chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had vacccine got them/suspected vaccination failure; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: had vacccine got them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was very true, he/she had the shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Injection site soreness, general itchiness, and headache on days 2 & 3.
Cough, Fever - Information has been received from a health care professional concerning a 7 year old female with a history of a rash after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Waes 00032638) who on 27 Mar 2000 was vaccinated with a second dose of varicella virus vaccine live (site unknown).  On 03 Apr 2000 the patient developed a possible reaction described as fever and cough.  Additional information has been  requested
Information has been received from a woman working in a physicians office concerning a patient who was vaccinated with a dose of varicella virus vaccine live. It was reported that three weeks later the patient developed shingles and then developed chickenpox. It was noted that ie was not a mild case but there were no complications. Additional information has been requested.
Lump in right groin area last week. Grandma states there were 3 lumps on 6/7/07.  She also thought the largest lump was decreasing in size on 6/10/07.  Patient also had "bug bite" near injection site that was noticed 12 days after immunization.
Client received HPV IM on 10/1/08 through clinic.  Client called PHN on 10/15/08 to report she had a (+) preg test on 10/14 and 10/15; she also had a TBST 10/13/08 but that was not administered at health dept.  Client's LMP 9/12 on 9/13/08.  Has 1st prenatal appt scheduled for 11/5/08.
Longer menstrual cycle. Typically 28-31 days and two cycles consecutively following the vaccine have been significantly longer. The first cycle was 40 days and this current cycle is at 39 days with still no bleeding.
Initial report received on 26 October 2009 from a consumer, who is  physician. A male patient (age not known) with a history of asthma developed a red, swollen, watery right eye on the same day of vaccination after he received FLUZONE (lot number U3173DA) on 06 October 2009. The patient self treated with topical steroids and cold compresses to the eye. The symptoms resolved within 48 hours. The patient declined to provide further information. List of Documents held by Sender: none.
Pt received DTP on 22-MAY-90 and experienced hypotensive, hyporesponsive episode from DTP.
Pt received the 2nd booster of COVID on 4/12/2022 around 5:30pm. Around 6:30pm, patient got a nosebleed (the flow was between gradually and profusely) and 5 minutes later, patient was coughing up blood clots. The whole process lasted about 15-20 minutes. Last night (4/19/2022), there was a couple of blood drops that came out from nose and there was a little blood this morning from throat.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022.  No adverse events were reported.  The vial did not undergo any temperature excursions.   No treatment medications were provided.
Fever 100 degree, chills, muscle pain, diarrhea, headache,, fatigue
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored (temperature 47.1 F for 10 minutes, because of data logger) doses of PNEUMOVAX 23, lot # L014420, expiry date, 23-FEB-2017, (dose, frequency and route of administration not reported). No previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. GARDASIL 9, and GARDASIL appeared on the product list as temperature stability questions were asked, however, no doses of improperly stored GARDASIL 9 or GARDASIL were administered to patients. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
no adverse effect reported; The patient was inadvertently administered a dose of VARIVAX; This spontaneous report was received from a nurse referring to an unknown age and unspecified gender patient. The patient's concurrent condition, medical history, allergies or drug reactions were not reported. Patient's concomitant therapies had included vaccine's sterile diluent.  Accordingly with the reporter, the Data Logger registered on 18-OCT-2019, the temperature was on -11.3 Celsius for 28 hours and 25 minutes; on 20-OCT-2019, it was on -10.8 Celsius for 14 hours and 5 minutes; on 30-OCT-2019, it was -13. 3 Celsius for 35 minutes; on 02-NOV-2019, it was -5.6 Celsius for 1 hour and 10 minutes; and on 04-NOV-2019, it was on -13.4 Celsius for 2 hours and 20 minutes.  On 11-NOV-2019,  the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration, frequency, and anatomical location were not provided) (lot number N035940 has been verified to be a valid lot number, upon internal validation expiration date was established as 18-DEC-2019) (product storage error). No adverse effect was reported.
Patient passed out, syncope episode while waiting in lobby after vaccine administration.   Technician alerted pharmacist.   Pharmacist immediately got red immunization emergency bag and approached patient.  I introduced myself  and prepared to activate the emergency response system (as recommended during CPR) but he had good pulse and respiration and immediately he spontaneously recovered!   We asked him to stay to be observed and offered him some water and food.  He accepted the water.   We did a wellness check phone call with him later in the afternoon to confirm that he was doing well, and he was.
After receiving the Hepatitis A vaccine he left our clinic and was in the bathroom of the hospital.  He reported he felt dizzy then awoke on the floor feeling sleepy and a stinging in the back of his head.  His mother went into the bathroom noted he was very light headed and pale, leaning up against the wall.  She reports he had wet himself.  Estimated time of LOC was 1-2 min.  He was then brought back to my clinic.  He was still very light headed and pale with tenderness over his right side of his neck.  He was sent to the EMD where a CT and cervical spine films were done which were negative.
Vasovagal syncope 3-5 minutes after administration.  Started to resolve after 20 minutes with administration of oral water, ice pack to neck and head, laying on ground with feet elevated.  EMS evaluated patient after 20-25 minutes and found systolic BP to be 98, blood glucose 112.  They offered to take patient to emergency department, but said patient will most like be ok after resting more and continuing to hydrate.  Patient declined going to ED.
The Moderna vaccination was issued on February 4th 2021 at 9:38 am and at the initial injection there was pain at needle insertion.  The adverse reaction started on Saturday February 6th at 10:00 pm and I woke up with severe left shoulder pain and could not sleep or get comfortable.  Sunday the 7th in the am I had limited movement of my left arm with a dull ache at rest and severe sharp pain when lifting my arm up or sideways.  There was severe pain in the rotator cuff.  The pain has continued through Monday, Tuesday and now Wednesday.  I have no prior history of any shoulder or arm issues.  I continue to have difficulty sleeping due to pain, limited arm movement and a contant dull ache.
High dose flu vaccine for seniors.  Immediate reaction:  fever, malaise, runny nose, coughing, bed ridden & refusing medical treatment
Swelling under arm into breast tissue, quivering sensation to lower lip that feels like some type of  nerve problem
Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 11:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient describes that on Monday afternoon (vaccine given the previous Friday afternoon) he felt very fatigued along with extreme tenderness on right hand side of head (described as very painful), right ear ache, dry cough, sore throat, whole body muscle aches. Now 4 weeks later (today) he says he still has tenderness on right side of head (it has improved "drastically") and still feels a little fatigued.
Dizziness, sweeting, and Nausea. Patient sat down and relaxed for 30 minutes then she started to feel better. she waited for another 45 minutes then she said she felt fine .
Right-sided weakness at school 4-2-08. Diagnosed with encephalopathy at hospital. Currently at another hospital. Reported to me by ED nurse. 6/30/08-records received for DOS 4/2-4/9/08-DC DX:Right sided weakness and slurred speech, resolved. Acute disseminated encephalomyelitis verus cerebrovascular event. On magnetic reasonce imaging parietal white matter abnormality. Presented with right sided weakness and dysarthria.
11 days p/vax pt devel typical varicella lesions; generalized malaise; fever;
Had a serious panic attack on 3/29/21 Had some cramping and spotting on 3/29/21 Manifested into a full-on period on 3/30/21 Much more intense than normal
After vaccine given, patient complained of discomfort to throat.  Patient felt like heart racing and slight chest heaviness..  O2 sat within normal limits.  Taken to ED.   HR 122, BP 141/66, O2 sat 98%.  Symptoms resolved on own.
fever overnight to 100 F., pain at the injection site and myaligias. 24 hours later, temp. 99.4 F. oral, and less muscle pain on Tylenol.
The patient is a 68 y.o. former smoker with a history of type 2 diabetes, obesity, HLD, HTN, and CAD that presents to the hospital on 2/8 complaining of sore throat, fever, and myalgias.  Patient reports symptoms have been ongoing for the last 4 to 5 days.  He endorses a nonproductive cough, decreased appetite, and congestion.  Work-up in the emergency department revealed COVID-19.  Chest x-ray shows no evidence of infiltrate, effusion, or congestion.  Labs show a creatinine of 1.72, lactate 1.8, white count of 14.51.  He has been admitted to the inpatient service for further evaluation and treatment.
Had 3 emergency room visits and one hospitalization; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient asked was it wise for the patient to get a COVID shot if the patient had 3 emergency room visits and one hospitalization after receiving the first shot of Shingrix.
Entire right side of my body (arm and leg) hurt after the shot. Leg stopped hurting the next day.  My arm is still hurting a month later.  I can not lift anything heavy or raise my arm without feeling pain and it constantly tingles all the way down to my fingers.  I have been taking medications prescribed by my physician to help with the pain.  I took Mobic for 10 days and now I am taking Methylprednesolone.  The vaccine was administered at my worksite location and was paid by my company.  No one else has had a similar reaction.  The company is aware of the problem as well and has filed an internal report.
mom reported that patient has had high fevers of up to 103 since the vaccine was given. Patient also developed a hard red swollen spot on the thigh that is the size of a baseball. It also has a ring around it that is not as red. The spot on the thigh is warm to touch.
CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Nov-2021, the patient experienced CHILLS (CHILLS). At the time of the report, CHILLS (CHILLS) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment drug was provided by reporter.  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.
I tested positive for COVID-19 on 4/2/23. I had a fever, runny nose, sneezing, and a cough. I contacted a doctor and was prescribed PAXLOVID. This lasted for about 10 days. I am feeling better now.
Baby was extremely fussy/agitated immediately following vaccination for several days. Also began to have breastfeeding issues (poor latch/suckling) which were not apparent prior to vaccination. Weight gain halted after vaccination.
temperature excursion; itching and redness to the thigh postvaccination/ itching and redness was located at the injection site; itching and redness to the thigh postvaccination/ itching and redness was located at the injection site; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, suspect vaccines were exposed to an unspecified temperature excursion.  On 26-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, once, lot # T030943, expiration date 09-MAR-2022, subcutaneously to thigh (unknown if left or right thigh) for immunization. On the same day, the patient was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and poliovirus vaccine inactivated (unspecified) for the same indication.  On an unknown date in April 2021, the patient experienced itching and redness to the thigh postvaccination. The itching and redness was located at the injection site. The patient's mom sought medical attention as she sent the physician a picture and video of the reaction. Physician told the parent to administer children's diphenhydramine (BENADRYL) and cetirizine (ZYRTEC) due to the reaction being localized. The outcome of the events was not reported.  The causal relationship between the events and the suspect vaccines was not reported.
Arm sore & swollen around injection site with red patches of skin in some areas that are warm to the touch.  This occurred several days after injection, and hadn't had any soreness in a few days.
mostly tired; sweats; unable to walk properly; hot and cold waves; very sick feeling; sleepy; dizziness; headaches; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), GAIT DISTURBANCE (unable to walk properly), FEELING OF BODY TEMPERATURE CHANGE (hot and cold waves), MALAISE (very sick feeling) and SOMNOLENCE (sleepy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMINS [VITAMINS NOS], OMEPRAZOLE and GABAPENTIN for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HYPERHIDROSIS (sweats), GAIT DISTURBANCE (unable to walk properly), FEELING OF BODY TEMPERATURE CHANGE (hot and cold waves), MALAISE (very sick feeling), SOMNOLENCE (sleepy), DIZZINESS (dizziness) and HEADACHE (headaches). 07-Apr-2021, the patient experienced NAUSEA (nauseous). On 08-Apr-2021, the patient experienced FATIGUE (mostly tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, GAIT DISTURBANCE (unable to walk properly), FEELING OF BODY TEMPERATURE CHANGE (hot and cold waves), MALAISE (very sick feeling), SOMNOLENCE (sleepy) and NAUSEA (nauseous) had resolved. At the time of the report, HYPERHIDROSIS (sweats), HEADACHE (headaches) and FATIGUE (mostly tired) was resolving and DIZZINESS (dizziness) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patient's demographic  and event dates updated and new events added (Nausea, feeling hot & cold, somnolence, fatigue).
Initial report received on 27 April 2007 from a health care professional. A patient (unknown gender and age) received in on an unspecified date ("days ago") in April 2007 a dose of rabies vaccine (unknown manufacturer) for unknown indication and experienced sore throat, swelling of the hand and soft palate. Reporter denied itchiness. The patient admitted to the hospital and treated with prednisone. The patient's outcome was unknown. No other information was provided.
Intense nausea, fever, night sweats, entire body chills, joint aches, muscle pain, intense headache in sinus areas of head and face, extreme fatigue.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE RESPIRATORY FAILURE HYPOXIA
Redness at injection site (left arm), hives lasting 2 days from elbow to shoulder, warmth & itchiness on upper left arm; resolved after 2 days with use of topical over the counter hydrocortisone 1% cream.