chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at injection site approximately 1/2 hour after shot. The rash continued to grow. Day 8 - itching at injection site, warm to touch. Day 9 and 10 - itching and rash continued to grow moving down left arm and into chest area. Benedryl started day 10.
Headache; Tiredness; Lightheadedness/Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 32-years-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0153) at the age of 32 years as DOSE 2, SINGLE for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot number is EP695, location: left arm.), administration date: 26Mar2021, when the patient was 32 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Tiredness"; DIZZINESS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Light-headedness/Dizziness". Therapeutic measures were not taken as a result of headache, fatigue, dizziness. Additional Information: It was reported that the tiredness for the second dose was the week of 16 Apr2021. Stated that the tiredness lasted for 3-5 days and she recovered completely. Stated that the light-headedness/dizziness lasted 3-5 days and she recovered completely. Stated that the second shot of Pfizer Covid 19 was on 16Apr2021. Stated that the lot number was EW0153. Stated that  the dosage was unknown that was given in her left arm. Stated that the first shot of Pfizer Covid 19 was on 26Mar2021. Stated that the lot number is EP695 and she cannot read the last digit after the number five. Stated that the dosage was unknown that was given in her left arm. No follow-up attempts are possible. No further information is expected.
11:55 AM-Non-contiguous erythema around dual injection site on left thigh and left ankle/foot, sparing left distal thigh, knee and upper lower leg. Area warm to the touch with raised area noted beneath injection site. Raised area approximately 4 cm x 6 cm. 11:55 AM-Ice pack applied to injection site. Benadryl 2.5 ml and Tylenol 2.5 ml given orally. 12:30 PM-Redness had resolved everywhere, but quarter sized diameter around injection site. 4:30 PM-Phone call to mom who stated all redness and swelling improved, except at injection site.  7-11-19 @ 10:30 AM-f/u in office, doing well, all swelling and redness resolved except for minimal redness surrounding injection site
Headache, fever, severe body aches, joint aches, chills, night sweats, bruise at inoculation sight, sore arm muscle at inoculation site, temporary loss of taste/smell, lack of appetite, cough, congestion, sinus pain , overall body pain. No treatment from doctors. Lasted 2 weeks
Parents reported that infant developed a fever of over 105 degrees approx. 3 hours after immunizations. No medical treatment was obtained. Infant was given Tylenol and temp. decrease for next 12 hours. temp. was normal the next day.
Nausea, loose stools, fever, body aches, chest soreness, sore arm - all occurred 9 1/2 to 10 hours after vaccine administered.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Vomiting-Severe, Additional Details: also had floor replaced that day, and there were fumes from glue. pt thought that could have made her vomit.  Nause and "vaso-vagal" symptoms (pt's words) started after flu shot just as covid being given. She had to lie on floor for 15 min, tried getting up several times and had to lie back down and then vomitted large amount of vomit.  After vomitting other symptoms cleared quickly.
A non-serious spontaneous report of positive for Influenza A by nasal swab was received from a 39-year-old female physician concerning herself, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. On 23-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 04-Nov-2009, the patient started having flu-like symptoms and experienced body aches, a low fever, and upper respiratory tract symptoms. On 05-Nov-2009, the patient tested positive for influenza A by nasal swab. The outcome of the event was unknown.
Nurse was called to evaluate a patient in the monitoring area of the vaccine clinic. Patient was sitting in chair AAO x 3. Patient complained of hives and itching on both palms. Hives and erythema were noted bilaterally on her palms. Some erythema was noted on her upper back and neck area. EMS was activated. Benadryl 50 mg IM was administered @ 1524 per standing orders in left deltoid. Patient had a previous mastectomy and was unable to receive shot in her right deltoid. VS were as follows: BP 154/92, HR 100, Pulse ox 97% room air. Patient denied any shortness of breath or chest tightness. Wheezing was noted bilaterally in upper lobes. 1527 VS were reassessed and were as follows: 144/78, HR 100,
Patient had a prolonged stay at select specialty hospital with a goal of titrating down his oxygen requirements and increasing his strength and conditioning so that he may be able to be discharged to a skilled nursing facility.  Patient was able to be titrated down as low as 7 L/min via high flow nasal cannula.  His prednisone dosage was titrated down to 15 mg daily.  He was doing well but still had issues with exertion requiring nonrebreather mask on top of his high flow nasal cannula.  Patient got to a point he was not progressing and further work-up was completed on 11/18 to rule out reversible causes of acute on chronic hypoxia.  He had a CT chest angiogram which showed no acute pulmonary emboli but worsening bilateral bacterial pneumonia.  Patient had steroids increased to IV Solu-Medrol 40 mg every 8 and restarted on IV cefepime and vancomycin.  24 hours later, patient had significant oxygen requirements and was placed on continuous BiPAP with Precedex drip for anxiety.  Despite this, patient had increased work of breathing and decision was made with together with his family to transition to comfort measures.  Patient was placed back on nonrebreather and heated high flow nasal cannula and started on intermittent morphine and Ativan pushes.  Patient died peacefully at 2:32 AM on 11/21.
pediatric patient received FLUBLOK QUADRIVALENT with no adverse event; Initial information received on 27-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Agency (under the reference 00831032).  This case involves a 9 years old patient (unknown gender) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV (lot QSAA2111 and expiration date: 30-JUN-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual a medication error due to Inappropriate age at vaccine administration (same day latency).  It was reported "Pharmacist asks for information on re-administration of influenza vaccine after a pediatric patient received FLUBLOK QUADRIVALENT."  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had cough and SOB.  These lasted for about 6 to 8 weeks.  I went to the doctor about this.  They did a Chest X-ray and blood work.  I did a home Covid-19 test, positive results.
Injection site pain Tiredness/fatigue  Headache  Muscle/joint pain Chills Nausea  Feeling unwell Cough
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. In June 2017, the patient was vaccinated with the improperly stored (in 7.2 degrees Fahrenheit for 30 minutes) dose of PROQUAD (for prophylaxis, lot # M014301, albumin status rHA, expiration date 22-SEP-2017; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. Data logger was involved. No previous temperature excursion and no adverse event (reported as no symptoms) were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010443.
Pt had instant headache & lied down for 15 minutes until felt well enough to walk
Information has been received from a physician, via a company representative, concerning a 15 year old female patient with asthma and rhinitis allergic, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided). A few hours after the vaccination, the patient became lethargic, developed a fever (value not specified) and had induration around the injection site. The symptoms lasted for approximately 3 days before the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
There was no adverse reaction. MMRV administered as a combined dose instead of 2 separate doses due to the age of the child.
I don't feel good, I feel like I have enough now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-COVID-19 Vaccine- Solution for injection), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I don't feel good, I feel like I have enough now".  Additional information: Reaction/Event as Reported: gave me a Pfizer shot the first time and when I went in to get my second one they gave me Moderna, I got two different kinds. Consumer stated, "I need to ask some questions, (Name Withheld)." Name of medication: Consumer stated, "Pfizer (COVID-19 Vaccine) and Moderna (COVID-19 Vaccine), I was calling about the Pfizer Vaccine."  Consumer stated, "What will happen if my shot was of Pfizer and second dose was of Moderna?" When paraphrased, Consumer stated, "No, they gave me a Pfizer shot the first time and when I went in to get my second one they gave me Moderna, I got two different kinds." Consumer further stated, "Correct and I don't feel good, I feel like I have enough now."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ant thigh redness + swelling 2 days after vaccine (R) ant leg (DTaP) 8.5 x 9 cm erythema (L) ant thigh (Varicela) 3.5 x 2.5 cm erythema No fever
Onset middle of night crying-by am favoring R leg with no hx of injury or cold sx's or break in skin-no hx of fever. Resolution 48 hrs.
Narrative:  About 20 minutes after vaccination, she began to experience lightheadedness/mild dizziness a/w nausea. She denied pruritus, flushing, angioedema, confusion/disorientation, SOB/wheezing, palpitations, vomiting, or abd cramping. She is her wife's primary caregiver and had to rush this morning to transport her to/from an appointment, then drove home prior to coming back to the facility and had not been able to eat/drink. O: VS: BP 139/94, HR 68, SpO2 98% on RA Gen: well groomed, sitting upright in chair, non-toxic in appearance answering questions appropriately, pleasant HEENT: atraumatic/normocephalic, PERRL, nares patent, throat non-erythematous/no exudate Neck: no lymphadenopaty CV: regular rate and rhythm, normal S1/S2, no murmurs/heaves Pulm: clear to auscultation bilaterally with no wheezes/rales/rhonci Ext: moves all 4 spontaneously, no edema, able to ambulate very short distance to another chair w/o disturbance in gait Skin: no lesions or rashes over visualized areas Neuro: CN III-XII grossly intact, 5/5 strength UE and LE, eating w/o difficulty Psych: appropriate, thoughts linear and non-tangential, A/Ox3 A/P: Patient developed adverse effect s/p COVID-19 vaccination demonstrated by mild dizziness/lightheadedness a/w nausea. Sx within normal realm of potential adverse effects, no current suspicion for immediate allergic reaction or anaphylaxis. Normalized reaction to vaccination. Provided with snacks and water. Snacks were consumed w/o difficulty. At completion of examination, the patient still w/o some dizziness. Advised to please continue to wait until this subsided prior to driving home. With rechecking + po intake, the patient stating feeling much better/able to drive ~50 minutes post vaccination. Reviewed potential reasons to seek emergent care for s/sx of immediate allergic reactions that may occur in 4 hours after vaccination or with any s/sx of anaphylaxis (which she has previously experienced). Additionally advised to please eat/drink prior to coming in for 2nd dose and, if possible, to have a driver.
diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea post chemotherapy, PEMBROLIZUMAB (KEYTRUDA), LEVOTHYROXINE, BIOTIN, CALCIUM, OMEPRAZOLE, MAGNESIUM, IRON, TOPIRAMATE, ESCITALOPRAM, ZOLPIDEM, NARATRIPTAN and NAPROXEN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhoea). The patient was treated with PREDNISONE at a dose of 40 mg. At the time of the report, DIARRHOEA (diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078198 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078198:first dose case
This spontaneous report was received from a nurse who referred to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA, dose and route of administration were not reported (lot # was reported as M038728, expiration date was not reported). No adverse effects were reported. VAQTA was stored between 0 Celsius degrees (C) and 1 C for 80 hours. There was previous temperature excursion between 0 C and 1 C for 41,5 hours. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up. Sender's Comments: US-009507513-1707USA002350.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sore, swollen, hot arm with a hard knot in it for 3 weeks and counting (still has not resolved). 3 days after vaccine, intense abdominal pain identified as lymphatic inflammation, not fully resolved until after 2 weeks. No fever, no nausea (excellent appetite), but blood work six days later showed three measures of inflammatory response.
Mother called to state that 1 day after receiving vaccines, patient complained of severe left arm pain, fever, nausea, and headache. Fever lasted about 24 hours, resolved with MOTRIN. Mom stated patient was unable to get out of bed due to the amount of pain she was in. She was not having any pain in her right arm at all. Mom had not given patient anything except 1 dose of MOTRIN. Mom was advised to alternate MOTRIN/TYLENOL, and to use a heating pad or to apply ice to the injection sites. Mom was contacted the following day for follow up, she stated all of patients symptoms had resolved.
Fever to 105.6 (infrared device), severe myalgias and arthralgias, chills, Headaches, dysuria and testicular pain.  Improvement with Ibuprofen and acetaminophen.
Sore arm where both were given. Got a little nauseated & headache. Two tetanus incorrectly given same day Td & tetanus toxoid.
Ringing in ears, light headedness, difficulty driving home. Felt like I was driving home drunk or high feeling. Was scared I was going to crash my car. Chest pain one hour after vaccine
Pt called office stating on 11-14-08 left deltoid area swollen, red, warm to the touch.
A rash began to develop around the injection site and spread to my chest, neck and back.  Rash began approx. 4 days ago and has steadily worsened.
Swelling of lymph nodes in armpit, groin and neck; Joint pain; Fever over 100 degrees; Off label use; Booster/ Dose received : 3; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Oct2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN); both from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 08Oct2021 at 22:00, the patient experienced swelling of lymph nodes in armpit, groin and neck, joint pain and fever over 100 degrees. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On same day, the patient underwent body temperature and the result was over 100 degrees. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of lymph nodes in armpit, swelling of groin and neck, joint pain and fever over 100 degrees was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had heart palpitations several times a day, every day until the end of May 2022 they stopped. I did a bunch of tests and Dr. did not determine anything that was wrong.
This is a spontaneous report from a contactable consumer or other non HCP (the patient). A 81-years-old male patient received the second dose of PREVNAR 13, intramuscular in the left deltoid on 23Jan2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose one of PREVNAR 13 for immunisation on 05Nov2015. The patient experienced polymyalgia rheumatica on 24Jan2019 with outcome of not recovered. Caller stated that joint pain and muscle pain started on 24Jan2019; he had a hard time walking; when he got out of bed, his left leg was so sore he could hardly walk. The patient stated he is in his 4th week, and it is the same; it hasn't gotten better or worse but has moved. His main problem now is his shoulders and arms. The prognosis is muscle aches and pain; it is still in his leg but mainly now in his shoulders and arms. The patient is receiving prednisone and ibuprofen. The patient underwent lab tests and procedures which included blood test and electrocardiogram on unknown date. The information on the batch number has been requested.
actually first all he had was just sore arm and slight warmth that was it; actually first all he had was just sore arm and slight warmth that was it; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), FEELING HOT (non-serious) all with onset 2021, outcome "unknown" and all described as "actually first all he had was just sore arm and slight warmth that was it".  Additional information: The patient was fully vaccinated at the time of reporting. He was not in any study. His second dose he noticed side effects more than first, actually first all he had was just sore arm and slight warmth that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.