chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female (age not reported) who on an unspecified date, the patient was vaccinated with second dose of Gardasil (lot # not reported) SQ. Subsequently, the patient experienced an unspecified adverse event after the second dose of Gardasil was given. The patient sought medical attention and was hospitalized. The reporting physician did not administer the vaccine and was requesting follow-up from a medical team member. No further information was available at the time of reporting. Additional information has been requested. 4/26/07 CDC spoke with a nurse at the reporters office (the reporter for 277262).  "While rounding in the hospital he was asked for advice about a patient (not his patient) who received her second HPV vaccine SQ instead of IM.  They wanted to know if they should repeat the dose or not.   He contacted Merck who responded with a letter saying they had not looked at this in the trials, etc.  The patient did not have any problems.....the vaccine was administered incorrectly. " 4/27/07 Per email from CDC, "the report says the patient was hospitalized. According to your note, the pt. was NOT hospitalized. Correct? If so, we will have this corrected in VAERS." 4/27/07 Per email from CDC, "according to the nurse the patient was NOT hospitalized" 4/27/07 Per email from CDC, "Please change this in the VAERS database."  Database change completed.
The patient experienced extreme nausea and headache started around bedtime. The symptoms began the night after receiving the flu vaccine (around 5pm).
I had a aches and pains, night sweats, and chills. The next day, I had a huge swollen lymph node. It remained for 5-6 days and then went away. About 2 weeks later, I had a dizzy spell that happened with my 2nd dose that wasn't as bad as the last time. This lasted 2 days.
Flares have worsened since Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): NUS2023US094002 (RA).  A 60-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Flares have worsened since Covid-19 Vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
- Lightheadedness - Fainting - Fever - Extreme fatigue - Dizziness - Headache - Nausea - Anxiety - Depressed mood/anhedonia  Called advice nurse. No treatment given.   Lasted for 3 (three) days
On 2/17 and 2/18 I was extremely fatigued. On 2/18 I was also nauseous after lunch time and had sweats toward the evening.
Anaphylactic reaction.  Epi-Pen 0.3mg IM and Solu-Medrol 125mg IM.
Developed chills PM of 10-26-06. Headache for 24 hours starting 10-28-06. Decreased appetite. 10-28-06 patient noted a 4X4 inch red swollen area right upper arm at injection site. 10-31-06 patient states she is feeling better. Still with small amount of redness and swelling at injection site.
NO ADVERSE EVENT. PATIENT HAD ANOTHER BIVALENT PFIZER VACCINE HAVING RECENTLY HAD THE SAME EARLY SEPTEMBER WHEN IT FIRST CAME OUT.
Within 24 hours experienced lightheadedness, wooziness and increased heart rate (approximately 160 bpm) when outside in 80-90 heat whether relaxing or performing moderate work. This happened after spending 3-4 hours outdoors and has not happened at any other time prior to vaccine or 2 or more days afterwards. Patient was hydrated and under no meds. Occurrence lasts 1 hour.
Expired dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a 75-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient took 2nd booster dose. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains no new information.
Extreme fatigue. Extreme gas. Left upper Abdominal pain. Nausea. Poor appetite. Feels similar to gastritis. Pain and discomfort wakes me up and disrupts daily activities. Onset 1-2 days after vaccination. Symptoms getting worse.
hardness at the injection site; redness at the injection site; swelling at the injection site; aching at the injection site/soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (aching at the injection site/soreness at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (aching at the injection site/soreness at the injection site). At the time of the report, VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (aching at the injection site/soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided
Client presented to the vaccination site on 12/7/21. The client reported that he received a first dose of Moderna COVID vaccine on 2/12/21 and a second dose of Moderna COVID vaccine on 3/19/21. Client reported about 4-5 hours after the second dose lower back pain and fever. Client described back pain as throbbing and rated it a 9/10. The client did not take his temperature with a thermometer. Client?s fever resolved after 2 days. Client?s back pain resolved after 4 days. Client took Advil for the back pain. The client reported difficulty sleeping due to his back pain. Client followed up with his provider who recommended Pfizer COVID vaccine as client?s next dose. Client has a history of genetic autoimmune hepatitis. Client did not report taking any medications but follows up with his doctor every 6 months. Client reported a history of penicillin allergy but didn?t know his reaction (client?s mom denied any history of allergy to penicillin). RN submitted a med consult via text message to clinical project coordinators requesting to proceed with Pfizer COVID vaccine. Per CDC guidance, approval to proceed with Pfizer COVID vaccine was obtained from medical consult team via text message from  clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FF8841 on 12/7/21 by, vaccinating nurse. The client did not report any symptoms during the 30-minute observation period. RN educated on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1659 unassisted with a steady gait.
adverse affection; A spontaneous report was received from a consumer concerning a female patient with an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events adverse affection/Vaccination complication.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event adverse affection.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, adverse affection was unknown.
Redness to left eye, edema to face below left eye, child c/o itchy feeling in left eye, no treatment, mother given verbal instructions to watch for any increased edema or irritation, instructed to seek medical attention if further concerns develop, follow telephone contact, mother states that redness and edema and irritation to left eye are gone.
Swelling and redness following day of administration. Urgent care physician diagnosed with cellulitis and patient returned to fill Rx for Bactrim DS (swelling is in upper left arm and in the fatty tissue where Zostavax was injected).
I called patient's mother to inform her of patient receiving TDAP although she had previously had one 07-19-10 - no adverse reaction noted at that time. Vaccine was given at a mobile site with no access to state Immunization Registry, when call was made to health dept. to verify vaccine dates, the wrong date was given to mobile unit staff therefore repeat TDAP was given.
Information has been received from a registered nurse concerning a "young " female who was vaccinated with Gardasil vaccine. Subsequently, the patient experienced syncope. She passed out, hit the floor "pretty hard" and broke her two front teeth. The patient required tooth repair. Additional information has been requested. It was reported that another patient experienced syncope after vaccination with Gardasil vaccine (WAES 0711USA01539).
Started experiencing repeated episodes of tendinitis first in one wrist, then the other in April 07 . Then, knees started bothering me.  Had blood test in Aug 07...tested positive for RA factor.  Diagnosis of RA in Nov07. DPT 8/25/06. Vaccinations given for Hep A and B. Twinrix 8/25/06 HepB 10/12/06 Twinrix 2/8/07 HepA 7/12/07 Listed below in order given...  difficult to read lot #s. Given methotrexate as treatment.
Fever over 100.  Body Aches and welts on arm of injection.  Improved 24 hours later
Information has been received from a nurse concerning a 21 year old female who on 11-MAY-2009 was vaccinated with the first dose of GARDASIL (LOT# 661952/1129X). Concomitant therapy included NUVARING and MACROBID. On an unspecified date, after vaccination, the patient experienced blisters in her fingers and toes. The patient sought medical attention and spoke with a nurse. The patient's outcome was not reported. No other information was provided at the time of report. Additional information has been requested.
I was pregnant shortly after getting the vaccine and I lost the baby due to a blood clot at 16 weeks. I was told it could be from the shot. Little worried because I am pregnant again.
Itchiness redness a rash in her arm near the injection site; Itchiness redness a rash in her arm near the injection site; Itchiness redness a rash in her arm near the injection site; Soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on her arm), VACCINATION SITE PRURITUS (Itchiness redness a rash in her arm near the injection site), VACCINATION SITE ERYTHEMA (Itchiness redness a rash in her arm near the injection site) and VACCINATION SITE RASH (Itchiness redness a rash in her arm near the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness on her arm). On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness redness a rash in her arm near the injection site), VACCINATION SITE ERYTHEMA (Itchiness redness a rash in her arm near the injection site) and VACCINATION SITE RASH (Itchiness redness a rash in her arm near the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 22-Jan-2021, VACCINATION SITE PAIN (Soreness on her arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchiness redness a rash in her arm near the injection site), VACCINATION SITE ERYTHEMA (Itchiness redness a rash in her arm near the injection site) and VACCINATION SITE RASH (Itchiness redness a rash in her arm near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Information has been received from a pharmacist referring to a female patient of unknown. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with her last dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. The patient's previous dose was received over a year ago (Inappropriate schedule of vaccine administered). No adverse events reported. The outcome of the events was unknown.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age. Reporter stated that she had a patient come in two months ago for follow up visit and reported that in October 2013 the patient was vaccinated with VARIVAX (Merck) or M-M-R II, reporter was unsure which vaccine was administered to the patient. Approximately in 2013, the patient experienced febrile seizure (medically significant). The patient sought medical attention for the same. The outcome of febrile seizure was reported as recovered. The relation between the drug and the event was unknown. Upon internal review event Febrile seizure was considered medically significant. Additional information has been requested.
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Narrative: Pt is a 89y.o. who died on 01/31/2021 w/ h/o T2DM, HTN, GERD, BPH, CAD, COPD, CKD3. Pt received Moderna Covid-19 Vaccination 1/2 on 01/16/2021. Facility notified of pt death by Agency on 03/03/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
CHEST TIGHTNESS; HEADACHE; CHILLS; BODY ACHES; This spontaneous report received from 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, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 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 08-MAR-2021, the patient experienced chest tightness, headache, chills and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, chest tightness, and body aches. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Severe bone pain, axillary Lynph node pain  , body aches and chills, headache. All has resolved except Lynph node pain
headache, fever, chills, achy; lasted about 15 hrs.; took 2 acetaminophen 500 mg about 13 hrs. after symptoms started; symptoms disappeared
On the 1st day that I noticed symptoms, it started as a minor, itchy rash around my abdomen - red bumps (pustule bumps). That night I took OTC Benadryl. When I woke up the next morning, I was head to toe rash that was extremely itchy to the point I had to go to Urgent Care. With the rash: some were pin point itchy dots and some had a fluid filled lump (those were far and few between).  Urgent care prescribed my Medrol dose Pak steroids and Benadryl. It took 24-36 hours for the meds to fully take affect.
Pt had a reaction on right leg. Injection site was red, warm to touch, slightly swollen pt was given rx. Benadryl.
she had a sore arm after her Covid vaccines for a day or so at the injection site; she had a sore arm after her Covid vaccines for a day or so at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, 0.3 ml single (Lot number: ER8727) at the age of 64 years, in right arm, on 17Apr2021 as dose 2, 0.3 ml single (Lot number: EW0161), in left arm and on 25Oct2021 as dose 3 (booster), 0.3 ml single (Lot number: 32030DB), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "she had a sore arm after her Covid vaccines for a day or so at the injection site".  Additional information: Caller said that she had a sore arm after her Covid vaccines for a day or so at the injection site. No significant side effects from the Covid vaccines. She got both Moderna and Pfizer. The patient received Moderna Covid-19 Vaccine (lot number: 066K21A) as dose 4 (booster) on 31Mar2022 in the left arm.
This was administered at " Pharmacy -long lasting headache  - Nausea that comes and goes - aching low back - injection site : red, warm, inflamed and itchy
Moderna: Initially had a burning sensation at injection site for a few hours. That turned into a sore arm with some localized swelling for two days. On 1/1/2021, I woke up with a very swollen lymph node on the left side of my neck. I was very tired and had no energy for three days. The lymph node is still swollen and I am 9 days out from the vaccine.
extreme swelling at injection site, hot skin for a week.  Nausea, intestinal distress for 7 days.  Still have a baseball size 'bruise' at the injection site with stiffness at the needle mark.
This spontaneous report was received from a pharmacist via field representative refers to two female patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in 2015 (also reported as in the past month), the patient was vaccinated with ZOSTAVAX, (dose, frequency and route of administration not provided). On an unknown date in 2015 (also reported as in the past month), both patients experienced injection site swelling and redness after receiving ZOSTAVAX. No treatment was given for adverse events. Therapy with ZOSTAVAX was continued. The outcome of events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was filed. Follow up information has been received on 02-OCT-2015 from a pharmacist via phone call referring to the approximately 60 year old female patient. Lot# of ZOSTAVAX was L012475 and expiration date was unknown at the time of reporting. The reporter confirmed the patient experienced injection site erythema and injection site swelling and both the events were resolved in about 2-3 days. The reporter also stated one of the reported female patients stated that the injection site "looked bad" but there was "no pain or itching" at the injection site. This is one of two reports received from the same reporter. Additional information has been requested. Patient information, event information and narrative were updated.