chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of injection site warmth in a 76-year-old female patient who received SHINGRIX. Concomitant products included PROLIA, amlodipine, famotidine, lorazepam, simvastatin, BENTYL, SYNTHROID and L-Methylfolate. On 7th May 2018, the patient received SHINGRIX. On 8th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, fever, headache, injection site induration, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site warmth was not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the headache was recovering/resolving and the outcome of the injection site induration, injection site swelling and injection site erythema were unknown. The reporter considered the injection site warmth, fever, headache, injection site induration, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left upper arm. The patient experienced symptoms the day after the patient received her first dose in the SHINGRIX series. The reporter had no further specific pharmacy or dosing information. The reporter examined the patient's arm at an office appointment. There was localized swelling at the injection site which is warm, hard, swollen, and red. The headache was described by the patient to had been severe and debilitating with the patient having described that she had thought she might have meningitis because of the severity of the headache. At the time of reporting, the left upper arm injection site reaction was still uncomfortable and swollen, and the headache has lessened. The patient received BENADRYL for the swelling. The call was transferred to the GlaxoSmithKline medical information regarding her inquiry of whether or not this patient should have a second dose in the series, no further doses, or perhaps a half of a dose.
About 1 minute after receiving the injection the patient was starting to feel light headed.   Despite having the patient place her head between her knees, she still felt dizzy.  I had her lay down with her knees bent.  She was becoming flushed as noticed by her color on her face.  I asked about breathing and she was feeling a tightening of her throat.  She was given 50 mg of diphenhydramine and 911 was called.  Within 2 minutes of laying down and taking the diphenhydramine her color was returning to normal and she was feeling better.  The EMTs conducted a thorough exam and her declined transport to the ER as she stated she was now feeling fine.
5"x5" redness & warmth & knot @ site w/lightheadedness & nausea;
SIDE EFFECTS; This spontaneous report received from a consumer via a company representative through social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The patient experienced side effects (adverse event NOS) when treated with covid-19 vaccine ad26. cov2 (Dose number in series 1). The outcome of side effects was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects (Adverse event NOS) (Dose number in series 2) and it was reported as "Ok, make that my wife. We've lived through these side effects mysteriously since 2 days after each of her injections. All the gaslit will swear by anything the government. So the actual truth is pointless to the uninformed sheep." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20221222808.
Pt received injection and 10 minutes mother noticed face was flushed and patient complained of a hot arm at the injection site.  Pt appeared with flat red blotches on her left deltoid which progressed to her arms neck and face. No blotches noted on her trunk. Pt was given 50 mg of Benadryl and monitored by EMS and NP for further reaction. Patient denied difficulty breathing or swelling in the oral area. Upon release patients mother instructed to monitor for any worsening symptoms or difficulty breathing. EMT counseled calling (!! if on a major highway and encountered any problems.
Accidentally administered vaccines to patients after the temperature excursion occurred; No adverse event; Accidentally administered vaccines to patients after the temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2022 at 2:29 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2022 at 2:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Accidentally administered vaccines to patients after the temperature excursion occurred) and POOR QUALITY PRODUCT ADMINISTERED (Accidentally administered vaccines to patients after the temperature excursion occurred).    No concomitant medication were provided.  It was reported that the temperature logger did not indicate correct temperature. The product was Covid-19 vaccine, orange cap for kids 5 to 11, maroon cap for 6 months to 4 years and gray cap. It was reported that the temperature was not recorded on the logger from 1:45PM until 9PM till yesterday, 31-Aug-2022 and one patient had received one of the vaccines. Later Clarified that vaccine that was administered was the Moderna vaccine not Pfizer. The Pfizer vaccines with orange cap for kids 5 to 11, maroon cap for 6 months to 4 years and gray cap were all involved but were not administered to patients. All those vaccines were located in the same refrigerator.   No treatment details were provided.
Initially upon receiving vaccine, it was very painful and I am not sure if that was vaccine placement or vaccine related. It was sore for about 2 weeks after that and then my shoulder froze up, I began stretching and trying to exercise it before I realized it was frozen in place. I am a type 1 diabetic and I have a neck fusion from a spinal injury. I thought the pain had something to do with that so I went to see my neurologist to get some scans done. Everything seemed fine from what they could see. Orthopedic also saw me and could not figure out what is going on so now I am awaiting steroid injections
This spontaneous report as received from a other health professional refers to an unspecified amount of patients. She reported that live ZOSTAVAX that underwent an unsupported temperature excursion may have been administered to the patients on unspecified dates. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Several hours after the shot I began to get body aches and fatigue, the intensity of the body aches increased the next day and started to decrease on the 2nd day. I also experienced headaches and chills.
Vertigo starting in the middle of the night after vaccination.  One incident while walking the next day.  Vertigo when turning over in bed- none while standing or walking.
Received the vaccine intramuscularly in right arm at 1:00 PM on 3/3/21. Pain and muscle soreness began approx. 10 minutes after receiving vaccine. Fatigue and headache present by 3:00 PM on 3/3/21. Began hydrating with water and Gatorade at this time. Muscle pain and join soreness present from right shoulder to right hand by 4:00 PM on 3/3/21. Pain and stiffness in fingers of right hand by 5:00 PM on 3/3/21. Mild congestion, brain fog by 6:00 PM on 3/3/21. Any contact between right arm and other objects or surfaces caused significant pain by 8:00 PM on 3/3/21. Took 800 mg ibuprofin to alleviate pain (pre-existing tolerance to NSAIDs necessitates higher than normal dosages). Swelling of the right arm and hand identified by 9:00 PM on 3/3/21. Swelling was most significant in the hand, and accompanied worsening joint pain and stiffness in the fingers. Applied a cold pack to address swelling (20 minutes on, 20 minutes off). Could not identify these specific side effects in the information available online, took a Benadryl in case it was an allergic reaction. Swelling decreased overnight and was gone by 5:00 AM on 3/4/21. Diarrhea began at 6:00 AM on 3/4/21 and is still present at the time of this report. Will continue to hydrate with water and Gatorade. At the time of this report, pain in right arm still present from shoulder to wrist and entire arm is tender to the touch, but pain level has lessened. Pain and stiffness in right side of neck present by 5:00 AM on 3/4/21 and is still present at the time of this report. Lymph nodes in right underarm swollen by 5:00 AM on 3/4/21 and swelling is still present at the time of this report. Will continue with regimen of ibuprofin as needed.  * I am recovering fine at home, but I wanted to log these side effects for data collection purposes. I couldn't find any information about these side effects online and that really freaked me out, so I hope that writing this report will help people in a similar situation.
Patient received a third dose (second booster) of Janssen which is not recommended or approved by the CDC.
Patient called morning after receiving vaccine (call placed today 5/6 around 12 noon/ vaccine given day prior 5/5 around 4pm) stating that he had gotten out of the shower this am and noticed a "symetrical, red, blotchy rash, with stitching pattern that looks like shingles" on right chest and back.  Patients daughter is MD, who they video chatted and she said it looks like shingles as well.  Patient states that he didn't feel the rash initially and only noticed it because he looked in mirror/ wife saw, but while talking then stated that it was "starting to burn a little"
Information has been received from a pharmacist referring to a male patient of unknown age. Concurrent condition and medical history were not reported. On an unspecified date in January 2014, the patient was vaccinated with one dose of GARDASIL (lot#, expiration date, dose and route were unknown). On 23-OCT-2015, the patient was vaccinated with the second dose of GARDASIL (lot#, expiration date, dose and route were unknown). No adverse effects were reported. Additional information is not expected as the pharmacist did not wish to be contacted further.
Severe headache; high fever 103degrees/101 degrees; muscle/joint pain; muscle/joint pain; tired; chills; Sore arm; achy; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfur and eggs. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and ezetimibe (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN8705), via an unspecified route of administration in the left arm on 09Mar2021 at 10:00, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 12:15, the patient experienced severe headache, high fever 103degrees/101 degrees, muscle/joint pain, tired, chills, sore arm. The patient also reported that the intensity lasted two 2 days and was still tired and achy. On 30Mar2021, the patient underwent test for body temperature and the result was 103 degrees and 101 degrees. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of the reported events. The clinical outcomes of the events severe headache, high fever 103degrees/101 degrees, muscle/joint pain, chills and sore arm were recovered on 01Apr2021 while the events tired and achy were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Registered Nurse refers to a 23 years old male student patient with no illness at time of vaccination, no adverse events following prior vaccination and carnitine-palitoyl transferase II deficiency (neuromuscular disorder). The patient was vaccinated with dose 1 GARDASIL on 11-MAY-2012 and with dose 2 GARDASIL, IM, left deltoid (dose not reported, lot # 672233/1561AA, exp. 26-AUG-2014) on 10-JUL-2012 at 12:10 PM. No other co-suspects were reported. There was no concomitant medications. On 10-JUL-2012 at 12:30 PM (also reported as "1 hour after vaccine"), the patient experienced fever to 100 and shaking chills. Chills occurred again 1 hour later. The Registered Nurse reported that 3 hours later examination and vital signs were normal except heart rate raised to 92. There was no nausea, itching, hives, etc. No treatment information was reported. The patient recovered on 10-JUL-2012. Laboratory tests done: T=98, O2 sat = 95%, BP 110/70. Additional information has been requested.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.   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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No adverse events were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.   This case was linked to MOD-2022-646512 (Patient Link).
Patient developed acute pericarditis Grade 2 per CTCAE V 4.03); This is a spontaneous report received from a contactable other health care professional. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3302), via intramuscular route of administration on 15Jan2021 (at the age of 37-year-old ) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included as multivitamins. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EJ1685, patient was 37-year-old at the time of vaccination), via intramuscular route of administration on 20Dec2020 as single dose for covid-19 immunisation and no event experienced. Patient had no underlying medical conditions, no history of cardiac events, or recent infections or trauma. No chronic health conditions or underlying medical history reported. No know allergies with past drug reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination, not tested for COVID-19 since the vaccination. On 15Jun2021 at 08:00, the patient experienced patient developed acute pericarditis grade 2 per ctcae v 4.03. Reported that event require emergency department visit after events experienced. The patient received treatment for event with Toradol 15mg IV, ASA 324 mg PO (orally). The outcome of event was not recovered.   Follow-up attempts are possible. Further information is expected.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PT HUSBAND SAID SHE IS COLD AND SHIVERING. PT GETS FLU VACCINE EVERY YEAR ACCORDING TO HUSBAND
Headache, nausea, diarrhea, myalgias, arthralgias, fever, intense arm pain, shooting pain in left axilla. This started the evening of my second vaccine, through the night and into the following day. All of this happened with my first vaccine also. Lot#  025L20A which was on 1/22/22 in the right deltoid.
Cyst filled with what appears to be sebum (though it could be white blood cells) on the TOP of my skin about one inch from the injection site. It appeared at some point while I had the bandaid on my arm, so I can't be certain of the exact time, but I noticed it the next day when I took my bandaid off. It's firm, but not hard. I can squeeze it and compress it.   It does not hurt, but doesn't seem like it's going to pop.
intermittent leg pain, uticarial rash on legs & trunk mild superficial skin peel, basically on palms onset 10 days p/vax;
Information has been received from a healthcare worker regarding a 8 year and 10 month old patient of unknown gender who on 29-OCT-2014 was vaccinated with a dose of GARDASIL intramuscular (dose, lot # and expiration date not reported). No known adverse effects. It was unknown if the patient sought medical attention. Additional information has been requested.
Return of the Sydenham's Chorea symptoms, including chorea movements and emotional lability.
This case was reported by a regulatory authority via regulatory authority and described the occurrence of malaise in a 40-year old female subject who received CERVARIX. In August 2010, the subject received the 1st dose of CERVARIX (intramuscular). In March 2011, the dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking. On an unknown date, the outcome of the malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking were unknown. It was not reported if the reporter considered the malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking to be related to CERVARIX.
Patient came back on 10/19/2018 and showed me her arm in which had redness and small hive like bumps that were itching. Patient came back on 10/22/2018 in which the injection site was very red, and still slightly itchy according to patient. That morning (10/22/18) she outlined the area with a marker to see if it will spread even more. According to the patient the redness was not as prominent and the itching is not as severe.