chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My mom went to pharmacy to obtain a 3rd PRIMARY (0.5mL) dose because she is severely immunocompromised. She received the dose approximately 7.5 months after the 2nd dose, per recommendations made in August 2021 that immunocompromised should receive a 3rd dose (NOT a booster dose, which is half). She received the 3rd dose on 9/11/2021 thinking that completed the primary dose of 3 Moderna doses as stated in the CDC guidelines.  On 3/2/22, she received her FIRST BOOSTER dose from pharmacy. Per CDC guidelines, she was eligible to get her 2nd booster after 4 months (as of 7/2/22).   She made an appointment with pharmacy for 7/22/22 and pharmacy canceled her appointment after two attempts. We called pharmacy and the pharmacist said ?She needs to wait 8 more days. It?s just 8 days.? This didn?t make sense as 8 days later was not even the 5 month mark, and the guideline was to take it after 4 months regardless. Pharmacy denied her the vaccine so we waited.   Today, 8/21/22, we went to pharmacy as scheduled. The pharmacist looked at her card and stated she could not have the vaccine. She stated ?I could just give it to you, but you?re up to date anyway. If your doctor wants you to have it, check with him again and have him send us something.? Pharmacist added ?You already had 2 booster doses. I know because I gave it to you. I recognize my writing.? She acknowledged my mom is immunocompromised but she already had 2 boosters. I stated that the first 3 lines of the vaccine card are part of the PRIMARY series. She said ?Primary doses are 0.5 mL and booster doses are 0.25mL. So I know she got 2 booster doses already.?  The only conclusion I can come up with is that this was a MEDICATION ERROR (vaccination administration error), as she skipped my mom?s 3rd primary dose and instead gave her a booster dose (0.25mL half dose) in its place.   My mom was just diagnosed with Stage 3 breast cancer last year. She had gone through surgery, and was actively going through treatment (chemotherapy, 33 rounds of radiation therapy, as well as oral therapy that lowered her immune response to dangerously low levels.  Depriving my mom of her primary dose and skipping ahead to the half dose could have put her at serious risk of illness or death. Per CDC guidelines, she would be up to date if she had 5 doses total (3 primary and 2 boosters). The pharmacist at pharmacy counted the FOUR doses to me multiple times and insists my mom is up to date. She said ?I know she?s immunocompromised. My mom is, too. We still have to wait.? She said there MIGHT be a new booster coming in September and maybe we should wait for it. She insists that my mom received all 4 doses when she should have 5. I imagine she is not self-reporting this ERROR made on her part.
Did not feel well all day, starting having irregular heartbeat around 8:00pm. Phone app indicated atrial fibrillation so wen to the ER where that was confirmed
Felt ill 2 days after COVID-19 booster, increased weakness and dyspnea.
Woke up exactly 12 hours after my second dose at 3am with a high fever, vomiting, and visual hallucinations probably due to the fever. It felt like things were moving in slow motion, frame by frame, when I woke up at 3am. Was light headed, couldn't stand, chills and shaking. I vomited from 3-4 am and then again at 8am when I woke up, with my visual disturbances limited to the 3-4am hours. I took Advil and was able to go back to sleep for most of the day, sleeping from around 9am to 1pm. Nausea, fever, and vomiting have all have cleared. Now I just have a headache and muscle aches, especially near the injection site. Almost 24 hrs after my vaccine now and I feel drastically better than I did overnight.
I had muscle aches all over but because it was so far from the vaccination, I didn?t think about it. When I had a stiff neck, pain on the right side of my neck, and couldn't turn my head without hurting. So, I thought I was out of alignment. I went my chiropractor, and he told me I was not out of alignment but that I had swollen lymph nodes. He said to use hot compress to decrease drainages.
Patient states that her face began to feel itchy 15 min after the vaccine. Itchy feeling isolated to face, no throat or mouth involvement, no other symptoms. V/S 157/85 100% RA, HR 75, RR 18. Pt given 50 mg of Benadryl po and monitored for additional 30  min
patient experienced tingling and numbness in hand. Twitching of thumb. Patient still experiencing symptoms and Dr. has referred patient to neurologist.
This spontaneous report was received from a medical assistant/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, intramuscularly, 0.5 ml, the second dose in series, lot # M000442, expiry date 31-MAR-2018 (anatomical location was not specified). The administered dose of RECOMBIVAX HB underwent temperature excursion of 32.2 Fahrenheit degrees for 5 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Redness and swelling at site of vaccination.  It is warm to the touch, swollen and hard.
This is a spontaneous report from a contactable unspecified healthcare professional (patient).  A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: 1284, via an unspecified route of administration in the right arm on 16Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included sulfur allergy. Patient was taking unspecified blood pressure medication/s concomitantly. Patient previously took codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 17Jan2021 08:00, the patient experienced just redness and swelling at injection site, no other side effects. Patient did not receive treatment for the events. The outcome of events was recovered. the events were considered as non-serious. Follow-up attempts are completed. No further information is expected. Information on the batch/lot number has been obtained.
Began with upper respiratory symptoms of cough, sneezing, headache and congestion. On 11/19/21 began to feel fullness in my left ear and began having dizzy/balance issues. Hearing and balance continue to decline and was seen by PCP on 11/29/21 and 12/17/21. Treated with antibiotics and steroids with no change. Referred to ENT and hearing test done which showed marked decline in hearing. referred to surgeon who completed my  stapedectomy in 2013. Balance tests completed on 3/14/22 . Tests concluded left ear deafness and balance issues. Suspect perilymphatic fistula occurred.
COVID vaccine  Erythema and swelling right arm around injection site, injection site pain leading to use of prescription pain reliever or prevent daily activity Chills, Fatigue, Fever Fever documented: 39.0-40.0 C or 1021.1-104.0 F
States starting itching all over after receiving yellow fever around 8 pm on 8/12/14 - call clinic on 8/13/14 - Had numerous complaints of headache dizziness, shortness of breath - weakness - no rash - or nausea. First to call 911/or have someone take to E.R. Dept. Spoke with patient 8/18/14 was evaluate in ER on 8/13/14 told reaction to yellow fever - no tx or medication. Call 911 on 8/14/14 because of elevated heart rate. Short breath was told vital stable no addition tx was not taken to E.R. spoke with patient 8/18/14 - Continue to complain of short of breath first to f/u with PCP.
No additional AE reported; improperly stored vaccines administered after a temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not provided.  On 29-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD), 0.5 milliliters (mL) (dose number, route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T035389 has been verified to be valid, expiration date reported and established as 14-APR-2022) as prophylaxis.   It was reported that the vaccine was exposed to a temperature excursion of minus 14 degrees Celsius (-14C) to minus 10 degrees Celsius (-10C) (-13.7C) during a time frame of 30 minutes; minus 10 degrees Celsius (-10C) to 8 degrees Celsius (-2.8C) during a time frame of 30 minutes; minus 10 degrees Celsius (-10) to 8 degrees Celsius (7.9C), during a time frame of 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
ipol vaccine was administered to a patient after the excursion with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4-year-old male patient, IPV (VERO) [IPOL] vaccine was administered to a patient after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On 24-Jul-2023, the patient received 0.5 ml total dose of suspect IPV (VERO) Suspension for injection (strength, expiry date: unknown) (lot: V1B901M) via intramuscular route in the right deltoid for Immunization.  On 24-Jul-2023 the patient had an event of ipol vaccine was administered to a patient after the excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown for the event.     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.
metallic taste in mouth; general malaise; This is a spontaneous report from a contactable other HCP (Nurse anesthetist) reporting for himself.  A 42-year-old male patient received bnt162b2 (BNT162B2, Batch/lot # EL0140) at single dose at left deltoid on 21Dec2020 08:30 for immunisation.  Medical history and concomitant medications were none.  On 22Dec2020 he was feeling just some general malaise that has since improved. On 23Dec2020, he woke up with a metallic taste in his mouth around 6:30 am and it is persisting. The patient stated he felt fine, he was afebrile, could still smell, went for a 7 mile run, but still had this metallic taste in his mouth. The outcome of malaise was recovering, of metallic taste in mouth was not recovered.
Herpes zoster diagnosis in herpes zoster vaccine recipient. Diagnosed at ED. Painful rash in one dermatome, on right side of face. Also had an upset stomach and passed out. Prescribed antiviral medication.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), administered by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On an unknown date during 2016, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX vaccine (Merck). On an unspecified date, 10 days post vaccination, the patient developed a rash. The rash was found to be positive for the vaccine strain VZV by PCR performed at CDC. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second doe AEs, particularly rashes in patients who have received a second dose of VARIVAX vaccine (Merck). She indicated that the other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX vaccine (Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from the same source. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a nurse for the pregnancy registry for HPV concerning a 22 female with gastroesophageal reflux and a history of headache, who on 11-AUG-2008, was vaccinated with the first dose of GARDASIL (660620/0571X), I.M. Concomitant therapy included ranitidine. On 11-Aug-2008 and 09-Sep-2008, the beta-human chorionic gonadotropin tests were negative. On 14-OCT-2008, the patient came to the office complaining of headache and nausea since receiving her first dose of GARDASIL. A pregnancy test during her visit revealed that she is pregnant. The patient's LMP was 13-SEP-2008 and EDD 20-JUN-2009.
Admitted on 8/10/21. Had both doses of Moderna vaccine, the last on 4/27/21. Patient presents with SOB, cough and chest pain x 2 weeks. Tested positive for COVID on 8/10/21. Diagnosed with sepsis, UTI and COVID pneumonia. Patient treated with COVID protocol, steroids, remdesivir and high flow oxygen. As of 8/15/21, pt remains inpatient, still on high flow oxygen, poor appetite and lethargic. 8/17/21: discharged.
Small lump in the area; Swollen lymph nodes; Left arm was sore; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 16Apr2021 at 10:45 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, heart condition and allergy to penicillin. 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 COVID vaccine. Concomitant medications included unspecified blood pressure medications from unknown date and unknown if ongoing. On 17Apr2021 at 07:00, the patient had a reaction to the vaccine which included swollen lymph nodes, a small lump in the area a day after the shot and the left arm was sore where the patient was vaccinated. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events small lump in the area, swollen lymph nodes and left arm was sore was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient received FluBlok Vaccine on December 28th 2020, patient called pharmacy on January 4th 2021 stating that she was experiencing pain and movement difficulties at the site of injection. During that first complaint patient was advised by pharmacist to follow up with primary care doctor if pain did not imporve with in the next 2 days. Patient called back the following week and informed that pain had increased and mobility was limited. At that point, patient was instructed to schedule an appointment with doctor. Patient saw Doctor on 01/18/21, of which reccommended she see a orthopedic doctor. During her visit with PCP, patient was prescribed Etodolac 400mg  and Norco 7.5/325 for pain. Patient was then scheduled to see a a specialist on 01/28/2021. The orthopedic specialist diagnosed patient with Left Subacromial bursitis/Rotator Cuff Tendinitis. At orthopedic clinic, patient received a left shoulder subacromial injection (  4 ccRopivacaine and 2cc of Kenalog-10)
day after vaccine slight fever and sore arm, 9 days after vaccine: lump in arm, hot to touch
GI Symptoms 24 hours, dizziness, seizure on 4/20/2000.
patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose).    Concomitant medications were not reported.                        Patient now wanting a booster dose.  No treatment information was provided by the reporter.
Case previously recorded as MA2009-3182. Initial case report received from a health care professional via MedCom on 21 OCT 2009. A 18-month-old female child was vaccinated with S-OIV FLUVIRIN (batch no. 1008131P) i.m. into the left deltoid on 13 OCT 2009. No adverse event was reported. Reference no.: NA09-006775.
felt very faint; lost visual clarity; profuse sweating; ears ringing; severe dizziness; heart palpitations; tension in my throat; severe nausea; This is a spontaneous report from a contactable consumer (patient) who reported for herself   A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318), in left arm on 25Mar2021 at 14:30 (at 28 years) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 25Mar2021 at 14:30 (as reported) the patient felt very faint, lost visual clarity, had profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in her throat and severe nausea. Events were also described as follows: about 2 mins after (as reported) felt very faint, lost visual clarity, profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in throat. Remained for about 5-10mins. Then severe nausea.  No treatment given for the events. The final outcome for all the events was reported as recovering.
swollen tongue & sore throat;seen in ER & tx w/epi, anti histamines & steroids;
went back for the second dose and was told they didn't have the vaccine to give; went back for the second dose and was told they didn't have the vaccine to give; This case is considered invalid as info not qualifying for AE reporting- all other sources, as there is no indication that the patient experienced an event under BNT162B2.   This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), 1st dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was told to go back in two weeks for the second dose, went back for the second dose and was told they didn't have the vaccine to give. The outcome of event was unknown.   Information on the lot/batch number has been requested.  Follow-up (21Apr2021): This is a follow up-spontaneous report received from a contactable consumer. This consumer (patient) reported in response to Non-HCP letter sent via follow-up letter which included that:  No information available on follow-up, No new medically significant AE/SD reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021200720 similar report from same reporter
per pt's fiance/boyfriend pt started to have severe pain in diaphragm, numbness in legs and arms, couldn't speak because she was in so much pain. Her and her fiance thought she was having a heart attack. He checked her blood pressure several times before the ambulance got there. He did not tell me what her blood pressure was. Pt went in ambulance to hospital. Pt then had chills from fever, throwing up and diarrhea (at the same time per pt fiance). Per pt fiance the hospital wanted to airlift her to a larger hospital but she stabilized.
pt recvd MMR vax on 15SEP88 & on 28FEB91 c/o (off & on) cold sx & an earache; dx w/conjunctivitis & BOM; 13MAR91 pt c/o vomiting & sore throat; 14MAR91 devel swollen rt eye, rash, koplik's spots dx poss measles;
first dose 11Sep2020, never returned for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th September 2020 with batch number 22ND2 and expiry date 16th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix and never returned for second dose. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. VAERS details reported for 1st dose of Shingrix. The reporter consented to follow up.