chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 13Feb2023 to 16Feb2023, the patient received Paxlovid as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a licensed vocational nurse and refers to 4 unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of an improperly stored ZOSTAVAX, lot number L011537, expiration date 30-JUL-2016, (dose and route were not reported). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports from the same reporter link. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 31-JUL-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Day following vaccine 6 am -> 8 am complete amnesia and confusion without other neur symptoms. Dx: Transient global amnesia.
After 5 minutes client became pale and fainted. 911 called. and responded. Client awake and oriented to time and space. Alert and responsive. B/P96/50. P-64 on O2 via mask. Refused to go to emergency room
likely exposure was by fellow passenger on airplane who was sneezing repeatedly on nine-hour flight... two days after the flight (6-7-22),  i had achiness/fever/fatigue and tested positive by home test... i drank large amounts of water, rested, and took full course of paxlovid beginning on 6/7/22... my fever was over by 6/9/22, but my achiness/fatigue persisted until about 6/14/22, gradually diminishing over that time... i also had subtle changes in my sense of taste but am unsure whether those were due to covid or to paxlovil, i found paxlovid to quite vile tasting especially initially but that also diminished over the week of June 7 to June 14
Patient walked to her seat in the observation ear and sat down. Within 1 minute she jerked back and fell to her right side hitting her head and face on the glasses display and landing sprawled out on the floor. She had her eyes wide open. She was not aware she fainted and was completely conscious. Her blood pressure was 123/70. 911 was immediately called. The EMTs took her to the ambulance due to low heart rate when they arrived. She ended up leaving on her own accord
This spontaneous case reported by a consumer, describes the occurrence of rash (around her abdomen), pyrexia (fever) and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. August 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. August 2021, patient experienced rash (around her abdomen), pyrexia (fever) and fatigue. At the time of the report, rash (around her abdomen), pyrexia (fever) and fatigue outcome: unknown. Patient given antihistamines. No concomitant medications provided.
Pt. noted 3" welt and itching at site of IPV injection. Pt. aware of welt about 36 hrs after IPV injection. Similar to reaction after allergy shot in past. By 48 hrs. welt and itching decreasing.
Information has been received from a physician concerning a 12 month old male who on 8/31/00 was vaccinated SC with the 1st dose of MMRII (lot 63593/0978K). On 9/7/00, the pt developed a "low grade fever". On 9/8/00, the pt's fever was 102F and he experienced a seizure. Later that same day, he was seen be a physician. On 9/9/00, the pt experienced 4 additional seizures and was taken to the ER. Upon internal review, seizure was considered to be an "Important Medical Event". The pt recovered from the event as of 9/11/00. No further information is available.
Twelve days after injection, patient noticed a round, reddish swollen rash on left arm near injection site. Mild itching. Swelling began to go down after 2-3 days with patient taking OTC Zyrtec tablets.
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient received the vaccine and fainted 3-5 minutes later. Patient was standing when he fainted and upon fainting fell down backwards and hit his head on the floor. Paramedics/911 was called immediately. Patient was unresponsive for about 5-10 seconds. Upon waking up, patient seemed dazed at first, but quickly realized where he was and was responsive to questions. Paramedics took patient's blood pressure - it was low - and patient was taken to emergency room for further assessment/monitoring.
Mom called office and said the baby had projectile emesis 4 days after her vaccinations. She gave Pedialyte and Zofran with no further emesis. Mother states the baby had a similar episode about 4 days after her 4 month immunizations with similar projectile vomiting and it occurred several times so they took the baby to the local ER where the baby was DX with gastroenteritis and given Zofran and Pedialyte. Mom thinks her reaction is related to the vaccines.
Twelve hours after the second moderna vaccine I had a temperature of 103, severe headache, chills, and body aches.  The fever lasted  18 hours. The  temperature  slowly decreased to 100 by  72 hours.
Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizziness
body aches, and felt feverish about 8-9 hours after vaccine.  symptoms went away throughout the night. next day woke up with a headache that went away throughout the day.
Slept for the rest of the afternoon/deep sleep; Weakness; Was so exhausted; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for the rest of the afternoon/deep sleep), ASTHENIA (Weakness) and FATIGUE (Was so exhausted) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Clostridium difficile infection (Resistant to antibiotics). Concurrent medical conditions included Allergy NOS since 1954, Asthma since 1954, Atrial fibrillation since 2018, Hyperthyroidism since 1984, Psoriasis since 1990, Autoimmune disorder NOS (Autoimmune conditions) and Cirrhosis liver. Concomitant products included LEVOTHYROXINE, MELATONIN, ZINC, COLECALCIFEROL (VIT D3), FLECAINIDE, APIXABAN (ELIQUIS), DILTIAZEM, LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN B+C [ASCORBIC ACID;BIOTIN;CALCIUM CARBONATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE] for an unknown indication.    On 10-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SOMNOLENCE (Slept for the rest of the afternoon/deep sleep) and FATIGUE (Was so exhausted). 10-Mar-2021, the patient experienced ASTHENIA (Weakness). At the time of the report, SOMNOLENCE (Slept for the rest of the afternoon/deep sleep), ASTHENIA (Weakness) and FATIGUE (Was so exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Antibody test: 80 (abnormal) The antibody titer was reported as 80.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.  Patient was wondering if she had a cytokine storm based on her antibody titer results and whether she could take the booster dose.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: The patients medical history was reported. On 20-Aug-2021: Updated patient's demographics, medical history information, concomitant medications and added an event asthenia.
Vaccine administered without issue to pt (behavior & appearance normal, engaged in conversation). Pt agreed to wait 15 min. for observation and left vaccination area for monitoring area. Shortly thereafter, RPh heard what sounded like pt falling. RPh observed pt lying supine on tile floor of monitoring area. RPh assumed occurance of vasovagal syncope and went to aid pt; however, pt seemed to immediately (<1 sec.) regain consciousness, was breathing without difficulty and was able to shift to chair under own power. Tech who had been monitoring remarked pt had opted to stand rather than sit after exiting vaccination area and that she'd "hit her head" upon falling. RPh provided ice pack while pt's mother retrieved water bottle. Pt seemed alert and cognizant of situation (denied pain, was overheard saying to assumed male relative, "You didn't help me."). RPh strongly encouraged pt to wait 30 min. instead of 15 min. but family left after original time; mother remarked pt had vasovagal rxn after an unspecified vaccine in past (RX had not been previously made aware). About 1.5 hours later, RPh called mother to follow-up & advise on signs/symptoms of concussion. At the time, mother said she would monitor pt. Perhaps another half hour later, mother called RX to ask for advice: pt complaint of pain (took Tylenol) and tiredness (despite getting enough sleep the previous night & not usually tired around that time). RPh recommended taking pt to ER as soon as reasonably possible (mother denied any other S/S like uneven pupils, confusion or being difficult to rouse). Mother seemed receptive to that suggestion as well as warning staff of vasovagal syncope for all future vaccinations, though she could not be reached for confirmation of action the next morning.
Unnecessary dose of HEP A administered to client. Client had already completed Hep A series.
This non-serious initial spontaneous case, was received from other health professional (pharmacist) on Sep-2017, concerning a 63-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: less than 0.5 ml (as reported), batch number: 1720701, expiry date: Apr-2018, route of administration: intramuscular and anatomical location: right deltoid). The patient did not receive full dose of vaccine as the vaccine was partially frozen (explicitly considered as underdose and incorrect product storage). The reporter assessed the report as non-serious. Follow-up report received on 02-Nov-2017: The route of administration and anatomical location was added. Reporter stated that, she does know patient returned to get another flu shot. The narrative was amended accordingly.
N17.9 - Acute renal failure (ARF) (CMS/HCC) N17.9 - Acute renal failure, unspecified acute renal failure type (CMS/HCC)
Information has been received from a physician about a 25 year old female patient who was vaccinated with her third dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently the patient experienced a lump at the injection site. The patient sought unspecified medical treatment. Subsequently, the patient recovered from lump at injection site a couple of weeks after the vaccination. Physician does not want to be contacted. No further information is available.
On the day following the administration of the Influenza Vaccine on the left arm, I again noticed significant swelling in the left axilla, coming down to the top of my left breast. Touching of the swollen glands in the area was indicative of swelling in the lymph nodes of the area. Additionally, at the site of the injection there was an elevated, red swelling of approximately 2.5 inches in diameter. This is the second time I have had the influenza vaccine administered. The first time was last year, 2001, in which I had more severe swelling of the inside upper arm, axilla, and full swelling of the left breast.
Approx 24 hrs after my first COVID19 Moderna shot I became overcome with severe dizziness that caused me to vomit without pause. During this time I was so dizzy that I could not walk and could barley move. I was completely disoriented. After approx 90 minutes my husband took me to the ER. There I continued to vomit uncontrollably for hours. In the ER they administered an IV, cat scan, and MRI. Scan and MRI were both normal, everything good. I was admitted to the hospital. Hours later I was diagnosed with BPPV. My BPPV is in the right ear in the posterior canal. During my time in the hospital I received 3 vestibular therapy sessions. After leaving the hospital, I received a fourth vestibular therapy at a PT practice. Hospital doctors have prescribed me Meclizine, methylprednisolone, famotidine, promethazine, and vestibular therapy. I still have serious vertigo and cannot drive and do normal activities. I have no history whatsoever of vertigo or dizziness.
Approximately 30 minutes after the vaccination of MMR and Tdap, the child experienced a left swollen cheek with redness. This quickly resolved, but later had numbness in left cheek.
Day after vaccine arm was sore and muscles achy but it went away next day or two. At day nine after vaccination arm got a bump and was itchy. At day 10, bump, itchy and now a red circle at vaccination site
Tired, fatigue, sleepy, Chills, Fever for 5 days. Took Tylenol and Advil On 25March2021 I started with some blisters on my torso and near my left eye. They were not itching and not oozing. After a few days the skin on the red Blisters  peeled and left a brown spot . As the days went by more blisters showed up and went away. They burn  during the day and itch at night.  On 22May2021 the blisters were on my ear  and all around  my right eye. I visited the. The doctor says it is Blepharitis. And prescribed Bactria DS Antibiotics.  I took the antibiotics for 1.5 days now and do not see any change
Information has been received from a nurse practitioner concerning an otherwise healthy white 28 year old female resident physician with no past medical history and no known drug allergies who on 6/5/02 and 7/5/02 was vaccinated SC with the first (on the right) and second (on the left) doses of varicella virus vaccine live (lot # 639490/0574L). There  was no illness at the time of vaccination. In February 2004, the patient had a negative varicella titer. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 6/3/02 (pre-vaccination), the patient had a VZV blood test that showed she was non-immune. The patient was then given two doses of varicella virus vaccine live 30 days apart. On 2/24/04 (post-vaccination), the patient had a VZV blood test that was negative (presumed non-immune to varicella zoster virus). No further information is expected.
Pt developed redness, heat  and then rash  within a couple hours of vaccine.  Rash slowly spreading down arm. Managing with Benadryl and observing. will follow -up with PCP.
diabetic; Comarinty 1st dose- fibromyalgia; Polymyalgia; heart problems; high blood pressure; had issues with her appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "pericarditis", start date: Jan2021 (unspecified if ongoing); "migraine", start date: Jan2021 (ongoing), notes: She is taking everything and still having migraines and polymyalgia.; "polymyalgia", start date: Jan2021 (ongoing), notes: She is taking everything and still having migraines and polymyalgia.; "fibromyalgia", start date: Jan2021 (unspecified if ongoing); "stomach issues", start date: Jan2021 (unspecified if ongoing); "Covid", start date: Jan2021 (unspecified if ongoing), notes: She added in January she had Covid. The patient's concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic"; FIBROMYALGIA (non-serious), outcome "unknown", described as "Comarinty 1st dose- fibromyalgia"; MYALGIA (non-serious), outcome "unknown", described as "Polymyalgia"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; APPETITE DISORDER (non-serious), outcome "unknown", described as "had issues with her appetite". Clinical course: The patient wants to know if there was any other way to help the situation. She was on oxycodone three times a day, on delta 8 gummies. She stated she had spoken to her health care provider and they don't know what to do. She had tried Prednisone and it did nothing. She added, she had diabetes and her sugar was below 50 the whole night, the whole night she was in the red and was even on a steroid.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event diabetes mellitus and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I noticed many days after getting the first shot a kind of sick all over feeling, loose stools and cramping lower GI, nausea gassiness, a lot of phlegm in throat, headache, and some chest pain, each evening just after dark and into bedtime. The last day I had it was yesterday and it was all day. My doctor asked me to report this to you. By the way I have the date wrong my vaccine was 02/19/2021 but the form won't let me go back to fix it. Symptoms came up suddenly 7 days later.
10 days after the vaccine I broke out in hives on my elbows, knees, and legs. I have had horrible hives that are not allowing me to live my life without taking Benadryl around the clock for 6 days so far. I developed a bright red circle on my left arm where I got the vaccine on 6th day of rash. I went to the dermatologist and there was no treatment.  The hives come and go every few hours.
Approx. 4 hrs after vaccine placed, MOC noticed "knot" in right leg, several hours later, area was red and tender. No fever was noted. Symptoms have now resolved fully.
Tinnitus,  mostly in left ear, on-going since the second shot and continued with the booster.  Mild, most of the time - but annoying.
11 minutes after first dose of Covid Pfizer vaccine, patient became unresponsive, pale, diaphoretic with possible seizure activity. Patient dropped all belongings, leaned to the left side, with eyes rolling back in her head.  Episode lasted about a minute. Patient could not remember what had happened. Vitals were BP 110/60, HR 64, RR 22. Patient was advised to go to ED for further evaluation but she refused. Patient was given a snack and an RN stayed with her for about 20 more minutes to monitor.
This case was reported by a physician via a sales representative and described the occurrence of passing out in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date in 2011 (believed to be in the last couple of weeks) the subject received unspecified dose of CERVARIX. Within 10 minutes of receiving the CERVARIX vaccination, the subject indicated that she did not feel well and then passed out, slumped to the floor and hit her head. The subject was kept in the office and observed for almost an hour because she kept saying she did not feel well. The overall outcome was not known. No additional details were reported.
Pain in left shoulder, difficulty sleeping, onset 10/06/2015 evening. On 10/08/2015 patient was in clinic for administration of son's flu shot, and relays clinic nurse said her flu shot had been administered high. On 10/12/2015 patient spoke with PHN re: left shoulder pain, no swelling or redness, was advised to come back if experiences tingling. Last night 10/13/15 patient states numbness & tingling started, down left arm to hand/fingers. This morning 10/14/15 patient saw another PHN- ice was applied for swelling of left shoulder; advised to see doctor. Patient saw doctor today (10/14/15) afternoon, was prescribed Flexeril, Neurontin, Tylenol-Codeine. To return to doctor Monday, 10/19/15 if no improvement. Note: I have it documented that patient's flu shot was administered in Right Deltoid on 10/06/2015.
Sore arm for a couple of days, fatigue for a couple of days, low grade fever ongoing  (under 100) and this is day 8. Fever was 99.4 yesterday and 99.2 when taken today. Still a bit more tired than normal as well.
MODERNA COVID VACCINE #3 GIVEN 10/27/21, LOT #076C21A; pt passed away at home; COD:  Adult Failure to Thrive, Atherosclerotic cardiovascular disease, HTN, DMT2, Vascular dementia; COVID-19 viral infection; PCP is unknown
received the recall batch of Shingrix that GSK issued on 02/10/2021; received the recall batch of Shingrix that GSK issued on 02/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the recall batch of Shingrix that issued on 10th February 2021. The reporter stated that, the lot number was not 9LH3Y and was not sure if this the lot number from one of the vials. The reporter stated that, the vaccine was administered to the patient before the recall of drug. This case was 1 of 8 linked cases, reported by same reporter for different patients. The reporter consented to follow up via email.
Infant given 2 month immunizations on Friday 11/30/2001. Monday 12/03/2001 infant was found dead in crib. Paramedics called and were unable to resuscitate. Medical examiner called. Autopsy pending. COD as per autopsy report -- SIDS