chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rec'd YF vaccine at 11 AM on 12/15 by RN. Pt stated that she went out for dinner that nite & felt fine. In AM awoke feeling sl. dizzy & muscle aches like flu. Pt. stated she was taking cough med. for bad cough & ABX - but could not name them. Enc. her to call physician.
Healthy 9/19/03 given DTaP, IPV. Strep, pharyngitis. 9/26 Rx'd with Amox. 9/28/03 Reported 107 degrees digital ear thermometer. 9/29/03 Tmax 101 degrees. Happy nontoxic.
Chills; an ache all over feeling; Fatigue; Ache all over feeling, specially in the area where I got the booster shot; Received a booster shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (an ache all over feeling), FATIGUE (Fatigue), VACCINATION SITE PAIN (Ache all over feeling, specially in the area where I got the booster shot) and EXTRA DOSE ADMINISTERED (Received a booster shot) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure.   On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a booster shot). On an unknown date, the patient experienced CHILLS (Chills), MYALGIA (an ache all over feeling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Ache all over feeling, specially in the area where I got the booster shot). On 04-Sep-2021, EXTRA DOSE ADMINISTERED (Received a booster shot) had resolved. At the time of the report, CHILLS (Chills), MYALGIA (an ache all over feeling), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Ache all over feeling, specially in the area where I got the booster shot) outcome was unknown.            No concomitant medications were not provided. No treatment information was provided.
blotchy red macular rash on face, scalp trunk & extremities in association w/cough, coryza, conjunctivitis;
No additional AE reported; A dose of VARIVAX expired on 12/23/2021 and was administered on 2/16/2022; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 16-FEB-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, anatomical location, and route of administration were not reported) (lot # R024144 has been verified to be a valid lot number, expiration date reported as 23-DEC-2021 but upon internal validation established as 23-AUG-2020) for prophylaxis (expired product administered).         No temperature excursions were reported. No additional adverse events were reported.
Patient calls on 10/14/2022 to report Rxn @ 5:30 PM same day as vaccination.   Sudden onset HA 6/10 pain  Congestion  Wheezing (due to cough) Coughing ~2 hrs.  persisted till midnight-1 am declines swelling/rash/itching  took expired Sudafed before bed Some congestion the next day, then  all sxs resolved.
Pt recvd vax 15FEB91; On 25FEB91 exp severe arthralgias; tx w/meds; approx 2 wks later exp severe ankle pain given more meds; MD states poss immune complex deposition disorder or lupus; Petechiae noted & feeling of heat; SEE WORM DETAILED
within roughly 5 minutes of injection Patient experienced strong  sudden feeling of heart palpitations, feeling of cold and numbness in both upper extremities and then entire face and chest feeling hot and flushed. Initial vitals signs taken within 2 minutes were heart rate 146, blood pressure 160/100 and O2 sat 96%. Benadryl 50mg PO given for reaction. Blood pressure and heart rate returned to normal approx 45 minutes after start of reaction. Pt still has complaint of "brain fog"  and just feeling "off, not normal self" since shot/reaction.
8 days after first dose, red and swollen at injection site with slight itching. Swelling is about 2 inches in diameter. This is not debilitating or hindering movement.
This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of M-M-R II, (rHA, lots #s L043703, expiry date 03-NOV-2017; M022407, expiry date 02-MAY-2018 and M029230, expiry date 08-JUN-2018). The vaccine was stored in refrigerator at a temperature of 47°F to 77°F (48 °F) for current excursion, but data not available for prior excursions. The time frame was 45 minutes. No previous temperature excursions were reported. No datalogger reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA012566, 1704USA013566, 1704USA013568 an 1704USA013569). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments:  US-009507513-1704USA012566: US-009507513-1704USA013566: US-009507513-1704USA013568: US-009507513-1704USA013569:
Patient became dizzy/loss coordination and collapsed after completing 15 minute observation period. He was able to stand back up and walk to a chair with assistance from family members. At the immediate time of him sitting down after fall, he was unresponsive when asked his name. Approximately 5 minutes after initiation of episode he began to communicate and regain responsiveness but stated he continued to feel dizzy, sweaty, and had some difficulty breathing. At this time EMS arrived on the scene and took over the care of the patient.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 76-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 24th May 2018 13:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th May 2018, less than an hour after receiving SHINGRIX, the patient experienced chills and vomiting. On an unknown date, the outcome of the chills and vomiting were not recovered/not resolved. The reporter considered the chills and vomiting to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional stated that the patient received SHINGRIX in the afternoon and with in 15 minutes he had chills and vomiting. The health care professional stated that the patient called the retail pharmacy to report this reaction. No medical intervention or other interventions were required. The patient was reported to be at home resting and "sleeping it off." The reported batch number of the SHINGRIX (LT5333) did not exist and, was updated to LT533 as per sales database.
Dose received: 3; Approximately 3 hours after receiving the injection, I experienced paresthesia in my left arm as a tingling feeling in my fingertips and hand, which makes using a keyboard difficult as I cannot feel the keys; This is a spontaneous report from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: FD0809) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine with aura" (unspecified if ongoing); "Acne" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing) and "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Strawberries. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0162; Anatomical location: left arm; Route of administration: unspecified), administration date: 14Apr2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0172; Anatomical location: left arm; Route of administration: unspecified), administration date: 05May2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022, outcome "unknown", described as "Dose received: 3"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "unknown", described as "Approximately 3 hours after receiving the injection, I experienced paresthesia in my left arm as a tingling feeling in my fingertips and hand, which makes using a keyboard difficult as I cannot feel the keys". Therapeutic measures were not taken as a result of paraesthesia.Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.No follow-up attempts are possible. No further information is expected.
Bilateral sensorineural hearing loss; This initial spontaneous report was received from a lawyer on 03-AUG-2020, regarding a case in litigation and refers to a female patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 13-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a decline in hearing and was diagnosed with bilateral sensorineural hearing loss. As a direct and proximate result of vaccination, the patient's symptoms resulted in physical limitations not present prior to the use of the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Patient complaining about soreness in left arm that she received Shingrix in. Having general dul pain, but also having trouble lifting objects over her head and holding objects such as drink glasses with that hand. Patient has been experiencing this since the shot was given 12 days ago. There is no outward sign of bruise or redness.
Sitting after shots, became light headed. Appeared to improve after juice and laying down. After another minute, slumped in chair when she fainted. Roused easily, rested. Vitals normal after 15 minutes.
Hives on face; swelling of the throat; swallowing was difficult; This is a spontaneous report from a non-contactable consumer (patient). An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 18May2021 as dose 2, single for covid-19 immunisation in hospital. Medical history included prior to vaccination, the patient was diagnosed with covid-19, and known allergies: antihistamines. Previously, the patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration in arm left on 26Apr2021 as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. other medications the patient received within 2 weeks of vaccination was Clindimicen. The patient stated that hives on face started 24 hours later (19May2021) after second shot, increased in intensity over 2 days with swelling of the throat. On 19May2021, breathing was somewhat normal, but swallowing was difficult. Went away 4 days after second shot. The events resulted in emergency room/department or urgent care. The patient lab test included covid-19 test was positive. Since the vaccination, the patient was not tested for COVID-19. Events considered as non-serious. No treatment medication was received for the adverse events. The outcome of the events was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a certified medical assistant concerning a 6 month old patient who on 22-SEP-2010 was vaccinated with a first dose of ROTATEQ (Lot# not reported), PO and on 08-FEB-2011 was vaccinated with a second dose of ROTATEQ (Lot# not reported), PO. No adverse effect. Follow up information has been received from a certified medical assistant. It was reported that on 08-FEB-2011 the female patient was vaccinated with a second oral dose of ROTATEQ (Lot number 668358/0917Z). Concomitant vaccinations given the same day included a second dose of PEDIARIX (lot number AC21B256AA) given IM, a second dose of ACTHIB (lot number UH239AB) given IM and a second dose of PREVNAR (lot number 914514) given IM. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (Lot number: FC3184), in left arm and in Oct2021 as dose  2, single (Lot number: FF2589) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: eye drops" (unspecified if ongoing); "Known allergies: BP medication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which include Paxlovid from 16Mar2023 to 20Mar2023.
TDAP & MENACTRA given (L) arm 12-3-10 developed hives 2d. late at injection sites & elbow to shoulder only, mildly itchy (-) fever (-) pain. sx resolved with BENADRYL.
Employee reported inflamed lymp node on the right axilla the following day he had the vaccine and did not disappear for more than a week.  Will seek advise from his primary care provider for further evaluation
Patient reported that approximately one hour after receiving the Flu Mist that her face became very red and flushed. She had no itching, no facial edema, no SOB, no other s/s at all.  She reports that this lasted approximately one hour and then disappeared.  She also reports that she is taking Accutane and wonders if there is some reaction with this medication and Flu Mist.
NOTE: Date of 2nd dose -- 2/10/2021 at 10:50 AM  (1) Around 2014, I developed a hydrocele. Cause is unknown. An ultrasound on the scrotum was performed Sept 2015. No action was required and I resolved to live with it. However, sometime in February 2021, the hydrocele grew substantially to the point where treatment was required. I had a hydrocelectomy on 4/27/2021.  (2) In November 2019, I fell on a concrete sidewalk, landing mainly on my right wrist and elbow. Bruises developed but eventually cleared up. A slight lump  a swollen bursa  soon appeared on my elbow but remained stable and small. However, sometime in February or early March, the bursa expanded dramatically. My primary care physician aspirated the bursa on April 12 and again on April 19. The bursa fully reinflated within a day of each aspiration. On June 10, the bursa was surgically removed.  Summary  Following my Covid vaccinations in January and February, two preexisting conditions  a hydrocele and a swollen bursa  worsened to an extent that surgeries were required  in April and June respectively. Both surgeries were outpatient surgeries.
Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 ml dose of Rotateq (no lot# provided) (dose of series unknown).  Subsequently the patient experienced intussusception.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from intussusception.  There was no product quality complaint.  Upon internal review, intussusception was determined to be an other important medical event.  This is one of two reports from the same source.  Additional information has been requested.  03/31/2008 MR received for DOS 10/3-5/2008 with DX:  Intussusception.  S/P Laparoscopic Appendectomy and reduction of Intussusception. Infant presented with fever, vomiting, abdominal pain and bloody stool.  Abd US (+) for IS and pt transferred to current facility for Tx. Unable to reduce by Barium Enema so taken to OR for surgical reduction. D/C home on POD#2.
A report has been received from a Health Professional concerning a 53 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 18-Nov-2013. It was reported they inadvertently gave FLUMIST QUADRIVALENT to a patient over 49 years of age. The outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a patient over 49 years of age is unknown. The report was considered to be non-serious. Corrected report 20-Jan-2014: Key ingredient and formulation corrected.
Approximately 12 hours after receiving the shot I started feeling chilled, weak and achy. No fever.
Patient reported soreness, numbness and tingling of arm and fingers. No sign of respiratory distress, only slight redness at injection sight, did not improve worsen or improve after several hours, patient call MD to report, MD asked patient to come in.
1 - 2 days after receiving Varicella and QUADRACEL in (L) arm developed red, painful left upper arm which worsened and followed by well shaped cluster of vesicles around 2 cm by 3 cm (remainder of skin clear). Pt. started on acyclovir at visit. I will follow up clinically. Wound culture and viral culture pending.
fever post 2nd Shingrix dose; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but taken as adult as per vaccine indication. The patient received the dose of Shingrix and experienced fever. The patient inquired how long it would last. The information regarding consent to follow up was not reported. No further information was available.
Varicella vaccine, VARIVAX (Oka Merck) given to employee, it is the #2 vaccine needed to complete the 2 shot series.  States, R arm deltoid, outer area, SQ started hurting, 6/19 noted in humeral area, injection site raised, red & swollen around the armpit.
Information has been received from a legal professional concerning her friend, a 46 year old female with kidney infection who on 16-FEB-2011 was vaccinated with a dose of MMR II (therapy route not reported, lot # reported as 08112, which is not valid, albumin status unknown). The patient was being treated concomitantly with BACTRIM for treatment of kidney infection. She had no relevant concomitant medications. On 17-FEB-2011 the patient began having swelling of her tongue. She also had blisters around the perimeter of her tongue and one under her tongue. Her whole tongue is sore and tongue had an appearance of being raw. On 19-FEB-2011 she sought treatment from her doctor and had 400 mg of ADVIL and had an unknown antihistamine of an unknown dose. She had no relevant laboratory tests. As of 19-FEB-2011 at 13:00, it was unknown if she had recovered from the blisters, swelling and pain in her tongue, and it was unknown if she continued to take the BACTRIM. Additional information has been requested.
Raised/itchy rash at the site of the injection. Two days later, the rash flattened out in a wide/red/itchy rash.
red, indurated wheal lt deltoid area approx size of half dollar; pt has pain moves lt arm slowly when requested to do so;pt crying fearful; t98.4 now; mom used cold compresses to area, gave APAP for pain advised to cont same
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Flushed / Sweating-Severe
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about September 2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (lot#, expiration date, dose and route were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an about September 2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster/shingles. The patient continued to suffer ongoing injuries with mental and physical pain and suffering. As a direct and proximate result of the ZOSTAVAX vaccine, 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, and pain and suffering, and other damages. The outcome of the events was unknown. The causality assessment of events was reported to be related.
I got a rash (large spots) only on the arm where shot was administered. It disappeared two weeks after shot was administered.
Patient was suppose to receive Zostavax but received Varivax instead. Patient is doing fine no adverse events reported. Patient contacted and informed of error and advised to return to clinic after 28 days to get the Zostavax vaccine as per recommendation of ACIP.