chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two days later the glands under my arm were swollen; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at vaccination was 46 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, two days later the glands under my arm were swollen. The reporter reported that, two days later the glands under my arm were swollen, I went to the doctor and he told me to take ibuprofen and to wait, it would go away on its own. I was scheduled to receive the second dose today and at the vaccination center they recognized me, and they told me that they could not minister the vaccine, that I had to speak to Pfizer so that you could tell me if I can receive it or not.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Initial report received from a health care professional on 10/27/05. A 59 year old male patient with a medical history of hypertension and an allergy to penicillin received in IM left deltoid injection of Fluzone, lot number U1756AA, on 10/21/05. Within a few hours post vaccination, he developed swelling and pain in the whole left upper extremity and also in the upper anterior chest and left shoulder. Per the reporter, the event required an emergency room/doctor visit and one day of hospitalization. The patient had a normal CBC, CMP and X-ray. The type of x-ray was not specified. The patient had illness at the time of vaccination for a few days, but the specific illness was not reported. The patient takes Diovan 80mg daily. At the time of this report, the patient had recovered.
The vaccines they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; The vaccines they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls; dying in bed; sick as a dog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: EW0162) at the age of 60 years as dose 1, single and administration date 07May2021 (Lot number: EW0171) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: UNDERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "The vaccines they received were overdiluted/The vaccines were diluted with 2.0 mls of diluent instead of 1.8 mls"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "dying in bed"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick as a dog".  Additional information: It was reported that the patient completed the primary series of the Pfizer Covid vaccine in May. The caller just received a letter from her vaccination provider stating that the vaccines they received were overdiluted, using 2.0 ml diluent instead of 1.8 ml. The letter stated that the patient needs to be revaccinated. The caller was asking for any available information regarding how to proceed. According to the letter that the caller received, between 01Apr2021 and November everyone had to have another vaccine because of this event. Both of the vaccines the caller received were diluted.
This spontaneous report was received from an other referring to a 4 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 24-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis (product storage error). The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA008334:
Raised rash and red   bumps over right shoulder and arm. Raised rash on left shoulder and back of neck. Red bumps and some bruising on both hips, red bumps on chest and pin prick red marks on lower abdomen.  Very itchy! A few red bumps on legs and back. Red bumps under front breasts.   Taking an antihistamine every 24 hours. Using a cortisone cream and spray for itching. It is ongoing after 5 days.  Currently on vacation. Going back in 2 days. If it persists, will see doctor at home.
This is a spontaneous report from a contactable consumer reporting for the son. A 17 year-old male patient received the first single dose of TRUMENBA via an unspecified route of administration in the left arm on 19Sep2016 for immunization. The patient medical history and concomitant medications were not reported. The patient's arm swelled up, injection site was hot to touch and he was in severe pain so he could not go to gym on an unspecified day in Sep2016. Outcome was unknown.
Right neck pain radiates from shoulder blade to occiput.; Tightness of chest and fluttering in chest that made me cough persistently; Tightness of chest and fluttering in chest that made me cough persistently; BP elevated 150/90; I had EKG report read occasional PVC.; This is a spontaneous report from a contactable nurse reporting for herself.  A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 18Dec2020 10:15 at single dose for covid-19 immunisation at hospital. Medical history included asthma, eczema, allergies to PCN (penicillin), whey, glutamate, gluten, sulfites. Concomitant medication included isosorbide mononitrate (FLO). On 18Dec2020 at 10:45 the patient experienced right neck pain radiates from shoulder blade to occiput. Tightness of chest and fluttering in chest that made her cough persistently. BP elevated 150/90, no prior history of hypertension. In ED for check-up, the patient had EKG report read occasional PVC. Labs all within normal limits and symptoms and BP better within 1.5 hours so discharged to home. The patient was not treated for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Pt developed rash 8d after MMR vaccine.  Accompanied by tactile fever.  Rash-blanching, macular; afebrile in office.
Narrative: PATIENT REPORTED HE HAD SWELLING OF RIGHT EYE AND LEFT KNEE AS WELL AS ITCHING OF HIS THIGHS AND EYELIDS AFTER THE FIRST DOSE OF MODERNA. NO INFORMATION AVIALABLE ABOUT WHERE/WHEN PATIENT RECEIVED INITIAL VACCINATION.
Headache, Sedation, Myalgia, Fever, chills, fatigue and swollen glands. pain and swelling at the injection site. Narrative:  Other Relevant History:
This spontaneous report was received from a office administrator refers to a male patient of unknown age. Two years ago, in 2011, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer unknown) as routine immunization. No other co-suspect therapy was reported. Concomitant medications were not provided. Patient recently approximately June 2013, had hepatitis A titers before a mission trip which were negative. At the time of the report, the outcome of the event was unknown. The patient did not receive any treatment for the event. The patient sought unspecified medical attention. Additional information is not expected.
Left arm is slightly swollen; Tender; Problems with my left shoulder; pain; Left arm ahs been sore off and on ever since/arm is still sore to touch/Where I had the shot and below/down into the muscle below also and the area below; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm is slightly swollen), TENDERNESS (Tender), MUSCULOSKELETAL DISCOMFORT (Problems with my left shoulder), PAIN (pain) and MYALGIA (Left arm ahs been sore off and on ever since/arm is still sore to touch/Where I had the shot and below/down into the muscle below also and the area below) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Coagulation disorder. Concurrent medical conditions included Celiac disease (An immune disorder.).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced MYALGIA (Left arm ahs been sore off and on ever since/arm is still sore to touch/Where I had the shot and below/down into the muscle below also and the area below). On an unknown date, the patient experienced PERIPHERAL SWELLING (Left arm is slightly swollen), TENDERNESS (Tender), MUSCULOSKELETAL DISCOMFORT (Problems with my left shoulder) and PAIN (pain). At the time of the report, PERIPHERAL SWELLING (Left arm is slightly swollen), TENDERNESS (Tender), MUSCULOSKELETAL DISCOMFORT (Problems with my left shoulder), PAIN (pain) and MYALGIA (Left arm ahs been sore off and on ever since/arm is still sore to touch/Where I had the shot and below/down into the muscle below also and the area below) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non significant follow-up received and includes no new information.
Small itchy spots on my arms and legs began on 1/17. By 1/20, a rash had formed all over my body on arms, legs, back, stomach, chest, scalp. Zyrtec, Benadryl, Hydrocortisone cream, and NSAIDs have helped relieve symptoms, but the rash is still in full cover today 1/23.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 69 year-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine), administered in arm (Lot number: FD8448) as dose number unknown, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "my arm was sore; it is swollen"; MASS (non-serious), outcome "unknown", described as "swollen, hard to touch; it has got a hard lump in it, big hard lump"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I can not even lift my arm like up to my nose"; PAIN (non-serious), outcome "unknown", described as "But it is like even hard to touch". Relevant laboratory tests and procedures included Blood test on an unknown date. No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer. This consumer reported for her son and stated that the son had received the full 4 dose series of PREVNAR 13, 0.5ml single dose on unknown date. The patient continued to get respiratory illnesses and ear infections. The doctor tested his antibodies and he did not produce any antibodies to the PREVNAR 13. He had a low IgG when he was one and a half and that had increased and was within range. The doctor told him that it was not unusual for the PREVNAR 13 not to stick. Any info on giving a 5th injection?
On 11/14/21, nursing staff  reported patient was not responding, presented with rapid breathing using his excessory muscles to breath, heart rate of 110, gurgling sounds, respiration 25-40 per minute and oxygen sats were 88.  Patient was sent to the ER at 12:15PM and is now in  Hospital.
Right arm at injection site became sore and started to swell - progressed down arm into hand within hours. Seen 4/6/07 - arm and hand swollen, erythema and warmth medical aspect. Tx - Methylprednisone dose pack; Keflex 250 mgm QID x 7 days.
I had an intermittent fever for a day and a half and some chills. I went to see my doctor and was told it was a common side effect of the vaccine.
3 hrs p/vax pt presented w/pain of the head w/pressure in the neck, pain in the eyes & insomnia; HP 140/90;
SHORTLY AFTER RECEIVING INJECTION SHE BEGAN TO NOTICE THROAT TIGHTNESS AND TINGLING SENSATION IN EXTREMITIES - TO ER FOR OBSERVATION - ADMINISTERED DIPHENHYDRAMINE HCL. RECOVERED AND DISCHARGED
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medications were reported.
On 09/30/11, patient came to report to me that after the flu shot she could not move (date of shot was 09/06/2011). She had called & report it. She is ok now.
Soreness around the injection site (left deltoid), lasting approximately 36 hours.  I was also told to enter:  ?Moderna COVID-19 Vaccine EUA?
Approximately 3 hours after receiving the injection, I developed chills, body aches, joint pain and extreme fatigue (and a sore arm at injection site).  No fever.  The only symptoms remaining upon waking the next morning were slight fatigue and a sore arm.  All symptoms were gone the next day.
Red, very firm, itchy spot at injection site. 15 weeks pregnant, due date Aug 25.
Patient started having vomiting on 5/17. On 5/18 she had projectile vomiting and diarrhea. She seemed to be doing well on 5/19 and had her 4 month check-up in which she received her regularly scheduled vaccines. Continued doing well until later that evening seemed pale. She waxed and waned until Sunday in which she was lethargic and mother brought in to the hospital. There she was found to be anemic and had elevated SCr and BuN. Hematologist reported that she had anisocytosis, poikilocytosis, and polychromasia. LDH and reticulocytes were elevated. She is currently being treated as having hemolytic uremic syndrome potentially in relation to her vaccines. Stool cultures are negative except for rotavirus. She is 4 months old and weight 8.4 kg. She received 204 mL of blood in first 24 hours of admission. Sending out congenital complement and TMA panels
Throat swelling, itchy rash on chest arms and back, and 9mm x 4mm rash around the injection site.
Really bad lower back pain on left and right side; So dizzy they could not stand up.; Like something was ripping out their kidneys; Arm red; Arm swollen; fever; Tired; joint pain; muscle pain; headache; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red) and PERIPHERAL SWELLING (Arm swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills). At the time of the report, BACK PAIN (Really bad lower back pain on left and right side), DIZZINESS (So dizzy they could not stand up.), FEELING ABNORMAL (Like something was ripping out their kidneys), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), PYREXIA (fever), FATIGUE (Tired), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-067367 (E2B Linked Report).; Sender's Comments:  MOD-2021-067367:Wife Case
I tested positive for covid on ~11/26. Relatively mild case with mild fatigue and lost of taste and smell. Possibly some worsening exercise tolerance ~3-4 weeks after initial onset date. I'm not sure if it was deconditioning vs lingering covid effects.   No side effects from first covid vaccine minus a sore arm. After second dose some mild fatigue ~2 days. Then 12 days after second dose significant more fatigue and in the next few days chills at night and tachycardia with pulse in 120s at rest. No fever, pain, sob, swelling or other symptoms. Presented to immediate care on 2/27 predominantly for the tachycardia. Was referred to the ED.  Discharged on 3/1 on metoprolol with possible diagnosis of viral myocarditis.
Vomiting  Fever Pneumonia due to COVID-19 virus Sepsis Acute respiratory insufficiency  -Continue supplemental oxygen as needed to maintain spO2 over 90% -Patient completed remdesivir as well as a convalescent plasma. -Patient will complete 5 more days of oral dexamethasone. oral Decadron.
Purple and white discoloration, tingling and numbness to bilateral hands. Also know as Raynauds.
Starting about 12 hours later I started feeling off, weak and achy. I wasn't able to sleep all night, sweating, aching. When I got up the next morning I had nausea all day and complete loss of appetite. My head hurt, my body was achy, and I fought throwing up all day on 4/3. When I woke up 4/4 my appetite wasn't fully there but I was feeling better. Now 4/5 and 4/6 I'm feeling normal.
After 3-4 days of receiving the first dose of the Moderna vaccine, I developed a sizeable lymph node in the arm pit of my left arm.  After two weeks, I saw my OBGYN who advised I get a sonogram.  The sonogram was performed on Jan 26th, 2021 and the radiologist had the doctor review the sonogram.  The doctor stated he was certain it was due to the vaccine, but advise I have a follow up sonogram in 12 weeks (it is scheduled for Apr 26th).  After my second vaccine (Jan 27th), the lymp node did swell a little, but has no subsided completely.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION OF 0.2ML AT 12 YO. CLIENT SHOULD'VE RECEIVED GRAY CAP FORMULATION OF 0.3ML DUE TO AGE.
2 prolonged hypomotor seizures captured by parents on video. Evaluated by Pediatric Neurology.
Case number PHEH2014US019580 is an initial spontaneous report from a pharmacist received on 26 SEP 2014. This report refers to a 59-year-old female patient. Past medical history and concomitant medication was not provided. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly on 25 SEP 2014. On 26 SEP 2014, the patient developed a 1 cm red, blistered area at the injection site. Outcome of the events was reported as ongoing at the time of this report. The seriousness and causality of the events was not reported.
Sudden Onset of Chest tightness and numbness in left arm.  History of AFIB and Diabetes.  PT Denies SOB, Nausea, or Vomiting.   Pt given 324 mg ASA prior to medic arrival.  M48/L48 responded and evaluated patient including cardiac monitoring.  Pt refused treatment or tx.
Patient felt hot & dizzy 5 minutes after vaccine, then syncopes for a few seconds approx 20 minutes after vaccines were administered.
Pt recvd vax & devel aching, fatigue, mild diarrhea/vomiting 24 hrs seen by MD & for 48 hrs p/inject; severe vomiting, diarrhea;
Headache, stomach ache almost immediately. Fever of 102.3, fatigue, red skin (face) and vomiting about 3 hours later fever rose to 103.6. Muscle pain and weakness, tired and fever rose to 104.2. Tylenol dropped it once to 103 but started to rise again within two hours to 104.6 then went to ER.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 23-OCT-2018, the patient was inadvertently vaccinated with two doses of PROQUAD lot # N021727, expiration date: 06-FEB-2019 (dose and route of administration were not provided) for prophylaxis. On 23-OCT-2018, the patient should have received one dose of rHA PROQUAD and one dose of DTAP vaccine (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. The vaccine was reconstituted in sterile diluent. No adverse effect was reported.
Client signed up for a vaccination clinic today. She answered no to having a first dose of vaccine. Her home health nurse called and said she's very confused and had her first dose of Pfizer on 1/25/21. She got Moderna today 2/10/21.
Period that I was currently on stopped completely the same day as first shot. Severe breast pain and cramps followed for a few days.   Period d not return until a week later.   Second dose, same issue there off my cycle by a week with changes to flow and pain.
15 minutes after getting the vaccine, she developed a pruritic rash over her neck, chest, and precordium. Also became tachycardic up to 130-140 (may be attributed to anxiety of having a rapid response called).  She reported feeling a lump in her throat but no facial swelling or angioedema, no lymphadenopathy.  Was treated with diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV. After 1 hour of observation and ongoing feeling of lump in her throat with new mouth tingling, was also given 0.15 mg epi IM. Was observed with resolution over 8 hours, and discharged to home with instructions to contue treatment with oral prednisone, famotidine, and cetirizine over the subsequent few days.
Patient was administered 0.3ml of the Pfizer vaccine that had been compounded in the pharmacy.  After administering a dose to another patient, the nurse recongized that the volume of the vaccine was low.  Normally, each vial is enough for 6 vaccines, but not in this case. The vaccine was returned to the pharmacy where it was discovered that the vial was diluted with 0.8ml of normal saline, instead of 1.8ml.  Based on the concentration in the vial, the patient received two times the normal dose of the vaccine.  Patient was observed and sent home without signs of an adverse reaction.
Received flu shot 11/06/2002, next day after had large area of erythema on upper left arm and trunk. Worsened over next 24 hours, fever 101.8 on 11/08/2002. Tx for possible cellulitis on 11/08/2002