chrisvoncsefalvay/vaers-outcomes huggingface dataset:
?COVID arm? - 4 days after the vaccine I noticed a lump in my arm. It was tender but not overly painful. 8 days after the vaccine the lump is still there, is warm to the touch, red, and itchy.
This spontaneous report as received from a pharmacist concerning a 52 year old female consumer with high blood pressure, anxiety and gastro esophageal reflux disease (GERD) (reporting on herself). There were no drug reaction allergies. On 18-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (Lot # J007210, exp date 20-SEP-2014) (0.65 ml dose, intramuscular route, in the upper arm). Concomitant therapies included pain medicines and unspecified anti-depressants. Pharmacist stated that she documented the ZOSTAAVX was administered by the subcutaneous route and was 99% sure ZOSTAVAX was administered by the subcutaneous route. The patient stated to the pharmacist over the phone that ZOSTAVAX was administered intramuscularly. On 18-APR-2014, the patient experienced puncture site pain and redness at the ZOSTAVAX injection site. The patient also described to pharmacist over the phone the location of the site of puncture site pain was reported as not recovered/not resolved. The outcome of redness at the ZOSTAVAX injection site was reported as recovered/resolved. Additional information has been requested.
Patient sent to ER from PCP after hemoglobin was found to be 6. Initial COVID test was negative. Patient was tested again 9/12 prior to an endoscopic procedure and tested positive but was asymptomatic.
VACCINE EXPOSURE VIA BREAST FEEDING; This spontaneous report received from a parent via a (VAERS- Vaccine Adverse Event Reporting System) (VAERS ID: 1714945) concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 22-MAY-2021, the patient experienced vaccine exposure via breast feeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast feeding was not reported. This report was non-serious. This parent/child case is linked to 20211009578.
This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a 65-year-old female patient who received SHINGRIX for prophylaxis.  In April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extremities hot feeling of, pain in arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the extremities hot feeling of and pain in arm were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extremities hot feeling of and pain in arm to be related to SHINGRIX. Additional details were provided as follows: In min April 2018, the pharmacy accidentally administered a dose of SHINGRIX via subcutaneous injection instead of intramuscular injection, which led to incorrect route of drug administration. The patient experienced injection site reaction that was warm and very painful and covered the arm below the injection site to the elbow about 6 to 8 inches and within a week it had resolved.
Called patient's mom, no symptoms reports. Pt received .5ml instead of .25ml for 1st dose (double dose) - contacted CDC.
Pt received Tdap on 4-22-2009, IM in left deltoid swelling stated 3 days later. Redness from top of deltoid to elbow and area is hard and warm to the touch. Treatment includes warm packs and watch for infection.
Information has been received from a physician concerning a 51 year old female patient with hepatitis C who on 10/30/02 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified) on 10/30/03, ribavirin and peginterferon alfa-2b for hepatitis. On 11/1/03 the patient had respiratory difficulties and on 11/3/03, she was hospitalized in the ICU and intubated. It was noted that the patient had ARDs symptomatology. It was also noted that she had multiple lab work and x-rays and was seen by a pulmonologist. This report did not involve a product quality complaint. No further information is available.
2nd dose given >35 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days from 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. CD9D21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulpha drugs) and Drug allergy (Allergy to Opioids).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days from 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given >35 days from 1st dose) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-508581, MOD-2022-508605 (Patient Link).
Started feeling extremely tired four hours later. Developed a cough, maybe pollen related. Went home and slept for a few hours. Woke with fever and sore all over.
Patient reported a yellow and greenish bruise on left arm from injection site to the elbow. He has also been reporting increasing weakness especially in his joints since administration, his doctor could not find any other cause.
Solid red rash around injection site. Pt was given Fluzone PFS which does not contain latex.
x2 days low grade temp & soreness @ inj site & general tiredness-nausea, h/a, dizziness w/sx continuing;
Cough productive of white sputum, SOB and diarrhea, fevers and chills.
Redness in face and clavicle; Fatigue; Headache; Achy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in face and clavicle), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Achy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (Redness in face and clavicle), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Achy). At the time of the report, ERYTHEMA (Redness in face and clavicle), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
03/02/2021 Vaccination. About 8-10 hours later, I started feeling like I was getting the flu. I had rough 3-4 days.
I exp GI symptoms and migraine. I exp burning, nausea (GI symptoms) lasting 3 days. It felt like acid reflux took medication seems as if someone poured acid down my throat. My arm pain was minimal, no fever and extreme fatigue (not a coffee drinker I was so tired wanted some caffeine).
Moderna vaccine (NDC 80777-0273-98) lot # 039D21A + GTiH 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna = no need to repeat the dose.
Patient was inadvertently administered an expired Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number H2PE2, expiry date 19-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Shingrix (left deltoid). On 01-JUN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Patient was inadvertently administered an expired Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 05-Jul-2023 The practice manager called to inquire if the patient needed to be revaccinate. The patient was inadvertently administered an expired Shingrix on June 01, 2023 which was expired on May 19, 2023, which led to expired vaccine used. The health care professional did not consent to follow up with the safety.
pt recv vax & devel a severe rash over the entire body, fever, cough;
On 4/19, at about 9:30PM, I felt very achy all over, from my hair to my heels. The pain continued on 4/20. I woke up on 4/21 and felt fine. On the evening of 4/24, I started having a persistent dry cough. On the morning of 4/25, I started to wheeze a bit. At my daughter's recommendation, I went to the urgent care clinic. They diagnosed me with bronchitis and they gave me antibiotics, prednisone, breathing treatment, albuterol nebulizer, and albuterol inhaler.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccines on 3/1/2021 and 3/29/2021. Presented to ED for COVID and failure to thrive. Per family COVID symptom onset 1/12/2022. Admitted to floor but transferred to ICU on maximized HFNC with oxygen saturation on the low 80's. Intubated on 2/6/2022. Developed worsening shock likely septic. Developed GI bleed due to mesenteric ischemia. Hemodynamics continued to decompensate. Tx'd w/dexamethasone, antibiotics, and pressors. Code status changed to DNR, expired 2/14/22.
PATIENT RECEIVED VACCINE PAST BUD, CONSIDERED AS AN INVALID DOSE. PATIENT CAME BY 05/20/2023 FOR RE-VACCINATING  NOT EXPERIENCING ANY ADVERSE EVENTS
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS; SWEATING; This spontaneous report received from a Pfizer on 25-JUN-2021 and concerned a 42 year old male. The patient's weight was 99.79 kilograms, and height was 191 centimeters. The patient's concurrent conditions included non smoker and patient had no medical history. He had no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 to right arm at 08:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in May 2021, patient underwent blood work a week before he knew he had COVID. On 02-JUN-2021, the patient experienced sinus, fever, body aches, diarrhea, congestion, nausea, headache, mild cough and sweating. On the same day, patient underwent SARS-CoV-2 rapid diagnostic test and the results came out to be positive. On an unspecified date the patient underwent SARS-COV-2 PCR TEST and the results came out to be positive (confirmed covid-19 infection and confirmed clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus, and sweating on JUN-2021, was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210701758 -COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Headache Fatigue, Sore Arm Narrative:  Other Relevant History:
Narrative: COVID infection following COVID vaccine series Q03/31, Pfizer, dose#1 04/31, Pfizer, dose #2 09/13 COVID swab, result: detected 09/13 pt admit to ED cc: SOB and productive cough dx: Covid infection LOS: 1 day 09/13 pt cc: SOB and productive cough exposure: unknown 09/13 CTA PE impression: Motion partly limits evaluation. No definite acute central pulmonary embolism. If there is high clinical suspicion of pulmonary embolism, consider venous Doppler sonogram. Left breast 1.8 cm nodular density could be correlated with physical exam/diagnostic mammogram. 09/13 CXR impression: Negative portable chest. 09/13 COVID-19 ANTIGEN (BINAX): not detected 09/13 DDIMER 1.03
Immediately following the vaccine, I had symptoms of aches, pains and tiredness that wiped me out for a day. In June, I had Inflammation of my intestine that built up slowly over time and led to another Diverticulitis flare up. For two weeks, I tried to handle it myself. I then went to urgent care to get antibiotics, but they referred to ER. They gave me IV antibiotics and then they sent me home to take oral antibiotics for two weeks, AUGMENTIN 2 times a day: and FLAGYL 3 times a day. It resolved the acute infection. I still have some lingering inflammation that comes and goes to this day. Had follow up with GI specialist doctor and with a primary care doctor.
Mother states child developed hives post vaccine, at 10:30 11/16/99.  Child c/o being itchy prior to that.  Mother gave child benadryl as instructed.  11/17/99, child had hives on back, cheeks were rosy.
reports getting the moderna coviud vaccine on 03/16/2021 and then had a "stroke" 4-5 days after
I got itchy under the vaccine site and have 2 warm red itchy welts.  I reached out to my doctor via email, sent a photo and she then  told me to report this.
Numbness of right arm Aches and joint pain Migraine. Next morning  Dizziness only an hour after. Fatigue. Nausea 4 hours after. Coughing 3 hours after. Puking. About 7 hours after vacc
I have your vaccine but still caught Covid while wearing a mask, feeling great though; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I have your vaccine but still caught Covid while wearing a mask, feeling great though) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I have your vaccine but still caught Covid while wearing a mask, feeling great though). At the time of the report, COVID-19 (I have your vaccine but still caught Covid while wearing a mask, feeling great though) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. No treatment was provided.
2-3 cm red, warm, raised whelp under inj. site (R) post. arm et fine rash to upper arms/neck causing itch et irritation. Tx - Dex4/BENADRYL 25 IM inj., ZYRTEC 10mg, BENADRYL prn.
A little achy; Fever of 101.8; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little achy), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever of 101.8) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). On 15-Apr-2021, the patient experienced PAIN (A little achy) and PYREXIA (Fever of 101.8). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (A little achy), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever of 101.8) outcome was unknown.            No relevant concomitant medication was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
The patient received the Pfizer booster on Sunday 12/26/21. She woke up on Monday 12/27/21 with a severe headache that was not alleviated with Ibuprofen. She also has had fever, chills, muscle aches, and a stiff neck. These symptoms have persisted since Monday morning.
Racing heartbeat, swelling in limbs and face, flush /red face and cheeks , mild headache, extreme fatigue, dizziness/light headed, dry mouth. Started about 10-15 minutes after getting vaccine and got better about 4 hours later. 24 hours later and swelling and racing heartbeat still present but mild.
INFANT WAS ALREADY ON MAINTENANCE DOSAGE OF CAFFEINE DAILY, APPROXIMATELY 12 HOURS AFTER VACCINES WERE ADMINISTERED, INFANT BEGAN HAVING INCREASED PERIODIC BREATHING SPELLS AND AN INCREASED O2 DEMAND WHICH RESULTED IN INCREASES IN CAFFEINE DOSAGE X2 AND INCREASED O2 ADMINISTRATION.
Myalgia, Arthralgia, Pain at the injection site Narrative:  Other Relevant History:
Received Janseen vaccine 6/10/21. Diagnosed with PE on 9/24/21.  No hx of PE or blood disorders.  Treated originally with lovenox 90 mg subcu Q 12 hours.  Outcome to be determined
Intermittent 102° fever with normal temperature of 97.7° three days in a row, cold sore on mouth, migraine, body aches, chills, insomnia.
Fever; Headache; Aches and pains in joints; Sore Arm 2nd vaccine dose; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore Arm 2nd vaccine dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Aches and pains in joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm 2nd vaccine dose) and ARTHRALGIA (Aches and pains in joints). On 11-Mar-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 11-Mar-2021, PAIN IN EXTREMITY (Sore Arm 2nd vaccine dose) and ARTHRALGIA (Aches and pains in joints) had resolved. At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-061491.
States she became very anxious, then developed itchiness in left hand which spread to trunk, feet, lower lip and "all over". Denies any shortness of breath. Took Benadryl, but anxiousness increased with lip swelling, so sought treament at local hospital emergency department.
Pt developed fever since this morning mom sys a rash starting to appear. On 04/01/2002 pt's family reports rash was resolved within 24 hrs. Given Tylenol and Benadryl.
Positive NAAT and lateral flow antigen test on day 9 after initial symptoms, after completing Paxlovid series. Previously tested negative using NAAT on May 9 12 hrs after finishing final Paxlovid dose; Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: ER8736) and on 12May2021 as dose 2, single (Lot number: EW0182) at the age of 40 years for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose 3 (booster), single (Lot number: 065F21A) for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Other medication in 2 weeks was reported as no. The following information was reported: COVID-19 (medically significant), 8 days 9 hrs after the suspect product(s) administration, outcome "unknown", described as "Positive NAAT and lateral flow antigen test on day 9 after initial symptoms, after completing Paxlovid series. Previously tested negative using NAAT on May 9 12 hrs after finishing final Paxlovid dose"; DRUG INEFFECTIVE (medically significant), 8 days 9 hrs after the suspect product(s) administration, outcome "unknown", described as "Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed; (unspecified date) Positive, notes: Positive NAAT and lateral flow antigen test on day 9 after initial symptoms (day 0) and after completing Paxlovid series as prescribed; (09May2022) Negative, notes: Previously tested negative using NAAT on May 9 at 9am (12 hours after finishing final Paxlovid dose). Currently asymptomatic. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Paxlovid started on 04May2022 and stopped on 08May2022 for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Fever, cough, congestion, wheezing, SOB. Nebulizer and inhaler for asthma.
Had full body hives about 2 weeks after shot. Began on left arm, then right arm, then across my diaphragm and up to neck and down to feet.
Erythema approx 6cm x 8cm and itching, tx with Prednisone and Benadryl.
Usually I have no adverse effects from the flu shot; however, last October after the shot I commented that it ached somewhat. I had the shot at our local store and have already recycled the paperwork, so I don't have much of the information requested on this form. The continuing discomfort is not debilitating, but occasionally my arm aches at night and requires a heating pad to sleep. During the day, it only rarely is uncomfortable. I would like to know if it will eventually heal and intend to speak to my doctor when I have a physical which is not scheduled until May.