chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couldn't lift or use arm; Awake all night with pain; Awake all night with pain/soreness; This is a spontaneous report from a contactable consumer or other non HCP (patient's spouse). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Feb2021 16:00 as unknown single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the shot (yesterday) on 04Feb2021 at 4PM. It was reported that, the patient can't lift or use his arm and he was awake all night with pain (Feb2021). When the shot went in, her husband felt the shot. Asked if the patient can take Ibuprofen or Aleve or something for the pain. Asked if it was normal to have that kind of soreness. Stated the guy who gave it to her husband might have hit a muscle. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Cellulitis of (L) arm at injection site and fever. Symptoms started night after injection. BACTRIM prescribed.
Swollen lymph node in under arm on side of vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 31Mar2021, the patient experienced swollen lymph node in under arm on side of vaccination. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Swollen lymph node in under arm on side of vaccination was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Chest pains for approximately 3 hours. EKGs, chest x-ray, Holter monitor, bloodwork, stress test - negative.
Patient without significant past medical history presented 5/18/21 to the ED with sudden shortness of breath, chest pain and syncope.  Found to have narrow complex tachycardia with 1st degree heart block with elevated troponin.  Patient was admitted 5/18/21 with diagnosis of myopericarditis.  Also found to have junctional tachycardia. Workup included CTA of chest negative for PE, echo showed preserved ejection fraction and cardiac cath was negative for CAD.  Patient was treated with colchicine with improvement in chest pain and was discharged on 5/21/22.  She was readmitted 5/22/21 with near syncopal event with sinus arrest and junctional bradycardia.
Dose 1: Severe fatigue lasting 3 days, confining me to bed. Severe digestive distress, resulting in frequent bowel movements and loose stool for 9 days. Moderate headache lasting multiple days.  Dose 2: Severe fatigue lasting 2 days, confining me to bed. Severe debilitating headache on the top of my head for 2 days, bad enough that I feared an aneurysm and considered going to the ER.
Experienced temporary loss of vision in left eye ( transient ischemic attack). No other known symptoms. Had full eye exam with no abnormalities. Had normal echo with ultrasound on heart and arteries three months later.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that (Merck) VARIVAX (lot#, expiry not reported) was exposed to a temperature of 7 degree Fahrenheit (F) for 18.5 hours. The nurse also reported that she thinks that the same (Merck) VARIVAX had three previous excursions prior in which the vaccine was exposed to 6 F for 96 hours, 6 F for 72 hours, and 6F for 12 hours. The nurse reported that she was unsure if the vaccine overall average temperature remained between -58F and 5F. She stated that the (Merck) VARIVAX may have been administered. No adverse effect reported. Additional information has been requested.
Pt. became very sick, high fever, runny nose, as time progressed she became secluded, stopped babbling, stopped eating solids, and only ate breastmilk for months. She was very sick on and off for a period of 3 months, with high fevers, inability to cope, irritability, lack of appetite. She lost weight, and the ability to socialize with others. For those 3 months she did almost nothing a normal 6-9 month old would do, she cried and cried and cried. As she got closer to her 1 yr mark she started eating again and slowly came out of her stunt. For her first 3 yrs of life she was delayed and stunted in just about every milestone. She still has the inability to control her emotions and doesnt eat very much at all. She is obsessed with certain things and seems to be very obsessive with certain behaviors.
10 x 5 cm. red, raised, warm, tender, itchy  patch at injection site of DTaP + IPV (admin.  on same leg)
FULLY VACCINATED WITH MODERNA - NO DATES DOCUMENTED ADMITTED TO FACILITY 7/6/2021 FOR RESPIRATORY FAILURE; PNEUMONIA DUE TO COVID-19; AKI
severe pain in her spine; her skin is burning to the touch its on and off; arm is swollen; head really hurts; More fatigue than normal/tired; Nausea; Body aches; Can't eat chicken anymore; Stomach cramps; Seem to not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen), FOOD INTOLERANCE (Can't eat chicken anymore) and ABDOMINAL PAIN UPPER (Stomach cramps) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21a and 027h20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Yellow fever: Yellow fever vaccine (When patient was 21 years old). Past adverse reactions to the above products included No adverse event with Yellow fever vaccine.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-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 SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off) and PERIPHERAL SWELLING (arm is swollen). 17-Mar-2021, the patient experienced HEADACHE (head really hurts). On an unknown date, the patient experienced FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen) and HEADACHE (head really hurts) outcome was unknown and FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches) had resolved.            No concomitant medication was reported.  Patient had put ice on her neck, spine and arm as treatment.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-112132 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 contains significant information including updated historic vaccine and added new events myalgia, nausea, fatigue, malaise, abdominal pain upper, foof intolerance.
Information has been received from a registered nurse concerning a 5 year old female who on an unspecified date was vaccinated with a second dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  It was noted that the patient received the first dose at 18 months of age.  Subsequently about 12 hours after receiving the vaccination the patient developed injection site redness, warmth and raised area about 4 1/2 inches in circumference.  The patient had no fever, but the red warm area at the injection site lasted and diminished in a 4 day period.  Unspecified medical attention was sought.  The nurse reported that the patient was fighting the injection so the red warm area may be linked to the behavior of the child while giving the injection.  The patient had recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested. Follow-up information form the licensed practical nurse indicated that the patient was vaccinated IM with a first (previously reported as second) dose of MMR II (Oka/Merck upgrade process) (Lot # 655747/1117F) at 13:20 on 27-AUG-2007. Subsequently the patient developed redness, swelling and itching at the injection site for four days. The patient recovered. No further information was provided. Additional information is not expected.
Fatigue started in the afternoon and took about 2 weeks to feel I no longer needed a daily nap. Lymph nodes swelled up in both underarms and took about 1 week to resolve. Extreme body aches started Tuesday and lasted 24 hours. Slight chest pain and feeling like I couldn't catch my breath for about a week. Slight headache but nothing like when I had COVID-19. It felt very similar to when I had COVID-19 and triggered my body to react.  This is why I have chosen not to do a 2nd dose.
Patient's husband contacted me 3 hours after vaccination to inform me that she passed out in the tub and wanted to know if it could be related to the vaccine.
Patient fainted after getting the vaccines.  Patient was clammy and felt like she was going to vomit. Gave water, skittles and ice pack at the pharmacy. paramedics were called and she went to the ER
COVID vaccine dose Moderna 07/24 to L arm- headache  07/27- upper back pain/ chest pain 07/29- rash with well demarcated redness/ tenderness/ itching/ blisters to L upper back/ L upper chest/ axilla  currently today improved, pain 1.5/10
Itchy hives appeared approximately 24 hours after flu vaccine administration. Treated by school nurse with Benadryl and hydrocortisone. Symptoms resolved, but returned approximately 5 hours later. Treated with another dose of Benadryl. Symptoms progressed for another 20 minutes, then began to improve.
This case was reported by a healthcare professional (nurse) and described the occurrence of intramuscular formulation administered by other route in an adult between 60 and 69 years old of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2013 at 14:30 the subject received a dose of FLULAVAL (.1 dose, intradermal, unknown arm) and experienced intramuscular formulation administered by other route, wrong vaccine administered, and underdose. The FLULAVAL is indicated as a 0.5ml dose to be administered intramuscularly; however this subject received 0.1 dose (underdose) "in the forearm" (intramuscular formulation administered by other route). The nurse reported that "she accidentally have" "a 0.1 dose of FLULAVAL as a PPD in the forearm, instead of intramuscularly." The nurse refused to provide any additional details at the time of the report. On 7 October 2013, on the same day as vaccination with FLULAVAL, the subject experienced injection site pruritus (described as "severe") and injection site redness. At the time of reporting the events were improved. The nurse reported 2 other cases with FLULAVAL. See cases A1045209A and A1045207A for details on the other cases. Follow up was received from nurse on 1 November 2013. The nurse reported that this case had been reported to a Regulatory agency; however, a reference number was not provided. The nurse documented that on 7 October 2013 at 14:00 (previously 14:30), a female subject between 60 - 69 years old (previously an adult of unknown gender) received a primary dose of FLULAVAL and experienced "marked pruritis for 10 minutes" (injection site pruritis). The nurse did not consider the events serious. The events were not life threatening, did not involve severe or permanent disability; did not involve hospitalization, did not involve congenital defect, and did not jeopardize the subject or required intervention. The subject was evaluated by a physician within 15 minutes of the vaccination. On 10 October 2013, the nursing report documented that there were no adverse reactions at that date; however, the specific date of resolution was not reported. The nurse also provided follow up for the other 2 cases of A1045207A and A1045209A.
- my injection shot started hurting me in the sense of my muscle ached and I could not move it fully. I felt my nerves were effected.  - at the second dose of moderna my nurse informed me that taking ibuprofen will help and that this is a common side affect post injection.  - the pain did not go away after my second dose in April, it got worse. I took ibuprofen for 5 days straight and my arm still hurt with certain movements.  - in the past two weeks, during the first of august till now, august 16 the pain has spread to both arms fully, but specifically shoulders as well as my back area/ shoulder blades. The pain feels like a burning with my nerves feeling drugged or flared with pain. Movement has been really limited with these symptoms.
I have been tired; dizzy on and off since I got my vaccine, 5 days ago; Today I realized I got my period a full week early.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00(at the age of 37-year-old) as a single dose for COVID-19immunisation. Medical history included asthma, gluten intolerance and sulfonamide allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00(at the age of 36-year-old) as a single dose for COVID-19immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021 at 09:30 the patient experienced that she had been tired (fatigue) and dizzy on and off since she got her vaccine, 5 days ago. She realized she got her period a full week early (menstruation abnormal) .Therapeutic measures were taken as a result of the adverse events and included treatment with acetaminophen (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN). On 31Mar2021, the patient underwent Nasal Swab test for COVID-19 and the result was Negative. On 03Apr2021, the patient underwent Nasal Swab test for COVID-19 and the result was Negative. The clinical outcome of the events she had been tired(fatigue) and dizzy on and off since she got her vaccine, 5 days ago, she realized that she got her period a full week early (menstruation abnormal)  were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
After second dose of Pfizer vaccine, after 5-6 hours had sore arm, then after mid night had chills and fever for around a day. The following day, felt tired. After 2 days started feeling normal but having pain especially on the left side of the lower part of head. After 5-6 days, noticed bruise like marks on the upper left arm ( on 9 different locations) that received the vaccine.
L arm swelling and pain; L arm swelling and pain; Fluid retention; Erythema; Warmth to touch; This spontaneous report was received from a primary care provided office, concerning to a 66 year old male patient. The patient's concurrent conditions included benign prostatic hyperplasia (BPH), hyperlipidaemia and gout. The patient's allergies was reported as no known allergies. Information regarding the patient's medical history was no reported.   On 06-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).         On 06-JUN-2019, the patient experienced L arm swelling and pain (peripheral swelling and pain in extremity), fluid retention, erythema and warmth to touch (skin warm); the patient visited emergency room on the same date, it was unknown if the patient received treatment for the events.     The outcome of the events was recovered and the causality between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events was not reported.   This is one of two reports received from the same reporter; Sender's Comments:  US-009507513-1907USA000663:
COMPLAINED OF PAIN IN LEG WHEN WALKING THAT CONTINUED TO NEXT DAY. MOM CALLED OFFICE NEXT DAY AND WAS GIVEN AN APPOINTMENT. EXAMINED BY DR, NO SWELLING OR DISCOLORATION NOTED. NOTED TO BE WHEN HIP WAS FLEXED HE WAS COMPLAINING OF PAIN. CLINICALLY DIAGNOSED WITH SYNOVITIS IN HIP. ADVISED IBUPROFEN. CALL BACK IF NO IMPROVEMENT OR INCREASING SYMPTOMS. WAS TOLD TO SCHEDULE APPOINTMENT FOR RECHECK NEXT WEEK.
My arm became red, swollen and tender-to-the-touch 11 days after receiving the shot.  My arm is still red two days after that, but not swollen or tender.  I missed my period after I got the shot.  It's physically impossible for me to be pregnant.
On Saturday 2/20 I had what appeared hemorrhaging through penis, it lasted 1/2 or so which looked like a menstural cycle, there was a lot of blood loss, headache and I took blood thinner which helped. I called my doctor and they suggested if it didn't resolve itself I should go to urgent care.
This spontaneous report as received from a physician and an office nurse via a field representative refers to a 17 year old male patient. The patient's medical history was unknown. On 17-JUN-2013, the patient received the first injection of GARDASIL, 0.5 ml, (administered intramuscularly). No co-suspected or concomitant medications were reported. On 17-JUN-2013, after receiving the injection with GARDASIL, the patient experienced mild seizures and passed out. Upon internal review, mild seizures and passed out were assessed as medically significant (serious) events. The office nurse reported that the patient had only passed out for a brief minute and recovered. The office nurse and the physician stated that the consumer's condition began to improve without further incident. The patient did not receive treatment for the adverse events. The action taken with GARDASIL was not applicable. A causality assessment was not provided. Additional information has been requested.
Hepatitis / Encephalopathy (seizures, ADEM, MISC/A)  PRESENTING PROBLEM: Fever and chills [R50.9] Hepatitis [K75.9] Febrile illness, acute [R50.9] Acute nonintractable headache, unspecified headache type [R51.9] Seizure (HCC) [R56.9] MIS-C associated with COVID-19 (HCC) [M35.81]     Active Issues Requiring Follow-up   MIS-C/A - 2/2 COVID-19 infection vs idiosyncratic reaction to  J&J vaccine  -prednisone taper over 16 days as above -ID will be arranging follow up serial labs (CBC with diff, CMP, Ferritin level, CRP, LDH) -Bactrim prophylaxis while on steroids -Acyclovir 400 mg BID for prophylaxis (hx of recurrent HSV infection of eyelid) - duration to be clarified by ID at follow up -ASA 81 mg daily -TTE w/ normal coronaries. She will need cardiac MRI, to be arranged by adult congenital cardiology   Generalized tonic-clonic seizures - witnessed and captured on EEG 4/9. No further events. Continue Keppra 1500 mg BID. outaptient f/u with neurology   Abnormal MRI brain - diffuse T2 white matter hyperintensities - non-specific. She will need follow up MRI brain w/ and w/o contrast in 1 month and follow up with neurology clinic   ADHD - given insomnia, Senthuri was recommended to avoid vyvanse for now. She will discuss with her outpatient prescriber Anxiety and depression - zoloft increased to 125 mg daily Insomnia - 2/2 trauma from critical illness. Improved with trazodone HS.    Elevated EBV PCR - ID will continue to monitor.    Nausea/vomiting - resolved. Likey 2/2 gastritis in setting of steroid use. PPI BID x 4 weeks   DISCHARGE DISPOSITION: Home without services
Patient states she received the COVID-19 vaccine approximately 10:00 A.M. this morning and within minutes after that she noticed a tingling sensation to her tongue and her throat, she then felt her tongue and throat were swelling.  She is given intramuscular Benadryl and referred immediately to the emergency room.  On arrival to the ER, she states her symptoms are mostly resolving, she denies any swelling in the throat, tongue swelling, shortness of breath, wheezing, abdominal pain, diarrhea, or rash. D/C with cetirizine and recommended follow up with primary care doctor before receiving the second dose of the COVID-19 vaccine.
body pain and nerve pain, skin pain and lung pain, headache.  The same symptoms occurred with my second covid vaccine and lasted 6 weeks.
1/11- starting spotting off cycle  1/12 Woke up at 12:30am due to fully body aches, chills and fever. 7:45am had fever of 102.2 body aches and leg cramps, 2:00pm had fever of 102 and body aches. 10:00pm still had body aches and fever. 10:00am took Tylenol, fever broke to 100.5 still body aches and leg cramps came back.
Swollen, red, sore right arm. Headache. Nausea. Generaly not feeling well.
Menstration stopped 18 hours after vaccination. I was on day 1 of menstrual the day of vaccination.
Tendered egg sz lump under arm-10-30-14. No redness, swelling at injection site. Noticed gait unsettled. Resolved.
Febrile illness temp to 104 degrees at home. ? severe myalgias. Headache. Mild nausea. Mild SOB. Fatigue. Began 2 d post vaccine. Improved. Tx for Myalgia and HA 5 d post vaccine. Pt currently recovering.
2-1/8 cm hives near DPT inject site lt leg; no redness, edema @ site; temp 99.2 R;
TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-1686) was received from a pharmacist on 28-Jun-2019. It describes a male consumer who "took one dose of unrefrigerated Vivotif" (Product storage error). He was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took an unrefrigerated dose of Vivotif. He left Vivotif unrefrigerated at room temperature for 48 hours before taking it.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.