chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to four male patients vaccinated with improperly stored ROTATEQ (oral; lot# N005078 with expiration date 22-NOV-2018) on 28-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
just pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just pain in left arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concomitant products included OCUVITE + LUTEIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PAIN IN EXTREMITY (just pain in left arm). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. On 17-May-2021, PAIN IN EXTREMITY (just pain in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the treatment information was not provided.
Over the course of 2 days developed redness and swelling on left arm that itched and was blotchy. On 9/3/09 went to Clinic to see physician. She stated it was starting to spread dawn bicep. Plan-Prednisone X 11 days and loratadine. Follow up in 2 wks.
Information has been received from a nurse concerning her 11 year old daughter who in approximately May 2008, was vaccinated with the first dose of GARDASIL. In approximately May 2008, the patient also received DTap-IPV. MENACTRA and medroxyprogesterone acetate (DEPO-PROVERA). About 7 to 10 days post vaccination, the patient experienced dizziness and fatigue. The patient was taken to the ER were unspecified test and studies were performed. The patient recovered. The nurse thought her daughter may have had the flu and did not attribute the event to the vaccine. No  further information is available.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided. In January 2016, reported as "six months ago", the patient was vaccinated with a dose of ZOSTAVAX (Route, anatomical location, lot number and expiration date were unknown). No other suspect or concomitant medication were reported. The pharmacist reported that in 2016, the patient was seen by an unknown physician and the provider feels the patient "now has a case of Shingles" (herpes zoster).
Symptoms commenced the day following the oral administration of the Rotavirus vaccine. Symptoms included fussiness, green frothy stools, currant jelly stools, suspected mild intussusception
Information has been received from a physician's assistant concerning a 14 year old female with no known drug allergies who on 10-MAY-2007 was vaccinated with a dose of GARDASIL, 0.5ml, intramuscularly (Lot# 654510/0962F). Concomitant therapy included hormonal contraceptives (unspecified). Within 24 hours of being vaccinated on 10-MAY-2007, the patient felt feverish and developed a small red rash on her abdomen, back and between her fingers. The patient's mother treated her with over the counter BENADRYL. On 11-MAY-2007, the patient recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information is not expected.
A non-serious spontaneous report of accidental exposure and swelling of her hands has been received from an immunization coordinator concerning an adult female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient is a nurse who administered H1N1, Intranasal to patients starting 01-Oct-2009. The patient did not receive the vaccine. Within the past three weeks in October 2009, the patient has experienced swelling of her hands. The outcome of the event was not reported.
pt had yellow fever shot 1 hr later devel chest tightness, wheeze, flushing & dizzy; given Epi x 1, nebulizer treatmnet, Seldane, Pred;
Pt received the Menactra vaccine (left arm) then the Gardasil vaccine (right arm). Immediately following the Gardasil vaccine she said her arm hurt but was feeling fine. She then immediately fell off the exam table, hit the wall and was unresponsive for about 2-3 seconds.
Delayed reaction occurred 6 days after receiving the shot. Arm where the shot was injected was very swollen, hard, red, and hot. This took about 2 days for the swelling to start to decline and a full week for the entire rash and swelling to disappear. The symptoms experienced were similar to others experiencing ?Covid Arm?.
lot of pain went around muscle shoulder pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on Jan2021 at single dose for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported. The patient experienced a lot of pain went around muscle shoulder pain on Jan2021. Patient took a paracetamol (TYLENOL) and takes aspirin. Patient was asking if it will reduce efficacy of vaccine dose and indicated that she will take second dose. The outcome of the event was unknown.   Information about lot/batch has been requested.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot# not reported). It was reported that on an unknown date the patient fainted after receiving GARDASIL. The outcome of fainted was unknown. It was unknown if the patient sought medical attention. This is one of the reports from the same reporter. Additional information has been requested.
This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates, multiple unspecified patients were vaccinated with doses of VAQTA (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
Tinnitus - persistent ringing in both ears.  Still occurring one month later.  ENT could not find other causes for Tinnitus.
Rash spread on part of her torso/ rash spread around neck/ rash on her arm/slightly itchy; Hives all over body; slightly itchy; Rash on her arm, rash spread around neck, rash spread on part of her torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash spread on part of her torso/ rash spread around neck/ rash on her arm/slightly itchy), URTICARIA (Hives all over body), PRURITUS (slightly itchy) and RASH (Rash on her arm, rash spread around neck, rash spread on part of her torso) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Hives (other things). Concurrent medical conditions included Pulmonary hypertension since 01-Jan-2017. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) from 15-Mar-2001 to an unknown date for Hysterectomy, METOPROLOL, SIMVASTATIN, DOXYCYCLINE and IPRATROPIUM for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced RASH PRURITIC (Rash spread on part of her torso/ rash spread around neck/ rash on her arm/slightly itchy), URTICARIA (Hives all over body), PRURITUS (slightly itchy) and RASH (Rash on her arm, rash spread around neck, rash spread on part of her torso). On 06-Apr-2021, RASH PRURITIC (Rash spread on part of her torso/ rash spread around neck/ rash on her arm/slightly itchy) had resolved, PRURITUS (slightly itchy) and RASH (Rash on her arm, rash spread around neck, rash spread on part of her torso) outcome was unknown. At the time of the report, URTICARIA (Hives all over body) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-255727.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up appended
I started experiencing all of the symptoms for yeast infection on Saturday (day after I received my vaccine). It was pretty severe and it was the first time I ever experienced a yeast infection. I contacted my provider on Monday and received 2 doses of flucanozole (2nd was supposed to be taken if my condition didn't improve). I had to take the second dose since my condition was pretty bad even after 3 days. The symptoms subsided after 10 days. I don't know if this is related to the vaccine or not and thought of reporting it.
Information has been received from a registered nurse concerning an 8 week old male, with a weakness in his right arm since birth, who on 12-JUL-2007 was vaccinated with a first dose of Rotateq (Lot # 656384/0237U). Concomitant vaccinee administered on the same day included an intramuscular first dose in the left thigh of Pediarix (Lot # AC218110AB), an intramuscular first dose in the right thigh of ActHib (Lot# UF067AA) and an intramuscular first dose in the right thigh of Prevnar (Lot# B08679D). There was no other concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. That night, on 12-JUL-2007 the patient started with green, watery, non-bloody diarrhea (four stools in the afternoon followed by six episodes in the evening) in the setting of slightly decreased oral intake. The patient was admitted to the hospital on 13-JUL-2007 for diarrhea and fever for observation. The patient was diagnosed with acute gastroenteritis. The patient was given rocephin and oral rehydration therapy. There was minimal diarrhea during hospital admission. The patient had one fever to 38.2 which was treated with Tylenol. The patient had a follow-up visit on 19-JUL-2007 and the diarrhea was resolving. It was reported that the patient recovered on 19-JUL-2007. Additional information has been requested. All available medical records will be provided upon request.
Large orange size red spot at injection site with lump, heat and tenderness. Beginning 10/14, tachycardia and PVCs lasting through the night.  I will contact my doctor Monday during clinic hours unless conditions worsen.
Wheezing  Shortness of breath  Hives  Muscle spams  Severe neck pain  Mobility of neck
Client is 17 year old and vaccine given. Unknown adverse reaction. Underage for vaccine approved.
This 55  year old white male received the Covid shot on  3/12/21    and went to the ED on  3/29/21  with the following diagnoses listed below. U07.1 - COVID-19
This spontaneous report as received from a consumer refers to a 66 years old female patient with prevention of shingles. The patient was vaccinated with ZOSTAVAX on 05-NOV-2012. No other co-suspects were reported. Concomitant medications included carbidopa, glipizide, hydrochlorothiazide, SYNTHROID, ascorbic acid, vitamin D (unspecified) (vitamin D (unspecified)), vitamin E (vitamin E) and biotin. On 15-NOV-2012 the patient experienced chickenpox, 11 days after onset of therapy. Patient reported blisters appearing on forehead that burned that worsened when they were touched. The patient was also running a low grade fever. The patient's doctor stated she had the chickenpox but did not do any cultures of the area. Blood work showed a high WBC. A medication was prescribed but the pharmacy refused to fill the script saying it was not chickenpox. No treatment information was reported. The outcome of chickenpox is unknown. The relatedness for chickenpox is unknown for ZOSTAVAX. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Severe, Additional Details: pt contracted shingles shortly after. after md visit, per pt md states shingles was triggered by vaccine
Side effects emerged approximately 12 hours after vaccinated.   1) temp that fluctuates  from regular to 101F.  20 hrs after vaccination, T100.7F, then persisted up and down for about a week. 2) Musculoskeletal pain to Left side of body: Mainly left upper body. -- 17 hrs after, woke up with severe pain to Lt shoulder and clavicle (thought it was broken somewhere.) The injected site was sore but mild. The Musculoskeletal pain still continues, and the pain comes in various sites, various forms, and in various level.  It can be at Left shoulder, scapula, armpit, rib, lumber, hip, knee, and foot. Once in a while, Left ear pain. Mostly Lt shoulder, scapula, armpit, rib lately (today is 0224/2021.)  Level changes depends on how it hurts; severe-moderate/shooting and needle pain, moderate/radiating pain, moderate-mild/dull pain, mild/annoying persistent uncomfortable pain.  3) neck and jaw joint stiffness only on left side. Current.  4) Extreme fatigue and brain fog--Extreme fatigue started on the next day and persisted for 3 days, then it became randomly daily. No warning signs given, suddenly feels extremely tired. This fatigue often comes with intermittent confusion. When severe, unable to move while laying. Today is 3rd week from vaccinated and unresolved completely.
Patient vaccinated with 2 doses of Moderna (lot # not documented) on 1/18/21 and 2/15/21
inconsolable crying while awake for more than 2 days, began 24hr p/vax given;
Rash, headache, bad taste in mouth, chills  Starting 8/1/19  Urine orange in color starting 8/4/19
Pt given a PNEUMOVAX 23 on 8-2-10 - called two days alter and said the injection site was OK, but the backside of her arm was red and swollen. Treated for cellulitis.
Blood clots in her leg and lungs; She is black and blue; She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle; She also felt pain midway between her knee and ankle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots in her leg and lungs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Dyslipidaemia. Concurrent medical conditions included Blood pressure high, Depression, Acid reflux (oesophageal) and Allergy.  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle). On 18-May-2021, the patient experienced THROMBOSIS (Blood clots in her leg and lungs) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CONTUSION (She is black and blue). The patient was hospitalized from 21-May-2021 to 22-May-2021 due to THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) on 22-May-2021 at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in her leg and lungs), CONTUSION (She is black and blue), GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle) outcome was unknown.  The patient thought there were bug bites on her leg on 12-May-2021.   Treatment also included IV blood thinner while she was hospitalized.  The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
Head cracked open. ER visit required; Collapsed; This non-serious case was reported by a consumer via call center representative and described the occurrence of head injury in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced head injury (Verbatim: Head cracked open. ER visit required) and fall (Verbatim: Collapsed). The outcome of the head injury and fall were unknown.   It was unknown if the reporter considered the head injury and fall to be related to Shingrix.     It was unknown if the company considered the head injury and fall to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2023 The friend of patient reported the case. Few weeks after receiving the Shingrix the patient collapsed and cracked his head opened. The patient went to the emergency room for stitches. The reporter had limited information, nothing else was reported. The reporter did not consented to follow-up. This case is linked with US2023057552, for the same reporter.; Sender's Comments:  US-GSK-US2023057552:Same reporter
None. Package insert had expiration date at 12/31/2069, unknown to us, this was not correct. Moderna found with proper storage, vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration.  Viability check done by Moderna and was found to be viable and effective.
Sever arm pain with limited mobility. Headache, profuse sweating, and nausea.
5:24pm Pt called staff over and sad he felt faint and then fainted. Parent in car, layed pt back in car, talking to him to help orient him. Vitals obtained, temp, 96.2 temporal, 62HR, 100 %spo2, 116/60 Bp. 116/60.  5:32 Pt awake enough, stable to be observed for another 10 minutes. Pt stated he is fasting ad thats probably why i fainted/ 5:47 pt awake and stable enough to leave. Mother is ok with Pts condition.
Pt. reported this today for 1st time - came in for Hep B #3 today and stated after both doses #1 and #2 of Hep B, developed itching and hives within 3-4 hours - on both arms only. Did not seek treatment or do anything and both times the itching and hives resolved within a few more hours. Before getting final dose, pt advised to have titer done or see allergist.
Dizziness, lightheadedness occurred 30 min following a 1st dose ofn Engerix b. Treatment & outcome unknown
t105.6;fussy but consolable;had full sepsis eval & hosp x 2 days-no infection identified;
got sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got sick).  The outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 9-Oct-2023 The reporter was elderly.  She stated that she could not remember the details.   She had two female friends, she could not even remember who, who each got a shingles shot (she did not know if it was Shingrix or Zostavax) and both of them got sick. She did not provide any further details. She provided limited information. Did not consent to follow-up. The case was linked with case US2023138513 and US2023AMR143832, reported by the same reporter for different patients.; Sender's Comments:  US-GSK-US2023138513:same reporter US-GSK-US2023AMR143832:same reporter
Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced FEELING ABNORMAL (Brain fog). At the time of the report, FEELING ABNORMAL (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient received a vaccine 6 months ago and had some brain fog. Unable to confirm which vaccine was received.  No treatment information was reported.   Reporter did not allow further contact
8JUL92 devel restlessness, fever w/in an hr of inject; fever cont to inc all day; pt taken to ER 430PM t106 MD told mom pt fighting off an infection prescribed Amoxicillin; pt also exp poor appetite;