chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an unspecified patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lots # M011116, M027879, M033611 with expiration dates 17-JUN-2017, 24-JAN-2018 and 02-MAR-2018 respectively, (dosages were not provided), for prophylaxis. The doses of VAQTA were exposed to a temperature > 46°F but  < 77°F and were out of range for 24 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA003012: US-009507513-1702USA003013.
Patient registered at the mass vaccination clinic while outside of the acceptable age requirement for vaccination.  We were alerted afterwards to this error.
Pt devel t102 fever aobut 5PM on day of immun which continued throughout next 48 hrs inspite of APAP, liquids, & frequent warm showers; Seen by MD 19DEC91 fever continued elevating to 104.8 & revisited MD; exam by MD 20DEC91 CXR & lab work;
Pt received vaccine 11/8, did not notice reaction until 11/9. Reaction resulted in swelling of upper arm. The entire upper arm was red, hot and painful. Pt reported feeling foggy for several days and very anxious. Took Benadryl as well as Benadryl cream topically to affected area. Reported event to hospital on 11/9, advised to continue Benadryl. Reported event to Pharmacy on 11/20. Stated only one sore area left on arm but feeling better. Stated took about a week and a half for the swelling to dissipate.
Patient reports acute onset fever to 104, drenching sweats and intense myalgias hours after vaccine.  9 wks later, intense muscle pain, fatigue and low grade fever, occasional sweats persist.
Patient called about 2 pm and stated that she had hives on her arms hours of getting the flu vaccine. I told her to take BENADRYL which she did. The following day I called and she said the hive a getting better and she is feeling better.
Fever, chills,  and bodyaches for 48 hrs. Then developed covid type symptoms like a runny nose.  Got tested for covid sat and it was negative. Went to dr mon and had double ear inf and throat infection.  He thinks my body is mimicking covid and causing my body to go haywire. I'm still fatigued.  Asthma flared up too
Headache, Myalgia, Fever, c/o chills,sore throat,injection site sore Narrative:
Pericarditis. Chest tightness, palpitations, weakness and fatigue. So far treated with colchicine but still unresolved
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SINUS PRESSURE; This spontaneous report received from a patient concerned a 40-year-old male. 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 administration was not reported, batch number: 1808982, and expiry: 21-SEP-2021) in left arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient received non-company booster vaccination with mrna 1273 (form of administration, route of administration were not reported, batch number: unknown and expiry: unknown) on 06-NOV-2021 for prophylactic vaccination.  On 22-JAN-2022, the patient experienced sinus pressure (dose number in series 2). On same day, he experienced headache and had suspected covid-19 infection (dose number in series 1) and suspected clinical vaccination failure (dose number in series 1). On 24-JAN-2022, the patient tested positive for coronavirus disease (Covid-19) using "Binax Now" take home antigen test. On 29-JAN-2022, the patient had a slight cough (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable (dose number in series 1). The patient recovered from sinus pressure and headache on 26-JAN-2022, and recovered from slight cough and suspected covid-19 infection on 30-JAN-2022. The outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216251.; Sender's Comments: V0: 20220200545 -Covid-19 vaccine ad26.CoV-2.s-Suspected clinical vaccination 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
Chills, general fatigue and myalgia, overall tenderness to touch of skin, nausea. Started about 5-6 hours after vaccine. Vaccine administration at approximately 03:30pm on 2/5/2021 and symptom onset at approximately 09:00pm on 2/5/2021.  Nausea was significant, moderate to severe in quality; took two meclizine 25 mg tablets (50 mg dose total) and nausea improved but did not resolve.  All symptoms resolved approximately 21 hours after vaccine administration.
MINIMUM CHILLS; ARM PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced arm pain. On 01-APR-2021, treatment medications included: paracetamol. On 02-APR-2021, the subject experienced minimum chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minimum chills on 02-APR-2021, and arm pain on APR-2021. This report was non-serious.
Follow-up information was received from a healthcare provider on 25 January 2012, who is also the patient. The patient had received an Intradermal (ID) injection of FLUZONE Intradermal; lot number UT4164AA. On an unspecified date, the patient developed a rash for two days and her whole arm swelled up. After applying cold compresses it eventually returned to normal. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
June 2 note read: MAY 17TH INJ. SITES WERE STILL RED AND  RAISED.
Left Shoulder Sore after 22 days.  Lumpy mass about 2 inches in diameter at the injection site.
patient to receive pfizer covid booster today AND prevnar.  in error, patient received two pfizer covid vaccines
Nine hours after injection, pt began having abdominal pain, chest pain, trouble breathing and coughing. Hands , feet and legs became cold and turning bluish. He was trembling and shivering, and  complaining he was cold. Jawline was numb, headache and dizzy, tingling in hands and feet. It was like his body went into shock. We rushed him to the ER where they administered ibuprofen and antihistamine.  At the ER, his vitals were normal and no temp. After 3 hours his hands and feet were warm again and he was released. The next day he had a slight temp and a red bullseye on his arm where he received the injection.  He felt worse as the week went on experiencing chest pain and trouble breathing. The bullseye on his arm turned into a bruise and spread down his arm. Sore throat and trouble  swallowing from all fo the coughing on the day of the reaction.
Bruise at injection site Left Deltoid Swelling, Redness, and warmth 3-4 inches from injection site.
Fast Heart rate, injection site pain golf ball size lump red hot,  48 hours later red sore spot, muscle pain at site feels like a punch, fever 100.9 for 4 hours after injection, mild scratchy throat.  12/24/20 symptoms subsided.
Narrative: Patient was not previously Covid 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 administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. No cause of death listed in chart, but patient was 87 w/ Alzheimer's, CKD, and CAD.
Shingles in the right side of the face, taking prednisone and Valaciclovir
Rt. arm injection site small yellowish bruise. Redness and swelling noted approximately 5 inches below injection site on the inferior surface of the upper arm and towards the axilla, area hot to touch. Pt. treated with KEFLEX.
HAD ERYTHEMATOUS SWELLING APPROXIMATELY 10 X 6 CM ON LEFT THIGH (ADMINISTRATION SITE OF HEP A AND DAPT VACCINES); SUBSEQUENT ECCHYMOTIC "RING" EVOLUTION AROUND BORDER OF ENTIRE LESION (SEVERAL MM IN WIDTH) WITH NON-PURULENT MICRO VESSICULAR FORMATION AT CENTER; SUSPECT LOCALIZED ALLERGIC REACTION, BUT CONCERN FOR SYSTEMIC (STEVENS JOHNSON SYNDROME) EXISTS. NO FEEVR, NO IRRITABILTY WHEN SEEN LAST NIGHT (7/27).
pt recvd vax & had convuls; fever; had been sick w/ fever; diarrhea; runny nose;
Erythematous papules and plaques along a dermatome left upper arm and back.
Pt began with slurred speech, balance problems, weakness - MRI's, LP done given IV Solumedrol, Plasmaphoresis, then pt unable to speak, mental status decreased ? ADEM.
flu-like symptoms; This is a spontaneous report from a Pfizer sponsored program. This is one of the 2 reports from same reporter. A contactable female consumer reported for her husband (patient) that: a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unknown date in Apr2021, the patient experienced mild flu-like symptoms. They scheduled to return tomorrow, 27Apr2021 for second dose.The reporter wants to know if it is okay for them to take the 2nd dose tomorrow. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 60 year old female pt who experienced a bad headache immediately following inadvertent administration.  She also developed muscle pain, fatigue, chills, a cold, and a runny nose. The pt received a dose on 10/31/03.  The pt's concurrent illnesses include increased intraocular pressure and osteoporosis.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 10/31/03.  Dose regimen was 0.25mL each nostril (IN).  Concomitant therapy included Evista, Paxil, Aciphex, Metamucil, Vitamin C, Vitamin E, Vitamin A, Vitamin D and calcium plus Vitamin D.  On 10/31/03, the pt developed a bad headache, which she described as severe, that began immediately after she "sniffed" the Flumist.  She indicated that she could taste the Flumist, but this only lasted a few minutes.  She also developed muscle pain (myalgia), fatigue, chills and runny nose and a cold which lasted a few days.  She recovered from all of the events.  The pt stated that Flumist was inadvertently administered (medication error) because she was not aware that it was a live virus vaccine or that it was not indicated for pt's her age.
A report was received from a health care professional on 11/19/03 concerning a 47 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half dollar in size, raised and warm to the touch. The vaccine had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of RECOMBIVAX HB underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of max 101.6. Strong chills. Loss of appetite.  Second dose of Moderna. Didn?t know where else to submit the data.
Symptoms came on sudden and fast.  Thumping in back of my head, severe headache, face pain below eyes, stuffy nose, pain all over body, streaks of pain in wrists, head, neck, hips, chest,  fast heart rate, (95) extreme chills that eventually turned into hot flashes, nausea, stomach pain, fatigue.
fever (topped out at 102.2), headache, nausea, dizziness, joint/muscle aches/pain, fatigue, loss of appetite, arm pain and inflammation at injection site accompanied by palm-sized area of redness and heat  Nothing taken for fever. Decided to ride it all out. Fever took 2.5 days to normalize.
pt recvd vax; devel purulent inject site rxn w/ erythema & swelling approx .5" diam;approx 1.5 purulent fluid drained from site; no cultures done; tx w/ amoxicillin; resolved
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "experiencing weight loss after getting the COVID vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Transferring agent stated, "I had a caller on the line, name (Name withheld), she was experiencing weight loss after getting the COVID vaccine." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6/7 87y.o. male admitted through the emergency room when he had a syncopal episode on the morning of presenting the ER via EMS;  he was COVID-positive and epidemiology has seen him and he was positive back in April he is asymptomatic at this time and he is not in isolation as they feel this is resolved COVID
9/26 (Day of vax): mild soreness at vax site; 9/27: full body aching, chills, muscle soreness, severe soreness at vax site, huge headache, total and absolute exhaustion; 9/28: moderate headache, moderate soreness around vax site, like more in the armpit and shoulders - mostly recovered but not 100%.
First 2 COVID vaccinations were Moderna with zero side effects. 10 days after booster (Moderna), hives developed behind my ear then my scalp. By day 11, I had hives all over chest, neck, face & torso area. It felt like my skin was on fire. Areas of rash would move around area to area, with chest sometimes being worse than stomach area. Ears felt swollen for a long period of time.  I have never had this reaction to anything in my life. Went on for days before seeing Urgent Care on 1/19. Prescribed prednisone, Pepcid & Zyrtec. I have tried twice to stop taking the antihistamines and on day 2 without them, I am once again covered in hives.  I have never had to take medication on a daily basis.
Very hot to touch; Initial swelling/ Came back larger than 2 inches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Initial swelling/ Came back larger than 2 inches) and FEELING HOT (Very hot to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced SWELLING (Initial swelling/ Came back larger than 2 inches). On 22-Jan-2021, the patient experienced FEELING HOT (Very hot to touch). On 19-Jan-2021, SWELLING (Initial swelling/ Came back larger than 2 inches) had not resolved. At the time of the report, FEELING HOT (Very hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. She put on cool packs/wet towels but the swelling is getting bigger and bigger.
Observed that vision was affected / beams from headlights appeared to be significantly dim; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 09Mar2021 at 16:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient was allergic to sulfa and adhesives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received glyceryl trinitrate (NITROSTAT) and experienced drug allergy. On 09Mar2021 at 18:45, later in the evening on the day of vaccination, the patient observed that his vision was affected. It was reported that, while driving he observed that the beams from the headlights appeared to be significantly dim. He attempted to verify that the headlights were in fact dim by visually inspecting them directly and found that they were not. Nevertheless, when observing the light that was thrown on the roadway, its appearance was significantly dim in appearance. The high beams threw more light but were also less bright than normal. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vision was affected was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had my vaccination on 10/017/2022. On 03/22/2023 I took off from work as I had a hoarse voice fatigue. Ruled out for Strep and COVID-19. I was prescribed a medication to help with the mucous. I had these symptoms for 7 days. The symptoms went away after 2 weeks.
Possible syncopal episode after vaccine adm. per MA, she gave pt flu vac. As she turned around to dispose the needle, she heard a loud noise & found pt fell down on exam table nonresponsive she ran to get me. Within a couple minutes, we ran back & found her sitting on exam table alert & oriented. She didn't recall what happened.
Patient states she did not realize she was getting GARDASIL with vaccine visit last month believes her Lyme symptoms have flared since and has been having all of the symptoms listed on site except for seizure: swollen glands, joint pain, fatigue, weakness and stomachache family feels like she can hardly function from the time of shot admin on 6/20/12, started feeling poorly 10 hours later with pain in stomach, head, and joints pain fever, night sweats all are worse like 2 years ago when she was diagnosed with her Chronic Lyme disease. Highest temp measured following vaccine was 102. not that high with Lyme prior more typically 99.
This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine. Additional information was reported as follows: The age at vaccination was not reported. The batch number for flu vaccine was not reported. The patient was vaccinated with a unspecified flu vaccine, a few years ago. The healthcare professional was not sure of which flu vaccine it was or when it happened. The healthcare professional did not have any further information.
Patient reported going to her doctors on oct 15th to receive antibiotic rx due to cellulitis. Dr believed flu shot was not placed in right part of her arm.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored doses of PEDVAXHIB lot # L012838, expiration date: 10-MAR-2018 and Lot # L030871, expiration date: 10-JUN-2018 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pounding headache, nausea, chills, muscle and body aching and pain at the injection site.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.  The vials were placed in the refrigerator on 21Apr2021 and stayed in the same location until their administration date on 25May2021