chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen left arm but not at injection site, in muscle; Itches in left arm but not at injection site; chills; aches/pain; Lightheaded/dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle), PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness), PRURITUS (Itches in left arm but not at injection site) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness) and CHILLS (chills). On 18-Mar-2021, the patient experienced PRURITUS (Itches in left arm but not at injection site). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle). At the time of the report, PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle), PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness), PRURITUS (Itches in left arm but not at injection site) and CHILLS (chills) outcome was unknown.            patient is taking medicine for high blood pressure, heart, diabetes (pills) patient has a surgery tomorrow and don't know if he should go or not.
2mo male with episode of lips and tongue twitching. "White" while breast feeding (after finishing one side) with eyes looking sleepy. Eyes not rolling. No shaking or limpness, followed by 30-45 min of not moving his body; able to follow mother with his eyes.
I tested negative as of may 18,2022I tested positive today may 22. I don't well; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested negative as of may 18,2022I tested positive today may 22. I don't well) in a 68-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 treatment.     Concurrent medical conditions included Drug allergy (Name of drug was not specified).    On 26-Apr-2022 at 2:00 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I tested negative as of may 18,2022I tested positive today may 22. I don't well). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I tested negative as of may 18,2022I tested positive today may 22. I don't well) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter.  Device date: 22-May-2022.  Treatment information was not provided. Company comment-This spontaneous case concerns a 68-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving second dose of mRNA-1273 vaccine. Patient was treated with Paxlovid from 9th May to 15th May 2022. She was tested covid negative 3 days after paxlovid, 4 days later she was tested positive. The outcome of the event was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving second dose of mRNA-1273 vaccine. Patient was treated with Paxlovid from 9th May to 15th May 2022. She was tested covid negative 3 days after paxlovid, 4 days later she was tested positive. The outcome of the event was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
5cc H1N1 vaccine IM L deltoid @ 4:20. 4:25 report arm hot about 10cm diameter redness gave 50mg po BENADRYL, decrease redness, decrease warmth.
Dizziness, headache, decreased appetite, vomiting, inability to move left arm, erythema, induration.
I woke up the day after my third dose I woke up extremely fatigued. My vision was very blurry in both eyes. The vision problems persisted, and my right eye was extremely blurry. It has improved over the five weeks since I got the shot. I went to the ophthalmologist on the third day. I had to get new glasses. I normally only wear my glasses to drive but I have had to wear them all the time. The left eye is almost normal, but the left eye is still blurry.
Patient developed soreness/itching feeling in back of throat. Patient was taken back to our treatment room where she was given 25mg Benadryl PO about 10 minutes after getting vaccine.
Pt had arm swelling about the size of a dollar bill, sore & warm to touch, sore and swollen for 4-5 days. Now resolved. Trted w/cool packs & antihistamine.
12x10 cm area erythema on lt deltoid-cellulitis;cellulitis vs subcutaneous fat necrosis
Patient experienced Rash/Hives all over the body and was treated at emergency room and doing ok.
The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am  two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-JUN-2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Shortly after receiving the vaccine, the patient became lightheaded, dizzy, pale, clammy, and diaphoretic.  Patient was laying on exam table and  patient's eyes rolled into the back of his head, became unconscious for about 30 seconds, foam noted from mouth. EMS was activated. Pt alert upon transport to ER. When EMS arrived and patient moved to gurney, he vomited a small amount of clear fluid twice. He was evaluated in the ER and diagnosed with Vasovagal Syncope.
Patient was brought in for possible reaction to tdap. It looked like a bug bite for weeks and today a round welt appeared but no longer present on right upper arm. She denies pain or itching. Denies SOB.
The pt started itching in the evening then later vomited about 8 times. She returned to the clinic with a fine papular rash on the face and neck. She was given Benadryl for itching.
joint aches; edema at inj site Narrative:  Patient reports myalgias, joint aches and edema around injection site 7 days after his second COVID vaccination.
This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER26B), via an unspecified route of administration in the right arm on 27Mar2021 at 11:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included severe penicillin allergy on an unknown date. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 01:30, the patient woke up with an extremely severe headache in the top front of head, that brought on severe vomiting for 20 minutes. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extremely severe headache in the top front of head and severe vomiting for 20 minutes were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Patient came to the pharmacy on 7-12-13. Her left arm was red. She pointed to the injection site and showed me a large red circle.
2nd dose 1/26/2021 on the morning of 1/29/2021 Woke up with intense rash and hives all over my neck , inner arms  and groins.  I was very itchy.  After concluding nothing has really changed  in my diet, toiletries etc... I read the notice from the vaccine, and went to  emergency .  Here I was treated for an allergic reaction.
Scleral hemorrhaging of the right eye; This spontaneous case was reported by a consumer and describes the occurrence of SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) (seriousness criterion medically significant). At the time of the report, SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.      This case was linked to MOD-2021-072179 (Patient Link).
Moderna COVID19 vaccine morning of 3/20/2021.  Later that evening had abdominal cramping, nausea/vomiting/ diarrhea x6 hours.  Described further abdominal sensitivity next 2-3 days.  No other family describes same symptoms.  Prescribed Zofran by PCP on 3/23/21  Described "burning" in left arm, no rash, itchy or redness on 3/23/20
Within 12 hours of Twinrix dose #1, patient noted aching arm, tactile fever, muscle spasm (back and leg). Symptoms persisted for 10 days.
1. Severe pain at injection site radiating to right fingers 2. Prostatitis flared up within 24 hours of receiving vaccine 3. General malaise 4. Elevated temperature of under 100 degrees F
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective with paxlovid from 31May2022 to 04Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It started with neuropathy in my right foot. Now it's worse in my left foot. I'm not able to place fuzzy socks on my feet without feeling irritation. My trigger finger (right hand) is stiffing and my joints are worse.
I started with a red rash over both arms centered around the elbows-more intense on my shot arm about four days after vaccination .  Then on the fifth day I took a shower and experienced burning on my skin when I got out my entire arms were red and splotchy. I applied lotion and took allergy medicine because it was also itchy. Further on my skin became abrasive in that area and then it started to spread every where on my body-legs, stomach, under my chin, arms, butt, and chest. Then my body started to peel excessively-almost as if I was sunburnt-I could rub my legs and tons of flakes came off. I used copious amounts of oil, lotion, and still continue to take an allergy pill and it has been a full week since it first started, and it is not getting better.-in fact it keeps spreading. I have not changed any products or switched medicine or been exposed to any other environment during this time.
Arm ache, arm swelling, headache, body aches, chills, low grade temp, some nausea. Fatigue.  Lasted 2 days.
PATIENT TESTED + FOR COVID 12-2020  AND EXPIRED 5-2022.  i HAVE NO OTHER INFORMATION.
43M w/ pmhx as noted p/w L arm pain after covid vaccine. The pain began about 12 hours after the injection, and has continued to be bothersome today. He denies fever, rash, or other symptoms. Has not taken any medication for the pain.  Narrative:  43M w/ pmhx above p/w arm pain after covid vaccine. Vitals wnl, exam as noted. This likely represents adverse effect of the vaccine; I see no evidence of infection, compartment syndrome, or other acutely dangerous process. I recommend NSAIDs as needed and f/u with PCP for further care.
Confirmed with caller no other AE occurred; Customer reported an AE for VARIVAX and MMRII. The caller said these products were administered to the patient after two temperature excursions occurred; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, two temperature excursions occurred for varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with a temperature of 5.9 and 8.8 degrees Celsius, for a time frame of 10 and 8 hours. No previous temperature excursions were reported.  On 31-AUG-2022, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U028164, expiration date 09-SEP-2023; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA])  (M-M-R II) 1 dose, lot # U019291 expiration date 18-JUN-2023 (route of administration and anatomical location were not provided) both as prophylaxis (product storage error). No other events were reported (no adverse event).; Sender's Comments:  US-009507513-2209USA003954: US-009507513-2209USA004005:
Exactly 1 week after receiving the MMR vaccine, previously healthy child developed sudden onset of full-body slightly raised, pinpoint red rash, high fevers (103.5 and higher), cough, runny nose, and bilateral conjunctivitis. Severe symptoms, including high fever and rash lasted 5 days and resulted in complication of bilateral otitis media. Also developed tachypnea in the last 2 days of acute illness. Clinical presentation very similar to measles. Resulted in 2 visits to PCP office and several days of lost work and missed daycare.
GIVEN 1 YEAR IMMUNIZATIONS ON 4/7/03. ON 4/10/03 DEVELOPED RASH TO UE, LE, TRUNK, NECK. PRESENTED FOR EVAL 4/11/03. RASH IS DISCRETE PAPULES/EARLY VESICLES CONSISTANT WITH VARICELLA TYPE RASH. AFEBRILE. DOES NOT APPEAR TO BE PRURITIC. PT AFEBRILE. SEEN WITH PEDS (DR.) WHO FELT RASH WAS ALSO C/W VARICELLA.
10 month old daughter was exposed to COVID at daycare (previous positive test 5/30/22,  vaccinated with had 2 Moderna shots 7/2/22 and 7/30/22) on 8/22/22, began having symptoms evening of 8/23/22, and tested positive with a home test 8/25/22.  I began having abdominal pain and fatigue 8/28 after caring for her at home (tried to wear a mask but it was impractical) and consulted with the on-call physician at Facility via phone. COVID19 home test was negative.  COVID-19 home tests were negative for several days until 9/3/2022 where I had a positive test, which was confirmed with a PCR test for documentation.
Lethargy and drowsiness the week following the vaccination. Found it hard to complete tasks I could do the month before like running and lifting weights.
swollen large area on lt leg red in appearance w/numerous blisters in middle 9x9mm in size total site size;
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite full vaccination (Pfizer dose 1 and 2). Hospitalized 11/23/21. Received dose #2 of vaccine on 2/24/21. No booster or 3rd vaccine dose received.
Per patient's Alert profile, she received first Moderna vaccine on 4/3/21, second Moderna vaccine on 4/27/21 and a third Moderna vaccine on 5/1/21.
Upset stomach, dry heaves, middle backache day following vaccination (8/3/05). This continued for 3 days.
CHILLS; FEVER; HEART WAS RACING; FLU; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced heart was racing. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) 132. On 08-MAR-2021 19:30, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart was racing, and fever, and the outcome of chills and flu was not reported. This report was non-serious.
Pt c/o severe right arm (deltoid) pain at 6AM (3/15/06. At 1PM right deltoid was noted to be red, warm and swollen, temp 102.4F. Pt did not eat lunch and c/o nausea. He was given Tylenol for pain and temp. At 2:40PM noted to be wheezing. O2 Sat 96-97%. Right arm red,induration 12cm x 27.5cm. He was given Prednisone 40 mg/day x 5 days. Claritin 10mg qid, Zantac 150mg bid.
30-45 minutes after  injection  I had the follow symptoms that were mild and lasted 15 minutes: 1. my tongue felt large, thick and I had trouble talking 2. lips felt numb 3.  bottom of throat felt closing - like a flap I was able to eat and drink and felt fine the rest of the day.
1-2 minutes after receiving vaccine Pt. was getting ready to walk out the door with parent - and fainted - Able to keep standing and assisted into chair.  Upon exam , NP noted mild diapheresis, Pallor, bradycardia. Responded with supine position and oral beverages. Discharged in stable cond. with limited activity x 24 hrs
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 27-MAY-2015 the patient was vaccinated with an improperly stored doses of M-M-R II 0.5 ml (rHA (recombinant human albumin), lot #J014876, expiration date 21-NOV-2015, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effect were reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, fever, fatigue, muscle pain, joint pain. Similar symptoms improved with time after the first dose.
Patient experienced chills, fatigue, and redness and warmth at the injection site.  Instructed to take Motrin/Tylenol for discomfort/fever and to use warm compresses to injection site.  Patient reports relief of symptoms.
I have had very mild tinnitus for many years, but about the second day after the first COVID vaccine, the tinnitus has about doubled in intensity and I have a slight fullness in my right ear when lying on that side for more than a few minutes.  No pain, nothing like that.  I am now almost three weeks out from the initial shot and tinnitus is still heightened.
PATIENT HAD A MISSED ABORTION, FOUND OUT 6DAYS AFTER VACCINATION. HAD HISTORY OF PREVIOUS MISCARRIAGES. WAS ON PROGESTERONE PESSARIES AND ASPIRIN. FETAL HEART BEAT MISSING ON ROUTINE REVIEW. GESTATION 10WEEKS+4DAYS. REQUIRED MEDICAL TERMINATION OF PREGNANCY.
On the day after the booster shot I had body aches and chills which were expected but later in that afternoon my uterus started cramping and I started passing huge blood clots. The cramping and clotting have continued episodically over the last 10 days (and continue to do so). I was ovulating when I got that booster so this is **not** just an early period and I haven't cramped with a period in decades. My OBGYN said this is an "expected stress response" and didn't feel it was necessary for me to do anything else but it's not stopping! If the makers of the booster expect this kind of bleeding it is UNACCEPTABLE treatment of women.
Patient came into the vaccine clinic asking for a flu shot. We asked him about the last time he got his flu shot and he said that his most recent flu shot was last year. We also asked his family members about his last flu shot and they agreed that his last flu shot was indeed last year. We took their word without checking his vaccine records and gave him the flu shot. Patient left the vaccine clinic afterwards without any symptoms.
Tightness of chest bones ached sweating (no temp) Chills light headed elevated heart rate (172 on pulse ox) took aspirin/hot tea