chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at injection; muscle swelling; hot; itching; red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red).   At the time of the report, INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
less than 30 mins p/vax pt woke up screaming & very hot to touch; mom states gave pt APAP prior to clinic visit; pt had sz during phone call; taken to ER; MD request all vax x/MMR be given in office;
Rec'd vaccination PPV 23 9/10/13 at 3:05 pm, 4 hours later noticed mild pain and swelling around vaccination area progressed to his left axilla area erythema 80x60 mm then seen 9/12/13 to 160mm x 110mm. Given ice and TYLENOL for discomfort. No s/s discomfort, no wheezing, SOB, no lymphadenopathy, no chest tightness, no abdominal pain.
Got my 2nd shot, sick now; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a month after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she just got the 2nd shingles shot and was sick (now) at the time of reporting, but one still needed to get it. The follow-up would not be possible as no contact details were available.
Throwing up; Feeling nauseous; blood sugar increased; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up) and NAUSEA (Feeling nauseous) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 37B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Chronic kidney disease and Thyroid disorder. Concomitant products included SODIUM BICARBONATE for Chronic kidney disease, LEVOTHYROXINE for Thyroid disorder, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up) (seriousness criterion hospitalization) and NAUSEA (Feeling nauseous) (seriousness criterion hospitalization). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at a dose of UNK dosage form. Patient stated that after each vaccination she was hospitalized but did not remember the specific dates of admission. She stated that it was a week after vaccination but could not provide a specific date. Patient stated that each hospitalization lasted for 4 days and she was in the same hospital for both hospitalization. She was admitted to the the hospital due to stomach infection and sugar was too high BLOOD SUGAR INCREASED (blood sugar increased) (seriousness criterion hospitalization). Another time she was admitted to the hospital was due to sugar was too high, feeling nauseous, throwing up .At the time of the report, VOMITING (Throwing up), BLOOD SUGAR INCREASED (blood sugar increased)  and NAUSEA (Feeling nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) was admitted to the hospital twice due to sugar was too high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-221023 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Patient initials were updated; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Patient medical condition may provide an alternative justification for the events occurrence.
MISSED LAST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2075) was received from a consumer on 12-Aug-2019. It described a 35-year-old adult female consumer who "missed last dose of Vivotif" (PT: Product dose omission), while being on Vivotif for travel.  Case report: The consumer missed to take her last dose of Vivotif, which was due on 09-Aug-2019. She will be travelling to country on 21-Aug-2019. The consumer has not taken the last dose till the time of report.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed last dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed last dose of Vivotif" was considered as not applicable.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 15-FEB-2016 the patient was inadvertently vaccinated with a dose of expired PROQUAD (Merck) (lot # K010209, expiration date 17-JAN-2016; strength and route not reported). No adverse effects were reported. Additional information has been requested.
ONSET SYMPTOMS ABOUT 12HRS AFTER INJECTION. SYMPTOMS INCLUDED FEVER UP TO 101.7, CHILLS, FATIGUE, HEADACHE, BODY ACHES.
Redness, swelling, and discomfort at injection site, tiredness. No severe reaction.
This is non-serious spontaneous case, initially received on 08-Feb-2018, from other non-health professional, concerning an 11-year-old, male child patient. On 06-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 07-Feb-2018, after one day of vaccination, the patient had soreness in arm. At the time of this report, the outcome of the event not reported. This case was considered as lost to follow-up since, the patient's mother requested not to be contacted for follow up.
Extremely heavy period started two days after shot was received. Very heavy flow with heavy clotting. Period lasted approx. 4 days tapering down in flow. Regular cycle commenced as expected on 26th. Same occurrence happened after second shot. Two days later a very heavy flow started with heavy clotting. Normal hormonal headache was present as well during this extra period.
12 hrs. after 1st vaccine, woke up with body aches and headache, feeling like I had the flu.  This all passed after 3 hrs. 13 hrs. after 2nd vaccine, woke up at 4:00 a.m., with sever body aches all over, slight fever, headache, severe tiredness, and general feeling sick, like I had the flu.  Took Tylenol, went back to bed, and slept 24 hrs,, then woke up feeling somewhat like I had a hangover, but as the day progressed, felt back to normal. Small price to pay to get vaccinated!!!!
the injection site got "very red, hot and painful"; the injection site got "very red, hot and painful"; the injection site got "very red, hot and painful"; the area is still "very pink and painful to the touch"; the red area became itchy; the red area "moved South towards elbow"; This spontaneous report as received from a 78-year-old patient who reported on herself. The patient's pertinent medical history and concomitant drugs medication were reported as none. Her drug allergies included aspirin (reported as "could not take anything with aspirin". On an unknown date in 2007, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and no adverse events occurred. It was also reported that an unknown date in June 2020 (reported as over the summer 2020); she had a "strange reaction to a new brand of biotin"; she was experiencing hives for approximately 30 minutes every morning after taking the medication.  On 12-OCT-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, lot # and expiration date were not reported) in the right arm for prophylaxis. On the same date, she was vaccinated with an unspecified "senior flu shot" in the opposite arm. On 12-OCT-2020, the patient stated that the injection site got "very red, hot and painful." After approximately 2 to 3 days after the injection in October 2020, the red area "moved south towards the elbow". The red area became itchy and she was taking acetaminophen (TYLENOL) and an unspecified antihistamine to help with itchiness. It was reported that the itching subsided but the area was still "very pink and painful to the touch." The patient sought medical attention- she reached out to the pharmacist who informed her that "some people had a strong reaction" and she wanted to know if her reaction was a common one. None of the laboratory diagnostics or studies were performed. The outcome of the events was reported as recovering.  The relatedness between the aforementioned events and the suspect vaccine was not provided.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2010USA007848:
I received the vaccine on 7/16/2021.  Early the next morning, I experienced severe heart palpitations and  could not catch my breath.   Approximately 2 weeks later, I experienced severe muscular cramps and experienced a shoulder injury at work (left arm) at which time I could not move my arm for several days.  I subsequently experienced lower than normal platelet counts (125) and have encountered severe bruising.  For example, I have developed bruising where my sock line is.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has PMH significant for t2dm, hyperlipidemia, htn, lipoma, cad, vitamin d deficiency. Patient received 2nd dose of moderna on 4/20/2021 and presented to a local emergency room on 4/28. Per note on 4/28, pt had a chief complaint of cardiac arrest/ ventricular fibrillation with cpr in progress. There is no other note regarding death or cause of death noted. Pt was 61 Years of age.
HEMIPLEGIA & HEMIPARESIS, LEFT NONDOMINANT SIDE, LATE EFFECT OF STROKE
14-year-old client was vaccinated with Pfizer COVID19 vaccine , contrary to manufacturer indications for use.
12/14/10 Client took 1st dose of oral Typhoid - waited 1 hr. to eat - said his stomach "felt upset - like the flu" & he became "depressed". He felt the vaccine "messed with my mind". The depression only occurred the day of the 1st dose. He didn't take any other dose but continued to have "upset stomach" for a wk. Client (after 1 wk) took Ranitidine x 3 days & symptoms ceased.
About 3 days after receiving the shot I began feeling tired and under the weather so to speak. I began feeling really tired, and unmotivated and assumed I was coming down with some sort of illness and tried to rest as much as possible. After the weekend following my shot I asked the nurse who gave me the shot, and he said that was pretty normal and that it should go away in a few days. About 7 days after the shot, I started to have slight pain in my right shoulder, trapezius, and neck area. Sort of felt like I had slept on it wrong, but each day it kept getting worse. On October 14th, I finally decided that what was going on wasn't getting better with time and by this point I was in severe pain. Previously it was more with movement that would cause the pain, and now it was constant. It also left a spot on my upper left forehead near my temple sensitive to pressure. After visiting with my doctor, it was determined that I had some sort of reaction to the flu shot that I was given that was causing my lymph nodes to be swollen and sore. Which in-turn caused muscle aches alone my trapezius area, and my right neck. It is also believed that the tension in my neck is causing the spot on my left temple to possibly be tense as well from the neck muscle issues. I've been prescribed an antibiotic and muscle relaxant. As of two days after treatment, things don't seem to be that much better, however, I'm hopeful things will turn around.
Patient states headache started the day after she received the vaccine and is still present today (1-13-15).
No adverse event; PROQUAD, improperly stored vaccine administered.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 29-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml orally, lot # S027467, expiration date 02-MAR-2021, for prophylaxis.  Temperature 6°F to 14°F (9.3F) for 15 minutes; 6°F to 14°F (9.lF) for 15 minutes Time frame see above Previous temperature excursion? NO Was call because of a "data logger"?
12 month was administrated with Kinrix; Kinrix was the patient's 4th dose of DTaP; was to have hep a and mmrv, received Kinrix by mistake; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received DTPa-IPV (Kinrix) (batch number h99j7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: The patient was administrated with Kinrix as 4th dose of DTaP and 4th dose of IPV. The patient was to have received a Hepatitis A and MMRV but received Kinrix by mistake. No adverse event was reported. The reporter did not consent to follow-up. Additional Supportive Information:  The patient received Kinrix as 4th dose of DTaP and 4th dose of IPV at 12 months of age and the patient was to have received a Hepatitis A and MMR vaccine, which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered, and wrong vaccine administered.
pain to left legs; tingly feeling to your feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient (reported as 38) received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain to left legs"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingly feeling to your feet". The events "pain to left legs" and "tingly feeling to your feet" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia.  Additional information: Reporter complaining of pain to left legs and tingly feeling to feet for 21 days. He went to an urgent care and they examined him and told him that he have no swelling in leg. And asked have these side effects been reported. Reporter asked was that okay for him to take Ibuprofen that was prescribed for him from the urgent care clinic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/24/23- headaches started, fainted, nausea, vomiting headaches daily since 10/24/23
redness around the injection site; injection site itches; injection site hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE PRURITUS (injection site itches) and VACCINATION SITE INDURATION (injection site hard) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE PRURITUS (injection site itches) and VACCINATION SITE INDURATION (injection site hard). At the time of the report, VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE PRURITUS (injection site itches) and VACCINATION SITE INDURATION (injection site hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medication and thyroid medication.  At the begging the patient had redness on her arm about the size of a 50 cent piece, it almost went away but then it came back bigger and it was red, about 4 by 4 inches in size. It also was itchy and was hard.
SORE ARM; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a social media.  This case involves patient (unknown demographics) who experienced sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  Past vaccination included flu shot every year for the past 20 years and never had any symptoms.  Medical history, medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information on the batch number for this case.
Upper left arm has been sore since receiving the shot on October 25, 2012. Pt described some swelling also from shoulder to elbow.
Patient fully vaccinated and boosted, had 5 days of rhinorrhea, cough, body aches, chills, vomiting (chronic, unchanged) and diarrhea.
Rash Right (injected) arm itchy, red, swollen 1.5 " diameter Narrative:  Per nursing report: "first Moderna vaccine on 2-3-21.  Yesterday and today [2/11 and 2/12] c/o right arm itchy, red and swollen about 1 1/2 inch in diameter at site of injection.   Other Relevant History:
About 4 months after my 4th dose of the COVID-19 vaccine I started to feel very fatigued. I had a cough, and I felt a little feverish. The cough was pretty mild, and it came and went. I went to an Urgent Care, and I was prescribed Paxlovid. The fatigue seemed to go away almost immediately after I took the prescription and the cough improved. I tested negative after taking the Paxlovid. I tested again because we had a vacation coming up on 08/05/2022. I took 2 tests that day and one was positive, and one was negative. The next day I tested negative. I felt unwell for only about 3 days.
Vomiting, dehydration, nausea,  fever, joint inflammation, muscle weakness, inability to ambulate, pain,  soreness and decreased appetite.
23 years old patient has a prescription to receive / vaccine / has not received it yet; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 23-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The 23 years old female patient has a prescription to receive Shingrix vaccine but she has not received it yet, which led to intercepted drug prescribing error. The reporter consented to follow up.
Shaking for about 6 hours; extreme cold and chills 2 hours; then hot and sweaty 12 hours; lost of appetite 36 hours; all joints ached 36 hours.
I am currently 22 weeks pregnant and experienced chills beginning approximately 14 hours after administration.  I then had persistent fever for the next 15 hours which was able to be controlled with 1000mg Acetaminophen (taken every 6 hours).  My fever even with the Acetaminophen remained in the 99.3-99.8 range, peaking at 100.4 approximately 15-16 hours after administration (2-3 hours after first symptoms of chills).  The fever resolved at around 32 hours following administration.