chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First generalized itchiness, then hives, then difficulty breathing. I went to the ER and was given epinephrine and was treated emergently for concerns over anaphylaxis. Since 02/08/22, I have been to the ER twice and have used my epi pen once. I am still breaking out into hives and have no idea what it could be from aside the vaccine. I have never had hives or allergies in the past, I was always healthy and since the booster this has since changed.
2 days p/inject pt started having severe pain in upper arm, shoulder & back of neck; referred pt to MD;
Parents state baby cried and stayed fussy ever since shots were given - could not console - ran fever of 102 at home - was 103.4.  Right in office day after shots were given - was 98.4 before shots were given.
that's when the itch came; light rash, a small area; red mark on where the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark on where the needle went in), RASH (light rash, a small area) and PRURITUS (that's when the itch came) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Biceps tenodesis (Patient has bicep tendonitis in both arms;). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE, FAMOTIDINE, LEVOTHYROXINE and AMLODIPINE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red mark on where the needle went in). On 30-Jan-2021, the patient experienced RASH (light rash, a small area). On an unknown date, the patient experienced PRURITUS (that's when the itch came). At the time of the report, VACCINATION SITE ERYTHEMA (red mark on where the needle went in) and RASH (light rash, a small area) had not resolved and PRURITUS (that's when the itch came) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PT prefers to get both vaccines at the same arm (right arm) and next day she start experiencing arm swelling, redness and soreness. After pt took tylenol 500 mg 2 days later pt felt better and the symptoms went away,
For 6 months I have had episodes of Ventricular Tachycardia,  PVCs, and PACs with no prior history. From April to about August I had chest pressure and numbness on left side of face. Thankfully this wasn't a stroke. I am still seeing cardiologists and a neurologist to figure out what exactly is wrong. Pain in neck going down to shoulder which is sometimes a dull tingling feeling. Body tremors all over body randomly throughout the day.
RINGING IN EAR; HARD TO CONCENTRATE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced ringing in ear, and hard to concentrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in ear and hard to concentrate was not reported. This report was non-serious.
Severe body pain that  was worse than body aches and some minor facial twitching that resolved within a couple of hours and swollen lymph nodes in my neck.
Shortly after receiving the COVID19 (Janssen) vaccine the patient reported being faint. While seated with her partner the patient briefly lost consciousness. She regained consciousness quickly and was provided with water, a snack, and a cool/damp towel. The patient was instructed to elevate her legs and maintain a clear airway. Patient remained seated. Patient affect normalized within 10 minutes and the patient reported feeling much better shortly thereafter. Patient and her partner remained waiting at the pharmacy for a total of 30 minutes to ensure that she was alright. Patient reported that she has experienced fainting episodes in high stress situations in the past (eg at concerts, events, etc) and maintained that she will be ok.
The 6/14/21 vaccine consent form completed by the patient and facility staff indicated that patient was not vaccinated with Covid-19 vaccine. However, after vaccination I found out that the patient was vaccinated with 2 dose series of Pfizer vaccine on 3/3/21 & 3/20/21.
Information has been received from a lawyer regarding a case in litigation concerning a patient (age and gender unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-JUN-2013, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a healthcare facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-SEP-2015, the patient was treated (by an unspecified healthcare professional) at a healthcare facility, for a persistent and severe vesicular rash, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Pain in her arm, red and swollen. Advised ice compress and Advil as needed for pain.
I noticed the area on my Left arm had become dark in the same place where the 1st rash presented.; Over the next few days, that area became red, itchy & inflamed; Over the next few days, that area became red, itchy & inflamed; Over the next few days, that area became red, itchy & inflamed; It started out as a dark spot about the size of a dime & grew in size to cover the entire arm crease and an area 1.25 inches above and below the crease; This 2nd rash has become more pronounced & I realized I needed to inform someone.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jul2021 16:30 (Lot number: FA7484) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: IRON. Past drug history included: Isoniazid, reaction(s): "known allergies: Isoniazid". Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EW0181, Administration date: 26Jun2021, time: 14:15, Vaccine location: right arm), administration date: 26Jun2021, when the patient was 47 years old, for Covid-19 immunisation, reaction(s): "I developed a very small rash in the crease of my Left arm", "few slight bumps in the crease of the right arm". The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 09Aug2021, outcome "not recovered", described as "I noticed the area on my Left arm had become dark in the same place where the 1st rash presented."; INFLAMMATION (non-serious), ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 09Aug2021, outcome "not recovered" and all described as "Over the next few days, that area became red, itchy & inflamed"; RASH MACULAR (non-serious) with onset 09Aug2021, outcome "not recovered", described as "It started out as a dark spot about the size of a dime & grew in size to cover the entire arm crease and an area 1.25 inches above and below the crease"; RASH (non-serious) with onset 09Aug2021, outcome "not recovered", described as "This 2nd rash has become more pronounced & I realized I needed to inform someone.". Therapeutic measures were taken as a result of skin discolouration, inflammation, erythema, pruritus, rash macular, rash.  Additional information: Initially, patient had put on 91 percent alcohol & iodine on it to prevent an infection and left it alone, thinking it would go away just like the 1st rash did after the 1st shot. However, this 2nd rash has become more. Patient had no covid prior to vaccination. Patient had not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
After 30 minute wait, c/o metallic taste in mouth, chest tightness, dizziness, tingling lips and tongue feels "swollen / hairy". Benadryl 50mg IM given and person taken to the Emergency Department for further evaluation and treatment.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no known drug reactions/allergies. The patient's medical history included cancer. On 11-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000427, 0.65 ml, subcutaneous in the left arm. Concomitant therapies included omeprazole (manufacturer unknown) and clobetasol propionate. Few days later, in approximately May 2013, the patient experienced throbbing and aching at the injection site. Recently, in approximately June 2013, the patient noticed blisters on the lower quadrant of the stomach, buttocks and scalp. The outcome of the events was reported as not recovered/not resolved. On 05-JUN-3013 the patient was given valacyclovir as a treatment for the AE. The patient saw physician seeking for medical attention, who gave the patient a prescription that was brought to the pharmacy. Additional information has been requested.
My period started on 09-05-2021, even though I was taking Junel. There was no reason why period started. It has finally started to taper off since yesterday.
Shaking uncontrollably; I became very hot and removed all the warm clothes; Aches; Sore arm; Chills; had a slight headache for a few hours; Had a little fatigue, tired earlier than normal; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shaking uncontrollably), FEELING HOT (I became very hot and removed all the warm clothes), PAIN (Aches), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 28-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 on 14-Jul-2022. Concomitant products included IBUPROFEN for an unknown indication.   On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 07-Nov-2023, the patient experienced TREMOR (Shaking uncontrollably) and CHILLS (Chills). 07-Nov-2023, the patient experienced FEELING HOT (I became very hot and removed all the warm clothes), PAIN (Aches), PAIN IN EXTREMITY (Sore arm), HEADACHE (had a slight headache for a few hours) and FATIGUE (Had a little fatigue, tired earlier than normal). On 07-Nov-2023, PAIN (Aches) had resolved. On 08-Nov-2023, TREMOR (Shaking uncontrollably), FEELING HOT (I became very hot and removed all the warm clothes), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), HEADACHE (had a slight headache for a few hours) and FATIGUE (Had a little fatigue, tired earlier than normal) had resolved.            Patient took both the COVID and Flu shots at the same time. He started with a sore arm a few hours after the shot that lasted for probably 12 hours and had a little fatigue, tired earlier than normal. About 12 hours after the shot, he woke up with chills and shaking uncontrollably, so he put on warm clothes and that stopped about 30 minutes later. He had a slight headache for a few hours and aches for 2 hours as well. Then, he became very hot and removed all the warm clothes that he had needed before. About 18 hours after getting the shot, he had slight fatigue but otherwise back to normal. Treatment information was not reported.
Not feeling well; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling well), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (Not feeling well), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Not feeling well), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact.
Expired Dose Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received HAB (Twinrix) (batch number 93KF5, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Itchy; Bright red all around it; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received Second dose of bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as dose 2, single for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On Mar2021, the patient experienced itchy, bright red all around it. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Symptoms began the night of 11/11/2021 with intense itching of back, then legs, trunk, then hands/feet. Severe symptoms lasted several days with itching, hives, dermatographia, and burning present. Benadryl taken with some relief. Symptoms persist currently but milder.
6th course of Anthrax vaccine. No previous reactions. Injection site appears similar to insect sting.  Swelling, redness, tenderness, painful, hot to the touch, itchy, right upper arm. Symptoms appeared morning after injection and have not subsided. Injection was more painful than normal.  Will visit clinic tomorrow. Pamphlet provided listed these symptoms as normal; I disagree.
Pt vaccinated with DTP became limp, had circumoral cyanosis & cyanotic nail beds lasting 45 seconds. Father did CPR and brought to ER. Pt admitted for apnea work-up.
Rec'd PPV 23 about noon 9 reports chills and fever of about 100 deg by 4pm. By next morning, (R) arm was swollen and warm, no discoloration. She treated with warm packs and movements. Took "long nap" 12-14-07. Arm back to normal by 12-16-07.
Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not use any concomitant or regular medication.  The vial did not undergo any temperature excursions. The patient did not experience any adverse events and no treatment was taken.
5/2/2018 Visit with FNP-Pt. states that she didn't notice any initial symptoms outside of the customary soreness that she normally has with vaccination to her arms. Three to four days after the injection she began to have an increase in her left shoulder pain that has led to inability to move the arm related to pain. Denies radiation down her arm but states that when attempting lift her left arm she will get a 'sting' that travels up her left neck. She has taken 800 mg ibuprofen every 6-8 hours for the past 3-4 days without good relief. She is also using moist heat packs to her shoulder. Pt. with TTP over lateral aspect of left deltoid with mild swelling. No noted erythema or drainage. Pain to left shoulder with active and passive abduction and with extension of the left shoulder posteriorly. No spinal or trapezius TTP. Pt. will continue resting shoulder and applying moist heat. Can alternate TYLENOL and Ibuprofen. Should use TYLENOL as main stay while taking Prednisone 50 mg tabs - take one tablet x7 days. RTC 1 week to see Dr. 5/9/2018-Visit with MD-Pt states "no change". Left Shoulder Exam: Visual Inspection: No swelling, no ecchymosis, no erythema, no deformity. Palpation: No warmth, no acromioclavicular tenderness or step-off, no sternoclavicular joint tenderness, no subacromial space tenderness. Small pinpoint of pain over old injection side below the ACJ laterally directly. Range of Motion: Does not have flexion and abduction past 90 without severe pain either passively or actively. Negative scarf sign and empty can test. No pain under axilla and no lymph nodes palpated. Pain is severe if passively goes above 90. Seems to favor the shoulder as well. Strength: Difficult for assessment due to pain. Special Tests: No pain with Hawkins test (impingement), no pain with Cross-Body Adduction test and negative Apprehension/Relocation test (shoulder instability). Shoulder injury related to vaccine administration SIRVA-PPT from Oct 2017 on CDC website found. Reviewed injury and history on site and fits with the description of about 1000 reported VAERS from 2010-16. Ice packs to shoulder for 20-30 minutes every 3-4 hours for 2-3 days or as needed. Anti-inflammatory medications, taken with food, as directed. PT appointment for other modalities. Will continue to ice and do ROM exercises as well. Will report to VAERS.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 09-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with  expiration date: 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 168 hours, with a lowest recorded temperature 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1 F (also reported as -1 Celsius degree) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
5 doses were given from a vial exposed to several tempereature excursions; 5 doses were given from a vial exposed to several tempereature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that vaccines exposed to temperature out of range. Too warm Too cold  On 28-Jan-22  at 1.8 Degrees Celsius for 1 hour On 27-Jan-22  at 8.7 Degrees Celsius for 30 mins On 03-Feb-22  at 12.3 Degrees Celsius for 1 hour On 09-Feb-22  at 11.4 Degrees Celsius for 30 mins On 10-Feb-22  at 8.2 Degrees Celsius for 30 mins On 09-Feb-22  at 11.4 Degrees Celsius for 30 mins On 28-Feb-22  at 8.7 Degrees Celsius for 30 mins On 03-Mar-22  at 11.7 Degrees Celsius for 30 mins On 08-Mar-22  at -199.9 Degrees Celsius for 30 mins which was the minimum temperature On 13-Mar-22  at 1.9 Degrees Celsius for 1 hour  Hours accumulated 3.5 2.5  It was reported that the storage condition at the time of the excursion was refrigerated storage and total 5 vials were involved.
severe screaming x 4-6hr;6hr post vax severe swelling of leg;tx w/cold packs & APAP;
Patient received 2nd dose of Pfizer on 9/28/21, eight days after the first dose