chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was exhausted; Felt awful for a few days in a row; She threw up in the middle of the night; She got a killer headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 60 years for COVID-19 immunisation. The patient's relevant medical history included: "GERD" (ongoing); "Had gall bladder removed" (unspecified if ongoing). Concomitant medication included: ESOMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "She was exhausted"; MALAISE (non-serious), outcome "unknown", described as "Felt awful for a few days in a row"; VOMITING (non-serious), outcome "unknown", described as "She threw up in the middle of the night"; HEADACHE (non-serious), outcome "recovered", described as "She got a killer headache". Therapeutic measures were taken as a result of headache. Additional information: The patient reported that for her reactions with her prior COVID shots, states one time she threw up in the middle of the night and the first two laid her low like she was exhausted and felt awful for a few days in a row and another one she got a killer headache with that Tylenol could not get rid of and had that a day or two and then after the immunization, she would feel better the next day after 2-3 days of misery, she would wake up feeling perfectly normal the next day. She and her friends would say that the previous symptoms they all had for throwing up and feeling and bad headaches and all that was just due to the immunization as was widely reported with a lot of people. She states she does not know which dose of her COVID vaccines the headache and throwing up were associated with. For the other patients or friends she spoke with that had symptoms after having the COVID vaccinations, she has no patient specific information to provide, no names or manufacturers of their vaccines, no lots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311396 same patient and vaccine; different dose and event;US-PFIZER INC-202300311393 same patient, vaccine, and event; different dose;US-PFIZER INC-202300311394 same patient and vaccine; different dose and event;US-PFIZER INC-202300310950 same patient and vaccine; different dose and event;US-PFIZER INC-202300311395 same patient and vaccine; different dose and event;
Patient reported a tingling sensation going down left arm and leg. VS were taken and patient was told to practice deep breathing and drink water. Resolved after 30 minutes
Pt was given Bexsero in right upper arm around 3:30 pm while sitting upright on exam table.  Within 5 minutes he fell to the right and laid sideways on the exam table.  He had LOC for 30 sec, pale, green in color and diaphoretic.  He was able to sit up and sip water and cool cloth to forehead.  Oreinted x 3 within 2 mintes after vaccine.  Alert and and no distress the rest of the time in office.
Chills, low grade fever, slight nausea, headache, body aches, fatigue.  Fatigue lasted approximately 1 week; other side effects about 3 days.  2 days after injection, had a 3 by 6 inch red raised itchy welt appear about 2 inches from injection site.  Gradually faded over a one week period.  I had an allergy injection 2 weeks prior to Covid vaccine.  Contacted allergy doctor and we agreed to postpone next allergy injection until after second Moderna vaccine, in case there was a connection.
Information has been received from a pharmacist concerning a female patient who was vaccinated with a dose of Gardasil. Subsequently, the patient experienced grand mal seizures sometime after receiving the vaccine. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Grand mal seizures were considered to be an other important medical event. Additional information has been requested.
Initial report received from a health care professional in the USA in 17 May 2007. A 4 year old male patient (with a history of no known allergies, possible heart murmur and tick bites) developed "ticks and high fever" 9 days after he received IPOL (lot number Y0576-2) subcutaneously in the left deltoid on 03 May 2007. The patient had no illness at the time of vaccination and was on Xantac. As the time of the report, the patient had not recovered. It was reported the family was going to follow up with a pediatric neurologist.
Pt reported 6 wks ago flu shot received. Guillian-Barre syndrome developed. 12/12-weakness developed. Admitted 12/13/08 to hosp for weakness, dysphasia, dizzy, disoriented.  12/31/08 Reviewed hospital medical records of 12/13-12/18/2008. FINAL DX: no d/c summary available.  Neuro consult states likely GBS. Records reveal patient experienced flu like syndrom approx 1 week after the flu shot.  Lives out of country & was visiting.  Nine days prior to admission fell while rollerblading & injured shoulder tx w/NSAIDS.  Three days prior to admission developed weakness of LEs & paresthesias of hands.  Weakness progressed to UEs, difficulty swallowing, difficulty walking, speech impairment.  Admitted to ICU Neuro consult done.  Areflexic on exam.  LP done.  Tx w/IVIG, improved & d/c to home.
Patient got his first dose 1/28/2021 and was to return for his 2nd dose 2/14/21-2/18/2021. He came to the clinic on 2/8/2021 and said he had an appt for his 2nd shot. Our computer where down, our appt package was down and our phone systems was also down and there was no way to verify his last vaccine.
9/11/21 PMH Quadriplegia due GSW, chronic foley, DVT, headaches admitted for worsening headaches associated with nausea and vomiting
Rt buttock-4.5cm urticarial type response @ inj site, +pruitis per pt; rx-cold compresses to site q2-3hrs x 20min-Hydramine 1-1 1/2 tsp q6hrs PRN redness, swelling, itching;
Had shot around 1045 AM. Around 200 PM started having pain down left arm. Continued to worsen to point I could not even touch or move my left arm without horrific pain. There was some swelling at injection site, but minimal at most.
This spontaneous report as received from a pharmacist refers to a 64 year old male patient. The patient had no drug allergies or reactions. On 28-FEB-2014 the patient was vaccinated with ZOSTAVA lot # J011333, Expiry date: 13-DEC-2014 in the right deltoid region. Concomitant therapies included inhaled corticosteroids (unspecified). On 03-MAR-2014, (reported as on Monday) the patient developed redness and warmth at his injection site. The patient sought medical attention by consulting the pharmacist. The pharmacist reported that his injection site was not raised and there was no evidence of a vesicular rash. No treatment as rendered for the event. The patient was recovering from the event. The patient did not notify his physician. Additional information has been requested.
arm was itching; Injection site rash; tender at the injection site; Sore at injection site; minor pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore at injection site), PRURITUS (arm was itching), INJECTION SITE RASH (Injection site rash), PAIN (minor pain) and VACCINATION SITE PAIN (tender at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Indocin).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore at injection site) and PAIN (minor pain). On 19-Feb-2021, the patient experienced PRURITUS (arm was itching), INJECTION SITE RASH (Injection site rash) and VACCINATION SITE PAIN (tender at the injection site). At the time of the report, INJECTION SITE PAIN (Sore at injection site), PRURITUS (arm was itching), INJECTION SITE RASH (Injection site rash), PAIN (minor pain) and VACCINATION SITE PAIN (tender at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included hydrocortisone.    This case was linked to MOD-2021-021818 (Patient Link).
pt recv vax 29APR99 & reported joint pain in both knees & hands on 12MAY99;Ecotrin bid;
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation and may schedule in future.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2017, the patient was treated at physician office for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles with complications. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Was inadvertently administered a dose of GARDASIL 9 on an unspecified date, that had been improperly stored; No adverse effect reported; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On an unknown date, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # 1586751 and expiration date of 16-FEB-2021 (strength, dose and anatomical route of vaccination were not provided) for prophylaxis, that had been improperly stored. No adverse effects were reported.   Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), was exposed to a temperature excursion of 65.3 °F for a 4 hours time frame. The vaccines was no involved in any previous temperature excursion. Call was made due to a data logger.
Patient received vaccine and proceeded to the post vaccination waiting area, patient experienced a syncope episode within 5 minutes of vaccination. Patient was back to being completely alert within 5 minutes and did not want to seek emergency treatment.  Patient left on his own power.
Head to toe Hives and itching.  She was treated in the ED on 10/8/2021 at 1600.
Extreme unilateral migraine (have never had migraines previously), nausea, weakness, faintness, diaphoresis, loss of equilibrium, fatigue. These symptoms came on suddenly and lasted until I fell asleep after two hours. Symptoms remained when awoke next day, but were much less intense. Had a period of one hour the next day where right arm and hand went numb. This resolved after one hour. Had BP checked and was equal in both arms and normal. No neurological symptoms. Nausea removed for two more days. Otherwise, all other symptoms resolved after one day.
Post meningococcal and MMR vaccines, pt verbalized dizziness and nausea, then proceeded to vomit twice. Observed pt looking pale and diaphoretic. VS initiated, legs elevated on chair, ice packs, water, and lollipop provided. Pt was reassessed after 10 minutes, pt still appeared pale and diaphoretic, pt was carefully moved to the sofa with another RN. RN Observed VS and color normalized after lying down.  Pt was moved to observation for continue monitoring.  At 2:50pm, Pt verbalized symptoms fully resolved, pt left observation in stable conditions with parent. Education and teaching provided to pt and parent.
A couple hours after receiving the vaccine, patient's whole right arm swelled up, especially the elbow region below the injection site. The arm was also sore and itchy. It lasted a total of 3 days, but the swelling went down significantly after 2 days.
For last three weeks (since second dose), Extreme fatigue, muscle, joint and all over body aches, nausea, vomiting
Syncope; Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Autonomic Dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date,  the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, postural orthostatic tachycardia syndrome (POTS), fatigue, dizziness, headache, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007522: US-009507513-2301USA007524: US-009507513-2301USA007498:
WHEN CHILD WOKE UP THIS MORNING, HE HAD A RED, RAISED PATCH AROUND INJECTION SITE THAT WAS ITCHY.
My armpit got swollen after the vaccine in the same arm and is still really sore and swollen.
Autism, developmental delay beginning after the vaccine. Follow-up dated 9/6/00 provided no additional data. 60 day follow up dated 10/30/00 provided no additional data. The annual follow-up states autism; developmental delay. A follow up report received 8/3/2000 adds: Spoke to mother of pt. Child displayed unusual behavior - unresponsive, started talking at one year, then stopped 4/95, does not play. Mother said that later vaccines may have contributed to problem - now in therapy.
This case was reported by a physician via other and described the occurrence of injection site discoloration in an unspecified number of patients who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, unknown after receiving INFANRIX, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was unknown. It was unknown if the reporter considered the injection site discoloration to be related to INFANRIX. Additional details were provided as follows: This case was received from the physician via the vaccine patient assistance program. The age at vaccination was not reported. It was reported that, more than one patient experienced tiny little black dots near the administration area after receiving INFANRIX vaccine.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old patient who received expired dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ. On 22-Feb-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5148AA via unknown route. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Contracted COVID July 4, 2022.  Approximately 2 weeks after the initial onset I began experiencing vision difficulties (including blurred vision and double vision).  Since the onset of COVID, I had dizziness and lightheadedness.  Both of these are still occurring.  After visiting with my primary care physician on August 30, 2022, for my symptoms, I was referred to my cardiologist as I was having a drop in my blood pressure when going from laying, sitting, and standing.  I visited my cardiologist on Sept 13, 2022, and at that time was told I had developed orthostatic hypotension possibly from having COVID.  My primary care physician also referred me back to my Ophthalmologist who I had last seen in May 2022 with no vision changes.  When I returned to the Ophthalmologist I was informed that my vision had changed possibly due to having COVID and my cornea having swelled.  Not sure if the things I am experiencing now is a result of the vaccine or due to having COVID.
2/27/21 hpi86 y.o. male with a past medical history notable for  Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline.  Hospital Course:    patient was admitted to the hospital for worsening dehydration and  finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment.  3/20/21 readmission acute renal failure
syncopal event 5 hrs later. Then hives next day. had second dose 6 weeks later and a second syncopal event again 5 hrs after the vaccine. Hypotensive on home BP meter
This spontaneous report as received from a physician (patient's daughter) refers to a 66 year old (also reported as 67 y.o.) male patient with no known drug allergies. It was stated the patient had no chicken pox history. On approximately 13-OCT-2014 (reported ad "about a week ago"), the patient was vaccinated at the pharmacy with a dose of ZOSTAVAX injection administered subcutaneously, once at dose 0.65 ml (strength, indication, lot# and expiry date unspecified). The consumer received unspecified flu vaccine (manufacturer unknown) at same time (approximately 13-OCT-2014) as dose of ZOSTAVAX (dosage unspecified). After vaccination, the patient initially experienced flu like symptoms, was dizzy with a fever, but the events resolved on their own and patient was doing better in October 2014 (exact dates unknown). Physician stated the patient noticed a vesicle like rash and was experiencing rib pain on 20-OCT-2014 (reported as "today"). The outcome of rib pain and vesicle like rash was reported as not recovered. No laboratory tests were performed. The relatedness between the events and ZOSTAVAX or influenza virus vaccine (manufacturer unknown) was not reported. The reporter inquired if anti-virals were standard of care when rash appears. Physician stated that an unspecified pharmacist from pharmacy might have reported this case as that was where vaccination occurred. The physician was advised of VZVIP and physician deferred program to pharmacist. Additional information has been requested.
Severe pain in shoulder and down arm. Could not lift arm pass heart level.  Burning pain in muscle in bone. Today is 5/7/11, Im able to lift my arm but it is still painful. The injection was tetanus with pertussis.
Patient was administered an expired, 10 May 21, Flublok instead of an unexpired Fluzone at 1548. The patient was administered a COVID-19 Pfizer vaccine at the same visit. He was monitored for 15 minutes before being allowed to leave the clinic at 1602. The patient showed no signs of an adverse reaction to the vaccine when he left the clinic. Once I was aware of the medication error, I informed my clinic manager and physician of the medication error. I contacted the patient's mother @ 1757 and informed her of the medication error.
USE OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. 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 use of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of use of expired vaccine was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and PAIN IN EXTREMITY (Sore arm/Arm pain) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI FE 1.5/30) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/Arm pain). On an unknown date, the patient experienced PRURITUS (Itchiness). On 28-Mar-2021, PAIN IN EXTREMITY (Sore arm/Arm pain) had resolved. At the time of the report, PRURITUS (Itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.   This case was linked to MOD-2021-102349 (Patient Link).
Information has been received from a 23 year old female with no medical history or drug allergy who on 01-May-2009 was vaccinated with the first dose of GARDASIL and found out later she was pregnant. Concomitant therapy included Flagyl. The patient stated that her original visit to the practice was because she thought she was pregnant, however after a urine test the office stated she wasn't and administered the vaccine. The patient reported after getting the vaccine she started experiencing some abdominal pain and went for testing again and found out she was pregnant. The patient had "blood work" performed. At the time of the report the patient was recovered. No further information is available.
(L) upper arm pain x 4 months since receiving the vaccine. No swelling nor rash, in 1st visit; gave prednisone 10 mg dispensed x 5 days.