chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned (4) multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patients experienced administration of expired vaccine. On 20-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of expired vaccine and off label use was not reported. This report was non-serious.
Day 15 post-vaccination, woke up with a vaginal bleeding similar to menstruation. It was very heavy, lasted 6 days, and I was passing clots. No medical help was needed or sought, but it was uncomfortable. I am in premature menopause and do not menstruate. I take HRT. Following my first Moderna shot, I had a very similar bleeding as well, starting the morning after. I have not had any vaginal bleeding following these two (after the first and second Moderna shot).  Besides these effects, within hours of this second dose, I was feeling tired. I woke up the next morning with body aches similar to that of influenza, a temperature of 99.5, which is quite elevated for me, and overall tiredness. These symptoms resolved by next morning, when I woke up with a throbbing headache. It resolve following one dose of 200mg generic ibuprofen.
could not move her arm up and down; stiffness left arm; slightly swollen arm/minor swelling in the left arm; painful arm/tender to touch/severe pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm up and down), MUSCULOSKELETAL STIFFNESS (stiffness left arm), VACCINATION SITE SWELLING (slightly swollen arm/minor swelling in the left arm) and VACCINATION SITE PAIN (painful arm/tender to touch/severe pain in left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis, Bronchitis, Seasonal allergy and Blood pressure high. Concomitant products included ATENOLOL for Blood pressure high.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm up and down), MUSCULOSKELETAL STIFFNESS (stiffness left arm), VACCINATION SITE SWELLING (slightly swollen arm/minor swelling in the left arm) and VACCINATION SITE PAIN (painful arm/tender to touch/severe pain in left arm). The patient was treated with PARACETAMOL (ACETAMINOFEN) at an unspecified dose and frequency. On 02-Apr-2021, MUSCULOSKELETAL STIFFNESS (stiffness left arm) and VACCINATION SITE SWELLING (slightly swollen arm/minor swelling in the left arm) had resolved, VACCINATION SITE PAIN (painful arm/tender to touch/severe pain in left arm) outcome was unknown. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm up and down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-118279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021, contains Significant information. Added Medical History, Concomitant Medication, Suspect drug details, Second dose details, Event outcome On 16-Jun-2021: Follow-up information received on 16-Jun-2021, contains non-significant information.
Patient experienced  dizziness, headache, nausea and arm tenderness about 5 minutes after receiving her 1st dose. Within 45 minutes that patient was noted to be "flushed." She laid down, was given water and oral Benadryl.
Pt was very sick from flu vaccine the next day w/ severe diarrhea and sweating and he could not leave bed.
Since I have twice/Suspected Vaccination Failure; had them but were very mild; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt date: 28-Feb-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. The severity for shingles was mild. Patient had shingles twice and decided to get the shingles shots.Since patient had twice had them but were very mild. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Right Eye twitching, right side of lip twitching. Lasting 30 seconds.
Client tested positive for COVID 4/1/21. Completed COVID vaccine series 1/26/21. Asymptomatic. Tested post travel. Traveled from one state to the next by car 3/25/21 through 3/29/21.
pt recvd vax 23SEP93 & devel rhinorrhea & a cough which lasted 2 wks;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 12-SEP-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated by her nurse practitioner at a health center for a painful rash that was diagnosed as shingles. On or about 06-SEP-2016, the patient was diagnosed with post herpetic neuralgia at the same facility, as worsening and residual effect of shingles. The patient was prescribed valacyclovir (VALTREX), lidocaine (LIDODERM), pregabalin (LYRICA)  and betamethasone dipropionate cream for management of these symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
had a fall; after the 2nd dose, they have been diagnosed with COVID19.; after the 2nd dose, they have been diagnosed with COVID19.; This is a spontaneous report from a contactable consumer (nursing assistant) via medical information team. An 85-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in upper left arm on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were none. On an unknown date, the patient after the 2nd dose, they have been diagnosed with covid-19. On 25Jul2021, the patient had a fall. The patient was hospitalized for fall from 25Jul2021 to 01Aug2021. She was in the hospital they were doing tests due to fall and when she contracted covid she was at the hospital and was admitted the day of the fall which was 25Jul2021. On an unknown date, the patient underwent lab tests and procedures which include: covid-19 test which was positive. She quarantined for three weeks in July2021. The reporter was wondering about the booster vaccine because after having their Pfizer COVID Vaccines, she came down with covid and wanted to know having had covid is it safe to take the booster vaccine. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101381139 same reporter/drug/event, different pt
Information has been received from a 45 year old female with an allergy to acetaminophen + oxycodone hydrochloride (Percocet) who on 5/8/00 was vaccinated with Hep-A virus vaccine inactivated. Concomitant therapy included alendronate sodium (MSD). On 5/10/00, the pt experienced nausea, sore throat, and was "very, very tired". She had to "slap her face to stay up". No further information is available.
Redness at the (L) arm where pt was injected 'erythema' no induration at site of injection 4-5 " in (L) - (status going down day 4).
pt recv vax 27JUN97 & 15JUL97 pt exp a mild case of varicella w/just a few vesicular pustular lesions on upper trunk, chin & chest;pt was afeb;
26AUG92 evening t102 lt arm tender & sore; 27AUG92 t39.9 lt arm extremely swollen w/yellow drainage;
Daughter began complaining of intermittent chest pain on 1/1/2022. Since 1/1 she has become increasingly more lethargic and continues to complain of chest pain. We are making an appointment with her pediatrician for 1/6.
Client tested positive for Covid-19 following completion of vaccine series (2 weeks following last dose)
Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 at 10 am. Took Advil with relief. Sunday afternoon low grade temperature of 99 at 3 pm. Reports arm soreness bilateral.
Patient called reporting that the day after receiving her first dose of Shingrix she developed swelling on the right side of her face, neck, armpit, and behind her right ear.  This is the same side she received the vaccine on.  She said her lymph nodes are swollen and tender to touch.  She had redness only at injection site per her account.  She called on 5/12/23 and stated it was a little worse today than the day before.
April 26 woke up with shoosh or thrum thrum sound in right ear.  Sound faded by April 27 about 75%.  Severe vertigo and nausea on April 27, 28 and 29, coming and going.  Unable to do much.  Too dizzy.  Saw my GP who said she is seeing a lot of moderna and Pfizer patients with this symptom 2-3 weeks after the shot and it goes away after 2-3 weeks maximum.  Reassuring, no ear infection or other symptoms.
Patient was inadvertently given the Janssen COVID-19 vaccine and the first dose the patient received in 4/2021 was Pfizer.   Patient was observed for the recommended 15 minutes post-vaccination with no adverse events noted.
Blood clot to eye causing substantial vision loss in right eye on 6/10/2022. After numerous tests (see below) no one can find any source or reason for the blood clot. Damage is permanent.
allergic reaction; lips started to get numb; throat feels like closing up; hard to swallow; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  AA female patient received bnt162b2 (BNT162B2), administration date 21Jan2022 (Lot number: FJ5683, Expiration Date: 31Jan2022) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL taken for premedication, start date: 21Jan2022. Vaccination history included: Covid-19 vaccine (Primary Immunization completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 21Jan2022, outcome "unknown", described as "allergic reaction"; HYPOAESTHESIA ORAL (medically significant) with onset 21Jan2022, outcome "unknown", described as "lips started to get numb"; THROAT TIGHTNESS (medically significant) with onset 21Jan2022, outcome "unknown", described as "throat feels like closing up"; DYSPHAGIA (medically significant) with onset 21Jan2022, outcome "unknown", described as "hard to swallow". The events "allergic reaction", "lips started to get numb", "throat feels like closing up" and "hard to swallow" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of throat tightness. Clinical course was as follows: The patient reported after getting her booster shot on 21Jan2022, she ended up having allergic reaction to it and she spent 2 and half hours in the urgent care. Patient stated that her lips started to get numb and her throat feels like closing up and it's hard to swallow. Patient also stated that prior to getting the booster shot, they gave her Benadryl, it wasn't liquid, it was a pill. 30 minutes prior to getting the shot, but it didn't help and gave her a breathing treatment. She experienced the adverse reaction within 2 minutes or so. Patient also stated that other people are telling her that their tongues are getting numb, and per patient she wants to report it.  No follow-up attempts are possible. No further information is expected.
Patient received a second flucelvax shot 19 days after receiving the first shot. Patient marked influenza vaccine on both consent forms, pharmacist did not verify that is what the patient wanted before injecting.
I started developing hives over my scalp and neck on a daily basis that I cannot seem to line up with another cause like a food or medication. I take benedryl nightly to sleep and that makes them go away, but when that wears off they come back.
This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of GARDASIL (lot # L012190 with expiration date at 13-APR-2017; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit nor provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA000822: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068:
After 2nd shot was administered, Pt reported she was feeling light headed. Had Pt take deep breathes and put her head between her legs. Seconds later, Pt loss consciousness and fell forward to the ground. RN was able to catch Pt, but lost balance. Both Pt and RN fell to the ground. Pt did hit her forehead/side of head on the ground, but impact was less due to RN catching Pt. Pt regained consciousness seconds later. Had Pt remain on the ground and reassured her that she is going to be "ok". Pt stated she was feeling nauseous and had her on her side. Mother had to leave the room, but Father remained. Assessed her head for any open wounds/blood that may have occurred from the fall, but none noted. Checked BP - 88/65. Continued to reassure Pt and had her drink some water and eat a glucose tablet. Pt stated she was still feeling dizzy and had her remain on the ground until her symptoms resolved. Pt reported that she ate only a granola bar for breakfast. Provided education about how fainting/syncope is not an uncommon reaction after shots. Provided education on why syncope/vasovagal reaction can happen after shots. Pt reported she had similar symptoms when having dental work done but she didn't lose consciousness. Checked BP again - 90/70. Pt stated she is a cross country runner and normally has lower BP. Pt was able to sit up with slight dizziness that only lasted for a few seconds. Continued to have Pt drink water. Attempted to stand Pt but she became very lightheaded. Had to rest head on counter and gave another glucose tablet to eat. After about 5 minutes, Pt was able to sit up again and a family member provided a granola bar for Pt to eat. Checked BP again - 96/75. Pt was eventually able to stand without dizziness. RN walked Pt and her father to the car where the rest of the family was. Reassured family Pt will be fine, but stated to check in with Primary MD if they have any other concerns. Notified Primary MD: Dr. of syncope event, he stated not uncommon reaction after shots - RN agreed. Reported to MD that Pt did hit her head on the ground but impact was minimal. MD didn't express any more concern. Checked in with Parent a few hours later after the event via phone call. Parent reported that Pt was feeling better and was currently sleeping. Reported to Parent that RN notified their Primary MD of the syncope event and to call him if they have any further concerns - Parent acknowledged.
The patient is a 32 y.o. female who presents for evaluation of light headedness, near syncope, vertigo and hyperglycemia since Covid vaccine.  32-year-old female with type 1 diabetes and history of anxiety with panic attack here complaining of borderline low blood sugars and feeling lightheaded since Covid vaccine on Sunday this past weekend.  Ports that she was feeling achy after the vaccine and then last night was feeling lightheaded.  She was lying down at night and felt that she was going to pass out.  She has room spinning but does report that her heart is racing.  Blood sugars have been around 70 which is low for her.
Pain under left arm, swollen armpit ( left), swollen on both sides of shoulders and neck (lymph nodes) and pain. Just took Tylenol and I am waiting couple days to see if it will resolve by itself, if not will see a doctor.
Patient states below injection site, warm, red area size of palm of her had. Pharmacist recommended to make appointment with doctor.
I had my 3rd vaccination on 06/03/2022. On 08/12/2022 I started have a sore throat and I brushed it off as allergies as it was so mild. I tested 08/13/2022 COVID-19 positive. I was not put on any prescription but over the counter medication. I developed pretty bad sinus pressure and congestion and my throat was pretty painful. I lost my sense of taste and smell. This is my second pregnancy and my first child. Estimated date of birth is 11/19/2022 but my 40 week gestational period is 12/10/2022.
Twenty four hours after I received the injection my arm had two red knots, one at the injection site and nother about 1/2 inch below the knot explained above.  These knots were extremely painful to touch, but didn't affect my ability to use my arm.  The knots expanded the next few day but I became unaware of them. Day eight, I woke up with my right arm itching and felt the knots there again. I am using a ice pack to manage my symptoms currently.
Coughing; Sore throat; Fever; Extreme fatigue; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and FATIGUE (Extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third 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 (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and FATIGUE (Extreme fatigue). At the time of the report, COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and FATIGUE (Extreme fatigue) had not resolved.        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 and treatment medications were provided by the reporter.The patient experiencing sore throat, coughing, fever and extreme fatigue. The symptoms were ongoing.
Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium
Client states he broke out in a rash all over his body. Client reported this on 03/04 clinic visit.
A very sore, red, and swollen upper arm where shot was given that lasted 5 days.
Information has been received from a registered nurse concerning 1 of 2 sisters (the sibling's report was reported as WAES # 0904USA04511) who was vaccinated with a first and second dose of VARIVAX (Merck). After the first dose, the patient developed recurring rash. The rash was not diagnosed. After the second dose, the patient's rash re-occurred and was diagnosed as chicken pox. The outcome was unspecified. This is one of several reports from the same source,. Additional information has been requested.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a patient (with unknown demographics) who experienced allergy, while he/she received vaccine FLUZONE QUADRIVALENT, Lisinopril and ZOMIG. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route in unknown administration site. On an unknown date, the patient started taking Lisinopril and ZOMIG dosage unknown route unknown (with an unknown batch number) for unknown indication. On an unknown date, the patient developed a non-serious allergy (allergy to vaccine) following the administration of Influenza Quadrival A-B Vaccine. On an unknown date, the patient developed a non-serious allergy (drug hypersensitivity) following the intake of Lisinopril and Zolmitriptan. Other relevant tests not reported. Final diagnosis was allergy. Lisinopril and ZOMIG action taken was not reported. It was not reported if the patient received a corrective treatment. The outcome for allergy was not reported. List of documents held by sender: none.
A physician reported that a 2 year old female received an injection of Prevnar on 9/20/00. That same day, the child developed a fever of greater than 102F. She recovered. This is 1 of 5 pts from this facility who experienced this event following receipt of 3 different lots of Prevnar.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox with greater than 300 lesions. The pt sought unspecified medical treatment. The pt was noted as covered with lesions but not in mouth. Additionally the physician noted course and recovery were uneventful. The pt recovered. No further information is available.