chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; fatigue; chills; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, first dose) solution for injection intramuscular in the left arm on 25Feb2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included daily vitamins and birth control pill. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Feb2021 at 16:00, the patient experienced nausea, fatigue, chills. No treatment was provided for the events nausea, fatigue, chills. The outcome of the events nausea, fatigue, chills was recovered on 25Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
Pain radiating from arm up into neck, swollen knot at site, itching, redness, swelling: pt being treated with antibiotics
2hr p/vax pt felt nauseated, dizzy, hot flashes & felt warm;did not take temp sx lasted for 1hr;did not go to MD for care for sx;RN was aware of these sx 21JUL97;
a little bit of Edema; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 (Batch/Lot Number: EN6201), at the age of 76-year-old at the time of vaccination, as SINGLE DOSE for COVID-19 immunization, fulvestrant (FASLODEX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; denosumab (XGEVA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included bone cancer from Jun2020 (Stage IV Bone Cancer), breast cancer. Concomitant medication included palbociclib (IBRANCE) taken for an unspecified indication from Jul2020; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (MULTIPLE VITAMINS) taken for an unspecified indication, start and stop date were not reported. On 12Feb2021, the patient experienced a little bit of Edema which was also stated as not bad with outcome of unknown. No treatment was received for the event.
Within 30 minutes developed localized pain and swelling. Was warm to touch. Developed generalized itching and headache 1.5 hours later.
Information has been received from a physician concerning a 38 year old female with no medical history or drugs allergies, who in April 2009, was vaccinated with a 0.5 mL first dose of GARDASIL. In June 2009 the patient received a second dose of GARDASIL. There was no concomitant medication. The patient had a routine pap smear in October 2009 which came back positive for HPV in the cervical area and condyloma in vaginal area and were considered to be cancer. The patient received laser treatment as an outpatient. The patient sought unspecified medical attention. At the time of this report the patient was recovering. Upon internal review pap smear positive for HPV and condyloma were determined to be an other important medical events. Additional information has been requested.
Severe lower backpain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 10:00, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 17Apr2021 at 23:45, the patient experienced severe lower backpain. The patient had no known history of back pain. The event 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe lower backpain was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right underarm swelled up - swelling filled in arm pit - injection site swollen & warm to touch.  This was shown to my pharmacist- she felt the injection site was too high - and told me to report to Health department, where I got booster shot. I did but guess they didn?t tell anyone. My arm and underarm was swollen for a week. Used ice pal & Tylenol.  But still took a good week to go back to normal.
Extreme pain in arm, swelling, redness, blotching, then fever of over 102 for three days. Took OTC pain and fever reducing medicine, applied ice.
Kinrix administered in the L. arm and MMRV administered in the R. arm. Mother called and reported the Left arm was reddened.  It was explained to her that the arm could be red down to the elbow and should reside in 3 days. No fever, No H/A.  Reported arm is sore.  No Treatment at this time. 8/12/16 Mother phoned in again and said arm is reddened and swollen to the elbow. State called her father, he examined the child and said "he had quite a reaction". I stated it was a local reaction and should reside in 2 days. Temp. normal, c/o soreness.  Phoned pt.'s mother on 8/15/16. Mother stated child doing fine.  Redness and swelling has subsided.  Child doing we..
None - monitor for symptoms of fever, malaise; injection site for redness, swelling, and N/V over the next week.
crying, whimpering constantly for 1 hr p/vax; t100.8, listless, lethargic
Received a dose of MMR that had expired on 1/12/22. No adverse event noted/ treatment given.
About 15 minutes had urge to cough, tickling in throat, redness in throat and started to feel swelling. Had my own kit of epic pen, steroids, Pepcid and Benadryl. Injected myself because the MA at site injected herself and not me, so had another. Did pen, 2 Benadryl, 2 20mg prednisone, I Prevacid. Drove to urgent care and had them monitor me. All the about seemed to work to relieve the swelling and not gonna watch myself for 24 hours.   I have environmental allergies and have reacted to 3 allergy shots with similar symptoms listed above. Had to stop doing them. Please look at people with severe allergies as a group to not require these shots.
devel pale, cold sweating & hypotonic collapse 16 hrs p/vax; taken to ER fever & vomiting;
expired dose of TENIVAC was administered ,with no reported adverse event; Initial information received on 25-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old female patient tp whom expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac] was administered ,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2023, the patient received a expired 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) with no reported adverse event (expired product administered) (lot U6922AA, expiry date: 25-JAN-2023 and strength not reported) via intramuscular route in left deltoid as immunization.  Action taken: not applicable.  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 guidelines. 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 started to experience symptoms of a sinus infection, on 12/20/2022. My husband had already tested positive and I had a feeling that it was Covid. I tested at home on 12/21/2022 and the result was positive. I woke up on 12/21/2022 with a fever and a deep cough. I visited the pharmacy at a grocery store and received another Covid test and it was positive. While there I saw the Nurse Practitioner. I was offered PAXLOVID, but declined because I know other's who have had the rebound case after taking it. As of today, I still have the deep cough. I am going to see my PCP tomorrow about the cough.
Less than 50 red lesions on face scalp, chest, abdomen and a few on extremities.  Several with clear vesicular tops.  Diagnosis varicella, treated with Acyclovir.
patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021). On 15-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the first dose of Moderna COVID-19 vaccine on 08-JAN-2021, and second dose on 15-FEB-2021) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-435133 (Patient Link).
All over body aches, extreme chills, fatigue, with pain and swelling and redness on left arm near injection site and covering an area of 4 X 6 inches.  Stayed in bed all day. The body aches, chills and fatigue lasted from 2:00 a.m. until about 3:00 p.m. (27th), which was the 1st day following the injection. Redness, slight pain, and swelling near the injection site persists today (29th), which is the 3rd day after injection. All other side effects went away by the end of the 27th.
Child went to bed early (6:30 pm) awakened @ 10 pm refused food or drink. Went back to sleep. Awoke @ 2 Am with shaking, chills and multiple episodes of vomiting & diarrhea. Mother did not take temp. Reports child was weak, fell on the way to the bathroom but did not lose consciousness. Mother took to ER. T-101, child recd 2 ivs -one to believe vomiting, 1 to replace electrolytes & fluids. T came down to 98 degrees. Able to drink. Disch @ 9AM with instructions to follow up with pediatrician 11/31/09 child returned to school with MD note authorizing return.
Resident given expired flu vaccine Influenza Vaccine Adjuvanted Fluad Quadrivalent 0.5ml GTN (01): 00370461121034 SN (21): 3PWARBCDF EXP (17): June 30, 2022 LOT (10): 312866
tingling in my arms and hands; light headed and dizzy; heart was beating fast; didn't feel right; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast), FEELING ABNORMAL (didn't feel right) and MYALGIA (Aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced MYALGIA (Aches) and CHILLS (Chills). On 24-Jan-2021 at 1:07 PM, the patient experienced PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast) and FEELING ABNORMAL (didn't feel right). On 25-Jan-2021, MYALGIA (Aches) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast) and FEELING ABNORMAL (didn't feel right) had resolved.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-021375, MOD-2021-102438 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Completed ADR form includes additional patient details, vaccine details, and event details
I started getting itchy. I didn't think anything of it at the time. I bought some Benadryl from a gas station and headed home.  I was tired and itchy. I had taken Claritin earlier that day. I went to bed. When I woke up, the Benadryl had worn off and I had hives. I took more Benadryl and went back to bed. My doctor was gone until Tuesday. I went to see her on 9/28. She gave me some medicine. I took up until 10/02. It must have been wearing off because I started getting itchy again at home. I am having such bad stomach trouble. I'm really itchy on my arms, feet, mouth, and all over. I am now on prednisone. I was told it must be an allergic reaction to the vaccine. It just continues. I am still itchy. After the first reaction, I woke up that first night and I was itchy. I did not think it was the shot. I didn't realize that you could get a reaction like that. That one pretty much went away on its own. I am just so exhausted. I got a horrible migraine type headache after the 2nd dose of the vaccine.
Patient marked the box to have never received  the covid vaccines. later noted off system patient received Jassen March 2021. no reaction noted.
stated she felt "hot, dizzy, tingling to face"  HR 84,  BP 129/84, O2 Sat 97% RA, temp 100.4.  Taken to ER for observation.
Patient has lower back pain, in the kidney area.  Will contact physician on 3-Sept-08 for follow-up.
Dizziness, Headache, Myalgia, NauseaVomiting, fatigue Narrative: 1/19 received the vaccine and approximately 6-7 hours later had onset of fatigue and myalgias. 1/20 - onset of headache, dizziness, and nausea 1/21- symptoms have resolved except headche 1/22 - symptoms resolved except some mild lingering joint pain
Patient with 2 Pfizer COVID vaccinations, last dose 01/29/21 who admitted to ED with pulmonary embolism and tested detected for COVID upon admission who subsequently died.  Provider discharge summary below:  "Patient was admitted for massive pulmonary embolism.  Started on a heparin drip.  Given his metastatic cancer, bleeding risk outweighed any risk from tPA or thrombolysis.  He was admitted to the intensive care unit on BiPAP and vasopressors.  Interventional Radiology was contacted and took him for mechanical thrombectomy on 02/01/2021.  He required vasopressor and respiratory support afterwards.  He did improve and eventually was able to wean off of BiPAP onto high-flow nasal cannula.  He was started on midodrine and was able to wean off of vasopressors.  He was transferred to the progressive care floor.  On 02/07/2022 his respiratory status and mental status began to worsen.  He started becoming tachycardic and hypotensive.  His respiratory support required increasing high-flow nasal cannula to maximum settings with addition of non-rebreather mask.  He was transferred back to the intensive care unit early in the morning on 02/08/2022.  Discussed with family code status and they reiterated that he remained a full code.  Patient was subsequently intubated for respiratory distress and work of breathing.  Post intubation he had a bradycardic/PA arrest lasting 4 minutes with return of spontaneous circulation.  He remained intubated on vasopressors.  Family was present during the code.  Family decided that they did not want to escalate care further.  He was made do not resuscitate/DNI with aggressive care.   Despite maximal supportive therapy on norepinephrine, vasopressin, and phenylephrine the patient went into a bradycardic rhythm resulting in pulseless electrical activity.  Family was present at the bedside during this time.  Patient expired at 9:17 p.m.."
The pt developed a temperature of 104.a (axillary). The temperature decreases to 102F with Tylenol; no relief with Motrin. Went to ER on 1/8/02 and MD found no problems.
This spontaneous report as received from a consumer via her sister-in-law refers to her 12 year old son. On 19-NOV-2013 the patient was vaccinated with his third dose of GARDASIL (lot #, expiration date, dose and route unspecified). In November 2013 the patient experienced redness, swelling, inflammation, and warmth at the injection site after administration. The injection site reaction was treated with ice compresses. The event outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Woke up with arm extremely swollen, red, painful, fingers and hands tingling and numbness. Notified plant hosp. Asked to come in, told normal side effects, use ice pack, arm still sore, numbness in hand and fingers continue.
Within 24 hours a sebaceous cyst on my back became inflamed and infected. Cyst was removed January 27 and was put on Augmentin for the infection. When starting augmentin I became consistently itchy at night. I spoke with my doc at a follow up appointment and she advised to stop taking the antibiotic if hives appeared. Hives appeared February 4 so I discontinued the antibiotics. The hives continued popping up after stopping the antibiotics, I followed up with my doc as I believe this has to do with the booster but she was not convinced. I'm still dealing with spontaneous hives multiple times a week. They typically start on my feet and travel up my legs but more recently they've started showing up on my chest and arms. There are days they are severely itchy and other days they just show up and are uncomfortable.
This spontaneous report as received from registered nurse refers to an 11 month old male patient with no drug reactions/allergies. On 07-NOV-2003 the patient was vaccinated with the first dose of VARIVAX (Merck), (0.5 ml/1 dose, lot# and route unspecified) (9 days before his first birthday)(Inappropriate schedule). On 19-DEC-2007 the patient was vaccinated with the second dose of VARIVAX (Merck), (0.5 ml/1 dose, lot# and route unspecified). The patient sought medical attention via visiting pediatrician office on an unspecified date. The outcome of the event was not reported. Additional information has been requested.
I saw patient today, not quite 48 hours after his four year vaccines, given as two injections to the left leg (MMRV and DTAP-IPV).  Yesterday he got a swollen right thigh at vaccine site and developed fever to 102.8. He was shaking at the time of fever and--with his seizure history-- parents wondered if could have been seizure (vs shaking with fever). Parents gave him Benadryl and took him to Urgent Care, where he was deemed to be having a vaccine reaction. He has not been walking well, and parents noted some puffiness around his eyes, so they brought him into the office today. He was febrile in the office and was walking holding onto dad's hand, gingerly, not wanting to bear weight on sore leg. There is tenderness, calor and splotchy erythema at his leg, but parents reports I am seeing it the way it looks improved after Benadryl.  No breathing problems/clear chest on exam. Mild periorbital edema bilaterally. No hip, knee or ankle pain. The area does not look like infection/cellulitis at this point, and--especially with the way it responds to Benadryl-- I feel his is a vaccine reaction. I have advised continuing Motrin q 6 hrs and Benadryl q 6 hrs and returning should fever persist in the next one to two days or should pain or symptoms worsen or continue.
Headache; nausea; abdominal pain; fever; body ache; swelling, redness, fever, pain at injection site
platelets dropped to 5,000.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from License Party. Other Case identifier(s): NVSC2021US288090 (Novartis).  A female 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: PLATELET DISORDER (non-serious), outcome "unknown", described as "platelets dropped to 5,000.". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Injection site was red from date of injection (9/13/2010).  On 9/19/2010 noticed that area under red mark (which remains red) is hard.  The lump is approximately the size of a kidney bean.  I consulted my pediatrician's office and reported the symptoms.  The nurse knew it was the DTaP and recommended warm compresses.  She advised that if the lump should change or redness intensify/become hot to bring him in.
She completed the second Moderna Covid vaccine in May 2021. (Second Moderna vaccine: unable to read LOT number on her card, but received in the store). She started having buttock cellulitis 2 weeks prior to the hospital admission. She also experienced fever and chills. She came to ED at due to increased drainage of buttock abscess on 1/21/22 and was subsequently hospitalized on the same day. On 1/22/22, she was tested COVID positive as part of presurgical tests. She has not presented respiratory or GI symptoms. Hospital day 7, she is hemodynamically stable. She is still hospitalized since she may need another surgery for a buttock abscess.
High fever, soreness, fatigue, injection site soreness, caused flare up of chronic health condition, joint pain, rash.
Pt devel a large area of erythema & induration (approx 3x7 cm) @ the inject site approx 48 hrs p/receiving Td;
red raised area @ inject site 3" long by 2" wide, worsening since; listness, pt is warm;
A couple of days after my first dose of the Moderna  Vaccine I started having sever joint pain. My hip joints are the worst. I asked my doctor about and he said that he was unsure of the cause so I went to a chiropractor to see if that would help. It did not help and I am still having sever hip joint pain
pt recv vax 29OCT97 & w/in1hr of vax pt exp arm swelling;pt also exp a temp & diff breathing;pt recovered from the temp w/in two nights;