported granulomas were simply present and did not bother them in any way.  The patient reported being uncertain of whether granulomas were related to receipt of Shingrix vaccine, but alleged they saw materials stating granulomas might be caused by vaccines. It was unknown if the company considered the granuloma and increased blood pressure to be related to COVID-19 VACCINE .  The reporter consented to follow up.
I noticed hives all across my torso/back about 6 hours after the vaccine. They wasn't terrible hives, but they were definitely there and a bit itchy. Hives stayed for two or three days.
Really bad headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headache) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE, ESTRADIOL, SERTRALINE, GABAPENTIN (NEURONTIN) and PROGESTERONE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (Really bad headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Really bad headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided          The patient noted that she did not normally get headaches, and that she experienced headache when she bent over and when she coughed specifically.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: contact details, concomitant medications and dosage information updated.
04/30/02 presents to office with hx of a scratch to right index finger ~ T wk prior. Today there is no visible scratch redness, or sign of wound of complications.
Stomach pain, nausea, back pain, acute  appendicitis by 02/17/2021 appendectomy on 02/17/2021
sore arm; feeling pressure in my chest; chills; fatigued; chest was pounding; BP was 155/102. Mine is normally 120/78 so very high for me; This is a spontaneous report from a contactable consumer. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER6955, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 16Apr2021 14:45 (age at vaccination 44 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 14:45 as dose 1, single for covid-19 immunisation and suffered from sore pain. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 19:00 the patient experienced sore arm, feeling pressure in my chest, chills, fatigued, fell asleep at 9:00 pm, woke up at 10:30 pm chest was pounding, bp was 155/102. mine is normally 120/78 so very high for me. The patient underwent lab tests and procedures which included blood pressure measurement was 120/78 (Mine is normally 120/78), blood pressure measurement was 155/102 on 17Apr2021 BP was (155/102). Patient did not receive any treatment for occurred events. The outcome of event was recovered.  No follow-up attempts are possible. No further information is expected.
1.5 subcutaneous nodule lasting approximately 2 weeks with accompanying 10 cm diameter patch of redness/swelling on left arm at injection site.
After 5 days  the patients arm was still very red and swollen. It was also very hot to the touch and it was getting worse. Patient was not running a fever but the swelling and redness was getting worse, not better. There was also a bruise about 4 inches in diameter surrounding the area from the vaccine. She denied taking any blood thinners or aspirin daily. She took Tylenol and used warm compresses to help with the swelling. I advised the patient to follow up with primary MD. I also contacted her MD to inform them of the adverse reaction.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 11-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.
Headache, Myalgia, bodyache;chills;ha;sorethroat;nasal congestion Narrative:  day 1-5: bodyache;chills 12/31: ha 1/3:ha; chills; sorethroat;nasal congestion
no AE; the vaccine was given four days after expiration; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 27-JAN-2022, the patient was vaccinated with expired dose (four days after expiration) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#T002843, expiration date: 23-JAN-2022) in dose 0.5 milliliter for prophylaxis (dose number, route of administration and anatomical location were not reported). No additional adverse events were reported. The outcome of expired product administered was not provided.
Seizure requiring 2 doses of IV medication. 6/29/09 Hospital ER records received DOS 6/17/09. Assessment: Second afebrile seizure. Patient presents with generalized convulsion. Post Diastat no acute findings. To follow up with PCP. Pedi neuro consult locally.
Following administration of dose 2 of moderna covid vaccine. pt has syncope episode and fell landing on butt and hitting head on floor. LOC elapsed 30 seconds. No seizures. Pt evaluated by onsite MD and placed on gurney to be evaluated at triage bay area. 1020am: BP 220/126 P120.  No meds and no previous allergies. 1050am: BP 176/104 P=85 . Pt was monitored and symptoms improved. Pt ambulated and was stable prior to d/c from vaccination site. onsite MD recommended for patient to follow-up with outside PCP if persistent elevated BP or symptoms.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 23-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml/once, subcutaneous, lot # J004266 expiry date 12-JUL-2014. Concomitant medications were not reported. The pharmacist reported that the patient was administered expired ZOSTAVAX. The ZOSTAVAX expired on 12-JUL-2014. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
When the administer jabbed me with the syringe she hit either my top joint area of the shoulder- left arm/bone or a nerve and I yelped fairly loud and by the time I was driving home (15 minutes) my arm went numb, while sitting at home after about an hour my arm was completely numb and I felt like my entire arm and fingers were not able to stretch out or movement was extremely limited, I could not work my arm up, out  or lift it to help myself... the aching was up my neck and down my side... Others within my house saw what was happening...I drank a lot of water and took an ibuprophen.  it has been 2 weeks and I still feel some pain, not as intense but if I try to put a sweater or shirt on, my shoulder still has a shooting pain.  It's better than the first week, but I will ask to have the next shot in my right arm and hope they inject lower down on my arm, closer to the muscle area.  This was a very very bad experience for me.
Patient's mother stated that the swelling and redness started on the night of 11/22/19. By the next morning the injection site was hard and red, swollen and big, Mom stated that child was sore and unable to do much all weekend. 11/24/19 mom stated that the site was 6.5  by 4.5 . This reaction was to the DTaP vaccine on the left thigh. This am 11/25/19 child's leg seems to be going down and is possibly getting better.
Day #1 Left upper arm, Flu shot. Day #2 Site extremely swollen, red, hot to touch, itchy deep under site. Approx 7"x7" cm site lymph node swollen under left arm lasted thru the weekend.
This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On 4th May 2018, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The caller said they failed to report an incident that was relayed to them on Friday, 4th May 2018. The nurse reported that her husband got SHINGRIX vaccine and experience adverse event.
1) All over body aches    2) Headache.   3)Chills.  4) Fever ( 100.6.).   5) Nausea
Within a couple minutes of the vaccination, pt reported "itching behind the ears", "then heart started beating quickly and felt panicked like I had to get out of the shot location and get mask off."  She developed hives on the chest around midnight that evening. She took an allegra. Hives resolved in about 3.5 hrs. She had intermittent itchy head for a couple of days after the vaccine. She also had a sore arm where the injection was administered for a few days.
Rash C4-C8 deimatomes vesicular patch g 1-3 inches.
Itching over my entire body. Body pain continues today. Fatigue; headache; swelling; loss of taste; unable to sleep. I have not slept for more that 2 hours since 10/12/2021. Treatment: Prednisone, Advair, Mometasone and Benadryl.
Shot given  2-4-21 at 1236, woke up at  2-5-21 at 0130 with severe uncontrollable shaking that last approximately 2.5 hours.  Joint pain was unbearable, felt like muscles were being torn apart,  tried getting out of bed and hit the floor because of lack of muscle control.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 10:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.47 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).