chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient under 65 received Fluad QIV; Shoulder-neck-jaw pain; Shoulder-neck-jaw pain; Shoulder-neck-jaw pain; Injection site pain; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via agency (reference number: SEQW20-04804) and concerned a 26-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reprorted.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced injection site pain and shoulder-neck-jaw pain. The patient was treated with Tylenol (paracetamol).   On an unknown date in 2020, three days after the onset, the patient recovered from the events.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 26-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced vaccination site pain, arthralgia, neck pain and pain in jaw. Reportedly, the patient had no relevant medical history. Causal role of the suspect vaccine is assessed as possibly for all events. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 26-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced vaccination site pain, arthralgia, neck pain and pain in jaw. Reportedly, the patient had no relevant medical history. Causal role of the suspect vaccine is assessed as possibly for all events. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
10/28/21-48-year-old male with a history of diabetes, hypertension and is fully vaccinated completed in April presents wanting a repeat rapid antigen because when he had his test done earlier at PRP he said that he received a call that he was negative but 20 minutes later his wife received a call to see that he was positive.  Patient states he had been feeling bad for 2 days.  He has had a cough but no shortness of breath and he has had a headache that is mild.  He states that he is seems his chest hurts with a cough. He has had chills but no fever. .
mild itching, redness and swelling @ site, site sore x 2 days, improving now. Still some itching, bump under skin going down over time.
Symptoms of itchiness and red, raised area of 4 x 2.5 inches which persisted for 4 days and then gradually resolved.
pharmacist reported on behalf of patient 8 days post 1st moderna shot a rash at site of injection with itching and a lump. The lump resolved and pt took benadryl and applied anti itch cream. pt reported "less itchy"
Patient came in for second COVID vaccine. Patient verbalized that he received is first dose Moderna vaccine on 6/12/2021. RN used state immunization system to verify receipt of a covid vaccine and type given. Documentation in system was Moderna as the vaccine given on 6/12/2021. RN administered the Moderna vaccine to patient. Before leaving clinic, patient presented his vaccine card from 6/12/2021 that showed Pfizer as vaccine given, which was also consistent with patient's signed registration /vaccine administration paperwork from 6/12/2021 (verified by RN). Patient received Pfizer vaccines on 6/12/2021 and Moderna vaccine on 7/13/2021. Patient displayed no adverse reactions.
10 min after vaccines administered child broke out in hives on the left arm and chest. Itchy. 25mg BENADRYL given.
Grand maul seizure. Dislocation of right shoulder which resulted in a full rotator cuff surgery in April 2023. Thoracic spine issues to which I have a herniated disc at T11-T12 and recently found out I have a compression fracture in T4 or T5. I have had no other incidents of trauma since the seizure 10 or 11 days after the vaccine.
Patient developed a varicella like rash at the injection site within 2 days of receiving the vaccine. Initial rash started to heal, then patient has developed little red dots on various places throughout her body on 4 separate occasions over the past 6 weeks.
2/22/2021 9 PM (angioedema) swollen/red lips, flushing chest, red earlobes, red behind ears, difficulty swallowing when eating, throat congestion throughout the day for 4 weeks 2/24/2021 benadryl 25 mg up to 4 times/day; prednisone 10 mg increased to 30 mg 2/26/2021; famotidine 20 mg once/day; zyrtec 5mg  discontinued after 2 days due to reactions - replaced with claritan 10 mg  daily 3/1/2021 emergency room admission for observation  continuing above medications
Fever, ache, chills for 12-15 hours on April 21, 2021.  Then, developed sever gout flare on April 18, 2021, which lasted 3 weeks.  No prior gout diagnoses.
COVID 19 Treatment; COVID 19 Treatment; JANSSEN COVID-19 VACCINE on 17Mar2021 as dose 1 and BNT162b2 on 24Oct2021 as dose 2/Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 16:00 as dose 4 (booster), single (Lot number: cah9703) at the age of 27 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Oct2021 as dose 2 (booster), single (Lot number: 320308D), in right arm and on 05Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Lot number: 1805025), in right arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination.  The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history included asthma. Patient had no known allergies. Other medication in 2 weeks included NYQUIL COUGH DM + CONGESTION. Concomitant medication(s) included: NYQUIL COUGH DM + CONGESTION, start date: 28Sep2022, stop date: 01Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2021, outcome "unknown", described as "JANSSEN COVID-19 VACCINE on 17Mar2021 as dose 1 and BNT162b2 on 24Oct2021 as dose 2/Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID-19 treatment. Patient received the vaccine. Patient received treatment for COVID-19 with Paxlovid from 28Sep2022 to 02Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium
When she tried to administer the vaccine, medication squirted all over the place; she took a look at the plastic cap and noticed that it was warped.; When she tried to administer the vaccine, medication squirted all over the place; she took a look at the plastic cap and noticed that it was warped.; It is like super warped it looks like Plastic melted in a weird way, so there was no way to puncture; I opened the fresh one out of the box of and it was warped; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5017, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG TECHNIQUE IN DEVICE USAGE PROCESS (non-serious), DEVICE LEAKAGE (non-serious) and all described as "When she tried to administer the vaccine, medication squirted all over the place; she took a look at the plastic cap and noticed that it was warped."; PRODUCT OUTER PACKAGING ISSUE (non-serious), described as "It is like super warped it looks like Plastic melted in a weird way, so there was no way to puncture; I opened the fresh one out of the box of and it was warped".  Additional information: she thought that she injected the vaccine or punctured the bottle all the way but when she tried to administer the vaccine, it squirted all over the place and she stated the medication squirted all over the place and she took a look at the plastic cap and noticed that it was warped. She stated she took a look at the plastic cap and she realized it was warped."So the cap of this plastic that connects to the adaptor or the adaptor itself and if you look at it, it is like super warped it looks like Plastic melted in a weird way, so there was no way to puncture."  Causality for "when she tried to administer the vaccine, medication squirted all over the place; she took a look at the plastic cap and noticed that it was warped." and "it is like super warped it looks like plastic melted in a weird way, so there was no way to puncture; i opened the fresh one out of the box of and it was warped" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: A possible contributory role of the device cannot be excluded based on the information available
pt recvd vax 14JUL93 & 21JUL93 pt started shaking on lt side especially lt leg, eyes rolled back in head, mouth opened, difficulty breathing, jerking was taken to hosp; sz stopped about 1115PM;
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  The vial did not undergo any temperature excursion.  Date of vaccine placed in refrigerator was 18-Oct-2021.  HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  Patient did not experience any adverse event.  No treatment information provided.
Hepatitis A vaccine given mistakenly instead of HIB. Patient received the correct HIB vaccine today 6/1/05. No swelling, no pain, no redness per mom. Patient is doing well.
Pfizer Dose 1 3/15/21 (EN6205) Pfizer Dose 2 4/7/21 (ER8737) COVID Positive 1/18/22  1/18/22: Patient is a 77-year-old male with a past medical history significant for coronary artery disease, chronic atrial fibrillation currently anticoagulated on warfarin, COPD, depression, type 1 diabetes, hyperlipidemia, hypertension, hypothyroidism, obesity.  The patient presents to the ED today via EMS from home after family found him confused, altered and agitated. The patient was seen and examined at the bedside in the ED; however, the patient is only making moaning sounds when asked questions which makes it difficult to obtain accurate HPI.  There is no family present during examination in the ED. Most of patient's HPI was obtained from ED records and previous medical records.  The patient apparently takes oxycodone at home and it was unknown if he was altered due to taking too much oxycodone, the patient did receive Narcan in the ED which did seem to help improve his orientation for a short period of time.  The patient does take warfarin at home, so a CT head was ordered to rule out a brain bleed.  The patient was found to have severe hyperglycemia upon arrival to the ED.   Upon arrival to the ED patient's temperature is 96.7°, heart rate 70, respirations 20, pulse ox 100% on room air, blood pressure 116/77.  CT of head reveals mild motion degradation without acute findings.  Chest x-ray reveals mildly decreased lung volumes with bibasilar atelectasis. Patient's laboratory findings are significant for sodium 133, potassium 6.3, chloride 88, CO2 14, a gap 31, glucose 759, BUN 61, creatinine 2.04, calc Osmo 321, hemoglobin 11.9, hematocrit 40.1.  UA is negative for infection. COVID-19 test is pending.  The patient received 2.5 mg IV droperidol, was started on an insulin drip, 25 mg IV Benadryl, 10 units IV insulin regular, 1 mg IV Ativan x2, 1 mg IV Versed, 1 mg IV Narcan, 2 L IV normal saline, 100 mcg IV fentanyl in ED.  1/31/22: Patient is a 77-year-old male admitted to hospital for acute metabolic encephalopathy due to diabetic ketoacidosis, his hospitalization was complicated by acute kidney injury, AFib with RVR and COVID-19 pneumonia. Patient was treated with supplemental oxygen and medical therapy as time progressed he clinically improved, prior to discharge patient was wean off of supplemental oxygen, he was evaluated by therapy recommended skilled nursing facility on discharge.  Patient will be discharged to another facility.
Fever/chills 104.8, N/V, severe fatigue/weakness, severe headache, body aches
received the third dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received the third dose without being immunocompromised) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A, 036B21A and 011D21A) for COVID-19 vaccination.     The patient's past medical history included Implantable cardioverter defibrillator insertion since an unknown date. Concurrent medical conditions included Heart disease, unspecified and Kidney disorder.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced OFF LABEL USE (received the third dose without being immunocompromised). On 16-Aug-2021, OFF LABEL USE (received the third dose without being immunocompromised) had resolved.            Concomitant medication information was  provided by the reporter  i.e., several for his heart (13 morning, 2afternoon, 5before going to bed).  Treatment information was not provided by the reporter
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Lot number: EN6199) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression" (unspecified if ongoing); "type 2 diabetes" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm.  Additional Information: No reactions to vaccinations other than sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same patient, different dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;
LEFT ARM, REDNESS AROUND THE VACCINE SITE. HEAD WAS ITCHING, FACE WAS SWOLLEN HAD TROUBLE BREATH, BENADRYL WAS GIVEN @ THE EMERGENCY ROOM
Inflamed lymph node in left arm pit, Forced early menstruation (2 weeks early)
patient experienced palpitations, sweating, one episode of vomiting, faint feeling. felt "back to normal" after about 45 minutes of observation.
Patient has seronegative spondyloarthropathy auto immune condition.  Has not had any issues in a while.  A few days after receiving the Moderna vaccine, developed some mild arthritic symptoms in R hand, R hip and sternum and eventually the right side of neck going up into skull area. Pt developed a fever blister under nose.  Pt did not have a fever.  In addition to the voltaren patient takes daily, added some ibuprofen.  Symptoms are improving.
No adverse event noted, patient received additional dose of SHINGRIX vaccine. Human error, nurse failed to note that 1st dose of SHINGRIX was administered on 6/30/21 and 2nd dose was administered on 9/22/21. Third dose was mistakenly administered on 10/27/21. Provider and patient immediately notified of error. Patient reported a headache later that day and follow-up call done by provider. Provider conducted a follow-up call the following day, and patient reported no symptoms or complaints.
Red, painful area on (L) arm. Mostly anterior. Went to doctor. Diagnosed as infection. Given KEFLEX treatment.
pricking sensation from injection site radiating to finger; Left arm has tingling; numbness; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 49-year-old) as a single dose for COVID-19 immunisation and also received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 28Mar2021 at 13:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C) both taken for an unknown indication from an unknown start date and unknown if ongoing. On 08Mar2021 at 16:00, the patient experienced left arm had tingling, numbness, pricking sensation from injection site radiating to fingers. Occurred intermittently after first shot but increased duration after second shot. The patient didn't receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events left arm had tingling, numbness, pricking sensation from injection site radiating to fingers was not recovered  at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
My arm hurt tremendously at the injection site and muscle for days after the shot. On the evening of March 29, I decided to look to see what was causing the itching on the inside of my left shoulder blade. I thought it might have been spider bites. They looked like volcanos that have lost their tops, and had a liquid center. Over the weekend the itching increased, and was accompanied by a burning pain. On Tuesday I went to see a doctor, and she said that it appeared to be an adverse reaction to the SHINGRIX vaccine--which had caused a small shingles rash. She gave me a prescription for Valacyclovir, and topical Lidocaine. My pharmacist was unable to fill the Lidocaine prescription due to my insurance--so she gave me an over the counter version instead. The pharmacist at pharmacy said that there was a chance that the Valacyclovir could lesson the effectiveness of the SHINGRIX vaccine. This was vaccine #1 in a two part series. Since the 29th, I have also been applying apple cider vinegar which I read would lesson the itching and pain. The rash has been scabbed over for days (today is April 7), yet the itching and pain has not gone away.
This spontaneous report as received from another health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose, route of administration and lot # were not reported). No adverse effects were reported. On 17-DEC-2014 a telephone call was placed to the medical assistant who stated that she was unfamiliar with the reported incident of incorrect product storage. The reporter transferred the call to another person who was also unfamiliar with the event. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling of my lymph nodes in the injection area; Tender/Hurts when I touch; Looks like a ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling of my lymph nodes in the injection area), VACCINATION SITE PAIN (Tender/Hurts when I touch) and VACCINATION SITE SWELLING (Looks like a ball) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of my lymph nodes in the injection area), VACCINATION SITE PAIN (Tender/Hurts when I touch) and VACCINATION SITE SWELLING (Looks like a ball). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling of my lymph nodes in the injection area), VACCINATION SITE PAIN (Tender/Hurts when I touch) and VACCINATION SITE SWELLING (Looks like a ball) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Runny nose, fever, sore throat. Fever noted 105.9 degrees Fahrenheit.