chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ARM WAS SORE; 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: Unknown) 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 subject experienced arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore. This report was non-serious.
Itchy rash 4 days ago few lesions on abdomen and mid chest, more lesions over next 2 days over scalp and lower legs. Skin shows 20 red papules, few with vesicles and low grade fever.
About 45 minutes after receiving the vaccine, the patient experienced nausea and vomiting.
pt recv vax 21MAY94 & shortly p/pt started to cry, scream & manifested unusual behavior including, arching of back;T103;next day pt to MD office & seen by MD who noted arching of back & was impressed by pt behavior which lasted over 24hr;
Do you really want this information? I see no point in filling out all this extraneous (BLEEPED) stuff. I simply had a sore shoulder starting the evening of the shot and continuing through the morning two days later. Other than that no other observable side effects and I did NOT see or contact a physician about this matter.
11x8cm induration on left thigh from Dtap vaccination and PCV left thigh.
26 hours after receiving the injection, I became very nauseous and had diarrhea.  At one time I passed out and when I woke up I was  covered in feces and vomit.  The symptoms remained until about 3:00 a.m. on the 18th of this month.  Today, the 18th, the vomiting and diarrhea subsided; but I remain very weak; and I have no appetite.
Breakthrough case admission after three vaccines  Pfizer 2/23/21 Lot# EN6200;  Pfizer 3/26/21 Lot# ER8733;  Pfizer 12/8/21 Lot# 330308D
I woke up at 9 am with a splitting headache, tried to stand up and I was dizzy and more sore than I had ever been across my whole body. It was incredibly hard to walk also, but I would contribute alot of that to the adductor exercise I had done the previous day. I was also drained of enegery and just wanted to sleep though no position was comfortable. I had an appetite and was able to eat and take some acetaminophen. This along with rest, alot of water and patience seemed to work. The side effects from the vaccine were gone by the next morning.
Large, red, swollen, itchy lump hurts when touched for 3 weeks. Size of a silver dollar. To date there is a shadow similar to a fading bruise.
Approximately 14 hours after injection, patient woke up with nausea, vomiting and dizziness which lasted 2 days.  The most severe nausea and vomiting were within the first 24 hours.  The effect subsided after 3 days.
5 minutes after administration of vaccine in upper right arm, right thumb joint pain began and lasted 20 minutes or so, next morning upper arm was extremely sore and tender to touch, 4 days later on September 12th, developed mouth ulcers, one on upper gums and one on base of tongue. Mouth sore on upper gum grew quite large (1/4 inch in diameter) and became extremely painful. Hard to talk and eat for 5 days, then began to heal, the sore on my upper gum left a red scar. Along with the sores, on the same day i developed sharp shooting headaches behind my eyes that only lasted 1 day.
Fever (4 hours) chills (6 hours) extreme fatigue (36 hours) body aches (24 hours) nausea (36 hours) decreased appetite (72 hours) sore arm at site of injection (4 days) fatigue (4 days)
Failed echocardiogram, failed stress test, heart catherization with 2 stents implanted.
Administration of an incomplete dose of Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) for prophylaxis.   On 10th November 2022, the patient received Fluarix Tetra 2022-2023 season. On 10th November 2022, unknown after receiving Fluarix Tetra 2022-2023 season, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter called to ask for information about the administration of an incomplete dose of Fluarix to a patient.  The reporter asked if the patient had to be re-vaccinated.  The reporter did not provide patient identifiers and data about the vaccine administered.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered with incomplete dose of Fluarix tetra, which led to incomplete dose administered.
Patient complained of 4 days of marked numbness in the right upper extremity, especially at the shoulder and bicep. On the day of vaccination pain and numbness were moderate. On day #2 pain improved but numbness was at its worse; patient had weakness of right upper extremity. On days #3 and #4 symptoms improved. On day #5 symptoms were completely resolved. Patient did have phlebotomy at the right antecubital fossa after receiving vaccination. On 9/6/18 physical exam showed normal cranial nerves use and normal muscle strength.
Patient states her left arm is swollen from elbow to armpit and it is very sore. Patient seen at clinic on 01/26/10 and diagnosed with cellulitis of left arm and is treated with Keflex.
Patient developed warmth, redness and swelling of entire RUE to elbow and shoulder. Started about 1-2 hrs after injection. 10/22/08-records received for DOS 10/17-10/18/08-DC DX: Right upper arm erythema, swelling and pain. Admitted with right painful upper right arm. Arm became erythematous, swollen, warm and tender, rash and pain.
loss of consciousness/passed out; dizziness/ feeling light-headed; This case was reported by a consumer via regulatory authority and described the occurrence of loss of consciousness in a 31-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 4RK3C, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 4302MF023, expiry date unknown) for prophylaxis.   The patient's past medical history included presyncope and drug hypersensitivity (Drug hypersensitivity with Bactrim (sulfamethoxazole and trimethoprim)). Concurrent medical conditions included milk allergy.   On 22nd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device and the 2nd dose of NOVAVAX COVID-19 VACCINE (intramuscular) 10 mg/ml. On 22nd October 2022, less than a day after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced loss of consciousness (serious criteria medically significant and other: serious as per reporter) and dizziness. On 22nd October 2022, the outcome of the loss of consciousness and dizziness were recovered/resolved.   It was unknown if the reporter considered the loss of consciousness and dizziness to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 21-NOV-2022 Reporter's Comment: The reporter reported that the patient received a dose of FluLaval Quadrivalent into right arm at military facility for influenza immunization and second dose of Novavax Covid-19 Vaccine adjuvanted 10 ug/mL into left arm at a military facility and on the same day after vaccination, the patient experienced loss of consciousness and dizziness (felt light-headed, then passed out while resting in chair). The doctor immediately attended to patient and blood pressure was 125/75 and heart rate was 104 (no units reported)  The patient reported this was a common reaction for him when receiving vaccinations.  The patient assisted to a lying position with his legs elevated as treatment. It was reported that the patient had an office visit as treatment.  No concomitant medications were reported. At the time of reporting, the event outcomes of dizziness and loss of consciousness were recovered/resolved. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events was considered possible.
do they hurt!! Worst shots I've ever had; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and its hurts. The reporter stated that the patient might want to check to see if need a booster.  The patient added that, these were worst shots but better than getting shingles and it was a newer vaccine and was supposed to be much more effective than the previous shingles vaccine.  The reporter advises taking Tylenol or something like it before. For tolerances of 2nd dose, refer case US2021AMR156335, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156335:same reporter
Information has been received from a physician concerning a 34 month old (also reported as 17 year old) male who on 20-MAY-2008 was vaccinated with the first dose of MMR II (route, site, and lot number not reported). The patient had not received the second dose. On 11-JAN-2010, the patient experienced mumps. The patient was diagnosed on 14-JAN-2010. The patient parotitis was on left side. On 14-JAN-2010, the first blood work was done which revealed serum IgM <1:10, serum IgG 4.66 and serum amylase 841. The outcome for mumps was not reported. This is one of several reports from the same source. Additional information has been requested.
Tinnitus in left ear, constant since December 5th 2021, several days after my booster.
This spontaneous report as received from a physician assistant via company representative to a 68 year old female patient. Pertinent medical history was unspecified by reporter. On 29-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K004483, expiry date: 16-AUG-2015, dose: 1 ml, route of administration was reported as IM or SQ). Concomitant medications were unspecified by reporter. On an unknown date the patient experienced cellulitis. The reporter was unable to provide any details regarding the event. The patient did seek medical attention with doctors (details unspecified). Antibiotics (details were unspecified) were given as a treatment for the event. The outcome of cellulitis was reported as recovering/resolving. The causality was unknown. No further information was provided. Additional information has been requested.
This spontaneous report as received from a 77 year old male patient who refers to himself. The patient's medical history and current conditions were not provided. On an unknown date approximately in 2012 (reported as "about 3 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and dose were not reported), subcutaneous. Secondary suspects and concomitant therapies were not reported. On an unknown date approximately in August 2015 (reported as "about a month ago"), the patient developed a painful rash on his right hip and leg. The patient sought medical attention via seeing his provider (unspecified provider). It was confirmed that the patient had shingles. The patient was treated with fentanyl patch and NEURONTIN. At the time of the report, the patient was experiencing the pain and rash from shingles. Additional information is not expected due to no consent to contact Health Care Professional was given.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 03-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
pt exp pain in the lt upper arm, lasting longer than 48hr p/vax;tx w/advil & recovered;this is 1 of 4 pt from this site to have an inj site rxn p/vax;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 01-APR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may have been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
2/10/2021 during my lunch break I still was not feeling better so I took a nap at 12:30 woke up at 12:50 because I was having chest pains and my mouth bottom row left side from my lip to my ear felt like someone had hit me in the face with a hammer, on 2/11/2021 I called into my supervisor stating I would need to go to urgent care, my mouth and face was in awful pain and had swollen, I went to Urgent care and they sent me to Hospital for a possible stroke. While I was there, I was given Tramodal of pain observed for several hours then told that my impending facial paralysis was just a allergic reaction to the shot, to take Tylenol and Motrin for pain. For 2 more days my face continued to swell and I suffered in pain , I went back to the urgent care , where I was provided something for the ?supposed allergic reaction? pain and to help with the swelling, well a few days  the new meds t last Thursday my mouth gushed with this fluid of Blood and puss mixed , very thick. I went back to the urgent care and they could not tell if this was coming from my jaw or my gum( also I have braces only on my top teeth and I went to the orthodontist the same day I received the shot, I go every for weeks) I was given more meds to take with the ones that I was already prescribed and told to contact my orthodontist because even though my face has gone down I have a hard knot in it that possibly holds infection.
Swelling, redness, tenderness, itchiness, raised red welt approximately 4 in long and an inch and a half wide, all at the site of the injection. Shortness of breath, muscle aches, shivering, low fever, diarrhea, abdominal cramping, headache, tiredness and fatigue.
supraclavicular nodule after receiving 1st dose of the Covid vaccine; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number and expiration date not provided), via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient developed supraclavicular nodule after receiving first dose of the COVID vaccine on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
tested positive for methamphetamine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 32 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Aug2021 (Lot number: FA7485, Expiration Date: 01Sep2021) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "spider bite" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL taken for pruritus, start date: 12Aug2021 (ongoing); REXULTI taken for depression, start date: 12Aug2021; WELLBUTRIN, start date: 12Aug2021; SULFAMETHOXAZOLE, start date: 12Aug2021; BUSPIRONE taken for anxiety, panic attack, start date: 12Aug2021; TYLENOL taken for pain, start date: 12Aug2021. Past drug history included: Methamphetamines for Drug addict, notes: tested positive for Methamphetamines. The following information was reported: DRUG SCREEN POSITIVE (non-serious) with onset 12Aug2021, outcome "unknown", described as "tested positive for methamphetamine". The event "tested positive for methamphetamine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was received 1st dose of the Pfizer COVID 19 vaccine and is also taking Bactrim and Benadryl for a spider bite; states this morning the patient went and was drug tested and tested positive for Methamphetamines and reporter is inquiring if this is from the Pfizer COVID vaccine. The patient has had the spider bite for about a week. States she takes Benadryl for itching and just got it as over the counter for the spider bite, takes Rexulti 3mg once per day by mouth for depression, takes Wellbutrin but does not have the bottle of Wellbutrin for the dosage or instructions, clarifies she takes the generic of Bactrim which is Sulfamethoxazole-TMPDS one by mouth twice per day but does not see the dosage anywhere on the orange pharmacy bottle; states for the Sulfamethoxazole-TMPDS the orange pharmacy bottle has the Rx number but no lot, expiry date or NDC. States the patient took two Tylenol 500mg by mouth today; states the patient takes as a mood stabilizer Buspirone HCP two tablets three times per day as needed for anxiety or panic attacks and all of these medications were ones that they prescribed for her to help her with her mental health and with withdrawal from drugs. Reporter confirms that all of these medications were started by the patient this morning.   No follow-up attempts are possible. No further information is expected.
On unspecified dates, the subjects received unspecified doses of HEPATITIS B vaccine (unknown).  At an unspecified time after vaccination with HEATITIS B vaccines, the subjects experienced not responding to therapy.  The sales representative reported that she "heard through hearsay that some college clinics  in her sales territory are testing all their nursing students and if their HEPATITIS B antibody titers are below 10, 000 mIU, they are revaccination them with on e or more doses of HEPATITITS B vaccine.  An unknown number of subjects have shown non-protective Hepatitis B antibody titers when tested anywhere from greater than two months to years after completing their last HEPATITIS vaccine series".  The sales representative did not have any further subject data at this time.  She did not know what brand of HEPATITIS B vaccine had been used in these subjects in the past.  The sales representative will attempt to get further information.  At the time of reporting, the outcome of the event was unspecified.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # K012456, expiration date: 28-APR-2017 (dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm hurts; Head feels like it is about to explode; Chills; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), HEAD DISCOMFORT (Head feels like it is about to explode), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts), HEAD DISCOMFORT (Head feels like it is about to explode), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, PAIN IN EXTREMITY (Arm hurts), HEAD DISCOMFORT (Head feels like it is about to explode), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not mentioned by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up not required : As reporter declined for further follow-up
Following day my arm was swollen, red and sensitive to the touch. Felt sick to my stomach.
Patient complaining of severe upper arm/shoulder pain the evening after receiving her flu shot. She called the pharmacy ~2 weeks later reporting arm/shoulder pain had not subsided and was referred to her primary care doctor to see what was going on since injection site pain normally does not last for more than a couple of days. Patient described pain as so severe that she has been unable to lift her arm up without discomfort and has not been able to even sleep on that side of her body. After 4 weeks, patient reported that she went in to see her doctor and they were going to order an MRI to see if there was any lingering inflammation due to possibility of vaccine being administered too high in the arm. We are still waiting for patient's MRI results to come back but if they do suggest inflammation to be present, she will likely need an injection of Cortisone.
Nursing home requested patient be vaccinated and patient signed consent form. We gave first dose pfizer and upon entering into vaccine system discovered patient previously received Janssen vaccine on 06/01/2021.  Patient had no adverse event during time period monitored post vaccine.
Received J&J on 8/8/21. Presented to ED on 1/1/22 due to STEMI. Found to be COVID positive but asymptomatic. Did not receive any COVID treatment. Discharged on 1/5/22