chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, a pharmacist at a pharmacy administered the ZOSTAVAX (dose, route of administration, and lot # were not reported) to the patient. On or about 2016, the patient was treated by a physician/MD for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment was related. Additional information has been requested.
Saturday 01/22/05, patient was taken to ER. She had a temp of 104.4, glands were swollen, rash on her neck and chest, and her groin area had some swelling. She had measles shot on 01/11/05. ER doctor performed a strep test, influenza and UA to rule out a bladder infection. All were negative. ER doctor also performed a white blood cell count. No treatment administered. Motrin and Tylenol was recommended to give for fever. 01/25/05, patient has a low grade fever and is fatigued.
SORE THROAT; ARM BRUISING; DIARRHEA; HAND TREMORS; HARF TO OPEN AND CLOSE HAND; BODY ACHES; ARM SWELLING; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced arm bruising. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced hand tremors. On 13-MAR-2021, the subject experienced harf to open and close hand. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced arm swelling. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. On 16-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand tremors, and had not recovered from arm swelling, arm bruising, headache, diarrhea, body aches, fatigue, harf to open and close hand, and sore throat. This report was non-serious.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
No fever, back aching, stiff arms, high pitched cry. Lasted about one hour.
headaches, Right upper back pain, Left arm pain, chills.  headaches still present, but improving
Pt recv vax on 1/13/98; on 4/16/99 pt exp shingles
pt recv vax 30OCT97 &  31OCT97 pt reported 2-3" hard area @ inj site;hot;no visible swelling or discoloration;c/o pain/stiffness radiating into shoulder/upper back/neck;
Extreme flu like symptoms at first, but then developed shortness of breath and chest pain. Pain worsened when attempting any activity and subsided somewhat when lying down. Went to the emergency room around 1:00 PM on the 20th, where my initial heart rate was at 163 bpm. The emergency staff gave me an EKG, fluids, and potassium pills. All my blood work and a cat scan came back ok. My heart rate eventually got down to about 120, and they sent me home.
FINGER ARTHRITIS LOOKED LIKE SAUSAGES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced finger arthritis looked like sausages. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from finger arthritis looked like sausages. This report was non-serious.
Raised red bumps appearing all over body of child 10 days from date of receiving MMR Vaccine.
Developed herpes simplex in the eye, April, 2009. Was treated by Dr. for it.
Patient received Moderna COVID vaccine at 12:13. Patient noted that at 12:25 she felt lightheaded and nauseous. She denied any throat itching/swelling or difficulty breathing.  At 12:40 vitals were: Blood Pressure: 118/84 Oxygen: 98 Pulse, 77.   After drinking water, patient noted she felt chills. After no improvement nor deterioration, patient was transferred to Convenient Care at 13:18.
Developed cholinergic urticaria which is now chronic. Prior to vaccines-regularly exercised without issue. Now, anytime I run 3 miles and start sweating, I break out in head to toe hives and get bronchospasms. I get hives all the time now.  I also have significantly worsened  allergy-induced asthma
Information has been received from a physician concerning a 13 week old white male who on 09-NOV-2000 was vaccinated IM with a dose of Comvax. On 09-NOV-2000, the pt developed a knot which appeared on injection site several hours after it was administered with no redness and no fever, Subsequently,  the pt recovered from the event. Additional information has been requested.
A report has been received from a Health Professional via MedImmune representative concerning a 5 year old female patient. The relevant history and concomitant drugs of patient were not reported. Patient was a healthy child-no medical issues. The patient had been receiving FLUMIST quadrivalent (intranasal) started on 23-Oct-2013. MedImmune representative stated that 3 patients contracted the flu after being vaccinated with FLUMIST. The patient was diagnosed with flu after vaccination with FLUMIST which started on 18-Nov-2013. She was treated with TAMIFLU. The outcome of the event of flu diagnosis after vaccination was unknown. The reporter considered the event of flu diagnosis after vaccination with FLUMIST to be non-serious.
severe h/a 3SEP91 AM-PM; vomiting p/MN; seizures 7AM on 4SEP91; coma-death 1225PM on 4SEP91;
Information has been received from a physician concerning a 21 month old white male patient with a cough, who on 11/18/2003 was vaccinated in the right arm with a first dose of varicella virus vaccine live.  On 08/30/2004 the patient started to develop chickenpox.  He had two pox on his torso and then seven more pox broke out on the opposite side of his torso.  The chickenpox lasted seven days.  The patient recovered on 09/07/2004.  Unspecified medical attention was sought.  No additional information is expected.
This case was reported by a consumer via call center representative and described the occurrence of malaise in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2018GSK150451). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than an hour after receiving SHINGRIX, the patient experienced malaise, chills, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance. In August 2018, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the malaise, chills, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the malaise, chills, pain in arm, bizarre dreams, fever, weakness, feeling abnormal and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: In the afternoon, the patient received SHINGRIX in the left deltoid. Within an hour or so after vaccination, the patient started to overall not feel well (described as malaise). By 10 pm that night (several hours after vaccination), the patient felt like she had been run over by a truck and by midnight, she started to experience high fever, chills, and weakness and slept off and on and had weird dreams. This lasted for 4 hours. By the morning of 8th August 2018, fever and chills were gone but the patient still had weakness. At the time of reporting, the patient felt better. Less than a week after vaccination, the patient experienced pain in the injected arm that was still sore at the time of reporting.
pt's sister fainted, and at the same time, pt fainted for a few seconds and regained consciousness. pt felt cold and warmed up after a few minutes
Mom states pt had fine red rash across face/trunk/inc temp x 2-3 days; Onset 24FEB-27FEB92 rash; Onset inc temp 20FEB - 24FEB92;
pt recv vax & devel herpes zoster (shingles) on chest in definite dermatomal distribution-vesicular clustered lesion;
Approximately 2 months after having vaccination my father started having episodes of weakness and fatigue  which he never had before, but he blamed on ?low blood sugar?.  These episodes culminated at the local park where he was walking his dog when he became weak and unsteady and began slurring his speech.  He got home and returned to base line that night, but the next morning woke up very confused, unable to effectively use phone to contact me, depth perception and coordination issues and fait and balance dysfunction.  He was taken to medical crnter ER where he was found to have had a stroke and was in afib with RVR which the doctors had significant difficulty getting  under control, returning multiple times over course of  6 day hospital stay.  He had diagnosis of afib, but had never had any issues once placed on beta blocker and aspirin treatment 7 years prior with f/u with his cardiologist just before vaccination initiated.
Pt. was given gardasil 10/15/08 at 1700 hrs,  immediately fainted and body jerked once body went limp from fainting. I believe Pt. had a seizure.  Within hours, suffered from severe abdominal pain where pt was guarding abdominal.  Clinic contacted 1000 hours on 10/16/08.  Instructed to return Pt to office at 1300 hrs. Pt was placed on bland diet and prescribed pedilite, and zantac 75 mg bid.  2330 hours, Pt. suffered severe abdominal pain and taken to hospital.  Pain rated 9 out of 10.  Given Lidocaine to numb pain,  no labs were performed.  Pt described pain as, "Pain is like when your foot falls asleep and you feel pins and needles in your foot.  Only the pain is much worse,  like 10 times worse."  Pt. is still have abdominal pain.  10/24/08 office note received from PCP with vax rec.  11/10/08 ER record received for 10/16/2008 with Dx: Abdominal pain. Pt presented with c/o abdominal pain since receiving vax 1 day prior. Pt reportedly fainted after the HPV injection and then developed severe abdominal pain described as pins and needles. PE WNL. Tx with Maalox/Lidocaine po with improvement and d/c home.
Swollen lymph nodes in neck and big red bruise on left wrist  bruise went away but neck swelling for 2months and ongoing...
Post vax, left deltoid area of arm became red, swollen and warm to the touch. The child was seen in the clinic the following day with left deltoid area indurated 16cm X 14cm. Child also had a fever of 38C. Suspected immunization reaction; however, also given 7 day course of Keflex just in case of cellulitis concern. By 2/15/02 (approx. 48 hours, post vax) affected left deltoid area was minimally reddened, no warmth and no fever but just slight erythema around the vaccine site by 2cm diameter.
Vertigo, onset 5:15 pm; lasted through going to bed (10:00 pm); had resolved by wake time next day
hot; bright red; round spot around the injection site; itching; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE DISCOLOURATION (round spot around the injection site), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (bright red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, FLUOXETINE, BUSPIRONE and LAMOTRIGINE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (round spot around the injection site) and INJECTION SITE PRURITUS (itching). On 17-Jan-2021, the patient experienced INJECTION SITE WARMTH (hot) and INJECTION SITE ERYTHEMA (bright red). On 18-Jan-2021, INJECTION SITE PRURITUS (itching) had resolved. On 19-Jan-2021, INJECTION SITE DISCOLOURATION (round spot around the injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (hot) and INJECTION SITE ERYTHEMA (bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 4:07 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 4:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Throat swollen, difficulty speaking, swallowing and breathing Still continues to have swollen throat, difficulty speaking. Skin broken out on legs and feet. Has been prescribed several medications.
First episode of Herpes Zoster in R C6 dermatome 3d after the #1 in series Pfizer Covid vaccine.
9 1/2cm D local reaction in R deltoid (erythema, induration).
several hrs p/the shot cried a high pitch cry for maybe an hr; gave pt APAP every 4 hrs until the next day; the next noc p/shot pt was pale & limp & had a t103.5; pt taken to ER:
The patient stood up after the vaccination and felt very lightheaded. She immediately sat back down since she lost her balance due to dizziness. She was very  pale and anxious. After drink water and sitting down for 10-15 minutes, she felt much better.  She walked out of the store once she felt better along with her parents.
Hives on face and legs 3 days after receiving vaccines, and still has Sx as of today.
pt recvd vax 26OCT93 & 18NOV93 URI sx, arthralgias, chills, voice hoarseness, abdo cramps, ?viral synd;19NOV93 facial pressure, put on amoxicillin;21NOV93 chills, chest pain, pruritic rash, flushing;23NOV93 swelling;6DEC93 ruptured appendix
Heavier flow during menstruation since vaccination More clotting during menstruation since vaccination Increased duration of menstruation since vaccination More cramping and diarrhea during and immediately prior to menstruation since vaccination
Extremely painful when vaccine was injected into my arm! The pain radiated up and into my left jaw.  I could taste the vaccine.  Before the injection I discussed the fact that I have many allergies and my concern that the form didn?t ask which vaccines I had had anaphlaxic reactions to. My tongue immediately became slightly swollen.  By the time I arrived home an hour later, I could barely left my left arm, I was sick to my stomach and almost started to dry heave; it passed in about 10 minutes. My tongue remained swollen until 7:00 pm 6/30/2021.  My arm remained extremely sore until 7/01/2021; the injection site still hurts a little as of 07/05/2021..  on 07/02/2021 I had chills until approximately 5:30 pm.  I carry Epi-pens should I need to self administer.
Went into a sustained A fib event at approximately 8:30 pm approximately 11 hours after receiving vaccine. Entered ER and was treated for A fib with A fib lasting approximately 10 hours with cardiziem administration and continued to be hospitalized for another 6 hours for monitoring for stability.
This case was reported by a pharmacist via Merck and described the occurrence of pertussis vaccination reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced pertussis vaccination reaction and possible gluten reaction. The pharmacist reported a subject had a "reaction to the gluten that's in the pertussis vaccine. The subject has recovered". At the time of the report no other information was provided. At the time of reporting the events were resolved.
3-5 mins post 1st dose vaccination on the left arm, patient began having a "funny taste" sensation on her mouth, tongue, and throat. She had dry mouth and numbness in her upper and lower left lip. She was brought over for observation. Vitals were within normal limit. Neurologic exam was normal. She was given Benardryl 25mg one tab and post administration, the "funny taste" sensation in her mouth resolved but the numbness in her her lips remained for another 20 mins. She reported feeling anxious since she had several deaths in the family within one month. She also admitted to feeling a funny taste in her mouth after getting shots. She denies any chest pain, SOB, wheezing, dizziness or nausea. She declined medical transportation to the ER. She was monitored for over an hour. She was advised to follow up with the ER if worsening symptoms of anaphylaxis. She was informed to follow up with her PCP or allergist for further evaluation prior to having her second dose.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The registered nurse reported that an unspecified number of patients were administered an unspecified number of doses on unspecified dates of VARIVAX (Merck) (lot# J012377 with expiration date 03-OCT-2015, lot# J009002 with expiration date 19-JUL-2015 and lot# J009728 with expiration date 07-AUG-2015) (dose, strength and route not reported) that were improperly stored. No adverse events were reported. It was unspecified if the patient seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
A baby received the Vaxelis vaccination yesterday afternoon. Overnight, the infant appeared sleepier per parents and had a few self-resolving A/B/D events. Throughout the morning, the infant became progressively lethargic with apneic spells and significant desaturations requiring blow-by, PPV, and ultimately NIPPV. A partial sepsis workup was completed, which was unremarkable. RVPCR negative. CXR and AXR were wnl as well. Blood and urine cultures are pending. By late afternoon, the patient had improved, and we were able to wean respiratory support and slowly restart feeds.    Prior to receiving the vaccination, the infant was PO'ing well, on RA, and preparing for discharge. On review of the vaccine information, it reports:  "Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant?s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely." Somnolence is also frequently reported (>40%).
Patient complained of abdominal pain and "feeling hot." Patient diaphoretic on upper lip and nose. Patient offered water. Denied SOB. Patient voiced feeling better after drinking water. Patient monitored until 12:15. All symptoms resolved at discharge. BP 114/72, BS 115, HR 97, O2 SAT 99%.
Localized reaction-site erythemic, swelling and warm to touch Duration-approx 8 days until resolved.
Pt with swelling of right upper arm 10cm x 10cm reaction, red, warm. No pain. Pt also with fever of 101 degrees last 24 hours. Tx: Benadryl q6 hours prn, Tylenol prn, ice packs prn.