chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hello. I had my  Gardasil-9 shot on 06.01.2021.  Since then untill today is 07.07.2021 i am experiencing  pain in my left arm, around sholder area, same area where shot was done. In the begining i felt like there was a little hard lump, felt like a little ball  under my skin. Today a month later, there is not like a ball , but already like a lump with blurred bigger boundaries. It hurts when pressed, also its hot when i touch it. I didnt feel any fatigue, or weakness or fever ever. Just this hard growing lump. My questions are:  1 . What is it could be?  2.  Can it heal up itself ?  3.  Should i do second vaccine scheduled in August 9th 2021 with this kind of simptoms? Best regards,
Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
swelling, redness, itching @ area, feverish & nausea x 3 days;the swelling & redness also moved down into forearm, as reported by pt;
3x5cm nodule at injection site noted 5 days after administration. Very slightly erythematous and warm.
felt bad after first dose; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 09:30 (Lot number: ER8730) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: before Holiday. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt bad after first dose".  Additional Information: The patient took Pfizer COVID vaccine because he had COVID before Holiday (2020) and for added protection. He was active and gets around. He had friends who had COVID and he had a bad run with it. The patient did not receive additional vaccines on same date of the Pfizer suspect. Adverse event did not require a visit to emergency room or physician office. There were no relevant tests done by the patient.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438332 Same patient and drug, different dose and events
I started to cramp on the 15th of January, I called the on-call doctor in the middle of all that was going on. My water broke and I had a miscarriage on the 16th of January.  They had me come in a day later for an ultrasound to ensure that everything had passed. Due date was July 22, 2023
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild
Pt stated feelings of "fullness of back of throat, palpitations".  Patient did not inform of previous vaccine reactions at time of administration when asked (had serious reactions at the time without stating exact symptoms). Sent to ED for observation. ED Note: She denies angioedema/ swelling, stridor, drooling, wheezing, hoarseness, SOB, tongue swelling. No rash or flushing.  Denies dizziness or syncope.  No itching.  No covid symptoms.  Meds given: NS 1L, diphenhydramine 25mg IVP, methylprednisolone 125mg IVP
Welt on arm about 2.5 inches in diameter. It itches and is sore to the touch.
This is a spontaneous report from a contactable consumer or other non hcp. A 16-years-old male patient received bnt162b2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration on 02May2021 11:00 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03May2021, the patient experienced high fever, chest pain and having trouble, like it hurts when he takes breath, ache. It was reported, reporter's son had the Pfizer vaccine, yesterday at 11AM, and he was fine and then this morning he had a high fever, the ache, all of that, but now, you know I have given him some Tylenol (treatment). He 16 and half, 17 in September and he was now complaining of some chest pain and having trouble, like it hurts when he takes breath, was this something that's normal, because have not heard about of this side effect. Therapeutic measures were taken as a result of events which includes TYLENOL. The clinical outcome for all events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right shoulder surrounding area  (above injection site) soreness, ache, stiffness. Increases with movement.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 27Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; SYNTHROID; WELLBUTRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Negative, notes: tested negative as of 01Jun2022; (11Jun2022) Positive, notes: I took a test today and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28May2022 to 02Jun2022. Patient took the full course of Paxlovid and tested negative as of 01Jun2022. Starting around the 6th, patient felt heavy fatigue. The cough returned on the 9th and the night of the 10th she barely slept due to cough and inability to breathe well. Patient took a test today (11Jun2022) and tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pain; This is spontaneous report received from the non-contactable female consumer (Patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced pain. The patient scheduled for the second dose on 21Apr2021. She supposed to receive injection shots for pain on 20Apr2021 Fl fluoro injection. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
CHEST PAIN, HIGH BLOOD PRESSURE, THROAT CLOSURE SENSATIONS, HEART PALPITATIONS, VERTIGO, DIZZY, LIGHTHEADED, MENSTRAL PERIOD STARTED EARLY WITH BLOOD CLOTTING AND STILL VERTIGO 2 WEEKS LATER
Swelling pain and redness on the arm. Redness got larger and it?s itchy. Looks like a rash.
Patient physician electronically sent a prescription to the pharmacy we filled the prescription and gave the vaccination. After giving the patient the vaccination we looked up the patient in the doctors office system and noticed that the patient already received the Prevnar 20 vaccination in January 2023. Patient was notified by provider and pharmacy of duplicate vaccination. Pharmacist followed up with patient the next day to check for any adverse reaction.  Patient stated that he had no signs of adverse reaction.
had the shot and had shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sister or brother. The age at vaccination was not reported. The reporter stated that, his or her sister had shingles vaccine and had shingles 5 times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Mild rash.  Applied 1% hydrocortisone.  Began last night.  Just treated it now about 24 hours after it started.  Feels better.  Who knows.  What does this mean for me taking the second shot with a larger payload?
muscle aches, chills, and high fever.  Ran a fever of about 103 for about 24 hours.  Rested and drank a lot of fluids and was fine about a day and a half after the injection
1 day Right upper arm with redness, warmth, swelling, and firmness-measured 16 1/2 cm x 14cm diameters and low grade fever 100.2 F measured at home x 1 day.
Received SHINGRIX 50MCG/0.5ML SUSR - first dose. Within hours felt pain where shot was given. Within 24 hours felt weak, headache, shivers, nausea, diarrhea and belly pain.
This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 87-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included NORTHERA, XARELTO, paroxetine and SYNTHROID. On 21st June 2018, the patient received SHINGRIX. On 21st June 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities. On 22nd June 2018, the patient experienced lip swelling. On 24th June 2018, the patient experienced back pain and stiff back. On an unknown date, the outcome of the lip swelling was unchanged and the outcome of the back pain, stiff back and erythema of extremities were recovering/resolving. The reporter considered the lip swelling, back pain, stiff back and erythema of extremities to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reported that a swollen lip, redness on the arm, near the elbow rather than at the injection site which was given higher up the arm, and back pain after receiving SHINGRIX. The patient noted she could not get out of bed. At time of reporting, symptoms had improved except for the swollen lip.
The first 2 days after the shot my arm was sore. That went away and then on 1/5/21 my arm became sore, red, raised and warm around the injection site. It still is 1/6/21 along with body aches
doses administered after excursion; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
Nurse asked how old he was, he said 12. Grandma who has custody did not correct.  He turns 12 in 2 weeks.  He was given a full dose instead of a pediatric dose.  When he comes back for his second he will be 12 and will receive a full dose.  He had no reaction while waiting his 15 minutes.
Autism. Did not reach typical milestones. Vocalizes, but does not really use speech as a tool to get what she wants. Follow up reports states  pt  has "PDD- Autism".
Nephritis Pt expressed to have experienced right and left flank pain 1 day following the 2nd dose of Pfizer Covid Vaccine. ADR submitted under Employee.  Narrative:  Pt inquired about possible SE associated with Covid Vaccination. Writer searched for Case Reports of Renal pain associated with administration of mRNA based covid vaccinations. Labs UA/CMP/CK ordered and case to be discussed with patient's PCP when Team returns to work.
New adverse effects 3 o 4 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (New adverse effects 3 o 4 days ago) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (New adverse effects 3 o 4 days ago). At the time of the report, ADVERSE EVENT (New adverse effects 3 o 4 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was reported.
At 1610 patient and parent was brought back to the exam room for vaccine administration.  Mom of patient was educated on vaccines that the patient would be receiving (Kinrix, MMR, Varicella) and given Vaccine Information Statements for each.  Allergy information was verified and mom advised that the patient had no known allergies and no previous vaccine reactions.  At 1615 patient was administered vaccines.  Patient began holding his breath and and developed tonic movement of the body.  Patient then urinated on himself.  Patient began to respond to verbal commands.  Patient's physician was contacted, vital signs were taken.  Patient was responsive but pale and sleepy.  SPO2 was 98% on room air and blood sugar was 91 and other vital signs were within normal range. Mom stated afterwards that child has had similar attacks, but it was not mentioned prior.  911 was called and patient was transferred to the hospital for further evaluation.
Pruritic rash - red papulo/vesicular with some crusted lesions x2 days.
hearing loss.  Began a few days after the first shot.  It got much worse, complete loss of hearing after second shot.  Couldn't get in to see an ENT and when he did he went to Doctor with Clinic but it was more than a month after the symptoms started.  Later was able to see Dr at Clinic who prescribed steroids but said only a 5% chance of that helping because it was so late after symptoms began.  He retired.  Dr is his replacement and Patient has an appointment with her on August 31 to determine what to do.  Some hearing has returned but he still cannot hear well enough to use a telephone.  I put my phone number for contact because he can't use a phone,  They are looking possibly doing an implant so he can hear.
Flare up of previous shingles.  Currently in treatment. Taking shingle meds  - anti viral.
Day of Vaccination:  Headache started approximately 4:30PM Fatigue and feeling cold began around 5:30PM Chills began around 8PM continued through the night, difficulty sleeping and muscle pain/myalgia began Day after Vaccination: Muscle pain/myalgia, headache and fatigue noted as continued through the following day Following Days: Fatigue noted through today
Neck swelling; Swollen Neck and thyroid,; soreness in the opposite arm; Rapid HR,; fever; Extreme body ache; Chills,; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck swelling), GOITRE (Swollen Neck and thyroid,), PAIN IN EXTREMITY (soreness in the opposite arm), TACHYCARDIA (Rapid HR,) and PYREXIA (fever) in an 18-year-old male patient 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced SWELLING (Neck swelling), GOITRE (Swollen Neck and thyroid,), PAIN IN EXTREMITY (soreness in the opposite arm), TACHYCARDIA (Rapid HR,), PYREXIA (fever), MYALGIA (Extreme body ache), CHILLS (Chills,) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, SWELLING (Neck swelling), GOITRE (Swollen Neck and thyroid,), PAIN IN EXTREMITY (soreness in the opposite arm), TACHYCARDIA (Rapid HR,), MYALGIA (Extreme body ache), CHILLS (Chills,) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications information was not reported. Treatment information was not provided.    This case was linked to MOD21-080553 (E2B Linked Report).; Sender's Comments:  MOD21-080553:
Severe muscle weakness impairing patient's ability to perform ADL, joint pain, and 101F fever. Resolved without intervention.
In less than 24 hrs developed non-raised, non-itchy pink rash extending in 3-4 different sites on outside of right arm; from injection site to elbow.  Spots were approximately 2"x4" in size .  Next day experienced extreme fatigue where Pt uncharacteristically slept all day.  Symptoms resolved by next day.
Shortly after receiving the flu vaccine, she began having shooting pains in her arms, swelling around her eyes and abdominal pain.
Woke up the next morning with a headache, lightheadedness upon standing, dry mouth, no appetite, fatigue, sore arm and redness the size of an apple at the injection site. A few hours later developed tingling in my entire body and chills. Made sure to drink plenty of fluids, eat small meals at regular intervals and laid down for most of the day. Took naps. After dinner, I started to feel much better - chills and tingling were gone, had more energy. By the next day, all symptoms were gone besides the sore arm and redness, which lasted another day and then also resolved.
sore left arm; headache; fatigue; sore neck; sore throat; This is a spontaneous report from a Non-contactable Consumer. This 56-Year-old female consumer reported that:  A 56-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 16:15 (at the age of 56-years-old) as dose 1, single for an unspecified indication. Medical history included total thyroidectomy - due to cancer, cancer. Patient had no Known allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from unknown start date; liothyronine (LIOTHYRO-NINE) taken for an unspecified indication from unknown start date; lamotrigine (LAMOTRIGINE) taken for an unspecified indication from unknown start date; cyanocobalamin (B12 GUMMIES) taken for an unspecified indication from unknown start date. Patient had not received any other vaccines within 4 weeks. No prior to vaccination, patient was not tested with COVID-19. On 09Feb2021 23:00, the patient experienced sore left arm started during the evening after the dose, headache, fatigue, sore neck, sore throat. No treatment received for the events. At the time of report, the outcome of events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.