chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & 1SEP95 & LMP 25JUL95;estimated date of delivery was 3MAY96;it was noted that pt perhaps exp a sl fever following vax;
Information has been received from a consumer concerning her 16 year old daughter with no allergies or medical history who in 1997 was vaccinated IM with a first dose of Varivax. There was no concomitant medication. On 16-OCT-2006, the patient developed shingles. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
LIGHTHEADED AND DIZZY RIGHT AFTER SHOT WAS GIVEN, GAVE HER SOME WATER TO SIP AND SHE SAT FOR ABOUT 15 MINUTES AT THE PHARMACY
BAD REACTIONS; This spontaneous report received from a consumer via a company representative concerned 45,000 patients of unspecified age and sex. 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 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 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 MAR-2021, the subject experienced bad reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reactions was not reported. This report was non-serious.
injection site pain, other symptoms; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2022 Reporter's comment: The patient received Bexsero and experienced injection site pain and other symptoms that led her to visit the emergency room. No other details were given. The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2022AMR112712, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR112712:same report, other patient
The morning after the first dose i woke up dizzy.  It subsided during the day, but returned that night upon lying down in bed.  This reoccurred every morning and night for well over a month and after the second dose.  It would subside during the day, but i did have periods of lightheadedness during the day.  These still occur every so often.  I had never had this issue before.  After the second dose i had a rash on parts of my arms and legs that i had never experienced before either.  It looked like tiny little bites all clustered but was not any kind of bug bite. None of the spots were severe, but they itched like mad and would appear randomly in different parts of limbs.  This lasted maybe a week or two. I took an over-the-counter allergy pill for a few days and it subsided.  I still get the occasional bump, but they are not as itchy nor do they last as long.  The last thing to happen is the almost chronic joint pain, especially in my hips.  I have worked on my feet for almost 40 years and have never had issues with my hips.  They just ache and this was a sudden onset, not gradual (as would be expected with aging) and is different than mere pain from workload.  This is the most bothersome and my fiance even said he has never heard me complain about the pain as much as i have lately.  I take an Aleve almost everyday, where i used to only take one occasionally for lower back pain.
Purpura-like rash along hair line and in scalp and also back of neck, with a few scattered on body. Child began crying loudly and moving about constantly, began about 15 minutes after vaccines were given. Benadryl given IM and sent to physician after about 15 minutes more observation.
very sick for 3-4 days,lethargic, diarrhea. and very very bad headaches  these headaches are still continuing and last 1-3 hours very sharp and go from the front of my head to the back of my neck. Lethargic is still continuing
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus ("improving as of today") and vaccination site pain (left sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022C21A) for COVID-19 immunization. No medical history reported. On Dec 1, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced  vaccination site pruritus ("improving as of today") and vaccination site pain (left sore arm). At the time of the report, vaccination site pruritus ("improving as of today"): not resolved and vaccination site pain (left sore arm): resolving. No concomitant medications reported. Patient had experienced symptoms in Dec 2021. Patient's treatment medications included nighttime medications to help her sleep.
Patient experienced 2 - 3" wide red, swollen area around injection site, plus general swelling and redness a few inches past that. Pt also experienced flu - like symptoms.
3-20-19 Mom called at 4 PM stating pt had been complaining of pain in arm where she got shot since vaccination. Mom had not looked at arm until now and states there is no swelling or redness. Mom encouraged to make contact with PCP if symptoms persist. No use of mobility. 3-22-19 Mom called again and states pt still C/O arm pain but mom has not followed up with MD. Questioned about prior injury or symptoms, over use etc. Pt is a cheerleader. 03-26-19 I called mom to follow up on pt and she states that pt hasn't complained since our last conversation on 3-22-19. Pt refused to go to ER for check per mom. Mom cut our conversation short stating she was "watching children and had to go". Again encouraged to follow up with PCP.
Fever  Feeling tired  short of breath all night and morning after the vaccine  My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed.
Her arm felt sore; Started to feel sick; This is a spontaneous report from a non-contactable healthcare professional. A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration "yesterday" on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the day after receiving the vaccine, the patient woke up and her arm felt sore. She started to feel sick. The patient wanted to know if it was normal that she was having the side effects the day after receiving the vaccine. The outcomes of arm felt sore and started to feel sick were unknown.  No follow-up attempts are possible. Information about lot number cannot be obtained.
Very bad headache , dizzy  now I am not talking right. Have not feel right since. Arm is still red and swollen
20 minutes after vaccine, cold chills sweat.  30 minutes after shortness of breath blochy rash neck/ torso.  went to urgent care, wouldnt let me enter becuase didnt have a phone on to call.  Went home, took 50 mg benadryl pepcid PO.  took albuterol inhaler due to tachypnea.    tried to wait it out at home.  apporox 0200, rigors/ seizure tachypnea continued with respirations ranging 32-38/min.  took 600 mg ibuprofen and albuterol inhaler, additional 50 mg benadryl.  continued blocky rash.  next day, called urgent care asking for appointment, thought needed steroid, they instructed to go to ED to check for covid.  explained to them not covid, but allergic reaction.  afraid to go to ED in thinking may need to get intubated.  approx 1030 am, had 2 addtional episodes of rigors/ seizure.  temp never above 99.0 F.  found epi pen in house and used it.  no further rigors, no further tachypnea, rash disappeared.
The patient received the vaccines on 6/3/22 around 1PM; parents reported about 24 hours later, his right thigh began to turn red and warm with swelling. He was seen in PCP office 6/6/22 with similar symptoms. Patient denied pain.
8/1/06 Client had severe generalized muscle aches and severe diarrhea 8/4/06 Client had bloody diarrhea, went to ED.  Client was given 2 hours of IV fluids, Vicodin, and antibiotic Levaquin.
9:57 Dose administered. 10:15 RN noted (3) -approximately 1 cm wheals to right arm. MD evaluated and Benadryl 25 mg PO was administered. Monitored for additional 15 minutes. No changes or worsening of symptoms were noted and pt. was dismissed.
pronounced swelling and redness; pronounced swelling and redness; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  An 82-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vacccine (diphtheria CRM197 protein) (PREVNAR 20), on 05Jul2023 at 03:00 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Hyperlipemia" (unspecified if ongoing); "DM" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 06Jul2023, outcome "recovering" and all described as "pronounced swelling and redness".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Chills, Fever, Nausea, Weakness in limbs, Very Sore Arm
This spontaneous report was received from a healthcare worker and refers to 5 patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number 100316 (lot number if not valid for zoster vaccine live), expiration date 30-APR-2016). Concomitant therapy information was not provided. On an unknown date, there was an incorrect product storage as the patients received a dose of improperly stored ZOSTAVAX. No adverse events were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
within hour of injection: pain spread throughout left shoulder.  Within 12 hrs: headache, lethargy, continued pain around deltoid,  slightly elevated body temperature, treatment with ibuprofen.  Within 42 hrs: loss of sense of taste, no headache, lessened pain at injection site, normal energy.
ringing in the ears; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s):   A 59-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 2022, outcome "unknown", described as "ringing in the ears".  Additional information: It was reported the patient experienced a severe reaction; the only specific symptom they described was ringing in the ears.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHILLS; STOMACH MUSCLE PAIN; This spontaneous report received from a patient 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced chills, and stomach muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and stomach muscle pain was not reported. This report was non-serious. The case is associated with Product Quality Complaint number: 90000187552.
Day 11 of: Extreme Fatigue Chills Headache Loss of appetite Foggy head
Patient began to develop rash about 36 hours after vaccine administration. Ten days later (9/1/12) she was admitted to our hospital with a generalized, erythematous rash which started in her extremities and spread to her trunk. Upon admission, the rash was desquamating in character and she was also hypotensive with SBP in the 70s. Patient was using OTC antihistamines which helped. In the hospital she received diphenhydramine 50 mg IV q8H PRN and triamcinolone cream applied to all rash areas. Patient was dicharged on 9/6/12.
Itching at injection site after 15 minutes post injection which progressed to itching and rash  of the flanks and neck. She did report itching in her throat. At no time did the individual develop any raised rash (no wheal) or respiratory / cardiac distress. No pulmonary distress or wheezing occurred. Her vital signs remained stable.  She responded well to diphenhydramine 25 mg po x one dose and famotadine 20 mg po x one dose. She was observed for 3 + hours while her spouse drove to pick her up as she was advised not to perate a vehicle due to her Benadryl dose.
(L) UE redness, occurred 24 hours after vaccine. Persistent pain/edema as of Tues 6/30 (6 days later)-50% improvement. T= 97.1 F.
Inconsolable crying, high fever up to 105, developed an intolerance to milk, got an ear infection. Fever was treated by rotating tylenol and ibuprofen every 4-6 hrs but the tylenol didn't help the fever, ibuprofen helped for short periods of time, alcohol baths with a rag helped a little. Called the dr and she stated that if her fever didn't drop to bring her in in the morning, we went to ER that night because her fever was entirely too high, she received an iv for fluids and tylenol. Her fever dropped after about 2 hours and we were sent home. Within 3 or 4 days the fever subsided and we then notice a milk intolerance. She started to get really constipated to the point where we had to give her laxatives. For the next 3-4 months she wouldn't sleep at night, she developed what we thought was colic, she wouldn't sleep in her bed anymore and had severe anxiety if I put her down for any amount of time, she also developed an ear infection within the first week after having the vaccines. Now she is 6 yrs old and showing signs of ADHD.
Pt received Fluzone HD and Pneumovax vacccine on discharge at 1100.  Pt started having fevers up to 103 by 1600 that eve. Represented to the hospital at 2000 that eve. Pt hospitalized for fever, ams.  On 10/11, the next day, pt developed a red rash around the injection site for the flu HD vaccine.
Patient received influenza vaccine at 2pm, around 7pm she noticed red, blotchy spots all over her upper trunk, stomach and back area that were warm to touch, no itching voiced, she then had several bouts of diarrhea and having periods of hot/cold with fever. She continued throughout the night with these symptoms. She stated that symptoms subsided about 430am and she felt much better and by 11am all symptoms were gone. She did take Tylenol for the fever.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 31-MAY-2016, the patient was vaccinated with a dose of improperly stored GARDASIL or GARDASIL 9 and lot number K010215 with expiration date of 05-APR-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 544 hours and at the lowest recorded temperature of 32 (0 Celsius degrees) for 168 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient reported a 1/4-1/2 dollar size red swollen area on Left arm with bruising and a 1/4 size knot on he right arm. Patient returned for follow-up employment vaccination on 12/5 and the right arm injection site was now red and swollen as well. Caregiver reports no loss of function or motion in either arm. Patient was told to treat with TYLENOL, Ibuprofen and ice. Patient has since recovered.
redness, pain, puss, skin warm to touch. recommended patient go to doctor. had vaccine 10 days ago
running nose w/in 5min;burning throat w/in 5min;burning arm shot area;inj site turned red immed & lasted four days;size larger than silver dollar;
pt had dizziness, nausea and warm feeling and tingling in her hands.  The dizziness and nausea occurred about 10 minutes after administration and seemed to get worse and the warm feeling and tingling occurred. We gave sips of water as she had dry mouth and placed cold compress on forehead, we contacted 911 and they decided to come and did go ahead and take her vitals, she refused to go with emts and seemed to be okay
Patient felt L sided weakness and couldn't stand up, had some slurred speech-admitted to PHC 4/26/21  At hospital-EKG- within normal limits, PTT elevated not a TPA candidate, CT of head unremarkable, no acute intercranial findings, unremarkable Circle of Willis and MRI of brain -pending.
This spontaneous report was received from a physician via field representative, refers to multiple unspecified patients (which included friends as well as individuals that were going to nursing school) of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant medications were not reported. On unknown dates, these patients were vaccinated with the complete three-dose series of RECOMBIVAX HB and subsequently received a booster dose as well, (inappropriate schedule of drug administration). On unknown dates, titers were drawn from these unspecified patients and they did not have antibody titers for hepatitis B (hepatitis B antibody negative). Outcome of the event, hepatitis B antibody negative was unknown. Reporting physician did not assessed the causality of the event with respect to therapy with RECOMBIVAX HB. Additional information has been requested.
The day following my vaccine, I became extremely nauseous and fatigued.  I was unable to lift my head or open my eyes because of extreme dizziness/nausea for 24 hours. Over the next 2 months, ending around June 11th, I had migraines almost every other day, constant nausea, and a few migraines that lasted 3-4 days.  At one point, I needed to go to the ER to get relief from the migraine.  This helped for about 3 days before the migraines returned.  At 2 months out, the migraines have improved, but I still have very tight muscles and stiffness throughout my body, a symptom that I often get along with migraines.
About 10 mins after receiving the shot I got itching on my neck, shoulder and arm by the injection site then inching in my mouth/tongue. I took BENADRYL and we monitored my VS- I had tachycardia and hypertension. Symptoms seemed to die down so I left at 40 mins and about 5 mins later I felt an impending sense of doom, rush of tachycardia, head rush, flushing and shortness of breath/dizziness. I then gave my epi pen and had my husband drive me back to the clinic where they had me then go to the ER for monitoring. I continue to have itching in my mouth, headache, intermittent tachycardia but am otherwise now feeling fine.
Facial tics then progressing to eye injection, redness and mild swelling to eyelids, hives to face and neck
Pt presented to the ED 1/14/22 with signs of stroke, a stroke alert was called, she was admitted to the hospital for observation.  Patient continued to have altered mental status and suicidal ideation.  CT angiography of the head neck did not show any large vessel occlusion.  CT perfusion scan did not show large vascular territory infarct.  MRI of the brain did not show acute CVA.  Chest x-ray did not show acute intrathoracic process. Pt diagnosed with COVID 1/24/22 however has remained stable not requiring any antiviral, breathing treatments or oxygen.  Physical therapy is recommending placement in a skilled nursing facility due to comorbidities.  Patient vaccinated Moderna 3/31/21, 5/3/21 & 10/20/21.
1.  Muscle soreness at injection site/arm 2.  High Uric Acid Levels as determined through blood teats 3.  Gout-type joint pain in the knees and back.  The pain limits movement and and causes stiffness of the joints when sitting or after sleep.  I still experience the pain.  I have altered my diet (Gout symptoms recommended foods) to try and reduce the uric acid levels.
Pfizer-BioNTech COVID-19 Vaccine EUA On 12/21/2020 13:17 the patient received the first dose of COVID-19 vaccine. During monitoring, the patient experience itching skin. Hives and welts were not located. The injection site was read and hot. No wheezing occurred, no tachycardia observed.  The patient report a history of anaphylactic reactions to food (Sesame), but has never had an anaphylactic reaction to vaccines in the past.  Patient also reports anaphylaxis to lidocaine. The patient was treated with ice pack on injection site, 50 mg diphenhydramine, 10 mg cetirizine, and 20 mg  famotidine. Patient was observed for a full hour. Advised to pre-medicate at 2nd dose and to alert vaccinator of this reaction.
Case number PHEH2014US005907 is an initial spontaneous report received from a nurse on 21 Mar 2014. This report refers to an 11 year old female patient. She inadvertently received only Men C, Y, W-135 liquid component of MENVEO (batch number: A13016) intramuscularly, without reconstitution with Men A lyophilized component on 21 mar 2014. No adverse event reported following this medication error.
Covid19 breakthrough.  1st Vaccine received on 01/05/2021.  90 y/o male with PMHx prostate ca, HTN, HLD, CAD with stents x3, AFib, pacemaker, Parkinson's, dementia presents to ED via EMS with c/o progressive generalized weakness, inability to get out of bed, episode of chest pain and RUQ tenderness.  CXR-no acute changes, afebrile and room air sat 95%.  Pt treated with steroids.
Covid-19 second vaccine  at first I had these symptoms:  Tiredness, muscle pain, feeling unwell, lower back & upper back (where longs are located ) moderate pain. After 11 days I still have mild lower back & upper back pain
Fever, chills, green diarrhea,  loss of taste,  excessive coughing for loss of voice, throat swollen, loss of appetite, sugar lows, coughing fits,  wheezing. Out of work Self quarantined
Onset day of vaccination continuing and worsening until next day. Vomiting, injection site swollen, fever. Patient was recommended fluid intake (electrolytes), BENADRYL.