chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little pain in the arm; trembling; chills; had fever (that was never more than 101.5); malaise in the body; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise in the body), PAIN IN EXTREMITY (a little pain in the arm), TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced MALAISE (malaise in the body), TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)). On an unknown date, the patient experienced PAIN IN EXTREMITY (a little pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, q4h. On 21-Mar-2021, TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)) had resolved. At the time of the report, MALAISE (malaise in the body) and PAIN IN EXTREMITY (a little pain in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient stated that it felt like COVID-19 symptoms which occurred previously.
a patient received a dose of GARDASIL 9 past expiration. Admin on 9/14/2022; This spontaneous report as received from a registered nurse, referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-SEP-2022, the patient was vaccinated with a dose (also reported as unknown by reporter) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687291 with expiration date: 11-SEP-2022, route and strength were unknown) for prophylaxis. The suspect vaccine was past expiration (expired product administered). There was no temperature excursion. No other issue or concerns noted.  The case is a non-valid due to lack of the patient's identifiers.  Follow up information has been received from a registered nurse on 31-OCT-2022. Details of patient information, suspect vaccine and event were provided. The patient is a 24-year-old male whose medical history included human immunodeficiency viruses (HIV) positive since 27-MAR-2019. The patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in left deltoid three days past expiration. There was no temperature excursion occur as a result of a reading from digital data logger. The outcome was resolved on an unknown date in 2022. The patient was called and checked on and had no complaints. There was no prescription drug treatment for the experience required. The de-challenge and re-challenge results were both considered as negative (de-challenge reported as did not experienced abate after stopping drug, re-challenge reported as did not reappear after reintroduction). The causality was considered as related (reported as the event attributable to the vaccine).
A few hours after receiving injection pt experienced redness in arm and shoulder, she also states it was swollen, warm to touch. Pt has a fever of 102. She took TYLENOL and ibuprofen. She states she is still experiencing tenderness at injection site.
Covid symptoms started on 06/18/2022; tested positive on 06/19/2022. He had a really bad headache and was treated with Tylenol and rizatriptan, and in the morning his fever was 102. He has abdominal pain, nausea, stuffy nose, runny nose, and general aches and pains in the back and neck, a headache still, and the only fever he had was that morning of the 19th and no fever since. Symptoms are still ongoing and he just finished the 3 day infusion of Remdisivir.   Last dose of series was Pfizer- 10/15/2021 Lot #30145BA- Unknown ARM- IM
tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a Contactable nurse reporting for herself.  A 58-years-old female patient received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 18Dec2020 10:30 at single dose for covid-19 immunisation .  Medical history included hypertension from an unknown date and blood cholesterol increased.  Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), ezetimibe (ZETIA), famotidine (PEPCID).  The patient  started having a headache and cough on 25Dec2020 and these symptoms worsened on 26Dec2020 in addition to her voice being hoarse. On 26Dec2020 she went to get tested at an urgent center and tested positive for Covid-19. The outcome of the event was not recovered.; Sender's Comments: The association between the event "tested positive for COVID-19, headache, cough, and dysphonia" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recvd vax; w/in few hrs later,began to exp tingling & numbness in the fingers; next day all sxs had resolved;
Febrile seizure 9 days after MMR. Generalized seizure lasting 5-10 minutes. Temp 103.4. Seen in ER had sores in throat. Faint red macular rash on trunk.
Patient reported about a week after receiving the vaccine he started to experience blurred and double vision. Patient must drive with eyepath and gets dizzy do to vision issues he believes resulted from vaccination. Patient is seeing ophthalmologist and doing lab testing to rule out any other possible causes but strongly believes it is due to vaccination as no other changes in medication or disease states has been notable in this time period.
p/vax pt woke w/small spot on lip; T103.1; Dx w/fever blister; spots on face devel; finger; rx: Bactroban; oral antibiotic; spots resolved; then mom devel rash on back w/3small knots; got progress worse; Dx-shingles-not recovered
two doses of Fluzone High Dose QIV within the same season with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 84 years old female patient who recieved two doses of fluzone high dose qiv (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE)within the same season with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 28-Oct-2022 the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ932AB via unknown route in unknown administration site as immunization.  On 09-Nov-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ917AB, Expiration date: 30-Jun-2023 via unknown route in the left deltoid as immunization.  On 09-NOV-2022 the patient received another dose (total 2 doses) of fluzone high dose qiv within the same season with no reported adverse event (extra dose administered) 12 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient was not using the product at the time of report.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (two doses of Fluzone High Dose QIV within the same season with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient presented with inflamed injection site 5" long 3" wide, warm to the touch. Taking TYLENOL for pain and BENADRYL for inflammation.
About 1 week after my first Moderna vaccine, my right arm started to hurt tremendously where I had the first vaccine. I am very healthy and I do not have any allergies. I developed a delayed, large rash (about 6-7 inches) in diameter right around the injection spot. It is very itchy, swollen, hot, and red. This happened after 6 days of receiving the first dose. I did not experience any significant adverse events right after the first dose except for a sore arm for a few days. I went skiing on the 6th day after receiving the vaccine. When I got home, I noticed this large rash breaking out on my arm. It felt as if I just received the shot. It is very swollen and tender to touch. Benadryl helped alleviate the pain. The rash seems to be getting better after 48 hours.
sz lasting about 1minute approx 4hrs p/vax given;t101 R taken immed p/sz;
Brief loss of consciousness/fall when getting up in the middle of the night for water; Brief loss of consciousness/fall when getting up in the middle of the night for water; Severe chills without fever; overall temperature dysregulation; Nausea (no vomiting or diarrhea); Notable pain in injected arm; Muscle and joint pains over body with focused pain in left knee (not a site of prior injury); Muscle and joint pains over body with focused pain in left knee (not a site of prior injury); fatigue; This is a spontaneous report from a contactable Consumer. A 43-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included seborrhoeic dermatitis from an unknown date. The patient's concomitant medications were not reported. The patient experienced brief loss of consciousness/fall when getting up in the middle of the night for water, severe chills without fever, overall temperature dysregulation, nausea, notable pain in injected arm, muscle and joint pains over body with focused pain in left knee (not a site of prior injury) and fatigue all on 01Mar2021 at 22:00. Outcome of overall temperature dysregulation was recovered on an unspecified date in Mar2021. all the other events was recovered on 02Mar2021.  Information on the lot/batch number has been requested.
Night of shot: fever, chills, extreme headache and body aches ( like I have never had before in my life!), dizziness, inability to move well. These  extreme symptoms lasted 2 days ( on couch). ( lost work).  Sept. 20th started to get painful sores in mouth and left side of outside of mouth. ( shingles). Still experiencing headache, dizziness, extreme fatigue, body aches. Sept 16th called MD office because still not feeling well. Gave my symptoms and their response was they did not know what the true side affects were of vaccine and that this was individual. Did not feel my symptoms life threatening. However these symptoms have debilitated me. Im alive but am still experiencing daily headaches, muscle aches, extreme fatigue and occasional days with severe dizziness. I was a super healthy person before the shot. I'm terrified to get the 2nd shot but am mandated to do so for my job. I did have Covid in November last year severely and was out of work for 2 weeks and did not feel back to normal for months.  I can't go on like this - I need to work.
patient reported a severe discoloration and a bruising in the left arm?.just a few inches below her left deltoid...  her entire left arm is sore and she can not move her left arm  also , she reported that the left side of her neck feels sore.
This is a spontaneous report from a contactable nurse. This nurse (RN) reported that a male patient of unknown age received on an unspecified date PREVNAR 13 (lot number 641025, expiration date Dec2014) via an unspecified route. Medical history and concomitant medications were not reported. On the same date, 30 minutes after patient received vaccine, he began to hallucinate. The patient stated he saw and felt bugs crawling and jumping up and down his arms and on to his face. He also was very itchy. No hives present. As treatment, he received 50 mg IV BENADRYL and a neurologist was contacted. Outcome was unknown.
PT's mom states after PT received DTaP on 2/4/03 that afternoon PT had redness with swelling at inject site. Denies any other s/s. States gave PT Motrin and applied a cold wash cloth to area as directed by "After the shots. What to do if your child has discomfort" Advised PT's mom if redness or tenderness after treatment to f/u with pediatrician. 2/6/03 PT's mom advised PT's leg is "a lot better" no redness and "smaller knot."
Patient has pain and redness at injection site also noticed a rash that started in the inner portion of her elbow.
Vaccine administration error. It is suspected that a 1/2? needle syringe was used instead of a 1? needle syringe IM.
Client stated she had fever, chills, and muscle aches for 3 days after shot. Continues to have limited mobility to (L) arm 11 days after shot.
mild cold symptoms all a week; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (mild cold symptoms all a week) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 047A21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (mild cold symptoms all a week). At the time of the report, NASOPHARYNGITIS (mild cold symptoms all a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: negative (Negative) all my rapid screens were negative. On an unknown date, Polymerase chain reaction: positive (Positive) rapid PCR test showed positive two days later.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported  The caller noted that she had been experiencing mild cold symptoms all a week. She stated that all my rapid screens were negative but, my rapid PCR test showed positive two days later.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received as significant information included patient details and lab data.
On an unspecified date, the pt received her 1st dose of Havrix. A "few" days later, the pt reported axilla pain. Physician is not "even sure the pain is related to the injection". The most recent information, received on 4/3/00, reports the condition of the pt is unknown.
Severe weakness, shortness of breath dizziness, very elevated blood pressure and heart rate for about 4 hours Had to be transported from clinic via ambulance to Medical Center; Doctor attending in ED Symptoms continued for 6 days
This spontaneous report as received from a nurse practitioner refers to a patients of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date the patients were vaccinated with a doses of improperly stored GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. Additional information has been requested. This is one of several reports received from the same reporter.
I was very tired the night of the shot with chills started at 8:00pm on 4/1/21.  On 4/2/21 around 7:00am I started vaginal bleeding. (I got my period.  I was not due to get this at this time.  This also happened after my 1st vaccine on 3/31.  Prior to this I have not had my period since November 2020.  The following day 4/2 at 1:00pm I had a fever of 100.7 for the afternoon.  On 4/3 at 12:00pm I felt better, my fever and chills were gone.  I then had a headache until 4/5, which finally subsided around 9:00pm.
Weakness noticed at 5:30pm. 12:00am awoke with severe, burning body (nerve type) pain. Severe spasticity causing sprain/strain injury to muscles and/or tendons/ligaments. After 1 week pain and spasticity was reduced to arms and legs. Still continues. Treating with Motrin, Tylenol, Tizanidine and steroids to follow this week possibly.
This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. The nurse reported that the patient received the first dose of GARDASIL 0.5 ml, intramuscularly in 2012, the second dose in 2013 and the third dose 2 months after the second dose. Lot numbers were not provided. No adverse effects were reported. No further information was provided. Additional information is not expected.
Started having mild to moderate seizures  4/5/2021. Continued off and on through 4//6/2021. Called Dr.  She said do not get a second dose.  Monitoring symptoms  still.
I had a stuffy nose, slightly runny and I took a shower and I noticed I did not smell and taste. My taste came back gradually after a couple days.
2 mins post vaccination, patient had dizziness and redness at injection site. Vitals: 115/73, 80, 18, 100% on RA. Patient given water and juice. Patient stable and released from the vaccination site.
On 12/31, showed signs/symptoms of redness/soreness: on 1/2/15 pt went to MD and got steroid shot due to symptoms. On 1/3/15 came to pharmacy ro notify and took BENADRYL.
After receiving the vaccine I had an injection site soreness. I felt fine afterwards. I work in health care, and I have been exposed to many patients who have tested positive for covid. I tested positive on 1/3/2022. My throat was scratchy, I felt achy, and I assume I had a fever last night because I was cold going to bed and then I woke up super sweaty. I feel under the weather. I have been trying to isolate myself from my family and wear a mask at home.
Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of vaccine. On 5/25/2021 around 4 am, started having chills and headache. On 5/26-5/27/2021 headache worsened and by Friday on 5/28/2021, along with headache, left sided pain in chest and arm. Per patient was taken to ER by wife and admitted to hospital on 5/28/2021. Per Client, was told first by hospital that he was having a heart attack. Client reported having labs collected, EKG, Catheterization and Ultra Sound. Per Client, later diagnosed with "myocarditis" and is now taking multiple mediations. Per Client was discharged from hospital on 5/29/2021, that evening. Will be following up with PCP in one week.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 25-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
4 hours after injection of vaccine could not move right arm without assistance, lightheaded and sweating lasted for about an 30 minutes to an hour.  24 hours after injection felt very ill and muscles were sore and achy.
Numbness in left arm/ Numbness in left side of face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in left arm/ Numbness in left side of face) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00UB21H) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in left arm/ Numbness in left side of face). At the time of the report, HYPOAESTHESIA (Numbness in left arm/ Numbness in left side of face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Vaccine given same day as revocation (Vaccine given prior to revocation of the bivalent vaccines)
Lymphomas under arm swelling all over again. This happened earlier in the month immediately following booster but went away after little over one week. Now I have a large area on bottom of forearm swelling red painful and very itchy. Been going on about 5 days now
Right away, pt felt a heavy arm and stiff neck. About 1-2 hrs later, had a difficult time swallowing, fatigue, dizzy, and extreme chills.  Her throat was also sore.  Had extreme thirst to where she felt as if she could not get enough to drink.  She continued to have symptoms for 4-5 days, so went to urgent care where she was tested for COVID, flu, and Strep.  All negative.  She called her PCP, but never consulted about this incident
Developed swelling in left arm, and fever. Went to urgent care and was diagnosed with cellulitis of left upper arm. Given prescription for cephalexin 250mg/5ml: take 5 ml by mouth 4 times a day for 10 days, total 200ml.