chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting about a week after vaccination started to see unexplained bruising on extremities, then a few days later (about a week and a half after vaccination) an unexplained spontaneous hematoma appeared on right arm (vaccination was given in left arm). The hematoma grew to about 3 inches in diameter, pain and swelling associated.  Later that evening stiff neck and sharp in point headache appeared. The headache would last maybe around 10-45 seconds and then would dissipate. Headaches were sharp and frequent but did seem to resolve overnight.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with doses of improperly stored GARDASIL (dose, frequency, route and lot# were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Fainting, Flashing lights, Blurred Vision, Trembling, Severe Nausea, Severe Headache, Lump in throat, Chills and Fever, Diarrhea, Tremors have persisted since date of shot and can no longer sleep.
Received Moderna vaccine on 3/11/21, 4/8/21, and 8/16/21. COVID positive on 1/21/22.transferred to us from outside facility for covid pneumonia, resp failure. He has been boarded in ER for the past 4 days, initially had AKI along with elevated O2 requirements. He could not be transferred until today. Today he was down to 1 liter of O2 and AKI had essentially resolved. He was also being treated for UTI, which grew e coli. He was on levaquin and zosyn. Also has a pressure ulcer over his sacral region which apparently patient is unaware of. He was transferred here for further care and management of his pressure ulcer. Patient states he has been weak and also dehydrated. He normally ambulates without any issues. Denies any trauma to his sacral region. Other lab work was unremarkable. Imaging of chest shows bilateral pneumonia. Kept on zosyn for UTI with history of resistant e. Coli, urine culture without growth and abx d/c'ed. Dexamethasone and remdesivir started 1/25 when O2 requirements increased to 3L NC. Discharged on 1/29/22.
Headache, Myalgia, Fever, NauseaVomiting, left arm pain, chills Narrative:
Chills; Fever; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine the day before and is having chills and fever on unknown date, and she would like to know what they can take for that since they had none of this information from the place where she got the vaccine at, no information on what to take for a reaction. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
severe pain on my scalp at the area where a baby would have asoft spot. severe pain at the base of my skull
four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date unknown), dose number 1 via an unspecified route of administration on 23Dec2020 09:00 at a single dose on the left arm for COVID-19 immunization. Medical history included vaccination of unspecified flu vaccine in Oct2020. No vaccines or new medications were received on the day of the vaccination. The patient stated that on 27Dec2020, four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test). The patient stated that she had been mostly asymptomatic for COVID. The outcome of the events was unknown.
Pt received a HPV to left deltoid at approx. 10:30am  mother reported they went to store after and pt started itching and noticed raised red areas to his back.  No further treatment needed or administered.  Mother stated the hives were gone after about 1 hour or less
Cold sxs, cough, runny nose, black/blue spot, oblong started AM of 10/8. No fever, no bleeding, no hard to touch; pt never had problems with vaccine.
I has a sore throat beginning on a Friday morning (Dec. 3) and a fever that developed Friday evening around 8pm. The fever continued through most of the night and reached levels as high as 102 degrees F (no fever reducing meds taken).  I tested for COVID-19 both Friday afternoon and Saturday morning (negative)At the advice of my I visited an urgent care facility on Sunday Dec. 5 due to continued sore throat and pain while swallowing. The doctor tested for strep (negative) and said that it was likely a viral pharyngitis and suggested over the counter Cepracol lozenges for pain. Sore throat and pain when swallowing continued through Monday morning (Dec. 6).
Patient fainted. Patient regained consciousness about 20 seconds later. Paramedic was called. They assessed the patient and said patient was okay to go home.
Fever of 102.2F; Fatigue; Pain at the injection site; Lightheadedness; A spontaneous report was received from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, pain at the injection site / vaccination site pain, lightheadedness / dizziness and fever of 102.2F / pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced fatigue, pain at the injection site and lightheadedness. On 22 Feb 2021, the patient had fever of 102.2F.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fatigue, pain at the injection site, lightheadedness and fever of 102.2F was unknown.
red swollen rash on right side of face and ear; red swollen rash on right side of face and ear; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9267), via an unspecified route of administration on 17Feb2021 at 11:00 (at the age of 68-years) as 1ST DOSE, SINGLE in Arm Left for covid-19 immunization. Medical history included Shrimp allergy. The patient was diagnosed with covid-19 prior to vaccination. Patient did not receive other vaccine within 4 weeks of vaccination. The patient received unspecified other medications within 2 weeks of vaccination. On 18Feb2021 at 07:00 AM, the patient experienced red swollen rash on right side of face and ear. The patient received treatment with fluocinolone Acet 0.01% cream 15gm. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with covid-19 post vaccination. The outcome of events was not recovered.
light itching all like having the chicken pox taking Benadryl 25mg every six to eight hours already had doctors appointment on 3/29/2021 3:30 pm will report the problem and if it's still going on.
Patient received second vaccine dose at 12:52pm, then walked into the observation area and sat down in a chair. At 12:58pm while still sitting in his chair, patient was noted to fall out of his chair hitting his right shoulder, right knee and head on the floor. EMT in observation area immediately went to the patient who was laying on the floor. Charge nurse and EMS staff also at patients side. Patient was noted to be pale,  and stated he was dizzy. VS stable, Pt stated he usually "passes out" with bloodwork but not with vaccines. EMT's recommended patient be transfered to the hospital due to a potential head injury. Patient consented to transfer to  via ambulance. This RN observed a small nickle sized abrasion to patients right knee from fall. Patient was transfered to  at 1:06pm.
Vaccines were administered, patient was alert. After leaving room to complete testing patient became pain and diaphoretic-upon returning to the room with results (within 30 seconds) patient became unresponsive and EMS was called. Patient had thready pulse at 50's, pulse ox was 98%. Patient became alert after a short time one became oriented x3. EMS cleared patient to leave.
1/11/21 8 am-received covid vaccine to left arm and left arm became painful around 10 am on 1/11/21 and she noticed a big read spot on left arm. She states that she could not sleep all night and left arm is still painful, feels like a lump, and is very red. Pt. states that she took tylenol lastnight. Pt. states that it helped with the pain.
Patient is a 93 y.o. female with a history of a fib, T1DM, CML, chronic thrombocytopenia who presented to ED 9/8/2023 for chest and back pain with cough and fevers. In ED, she was found to be in a fib with RVR, COVID 19 positive and with bacteruria. CTA TAP nonacute. She was transferred to Facility 9/8/2023 for ongoing management.   1. Atrial fibrillation with RVR: known history of A fib. CHADS2Vasc 5. Follows with Dr. (cardio). S/p cardizem drip on admit. Improved on arrival to Facility. BB and eliquis continued.  2. COVID-19 Infection: presented with sore throat, fevers, cough on 9/7/23. Vaccinated. Positive test 9/8/23. CTPA nonacute on admit. Started on decadron on admit due to hypoxia, continued on discharge; pt requested paxlovid. Isolation per protocol. 3. Acute Respiratory Failure with Hypoxia: in setting of COVID. Required 2LPM per NC in ED. CTPA on admit nonacute; no PE. Weaned off O2 9/9/23.  4. Bacteruria: with increased frequency and mild dysuria as well as occasional right flank pain PTA. UA with bacteria on admit; Cx 9/8/23 grew >10K EColi. 1 of 2 blood cx 9/8/23 grew strep mitis; suspect contaminant. IV Rocephin completed 9/10/23.  5. T1DM: per history. Follows with Dr. (endo). A1c 6.1 on 8/30/23. Continued home dose of Lantus on admit, dose reduced her carb coverage on admit as she reported not being exact at home.  6. CML: per history, follows with Dr. (heme/onc). Previously on hydroxyurea, stopped in 7/2023 due to minimal improvement in labs. Continued outpatient follow up  7. Chronic Thrombocytopenia: in setting of CML. Plt on admit 44, baseline around 50-80.  8. Anemia: in setting of CML. Hbg on admit at baseline at 10.7.  9. Code status: full code, confirmed on admit 10. DVT Prophylaxis: Eliquis
This is the booster shot : Within 12 hours I felt  nauseous, dizzy, body ache , chills , sweating, arm hurt , light fever (100.4f) . The dizziness went away after 24 hours but everything else stayed the same . It?s been 48 hours and my upper arm is swollen (circle patch), hot and hard .  I read it?s called Covid arm
approximately 40 minutes after the vaccine I developed a mild head ache that lasted about 1/2 hour.  That night I woke up due to injection site pain that lasted through the night.  Friday morning I realized my lymph node was swollen.  By Saturday all symptoms had resolved.
The adult dose (0.5 ml) of the COVID-19 Moderna Bivalent booster was given to an 11 years and 8 month old child instead of the reduced dose (0.25 ml).
Redness of skin on the ankles; mild swelling; mild warmth/slight warmth in the area; mild heat swelling; slight numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 11:00 (Lot number: FF2588) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "Redness of skin on the ankles"; SWELLING (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "mild swelling"; FEELING HOT (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "mild warmth/slight warmth in the area"; FEELING HOT (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "mild heat swelling"; HYPOAESTHESIA (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "slight numbness". Therapeutic measures were not taken as a result of erythema, swelling, feeling hot, feeling hot, hypoaesthesia.   Additional information: No other vaccine in four weeks. No Covid tested post vaccination. No known allergies. patient had covid prior vaccination.    No follow-up attempts are possible. No further information is expected.
Bad headache, severe nausea, palitations, dysuria and blood on tissue when wiped.  Large red itchy injection site.
Lethargy, sore throat, fever to 102 - 1 day after vaccine; continuing for 3 days than fine for  2 days; then low grade fever; cough started.
Rash at injection site 2" x 1" redness w/ 2" raised areas w/i. No vesicle. No streaky redness.
Chest pain- no treatment provided 2 days Left face twitching- 6 days, on going Increased heart rate 5 days
Approx 2 hrs p/immun pt had cont high pitched crying & despite APAP pt spiked a temp 104 R; pt began vomiting; Later pt appeared well;
having short term memory/can not recall things from 2 months ago; soreness in arm; This is a spontaneous report from a contactable Physician.   A female patient (Reporter's wife) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on unknown date for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 29Dec2020 the patient experienced soreness in arm and at 4 o'clock pm she having short term memory, cannot recall things from 2 months ago. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.
had diarrhea; my stool turned bile colored; I was sick for months; I had left shoulder pain for 6 months; I had joint pain; My arm sore was sore at the injection site; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea), FAECES DISCOLOURED (my stool turned bile colored), ILLNESS (I was sick for months), ARTHRALGIA (I had left shoulder pain for 6 months) and ARTHRALGIA (I had joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced DIARRHOEA (had diarrhea), ILLNESS (I was sick for months), ARTHRALGIA (I had left shoulder pain for 6 months), ARTHRALGIA (I had joint pain) and NAUSEA (nauseated). 29-Mar-2021, the patient experienced FAECES DISCOLOURED (my stool turned bile colored) and VACCINATION SITE PAIN (My arm sore was sore at the injection site). In September 2021, ARTHRALGIA (I had left shoulder pain for 6 months) had resolved. At the time of the report, DIARRHOEA (had diarrhea), FAECES DISCOLOURED (my stool turned bile colored), ILLNESS (I was sick for months), ARTHRALGIA (I had joint pain), VACCINATION SITE PAIN (My arm sore was sore at the injection site) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-386019, MOD-2021-386089 (Patient Link).
If you are tallying adverse reactions to flu shots, you can add mine:  I received a flu shot at my local pharmacy on Tuesday, October 16, 2007.  My reaction was a sore arm, as usual; however, what was not usual was an itching, swollen, red and feverish upper arm, from shot site to elbow--one huge hive.  I treated it with Benadryl spray and internal Benadryl capsules, which gave relief from the itching.  The swelling and redness lasted a long time.  Now, more than two weeks later, there is still residual redness.  I have received flu shots every year since they were first introduced in the 70's.  I always have soreness for a few days, but I have never had a hive reaction before.  Just thought you would like the input.
administered a full vial of the purple cap covid vaccine as a single dose; sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient in his 50's received bnt162b2 (BNT162B2), administered in deltoid left, administration date 13Nov2021 (Lot number: FD0809) 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: OVERDOSE (non-serious) with onset 13Nov2021, outcome "unknown", described as "administered a full vial of the purple cap covid vaccine as a single dose"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "sore arm".  Additional information: Reporter reported that Patient was inadvertently administered a full vial of the purple cap covid vaccine as a single dose. What are the recommendations for proceeding with the second vaccination in series? the nurse had not done these vaccines before and didn't want to wait for the other nurse to come explain it, so she just grabbed a vial and administered the full vial without diluting. The patient reported he had a sore arm for only a day and then it was fine. No other AEs reported. He was planning on getting the second dose at the scheduled interval. She has not heard anything new from the patient and he has not gotten his second dose yet. He was due for it, but since he has not come in yet she's not sure if he was waiting. The patient had not reported any adverse events to them since the overdose event. Phone answered by reporter who provided an update. She said the patient is still doing well so no new adverse events to report.  No follow-up attempts are possible. No further information is expected.
Sudden onset of dyspnea without wheezing present approximately 16 hours post vaccination. No wheezing present. Oxygen 100%. To ER via ambulance. Given iopamidol, ipratropium, methylprednisolone sodium succinate, sodium chloride. Patient was sent home with albuterol and prednisone.  Diagnosis: shortness of breath.  PATIENT CONTINUED TO HAVE SEVERE SHORTNESS OF BREATH WITH EXERCISE, POOR AIR QUALITY, AND ALTITUDE, CAUSING MISSED WORK DAYS, FOR THE NEXT EIGHT MONTHS, WITH CHRONIC SYMPTOMS WORSENING AFTER A FULL DOSE OF MODERNA WAS ADMINISTERED AS A BOOSTER ON  9/17/21.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 08-NOV-2016, the patient was inadvertently administered PNEUMOVAX 23 (lot # L022795) that was expired on 05-NOV-2016. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Severe chest and back pain 7 days after Zostavax injection. No respiratory or cardiac symptoms and pain was worse with movement of the torso. No fever and Tylenol helped but did not resolve the pain.
chills; fever; very swollen / injection site; painful injection site; This case was reported by a consumer and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever, injection site swelling and injection site pain. On an unknown date, the outcome of the chills, fever, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the chills, fever, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient had received 1st Shingrix vaccination and had a very swollen and painful injection site with injection. The patient had chills and fever also. For tolerance of 2nd dose US2021AMR013034.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013034:SAME reporter
Dose administration too soon Narrative: Second dose in COVID-19 Vaccination series administered too soon. Patient did not have reaction as a result. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Temp, diarrhea  for 4 hrs, malaise, bad headache , insomnia
On 09/27/2001 it was reported that on 09/18/2001 the patient experienced a severe headache, nausea and vomiting. On 09/19 the nausea and vomiting subsided but the headache remained. No medical care as symptoms slowly resolved over 72 hours.
Probable break-through varicella infection (macules -> scabs).  Calamine lotion, Benadryl po for itchiness.  Diphenhydramine, syrup 12.5 mg/5 ml: 1 tsp p.o. Q 8 hr 12 hr x prn itchy rash.  120 ml.
This spontaneous case, initially received on 31-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received ALFURIA for indication not reported from 31-OCT-2016 to 31-OCT-2016. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 31-Oct-2016, as the nurse was taking the syringe needle out of the vial, the vaccine splashed upwards and got in her eye. No reaction reported. Nurse will flush her eyes with water, she flushed it with 10 ml of water. The nurse stated her eye is a little sore (outcome: unknown). The nurse does not report any trouble with vision, burning or other eye discomfort. Special circumstances: accidental exposure to product. The healthcare professional classified the event as a medication error. The nurse states that her eye is a little sore, but she believes that is because of all the fluid that has been in it.
2 hours after vaccine pt developed left arm pain, then pain traveled to left scapular/shoulder area. Next day, rash, red, flat, diffuse, appeared on front of trunk, chest, hip level, going around sides and less to back, Rash itchy. Also low grade fever 99 F. Took ASA for pain. 09/15/2005 no rash or fever, pain improving.
p/vax pt sought MD attention & routine blood test revealed mild anemia; blood tests showed decreases in all red cell lines & leukemoid react; f/u info revealed pt needed blood transfusion; Dx= viral infection vs beginning of leukemia
10 hours after injection: chills, aches, sweats, trouble sleeping. Following day: fatigue, muscle aches, headache near top of head. Symptoms subsided about 24 hours after.
Large localized area of erythema, swelling that is warm, tender to touch. Will treat with KEFLEX x 7 days for possible cellulitis.