chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administrative deviation only; no adverse event resulted from this deviation.                                                                       Administrative deviation only; no adverse event resulted from this deviation.  This patient received a mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer - box #4 above reflects the date of the second dose). The decision to administer a mixed series to the patient was due to an "exceptional circumstance" stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was  This patient received a mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer - box #4 above reflects the date of the second dose). The decision to administer a mixed series to the patient was due to an "exceptional circumstance" stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was due.  We understand that although CDC provides considerations for a mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires VAERS reporting. Note that the date of vaccination on this form reflects the date the patient received his/her second vaccine dose.
Information has been received from a third party claims administrator, concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # 1947AA, .05 ml. It was also noted ZOSTAVAX involved in the incident (conflicting information). The patient was diagnosed with cellulitis after receiving the PNEUMOVAX 23. At the time of the report, the outcome of cellulitis was unknown. Additional information has been requested.
Patient had a stroke on June 4. Developed unusual headache evening of June 3. Went to see doctor on June 4 . Bp remained elevated  even after taking bp medicine . Doctors office sent him to ER. First it was said he had a aneurysm in heart which was ruled out . Then it was advised to us he had a brain stem stroke . Patient still in icu. Still in hospital as of today .06/16/2021.   Patient will be going to pt therapy snd of therapy . Has dysphagia unable to eat and left side weakness . Peg tube inserted .  Want to establish if Johnson and Johnson vaccination was linked to him having stroke . Patient current illness was maintained and under control until this event happened suddenly .
Following pneumococcal conjugate vaccine PREVNAR 13 injection attending nurse went to place the safety device on the needle. The lure lock snapped breaking in half; empty syringe one end and separated needle the other end. No injury and reported Nurse Manager and retained in Biohazard Bag.
Extensive Rash 4 days after 1 st shot. Took Benadryl. Got headache. Sleepy. Rash ongoing
Pt recvd 2 doses of Engerix-B & following the 2nd dose exp arthralgias & elevated liver function tests;
Tongue started to swell 5 minutes after injection.  Stayed swollen for about 1 hour after shot, then went back to normal.   Impacted ability to speak clearly, but tongue swelling did not block air passage.
felt my lip tingle (after the first shot); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (felt my lip tingle (after the first shot)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (felt my lip tingle (after the first shot)). At the time of the report, PARAESTHESIA ORAL (felt my lip tingle (after the first shot)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.   This case was linked to MOD-2021-347123 (Patient Link).
About 25 minutes after vaccine was administered, the patient developed erythematous patches bilateral deltoid muscles, bilateral forearms, upper back, and bilateral shins/ankles.  He denied itching.  He did not experience any additional symptoms.  His vital signs were stable and he was breathing comfortably and speaking in full sentences.  He received 25 mg capsule of Benadryl with some improvement seen in rash on arms and shins.  He was discharged to home after being monitored in the health center for about 90 minutes after vaccination.  Vital signs remained normal.  He was accompanied by his mother who was going to be able to watch him closely and with a prescription for Benadryl to take prn every 6 hours.  Mom was instructed to call 911 for any worsening including difficulty breathing.
EDD 04/15/2021 Pregnancy history: hyperemesis gravitorium POTS orthostatic hypotension  Mildly sore left arm that afternoon and next day Approximately 2 weeks later developed 2 lumps in right breast awaiting ultrasound to evaluate
left arm soreness but within hours became weak with muscle pain and fever; temp 99.8 progressing to 100.2 over the 24 to 30 hours.  Feeling fine by 48 hrs after administration.
This spontaneous report as received from a 68 year old female consumer refers to herself with drug reactions/allergies to LEVAQUIN. Patient medical history included high blood pressure. On 25-MAR-2014, some time in the afternoon, the patient was vaccinated with unspecified vaccination pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot#, expiration date, dose, route of administration, location of administration were not reported). Concomitant therapies included losartan potassium (manufacturer unknown). On 25-MAR-2014 the patient experienced trouble falling asleep that evening since her arm hurt. She also reported that around 3 am in the morning of 26-MAR-2014 she experienced hallucinations. After that morning, she had no further reactions. There were no laboratory tests performed. There was no treatment given for the reported events. The outcome of the events was reported as recovered/resolved on 26-MAR-2014. The patient sought medical attention by calling physician. The relatedness between the reported events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Additional information has been requested.
Pain in the injection site for several hours (probably 5 hours or less), with a pain scale of 3/10. Pain is manageable, can still use the affected arm, no pain medication taken.
Patient contacted our office 24 hours of receiving a vaccination. Patient was experiencing joint type pain at the shoulder. Denies radiating pain. Per patient the vaccine was given 2.5 finger width below the acromion process. Director suggested patient use NSAID's and Ice to reduce any swelling. Recommended seeing primary care provider if pain increases.  Followed up with Patient 48 hours after. Patient stated the pain has decreased, but not subsided. Patient is taking an NSAID and stated it has helped.
Sore arm; Didn't feel right; Slight body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE for an unknown indication.    On 29-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 PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-031627 (Patient Link).
Patient described severe muscle aches, joint pain, and fatigue for approximately one week following vaccination. She reported no injection site reaction.
This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable other HCP (patient/herself). A 65-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported, expiration date: unknown), via an unspecified route of administration, on an unspecified date, in Apr 2021, single dose, for COVID-19 immunisation. The patient also received Xeljanz XR 11 mg (tofacitinib citrate) tablet, via oral route of administration, from Dec 2020, ongoing, daily, for rheumatoid arthritis. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a cough, discomfort in chest and joint pain for couple of days. Patient reported after start of therapy may forget or miss a dose every other day or not often without change in symptoms. Doing pretty good on Xeljanz. Weather change cause symptoms to worsen (no details provided). The outcome of events recovered. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Mild hives on hands, upper thigh, and left arm,used topical lotion. Lasted about 5days
Pt. mom called today stating that pt. has been sick since Wednesday with weakness, tiredness, diarrhea, nausea, not eating and 7 pound weight loss. I encouraged her to see her doctor ASAP. He father is a urologist and is treating with gatorade and immodium. I recommended lab and stool workup asap. Mom was thankful for call. Dr. notified VAERS report done.
Describe Event, Problem, or Product Use Error: [Moderna] use for COVID-19 under Emergency Use Authorization (EUA): per hospital record patient Received his primary Moderna vaccination at this location and is in his chart but not showing up on the immunization registry
Seven hours after the COVID injection, my heart rate dropped from 80 to 45.  This lasted for 7 hours.  I woke up and HR was normal, and again went down into the 40s for several hours. On day 3, the HR swung from 45 - 165 in a matter of seconds.  On day 4, the HR did the same swing.  Had an EKG, and heart monitor was placed on chest for 10 days.  On day 6, BP went from 130/80 (typical for me) to 199/100.  This very high pressure lasted for 6 days.  The heart rate variability issue went away, and was replaced by a high BP side effect.  The high BP was managed by 50-75mg of atenelol.  BP began to return to normal after 6 days.  I had no other symptoms, just the heart rate variability, and high blood pressure.
Information has been received from a father concerning a 8 months old (also reported as "9 months old" by the father) daughter with no pertinent medical history and no allergies who on "last Thursday morning" (03-MAR-2011) was vaccinated with a dose of RECOMBIVAX HB (Expiration date: December 2012). There was no concomitant medication. The patient's father reported that "immediately after the vaccine" on, the patient was not feeling good. She slept for 6 hours after the shot. She was having diarrhea, vomiting and fever that lasted until Sunday, on 06-MAR-2011. The patient sought medical attention and was kept giving milk and treatment of PEDIALYTE. No lab diagnostics studies performed. At "last night" (on 06-MAR-2011), the patient was recovered. Follow up information has been received from a physician concerning the 8 month old female patient with no pre-existing allergies, birth defects, medical conditions and no adverse event following prior vaccination who on 10-JUN-2010 and 14-JUL-2010 was vaccinated with the first and the second dose of RECOMBIVAX HB respectively, and on 03-MAR-2011 was vaccinated IM with the third dose of RECOMBIVAX HB on thigh (Lot number 04822 is an invalid lot number for RECOMBIVAX HB). For 24 hours after vaccination on 03-MAR-2011 the patient experienced diarrhea and vomiting. Hydration status was maintained. No lab diagnostic test was performed. Within 2 days, on approximately 05-MAR-2011, the patient was recovered from vomiting and diarrhea. Additional information is not expected.
Patient states started having muscle ache, cough and chest congestion a day after the vaccine was administered, no fever was reported. Patient called to the office on 11/27, he was encouraged to come to the office for a check up, which he refused stating that he was feeling better than Monday 11/25 when everything started.   Patient was advised of how to treat the mild symptoms he was experiencing with over the counter medications, and go to the emergency room if symptoms worsen.  Patient has been called today 12/2 for follow up on symptoms and he states feeling well except for a little cough and chest tightness.
Patient complained of dizziness, shortness of breath and chest heaviness about 5 minutes after receiving second dose.  Diaphoretic.  BP 120/80. Heart Rate 88, resp. 32, and pulse ox 99%.   Pt. experienced a small bit of emesis from nausea. RN notified and came to talk to patient.  911 called and transferred patient to the hospital for evaluation at 1:55pm.  Pt. remained conscious and alert and oriented throughout.
Moderna Booster/ Afluria Vaccine: Swollen lymphnode, pain in armpit, numbness around swollen lymphnode.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 14:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 22Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 21May2022 at 14:30 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) Positive; (17Feb2023) Negative; (20Feb2023) Positive. Clinical course: covid rebound, symptoms returned, tested positive again on 20Feb2023 after a negative test on 17Feb2023, first positive test was 11Feb2023. Therapeutic measures paxlovid were taken  from 12Feb2023 to 16Feb2023 as a result of vaccination failure, covid-19.
Pt received 2nd COVID vaccine in May of 21, reports that 1-2 weeks later began to exhibit chest tightness with shortness of breath. Pt presented to ED at the Medical Center where an EKG showed ST elevation in V1-V2 concerning for pericarditis with negative troponin. Pt underwent left heart cath and diagnosis was confirmed.
Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck.  Began to feel difficulty swelling due to inflamed lymph nodes  Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes.  Outcome- all symptoms resolved by 1/14 except some fatigue
None, no known adverse event (pt. died 9/7/02-SIDS).
On May 8th, I discovered a lump on my left breast.   Tender to touch.  Went to Dr. on May 10;May 20, mammogram/Ultrasound,;June 3 core biopsy; June 7 - disagnosie - Invasive ductal adenocarcinoma - triple negative. ; July 7 lumpectomy and sentinel node biopsy
Patient complained of vertigo, bilateral asthenia of the legs, with tingling in the toes after COVID vaccination.   Although patient was able to ambulate to post-vaccination waiting area without assistance, she complained of some more vertigo, and general weakness in the ensuing minutes.  Patient admitted to feeling anxious.  Patient was placed in a reclined position with feet above her head and heart.  Patient was also given Gatorade, water, and Tylenol.  Patient was able to leave the clinic under her own power without ambulatory assistance.
Chronic hives.  Started 11/20 - visited urgent care - prescribed a steroid .  PCP visit on 12/29 - referred to allergist. Allergist visit on 2/10/23 - allergist concluded allergies were not cause, and was an internal problem.   Hives have continued to be present and had no prior history.
Shot at 9 am 4/2/2021 Back pain: 6pm   4/2/2021  Chills and body aches 7 pm Fever 9 pm( lasted about 12 hours) Body aches for the next 36 hours Arm pain and bruising
patient describes itchy rash on arm that she was shot in, but rash did not start until a week after her vaccine
p/vax pt subsequently devel severe diarrhea; pt dehydrated & hosp
G40.909 DEMENTIA, UNSPECIFIED SEVERITY, DUE TO EPILEPSY W OTHER BEHAVIORAL DISTURBANCE. 5/13/2023 CKD STAGE 3B (GFR 30-44)
Patient experience chest pressure, increased blood pressure within 10 minutes of receiving COVID vaccine dose #2. H/O Myasthenia gravis and experienced exacerbation of myasthenia gravis.
Initial report was received on 30 November 2012 from an unverified source via a company website from a consumer. A 20-year-old female patient received dose one of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, manufacturer unknown, lot number, route, site and side not reported on an unreported date, 13 months prior to developing whooping cough. The patient stated she just received dose two of the TDAP vaccine on an unreported date. No further information was provided. The patient's outcome was not reported. Documents held by sender: None.
Missed dose for Varivax; No adverse event; This spontaneous report was received from a physician and refers to a 9 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  In August 2012, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis. The patient did not receive the second dose of varicella virus vaccine live (oka/merck) (VARIVAX).
A few minutes after the shot, the patient said he had a strange feeling, then we made him sit on a chair, by then his face turned read and he asked for water with a face which appeared like difficulty to breath. I administered an epinephrine shot and called 911. He was still talking to us and didn't want us to call 911. After the epipen, he sat upright and started talking again, by then his face started looking very pale. The paramedics arrived by this time and took it over. Paramedics urged the patient to go to ER but he refused. He was at the store for about half an hour more after the event. Then was taken home by his wife. At 7:45 pm, we checked on the patient and he said he was feeling normal.
No adverse effects were reported in the patient; A patient received "an extra dose of VAQTA"; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent condition, concomitant therapies and drugs or allergies reactions.   On 24-APR-2019, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), 25/0.5 (units not provided), by intramuscular route, lot #S002460, expiration date of 15-MAY-2020, for prophylaxis (dose and anatomical site of injection were not reported).   On the same date, the patient received an extra dose of Hepatitis A Vaccine, Inactivated (VAQTA) (extra dose administered). No adverse effects were reported.   The outcome for the event was not provided.
Delayed rash and redness, heat, itching, and discomfort at injection site 8 days after shot.  Still itchy and red rash 5 days after appearance.
This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the second of eight reports. A patient of unspecified age, ethnicity and gender received TRUMENBA via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
pt admitted to hospital with CHF and on heart transplant list, status 3 on wait list; during hospitalization pt tested positive for COVID; given monoclonal antibodies; pt's condition declined; VT arrest with ACLS protocol and obtained ROSC; intubated and on mechanical ventilation; pt's mental status worsened; CT scan showed subacute left thalamic infarction; condition continued to deteriorate; decision was made to withdraw care and pt died in the hospital
pt recvd vax 17OCT95 & pt was hospitalized w/partial paralysis;neurologist dx transverse myelitis;pt was to be discharged on 5JAN95;
Pneumonia vaccine given on right deltoid then while discharge instructions were begin given, noted pt having flushed face, voiced dizzy, pressure on her chest, complaint of severe pain to pelvic area to the lower back, VS 174/74, P 85, RR20. Pt was calm and denied any other symptoms prior to vaccine. records received. DOS 10/15-10/19/06 Reason for admission: treament of left hip fracture. Fell at work, tripped over a cord.
pt recv vax 20OCT97 & 2AM pt felt had convulsion & given fever med;no further problems;seen by PMD 2-3 days later;had episode NOV97 time of fever w/OM;had sz;
2 days post-immunization pt. developed hand-sized erythema at site if injection, distant seperated urticaria-type patches on bilateral wrists, myalgias, arthralgias, lymphadenitis, and feverof 101.5
Thirteen days after vaccination initially felt a tingle on lower left side of lip which progressed to a patchy hypothesia extending from left lower jawline up to left brow line and back of left ear. These symptoms wax and wane but still persist to this day.
It was reported that a 66 year old female pt, post vax, experienced facial edema.
Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips and face with urticaria
Left armpit sore and swollen.  Left back side of neck sore and hurt to turn head.  This lasted about 3-4  days.   I can't take any Tylenol or IBUprofen, so I just used a heating pad on them a lot.  Left elbow hurt to bend as well.
Patient stated hives, redness, hot around injection site. Went to Dr. he thought she might have infection. Got antibiotic. Got flu shot same night-no problem.
1:15pm Friday- received vaccine 4am Saturday- headache - took Tylenol   7am- chills, fever (99.4), body aches 8am- took ibuprofen  11am- took more Tylenol  12pm- took a nap, woke up to no more chills 4pm- headache gone 7pm- took ibuprofen and went to bed 7am Sunday - only minor body aches 1:30pm (now) - minor body aches continue but left house and doing fine
COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received pf-06928316 (ABRYSVO), in Aug2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "COVID 19".  The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.