chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nauseated; This is a spontaneous report from a contactable nurse (patient).   A 54-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EK5730, Exp date Mar2021) at single dose  at right deltoid on 17Dec2020 08:15 for immunization, administered at hospital.  Medical history was none. There were no concomitant medications. No additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No adverse events followed prior vaccinations. The patient was really nauseated last night on 17Dec2020 from 21:00 and has been slightly nauseated 18Dec2020. The outcome of event was recovering. The event was assessed as non-serious.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021; 606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13 Oct 2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 04-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It mentioned that the vial was placed in the refrigerator on 04-Nov-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment information was provided.
Information has been received from a registered nurse concerning a 39 year old male patient with no known drug allergies or pertinent medical history who on 27-AUG-2009 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot #661897/1333X). There was no concomitant medication. On 29-AUG-2009 the patient experienced fever, nausea, lightheadedness and aching. It was unknown if the patient required medical treatment but he returned to the clinic 09-SEP-2009 and stated his symptoms were improving. No laboratory tests were performed. Follow up information has been received from a registered nurse concerning a 39 year old male smoker (1 ppd) patient who on 13-AUG-2009 was vaccinated IM on the deltoid with the first dose of PNEUMOVAX 23 (Lot #661897/1333X). There was no illness at the time of vaccination. On 14-Aug-2009 the patient experienced 2 days of fever, myalgia and fatigue. No office visit, testing or additional follow up. On 17-AUG-2009 the patient recovered. This is one of two reports from the same source. No further information is available.
Onset of palpitations and tachycardia beginning approximately four hours after injection and continuing three months post injection.  Tingling, itching and rash at injection site, varying in intensity.  Onset two days post injection, intermittent and continuing three months post injection
On 1/3, experienced redness, "blotchy chest," "red dots to skin," "hives on both palms." Feet itching, but "I didn't investigate that." Took Benadryl 25mg x 2 tablets on 1/3 morning. Resolved on 1/3 in the evening.
It was tender to lay on my arm on 04/10/21. That morning my arm was swollen with red blotches. It didn?t bother so I ignored it until today?04/16/21, because it was itching.  My arm is warm with many red blotches. Does not bother enough to take any meds.
After 1 hr of receiving the vaccine patient returned to pharmacy stating they are developing a rash on the inner side near the armpit area. The rash was about the size of a fist. They confirmed they were not having any trouble breathing. I provided 6 tablets of Benadryl 25mg and suggested if it continues or worsens they may take Benadryl. If there is worsening and trouble breathing, I recommended seeking ED. I followed up with a phone call after 1.5 hrs of the reporting and the daughter stated pt is doing better and the rash was resolved.
RT DELTOID AREA WHERE SHOT WAS GIVEN VERY PAINFUL, REDDENED, 4X4 AREA INFLAMMED,  HOT TO TOUCH, AND ITCHING. TREATED WITH COLD COMPRESSES AND IBUPROFEN. THEN ORDERS GIVEN TO GIVE BENADRYL, SOLUMEDROL, PREDNISONE, PEPCID, AND KEFLEX. FOLLOW UP WITH NURSE PRACTITIONER OR PHYSICIANS ASSISTANT IN 2 DAYS. SIGNS AND SYMPTOMS IMPROVING.
Hoarseness within a week of 1st Pzifer-BioNTech SARS-CoV-2, intermittent  1st dose on 1/6/21 2nd dose on 1/27/21  Hoarseness now occurring daily starting 5/5/21
Rash developed on right arm the morning after vaccinations.  Found to have probable necrotizing fasciitis.
after first vaccine, pt had local injection site reactions of redness and swelling intermittently for a few weeks.  For this second time, she had a more quick onset.  Within 20 minutes, she started having swelling and warmth around the site of the first injection (which was about 3 inches lower than the second injection site) and arm numbness.  No distal motor changes.  Also developed headache.  No itching or redness.   Recieved tylenol, observed extra time.  Had some chills.  Had slight worse swelling but improvmenet in numbness.  Sent home with precautions.
Eczema, red and dry patches appear on neck and around eyes. And dry above the lips. Patches also itch. Itchy and red packets on arms (opposite side of elbow, where arms bend)
Initial and follow up information has been received via Merck pregnancy registry, from a registered nurse, concerning a 24 year old caucasian female patient with a history of an abnormal papanicolaou (PAP) smear and one prior pregnancy resulting in a full term delivery, who on 25-SEP-2007 was vaccinated IM with the first dose, 0.5 ml of GARDASIL (lot # 655503/0012U). There was no concomitant medication. On 04-OCT-2007, the patient had her LMP and subsequently became pregnant. On 26-NOV-2007, she was vaccinated IM with the second dose, 0.5 ml of GARDASIL (lot # 655618/0186U). On 28-NOV-2007, a urine pregnancy test was positive. On 05-DEC-2007, she called the physician's office. The estimated date of delivery was 10-JUL-2008. Follow up information from the nurse indicated the patient was prescribed prenatal vitamins on 29-NOV-2007, and added that the patient occasionally took acetaminophen (TYLENOL) (indication not specified) during her pregnancy. Also, on 04-DEC-2007, the patient was prescribed metronidazole (FLAGYL), 500mg twice daily for 7 days, for treatment of bacterial vaginosis. The outcome of the event was not specified. Additional information has been requested.
I developed a bruise in my right upper arm with a hard knot in it.  I do not remember hitting or hurting my arm.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE; DESCOVY. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200810645 samer reporter/pt, different drug/event;
Information has been received from a 70 year old female patient with no prior history of cancer who on an unspecified date was vaccinated with one dose of ZOSTAVAX (Merck) (lot # not reported). On an unspecified date after received the vaccine the patient experienced lymphoma. The patient outcome was unknown. Lymphoma was reported to be immediately life-threatening and disabling. Additional information has been requested.
Patient received Covid19 vaccine at 3:20pm to the left upper arm, and seated in front of myself (CNP) for monitoring. At 3:40Ppm, he stated that his throat felt tight, and he placed his hands to his neck. He had his epinephrine pen in his pocket. I injected 3mg IM to left upper thigh, and 50mg diphenhydramine IM to right upper arm. 911 was already activated by another staff member. Vital signs were monitored during entire event, and were stable. EMS arrived at 3:45pm, and transported patient to ER. Patient reported that he felt much better when he was taken by EMS.
Mom called today (6/14/12) and reported that pt fainted 3 wks after GARDASIL #2. Episode approx 3 min. Occurred when pt got out of bed in am. Also reporting today same thing occurred after GARDASIL #1.
I had a headache on Wednesday and Thursday. My throat was also hurting. On Friday I had a fever thru the night and still tested negative. I also had some sinus congestion and nausea. On Saturday I had fever, nasal congestion, and nausea. My fever got 103.0. I finally tested positive on Saturday. I went to a walk in center and had a COVID 19 test completed and it was also positive. My symptoms got worse over the weekend. I was very congested and could not breath out of my nose. My doctor prescribed Sudafed and Paxlovid but I did not take the Paxlovid as I was past the date. I rotated Motrin and Tylenol as well. I still have lingering fatigue but everything else got better after 2 weeks.  I do not feel like I have recovered. My heart rate still jumps around like it did when I had post COVID-19 in 2020.
Felt like a bee sting; Weakness; Cough; Sharp pains rotating across her body but mostly in arm pit on right arm; Sharp pains rotating across her body but mostly in arm pit on right arm; At injection site had sore arm; Chills; Headaches; Fever; Tired/ tiredness and fatigue; Shortness of breath; Started not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), MALAISE (Started not feeling well), PAIN (Felt like a bee sting), ASTHENIA (Weakness) and COUGH (Cough) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), MALAISE (Started not feeling well), ASTHENIA (Weakness), COUGH (Cough), AXILLARY PAIN (Sharp pains rotating across her body but mostly in arm pit on right arm), MYALGIA (Sharp pains rotating across her body but mostly in arm pit on right arm), VACCINATION SITE PAIN (At injection site had sore arm), CHILLS (Chills), HEADACHE (Headaches), PYREXIA (Fever) and FATIGUE (Tired/ tiredness and fatigue). On 14-Mar-2021, the patient experienced PAIN (Felt like a bee sting). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PAIN (Felt like a bee sting), ASTHENIA (Weakness), COUGH (Cough), AXILLARY PAIN (Sharp pains rotating across her body but mostly in arm pit on right arm), MYALGIA (Sharp pains rotating across her body but mostly in arm pit on right arm), VACCINATION SITE PAIN (At injection site had sore arm) and HEADACHE (Headaches) outcome was unknown and MALAISE (Started not feeling well), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tired/ tiredness and fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Patient received the 1st Moderna vaccine 11Mar2021 on right arm. 24 hours later, she "started not feeling well". She was tired, had chills and fever. She is still feeling same way. Has sharp pains rotating across her body but mostly in arm pit on right arm. At injection site had sore arm. On 3rd day it felt like a bee sting. She had headaches, weakness, fatigue. Has a cough and a little shortness of breath due the tiredness and fatigue. Took Tylenol.
Pt has a golf ball sized lump on right thigh area is red and warm to the touch. Pt's mother was advised by staff to give pt Benadryl and apply a cold compress to area. Advised to call this clinic if symptoms increase.
Swelling, erythema in site of injection/dizziness. SOB night of injection. Burning sensation in both legs, burning in legs resolved, now tingling in mouth and lower extremities.
Severe nausea; Feeling unwell; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 12Apr2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and spinal stenosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 16Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient previously took hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 12Apr2021 at 17:00, the patient experienced severe nausea, was feeling unwell and experienced headache. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea, feeling unwell and experienced headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Shot site soreness next morning (about 12hours),  Fever, chills, headache, body aches at about 20 hours.  These subsided mostly by 36 hours but then:   back pain in lower back to sacrum at about 60 hours that became SEVERE at 72 hours.  Unable to walk or sleep.  Recovered by 84 hours,
3 days after flu shot, She developed headache, running nose, watery eyes, phlegm, sneezing and 1 day fever of 100 F. Up to today 11/14/06, she still has very bad running nose and watery eyes.
Leak Between Needle And Vial of Heplisav-B, Only Received Half The Dose; Initial Report Received on 24-Feb-2023.  A non-significant follow-up report received on 29-Mar-2023 that included the QA investigation results of the mixed product quality complaint:  the investigation did not identify a potential lot-related issue, there was no trend, this was the first AE associated with HEPLISAV-B Lots 941061, no potential impact to the lot was identified, no CAPA was recommended, and the case was closed on 29-Mar-2023.  A pharmacist in the reported that a 34-year-old female patient (race and ethnicity unknown) received a half a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization because there was a leak between the needle and the vial of HEPLISAV-B.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 24-Feb-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 941061, expiration date 10 Dec-2024, NDC # 43528-0003-05; and route not reported) in the left deltoid. There was a leak between the needle and the vial of HEPLISAV-B and the patient only received about half of the dose. The needle went into the vial as usual. The vial and needle were not retained by the reporter as they were thrown away in the sharps container. No adverse effects were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Red welt starting the second day lasted for 3 days. Red thick skin mild itchy starting day 7 (still on going as of reporting)
No adverse symptoms reported; A pharmacist states that a patient received HA VRJX (unknown lot and expiration date) on 10/11/2019 and received VAQTA (lot S012250 expiration 07/06/2020) on 11/18/2019.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, concurrent condition and drug reactions/allergies were not provided.  On 11-OCT-2019, the patient received hepatitis A virus vaccine inactivated (HAVRIX).    On 18-NOV-2019 the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (lot# S012250, expiration date reported as 06-JUL-2020, but internal generated as 07-JUL-2020; dose, strength and route were not provided) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms were reported.
Day after vaccine: Chills Fever  Body aches High hear rate (160)  Second day after vaccine: Irregular heart rate
Narrative: Patient reported having a headache, as well as fever, fatigue, and arm pain after receiving the 1st dose of vaccine.
Moderna COVID-19 Vaccine EUA- dose given 16 days after BUD for refrigeration
BOOBS WERE FILLED WITH CYSTS; PAINFUL BOOBS; SWOLLEN BOOBS; NIGHT SWEATS; LITTLE FAINT; GOT PERIODS EARLY/IMPACTING CYCLE; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced boobs were filled with cysts, painful boobs, swollen boobs, night sweats, little faint, got periods early/impacting cycle, chills, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, little faint, and tired, had not recovered from fever, and chills, and the outcome of painful boobs, swollen boobs, boobs were filled with cysts and got periods early/impacting cycle was not reported. This report was non-serious.
Immediately after receiving Varicella (VARIVAX) vaccine, child developed 1 hive (urticaria) surrounded by redness & swelling 1.5 cm x 3 cm. Cold pack applied. Waited in office 45 minutes. Hive resolved. No other symptoms. Heart & lungs auscultated with stethoscope - within normal limits.
Racing Heart beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Racing Heart beat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced TACHYCARDIA (Racing Heart beat). At the time of the report, TACHYCARDIA (Racing Heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
I had pain in arm from injection immediately, after injection, which was much different than first dose.  But not unexpected.  But the adverse symptoms started about 5 hours in or so, i developed a cough, and dyspnea, it was tight in my chest, hard to breathe.  the cough was/is (it remains), sometimes hard and raspy, i was a bit wheezy, and I had air hunger, like i could not breathe or get air.  if i exhale to strongly i cough, if i talk to much i cough, if i sing i cough, if i inhale too deeply i cough.  I also have been very dizzy since the shot and vertigo.  I am still coughing and it is 5 days post shot.    I started developing headache and severe body pain, pain in  my spine, low back and joints.  which is expected, but i also had scalp pain and it hurt to be even touched the slightest bit on my scalp and everywhere on my body.  I had very stiff neck and eye socket pain as well.  I also feel "funny" in my head.  LIke dizzy, and vertigo, but also like it is wrapped in a heavy towel and my eyes feel heavy and like i can't see well.  my vision is as if it has diminshed.    5 hours after shot cough started, and the dyspnea, i started feeling chills and deep squeezing ache in my arm at jab site, and soon had fever of 100.6, over night it went to 100.8 and i felt terrible, headache, body ache, restless.  but next day fever was 102.  it remained all day, i had zero energy slept the whole day.  no appetite, did not eat anything except a scramble egg which made me nausea.  fever remained all day at 101.8. over night.  next day temp was 99.8 (my normal is 97.6) and it was 99.8 all day.  Cough was persistent and really bad with the dyspnea this whole time and i still have cough 5 days out, just giving a timeline here.  by friday, my temp was 98 but i felt extreemly fatigued.  I went and got a covid test which was negative.  i saw the chiropractor and they helped my back and headache a little bit.  went home and rested.  cough has lingered, dizzy lingers, chest tight and sob lingers.  fatigue lingers.   Cough and dyspnea are NOT signs, the sheet i got for V-safe says right on it these are NOT expected.