chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in with rash on chest and shoulders. She said it started the evening of vaccine and was improving by next day. Advised her to take BENADRYL and go to ER if symptoms worsen.
This spontaneous report as received from a registered nurse refers to a patient of unknown age who four years ago, in 2008, was vaccinated with the first two doses of GARDASIL and "today" on 18-JUL-2012, was in the office to get the third dose (Doses, routes and lot numbers not reported), No adverse effects were reported. Additional information has been requested.
Patient was admitted to the hospital on 11/25/2007 complaining of ascending progressive bilateral lower extremities weakness.  On 11/27/2007  patient developed respiratory distress that required intubation. Patient is currently on mechanical ventilator by tracheostomy.  3/21/08 Reviewed hospital medical records of 11/25/2007-03/06/2008. FINAL DX: Guillian Barre syndrome; acute respiratory failure.  Records reveal patient experienced progressivly ascending bilateral LE weakness/paralysis & HA w/falls.  Exam revealed SOB, flaccidity & quadriplegia w/absent reflexes & decreased gag reflex.  ICU & mechanical ventilation.  Tx w/IVIG, PEG feeding tube & tracheostomy.  Developed UTI; metabolic encephalopathy; nephropathy; myoclonus; anemia; hypoalbuminemia; hepatic dysfunction; exposure kerato-conjunctivitis; sepsis; mod-severe dysphagia; decubitus ulcers.  Despite aggressive PT, patient remained bedridden at d/c. 1/19/2010 Patient was discharged (transferred) to a skilled nursing facility.
Sore shoulder, radiating pain down arm, tingling in fingers. Still exists 12/27/2011.
pt recv vax 30OCT97 & approx 4:30PM gen edema @ site, warm to touch & tender to site;BP 106/70
Narrative:  COVID infection after completion of COVID vaccine series: 01/18/2021 COVID vaccine dose #1 02/09/2021 COVID vaccine dose #2 05/03/2021 COVID negative per pre-procedure nasopharyngeal swab 07/13/2021 Pt presented to scheduled nursing f/u appt c/o 2-day hx of fatigue, myalgia, dry cough 07/13/2021 COVID positive per nasopharyngeal swab 07/14/2021 Pt reported onset of chills and continuation of other sx 07/15/2021 Pt reported improvement of sx 07/16/2021 Pt reported improvement of sx 07/17/2021 Pt reported improvement of sx and intended compliance to self-isolate until 07/20/2021. Requested to be dc'd from daily telephone contact. 07/21/2021 Pt reported doing well and intending to attend upcoming scheduled appts
In the night post recieving Fluarix vaccine c/o severe bilateral calves cramping 2 hours. Resolved by morning.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 03-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician for concerning a 22 year old female patient with asthma, no allergies and no medical history, who on 07-OCT-2010 was vaccinated with a first dose of GARDASIL (Lot# 666945/0886Z, Exp date. 21-NOV-2012) and on 02-DEC-2010 was vaccinated with a second dose of GARDASIL (Lot# 666945/0886Z, Exp date. 21-NOV-2012). Concomitant therapy included Asthma inhaler and DESOGEN. The physician reported  that on 02-DEC-2010 the patient experienced redness and a surface nodule at the injection site after administration of the second dose of GARDASIL. The patient was treated with warm packs applied to the area. As of 10-DEC-2010 the redness resolved and the surface nodule was gone, but at the time of the report she had a 4 by 7 mm subsurface nodule. There were no laboratories performed. At the time of the report the patient's outcome from the subsurface nodule was unknown. The patient sought unspecified medical attention. Follow-up information was received which stated that the female patient with no illness at the time of vaccination was vaccinated with a second dose of GARDASIL on 02-DEC-2010, Right deltoid, unknown time. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Information  has been received from a nurse practitioner concerning a 1 year old female with no medical history and no drug allergies, who on 04-FEB-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 659693/1766U). Concomitant vaccination included PREVNAR vaccine(CRM197), administered in a different injection site from the varicella virus vaccine live (Oka/Merck). On 13-FEB-2008 the patient developed an injection site reaction where the varicella virus vaccine live (Oka/Merck) was administered. The symptoms included redness, local heat, and swelling. The patient was treated with an antibiotic. No laboratory diagnostics were performed. At the time of the report the patient was recovering. This is one of two reports from the same source. Additional information has been requested.
Pt. c/o weakness, chest tightness, bottom lip swollen, HA, body aches - mom feels it is related to MENACTRA vaccine given day before.
Bruise at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), QUETIAPINE FUMARATE (SEROQUEL) and CLONAZEPAM for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had no fever and a cyst was removed from opposite left arm on 23-Apr-2021. Treatment information also included Ice pack.
Pain where shot was given, muscle pain, feeling weak, headache, shivering, fever, stomach pain.
They have not been tested enough andall shots made the patient extremely ill; The patient had long term effects; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and IMMUNISATION REACTION (The patient had long term effects) in a 48-year-old female patient 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) 1 dosage form. On an unknown date, the patient experienced ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and IMMUNISATION REACTION (The patient had long term effects). At the time of the report, ILLNESS (They have not been tested enough andall shots made the patient extremely ill) and IMMUNISATION REACTION (The patient had long term effects) outcome 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.   The treatment medication was not reported. The concomitant medication was not reported. The case was reported for patient number 24 out of 63 patients (Bivalent).   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report). This case was linked to MOD-2023-714836 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Rec'd 0.5 Quad. flu injection at office 1/22/14. S/S began 1/23/14; seen in office for (+) light pink erythema area 12-15 cm and (+) pruritus at site. Afebrile. ((+) warmth to touch). Tx with ice packs, BENADRYL and to c/ office if fever or other s/s occur.
Pt came in to receive 2nd shot but after he got his shot staff realized he had already received 2nd shot and this one would be the third.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 9:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.37    No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 27-OCT-2021 with temperature 29,32 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-OCT-2021 and beyond use date for the vial was reported as 04-NOV-2021. Product moved to clinic on 27-OCT-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
pt recvd vax; cried x 7hrs; irritable & fussy for 4 days; on 5th crying x several hrs;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-SEP-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # R013303, expiry date: 08-MAY-2020) and properly stored diluent (N037594, expiry date: 25-AUG-2020) on 18-SEP-2018. The vaccine was stored at a temperature of 6°F to 14°F for 105 minutes and at 15 °F to 46 °F for 75 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported.
8/11/19 Golf ball size redness, heat, hardness at injection site.  8/16/19 Vesticular rash on legs, arms, stomach, headache 8/19/19 Vesticular rash remains the same  8/27/19 rash improving
I have never had this before, but since getting the vaccine, I have had horrible nightmares every night since getting the Pfizer vaccine. My husband has to wake me every night, and this has not let up. Also, I have had a Fibromyalgia flare-up since getting the vaccine.
No additional AE details available/he patient has not experienced any adverse effects from the expired dose; administered a dose of VAQTA on 1/14/2021 that expired on 1/11/2021; This spontaneous report was received from a physician's office manager and refers to a 12-month-old patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 14-JAN-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) prefilled syringe, 0.5 ml, lot # S032359 was confirmed to be valid, expiration date was 22-JAN-2021 (route of administration and anatomical location were not reported) for prophylaxis.  The patient did not experienced any adverse effects from the expired dose and the expired product had not had a temperature excursion at any time. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Extreme tiredness, excessively sleepy - lasted for around 36 hours.  Able to stay awake, but like I had taken 6 Benadryl and was trying to stay awake.
I spoke with the nurse manager at the facility after 1st injection.  My arm was red hot and had a "blotch" about 4" wide and 6" tall.  I mentioned it during a OB visit and she gave me 10 days of Keflex bid; no relief at all.  I went to urgent care and they dx it as cellulitis; gave me a Rocephin injection.  That was the left arm (shot given on 1-11-21. Now on 02-09-21 I went for 2nd shot in right arm.  (left arm is still not "right" color and is warmer to the touch than it should be). And the right arm is doing the exact same thing.  Bright red.  Very hot.  Creeping down my arm.  It's about 3x3 right now. I am taking Benadryl just to help in case its inflammation.
Skin rashes started appearing on my forehead and started spreading over my forehead is very itchy and the head feels heavy   I have started  seeing another patch of rashes slightly above my right knee on the inside of the thigh.  This is also itchy.  Applying coconut oil to prevent dryness.
Erythema and swelling of 6" that was mildly tender with increased irritability.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL lot # L035105/expiration date 14-MAY-2017. No adverse event. Excursion temperature was 31 F and timeframe was 152 days (worst case). There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an 81 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K006681, expiration date: 21-OCT-2015 (dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Pt developed redness and itching at vaccine site. Initially resolved after 3-4 days then recurred in 1 wk after vaccine was administered. (R) thigh.
Headache, nausea, dizziness, lightheadedness, lack of concentration  and memory issues
Suspected vaccination failure; Shingles; little patch of blisters about two inches wide; deep pain in my shoulder before I even broke out; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and shoulder pain. The patient was treated with steroids nos (Steroid Shot (Nos)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, blister and shoulder pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and shoulder pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated anyone could get shingles from both vaccines. The patient got shingles after receiving the Shingrix vaccine. The patient noticed the little patch of blisters about two inches wide. The patient went to urgent care and they said it was shingles and gave a steroid shot and a steroid prescription. Shingles were on shoulder and patient had deep pain in shoulder before the shingles even broke out.  The reporter stated that sooner you get a shot and medicines the better it was. The patient never got any worse. The shingles without the vaccine would be way worse. The reporter stated the key was did not wait if you suspect you have them. Get treated immediately. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown. For tolerance of 1st dose of Shingrix, refer case US2021AMR063231.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063231:same patiet
Runny nose and prickly skin like hives were going to occur. I took an eighth of 25 mg Atarax and Clariton D.  Again at night. The site was itchy. I used Benadryl cream and massage, which was affective.  At no time did I feel sick or unable to go through my normal, retired life. Today is Monday. I am fine.
Information has been received from a physician who reported that she had received a call from an OB/GYN concerning a newborn female who was vaccinated with Hep-B vaccine recombinant (yeast). The female died of sudden infant death syndrome. The reporting physician noted that the infant's father, also a physician, had a listing of as many as 40 additional cases of sudden infant death syndrome with Hep-B vaccine recombinant (yeast) (WAES01050372). No further details were provided. Additional information has been requested. Additional info from the physician indicated that this was a case of a newborn who was vaccinated with hep b vaccinee shortly after birth. A few days after birth, the newborn went home from the hospital and started to have "blue episodes." The infant was admitted to the hospital to rule out "SIDS, jaundice and sepsis." In the hospital, the infant's bilirubin was 20 and the jaundice was associated with the infant being breast-fed. The infant was subsequently discharged to home from the hospital. The physician reported that the infant did not die of SIDS, and the diagnoses had nothing to do with the hep b vaccine. At a later unspecified date the infant's mother was in the physician's office for a sick visit with an older sibling of the infant patient. The physician asked the mother how the infant was doing. The mothe rtold the physician that the infant was still having "blue episodes during feeding." The physician examined the infant and could see that the infant had "vocal cord damage due to gastric reflux." The physician referred the infant to an ENT, who made the diagnosis of gastroesophageal reflux disease. The physician reported that the infant has since recovered 100% and that the blue episodes, and the diagnosis of gastroesophageal reflux had nothing to do with the hep b vaccine. No further details were provided.
Started to experience chills, headache, as well as sensation of chest tightness.  The chest tightness feels the same as what I experienced when I had Covid.  It is mild, and I do not have a cough.   The chest tightness that I had from Covid went away about 3 weeks after my positive test.  It had been gone for about 5-6 days when it came back after getting my Pfizer shot.
Arthralgia l shoulder Narrative:  Reports noticed l shoulder pain sometime after flu vaccination on 10/2/2020, pain is 4/10.
Progressive generalized weakness which began approx 7-10 days after administration of influenza vaccine. (Guillain Barre).
Patient claims that ER told him that he had MRSA and it was from one of the vaccines administered.
Developed joint pain (left shoulder) one week after vaccination. Then similar symptoms in right shoulder; hands and fingers. No erythema or edema. No systemic symptoms. Symptoms have been resolving.
Headache - moderate.  Facial numbness - started at the nose, across the bridge of the nose and upper cheeks, then spread to entirety of face.  Face is still somewhat numb 55 minutes after symptoms began.  Headache also still present.