chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day of vaccine, just soreness in the left arm.  Next day, fatigue.  Saturday, Nov 26 joints and muscles began aching and heart felt weird.  Sunday, I considered going to the Emergency Room, pain in joints was severe, had 'sniffles',  a headache, unbalanced/dizzy and heart felt weird.  Today, Monday, Nov 28th.  Achy muscles and joints continue; headache.
Onset on 10/11/12 difficulty breathing, facial swelling, bilateral arm tingling sensation and tachycardia.  Seen in ER tx with Lorazepam & Diphenhydramine. F/u with PCP on 10/12 - Tx with 1000 ml Normals Saline, 25 mg Hydroxyzine and Prednisone.  F/u on 10/16 (Tachycardia and Panic Attack) tx with Lorazepam - over 6 week period.  Pt doing well.
CHILDS DATE OF BIRTH WRITTEN AS AND AGE WRITTEN AS 12 ON SIGNED CONSENT. CHILD IDENTIFIED IN  (#149071164) WITH DATE OF BIRTH.
Injection given on - 1-7-15. Chicken pox lesion with red line started 1/15/15.
My arm hurt after the shot, but instead of getting better it kept getting worse until the point I could not sleep, much pain. Its still painful, am on a prescription for pain as of 10/12/2011.
1/2/2021 vaccination couple days later, developed swollen lymph nodes. No other symptoms. Lasted a couple days.  *PCM to monitor
9 days after vaccination she began vomiting immediately after she ate or drank.  11 days after vaccination she began having seizures, (no temperature), and was hospitalized and put on phenobarbital which she is currently taking.  She was hospitalized for testing for 3 days. Follow up information received states "long term effects are unknown at this times." The annual follow-up states "long term effects are unknown at this time."
Pt reported  on 1/10/23- he thinks he may have had a reaction to the flu shot he had- said he was feeling great at his appt and then a little while after he got home he started having a lot of body aches, was shivering, and he was hearing a "wooshing" sound in his ears. He went to sleep to see if that would help but when he woke up he was still in a lot of pain and had to call his aid to come help him out of bed so he could get to the ER. He said he is feeling about 80% better now but still has a fever and feels a little dizzy. Said they didn't check for flu or covid.
slight swelling of arm just below the vaccine site with swelling covered initially with red blotches, slightly itchy. swollen area about 2 inches in diameter initially.  red blotches started to blend together into a somewhat solid red patch. As of last night, 3/17, the swollen part seems to have moved down arm towards elbow with the redness remaining above. Does not hurt
After I got the shot, I felt tired, I felt sick. I started having bad abdominal pain, hurt so much I could not even touch it. Then on top of that pain, with the leg pain and the numbness and the hotness, my husband had to come help me out of bed, I could not walk. I could not stand up straight because my stomach hurt so bad. I should of had him carry me, that's how bad it hurt. My legs were hot and tingling and they just felt horrible. Then my neck hurt, so bad that I couldn't move it from side to side. It felt like it was stiff. And then I felt like the gland underneath your throat were enlarged, I was a mess! Blurriness, that still have not gone away. I did throw up, all day Saturday. Everything I drinked, nothing but water, it just kept coming up. No fever, no diarreah. I was so scared, it was bad. My stomach still hurts, not as bad, but pain has not gone away completely.
I had already had my period for the month of august but once I got the first shot it kick started my period and had symptoms related to PMS. Sore breasts, cramps, fatigue and then eventually the usual bleeding resulting in the second period for the month of august. I am not on birth control and my periods are usually very regular.
This spontaneous report as received from a pharmacist refers to a 54 year old female patient. No concurrent conditions, medical history or allergy/drug reactions were reported. On 06-OCT-2015, the patient was vaccinated with ZOSTAVAX vial (lot# L025001, expiry date: 06-OCT-2016) (dose and route unspecified) for prevention of shingles. No concomitant medication was reported. On 08-OCT-2015, the patient presented to her pharmacy with a large, red and swollen bump on her arm at the injection site. The patient was administered with BENADRYL, aspirin, and TYLENOL. Lab tests were reported as none. The outcome of the events was reported as not recovered. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
possible monoreactive arthritis; right knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS REACTIVE (possible monoreactive arthritis) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CORTISONE ACETATE (CORTISONE SHOT) for Inflammation, PREDNISONE and METHOTREXATE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-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 ARTHRITIS REACTIVE (possible monoreactive arthritis) (seriousness criterion medically significant) and ARTHRALGIA (right knee pain). At the time of the report, ARTHRITIS REACTIVE (possible monoreactive arthritis) and ARTHRALGIA (right knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a female (age unknown) who was vaccinated with GARDASIL, and date of therapy started was unspecified by reporter. Subsequently (reported as "years ago") the patient experienced encephalitis after receiving GARDASIL. It may have happened around the time that GARDASIL first came out, and it didn't mention if it was after the first dose or at what point in the series it was. Physical therapy was given for AE. The therapy with GARDASIL was discontinued on an unspecified day. Upon internal review, encephalitis was considered as an other medical important event. Additional information has been requested.
Participant moved while nurse was administering flu shot/ participant had lump in left arm where shot was given/ area was sore and swollen, nurse advised to apply heat.
headache/She stated she felt kind of headachy and her head was a bit fuzzy; felt lightheaded/Light-headed; head was a bit fuzzy; This is a spontaneous report from two contactable consumer. This female consumer (patient) was reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 11Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache/she stated she felt kind of headachy and her head was a bit fuzzy, felt lightheaded/light-headed on 12Feb2021. The caller stated she received her first dose of the vaccine yesterday and felt fine. This morning she had a headache and felt lightheaded. She stated she felt kind of headachy and her head was a bit fuzzy, it was like the feeling you get when you are catching a cold when you just feel bleh. She stated she took two Ibuprofen and her friend told her she wasn't supposed to do that, and she needed to call her doctor immediately. She stated the headache isn't even terrible, it is just annoying, and she feels good otherwise. She stated she will skip the Ibuprofen for a couple of days. She didn't read the instructions. She thought it said okay to take Ibuprofen, so she took 2 Ibuprofen. She doesn't want to do a side effect report. She feels like these side effects are minimal. She wasn't really worried about it until a friend freaked out and told her she wasn't supposed to take Ibuprofen. The events were reported as non-serious. The outcome of events was unknown.    Information about lot/batch has been requested.
Pt presented to the ER 7/11/21 with joint pain in bilateral arms, left hip, and posterior knees, and 1 episode of SOB for over a week.  3 weeks prior he reported having a fever and headache but that resolved.   Pt at this time was Diagnosed with Rhabdomyolysis
Multiple swollen lymph nodes in left neck/collar bone. One lymph node noticed at 7pm on 02/16. On the morning of 02/17 there were 3 and the original had grown in size. Original swollen lymph node is red and uncomfortable.
Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to ambulate to observation on her own and then signaled staff for help, felt hot, felt dizzy, felt nausea, staff immediately assisted to chair, RN @ side; inquired re food; had lunch; sips of beverage w sugar given able to eat cracker. She stated she felt better, was upright in her chair, no SOB, no complaints of swelling throat, itchy etc.  After some initial sips of liquid, still feeling dizzy lowered to floor by staff w wedge cushion and legs and feet elevated above heart per protocol b/p 140/96 pulse 86. Stated she had been anxious re injection, but denied ever having this experience after injection. Additional information for Item 18: Reviewed the POD form questions again with her, denied any issues.  She then stated she was feeling much better again,  her warm feelings were going away from ice  in a glove that we had used from her initial dizzy, warm/hot feeling.  Around 3:30 she felt nausea again, so we sat her up and gave her a bucket to use to vomit if needed. She was unable to vomit. She wanted to sit up on floor. We sat with her and she sipped on clear beverage. She began to get cold. We put her legs back up took b/p 140/91 pulse 86. No change. We called nursing DON for District to make her aware and by that time patient experiencing chills. We called her husband to be on his way to drive her home after 30 minutes @ 3:45. She continued to tell us she felt better for a few minutes only to then tell us she was feeling nausea again. Rolled her to left side, helped her to prop us to vomit but she was unable to vomit anything. B/p readings 147/91, 150/90, 140/87,150/88She desired to sit upright again. So on floor with nurse holding and b/p cuff on sat her up to try to vomit, unable to do so.  Lowered back to floor with legs upright where she remained local Paramedic on site and he came to assist, a portable recliner that allowed for legs to be elevated above heart was set up. Patient felt that she could transfer with paramedic and staff help and passed out while attempting briefly, chilling when she was alert, then passing out again; 911 was called and arrived by 3:55, patient and husband initially wanted to take patient home after hearing patient state she felt better once paramedics had evaluated her. However in front of husband, patient again passed out, and after she was conscious stated she could not feel her arms. and when he observed this he agreed it was best for her to be evaluated and then was transported to ER. Per phone conversation this morning, at 10:41 husband stating that patient still not able to stand without passing out on her own and they were continuing to evaluate her. No additional medication given on site at Mass vaccine site.
cough, headache, body aches, congestion, fever 101 two days ago, chills, upset stomach, was sweaty/chilled last night starting 1/1/2022
No injection pain, day three started with a rash. Over the next four days, the rash extended to cover a 10? x 8? area. The area was red, and hot to touch.  By Day 7, the entire upper arm was swollen with pitting Edema.  On day three, topical steroids were applied, multiple times a day, and oral Benadryl taken. Over the counter, one tab three times a day. On day 10, Patient took 20 mg of prednisone and tapered over the course of five days. Rash improved but was not fully resolved until day 14. On day 11 as rash improved a deep, under the surface purple reaction appeared. And resolved by day 14.
approx 6 hrs p/vax pt began feeling hot, throbbing head, nausea, vomiting, shaking, bilateral pedal edema; also slurred speech;
pt devel fever 10NOV; tx 10NOV w/amox for OM; fever cont up to 105; devel mac pap rash 11NOV: seen 12NOV w/petechiae, gums bleedy, plats <5K; adm to ICU; had pulmonary hemmorrage;
Arm was swollen; On the spot where she receive the vaccine is now swollen; arm was swollen starting on 26Jul2021 but she did not noticed it was swollen and red; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: FA7484) via an unspecified route, administered in left arm on 26Jul2021 (at the age of 41 years) as dose 1, single for covid-19 immunization. The patient's medical history included diabetic, blood pressure high. There were other products. The patient was on two different types of insulins and a blood pressure pill. The patient had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 26Jul2021. On the spot where she received the vaccine was swollen wanted to know if there was anything she could do and was it expected. She also wanted to know if the swelling was safe. The patient was not sure if that was a side effect or not, but the spot where she received the vaccine was swollen. The patient's arm was swollen starting on 26Jul2021 but she did not noticed it was swollen and red until the day before reporting. The outcome of events was not recovered.  Follow-up attempts were completed. No further information was expected.
Itchy rashes, mostly on the extremities; Minor pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rashes, mostly on the extremities) and PAIN (Minor pains) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Minor pains). On 06-Mar-2021, the patient experienced RASH PRURITIC (Itchy rashes, mostly on the extremities). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. On 13-Mar-2021, RASH PRURITIC (Itchy rashes, mostly on the extremities) had resolved. At the time of the report, PAIN (Minor pains) had resolved. Not Provided          Concomitant medications were not reported.
I started having body aches, difficulty breathing, diarrhea, fatigue, and cough. My oxygen levels never went down 95%. I felt warm but I never had a fever. I went to the doctor last week and they said I probably had the flu and since I got the booster shot that must have activated it. They gave me some medications, antibiotics, and I am doing respiratory therapy. I had 2 Covid tests, which came back negative. I have been in bed resting. I feel like I have Covid but it is not showing in the test results. They also did blood work and everything came back normal. Yesterday I went to the cardiologist and they said everything is fine. Last year I experienced the same symptoms because I had Covid. I did receive the flu vaccine on 09/29/2021.
slept the next day; headache; arm was sore; felt unwell/ felt like she had chemicals thru her whole body and felt unwell; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept the next day), MALAISE (felt unwell/ felt like she had chemicals thru her whole body and felt unwell), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (felt unwell/ felt like she had chemicals thru her whole body and felt unwell), CHILLS (chills), PYREXIA (fever) and MYALGIA (arm was sore). On 06-Apr-2021, the patient experienced SOMNOLENCE (slept the next day) and HEADACHE (headache). On 06-Apr-2021, SOMNOLENCE (slept the next day) and PYREXIA (fever) had resolved. On 07-Apr-2021, CHILLS (chills) had resolved. On 11-Apr-2021, MYALGIA (arm was sore) outcome was unknown. On 12-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, MALAISE (felt unwell/ felt like she had chemicals thru her whole body and felt unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-090255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090255:
he and his husband are presenting tinnitus and they believe it is an adverse reaction from the vaccine/ringing on his hear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 14Oct2021 (Lot number: FE3590) as dose 3 (booster), single, administration date 31Mar2021 (Lot number: EP6955) as dose 2, single and administration date 08Mar2021 (Lot number: EN6200) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "he and his husband are presenting tinnitus and they believe it is an adverse reaction from the vaccine/ringing on his hear".  Additional information: It was reported that, Caller was a consumer of Pfizer Covid-19 Vaccine, reached to report that he and his husband are presenting tinnitus and they believe it was an adverse reaction from the vaccine. Caller also reported that he read an article, mentioned that the author was Dr. The caller was a male, 54 years old, he reported never have had problems with hearing, but he was having a ringing on his hear during the day, it was not loud, and it starts when it's really silent with a dead silence.  No follow-up attempts are possible. No further information is expected.
Joint pain; Hip surgery; Drug effect incomplete; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240194-00.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and intramuscular, administration date 15Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from Jan2021 (Batch/Lot number: unknown) to 11Jun2021 and second regimen subcutaneous since 2021 (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HIP SURGERY (medically significant) with onset 2021, outcome "unknown", described as "Hip surgery"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious) with onset 2021, outcome "unknown", described as "Drug effect incomplete"; ARTHRALGIA (non-serious) with onset 02Oct2021, outcome "unknown", described as "Joint pain". The action taken for adalimumab was dosage permanently withdrawn.  Causality of drug Humira (Drug/Vaccine) as per Mfr. for event Hip surgery, Drug effect incomplete and Joint pain was No reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event and suspect product BNT162B2 cannot be 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