chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad welts everywhere; hard time breathing; his hands, arms,swollen; testicles are swollen; a full-blown rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (bad welts everywhere), DYSPNOEA (hard time breathing), PERIPHERAL SWELLING (his hands, arms,swollen), TESTICULAR SWELLING (testicles are swollen) and RASH (a full-blown rash) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (bad welts everywhere), DYSPNOEA (hard time breathing), PERIPHERAL SWELLING (his hands, arms,swollen), TESTICULAR SWELLING (testicles are swollen) and RASH (a full-blown rash). At the time of the report, URTICARIA (bad welts everywhere), DYSPNOEA (hard time breathing), PERIPHERAL SWELLING (his hands, arms,swollen), TESTICULAR SWELLING (testicles are swollen) and RASH (a full-blown rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist noted that it was a severe allergic reaction and did not recommend patients to receive the second dose. The pharmacist recommended the patient to go to urgent care to receive a corticosteroid injection as his hands and arms were still swollen at the time of reporting.  No concomitant drug information provided.  No treatment drug information provided.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Patient received the flu vaccine around 11:30 am, towards the end of her WCC appointment today. She reports developing a couple itchy red bumps around noon while at school. States she developed more itchy red bumps to stomach, chest, shoulders over the course of the afternoon. Father brought patient back to the clinic at about 4:30 pm. There were no other changes to meds, foods, detergents, lotions or any other possible cause of allergic reaction. Denies respiratory or swallowing concerns - vitals stable. Patient was given BENADRYL 25 mg PO x 1 and she can receive every 6 hours. ER precautions provided for any respiratory involvement or difficulty swallowing.
Redness and swelling at inj site back of RT arm. Noticed swelling and redness 2 days after imm given. Area of redness 2 inches wide and 2 1/2 inches long warm to touch (top to bottom).
Patient developed a diffuse maculo-papular rash (papular urticaria) all over body on 3/6/2021.
This spontaneous report as received from a pharmacist refers to a 71 years old female patient with penicillin. No pertinent medical history reported. It was reported that the patient was given on 25-OCT-2012, the patient was vaccinated subcutaneously with a 0.65 mL dose ZOSTAVAX (lot # 0168AE; exp. date: 06-MAR-2013) and went to the pharmacy 1 week later (November 2012 approximately) because the injection site was red and inflamed. The patient went to the pharmacy on 14-NOV-2012 and the area was the size of a tennis ball circumference and black and bruised. No treatment was given. At the time of the report there were not any issues from it such as pain but it was still there. The patient seek medical attention, he visited the pharmacy. Concomitant therapy included 7-8 unspecified maintenance medications. The outcome of the events was unknown. The relatedness of the event with ZOSTAVAX was not provided. Additional information has been requested.
Sore arm, swollen, red, hot injection site, headache, muscle aches.
Within 2 hours of injection my arm was really sore, unlike the first shot. Around 3-4pm extreme headache started, along with swelling and redness and heat in rt arm. About 8pm arm was burning, huge lump and bright red. Could barely move arm. Headache persisted and I was starting to feel exhausted and nauseous. Went to bed and woke up at 3am disoriented, couldn?t move arm(still had fire/burning sensation, large lump), headache and nausea.  At 7am got up,  for maybe 1 hour and had to go back to bed. Exhausted, extreme headache, nausea and severe arm pain. Was more red, swollen and still burning. Literally slept all day and night. Around 4pm I had a fever of 102.3 and that was after having taken 3 hydrocodone pills throughout the day.  Head and arm hurt so bad I couldn?t get out of bed, was too fatigued and exhausted to do so anyway. Woke up at 10 am next day and all symptoms were still there.  Fever was down to 101.3 at 3pm, again after having taken pain medication. I slept all that day as well. Upon waking Sunday morning around 8am my headache was now la little less severe, nausea was gone and I felt like I was thinking clearer. Got up for only about 5 minutes and had to go back to bed due to exhaustion and fatigue. This went on until about 5pm. I think I got up 3 times trying to stay out of bed. I think fever broke around 8 pm that That night. Now I have a rash and burning/redness on arm that is itchy.
Migraines, nausea,  fatigue,  muscle pain throughout body, sore throat. Symptoms started on 4/9.
Joint pain, some SOB, nausea, chills, and sweats. 4 cm erythematous area at site of injection.
Information has been received from a registered nurse concerning a 10 year old female who on 04-JUN-1997 was vaccinated with Varivax. The patient had no pertinent medical history and no allergies/reactions. There was no concomitant therapy. On 09-JUL-2006, the patient sought medical attention for chickenpox. She had more than 50 lesions all over her body. The patient's chickenpox persisted. It was reported that the patient had been vaccinated at another office. Thus, the vaccine lot# was not available at the time of reporting. Follow-up information from the registered nurse indicated that the office did not administer the  vaccine and they could not provide any additional adverse event information. Chickenpox was considered to be immediately life-threatening. Additional information is not expected.
Patient felt tingling on lips and hot within 15 minutes of vaccination.  Took Benedryl and was released to home.
back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.
Patient came to the receptionist's desk shortly after recieving his vaccination stating his abdomen felt "tight."  With further questioning by provider, he also endorsed feeling slightly lightheaded and dizzy.  He was moved to an exam room for examiniation and monitoring.  Patient found to be bradycardic but otherwise normal vitals (108/70, HR 56, T 97.5, O2 98%).  Patient slightly pale.  Patient given water and offered a snack which he declined.   Patient later reported he had experienced this same abdominal sensation earlier in the day prior to vaccination.  Described as "tight" and "like something's in there that needs to come out."  Denied history of constipation or recent GI illness including nausea, vomiting, and diarrhea.  During his vasovagal response, he was unclear if he felt nauseated; at one time he thought he might feel a bit nauseated but then later denied nausea.  No emesis occurred. Patient was monitored for ~30 minutes and released to go home with his spouse when he was feeling better (resolution of lightheadedness/dizziness).  He was given ER precautions and instructed to call his PCP in the morning if his abdomen still felt tight.  A clinic nurse was asked to follow the patient home to ensure he arrived without incidence, and no adverse event occurred between the clinic and his house.  Patient was called the following morning and reported he felt better with resolution of his abdominal tightness.
I received a pneumonia shot on Monday, February 16 around 9:00 a.m.  By that evening I had chills and body aches.  The entire upper arm where the shot was administered was very painful to the touch, with red areas that were hot to the touch.  Fever, coughing and congestion followed. Coughing was so severe for days after the shot that my rib cage hurt.  I was too weak to stand for any length of time and had no appetite. Didn't want to do anything but sleep.  I went back to the doctor's office on Thursday, 2/19/09.  Had a chest x-ray and was put on an antibiotic, which cleared up the arm condition within a few days. I was told the illness had nothing to do with the pneumonia shot, but the arm condition indicated I had a reaction to the shot.  He told me another patient was there the week before with a similar condition on the arm after receiving a pneumonia shot.  On 2/25/09 I called the doctor's office again.  Still on the antibiotic, but still coughing with congestion and feeling weak.  I was put on another antibiotic, that I began taking last night.  Still not doing well.
Blurred vision, twitching of eyes, vomiting, numb lips, fever 102, pain in nose, ears and throat, pain in hands and feet, severe headache, tinnitus, fatigue, chills, skin crawling, rash and swelling and pain and skin peeling at inje toon sire.
This spontaneous report as received from a patient's mother via company representative refers to a currently 15 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not reported). The patient's concomitant therapies were not reported. On an unknown date, after the second dose of GARDASIL, the patient experienced a rash and the patient generally was not feeling well for about 2-3 days. On an unknown date, the patient recovered from the events, but the therapy with GARDASIL was discontinued (the patient did not receive the third dose of GARDASIL). The relatedness between the events and the therapy with GARDASIL was not provided. Additional information has been requested.
Left upper arm, swollen, red, warm to touch; ice arm - 10 minutes on / 10 minutes off - Tylenol as directed. Call MD if swelling worsens or pain increases.
Patient vaccinated with second dose of Moderna COVID vaccine in February 2021.  He developed cough at the beginning of October 2021, but then started to develop shortness of breath a few days prior to hospital admission.  He was admitted to the hospital on 10/28/2021.  He received steroids and baricitinib.  He  developed shock, severe respiratory failure,  and did not improve with treatment.  A compassionate wean was done on 11/7/2021 and he passed away quickly.
Left nostril has a slight, but near-continuous drip, to the point where the inner edge of my nostril cracks and bleeds occasionally. There is also an odor associated with that nostril, possibly a slight infection of some sort. It messes with my sense of smell - making it easier to confuse some smells for others. For example, I might smell something that seems like incense, but we don't burn incense.  The actual source may be the scented cat litter we use, which normally smells quite different. This isn't constant, and I definitely haven't lost my sense of smell - it's just different some days.  Other disclosures: I have mild seasonal allergies, so used Flonase over the summer. I stopped using it when this issue started to appear. That was probably August or so, but I didn't keep an exact record. I have also had a Tdap and a flu vaccine within the last few months, all in the left arm.  Normally I would just chalk this up to allergies, but the issue has persisted for a few months, and I don't recall ever having my nostril so irritated that it cracked and bled this much. I know COVID can mess with one's sense of smell, and I would guess it could contribute to nasal issues too, so it seemed worth reporting. It could also be an adverse effect of using Flonase.
Anaphylaxis of face, neck and lymph nodes. Noted with pictures Fever Nausea Body aches Oxygen levels into the low 90s Dizziness Fatigue Eyes not staying aligned with each other. Noted in pictures
BODY ACHES, FEVER AND BODY RASH. MOTHER GAVE BENADRYL TO PATIENT. RASH DIMINISHED, BUT DID NOT RESOLVE. WAS TAKEN TO URGENT CARE AFTER CLINIC HOURS FOR CONTINUED BODY RASH.
migraine that lasted 2 days, redness, pain, firm & itchy around injection site that appeared the day after injection and is still present and approx the size of a golfball in diameter, nausea, mild fever & muscle aches
My arm from shoulder to elbow turned red, hot, and was swollen up to double size.  My arm was extremely painful and I was unable to move my arm.  My entire body ached, including my back and legs, and neck.  I had a low-grade temperature.
One week after each vaccine, my skin beneath my right eye started swelling, getting very red, and very itchy. I look like I've been punched in the face.  The first time, it lasted about 4-5 days before it went away. My vaccine date for dose #1 was Friday 1/29/21 and the swelling started on 2/5 (the following Friday). My second vaccine date was Monday 2/22 and the skin beneath the eye started reacting 3/2 (Tuesday). It itches a huge amount. The skin beneath the eye is dark red, and puffy. The skin beneath the left eye is normal.
Don't take it if it is still a live virus. I did and got shingles/ suspected vaccination failure; Don't take it if it is still a live virus. I did and got shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that did not take it if it was still a live virus. The patient did receive and experienced shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
02/04/22 presents to ED for "Nausea, poor oral intake". PMHx of "GIB (AVM), CKD, diastolic HF, paroxysmal Afib on eliquis, SSS s/p PPM
Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe
No additional information; Dose of MMR II that was administered 1 day after expiration; This spontaneous report was received from registered nurse referring to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies.  On 28-FEB-2022, the patient was vaccinated one day after expiration of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) (Expired product administered) (lot # T007234 was a valid lot number, expiration date was reported as 27-FEB-2022; dose, frequency, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. The vaccine had not gone any temperature excursions.   No PQC. No additional information was reported.
swollen from her elbow to her shoulder; had arm pain/  her arm is still hurting; her arm is still hurting, hot; 25G needle was used by the office which she believes may have caused a muscle injury.; , and lost the use of her arm for 5 days,; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injected limb mobility decreased, pain in arm, extremities hot feeling of and muscle injury. The patient was treated with ibuprofen and lidocaine (Lidocaine Patch). On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, extremities hot feeling of and muscle injury were not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injected limb mobility decreased, pain in arm, extremities hot feeling of and muscle injury to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received 1st dose of shingrix and experienced  arm pain, and lost the use of her arm for 5 days, her arm was still hurting, hot and swollen from her elbow to her shoulder. The reporter informed that 25g needle was used by the office which she believed might had caused the muscle injury. The patient took medication Ibuprofen 800 mg every 4 hours and put a Lidocaine patch on her arm for pain relief. The reporter consented to follow up
Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 012F21A, 001A21A and 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor). At the time of the report, FALL (Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor) outcome was unknown. No concomitant medication were provided. No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-606177, US-MODERNATX, INC.-MOD-2022-606162 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606177:(Mother-in-law case) US-MODERNATX, INC.-MOD-2022-606162:(Wife case)
chills; fever; body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination.     Concurrent medical conditions included Ehlers-Danlos syndrome and Mast cell activation syndrome.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). At the time of the report, CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown.            Concomitant medications include medications for connective tissue disorder (Ehlers-Danlos syndrome) and Mast Cell Activation Syndrome.
double dose was given within a week; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent).   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 Information: GSK Receipt Date:28-DEC-2022. Reporter's Comment: Reporter stated that subject received an accidental double dose of flulaval was given within a week. This was a chat, the chat disappeared after picked it up, this will probably be reported again but this is all  they have, couldn't even confirm if the chatter was an HCP.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/12/21pfizer,Lot#EL3248 2nd dose: 02/10/21Pfizer,Lot# EM9810 Diagnosed covid positive:04/24/21 Exposure:Home Exposure Symptoms:Fever, sore throat,fatigue,chills,runny nose,Headache,nasal congestion.