chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; patient received a dose of VARlVAX and the patient wanted ashingles vaccine; This spontaneous report was received from a pharmacist referring to a 68-year-old patient of unspecified gender.    No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 05-APR-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not reported), but the patient wanted a shingles vaccine  (Zoster Vaccine Live (ZOSTAVAX)).  The reporter stated that they were overwhelmed with Coronavirus disease (Covid) vaccines that she did not catch the error before.  No additional adverse events or product quality complaints were reported.  This was one of several patient reports made by the same reporter.
Patient received her second dose of vaccine at 6:40 PM.  After the minute observation period, she left the facility en route to her home.  When she got to her car, she felt that the base of her tongue was swollen.  She returned back to the vaccination center.  At 7:05 PM, she was assessed by the post vaccine RN.  BP 155/98, HR 103.  O2 Sat 98% RA. She continues to verbalize that she feels minor swelling of tongue and "congested" nostrils.  7:15 PM BP 174/112 HR 103 O2 - 97% RA.  Patient was also assessed by pharmacy.  Epi-pen was not administered.  Patient's symptoms were not improving.  EMS called to transport patient to hospital for adverse reaction and increased blood pressure.  BP 165/102 HR 103.  Patient transported to hospital via stretcher.
mild fever; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 48-years-old) (Lot Number: EL3247) as 2nd DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no COVID prior vaccination and not tested to covid post vaccination. On 01Feb2021, the patient administered first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration, administered in Arm Left (Lot Number: EL3247). On 24Feb2021, the patient experienced mild fever, headache. No treatment was received for the events caused. The patient underwent lab tests and procedures on 24Feb2021 which included body temperature as mild fever. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Patient experienced severe nerve pain around her arm and down to her abdomen that has not resolved. It is very similar to what shingles would feel like according to the patient. There is nothing visible to the eye. She said it feels like it is internal and even hurts to lift her arm. She is seeking medical attention.
TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a physician (consumer's mother) (PVX2019-491) on 25-Feb-2019. The report described a male consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer left Vivotif out of the refrigerator for at least 3 to 5 days and then he took three doses.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Arm, numb and tingling radiating into the L jaw, 50mg Benadryl given
10/24/21- SOB, dyspnea and right sided chest pain began   see item 19 for more details
Sepsis; Had kidney stones; Have double vision problems; This is a spontaneous report from a contactable pharmacist. A 20-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 30Aug2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   The patient experienced sepsis, had kidney stones, had double vision problems. The reporter a pharmacist, stated a mother called her on behalf of her 20-year-old daughter. The daughter got the first dose of the Pfizer covid 19 vaccines on 30Aug2021. Shortly after the vaccine, the daughter started to have double vision problems and has not had the second dose due to this problem. Mother stated the daughter school is requiring the second dose. The mother reported the daughter had kidney stones and sepsis and had a stent put in 10 days after the vaccine. Mother stated the daughter has not seen an eye doctor or other HCP for the double vision. Mother stated they did not ask about the double vision at the time of the kidney stones stating they did not think about the double vision. Mother reported the double vision was constant at first and is now random. The double vision started after the vaccine and before the kidney stones. Caller stated she reported AE in VAERS. The events sepsis and had kidney stones was considered as medically significant. Caller wanted to know if double vision has been reported. The outcome of all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Sepsis, nephrolithiasis, double vision cannot be totally excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Immediate and severe pain at injection site. Within 30 minutes, worsening pain at site and in armpit. By 3 am, I awoke with a headache, dry heaves and had trouble walking. I had chills and sweats. I felt awful the next day, too. The injection site and armpit pain made it hard to move my left arm. After a week, I went to my physical therapist. He worked on a suspected rotator cuff tear earlier in the summer. I reported the event to the facility.
Information has been received from a physician concerning a 51 year old male who on Nov 09 2004 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown). the patient subsequently developed an injection site reaction to include redness and swelling from his shoulder to his elbow around the injection site. It was also reported that the patient sought unspecified medical attention and was recovering. No product quality complaint was involved. Additional information has been requested.
After the vaccination I suffered loss of hearing which is still ongoing, and the sensation of fullness and pressure is in the middle ear as if I'm landing from a plane ride. And I am currently under the care of an ENT Dr.  I suffer from chronic pain and muscle weakness.  The lower and center of the back is out, and I get spasms that move bilaterally around from the front to the back.  When getting up from a sitting position I have to get up a certain way because I suffer from extreme pain in the torso, and I can't stand if it's not done a certain way.  And In my front rib area I have horrendous pain ever since I've gotten the vaccination.
Pneumonia vax was given and later that day pt exp soreness of rt deltoid. Arm became swollen around inject site to size of a baseball w/ redness. Also complains of nausea & dizziness.
Complained of tingling in and off and on since shot given on 10/26.  Area around where shot given still tender to touch and from side of elbow to hand still continues to "tingle" off and on.  Advised to see MD and let know outcome.
Information has been received from a nurse practitioner concerning a 16 year old female who was vaccinated with the first dose of GARDASIL on 02-Aug-2007, second dose on 02-Oct-2007, and third dose on 20-Mar-2008. The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. In approximately November 2007, the patient began to have signs and symptoms of Adrenal Insufficiency. The patient had sought medical attention. At the time of reporting, the outcome of adrenal insufficiency was unknown. Additional information has been requested.
a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised). On 26-Oct-2021, ACCIDENTAL UNDERDOSE (a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Approx 4 hours after injection, malaise, chills, muscle and joint aches.  Then headache nausea and vomiting followed approx  12 hours after injection.  Symptoms  lasted 36 hours.
feels like she's "coming down with something"; This is a spontaneous report received from a non-contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feels like she's "coming down with something"".  Additional Information: The patient needed to reschedule second dose. She felt like she's "coming down with something." She wasn't able to reschedule it on website. She wanted to know if she could get second dose at another site. She also wanted to know how soon second dose to be effective.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experienced near syncope post vaccination. He was attended to by the medic and was NOT transferred to the emergency department.
Extremely heavy and sore left arm, heavy legs, swelling in left leg, sore throat, body pain to the touch, upset stomach, constipation, swelling in left armpit, breast pain, pain and throbbing in both eyes, palpitation and pain in fingers and toes as if they were going to explode, tickling or tingling in legs and feet. Rapid throbbing in chest, pain in hand and leg joints.
Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report as received from a consumer referred to a patient of unknown age and gender.   On 22-JUN-2023, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters (lot # 1968385, expiration date 22-MAY-2024), orally for prophylaxis (strength, frequency, and dose# were not provided) (improper storage of product in use). The vaccine underwent multiple temperature excursions since 20-JUN-2023 until 05-JUL-2023. There were no previous temperature excursions reported. No product quality complain (PQC) reported.  This is one of several cases received from the same reporter (cross-referenced with US-009507513-2307USA009292 and US-009507513-2307USA009675).; Sender's Comments:  US-009507513-2307USA009292: US-009507513-2307USA009675:
Got many of the major side effects; This case was reported by a physician via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The case was reported by patient's friend. The reporter stated that after vaccination the patient got many of the major side effects. The reporter stated that the side effects seemed to improve but approximately 6 days later side effects were worse again. The reporter asked is there ant treatment and how long will this last is this an arthus reaction igm or igg.
Fainting, exhaustion, insomnia, stomach issues, dangerously low blood pressure, dangerously low blood sugar, fatigue. Diagnosed 4 years later with Postural Orthostatic Tachycardia Syndrome, Ehlers Danlos Syndrome, and Fibromyalgia.
Tinnitus occurring within days and lingering to-date. Left ear only. I (patient) have a history of left ear infections in my lifetime but none in recent years.
face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous report from a contactable healthcare professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 28Dec2020 at 17:30 (at the age of 34-years-old) at a single dose for COVID-19 immunization. Medical history included sulfonamides allergy. The patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks prior to vaccination, included ascorbic acid (VIT C; MANUFACTURER UNKNOWN), curcuma longa (TURMERIC), and collagen (MANUFACTURER) taken as supplement. Additional concomitant medications included unspecified multivitamin (MANUFACTURER UNKNOWN). The patient previously took azithromycin (MANUFACTURER UNKNOWN) and experienced allergy and vortioxetine hydrobromide (TRINTELLIX) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tingling that started at nose and spread across cheeks and lips on 28Dec2020 at 18:00 and face puffy on 29Dec2020. The events were reported as non-serious. Therapeutic measures were taken as a result of tingling that started at nose and spread across cheeks and lips, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling that started at nose and spread across cheeks and lips was recovered in Dec2020 and of and face puffy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
She got aches and pain, mild; She got aches and pain, mild; 99.9 fever; her arm was very sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202/EN6206), via an unspecified route of administration, administered in right arm on 01Mar2021 11.30 (at the age of 78-years-old) as dose 1, single for covid-19 immunization. Patient relevant medical history includes pancreatic duct narrowing and stent placed (2 years ago and she had a stent placed and now it is working fine). The patient concomitant medications were not reported. The patient did not had family history. The patient did not had a gallbladder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adds the patient had a fever but it was not high and had everything but it was easing up. Clarifies the patient received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 at 11:30AM in the right arm. The patient got aches and pain, mild, not bad and a 99.9 fever for one day and her arm was very sore. The next day everything was easing up and the patient was fine by the night time. Their was not history of all previous immunization with the Pfizer vaccine considered as suspect. The patient underwent lab tests: fever: 99.9 Fahrenheit (normal range: 97.7-99.5 Fahrenheit). The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Vaccine administered to a patient which is below the age range approved by EUA. During observation period and in the following 24 hours no side effects were noted.
INJECTION SITE WARM TO TOUCH.  FEVER, FUZZINESS, AND RASH.
No known heart issues. On Friday 2/26, very suddenly I went into atrial fabulation rapid ventricular response. I went to the ER. This was confirmed many times by EKGs and lasted 4.5 hours with HR ranging from 8-173 at rest. I was given a medication, Diltiazem 30 mg tab, and my heart rate regulated. Many tests were completed at ER and so far, no known cause for this event has been determined based on test findings. So symptoms lasted from 5pm to 9:45pm. Given medication which resolved the Afib. Stayed at ER running tests until 3:30am.
Patient states she got a severe headache and could not see out of Right eye.  Felt like a stroke.  Complained of nausea and vomiting and chest tightness.
Patient was given the wrong vaccines; pt received KINRIX and PROQUAD but needed hepatitis B and Hib vaccines.
Redness on inj site, raised and red lesions, itchy, feels hot, mild pain. TX: diphenhydramine 12.5mg/5ml oral liquid directions 8mL PO TID.
Information has been received from a college health registered nurse concerning a female who was vaccinated with either a second or third dose of GARDASIL (lot # 6559962/1740U). Subsequently the patient developed pain at the injection site. It was reported that it was the worst shot she ever had. The patient had to lie down because "the shot hurt so bad." The patient was weak and "felt like fainting." The patient sought medical attention in the office. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check. Additional information has been requested.
Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly after these symptoms I begin to have uncontrollable chills followed by a fever and Nausea. The whole time starting around 8pm I had pretty bad muscle aches as well. I took a warm shower and bundled up the whole night because I had a fever, aches, chills, and nausea. It was impossible to sleep because of this and sometimes my heart was beating fast as well. The next morning I had a headache that would not go away until I took Tylenol. The whole next day I felt exhausted as well and very weak. I began to feel better on day 3 but still feel somewhat foggy from the shot. I would not recommend this vaccine to anyone and would never get it again and hopefully the foggy sensation goes away.
Lightheadedness, vertigo, increased tinnitus, imbalance, vertigo, migraine, watery eyes, vertigo upon sudden movement
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 27-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 25-May-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy. The delivery occurred  on 12-Apr-2021, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. Intestinal Artesia of the jejunum, water broke 4/5 and baby born 6 weeks early. On 29-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2020, Pregnancy test: positive (Positive) positive.         No concomitant medications were reported. No treatment medications were reported.   Company Comment: This case concerns a 27 year-old, female patient, who is pregnant (the estimated date of delivery is 25-May-2021) and experienced an event of drug exposure during pregnancy after receiving her first dose of mRNA-1273 vaccine on 29Jan2021 and second dose on 05Mar2021.  No adverse events were reported.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up attached on 7 May 2021 and VAERS with outcome of pregnancy; Sender's Comments: This case concerns a 27 year-old, female patient, who is pregnant (the estimated date of delivery is 25-May-2021) and experienced an event of drug exposure during pregnancy after receiving her first dose of mRNA-1273 vaccine on 29Jan2021 and second dose on 05Mar2021.  No adverse events were reported.  Further information has been requested.
The first two days, the injection site was red, puffy and a bit sore. The soreness abated over two days. I noticed 8 days later (3/17/21) that it is still a large red circle at the site. It is a bit puffy and warm to the touch.   It is not impacting my life, but I don't think it should still be red and warmer than the surrounding skin.  I took ibuprofen today. The redness still exists.   Not sure if I should worry or not.  I have not gone to any clinic or doctor.   Looking for advice as well as wanting to report this to you.   Thank you.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 15-JAN-2013 had administered dose of GARDASIL (lot # H011350 expiration date 21-FEB-2015) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
pt recvd vax; 12jul95 devel about 12 gen lesions;