chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARMS; CHILLS; This spontaneous report received from a consumer 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 not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arms, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arms and chills was not reported. This report was non-serious.
Pt went to a pharmacy clinic to receive Zostavax. Pt is s/p renal transplant and on chronic immunosuppression.  Screening questionnaire used was downloaded from your (CDC) site per pharmacist on later inquiry by me. Immunosuppression is addressed but transplant is not specifically mentioned.  THE PATIENT DOES NOT READ OR WRITE (unknown by pharmacist). The patient was immunized. Fortunately, there was no adverse reaction. (Specific date and time of vaccination are not known by me; did try to obtain from pharmacist. Pt unsure and family was not aware.)I am basically reporting in hopes of getting you to change your screening form to specifically mention transplant as a contraindication. Many health care providers and patients call us to ask if transplant patients can be vaccinated. This gentleman could have had a much worse outcome. Not all patients make the connection between immunosuppression and transplant.  Pharmacist was not particularly concerned; I called him at the request of the patient's primary care provider who I had alerted to the situation.  He also thought the pharmacy might change the form.  After alerting our pharmacies of the situation, we have changed our screening form to specifically mention transplant.
So the whole adverse event would have started around the 13th of October and I felt a little weak to begin with. I am low on iron so I just figured it was that, I get weak sometimes easier than other days. Meanwhile, I did forget to tell you, I did have an infection - a UTI, I had went to the Clinic and they did give me antibiotics for that but that was unrelated it seems. So anyways I just was getting weaker and weaker and thought I would go to the ER, and I went there on 10/17/2021 and that was it. The outcome was pneumonia, that is why I had the shortness of breath. I was there for a few hours anyway. I went home with my treatment, antibiotics and I have been feeling better every day. I was given Albuterol, Dextral Methorphan, Doxycycline, Prednisone.
A week after receiving my vaccine, I would get dizzy when laying in bed. It wasn't as bad, but as time progressed, it worsened. I would be in the midst of driving and would get dizzy and have to pull over. In November, I started experiencing cold-like symptoms started to add including sneezing, lightheadedness, and dizziness when looking up and down. I got a referral from my physician to see a physical therapist; I had a session and instantly felt better days later. Now, after some holiday travels recently, my vertigo has seemed to return. I have another appointment my PT soon see if another session could aid my current episode.
DIED; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (6) of an unspecified age, sex, race and ethnicity.  . The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the 6 patients died after getting the vaccine. It was reported as "The only people that my husband and I know that died during this pandemic time were 6 people that died after getting the jab". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221100410.; Sender's Comments: V0:20221101100-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
RESIDENT EXPERIENCE SUDDEN ONSET OF INTERNAL INNER RIGHT EAR BLEEDING WITH DRAINAGE TO OUTER EAR THEN DRIPPING DOWN EAR LOBE FROM 0015 TO 0600 ON 12/31/2020
Redness, swelling, itching, pain from left shoulder to left elbow. Instructed to take diphenhydramine and call physician.
RIGHT AFTER I GAVE THE SHOT, THE SITE OF ADMINISTRATION BECAME SWOLLEN AND THE BLOOD WAS MORE THAN USUAL THAT THE BAND AID GOT SOAKED AND BLOOD WAS RUNNING THROUGH HER ARM. I CLEANED IT WITH COTTON AND ALCOHOL SWAB AND IMMEDIATELY THE BLEEDING STOPPED SO I STARTED MASSAGING IT AND IT BECAME SMALLER AND AT FIRST IT WAS KIND OF HARD LIKE A BALL BUT EVENTUALLY AFTER A FEW MINUTES OF MASSAGING IT BECAME SOFTER AND REDUCED OF SWELLING IMPROVED. SHE DID NOT COMPLAIN OF ANY PAIN OR UNCOMFORTABILITY. SHE WAS JUST SURPRISED HAVING THAT REACTION FOR THE FIRST TIME. SHE LEFT THE VACCINATION AREA FEELING AND LOOKING OKAY BUT I WILL FOLLOW UP ON HER OVER THE PHONE LATER AND TOMORROW TO MAKE SURE SHE'S OKAY.
Came in Clinic due to rash, sores all over body times days. No fever, with central vesicle appears cloud.l
Has dime sized, slightly raised area at injection site. Area affected has diminished slightly over months since dosage administered. No pain; no discoloration. No temperature diff.
Cough that "goes with the condition" / being tested for lung disease; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough that "goes with the condition" / being tested for lung disease) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 09762A and 025020A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Cough that "goes with the condition" / being tested for lung disease). At the time of the report, COUGH (Cough that "goes with the condition" / being tested for lung disease) outcome was unknown.            Patient was being tested for lung disease. No concomitant products were reported. No treatment information was provided.
Shortness of breath  Left sided weakness and drooping of the left side of face, treated for a possible stroke 3/31/23-4/3/23. Neurologist said that this has been known to happen one the body needs to be reset with the brain and has no long term effects of the body once the reset is complete, it's not the first time they have seen this in the last 2 or 3 years and there is no definite reason why except most people have this from some of the Covid vaccine or virus.
The patient had a covid test on 15Mar2021 and tested positive.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunization. Medical history included exposure to sars-cov-2 on 10Mar2021. The patient's concomitant medications were not reported. The patient had a covid test on 15Mar2021 and tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Mar2021. The patient is scheduled for his second dose on 28Mar2021. The patient is asking if he is still eligible for the second dose. It will be 13 days from the positive COVID test. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Redness began to appear to the left of the injection site; Itchness / Arm was still currently itchy; Fatigue; Soreness at injection site; Difficult to sleep; Injection site started to feel hot / Injection site was now warm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th September 2019, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site pain and difficulty sleeping. On 26th September 2019, the patient experienced fatigue. On 27th September 2019, the patient experienced injection site erythema and pruritus. On an unknown date, the outcome of the injection site erythema, pruritus and injection site warmth were not recovered/not resolved and the outcome of the fatigue and injection site pain were recovered/resolved and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the injection site erythema, pruritus, injection site warmth, fatigue, injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine on right arm. The reporter indicated that the night after receiving the Shingrix vaccine she developed soreness at the injection site that made it difficult to sleep. The redness began to appear to the left of the injection site (measuring 2 inches long and 1.5 inches wide) on Friday, September 27th, 2019, as well as itchiness. The redness was lighter. The injection site started to feel hot within a day of receiving the vaccination. Currently, the injection site was now warm. The patient arm was still currently itchy. She experienced fatigue that started on Thursday, September 26th, 2019, through Sunday, September 29th, 2019. The reporter did not consent to follow-up. The reporter would not provide any additional information. She was difficult to follow because she kept changing her description of the adverse events.
Oral swelling and enlarged submandible lymph nodes.  Airway and swallowing not affected.
Itchy, warm red circle on arm the size of a softball. Advised to treat with OTC benadryl, OTC hydrocortisone cream and OTC ibuprofen if needed.
SEVERE RED RASH ON BOTH ARMS AND LEGS.  RASH LASTED THREE MONTHS.  NO ITCH OR OTHER EFFECTS JUST THE RASH
Headache, Sedation, Myalgia, Arthralgia, SkinRash & NauseaVomiting Narrative:  1/3/20 rash/ hives: depo-Medrol in ER and Pepcid, taking Benadryl  Other Relevant History:
The pt experienced a fever, swelling and redness to the thigh. Treated with Tylenol as needed and warm compresses to area.
Fever 105 w/in 1 hrs, listless, eyes rolled back, talking out of head, red-sore arms for 24 hrs; had blood, & nitrite in urine;
I am experiencing tinnitus or ringing from my left ear since the late evening of March 24, 2021 (The same date after receiving 2nd dosage of the vaccine.)  I  have noticed the ringing has become louder during the late evenings in the past two days; however, the volume subsides after waking in the morning and continues throughout the day and evening.
Sat 4/24/21:  2pm - 4:30pm vomit 3x, migraine headache, ears ringing. Sat 4/24/21: 8pm - Mon 4/26/21 9am - fever, severe chills, nausea, migraine headache, ears ringing, full body muscle aches. Tues 4/27/21: 5am - current red, itchy hives from top of head to buttocks, headache.
Systemic: Dizziness / Lightheadness-Mild, Systemic: other-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Additional Details: Transient lasting about 10 minutes then was able to leave on his own
Felt flushed and itchy right after. Broke out in cold sores within 28 hours of second shot.
Headache Body aches Diarrhea Fever Chest congestion Cough Fatigue Arm sore
The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.; A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.) and PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.). On 31-Aug-2021, OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The second dose was not yet administered. Patient did not report any symptoms or side effects after receiving the vaccine.    Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Follow up information received on 11-OCT-2021 included ethnicity and race of the patient.
12/20/21 presents to ED for "Shortness of breath". PMHx of "OSA (intolerant of CPAP therefore on 2-3L of 02 @HS), asthma, COPD, anxiety, obesity, HTN, hyperlipidemia"
2/19 around 10 pm (same day as vaccination): chills, weakness, body aches  2/20 all-day: headache, weakness, fatigue
Symptoms starting August 25 with right shoulder pain proceeding to muscular weakness of right shoulder. Diagnostics leading to diagnosis of ParsonageTurner syndrome which effected motor boy nerves and significant weakness and denervation of supraspinatus, infraspinatus,serrated anterior, teres minor and deltoid. Weakness ongoing at this time.
no adverse event; expired PNEUMOVAX 23 was inadvertently administered to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown ange and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-JUL-2022, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #T034630, expiration date: 22-JUN-2022 (strength, and route of administration were not provided) administered for prophylaxis. The reporter stated that the vaccine did not experience any temperature excursion through the date of administration. No adverse event was reported.
Patient admitted with nausea, vomiting, and diarrhea. Patient also experiences pain.
Patient  received 1st dose at SCHD Covid 19 Vaccine Janssen 3/25/2021 Lot # 180518 Patient received 2nd dose at SCHD Covid 19 Vaccine Pfizer 06/28/2021 Lot # EW0176 Patient received 3rd dose at SCHD Covid 19 Vaccine Pfizer 08/13/2021 Lot # EWO176
expired vaccine accidentally administered/ no AE; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/non-healthcare professional via call center via Medical Information (Reference number- 00810618).  This case is linked to case 2021SA340303(CLUSTER).  This case involves a 71-year-old female patient who was vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE; and HEPATITIS B VACCINE for prophylactic vaccination.  On 13-Oct-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A741M and expiry date: 05-Oct-2021) (frequency: once) via intramuscular route in the right upper arm  for prophylactic vaccination.  It was reported "Even though the expiration date stated 10/5/2021, the nurse just focused on the 10/21 and assumed that the TYPHIM VI did not expire until the end of the Oct2021. The nurse did not realize the the TYPHIM VI actually expired on 05Oct2021 until she was entering it into the computer after the 2 vaccines were completed."  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
In for recheck following some asthma and otitis-all were on right arm: given MMR #2: First dose was given by allergist because of egg allergy and did okay. Allergist has checked and said no longer allergic- Developed cough and chest pain with some wheezing around 10 min-15 min post shot. Tried  Nebulizer + Orapad. Vomited - called EMT.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-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 10Nov2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6199), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9729) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 01Sep2023 to 05Sep2023 as COVID 19 Treatment. Patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302452 same patient, different drug/event;
Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves unknown age of male patient who experienced fever and diarrhea, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 14-Mar-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date (unknown latency) after receiving meningococcal A-C-Y-W135 (D conj) vaccine, the patient developed a non-serious fever and diarrhea. Relevant laboratory test results included: Body temperature - On an unknown date: 101 F. Final diagnosis was diarrhea and fever. An unknown corrective treatment was received: rest and let it run its course. The outcome of event of was unknown. List of documents held by sender: none.
Breakthrough case admission after 2 vaccines MOderna 2/28/21 lot# 004M20a;  Pfizer 12/13/21 lot# FE3594
Moderna vaccine was administered outside of facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------- I20.0 UNSTABLE ANGINA 4/5/2023 UNSTABLE ANGINA I20.0 UNSTABLE ANGINA 4/5/2023 CHEST PAIN
Evening of June 10th, slept 4 hours (usual is 2 hour nap). 3 hr naps since then. Day of vaccine, slight cough. Some light-headedness since then. 3 July severe chills at about 3 AM. Severe weakness, lightheaded, 22 hours sleeping through to next day. 101° temp at 3 PM followed by 102.6° temp at 7:40 PM. On 14 July, he called to let his PCP know that he'd "lost short term memory."
Area has Very hard lump; Area is being black and blue; itches at the area of injection; Sorenessat the area, hurts; Area is being Red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches). At the time of the report, INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: new events coded
PT FAINTED SHORTLY AFTER RECEIVING COVID VACCINE. BP 92/66, HR 64. NO INJURIES REPORTED, NOT AMBULANCE/MEDICAL CARE REQUIRED. PT WAS ABLE TO WALK TO CAR AFTER FULL RECOVERY.
Hives to head and spreading to chest and back. Reaction started about 1 hour and 15 min later. BENADRYL given in office and symptoms resolved. No breathing concerns. No facial swelling.
Headache, Myalgia, Fever, FACE FEELS WARM, RED EYES Narrative:
Patient complained of severe chills the night of vaccine administration followed by fever and fatigue the next day. As of 2 days later, she said she was better.