chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tendinitis 1.5 week after the first shot; Sick after first shot; Fever 100F after first shot; Nausea after first shot; Chills after first shot; Bad Headache after first shot; Could not run any more after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not run any more after first shot), TENDONITIS (Tendinitis 1.5 week after the first shot), ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot) and NAUSEA (Nausea after first shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HYPOKINESIA (Could not run any more after first shot), ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot), NAUSEA (Nausea after first shot), CHILLS (Chills after first shot) and HEADACHE (Bad Headache after first shot). On 01-Dec-2021, the patient experienced TENDONITIS (Tendinitis 1.5 week after the first shot). The patient was treated with Physical therapy for Hypokinesia and Physical therapy for Tendonitis. On 23-Nov-2021, ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot), NAUSEA (Nausea after first shot), CHILLS (Chills after first shot) and HEADACHE (Bad Headache after first shot) had resolved. At the time of the report, HYPOKINESIA (Could not run any more after first shot) had not resolved and TENDONITIS (Tendinitis 1.5 week after the first shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  It was reported that patient did not take any medications. Patient was an athletic and had been running since she was in her 20's. She never had tendinitis in the past. Reporter stated that she believes it was caused by the vaccine. Patient did not saw the doctor yet. She was making an appointment with her PCP.
01/07/2021  Chills, hot and swollen arm (Vaccine site), swollen Left Lymph node, Second Vaccine 02/06/2021 Chills, hot and swollen arm (Vaccine site), swollen Left Lymph node, fever
Day 1) Local soreness where vaccine was administered.  Day 2 & 3) Increased soreness, unable to use arm. Day 4) Beginnings at abdomen px, soreness traveled to neck and left arm. Day 6 & 7) Nausea, abd px and soreness to arms and neck.  Day 8) Abd px, vomiting, headache. Day 8) Vomiting, headache, diarrhea, soreness increased.
Apnea event requiring noninvasive respiratory support and resuscitation. 11/16/19 at 0330 Infectious screen negative History of apnea of prematurity
The achiness if I touch its sore/ it's little achy when I drive with my left arm then I feel little achiness in there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 08Sep2021, when the patient was 60 years old, for Covid-19 Immunization, reaction(s): "its like a bubble its still there its on my body its not breaking down", "my body is encapsulating the vaccine and its not releasing". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "The achiness if I touch its sore/ it's little achy when I drive with my left arm then I feel little achiness in there". The event "the achiness if i touch its sore/ it's little achy when i drive with my left arm then i feel little achiness in there" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Consumer stated, "This is the problem I am having. When I got my Vaccine the first one on 08Sep2021. You know, how you get the injection, it has a little bubble to it. well, its like a bubble it's still there its on my body it's not breaking down. I went to my PCP, and they did that they believe that my body is encapsulating the vaccine and it's not releasing and from day one it's still there. And I went to go get my second shot and the technician the medical technician said they are not comfortable doing it because it shouldn't be like this (Further clarification unknown) it's the same person I went to who did my the first one and he was like it should not like this. My husband had this on the same time he is fine no problem you can't even tell he had it but for me it's not."When asked for any medical assistance Consumer stated, "Yes. I did go to my PCP. The achiness if I touch its sore. I sleep by my side so sometimes I wake up because it feels like right now it's little achy when I drive with my left arm then I feel little achiness in there and I still feel that right now." Still Experiencing (Adverse Event): Consumer stated, "Yes." Outcome of event (worsened, improved or persisting): Consumer stated," its the same."Treatment (Adverse Event): Consumer stated, "Yes, I went to my Primary care Physician." When probed for any further assistance, consumer stated, "No, can you just note that I do have pain when I touched that area or if I lay down or If I drive with that arm. Right now, I am driving with my left arm because I am holding the paper with my right. but I do experience little achiness." No Prior Vaccination Within four weeks. No Prior Medical History. No Family History.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client complained of muscle pain and tenderness on left arm radiating to nipple on left side of chest.
Hot flashes, tired, no energy, sick to stomach, headache, dizzy, nause chills,
When I arrived home approximately 5pm, a headache so bad felt I was hit hard with a bat in the front lobal area, was numb. Arm at injection site was painful, hurt to lift arm, stung and burned. Total body began to slow down with painful aches all over,, especially across both back of shoulders which now was painful to lift either arm.Moaning and struggling to walk. Difficulty using the toilet. That evening I was leaning back in my chair and experienced a tightening of the throat like waving up and down both sides of my throat, struggling to get air. Nausea. 2nd day same as 1st. 3rd day Dizzy, nausea, throat relaxing. Day 4 headaches, throat r e laxing more.
Pt developed arm soreness, myalgias and a headache with onset 4 hours after administration. Missed work x 1 day. No known prior COVID infection.
Swollen lymph nodes in left armpit causing significant level of pain; Swollen lymph nodes in left armpit causing significant level of pain; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Dec2021 at 15:00 (Lot number: FE3594) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none; Known allergies: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: left arm; Lot number: EP7534; Administration time: 17:00), administration date: 23Mar2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Anatomical location: left arm; Lot number: EW0150; Administration time: 17:00), administration date: 13Apr2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 15:00, outcome "unknown", described as "Dose number 3"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 27Dec2021, outcome "recovering", and all described as "Swollen lymph nodes in left armpit causing significant level of pain". Therapeutic measures were not taken as a result of lymphadenopathy and lymph node pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Pain occurred two days after the booster shot, pain continued on day 3 somewhat reduced. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Had senior flu shot up high in left shoulder 8/28/15. Within 6 hours, could not move left arm. Had a lot of pain, went to urgent care 9/30/15. Also doctor 10/13/15, it still pains mostly at nite. I reported it to pharmacy. I don't use a computer.
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient. Patient reported no adverse events other than typical ones from covid vaccine. Patient will consider offer to come back to receive a replacement booster dose.
a little sluggish; tested positive for COVID; fever of 99.6 that night; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (a little sluggish), COVID-19 (tested positive for COVID) and PYREXIA (fever of 99.6 that night) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PYREXIA (fever of 99.6 that night). On 16-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). On an unknown date, the patient experienced SLUGGISHNESS (a little sluggish). At the time of the report, SLUGGISHNESS (a little sluggish), COVID-19 (tested positive for COVID) and PYREXIA (fever of 99.6 that night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5/9 noticed itching lump at injection site. It is red and warm. Not painful to touch. About dime size today. A little bit smaller lump than yesterday
Pt elbow of same left arm, was swollen, and hot to touch. Pt came in following day still swollen, pink, and warm to touch.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 30-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Narrative:  67 year old male admitted on August 8 2022 with fever of 102.3F.. He had received Moderna vaccine x 4 on January 24 2021, March 1 2021, October 1 2021, July 11 2021. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 4 days and dexamethasone 6 mg daily x 5 days.. He symptomatically improved and was discharged home on August 13 2022.
Product Storage Error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L52, expiry date 28-MAR-2025) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7X574, expiry date 30-JUN-2023) for prophylaxis.   On 05-MAY-2023, the patient received Pediarix and FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Pediarix and FluLaval Quadrivalent 2022-2023 season, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with  Pediarix and FluLaval QIV vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of  Pediarix and FluLaval QIV vaccines after temperature excursion, which led to incorrect storage of drug.
This case was reported by a healthcare professional and described the occurrence of needle stick injury in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown) and experienced needle stick injury and pharmaceutical product complaint. The sales representative reported while the nurse administered the vaccine, "there was an air bubble in the body of the syringe and the syringe blew up; it was not known if the needle was in the subject at the time of the explosion". The contents of the vaccine went into the nurse's eyes (see case A0853360A). At the time of reporting the outcome of the needle stick injury was unspecified.
Headache, Myalgia, Arthralgia, chills, arm swelling and red mark Narrative:
RASH THAT LOOKED LIKE MEASLES, NO FEVER/NO OTHER SYMPTOMS.
7d post vax tender indurated red 2" area observed lt upper arm area (deltoid); t97.5;
no adverse event; one dose of VARIVAX was administered following a temperature excursion; VARIVAX W025277 expiration date reported as 8/10/2024, but validated internally as 28-SEP-2022; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On 23-MAR-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number: W025277 (expiration date: 10-AUG-2024, but internally validated as 28-SEP-2022 (expired product administered)) for prophylaxis (strength, route, dose or units were not provided).   The storage characteristics were the following: Temperature: 25.9F Time frame: 2 hours 0 minutes Previous temperature excursion? NO   No adverse effects were reported.
Triggered migraines that normally come in the spring/early summer lasting 1 to 2 weeks.  They have been treated daily with Zomig nasal and Aimovig injection and started on propanolol 80 mg.  Nothing has helped.  Continue to have have migraines.
Child awoke this morning complaining with Rt arm. Mom brought him into the office with upper arm red, swollen and warm to the touch. Physician assessed area and also viewed a small papule. So, Child was treated for ? infection vs localized reaction. Parent was also instructed to apply cool compresses, along with giving either BENADRYL or Cetirizine and to follow up if not improved.
2 minutes after receiving vaccination, patient developed left upper arm pain and left sided chest pain, described as constant tight and heavy with a 5/10 intensity, w/o SOB, abdominal pain, pruritic, hives or swelling, no numbness or tingling, chest pain  Allergy to amoxicillin - unsure of reaction Current medications include atomoxetine, Pristiq, singular, larin, trazodone heart rhythm regular, lungs clear, no facial/lip/tongue/oropharyngeal swelling. No hives and no meds given
This spontaneous report was received from a licensed practical nurse and referred to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD with one of the following lot# M002056 (rHA) and expiration date: 11-JUL-2017 or lot# M043307 (rHA) and expiration date: 24-APR-2018 or lot# N001488 (rHA) and expiration date: 12-JUL-2018. Other suspect therapies included an improperly stored dose of VARIVAX with one of the following lot# M043582 and expiration date: 28-OCT-2018 or lot# N001530 and expiration date: 13-JAN-2019 or lot# M039316 and expiration date: 20-SEP-2018. Concomitant therapies included sterile diluent. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. Additional information has been requested.
patient developed swelling "across her shoulders to her shoulder blades"; This spontaneous report was received from a nurse referring to a 41 years old female patient. The patient's medical history included severe asthma. The patient's concomitant therapies included losartan potassium (+) hydrochlorothiazide(HYZAAR); albuterol(manufacture unknown); azathioprine(IMURAN); dupilumab(DUPIXENT); fluticasone furoate(+)vilanterol trifenatate(BREO); mycophenolate sodium(MYFORTIC); prednisone; venlafaxine hydrochloride(EFFEXOR); alprazolam(XANAX). The patient was allergic to levofloxacin (LEVAQUIN). On 03-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot# R031810,expiration date not reported, but upon internal validation established as 02-SEP-2020, intramuscular, dose and location were not reported)for prophylaxis. On the same day the patient developed swelling across her shoulders to her shoulder blades following vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The patient called physician's office to seek medical attention.There were no treatment or lab diagnostics given for the event. The patient recovered from swelling on 15-JUL-2019. The causality between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
11 years old Patient ordered for Pfizer COVID vaccine prior to discharge. Order was processed as COVID vaccine for 12 y/o+ (which is 0.3 mL). Initial wrong dose error caught by IV pharmacist. Dose re-entered as pediatric COVID vaccine 10 mcg/0.2 mL. Pfizer COVID vaccine that pharmacy carries was utilized to prepare and send dose. However the dose was not built into DoseEdge so it was bypassed and written up.   5 days later, Another pharmacist discovered that the patient received double the intended dose (20 mcg/0.2mL) due to vial concentration differences between the 12 y/o+ Pfizer COVID vaccine vial and the one intended for pediatric use. The 12 y/o+ COVID vaccine vial does not have the actual concentration listed anywhere on the product or in the package insert.   No patient harm was reported
Patient stated she has a red round mark at the site of injection 13 days after receiving vaccine. Spot was itchy and 3 inches round.
Arm pain; Joint pain (in all joints); This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and joint pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm and joint pain were unknown.   It was unknown if the reporter considered the pain in arm and joint pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The age at vaccination was not reported. The patient experienced arm pain and Joint pain (in all joints) after receiving Shingrix. The patient was not alarmed as she expected it, and received Advil to minimize the impact. The reporter agreed to follow up from GSK.
Initial report received from non-health care professional on 20 September 2012. A 82-years-old female patient, whose concomitant medications included TYLENOL and concurrent conditions included: Arthritis, Kidney problems and Knee replacements, had received intramuscular FLUZONE HD (Lot number was unavailable) on left deltoid 12 September 2012. The same day i.e. on 12 September 2012, the patient had pain in both arms up to shoulders and problems with her knees and had to use walker to get around. It was reported that the patient was self-medicating with extra strength of TYLENOL. Corrective treatment was not reported. Outcome of the events was reported as "unknown". List of documents held by sender none. Follow-up information was received from a healthcare professional on 19 November 2012. The patient was treated with intramuscular DEPO-MEDROL and tramadol for knee pain and pain in both arms on unspecified date.
Vaccinated at 9:45; At 11:30 flushed; 12:10 reported to RN vitals 184/108, 99F > 6-18; 12:20 arms red, shoulders warm left greater than right warm. 12:40 Benadryl 75mg po MD notify. 12:50 symptoms subsiding. 14:14 to ER for evaluation.
Headache; Tiredness; Fever; Sore arm for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Tiredness), PYREXIA (Fever) and MYALGIA (Sore arm for 12 hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (Tiredness), PYREXIA (Fever) and MYALGIA (Sore arm for 12 hours). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 25-Feb-2021, HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Sore arm for 12 hours) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.        Treatment drug reported  NSAIDS after 2nd dose of vaccination   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information  As per follow-up( received on APR 29 2021): updated the lot numbers of vaccines (both 1 and 2), updated the date of ist moderna vaccine, updated the dates of Events, changed the outcome of events from unknown to recovered/ resolved , added the event "sore arm"
Developed rash or hives on right side of face/neck within a couple hours of vaccination. That evening arm was sore. Developed low grade fever, aches, chills x 2 days. No treatment. Called in sick to work on 10/4/13 - next day. Resolved spontaneously.
ER visit 29th both sides of neck swollen; cough; head congestion; afeb; green nasal drainage; mom thought had upper resp infect; MD in ER felt it was a rxn to MMR;
10 days after the second injection, I went to the hospital because I had abdominal pain and had been throwing up. They found blood in my urine, but no other reason for the right flank pain or abdominal pain.  At one point my arms were swollen and would wake me up with intense pain - tingling and numb  Lyme Disease - Doxy for a 4 weeks - no help, not retested for it 2 UTIs - Ciprofloxacin (500 mg - 10 days) and another antibiotic before that