chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse affects reported; the lot number documentation is accurate and the patient was administered MMR II, the patient will need "catch up" vaccines due to the assumption that she received her second and final dose of PROQUAD, not MMR II as document/ patient missing vaccines; The documentation of the vaccine/lot number was as MMR II and administered to a 14-year-old patient. The patient/guardian were under the impression the vaccine administered and associated with this lot number was the 2nd dose of PROQUAD, not MMR II; This spontaneous report was received from a pharmacist and refers to a 4-year-old female patient. The patient's concurrent and historical conditions, previous drugs reactions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, lot #, expiry date, and route of administration were not provided). Then, on an unspecified date in February 2014, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, administered subcutaneously, lot # J004204 with an expiration date on 12-APR-2015 (which was documented in the vaccine database), for prophylaxis (wrong product administered).  The patient's guardians were under the impression the vaccine administered and associated with this lot number was the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), not measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Therefore, the patient would need "catch up" vaccines due to the assumption that she received her second and final dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), not measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as documented (product dose omission in error). No adverse affects reported.
As of 5/10/2021 Pt presented to hospital on 4/25 for extreme SOB. Pt SX onset 4/20: thought it was just allergies at first. Pt drove out of town on 4/18 to stay at vacation home, but grandson tested positive 4/19, so pt had brief contact w/ grandson and returned home 4/19- contracted through community exposure. Pt lives w/ husband- tested positive 4/26- LTF (going to reach back out to pt daughter to collect IX). Pt HX asthma, RA, HTN. Pt was wheezy before COVID due to newly DX asthma. Pt is on max oxygen. Unclear if pt DX pneumonia- doctors said that pt's lungs are damaged by asthma & COVID. Unclear if pt was administered Remdesivir. Pt can barely speak. Pt's lung collapsed on 5/8, and pt is to be placed on ventilator soon if no improvement. Pt is fully vaccinated- received 2nd dose on 2/4/21.
Immediately following injection, pt broke out in a localized rash on ant aspect of left arm resulting in 7-8 pruritic raised red lesions.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 10 patients (demographics unknown) who received vaccines FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was a case of actual medication error due to product storage error. Vaccine shipped greater than 2 days to deliver and reported that it was also administered to patients. It was unknown whether adverse event occurred or not. 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 Directive and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer; No Adverse event; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer) and NO ADVERSE EVENT (No Adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Two women who just gave birth. One has the Moderna vaccine and the other has Pfizer) had resolved and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a female patient of unknown age, with no medical history reported, who experienced no adverse event. An unspecified dose of mRNA-1273 vaccine was received on an unknown trimester of gestation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a female patient of unknown age, with no medical history reported, who experienced no adverse event. An unspecified dose of mRNA-1273 vaccine was received on an unknown trimester of gestation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Large red welt, 1" in diameter; 2 hrs of unconsolable crying;
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a nursing and rehabilitation center. On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
This consumer report (initial receipt 12-Nov-2013) concerns a 24 year old female patient with a medical history of diabetes. Concomitant medications include NOVOLOG and LEVEMIR. On 17-Sep-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not specified) and GARDASIL (batch number not specified). On an unspecified date, after her first dose of GARDASIL the patient developed muscle weakness, bad left arm pain, fatigue, leg pain and bruising. The patient only had one dose of GARDASIL and it was unknown whether the patient will continue to get the rest of the doses in the series. The patient went to the physician. A Doppler test was negative. No treatment was provided. Outcome was reported as not recovered.
Patient was mistakenly given a dose of 0.5 mL instead of the protocol dose of 0.25 mL for the Moderna booster. We have attempted to contact the patient's family, and left a message asking them to contact us that we may inform them. The Long-Term Care facility at which the patient is residing has been notified and is monitoring the patient for adverse reactions. We have contacted Moderna as well, who have instructed us that the only risk we should expect is a slight increased chance in the normally observed vaccine-related side-effects.
wife is having chills; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (husband) reported for a female patient. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Feb2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Caller said he and his wife got the Pfizer vaccine yesterday and her wife is having chills on Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
15 minutes after vaccine I started to feel a throbbing under by jaw bone on both sides of my neck.  It was not too bad but then both sides of my facial muscles began to ache an hr after and the throbbing and aching continued most of the time , about 1 to 2 on a scale of 1-10 for 14 days nonstop. At day 15 a bit better but still there, mostly now like my glands are swollen. I went to my physician,  was seen by nurse practitioner who took EKG just in case it was cardiac. I have never had this before, no reactions with file shots or any other shot. It?s still there slightly and I am wondering if I should be the second one. Will someone call me and let me know if I can delay getting the second shot and how to do that.
Soreness at injection site; This is a spontaneous report from a non-contactable consumer. A 77-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, GERD (gastroesophageal reflux disease) and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Feb2021, the patient experienced soreness at injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event soreness at injection site was recovering at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two dose of VARIVAX were administered on 05/27/2021 and expired on 05/20/2021; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.  On 27-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter, lot number S015460 expiration date 20-MAY-2021 (route of administration was not provided) as prophylaxis.; Sender's Comments:  US-009507513-2106USA001319:
According to mother patient had episodes of crying in extreme pain with her body stiffening up that lasted for a total of 45-60 minutes. She called and spoke to the on call nurse who advised she be evaluated in the E/R. Mother took her to the E/R where she was evaluated and discharged home. Dr. contacted mom on 11/01/2013 and reviewed symptoms, E/R note was reviewed. No treatment done. Discussed with mother giving Dtap alone at the fifteen month visit.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient came for 2nd dose, Patient was in  good shape. After receiving the 2nd dose after maybe 5 to 7 mins patient fainted.  i was standing at the door with my back and then i heard patient fell to the floor and bleeding from the nose. i asked him with happended, and patient responsed that he felt light headed and fainted.  Patient then was able to get up and sit on the chair, i called 911 and 10 to 15 minutes later Police arrive and few mins later the Paramatics arrived.
Patient had first Pfizer COVID-19 vaccine at 3 PM on 7/21/21. Around 8 PM, she noticed her glucose level was low at 86-- this resolved with eating. She was woken up at 0400 on 7/22/21 due to her continuous glucose monitor alerting her. At that time her vision was obscured by "white cotton." Her husband checked her glucose and it was 44. The change in vision lasted 10 minutes and resolved with increase in her glucose level after eating.   After the second Pfizer COVID vaccine administered at 3 PM on 8/11/21, around 8 PM she again noticed her glucose level was dropping to the 112. This resolved with eating. Did not have further episodes of hypoglycemia overnight, but was concerned and monitoring for this.
3/3/15 poss reaction to vaccine no appetite-rash all over body fussy-and diarrhea.
[Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization  (EUA): 37-year-old gentleman with history of nonischemic cardiomyopathy, congestive heart failure, polycythemia, obstructive sleep apnea, diabetes, obesity presents to emergency room with increasing dyspnea on exertion and hypoxia. He was diagnosed with acute on chronic systolic congestive heart failure exacerbation due to cardiogenic pulmonary edema and is getting admitted to hospital. Patient received the J&J vaccine on 4/10/2021 and 1st dose of Pfizer vaccine on 1/11/2022- same day as the admission
Redness and Swelling at injection site. Patient reported severe itching at site. Treatment included oral BENADRYL and hydrocortisone cream applied to injection site. Symptoms were no longer present 01/14/2017.
9th pneumonia 23 vaccine. My husband got this in his right arm with seasonal flu vaccine. He got another vaccine for whooping cough in his left arm. 10th and 11th he had fever 102.7, chills, pains throughout body...worse in joints. His right arm at injection site was swollen, red, hot to touch, painful. On the 11th, we went to the doctor, Dr. Dr. prescribed antibiotic and pain killer. 12th continued pain and redness, but fever broke. Redness and pain persists for about a week. I have pictures of his arm...documented evidence each day. Now, legs continue to spasm before bed.
5 mins after the vaccine metallic taste in mouth, nausea, dizziness, chest pain, headaches
pt recv vax 21OCT98 & initially lt arm felt hard,  & sore to touch;26OCT98 observed welts, raised, red & hot;
some very pain/soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient).  A 32-year-old female patient receive  the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN 5318, expiry date: 31May2021), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that in the morning on 27Jan2021, the patient experienced some very pain/soreness at the injection site  but was less intense than what the experienced with a non-Pfizer influenza shot on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
That morning left arm was very painful and a golf ball sized lump was noted in left axilla.  Patient couldn't put arm down by side because of pain.
Red, splotchy spot near injection site approximately 72 hours after receding in vaccine. Warm to touch, no fever, spot got larger during the day.
Extra Dose given - 0.3 mL of undiluted Pfizer dose given. (Explained to patient about the situation and the expected side effects, if any)
Information has been received from a physician concerning a 75 year old female with high cholesterol, mild chronic obstructive pulmonary disease, osteoporosis and no allergies, who on 04-OCT-2006 was vaccinated SC with a dose of PNEUMOVAX (lot# 651320/1008P).  Concomitant therapy included ezetimibe (MSD), "ENTERA", risedronate sodium (ACTONEL) and aspirin.  On 05-OCT-2006, the patient experienced swelling of arm and redness at the injection site.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Developed shingles treated with acyclovir and Prednisone. Symptoms began 21 days after first dose, currently not resolved
No additional AE; Patient was inadvertently administered GARDASIL 9 instead of the intended PEDVAX HIB; This spontaneous report was received from a medical assistant and refers to 4-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-APR-2021, the patient was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) instead of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). The vaccine was administered for prophylaxis. No additional adverse event was reported.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered VAQTA (dose, units, route of administration, lot number were not reported) that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Mother reported whole thigh swelling the following day AM. Seen in the ER a day later and was prescribed oral steroid for swelling and an injection was given.
Couldn't wake up all day next day (Sat.). Slept on the floor while her child played. On 10/11 noted numbness in face and mouth to right shoulder. On 10/12 noted numbness and pain down right arm (shot given in left.) Began to have numbness left hand. Later, in ED, right arm became paralyzed. 11/9/09:  ED Records received for date of service 10/12/09:  Dx:  peripheral neuropathy  Assessment:  Presented with numbness of arms, fingers and mouth.  Normal reflexes, RUE weakness, no LUE weakness.  Had flu shot and  felt sick the next day:  dizzy, fatigue, slight sore throat. No lower extremity weakness.  Gait normal.  IV fluids given.  Appointment made to follow up in neurology clinic.
xeljanz has been less effective; Reports More Pain In Her Legs And Hips Especially When sitting for more than 20 min; Reports More Pain In Her Legs And Hips Especially When sitting for more than 20 min; This is a spontaneous report from a contactable consumer (patient) and a nurse. A 55-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Jun2017 (Batch/Lot number was not reported; Expiration Date: 30Jan2023) to Oct2020, at 11 mg, daily for an unspecified indication. Medical history included headache unspecified, pyrexia from Oct2020 to an unknown date. Patient was COVID negative. Patient reported since taking her covid vaccine, tofacitinib citrate had been less effective and reported more pain in her legs and hips especially when sitting for more than 20 minutes. Patient was adherent with medication, though she was now taking out the count(OTC) pain relievers for the increase in pain levels. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
On Saturday, 4/17/21, client was vaccinated with her first dose of Pfizer Covid-19 vaccine (LOT #: EW0171, exp: 8/31/2021) by RN however client was still 15 years old at time of vaccination. Client has no history of allergic reactions to medications or vaccinations and left vaccination site after a 15 minute observation. When client came back for her second dose, ancillary staff outside noticed client was not 16 years old yet and Lead RN explained to client's parents who accompanied her that per CDC guidelines, we can not vaccinate individuals under 16 years old at this time. Parents visibly upset and threats were made to Lead RN. Lead RN also explained to parents guidelines may soon change and the County may open tier up to 12 to 15 year olds. Lead RN  gave parents the County's website to check for the latest updates.
Pt. given flu vaccine at the pharmacy. Pt. states had discomfort as soon after given. He went home from working 3rd shift and went to bed. When he woke up 6 hours later he stated the Band-Aid covering the injection site was saturated with blood. As soon at the pt. took the Band-Aid off pt. stated "the area was red and hurting, starting to swell then" and progressively became worse.
This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involve 2 children, 7 adults and 1 elderly reported. This case (7 of 10) concerns a 56-year-old female patient, who was involved in motor vehicle crash leaving clinic after H1N1 vaccination and died of trauma. Vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Time to onset was 0 day. Reporter's comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of death occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).