chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 62 year old male patient, with no medical history, drug reactions or allergies. The pharmacist reported that the wife of the patient stated that her husband on 17-SEP-2013, was vaccinated with a dose of 0.65 ml ZOSTAVAX vial 19400 PFU lot # J000444; expiration date 11-APR-2014, subcutaneous in the left arm. Concomitant medication was unspecified by the reporter. On 20-SEP-2013, 4 days after onset of therapy the patient experienced redness, soreness and lump the shape and size of an egg at his left arm injection site. Treatment, lab diagnostic and if the patient sought medical attention were unspecified by the reporter. The outcome of redness, soreness and a lump the shape and size of an egg at his left arm injection site were reported as not recovered/not resolved. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; INFECTED WITH  DELTA VARIANTS; This spontaneous report received from a company representative via a consumer at a social gathering (a hearsay case), concerned multiple patients (exact number unknown) of unspecified sex, age, race and ethnicity Height and weight of the patients were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry date; unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the multiple patients who received the Janssen vaccine were infected with the delta variants (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and infected with delta variants was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187265.; Sender's Comments: V0: 20210803410- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Myalgia & Fever Narrative: per supervisor report: "received 2nd injection on Wednesday 2/24/21 experiencing elevated temp, body aches"
sore arm; sneezing alot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SNEEZING (sneezing alot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and SNEEZING (sneezing alot). At the time of the report, PAIN IN EXTREMITY (sore arm) and SNEEZING (sneezing alot) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
CALLED FOR ADVERSE REACTION.  ADVISED, THERE MAY BE LOCAL SWELLING, REDNESS.  WILL CONTINUE TO MONITOR PATIENT.
Received expired dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
6/16/17 - seen for 5 yr. well had MMRV, QUADRACEL in Lt. arm. Temp. 101 - redness, warm to touch started that night. Seen in office on 6/18/17 - cellulitis left arm transfer to ER who started him on KEFLEX. Had follow up appt. in office 6/19/17 - Mom cancelled as cellulitis improving.
hepatitis B; little soreness; dates of vaccination: on 19-MAR-2015 and on 05-MAY-2015; This spontaneous report has been received from a lawyer via Plaintiff Fact Sheet (FS), from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2108USA004335), concerning a 69-year old female patient (pt). The pt's historical vaccinations included influenza vaccine inact split (provided as "influenza split (INFs) virus", administered 3 times) and zoster vaccine live (ZOSTAVAX). Concomitant vaccine included hepatitis a vaccine, inactivated (manufacturer unknown) (information captured in split case # 2203USA006565).  On 19-MAR-2015, the pt was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (provided as "HAV adult hepatitis B") (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis by a registered nurse. On an unspecified date after administration, the pt experienced vaccine side effect: hepatitis B (reported as "HAV adult hepatitis B"). On 05-MAY-2015, the pt received another dose of the vaccine (inappropriate schedule of product administration). On an unspecified date after another dose with hepatitis b vaccine (recombinant) (manufacturer unknown), the pt experienced vaccine side effect: a little soreness. The outcome of the events was not provided. The causality between the hepatitis b vaccine (recombinant) (manufacturer unknown) and the events was considered to be related.  Upon internal review, the event of hepatitis B was determined to be medically significant.  This is one of 3 linked reports regarding the same patient (cross referenced with # 2203USA006565 and 2108USA004335).; Sender's Comments:  US-009507513-2108USA004335: US-009507513-2203USA006565:
swelling and tingling on upper lip, right side; swelling and tingling on upper lip, right side; Slight swelling on roof of mouth on right side.; This is a spontaneous report from a contactable consumer or other non hcp. An 82-years-old female non pregnant patient received first dose of bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: En6206) via an unspecified route of administration, administered in arm left on 06Mar2021 11:00 (Facility type Vaccine: Hospital) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Medical history included tachycardia. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) and digoxin (DIGOXIN). The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, about 11:30 AM slight swelling and tingling on upper lip, right side and slight swelling on roof of mouth on right side. This report is being created at 4:55 and took Benadryl at 4:30 on the advice of pharmacist and effects are still ongoing. The patient received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Moderate fever, fatigue, muscle soreness and cramps, soreness at injection site, flushed skin during fever.
Left deltoid hard lump and nickel size red swelling at injection site December 6, 4pm. Left deltoid hard lump and quarter size red swelling at injection site with more pain December 7, 9am. Left deltoid hard lump and $0.50 size red swelling at injection site with increased pain and increased fatigue and nausea; left hand cold and tingling.
70M with a rash after getting the Moderna Covid vaccine. on 3/11, he received the first dose and developed rash over his neck and face that was persistent though unchanged. He then received his second dose and developed 2 days of generalized fatigue and malaise with worsening rash to the neck, face, eyes, and ears as well as skin cracking and soft tissue swelling to the neck. There was no mucosal involvement though he endorsed his lips were "bumpy and numb". Given single system involvement, epipen was held and he was treated with Benadryl, Solu-Medrol and famotidine  70M presented with persistent rash with onset after the first vaccine and worsened after the second, though without multiple system involvement. Given timing of symptom onset in proximity to vaccine exposure, likely due to vaccine, especially considering no similar reactions in the past.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: OPTIC NEURITIS (medically significant) with onset Apr2021, outcome "not recovered", described as "Bilateral optic neuritis"; OPTIC NEUROPATHY (medically significant) with onset Apr2021, outcome "not recovered", described as "Bilateral optic neuropathy"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Doesn't feel good". The events "bilateral optic neuritis" and "bilateral optic neuropathy" were evaluated at the physician office visit and emergency room visit. The event "headache" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results. Clinical course of the events was reported as follows: 2.5 weeks after the dose, the patient began having vision problems. She started losing vision in her left eye and then in her right eye so she went to the emergency room in a hospital that specializes in eyes and they told her she has bilateral optic neuropathy and also was diagnosed with bilateral optic neuritis and was even in danger of going blind. The neurologist and other doctors advised her not to take the booster dose. Two months ago, she started having symptoms similar to the first time and called to see if we had any new information about reports of this nature. She has an appointment with the neurologist next 25Mar2022 and would like to know what information Pfizer can provide to her and indicated that her vision problems has not improved. The patient reported that she has had many medical tests and appointments with doctors. It was further reported that that patient was still having problems and can see but is having dark spots, having headaches and vision blurriness. She already went to a neurologist to see if she had another type of disease and they cannot find anything, so even the neurologist told her not to take the booster. She doesn't feel good and feels something is wrong in her eye. She stated that the doctor said they were going to do a report and send it in because she was not getting any better. The lot number for bnt162b2 was not provided and will be requested during follow up.
I had a very mild case of Covid-19 in July 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had a very mild case of Covid-19 in July 2022) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Chemotherapy, Mitral valve replacement in 2008 and Thyroidectomy in 2001. Concurrent medical conditions included Cardiomyopathy, Premature beats, Neuropathy and Osteopenia. Concomitant products included LISINOPRIL, SPIRONOLACTONE and CARVEDILOL for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (I had a very mild case of Covid-19 in July 2022). At the time of the report, COVID-19 (I had a very mild case of Covid-19 in July 2022) had resolved.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not reported.   Reporter did not allow further contact
Chills, rapid, pounding heart rate, chest pain, cough (when taking a deep breath) and nausea. Resting heart rate almost 40 beats more than usual baseline heart rate.
Td administered subcutaneously; Td administered at forearm; Red halo around injection site; Itchiness around injection site; On 03/24/2020 a 31 year old male inadvertently received a subcutaneous injection of TDVAX (Lot # A122A) in the forearm instead of intramuscular in the deltoid.  The correct product and dose (0.5mL) was administered; however it was an incorrect site and route.  On the day of administration, the patient experienced redness (halo) and itchiness at injection site.  The patient's adverse events resolved within two days.  The reporter indicated that the administration error occurred to confusion with TB product and not verifying administration instructions beforehand.; Sender's Comments: The reactions of itchiness and redness were accessed as non-serious and labelled.  The medication error was accessed as non-serious.
The nurse misread my childs medical records and administered an unnessesary dose of MMR, polio, and DTaP boosters.
patient received first covid 19 shot on 6/1 immediately had a rxn of turning very pale, clamy, dizzy, and was incoherent off and on.  She never fully lost consciousness however we called 911 and she was checked out by emt.  Mother reported she was filling better later in the day
Myalgias, headache, fever (highest temp = 101 degrees F), and swelling of arm.   Still has a large hardened area on her arm.
Bruise, swell, erythema and itching started late evening the day of shot itching started day after shot.
Approximately 12:00 noon  headache began. At approximately 16:30 chills, shortness of breath, nausea, loss of appetite. shakiness, nausea, vomiting. lasted through out night.
underdose of Boostrix via needle leak on; administered underdose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 1st July 2022, the patient received Boostrix. On 1st July 2022, unknown after receiving Boostrix, the patient experienced accidental underdose. On an unknown date, the patient experienced needle leak. On an unknown date, the outcome of the accidental underdose and needle leak were unknown.   Additional Information: GSK Receipt Date: 6-Jul-2022 Reporter's Comments: The pharmacist reported that the patient was administered an underdose of Boostrix  The pharmacist stated administered an underdose of Boostrix via needle leak. Adverse event contained all reported information by health care professional. HCP gave consent for safety team follow up. Additional Supportive Information: The patient was administered an underdose of Boostrix, which led to accidental underdose.
57yo F with PMh of MS, HTN, chronic b/l lymphadenopathy, urge/stress incontinence, morbid obesity, depression who presents from home after confusion and episode of bowel and bladder incontinence. pt's daughter was contacted and states pt has been alone at home for most of the last 3 weeks and during that time. One of the pt's daughters had covid 3 weeks ago and left the house. Pt's daughter states she left the home 1 week ago to visit her dad. Pt was confused over the phone 2-3 days ago and pt's daughter called EMS for well check. EMS did not transport pt to hospital at the time. Today, pt's daughter returned home to find pt confused sitting in her own feces and urine. Pt had not taken any of her meds for at least the last 2 days
Extreme swelling, redness for a 3.75-inch circle across the injection site. Hot to the touch. Very painful. During the first night after administration I experienced nausea and chills. I ran a low-grade fever of 100.3 during the second day after being injected. As of today (day 5), I still feel some pain and have noticeable swelling, but it seems to be a little less with each passing day; the injection site is still warm to the touch but no longer hot. Other than two reactions to live-vaccine flu shots, I have not experienced any previous adverse reactions to vaccines.
Awful, itchy, blotchy rash on right shoulder onto back currently. Itchy bumps that are raised and pop up out of nowhere.
No additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 07-SEP-2022, the patient was administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) syringe, intramuscular injection, lot # W002889 with expiration date 06-MAR-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).
Fever to 101; Swollen nodes in armpit on the left side, tender and can barely move arm; Swollen nodes in armpit on the left side, tender and can barely move arm; Swollen nodes in armpit on the left side, tender and can barely move arm; myalgia; slept for 24 hrs; This is a spontaneous report from a contactable physician. A 61-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, Sulfa drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. On 12Aug2021 20:00 the patient experienced fever to 101, swollen nodes in armpit on the left side, tender and can barely move arm, swollen nodes in armpit on the left side, tender and can barely move arm, swollen nodes in armpit on the left side, tender and can barely move arm, myalgia, slept for 24 hrs. The outcome of the events was recovering. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 12Aug2021, sars-cov-2 test: negative on 11Aug2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
PT was fully vaccinated with Pfizer COVID-19 vaccine received first dose 10Mar and second dose 31 Mar. PT tested positive for COVID-19 via nasal swab on 13 May.
This spontaneous prospective pregnancy report as received from a nurse refers to a 24 year old female patient. The patient's concurrent conditions and medical history were not reported. On 17-JUN-2015, the patient while being pregnant was vaccinated with VARIVAX (Merck) lot # J014128 and expiry date of 07-NOV-2015 and GARDASIL lot # K011562 with expiry date of 08-APR-2017. Concomitant medications were not reported. The patient's Last month period (LMP) was 15-MAY-2015 and expected date of delivery is 19-FEB-2016. Initial exposure to VARIVAX (Merck) and GARDASIL was at fourth week of pregnancy. The pregnancy outcome was pending. There were no adverse experiences. Additional information has been requested.
Myalgia, Fever, Left arm soreness, left neck side soreness, fatigue, chills  Narrative:
Rash - Papular purpuric lesions to arms and legs, some surrounded with erythemia.  Some noted raised with vesicle appearance.  Sed Rate and liver enzymes elevated, Heachache
Patient had a shingles outbreak post dose one of Moderna.  Outbreak confined to 1/4 of patients face.
pt recvd vax; 1may95 devel swollen, painful lymph nodes under lt armpit & near  lt knee;
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number ZP3P9, expiry date unknown) for prophylaxis. On 20th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site blisters. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site blisters were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site blisters to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on right arm. The patient experienced redness, swelling and 2 blisters right below injection site. There was consent to follow up.