chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt returned to drive up area 30 mn post vaccination. She initially had no symptoms and left the triage area as she was driving, she noted her lips felt"funny" and had "bumps" developing so she drove back to the site.  Initial NP evaluation after she was transported to observation area.    VS: 127/97, 108, 99%  HEENT: small papules notes on intra oral buccal mucosa and lower lip.  Lungs CTA  CV: reg   Benadryl 25 mg po givben at 1858  Re evaluation: 1915:  VS: 135/93, 87, 99%  PT cont to c/o "feels like a need to clear my throat"  HEENT: No increase in papules oropharyngx wnl  Benadryl 25 mg po given at 1915.  Re evaluation: 1940  VS: 150/98, 118, 99%  PT now with increased c/o needing to clear throat. On examination. Now noted with edema on the left side of oropharyngx. Also noted with redness on hard palate.  Doctor present agreed to Epi pen injection  ALS ambulanced called.
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-559357, MOD-2022-560044 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up contains no new information.
Information has been received from an 80 year old male patient concerning himself. The patient did not have pertinent medical history, drug reactions or allergies. Concurrent conditions were not reported. In October 2012, the patient was vaccinated with an unspecified dose of ZOSTAVAX (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies included ZOCOR and terazosin. Other suspect medications were not reported. The patient stated that on 11-JUN-2016, "while on ZOSTAVAX, he got the shingles, and he still had nerve pain and tingling in his legs". The patient sought medical attention by visited the doctor, on an unspecified date and an unspecified treatment was given for the adverse event. Laboratory diagnostic studies were not performed. No product quality complaint was involved. At the time of reporting, the patient was not recovered from the herpes zoster. The relatedness between the herpes zoster and therapy with ZOSTAVAX was not reported. Additional information is not expected because the reporter did not consent for further follow up.
4-5 hrs p/receiving vax, devel difficulty breathing, h/a, abdo discomfort; treated w/Atarax & resolved; past hx of DEV 17 yrs prior; bitten by ferret which escaped; 23NOV92 f/u no addtl event info; pt recovered;
Immediate onset with pre-syncope. Persistent profound fatigue, diaphoresis, nausea, foggy, weak legs, muscle aches. Improving after 8 days.
Abnormal swelling at the injection site; Abnormal redness at the injection site; Injection site is hot; Injection site is painful; This case was reported by a other health professional via other manufacturer and described the occurrence of injection site swelling in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date unknown) for prophylaxis.   Concurrent medical conditions included hypertension, depression, bladder cancer, chronic pain, infection and sulfonamide allergy. Concomitant products included fluticasone propionate (Fluticasone), salbutamol sulphate (Ventolin Hfa), umeclidinium bromide, vilanterol trifenatate (Anoro), sertraline, amoxicillin + clavulanic acid (Augmentin), hydrocodone bitartrate + paracetamol (Norco) and citalopram.   On 29th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th May 2019, 1 days after receiving Shingrix and an unknown time after starting Fluticasone, Ventolin Hfa, Anoro and sertraline, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported bit it could be 68 or 69 years. It was reported that patient had abnormal swelling and redness at the injection site 4 days post  Injection, the site was hot red and swollen. The patient advised to take appointment with physician. The patient said small amount of swelling started at day one had gotten worst in past few days, it was painful red and swollen.
Felt dizzy, short of breath during class; went to school nurse's office and fell to floor nearly fainting, pale, fast pulse, lips swollen and red/blue, nauseated.
Fever of 101, aches throughout body, no appetite, chills, extreme tiredness, no energy the day after injection.  Lasted until morning of 3rd day.  Took Tylenol and drank plenty of water.
Tenderness, swelling and redness. Started on Cipro 500mg bid X 5 days.
Flushing/sweating, dizziness. BP 106/64, HR64, RR 16, given juice and monitored, patient left in stable condition
Constant diarreah,  bacteria and white blood cells were found in colon, prescribed Lotrimin. Is currently being treated for lymphocytic colitis.
Information has been received from a doctor of pharmacy concerning a patient (age and gender not given) who was vaccinated on an unknown date with a dose of MMR vaccine live (second generation) (lot # not given). Subsequently the patient developed autism. The reporter had no details about the patient or the experience. It was unknown if the patient sought medical attention. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Case number PHEH2015US000589 is a combined initial and follow up spontaneous reports received from a pharmacist via another pharmaceutical company on 06 Jan 2015 and from the Quality Assurance department (QA reference number: 345284) on 07 Jan 2015. This report refers to a patient of an unspecified age and gender. Past medical history and concomitant medications of the patient were not reported. On an unspecified date, the patient was vaccinated with RABAVERT (batch number: not reported) and with IMOVAX (other manufacturer, batch number: not reported). On an unspecified date, several years prior to this report, the patient developed an anaphylactic reaction to either to RABAVERT or to IMOVAX. The outcome of the events was not reported. The seriousness of the event was not reported but the seriousness of anaphylactic reaction was upgraded based on the NVS-IME list. The causality of event was not reported.
This spontaneous report was received from a medical assistant, and refers to two unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, one patient was vaccinated with improperly stored Oka-Merck VARIVAX lot number: M047662 with expiration date: 02-DEC-2018, for prophylaxis (route of administration was not provided). On an unknown date, the other patient was vaccinated with improperly stored Oka-Merck PROQUAD lot number: N021727 with expiration date: 06-FEB-2019, for prophylaxis (route of administration was not provided). On unknown dates, the doses of Oka-Merck VARIVAX and Oka-Merck PROQUAD underwent unspecified temperature excursions (reported as "unspecified out of the range temperature") for an unspecified time out of the range time frame, which were detected by the data logger. There were multiple unspecified previous temperature excursions reported. No adverse symptoms were reported. Follow-up has been received on 13-FEB-2018 from a medical assistant. The medical assistant reported that on an unspecified date, the patient (name was provided) received a improperly stored dose of Oka-Merck VARIVAX reconstituted with properly stored sterile diluent (manufacturer unknown). The second patient received improperly stored dose of Oka-Merck PROQUAD (captured in MARRS # 1802USA007496). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 9 hours and 15 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1802USA007496.
Approximately 8 hours after injection: sore shoulder Approximately 10 hours after injection: body aches, joint pain, chills, HA, nasal congestion; extreme fatigue These symptoms continued from Thursday Dec 17 approx 10pm to this morning Dec 19 at 8am.  I also had a low grade temp on 12/18 of 99.4 at 5pm. Today, Dec 19 at 11:13 am my R deltoid, arm, armpit, and side is still sore; other symptoms have resolved. Still experiencing fatigue; however I had Covid in September and have had residual fatigue since then anyway.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (17 doses) (lot # M004894, expiry date 26-JUL-20187) (dose and route were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013772.
Because I had adverse reactions to my first 2 Moderna injections, I was advised to avoid another MRNA booster by two doctors. However they suggested a J&J might be a better choice. My reaction was milder initially, slight chills , muscle aches, stomach pain and on day 3 post vaccine, diarrhea. I also experienced problems with temperature regulation, hot and cold spells Then I developed nerve pain in my hip and upper leg that became excruciating. When I couldn't sleep, I needed to seek help on day 7 post-booster. I was unable to reach my PCP during this time and talked with another specialist I see regularly She ordered Gabapentin 300 mg bid and Diazepam 5 mg tid prn, which helped. During the nerve pain, I also experienced abdominal pain, constipation and difficulty urinating. I have greatly improved as of  12/17/2021, but still need to take gababpentin 100 mg BID for hip pain. I am back to my usual course of low dose naltrexone,Tylenol Arthritis Strength 2 tabs bid, and alprazaolam 1/2 tab .25mg tid. This has been extremely stressful, especially since the J&J is no longer being recommended as a booster. I have underlying fibromyalgia and an hypersensitivity to medications, often needing 1/2 doses of many medications. Not sure I can tolerate more vaccinations. I developed an autoimmune skin condition as an adverse reaction to Moderna 2nd shot. This is ongoing with new breakouts of annulare granulomas which my dermatologist treats with steroid injections.(See previous Vaers report)
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with VARIVAX (merck) (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with VARIVAX (merck) that was stored improperly on unknown date. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from a healthcare professional refers to a 5 years old patient. On 04-JUN-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (merck) (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional information has been requested.
I was having blurry vision with both my eyes. When they covered my eyes I have double vision in my left eye. The doctor said I have visceral detachment in my left eye.
The patient was given the adult version of Pfizer because the mother inputted the wrong DOB and we were mislead to giving the adult vaccine.
Developed high grade fever (105) at 5pm the evening of vaccination date. Overnight fever continued with increasing myalgia, arthralgia and fatigue. Attempted Tylenol to reduce fever without improvement. Felt things were "settling in his chest". Went to emergency department afternoon of 3/24 and was admitted overnight for observation. Discharged next day, feeling improved.
i felt slight body aches; pain in the injection area.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (i felt slight body aches) and VACCINATION SITE PAIN (pain in the injection area.) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced MYALGIA (i felt slight body aches) and VACCINATION SITE PAIN (pain in the injection area.). The patient was treated with PARACETAMOL ongoing since an unknown date at a dose of 1 dosage form. On 24-Jul-2021, MYALGIA (i felt slight body aches) and VACCINATION SITE PAIN (pain in the injection area.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional follow up received does not contain any new information (NNI)
Patient stated that she felt her throat was closing. Heart rate was assessed no interruptions in breathing. Examined throat no inflammation or redness noted. Patient had normal chest rise and fall through entire assessment. Was observed an additional fifteen minutes after initial thirty minute observation due to patient's allergy to cats and diagnosis of Celiac's disease.
Employee reports receiving MMR and Tdap on 2/23/07. That evening developed soreness erythema and axilla discomfort.
The morning after receiving Zostavax, the patient reported to the pharmacist that he experienced what he described as "chicken pox". Patient further explained that it was on his left side of the chest and shoulder and denied any fever, pain, rash or itchiness with it. The above described condition lasted for approximately 5-6 days and he was shedding dry scaly skin after a couple days. He reports taking no medications to help with it.
Patient had the HPV vaccine in a series of 3 shots - 6/22/15 - shot 1 - after that shot became extremely tired, started losing hair & was acting differently - not focusing. 1/12/16 shot #2 - continued to be tired and got real sick with bad headache, feverish and back neck pain - went into ER in Feb 2016 with what they thought was a bad virus - possibly viral meningitis. Bad headaches got better after a few weeks but still gets a lot of headaches and neck pain. 7/14/16 - shot #3 - On 7/18 she became extremely sick - Bad stomach pain, bad headache, extreme fatigue - stayed in bed, mind was "foggy". She has been the same ever since - we have been to several doctors to find out what is wrong and to get treated.
Tender site 3 wks, pain when moving arm, body aches & fatigue - week and a half.
Patient is a 17 year old female who was given the adult booster dose of the Moderna Covid-19 vaccine. FDA does not have Moderna approved for anyone under the age of 18.
This case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Influenza vaccine. Previously administered products included Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated her brother's wife (patient) had the flu right now (at the time of reporting). She reported that it was just not working this year. Permission to contact the reporter was provided. No other details were known. This case was considered as suspected vaccination failure because the time to onset and laboratory confirmation for influenza was unknown at the time of reporting. The case was linked with the case US2018GSK021382, reported by the same reporter.
After receiving the vaccine pt stood up and fainted, fell on the floor. Pt was bradycardic although systolic BP was 90 by nurse. Pt complained of nausea. Vasovagal episode.
no adverse event; a 4 1/2 month old baby received his first dose of ROTATEQ today; This spontaneous report was received from a nurse referring to a 4 1/2 months male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 18-JUN-2020 (reported as today), the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml (lot # was reported as 16620944, expiration date was reported as 16-APR-2021) (strength, exact dose and route of administration were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse effects were reported.
10:30am: Pt was sitting in the vaccine site observation area after receiving vaccine for COVID-19 (Janssen). Pt had been sitting for approximately 15 min when RN noticed pt dropped paperwork and cell phone onto the floor. Pt's head went back, mouth open and eyes closed. Pt visibly pale. RN quickly approached pt while speaking loudly, pt did not respond. Audible "snoring" heard. RN placed pt's torso and head in her arms and moved patient to the floor into a supine position with legs raised onto his chair (pt did not fall to the ground). Once on the floor, pt opened eyes and asked RN, "Did I fall asleep?" RN reassure pt that he may have fainted while sitting in his chair. RN reassured pt and gave pt bottle water to drink. Color returning to patients face.   10:40: Pt reports "I'm feeling much better." Pt sitting upright  on the floor.   10:45: Pt sitting up in chair. Alert to person, place, and time. Color WNL, peripheral pulses strong. Pt reports feeling well enough to leave. RN encourage pt to stay a few minutes longer to make sure able to stand/walk to his car.  10:50: Pt left observation area.
Patient with J+J vaccine 11/28/21 who tested detected for COVID prior to admission to inpatient behavioral health unit.  Patient largely asymptomatic for COVID during stay, no oxygen needs.
1.  First day of injection, no problems. 2.  Second day afternoon, slight headache.  Second day evening, slight headache and stomach ache.  3.  Third day morning, full-blown headache, stomach ache, no fever.  Bed-ridden. 4.  Major flu symptoms and body aches.  No fever.  All symptoms are lasting through today, 3/25/21, and continue. Medications taken for flu-like symptoms were Tylenol, Pepto Bismol,  drinking water and carbonated non-sugar fluids.  Haven't been able to eat much, and have lost 4-5 lbs.    During  this time, 3/17/21, I was attacked by neighbor's cat and was given antibiotics.  This medication was taken before and after the 2nd Covid -19 vaccination.
Headaches almost every day since 1st does of Phizer vaccine. Low level persistent headache most days but some days are more painful and feel like increased pressure in the forehead area. Also have noticed my eye twitching during the headaches the last couple of weeks. Almost feels like pressure. Blurred vision sometimes accompanies headaches.
This spontaneous report was received from a healthcare professional refers to an unknown number of patients of unknown age. Since 05-APR-2016, the patients were vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # L023936, 15-MAR-2017. Temperature excursion 34 Fahrenheit for 93 minutes. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 13-AUG-2013, one patient was vaccinated with an improperly stored dose of GARDASIL (lot #H015555 expiration date 13-APR-2015) (dose and route not specified) that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS1308USA008790) another patient was vaccinated with improperly stored PEDVAX (MARRS1308USA009657), another patient was vaccinated with improperly stored ROTATED (MARRS1308USA009659) and another one was vaccinated with improperly stored VAQTA (MARRS1308USA009656). This is one of several reports from the same reporter. Additional information has been requested.