chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (prior dates of expiration), the patients were vaccinated with improperly stored PROQUAD (lot # H020137, expiration date 07-MAY-2014; lot# J002933, expiration date 12-SEP-2014; lot# reported as J002930, expiration date 12-SEP-2014; dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: tingling and numbness in extremities
down for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for 3 days) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (down for 3 days). At the time of the report, DEPRESSED MOOD (down for 3 days) outcome was unknown.            The patient's concomitant medication was not reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
nose itching at the tip; ears going numb and getting red; eyes started itching; wants to claw out eyes; having trouble breathing; itching all over; joints hurt; pins in fingers where the veins are; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (nose itching at the tip), HYPOAESTHESIA (ears going numb and getting red), EYE PRURITUS (eyes started itching), ASTHENOPIA (wants to claw out eyes) and DYSPNEA (having trouble breathing) 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.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRURITUS (nose itching at the tip), HYPOAESTHESIA (ears going numb and getting red), EYE PRURITUS (eyes started itching), ASTHENOPIA (wants to claw out eyes), DYSPNEA (having trouble breathing), PRURITUS (itching all over), ARTHRALGIA (joints hurt), PARAESTHESIA (pins in fingers where the veins are) and PARAESTHESIA (pins up and down the back). At the time of the report, PRURITUS (nose itching at the tip), HYPOAESTHESIA (ears going numb and getting red), EYE PRURITUS (eyes started itching), ASTHENOPIA (wants to claw out eyes), DYSPNEA (having trouble breathing), PRURITUS (itching all over), ARTHRALGIA (joints hurt), PARAESTHESIA (pins in fingers where the veins are) and PARAESTHESIA (pins up and down the back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a consumer concerning an approx. 1 year old twin who in approx. 3/98, was vaccinated with MMRII. It was reported that the child has been dx'd with autism. Three other pts (WAES 01081467; 01082120; 01082119 (twin)) had similar experiences after vaccination with MMRII. The consumer reported that there may be other cases as well. Upon internal review, Autism was considered to be an "Other Important Medical Event". Additional information has been requested.
Left arm was Swollen to her elbow; Muscle Pain; Fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, muscle pain, fatigue and headache. On an unknown date, the outcome of the extensive swelling of vaccinated limb, muscle pain, fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, muscle pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix in left arm. After vaccination patient had fatigue,  Headache, Muscle Pain, and her left arm was Swollen to her elbow. The reporter did not consent to follow up. All information was not available
opened IPOL was administered to 2 patients with no reported adverse event; temperature excursion for IPOL, highest temperature of 47.5 degrees F for 30 minutes with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender 2 patients and reporter reported temperature excursion for IPV (VERO) [IPOL], highest temperature of 47.5 degrees f for 30 minutes with no reported adverse event and opened IPOL was administered to 2 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller reported that IPV (VERO) Suspension for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) was exposed to temperature excursion on 14-SEP-2023, highest temperature of 47.5 degrees f for 30 minutes with no reported adverse event (product storage error) (unknown latency) and opened IPOL was administered to 2 patients with no reported adverse event (poor quality product administered) (latency- same day). Batch/lot number requested, not available at the time of call.  Reportedly, Reason of the excursion: unknown Did excursion occur due to a human error: unknown   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Caller refused follow-up. No further information provided by reporter.
Received Hepatitis B vaccine on 11/22/13 at 14:00. Started having symptoms in L arm at 15:00. Progressed from pain at injection to redness, swelling and numbness down arm past elbow. Eval at local ED. Allergic reaction vs infection. Benadryl and course of Keflex given. Symptoms lessened in 24 hr and gone completely by 11/25/13.
Received full dose of Moderna booster I/O half dose, no adv rx for pt
Developed  rash with subsequent swelling, color change, warmth and pain.  14 cmx10 cm in size to left inner upper arm. Still present today on exam. 5/9/22
Started with tingling and weakness in legs (felt heavy), then rapidly progressed to complete lower body paralysis, including incontinence.  (Diagnosis-Guillain-Barre Syndrome).
In the week after getting my second dose I developed a weird sensation in my chest near my heart that I just maybe thought was my lungs. After about a month it got a bit worse and went to an urgent care where they said I had pericarditis. I have been on anti inflammatory medications for past 3 weeks and it?s just now finally starting to get better but symptoms still persist.
This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that on an unknown dates from 13-OCT-2014 through 29-OCT-2014, 8 doses of improperly stored VARIVAX (Merck) were inadvertently administered to the patients. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This case is linked to #1411USA001398 via same reporter link. Additional information has been requested.
PT GOT FLUAD ADMINISTERED AT PHARMACY (NDC 70461-120-03) 9-11-20. SHE CALLED PHARMACY ON 9-12-20 AND REPORTS EYE SWELLING UNDER EYE. RASH MILD. SHE WENT TO URGENT CARE AND THEY GAVE HER STEROIDS. SHE REPORTS SHE WILL CHECK WITH PCP FOR FOLLOWUP
October 19th woke up nauseated, shaky, heart felt like it was flipping around, fast irregular pulse, I thought I was having a PVC however it did not go away, I waited until the time to take my medicine, and at 8:30A.M. I thought I was going to pass out, went to ER and from EKG stated that I was in Atrial fibrillation, Given Cardizem in an IV and this got me back to a sinus rhythm. Saw cardiologist next day. Ordered medication changes and set up for a stress test and heart monitor. I have had more episodes 10/26/2021 Atrial fibrillation at 04:00A.M. Oct 29/2021 04:20A.M. Oct. 31st, 2021, at 07:00 A.M.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient 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: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: It was reported that vaccine made patient so sick for months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369200 same  drug/reporter, different patient/AE;
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
After receiving the vaccine, I just had really bad migraines all the time. I went to the doctor for my migraines but they still don't know what's causing my migraines.
Moderna Covid-19 Vaccine EUA Extremely elevated blood pressure and heart rate. Given Benedryl and Steroid shots. Symptons continued into third day. Prescribed Metaprolol.Gradually improving.
Patient was seen in the ED on 12/16/22 for evaluation of shortness of breath. He reported a recent COVID diagnosis ~one week prior. Of note, he was previously hospitalized at another healthcare facility 12/8/22 - 12/13/22 for COVID-19 infection. Repeat COVID PCR testing preformed 12/16/22 was also positive. He was admitted 12/16/22 for worsening hypoxia, and generalized weakness. He was found to have acute hypoxic respiratory failure secondary to COVID-19 pneumonia with concurrent bacteremia pneumonia. Patient required 2 L supplemental O2 but was weaned down to room air. He was discharged 12/13/22. Patient has received the primary COVID vaccine series and two boosters.
Had first shot at 1:30pm no probs all day and night....Sunday morning no probs....then approximately 11pm at night start feeing a little itchy  on upper torso down to groin.....but not bad.....approximately 3am...I was really itchy....got up looked at my torso and it was bright red and had hives(welts) on torso, breasts, stomach and groin areas.....No problem with breathing or swallowing.....Took 2 benedryl pills and within 30 minutes itching subsided ...redness starting to tone down....welts getting smaller.  All is clear as of now.
extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue lasted from around 2am 1/6 until 5pm 1/6.
REDNESS, ITCHING AT INJECTION SITE, RASH COVERING ENTIRE UPPER ARM WARM TO TOUCH
Headache, fever, nausea, body aches, injection site swelling and red, sore arm, difficulty breathing and 2 possible seizures
This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not provided). Concomitant therapies were not provided. On an unspecified date, "two weeks" after receiving the dose of ZOSTAVAX; the patient developed an unspecified rash on an unspecified part of the body. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
FEVER; ACHES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced fever, and aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and aches was not reported. This report was non-serious. This case, from the same reporter.
Fever and lost all muscular strength. Fell onto floor and could not get up or turn over. Confused stated of mind and garbled speech. Spouse thought I was having a stroke and called 911. At ER, I was treated for dehydration and given Hydrocortisone due to my ACTH Insufficiency. Recovered in about 2 days.
chest tightness red rash around mouth body aches swollen lymph node on right side side of neck
Low grade fever 24 hours after immunization, also direct exposure to person with covid 19.
Information has been received from a physician concerning a female consumer with no pertinent history who on approximately 05-SEP-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. On approximately 05-SEP-2007 the patient developed a cerebral hemorrhage and was hospitalized. The condition was considered to be immediately life-threatening per the physician. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
fever; body aches; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Reporter informed that she knew of someone who had the Pfizer vaccine and developed a fever and body aches after the second dose on 02Apr2021. The fever and body aches last for a day. Seriousness of the events were reported as non-serious. The outcome of the events was recovered on 03Apr2021.  Follow-up (07Apr2021): New information was received from a contactable consumer includes: reporter informed that she was aware of the event on Friday, 02Apr2021 and reported the event within the 24 hours reporting requirement.  Follow-up attempts completed. No further information expected.
Pfizer 12/20/21, 2/2/22. Positive on 9/8/22
Severe swelling in left armpit/lymph nodes. Tender to touch of lymph nodes, constant dull ache/pain. Pain more prominent when sleeping or when arm is down at side.
high fever & sz w/in 12 hrs of vax (no prev hx of sz);
doses were given after expiration date; Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 29-Oct-2021 and administered on 09-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 29-Oct-2021 and administered on 09-Nov-2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 29-Oct-2021 and administered on 09-Nov-2021). On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Expiration date provided by Moderna is 13-Oct-2021,vaccine placed in refrigerator on 29-Oct-2021 and administered on 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No temperature excursion and no adverse event was reported.  No treatment information was reported.
This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot # L042257, expiration date: 17-AUG-2018; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
could also be due to Covid 19, but much worse after started paxlovid; could also be due to Covid 19, but much worse after started paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Other medical history: Fibromyalgia, depression; "depression" (unspecified if ongoing), notes: Other medical history: Fibromyalgia, depression. Concomitant medication(s) included: VYVANSE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; WELLBUTRIN. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "could also be due to Covid 19, but much worse after started paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks brand Vyvanse, Wellbutrin, Zyrtec. COVID 19 Treatment, Paxlovid, Treatment start date: 19May2022, Lot number: GA5120. Adverse event: Terrible, bitter taste in my mouth after starting Paxlovid. Very bad headache on left side of head (could also be due to Covid 19, but much worse after started paxlovid. Adverse event start date: 19May2022. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme sourness at injection has persisted since the second dose was administered. A sharp pain is present at a pencil eraser size spot at the injection site.
Symptoms of unknown causation. Some of which I thought might be food poisoning at the time. Feeling unwell, tired, slightly elevated temp up to 99.5 F, some nausea, gas, abnormal fecal quality, some diarrhea, a little vomitting upon burping one day, symptoms seem to come and go over one or two days but continue to reappear again with very little time in between as in a few days at most usually not but one or two days.
rash at base of neck similar to shingles (left side) rash upper chest similar to chicken pox (right side)
my mom had the shots and ended up with shingles/suspected vaccination failure; shingles / has them now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The reporter stated that, although the shots were effective, they were not 100 percent. The patient had the shingles shots and still ended up with shingles. The patient had shingles now, having got the Shingles shot several years ago from reporting.  The reporter further stated that, she was going through exact experience and he/she was miss hugging her. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2022AMR151921, reported by the same reporter. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR151921:same reporter