chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient started with abnormal jerking movements during sleep that night, about 6 hours after getting the vaccine. The movements were interrupting his sleep. The twitching became severe over the next few days, but was only during sleep. He was also aggressive and hyperactive on the days following the vaccine.
No additional AEs/ There was no adverse event; if STERILE DILUENT used to reconstitute MMR II can be interchanged with VARlVAX; if STERILE DILUENT used to reconstitute MMR II can be interchanged with VARlVAX; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 16-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection, dose reported as 1 time dose, lot # T025946 (Lot No. T025946 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck)), expiration date: 30-JUL-2022 (dose number, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of vaccine was reconstituted using sterile diluent (STERILE DILUENT) (lot number and expiration date were not reported) that came with the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (preparation issue and product quality issue). The shortage of appropriate diluent was noted when product was received on unspecified date in February 2021 (reported as last week). No pictures were available and product would not be retrieved.  The nurse practitioner reported that the regulatory authority advised that it was acceptable to mix the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) diluent with the varicella virus vaccine live (oka/merck)(VARIVAX). There was no adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA007096:
diarrhea; dizziness; shortness of breath; 101 degree fever; headache; nausea; vomiting; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011a21a and 012m20a) 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 VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches/body aches). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches/body aches) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.     This case was linked to MOD21-088796 (E2B Linked Report).; Sender's Comments:  MOD21-088796:Husband's case
Pain severe soreness, with some numbness and tingling to her arm she also developed some welts in the arm. Pain/soresness was under the arm with radiation to her chest.
Tachycardia, Tachypnea, achy joints, feeling febrile but no fever, near syncope, anxiety, redness and hard at injection site 2 days late
Swollen, hot & red upper left arm, 3 inches by 2 inches & raised x36 hours. Ibuprofen given.
Approximately 2 days after receiving the vaccination the patient reports feeling like "the flu came to her". Episodes of nausea. Muscle soreness in the arm and also in other areas of the body. She reports still feeling nauseous. Pt has taken advil to help with some of the muscle pain.
Patient received pneumonia vaccine 8/13/12. Returned to office on 8/14/12 reporting painful L arm, decreased movement. Reported chills through the night & felt ill. Pt evaluated if officer no cellulitis or significant edema, but tender to touch.
Parent reports hard lump on left leg of child at the vaccination site. Not visible until by site but can be felt if the site is palpated.  Parents reports that child is moving the left leg less and is in pain when using the leg. Reports no redness site or respiratory distress or fever.
Almost 24 hours after receiving my shot on 7/20/2021 I felt extreme fatigue, malaise, moderate to severe headache and eye pain,  chills all over body with sensitivity to skin all over body, diarrhea, loss of appetite, loss of smell. All of these symptoms have continued 48 hours later with no relief.
Brief lapse of memory and asking off-the-wall sounding question to wife completely unrelated to conversation. No recurrence, but felt this was very out of character for him.
Patient got an outbreak at shingles shortly after the vaccine at about 30-40 eruptions going form spine to (L) breast.
Redness, tenderness and swelling around injection site right deltoid. Chills, nausea, low grade fever, near syncope.
Information has been received from a physician concerning a 9 year old male who on 06-SEP-1995 was vaccinated with VARIVAX (Merck) (lot # not recorded). In approximately September 2004, "at age 9" the patient was diagnosed with shingles and placed in an oral medication (acyclovir). On 12-OCT-2004 the patient was seen by a dermatologist and was diagnosed with eczema vs recurrent herpes simplex virus and was treated with aquaphor. Additional information is not expected.
Pt. returned to pharmacy  approximately 1 week after receiving her first Shingrix vaccination to report a red, raised rash.  She raised her shirt sleeve to reveal the 'rash' and I looked at it very closely.  It was fairly large, approximately the size of an orange and had a very red and inflamed appearance.  It was noticeably raised and occupied a very circular area.  The affected area wasn't smooth, it had a slightly indented appearance, much like that of an orange peel.  It was slightly feverish to the touch.  I spoke with her a couple of weeks after the visit in which she showed me the rash and it had completely disappeared.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2006, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient has been prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
He got the COVID vaccine on 12/23/20 at 11. Stayed at the facility for 30 minutes and then drove to another facility. Upon arrival at 12, he started feeling flushed. No SOB, no breathing difficulties.   He started feeling itchy about 2 hours post vaccine. He took an Aleve. At home in the evening, took Benadryl with improvement of symptoms  The following day also took Benadryl.   On 12/25/20 & 12/26/20 he still had some itching, but not bothersome enough to take medications.   On 12/27/20 he was working cutting tile and wearing protective eye wear, but the dust that landed on his face caused hives. He has been taking Benadryl since.     He says this has occurred in past when his body is hypersensitive, the hives. He has seasonal allergies but no allergies to food or medications.      Case discussed with Bolaris and recommendation is to take a Claritin or anti-allergy prior to next vaccine.
Systemic: Weakness-Severe, Additional Details: patient was unresponsive and staring blankly later that evening after receiving the first dose of vaccine, she was not able to verbalize symptoms, however, she experienced weakness in legs requiring assistance to walk per her caregiver
Unexplained bruising; petechiae on torso/chest/left arm; muscle spasms; nerve pain; This is a spontaneous report from a contactable consumer, the patient. A 36-years-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 25Apr2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, GERD and allergy to kiwi. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (ACETAMINOPHEN); both from an unknown date, for unknown indication and unknown if ongoing. On 30Apr2021 at 17:00, the patient experienced unexplained bruising, petechiae on torso/chest/left arm, muscle spasms and nerve pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events unexplained bruising, petechiae on torso/chest/left arm, muscle spasms and nerve pain was not recovered at the time of this report.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
On 12/26/2022 I tested positive for Covid.   Sore throat, coughing, headache, low grade fever, fatigued and severely congested, lack of appetite.  All the symptoms are gone except some minor congestion and coughing.    First negative test on 1/4, second on 1/6.  The low grade fever and headache were gone by 1/1/2023.  Still mildly congested from time to time during the day and I cough more when I am trying to lie down.  I am getting less fatigued each day.
POSSIBLE SEIZURES; BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 22-MAR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced possible seizures, body ache, fever and headache after receiving the vaccine. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible seizures, fever, and headache, and had not recovered from body ache. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210350457-COVID-19 VACCINE AD26.COV2.S-Possible seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
8/15/21: Patient arrived at the ER due to sudden collapse. EMS was called at 1349 and on arrival the patient was in asystole and apneic.  Patient underwent emergent right frontal ventriculostomy.  COVID-19 PCR came back positive on 8/15/21. Serum creatinine on admission was 1.39 which has gotten worse at 2.67.  Patient intubated/mechanically ventilated, sedated; on 3 vasopressors. Stage 5 [Hunt and Hess] SAH associated with diffuse brain edema/herniation. 8/17/21: patient expired.  Note: Spouse did not report symptoms of COVID-19 prior to cardiac  event. Unknown if COVID-19 was symptomatic or asymptomatic due to patients unresponsive at admission.  Please note: Spouse reports 2 doses of Pfizer vaccine in March 2021. Patient received first dose Pfizer vaccine on 3/31/2021 Lot # EN6198 and the second dose on 4/21/2021 Lot # ER8732
We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).; We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).), PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).), PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).), PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).).    Concomitant medication was not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2023: Follow-up received and had no new information.
pt recvd vax;d @5:30pm,fever 102.3;gave tempra;6:30pm crying,screaming till 12 mid noc x/ from 9-9:20pm;fell asleep,woke up screaming;disoriented;eyes looked "sunken in";PC to MD,said not to be concerned unless cry >4 hrs;advised tempra
gave me an injection at the time I had the shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The doctor gave an injection at the time patient had the shingles, which led to off label use. The follow up would not be possible as no contact details were available.
Client was placed in 15-minute observation, was asked by support staff how he did with first dose and said ?his tongue felt funny?, but did fine.  Support staff later heard him say ?I?m confused? and said he felt lightheaded, the lead observation nurse was called. He mentioned to lead nurse he had visual disturbance. He mentioned to her he had just come from football practice and his shirt was wet with sweat. He was about 6 feet and 250 lbs + and was able to lay himself on a mat. His BP was 116/64 and taken at 18:30; SPO2 at room air 98 and HR 85 at 18:35. Cool wet towel was placed on his head and was lucid describing what he was feeling, he had no difficulty breathing or anaphylactic reaction noted.  Client described a pain sensation on side where he received vaccine ?right side of body starting from his jugular to his feet? said pain level 8 from 0-10. EMR was called.  His mother had gone to the car to get his vaccination card. She was called back to Observation area.  He then mentioned he could now feel pain pressure in his stomach and then the rest of his body. When EMR team arrived, they noted his BP 180/70. His pain continued and was taken to. Follow up 8/10/21 with mother, says within an hour at the hospital he seemed to be back to his normal self and was discharged that evening. Says he is home and just has some fever, muscle aches and headaches, doing okay.
Headache, Arthralgia, Site discomfort, Faitgue Narrative:  States headache severe  Other Relevant History:
Moderna Covid-19 vaccine EUA - Pt received an invalid dose of moderna vaccine.  Pts second dose was administered 7 days early .  Pt was also given a dose of 0.25ml instead of 0.5ml.  Will consider dose invalid and revaccinate at proper scheduled interval with 0.5ml.
Pt recvd vax & exp lightheadedness, hypotension, became pale & legs began throbbing 15 to 20 mins p/vax; taken to ER: treated & released; sx are resolved;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored dose of M-M-R II (which had the lot # L020188, expiry date: 03-JUN-2017, route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccine was exposed to temperature of 34.2 Fahrenheit 24 hours and 34.5 Fahrenheit 12 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No product quality complaint (PQC) involved and no further information provided. Additional information has been requested.
Localized rxn 1cm increasing to 4cm. Patient experiencing wheezing. Pt given prednisone by physician which resolved wheezing, shortly after.
Three to four days after injections, client's left arm from the elbow to the shoulder became red and feverish, and had an itchy rash. First couple of days it was sore to the touch. Denies swelling. As of this day 1/31/05, client states her arm feels feverish, not as red and is a little better. Lanacane relieves the itching.
SEVERE HA;  DIZZINESS;  PREVIOUS BODY INJURIES PAIN AND INFLAMMATION AWAKENED;   JOINT STIFFNESS;  FEVER; CHILLS;  BLURRED VISION (DEHYDRATION?);  NO APPETITE;  FLAVORS AND TASTES CHANGED. FATIGUE;  CONFUSION.   ALL LASTING 48 HOURS.  FEVER BROKE OVER 24 HOURS.  BODY ACHES/PAIN WITHIN 48 HOURS.   DECREASED APPETITE,  TASTE CHANGE AND HEAD ACHE REMAINS AT DAY 5.  NONE OF THE SYMPTOMS RELIEVED WITH ANY TYPE OF PAIN RELIEVER.
Extreme numbness and tingling in left hand, beginning 15 minutes after vaccination. Numbness was severe enough to interfere with normal activities such as typing, texting, dialing phone.  Patient became nauseated and very dizzy (unable to walk unaided) within 1 hour of vaccination.   Numbness improved after 24 hours, and was back to normal after 72 hours.  Nausea and dizziness lasted for 24 hours. No previous reactions to vaccines of any kind.
Infant has received Kinrix, patient is 4 months. No current adverse effect/outcome/treatment.
severe soreness at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (severe soreness at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (severe soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (severe soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use and treatment information was not provided by the reporter.
Local reaction redness, swelling, itching. Sought medical care 3 days after administration of vaccine. Rx'd MOTRIN, BENADRYL, icing, elevation.
Patient presented from his adult foster care facility to the emergency department due to generalized weakness and high blood sugar. He was found to have a UTI. During screening for post acute placement, patient was found to be COVID-19 positive. He remained asymptomatic during stay and was given dexamethasone for treatment. He was discharged to post-acute rehab facility on 10/22/2021.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Pink spot at the injection site) and INJECTION SITE PAIN (Sore left arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.  Concurrent medical conditions included Cholesterol blood excessive. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol blood excessive. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore left arm). On 21-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (Pink spot at the injection site). On 14-Feb-2021, INJECTION SITE PAIN (Sore left arm) outcome was unknown. At the time of the report, INJECTION SITE DISCOLOURATION (Pink spot at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that after the injection, he experienced a sore left arm that resolved in two days. On 21-Feb-2021, the patient stated that his left arm became sore again. No treatment medications reported. Reporter did not allow further contact
Three days after receiving the shot, I awoke with tinnitus.  I went to an ENT and audiologist, and had some high frequency hearing loss.  The ENT prescribed prednisone, which did not help.  I still have tinnitus as of the time of this report, which is one week after it started.