chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LUMP AT INJECTION SITE; PAIN AT INJECTION SITE; WARM AT INJECTION SITE; This spontaneous report received from a consumer concerned a 65 year old female. 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 not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced lump at injection site. On 13-MAR-2021, the subject experienced pain at injection site. On 13-MAR-2021, the subject experienced warm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site, pain at injection site, and warm at injection site. This report was non-serious.
She had her first dose of Pfizer vaccine on 8/16/2021.  She reports that she developed racing heart and left chest pain when she laid down within hours of receiving her vaccine.  She also had vertigo intermittently over several weeks.  She reports some mild chills but no fever.  After approximately 4 weeks, these symptoms spontaneously resolved.  She did not present to clinic for evaluation or workup of these complaints.
Patient woke up with temp 100.3.  Complained of pain in left arm.  Mother noted entire arm was swollen.  Mother administered tylenol.  Took patient to ER, where antibiotics and benedryl administered along with IV fluids. 11/5/09 Medical records received for date 10/3/09. DX: Allergic RX to flu vax, cellulitis. Presenting SX: received flu vax 1 day ago, since that time c/o arm swelling, red, fevers, facial redness/swelling. Painful in appearance. Assessment: (+)above sx. febrile. IV meds given, no change in status, pt admitted for observation. At time of dc pt stable.
I was exposed to COVID-19 on 03JAN2023 I stared with a cold and fatigue, loss of smell and taste with a pretty intense cough for several days.  I got Pacxlovid the next day and took it for five days but on day nine I started to feel sick again and was left without taste and smell that is just improving now. I tested positive for three weeks before having a negative test.
ITCHING ON THE PALM OF HANDS, BACK , STOMACH, SCALP AND LEGS. HE VISIT A DOCTOR OFFICE WHERE THEY PRESCRIBED HIM CTIRIZINE 10MG DAILY FOR 30 DAYS. HE IS ON THE SECOND ROUND OF PRESCIBED MEDICATION AND STILL EXPERIENCING ITCHING.
Arm is really hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really hurting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is really hurting). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm is really hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
After shot #1; about 2hrs later I experienced itchy eyes, scalp and face...some tingling sensation in lips.  Symptoms lasted 2/3 weeks No problem after shot #2 Booster full strength shot#3...no immediate problems but after 10 days developed itchy eyes, scalp and face.  These symptoms are barely controlled by taking 2 Zyrtecs and 1 Pepcid twice a day.  It has been going on for 5 months now
On Feb 14, 2022, I came home and walked from the garage through my kitchen, became weak and lightheaded, sat down, got up, took a few steps, became extremely sweaty. Called a family member to check on me. By the time they got here, we both agreed I was too weak to walk to the car. We called 911, their initial checks could not find anything specific wrong, they took me to the emergency room. Extreme weakness, labored breathing. 4 hours of tests and a CT scan to reveal a severe saddle embolism at the aorta at the branch point where it goes to the lungs. I was hospitalized for 5 days. Treatment was heparin. I am now on Eliquis 5 mg twice daily.
Ten minutes after the injection I experienced a metallic taste on my tongue. The sensation continued until the end of the day. Also, I experienced nausea and a lost of appetite. The next day I felt better but my left arm was slightly swollen.
9/6/21 PMH of DM type II, hypertension, hyperlipidemia and COPD presented to HCF with c/o worsening shortness of breath
Received immunization 12/2/11. Got shingles 12/5/11.
Premature atrial contraction; Occasional palpitations which became severe waking her up at night; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Occasional palpitations which became severe waking her up at night) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Stevens Johnson syndrome (Allegedly precipitated by Mycoplasma Infection) in 1991 and Mycoplasma infection.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PALPITATIONS (Occasional palpitations which became severe waking her up at night). On 09-Apr-2021, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction). The patient was treated with DIAZEPAM (VALIUM) for Palpitations, at a dose of 3-4 doses. On 16-Apr-2021, PALPITATIONS (Occasional palpitations which became severe waking her up at night) and SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Echocardiogram: abnormal (abnormal) Diagnosed with premature Atrial Contraction.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose of the Moderna Covid-19 vaccine and on 02-Apr-2021, the patient developed palpitations initially, occasionally but got worse until it woke them up at night. The patient's symptom persisted until it became severe. On 09-Apr-2021, the patient was advised by their healthcare provider to go to the emergency room and had an electrocardiogram done. The patient was diagnosed with premature atrial contraction.  Reportedly, the patient was told that it was not serious and was sent home. The patient was on beta blocker and was advised to take an extra half dose of the beta blocker together with valium if the palpitations occur. All in all, the patient was able to take 2 doses of the half dose beta blocker and 3-4 doses of valium which the patient claimed not to have helped with the palpitations. The palpitations tapered off in two weeks 16-Apr-2021 although the patient stated that they still would have occasional flip-flop skip beats.   On 06-May-2021, the patient had an echocardiogram as a workup for their palpitations but was still waiting for their appointment with a cardiologist to know the final result.  Concomitant medication included Beta blocker.  Treatment medications included Beta blocker and Valium.   This case was linked to MOD-2021-193514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up was received on 30-Jun-2021 and updated the outcome of the event Premature atrial contraction and Palpitations from unknown to Recovered.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 17 year old male patient. On 03-MAY-2013 the patient was vaccinated with VARIVAX (Merck) lot # H007704, subcutaneous in the upper right outer arm for prophylaxis. The dose number was not reported. Between 06-MAY-2013 and 06-MAY-2013 the patient returned to the office and had developed a swelling and redness over an area covering 12 by 17 centimeter. The patient experienced no pain, itching, discomfort or systemic symptoms. Treatment for the events included oral BENADRYL, dose and manufacturer were not reported. The outcome of the swelling and redness was not reported. Additional information has been requested.
Arm is painful, red, and swollen from her armpit to her breast; Pain in her left arm; Pain in her left arm where the injection site; Arm is painful, red, and swollen from her armpit to her breast; Arm is painful, red, and swollen from her armpit to her breast; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 18:00 (Batch/Lot number: unknown) at the age of 61 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 18:00, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), AXILLARY PAIN (non-serious) all with onset 10Dec2021, outcome "not recovered" and all described as "Arm is painful, red, and swollen from her armpit to her breast"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Pain in her left arm"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Pain in her left arm where the injection site". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, vaccination site pain, erythema, axillary pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Upset stomach; Abdominal cramps have gotten worse/cramps still persisting after vomiting/hurts more when moving or breathing deeply; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0183), via an unspecified route of administration, administered in the left arm on 14May2021, at 14:30 (at the age of 30 years old) as second dose, single dose for COVID-19 immunization at a public health clinic/ veterans administration facility. Medical history included penicillin allergy. The patient was not pregnant by the time of vaccination. Concomitant medications included fluticasone and desogestrel, ethinylestradiol (ENSKYCE). The patient previously received the first dose of BNT162B2 (Lot number: EW0171), administered in the left arm on 23Apr2021, at 14:30 for COVID-19 immunization with no reaction on previous exposure to vaccine. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. On 14May2021 at 16:30, the patient experienced upset stomach about two hours after the second dose. Her abdominal cramps had gotten worse for eight hours until she experienced vomiting. Her cramps was still persisting after vomiting and it hurts more when moving or breathing deeply. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events which included famotidine (PEPCID AC), bismuth subsalicylate (PEPTO-BISMOL), and drinking plenty of liquids. The patient reported that famotidine and bismuth subsalicylate didn't help. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
n/a - Moderna was give to 17year and 11 month patient. Patient is doing good and school nurse is following up. They will make sure to let us know if they need anything.  Pt will be 18 for the second dose.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored dose RECOMBIVAX HB (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Post vax, that day, developed red, hot and bumpy rash on trunk and in corners of arms and legs. Was not scratching. Given Benadryl with no help. Temperature not taken. Rash persisted for about 1 week. Also had quarter-sized swelling at the injection site.
About 24 hrs after immunizations, felt warm, suddenly became stiff, unresponsive, jerky mvmts consistent with seizure x 4min. In ER temp 102.3, slightly red throat (strep test neg). Diagnosed febrile seizure. No other work up obtained. Pt fine following. No fever by next day.
Pregnant patient about 30 weeks came in for Tdap as recommended by her OB/GYN. After administration, the patient bled for a moment and a small hematoma developed under the skin after applying pressure.
1 day after immunization went to ER had febrile seizure. Was diagnosed with bilat AOM.
Approx 10 days post vax had diarrhea, fever, no appetite, no rash, tugging on ears, Seen by MD dx w/ vaccine rxn & sl ear infect, on antibiotics;
no second dose received; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim:  no second dose received).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 31-AUG-2023 The reporter was a patient who resides out of town. The reporter stated that she received first dose of Shingrix 1 or 2 years ago from the reporting day and no second dose was received. The reporter refused to provide any other information. The reporter referred to GSK. The reporter did not consent to follow up. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Information has been received from a certified medical assistant concerning a 12 year old female who in 1999 (as reported by her father) was vaccinated with a dose of Varivax. On 29-NOV-2006 the patient was seen in the office with a chickenpox rash. It was reported that the patient had about 30 rashes with different stages. It was reported that the rash started after a few days of fever and cold symptoms. No diagnostic lab tests were performed. It was also reported that her brother had chickenpox 2-3 weeks before the patient. The patient's recovery status was unknown. No other information was available. There was no product quality complaint involved. Additional information has been requested.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported. No concomitants drugs were reported.  VIAL REMOVED FROM FREEZER 8 AM, 10/18/21
pt recvd vax & following pt devel local irritation & soreness & swelling @ the inject site; pt underwent shoulder surgery & exp limited ability to move rt arm & fingers;
SOB, HEADACHE, MYALFIA, SORE THROAT, RHINORRHEA, COUGH, MINOR CHEST PAIN
This spontaneous report was received from a registered nurse, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with GARDASIL (strength, dosage, route, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information is not expected because the physician refused to be contacted.
This form not "user friendly".   I received J&J dose in March.   In November 2021 I had blood test as part of my annual physical.  White blood cell count was high.  More testing - including a bone marrow biopsy have resulted in a diagnosis of chronic myelogenous leukemia.  To be clear I don't think this is a result of the vaccine but I have been reporting via text post vaccine regarding symptoms.   I received a phone call and the caller suggested I complete this form.  I am doing so in an attempt to be helpful!
pt recv vax 1JUN96 & 1FEB97 lab eval revealed a failure to seroconvert;
Fever, Chills, Headache (with light sensitivity), Muscle aches, Fatigue, Stomach upset
Fever of 101.3. Minor chills. Achy arm and joints all over. Achy back. Achy jaw. Headache. Very tired. Ibuprofen seems to help a bit. Sleeping is best.
Urticaria to face minutes following vaccine. Oral BENADRYL given per mom w/resolution.
Information has been received from a physician concerning a 10 year old male who on 25-APR-2002 was vaccinated with the first dose of MMR II and on 17-AUG-2004 was vaccinated with the second dose of MMR II.  On 09-DEC-2009, the patient was diagnosed with mumps.  The patient was febrile.  The patient had right parotitis.  The onset of mumps was reported as 14-DEC-2009.  At the time of the report, the patient status was unknown.  Follow-up information was received which reported that the 10 (also reported as 6) year old patient on 11-JAN-2010 developed mumps.  The patient had cough 2 weeks and vomit once.  On 13-JAN-2010, the patient was fever 104 F and was diagnosed.  The patient had parotitis on both sides.  On that day, laboratory data revealed that IgM <1:10, IgG 5.29 and serum amylase 509.  At the time of the report, the patient status was unknown.  No further information is available.
No additional AE reported; Improperly stored vaccine was administered to patient; This spontaneous report was received from a medical assistant and refers to a 15-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported  On 08-DEC-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered intramuscularly in right thigh for prophylaxis, lot #W018828, expiration date: 14-JUN-2024 (lot #W018828 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) [VARIVAX]). Administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) had undergone temperature excursion on 05-DEC-2022 (Product storage error). There were no adverse events reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007822:Original Case : 2303USA002114 US-009507513-2304USA007836:Original Case : 2303USA002114 US-009507513-2304USA007843:Original Case : 2303USA002114 US-009507513-2304USA007931:
Numbness and tingling from, and including, tips of left thumb, index, and middle finger (ring and little finger unaffected) and extending up top of arm to elbow and tightness in the entire shoulder area.  Has been ongoing since onset, and is affected by arm position.  Symptoms never fully alleviate, as there is always residual mild numbness in my fingers/hand.  Have not sought treatment yet, as I am uninsured and have no idea what my options are.  Symptoms are ongoing.
Caller stated he has 1st Pfizer Covid 19 vaccine in March and within 8 hours developed Bells Palsy; This is a spontaneous report from a Pfizer-sponsored program Support. A non-contactable male consumer (patient) reported for himself that: A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had first dose of Pfizer Covid-19 vaccine on Mar2021 and within 8 hours developed Bell's Palsy with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
standard pain; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number P7HK7, expiry date unknown) and (batch number 275KY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to FluLaval Quadrivalent.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that the Immunization Consultant from the Immunization Program provided a high-level overview. It was reported that one clinic site got call and patient reported that after the vaccination with FluLaval experienced standard pain, redness, swelling.  It was stated It was possible that these were administration technique errors and not related to vaccine product quality. They are currently evaluating the administration technique and retraining. This case is 1 of the 4 cases reported by same reporter. The reporter did not consent to follow up. The reporter reported 2 different batch number for FluLaval. It was unknown for which case which batch number was provided, hence both batch number were been captured in the case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189449:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:same reporter