chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-JAN-2019, the patient was vaccinated with VAQTA 25/0.5 (units not provided), lot # N023953, which expired on 05-NOV-2018 (dose, route and anatomical location were not reported). No adverse event was reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1901USA002741.
pt recvd vax 30SEP93 & on 21OCT93 pt devel a persistent low-grade fever & a cough felt to be secondary to aspiration; during the winter months pt MS deteriorated; MD reported that pt's exp were not complications of the vax;
11/10/2021: Johnson and Johnson vaccine.   ~ 35 minutes alter: Sip of water, hard to swallow water.  Lip began to tingle, throat hard to swallow, water came out, went back to vaccine tent.  Kept there for another 30 minutes  Within 1 hour: Lips began to swell (patient felt), numbness / swelling on lip and tongue,   Took 2 benadryl, could not feel tongue.    Slurry words.  Husband took patient to ER.  Also had chills, diarrhea, stomach pain, fever, felt "head was under water"
Six hours after receiving the influenza vaccination; employee experienced "very bad headache, extreme chills".
Patient presented to pharmacy with red bruised area about 3 in in diameter on her left arm (the injection site). Pt stated the injection site started to swell, turn red and become warm the next day. Two days later she stated the left arm was very sore. No other symptoms were present.
Patient states that on Friday 4/2/2021 she received her first dose of a moderna Covid vaccine at around 1 PM.  She was started having  a hard time swallowing her dinner around 5 pm. She administered her epi-pen and went to the ER. This patient is not 100% sure if it was due to covid vaccine because 4 days later 4/6 she had another anaphylactic reaction similar to the one on 4/2 but states throat felt tight and itchy along with itchiness on her body.
Pt was feeling nervous and felt lightheaded and fainted and was still conscious but wanted to take the ambulance to be safe
Rash on legs; Bruising easily; Fatty liver; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on legs), CONTUSION (Bruising easily) and HEPATIC STEATOSIS (Fatty liver) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 03621A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced RASH (Rash on legs), CONTUSION (Bruising easily) and HEPATIC STEATOSIS (Fatty liver). At the time of the report, RASH (Rash on legs), CONTUSION (Bruising easily) and HEPATIC STEATOSIS (Fatty liver) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.
This case was described by a healthcare professional (nurse who was the also the subject) and described the occurrence of hard lump at injection site in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 4 November 2011, less than one day after vaccination with FLULAVAL, the subject experienced hard lump at injection site ("hard bump" and "arm firm" at injection site) and in November 2011, less than a week after vaccination with FLULAVAL, the subject experienced erythema of arm at injection site, arm swelled at injection site, arm pain at injection site and arm warm at site of injection. At the time of reporting the hard lump at injection site and erythema of arm at injection site were unresolved; the arm swelled at injection site and arm pain at injection site were resolved; and the outcome for arm warm at site of injection was unknown. The subject had received Tetanus in the past, but it was unclear if any reaction occurred. The healthcare professional reported events for herself and two other females with FLULAVAL. See cases A0953257A and A0953274A for details regarding the other two cases.
pt reports getting rashes, eczema all over body, bottom of ankles, front and back, elbows, all over legs, parts of torso, went up legs around 3 months after 1st covid-19 vaccine, extreme itching
I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, symptoms started to gradually surface that progressed throughout the day, such as: - intense pain at the site of the injection that spread to my underarm and left side of ribcage/breast - chills - low grade fever - aching joints - painful skin surface on my whole body - headache - shortness of breath - neuropathy - nausea - loss of appetite - loss of taste - stuffy nose
Approximately a week after the first Moderna COVID-19 shot I experienced severe night sweats.  Woke up drenched in sweat, couldn't get back to sleep (sheets and pajamas were soaked).  Tossed and turned most nights causing severe tiredness during the day.  Nightmares only a few nights, but woke me up out of a dead sleep (highly unusual for me).  Hungry all the time.  Stomach is always feeling empty even when I eat.  As a result, I have gained weight.  Arm was very sore at injection site 24 hours after the shot but that subsided by the following day.
Kinrix given to a 4 month old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 24th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     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: 31-Jan-2023 Reporter's comment: Adverse event contains all reported information. The health care professional gave consent for safety team follow-up. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently administered of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. Patient's age was captured based upon date of birth and vaccination date and further clarification request was already raised by the intake team.
Headache; Chills; Really bad cough and when I cough my ribs hurt; Really bad cough and when I cough my ribs hurt; Feel lousy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ER8730, Expiration Date: not reported) via an unspecified route of administration on 28Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient woke up with headache and chills. The patient had been having the side effects all week (as reported) and the patient had chills real bad which lasted all night but went away. On an unspecified date, the patient had this really bad cough and his/her ribs hurt when the patient coughs. The patient didn't know if that was from the side effects of the vaccine. On an unspecified date, the patient started feeling a little bit better but the cough was really hurting his/her ribs and the patient was also feel lousy. However, the patient's son that doesn't live with him/her and had his son (patient's grandson) at his/her house on the weekend. But when the patient had tried to drop him off they told the patient that they were exposed to Covid and the patient's son and his wife tested positive (as reported). The patient did not know what to do and was asking if he/she should get the test done. The patient is scheduled for the second shot on 19Apr2021. The patient recovered from chills on an unspecified date, an outcome of unknown for headache and an outcome of not recovered for the rest of the events.  No follow-up attempts are needed. No further information is expected.
he immediately stated he did not feel well and was going to faint. chair was lowered. patient given H2O and cool cloth BP dropped to 73/40. he was diaphoretic and pale. with laying flat bp returned to normal he felt better and left
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician at the physician's office for the event. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Developed tinnitus ringing in both ears which I never had.  Then when I got COVID, the virus immediately attacked my left ear with sharp pains in the ear enough to make me bellow out.  The tinnitus is causing me sleep deprivation.  I have scheduled a hearing appointment with an audiologist.  This is no joke.
At approximately 0940 student complained to Observer that he was getting itchy.  Client evaluated possible red fine rash on lower arms, possible very faint areas to stomach and back.  Student alert and oriented in no acute distress.  0945-Pulse 72 color good alert oriented and talking given Benadryl 12ml orally.  0950- Pulse 72 responsive and talking in no distress.  0955- pulse 72 no change in status or progression of symptoms, 1000- pulse 66 no cmplaints no further itching alert and well oriented continued with redish areas on lower arms (student witn very dry skin) nothing noted on back and stomach.  1015 pulse 66 alert oreinted an very talkative 1030 turned over to School nurse to supervise awaiting parent to pick up child.
EMPLOYEE TESTED POSITIVE FOR COVID-19 ON 03/26/21 EMPLOYEE IS CONSIDERED "FULLY VACCINATED. SYMPTOMS INCLUDE: CHILLS, MOD. PRODUCTIVE COUGH,                                 HEADACHE (X 12 DAYS)
heart pounding very hard; it pounds more than it use to and she has a racing feeling; arm hurt; itching; not feeling well; This is a spontaneous report received from a contactable consumer. This 70-Year-old female consumer (patient) reported for herself that:  A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Right arm on 09Aug2021 (around 2 o'clock) (70-years-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included only takes supplements. She is not on heart medicine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had not received prior vaccinations within 4 weeks. On 10Aug2021, heart pounding very hard, it pounds more than it use to and she has a racing feeling. On an unspecified date on 2021, the patient's arm was hurt, itching and not feeling well. Later that night, on 10Aug2021, around 2-3 am she felt her heart pounding very hard. That went away but her heart isn't the same. she reported that it pounds more than it use to and she has a racing feeling. She is due for her second dose of the vaccine on Monday 30AUG and wants to know if she should get the vaccine. She also reported that her arm hurt after the vaccine and a few days later she experienced some itching. The patient reported that if she feels this way when her second vaccine is due, she will probably not get the second dose. At first she do not realize what it was. She had it as bad since then. Her heart had not been the same since that night. It is pounding more than it used to. She is supposed to take the second dose next week. If she felt this same way then she do not want to take it. She was not feeling well. Should she take the next shot feeling this way. The reporter do not have a prescribing doctor. She did report with Vsafe a couple days afterwards did put her heart was slightly pounding after Wednesday (01Sep2021) when really pounding. The pounding was not as hard as it was that one night. She only takes supplements. She is not on heart medicine. Time the vaccination was given (24 hour clock)-around 2 o'clock. The clinical outcome of events heart pounding very hard, it pounds more than it use to and she has a racing feeling were recovering and other events were unknown.
Vaccine (PNEUMOVAX) given on 12-15-2009, patient called 12-17-2009 to report arm soreness on evening of vaccination.  Then next day a swollen area a few inches below injection site.  Then on morning of 12-17-2009 redness, heat, swelling had improved but still present and also a red inflamed area near face.  I referred pt to call her physician.
burning sensation in my leg is not going away; taking Tramadol, but just at night, so he/she could sleep, and during the day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced burning sensation (Verbatim: burning sensation in my leg is not going away) and sleep disorder (Verbatim: taking Tramadol, but just at night, so he/she could sleep, and during the day). The patient was treated with tramadol and gabapentin. The outcome of the burning sensation was not resolved and the outcome of the sleep disorder was not reported.   It was unknown if the reporter considered the burning sensation and sleep disorder to be related to Shingles vaccine.   It was unknown if the company considered the burning sensation and sleep disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-AUG-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated shingles vaccine, after they gave him/her it he/she got a bit better, he/she could walk but the burning sensation in his/her leg was not going away.  The patient had everything done and he/she was taking Tramadol, but just at night, so he/she could sleep, and during the day, two Gabapentin after eating breakfast and another two, two hours before going to sleep.
Hospital Course and Significant Findings: Per Dr. Conceptions HPI 1/17/2023 :The patient is a 75 Y old female with a history of diastolic dysfunction, breast cancer, diabetes, CKD, presenting after being on the ground for prolonged period of time.  She was cleaning the toilet yesterday at 10 AM and could not raise herself from a squatting position.  She then lowered himself to the floor, skidded into the hallway, and laid on the ground with her face down.  Unfortunately, her life alert was charging and her phone was in the bedroom.  Her son went to visit her today at 2:30 PM and found her on the floor, then called 911.  She lives alone.In the ER, patient was noted to have swelling in her face and neck.  I did not see no effect or swallowing.  She was also noted to have bipedal edema.Thus far, labs are notable for a CK of 565, a BNP of 589, minimal transaminitis, leukocytosis of 18,000, and a positive but "dirty" UA.  In addition, her COVID test was positive.She was afebrile with unremarkable vital signs.  Her O2 sat is ranging 95 to 97% on room air. In the emergency department, she was treated with remdesivir, ceftriaxone for the UTI, and Lasix 20 mg IV for hypervolemia. On the inpatient patient did fairly well remained off of oxygen tolerated RDV treatment well stable renal function and LFTs.  I discharged home health was written for Home health company.  Family was notified of patient's diagnosis and discharge.
Tired a lot; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired a lot) and PAIN IN EXTREMITY (Pain in arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired a lot) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, FATIGUE (Tired a lot) outcome was unknown and PAIN IN EXTREMITY (Pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
Pt did not report any adverse events. This first dose of Pfizer was inadvertently administered after the patient had received Janssen on 3/17/21 at the Health Dept.
caller had red blotches to appear; This is a spontaneous report from a contactable consumer (patient). A-81-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration on 18Mar2021 (at the age of-81-year-old) as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Patient experienced about one week out from the vaccine. On an unspecified date, she had red blotches to appear. The blotches only appear for about 5 minutes at a time with each occurrence. The treatment given to event was unknown. The outcome of event was known.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Anxiety. Ocular hyperaemia. Eye discharge. Eye pruritus. Feeling of warmth facial. Nasal congestion. Hoarse voice. Throat tightness. Throat irritation. Headache. This case was extracted from the VAERS database via QSCAN on 24 February 2009 (reference 330621). A 56 year old female patient received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2753AA) on 29 October 2008. Approximately one hour post-vaccination, she reported feeling like there was a golf ball in her throat, and felt anxious. Four and one-half hours later she developed red, glassy, and filmy eyes, facial burning, a sore and scratchy throat, nasal stuffiness, and a hoarse voice. At that time she took ibuprofen and TYLENOL, and reported to the employee health clinic where she was given CLARITIN and FLONASE. By 10 hours post-vaccination she continued to have scratchy eyes, a headache, stuffy nose, and yellow drainage from the eyes. All events subsequently recovered. Of note, the patient reported that "six years ago had MMR, and got Mumps/Measles".
At about 1458 patient received first dose of Moderna COVID-19 vaccine Lot number 031L20A expire 07/22/2021 in Left Deltoid by RN at vaccine site. Pt was instructed to wait 15 minutes in personal vehicle in designated parking area for monitoring. At 1508 patient whom was sitting the passenger seat of personal vehicle c/o SOB, and chest tightness to LPN who was monitoring the parking lot. Nursing Supervisor was dispatched over to the patients vehicle. On assessment patient stated she had a "loss of senses, SOB, chest tightness and cold chills". Pt confirmed she has no allergies and never had any reactions to medications or vaccinations. When asked pt to elaborate on s/s pt explained tunnel vision and sweating and "throat itchiness". Pt was breathing slightly labored 12 respirations a minute pulse rapid and bounding pt pale and diaphoretic and cool to touch. 1510 called made to 911. 1510 bp 60/30 Diphenhydramine and Epinephrine drew up into syringe for precaution. While RN rechecked bp to confirm. Recheck was confirmed 60/30. At 1513 pt states "I think I am feeling better, my senses are starting to come back and breathing feels better" Pt reports she passed out once giving blood. EMS arrived at 1515. At 1515 recheck b/p was 80/40. It was determined that pt did not require Diphenhydramine and Epinephrine due to pt quickly feeling better and s/s improving pt was determined to have a vasovagal response. At 1520 b/p 106/62 normal respirations at 14 a minute. EMS left at 1522 gave pt a cold paper cloth and water to drink. Dr. was called at 1525 where he was made known of the situation. His instructions where to advise pt to get second dose of Moderna in a hospital setting for close monitoring and advise that pt do not drive home. Pt made aware of instructions from MD. Pt was not driving. At 1552 patient feeling better and requests to leave. Pt reported she has no feeling of SOB or tightness. Pt not as pale as she was at begging of the event.
This spontaneous report as received from a nurse refers to a 9 months 6 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Nausea & vomiting 3OCT91, aching from head to feet, itching between legs & buttocks; t98.6 oral on 4OCT91; no swelling or local reaction noted around inject site;
Pt recvd vax & exp itching beginning 3-4 days post vax;
She had orthostatic hypotension and dizziness 2-3 hours post vaccination with blood pressure on standing of 70 systolic. She was observed in the hospital overnight
Anxiety, crying, nausea. Watched 30 minutes. Comforted, provided juice and granola bar. No symptoms after 15 minutes. checked back in with her after 4 hours and no other side effects.
She has had chronic muscle and joint pains.  Initially it started with swelling in her knees. She has tried multiple medications and is seeing a chiropractor, had accupuncture and is seeing a rheumatologist.
Exactly one week after getting 3rd dose of COVD-19 vaccine: generalized, wide spread hives that grew in size throughout entire body (including:  face, buttocks, legs, arms, wait, torso, breasts, wrists, ears). These were red, and itchy.......some relief provided w/10mg Zyrtec, some hives went down in size & minimized itchy, but did not completely stop
notice that my upper arm was red Saturday 4/10/21. On Monday 4/12 it seemed to have covered more of my upper arm and is warm to the touch. Looks like a sunburn.  Also, feels like slight itch.