chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient missed second dose after recommended interval; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed second dose after recommended interval) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient missed second dose after recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed second dose after recommended interval) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Swollen lymph node on collar bone, went to ER, they did ultrasound and chest x-ray on 01-11-21 suggested follow up with doctor. 1/14/21 saw the doctor. He recommended a CT scan. The CT scan was completed on 1-29-21 and found multiple swollen lymph nodes throughout neck and chest. A biopsy was ordered. A needle biopsy was performed on the swollen lymph node on the collar bone on 2-2-21. No cancer was found. It was recommended to observe and wait and redo in 3 months if necessary. The swelling has been gradually lessening and is almost gone.
pt recv vax & c/o hives on rt arm & lt leg;referred secretary to call parents;rash;seen in ER;
Sz lasting 30 min @ approx 930; t102, taken to local hosp ER & admitted; red throat only other sign noted; d/c 16AUG91 @ 9AM; Seen by MD in office 17AUG91 & tx for ear infect;
had left leg cellulitis, 14x9cm area of erythema, treated with keflex
Fever reported of 101F; Whole body aches developed/ Achy; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2019 16:00, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose Shingrix vaccine in her left upper arm. On 30th September 2019, during the middle of the night a fever reported of 101F and whole body aches developed. The events Fever and aches are unresolved. The reporter was consented to follow up. The reporter did not know lot number and expiry date, volume administered or exact route of administration.
upset stomach; mild diarrhea; This is a spontaneous report from a contactable other hcp. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=ej1686 and expiry date unknown, intramuscular (right arm) on 05Jan2021 14:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing and drug hypersensitivity to Cipro from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ciprofloxacin. The patient experienced upset stomach and mild diarrhea (non-serious) on 06Jan2021 22:00. The outcome of the events was recovering.
rash over her ear; The rash then spread on her elbow, hips, legs, stomach and back; The rash then spread on her elbow, hips, legs, stomach and back; This is a spontaneous report from a non-contactable nurse reporting for herself. A 55-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 19Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash over her ear on 21Dec2020 with outcome of unknown, the rash then spread on her elbow, hips, legs, stomach and back on 21Dec2020 with outcome of unknown. The events were considered non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Became pale diaphoretic, and passed out.  Was out for a minute. Layed on floor for 10 min and recovered well.  Went home from clinic after 15 more minutes of recovery.
This spontaneous report as received from a Licensed Practical Nurse via a company representative refers to a 16-year-old female patient. On 22-AUG-2016, the patient was vaccinated with the first dose of VARIVAX lot number M009768 (dose and route of administration not reported). On 09-SEP-2016, the patient received the second dose of VARIVAX lot number M009768 (dose and route of administration not reported) sooner that the recommended dosing schedule. The nurse also reported that the patient received an unspecified meningococcal vaccine at the same time the second dose of VARIVAX was administered. No adverse effects reported. Additional information has been requested.
Patient came in for her IMZ appointment and checked in. Prescription was typed up correctly and given to administrator to administer. Administrator grabbed the pre-drawn bivalent. She checked in with patient, asked DOB and vaccine receiving. Patient stated Moderna, but still did not register that it was to be a first time primary injection. Gave injection and mom said, "since this is her first shot she should wait 15 minutes, right?". Administrator realized she had given Bivalent. I informed mom and patient right away, apologized and stated I needed to research the proper next steps. Called Moderna who referred to CDC interim clinical considerations. According to Table D - it stated to give the Primary injection right away as bivalent would not be enough dose to create a proper initial response. I llet patient know this may mean an increase of side effects of fatigue, site reactions
A report was received from a consumer on 10/23/2003 concerning a male vaccinee of unspecified age who believes he received half the recommended dosage of Fluvirin on an unspecified date. The vaccinee indicated that while the nurse was administering Fluvirin, he saw a bubble in the syringe and the amount in the syringe was 0.25ml. The vaccinee did not report any adverse events in association with the incident. No follow up. The reporter declined to give permission to contact his physician.
Body aches, head ache, extreme tired.  Treated with rest and Tylenol/Tylenol PM
This initial non-serious spontaneous case, received from a nurse on 05-Oct-2017 concerning a 33-year-old female patient. The patient's concomitant medications included Levothyroxine, colestyramine, omeprazole; XYZAL and NASONEX. On 04-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195216 and expiry date: Apr-2018). It was reported that, FLUCELVAX was stored at the back of the refrigerator and one of the vials of FLUCELVAX was frozen. On an unspecified date, patient received frozen vaccine. It was reported that, the nurse wanted to know what has been tossed out and left over 8 vials were still ok to use. It was reported that, FLUCELVAX should be stored and protected from light (in the original carton) and refrigerated between 36 degrees F and 46 degrees F (2 degrees C and 8 degrees C). On an unspecified date, it was reported that the patient did not experience any adverse events after vaccination. The outcome of the events was not reported. The reporter assessed the event as non-serious. Follow-up report received on 18-Oct-2017: No adverse events were experienced after vaccination, the same have been updated and amended narrative accordingly.
Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired.  Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.
Aching and soreness all over body particularly at injection site. Mild headache. Fatigue and lethargy. Difficulty moving around.
About 4 hours after receiving the vaccine (day 1) I developed itchy, watery eyes, swelling at the back of my throat and diarrhea. An hour later I developed uncontrollable shaking chills. I took Benedryl and Tylenol and laid down under the covers. After an hour I fell asleep but awoke a couple of hours later with nausea. Day 2: I was very weak and tired all day. The diarrhea continued until the afternoon. By evening I was able to tolerate some soup.
I had sore throat, malaise and mild fever about 4 hours after the shot. This lasted for 3 days. On the 4th day post vaccine shot, I had generalized itchiness on my trunk. Scratching on it made me realize 2 days later that I had developed generalized and countless irregularly shaped vesicular rashes roughly measuring 1cm by 0.5 cm each)including multiple erythematous "office-needle" head sized (kind of papular) rashes as well. The vesicular rashes were in some kind of evolution and some of them were drying up and forming scabs and scales. I reported to my doctors office on 05/13/2010. The doctor explained that it was an adverse reaction and said to stay away from work for 5 days. I did not receive any treatment but was told to get some antihistamines for the itching. These rashes have persisted till date and new ones are forming. I have for the past 2 days used Bond medicated powder on my skin before sleep and they appear to be helping but new rashes are coming out and I have been missing work and losing money.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Shingrix for prophylaxis. In September 2018, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, fatigue, injection site erythema and injection site warmth. On an unknown date, the outcome of the fever, fatigue, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the fever, fatigue, injection site erythema and injection site warmth to be related to Shingrix. Additional details were provided as follows: On Saturday 15 September 2018, the patient received a dose of Shingrix. The patient had a low-grade fever afterwards and continued to have fatigue. The patient's injection site was red, hot and the area covered 3 inches by 6 inches. The patient was asking, if these side effects were normal. The symptoms were continuing for more than 72 hours and the patient was asking how long were these supposed to last.
Runny nose, tired, sore arm after 12 hours; Runny nose, tired, sore arm after 12 hours; Runny nose, tired, sore arm after 12 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Sep2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Concomitant medications taken within two weeks of vaccination were not reported. 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. On an unknown date in Sep2021 after 12 hours, the patient experienced runny nose, was tired and had sore arm. It was also reported that this may be common to all vaccines though. 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 been tested for COVID-19. On an unknown date in Sep2021, the patient underwent COVID-19 virus test and the result was unknown. The clinical outcome of the events runny nose, tired, sore arm after 12 hours was resolving 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.
Swollen lips at 9am after my 2nd dose of moderna vaccine. History of lip filler (revanesse versa)  in September 2020.
Patient initially started with really bad pain at injection site and a ball formed. Shortly after that, patient had extensive bruising on his arm. A week later, he reports no pain. However, he still has prominent bruising that seems to be going away.
Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Back pain (It was due to stones in his bladder before receiving the vaccine), Gallbladder stones (before receiving the vaccine) and Gallbladder operation (after receiving the 1st dose of the vaccine). Concomitant products included PREDNISONE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.). At the time of the report, OFF LABEL USE (Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unknown dates, the patients received doses of improperly stored GARDASIL (lot #K004205, expiration date: 12-JAN-2017, lot#K001631, expiration date: 06-NOV-2016 and lot#K009482, expiration date: 06-MAR-2017), dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
DVT left lower extremity treated with Xarelto. Symptoms have resolved. He also has a history of DVT 2003.
Suspect COVID breakthrough case Admitted for portal vein thrombosis as well as small bowel obstruction secondary to ileostomy stenosis  Incidental COVID finding
Patient received a Covid booster vaccine 5 days after vial thaw expiration date. Pfizer was contacted for guidance.
Pt. reported, swelling, erythema, tenderness. Seen by MD- treat with ibuprofen, diphenhydramine, elevation. No hospitalization.
Fever, chills, body aches lasting about 24-36 hours. patient had to stay in bed all day
This spontaneous report was received from a pharmacist, concerning a 49 year old male patient with no pertinent medical history or drug pre-existing medical conditions. On 11-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number and route were not reported), lot # J012679, expiration date 21-JAN-2015 (also reported as 01-FEB-2015), dose and frequency reported as 1 injection. Co-suspect and concomitant therapies were not reported. On 11-SEP-2014 his arm was swollen, painful and red. On 14-SEP-2014 patient reported the symptoms to the pharmacist. It was unknown if there was any relevant laboratory data. At the time of the report it was unknown if he would get another ZOSTAVAX and his arm continued to be swollen, painful and red. Additional information is not expected. The pharmacist did not give the consent for follow up.
face and neck flushing, feeling hot, sensation of lump in throat Narrative:  Patient was administered Pfizer COVID19 vaccine at outpatient clinic in the morning of 4/2. Developed rapid heart rate and reported feeling hot. Vitals were taken and HR 135, BP 184/134, RR 20, SaO2 100 room air. Epi-Pen, methylprednisolone, and diphenhydramine administered in clinic. Patient reported feeling "a lump in her throat" which improved following medication administration. EMS was called however patient declined ambulance transport to nearest ED. Agreed to report to ED for monitoring and was discharged from clinic. Patient was called in the afternoon and stated she was evaluated and discharged from local ED with no further complications.
Approximately 3 days post vax, this pt developed vomiting, chest congestion, fever to 101 degrees F, diarrhea, and myalgia. He consulted physician one week later on 11/13/00. He later developed a severe arthralgia and discoloration of both distal feet. Testing conducted yielded results consistent with polyarthralgia and vasculitis. Also mild anemia.
Information has been received from a 65 year old male consumer with asthma who on 20-OCT-2006 was vaccinated with Pneumovax 23 and influenza virus vaccine (unspecified). Concomitant therapy included SINGULAIR.  On 20-OCT-2006 the patient experienced "arm got red and swollen" at injection site, and also had an upset stomach, diarrhea and just "wasn't feeling good".  The patient sought unspecified medical attention.  Subsequently, the patient is recovering from "arm got red and swollen" at injection site, upset stomach, diarrhea and just "wasn't feeling good".  No further information is available.
Swollen eyes, aching joints especially jaw which made it painful to chew. Throat closing up, swollen tongue symptoms continued next day. Seen by doctor on 10/17 prescribed prednisone. Medication helped, was able to eat something and today does not feel as achy. Extreme achiness, headache, bothered my eyes, some dizziness, persisted for several weeks. Ultimate duration a month. Doctor prescribed  "Prednisone". Finally cleared up.
Urticarial rash develop over the site of injection, spreading to inner thigh and to (L) thigh treated with BENADRYL, ZYRTEC and cool compress.
Patient received Tdap 0.5ml to left arm and Pneumococcal 0.5ml to left arm.  Patient developed fever reaching a maximum of 101.8F.  He also developed cellulitis to the left arm at the site of injection.
Swollen left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swollen left arm). At the time of the report, VACCINATION SITE SWELLING (Swollen left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-315465 (Patient Link).
Received expired dose of ZOSTAVAX; This spontaneous report was received from a physician and refers to a 69-year-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 20-DEC-2020, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) lot # N035033, expiration date: 07-MAR-2019 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis.
DOSE GIVEN FROM VIAL POSSIBLY  OUT OF ACCEPTED TEMPERATURE  RANGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the subject experienced dose given from vial possibly out of accepted temperature range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given from vial possibly out of accepted temperature range was not reported. This report was non-serious.
Rash on vaccination site on deltoid.  Started as itchy, raised rash covering left upper arm.  From picture from yesterday, my impression papular rash.  Picture from today, showed rash changed to smooth surface today but still with redness.  Patient denied pain but says area increased.  Patient contacted pcp and waiting for call back.  He did not appear in distress.  I advised to watch and wait since it appeared to have improved.  I advised to seek further treatment if rash symptoms worsen or if becomes painful.
48 hours of extreme fatigue, fevers, chills and continued body aches and muscle soreness.
COVID-19 Vaccine (Pfizer) EL3302 Exp 05/21.  Tingling in left arm and hand(same arm as side of injection) following adminstration of Dose#2.  Patient also reports that he experienced numbness immediately after the first dose which went away after about 1 hour, followed by fatigue.  All symptoms resolved by next morning following the first dose.  BP 134/82   HR=71 @1:45pm.  Patient clinically stable.  Symptoms of tingling resolving.  Patient was released from clinic at 1:50pm.
On April 17th, approximately 2 weeks after receiving the second shot, I woke up to use the bathroom at which point I passed an extreme amount of blood from my rectum along with what appeared to be remnants of blood clots. I took myself to the hospital who confirmed that hemorrhaging and blood clots had formed behind the site of my old ostomy scar inside of my intestines. I had no other signs of ulcerative colitis when scoped and no active flare, only this clotting that arose specifically after this second vaccine dose.
Right arm with 2 1/2" x 1 1/8" erythematous area, warm to touch. (+) pain when touched; (+) itching. Patient's mother noticed a small erythematous area on 2/04/2009 approximatly six hours after the shot was given. Patient was sent to school and complained of pain. Was brought into the school nurse.
@ 3-4 hrs post vax pt exp paleness, scrunching face to one side & inc jitteriness; this lasted 1/2 hr then pts color returned;
Pt. was administered H1N1 vaccine intranasal instead of intramuscular. No symptoms of flu noted as of 12/16/09. Thinking that this is protocol, no MD order in place.
STARTING WITHIN 24 HOURS AND LASTING FOR 6 WEEKS, I EXPERIENCED AN IRREGULAR HEART RATE ALONG WITH DIZZINESS AND FOGGY THINKING.
Swelling and rash at injection site Thursday and Friday.  Hives developed Friday-Sunday. Benadryl.