chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021 at 10:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:14 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 65.91 for dose administered on 31-MAR-2021and 65.83 for dose administered on 03-MAR-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 31-MAR-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09.00 AM. This vial was moved to fridge on 30-MAR-2021 and beyond use date for the vial was reported as 29-APR-2021. Product moved to clinic on 31-MAR-2021. Batch number 014M20A underwent temperature excursion on 03-MAR-2021 with temperature 34 degrees Fahrenheit from 09:00 AM to 10.00 AM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-MAR-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 Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
chills; headache; fever / low grade temp; sore arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date. please refer the case US2020240919).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced chills, headache and fever. In December 2020, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, headache, fever and pain in arm were unknown.   It was unknown if the reporter considered the chills, headache, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix. The patient reported headache, chills, fever, and a sore arm. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240919:same patient
Case number PHEH2015US021597, is an initial spontaneous report received from health care professional on 22 Oct 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514901) intramuscularly on an unknown date. On 19 Oct 2015 the patient experienced numbness in her left arm that radiates down her arm towards her hand. This was the same arm where she received vaccination. The patient was planning to consult primary doctor on 23 Oct 2015. The outcome, seriousness and causality of the event were not reported.
Left arm tingling and numbness - continues today.  Left eye droopiness - x 1.5 weeks.  Resolved.
Injection site sore, not red, not swollen remains pain level 2-3 (1-10 scale). Thumb on same arm is painful to use since given shot, not red, some swelling, no tingling, pain level 6-7 without acetaminophen; w/acetaminophen pain level 2-3 at rest. Pain in both worsens when uses arm and thumb. Has used Advil and acetaminophen past few days inconsistently. Applied some heat.
- Burning sensation right after administration. - Arm  turned bright red and swollen the size of a baseball. - MD suggested ice and  prescribed Meloxicam for 7 days. - Swelling better after 14 days .
Redness and itching at injection site 15 minutes after injection. Symptoms resolved within one hour.
Presented w/ increased generalized weakness and urinary incontinence.  He has not been able to stand or ambulate today. She also noted he has increased balance problems and fell last week.  He was exposed to Covid 19 last week through a family member; tested positive for COVID-19; dx w/pna; tx w/abx, Vit C/D, zinc, steroids, remdesivir, did not require O2.
Bleeding and continue to erupt; Rash started on Right Arm and Spread (After Second Dose); Little Bumps All over the body (After Second Dose); Itchy All over the body (After Second Dose); Bleeding from scratching All over the body (After Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Little Bumps All over the body (After Second Dose)), PRURITUS (Itchy All over the body (After Second Dose)), SKIN HAEMORRHAGE (Bleeding from scratching All over the body (After Second Dose)), RASH ERYTHEMATOUS (Bleeding and continue to erupt) and RASH (Rash started on Right Arm and Spread (After Second Dose)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced BLISTER (Little Bumps All over the body (After Second Dose)), PRURITUS (Itchy All over the body (After Second Dose)), SKIN HAEMORRHAGE (Bleeding from scratching All over the body (After Second Dose)) and RASH (Rash started on Right Arm and Spread (After Second Dose)). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Bleeding and continue to erupt). At the time of the report, BLISTER (Little Bumps All over the body (After Second Dose)), PRURITUS (Itchy All over the body (After Second Dose)), SKIN HAEMORRHAGE (Bleeding from scratching All over the body (After Second Dose)), RASH ERYTHEMATOUS (Bleeding and continue to erupt) and RASH (Rash started on Right Arm and Spread (After Second Dose)) had not resolved.            No concomitant medication reported. Treatment medication included topical allergy medicine, anti iItch medicine green pills, Steroid Dose pack.
Headache, Arthralgia, Fever,  FATIGUE, CHILLS, LOCAL LYMPH NODE TENDER/SWELLING, PAIN/SWELLING INJ SITE Narrative:
chills; fatigue; injection site pain; swelling of neck; swelling throat; This is a spontaneous report form a contactable consumer(patient). A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 at 15:30 at single dose for COVID-19 immunisation at the age of 30-year-old. Medical history was none. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D 12 HOUR), ergocalciferol, retinol palmitate (VITAMINS A & B), paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient experienced chills, fatigue, injection site pain, swelling of neck and throat on unknown date. The patient was not treated due to the events. The patient recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained
15 minutes after injection, c/o numbness & tingling in rt. arm from deltoid to fingertips. No redness or swelling noted at injection site. Referred to PMD for follow-up.
The day of my shot, I fell asleep on my couch around 10p and woke up at 2:30 am shaking uncontrollably.  I didn?t have goosebumps, but felt cold from the inside, if that makes sense.   The only way I could get comfortable was to sleep in a bathtub in hot water for 4-5 hours.  I then went to my bed and slept for another 5 hours.    I called out of work Friday.
Approx 15 mins. after receiving vaccine, client c/o dizziness and nausea. V/S @ 1:25pm BP 162/82, HR 92, O2 98, AOx3 V/S @ 1:31pm BP 156/84, HR 80, O2 99. Client asked for and provided water; stated "feeling better." V/S @ 1:41 BP 152/86, HR 82, O2 98. No additional adverse reactions reported or observed. At 1:50 pm client left observation area unassisted and with a steady gait.
Dry heaves, vagal reactions that were super unpleasant including loss of bodily controls, argue all lasting from 7:00 am until 10:00 pm
her neuropathy was also a bit worse after those doses; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes and Neuropathy.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (her neuropathy was also a bit worse after those doses) outcome was unknown.            It was reported that patient had no any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that She experienced no other symptoms. She didn´t experience anything with the previous doses. Maybe her neuropathy was also a bit worse after those doses, but it was not unbearable, she could deal with it.  Treatment information was not provided. Company Comment: This is a spontaneous case concerning a 68-year-old female patient with a history of Diabetes and Neuropathy, who experienced the serious (due to medically significant) unexpected, event of neuropathy peripheral, which occurred on an unknown date after a dose of mRNA-1273 vaccine. It was reported that she experienced no other symptoms. She didn´t experience anything with the previous doses. Maybe her neuropathy was also a bit worse after those doses, but it was not unbearable, she could deal with it. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749431, US-MODERNATX, INC.-MOD-2023-749436 (E2B Linked Report). This case was linked to MOD-2023-749431, MOD-2023-749436 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749431:Same patient, spikevax 2023-2024 US-MODERNATX, INC.-MOD-2023-749436:same patient spikevax NOS case
24 hours later started to notice hives on my body. It started to progress as the time went by.
Developed a rash on my right arm, mostly by my shoulder, about a day after my 2nd covid vaccine does. Doctor felt that it was consistent with shingles. Rash persists a week later, itchy and red but mild. Treating with hydrocortisone.  No other discernable reaction to the vaccine.
INCREASED UPPER RESPIRATORY TRACT CONGESTION; STILL HAD SOME QUARTER SIZED PLAQUE FROM PLAQUE PSORIASIS WITH DRY SKIN; flush for 12 hours; fatigue and sore arm for four to five days; fatigue and sore arm for four to five days; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT CONGESTION (INCREASED UPPER RESPIRATORY TRACT CONGESTION), PSORIASIS (STILL HAD SOME QUARTER SIZED PLAQUE FROM PLAQUE PSORIASIS WITH DRY SKIN), FLUSHING (flush for 12 hours), PAIN IN EXTREMITY (fatigue and sore arm for four to five days) and FATIGUE (fatigue and sore arm for four to five days) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis.   On 11-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT CONGESTION (INCREASED UPPER RESPIRATORY TRACT CONGESTION), PSORIASIS (STILL HAD SOME QUARTER SIZED PLAQUE FROM PLAQUE PSORIASIS WITH DRY SKIN), FLUSHING (flush for 12 hours), PAIN IN EXTREMITY (fatigue and sore arm for four to five days) and FATIGUE (fatigue and sore arm for four to five days). At the time of the report, UPPER RESPIRATORY TRACT CONGESTION (INCREASED UPPER RESPIRATORY TRACT CONGESTION) and PSORIASIS (STILL HAD SOME QUARTER SIZED PLAQUE FROM PLAQUE PSORIASIS WITH DRY SKIN) had not resolved and FLUSHING (flush for 12 hours), PAIN IN EXTREMITY (fatigue and sore arm for four to five days) and FATIGUE (fatigue and sore arm for four to five days) had resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient had upper respiratory involvement and increased congestion. The Skyrizi was less effective than hoped and still had some plaques quarter sized with dry skin. After covid-19 vaccination patient had flush for 12 hours, fatigue and sore arm for four to five days. The reporter causality for the events Upper respiratory tract congestion and Drug ineffective with SKYRIZI was a reasonable possibility and events Plaque psoriasis, Flushing, Pain in arm and Fatigue with SKYRIZI was not provided. The reporter causality for the events Upper respiratory tract congestion, Plaque psoriasis, Flushing, Pain in arm, Fatigue and Drug ineffective with PFIZER was reported as possible.  No treatment information was reported.
Tingling in the mouth; This case was reported by a pharmacist via call center representative and described the occurrence of tingling mouth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tingling mouth. On an unknown date, the outcome of the tingling mouth was recovered/resolved.   It was unknown if the reporter considered the tingling mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced tingling in mouth. The event resolved after an unknown period of time. The reporter consented to follow up.
pt recvd 2 doses of Engerix-B & w/in 1 hr of 2nd dose began to exp h/a, nausea, vomiting, substernal chest pressure & some SOB; pt took DPH; exp difficulty breathing, tightness in chest & diaphoresis; pt taken to ER given 02; chest pain;
Local reaction at injection site (Severe swelling, purple in color, hot to touch, extremely painful), Nausea and Vomiting, Diarrhea, Fever of 101.3 at highest, Dizziness, Headache, Body Pain, Weakness and Fatigue, Chills. All symptoms have lasted, at this time of report, for almost 48 hours so far.
Urticaria  She is working with an outside allergist She is still noticing some urticaria. She is on cetirizine still. Overall this is improving. If she misses even one dose of antihistamines, urticaria recurs within a couple hours She is on Allegra 180mg in AM If has urticaria in AM- take two of these Midday she is on cetirizine 10mg daily Singulair 10mg in evening She did have her second dose of COVID vaccine (Moderna)just prior to the onset 2/16 and about 8-10 days after that, had onset Primary Care Dr. consulted with infectious disease
Obstructive jaundice with newly suspected widely metastatic pancreatic cancer, pathology pending.
The pt developed a fever approximately 4-5 hours post vax. The pt became listless. The fever went as high as 102. He had a poor appetite and drank very little. By the following day, the fever had resolved, but the pt still had a poor appetite and was tired.
Right biceps (where shot was administered) became pink, slightly inflamed, hot to the touch and extremely sore across a broad area. The inflamed area and soreness spread over the next 24-36 hours, including lymph node swelling under the armpit, then receded. also had a fever of around 99.6 to 99.8 in the 36 hours after vaccination; temperature returned to normal inside 48 hours. Also had general muscle ache and soreness similar to a cold/flu, which escalated in the first 24-36 hours and went away with the fever within 48 hours. Treated with Benadryl and Acetaminophen twice when symptoms were most severe but it wasn't particularly helpful.
21 year-old right-hand-dominant female received Flublok vaccine in left upper arm on 7 Dec 2019.  No other vaccines were administered that day. Patient denies anything unusual about vaccine administration. (Both vaccinator and vaccinee standing at time of IM injection.) Noted localized pain in deltoid at vaccination site (2/10 using pain scale of 0 (=no pain) and 10 (= worst pain ever experienced); described as "throbbing" type pain. Later that day, noted pain and swelling behind left clavicle. Did not think too much about the pain, as she thought it was a normal reaction.  Denies fever, chills, fatigue, generalized aching, headache, rashes, dyspnea, nausea, vomiting, and diarrhea. After 2 days, pain increased (highest intensity was 8/10, but usually rates as 5/10). Pain increases with movement (including reaching, lifting, adduction, and abduction of left upper extremity). Started taking Motrin for pain around post-vaccination day 3; reports Motrin helps  seems to "dull the pain". Has been limiting left upper extremity/shoulder range of motion due to pain. Notes pain when she lays on her left side, so she has been sleeping on her right side; as long as she does that, pain does not interfere with sleep. Denies significant local vaccination site reaction (i.e., redness, swelling, warmth, tenderness) or bruising at vaccination site. Denies left upper extremity weakness, paresthesias, numbness, or tremors.  Sought medical evaluation on 17 Dec 2019. Left shoulder exam noted  shoulder tender on palpation with focal tenderness to left clavicle with deep palpation. FROM without weakness. Pain elicited on motion. No swelling, erythema, warmth, and misalignment. No pain elicited during Neer impingement test, during Hawkins-Kennedy impingement test, and during O'Brien's test. No instability noted.  On Neurological exam, no weakness of left shoulder observed. Left shoulder x-ray was unremarkable. Patient was prescribed Diclofenac 1% topical gel for pain, which she is using and reports it helps decrease pain. Also, applying heat to area. Plan is to return for follow-up in 2 weeks if pain persists. Physical therapy referral will be considered if no improvement.  No history of trauma or injury to left upper extremity, shoulder, or clavicle. No previous reported pain impacting left upper extremity. History of chronic right shoulder pain starting in 2014 and continuing through 2018, with Orthopedic evaluation in summer of 2018.  Denies significant PMH. Not taking any routine medications. Allergies: PCN, amoxicillin. No history of previous vaccine reactions.
after the second one a undisclosed problem with my colon caused hospitalization; This is a spontaneous report from a contactable consumer reporting for self:  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included scalp psoriasis, itching scalp. Historical vaccine dose 1 of bnt162b2 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced after the second one a undisclosed problem with my colon caused hospitalization in 2021 with outcome of unknown. Therapeutic measures included "many bags of saline and antibiotics drips".  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
26 Y female who presents with a chief complaint of syncope.  Pt says that pta, she passed out shortly after she got her covid vaccine.  Says she received the vaccine, and stood up to go to the observation area.  Was walking through the doorway when she started to get lightheaded.  Says she grabbed ahold of the door frame, and slid down to the ground.  Denies injury.  Denies any prodromal symptoms, no sob, chest pain, rash, abd pain, back pain.  No leg swelling or calf muscle pain.  No other complaints.   History/exam more consistent with vasovagal syncope as opposed to reaction from the vaccine.  Canadian syncope rule puts her at very low risk (-3 points, 0.4% risk of 30-day serious adverse event).  Pt without ectopy on ED monitoring during observation period. F/u with pmd in 3 days for recheck, pt agrees to return for any further concerning symptoms
The patient complained that she had fever and chills the night of the administration on 12/19/18. She stated she felt "ill" all of Wednesday 12/20/2018 and could not get out of bed. The following day she was fine on 12/21/18. She has had no further complaints/problems. The patient stated she had trouble with the first dose in the series as well. She had stated she felt very poorly the next day after immunization and also had a red like rash lower on the left arm than where the injection site was on her first dose. She stated she did not have the rash with the second dose.