chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Administered vaccine to patient which was refrigerated for more than 30 days. Vaccine was defrosted on 30-AUG-2021 and administered on 01-OCT-2021. It was administered as a third dose but unknown if the patient is immunocompromised or not.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Information has been received from a pharmacist regarding a 69 years old male patient. The patient's medical history included previous history of recurrent shingles at the time of vaccination. On 24-SEP-2012, the patient was vaccinated with 0.65 ml dose of live ZOSTAVAX subcutaneous, (Lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. About the first week of January 2013, the patient stated to developed shingles lesions. The patient had not been to see his health care provider about the case of shingles and was currently not on treatment for them. Laboratory test was not performed. At the time fo the report, the patient's outcome was unknown. Additional information has been requested.
inject site became very red & is spreading down leg becoming blotchy; t102.7 yesterday; pt 2 days later barely able to walk because of pain;
Right after administering the vaccination, patient became very lightheaded and dizzy.  She said she could not see and everything went black. We called paramedics and they monitored her HR and BP.
Vaccine given then immediately reported to mom he didn't feel well. HE began to turn red and became flushed. Developed facial hives, nausea and moderate SOB. HR increased to 140, Biox 96%, pt remained alert and responsive. Lungs clear. Pulses normal but tachy. Given 1/2 L O2, albuterol treatment, BENADRYL 10 ml, Prelone. After 10-15 min symptoms improved significantly. Skin still itchy but less flushed. HR decreased to 110, Biox 99%.
Pain in the left deltoid spreading down to hand. Was prescribed Percocet and gabapentin around 7pm
My arm was sore next day, red and swollen around injection site, but disappeared next day.   Then 7 days later in the evening, the injection site began to itch.   The area around the injection site is raised and slightly red again,  It is not painful like the first time, but now itchy.   It had totally disappeared and is back again.   Is this normal and nothing to worry about?
This spontaneous report as received from a 76 year old female patient with acid reflux refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX parenteral (dose, lot # not reported). Concomitant therapies included SYNTHROID and NEXIUM. On 12-OCT-2014 the patient experienced shingles after receiving ZOSTAVAX. The patient visited physician on 14-OCT-2014 and acyclovir 800mg was given as a treatment. There was no lab diagnostic studies performed. The patient did not recovered from shingles. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication included: SILODOSIN, start date: 11Oct2015, stop date: 02Mar2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 29-JUN-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch: unknown) dose was not reported, 1 total administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The patient experienced confirmed immunological vaccine failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184327.; Sender's Comments: V0:20210663851-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Day 8- arm tender and painful/flu like symptoms of feverish and body aches.  Bad backache and neck pain.  Day 9- arm with redness; hot; painful; swollen. dull headache and neck ache
taste changes /regular coffee tastes horrible to her now; stomach hurt; sick to her stomach; very weak / felt like Jell-O all over; sore arm; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
redness/swelling @ site of DTAP beginning evening of 24SEP inc until mom took to ER p/church on 27APR;hot to touch, red, measured in ER 5 x 6-told infect;given med;
Couldn't breath; SHARP CHEST PAIN (like cid reflex); ITCHING; STOMACH PAIN; Rapid stool pain; Couldn't eat too much; FATIGUE; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN) and FATIGUE (FATIGUE) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal) (medical history of acid reflux, start/stop date, ongoing not provided).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN), FATIGUE (FATIGUE), ABNORMAL FAECES (Rapid stool pain) and DECREASED APPETITE (Couldn't eat too much). On 31-Jan-2021, DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN), FATIGUE (FATIGUE), ABNORMAL FAECES (Rapid stool pain) and DECREASED APPETITE (Couldn't eat too much) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Pyrexia - headache, temperature flux - persisted approximately 36 hours - Ibuprofen, fatigue and insomnia - persisted approximately 20 hours. Neck and back pain - persisted 48 + hours, myalgia - persisted approximately 40 hours. Abdominal and pelvic cramping, diarrhea, nausea w/o emesis - persisted approximately 12 hrs - treated with pepto Bismol, vertigo - persisted approximately 6 hours.
This spontaneous report as received from a 26 years old female patient refers to herself. Patient stated her misuse of getting 2 of the 3 GARDASIL. The patient stated she received first dose of GARDASIL (subcutaneous, Lot#, dose unspecified) in June 2011 and second dose (Lot#, dose, route unspecified) in October 2011, but had not ever received the 3rd dose. The patient did not sought medical attention and no treatment was given for the event. The outcome was unknown. Additional information has been requested.
Patient has red rash which is stingy and quite itchy and had it for a week.
She developed left arm pain the day she received the vaccine. The day after she received her vaccine she developed redness and swelling over her left shoulder and down over her left breast with left breast pain. Symptoms resolved on their own after about a week.
Approximately 15 minutes following vaccination, the patient complained of headache, dizziness, chest pain and throat burning. I asked that she wait an additional 15 minutes so that we could monitor her.  Approximately 30 minutes after vaccination, patient appeared to experience syncope or absence seizure (prev. history). we called 911 and paramedics transported her to  hospital
Sore arm; Arm is swollen; Itching; Arm is red; Arm is very hard; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red) and VACCINATION SITE INDURATION (Arm is very hard) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red) and VACCINATION SITE INDURATION (Arm is very hard). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red), VACCINATION SITE INDURATION (Arm is very hard) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose of the Moderna COVID-19 vaccine and experienced a sore arm and itching right after the vaccine and the next day. On 05-Mar-2021, the patient experienced chills all day long and noticed in the evening that their arm was swollen, was very hard and red.  Treatment medication also included Allergy Relief.
On 18 Oct 2008, service member rec'd Flu mist via nostril at about 1330. Service member subsequently experienced nose bleeding from bilateral nostrils @ about 1730 - "It was a large amount" per service member. At about 2130, service member experienced another nose bleed and was apparently "more" per service member. After both episodes, bleeding was controlled via conservative means (i.e. 2 pressure, cool packs).
Patient was rechecked by nurse after 15 minutes after administering the HPV vaccine about 5:48pm per notes. Nursing reported to me that she complained of dizziness and that she had given her water and graham crackers and had her lying down on the exam table.  When I went in to evaluate her she was lying on exam table supine and said she felt "lightheaded".  She denied any vision changes, denies nausea or vomiting or shortness of breath or any myalgias.  On examination she was verbally communicating to me and non-distressed. Examination was normal and nursing was asked to obtain vital signs which were also stable.  She was asked to rest in the exam room.  Nursing was asked to recheck her in another 15 minutes.  At that time about 6:32pm she denied any nausea, dizziness, or lightheadedness.
(L) chin swelling. Increase fever of 45° C and with projectile vomiting 15-20 mins. after vaccine given symptoms started.  Pt went to ER 11 pm 1/8/09 until 5AM 1/9/09
About 2-3 minutes after the vaccine, I started to feel lightheaded, nauseous, dizzy, etc. I saw yellow spots. I felt like I would pass out. A nurse gave me water about 2 minutes into the reaction, and I poured it all over my head and back. Right after that I started to feel much better. I was much relieved, since I'd had a worse reaction the day before.  I sat hunched over until the feelings subsided, and I just felt weak and shaky. The nurses checked my blood pressure and monitored me for about 10-15 minuted, then had my mother drive me home. I still felt tired and weak, so I rested when I went home.
sore arm; very tired; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on 14Apr2021 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 24Mar2021 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The information about patient's known allergies to medications, food or other products was not applicable. On 14Apr2021, the patient experienced sore arm and 5 hours after dose patient was very tired, which continued into next day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event sore arm and very tired, which continued into next day was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
On 3/31/10 my son developed a pimple like rash that covered his entire right buttock and that rash continued in a line down the back of this right thigh and along the outside of his right foot.  He also had a very mild fever.  He was extremely fussy.   On 4/5/10 his doctor diagnosed cutaneous herpes and prescribed Acyclovir 200/5ML oral suspension 3/4tsp three times daily for 10 days. As of 4/12/09 the rash is improving but has not gone away completely. His fever is gone and his demeanor has returned to normal.
This spontaneous report as received from a Registered Nurse refer to a currently (at the time of reporting) 56 years old non pregnant female patient. The patient's concurrent conditions, medical history and concomitant therapy was not reported. On an unknown date, the patient was vaccinated with ATTENUVAX (dose, route of administration, lot# and expiry date were not reported). The patient required evidence of immunity for Measles, Mumps and Rubella for school. The reporter believed that the patient received the vaccine as a child but immunization records were not able to be located. Titers were drawn at an unspecified time (reported as recently) and the patient showed negative for immunity to measles only. On 02-AUG-2016, the patient was vaccinated with M-M-R II. The outcome of the event was unknown, however the patient was doing fine. The relatedness between the event and ATTENUVAX was not reported. Additional information has been requested.
p/vax pt had T105 & rash present over entire body;vomiting, colicky, no diarrhea;saw MD in ER;
atient presents with Shortness Of Breath wears O2 3L NC at home.  cough, fever/chills x 2 days .  Patient was diagnosed with Covid 19 on January 9.  Covid Positive test on 3/2/2022. continuous 2 L of oxygen since then, presented to the ER on 03/02.   Bilateral air entry, diminished with wheezing.  Acute on chronic respiratory failure due to status asthmaticus- contributed from Covid.  Started on dexamethasone.  She will be discharged  to home
p/ being vax in 10/7/96 pt lab tests in 97 revealed negative varicella titer.
first dose September 2020, second dose June 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   In June 2022, the patient received the 2nd dose of Shingrix. In June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The patient stated he was not able to get his second dose until June 2022. The reporter did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Information has been received from a physician concerning a 24 year old old female who on 06-MAR-2008 was vaccinated with a first dose of GARDASIL vaccine (lot # not reported). On 06-MAR-2008, the patient was vaccinated intramuscularly with a second dose of GARDASIL vaccine (lot # not reported). The physician reported that "the patient received two doses of GARDASIL vaccine and experienced swelling of her jaw the night of vaccine both times. The 1st dose was given when she was 24 year sold and the 2nd dose was given when she was 25 years old. The swelling resolved in a few days without treatment for both instances." The patient sought unspecified medical attention during an office visit. No other details were reported by the physician. Additional information has been requested. Follow-up information was received from a physician, concerning the now 25 year old white female patient with no previous medical history and pre-existing allergies reported. The physician reported that on 06-MAY-2008, the patient was vaccinated with the second dose of GARDASIL. The next morning the patient had noted swelling and tenderness of right jaw. The patient were to the reporter's office later on 07-MAY-2008, and still had mild fullness at right jaw area, but no mass or oro-pharyogeal swelling. Left deltoid injection site was not swollen. Swelling jaw improved during the course of the day. The patient indicated similar swelling of jaw "a few days after" her first dose of GARDASIL. In both cases, swelling resolved spontaneously. Additional information has been requested.
01/08/2021 I felt fatigued and had a headache 01/09/2021 I felt fatigued, had a headache and my arm where I had received the vaccination had a raised, red area that was warm to the touch. It was that way for a few days then went away completely.   I felt great Monday-Thursday this past week.  01/15/2021 In the evening I developed a slight headache and sore throat 01/16/2021 I woke up feeling sick. I am fatigued, having some muscle aches,  a sore throat, headache, nasal congestion and slight cough. At about 6 p.m. I noticed that my left arm suddenly had the same red, inflamed raised area again and is slightly itchy.  I called a telemedicine general physician as I work in Covid testing and wasn't sure if I was experiencing a primary infection or if this is a result of the vaccination. He advised that I reach out to report a possible adverse reaction.
pt to ED and had a positive COVID test 8/20/22; Atrial Fibrillation with RVR, UGIB; intubated; hospitalized and treated;  dc'd on 8/27/22 to SNF; 8/28/22 back to ED with  UTI, treated with ABX and dc'd to SNF; 9/27/22 pt found unresponsive, agonal breathing; brought to hospital; intubated; tachycardic and hypotensive; CT of abdomen showed distended gallbladder with layering stones, possible colitis, possible diverticulitis; MSICU; aggressive sepsis protocol followed; multiorgan failure, coma, AKI; transitioned to comfort measures and pt passed away in the hospital
About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extreme thirst, temperature of 100.1. The next morning she had a temperature of 101.2 with improvement of the chills but ongoing headache and body aches.
swollen lymph nodes, fatigue, brain fog, myocarditis, depression, anxiety.
This spontaneous report as received from a nurse practitioner refers to approximately 2 year old female patient who was allergic to ZOFRAN. The patient had no pertinent medical history. On an unknown date in 1998, the patient was vaccinated with a dose of VARIVAX (merck) (lot number was reported as 1419E, expiry date, dose and route were not reported). Approximately on an unknown date in 1998, the patient developed hives post vaccination. Skin allergy test was performed on an unknown date (details were not specified). The patient sought medical attention and was treated with an unspecified treatment. On an unknown date, the event hives was resolved. This is one of reports from the same Same Reporter Link (MARRS# 1302USA005316). Additional information is not expected.